Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Disclosure Controls and Procedures.
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
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The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of December 31, 2023. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2023, our disclosure controls and procedures were not effective due to the material weakness in internal control over financial reporting described below.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Exchange Act Rules 13a-15(f) and 15d-15(f) define this as a process designed by, or under the supervision of, our Chief Executive Officer and our Chief Financial Officer and effected by the Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. GAAP.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Furthermore, projections of any evaluation of the effectiveness of internal controls to future periods may prove invalid due to changes in our circumstances and the risk that compliance with policies, procedures and controls is not sustained.
Management has assessed the effectiveness of internal control over financial reporting as of December 31, 2023, based on the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on this assessment, our management has concluded that our internal control over financial reporting as of December 31, 2023 was not effective due to the material weakness in internal control over financial reporting described below.
Material Weakness and Remediation Plan
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. In connection with the audit of our financial statements for the year ended December 31, 2023, our management identified a material weakness that resulted from our misinterpretation and application of ASC Topic 740, Income Taxes, in relation to our UK small medium enterprise tax credits, which we historically presented in income tax benefit (expense) rather than as a reduction to research and development expense. The material weakness in our internal control resulted in the restatement of our consolidated financial statements as of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021 included in this report.
Management is in the process of designing and implementing a remediation plan intended to address the control deficiency that resulted in the material weakness described above. These remediation efforts are underway and include enhancing the training provided to the individuals operating the income taxation controls. Management will report regularly to the Audit Committee regarding the status of the implementation activities.
Changes in Internal Control Over Financial Reporting
Except as described above, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the fourth quarter of our fiscal year ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Attestation Report of the Registered Public Accounting Firm.
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption for “non-accelerated filers.”
Item 9B. Other Information
Insider Trading Arrangements
During the three months ended December 31, 2023, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
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Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The following table sets forth information regarding members of our senior management and our directors, including their ages as of March 21, 2024. There are no family relationships among any of our senior management or our directors.
NAME AGE POSITION(S)
Senior Management:
Christian Itin, Ph.D. 59 Chief Executive Officer and Director
Robert Dolski 54 Senior Vice President, Chief Financial Officer
Edgar Braendle, M.D.* 64 Senior Vice President, Chief Development Officer
David Brochu 68 Senior Vice President, Chief Technical Officer
Martin Pulé, MBBS 51 Senior Vice President, Founder, Chief Scientific Officer
Brent Rice 57 Senior Vice President, Chief Commercial Officer
Alexander Swan 59 Senior Vice President, Chief Human Resources Officer
Christopher Vann 59 Senior Vice President, Chief Operating Officer
Christopher Williams, Ph.D. 44 Senior Vice President, Chief Business Development Officer
Non-Executive Directors:
John Johnson 66 Chairman of the Board of Directors
Joseph Anderson, Ph.D. 64 Director
Robert Azelby 56 Director
Linda Bain 53 Director
John Berriman 75 Director
Cynthia Butitta 69 Director
Robert Iannone, M.D., M.S.C.E. 57 Director
Elisabeth Leiderman, M.D. 47 Director
Martin Murphy, Ph.D. 55 Director
William Young, Ph.D. 79 Director
*On March 14, 2024, we announced Dr. Edgar Braendle had tendered his resignation.
Senior Management
Christian Itin, Ph.D. has served as our Chief Executive Officer since 2016 and as a director since 2014. He served as Chairman of our board of directors from 2014 to September 2021. Prior to joining us, Dr. Itin served as chief executive officer and chairman of the board of directors at Cytos Biotechnology Ltd, a biotechnology company, from 2012 until it merged with Kuros Biosurgery Holding Ltd in 2016. From 2016 until 2018, he served as chairman, and from 2018 to 2019 as non-executive director, of Kuros Biosciences Ltd. Dr. Itin served as president, chief executive officer and director of Micromet, Inc., a biopharmaceutical company, from 2006 until it was acquired by Amgen Inc. in 2012. From 1999 until 2006, he served in a number of capacities with Micromet, Inc.’s subsidiary, Micromet AG, including head of IP and licensing, vice president of business and corporate development, chief business officer and ultimately as its chief executive officer. Before joining Micromet, Dr. Itin was a co-founder of Zyomyx, a protein chip company. Dr. Itin also served as a non-executive director of Kymab Ltd., a privately held biopharmaceutical company, from 2012 until its sale to Sanofi in 2021. Dr. Itin received a Diploma in Biology and a Ph.D. in Cell Biology summa cum laude from the University of Basel, Switzerland. In addition, he performed post-doctoral research at the Biocenter of University of Basel and at the Stanford University School of Medicine. We believe that Dr. Itin is qualified to serve on our board of directors because of his deep knowledge of our company and his extensive experience serving in executive and non-executive leadership positions at other public and private biotechnology companies.
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Robert Dolski has served as our Chief Financial Officer since August 2023. He previously served as Chief Financial Officer at Checkmate Pharmaceuticals from January 2021, until its acquisition by Regeneron Pharmaceuticals in May 2022, where he was responsible for investor relations, financial strategy and management. He served as Vice President, Finance at Akcea Therapeutics from May 2019, until its acquisition by Ionis Pharmaceuticals in October 2020, where he held similar finance responsibilities and supported the development and commercialization of several rare disease programs. Mr. Dolski served as Vice President, Head of Financial Planning and Analysis at Moderna Therapeutics from 2016 to May 2019, as Senior Director, Finance at Forum Pharmaceuticals, Inc., and as Vice President, Finance and Treasury at Human Genome Sciences, Inc., prior to its acquisition by GlaxoSmithKline. Mr. Dolski started his career as Director of Finance at Amgen Inc. He holds an MBA from The Wharton School of the University of Pennsylvania and a B.S..degree in civil engineering and strategic management from the University of Pennsylvania.
Edgar Braendle, M.D., has served as our Chief Development Officer since July 2021. Prior to joining us, he served as Chief Medical Officer and Global Head of Development at Sumitomo Dainippon Pharma Oncology (“SDPO”) from July 2020 to July 2021, where he was responsible for leading the global oncology development programs. Prior to then, from October 2017 until July 2020, Dr. Braendle served as Executive Vice President, Head of Research and Development and Chief Medical Officer at Boston Biomedical Inc., where he led their discovery research and clinical strategies. He started his industry career at Schering AG. Dr. Braendle has a M.D and training in hematologic malignancies and solid tumor oncology, pharmacology and urology at the University of Aachen, University of Bonn, and the University of Ulm in Germany.
David Brochu has served as our Senior Vice President, Chief Technical Officer since January 2021, having previously served as our Senior Vice President, Head of Product Delivery from October 2019 to January 2021 and as our Vice President of Technical Operations from March 2019 to October 2019. Mr. Brochu previously served as vice president of technical operations and program head at Kedrion USA, leading its next generation IVIG development and industrialization effort. Prior to this, he was the vice president of plasma collection operations for Talecris Biotherapeutics (formerly Bayer HealthCare LLC), where he led the operations buildout in the Western United States. He previously held engineering and technical operations leadership roles at Bayer and Warner Lambert in the United States, EU and South America. Mr. Brochu has over 30 years of operational and development experience. He holds a B.S. degree in chemical engineering from Northeastern University.
Martin Pulé, MBBS founded our predecessor company and has served as our Senior Vice President and Chief Scientific Officer since 2014. He also served as a member of our predecessor company’s board of directors from 2014 to 2018. Dr. Pulé has served as a clinical senior lecturer in the Department of Hematology at UCL Cancer Institute since 2010 and as an Honorary Consultant in Hematology at UCL Hospital since 2010. He entered the T cell engineering field in 2001 as a travelling Fulbright Scholar at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston, Texas. Dr. Pulé holds an M.B.B.S. degree from University College Dublin and is a Fellow of the Royal College of Pathologists.
Brent Rice has served as our Senior Vice President, Chief Commercial Officer since December 2021, having previously served as our Vice President, Chief Commercial Officer (US) from June 2020 to December 2021 and as our Vice President, Global Market Access from October 2018 to June 2020. Previously, Mr. Rice served as the Head of Managed Markets for Juno Therapeutics from 2017 to 2018, where he was responsible for building its payer, access and reimbursement strategy and capability. Prior to joining Juno Therapeutics, Mr. Rice served with Amgen Inc. from 1999 to 2017 in positions of escalating responsibility, where he supported Amgen’s portfolio of products through partnerships and life cycle management. Mr. Rice holds a B.A. degree in Russian Studies from the University of California at Los Angeles and an M.B.A. from the University of Denver.
Alexander Swan has served as our Chief Human Resources Officer since January 2023, having previously served as our Senior Vice President, Human Resources from October 2021 to January 2023 and as our Vice President, Human Resources from May 2018 to October 2021. Prior to joining our company, he was EMEA Head of Human Resources for Kite Pharma, where he was responsible for all aspects of human resources, including talent management, organization development, policy and procedure development and compensation and benefits. Previously, Mr. Swan was involved in a number of start-up companies, including Amryt Pharmaceuticals, Taiho Oncology and Aegerion Pharmaceuticals. From 2004 to 2012, Mr. Swan was responsible for developing and leading all HR-associated activities for Celgene in EMEA. He has also held a number of positions within local government and the UK National Health Service, helping strategically with talent acquisition and organization development. Mr. Swan holds a Master’s degree in Law from the University of Leicester and is also a Fellow of the Chartered Institute of Personnel and Development.
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Christopher Vann has served as our Senior Vice President, Chief Operating Officer since 2016. Prior to joining us, he worked at Hoffmann-La Roche’s Swiss headquarters from 1994 to 2016, most recently serving as its commercial director from 2011 to 2016, where he was primarily responsible for leading the lung cancer commercial team and general management of the Tarceva brand. Mr. Vann has significant experience in global lifecycle management of oncology products as well as implementing marketing strategy at a regional and national level. This includes launching several oncology, immunology and transplant products in the United States, United Kingdom, Romania, Russia, South Africa and countries in Asia, including Japan. Mr. Vann holds a B.S. degree in Toxicology and Pharmacology from the School of Pharmacy, University of London.
Christopher Williams, Ph.D. has served as our Chief Business Officer since January 2024. Prior to this role, he served as Senior Vice President, Corporate Development from October 2021 to February 2024, and as Vice President, Global Head of Business Development from December 2018 to October 2021. Dr. Williams was part of the team that founded our predecessor company in 2014 and he initially served as a non-executive director of Autolus Limited. In 2016, he transitioned to establish our business development function as Director, Business Development. He previously worked at UCL Business, where he led the establishment of strategic collaborations, licensing deals, new companies, and financing transactions across a portfolio of cell and gene therapies in oncology and rare diseases. He served as non-executive director of Orchard Therapeutics, a company he founded during his tenure at UCL Business, and has worked in business development roles at Thiologics, Canbex and Eli Lilly. He has also worked in research roles at GSK, Inpharmatica and Imperial College London. Dr. Williams holds a Ph.D. in Biochemistry from Imperial College London and a B.Sc. degree in Genetics from Cardiff University.
Non-Executive Directors
John H. Johnson was appointed as Chairman of our board of directors in September 2021. Since May 2022, he has served as the Chief Executive Officer and a non-executive director of Reaction Biology, a provider of drug discovery services. Previously, he served as Chief Executive Officer of Strongbridge Biopharma plc, between July 2020 and October 2021, until its acquisition by Xeris Biopharma Holdings. Since October 2021, he has served as a non-executive director for Xeris. He previously served as chairman of Strongbridge’s board of directors from 2015 until November 2019 and Executive Chairman from November 2019 until July 2020. Additionally, he has served as a member of the board of directors of Verastem, Inc. since April 2020, and Axogen, Inc. since July 2021. Mr. Johnson served as a board member of Melinta Pharmaceuticals, Inc. through September 2019, having served as Chief Executive Officer from February 2019 through August 2019 and as interim Chief Executive Officer from October 2018 through February 2019. Mr. Johnson is the former lead independent director of Sucampo Pharmaceuticals, Inc., from 2016 until 2018, and a former director of Histogenics Corporation, from 2013 until 2019, AVEO Pharmaceuticals, Inc., from 2018 until 2019, and Portola Pharmaceuticals, Inc., from 2014 until 2020. From July 2018 to November 2018, Mr. Johnson served as an interim executive officer of Portola. He is a recognized leader in the biopharmaceutical industry with more than 30 years of experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc. Mr. Johnson previously served on the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ, and holds a B.S. degree from East Stroudsburg University of Pennsylvania. We believe that Mr. Johnson is qualified to serve on our board of directors because of his extensive experience with life science companies.
Joseph Anderson, Ph . D . has served on our board of directors since 2016. He is a Partner at Sofinnova Partners, an investment firm that he joined in October 2020. He served as the chief executive officer and a member of the board of directors of Arix Bioscience plc, a global life sciences company, from 2016 to 2020. He has founded and managed public equity funds and served as a member of the following boards of directors: Algeta ASA (acquired by Bayer AG) from 2009 to 2013, Amarin plc from October 2009 to 2013, Cytos Biotechnology Ltd, a biotechnology company, from 2012 until it merged with Kuros Biosurgery Holding Ltd in 2016, and Epigenomics AG from 2012 to 2014. He was a partner at Abingworth LLP, an international investment group dedicated to the life sciences and healthcare sectors, from 2004 to 2015. From 1999 to 2003, Dr. Anderson served at First State Investments in London, part of the Commonwealth Bank of Australia, where he was head of global healthcare equities and portfolio manager. He was a pharmaceuticals analyst at the investment bank Dresdner Kleinwort Benson from 1998 to 1999. From 1990 to 1998, Dr. Anderson established and was head of the strategy unit at The Wellcome Trust, one of the world’s largest medical foundations. He currently serves as a non-executive director of RedX Pharma plc and F2G Limited. Dr. Anderson holds a Ph.D. in Biochemistry from the University of Aston and a B.S. degree in Biological Science from Queen Mary College, University of London. We believe that Dr. Anderson is qualified to serve on our board of directors because of his extensive experience with life science companies.
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Robert Azelby has served on our board of directors since January 2024. He most recently served as President and Chief Executive Officer of Eliem Therapeutics Inc., between October 2020 and February 2023. Prior to Eliem, he served as the Chief Executive Officer of Alder BioPharmaceuticals, Inc. from 2018 until its acquisition by H. Lundbeck A/S in October 2019. Mr. Azelby served as Executive Vice President, Chief Commercial Officer of Juno Therapeutics, Inc. from 2015 through its acquisition by Celgene in 2018. Earlier, during a 15-year tenure at Amgen, Mr. Azelby served in commercial roles including Vice President and General Manager of Amgen Oncology, Vice President of Oncology Sales, Vice President of the Commercial Effectiveness Unit and General Manager of Amgen Netherlands. He currently serves on the Board of Directors at ADC Therapeutics SA, since June 2023, and also served on the Board of Directors of Chinook Therapeutics Inc. between April and August 2023, Clovis Oncology Inc. from 2018 until July 2023, Eliem Therapeutics Inc. from 2020 until February 2023, Alder BioPharmaceuticals Inc. from 2018 until November 2019, and Immunomedics, Inc. from February 2020 to October 2020. He holds a B.A. degree in Economics and Religious Studies from the University of Virginia and an MBA from Harvard Business School. We believe that Mr. Azelby is qualified to serve on our board of directors because of his broad experience in our industry, his commercial and management background and his track record of effective leadership.
Linda Bain has served on our board of directors since 2018. She currently serves as the Chief Operating Officer and Chief Financial Officer of Mariana Oncology, Inc., positions she has held since May 2023. She has also served as a non-executive director of Arvinas, Inc. since June 2020 and Hemab Therapeutics since January 2022. Between July 2021 and September 2022, Ms. Bain served as a non-executive director for VBI Vaccines, Inc. Prior to joining Mariana Oncology, Ms. Bain served as the Chief Financial Officer of Codiak Biosciences, Inc. from 2015 to April 2023 and Chief Financial Officer and treasurer of Avalanche Biotechnologies, Inc. from 2014 to 2015. Ms. Bain served at Bluebird bio, Inc., a gene therapy biotechnology company, as vice president of finance and business operations from 2011 to 2014, and Chief Accounting Officer and treasurer from 2013 to 2014. From 2008 to 2011, Ms. Bain served as Vice President of Finance at Genzyme Corporation. From 2007 to 2008, she served as vice president at Fidelity Investments, and from 2000 to 2007, she held a number of positions at AstraZeneca plc. She received her B.S. degree in Accounting and Business Administration and an Honors Degree in Accounting and Business Administration from the University of the Free State in South Africa. Ms. Bain is a certified public accountant. We believe that Ms. Bain is qualified to serve on our board of directors because of her extensive experience in our industry, her background in accounting and finance and her leadership skills.
John Berriman has served on our board of directors since 2014. He has served as chairman of the board of directors of Depixus SAS since 2015, and Autifony Therapeutics Ltd. since 2011. He previously served as chairman of the board of directors of Confo Therapeutics NV, between 2016 and August 2023, ReNeuron Group plc between 2015 and September 2020, Heptares Therapeutics Ltd from 2007 until its acquisition by Sosei Group in 2015, Algeta ASA from 2004 through its listing on the Oslo Stock Exchange in 2007 (and subsequently served as deputy chairman from 2008 until it was sold to Bayer AG in 2014), and as a director of Micromet, Inc. from 2006 until it was sold to Amgen Inc. in 2012. From 1997 to 2004, he was a director of Abingworth Management, an international healthcare venture capital firm, where he was involved in founding, financing and serving as a director of several biotechnology companies in Europe and the United States, many of which obtained listings on public stock exchanges. Prior to that, Mr. Berriman spent 14 years with Celltech Group plc and was a member of its board when it listed on the London Stock Exchange in 1994. He holds a M.S. in Chemical Engineering from the University of Cambridge and an M.B.A. from the London Business School. We believe that Mr. Berriman is qualified to serve on our board of directors because of his extensive experience in our industry, including his strategic management and operational experience, his experience serving on public company boards and his experience with public offerings, private investments and mergers.
Cynthia Butitta has served on our board of directors since 2018. Ms. Butitta served as the executive vice president and chief financial officer of Kite Pharma Inc., a biopharmaceutical company, from 2014 to 2016 and as its chief operating officer from 2014 to 2017. From 2011 to 2012, she served as senior vice president and chief financial officer at NextWave Pharmaceuticals, Inc., a specialty pharmaceutical company. Ms. Butitta served as chief operating officer of Telik, Inc., a biopharmaceutical company, from 2001 to 2010 and as its chief financial officer from 1998 to 2010. She has served as a member of the board of directors of UroGen Pharma Ltd. since 2017, Olema Pharmaceuticals Inc. since 2020 and Century Therapeutics since 2021 . Ms. Butitta holds a B.S. degree with honors in Business and Accounting from Edgewood College in Madison, Wisconsin and an M.B.A. in Finance from the University of Wisconsin, Madison. We believe that Ms. Butitta is qualified to serve on our board of directors because of her extensive financial and operational experience within the biotechnology and high-technology industries, as well as her leadership skills.
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Robert Iannone, M.D., M.S.C.E. has served on our board of directors since June 2023. Since May 2019, he has served as Executive Vice President, Global Head of Research & Development of Jazz Pharmaceuticals plc., and also served as its Chief Medical Officer from December 2019 until October 2021. From April 2018 until May 2019, Dr. Iannone served as Head of Research and Development and Chief Medical Officer of Immunomedics, Inc., a biopharmaceutical company. From 2014 to 2018, he served as Senior Vice President and Head of Immuno-oncology, Global Medicines Development, and the Global Products Vice President at AstraZeneca plc. From 2004 to 2014, Dr. Iannone held several management roles at Merck & Co., Inc., culminating in his role as Executive Director and Section Head of Oncology Clinical Development. Before joining industry, Dr. Iannone was Assistant Professor of Pediatrics at the University of Pennsylvania School of Medicine. He has served on the board of directors of iTeos Therapeutics, Inc., a clinical-stage biopharmaceutical company, since May 2021, and previously served on the Board of Jounce Therapeutics between January 2020 and its acquisition by Concentra Biosciences in May 2023. He has served on the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011. Dr. Iannone received an B.S. degree from The Catholic University of America, an M.D. from Yale University and an M.S.C.E. from the University of Pennsylvania. He completed his Residency and Chief Residency in Pediatrics and a Fellowship in Pediatric Hematology-Oncology at Johns Hopkins University. We believe that Dr. Iannone is qualified to serve on our board of directors because of his extensive experience as a pharmaceutical company executive and in the clinical development and regulation of pharmaceuticals.
Elisabeth Leiderman, M.D, has served on our board of directors since December 2023. She most recently served as the Chief Financial Officer and Chief Business Officer of Atsena Therapeutics, a clinical-stage gene therapy company focused on reversing and preventing blindness, from November 2022 until November 2023. From September 2020 until October 2022, she served as Chief Financial Officer and Head of Corporate Development for Decibel Therapeutics, a clinical-stage biotechnology company developing novel gene therapeutics for restoration of hearing loss and balance disorders. Before joining Decibel, from January 2020 to August 2020, Dr. Leiderman served as Chief Business Officer for Complexa, Inc., a clinical stage biopharmaceutical company focused on life-threatening fibrosis and inflammatory diseases. Prior to Complexa, she served as Senior Vice President, Head of Corporate Development at Fortress Biotech from 2016 to 2019. Dr. Leiderman is currently a member of the board of directors and chair of the audit committee of bluebird bio, Inc., a position she has held since October 2021. Earlier in her career, from 2007 to 2016, Dr. Leiderman developed transaction and capital markets expertise in the healthcare investment banking groups at Nomura, Credit Suisse, Jefferies and UBS. Dr. Leiderman began her career in medical affairs at AstraZeneca, where she analyzed product and industry trends related to the central nervous system. Dr. Leiderman holds an M.D. from the Sackler School of Medicine at Tel Aviv University, an M.B.A. from The Wharton School at the University of Pennsylvania and a B.A. degree from the University of Pennsylvania. We believe that Dr. Leiderman is qualified to serve on our board of directors because of her extensive experience as a pharmaceutical company executive, her financial and operational expertise, and her leadership skills.
Martin Murphy, Ph.D. has served on our board of directors since 2014. He served as Chair of Syncona Investment Management Limited, part of the global life science company Syncona Ltd., from January 2023 until November 2023 and as the chief executive officer of Syncona Investment Management Limited from 2016 until December 2022, and he founded Syncona Partners LLP and served as its chief executive officer from 2012 to 2016. He was a partner at MVM Life Science Partners LLP, a venture capital company focused on life science and healthcare investments, from 2003 to 2012. During his time at MVM, Dr. Murphy was a member of the management and investment committees and led MVM’s European operations. Before MVM, Dr. Murphy worked at 3i Group plc and McKinsey & Company. He has a Ph.D. in Biochemistry from the University of Cambridge. We believe that Dr. Murphy is qualified to serve on our board of directors because of his extensive experience as an investor, particularly in the life sciences industry.
