Item 9A. Controls and Procedures
ITEM 9A – CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and co-principal financial officers, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined under Rules 13a-14(c) and 15d-14(c) promulgated under the Securities Exchange Act of 1934, as amended (Exchange Act), as of June 30, 2020. Based on that evaluation, our principal executive officer and our co-principal financial officers concluded that the design and operation of our disclosure controls and procedures were effective. The design of any system of controls 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, regardless of how remote. However, management believes that our system of disclosure controls and procedures are designed to provide a reasonable level of assurance that the objectives of the system will be met.
Management’s Annual Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance concerning both the reliability of our financial reporting and the preparation of our financial statements in accordance with generally accepted accounting principles. This control includes policies and procedures that obligate us to maintain reasonably detailed records that accurately and fairly reflect our transactions and the disposition of our assets, provide assurance that our transactions are properly recorded, ensure that our receipts and expenditures are authorized by management and, where applicable, our board of directors, and prevent or allow us to timely detect material unauthorized acquisitions, uses or dispositions of our assets.
We have evaluated the effectiveness of our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control Integrated Framework (2013). This evaluation was performed under the supervision and with the participation of our management, including our chief executive officer and our co-principal financial officers and principal accounting officer, all of whom concluded that our internal control over financial reporting was effective as of June 30, 2020. Our evaluation of the effectiveness of our internal control over financial reporting in future periods may differ due to changing conditions or non-compliance with the policies and procedures we have established.
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Changes in Internal Control over Financial Reporting
There have not been any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B – OTHER INFORMATION
Not applicable
PART III
ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Board Membership and Board Committees
The directors serving the Company as of June 30, 2020 were as follows:
Audit
Compensation
Nominations
Litigation
Name
Type
Age
Committee
Committee
Committee
Committee
Lori Woods, Chief Executive Officer
Employee
57
N/A
N/A
N/A
N/A
Philip Vitale, MD
Independent
74
Member
Chairman
Member
N/A
Alan Hoffmann
Independent
59
Chairman
Member
Member
Chairman
Michael McCormick, Chairman
Independent
57
Member
Member
Chairman
Member
Each member of the Board of Directors serves a one-year term and is subject to reelection at the Company’s Annual Meeting of Stockholders held each year.
The Company’s directors, as named above, will serve until the next annual meeting of the Company’s stockholders or until their successors are duly elected and have qualified. Directors will be elected for one-year terms at the annual stockholders meeting. There is no arrangement or understanding between any of the directors or officers of the Company and any other person pursuant to which any director or officer was or is to be selected as a director or officer, and there is no arrangement, plan or understanding as to whether non-management stockholders will exercise their voting rights to continue to elect the current directors to the Company's board. There are also no arrangements, agreements or understandings between non-management stockholders that may directly or indirectly participate in or influence the management of the Company’s affairs.
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Lori Woods – Ms. Woods has been a Director of the Company since June 4, 2018 and brings more than 30 years of experience in the healthcare industry and is particularly well-known and respected in the brachytherapy community. Ms. Woods returned to Isoray after previously serving as Vice President from 2006 to February 2008, at which time she was appointed Acting Chief Operating Officer before her appointment to Chief Operating Officer in February 2009, a position she held until January 2010. Beginning in February 2016, and continuing until her appointment as Interim CEO on June 4, 2018, Ms. Woods served as a senior consultant to Isoray. Ms. Woods was appointed CEO of the Company on December 12, 2018. From February 16, 2016 to June 3, 2018, Ms. Woods was a founder of Medvio, LLC, a medical device consulting company focused on the urology and oncology space. During her time at Medvio she worked with large public and international medical device companies, supporting the approval process and distribution of products in diverse international markets. Further, she worked with various partners to develop proprietary technologies for the colorectal and liver treatment markets. Previously, from January 2002 to July 2006, Ms. Woods served as Chief Executive Officer of Pro-Qura, Inc., a privately-owned cancer treatment management company focused on the quality delivery of brachytherapy treatments for prostate cancer. She has also served as the Director of Business Development for the Tumor Institute Radiation Oncology Group and the Seattle Prostate Institute (SPI) in Seattle, WA. SPI was an early innovator in prostate brachytherapy treatments and assisted in the training of more than 2,000 physicians in the use of prostate brachytherapy. Ms. Woods served as a board member of the Northwest division of the Juvenile Diabetes Research Foundation, focusing on their digital awareness programs, including their website and SEO strategy, and their public relations efforts. Ms. Woods earned a Bachelor of Science degree in Business Administration – Marketing and Communications from Loma Linda University, CA. Ms. Woods brings to the Board extensive experience and credibility in the brachytherapy industry and strong relationships with suppliers and distributors of brachytherapy products.
Philip Vitale, MD – Dr. Vitale has been a Director of the Company since 2014 and is a board certified urologist. He practiced Urology from 1978 to 2005 at Lovelace Health Systems in Albuquerque. He also served on the Board of Governors for 9 years and held various administrative positions including Chief Medical Officer and Senior Vice President at Lovelace. He was a staff urologist at Albuquerque VA Medical Center from 2005 until his retirement in November 2014. He served as Chief of the Urology section from 2008 to November 2013. Dr. Vitale was also an Assistant Professor at the University of New Mexico, Division of Urology. He is a member of the American Urological Association and the South Central Section of the American Urological Association. Prior to his retirement, Dr. Vitale’s clinical trials included: chemotherapy after prostatectomy (cap); a phase III randomized study for high risk prostate carcinoma; RTOG 0415 a phase III randomized study of hypofractionated 3d-crt/IMRT versus conventionally fractionated 3d-crt/IMRT in patients with favorable-risk prostate cancer; RTOG 0815 a phase III prospective randomized trial of dose-escalated radiotherapy with or without short-term androgen deprivation therapy for patients with intermediate-risk prostate cancer; and YP19A1 gene and pharmacogenetics of response to testosterone therapy. Dr. Vitale holds a B.A. in Biology from LaSalle College and obtained his M.D. from the New Jersey College of Medicine and Dentistry. He received his M.S. in Health Services Administration from the College of St. Francis. Dr. Vitale brings to the Board medical expertise in the industries the Company is targeting.
Alan Hoffmann – Mr. Hoffmann has been a Director of the Company since January 2016. He is the owner of Alan Hoffmann, CPA, PC, a certified public accounting firm he founded in 1996. The firm performs audits and reviews of private companies. In addition, Mr. Hoffmann currently serves as CFO for Cognitive Research Corporation, a privately-held, full-service contract research organization that specializes in central nervous system product development for pharmaceutical, nutraceutical, biotechnology and medical device companies. In 2011, he served as CFO for an international manufacturing company, Kinematics Manufacturing, Inc. His prior employment included Price Waterhouse from 1985-1989, and local firms in Arizona from 1989 to 1996, where he held multiple positions including Senior Tax Analyst, and Tax Manager. After receiving his undergraduate accounting degree with honors from the University of Wisconsin-Milwaukee in 1985, he became a Certified Public Accountant in 1989. He also served in the United States Marine Corps and was honorably discharged in 1985. He brings over 33 years of public accounting experience to the Company and the Board. Mr. Hoffmann brings to the Board his experience as a public accountant and understanding of oversight and review of financial statements prepared by the Chief Financial Officer.
Michael McCormick – Mr. McCormick has been a Director of the Company since June 2015 and brings over 25 years of senior executive positions in global management, sales, and marketing to the Company. He was appointed Chairman of the Board effective as of June 4, 2018. He serves as a founder and partner of GO Intellectual Capital, which offers marketing services with a focus on the medical and aviation industries, as well as financial services. Previous to his service with GO, Mr. McCormick served as Executive Vice President of Global Sales and Marketing for Columbia Sportswear from 2006-2012, where his team successfully launched several new patented technologies, including Omni-Heat® Reflective and Omni-Freeze® Zero. During Mr. McCormick’s tenure, Columbia built an intellectual property portfolio with over 200 patents. Mr. McCormick started his career with Nike, working in several senior management roles and ultimately becoming the Director of National Sales, U.S., prior to his departure in 1999. He also served as Chief Marketing Officer of Golf Galaxy from 2003-2006 and Executive Vice President of Global Sales and Marketing of Callaway Golf from 2000-2003. Mr. McCormick brings over 26 years of marketing experience in a diverse group of industries to his service on the Company’s Board.
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Executive Officers
The executive officers serving the Company as of September 24, 2020 were as follows:
Name
Age
Position Held
Lori Woods 1
58
Chief Executive Officer, Director
Jonathan Hunt
53
Chief Financial Officer, Co-Principal Financial Officer
Mark Austin 2
33
Controller, Co-Principal Financial and Principal Accounting Officer, Corporate Secretary
William Cavanagh III
54
Chief Research and Development Officer
Michael Krachon 3
49
Executive Vice President, Sales and Marketing
Jennifer Streeter 4
51
Chief Operating Officer, Vice President, Human Resources
Krista Cline 5
38
Director of Operations
1.
Ms. Woods’ biographical information is incorporated by reference in the board membership section of Part III, Item 10.
2.
Effective September 15, 2020, Mr. Austin was appointed Corporate Secretary.
3.
Effective June 23, 2020, Mr. Krachon was appointed Executive Vice President of Sales and Marketing.
4.
Effective June 23, 2020, Mrs. Streeter was appointed Chief Operating Officer.
5.
Ms. Cline also served as Corporate Secretary until September 15, 2020.
Jonathan Hunt – Mr. Hunt was appointed as Chief Financial Officer of the Company on December 3, 2018. On February 12, 2019, Mr. Hunt was appointed as Co-Principal Financial Officer. Before joining the Company, Mr. Hunt was Chief Financial Officer at Vivid Learning Systems, an online safety training company, from 2009 to 2018, where he had a central role in its turnaround, including growing revenues and implementing financial policy and process changes that ultimately resulted in the successful sale of the business. Mr. Hunt previously served as Chief Financial Officer of the Company from 2006 to 2009. Prior to that, Mr. Hunt worked at Hypercom Corporation, a global provider of electronic payment solutions and manufacturer of credit card terminals, where he served as Assistant Corporate Controller from 2005 to 2006. Mr. Hunt holds a Bachelor of Science, Accountancy, and a Masters of Accountancy degree from Brigham Young University.
Mark Austin – Mr. Austin has served as Controller, Principal Financial and Accounting Officer, since July 2017 and Co-Principal Financial Officer since February 12, 2019. On September 15, 2020, Mr. Austin was appointed Corporate Secretary. Prior to joining the Company, Mr. Austin practiced as a Certified Public Accountant with the accounting firm KPMG where he worked from October 2009 to July 2017. At KPMG, Mr. Austin served as a Senior Manager and before that, as a Manager and Senior Associate in Portland, Oregon, where he served as lead for financial statement and internal control audits within the technology industry, including for software and manufacturing companies. While at KPMG, Mr. Austin served as lead manager for a global public company; supervised, coached, and lead teams and team members; and researched technical accounting issues relevant to the technology industry. Mr. Austin holds a Bachelor of Science in Commerce degree in Accounting, from Santa Clara University, in Santa Clara, California.
William Cavanagh III – Mr. Cavanagh joined Isoray Medical, Inc. in January 2010 and served as Vice President, Research and Development until March 3, 2016, other than serving as interim Chief Executive Officer for Isoray from January 7, 2016 to February 14, 2016. He was appointed Chief Operating Officer of Isoray effective March 3, 2016 and Chief Scientific Officer effective August 15, 2016 and served in these positions until February 12, 2019. On February 12, 2019, Mr. Cavanagh was appointed to the position of Chief Research and Development Officer. Immediately prior to joining Isoray Medical, Mr. Cavanagh was engaged in the research and development of dendritic cell therapies for cancer and infectious diseases. He served as Chief Scientific Officer for Sangretech Biomedical, LLC for the six years prior to joining Isoray Medical. At Sangretech, he oversaw the design and implementation of a novel cancer therapy. Mr. Cavanagh began his extensive career in cancer treatment technologies in the early 1990s, when he helped lead research and development of a therapy involving the insertion of radioactive sources directly into the prostate for the treatment of prostate cancer (prostate brachytherapy). He has designed several cancer treatment-related studies, is listed as an author on 34 peer-reviewed publications and is the listed inventor on a U.S. patent application detailing a novel treatment for cancer. Mr. Cavanagh has also served as Director of the Haakon Ragde Foundation for Advanced Cancer Studies in Seattle, Washington, where he led the research foundation in the selection of viable research projects directed at treating advanced cancers. Mr. Cavanagh holds a B.S. in Biology from the University of Portland (Oregon) and attended two years of medical school before beginning his career in research management.
