What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-08-05 compared with 2021-05-05 · 92 added, 63 removed, 130 unchanged (54% of the section changed)

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Our vision is to create, develop and commercialize highly differentiated combination cancer therapies.

We currently have five investigational products in clinical development.

In 2020, we entered into an Option, License and Collaboration Agreement (Gilead Collaboration Agreement) with Gilead Sciences, Inc.

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For each program to which Gilead exercises their option, the parties will co-develop globally and co-commercialize in the U.S., subject to certain exceptions, and Gilead will have the right to commercialize the program outside of the United States, subject to the rights of our existing partners to certain territories.

In connection with the Gilead Collaboration Agreement, we also entered into a Common Stock Purchase Agreement (as amended and restated in January 2021), pursuant to which Gilead purchased an aggregate of 11,613,029 shares of our common stock for aggregate gross proceeds of $420.4 million and has the right, at its option from time to time over a five year period, to purchase up to a maximum ownership of 35% of our then-outstanding voting common stock, and an Investor Rights Agreement that provides for a three-year standstill, two-year lockup and the right to designate two individuals to be appointed to our Board of Directors.

In 2017, we entered into an Option and License Agreement (Taiho Agreement) with Taiho Pharmaceutical Co., Ltd.

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To date, Taiho has exercised their option rights to our adenosine receptor antagonist program (including etrumadenant) and our anti-PD-1 program (including zimberelimab).

We currently have five investigational products in clinical development.

Domvanalimab (formerly referred to as AB154), our anti-TIGIT monoclonal antibody, is being evaluated in combination with zimberelimab with or without etrumadenant vs.

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Etrumadenant (formerly referred to as AB928), our small molecule dual A 2a /A 2b adenosine receptor antagonist, is being evaluated by us in several randomized or Phase 2 trials across major tumor types, including in our ARC-4, ARC-6, ARC-7, and ARC-9 studies, as well as in two randomized Phase 1b/2 trials being conducted by Genentech (the Morpheus trials).

AB680, our small-molecule CD73 inhibitor, is being evaluated in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer (ARC-8) as well as late-line metastatic prostate cancer (ARC-6).

Quemliclustat (formerly referred to as AB680), our small-molecule CD73 inhibitor, is being evaluated in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer (ARC-8) as well as late-line metastatic prostate cancer (ARC-6).

Zimberelimab (formerly referred to as AB122), our anti-PD-1 monoclonal antibody, is the cornerstone of our combination strategy.

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The dose escalation study will further evaluate the safety, pharmacokinetics and pharmacodynamics of AB308 in combination with zimberelimab.

Gilead Collaboration

On May 27, 2020, we entered into the Gilead Collaboration Agreement, a Common Stock Purchase Agreement (the Stock Purchase Agreement), and an Investor Rights Agreement, (collectively, the Gilead Agreements), each with Gilead.

The transaction closed on July 13, 2020 following expiration of the antitrust waiting period.

Upon closing, Gilead made an upfront payment of $175 million pursuant to the Gilead Collaboration Agreement, and Gilead made an equity investment of approximately $200 million in us by purchasing 5,963,029 shares of our common stock at a per share price of $33.54 pursuant to the Stock Purchase Agreement.

Gilead made an additional equity investment in us of approximately $56.7 million, net of offering costs, by purchasing 2,200,000 shares of

our common stock at a per share price of $27.50 in our May 2020 Public Offering.

Pursuant to the Investor Rights Agreement, w e also appointed Gilead’s designee s , Merdad Parsey , M.D., Ph.D.

and Michael Quigley, Ph.D., to our Board of Directors.

Pursuant to the terms of the Gilead Collaboration Agreement, Gilead has an exclusive license to develop and commercialize zimberelimab in certain markets and obtained exclusive options to acquire an exclusive license to develop and commercialize all of our current and future clinical programs during the 10-year collaboration term, contingent upon Gilead’s payment of $400 million, with the first payment of $100 million in 2022 and an additional $100 million payment due at Gilead’s option on each of the fourth, sixth, and eighth anniversaries of the agreement.

For those programs that enter clinical development prior to the end of the collaboration term, Gilead’s option rights will extend for up to an additional three years thereafter.