William D. Young, Ph.D. has served on our board of directors since November 2021 and was appointed to our board of directors as Blackstone’s designee pursuant to the terms of the collaboration and financing agreement we entered into with Blackstone in November 2021. He has served as a Senior Advisor to the Blackstone Life Sciences group since 2018, following Blackstone’s acquisition of Clarus Ventures. Mr. Young became a Venture Partner with Clarus in 2010 after serving as Chief Executive Officer of Monogram Biosciences, from 1999 until the sale of the company to LabCorp in 2009. Prior to then, he was at Genentech for 19 years, serving in various positions of increasing responsibility, most recently serving as Chief Operating Officer, and was responsible for all of the biotechnology company's development, operations and commercial functions. Prior to Genentech, Mr. Young was at Eli Lilly and Company for 14 years. Mr. Young has served as chairman of the board of directors of Nanostring Technologies since 2010 and as a non-executive director of Praxis Precision Medicine since 2016. Previously he served on the board of directors of Theravance Biopharma between 2013 and 2014 and as its lead independent director between 2014 and May 2023, and as a director of Vertex Pharmaceuticals from 2014 until 2020. Mr. Young received his B.S degree in chemical engineering from Purdue University, his MBA from Indiana University and an honorary doctorate in engineering from Purdue University. In 1993, he was elected to the National Academy of Engineering for his leadership in research, development and manufacturing of recombinant proteins using recombinant DNA technology. We believe that Dr. Young is qualified to serve on our board of directors because of his extensive experience in the life sciences industry.
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Board Diversity
The table below provides certain information regarding the diversity of our board of directors as of March 21, 2024. Our 2023 Board Diversity Matrix is included in our Annual Report on Form 20-F, filed with the SEC on March 7, 2023.
Board Diversity Matrix
Country of Principal Executive Offices: United Kingdom
Foreign Private Issuer Yes
Disclosure Prohibited under Home Country Law No
Total Number of Directors 11
Male Female Non-Binary Did Not Disclose Gender
Part I: Gender Identity
Directors 8 3 0 0
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction 0 0 0 0
LGBTQ+ 0
Did Not Disclose Demographic Background 0
Code of Ethics
We have adopted a Code of Business Conduct and Ethics, or the Code of Ethics, that is applicable to all of our employees, officers and directors and is available on our website at https://www.autolus.com/investor-relations/corporate-governance/documents-charters. Information contained on, or that can be accessed through, our website does not constitute a part of this report and is not incorporated by reference herein. If we make any amendment to the Code of Ethics or grant any waivers, including any implicit waiver, from a provision of the Code of Ethics, we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC. If a waiver or amendment of the Code of Ethics applies to our principal executive officer, principal financial officer, principal accounting officer or controller and relates to standards promoting any of the values described in Item 16B of Form 20-F, we are required to disclose such waiver or amendment on our website.
Composition of Our Board of Directors
Our board of directors presently has eleven members. As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except that our audit committee is required to consist fully of independent directors, subject to certain phase-in schedules. However, our board of directors has determined that Drs. Anderson, Iannone, Leiderman and Murphy, Mses. Butitta and Bain and Messrs. Azelby, Berriman, Johnson and Young representing ten of our eleven directors, do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of director and that each of these directors is “independent” as that term is defined under Nasdaq rules.
Pursuant to the BioNTech Letter Agreement, BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights under the BioNTech Letter Agreement shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages.
In accordance with our Articles of Association, our board of directors are divided into three classes with staggered three-year terms. At each annual general meeting of shareholders, the directors whose terms expire will retire and are eligible for re-appointment by ordinary resolution at such annual general meeting. At each annual general meeting, the successors to directors whose terms then expire or the directors who have been re-appointed will be elected to serve from the time of election and qualification until the third annual meeting following election. Our directors are divided among the three classes as follows:
• Class I, which consists of Joseph Anderson, Martin Murphy and Robert Iannone vacancy, whose terms will expire at our 2025 annual general meeting;
• Class II, which consists of John Johnson, Robert Azelby, John Berriman and Elisabeth Leiderman, whose terms will expire at our 2026 annual general meeting;
• Class III, which consists of Christian Itin, Cynthia Butitta, Linda Bain and William Young, whose terms will expire at our 2024 annual general meeting.
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Each director shall serve until his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal.
Committees of Our Board of Directors
Our board of directors has four standing committees: an audit committee, a compensation committee, a nominating and corporate governance committee, and a research and development committee. The board has adopted a written charter for each of the committees below that is available to shareholders on our website at http://www.autolus.com/investor-relations/corporate-governance.
Audit Committee
The audit committee is composed of Ms. Bain (chair), Dr. Anderson, Ms. Butitta and Dr. Leiderman, and assists the board of directors in overseeing our accounting and financial reporting processes. The audit committee consists exclusively of members of our board who are financially literate, and our board of directors has determined that Ms. Bain is an “audit committee financial expert” as defined by applicable SEC rules and has the requisite financial sophistication as defined under the applicable Nasdaq rules and regulations. Our board of directors has determined that each member of the audit committee is an independent director under Nasdaq listing rules and under Rule 10A-3 under the Exchange Act. Our audit committee meets at least four times per year and oversees and reviews our internal controls, accounting policies and financial reporting, and provides a forum through which our independent registered public accounting firm reports. Our audit committee meets regularly with our independent registered public accounting firm without management present.
The primary functions of the audit committee include:
• recommending the appointment of the independent auditor to shareholders for approval at the general meeting of shareholders;
• the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit services;
• pre-approving the audit services and non-audit services to be provided by our independent auditor before the auditor is engaged to render such services;
• evaluating the independent auditor’s qualifications, performance and independence, and presenting its conclusions to the full board of directors on at least an annual basis;
• reviewing and discussing with management and our independent registered public accounting firm our financial statements and our financial reporting process; and
• reviewing, approving or ratifying any related party transactions.
Compensation Committee
The compensation committee is composed of Mr. Berriman (chair), Ms. Butitta and Dr. Murphy. Under SEC and Nasdaq rules, there are heightened independence standards for members of the compensation committee, including a prohibition against the receipt of any compensation from us other than standard board member fees. Although foreign private issuers are not required to meet this heightened standard, all of our compensation committee members meet this heightened standard.
The primary functions of the compensation committee include:
• identifying, reviewing, overseeing and proposing policies relevant to the compensation and benefits of our directors and senior management;
• evaluating the performance of senior management in light of such policies and reporting to the board; and
• overseeing and administering our share option plan, equity incentive plan and other benefit plans in operation from time to time.
Nominating and Corporate Governance Committee
The nominating and corporate governance committee is composed of Mr. Young (chair), Dr. Anderson, Mr. Azelby and Ms. Bain.
The primary functions of the nominating and corporate governance committee include:
• drawing up selection criteria and appointment procedures for directors;
• recommending nominees for appointment to our board of directors and its corresponding committees; and
• assessing the functioning of individual members of our board of directors and management and reporting the results of such assessment to the full board of directors.
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Research and Development Committee
The research and development committee is composed of Drs. Iannone, Itin and Murphy and Mr. Young.
The primary functions of the research and development committee include:
• overseeing our scientific, technical, research and development strategy, and the implementation thereof;
• advising our board of directors and management regarding program prioritization, clinical development strategy, regulatory strategy and interactions, intellectual property, product manufacture and supply, and related matters; and
• reviewing and assessing business development opportunities related to research collaborations, licensing or strategic transactions.
Corporate Governance.
We qualify as a “Foreign Private Issuer,” as defined in Rule 3b-4 under the Exchange Act. As a result, in accordance with Nasdaq listing requirements, we may rely on home country governance requirements and certain exemptions thereunder rather than complying with Nasdaq corporate governance standards.
Although we have voluntarily chosen to file registration statements, periodic reports and current reports on U.S. domestic issuer forms, we will maintain our status as a foreign private issuer. While we voluntarily follow most Nasdaq corporate governance rules, we may choose to take advantage of limited exemptions from the following:
• U.S. federal proxy rules pursuant to Section 14 of the Exchange Act and Regulations 14A and 14C thereunder;
• Regulation FD;
• Section 16 rules requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades in a short period of time, which will provide less data in this regard than shareholders of U.S. companies that are subject to the Exchange Act;
• the requirement that our board have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities; and
• the requirement to have independent director oversight of director nominations.
We intend to follow U.K. corporate governance practices in lieu of Nasdaq corporate governance requirements as follows:
◦ We do not intend to follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under English law. In accordance with generally accepted business practice, our Articles of Association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
◦ We do not intend to follow Nasdaq Rule 5605(b)(2), which requires that independent directors regularly meet in executive sessions where only independent directors are present. Our independent directors may choose to meet in executive sessions at their discretion.
Although we may rely on certain home country corporate governance practices, we must comply with Nasdaq’s Notification of Noncompliance requirement (Nasdaq Rule 5625) and the Voting Rights requirement (Nasdaq Rule 5640). Further, we must have an audit committee that satisfies Nasdaq Rule 5605(c)(3), which addresses audit committee responsibilities and authority and requires that the audit committee consist of members who meet the independence requirements of Nasdaq Rule 5605(c)(2)(A)(ii).
We intend to take all actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley Act, the rules adopted by the SEC and Nasdaq listing rules. Accordingly, our shareholders will not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
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Item 11. Executive Compensation
As a foreign private issuer, we are permitted by Item 402(a)(i) of Regulation S-K to respond to this Item 11 by providing the information required by Items 6.B. and 6.E.2 of Form 20-F. Accordingly, we are not required to disclose executive compensation according to the requirements of Regulation S-K that are applicable to U.S. domestic issuers.
The following discussion provides the amount of compensation paid, and benefits in-kind granted, by us and our subsidiaries to our directors, members of our senior management and non-employee directors for services in all capacities to us and our subsidiaries for the year ended December 31, 2023, as well as the amount contributed by us or our subsidiaries into money purchase plans for the year ended December 31, 2023 to provide pension, retirement or similar benefits to, our directors, members of our senior management and non-employee directors.
Director Compensation
For the year ended December 31, 2023, the table below sets forth the compensation paid to our directors. In the case of Dr. Itin, our Chief Executive Officer, the table below sets forth the compensation paid to him for services as a member of our senior management. He does not receive any compensation for serving as an executive director. All such amounts are established and paid in pounds sterling.
Name Salary/Fees Annual Bonus Pension
Benefit
All Other
Compensation
Total
Christian Itin, Ph.D.
Executive Director £ 432,000 £ 362,880 £ — £ 1,126,261 £ 1,921,141
John Johnson
Chairman of the Board £ 51,876 £ — £ — £ 154,774 £ 206,650
Joseph Anderson, Ph.D.
Non-Executive Director £ 40,872 £ — £ — £ 122,273 £ 163,145
Jay Backstrom, M.D, M.P.H*
Non-Executive Director £ 7,000 £ — £ — £ — £ 7,000
Linda Bain
Non-Executive Director £ 47,250 £ — £ — £ 122,273 £ 169,523
John Berriman
Non-Executive Director £ 40,872 £ — £ — £ 122,273 £ 163,145
Cynthia Butitta
Non-Executive Director £ 42,372 £ — £ — £ 122,273 £ 164,645
Kapil Dhingra, M.D.****
Non-Executive Director £ 48,581 £ — £ — £ 75,814 £ 124,395
Robert Iannone, M.D., M.S.C.E**
Non-Executive Director £ 20,481 £ — £ — £ 114,382 £ 134,863
Elisabeth Leiderman, M.D.***
Non-Executive Director £ 1,169 £ — £ — £ 11,556 £ 12,725
Martin Murphy, Ph.D.
Non-Executive Director £ 36,003 £ — £ — £ 122,273 £ 158,276
William Young, Ph.D.
Non-Executive Director £ 37,708 £ — £ — £ 138,116 £ 175,824
* Dr. Backstrom resigned from the board of directors effective February 28, 2023.
** Dr. Iannone joined the board of directors effective June 15, 2023.
*** Dr. Leiderman joined the board of directors effective December 20, 2023.
**** Dr. Dhingra resigned from the board of directors effective December 31,2023.
Non-Executive Letters of Appointment
Non-executive directors are engaged on letters of appointment that set out their duties and responsibilities. The non-executive directors do not receive benefits upon termination or resignation from their respective positions as directors.
Non-Executive Director Compensation Policy
In April 2023, following market research and advice from its compensation consultant, our board of directors amended our non-executive director compensation policy to increase the retainer fee and equity awards for, respectively, the chair and other non-executive directors.
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Under this policy, we pay each of our non-executive directors a cash retainer for service on our board of directors and committees of our board of directors. Our chair or lead independent director, as applicable, also receives an additional cash retainer. These retainers are payable in arrears in twelve equal monthly installments at the end of each calendar month, provided that the amount of such payment will be prorated for any portion of such month that the director is not serving on our board. Non-executive directors residing outside the UK will be paid the applicable amounts converted from pounds sterling into a currency of their request at the time of payment. We will also reimburse our directors for their reasonable out-of-pocket expenses in connection with attending board and committee meetings.
Non-executive directors are eligible to receive cash compensation as follows:
Annual Cash Retainer
( £)
Annual retainer for board of director chair 52,500
Annual retainer for board of director member 31,500
Additional retainer for audit committee chair 13,000
Additional retainer for audit committee member 6,500
Additional retainer for compensation committee chair 10,000
Additional retainer for compensation committee member 5,000
Additional retainer for nominating and governance committee chair 7,000
Additional retainer for nominating and governance committee member 3,500
Additional retainer for research and development committee chair 12,000
Additional retainer for research and development committee member 6,000
Equity Compensation
In addition to cash compensation, each non-executive director is eligible to receive share options under our equity incentive plans. Any share options granted under this policy shall have a term of ten years from the date of grant, subject to earlier termination in connection with a termination of service. Vesting schedules for equity awards are subject to the non-executive director’s continuous service on each applicable vesting date.
Notwithstanding any vesting schedule, for each non-executive director who remains in continuous service with us until immediately prior to the closing of a change in control (as such term is defined in our 2018 Plan), the shares subject to his or her then-outstanding initial or annual equity awards that were granted pursuant to this policy will become fully vested immediately prior to the closing of such change in control.
Upon the termination of the membership of the non-executive director on the board for any reason, his or her options granted under this policy shall remain exercisable for three months following his or her date of termination (or such longer period as the board may determine in its discretion on or after the date of grant of such options).
Initial Award
Each new non-executive director elected to our board of directors is granted an initial, one-time equity award of options to purchase 80,000 of our ADSs on the date of such director’s initial election or appointment to the board of directors, which will vest in equal monthly installments through the third anniversary of the grant date. In addition, a non-executive director who is initially appointed to serve as chair of the board receives an option to purchase 40,000 of our ADSs on the date of such appointment to chair, which will vest in equal monthly installments through the third anniversary of the grant date.
Annual Awards
On the date of each of our annual meeting of shareholders, each non-executive director that continues to serve will be granted an option to purchase 80,000 of our ADSs or ordinary shares, which will vest in equal monthly installments through the first anniversary of the grant date. In October 2022, the Compensation Committee of the board approved a one-time increase in the annual equity award grant to non-executive directors, from 80,000 to 105,000 shares, to be awarded at the conclusion of our 2023 Annual General Meeting of Shareholders.
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Senior Management Compensation
The compensation for each member of our executive management comprises the following elements: base salary, annual bonus, personal benefits, pension or 401(k) plan and long-term incentives. For the year ended December 31, 2023, the aggregate compensation accrued or paid to the members of our senior management for services, whether or not a director, in all capacities was $11.4 million . T he amount set aside or accrued by us to provide pension, retirement or similar benefits to members of senior management amounted to a total of $1,108 in the year ended December 31, 2023.
Management Incentive Compensation Plan
On May 17, 2016, the board of directors adopted the Management Incentive Compensation Plan. The Management Incentive Compensation Plan is designed to offer annual incentive compensation to our members of senior management and managers by rewarding the achievement of corporate goals and specifically measured personal goals that are consistent with and support the achievement of the corporate goals. The key terms of the Management Incentive Compensation Plan are summarized below.
Administration and Eligibility
Our Chief Executive Officer is responsible for the administration of the Management Incentive Compensation Plan; however, the compensation committee of the board of directors is responsible for approving any incentive awards to our Chief Executive Officer and other members of our senior management.
In order to be eligible to receive an incentive award under the Management Incentive Compensation Plan, an individual must have been employed with us for at least three consecutive months during a plan year, which runs from January 1 to December 31, and must achieve a rating of at least 75% of his or her personal goal.
For the year ended December 31, 2023 the Compensation Committee of our board of directors determined that our corporate goals were achieved at a level of 120%. Pursuant to the terms of the Management Incentive Compensation Plan, our Chief Executive Officer and executive director received an incentive award of £362,880, based on his target bonus percentage of 60%, an overall goal achievement level of 140%, and his base salary of £432,000.
Form and Determination of Incentive Awards
Incentive award payments may be made in cash, or, at the discretion of the compensation committee and subject to the approval of our board of directors, through the issuance of equity.
An individual’s potential incentive award is calculated by multiplying his or her base salary as of the end of the plan year by the participant’s “target award multiplier,” which is a percentage ranging from 10% to 60%. The resulting amount is then divided between a corporate component and an individual component based on the weighting assigned for the individual’s management level. After the end of the plan year, the actual achievement of the corporate and individual goals is determined, each expressed as a percentage of complete achievement, resulting in the calculation of the individual’s total incentive award.
Annual performance reviews for participants in the Management Incentive Compensation Plan are completed following the end of the applicable plan year, with payment of incentive awards made as soon as practicable thereafter.
Termination of Employment
If a participant in the Management Incentive Compensation Plan gives or receives notice of termination or his or her employment is terminated prior to the payment of an incentive award under the Management Incentive Compensation Plan, our board of directors has discretion as to whether or not to pay an incentive award and whether to pay the full amount of the incentive award or a portion thereof.
Amendment
Our board of directors may abolish or alter the Management Incentive Compensation Plan at any time before, during or after a plan year is completed.
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Senior Management Employment Arrangements
We have entered into arrangements with members of our senior management to grant restricted shares that are subject to vesting and a repurchase right in favor of us in the event the individual terminates his or her employment prior to the vesting date.
In order to align the interests of our executive management with our shareholders, members of our executive management are eligible to receive share-based awards pursuant to our equity incentive plans. The amount of the awards will generally be subject to the discretion of our board of directors and our compensation committee.
Outstanding Equity Awards, Grants and Option Exercise
The following table summarizes the equity awards that we granted to members of our board of directors and senior management pursuant to the terms of the 2017 Plan or 2018 Plan during the year ended December 31, 2023.
Name Ordinary Share Underlying Option Exercise Price Grant
Date
Expiration
Date
Senior Management
Christian Itin, Ph.D. 500,000 $ 1.91 3/6/2023 3/6/2033
500,000 $ 2.31 10/12/2023 10/12/2033
Robert Dolski 500,000 $ 2.50 7/17/2023 7/17/2033
250,000 $ 2.31 10/12/2023 10/12/2033
Edgar Braendle, M.D. 200,000 $ 1.91 3/6/2023 3/6/2033
200,000 $ 2.31 10/12/2023 10/12/2033
David Brochu 250,000 $ 1.91 3/6/2023 3/6/2033
250,000 $ 2.31 10/12/2023 10/12/2033
Martin Pule, MBBS 150,000 $ 1.91 3/6/2023 3/6/2033
150,000 $ 2.31 10/12/2023 10/12/2033
Brent Rice 150,000 $ 1.91 3/6/2023 3/6/2033
150,000 $ 2.31 10/12/2023 10/12/2033
Alexander Swan 250,000 $ 1.91 3/6/2023 3/6/2033
250,000 $ 2.31 10/12/2023 10/12/2033
Christopher Vann 200,000 $ 1.91 3/6/2023 3/6/2033
200,000 $ 2.31 10/12/2023 10/12/2033
Non-Executive Directors
John Johnson 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
Joseph Anderson, Ph.D. 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
Linda Bain 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
John Berriman 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
Cynthia Butitta 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
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Name Ordinary Share Underlying Option Exercise Price Grant
Date
Expiration
Date
Non-Executive Directors
Kapil Dhingra, M.D.* 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
Robert Iannone, M.D., M.S.C.E. 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
Elisabeth Leiderman, M.D. 80,000 $ 5.50 12/20/2023 12/20/2033
Martin Murphy, Ph.D. 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
William Young, Ph.D. 80,000 $ 2.38 6/30/2023 6/30/2033
25,000 $ 2.38 6/30/2023 6/30/2033
*Dr. Dhingra resigned from the board of directors effective December 31,2023.
As of December 31, 2023, members of our board of directors and senior management held vested share options to purchase an aggregate of 4,116,298 ordinary shares. No share options were exercised by any members of our board of directors and senior management during the year ended December 31, 2023.
Equity Incentive Plans
We have granted equity securities under a share option plan and an equity incentive plan, which are summarized below.
2017 Share Option Plan
In 2017, our board of directors and shareholders approved the 2017 Plan to provide equity incentives to certain eligible employees and directors, consultants and advisors. The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives (“EMI”), options to our UK employees and for the grant of options to our U.S. employees. The 2017 Plan terminated in connection with our IPO; accordingly, as of September 30, 2018, there were no shares available for future grants under the 2017 Plan. Options previously granted pursuant to the 2017 Plan and that are currently outstanding remain subject to the terms of the 2017 Plan.
2018 Equity Incentive Plan
The 2018 Plan was approved by our board of directors and shareholders in June 2018 and became effective as of our IPO. The 2018 Plan allows for the grant of equity-based incentive awards to our employees and directors, including directors who are also our employees. Except where the context indicates otherwise, references hereunder to our ordinary shares shall be deemed to include a number of ADSs equal to the number of ordinary shares. The material terms of the 2018 Plan are summarized below:
Eligibility and Administration
Our employees and directors, and employees and consultants of our subsidiaries, referred to as service providers are eligible to receive awards under the 2018 Plan. The 2018 Plan is administered by our board of directors, which may delegate its duties and responsibilities to one or more committees of our directors and/or officers (referred to as the plan administrator below), subject to certain limitations imposed under the 2018 Plan, and other applicable laws and stock exchange rules. Our board of directors has delegated concurrent authority to administer the 2018 Plan to the compensation committee. The plan administrator has the authority to take all actions and make all determinations under the 2018 Plan, to interpret the 2018 Plan and award agreements and to adopt, amend and repeal rules for the administration of the 2018 Plan as it deems advisable. The plan administrator also has the authority to determine which eligible service providers receive awards, grant awards, set the terms and conditions of all awards under the 2018 Plan, including any vesting and vesting acceleration provisions, and designate whether such awards will cover our ordinary shares or ADSs, subject to the conditions and limitations in the 2018 Plan.