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Michael Krachon – Mr. Krachon brings more than 20 years’ experience of progressive growth in sales and marketing in the medical industry to the Company. He joined Isoray in March 2016 as Vice President, Sales and Marketing and on June 23, 2020, was appointed Executive Vice President of Sales and Marketing. Prior to joining Isoray, Mr. Krachon was employed by C.R. Bard Inc. since 2001, and was a key member of the Bard Urological and Medical Division which developed brachytherapy devices and delivery systems for the U.S. and international markets. He was the leader of the brachytherapy commercial team, which grew to be the global brachytherapy market leader. Mr. Krachon assisted in the business unit’s strategic planning, development of the international business segment and creating and delivering the international product launches which resulted in market leadership across Europe, Japan and Africa. His responsibilities included: the development of strategic brachytherapy sales and marketing programs; the implementation of industry leading national and international training programs; and supporting the product development process. Finally, Mr. Krachon has been instrumental in successfully supporting the industry through congressional lobbying efforts to establish and maintain reimbursement codes for brachytherapy. He served as Chairman of the Coalition for Advancement of Brachytherapy from 2009 to 2016 and has been recognized as a national speaker for brachytherapy by the industry. Mr. Krachon received a B.S.E. in biomedical engineering from Duke University and his M.B.A. from the Goizueta Business School at Emory University.
Jennifer Streeter – Mrs. Streeter brings more than 10 years’ experience of progressive growth in the Human Resources field. She joined Isoray in July 2016 as Vice President of Training. In September 2016, she accepted responsibility as Vice President of Human Resources. Effective July 19, 2019, she was appointed Interim Chief Operating Officer and on June 23, 2020, was appointed Chief Operating Officer. Prior to joining Isoray, Mrs. Streeter was employed by Supershuttle International as the Vice President of Learning Development, where she led a team of training managers providing overall training and organizational development activities. Mrs. Streeter was employed by Supershuttle International from 2010 to 2016. Previously Mrs. Streeter has facilitated both on ground and online courses at the undergraduate and graduate levels for universities including Grand Canyon University, Ottawa University and Western International University. The courses focused on Human Resource and Organizational Development. Mrs. Streeter received her Bachelor’s Degree in Management/Marketing and her Master’s Degree in Leadership Studies from Baker College, in Michigan.
Krista Cline – Ms. Cline joined Isoray Medical in 2005 and has since held multiple senior management positions. In January 2016, Ms. Cline was appointed Director of Operations and in July 2018, Ms. Cline was appointed Senior Director of Operations. Ms. Cline has guided many of Isoray’s operational improvements and milestones including: automation, 510(k) clearances and CE Marks, and FDA and ISO audits of Isoray’s products. Her strong commitment to fostering innovation, leadership and her understanding of business strategies have propelled her into her current management role. At Isoray, she is responsible for the overall management and execution of the manufacture and distribution of Isoray’s products. Ms. Cline also assists in the coordination of multiple projects for new product development. She holds a Bachelor of Science in Biochemistry from Washington State University.
There are no agreements or understandings for any officer or director to resign at the request of another person, and none of the officers or directors is acting on behalf of, or will act at the direction of, any other person. There are no family relationships among our executive officers and directors.
Delinquent Section 16(a) Reports
Section 16(a) of the Exchange Act requires the Company’s directors and executive officers, and persons who beneficially own more than ten percent of a registered class of our equity securities, to file with the SEC initial reports of beneficial ownership and reports of changes in beneficial ownership of our Common Stock. The rules promulgated by the SEC under Section 16(a) of the Exchange Act require those persons to furnish us with copies of all reports filed with the SEC pursuant to Section 16(a). The information in this section is based solely upon a review of Forms 3, Forms 4, and Forms 5 received by us.
We believe that Isoray’s executive officers, directors and 10% stockholders timely complied with their filing requirements during the year ended June 30, 2020.
Code of Ethics
We have adopted a Code of Conduct and Ethics that applies to all of our officers, directors and employees and a separate Code of Ethics for Chief Executive Officer and Senior Financial Officers that supplements our Code of Conduct and Ethics.
The Code of Conduct and Ethics was previously filed as Exhibit 14.1 to our Form 10-KSB for the period ended June 30, 2005, and the Code of Ethics for Chief Executive Officer and Senior Financial Officers was previously filed as Exhibit 14.2 to that same report. The Code of Ethics for Chief Executive Officer and Senior Financial Officers is also available to the public on our website at http://www.isoray.com/about/investors/. Each of these policies comprises written standards that are reasonably designed to deter wrongdoing and to promote the behavior described in Item 406 of Regulation S-K promulgated by the Securities and Exchange Commission. Any amendments to or waivers of the Codes will be promptly posted on our website at www.isoray.com or in a Report on Form 8-K, as required by applicable laws.
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Nominating Procedures
There have been no material changes to the procedures by which our stockholders may recommend nominees to the Board of Directors during our last fiscal year.
Audit Committee
The Company has a separately designated standing audit committee established in accordance with Section 3(a)(58)(A) of the Exchange Act. The Audit Committee was established on December 8, 2006, the date on which its Charter was adopted. The Audit Committee Charter lists the purposes of the Audit Committee as overseeing the accounting and financial reporting processes of the Company and audits of the financial statements of the Company and providing assistance to the Board of Directors in monitoring (1) the integrity of the Company’s financial statements, (2) the Company’s compliance with legal and regulatory requirements, (3) the independent auditor’s qualifications and independence, and (4) the performance of the Company’s internal audit function, if any, and independent auditor.
Mr. Vitale, Mr. Hoffman, and Mr. McCormick are each members of the Audit Committee. The Board of Directors has determined that Mr. Hoffmann is an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K promulgated by the SEC, and each Audit Committee member is independent under applicable NYSE American standards. The Board’s conclusions regarding the qualifications of Mr. Hoffmann as an audit committee financial expert were based on his service as a chief financial officer, his experience as a certified public accountant and his degree in accounting.
ITEM 11 – EXECUTIVE COMPENSATION
The following summary compensation table sets forth information concerning compensation for services rendered in all capacities during our past two fiscal years awarded to, earned by or paid to each of the following individuals. Salary and other compensation for these officers are set or recommended to the Board by the Compensation Committee.
Summary Compensation Table
Non-equity
Name and
Option
incentive plan
All other
principal
Salary
awards
compensation
compensation
Total
position
Year
($)
($) 1
($)
($) 3
($)
Lori Woods
2020
315,612
98,700
77,325
-
491,637
CEO and Director
2019
315,612
74,700
15,781
10,431
416,524
William Cavanagh
2020
220,256
59,220
38,545
-
318,021
CRDO
2019
220,256
44,820
11,013
33,617
309,706
Michael Krachon
2020
243,338
59,220
42,584
-
345,142
EVP – S&M 2
2019
243,338
44,820
28,350
26,508
343,016
1.
Amounts represent the ASC 718 , Compensation – Stock Compensation valuation for the fiscal years 2020 and 2019, respectively. Options awarded vest in three to five equal annual installments and expire ten years after the date of grant. All options were granted at the fair market value of the Company’s stock on the date of grant and the Company used a Black-Scholes methodology as discussed in the footnotes to the financial statements to value the options.
2.
Effective June 23, 2020, Mr. Krachon was appointed Executive Vice President of Sales and Marketing.
3.
During fiscal year 2019, the vacation policy was changed for these individuals to an unlimited vacation policy with no accrual. The amounts represent vacation accrued under the prior policy. Mr. Cavanagh’s includes $10,000 to assist with his relocation to Richland, WA.
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Outstanding Equity Awards at Fiscal Year-End
Option awards
Equity Incentive Plan awards:
Number of
Number of
securities
securities
underlying
underlying
unexercised
unexercised
Option
options
options
exercise
Option
(#)
(#)
price
expiration
Name
exercisable
unexercisable
($)
date
Lori Woods
62,500
7
187,500
7
0.61
06/23/2030
CEO and Director
62,500
6
125,000
6
0.43
06/18/2029
62,500
4
62,500
4
0.46
06/13/2028
25,000
1
-
1
0.605
06/27/2027
William Cavanagh
37,500
7
112,500
7
0.61
06/23/2030
CRDO
75,000
6
75,000
6
0.43
06/18/2029
112,500
5
37,500
5
0.46
06/13/2028
225,000
1
-
1
0.605
06/27/2027
6,660
2
-
0.98
06/27/2022
20,000
3
-
2.46
06/17/2024
Michael Krachon
37,500
7
7
0.61
06/23/2030
EVP – S&M
75,000
6
75,000
6
0.43
06/18/2029
112,500
5
37,500
5
0.46
06/13/2028
225,000
1
-
1
0.605
06/27/2027
1.
Represents a June 27, 2017, grant, all of which are exercisable as of June 27, 2020.
2.
Represents a June 27, 2012, grant, all of which were exercisable as of June 27, 2015.
3.
Represents a June 17, 2014, grant, all of which were exercisable as of June 17, 2017.
4.
Represents a June 13, 2018, grant, one-fourth of which became exercisable on December 13, 2018, one-fourth of which became exercisable on June 13, 2019, one-fourth of which became exercisable on June 13, 2020, and the final fourth will become exercisable on June 13, 2021.
5.
Represents a June 13, 2018, grant, one-fourth of which became exercisable on June 13, 2018, one-fourth of which became exercisable on June 13, 2019, one-fourth of which became exercisable on June 13, 2020, and the final fourth will become exercisable on June 13, 2021.
6.
Represents a June 18, 2019, grant, one-fourth of which became exercisable on June 18, 2019, one-fourth of which became exercisable on June 18, 2020, one-fourth of which will become exercisable on June 18, 2021, and the final fourth will become exercisable on June 18, 2022.
7.
Represents a June 23, 2020, grant, one-fourth of which became exercisable on June 23, 2020, one-fourth of which will become exercisable on June 23, 2021, one-fourth of which will become exercisable on June 23, 2022, and the final fourth will become exercisable on June 23, 2023.
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The Company has a 401(k) plan that covers all eligible full-time employees of the Company. Contributions to the 401(k) plan are made by participants to their individual accounts through payroll withholding. Additionally, the 401(k) plan provides for the Company to make contributions to the 401(k) plan in amounts at the discretion of management. The Company has not made any contributions to the 401(k) plan and does not maintain any other retirement plans for its executives or employees.
Role of the Compensation Consultan t
Pursuant to its Charter, the Compensation Committee has the authority to engage independent compensation consultants and other professionals to assist in the design, formulation, analysis, and implementation of compensation programs for our executive officers. During fiscal 2020, the Committee engaged Pearl Meyer to review various elements of the Company's overall compensation program, including performing reviews of the Company's 2020 executive compensation plans.
Role of Benchmarking and Peer Groups
As part of our pay philosophy, our executive compensation program is designed to attract, motivate and retain our executives in an increasingly competitive market. To this end, during fiscal 2020 we evaluated industry-specific and general market compensation practices and trends to ensure that our program features and NEO pay opportunities remain appropriately competitive. When determining salaries, target bonus opportunities and long-term incentive grants for NEOs, the Committee considers the performance of the Company and the individual, the nature of an individual's role within the Company, experience in the officer's current role, as well as input from its independent compensation consultant, among other variables.
In fiscal 2020, to facilitate its review and determination of executive compensation, the Committee engaged Pearl Meyer to conduct a comprehensive competitive review of our executive compensation program. In connection with this review and in consultation with Pearl Meyer and senior management of the Company, Pearl Meyer identified a peer group comprised of healthcare equipment, pharmaceutical and biotechnology companies roughly similar to the Company in revenue size or market capitalization, and focused on cancer treatments to the extent possible; the peer group consists of the 16 companies listed below:
AVEO Pharmaceuticals, Inc.
Fortress Biotech, Inc.
Sunesis Pharmaceuticals, Inc.
Cancer Genetics, Inc.
Idera Pharmaceuticals
TRACON Pharmaceuticals, Inc.
Capricor Therapeutics, Inc.
Northwest Biotherapeutics, Inc.
ViewRay, Inc.
Cleveland BioLabs, Inc.
Onconova Therapeutics, Inc.
Cyclacel Pharmaceuticals, Inc.
Pieris Pharmaceuticals, Inc.
Fate Therapeutics, Inc.
Plus Therpeutics, Inc.
The median (50 th percentile) revenue size of the peer group was approximately $4 million, while the median market capitalization was $39 million; Isoray's revenue and market capitalization were roughly at the 59 th and 52 nd percentiles of the peer group, respectively.
In addition to peer group data, four published or private compensation surveys were also utilized in Pearl Meyer's 2020 report and comparisons to survey benchmark positions were made based on the Company's revenue or employee size. Pearl Meyer completed its review in May 2020 and presented its analysis of the Company's executive compensation program relative to peer and survey 25 th , 50 th and 75 th percentile levels. Overall, the study suggested that total direct compensation was below the 25 th percentile market levels.