Gilead may exercise its option, on a program-by-program basis, upon payment of an option fee that ranges from $200 million to $275 million per program for our clinical programs in existence at the date of the agreement, and $150 million per program for all other programs that enter clinical development thereafter.

If Gilead exercises its option with respect to our TIGIT program, we are also eligible to receive up to $500 million in potential U.S.

regulatory approval milestones with respect to domvanalimab.

Upon Gilead’s exercise of its option to a program, the two companies will co-develop and equally share global development costs, subject to certain of our opt-out rights, and expense caps on our spending and related subsequent adjustments.

For each optioned program, provided we have not exercised our opt-out rights, we have an option to co-promote in the United States with equal sharing of related profits and losses.

Gilead has the right to exclusively commercialize any optioned programs outside of the U.S., subject to the rights of our existing partners to any territories, and Gilead will pay to us tiered royalties as a percentage of revenues ranging from the high teens to the low twenties.

Pursuant to the Stock Purchase Agreement and the Investor Rights Agreement, Gilead has the right, at its option, to purchase additional shares from us, up to a maximum ownership of 35% of our then-outstanding voting common stock, from time to time over a five year period, at a purchase price equal to the greater of a 20% premium to market (based on a trailing five-day average closing price) at the time Gilead exercises such option, and the $33.54 initial purchase price.

The Investor Rights Agreement also includes a three-year standstill and a two-year lockup and provides Gilead with registration rights commencing at the end of the lockup period, pro rata participation rights in certain future financings and the right to designate two individuals to be appointed to our Board of Directors.

On January 31, 2021, we and Gilead entered into an Amended and Restated Common Stock Purchase Agreement, which amended and restated in its entirety the Common Stock Purchase Agreement, pursuant to which Gilead purchased from us 5,650,000 shares of our common stock at a purchase price of $39.00 per share, for gross proceeds of $220.4 million.

All other terms of the original Common Stock Purchase Agreement, including Gilead’s option to purchase additional shares from us, up to a maximum ownership of 35% of our then-outstanding common stock, remain unchanged.

Recent Developments

In June 2021, we announced results from the first interim analysis of ARC-7, our randomized, three- arm Phase 2 trial in first-line metastatic PD-L1≥50% non-small cell lung cancer.

The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting and the domvanalimab-based combination arms showed encouraging clinical activity (measured by overall response rate).

At the time of data cut off, no unexpected safety signals were observed, and the safety profile for each arm appeared to be consistent with known immune checkpoint inhibitors in this setting.

Based on the results from the interim analysis, we determined that all three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, should continue to enroll as planned.

We and Gilead, which maintains an exclusive option to our TIGIT program, are continuing preparations for additional Phase 3 studies of domvanalimab-based combinations and are exploring development plans for combinations including domvanalimab and etrumadenant.

COVID-19 Pandemic

The degree to which COVID-19 impacts our business operations, research and development programs and financial condition will depend on future developments, including the ultimate duration and/or severity of the outbreak, the impact of any resurgences and new strains that emerge, actions by government authorities to contain the spread of the virus, the timing, availability and effectiveness of any vaccines, and when and to what extent normal economic and operating conditions can resume.

The degree to which COVID-19 impacts our business operations, research and development programs and financial condition remains highly uncertain and will depend on future developments, including the ultimate duration and/or severity of the outbreak, the impact of any resurgences and new variants that emerge, actions by government authorities to contain the spread of the virus, the availability, adoption and effectiveness of any vaccines, and when and to what extent normal economic and operating conditions can resume.

Our management continues to actively monitor this health crisis and its effects on our operations, key vendors and workforce.

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and internationally in geographic regions that are impacted by COVID-19 to varying degrees.

While we have seen relatively robust enrollment across our ongoing Arcus-sponsored studies, we expect to see volatility as local governments respond to resurgences and the emergence of new strains, each of which may result in the prolonged reinstitution, extension or enhancement of shelter-in-place measures.

While we have seen relatively robust enrollment in most of our ongoing Arcus-sponsored studies, disruptions caused by the COVID-19 pandemic may impact our ability to initiate, enroll, conduct or complete our ongoing or planned clinical trials.

The American Cancer Society has also reported that the pandemic has led to declines in screening, diagnosis and treatment for cancer patients, which will impact the enrollment of patients in clinical trials targeting early stage cancers and retention of patients overall in our trials.