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Shares Available for Awards
The maximum number of ordinary shares that may be issued under our 2018 Plan was initially 3,281,622 shares, which consisted of 3,025,548 ordinary shares under the 2018 Plan at the time of its adoption and 256,074 ordinary shares that remained available for future grants under the 2017 Plan at the time of its termination. Additionally, the number of ordinary shares reserved for issuance under the 2018 Plan will automatically increase on October 1st of each year, for a period of not more than ten years, commencing on October 1, 2018 and ending on (and including) October 1, 2027, by an amount equal to the lesser of (i) 4% of the total number of ordinary shares outstanding on September 30 of the same calendar year or (ii) such fewer number of ordinary shares as the board of directors may designate prior to the applicable October 1st date. As of December 31, 2023 , 22,298,243 ordinary shares may be issued under the 2018 Plan, of which 3,833,665 ordinary s hares were available for future grant as of that date.
If an award under the 2018 Plan, or any prior equity incentive plan, expires, lapses or is terminated, exchanged for cash, surrendered, repurchased, canceled without having been fully exercised or forfeited, any unused shares subject to the award will, as applicable, become or again be available for new grants under the 2018 Plan. Awards granted under the 2018 Plan in substitution for any options or other equity or equity-based awards granted by an entity before the entity’s merger or consolidation with us or our acquisition of the entity’s property or stock will not reduce the shares available for grant under the 2018 Plan, but will count against the maximum number of shares that may be issued upon the exercise of incentive options.
Awards
The 2018 Plan provides for the grant of options, share appreciation rights (“SARs”), restricted shares, dividend equivalents, restricted share units (“RSUs”), and other share-based awards. All awards under the 2018 Plan will be set forth in award agreements, which will detail the terms and conditions of awards, including any applicable vesting and payment terms, change of control provisions and post-termination exercise limitations. A brief description of each award type follows.
Options and SARs . Options provide for the purchase of our ordinary shares in the future at an exercise price set on the grant date. SARs entitle their holder, upon exercise, to receive from us an amount equal to the appreciation of the shares subject to the award between the grant date and the exercise date. The plan administrator will determine the number of shares covered by each option and SAR, the exercise price of each option and SAR and the conditions and limitations applicable to the exercise of each option and SAR.
Restricted Shares and RSUs . Restricted shares are an award of nontransferable ordinary shares that remain forfeitable unless and until specified conditions are met and which may be subject to a purchase price. RSUs are contractual promises to deliver our ordinary shares in the future, which may also remain forfeitable unless and until specified conditions are met and may be accompanied by the right to receive the equivalent value of dividends paid on our ordinary shares prior to the delivery of the underlying shares. The plan administrator may provide that the delivery of the shares underlying RSUs will be deferred on a mandatory basis or at the election of the participant. The terms and conditions applicable to restricted shares and RSUs will be determined by the plan administrator, subject to the conditions and limitations contained in the 2018 Plan.
Other Share-Based Awards . Other share-based awards are awards of fully vested ordinary shares and other awards valued wholly or partially by referring to, or otherwise based on, our ordinary shares or other property. Other share-based awards may be granted to participants and may also be available as a payment form in the settlement of other awards, as standalone payments and as payment in lieu of compensation to which a participant is otherwise entitled. The plan administrator will determine the terms and conditions of other share-based awards, which may include any purchase price, performance goal, transfer restrictions and vesting conditions.
Performance Criteria
The plan administrator may select performance criteria for an award to establish performance goals for a performance period.
Certain Transactions
In connection with certain corporate transactions and events affecting our ordinary shares, including a change of control, another similar corporate transaction or event, another unusual or nonrecurring transaction or event affecting us or our financial statements or a change in any applicable laws or accounting principles, the plan administrator has broad discretion to take action under the 2018 Plan to prevent the dilution or enlargement of intended benefits, facilitate the transaction or event or give effect to the change in applicable laws or accounting principles. This includes canceling awards for cash or property, accelerating the vesting of awards, providing for the assumption or substitution of awards by a successor entity, adjusting the number and type of shares subject to outstanding awards and/or with respect to which awards may be granted under the 2018 Plan and replacing or terminating awards under the 2018 Plan. In addition, in the event of certain non-reciprocal transactions with our shareholders, the plan administrator will make equitable adjustments to the 2018 Plan and outstanding awards as it deems appropriate to reflect the transaction.
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Plan Amendment and Termination
Our board of directors may amend or terminate the 2018 Plan at any time; however, no amendment, other than an amendment that increases the number of shares available under the 2018 Plan, may materially and adversely affect an award outstanding under the 2018 Plan without the consent of the affected participant and shareholder approval will be obtained for any amendment to the extent necessary to comply with applicable laws. Further, the plan administrator cannot, without the approval of our shareholders, amend any outstanding option or SAR to reduce its price per share or cancel any outstanding option or SAR in exchange for cash or another award under the 2018 Plan with an exercise price per share that is less than the exercise price per share of the original option or SAR. The 2018 Plan will remain in effect until the tenth anniversary of its effective date unless earlier terminated by our board of directors. No awards may be granted under the 2018 Plan after its termination.
Transferability and Participant Payments
Except as the plan administrator may determine or provide in an award agreement, awards under the 2018 Plan are generally non-transferable, except by will or the laws of descent and distribution, or, subject to the plan administrator’s consent, pursuant to a domestic relations order, and are generally exercisable only by the participant. With regard to tax withholding obligations arising in connection with awards under the 2018 Plan, and exercise price obligations arising in connection with the exercise of options under the 2018 Plan, the plan administrator may, in its discretion, accept cash, wire transfer or cheque, our ordinary shares that meet specified conditions, a promissory note, a “market sell order,” such other consideration as the plan administrator deems suitable or any combination of the foregoing.
Non-U.S. Participants
The plan administrator may modify awards granted to participants who are non-U.S. nationals or employed outside the United States or establish sub-plans or procedures to address differences in laws, rules, regulations or customs of such foreign jurisdictions.
U.S. Taxpayers
Awards may be granted under the 2018 Plan to U.S. taxpayers.
2018 Non-Employee Sub Plan
The 2018 Non-Employee Sub Plan will govern equity awards granted to our non-executive directors and our service providers. The 2018 Non-Employee Sub Plan was adopted under the 2018 Plan and provides for equity- and cash-based awards to be made on identical terms to awards made under our 2018 Plan. If all or any part of an award granted under the 2018 Non-Employee Sub Plan expires, lapses or is terminated, exchanged for cash, surrendered, repurchased, canceled without having been fully exercised or forfeited, any unused shares covered by the award will become or again be available for new grants under the 2018 Non-Employee Sub Plan.
Clawbacks
As a U.S. public company, if we are required to restate our financial results due to our material noncompliance with any financial reporting requirements under the federal securities laws as a result of misconduct, our Chief Executive Officer and Chief Financial Officer may be legally required to reimburse us for any bonus or other incentive-based or equity-based compensation they receive in accordance with the provisions of Section 304 of the Sarbanes-Oxley Act. Additionally, we have implemented a Dodd-Frank Act-compliant clawback policy, as required by SEC rules.
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Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of February 29, 2024 by:
• each beneficial owner of 5% or more of our outstanding ordinary shares;
• each of our current directors and each member of our senior management; and
• all of our directors and senior management as a group.
Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of February 29, 2024. These ordinary shares, however, are not included in the computation of the percentage ownership of any other person. Percentage ownership calculations are based on 265,812,217 ordinary shares outstanding (including ordinary shares in the form of ADSs) as of February 29, 2024 .
Except as otherwise indicated, all of the shares reflected in the table are ordinary shares and all persons listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community property laws. The information is not necessarily indicative of beneficial ownership for any other purpose.
Except as otherwise indicated, the addresses of the persons listed in the table is c/o Autolus Therapeutics plc, 191 Wood Lane, White City, London W12 7FP, United Kingdom.
NAME OF BENEFICIAL OWNER Number of Ordinary Shares Beneficially Owned (#) Percent of Ordinary Shares Beneficially Owned (%)
5% or Greater Shareholders:
Syncona Portfolio Limited (1) 33,527,162 12.6 %
BioNTech SE (2)
33,333,333 12.5 %
BXLS V - Autobahn L.P (3)
23,750,917 8.9 %
Paradigm BioCapital Advisors LP (4)
16,028,002 6.0 %
Deep Track Capital, LP (5)
15,619,297 5.9 %
Qatar Investment Authority (6)
15,000,000 5.6 %
PPF Capital Partners Fund B.V. (7)
14,612,275 5.5 %
Senior Management and Directors:
Christian Itin, Ph.D. (8)
2,258,501 0.8 %
Robert Dolski (9)
— *
Edgar Braendle M.D.(10)
418,162 *
David Brochu (11) 518,541 *
Martin Pulé, MBBS (12)
1,030,648 *
Brent Rice (13)
207,724 *
Alexander Swan (14)
259,165 *
Christopher Vann (15)
676,792 *
Christopher Williams, Ph.D. (16)
228,521 *
John Johnson (17)
130,276 *
Joseph Anderson, Ph.D. (18)
139,999 *
Robert Azelby (19)
2,222 *
Linda Bain (20)
171,396 *
John Berriman (21)
292,028 *
Cynthia Butitta (22)
197,094 *
Robert Iannone, M.D, M.S.C.E (23)
69,999 *
Elisabeth Leiderman M.D. (24)
4,444 *
Martin Murphy, Ph.D. (25)
139,999 *
William Young, Ph.D. (26)
108,749 *
All directors and senior management as a group (19 persons) (27)
6,854,260 2.6 %
* Represents beneficial ownership of less than one percent.
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(1) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by Syncona Portfolio Limited. The number reported consists of (i) 12,180,333 ordinary shares and (ii) 21,346,829 ADSs. Syncona Portfolio Limited is a wholly owned subsidiary of Syncona Holdings Limited, which, in turn, is a wholly controlled subsidiary of Syncona Limited, a publicly-listed company. Each of Syncona Holdings Limited and Syncona Limited may be deemed to have voting and dispositive power over the securities held by Syncona Portfolio Limited. Investment and voting decisions with respect to these securities are made by Syncona Portfolio Limited acting upon the recommendation of an investment committee of Syncona Investment Management Limited, also a subsidiary of Syncona Holdings Limited. The members of this investment committee consist of Roel Bulthuis and Christopher Hollowood. The address for Syncona Portfolio Limited is PO Box 273, Sir William Place, St Peter Port, Guernsey GY1 3RD, Channel Islands.
(2) The information shown is based, in part, upon disclosures filed on a Schedule 13D on February 21, 2024 by BioNTech. The number reported consists of 33,333,333 ADSs. The members of the Management Board consists of Prof. Ugur Sahin, M.D., Jens Holstein, Sean Marett, Dr. Sierk Poetting, Dr. Özlem Türeci, Ryan Richardson and James Ryan. The members of the Supervisory Board of BioNTech consist of Helmut Jeggle, Michael Motschmann, Baroness Nicola Blackwood, Prof. Anja Morawietz, Dr. Ulrich Wandschneider and Prof. Rudolf Staudigl. The address of the principal business office, Management Board and Supervisory Board of BioNTech is An der Goldgrube 12, D-55131 Mainz, Germany.
(3) The information shown is based, in part, upon disclosures filed on a Schedule 13D/A on December 13, 2022 by Blackstone Inc. The number reported consists of (i) 20,485,611 ADSs and (ii) 3,265,306 warrants. Blackstone Life Sciences Associates V (CYM) L.L.C. (“Autobahn GP”) is the general partner of BXLS V – Autobahn L.P. (“BLXS V”). Blackstone Clarus GP L.L.C. is the general partner of Autobahn GP. The sole member of Blackstone Clarus GP L.L.C. is Blackstone Holdings I L.P. The general partner of Blackstone Holdings I L.P. is Blackstone Holdings I/II GP L.L.C. The sole member of Blackstone Holdings I/II GP L.L.C. is Blackstone Inc. The sole holder of the Series II preferred stock of Blackstone Inc. is Blackstone Group Management L.L.C. Blackstone Group Management L.L.C. is wholly-owned by Blackstone’s senior managing directors and controlled by its founder, Stephen A. Schwarzman. The address of the principal business office of BLXS V and Autobahn GP is 101 Main Street, Suite 1210, Cambridge, MA 02142. The address of the principal business office of each of the other Blackstone entities and Mr. Schwarzman is c/o Blackstone Inc., 345 Park Avenue, New York, NY 10154.
(4) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by (1) Paradigm BioCapital Advisors LP (the “Adviser”); (2) Paradigm BioCapital Advisors GP LLC (the “GP”); (3) Senai Asefaw, M.D. (“Senai Asefaw”); and (4) Paradigm BioCapital International Fund Ltd. (the “Fund”). The number reported consists of 12,611,335 ADSs. The Fund is a private investment vehicle. The Fund and a separately managed account managed by the Adviser (the “Account”) directly beneficially own 12,611,335 ADSs. In addition Paradigm BioCapital Advisors LP purchased a further 3,416,667 ADSs in February 2024. The Adviser is the investment manager of the Fund and the Account. The GP is the general partner of the Adviser. Senai Asefaw is the managing member of the GP. The Adviser, the GP and Senai Asefaw may be deemed to beneficially own the Ordinary Shares directly beneficially owned by the Fund and the Account. Each Reporting Person disclaims beneficial ownership with respect to any Ordinary Shares other than the Ordinary Shares directly beneficially owned by such Reporting Person. The principal business office of the Reporting Persons is 767 Third Avenue, 17th Floor, New York, NY 10017.
(5) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by Deep Track Capital, LP. The number reported consists of 11,869,297 ADSs. In addition Deep Track Capital, LP purchased a further 3,750,000 ADSs in February 2024. Deep Track Biotechnology Master Fund, Ltd is a wholly owned subsidiary of Deep Track Capital, LP. The address of the principal business office of Deep Track Capital, LP is 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830. The address of the principal business office of Deep Track Biotechnology Master Fund, Ltd. is c/o Walkers Corporate Limited, 190 Elgin Ave, George Town, KY1-9001, Cayman Islands. Deep Track Capital, LP. and Deep Track Biotechnology Master Fund, Ltd are controlled by its founder, David Kroin. The address of the principal business office of Mr. Kroin is c/o Deep Track Capital, LP, 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830.
(6) The information shown is based, in part, upon disclosures filed on a Schedule 13G on December 13, 2022 by Qatar Investment Authority. The number reported consists of 15,000,000 ADSs. The address of the principal business office of Qatar Investment Authority is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, P.O. Box 23224, Qatar.
(7) The information shown is based, in part, upon disclosures filed on a Schedule 13D/A on June 23, 2021 by PPF Capital Partners Fund B.V., PPF Group N.V. and Renata Kellnerova. The number reported consists of 14,612,275 ADSs. The principal shareholder of PPF Capital Partners Fund B.V. is PPF Group N.V., which is ultimately beneficially owned by Renata Kellnerova. The address of the principal office of each of PPF Group and PPF Capital is Strawinskylaan 933, 1077XX Amsterdam, The Netherlands. The address of the principal office of Renata Kellnerova is c/o PPF a.s., Evropská 2690/17, P.O. Box 177, 160 41 Prague 6, Czech Republic.
(8) Consists of (i) 1,066,009 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 50,000 ordinary shares issuable upon restricted stock units and (iii)) 1,142,492 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(9) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(10) Consists of (i) 79,622 ordinary shares issuable upon conversion of restricted stock units and (ii) 338,540 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(11) Consists of (i) 113,125 ordinary shares issuable upon conversion of restricted stock units and (ii) 405,416 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(12) Consists of (i) 538,677 ordinary shares, (ii) 160,064 ordinary shares issuable upon conversion of restricted ordinary shares, and (iii) 331,907 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(13) Consists of (i) 9,400 ADSs and (ii) 37,907 ordinary shares issuable upon conversion of restricted stock units and (iii) 160,417 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(14) Consists of (i) 38,657 ordinary shares issuable upon conversion of restricted stock units, and (ii) 220,508 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(15) Consists of (i) 112,211 ordinary shares issuable upon conversion of restricted ordinary shares, ii) 40,000 ordinary shares issuable upon conversion of restricted stock units and (iii) 524,581 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(16) Consists of (i) 8,198 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 19,808 ordinary shares issuable upon conversion of restricted stock units and (iii) 200,515 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(17) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(18) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(19) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(20) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(21) Consists of (i) 62,794 ordinary shares and (ii) 73,537 ordinary shares issuable upon conversion of restricted ordinary shares, and (iii) 155,697 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(22) Consists of (i) 10,000 ADSs and (ii) 187,094 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(23) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(24) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(25) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(26) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
(27) Consists of (i) 19,400 ADSs, (ii) 601,471 ordinary shares, (iii) 1,420,019 ordinary shares issuable upon conversion of restricted ordinary shares, (iv) 379,119 ordinary shares issuable upon conversion of restricted stock units and (v) 4,434,251 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
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Significant Changes in Percentage Ownership
The significant changes in the beneficial ownership percentage held by our major shareholders during the past three years result from our February 2021 and December 2022 follow-on offerings of ADSs, our February 2024 underwritten offering of ADSs, our sale of ADSs to Blackstone in November 2021 in connection with our Blackstone strategic collaboration agreement and our sale of ADSs to BioNTech in February 2024 in the BioNTech Private Placement, and the dilution resulting from these offerings.
Voting Rights
The voting rights of the principal shareholders do not differ from the voting rights of other shareholders.
Shareholders in the United States
As of December 31, 2023, assuming that all of our ordinary shares represented by ADSs are held by residents of the United States other than ADSs held by the entities set forth in the table above and certain other holders that we know to be non-residents of the United States, we estimate that appr oximately 44.1% of our outstanding ordinary shares (including ordinary shares underlying ADSs) were held in the United States by 92 hol ders of record . The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares are held in street name by brokers and other nominees. This number of holders of record also does not include holders whose shares may be held in trust by other entities.
Equity Compensation Plan Information
Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights
(a) Weighted-average exercise price of outstanding options, warrants and rights
(b) Number of securities remaining available for issuance under equity compensation plans (excluding securities reflected in column (a))
(c)
Equity compensation plans approved by security holders: 17,956,385 (1) $5.64 (2) 3,833,665 (3)
Total 17,956,385 3,833,665
(1) Includes shares issuable upon exercise of outstanding options under the 2017 Share Option Plan and shares issuable upon exercise of outstanding options and issuable upon settlement of outstanding restricted stock units under the 2018 Equity Incentive Plan.
(2) Gives effect to outstanding RSUs, which have no exercise price. Excluding the RSUs, the weighted average exercise price would be $5.64 per share.
(3) Following the adoption of the 2018 Equity Incentive Plan, no additional stock awards may be granted under the 2017 Share Option Plan. The number of shares of our common stock reserved for issuance under our 2018 Equity Incentive Plan automatically increases on October 1 of each year, from October 1, 2018 continuing through October 1, 2027, by 4% of the total number of shares of our common stock outstanding on September 30 of the same calendar year, or a lesser number of shares as may be determined by our Board.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Policies and Procedures for Related Person Transactions
We have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions. For purposes of our policy only, a related person transaction is a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we or any of our subsidiaries and any related person are, were or will be participants in which the amount involved exceeds $120,000 or which is unusual in its nature or conditions. Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. A related person is any executive officer, director or beneficial owner of more than 5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons.
For so long as we qualify as a foreign private issuer, a related person will be any:
• enterprise that directly or indirectly controls or is controlled by or is under common control with us;
• enterprise over which we have a significant influence or which has significant influence over us;
• individual owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family;
• persons having authority or responsibility for planning, directing or controlling our activities, including directors and senior management and close members of such individuals’ families; or
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• enterprise in which a substantial interest in our voting power is owned, directly or indirectly, by any person described above or over which such a person is able to exercise significant influence, including enterprises owned by our directors or major shareholders and enterprises that have a member of key management in common with us.
If we cease to be a foreign private issuer, then, under our policy, a related person will be any:
• person who is, or at any time since the beginning of our last fiscal year was, a director or member of senior management of us or a nominee to become a director of us;
• security holder known by us to be the beneficial owner of more than 5% of any class of our voting securities;
• immediate family member of any of the foregoing; and
• firm, corporation or other entity in which any of the foregoing persons is an executive, partner or principal or similar control position or in which such person has a 5% or greater beneficial ownership interest.
Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, our management must present information regarding the related person transaction to our audit committee, or, if audit committee approval would be inappropriate, to another independent body of our board of directors for review, consideration and approval or ratification. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information that we deem reasonably necessary from each director, member of senior management and, to the extent feasible, significant shareholder to enable us to identify any existing or potential related person transactions and to effectuate the terms of the policy. In addition, under our Code of Ethics, our employees, members of senior management and directors have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
Transactions with Our Principal Shareholders, Directors and Members of our Senior Management
The following is a description of related party transactions we have entered into since January 1, 2023 with our directors, members of our senior management and holders of more than 5% of our outstanding voting securities and their affiliates, whom we refer to as our related persons, in which the amount involved exceeds $120,000 and that are material to us, other than the compensation arrangements we describe in Item 11. “Executive Compensation”
License Agreement with Syncona
We entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020, a holder of more than 5% of our share capital. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the year ended December 31, 2023 , we received $0.4 million arising from the achievement of a development milestone. Consequently, we recognized license revenue of $0.4 million (net of foreign exchange differences).
2024 Underwritten Offering
In connection with our February 2024 underwritten offering, certain of our related parties purchased our ADSs from the underwriters at the public offering price of $6.00 per ADSs, and on the same terms as other investors in registered direct offering. The following table summarizes purchases of ADS by our related parties:
Related party ADSs purchased Total purchase price (in millions)
Paradigm BioCapital Advisors LP (1)
3,416,667 $ 28.0
Deep Track Capital, LP (2) 3,750,000 $ 30.0
(1) Paradigm BioCapital Advisors LP was a holder of more than 5% of our share capital as of December 31, 2023.
(2) Deep Track Capital, LP was a holder of more than 5% of our share capital as of December 31, 2023.
Agreements with Our Senior Management and Directors
We have entered into service agreements with the members of our senior management and non-executive directors. See Item 11, “Executive Compensation” These agreements contain customary provisions and representations, including confidentiality, non-competition, non-solicitation and inventions assignment undertakings by the members of our senior management. However, the enforceability of the non-competition provisions may be limited under applicable law.
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Indemnification Agreements
We have entered into a deed of indemnity with each of our directors and members of our senior management. These agreements and our Articles of Association require us to indemnify our directors and senior management to the fullest extent permitted by law.
Item 14. Principal Accountant Fees and Services
Ernst & Young LLP has served as our independent registered public accounting firm since September 2017 and has audited our consolidated financial statements for the years ended December 31, 2023 and 2022.
The following table shows the aggregate fees for services rendered by Ernst & Young LLP to us and our subsidiaries for the years ended December 31, 2023 and 2022.
Year Ended December 31,
2023 2022
(in thousands)
Audit fees $ 1,227 $ 965
Audit-related fees 81 267
Total $ 1,308 $ 1,232
Audit fees . Audit fees consisted of fees for the audit of our annual financial statements and other professional services provided in connection with the statutory and regulatory filings or engagements, including fees for the review of our interim financial information.