In June 2020, the Compensation Committee of the Company set the annual base salary for fiscal 2021 for Lori Woods, our Chief Executive Officer and Director, at $347,173 (10% increase), for William Cavanagh, Chief Research and Development Officer, at $240,080 (9% increase) and for Michael Krachon, our Vice President Sales and Marketing, at $267,670 (10% increase).
Fiscal Year 2020 Director Compensation
Fees
earned
or paid in
Option
cash
awards
Total
Name
($)
($)
($)
Alan Hoffmann
41, 000
11,844
52,844
Michael McCormick
41,000
11,844
52,844
Philip Vitale MD
41,000
11,844
52,844
Each non-employee director had stock options to purchase shares of the Company’s common stock outstanding as of June 30, 2020 as follows - Mr. Hoffmann had stock options to purchase 145,000 shares of common stock, Mr. McCormick had stock options to purchase 145,000 shares of common stock, and Dr. Vitale had stock options to purchase 145,000 shares of common stock.
During the fiscal year 2020, the independent directors received $3,000 per month for their service. In addition, each non-employee director received $1,000 per Board meeting attended in person or $500 per Board meeting attended via telephone and $500 per committee meeting attended. Employee directors do not receive any compensation for their service on the Board.
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Performance-Based Annual Bonus
We provide for an annual cash incentive that reinforces our pay-for-performance approach. This incentive compensation is a short-term incentive program that rewards achievement. Annual incentive awards are awarded at the sole determination of the Compensation Committee (on behalf of the Board) based on the actual and measurable performance of the Company based on a set of corporate objectives for the previous year.
For fiscal year 2020, the bonus plan was such that the Chief Executive Officer had an opportunity to earn a bonus of seven percent (7%) of his or her annual base salary and each other named officer had an opportunity to earn a bonus of five percent (5%) of his or her annual base salary by meeting the following parameters: half of the bonus was paid if the Company had a twenty-five percent (25%) increase in revenue from the prior year’s comparable quarter; one quarter of the bonus was paid if the Company had a gross margin percentage of fifty percent (50%) or higher in the applicable quarter; and one quarter of the bonus was paid if the Company had a net loss margin of negative forty percent (-40%) or less in the applicable quarter. Additionally, the Chief Executive Officer had an opportunity to earn a bonus of seven percent (7%) of his or her annual base salary and each other named officer had an opportunity to earn a bonus of five percent (5%) of his or her annual base salary by meeting the following parameters: half of the bonus was paid if the Company had a twenty-five percent (25%) increase in revenue from the prior fiscal year; one quarter of the bonus was paid if the Company had a gross margin percentage of fifty percent (50%) or higher in the fiscal year; and one quarter of the bonus was paid if the Company had a net loss margin of negative forty percent (-40%) or less in the fiscal year.
For fiscal year 2020, all of the metrics were met for the first and third fiscal quarters as well as for the full fiscal year. During the second fiscal quarter for 2020, fifty percent (50%) of the metrics were acheived.
NEO
2020 Bonus ($)
Lori Woods – CEO and Director
77,325
William Cavanagh – CRDO
38,545
Michael Krachon - Executive Vice President Sales and Marketing
42,584
For fiscal year 2021, the bonus plan was revised so that the Chief Executive Officer has an opportunity to earn a bonus of eight percent (8%) of his or her annual base salary and each other named officer has an opportunity to earn a bonus of six percent (6%) of his or her annual base salary by meeting the following parameters: half of the bonus will be paid if the Company has a twenty-five percent (25%) increase in revenue from the prior year’s comparable quarter; one quarter of the bonus will be paid if the Company has a gross margin percentage of fifty-five percent (55%) or higher in the applicable quarter; and one quarter of the bonus will be paid if the Company has a net loss margin of negative twenty-five percent (-25%) or less in the applicable quarter. Additionally, the Chief Executive Officer has an opportunity to earn a bonus of eight percent (8%) of his or her annual base salary and each other named officer has an opportunity to earn a bonus of six percent (6%) of his or her annual base salary by meeting the following parameters: half of the bonus will be paid if the Company has a twenty-five percent (25%) increase in revenue from the prior fiscal year; one quarter of the bonus will be paid if the Company has a gross margin percentage of fifty-five percent (55%) or higher in the fiscal year; and one quarter of the bonus will be paid if the Company has a net loss margin of negative twenty-five percent (-25%) or less in the fiscal year.
On June 23, 2020, the Committee approved stock option grants to our named executive officers outlined in the table below, at an exercise price of $0.61, our closing stock price on June 23, 2020.
NEO
Option grant (# of
shares)
Lori Woods – CEO and Director
250,000
William Cavanagh – CRDO
150,000
Michael Krachon - Executive Vice President Sales and Marketing
150,000
Risks Related to Compensation Policies and Practices
The Compensation Committee has considered whether our overall compensation program for employees in 2020 creates incentives for employees to take excessive or unreasonable risks that could materially harm our Company. We believe that several features of our compensation policies for management employees appropriately mitigate such risks, including a mix of long- and short-term compensation incentives that we believe is properly weighted, our Executive Compensation Clawback Policy and the uniformity of compensation practices across our Company, which the Compensation Committee regards as setting an appropriate level of risk taking for us. We also believe our internal legal and financial controls appropriately mitigate the probability and potential impact of an individual employee committing us to a harmful long-term business transaction in exchange for short-term compensation benefits.
Recoupment Policy
In order to align further management’s interests with the interests of our stockholders and to support good corporate governance practices, the Board has adopted a recoupment policy. Subject to rules of the SEC and NYSE American, in the event that we are required to prepare an accounting restatement due to the material noncompliance with any financial reporting requirement under the federal securities laws, we will form a committee of the independent directors to determine whether we will recover from any of our current or former executive officers, as determined in accordance with such rules, who received performance-based compensation (including stock options awarded as compensation) during the period for which we are required to prepare an accounting restatement, based on the erroneous data, in excess of what would have been paid to the executive officer under the accounting restatement. The committee may also take any other actions authorized by our Executive Compensation Clawback Policy.
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ITEM 12 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following tables set forth certain information regarding the beneficial ownership of the Company’s common stock and preferred stock as of September 21, 2020 for (a) each person known by the Company to be a beneficial owner of five percent or more of the outstanding common or preferred stock of the Company, (b) each executive officer, director and nominee for director of the Company, and (c) directors and executive officers of the Company as a group. As of September 21, 2020, the Company had 68,897,779 shares of common stock and 59,065 shares of Series B preferred stock outstanding. Except as otherwise indicated below, the address for each listed beneficial owner is c/o Isoray, Inc., 350 Hills Street, Suite 106, Richland, Washington 99354.
Common Stock Share Ownership
Name of Beneficial Owner
Common
Shares Owned
Common Stock
Options 1
Percent of Class 2
Lori Woods
542,500
212,500
1.10
%
Alan Hoffmann
45,000
100,000
0.21
%
Michael McCormick
22,000
100,000
0.18
%
Philip Vitale M.D.
110,000
100,000
0.30
%
William Cavanagh III
20,000
476,660
0.72
%
Michael Krachon
105,000
450,000
0.81
%
Jonathan Hunt
-
187,500
0.27
%
Jennifer Streeter
5,440
287,500
0.43
%
Mark Austin
16,000
182,500
0.29
%
Krista Cline
22,933
172,500
0.28
%
Directors and Executive Officers as a group
888,873
2,269,160
4.58
%
1.
Only includes those common stock options that could be exercised for common stock within 60 days after September 21, 2020.
2.
Percentage ownership is based on 68,897,779 shares of Common Stock outstanding on September 21, 2020. Shares of Common Stock subject to stock options which are currently exercisable or will become exercisable within 60 days after September 21, 2020 are deemed outstanding for computing the percentage ownership of the person or group holding such options but are not deemed outstanding for computing the percentage ownership of any other person or group.
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Series B Preferred Stock Share Ownership
Series B
Preferred
Shares
Percent of
Name of Beneficial Owner
Owned
Class 1
Aissata Sidibe 2
20,000
33.86
%
William and Karen Thompson Trust 3
14,218
24.07
%
Jamie Granger 4
10,529
17.83
%
Hostetler Living Trust 5
9,479
16.05
%
Leslie Fernandez 6
3,688
6.24
%
1.
Percentage ownership is based on 59,065 shares of Series B Preferred Stock outstanding on September 21, 2020.
2.
The address of Aissata Sidibe is 99302 E Sidibe PR SE, Kennewick, WA 99338.
3.
The address of the William and Karen Thompson Trust is 285 Dondero Way, San Jose, CA 95119.
4.
The address of Jamie Granger is 53709 South Nine Canyon Road, Kennewick, WA 99337.
5.
The address of the Hostetler Living Trust is 9327 NE 175th Street, Bothell, WA 98011.
6.
The address of Leslie Fernandez is 2615 Scottsdale Place, Richland, WA 99352.
No officers or directors beneficially own shares of any class of Preferred Stock.
The “Securities Authorized for Issuance Under Equity Compensation Plans” contained in Item 5 of this Form 10-K is hereby incorporated by reference into this Item 12.
ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Transactions with Related Persons
None requiring disclosure under Reg. S-K Item 404.
Review, Approval or Ratification of Transactions with Related Persons
The Company’s Code of Ethics emphasizes the importance of avoiding situations or transactions in which personal interests may interfere with the best interests of the Company or its shareholders. In addition, the Company’s general corporate governance practice includes Board-level discussion and assessment of procedures for discussing and assessing relationships, including business, financial, familial and nonprofit, among the Company and its officers and directors or their immediate family members, to the extent that they may arise. The Board and either the Audit Committee or the Nominations and Corporate Governance Committee review any transaction with an officer or director or their immediate family members to determine, on a case-by-case basis, whether a conflict of interest exists. The Board ensures that all directors voting on such a matter have no interest in the matter and discusses the transaction with counsel as the Board deems necessary. The Board will generally delegate the task of discussing, reviewing and approving transactions between the Company and any related persons to either the Audit Committee or the Nominations and Corporate Governance Committee.
As required under SEC rules, transactions that are determined to be directly or indirectly material to the Company or a related party would be disclosed in our Annual Report; however, during our fiscal year ended June 30, 2020, we did not have any related party transactions requiring disclosure under Reg. S-K Item 404.
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Director Independence
Using the standards of the NYSE American, the Company’s Board has determined that Mr. Hoffmann, Mr. McCormick and Dr. Vitale each qualify under such standards as an independent director. Mr. Hoffmann, Mr. McCormick and Dr. Vitale each meet the NYSE American listing standards for independence both as a director and as a member of both the Audit Committee and the Compensation Committee. No other directors are independent under these standards.
None of our existing directors were disqualified from independent status under the objective standards of the NYSE American other than Ms. Woods, who did not qualify as she is an employee director. In reviewing the subjective criteria of “any relationship that would interfere with the exercise of independent judgment” in carrying out the responsibilities of a director, the Board determined that all directors other than Ms. Woods met this criteria as well.
With respect to Audit Committee independence, the Board determined each member of the Committee qualified as independent for Committee service.
The Company did not consider any other relationship or transaction between itself and these independent directors not already disclosed in this Report in making this independence determination.
ITEM 14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES
The Company paid or accrued the following fees in each of the prior two fiscal years to its principal accountant, DeCoria, Maichel & Teague, P.S. (in thousands):
For the Year Ended June 30,
2020
2019
1.
Audit fees
$
74
$
47
3.
Tax fees
12
9
4.
All other fees
13
14
Totals
$
99
$
70
Audit fees include fees for the audit of our annual financial statements, reviews of our quarterly financial statements, and related consents for documents filed with the SEC. Tax fees include fees for the preparation of our federal and state income tax returns. All other fees are from consulting costs created by the review of documents related to equity offerings.
As part of its responsibility for oversight of the independent registered public accountants, the Audit Committee has established a pre-approval policy for engaging audit and permitted non-audit services provided by our independent registered public accountants, DeCoria, Maichel & Teague, P.S. In accordance with this policy, each type of audit, audit-related, tax and other permitted service to be provided by the independent auditors is specifically described and each such service, together with a fee level or budgeted amount for such service, is pre-approved by the Audit Committee. The Audit Committee has delegated authority to its Chairman to pre-approve additional non-audit services (provided such services are not prohibited by applicable law) up to a pre-established aggregate dollar limit. All services pre-approved by the Chairman of the Audit Committee must be presented at the next Audit Committee meeting for review and ratification. All of the services provided by DeCoria, Maichel & Teague, P.S. described above were approved by our Audit Committee.
The Company’s principal accountant, DeCoria, Maichel & Teague, P.S., did not engage any other persons or firms other than the principal accountant’s full-time, permanent employees.