Audit-related fees. Audit related fees include fees for assurance reporting on our current and historical financial information included in our SEC registration statements in connection with our follow-on capital raises and our at-the-market facility program, including services that generally only the independent accountant can reasonably provide such as comfort letters.
Audit Committee Pre-Approval Policies and Procedures
Our audit committee reviews and pre-approves the scope and the cost of audit services related to us and permissible non-audit services performed by the independent auditors, other than those for de minimis services which are approved by the audit committee prior to the completion of the audit. All of the services related to us provided by Ernst & Young LLP during the year ended December 31, 2023 were pre-approved by the audit committee.
PART IV
Item 15. Exhibit and Financial Statement Schedule
(a) 1. Financial Statements
See the financial statements beginning on page F-1 of this Annual Report.
2. Financial Statement Schedules
All schedules have been omitted because they are not required, not applicable, not present in amounts sufficient to require submission of the schedule, or the required information is otherwise included.
3. Exhibit Index
EXHIBIT
NUMBER DESCRIPTION OF EXHIBIT INCORPORATED BY REFERENCE
SCHEDULE/
FORM FILE NUMBER EXHIBIT FILE
DATE
3.1 Articles of Association of Autolus Therapeutics plc.
Form F-1/A 333-224720 3.1 6/19/18
4.1 Deposit Agreement by and among the registrant, Citibank, N.A., as the Depositary bank and the holders and beneficial owners of A DSs issued thereunder.
Form F-1/A 333-224720 4.1
6/19/18
4.2 Form of American Depositary Receipt (included in exhibit 4 .1).
Form F-1/A 333-224720 4.2
6/19/18
4.3 Description of Securities
Form 20-F
001-38547 2.4 3/3/20
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4.4 Warrant issued to BXLS V – Autobahn L.P. dated November 6, 2021.
Form 6-K 001-38547 99.3
11/8/21
10.1†#
Supply Agreement, dated as of March 23, 2018, by and between the registrant and Miltenyi Biotec GmbH .
Form F-1/A
333-224720 10.2 6/8/18
10.2†#
Autolus Therapeutics plc 2018 Equity Incentive Plan.
Form F-1/A
333-224720 10.3 6/19/18
10.3+
Non-employee Sub Plan to the Autolus Therapeutics plc 2018 Equity Incentive Plan.
Form F-1/A
333-224720 10.4 6/19/18
10.4+
Management Incentive Compensation Plan.
Form F-1/A
333-224720 10.5 6/8/18
10.5+
Form of Deed of Indemnity between the registrant and each of its members of senior management and directors.
Form F-1/A 333-224720 10.6 6/8/18
10.6†#*
License Agreement, dated as of September 25, 2014 by and between the registrant and UCL Business Ltd., as amended on March 2, 2016, March 28, 2018.
Form F-1/A 333-224720 10.1
6/8/18
10.7†#*
Amendment to License Agreement, dated as of September 25, 2014 by and between the registrant and UCL Business Ltd., dated as of October 15, 2020.
Form F-1/A
001-38547
4.7
3/4/21
10.8 Autolus Therapeutics plc, Registration Rights Agreement, dated as June 26, 2018
Form 20-F
001-38547 2.3 11/23/18
10.9
Collaboration and Financing Agreement, dated as of November 6, 2021, between Autolus Limited and BXLS V — Autobahn L.P.
Form 20-F 001-38547 4.7 3/10/22
10.10 Securities Purchase Agreement by and between the Registrant and BXLS V – Autobahn L.P. dated November 6, 2021.
Form 6-K 001-38547 99.1 11/8/21
10.11 Registration Rights Agreement by and between the Registrant and BXLS V – Autobahn L.P. dated November 6, 2021.
Form 6-K 001-38547 99.2
11/8/21
10.12*†#
License and Option Agreement between the registrant and BioNTech SE, dated February 6, 2024.
10.13 Securities Purchase Agreement between the registrant and BioNTech SE, dated February 6, 2024.
Form 8-K 001-38547 10.1 2/8/24
10.14 Registration Rights Agreement between the registrant and BioNTech SE, dated February 6, 2024.
Form 8-K 001-38547 10.2
2/8/24
10.15 Letter Agreement between the registrant and BioNTech SE, dated February 6, 2024.
Form 8-K 001-38547 10.3 2/8/24
10.16†
Lease Agreement, dated September 19, 2023, between Forge Life Sciences Nominee I Limited and Forge Life Sciences Nominee 2 Limited, Autolus Limited and Autolus Therapeutics plc relating to The Nucleus Marshgate, Stevenage.
Form 10-Q 001-38547 10.1 11/9/23
10.17†
Amendment 2 to Supply Agreement, dated as of September 27, 2023, by and between Autolus Limited and Miltenyi Biotec B.V. & Co. KG.
Form 10-Q 001-38547 10.2 11/9/23
21.1*
Subsidiaries of the registrant.
23.1* Consent of Ernst & Young LLP, independent registered public accounting firm
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24.1*
Power of Attorney (included on signature page)
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Exchange Act , as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Exchange Act , as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
9 7.1 *
Policy relating to recovery of erroneously awarded compensation, as required by applicable listing standards adopted pursuant to 17 CFR 240.10D-1
101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH* XBRL Taxonomy Extension Schema Document
101.CAL* XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF* XBRL Taxonomy Extension Definition Linkbase Document
101.LAB* XBRL Taxonomy Extension Label Linkbase Document
101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
+ Indicates management contract or compensatory plan.
† Certain portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.
# Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.
* Filed herewith.
** Furnished herewith.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AUTOLUS THERAPEUTICS PLC
Date: March 21, 2024
By: /s/ Christian Itin, Ph.D.
Christian Itin, Ph.D.
Chief Executive Officer
POWER OF ATTORNEY
We, the undersigned officers and directors of Autolus Therapeutics plc, hereby severally constitute and appoint Christian Itin and Alex Driggs our true and lawful attorneys with full power to any of them, and to each of them singly, to sign for us and in our names in the capacities indicated below to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S. Securities Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and either of them, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Christian Itin, Ph.D.
Chief Executive Officer and Director
March 21, 2024
Christian Itin, Ph.D.
(Principal Executive Officer)
/s/ Robert Dolski
Chief Financial Officer
March 21, 2024
Robert Dolski
(Principal Financial Officer)
/s/ Andrew Mercieca
Vice President, Finance
March 21, 2024
Andrew Mercieca
(Principal Accounting Officer)
/s/ John Johnson
Chairman of the Board of Directors
March 21, 2024
John Johnson
/s/ Joseph Anderson, Ph.D.
Director
March 21, 2024
Joseph Anderson, Ph.D.
/s/ Robert Azelby
Director
March 21, 2024
Robert Azelby
/s/ Linda Bain
Director
March 21, 2024
Linda Bain
/s/ John Berriman
Director
March 21, 2024
John Berriman
/s/ Cynthia Butitta
Director
March 21, 2024
Cynthia Butitta
/s/ Robert Iannone, M.D., M.S.C.E.
Director
March 21, 2024
Robert Iannone, M.D., M.S.C.E
/s/ Elisabeth Leiderman, M.D.
Director
March 21, 2024
Elisabeth Leiderman, M.D.
/s/ Martin Murphy, Ph.D. Director
March 21, 2024
Martin Murphy, Ph.D.
/s/ William Young
Director
March 21, 2024
William Young
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 0 1438 )
F-2
Consolidated Balance Sheets as of December 31, 2023 and 2022
F- 4
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023, 2022 and 2021
F- 5
Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2023, 2022 and 2021
F- 6
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021
F- 7
Notes to Consolidated Financial Statements
F- 9
F-1
Table of con tents
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Autolus Therapeutics plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Autolus Therapeutics plc (the Company) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2023 and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Autolus Therapeutics plc at December 31, 2023 and 2022, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
Restatement of 2022 and 2021 Financial Statements
As discussed in Note 3 to the consolidated financial statements, the 2022 and 2021 consolidated financial statements have been restated to correct a misstatement.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Liabilities related to future royalties and sales milestones
Description of the matter As explained in note 11 to the consolidated financial statements, the Company entered into a collaboration agreement with BXLS V- Autobahn L.P (“Blackstone”) in 2021 for the development of certain CAR T therapy products for which the Company received an upfront payment and subsequently certain milestone payments which was initially recognized as a liability. The Company remeasures the liability as the present value of future royalties and sales milestones payable, when significant assumptions associated with the underlying cash flows change. The liability is sensitive to forecasts of future royalties and sales milestones payable, which are based on management estimates which include the probability of success of the clinical trial and regulatory approval (‘POS’) and the estimated selling prices of products in different territories.
Auditing the Company's measurement of the liability for future royalties and sales milestones, net is especially challenging because the calculation involves significant management judgement about future events, which are inherently uncertain. In particular, the measurement was sensitive to the Company’s estimates of the timing and likelihood of regulatory approvals and pricing of the products on which royalties will be paid.
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How we addressed the matter To test the liability related to future royalties and sales milestones, net and the related financial model our audit procedures included among others, meeting with management and its expert to understand the basis for changes in the POS and forecast selling prices. We also evaluated the reasonableness of the POS assumption, with the assistance of a specialist, by assessing analysts’ reports, industry standards and publicly available information for similar products. We evaluated the appropriateness of management’s selling price assumptions by comparing the pricing of the Company’s product with competitor pricing from publicly available information in different market segments. We evaluated the reasonableness of the underlying financial model by performing a roll-forward of the prior year valuation, performing certain sensitivity analysis on the significant assumptions and comparing it to the significant assumptions used by management. We also tested the clerical accuracy of the model.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2017.
Reading, United Kingdom
March 21, 2024
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AUTOLUS THERAPEUTICS PLC
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
Note 2023
2022
Assets
Current assets:
Cash and cash equivalents $ 239,566 $ 382,436
Restricted cash 769 325
Prepaid expenses and other current assets 7 34,967 43,010
Total current assets 275,302 425,771
Non-current assets:
Property and equipment, net 8 34,862 35,209
Prepaid expenses and other non-current assets 380 2,176
Operating lease right-of-use assets, net 18 60,791 23,210
Long-term deposits 983 1,832
Deferred tax asset 17 3,063 2,076
Total assets $ 375,381 $ 490,274
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 103 531
Accrued expenses and other liabilities 10 39,581 40,797
Operating lease liabilities, current 18 5,053 5,038
Total current liabilities 44,737 46,366
Non-current liabilities:
Operating lease liabilities, non-current 18 47,914 19,218
Liability related to future royalties and sales milestones, net
11, 23
170,899 125,900
Other long-term payables
357 116
Total liabilities 263,907 191,600
Commitments and contingencies 19
Shareholders' equity:
Ordinary shares, $ 0.000042 par value; 290,909,783 shares authorized at December 31, 2023 and 2022, 174,101,361 and 173,074,510 shares issued and outstanding at December 31, 2023 and 2022
13 8 8
Deferred shares, £ 0.00001 par value; 34,425 shares authorized, issued and outstanding at December 31, 2023 and 2022
13 — —
Deferred B shares, £ 0.00099 par value; 88,893,548 shares authorized, issued and outstanding at December 31, 2023 and 2022
13 118 118
Deferred C shares, £ 0.000008 par value; 1 share authorized, issued and outstanding at December 31, 2023 and 2022
13 — —
Additional paid-in capital 1,018,902 1,007,625
Accumulated other comprehensive loss ( 28,992 ) ( 38,898 )
Accumulated deficit ( 878,562 ) ( 670,179 )
Total shareholders' equity 111,474 298,674
Total liabilities and shareholders' equity $ 375,381 $ 490,274
The accompanying notes are an integral part of these consolidated financial statements.
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AUTOLUS THERAPEUTICS PLC
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
December 31,
Note
2023
2022
(As Restated)
2021
(As Restated)
Grant income $ — $ 166 $ 823
License revenue 4
1,698 6,194 1,507
Operating expenses:
Research and development 3
( 130,481 ) ( 117,354 ) ( 110,839 )
General and administrative ( 46,745 ) ( 31,899 ) ( 31,865 )
Loss on disposal of property and equipment ( 3,791 ) ( 515 ) ( 676 )
Impairment of operating lease right-of-use assets and related property and equipment ( 382 ) — —
Total operating expenses, net ( 179,701 ) ( 143,408 ) ( 141,050 )
Other income (expense), net 2,861 2,038 ( 145 )
Interest income 13,505 1,708 262
Interest expense
5
( 45,067 ) ( 8,905 ) ( 1,105 )
Total other expenses, net ( 28,701 ) ( 5,159 ) ( 988 )
Net loss before income tax ( 208,402 ) ( 148,567 ) ( 142,038 )
Income tax benefit (expense)
3, 17
19 ( 272 ) ( 58 )
Net loss attributable to ordinary shareholders ( 208,383 ) ( 148,839 ) ( 142,096 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 9,906 ( 30,328 ) ( 2,709 )
Total comprehensive loss $ ( 198,477 ) $ ( 179,167 ) $ ( 144,805 )
Basic and diluted net loss per ordinary share 15
$ ( 1.20 ) $ ( 1.57 ) $ ( 1.97 )
Weighted-average basic and diluted ordinary shares 15
173,941,926 94,993,400 72,084,078
The accompanying notes are an integral part of these consolidated financial statements.
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AUTOLUS THERAPEUTICS PLC
Consolidated Statements of Shareholders’ Equity
(In thousands, except share amounts)
Ordinary shares Deferred Shares Deferred B shares Deferred C Shares
Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid in Capital Accumulated other comprehensive loss Accumulated deficit Total
Balance at December 31, 2020 52,346,231 $ 3 34,425 $ — 88,893,548 $ 118 1 $ — $ 595,016 $ ( 5,861 ) $ ( 379,244 ) $ 210,032
Issuance of ordinary shares, net of issuance costs 38,202,155 1 — — — — — — 228,160 — — 228,161
Share-based compensation expense — — — — — — — — 9,937 — — 9,937
Vesting of restricted stock 163,375 — — — — — — — — — — —
Exercise of stock options 196,069 — — — — — — — 127 — — 127
Issuance of warrants, net of transaction costs — — — — — — — — 9,868 — — 9,868
Unrealized loss on foreign currency translation — — — — — — — — — ( 2,709 ) — ( 2,709 )
Net loss attributable to ordinary shareholders — — — — — — — — — — ( 142,096 ) ( 142,096 )
Balance at December 31, 2021 90,907,830 $ 4 34,425 $ — 88,893,548 $ 118 1 $ — $ 843,108 $ ( 8,570 ) $ ( 521,340 ) $ 313,320
Issuance of ordinary shares, net of issuance costs 81,927,012 4 — — — — — — 152,386 — — 152,390
Share-based compensation expense — — — — — — — — 12,014 — — 12,014
Vesting of restricted stock 76,804 — — — — — — — — — — —
Exercise of stock options 162,864 — — — — — — — 117 — — 117
Unrealized loss on foreign currency translation — — — — — — — — — ( 30,328 ) — ( 30,328 )
Net loss attributable to ordinary shareholders — — — — — — — — — — ( 148,839 ) ( 148,839 )
Balance at December 31, 2022 173,074,510 $ 8 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,007,625 $ ( 38,898 ) $ ( 670,179 ) $ 298,674
Share-based compensation expense — — — — — — — — 11,250 — — 11,250
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding 1,006,382 — — — — — — — — — — —
Reversal of restricted share forfeited 10,362 — — — — — — — — — — —
Exercise of share options 10,107 — — — — — — — 27 — — 27
Unrealized gain on foreign currency translation — — — — — — — — — 9,906 — 9,906
Net loss attributable to ordinary shareholders
— — — — — — — — — — ( 208,383 ) ( 208,383 )
Balance at Balance at December 31, 2023 174,101,361 $ 8 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,018,902 $ ( 28,992 ) $ ( 878,562 ) $ 111,474
The accompanying notes are an integral part of these consolidated financial statements.
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AUTOLUS THERAPEUTICS PLC
Consolidated Statements of Cash Flows
(In thousands)
December 31,
2023 2022 2021
Cash flows from operating activities:
Net loss attributable to ordinary shareholders $ ( 208,383 ) $ ( 148,839 ) $ ( 142,096 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 6,565 7,422 8,458
Loss on disposal of property and equipment 3,791 515 672
Share-based compensation net of amounts capitalized 11,204 12,014 9,937
Interest expense accrued on liability related to future royalties and sales milestones, net and cumulative catch-up adjustment
44,999 8,884 1,093
Foreign exchange differences ( 7,604 ) 3,996 —
Non-cash operating lease expense
4,058 3,432 3,728
Loss on lease incentive and reassessment
— — 9
Loss on termination of operating lease
95 — —
Impairment of operating lease right-of-use assets and related property and equipment 382 — —
Deferred income tax ( 986 ) ( 268 ) ( 72 )
Changes in operating assets and liabilities
Decrease (increase) in prepaid expenses and other current assets
10,695 ( 10,962 ) 5,574
Decrease in prepaid expenses and other non-current assets
1,726 161 503
Decrease (increase) in long-term deposits
937 ( 5 ) 575
(Decrease) increase in accounts payable
( 509 ) 22 ( 1,816 )
(Decrease) increase in accrued expenses and other liabilities
998 16,007 ( 2,021 )
(Decrease) increase in operating lease liability
( 13,555 ) ( 4,687 ) ( 2,405 )
Net cash used in operating activities ( 145,587 ) ( 112,308 ) ( 117,861 )
Cash flows from investing activities:
Purchases of property and equipment ( 10,986 ) ( 10,841 ) ( 8,857 )
Net cash used in investing activities ( 10,986 ) ( 10,841 ) ( 8,857 )
Cash flows from financing activities:
Proceeds of issuance of ordinary shares — 163,854 245,900
Proceeds from exercise of share options 27 117 125
Proceeds from liability related to future royalties and sales
milestones, net
— 70,000 50,000
Payments of equity issuance costs ( 910 ) ( 10,361 ) ( 11,453 )
Payments of issuance costs related to the liability related to the sale of
future royalties and sales milestones, net
— — ( 509 )
Net cash (used in) provided by financing activities ( 883 ) 223,610 284,063
Effect of exchange rate changes on cash, cash equivalents and restricted cash 15,030 ( 28,376 ) ( 754 )
Net (decrease) increase in cash, cash equivalents and restricted cash ( 142,426 ) 72,085 156,591
Cash, cash equivalents and restricted cash, beginning of period 382,761 310,676 154,085
Cash, cash equivalents and restricted cash, end of period $ 240,335 $ 382,761 $ 310,676
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AUTOLUS THERAPEUTICS PLC
Consolidated Statements of Cash Flows
(In thousands)
December 31,
2023 2022 2021
Supplemental cash flow information
Cash paid for taxes - primarily related to the United States of America
$ ( 551 ) $ ( 471 ) $ ( 364 )
Supplemental non-cash flow information
Property and equipment purchases included in accounts payable or accrued
expenses
$ 433 $ 2,864 $ 3,712
Leased assets terminated and obtained in exchange for operating lease liabilities, net $ 3 $ — $ 28,517
Leased assets obtained in exchange for operating lease liabilities $ 41,148 $ 9,785 $ 627
Capitalized share-based compensation, net of forfeitures $ 46 $ ( 6 ) $ —
Capitalized implementation costs included in accrued expenses
$ 564 $ 230 $ 100
Issuance costs included in accounts payable and accrued expenses $ 272 $ 1,103 $ 245
Warrants issued in relation to Blackstone Agreements at relative fair
value
$ — $ — $ 9,868
Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets:
Cash and cash equivalents $ 239,566 $ 382,436 $ 310,338
Restricted cash
769 325 338
Total cash, cash equivalents and restricted cash
$ 240,335 $ 382,761 $ 310,676
The accompanying notes are an integral part of these consolidated financial statements.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements
Note 1. Nature of the Business
Autolus Therapeutics plc and its subsidiaries (collectively “Autolus” or the “Company”) is a biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and attack and kill these cells. The Company believes its programmed T cell therapies have the potential to be best-in-class and offer cancer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.
The Company is a public limited company incorporated under the laws of England and Wales, and qualifies as a “foreign private issuer,” as such term is defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), and Rule 3b-4 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and, therefore, is not subject to the same requirements that are imposed upon U.S. domestic issuers by the Securities and Exchange Commission (the “SEC”). The Company has decided to voluntarily file periodic reports, such as annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K on U.S. domestic issuer forms, which are more detailed and extensive in certain respects, and which must be filed more promptly than the forms currently required for foreign private issuers. Although the Company has voluntarily chosen to file periodic reports and current reports on U.S. domestic issuer forms, the Company will maintain its status as a foreign private issuer and is not subject to certain other requirements imposed on U.S. domestic issuers including its officers, directors, and principal shareholders are not subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All intercompany accounts and transactions between the Autolus Therapeutics plc and its subsidiaries have been eliminated upon consolidation.
Going concern
In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.
As of December 31, 2023, the Company held cash and cash equivalents of $ 239.6 million and a net loss attributable to ordinary shareholders for the year the ended December 31, 2023 of $ 208.4 million. As of December 31, 2023, the Company had an accumulated deficit of $ 878.6 million. The Company concluded with its existing cash and cash equivalents of $ 239.6 million together with the total aggregate gross proceeds received post year end of $ 600.0 million ($ 250.0 million and $ 350.0 million received from BioNTech SE and an underwritten offering, respectively as further details described in Note 24 - Subsequent events) that it can fund its operations for at least the next twelve months from the date of issuance of these financial statements and as such has prepared the consolidated financial statements on the going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company's planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and accrued interest expense on liability related to future royalties and sales milestones, net and related cumulative catch-up adjustment, initial lease term of the Company's new manufacturing facility (The Nucleus), and incremental borrowing rates related to the Company's leased properties. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision maker, the Company’s Chief Executive Officer, view the Company’s operations and manages its business as a single operating segment, which is the business of developing and commercializing CAR T therapies.
Cash and cash equivalents
The Company considers cash and cash equivalents in the consolidated financial statements to include cash and highly liquid investments at financial institutions. The Company invests in variety of short-term interest-bearing instruments including money market funds, which are subject to an insignificant risk of changes in value. Cash equivalents are primarily accessible on demand and have a weighted average maturity date of less than 95 days.
Restricted Cash
The Company's restricted cash consists of cash providing security for corporate credit cards, rental deposits relating to the sub-lease of facilities to third parties and cash deposited with a financial institution for the incorporation of the Company's newly incorporated Swiss subsidiary. The Company has a security deposit relating to entered into a credit card arrangement with one of its financial institutions amounting to $ 0.6 million. In October 2021, the Company entered into two sub-leasing agreements relating to the Enfield facility, which require aggregate rental deposits of $ 0.1 million to be held by the Company. The cash deposited with a financial institution for the incorporation of Company's newly incorporated Swiss subsidiary amounted to $ 0.1 million
Fair Value Measurements
The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels:
• Level 1 — Quoted prices in active markets for identical assets or liabilities.
• Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
• Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents and restricted cash. The Company places cash and cash equivalents and restricted cash with established financial institutions with strong credit ratings. The Company holds significant amounts of cash and cash equivalents that are in excess of federally insured limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements. The Company's cash and cash equivalents are held with multiple banks and financial institutions. Management monitors the credit rating of those banks and financial institutions on a regular basis. The Company has no significant off-balance-sheet risk or concentration of credit risk, such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.
Implementation Costs in a Cloud Computing Arrangement
The Company’s cloud computing arrangements primarily comprise hosting arrangements which are service contracts, whereby the Company gains remote access to use enterprise software hosted by the vendor or another third party on an as-needed basis for a period of time in exchange for a subscription fee. Implementation costs for cloud computing arrangements are capitalized if certain criteria are met and consist of internal and external costs directly attributable to developing and configuring cloud computing software for its intended use. These capitalized implementation costs are presented in the consolidated balance sheet in prepaid expenses and other assets, current and non-current, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Property and Equipment
Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets. As of December 31, 2023 and 2022, the Company’s property and equipment consisted of office equipment, lab equipment, furniture and fittings, and leasehold improvements.
Depreciation is computed using the straight-line method over the estimated useful lives of the related assets. The following table provides the range of estimated useful lives used for each asset type:
Office equipment 3 years
Lab equipment 5 to 10 years
Furniture and fittings 5 years
Leasehold improvements shorter of the lease term or the estimated useful life of the asset
Assets under construction consist of costs incurred with leasehold improvements and, once placed into service, will be depreciated over the shorter of the lease term or the estimated useful life of the asset. Upon retirement or sale, the cost of assets disposed of, and the related accumulated depreciation, are removed from the accounts and any resulting gain or loss is included in the statement of operations and other comprehensive loss.
Repairs and maintenance expenditures, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred.
The Company routinely evaluates the useful life attributed to its assets.
Impairment of Long-Lived Assets
The Company evaluates an asset for potential impairment when events or changes in circumstances indicate the carrying value of the asset may not be recoverable. Recoverability is measured by comparing the carrying value of the asset to the expected future net undiscounted cash flows that the asset is expected to generate. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying value of the asset exceeds the fair value. The Company recognized an impairment of long-lived asset s located in the United Kingdom amounting to $ 0.4 million for the year ended December 31, 2023. The Company did not recognize any impairment of long-lived assets for the year ended December 31, 2022 and 2021 .
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet, leases with terms of one year or less. Instead, these lease payments are recognized in the statements of operations on a straight-line basis over the lease term. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as incentives received, initial direct costs, or prepayments.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
In accordance with the guidance in Topic 842, Leases (“ASC 842”), components of a lease should be split into three categories: lease components ( e.g. , land, building, etc.) and non-lease components ( e.g. , common area maintenance, consumables, etc). Many of the Company's leases contain variable non-lease components such as maintenance, taxes, insurance, and similar costs for the spaces it occupies. The Company expenses the variable lease payments in the period in which it incurs the obligation to pay such variable amounts and will be included in variable lease costs in the leases footnote disclosure. Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components.
For new and amended leases, the Company has elected the practical expedients to account for the lease and non-lease components for leases for classes of all underlying assets and allocate all of the contract consideration to the lease component only. The Company determined the underlying lease to be the predominant component, and therefore, the entire agreement was accounted for under ASC 842.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities during the adoption of ASC 842:
• As the Company's leases do not provide an implicit rate, it estimated the incremental borrowing rate for each lease based on a yield curve analysis, utilizing the interest rate derived from the fair value analysis of its existing leases and adjusting it for factors that appropriately reflect the profile of secured borrowing over the lease term. For leases existing as of the adoption date, the Company has utilized its incremental borrowing rate based on the remaining lease term as of the adoption date. For leases that commenced after the adoption date, the Company determined the incremental borrowing rate based on the lease term as determined at the commencement date of the lease.
• The expected lease terms include both contractual lease periods and, when applicable, cancellable option periods where failure to exercise such options would result in an economic penalty.
• Since the Company elected to account for the classes of underlying assets and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.
Intangible Assets Subject to Amortization
The Company’s intangible assets have been related to acquired software licenses with finite lives which are amortized over their useful lives and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount ( i.e. , the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. The Company evaluates the useful lives for these intangible assets each reporting period to determine whether events and circumstances warrant a revision in their remaining useful lives. At December 31, 2023 and 2022 these intangible assets were fully amortized.
R esearch and Development Costs
Research and development (“R&D”) costs are expensed as incurred. R&D expenses consist of costs incurred in performing R&D activities, including salaries, share-based compensation and benefits, depreciation expense, third-party license fees, external costs of outside vendors engaged to conduct clinical development activities, clinical trials, costs to manufacture clinical trial materials and certain tax credits associated with research and development activities.
UK Research and Developments Tax Credits
As a company that carries out extensive R&D activities, the Company benefits from research and development tax credits in the UK. The Company claims UK research and development tax credits under the regimes for small or medium-sized enterprises (“SME R&D tax credit”), and UK Research and Development Expenditure Credit (“RDEC”), to the extent that the Company's projects are grant funded.
The UK research and development tax credits are fully refundable to the Company and are not dependent on current or future taxable income. As a result, the Company records the entire benefit from the UK research and development tax credits as a benefit, which is included in net loss before income tax and accordingly, not reflected as part of the income tax provision. If, in the future, any UK research and development tax credits generated are needed to offset a corporate income tax liability in the UK, that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded as a reduction of research and development expenses.
The benefits from UK research and development tax credits are recognized in the statements of operations and comprehensive loss as a reduction of research and development expenses and represents the sum of the research and development tax credits recoverable in the UK.
The SME regime has been particularly beneficial to the Company, as under such program the trading losses that arise from the Company's qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreasing to 18.6% after April 1, 2023. Additionally, the UK Government has enacted further changes to the SME regime on March 4, 2024 which include the introduction of a new rate for R&D intensive companies of 27% (which the Company may qualify for) and comes into effect for expenditures incurred after April 1, 2024. Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which the Company do not receive income. A large proportion of costs in relation to the Company's pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by its wholly owned subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Under the RDEC Program, tax credits for qualifying R&D expenditure incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenditure. The headline rate of RDEC increased to 20% on April 1, 2023 and can generate cash rebates of up to 15% on qualifying R&D expenditure incurred from this date.
Amendments to the current SME and RDEC programs that are contained in the Finance Bill currently proceeding through the UK Parliament will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the UK or such workers are not subject to UK payroll taxes, and (ii) merge the SME regime and the RDEC regime into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies.
The Company currently meet the conditions of the SME regime, but also can make claims under the RDEC regime to the extent that our projects are grant funded. In addition, the Company may meet the conditions of the R&D intensive scheme and may be able to make claims under merged SME R&D intensive regime. The Company may not be able to continue in the future to qualify as a small or medium-sized enterprise under the SME Regime, based on size criteria concerning employee headcount, turnover and gross assets. If the Company ceases to qualify under the SME regime, the Company may make a claim under the RDEC regime for periods ending December 31, 2024, or the merged R&D regime from period ending December 31, 2025. It should be noted, however, that the types of qualifying expenditure in respect of which the Company may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the RDEC regime).
R&D tax credits of $ 19.5 million, $ 24.6 million and $ 24.0 million were recognized for the years ended December 31, 2023, 2022 and 2021 , respectively, and are recorded as offsets to research and development expense in our consolidated statement of operations and comprehensive loss.
Accrued Research and Development Expenses
As part of the process of preparing consolidated financial statements, the Company is required to estimate accruals for research and development expenses. This process involves reviewing and identifying services which have been performed by third parties on the Company’s behalf and determining the value of these services. In addition, the Company makes estimates of costs incurred to date but not yet invoiced, in relation to external clinical research organizations and clinical site costs. The Company analyzes the progress of clinical trials, including levels of patient enrollment; invoices received and contracted costs, when evaluating the adequacy of the accrued liabilities for research and development. The Company makes judgments and estimates in determining the accrued balance in any accounting period.
Share-Based Compensation
The Company recognizes share-based compensation expense for equity awards based on the grant date fair value of the award. The Company recognizes share-based compensation expense for awards granted to employees and non-employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche. For equity awards with a graded vesting schedule and a combination of service and performance conditions, the Company recognizes share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date. For performance conditions related to regulatory approvals those regulatory approvals are deemed probable when actually achieved. The Company accounts for forfeitures as they occur.
The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model. See Note 14, “ Share-based compensation ” , for the Company’s assumptions used in connection with share option grants made during the periods covered by these consolidated financial s tatements.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Assumptions used in the option pricing model include the following:
▪ Expected volatility. The Company lacks company-specific historical and implied volatility information for the Company's ADSs for expected terms greater than 5.5 years. Therefore, it uses a combination of the historical volatility of the ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded ADS price.
▪ Expected term . The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
▪ Risk-free interest rate . The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
▪ Expected dividend. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
▪ Fair value of ordinary shares. The fair market value of the Company’s ADSs underlying the share option is equal to the closing price of the ADSs on the Nasdaq Global Select Market on the date the grant is approved by the Compensation Committee or delegate of the Compensation Committee.
Foreign Currency Translation
The Company maintains its accounting records in its functional currency, which is pound sterling. Monetary assets and liabilities denominated in currencies other than the functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods. The Company recorded a foreign exchange gain of $ 2.6 million and $ 1.8 million for the year ended December 31, 2023 and 2022, respectively, and a foreign exchange loss of $ 2.3 million for the years ended December 31, 2021. Foreign exchange gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss.
For financial reporting purposes, the financial statements of the Company have been translated into U.S. dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to other comprehensive loss, a component of shareholders’ equity.
Patent Costs
The Company expenses patent prosecution and related legal costs as they are incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss.
Grant Income
The Company has received research grants under which it is reimbursed for specific research and development activities. Payments received are recognized as income in the statements of operations and comprehensive loss over the period in which the Company recognizes the related costs. At the time the Company recognizes grant income, it has complied with the conditions attached to it and the receipt of the reimbursement is reasonably assured. The Company has received grants from the UK government, which are repayable under certain circumstances, including breach or noncompliance. For grants with refund provisions, the Company reviews the grant to determine the likelihood of repayment. If the likelihood of repayment of the grant is determined to be remote, then the grant is recognized as grant income. The Company has determined that the likelihood of any repayment events included in its current grants is remote.
Interest Income
Interest income arises on the Company's cash and cash equivalents including money market funds and short-term deposits.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
License Revenue
The Company accounts for its revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”). The Company has no products approved for commercial sale and have not generated any revenue from commercial product sales. The revenue to date has been generated principally from out-licensing agreements with a small number of the Company's customers.
In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
License Fees and Multiple Element Arrangements
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that the Company promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer Options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.
Contingent Research Milestone Payments
ASC Topic 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, the Company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if the Company’s entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. The Company considers all relevant factors when assessing whether variable consideration should be constrained
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Accounts receivable
Accounts receivable are recorded at the invoiced amount and do not bear interest. Amounts collected on accounts receivable are included in net cash used by operating activities in the consolidated statements of cash flows. Accounts receivable are recorded within prepaid expenses and other current assets on the balance sheet.
Liability Related to Future Royalties and Sales Milestones, net and related interest expense accrued on liability related to future royalties and sales milestones, net and cumulative catch-up adjustment
The Company accounted for the Blackstone Collaboration Agreement (as defined in Note 11, “Liability relating to future royalties and sales milestones, net”) as a liability. The carrying amount of the Blackstone Collaboration Agreement liability is based on the Company’s estimate of the future royalties and sales milestones to be paid to Blackstone and the Blackstone Development Payments (as defined in the Blackstone Collaboration Agreement) to be received over the life of the arrangement as discounted using an effective interest rate. The excess estimated present value of future royalties and sales milestone payments over the initial carrying amount and future Blackstone Development Payments received, is recognized as a cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Agreement liability was approximately 15.80 % as of December 31, 2023, 2022, and 2021, respectively.
At each reporting period, the Company assesses the estimated probability, timing and amount of any future royalty and sales milestone payments to be made by the Company and Blackstone Development Payments to be received from Blackstone over the term. There are a number of factors that could materially affect the probability, amount and timing of royalty and sales milestone payments to be made by the Company and Blackstone Development Payment to be received from Blackstone, most of which are not within the Company’s control. The Blackstone Collaboration Agreement liability is recognized using significant unobservable inputs. These inputs are derived using internal management estimates developed based on third party data and reflect management’s judgements, current market conditions surrounding competing products, and forecasts. The significant unobservable inputs include regulatory approvals, estimated patient populations, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. The Company may use a specialist third party valuation team in the determining the present value of the Blackstone Collaboration Agreement liability at each reporting date. Additionally, the transaction costs associated with the liability will be amortized to accrued interest expense over the estimated term of the agreements.
Income Taxes
The Company accounts for income taxes under the asset and liability method which includes the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s financial statements. Under this approach, deferred taxes are recorded for the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. The provision for income taxes represents income taxes paid or payable for the current year plus deferred taxes. Deferred taxes result from differences between the financial statements and tax bases of the Company’s assets and liabilities and are adjusted for changes in tax rates and tax law when changes are enacted. The effects of future changes in income tax laws or rates are not anticipated.
The Company is subject to income taxes in the United Kingdom, the United States, Germany and Switzerland. The calculation of the Company’s tax provision involves the application of tax law in multiple jurisdictions and requires judgement and estimates.
The Company evaluates the realizability of its deferred tax assets at each reporting date, and establishes a valuation allowance when it is more likely than not that all or a portion of its deferred tax assets will not be realized.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the same character and in the same jurisdiction. The Company considers all available positive and negative evidence in making this assessment, including, but not limited to, the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. In circumstances where there is sufficient negative evidence indicating that the Company’s deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The Company uses a two-step approach for recognizing and measuring uncertain tax positions. The first step is to evaluate tax positions taken or expected to be taken in a tax return by assessing whether they are more likely than not sustainable, based solely on their technical merits, upon examination, and including resolution of any related appeals or litigation process. The second step is to measure the associated tax benefit or each position as the largest amount that the Company believes is more likely than not realizable. Differences between the amount of tax benefits taken or expected to be taken in the Company’s income tax returns and the amount of tax benefits recognized in its financial statements represent the Company’s unrecognized income tax benefits, which it either records as a liability or reduction of deferred tax assets.
Un-surrendered UK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits.
Comprehensive Loss
The Company follows the provisions of the Financial Accounting Standards Board (“FASB”) ASC Topic 220, Comprehensive Income , which establishes standards for the reporting and display of comprehensive income and its components. Comprehensive gain or loss is defined to include all changes in equity during a period except those resulting from investments by owners and distributions to owners.
Restructuring expenses
The Company records costs and liabilities associated with exit and disposal activities in accordance with FASB ASC Topic 420, Exit or Disposal Cost Obligations (“ASC 420”). Such costs are based on estimates of fair value in the period liabilities are incurred. The Company evaluates and adjusts these costs as appropriate for changes in circumstances as additional information becomes available. Refer to Note 22, “Severance Plan”.
Net Loss per Share
Basic and diluted net loss per ordinary share is determined by dividing net loss by the weighted average number of ordinary shares outstanding during the period. For all periods presented, the outstanding but unvested restricted shares, unvested restricted stock units (“RSU”), share options and warrants have been excluded from the calculation, due their effects being anti-dilutive in nature. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per share are the same for each period presented. Refer to Note 15, “Net loss per share” .
Recently issued accounting pronouncements not yet adopted
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures. This ASU modified the disclosure and presentation requirements primarily through enhanced disclosures of significant segment expenses and clarified that single reportable segment entities must apply Topic 280 in its entirety. This guidance is effective for the Company for the year beginning January 1, 2024, with early adoption permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statement. The Company is currently assessing the impact of this guidance on its disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company is currently assessing the impact of this guidance on its disclosures.
Note 3. Restatement of previously issued consolidated financial statements
In connection with the preparation of the Company's consolidated financial statements as of and for the year ended December 31, 2023, the Company discovered that in prior years it incorrectly accounted and presented its U.K SME tax credit in accordance with ASC 740 - Income taxes . The error resulted in an overstatement of both income tax benefit and research and development expense, and therefore total operating expenses, of $ 24.6 million and $ 24.0 million for the years ended December 31, 2022 and 2021, respectively.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
In accordance with Staff Accounting Bulletin (“SAB”) No. 99, “ Materiality ”, and SAB No. 108, “ Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements ”, the Company evaluated these errors as material to its previously issued consolidated financial statements. As a result, the Company has restated its Consolidated Statement of Operations and Comprehensive Loss. There is no effect on the Company's Consolidated Balance Sheet, Consolidated Statements of Shareholders' Equity, or Consolidated Statements of Cash Flows as of and for the years ended December 31, 2022 or 2021. Furthermore, the error had no effect on the Company's net loss attributable to ordinary shareholders or basic diluted net loss per ordinary share.
The following table presents the effect of the restatement adjustments on the Company’s Consolidated Statement of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts):
Year ended December 31, 2022
As previously Reported
Restatement adjustments
As Restated
Research and development expenses
$ ( 141,992 ) $ 24,638 $ ( 117,354 )
Total operating expenses, net
( 168,046 ) 24,638 ( 143,408 )
Income tax benefit (expense)
24,366 ( 24,638 ) ( 272 )
Basic and diluted net loss per ordinary share $ ( 1.57 ) $ — $ ( 1.57 )
Year ended December 31, 2021
As previously Reported
Restatement adjustments
As Restated
Research and development expenses
$ ( 134,789 ) $ 23,950 $ ( 110,839 )
Total operating expenses, net
( 165,000 ) $ 23,950 $ ( 141,050 )
Income tax benefit (expense)
23,892 ( 23,950 ) $ ( 58 )
Basic and diluted net loss per ordinary share $ ( 1.97 ) $ — $ ( 1.97 )
The Company has also restated its unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023. The unaudited Condensed Consolidated Statement Balance Sheet, Condensed Consolidated Statement of Changes in Equity and Condensed Consolidated Statement of Cash Flows for the periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023 were not affected by the misstatement. Furthermore, the error had no effect on the Company's unaudited net loss attributable to ordinary shareholders or basic or diluted net loss per ordinary share for each of the above mentioned quarterly periods. Refer to Note 25, “Restatement of previously issued quarterly condensed consolidated financial statements (unaudited)” for further details.
Note 4. License revenue
Revenue comprises of license revenue only for the years ended December 31, 2023, 2022 and 2021:
Total revenue by geographical location (in thousands):
Year Ended December 31,
2023 2022 2021
License revenue
United Kingdom $ 346 $ — $ —
United States 1,352 6,194 1,507
Total License revenue $ 1,698 $ 6,194 $ 1,507
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Research, Option and License Agreement with Cabaletta:
On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta Bio Inc. (“Cabaletta”), pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company's safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $ 1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement.
The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee.
The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract.
The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the one performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $ 1.2 million related to the Cabaletta Agreement for the year ended December 31, 2023.
Upon execution of the Cabaletta Agreement, the transaction price included only the $ 1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
Research, Option and License Agreement with an Investee of Syncona Portfolio Limited
The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020 relating to the Company's RQR8 technology. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, sales milestones payments and royalties on product sales. Upon the execution of the license agreement, the Company made available the RQR8 licensed know-how to investee of Syncona Portfolio Limited for a non-refundable license fee of $ 0.3 million. The Company has no further material performance obligations related to the agreement.
The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to the investee of Syncona Portfolio Limited. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as the investee of Syncona Portfolio Limited required the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract.
Upon execution of the license agreement, the transaction price included only the $ 0.3 million non-refundable license fee payable to the Company. The Company may receive further payments upon the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
During the year ended December 31, 2023 , Company received variable consideration arising from the achievement of a development milestone amounting to $ 0.35 million. Consequently, the Company recognized license revenue of $ 0.35 million (net of foreign exchange differences).
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Option and License Agreement with Bristol-Myers Squibb:
On October 3, 2022, the Company entered into an Option and License Agreement (the “BMS Agreement”) with Bristol-Myer s Squibb Company (“BMS”), pursuant to which the Company granted to BMS a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company's RQR8 technology. Upon the execution of the BMS Agreement, the Company made available the RQR8 licensed know-how to BMS for a non-refundable upfront license fee of $ 3.5 million. The Company has no further material performance obligations related to the BMS Agreement, as discussed below. BMS have agreed to pay non-refundable development milestones and low single-digit royalties based on net sales of each product covered by the licensed intellectual property.
The Company further granted to BMS the option (the “Target Option”) to expand the rights and licenses granted hereunder to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of licensed targets upon payment of an option exercise fee (“Option Exercise Fee”).
The Company identified the following material promises in the arrangement: the granting of a non-exclusive license for research and preclinical development activities as well as the initial transfer of know-how and information to BMS. The Company determined that the Option Exercise Fee was not offered at a significant and incremental discount. Accordingly, the Commercial Option did not represent a material right and, therefore, was not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation (the “BMS Combined Performance Obligation”). This is because BMS requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract: the BMS Combined Performance Obligation. The Company further determined that the up-front payment of $ 3.5 million constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the BMS Combined Performance Obligation. The amount of the transaction price allocated to the BMS Combined Performance Obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the BMS Combined Performance Obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to BMS.
Upon execution of the BMS Agreement, the transaction price included only the $ 3.5 million up-front payment owed to the Company. The Company may receive further payments upon the exercise of the Target Option, the achievement of certain milestones, as well as royalty payments that reach low-single digit based on future net sales. The Company received an upfront non-refundable cash payment of $ 3.5 million in November 2022 and recognized license revenue of $ 3.5 million for the year ended December 31, 2022.
Research, Option and License Agreement with Moderna
On June 22, 2021, the Company entered into a Research, Option and License Agreement (the “Moderna Agreement”) with Mode rnaTX, Inc. (“Moderna”), pursuant to which the Company granted to Moderna an exclusive research license to perform research and pre-clinical development activities relating to target sequences with respect to certain of the Company’s research targets and products. The Company also granted Moderna on a research target-by-research target basis, the right to obtain an exclusive commercial license upon payment of a commercial option fee of $ 2.0 million (the “Commercial Option”).
Pursuant to the Moderna Agreement, the Company received an upfront non-refundable cash payment of $ 1.5 million in October 2021 and is entitled to receive development milestones payments per product and in sales milestones payments per product from Moderna if certain clinical, regulatory and sales performance milestones are achieved. The Company is further eligible to receive royalties in the low to mid-single digits on net sales on a product-by-product basis.
The Company identified the following material promises in the arrangement: the granting of an exclusive license to research and preclinical development activities as well as the initial transfer of know-how and information to Moderna. The Company determined the Commercial Option fee was not offered at a significant and incremental discount. Accordingly, the Commercial Option did not represent a material right and, therefore, was not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation (the “Moderna Combined Performance Obligation”). This is because Moderna requires the know-how to derive benefit from the research license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract: the Moderna Combined Performance Obligation.