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ITEM 15 – EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Isoray, Inc. and Subsidiaries
Index to Consolidated Financial Statements
Reports of Independent Registered Public Accounting Firm
67
Consolidated Balance Sheets
68
Consolidated Statements of Operations
69
Consolidated Statements of Changes in Stockholders’ Equity
70
Consolidated Statements of Cash Flows
71
Notes to the Consolidated Financial Statements
72
EXHIBIT INDEX
(Except as otherwise indicated (a) all exhibits were previously filed, (b) all omitted exhibits are intentionally omitted, and (c) all Reports referenced below were filed under SEC file number 001-33407.)
Exhibit #
Description
2.1
Plan of Conversion, incorporated by reference to Appendix A of the Form Def 14A filed on November 9, 2018.
3.1
Certificate of Incorporation, incorporated by reference to Exhibit A of the Form Def 14A filed on November 9, 2018.
3.2
Bylaws, incorporated by reference to Exhibit C of the Form Def 14A filed on November 9, 2018.
4.2
Warrant to Purchase Common Stock, dated May 20, 2018, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on May 21, 2018.
4.3
Warrant to Purchase Common Stock, dated October 3, 2017, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on October 10, 2017.
4.4
Form of Warrant, dated July 11, 2018, incorporated by reference to Exhibit 10.3 of the Form 8-K filed on July 11, 2018.
10.1
Royalty Agreement of Invention and Patent Application, dated July 12, 1999 between Lane A. Bray and Isoray LLC, incorporated by reference to Exhibit 10.3 of the Form SB-2 filed on November 10, 2005 (Reg. No. 333-129646).
10.2
Section 510(k) Clearance from the Food and Drug Administration to market Lawrence CSERION Model CS-1, dated March 28, 2003, incorporated by reference to Exhibit 10.5 of the Form SB-2 filed on November 10, 2005 (Reg. No. 333-129646).
10.3
Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Sealed Source, dated September 17, 2004, incorporated by reference to Exhibit 10.10 of the Form SB-2/A2 filed on April 27, 2006 (Reg. No. 333-129646).
10.4
State of Washington Radioactive Materials License dated October 6, 2005, incorporated by reference to Exhibit 10.18 of the Form SB-2 filed on November 10, 2005 (Reg. No. 333-129646).
10.5***
Form of Officer and Director Indemnification Agreement, incorporated by reference to Exhibit 10.35 of the Form SB-2 Post-Effective Amendment No. 2 filed on October 13, 2006 (Reg. No. 333-129646).
10.7
Stipulation of Settlement, dated September 23, 2016, by and between Isoray, Inc., Dwight Babcock, and the settlement class, incorporated by reference to Exhibit 10.1 of the Form 10-Q filed on November 9, 2016.
10.10
Irradiation Services Agreement, dated November 29, 2016, between The Curators of the University of Missouri and Isoray Medical, Inc. (confidential treatment granted for redacted portions), incorporated by reference to Exhibit 10. 1 of the Form 10-Q filed on February 9, 2017.
10.11
Contract Modification, entered into on November 15, 2016 with an effective date of November 1, 2016, to Contract No. X-40403 between Energy Northwest and Isoray Medical, Inc., incorporated by reference to Exhibit 10.2 of the Form 10-Q filed on February 9, 2017.
10.12
Separation Agreement, dated February 28, 2017, between Brien Ragle and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on March 3, 2017.
10.13***
Isoray, Inc. 2017 Equity Incentive Plan (incorporated by reference to Appendix B to Isoray, Inc.'s Definitive Proxy Statement on Schedule 14A, filed on May 17, 2017).
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10.14
Rescission and Release Agreement, dated May 2, 2017, between Isoray Medical, Inc., and the Port of Benton, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 8, 2017.
10.15
Separation Agreement, dated May 1, 2017, between Matthew Branson and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 23, 2017.
10.16***
Form of Isoray, Inc. Stock Option Agreement and Notice of Grant of Stock Option, by and between each grantee thereunder and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 30, 2017.
10.17***
Employment Agreement, dated June 30, 2017, between Mark Austin and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on July 7, 2017.
10.18
Consignment Agreement, dated August 25, 2017, between Isoray Medical, Inc. and MedikorPharma-Ural LLC, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on August 31, 2017.
10.19
Service Agreement, dated August 25, 2017, between Isoray Medical, Inc. and MedikorPharma-Ural LLC, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on August 31, 2017.
10.21
Manufacturing and Supply Agreement, dated January 3, 2018, between Isoray Medical, Inc. and GT Medical Technologies, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on January 8, 2018.
10.22
Collaborative Development Agreement, dated effective as of March 13, 2017, between Isoray Medical, Inc. and GammaTile, LLC, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on January 8, 2018.
10.23
Sales Agreement between Isoray, Inc. and H.C. Wainwright & Co., LLC, dated May 8, 2018, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on May 8, 2018.
10.24
Lease Agreement, dated effective May 2, 2007, between Isoray Medical, Inc. and Energy Northwest, incorporated by reference to Exhibit 10.42 of the Form 8-K filed on May 8, 2007.
10.25***
Employment Agreement, dated effective June 13, 2018, between Lori A. Woods and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 19, 2018.
10.26***
Isoray, Inc. Stock Option Agreement and Notice of Grant of Stock Option to Lori A. Woods, dated June 13, 2018, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on June 19, 2018.
10.27
Separation Agreement, dated June 25, 2018, between Thomas C. LaVoy and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 29, 2018.
10.28
Letter Agreement, dated July 9, 2018, between H.C. Wainwright & Co. LLC and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on July 11, 2018.
10.29
Form of Securities Purchase Agreement, dated July 9, 2018, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on July 11, 2018.
10.30
Professional Services Agreement, dated August 15, 2018, between Isoray Medical, Inc. and J. Squared Partners, Inc., DBA Global IR Group, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on September 25, 2018.
10.31
Services Agreement, dated August 13, 2018, between Isoray Medical, Inc. and Schultz Public Relations, LLC, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on September 25, 2018.
10.32***
Form of Employment Agreement, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on October 12, 2018.
10.33***
Employment Agreement, dated effective December 3, 2018, between Jonathan Hunt and Isoray, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on December 3, 2018.
10.34***
Employment Agreement between Isoray, Inc. and Lori A. Woods, dated effective January 1, 2019, incorporated by reference to the Form 8-K filed on December 17, 2018.
10.36
Amendment to Exhibit B of Manufacturing and Supply Agreement between Isoray Medical, Inc. and GT Medical Technologies, Inc., dated December 28, 2018 (confidential treatment granted for redacted portions), incorporated by reference to Exhibit 10.5 of the Form 10-Q filed on February 13, 2019.
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10.37***
Employment Agreement between Isoray, Inc. and Michael Krachon, dated effective February 6, 2019, incorporated by reference to the Form 8-K filed on February 12, 2019.
10.38
Amended and Restated Manufacturing and Supply Agreement, dated April 26, 2019, between Isoray Medical, Inc. and GT Medical Technologies, Inc., (confidential treatment granted for redacted portions), incorporated by reference to the Form 8-K filed on May 2, 2019.
10.39
Amendment to Exhibit B of Manufacturing and Supply Agreement between Isoray Medical, Inc. and GT Medical Technologies, Inc., dated December 28, 2018 (confidential treatment granted for redacted portions), incorporated by reference to the Form 8-K filed on May 28, 2019.
10.40
Revision to Bonus Plan for fiscal year 2020, dated June 18, 2019, incorporated by reference to Item 5.02 of the Form 8-K filed on June 24, 2019.
10.42***
Amended and Restated Employment Agreement between Isoray Inc. and Jennifer Streeter, dated effective July 19, 2019, incorporated by reference to the Form 8-K filed on July 24, 2019.
10.43
Supply Contract, dated July 30, 2019, between Isoray Medical, Inc., and Joint Stock Company «Isotope» (confidential portions of the exhibit have been omitted), incorporated by reference to the Form 8-K filed on August 5, 2019.
10.44
Contract Modification, entered into on November 15, 2016 with an effective date of November 1, 2016, to Contract No. X-40403 between Energy Northwest and Isoray Medical, Inc, incorporated by reference to Exhibit 10.2 of the Form 10-Q filed on February 9, 2017.
10.45
Contract Modification, entered into on August 19, 2019 with an effective date of July 3, 2019, to Contract No. X-40403 between Energy Northwest and Isoray Medical, Inc., incorporated by reference to Exhibit 10.45 of the Form 10-K filed on September 27, 2019.
10.46***
2020 Equity Incentive Plan, incorporated by reference to Appendix A to Isoray, Inc.'s Definitive Proxy Statement on Schedule 14A filed on October 25, 2019.
10.47***
Form of Amendment to Employment Agreement, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on December 17, 2019.
10.48
Amendment to Exhibit A and Amendment No. 2 to Exhibit B of Amended and Restated Manufacturing and Supply Agreement, dated effective January 13, 2020, between Isoray Medical, Inc. and GT Medical Technologies, Inc., incorporated by reference to Exhibit 10.1 of the Form 8-K filed on January 16, 2020 (confidential portions of the exhibit have been omitted).
10.49***
Form of Indemnification Agreement, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on February 19, 2020.
10.50
Equity Distribution Agreement, incorporated by reference to Exhibit 10.1 of the Form 8-K filed on April 6, 2020.
10.51***
Amendment to Employment Agreement between Isoray, Inc. and Jennifer Streeter, dated June 25, 2020 , incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 26, 2020.
10.52***
Second Amendment to Employment Agreement between Isoray, Inc. and Michael Krachon, dated June 25, 2020, incorporated by reference to Exhibit 10.2 of the Form 8-K filed on June 26,2020 .
10.53
Supply Contract, dated August 26, 2020, between Isoray Medical, Inc., and Joint Stock Company «Isotope», incorporated by reference to Exhibit 10.1 of the Form 8-K filed on August 31, 2020 (confidential portions of the exhibit have been omitted) .
10.54*
Addendum No. 1, dated August 5, 2019, to the Supply Contract dated July 30, 2019, between Isoray Medical, Inc., and Joint Stock Company «Isotope».
10.55*
Addendum No. 2, dated August 14, 2020, to the Supply Contract dated July 30, 2019, between Isoray Medical, Inc., and Joint Stock Company «Isotope» (confidential portions of the exhibit have been omitted).
14.1
Code of Conduct and Ethics, incorporated by reference to Exhibit 14.1 of the Form 10-KSB filed on October 11, 2005. (File No. 000-14247)
14.2
Code of Ethics for Chief Executive Officer & Senior Financial Officers, incorporated by reference to Exhibit 14.2 of the Form 10-KSB filed on October 11, 2005. (File No. 000-14247)
21.1*
Subsidiaries of the Company.
23.1*
Consent of DeCoria, Maichel & Teague, P.S.
31.1*
Rule 13a-14(a)/15d-14(a) Certification - Chief Executive Officer.
31.2*
Rule 13a-14(a)/15d-14(a) Certification of Co-Principal Financial Officer
31.3*
Rule 13a-14(a)/15d-14(a) Certification of Co-Principal Financial Officer
32**
Section 1350 Certifications.
101.INS*
XBRL Instance 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.
*
Filed Herewith
**
Furnished Herewith
***
Denotes Management Contract or Compensatory Plan or Arrangement
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Report of Independent Registered Public Accounting Firm
To the shareholders and the board of directors of Isoray, Inc. and Subsidiaries
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Isoray, Inc. and Subsidiaries (the "Company") as of June 30, 2020 and 2019, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the three years in the period ended June 30, 2020, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2020 and 2019, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2020, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's 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.
/s/ DeCoria, Maichel & Teague, P.S.
We have served as the Company's independent auditor since 2005.
Spokane, Washington
September 24, 2020
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Isoray, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except shares)
June 30,
June 30,
2020
2019
ASSETS
Current assets:
Cash and cash equivalents
$
2,392
$
5,326
Accounts receivable, net
2,044
1,154
Inventory
645
530
Prepaid expenses and other current assets
426
305
Total current assets
5,507
7,315
Property and equipment, net
1,735
1,609
Right of use asset, net
1,001
-
Restricted cash
181
181
Inventory, non-current
137
155
Other assets, net
138
162
Total assets
$
8,699
$
9,422
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses
$
654
$
683
Lease liability
236
-
Accrued protocol expense
35
133
Accrued radioactive waste disposal
94
74
Accrued payroll and related taxes
352
89
Accrued vacation
204
142
Total current liabilities
1,575
1,121
Non-current liabilities:
Lease liability, non-current
769
-
Accrued payroll and related taxes, non-current
55
-
Asset retirement obligation
577
621
Total liabilities
2,976
1,742
Commitments and contingencies (Note 14)
Stockholders' equity:
Preferred stock, $.001 par value; 7,000,000 shares authorized: Series B: 5,000,000 shares allocated; 59,065 shares issued and outstanding
-
-
Common stock, $.001 par value; 200,000,000 shares authorized; 68,897,779 and 67,388,047 shares issued and outstanding
69
67
Additional paid-in capital
93,592
92,105
Accumulated deficit
(87,938
)
(84,492
)
Total stockholders' equity
5,723
7,680
Total liabilities and stockholders' equity
$
8,699
$
9,422
The accompanying notes are an integral part of these consolidated financial statements.