The Company further determined that the up-front payment of $ 1.5 million constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the Combined Performance Obligation. The amount of the transaction price allocated to the Moderna Combined Performance Obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the Moderna Combined Performance Obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Moderna.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Upon execution of the Agreement, the transaction price included only the $ 1.5 million up-front payment was owed to the Company. The Company may receive further payments upon the exercise of the Commercial Option, the achievement of certain milestones, as detailed above, as well as royalty payments that reach mid-single digits based on future net sales. In September 2022, Moderna exercised its option, pursuant to the terms of the Moderna Agreement, to obtain the commercial license of the Company’s proprietary binders against an undisclosed immuno-oncology target for the development and commercialization of mRNA therapeutics resulting in the Company recognizing $ 2.0 million of license revenue for the year ended December 31, 2022.
The future milestones, which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts were fully constrained as of December 31, 2023 and 2022 , respectively. As part of the Company’s evaluation of the constraint, it considered numerous factors, including that receipt of such milestones is outside the Company’s control. Separately, any consideration related to development milestones, sales-based milestones, as well as royalties on net sales upon commercialization by Cabaletta, BMS, Moderna and the investee of Syncona Portfolio Limited, will be recognized when the related sales occur, and therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.
For the years ended December 31, 2023, 2022 and 2021, the Company has no t recognized any variable consideration with regards to the development milestones, sales-based milestones which are included in the revenue generating license agreements with Cabaletta, BMS and Moderna. These development milestones are not yet probable and therefore no revenue has been recognized.
For the years ended December 31, 2023, 2022 and 2021 the Company has no t recognized any royalty revenue from the license agreements that were executed in the current and prior periods.
Note 5. Interest expense
Interest expense consisted of the following (in thousands):
Year Ended December 31,
2023 2022 2021
Interest expense accrued on liability related to future royalties and sales milestones, net (refer to Note 11)
$ 19,892 $ 8,005 $ 1,093
Cumulative catch-up adjustment arising from the liability related to future royalties and sales milestones, net (refer to Note 11)
25,107 879 —
Other interest expense
68 21 12
$ 45,067 $ 8,905 $ 1,105
Note 6. Fair value measurements
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
December 31, 2023
Total
Quoted Prices in Active Markets for Identical Assets (Level 1)
Significant Other Observable Inputs (Level 2)
Significant Unobservable Inputs (Level 3)
Financial assets
Cash and cash equivalents:
Money market funds
$ 184,635 $ 184,635 $ — $ —
Total
$ 184,635 $ 184,635 $ — $ —
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
December 31, 2022
Total
Quoted Prices in Active Markets for Identical Assets (Level 1)
Significant Other Observable Inputs (Level 2)
Significant Unobservable Inputs (Level 3)
Financial assets
Cash and cash equivalents:
Money market funds
$ 28,593 $ 28,593 $ — $ —
Total $ 28,593 $ 28,593 $ — $ —
Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1.
Note 7. Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following (in thousands):
December 31,
2023 2022
Research and development claims receivable $ 19,209 $ 24,685
Prepayments 8,638 12,337
VAT receivable 2,771 2,701
Deferred cost 1,787 1,494
Other receivable 1,515 1,435
Lease and lease deposit receivable 938 32
Accounts receivable 109 121
Other assets — 203
Grant income receivable — 2
Total prepaid expenses and other current assets $ 34,967 $ 43,010
Note 8. Property and equipment, net
Property and equipment, net consisted of the following (in thousands):
December 31,
2023 2022
Lab equipment $ 32,232 $ 31,188
Office equipment 3,777 3,573
Furniture and fittings 2,360 1,221
Leasehold improvements 12,728 11,688
Assets under construction 12,539 13,186
Less: accumulated depreciation ( 28,774 ) ( 25,647 )
Total property and equipment, net $ 34,862 $ 35,209
Depreciation expense recorded for the years ended December 31, 2023, 2022 and 2021 was $ 6.6 million, $ 7.3 million and $ 8.6 million, respectively.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Note 9. Intangible assets, net
The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
December 31,
2023 2022
Software licenses $ — $ 258
Less: accumulated amortization — ( 258 )
Total intangibles assets, net $ — $ —
Software licenses have an estimated useful life of 3 years. Amortization expense for the years ended December 31, 2023, 2022 and 2021 was nil , $ 65,000 and $ 90,000 , respectively.
Note 10. Accrued expenses and other liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
December 31,
2023 2022
Research and development costs $ 19,825 $ 26,478
Compensation and benefits 14,757 10,181
Professional fees 4,466 3,745
Other liabilities 533 393
Total accrued expenses and other liabilities $ 39,581 $ 40,797
Research and development costs have decreased primarily due to a reduction in clinical trials related costs relating to the Company's product candidate obe-cel.
Note 11. Liability related to future royalties and sales milestones, net
Blackstone Agreements
On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”) collectively called the “Blackstone Agreements”:
(i) Strategic Collaboration and Financing Agreement, (the “Blackstone Collaboration Agreement”);
(ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”) - refer to Note 13. “Shareholders' equity”;
(iii) Warrant Agreement (the “Blackstone Warrant”) - refer to Note 12, “Warrants"; and
(iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”).
The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate.
Blackstone Collaboration Agreement
Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $ 150 million to support the c ontinued development of the Company's CD19 CAR T cell investigational therapy product candidate, obecabtagene autoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies. These payments include (i) an upfront payment of $ 50 million and (ii) up to $ 100 million payable based on the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”)
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
In November 2021, the upfront payment of $ 50 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $ 35 million each as a result of (i) the joint steering committee’s review of Autolus’ interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL) and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. The remaining $ 30 million will be payable to the Company on the achievement on certain specified regulatory milestones. The Company considers the achievement of the specified regulatory milestone as probable when actually achieved.
In exchange for the Blackstone Development Payments, the Company agreed to make payments to Blackstone (the “Revenue Share Payments”) equal to a mid-single digit royalty, subject to the Aggregate Cap (as defined in the Blackstone Collaboration Agreement) on payments under the Blackstone Collaboration Agreement, based on net sales anywhere in the world of (i) Collaboration Products in B-cell malignancies, (ii) subject to certain conditions set forth in the Blackstone Collaboration Agreement, its CD19 and CD22 CAR T cell investigational therapy product candidate known as AUTO3 in B-cell malignancies, and (iii) certain Collaboration Products to the extent developed or commercialized in indications other than a B-cell malignancy (“Obe-cel Franchise Products”). The Company is also obligated to make payments (the “Sales Milestone Payments”), subject to the Aggregate Cap, if certain cumulative net sales levels are achieved.
The Company, and all of its subsidiaries have provided, and all of its future subsidiaries will provide, a guaranty to Blackstone of its obligations under the Blackstone Collaboration Agreement. In addition, the Company has granted a security interest in its subsidiary Autolus Limited to Blackstone in (a) intellectual property that is necessary or useful for the development, manufacture, use, commercialization, import, or export of Collaboration Products (the “Autolus IP Collateral”), (b) a segregated and blocked cash collateral account that will be established following regulatory approval of any Collaboration Product, solely for the purpose of receiving remittance of Revenue Share Payments and Sales Milestone Payments and disbursement thereof to Blackstone as provided in the Blackstone Collaboration Agreement, (c) a segregated cash collateral account established solely for the purpose of receiving Blackstone Development Payments and disbursing them for use by the Company in accordance with the terms of the Blackstone Collaboration Agreement, (d) all assets or property of the Company related to or arising from the Collaboration Products in any B-cell malignancy or the obe-cel Franchise Products in any indication other than a B-cell malignancy, and (e) all proceeds and products of each of the foregoing (collectively referred to as the “Collateral”). The security interest will be maintained until the earlier of (i) such time at which cumulative payments made by the Company under the Blackstone Collaboration Agreement equal $ 150 million and (ii) the first commercial sale in the United States of obe-cel or any other Lead Product (as defined in the Blackstone Collaboration Agreement) selected to replace obe-cel following a Program Failure (as defined in the Blackstone Collaboration Agreement) (such time, the “Release Time”).
The Blackstone Collaboration Agreement contains negative covenants that restrict the Company from, among other things, (a) granting liens or otherwise encumbering its assets that constitute Collateral, (b) paying dividends or making distributions on account or, or redeeming, retiring or purchasing any capital stock, (c) other than certain permitted licensing transactions, transferring to third parties rights to commercialize any Collaboration Product or the Autolus IP Collateral anywhere in the world and (d) selling, transferring or assigning any rights to receive payments of royalties, returns on net sales, revenue share or other compensation or license fees with respect to a Collaboration Product in a B-cell malignancy and/or obe-cel Franchise Product in any indication other than a B-cell malignancy. Each of the negative covenants is subject to exceptions and carve outs set forth in the Blackstone Collaboration Agreement. The negative covenants will fall away upon the Release Time.
Termination of the Blackstone Collaboration Agreement by Blackstone due to certain breaches of the Blackstone Collaboration Agreement or other actions by the Company will require the Company to make liquidated damage payments to Blackstone in excess of the Blackstone Development Payments.
The Company has accounted for the Blackstone Collaboration Agreement as a liability primarily due to the Company's significant continuing involvement in generating the royalty stream. If and when obe-cel is commercialized and royalties or sales milestones become payable, the Company will recognize the portion of royalties paid to Blackstone as a decrease to the Collaboration Agreement liability with a corresponding reduction in cash.
The Company concluded the Blackstone Agreements comprised of the following three units of accounting for the consideration received: (i) the Blackstone Collaboration Agreement, (ii) the purchase of ADSs, representing its ordinary shares, and (iii) Blackstone Warrants. The three units of accounting were recorded at relative fair value upon initial recognition and are not subsequently measured at fair value.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
During 2021, the Company allocated the initial total gross proceeds arising from the Blackstone Collaboration Agreement and the Blackstone Securities Purchase Agreement along with the issuance of the Blackstone Warrant among the three units of accounting on a relative fair value basis at the time of the transaction as follows:
Units of Accounting Gross proceeds (in millions)
Initial fair value
(in millions)
Allocated consideration based on relative fair value
(in millions)
Net allocated consideration based on relative fair value after transaction costs*
(in millions)
Liability related to future royalties and sales milestones, net (Blackstone Collaboration Agreement)
$ 50.0 $ 49.6 $ 46.4 $ 45.9
ADSs, representing ordinary shares 100.0 100.0 93.6 91.6
Warrants — 10.7 10.0 9.9
Total $ 150.0 $ 160.3 $ 150.0 $ 147.4
* In addition, the total shared transaction costs of $ 1.7 million, relating to the Blackstone Agreement have been allocated to the three units of accounting on a relative fair value basis.
The Company allocated the consideration and issuance costs on a relative fair value basis to the Collaboration Agreement, securities purchased and warrants issued to Blackstone which resulted in the Blackstone Collaboration Agreement being initially recognized at $ 46.4 million (relative fair value of $ 45.9 million, net of issuance costs).
The two Blackstone Development Payments received during the year ended December 31, 2022 were allocated solely to the Blackstone Collaboration Agreement liability.
Changes to the Blackstone Collaboration Agreement liability related to future royalties and sales milestones are as follows:
Amount in thousands
Balance at December 31, 2021 $ 47,016
Proceeds from Blackstone Development Payments received
70,000
Interest expense accrued on liability related to future royalties and sales milestones, net (included interest expense)
8,005
Cumulative catch-up adjustment (included in interest expense)
879
Balance at December 31, 2022 $ 125,900
Interest expense accrued on liability related to future royalties and sales milestones, net (included interest expense)
19,892
Cumulative catch-up adjustment (included in interest expense)
25,107
Balance at December 31, 2023
$ 170,899
Note 12. Warrants
On November 6, 2021, in connection with the Blackstone Agreement, pursuant to the Blackstone Warrant, the Company issued Blackstone a warrant to purchase up to 3,265,306 ADSs representing 3,265,306 of the Company's ordinary shares, at an exercise price of $ 7.35 per ADS. The Blackstone Warrant is exercisable in whole or in part until November 6, 2026.
The Blackstone Warrant mechanism does not create any obligation to transfer cash to the investor but a fixed amount of ordinary shares upon exercise. Therefore, the Company has accounted for the Blackstone Warrant as equity-classified instruments (recognized within additional paid-in capital), per ASC 815-40. The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability or whether the warrants meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own shares, among other conditions for equity classification. On November 6, 2021, the Blackstone Warrant had a relative fair value of approximately $ 10.0 million. As a result, the Company recorded a discount on the Blackstone Collaboration Agreement of $ 3.6 million during the year ended December 31, 2021. In addition, the Company also applied an offset to additional paid-in capital in an amount of $ 6.4 million related to the issuance of the Company’s ordinary shares arising from the Blackstone Securities Purchase Agreement. Refer to Note 13, “ Shareholders' equity ” .
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The fair value of each Blackstone Warrant issued was estimated on the date of issuance using the Black-Scholes option pricing model. The assumptions used in the Black Scholes option pricing model relating to the Blackstone Warrant issued in 2021 included the following:
Expected volatility. The Company lacks company-specific historical and implied volatility information for our ADSs for expected terms greater than 3.5 years. Therefore, the Company uses a combination of the historical volatility of its ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded security price.
▪ Expected term . The expected term of the Company’s warrants has been determined utilizing the contractual term of the warrants.
▪ Risk-free interest rate . The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of granting of the warrant for time periods that are approximately equal to the expected term of the award.
▪ Expected dividend. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
▪ Fair value of ordinary shares. The fair value of each ordinary share was based on the closing price of the Company's publicly traded ADSs as reported on date of issuance.
The assumptions used in the Black-Scholes option pricing model to determine the fair value of the warrants issued to Blackstone as at November 6, 2021 were as follows:
Expected warrant life (years) 5
Risk-free interest rate 1.04 %
Expected volatility 80.23 %
Expected dividend yield 0 %
The Company determined the initial fair value of Blackstone Warrant using the Black-Scholes option pricing model to be $ 10.7 million.
Note 13. Shareholders’ equity
Ordinary Shares
Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the board of directors and declared by the shareholders. As of December 31, 2023, the Company has not declared any dividends.
The Company has obtained shareholder approval to allot additional ordinary shares for a period of five years from June 2022 (being the date on which the Company's shareholders, at the Company's Annual General Meeting of Shareholders, approved an ordinary resolution containing the relevant authorization), up to a maximum nominal amount of $ 8,400 , which authorization will need to be renewed upon expiration ( i.e. , at least every five years ) but may be sought more frequently for additional five-year terms (or any shorter period).
As of December 31, 2023, the Company’s issued capital share consisted of i) 174,101,361 ordinary shares, with a nominal value of $ 0.000042 per share, (ii) 34,425 deferred shares, with a nominal value of £ 0.00001 per share, (iii) 88,893,548 B deferred shares, with a nominal value of £ 0.00099 per share and (iv) one C deferred share, with a nominal value of £ 0.000008 . Each issued share has been fully paid.
Initial Public Offering and Impact of Corporate Reorganization
On June 18, 2018, Autolus Therapeutics Limited re-registered as a public limited company and its name was changed from Autolus Therapeutics Limited to Autolus Therapeutics plc.
On June 26, 2018, the Company closed its IPO. Upon the closing of the IPO, each separate class of ordinary shares of Autolus Therapeutics plc was converted into a single class of ordinary shares of Autolus Therapeutics plc as described further below.
Prior to the Company’s June 2018 reorganization and IPO, the Company had issued series A preferred shares, ordinary B shares, and ordinary C shares to fund its operations and upon the completion of the IPO, the different classes of shares were converted into a single class of ordinary shares on a 3.185 -for-1 basis and created various classes of deferred shares.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The following deferred share classes were created:
Deferred Shares - The 34,425 deferred shares, aggregate nominal value less than $ 1.00 , existed in Autolus Limited and were re-created in Autolus Therapeutics plc as part of the share exchange to place Autolus Therapeutics as the ultimate parent entity. The Company was required to replicate the shares to ensure the existing share has the correct nominal value to ensure stamp duty mirroring relief is available on the subsequent share for share exchange. These deferred shares have no voting rights.
Deferred B Shares - The deferred shares were the product of the reorganization of the series A preferred shares and ordinary B shares into ordinary shares. The nominal residual value was utilized by management as the required £ 50,000 of share capital to re-register Autolus Therapeutics Limited as Autolus Therapeutics plc. The resulting 88,893,548 deferred shares, aggregate nominal value of $ 118,000 , is presented as a separate class of equity on the balance sheet and statement of shareholder’s equity. These deferred B shares have no voting rights.
Deferred C Share - The deferred share, nominal value less than $ 1.00 , was created when the shares in the Company were redenominated from pounds sterling to U.S. Dollars as part of the capital reduction to deal with rounding issues that would otherwise have unbalanced the company’s nominal share capital. This deferred C share has no voting rights.
February 2021 Public Offering
On February 12, 2021, the Company completed an underwritten public offering of 14,285,715 ADSs representing 14,285,715 ordinary shares at a public offering price of $ 7.00 per ADS. In addition, the underwriters exercised their right to purchase an additional 2,142,857 ADSs representing 2,142,857 ordinary shares, at a public offering price of $ 7.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 106.9 million.
Blackstone Securities Purchase Agreement
On November 6, 2021, pursuant to the Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), the Company sold 17,985,611 ADSs, representing 17,985,611 ordinary shares, at a private placement price of $ 5.56 per ADS to Blackstone, resulting in gross proceeds of $ 100 million. Aggregate net proceeds to the Company after offering expenses, were $ 98.0 million. Net allocated consideration based on relative fair value after deducting direct and allocated shared transaction costs relating to the issuance of ADSs, were $ 91.6 million. For further details of the Blackstone Agreements, see Note 11, “Liability related to future royalties and sales milestones, net” and Note 12, “Warrants”.
December 2022 Public Offering
In December 2022, the Company completed an underwritten public offering of 81,927,012 ADSs representing 81,927,012 ordinary shares, which includes the partial exercise by the underwriters to purchase an additional 6,927,012 ADSs, at a public offering price of $ 2.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 152.4 million.
February 2024 Private Placement with BioNTech SE and Underwritten Offering
Refer to Note 24, “ Subsequent events ” for further information.
Open Market Sale Agreement
In September 2020, the Company entered into an Open Market Sale Agreement, or the “Sales Agreement”, with Jefferies LLC, or Jefferies, under which the Company could, at its option, offer and sell ADSs having an aggregate offering price of up to $ 100.0 million from time to time through Jefferies, acting as sales agent. Any such sales made through Jefferies could be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act, or in other transactions pursuant to an effective shelf registration statement on Form F-3. The Company agreed to pay Jefferies a commission of 3.0 % of the gross proceeds of any sales of ADSs sold pursuant to the Sales Agreement. During the year ended December 31, 2021, the Company issued an aggregate of 3,787,972 ADSs under the Sales Agreement for net proceeds, after underwriting discounts and offering expenses, of $ 29.6 million. There were no similar sales in 2022 and 2023. The Sales Agreement expired in September 2023.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Note 14. Share-based Compensation
In February 2017, the Board adopted the 2017 Share Option Plan, or the 2017 Plan. The 2017 Plan was set to expire on February 21, 2027. The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives, or EMI, options to the Company's UK employees and for the grant of options to its U.S. employees.
In June 2018, as part of the Company's reorganization and IPO, the Company’s board of directors and shareholders approved the 2018 Equity Incentive Plan, or the 2018 Plan. The initial maximum number of ordinary shares that may be issued under the 2018 Plan was 3,281,622 . This number consists of 3,025,548 new ordinary shares and 256,074 ordinary shares that would have otherwise remained available for future grants under the 2017 Plan. The number of ordinary shares reserved for issuance under the 2018 Plan will automatically increase on October 1st of each year, for a period of not more than ten years , commencing on October 1, 2018 and ending on (and including) October 1, 2027, by an amount equal to the lesser of (i) 4 % of the total number of ordinary shares outstanding on September 30th of the same calendar year or (ii) such fewer number of ordinary shares as the board of directors may designate prior to the applicable October 1st date.
The updated maximum number of ordinary shares that may be issued under the 2018 Plan is 22,298,243 as of December 31, 2023 . The total shares issued under the 2018 Plan may be authorized but unissued shares, shares purchased on the open market, treasury shares or ADSs.
Share options granted under the 2018 Plan and 2017 Plan, as well as restricted shares granted as employee incentives, typically vest over a four-year service period with 25 % of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three-years , unless the award contains specific performance vesting provisions.
Share options granted under the 2018 Plan and 2017 Plan generally expire ten years from the date of grant. For certain senior members of management and directors, the board of directors has approved an alternative vesting schedule.
Share Option Valuation
The assumptions (see Note 2) used in the Black-Scholes option pricing model to determine the fair value of the share options granted to employees and directors during the years ended December 31, 2023, 2022 and 2021 were as follows:
Year Ended December 31,
2023 2022 2021
Expected option life (years) 5.19 to 6.08
5.27 to 6.08
5.27 to 6.08
Risk-free interest rate 3.37 % to 4.86 %
2.20 % to 4.23 %
0.62 % to 1.34 %
Expected volatility 83.25 % to 85.51 %
78.73 % to 84.79 %
80.05 % to 82.03 %
Expected dividend yield 0 % 0 % 0 %
Share Options
The table below summarizes Company's share option activity during the year ended December 31, 2023.
Number of
Options Weighted-
Average
Exercise
Price per share Weighted-
Average
Remaining
Contractual
Term
(Years) Aggregate
Intrinsic
Value (1)
(in thousands)
Outstanding as of December 31, 2022 10,310,800 $ 8.90 8.18 $ 96
Granted 8,783,330 2.29 — 36,412
Exercised ( 10,107 ) 2.69 — 11
Forfeited ( 487,607 ) 4.10 — 1,203
Expired
( 640,031 ) 13.60 — 90
Outstanding as of December 31, 2023 17,956,385 $ 5.64 8.35 $ 48,968
Exercisable as of December 31, 2023
6,318,107 $ 10.48 6.95 $ 7,601
Vested and expected to vest as of December 31, 2023 17,956,385 $ 5.64 8.35 $ 48,968
(1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of December 31, 2023
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The total intrinsic value of options exercised was $ 0.01 million, $ 0.4 million, and $ 1.2 million for the years ended December 31, 2023, 2022, and 2021, respectively. The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s underlying ordinary shares for those share options that had exercise prices lower than the fair value of the Company’s underlying ordinary shares. The total fair value of share options vested (including performance-based share options) amounted to $ 11.4 million, $ 11.1 million, and $ 13.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
The weighted average grant-date fair value of share options granted was $ 1.69 , $ 2.24 and $ 4.91 per option for the years ended December 31, 2023, 2022 and 2021 respectively.
As of December 31, 2023, the total unrecognized compensation expense related to unvested share options without performance conditions was $ 12.8 million, which the Company expects to recognize over a weighted average vesting period of 3.25 years.