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Isoray, Inc. and Subsidiaries
Consolidated Statements of Operations
(Dollars and shares in thousands, except for per-share amounts)
Year Ended June 30
2020
2019
2018
Sales, net
$
9,680
$
7,314
$
5,923
Cost of sales
4,556
4,267
4,081
Gross profit
5,124
3,047
1,842
Operating expenses:
Research and development
Proprietary research and development
1,126
1,429
1,351
Collaboration arrangement, net of reimbursement (Note 14)
-
45
395
Total research and development
1,126
1,474
1,746
Sales and marketing
2,976
2,679
2,660
General and administrative
4,571
4,172
4,165
Gain on equipment disposals
-
(24
)
-
Change in estimate of asset retirement obligation (Note 8)
(73
)
-
-
Total operating expenses
8,600
8,301
8,571
Operating loss
(3,476
)
(5,254
)
(6,729
)
Non-operating income:
Interest income
30
108
29
Other income
-
2
-
Non-operating income, net
30
110
29
Net loss
(3,446
)
(5,144
)
(6,700
)
Preferred stock dividends
(11
)
(11
)
(11
)
Net loss applicable to common stockholders
$
(3,457
)
$
(5,155
)
$
(6,711
)
Basic and diluted loss per share
$
(0.05
)
$
(0.08
)
$
(0.12
)
Weighted average shares used in computing net loss per share:
Basic and diluted
67,601
67,042
55,159
The accompanying notes are an integral part of these consolidated financial statements.
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Isoray, Inc. and Subsidiaries
Consolidated Statement of Changes in Stockholders' Equity
(In thousands, except shares)
Series B
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-in
Capital
Accumulated Deficit
Total
Balances at June 30, 2017
59,065
$
-
55,017,419
$
55
$
83,151
$
(72,604
)
$
10,602
Issuance of common stock pursuant to exercise of options
82,810
-
50
50
Issuance of common stock pursuant to at the market offering, net
980,918
1
478
479
Issuance of common stock pursuant to exercise of warrants
250,000
-
3
3
Payment of dividend to preferred stockholders
(11
)
(11
)
Share-based compensation
404
404
Share-based compensation for third party services
203
203
Adoption of ASU 2016-09
44
(44
)
-
Net loss
-
-
-
-
-
(6,700
)
(6,700
)
Balances at June 30, 2018
59,065
$
-
56,331,147
$
56
$
84,322
$
(79,348
)
$
5,030
Issuance of common stock pursuant to exercise of options
56,900
-
15
15
Issuance of common stock, pursuant to registered direct offering, net
11,000,000
11
7,359
7,370
Payment of dividend to preferred stockholders
(11
)
(11
)
Share-based compensation
420
420
Net loss
-
-
-
-
-
(5,144
)
(5,144
)
Balances at June 30, 2019
59,065
$
-
67,388,047
$
67
$
92,105
$
(84,492
)
$
7,680
Issuance of common stock pursuant to exercise of options
262,500
1
130
131
Issuance of common stock pursuant to at the market offering, net
1,247,232
1
873
874
Payment of dividend to preferred stockholders
(11
)
(11
)
Share-based compensation
495
495
Net loss
-
-
(3,446
)
(3,446
)
Balances at June 30, 2020
59,065
$
-
68,897,779
$
69
$
93,592
$
(87,938
)
$
5,723
The accompanying notes are an integral part of these consolidated financial statements.
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Isoray, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Year Ended June 30,
2020
2019
2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
(3,446
)
$
(5,144
)
$
(6,700
)
Adjustments to reconcile net loss to net cash used by operating activities:
Lease expense
4
-
-
Depreciation expense
147
136
80
(Gain) loss on equipment disposals
-
(24
)
-
Amortization of other assets
38
50
50
Accretion of asset retirement obligation
29
31
29
Change in estimate of asset retirement obligation
(73
)
-
-
Share-based compensation
495
420
404
Share-based compensation for third party services
-
-
203
Changes in operating assets and liabilities:
Accounts receivable
(890
)
38
(466
)
Inventory
(97
)
128
23
Prepaid expenses and other current assets
(121
)
30
(64
)
Accounts payable and accrued expenses
(29
)
(708
)
761
Accrued protocol expense
(98
)
56
2
Accrued radioactive waste disposal
20
37
(88
)
Accrued payroll and related taxes
318
(66
)
17
Accrued vacation
62
(33
)
37
Net cash used by operating activities
(3,641
)
(5,049
)
(5,712
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Additions to property and equipment
(273
)
(444
)
(337
)
Additions to other assets
(14
)
(14
)
(18
)
Proceeds from sale of equipment
-
34
-
Proceeds from maturity of certificates of deposit
-
5,550
6,268
Purchases of and interest from certificates of deposit
-
(4,725
)
(4,054
)
Net cash provided by (used in) investing activities
(287
)
401
1,859
CASH FLOWS FROM FINANCING ACTIVITIES:
Preferred dividends paid
(11
)
(11
)
(11
)
Proceeds from sales of common stock, pursuant to registered direct offering, net
-
7,370
-
Proceeds from sales of common stock, pursuant to at the market offering, net
874
-
479
Proceeds from sales of common stock, pursuant to exercise of warrants, net
-
-
3
Proceeds from sales of common stock, pursuant to exercise of options
131
15
50
Net cash provided by financing activities
994
7,374
521
Net increase (decrease) in cash, cash equivalents, and restricted cash
(2,934
)
2,726
(3,332
)
Cash, cash equivalents, and restricted cash beginning of year
5,507
2,781
6,113
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH END OF YEAR
$
2,573
$
5,507
$
2,781
Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets:
Cash and cash equivalents
$
2,392
$
5,326
$
2,600
Restricted cash
$
181
$
181
$
181
Total cash, cash equivalents, and restricted cash
$
2,573
$
5,507
$
2,781
Non-cash investing and financing activities:
Recognition of operating lease liability and right of use asset
$
1,228
$
-
$
-
Warrants issued to placement agent of registered direct offering
$
-
$
163
$
-
The accompanying notes are an integral part of these consolidated financial statements.
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Isoray , Inc.
Notes to Consolidated Financial Statements
For the years ended June 30, 2020, 2019 and 2018
1.
Organization
Isoray, Inc. was incorporated in Minnesota in 1983. On July 28, 2005, Isoray Medical, Inc. (Medical) became a wholly-owned subsidiary of Isoray, Inc. (formerly known as Century Park Pictures Corporation) pursuant to a merger. In December 2018, upon approval of a majority of stockholders, Isoray, Inc. was redomiciled to Delaware. Medical was formed under Delaware law on June 15, 2004 and on October 1, 2004 acquired two affiliated predecessor companies which began operations in 1998. Medical, a Delaware corporation, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. Medical is headquartered in Richland, Washington.
Isoray International LLC (International), a Washington limited liability company, was formed on November 27, 2007 and is a wholly-owned subsidiary of Isoray, Inc. International has entered into various international distribution agreements.
2.
Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP), and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries (collectively the Company). All significant inter-company transactions and balances have been eliminated in consolidation.
Cash Equivalents
The Company considers currency on hand, demand deposits, time deposits, and all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. Cash and cash equivalents are held in various financial institutions in the United States.
Investments
Investments with original maturities greater than three months and remaining maturities less than one year are classified as “Short-term investments” and included in current assets. Investments with remaining maturities greater than one year are classified as “Investments, non-current” and are included in noncurrent assets. These investments are held to maturity and carried at amortized cost.
Accounts Receivable
Accounts receivable are stated at the amount that management of the Company expects to collect from outstanding balances. Management provides for probable uncollectible amounts through an allowance for doubtful accounts. Additions to the allowance for doubtful accounts are based on management’s judgment, considering historical experience with write-offs, collections and current credit conditions. Balances which remain outstanding after management has used reasonable collection efforts are written off through a charge to the allowance for doubtful accounts and a credit to the applicable accounts receivable. Payments received subsequent to the time that an account is written off are treated as bad debt recoveries.
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Inventory
Inventory is reported at the lower of cost or net realizable value. Cost of raw materials is determined using the weighted average method. Cost of work in process and finished goods is computed using standard cost, which approximates actual cost, on a first-in, first-out basis.
The cost of materials and production costs contained in inventory that are not usable due to the passage of time, and resulting loss of bio-effectiveness, are written off to cost of sales at the time it is determined that the product is no longer usable.
Property and Equipment
Fixed assets are capitalized and carried at cost less accumulated depreciation. Normal maintenance and repairs are charged to expense as incurred. When any assets are sold or otherwise disposed of, the cost and accumulated depreciation are reversed with any resulting gain or loss being recognized on the consolidated statement of operations.
Depreciation is computed using the straight-line method over the following estimated useful lives:
Production equipment (in years)
3
to
7
Office equipment (in years)
2
to
10
Furniture and fixtures (in years)
2
to
10
Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset.
Management periodically reviews the net carrying value of all of its long-lived assets on an asset by asset basis. An impairment loss is recognized if the carrying amount of a defined asset group is not recoverable and exceeds its fair value.
Although management has made its best estimate of the factors that affect the carrying value based on current conditions, it is reasonably possible that changes could occur which could adversely affect management’s estimate of net cash flows expected to be generated from its assets that could result in an impairment adjustment.
Prepaid Expenses and Other Assets
Prepaid expenses and other assets, which include website development costs, trademarks, patents and licenses, are stated at cost, less accumulated amortization. For website development, costs incurred in the planning stage are expensed as incurred whereas costs associated with the application and infrastructure development, graphics development, and content development are capitalized. Amortization of website development costs is computed using the straight-line method over the estimated economic useful lives of the asset. Trademarks and patents include costs, primarily legal, incurred in obtaining them. Amortization of trademarks and patents is computed using the straight-line method over the estimated economic useful lives of the assets. Licenses include costs related to licenses pertaining to the use of technology or operational licenses. These licenses are recorded at stated cost, less accumulated amortization. Amortization of licenses is computed using the straight-line method over the estimated economic useful lives of the assets. The Company periodically reviews the carrying values of other assets and evaluates the recorded basis for any impairment. Any impairment is recognized when the expected future operating cash flows to be derived from the licenses are less than their carrying value.
Asset Retirement Obligation
The estimated fair value of the future retirement costs of the Company’s leased assets and the costs for the decontamination and reclamation of equipment located within the footprint leased asset are recorded as a liability on a discounted basis when a contractual obligation exists; an equivalent amount is capitalized to property and equipment. The initial recorded obligation is discounted using the Company's credit-adjusted risk-free rate and is reviewed periodically for changes in the estimated future costs underlying the obligation. The Company amortizes the initial amount capitalized to property and equipment and recognizes accretion expense in connection with the discounted liability over the estimated remaining useful life of the leased assets.
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Financial Instruments
The Company discloses the fair value of financial instruments, both assets and liabilities, recognized and not recognized in the balance sheet, for which it is practicable to estimate the fair value. The fair value of a financial instrument is the amount at which the instrument could be exchanged in a current transaction between willing parties, other than a forced liquidation sale. At June 30, 2020 and 2019, the carrying value of financial instruments, which include U.S. Treasury Securities and restricted cash, approximated fair value.
Fair Value Measurement
When required to measure assets or liabilities at fair value, the Company uses a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used. The Company determines the level within the fair value hierarchy in which the fair value measurements in their entirety fall. The categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Level 1 uses quoted prices in active markets for identical assets or liabilities, Level 2 uses significant other observable inputs, and Level 3 uses significant unobservable inputs. The amount of the total gains or losses for the period are included in earnings that are attributable to the change in unrealized gains or losses relating to those assets and liabilities still held at the reporting date. The Company has no financial assets or liabilities that are adjusted to fair value on a recurring basis.
At June 30, 2020 and 2019, there were no assets or liabilities measured at fair-value on a recurring basis which were measured using Level 3 inputs. Certain assets and liabilities are measured at fair value on a non-recurring basis; that is, the instruments are not measured at fair value on an ongoing basis, but are subject to fair value adjustments only in certain circumstances (for example, when there is evidence of impairment).
The following table sets forth the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. (In thousands)
Fair value at June 30, 2020
Total
Level 1
Level 2
Level 3
Cash, cash equivalents, and restricted cash
$
2,573
$
2,573
$
-
$
-
Fair value at June 30, 2019
Total
Level 1
Level 2
Level 3
Cash, cash equivalents, and restricted cash
$
5,507
$
5,507
$
-
$
-
The Company’s cash and cash equivalent instruments are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices.
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Revenue Recognition
The Company recognizes revenue based on the five-step model for revenue recognition as prescribed by ASC 606, Revenue from Contracts with Customers , as follows: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the prices to the performance obligations; and (5) recognize revenue. The Company has some agreements that contain general commercial terms and product prices but do not contain an obligation to provide goods to the customer. Our performance obligation, which is established when the customer submits a purchase order and the Company accepts the order, is to deliver the product based on the purchase order received. The Company typically recognizes revenue at the time of shipment, at which time the title passes to the customer, and there are no further performance obligations. See Note 17.
Shipping and Handling Costs
Shipping and handling costs include charges associated with delivery of goods from the Company’s facilities to its customers and are reflected in cost of sales. The Company has elected to account for shipping and handling activities as a fulfillment cost. Shipping and handling costs paid to the Company by its customers are included in revenue.
Share-Based Compensation
The Company measures and recognizes expense for all share-based payments at fair value. The Company uses the Black-Scholes option valuation model to estimate fair value for all stock options and stock warrants on the date of grant. For stock options that vest over time, the Company recognizes compensation cost on a straight-line basis over the requisite service period for the entire award. The Company recognizes forfeitures as they occur.
Research and Development Costs
Research and Development - Proprietary
Research and development costs, including salaries, research materials, administrative expenses and contractor fees, are charged to operations as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development is classified as research and development expense in the year recognized.
Research and Development - Collaborative Arrangement
Research and development costs incurred and shared in connection with a collaborative research and development project are separately stated in the consolidated statement of operation under “Research and development: Collaboration arrangements, net of reimbursement.”
Advertising and Marketing Costs
Advertising costs are expensed as incurred except for the cost of tradeshows and related marketing materials which are deferred until the tradeshow occurs. (In thousands)
For the Years Ended June 30,
2020
2019
2018
Advertising and marketing costs expensed (including tradeshows)
$
141
$
210
$
329
At June 30,
2020
2019
Prepaid marketing expenses deferred until event occurs
$
14
$
9
Legal Contingencies
The Company records contingent liabilities resulting from asserted and unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable. Estimating probable losses requires analysis of multiple factors, in some cases including judgments about the potential actions of third-party claimants and courts. Therefore, actual losses in any future period are inherently uncertain. Currently, the Company does not believe any probable legal proceedings or claims will have a material adverse effect on its financial position or results of operations. However, if actual or estimated probable future losses exceed the Company’s recorded liability for such claims, it would record additional charges as other expense during the period in which the actual loss or change in estimate occurred.
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Income Taxes
Income taxes are accounted for under the liability method. Under this method, the Company provides deferred income taxes for temporary differences that will result in taxable or deductible amounts in future years based on the reporting of certain costs in different periods for financial statement and income tax purposes. This method also requires the recognition of future tax benefits such as net operating loss carry-forwards, to the extent that realization of such benefits is more likely than not. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment of the change. In the event that the Company is assessed penalties and or interest, penalties will be charged to other operating expense and interest will be charged to interest expense in the period that they are assessed.
Leases
Effective July 1, 2019, the Company accounts for its leases under ASC 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded when incurred.
Income (Loss) Per Common Share
Basic earnings per share is calculated by dividing net income (loss) available to common stockholders by the weighted average number of common shares outstanding, and does not include the impact of any potentially dilutive common stock equivalents, including preferred stock, common stock warrants or options that are potentially convertible into common stock, as those would be antidilutive due to the Company’s net loss position.
Securities that could be dilutive in the future are as follows:
June 30,
2020
2019
2018
Preferred stock
59,065
59,065
59,065
Common stock warrants
6,080,000
6,080,000
250,000
Common stock options
5,497,505
4,645,315
3,759,840
Total potential dilutive securities
11,636,570
10,784,380
4,086,905
Use of Estimates
The preparation of consolidated financial statements in accordance with generally accepted accounting principles in the United States of America requires management of the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes of the Company including the allowance for doubtful accounts receivable; net realizable value of the enriched barium inventory; the estimated useful lives used in calculating depreciation and amortization on the Company’s fixed assets, patents, trademarks and other assets; estimated amount and fair value of the asset retirement obligation related to the Company’s production facilities; and inputs to the Black-Scholes calculation used in determining the expense related to share-based compensation including volatility, estimated lives and forfeiture rates of options granted. Accordingly, actual results could differ from those estimates and affect the amounts reported in the financial statements.
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Recent Accounting Pronouncements
In February 2016, the FASB issued ASU 2016-02 Leases (Subtopic 842), which will require lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by most leases. The update is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The modified retrospective transition approach is required. The Company adopted the new standard in the first quarter of fiscal year 2020 and the most significant effects of this ASU relate to the recognition of a new right-of-use asset and corresponding lease liability.
In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606. The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company is in the process of evaluating the impact the standard will have on its financial statements.
Other accounting standards that have been issued or proposed by FASB that do not require adoption until a future date are not expected to have a material impact on the consolidated financial statements upon adoption. The Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition, results of operations, cash flows or disclosures.
3.
Inventory
Inventory consisted of the following (in thousands):
June 30,
Inventory, current
2020
2019
Raw materials
$
401
$
333
Work in process
221
166
Finished goods
23
31
Total inventory, current
$
645
$
530
June 30,
Inventory, non-current
2020
2019
Enriched barium, non-current
$
117
$
117
Raw materials, non-current
20
38
Total inventory, non-current
$
137
$
155
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Inventory, non-current represents raw materials that were ordered in quantities to obtain volume cost discounts which based on current and anticipated sales volumes will not be consumed within an operating cycle. On August 25, 2017, the Company entered into a Consignment Agreement and related Services Agreement with MedikorPharma-Ural LLC to begin utilizing our enriched barium-130 carbonate inventory. The Company anticipates obtaining enough Cesium-131 under this arrangement to obtain approximately 4,000 curies of Cesium-131. During the year ended June 30, 2020, the Company obtained 31 curies under this agreement which has been used in production. At June 30, 2020, the Company estimates that the remaining enriched barium will result in 894 curies; approximately 62 of which will be obtained in the year ended June 30, 2021 and 832 will be obtained after June 30, 2020. There is no assurance as to whether the agreement will be terminated before this full amount is obtained and other supply sources are used, nor is there assurance that the third-party reactor which relies on this Consignment Agreement will be used by the Cesium-131 supplier under contract with the Company.
4.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
June 30,
2020
2019
Prepaid insurance
$
95
$
38
Other prepaid expenses
273
154
Other current assets
27
27
Other receivables
31
86
Total prepaid expenses and other current assets
$
426
$
305
5.
Property & Equipment
Property & equipment consisted of the following (in thousands):
June 30,
2020
2019
Land
$
366
$
366
Equipment
3,872
3,825
Leasehold improvements
4,143
4,143
Other 1
871
645
Property and equipment
9,252
8,979
Less accumulated depreciation
(7,517
)
(7,370
)
Property and equipment, net
$
1,735
$
1,609
1.
Plant and equipment, not placed in service are items that meet the capitalization threshold or which management believes will meet the threshold at the time of completion and which have yet to be placed into service as of the date of the balance sheet, and therefore, no depreciation expense has been recognized. Also included at June 30, 2020 and 2019 are costs associated with advance planning and design work on the Company’s new production facility of approximately $207,000. The advance planning and design work was primarily incurred in fiscal year 2017. The new production facility is currently on hold as the Company has sufficient production capacity to meet future demands and while the Company focuses its resources on revenue growth. It is anticipated that the Company will continue work on the new production facility process in the next four to five years.
6.
Restricted Cash
The Washington Department of Health requires the Company to provide collateral for the decommissioning of its facility. To satisfy this requirement, the Company has a bank account with a balance of $181,000. The account is termed restricted cash and classified as a long-term asset as the Company does not anticipate decommissioning the facility until the end of the current lease. The current lease as extended in July 2019 expires April 30, 2026. The cash will become unrestricted following the decommissioning of the facility and the release of the facility by the Washington Department of Health back to the landlord.
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7.
Other Assets, net
Other assets, net of accumulated amortization consisted of the following (in thousands):
June 30,
2020
2019
Website development
$
90
$
90
Licenses
516
516
Patents and trademarks
366
366
Total Other Assets
972
972
Less: Accumulated Amortization
(834
)
(810
)
$
138
$
162
Year Ended June 30,
2020
2019
2018
Amortization expense on website development
$
8
$
14
$
14
Amortization expense on licenses
14
18
18
Amortization expense on patents and trademarks
16
18
18
Total amortization expense
$
38
$
50
$
50
Future amortization is expected to be as follows (in thousands):
Year ended June 30, 2021
$
37
2022
23
2023
23
2024
23
2025
23
Thereafter
9
$
138
8 .
Leases
The Company maintains a production facility located at Applied Process Engineering Laboratory (APEL) in Richland, Washington. The APEL facility became operational in September 2007. The production facility has over 15,000 square feet and includes space for isotope separation, seed production, order dispensing, a clean room for assembly of our product offerings, and a dedicated shipping area. In 2015, the Company entered into a modification to the production facility lease that modified the requirement to return the facility to ground at the time of exit at Company discretion, exercised an extension in 2017 to increase the lease term to April 30, 2021, and reduced the required notice to terminate the lease early from twelve months to six months. In July 2019, the Company entered into another modification of the production facility lease that extends the term to April 20, 2026 and provides for an eighteen month termination notice with an early termination penalty of up to $40,000 which decreases in the future beginning May 1, 2022.
Upon the adoption of Topic 842 on July 1, 2019, the Company recognized a right-of-use asset and lease liability of approximately $1.2 million. In determining the amount of the right-of-use asset and lease liability, we assumed the termination of the lease in April 2024 and incurring a termination penalty of $20,000. As of the date of adoption, a right of use asset and a corresponding lease liability of approximately $1.2 million were recognized on the balance sheet based upon the present value of the future base payments discounted at a 6% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. The weighted average remaining term and discount rate as of June 30, 2020 was 3.85 years.
For the fiscal year ended June 30, 2020, 2019, and 2018 our operating lease expense was approximately $294,000, $285,000, and $285,000 respectively, and is recognized in the statement of operations in cost of sales and general and administrative expenses.
The following table presents the future operating lease payments and lease liability included on the consolidated balance sheet related to the Company’s operating lease as of June 30, 2020 (in thousands):
Year Ending June 30,
2021
290
2022
290
2023
290
2024
261
Total
1,131
Less: Imputed interest
(126
)
Total Lease Liability
1,005
Less current portion
(236
)
Non-current Lease Liability
$
769
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Asse t Retirement Obligation
The Company has an asset retirement obligation (ARO) associated with the facility it currently leases. In connection with the lease modification executed in July 2019, and the accretion of the lease liability, the ARO changed as follows (in thousands):
Year ended June 30,
2020
2019
Beginning balance
$
621
$
590
Accretion of discount
29
31
Gain on change in ARO estimate due to lease modification
(73
)
-
Ending Balance
$
577
$
621
In July 2019, the Company extended the lease term an additional five years thus extending the time before asset retirement costs would be incurred. The Company estimated retirement costs to be $704,000, which was discounted utilizing an interest rate of 5.1% for a new ARO liability of $555,000, a reduction of $73,000. At the time of extension, the asset retirement asset had been fully amortized, thus the Company recognized a gain on change in the estimate of $73,000.
9.
Share-Based Compensation
The Company currently provides share-based compensation under two equity incentive plans approved by the Board of Directors and the stockholders:
■
2017 Equity Incentive Plan (2017 Incentive Plan).
■
2020 Equity Incentive Plan (2020 Incentive Plan).
The 2006 Director Plan allowed the Board of Directors to grant options to purchase up to 1,000,000 shares of common stock to directors of the Company. The plan expired on August 16, 2016.
Options granted prior to fiscal 2017 were made pursuant to plans that have expired or were terminated.
The Company’s stockholders approved the 2017 Incentive Plan (“2017 Plan”) in June 2017. The 2017 Plan allows the Board of Directors to grant up to 4,000,000 shares of common stock to directors, officers, employees and consultants in a combination of equity incentive forms including incentive stock options (ISO), non-qualified stock options (NQSO), stock appreciation right (SAR) or restricted shares (RSU) of common stock.
The Company’s stockholders approved the 2020 Incentive Plan (“2020 Plan”) in December 2019 . The 2020 Plan allows the Board of Directors to grant up to 6,000,000 shares of common stock to directors, officers, employees and consultants in a combination of equity incentive forms including incentive stock options (ISO), non-qualified stock options (NQSO), stock appreciation right (SAR) or restricted shares (RSU) of common stock. Options granted under all of the Plans have a ten year maximum term, an exercise price equal to at least the fair market value of the Company’s common stock (based on the trading price on the NYSE American) on the date of the grant, and with varying vesting periods as determined by the Board.