Performance based share options
During the year ended December 31, 2021, the Company granted 1,602,500 share options with performance conditions related to specified regulatory milestones, of which 222,500 share options with performance conditions were forfeited. During the year ended December 31, 2021, 80,000 of these share options were modified to remove the performance conditions, thereby accelerating the vesting.
During the year ended December 31, 2022, the Company did not grant any share options with performance conditions. However, during the year ended December 31, 2022, 222,500 share options with performance conditions were forfeited. In addition, 120,000 performance-based share options were modified during the year ended December 31, 2022 to remove the performance conditions, thereby accelerating the vesting and resulting in associated share-based compensation expen se of $ 0.3 million.
During the year ended December 31, 2023, the Company granted 107,600 share options with a specified regulatory performance condition. No performance-based share options were forfeited during the year ended December 31, 2023. In addition, during the year ended December 31, 2023, 478,750 performance-based share options vested upon the achievement of the relevant regulatory milestone.
As of December 31, 2023, 2022 and 2021, a performance condition related to these performance-based share options was deemed probable. As a result, $ 1.0 million, $ 1.1 million and $ 1.4 million share-based compensation expense was recognized for the years ended December 31, 2023, 2022 and 2021, respectively. As at December 31, 2023, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $ 3.1 million, which the Company expects to recognize over a weighted average vesting period of 2.33 years.
Restricted Stock Units
An RSU award represents the right to receive one of the Company’s ADSs upon vesting of the RSU. The fair value of each RSU award is based on the closing price of the Company’s ADSs on the date of grant. Prior to 2021, the Company historically granted RSU awards with service conditions that vest over a three-year service period with 50 % of the award vesting one-and-half years from grant date and the remaining 50 % of the award vesting at the end of the third year. In January 2021, the Company awarded RSU awards that contained a performance condition based on a condition related to a specified clinical milestone. These performance-based RSU awards vest upon achievement of the related performance condition. In March 2021, the Company awarded RSU awards with service conditions that vest over a four-year service period with 25 % on the first anniversary of the grant date, and the balance vesting quarterly over the remaining three-years . In July 2021, the Company awarded RSU awards with service conditions that vest over a two-year period, with 100 % of the award vesting on the second anniversary of the grant date.
In 2022, RSUs awarded during the year typically vest over a four-year service period, with 25 % of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years . However, in September 2022, the Company awarded RSU awards with service conditions that vest over an 11-month period, with 50 % of the award vesting eight months from grant date and the remaining 50 % of the award vesting at the end of the eleventh month. In addition, in December 2022, the Company awarded RSU awards with service conditions that vest over a 15 month period, with 50 % of the award vesting twelve months from grant date and the remaining 50 % of the award vesting at the end of the fifteenth month.
In July 2023, the Company granted 90,000 RSU awards with a performance condition related to a specified regulatory milestone. These performance-based RSU awards vest upon achievement of the related performance condition.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
The following is a summary of the Company's RSU activity for the 2018 Plan for the year ended December 31, 2023:
Number of
restricted
units Weighted average
grant date
fair value
Unvested and outstanding at December 31, 2022 403,331 $ 3.50
Granted 90,000 2.54
Vested ( 351,427 ) 3.34
Forfeited ( 25,468 ) 2.65
Unvested and outstanding at December 31, 2023 116,436 $ 3.43
As of December 31, 2023, there was $ 0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which are expected to be recognized over a weighted average period of 1.69 years.
The total fair value of share RSU awards vested (including performance-based RSU awards) amounted to $ 1.3 million, $ 1.5 million, and $ 1.5 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Performance-based RSU awards
During the year ended December 31, 2021, the Company awarded an aggregate of 1,020,000 RSU awards with a performance condition related to a specified clinical milestone. As of December 31, 2021, the related clinical milestone performance condition was determined to be probable and accordingly, $ 4.4 million of share-based compensation expense was recognized.
During the year ended December 31, 2022, 617,500 of these RSU award s vested due to the achievement of a specified clinical milestone resulting in the recognition of $ 1.2 million of share-based compensation expense. A further 60,000 of these RSU award s were modified during the year ended December 31, 2022 by removing the performance condition, thereby accelerating the vesting and resulting in related share-based compensation expense of $ 0.2 million. An aggregate of 152,500 and 222,500 performance based RSU awards with performance conditions were forfeited during the year ended December 31, 2022 and 2021, respectively.
During the year ended December 31, 2023, the Company granted 90,000 RSU awards with performance condition related to a specified regulatory milestone. These performance-based RSU awards also vested during the year upon the achievement of the relevant regulatory milestone. This resulted in the recognition $ 0.2 million share-based compensation expense during the year ended December 31, 2023.
As of December 31, 2023 there was no unrecognized share-based compensation expense relating to performance based RSU awards.
During the year ended December 31, 2023, 57,624 RSU awards vested but were not issued as of December 31, 2023, and as such are not included in the Company's outstanding shares at December 31, 2023. 57,524 of these RSU awards were issued in February 2024.
Share-based compensation expense
Share-based compensation expense recorded as research and development and general and administrative expenses is as follows (in thousands):
Year Ended December 31,
2023 2022 2021
Research and development $ 6,732 $ 7,171 $ 5,241
General and administrative 4,472 4,849 4,696
Capitalized to intangible assets, net / property and equipment 46 ( 6 ) —
Total share-based compensation expense $ 11,250 $ 12,014 $ 9,937
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Note 15. Net loss per share
Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts):
Year Ended December 31,
2023 2022 2021
Numerator
Net loss $ ( 208,383 ) $ ( 148,839 ) $ ( 142,096 )
Net loss attributable to ordinary shareholders - basic and diluted $ ( 208,383 ) $ ( 148,839 ) $ ( 142,096 )
Denominator
Weighted-average number of ordinary shares used in net loss per share - basic and diluted 173,941,926 94,993,400 72,084,078
Net loss per share - basic and diluted $ ( 1.20 ) $ ( 1.57 ) $ ( 1.97 )
For all periods presented, outstanding but unvested restricted shares, unvested RSUs, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share are the same for all periods presented.
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
December 31,
2023 2022 2021
Unvested RSUs 116,436 403,331 1,089,650
Share options 17,956,385 10,310,800 7,772,455
Warrants 3,265,306 3,265,306 3,265,306
Total 21,338,127 13,979,437 12,127,411
Note 16. License Agreements
University College London Business Ltd. (UCLB) License
In September 2014, the Company entered into an exclusive license agreement (the “License”) with UCL Business Ltd. (“UCLB”), the technology transfer company of University College London (“UCL”), to obtain licenses to certain technology rights in the field of cancer therapy and diagnosis. In March 2016, the License was amended to include additional rights.
As part of the consideration for the License in September 2014, the Company issued 1,497,643 ordinary shares to UCLB. The Company paid upfront fees of £ 0.3 million and issued an additional 313,971 ordinary shares to UCLB when the License was amended in March 2016.
In March 2018, the License was further amended and restated to include a license to the Company's product candidate, obe-cel, for which UCL is conducting Phase 1 clinical trials in pediatric and adult ALL patients. The Company paid an upfront fee of £ 1.5 million for consideration for the amended and restated License and paid the additional £ 0.35 million in connection with UCLB's transfer of clinical data to the Company in December 2020. No equity was issued as part of the upfront fee consideration.
In October 2020, the License was further amended and restated to reflect the Company's election to have various patent rights assigned to the Company, and to include a license to new technology and further licenses to obe-cel for which UCL is conducting Phase 1 clinical trials in primary CNS Lymphoma patients.
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Notes to Consolidated Financial Statements — Continued
Additionally, the Company may be obligated to make payments to UCLB under the amended and restated License upon the initiation of certain clinical activities in an aggregate amount of £ 0.18 million, the receipt of specified regulatory approvals in an aggregate amount of £ 37.5 million, the start of commercialization in an aggregate amount of £ 18.0 million, and the achievement of net sales levels in an aggregate amount of £ 51.0 million, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technologies. On a per-product basis, these milestone payments range from £ 1.0 million to £ 18.5 million, depending on which T cell programming modules are used in the product achieving the milestone. The Company considers the regulatory approval and commercial milestones probable when actually achieved.
Under the terms of the license, the Company has the right to grant sub-licenses to third parties, subject to certain restrictions. If the Company receives any income in connection with such sublicenses, it must pay UCLB a percentage of the income allocable to the value of the sublicensed intellectual property rights ranging from the low twenties to mid-single digits percent, decreasing based on the development expenses incurred by us and the passage of time. During the year ended December 31, 2023, $ 0.2 million was payable to UCLB by the Company relating to the income allocable to the value of the sublicensed intellectual property rights. UCLB has retained the right to use the licensed T cell programming modules for academic research purposes at UCL and with other academic institutions, subject to certain restrictions.
Upon commercialization of any of the Company’s products that use the in-licensed patent rights, the Company will be obligated to pay UCLB a flat royalty for each licensed product ranging from the low- to mid-single digits, depending on which technologies are deployed in the licensed product, based on worldwide annual net sales of each licensed product, subject to certain reductions, including for the market entry of competing products and for loss of patent coverage of licensed products. The Company may deduct from the royalties payable to UCLB one-half of any payments made to a third party to obtain a license to such third party’s intellectual property that is necessary to exploit any licensed products. Once net sales of a licensed product have reached a certain specified threshold, the Company may exercise an option to buy out UCLB’s rights to the remaining milestone payments, royalty payments, and sublicensing revenue payments for such licensed product, on terms to be negotiated at the time.
The License expires on a product-by-product and country-by-country basis upon the expiration of the royalty term with respect to each product in each country. The Company may unilaterally terminate the license agreement for any reason upon advance notice to UCLB. Either party may terminate the License for the uncured material breach by the other party or for the insolvency of the other party. If UCLB terminates the License following the Company’s insolvency or the Company’s material breach of the License, or if the Company terminates the License unilaterally, all rights and licenses granted to the Company will terminate, and all patent rights and know-how transferred to the Company pursuant to the License will revert back to UCLB, unless and to the extent the Company has exercised its option to acquire ownership of the licensed patent rights. In addition, UCLB has the right to negotiate with the Company for the grant of an exclusive license to the Company’s improvements to the T cell programming modules the Company has licensed on terms to be agreed upon at the time.
Noile-Immune Biotech Inc.
In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc. (“Noile”) under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology. The PRIME technology is designed to improve proliferation and trafficking into solid tumors of both engineered CAR T cells as well as the patient’s own T cells.
The Company paid an upfront fee and may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals, product sales milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology.
Miltenyi Biotech B.V. & Co. KG
In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG (“Miltenyi”) under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $ 0.4 million in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023 .
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Note 17. Income Taxes
Loss before income tax benefit (expense) is as follows (in thousands):
Year Ended December 31,
2023 2022
(As Restated)
2021
(As Restated)
UK $ ( 209,766 ) $ ( 149,455 ) $ ( 142,736 )
U.S.
1,082 722 664
Switzerland and Germany
282 166 34
Net loss before income taxes
$ ( 208,402 ) $ ( 148,567 ) $ ( 142,038 )
The components of income tax benefit (expense) are as follows (in thousands):
Year Ended December 31,
2023 2022
(As Restated)
2021
(As Restated)
U.S.
Federal
$ ( 859 ) $ ( 440 ) $ ( 148 )
State and local
( 5 ) ( 19 ) ( 19 )
UK — — —
Switzerland and Germany
( 104 ) ( 26 ) ( 1 )
Total current tax benefit (expense)
( 968 ) ( 485 ) ( 168 )
U.S.
Federal
1,002 218 162
State and local
( 15 ) ( 5 ) ( 52 )
UK — — —
Switzerland and Germany
— — —
Total deferred tax benefit (expense)
987 213 110
Total income tax benefit (expense)
$ 19 $ ( 272 ) $ ( 58 )
The Company recorded an income tax benefit (expense) of $ 19.5 thousand, $ 0.3 million and $ 0.1 million, for the years ended December 31, 2023, 2022 and 2021, respectively.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
A reconciliation of income tax benefit at the U.K statutory corporate income tax rate to the income tax benefit is as follows (in thousands):
Year Ended December 31,
2023 2022
(As Restated)
2021
(As Restated)
Net loss before taxes $ ( 208,402 ) $ ( 148,567 ) $ ( 142,038 )
UK statutory tax rate 23.5 % 19.0 % 19.0 %
Income tax benefit at UK statutory tax rate ( 48,974 ) ( 28,228 ) ( 26,987 )
Tax-exempt reimbursable tax credits included within research and development expense ( 4,589 ) ( 4,681 ) ( 4,595 )
Non-deductible expenses 31,268 16,900 13,984
Adjustments in respect of prior years 96 10 167
Valuation allowance changes affecting the provision for income taxes
21,245 15,670 15,745
Other, net 961 583 1,727
Foreign rate differential ( 26 ) 18 17
Total income tax benefit (expense)
$ ( 19 ) $ 272 $ 58
Current income tax benefit 968 485 168
Deferred income tax benefit ( 987 ) ( 213 ) ( 110 )
Effective rate of income tax — % ( 0.2 )% — %
The Company is headquartered in the United Kingdom and has subsidiaries in the United Kingdom, the United States, Germany and Switzerland. The Company incurs tax losses in the United Kingdom. The UK corporate income tax rate for the year ended December 31, 2023 was 23.5%, and was 19% for the years ended December 31, 2022 and 2021, respectively. On April 1, 2023, the U.K government increased and enacted the corporate rate from 19% to 25%. The Company’s subsidiary in the United States has generated taxable profits due to a service agreement between the Company’s subsidiaries in the United States and the United Kingdom. The U.S. federal corporate income tax rate was 21% for the years ended December 31, 2023, 2022 and 2021, respectively.
Deferred tax assets and liabilities consisted of the following at December 31, 2023 and 2022 (in thousands):
December 31,
2023 2022
Deferred tax assets:
Other differences $ 14,834 $ 13,576
Tax losses 104,534 80,203
Fixed assets 6,653 4,252
Total deferred tax assets 126,021 98,031
Valuation allowances ( 122,958 ) ( 95,955 )
Net deferred tax asset $ 3,063 $ 2,076
Deferred tax assets resulting from loss carryforwards, fixed assets and retirement benefits, with total deferred tax assets increasing by $ 1.0 million in 2023. The Company has recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown. The $ 3.1 million deferred tax asset balance is related to the Company's U.S. subsidiary entity.
At December 31, 2023, the Company had UK trading losses carryforward of $ 418.1 million. These losses are carried forward indefinitely under local law, but are subject to numerous utilization criteria and restrictions.
As required by the authoritative guidance on accounting for income taxes, the Company evaluates the realizability of deferred tax assets at each reporting date. Accounting for income taxes guidance requires that a valuation allowance be established when it is more likely than not that all or a portion of the deferred tax assets will not be realized. In circumstances where there is sufficient negative evidence indicating that the deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
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Notes to Consolidated Financial Statements — Continued
The Company operates in multiple jurisdictions with complex tax and regulatory environment and its tax returns are periodically audited or subjected to review by tax authorities. The following table summarizes tax years that remain subject to examination by tax jurisdiction as of December 31, 2023:
Jurisdiction
Open Tax Years Based on Originally Filed Returns
United Kingdom
2021 - 2022
United States
2020 - 2022
Note 18. Leases
Operating Leases
In September 2017, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through May 2021, at which time the Company had the option to renew or terminate the lease. The lease had a six-month rent-free period. In December 2018, the Company executed an additional lease arrangement for additional manufacturing space for a term through September 2023, at which time the Company had the option to renew or terminate the lease. In addition, in May 2020, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a different manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through April 2024. In July 2022 the Company and Cell Therapy Catapult Limited mutually agreed: (i) to extend the lease term of a manufacturing suite leased by the Company from April 2024 to February 2025, and (ii) to reduce the lease term of a different manufacturing suite leased by the Company from July 2024 to June 2023. In March 2023, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to terminate the lease relating to the leased manufacturing suite which originally had a lease term until February 2025, (ii) to extend the lease term of one of the remaining manufacturing suites from June 2023 to August 2024, and (iii) to extend the lease term of a third manufacturing suite leased by the Company from September 2023 to August 2024.
The Company recognized a lease termination loss of $ 0.1 million, which is included in Other income (expense), net on the Consolidated Statement of Operations and Comprehensive Loss for the year ended December 31, 2023, related to the manufacturing suite terminated and exited on March 31, 2023. In addition, during the year ended December 31, 2023, the Company recognized a loss on disposal on leasehold improvements of $ 3.8 million arising from the manufacturing suite terminated and exited on March 31, 2023.
In October 2018, the Company executed an agreement to sublease office space in Rockville, Maryland for a term through October 2021. The Company then terminated the sublease in February 2020 and immediately entered into a five-year lease for the same space with the landlord. As a result of the sublease termination, the Company recognized a $ 0.2 million gain in other (expense) income in March, 2020. The lease related to this facility is classified as an operating lease. The Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
In January 2019, the Company executed a lease agreement with Whitewood Media Village GP Limited and Whitewood Media Village Nominee Limited to lease the fifth floor of MediaWorks including laboratory space. The Company has the option to terminate the lease in November 2026. In August 2021, MediaWorks became the Company's main corporate headquarters. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. The lease agreement includes an option to lease additional space. The lease term is nine years and eleven months with an eighteen-month rent free period at the beginning of the lease term.
In January 2019, the Company executed a lease agreement to lease additional office and manufacturing space in Rockville, Maryland. The lease agreement required the Company to enter into a lease provided that the landlord completed the required leasehold improvements described in the agreement. The lease commenced in August 2020 for a term through June 2036. In March 2021, the Company announced plans to move the site of its global manufacturing headquarters to the United Kingdom from the United States. As a part of this strategy, the Company entered into a termination agreement with the landlord of its Rockville, Maryland property to terminate the lease for office and manufacturing space. As a result, the Company recognized a $ 2.0 million termination fee gain from the landlord, a $ 2.3 million gain from the removal of the leased right of use asset and corresponding lease liability, and expensed $ 2.4 million of leasehold improvements for the year ended December 31, 2021 within Other income (expense), net. The $ 2.0 million termination fee was received from the landlord in April 2021.
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Notes to Consolidated Financial Statements — Continued
In February 2019, the Company agreed to enter into a fifteen-year lease for manufacturing space units located in Enfield, United Kingdom, provided that the landlord completed the required leasehold improvements described in the agreement. The Company executed these lease agreements for 3 manufacturing space units, each for fifteen-year lease terms upon such completion. The leases commenced in February 2019, with the option to terminate the lease in February 2029. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. The Company reduced the right-of-use asset and lease liability based on the contractual option termination date. The Company expensed $ 4.1 million of leasehold improvements from assets under construction as of December 31, 2019 as a result of discontinuing the fit-out of the manufacturing facility. In March 2021, one of the units was split in two separate units and the Company surrendered one of those units back to the landlord. Upon the surrender of the unit, the Company recognized a $ 0.1 million gain in other (expense) income after recognizing a termination fee of $ 0.2 million. The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit were written off during the year ended December 31, 2021. In October 2021, the Company subleased two of the three remaining units to third parties with lease terms ending in February 2029 and October 2026, respectively. Refer to “Sublease agreements” below for further details . The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of December 31, 2023.
In September 2021, the Company entered into an arrangement for lease with the landlord, Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of a new 70,000 square foot commercial manufacturing facility in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility, which is called The Nucleus, to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023. The Company was required to pay a pro-rated license fee for each portion of the facility for which the Company was granted access until the execution of a lease agreement. The Company cumulatively contributed $ 7.5 million as part as of landlord works and tenant contributions towards the lease as of December 31, 2023 resulting in these payments being taken into account in the determination of the right of use asset for this facility. On July 31, 2023, the landlord and its contractors accepted practical completion of The Nucleus. On September 19, 2023, the Company entered into a 20 -year lease agreement with the landlord for The Nucleus. The Company made fit-out costs in other areas of the building and may be required to be removed at the end of the lease term. As a result, as of December 31, 2023, the Company has recognized an estimated Asset Retirement Obligation (“ARO”) amounting to $ 0.2 million. The Company will continue to assess the ARO as more related assets are brought into use.
In September 2021, the Company also entered into a lease agreement for 2,762 square feet of laboratory and office space in Gaithersburg, Maryland, with a term until March 2024. In September 2023, the Company extended the original lease term to March 2027.
The following table shows the lease balance sheet classification of leases for the years ended December 31, 2023 and 2022 (in thousands):
As of December 31,
2023 2022
Assets
Operating lease right-of-use assets, net
$ 60,791 $ 23,210
Liabilities
Current
Operating lease liabilities, current 5,053 5,038
Non-current
Operating lease liabilities, non-current 47,914 19,218
Total lease liabilities $ 52,967 $ 24,256
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Notes to Consolidated Financial Statements — Continued
The following table shows the lease costs for the years ended December 31, 2023, 2022 and 2021 (in thousands):
Year ended December 31,
Lease costs Statement of Operations classification 2023 2022 2021
Operating lease costs Operating expenses: research and development $ 6,340 $ 3,733 $ 4,801
Variable costs Operating expenses: research and development 1,041 769 1,144
Short term lease costs Operating expenses: research and development 786 270 193
Operating lease costs Operating expenses: general and administrative 956 984 1,178
Variable costs Operating expenses: general and administrative 51 45 147
Short term lease costs Operating expenses: general and administrative 90 86 12
Total lease costs $ 9,264 $ 5,887 $ 7,475
Year ended December 31,
Other information 2023 2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash outflows from operating leases (in thousands) $ 10,407 $ 4,575
Weighted-average remaining lease term - operating leases (in years) 16 years 10.40 years
Weighted-average discount rate - operating leases 7.44 % 6.77 %
Future fixed payments for non-cancellable operating leases in effect as of December 31, 2023 are payable as follows:
Operating Leases
Maturity of lease liabilities for the years ending December 31, (in thousands)
2024
$ 7,937
2025
6,899
2026
6,667
2027
6,524
2028 5,803
Thereafter 57,038
Total lease payments 90,868
Less: imputed interest ( 37,901 )
Present value of lease liabilities $ 52,967
Sublease agreements
In October 2021, the Company entered into separate two sublease agreements with two third parties for two manufacturing spaces in Enfield which is currently leased by the Company. The annual lease payments to be received for each of subleased units is £ 97,000 and £ 109,000 , over lease terms from October 2021 to February 2029 and October 2026, respectively. In October 2021, the Company received $ 127,000 in rental deposits, arising from the sublease agreements which have been classified as restricted cash as of December 31, 2023 and 2022, respectively. Both sub-leases have been classified as operating leases. The Company recognized the sublease payments on a straight-line basis from the commencement of the sublease agreements.