The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility. The Company uses the Black-Scholes option valuation model because management believes the model is appropriate for the Company. However, management understands that because changes in the subjective input assumptions can materially affect the fair value estimate, this valuation model does not necessarily provide a reliable single measure of the fair value of its stock options. The risk-free interest rate is based on the U.S. treasury security rate with an equivalent term in effect as of the date of grant. The expected option lives and volatility assumptions are based on historical data of the Company.
The weighted average fair value of stock option awards granted and the key assumptions used in the Black-Scholes valuation model to calculate the fair value are as follows:
For the Year Ended June 30,
2020
2019
2018
Weighted average fair value
$0.39
$0.31
$0.34
Options issued
1,330,000
1,252,500
1,125,000
Exercise price
$0.32
to
$0.61
$0.37
to
$0.55
$0.44
to
$0.58
Expected term (in years)
5
5
5
Risk-free rate
0.33%
to
1.80%
1.83%
to
2.91%
1.83%
to
2.85%
Volatility
83%
-
89%
89%
-
105%
94%
-
101%
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The following table presents the share-based compensation expense (in thousands):
For the Year Ended June 30,
2020
2019
2018
Cost of sales
$
21
$
38
$
62
Research and development expense
111
84
92
Sales and marketing expense
125
96
92
General and administrative expense
238
202
158
Total share-based compensation
$
495
$
420
$
404
The total value of the stock options awards is expensed ratably over the vesting period of the employees receiving the awards. As of June 30, 2020, total unrecognized compensation cost related to stock-based options and awards was approximately $652,000 and the weighted-average period over which it is expected to be recognized is approximately 1.25 years.
A summary of stock option information within the Company’s share-based compensation plans during the fiscal years is presented below:
Options
Outstanding
Price (a)
Life (b)
Value (c)
Balance at June 30, 2017
3,379,191
$
0.78
7.86
$
151
Granted (d)
1,125,000
.47
Expired
(100,000
)
.75
Forfeited
(561,541
)
.77
Exercised
(82,810
)
.61
Balance at June 30, 2018
3,759,840
$
0.69
7.75
$
49
Granted (d)
1,252,500
.44
Expired
(242,000
)
.41
Forfeited
(68,125
)
.54
Exercised
(56,900
)
.26
Balance at June 30, 2019
4,645,315
$
0.64
7.95
$
1
Granted (d)
1,330,000
.61
Expired
(192,810
)
1.33
Forfeited
(22,500
)
.42
Exercised
(262,500
)
.49
Balance at June 30, 2020
5,497,505
$
0.62
7.85
$
233
Vested and expected to vest at June 30, 2020
5,497,505
$
0.62
7.85
$
233
Exercisable at June 30, 2020
3,702,296
$
0.66
7.12
$
138
(a)
Weighted average exercise price per share.
(b)
Weighted average remaining contractual life.
(c)
Aggregate intrinsic value (in thousands).
(d)
All options granted had exercise prices equal to or greater than the ending closing market price of the Company’s common stock on the grant date. The options were granted to employees and management by the Compensation Committee and had vesting periods from immediate to five years.
For the Year Ended June 30,
2020
2019
2018
Aggregate intrinsic value of options exercised (in thousands)
$
83
$
11
$
-
The Company’s current policy is to issue new shares to satisfy option exercises.
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10.
Stockholders’ Equity
The authorized capital structure of the Company consists of $.001 par value preferred stock and $.001 par value common stock.
Common Stock
On March 31, 2020, the Company entered into an Equity Distribution Agreement (the “Agreement”) with Oppenheimer & Co., Inc. (“Oppenheimer”). The common stock sold pursuant to the Agreement will be distributed at the market prices prevailing at the time of sale. The Agreement provides that Oppenheimer will be entitled to compensation for its services at a commission rate of 3.0% of the gross sales price per share of common stock sold plus reimbursement of certain expenses. Net proceeds from the sale of the Shares will be used for general corporate purposes. As of June 30, 2020, the Company had sold an aggregate of 1,247,232 shares under the distribution agreement at an average price of approximately $0.738 per common share for gross proceeds of approximately $920,000 and net proceeds of approximately $874,000.
On May 8, 2018, the Company entered into a Sales Agreement with H.C. Wainwright & Co., LLC (“Wainwright”). The common stock sold in the Sales Agreement was distributed at the market prices prevailing at the time of sale. As of June 30, 2018, the Company had sold an aggregate of 980,918 shares under the Sales Agreement at an average price of approximately $0.515 per common share for gross proceeds of approximately $505,000. Net proceeds from this raise totaled approximately $479,000. No additional sales were made in July 2018 and this offering was suspended on July 9, 2018.
On July 11, 2018, the Company sold 11,000,000 shares of its common stock at a price of $0.75 per share, for aggregate gross proceeds of $8.25 million.
Additionally, the Company issued to the purchasers unregistered warrants to purchase up to 5,500,000 shares of common stock. The warrants have an exercise price of $0.75 per share common stock, are exercisable commencing six months following the issuance date, and expire five and one-half years from the issuance date. The Company also issued warrants to purchase up to 330,000 shares of common stock of the Company, at an exercise price of $0.9375, to representatives of Wainwright, the placement agent for the registered direct offering, as part of its compensation. If exercised for cash, future exercises of these warrants will provide additional capital to the Company. The Company evaluated the warrants under ASC 815 , Derivatives and Hedging, and ASC 480, Distinguishing Liabilities from Equity. Based on the guidance from ASC 815 and ASC 480, the warrants meet the requirement for equity classification as they meet the definition of a derivative, are indexed to the Company's own stock and cannot be net cash settled. The fair value of the warrants with an exercise price of $0.75 was estimated to be $2.8 million and the fair value of the warrants with an exercise price of $0.9375 was estimated to be $0.2 million on the issuance date using a Black-Scholes valuation model. The assumptions used in the Black-Scholes valuation model are in the table below.
Preferred Stock
The Company’s Certificate of Incorporation authorizes 7,000,000 shares of $0.001 par value preferred stock available for issuance with such rights and preferences, including liquidation, dividend, conversion, and voting rights, as described below. In connection with redomiciling the Company to Delaware, Preferred Stock Series A, C and D designations were terminated. There were no shares issued under these Series. Series B is the remaining Series authorized at June 30, 2020 and had 59,065 issued and outstanding shares at June 30, 2020.
Series B
Series B preferred shares are entitled to a cumulative 15% dividend annually on the stated par value per share. These shares are convertible into shares of common stock at the rate of one share of common stock for each share of Series B preferred stock, and are subject to automatic conversion into common stock upon the closing of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of common stock in which the gross proceeds to the Company are at least $4,000,000. Series B preferred stockholders have voting rights equal to the voting rights of common stock, except that the vote or written consent of a majority of the outstanding preferred shares is required for any changes to the Company’s Certificate of Incorporation, Bylaws or Certificate of Designation, or for any bankruptcy, insolvency, dissolution or liquidation of the Company. Upon liquidation of the Company, the Company’s assets are first distributed ratably to the Series B preferred stockholders and then to the holders of the Common Stock.
On December 10 , 2019, the Board of Directors declared a dividend on the Series B Preferred Stock of all outstanding and cumulative dividends through December 31, 2019. The total dividends of $11,000 were paid as of December 31, 2019. On December 18, 2018 , the Board of Directors declared a dividend on the Series B Preferred Stock of all outstanding and cumulative dividends through December 31, 2018 . The total dividends of $11,000 were paid as of December 31, 2019 . At June 30, 2020 and 2019, there were 59,065 Series B preferred shares outstanding and cumulative dividends in arrears were $5,000.
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Warrants
During the year ended June 30, 2020 the Company did not issue any warrants.
During the year ended June 30, 2019 the Company issued a total of 5,830,000 warrants in connection with the registered direct offering that was completed on July 11, 2018. The weighted average fair value of warrants issued and the key assumptions used in the Black-Scholes valuation model to calculate the fair value, are as follows:
Weighted average fair value
$0.51
Warrants issued
5,830,000
Exercise price
$0.75
to
$0.9375
Expected term (in years)
5.5
Risk-free rate
2.74%
Volatility
102.73%
During the year ended June 30, 2018, the Company issued warrants as share-based compensation for third party services, principally marketing. The weighted average fair value of warrants issued and the key assumptions used in the Black-Scholes valuation model to calculate the fair value, are as follows:
Weighted average fair value
$0.41
Warrants issued
500,000
Exercise price
$0.01
to
$0.54
Expected term (in years)
2
to
3
Risk-free rate
1.62%
to
2.55%
Volatility
60%
-
82%
The following table summarizes the activity of all stock warrants and weighted average exercise prices.
Warrants
Price (a)
Balance at June 30, 2017
-
-
Warrants issued
500,000
0.28
Warrants exercised
(250,000
)
0.01
Balance at June 30, 2018
250,000
$
0.54
Warrants Issued
5,830,000
0.76
Balance at June 30, 2019
6,080,000
$
0.75
Balance at June 30, 2020
6,080,000
$
0.75
(a)
Weighted average exercise price per share.
As of June 30, 2020, the Company had 6,080,000 common warrants outstanding exercisable on or before January 11, 2024 with a weighted average remaining contractual life of 3.37 years.
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11.
Income Taxes
Due to net losses, the Company did not record an income tax provision or benefit for the years ending June 30, 2020, 2019 and 2018.
The significant deferred tax components using a federal income tax rate of 21% for the years ended June 30, 2020 and 2019 are as follows (in thousands):
As of June 30,
2020
2019
Fixed assets
$
124
$
204
Share-based compensation
682
578
Other accruals
37
27
Asset retirement obligation
121
130
Research credit carryforwards
218
96
Other
6
6
Net operating loss carryforwards
15,799
15,207
Total deferred tax assets
16,987
16,248
Valuation allowance
(16,987
)
(16,248
)
Total
$
-
$
-
As management of the Company cannot determine that it is more likely than not that the Company will realize the benefit of the net deferred tax asset, a valuation allowance equal to 100% of the net deferred tax asset has been recorded at both June 30, 2020 and 2019.
The Company has federal net operating loss carryforwards of approximately $67.5 million on June 30, 2020 that can be used to offset future regular taxable income. These net operating loss carryforwards expire at various times through the years 2025 to 2038. Additionally, the Company has federal net operating loss carryforwards of approximately $7.7 million on June 30, 2020 that can be used to offset future regular taxable income that do not have an expiration date.
The Company has a research credit carryforward of approximately $0.2 million on June 30, 2020 that expire at various times through the years 2037 to 2040.
On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the "Act") resulting in significant modifications to existing law. The Company did not incur any income tax benefit or provision for the year ended June 30, 2018 as a result of the changes to tax laws and tax rates under the Act. The Company’s net deferred tax asset was reduced by approximately $9.5 million during the year ended June 30, 2018, which consisted primarily of the remeasurement of federal deferred tax assets and liabilities from 35% to 21%.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the "Cares Act") was enacted. The CARES Act changed net loss carryforward and back provisions and the business interest expense limitation. The Company has evaluated the impact of the CARES Act and determined that none of the changes would result in a material cash benefit to the Company.
The Company’s statutory rate reconciliation is as follows (in thousands):
For the year ended June 30,
2020
2019
2018
U.S. federal statutory income tax rate
21
%
21
%
28
%
Expected income tax benefit
$
(724
)
$
(1,080
)
$
(1,878
)
Meals and entertainment
8
12
21
Non-deductible penalties
24
18
4
Impact on the change in income tax rate
-
-
9,556
Change in estimate
(58
)
(178
)
-
Research credit
11
-
-
Change in valuation allowance
739
1,228
(7,703
)
Income tax expense (benefit)
$
-
$
-
$
-
The Company has reviewed the tax positions taken and concluded that it does not have to book a liability for uncertain tax positions.
Currently, tax years 2018-2020 remain open for examination by United States taxing authorities. Net operating losses prior to 2018 could be adjusted during an examination of open years.
12.
401(k) and Profit Sharing Plan
The Company has a 401(k) plan, which commenced in fiscal year 2007, covering all eligible full-time employees of the Company. Contributions to the 401(k) plan are made by the participants to their individual accounts through payroll withholding. The 401(k) plan also allows the Company to make contributions at the discretion of management. To date, the Company has not made any contributions to the 401(k) plan.
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13.
Distribution Agreements
On July 14, 2017, the Company entered into an agreement with a new distributor in Russia that provides for the ability to sell the entire product line in the Russian Federation. The agreement had a one-year initial term with two additional one-year terms which automatically renew unless either party invokes their right to terminate earlier under the provisions of the agreement. The agreement was automatically renewed through July 2020. On September 22, 2020, the Company entered into an agreement with the same distributor. The agreement has a one-year initial term with two additional one-year terms which automatically renew unless either party invoke their right to terminate earlier under the provisions of the agreement. In fiscal year 2020, the Company entered into a three-year agreement with a distributor in India that provides for the ability to sell Cesium-131 brachytherapy seeds in different configurations within India. The Company and the distributor for Italy and Switzerland executed the distribution agreement on August 1, 2016. The agreement has a one-year initial term with two additional one-year terms which automatically renew unless either party invoke their right to terminate earlier under the provisions of the agreement. The agreement expired on August 1, 2019 and was not renewed. As the Company elected to not renew its CE mark in fiscal 2019, distribution will be limited to those countries outside the European Union.
14.
Commi tments and Contingencies
Royalty Agreement for Invention and Patent Application
A former employee and stockholder of the Company previously assigned his rights, title and interest in an invention to Isoray Products LLC (a predecessor company) in exchange for a royalty equal to 1% of the Gross Profit, as defined, from the sale of “seeds” incorporating the technology. The patent and associated royalty obligations were transferred to the Company in connection with the merger transaction.
The Company must also pay a royalty of 2% of Gross Sales, as defined, for any sub-assignments of the aforesaid patented process to any third parties. The royalty agreement remained in force until the expiration of the patents on the assigned technology. The patent expired in April 2019 and no royalties were paid on sales after the expiration of the patent.
During fiscal years 2020, 2019 and 2018, the Company recorded royalty expenses of $0, $33,000, and $27,000, respectively.
Irradiation Services Agreement
On November 29, 2016, Medical, a wholly owned subsidiary of Isoray, entered into an Irradiation Services Agreement (MURR Agreement) with the Curators of the University of Missouri, a public corporation of the State of Missouri, on behalf of its University of Missouri Research Reactor (MURR). The MURR Agreement provides Medical with access to reactor space for the irradiation of natural or enriched barium to produce Ba-131, which is used by Medical to produce Cesium-131 for use in its product. The MURR Agreement has a term of five years concluding November 29, 2021 and will automatically renew for successive twelve-month periods unless terminated by either party, and can be terminated by either party upon three months written notice. The MURR Agreement does not require minimum orders or obligate Medical to future minimum payments. After a thorough review of the capacity and quality of production at the MURR facility, the Company determined to terminate its supply agreement with MURR and the last shipment of isotope from MURR was received in January 2019.
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Isotope Purchase Agreement
In December 2015, the Company completed negotiations with The Open Joint Stock Company (located in Russia) for the purchase of Cesium-131 manufactured by the Institute of Nuclear Materials. The purchase agreement provided the Company with one year’s supply of Cesium-131. The original agreement was due to expire on March 31, 2017, but in December 2016 an addendum was signed extending it until December 31, 2017. On October 23, 2017, the Company, together with The Open Joint Stock Company, signed an addendum to the contract to include Cesium-131 manufactured at RIAR and extending it until December 31, 2018. On December 24, 2018, an addendum was signed extending the term of the supply contract through December 31, 2019 and modifying the volume of additional shipments of Cesium-131. Under the addendum, current pricing and volumes for Cesium-131 purchases remained in place until May 31, 2019. On July 11, 2019, another addendum was signed extending the pricing terms until August 4, 2019. On July 30, 2019, a new supply contract was signed with The Open Joint Stock Company for a term of August 2019 to December 2020 as the Company had purchased the maximum amount of Cesium-131 permitted under the prior agreement. On August 6, 2019, an addendum was signed adding a manufacturer of Cesium-131. On August 14, 2020, another addendum was signed modifying the volume of additional shipments of Cesium-131. On August 26, 2020, a new supply contract was signed with The Open Joint Stock Company for a term of August 2020 to December 2021 as the Company had purchased the maximum amount of Cesium-131 permitted under the prior agreement.
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Research and Development - Collaborative Arrangement
On March 13, 2017, Medical entered into a Collaborative Development Agreement (CDA) with GammaTile, LLC, now known as GT Medical Technologies, Inc. (GT Med Tech), to further develop a brachytherapy medical device for the treatment of cancerous tumors in the brain and to seek regulatory approval for the new product. As the project manager, Medical incurs all costs in connection with the collaboration project which will be shared equally by both parties as of November 8, 2016 when they informally began the collaboration. The arrangement is accounted for as a collaborative arrangement and related costs are incurred, shared, and separately stated in connection with a collaborative research and development project. These costs are reported on the financial statements under “Research and development: Collaboration arrangements, net of reimbursement.”
Gross costs incurred in connection with the collaboration agreement during fiscal years 2020, 2019 and 2018 were $0, $266,000 and $769,000, respectively. As of June 30, 2020 and 2019, the Company had no receivable balance related to this CDA.
The CDA with GT Med Tech terminated in March 2018 but the Company continued to work collaboratively with GT Med Tech to obtain 510(k) clearance from the FDA and on the design transfer to production without a formal agreement. Beginning in April 2018 costs were no longer shared equally as had been done historically and GT Med Tech was responsible for more than 50% of the costs. The Company stopped sharing costs with GT Med Tech related to the development of GammaTile™ in December 2018 when the product entered a limited market release.
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15.
Concentrations of Credit and Other Risks
The Company’s financial instruments that were exposed to concentrations of credit risk consist primarily of cash and cash equivalents, U.S. Treasury securities, and accounts receivable.
The Company’s cash and cash equivalents were maintained with high-quality financial institutions at June 30, 2020 and 2019, respectively. At June 30, 2020 and 2019, respectively, all cash balances were guaranteed by the Federal Deposit Insurance Corporation (FDIC) and all cash equivalents consisted of U.S. Treasury securities.
The Company routinely assesses the financial strength of its customers and provides an allowance for doubtful accounts as necessary. At both June 30, 2020 and 2019, the allowance was approximately $26,000.
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Inventories
Most components used in the Company’s product are purchased from outside sources. Certain components are purchased from single suppliers. The failure of any such supplier to meet its commitment on schedule could have a material adverse effect on the Company’s business, operating results and financial condition. If a sole-source supplier were to go out of business or otherwise become unable to meet its supply commitments, the process of locating and qualifying alternate sources could require up to several months, during which time the Company’s production could be delayed. Such delays could have a material adverse effect on the Company’s business, operating results and financial condition. Sanctions placed on financial transactions with Russian banking institutions may interfere with the Company’s ability to transact business in Russia on a temporary or other basis resulting in an interruption of the Cesium-131 supply which could have a material adverse effect on the Company’s business, operating results and financial condition.
16 .
Quarterly Financial Data (unaudited)
The following table provides the selected quarterly financial data for fiscal years 2020 and 2019 (dollars and shares in thousands, except for per share amounts):
Quarters ended
September 30,
December 31,
March 31,
June 30,
2019
2019
2020
2020
Net revenue
$
2,315
$
2,206
$
2,880
$
2,279
Gross profit
$
1,236
$
1,111
$
1,706
$
1,071
Net loss
$
(816
)
$
(897
)
$
(545
)
$
(1,188
)
Net loss per share – basic and diluted
$
(0.01
)
$
(0.01
)
$
(0.01
)
$
(0.02
)
Shares used in basic and diluted per share calculation
67,388
67,388
67,558
68,075
Quarters ended
September 30,
December 31,
March 31,
June 30,
2018
2018
2019
2019
Net revenue
$
1,562
$
1,904
$
1,924
$
1,924
Gross profit/(loss)
$
524
$
765
$
879
$
879
Net loss
$
(1,508
)
$
(1,414
)
$
(1,127
)
$
(1,095
)
Net loss per share – basic and diluted
$
(0.02
)
$
(0.02
)
$
(0.02
)
$
(0.02
)
Shares used in basic and diluted per share calculation
66,147
67,331
67,333
67,357
1.
Due to rounding, the total of the individual quarters and the year-end calculation on the Consolidated Statement of Operations may be different.
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17.
Contracts with Customers
We routinely enter into agreements with customers that include general commercial terms and conditions, notification requirements for price increases, shipping terms, and in most cases, prices for the products that we offer. However, these agreements do not obligate us to provide goods to the customer and there is no consideration promised to us at the onset of these arrangements. For customers without separate agreements, we have a standard list price established for all products and our invoices contain standard terms and conditions that are applicable to those customers where a separate agreement is not controlling. Our performance obligations are established when a customer submits a purchase order or e-mail notification (in writing or electronically) for goods, and we accept the order. We identify performance obligations as the sale of our products and services as requested from our customers. We generally recognize revenue upon the satisfaction of these criteria when control of the product has been transferred to the customer at which time we have an unconditional right to receive payment. Our prices are fixed and are not affected by contingent events that could impact the transaction price. We do not offer price concessions and do not accept payment that is less than the price stated when we accept the purchase order, except in rare credit related circumstances. We do not have any material performance obligations where we are acting as an agent for another entity.
Revenues for all products are typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations.
Sources of Revenue
We have identified the following revenues disaggregated by revenue source:
1.
Domestic – direct sales of products and services.
2.
International – direct sales of products and services.
During the fiscal years 2020, 2019 and 2018, the Company had revenue from both sources. International revenues in all periods was immaterial. For the fiscal year 2020, prostate brachytherapy comprised 86% of our revenue while other revenue comprised 14% compared to 89% and 11%, respectively, in the fiscal year 2019 and 86% and 14%, respectively, in the fiscal year 2018.
Contract Balances
We incur obligations on general customer purchase orders and e-mails that have been accepted but unfulfilled. Due to the short duration of time between order acceptance and delivery of the related product, we have determined that the balance related to these obligations is generally immaterial at any point in time. We monitor the value of orders accepted but unfulfilled at the close of each reporting period to determine if disclosure is appropriate.
Warranty
Our general product warranties do not extend beyond an assurance that the product delivered will be consistent with stated specifications and do not include separate performance obligations.
Returns
Generally, we allow returns if not implanted and we are notified within a few weeks after satisfying our performance obligations of a return. Returns after shipment may result in a 50% restocking fee.
Significant Judgments in the Application of the Guidance in ASC 606
There are no significant judgments associated with the satisfaction of our performance obligations. We generally satisfy performance obligations upon shipment of the product to the customer. This is consistent with the time in which the customer obtains control of the products. Therefore, the value of unsatisfied performance obligations at the end of any reporting period is generally immaterial. We use historical information along with an analysis of the expected value to properly calculate and to consider the need to constrain estimates of variable consideration. Such amounts are included as a reduction to revenue from the sale of products in the periods in which the related revenue is recognized and adjusted in future periods as necessary.
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Commissions and Contract Costs
We expense commissions on orders to our sales team upon satisfaction of our performance obligations. We generally do not incur incremental charges associated with securing agreements with customers which would require capitalization and recovery over the life of the agreement.
Practical Expedients
Our payment terms for sales direct to customers and distributors are substantially less than the one year collection period that falls within the practical expedient in determination of whether a significant financing component exists.
Shipping and Handling Charges
Fees charged to customers for shipping and handling of products are included as revenue and the costs for shipping and handling of products are included as a component of cost of sales.
Taxes Collected from Customers
As our products are used in another service and are exempt, to this point we have not collected taxes. If we were to collect taxes they would be on the value of transaction revenue and would be excluded from revenues and cost of sales and would be accrued in current liabilities until remitted to governmental authorities.
Concentration of Customers
One group of customers, facilities or physician practices has revenues that aggregate to greater than 10% of total Company sales. This group of facilities individually do not aggregate to more than 10% of total Company sales. They are serviced by the same physician group, one of whom is our Medical Director:
Year ended June 30,
Facility
2020
% of
total
revenue
2019
% of
total
revenue
2018
% of
total
revenue
El Camino, Los Gatos, & other facilities
26.8
%
22.1
%
24.2
%
ITEM 16 – FORM 10-K SUMMARY
None
92
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: September 24, 2020
ISORAY, INC., a Delaware corporation
By /s/ Lori A. Woods
Lori A. Woods, Chief Executive Officer, Director
By /s/ Jonathan Hunt
Jonathan Hunt, Chief Financial Officer,
Co-Principal Financial Officer
By /s/ Mark J. Austin
Mark J. Austin, Controller,
Co-Principal Financial and Principal Accounting Officer, Corporate Secretary
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Dated: September 24, 2020
/s/ Lori A. Woods
Lori A. Woods, Chief Executive Officer, Director
/s/ Jonathan Hunt
Jonathan Hunt, Chief Financial Officer,
Co-Principal Financial Officer
/s/ Mark J. Austin
Mark J. Austin, Controller,
Co-Principal Financial and Principal Accounting Officer, Corporate Secretary
/s/ Michael McCormick
Michael McCormick, Chairman
/s/ Alan Hoffmann
Alan Hoffmann, Director
/s/ Philip Vitale
Philip Vitale, Director
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