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Notes to Consolidated Financial Statements — Continued
The following table shows the sub-lease rental income for the years ended December 31, 2023, 2022 and 2021 (in thousands):
Year ended December 31,
Sublease rental income
Statement of Operations classification 2023 2022 2021
Sublease rental income
Other income (expense), net
$ 241 $ 240 $ 49
Total sublease rental income
$ 241 $ 240 $ 49
Future fixed receipts for non-cancellable operating subleases in effect as of December 31, 2023 are receivable as follows:
Operating Leases
(in thousands)
2024 $ 261
2025 261
2026 203
2027 123
2028 106
Total lease payments receivable $ 954
Note 19. Commitments and Contingencies
License Agreements
The Company has entered into an exclusive license agreement, as amended, with U CLB (Refer to Note 16, “ License Agreements ” ). I n connection with the UCLB license agreement, the Company is required to make annual license payments and may be required to make payments upon the achievement of specified milestones. The Company has estimated the probability of the Company achieving each potential milestone in accordance with ASC 450, Contingencies .
In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc. (“Noile”) under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology. The Company may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals, product sales milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology.
In July 2022, the Company renegotiated a master services agreement with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from relapsed/refractory B Cell Acute Lymphoblastic Leukaemia (rrB-ALL) patients. Under the agreement, the Company is obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company's use of the Adaptive assay. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract which were deemed probable.
In August 2022, the Company entered into an agreement with Evercore Partners International LLP (“Evercore”) to act as advisors for the Company. The Company is obligated to make specified payments to Evercore upon the achievement of certain strategic transactions involving the Company. The Company became obligated to make a single low- to mid-million dollar payment upon the completion of the BioNTech Collaboration Agreement. (Refer to Note 24 - “Subsequent events”), which will be paid in the first quarter of 2024.
In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG (“Miltenyi”) under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $ 0.4 million in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023.
In November 2023, the Company entered into an agreement with goetzpartners securities Limited (“goetzpartners”) to act as advisors for the Company. The Company is obligated to make specified payments to goetzpartners upon the achievement of certain strategic transactions involving the Company. The Company became obligated to make a single low to mid million dollar payment upon the completion of the BioNTech Collaboration Agreement (Refer to Note 24 - “Subsequent events”), which was paid in the first quarter of 2024.
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Notes to Consolidated Financial Statements — Continued
The Company has estimated the probability of the Company achieving each potential milestone in relation to the license agreements with UCLB, Noile, Miltenyi and agreements with Evercore and goetzpartners in accordance with ASC 450, Contingencies . The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company considers clinical milestones recognizes clinical milestones when deemed probable. The Company concluded that, as of December 31, 2023, there were other no milestones for which the likelihood of achievement was currently probable.
Legal Proceedings
From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of December 31, 2023.
Capital Commitments
As of December 31, 2023, the Company’s unconditional purchase obligations for capital expenditure totaled $ 4.3 million and include signed orders for capital equipment and capital expenditure for construction and related expenditure relating to its properties in the United Kingdom and the United States, of which the Company expects to incur $ 0.4 million within one year, and $ 3.9 million within one to four years.
Master Supply Commitments
In March 2018, the Company entered into a long-term supply agreement with Miltenyi Biotec GmbH, or Miltenyi, for the supply of Miltenyi’s CliniMACS Prodigy instruments, reagents and disposables for the manufacture of the Company's programmed T cell therapies for preclinical and clinical use and, if approved, for commercial use, as well as support services. The supply agreement sets forth procedures to ensure continuity of supply to the Company of Miltenyi’s products, both during the clinical phase and any future commercial phase of our product candidates. After the initial ten-year term of the agreement, the Company has two separate options to renew the agreement, each for an additional five-year term. The Company has a three-month firm commitment to purchase to reagents and disposables pursuant to the agreement.
As of December 31, 2023, the Company’s unconditional purchase obligations for reagents and disposables totaled $ 0.6 million, which the Company expects to incur within one year.
Leases
Lease payments under operating leases as of December 31, 2023 and information about the Company’s lease arrangements are disclosed in Note 18, “Leases”.
Blackstone Strategic Collaboration and Financing Agreement
Refer to Note 11, “Liability related to future royalties and sales milestone, net” for further details about the Blackstone Collaboration Agreement .
Note 20. Employee Benefit Plans
In the United Kingdom and Switzerland, the Company makes contributions to defined contribution pension schemes on behalf of its employees. The Company expensed $ 2.0 million, $ 1.7 million and $ 1.6 million, in the years ended December 31, 2023, 2022 and 2021, respectively.
In the United States, the Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company matches employee contributions up to five percent of the employee’s annual salary. The Company expensed $ 0.4 million, $ 0.3 million and $ 0.3 million in contributions in the years ended in the years ended December 31, 2023, 2022 and 2021, respectively. The Company pays all administrative fees related to the Plan.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Note 21. Geographic Information
Operations by geographic area
Revenue
Revenue recognized by geographic area are disclosed in Note 4, “ Revenue ” .
Major customers
During the year ended December 31, 2023, 76 % and 20 % of the Company’s license revenues were generated from Cabaletta, and an investee of Syncona Portfolio Limited, respectively.
Long-lived assets
Long-lived assets (excluding intangibles, deferred tax and financial instruments) were located as follows (in thousands):
December 31,
2023
2022
United Kingdom
$ 94,033 $ 56,379
United States of America
1,620 2,040
Total long-lived assets
$ 95,653 $ 58,419
For the year ended December 31, 2023, the Company recognized an impairment of long-lived assets relating to the operating lease right-of-use assets and related property and equipment of $ 0.4 million related to a leased property in Stevenage, United Kingdom. There was no impairment recognized for the year ended December 31, 2022.
Note 22. Severance Plan
During January 2021 there was a restructuring program executed by the Company leading to a reduction in workforce and resulting in a corresponding severance charge of $ 1.2 million, which has been presented on a proportionate basis within research and development expenses and general and administration expenses.
There have been no similar severance charges incurred during the year ended December 31, 2023 and 2022.
Note 23. Related Party Transactions
Blackstone
On November 6, 2021, the Company concurrently entered into the Blackstone Agreements. Refer to Note 11, “Liability relating to future royalties and sales milestones, net”, Note 12, “Warrants” and Note 13, "Shareholders Equity”. Subsequent to the execution of the Blackstone Agreements, Blackstone became a related party as Blackstone owns more than 10 % of the Company's outstanding voting securities and is therefore one of the principal owners of the Company. In addition, Blackstone received the right to nominate one director to the board of directors of the Company; William Young was appointed to the Company's board of directors as Blackstone’s designee pursuant to this right.
As of December 31, 2023, the carrying amount of the Blackstone Collaboration Agreement liability was $ 170.9 million, which included accrued interest expense and cumulative catch-up adjustment , of $ 45.0 million, $ 8.9 million and $ 1.1 million for the years ended December 31, 2023, 2022, and 2021, respectively. Refer to Note 11, “Liability related to sales of future royalties and sales milestone, net” for further details.
Syncona Portfolio Limited
Syncona Portfolio Limited is a related party as Syncona Portfolio Limited owns more than 10 % of the Company's outstanding voting securities and is therefore one of the principal owners of the Company. In addition, a member of the Company's board of directors was the chair of the ultimate parent company of Syncona Portfolio Limited until November 2023.
In the Company's February 2021 public offering, Syncona Portfolio Limited purchased 3,571,428 ADSs, representing 3,571,428 ordinary shares. This purchase was made through the underwriters at the public offering price.
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Notes to Consolidated Financial Statements — Continued
December 2022 public offering
In connection with the Company’s December 2022 public offering, certain of the Company's related parties purchased the Company's ADSs from the underwriters at the public offering price of $ 2.00 per ADSs, and on the same terms as other investors in the Company's public offering. The following table summarizes purchases of ADS by the Company's related parties:
Related party ADSs purchased Total purchase price (in millions)
Syncona Portfolio Limited (1) 14,000,000 $ 28.0
Deep Track Capital, LP (2) 15,000,000 30.0
Qatar Investment Authority (3) 15,000,000 30.0
Armistice Capital, LLC (4) 10,000,000 20.0
Entities affiliated with Blackstone (5) 2,500,000 5.0
56,500,000 $ 113.0
(1) Syncona Portfolio Limited is a holder of more than 10% of the Company's share capital.
(2) In connection with this transaction, Deep Track Capital, LP became a holder of more than 5% of the Company's share capital.
(3) In connection with this transaction, Qatar Investment Authority became a holder of more than 5% of the Company's share capital.
(4) In connection with this transaction, Armistice Capital, LLC became a holder of more than 5% of the Company's share capital.
(5) Entities affiliated with Blackstone collectively hold more than 10% of the Company's share capital.
Investee of Syncona Portfolio Limited
The Company entered into a collaboration agreement in 2020 with an investee of Syncona Portfolio Limited, a holder of more than 10 % of the Company's share capital. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the year ended December 31, 2023 , Company received variable consideration arising from the achievement of a development milestone amounting to $ 0.4 million. Consequently, the Company recognized license revenue of $ 0.4 million. The Company did no t recognize any license revenue for the year ended December 31, 2022 and 2021.
Note 24. Subsequent Events
The Company evaluated subsequent events through March 21, 2024, the date on which these consolidated financial statements were is sued.
On February 6, 2024 (the “Execution Date”), the Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (UK) Limited entered into a License and Option Agreement (the “License Agreement”) with BioNTech SE (“BioNTech”) pursuant to which the Company granted to BioNTech an exclusive, worldwide, sublicensable license (the “License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”).
In addition to the License, under the License Agreement the Company has granted to BioNTech several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $ 582.0 million pursuant to the License Agreement. This maximum amount includes upfront payments, the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.
License and Options
In consideration for the License and the Options, BioNTech made an initial payment to the Company of $ 10.0 million. The Company is eligible to receive milestone payments of up to $ 32 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which reductions are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the License Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Under the terms of the License Agreement, the Company has agreed to grant BioNTech the following time-limited Options:
• an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG, in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize such product candidate;
• an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
• an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and
• an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target.
There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
Obe-cel Product Revenue Interest
Under the License Agreement, BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $ 40 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $ 100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
Manufacturing and Commercial Agreement
Under the terms of the BioNTech License Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Agreement”). The Manufacturing and Commercial Agreement, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.
Securities Purchase Agreement, Registration Rights Agreement and Letter Agreement
Concurrently with the execution of the BioNTech License Agreement, the Company and BioNTech entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company sold to BioNTech American Depositary Shares (“ADSs”), each representing one ordinary share, with a nominal value of $ 0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $ 6.00 per ADS. Aggregate gross proceeds to the Company, before underwriting discounts and offering expenses, were $ 200.0 million .
In the event that BioNTech and the Company enter into a Manufacturing and Commercial Agreement (as defined above) within 18 months of the Initial Closing, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $ 20 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.
The Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.
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Notes to Consolidated Financial Statements — Continued
Concurrently with entry into the Purchase Agreement, the Company and BioNTech entered into a letter agreement (the “Letter Agreement”) providing BioNTech with certain additional rights and subjecting BioNTech’s investment in the Company to certain restrictions. Pursuant to the Letter Agreement, BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30 % of the issued and outstanding Ordinary Shares of the Company within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights under the Letter Agreement shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, pursuant to the Letter Agreement, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
Pursuant to the Letter Agreement, subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs.
The Letter Agreement terminates upon the earlier of (a) the later of (i) three years from the Execution Date and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.
The Company and BioNTech also entered into a registration rights agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs. The foregoing descriptions of the License Agreement, the Purchase Agreement, the Registration Rights Agreement and the Letter Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.
February 2024 Underwritten Offering
On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $ 6.00 per ADS. Aggregate gross proceeds to the Company, before underwriting discounts and offering expenses, were $ 350.0 million .
Note 25. Restatement of previously issued quarterly condensed consolidated financial statements (unaudited)
The Company has restated its unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023. The unaudited Condensed Consolidated Statement Balance Sheet, Condensed Consolidated Statement of Changes in Equity and Condensed Consolidated Statement of Cash Flows for the periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023 were not affected by the restatement. Furthermore, the error had no effect on the Company's unaudited net loss to ordinary shareholders or basic or diluted net loss per ordinary share for any of the above mentioned quarterly periods.
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
March 31
2023 2022
Assets
Current assets:
Cash and cash equivalents $ 343,027 $ 268,558
Restricted cash 328 334
Prepaid expenses and other current assets 50,530 40,571
Total current assets 393,885 309,463
Non-current assets:
Property and equipment, net 34,667 31,017
Prepaid expenses and other non-current assets 465 2,119
Operating lease right-of-use assets, net 26,861 17,366
Long-term deposits 1,821 1,983
Deferred tax asset 2,272 2,000
Intangible assets, net — 46
Total assets $ 459,971 $ 363,994
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 353 153
Accrued expenses and other liabilities 34,463 24,513
Operating lease liabilities, current 4,821 4,174
Total current liabilities 39,637 28,840
Non-current liabilities:
Operating lease liabilities, non-current 22,495 15,081
Liability related to future royalties and sales milestones, net
130,805 48,806
Other long-term payables
114 124
Total liabilities 193,051 92,851
Commitments and contingencies
Shareholders' equity:
Ordinary shares, $ 0.000042 par value; 290,909,783 and 200,000,000 shares authorized at March 31, 2023 and 2022, 173,074,510 and 90,907,941 shares issued and outstanding at March 31, 2023 and 2022
8 4
Deferred shares, £ 0.00001 par value; 34,425 shares authorized, issued and outstanding at March 31, 2023 and 2022
— —
Deferred B shares, £ 0.00099 par value; 88,893,548 shares authorized, issued and outstanding at March 31, 2023 and 2022
118 118
Deferred C shares, £ 0.000008 par value; 1 share authorized, issued and outstanding at March 31, 2023 and 2022
— —
Additional paid-in capital 1,010,041 845,448
Accumulated other comprehensive loss ( 33,257 ) ( 16,025 )
Accumulated deficit ( 709,990 ) ( 558,402 )
Total shareholders' equity 266,920 271,143
Total liabilities and shareholders' equity $ 459,971 $ 363,994
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
June 30
Condensed Consolidated Balance Sheets (Unaudited) 2023 2022
Assets
Current assets:
Cash and cash equivalents $ 307,500 $ 216,437
Restricted cash 332 325
Prepaid expenses and other current assets 47,533 42,198
Total current assets 355,365 258,960
Non-current assets:
Property and equipment, net 36,857 33,794
Prepaid expenses and other non-current assets 295 1,888
Operating lease right-of-use assets, net 54,251 15,230
Long-term deposits 1,864 1,835
Deferred tax asset 2,360 2,244
Intangible assets, net — 25
Total assets $ 450,992 $ 313,976
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 3,878 162
Accrued expenses and other liabilities 30,954 31,360
Operating lease liabilities, current 6,231 3,995
Total current liabilities 41,063 35,517
Non-current liabilities:
Operating lease liabilities, non-current 44,707 13,208
Liability related to future royalties and sales milestones, net
135,764 50,615
Other long-term payables
122 115
Total liabilities 221,656 99,455
Commitments and contingencies
Shareholders' equity:
Ordinary shares, $ 0.000042 par value; 290,909,783 shares authorized at June 30, 2023 and 2022, 173,680,872 and 90,909,783 shares issued and outstanding at June 30, 202 and 2022
8 4
Deferred shares, £ 0.00001 par value; 34,425 shares authorized, issued and outstanding at June 30, 2023 and 2022
— —
Deferred B shares, £ 0.00099 par value; 88,893,548 shares authorized, issued and outstanding at June 30, 2023 and 2022
118 118
Deferred C shares, £ 0.000008 par value; 1 share authorized, issued and outstanding at June 30, 2023 and 2022
— —
Additional paid-in capital 1,012,709 848,370
Accumulated other comprehensive loss ( 27,957 ) ( 33,510 )
Accumulated deficit ( 755,542 ) ( 600,461 )
Total shareholders' equity 229,336 214,521
Total liabilities and shareholders' equity $ 450,992 $ 313,976
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
September 30
Condensed Consolidated Balance Sheets (Unaudited) 2023 2022
Assets
Current assets:
Cash and cash equivalents $ 256,415 $ 163,053
Restricted cash 434 315
Prepaid expenses and other current assets 51,533 48,943
Total current assets 308,382 212,311
Non-current assets:
Property and equipment, net 34,637 32,474
Prepaid expenses and other non-current assets 136 1,718
Operating lease right-of-use assets, net 59,403 13,235
Long-term deposits 943 1,688
Deferred tax asset 2,597 2,396
Intangible assets, net — 8
Total assets $ 406,098 $ 263,830
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 661 334
Accrued expenses and other liabilities 31,388 34,669
Operating lease liabilities, current 5,491 3,815
Total current liabilities 37,540 38,818
Non-current liabilities:
Operating lease liabilities, non-current 46,967 11,310
Liability related to future royalties and sales milestones, net
140,778 52,443
Other long-term payables
295 105
Total liabilities 225,580 102,676
Commitments and contingencies
Shareholders' equity:
Ordinary shares, $ 0.000042 par value; 290,909,783 shares authorized at September 30, 2023 and 2022, 173,936,794 and 91,132,356 shares issued and outstanding at September 30, 2023 and 2022
8 4
Deferred shares, £ 0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2023 and 2022
— —
Deferred B shares, £ 0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2023 and 2022
118 118
Deferred C shares, £ 0.000008 par value; 1 share authorized, issued and outstanding at September 30, 2023 and 2022
— —
Additional paid-in capital 1,015,577 851,824
Accumulated other comprehensive loss ( 33,794 ) ( 47,564 )
Accumulated deficit ( 801,391 ) ( 643,228 )
Total shareholders' equity 180,518 161,154
Total liabilities and shareholders' equity $ 406,098 $ 263,830
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended March 31, 2023
Three Months Ended March 31, 2022
As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
Grant income $ — $ — $ 166 $ 166
License revenue 1,292 1,292 — —
Operating expenses:
Research and development ( 31,344 ) 3,956 ( 27,388 ) ( 33,963 ) 5,598 ( 28,365 )
General and administrative ( 9,284 ) ( 9,284 ) ( 7,987 ) ( 7,987 )
Loss on disposal of property and equipment ( 3,768 ) ( 3,768 ) — —
Total operating expenses, net ( 43,104 ) 3,956 ( 39,148 ) ( 41,784 ) 5,598 ( 36,186 )
Other income (expense), net 782 782 860 860
Interest income 3,446 3,446 28 28
Interest expense
( 4,905 ) ( 4,905 ) ( 1,790 ) ( 1,790 )
Total other expenses, net ( 677 ) — ( 677 ) ( 902 ) — ( 902 )
Net loss before income tax ( 43,781 ) 3,956 ( 39,825 ) ( 42,686 ) 5,598 ( 37,088 )
Income tax benefit
3,970 ( 3,956 ) 14 5,624 ( 5,598 ) 26
Net loss attributable to ordinary shareholders ( 39,811 ) — ( 39,811 ) ( 37,062 ) — ( 37,062 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 5,641 5,641 ( 7,455 ) ( 7,455 )
Total comprehensive loss $ ( 34,170 ) $ — $ ( 34,170 ) $ ( 44,517 ) $ — $ ( 44,517 )
Basic and diluted net loss per ordinary share $ ( 0.23 ) $ — $ ( 0.23 ) $ ( 0.41 ) $ — $ ( 0.41 )
Weighted-average basic and diluted ordinary shares 173,825,825 173,825,825 173,825,825 90,914,175 90,914,175 90,914,175
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended June 30, 2023
Three Months Ended June 30, 2022
As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
Grant income $ — $ — $ — $ —
License revenue — — — —
Operating expenses:
Research and development ( 36,742 ) 3,510 ( 33,232 ) ( 38,212 ) 7,418 ( 30,794 )
General and administrative ( 11,122 ) ( 11,122 ) ( 8,269 ) ( 8,269 )
Loss on disposal of property and equipment ( 23 ) ( 23 ) — —
Total operating expenses, net ( 47,887 ) 3,510 ( 44,377 ) ( 46,481 ) 7,418 ( 39,063 )
Other income (expense), net 482 482 ( 1,331 ) ( 1,331 )
Interest income 3,403 3,403 89 89
Interest expense
( 5,020 ) ( 5,020 ) ( 1,810 ) ( 1,810 )
Total other expenses, net ( 1,135 ) — ( 1,135 ) ( 3,052 ) — ( 3,052 )
Net loss before income tax ( 49,022 ) 3,510 ( 45,512 ) ( 49,533 ) 7,418 ( 42,115 )
Income tax benefit (expense) 3,470 ( 3,510 ) ( 40 ) 7,474 ( 7,418 ) 56
Net loss attributable to ordinary shareholders ( 45,552 ) — ( 45,552 ) ( 42,059 ) — ( 42,059 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 5,300 5,300 ( 17,485 ) ( 17,485 )
Total comprehensive loss $ ( 40,252 ) $ — $ ( 40,252 ) $ ( 59,544 ) $ — $ ( 59,544 )
Basic and diluted net loss per ordinary share $ ( 0.26 ) $ — $ ( 0.26 ) $ ( 0.46 ) $ — $ ( 0.46 )
Weighted-average basic and diluted ordinary shares 173,860,491 173,860,491 173,860,491 90,931,964 90,931,964 90,931,964
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AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended September 30, 2023
Three Months Ended September 30, 2022
As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
Grant income $ — $ — $ — $ —
License revenue 406 406 2,369 2,369
Operating expenses:
Research and development ( 37,237 ) 4,919 ( 32,318 ) ( 37,632 ) 6,147 ( 31,485 )
General and administrative ( 10,611 ) ( 10,611 ) ( 8,231 ) ( 8,231 )
Impairment of operating lease right-of-use assets and related property and equipment ( 382 ) ( 382 ) — —
Total operating expenses, net ( 47,824 ) 4,919 ( 42,905 ) ( 43,494 ) 6,147 ( 37,347 )
Other income (expense), net ( 1,597 ) ( 1,597 ) ( 3,740 ) ( 3,740 )
Interest income 3,646 3,646 165 165
Interest expense
( 5,014 ) ( 5,014 ) ( 1,850 ) ( 1,850 )
Total other expenses, net ( 2,965 ) — ( 2,965 ) ( 5,425 ) — ( 5,425 )
Net loss before income tax ( 50,789 ) 4,919 ( 45,870 ) ( 48,919 ) 6,147 ( 42,772 )
Income tax benefit
4,940 ( 4,919 ) 21 6,152 ( 6,147 ) 5
Net loss attributable to ordinary shareholders ( 45,849 ) — ( 45,849 ) ( 42,767 ) — ( 42,767 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment ( 5,837 ) ( 5,837 ) ( 14,054 ) ( 14,054 )
Total comprehensive loss $ ( 51,686 ) $ — $ ( 51,686 ) $ ( 56,821 ) $ — $ ( 56,821 )
Basic and diluted net loss per ordinary share $ ( 0.26 ) $ — $ ( 0.26 ) $ ( 0.47 ) $ — $ ( 0.47 )
Weighted-average basic and diluted ordinary shares 173,984,101 173,984,101 173,984,101 91,240,801 91,240,801 91,240,801
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