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Our third-party contract manufacturers continue to operate at or near normal levels and, at this time and subject to further COVID-19 implications, we do not anticipate any disruptions to our drug supply chain.

Our discovery programs are impacted by reduced operating capacity in our laboratories due to employee safety measures, such as social distancing requirements and shift work.

This has slowed the pace of our discovery efforts, and our HIF-2α program is now expected to enter clinical development in the second half of 2021.

The full impact of the COVID-19 outbreak remains highly uncertain and subject to change.

The safety, health and well-being of our employees remains a primary concern, and we instituted remote work arrangements for our office-based employees and regular

COVID-19 testing services for our laboratory-based employees in order to reduce the risk of exposure to COVID-19 among our employees.

These actions have increased our operating costs, whjch together with the absence of any furlough or measures to reduce personnel costs despite reduced laboratory capacity, will have a negative impact on our operations and financial condition.

We do not expect the forward impact will be material due to adjustments in operations that we have made.

However, there are many uncertainties around the COVID pandemic and future developments, which are unpredictable, may result in a material, negative impact to our operations and financial condition.

Our discovery programs were impacted by reduced operating capacity in our laboratories;

however, our laboratory operations are returning to normal levels following the availability of vaccines to the general public and the high level of adoption among our laboratory-based personnel.

As we begin to resume normal business activities, the safety, health and well-being of our employees remains a primary concern, and we may restrict our business activities or modify our employee work arrangements in order to reduce the risk of exposure to COVID-19 among our employees.

The COVID-19 pandemic continues to evolve and future developments, which are unpredictable, may result in a material, negative impact to our operations and financial condition.

Components of Operating Results

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Our condensed consolidated financial statements have been prepared in accordance with U.S.

generally accepted accounting principles (GAAP).

generally accepted accounting principles (U.S.

The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue and expenses incurred during the reporting periods.

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We believe that the accounting policies relating to revenue recognition, clinical trial accruals and stock-based compensation reflect the more significant estimates and assumptions used in the preparation of our condensed consolidated financial statements.

There have been no significant changes in our critical accounting policies and estimates during the three months ended March 31, 2021, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2020 and more fully described in Note 2 of the accompanying condensed consolidated financial statements.

There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2021, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2020 and more fully described in Note 2 of the accompanying condensed consolidated financial statements.

Results of Operations

Three Months Ended March 31, 2021 and 2020

The following table summarizes our results of operations for the three months ended March 31, 2021 and 2020 (in thousands):

Three Months Ended March 31,

Three Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,

Collaboration revenue

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Collaboration and License Revenue

Collaboration and license revenue increased $7.7 million, from $1.8 million for the three months ended March 31, 2020 to $9.5 million for the three months ended March 31, 2021.

In the three months ended March 31, 2021, we recognized $7.7 million in collaboration revenues related to Gilead’s ongoing rights to access our intellectual property in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement.

In the three months ended March 31, 2020, we recognized $1.8 million under the Taiho Agreement.

Collaboration and license revenue increased $7.7 million, from $1.8 million for the three months ended June 30, 2020 to $9.5 million for the three months ended June 30, 2021.

In the three months ended June 30, 2021, we recognized $7.7 million in collaboration revenues related to Gilead’s ongoing rights to access our intellectual property in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement.

In the three months ended June 30, 2020, we recognized $1.8 million under the Taiho Agreement.

Research and Development Expenses

Research and development expenses increased $43.3 million, or 187%, from $23.1 million for the three months ended March 31, 2020 to $66.4 million for the three months ended March 31, 2021.

The increase in research and development expenses included $15.0 million in development milestone expenses incurred, consisting of a $10.0 million milestone payment due to WuXi Biologics pertaining to zimberelimab and a $5.0 million milestone payment due to Abmuno pertaining to domvanalimab, with no similar expense in the same quarter in the prior year.

There was also an increase of $10.5 million in employee compensation costs, approximately $4.4 million of which consists of non-cash stock-based compensation.

This increase is driven by our growing headcount as well as our 2021 stock awards.

Manufacturing costs and clinical costs for our ongoing studies increased $9.9 million and $9.0 million, respectively, as a result of the increased number of programs and clinical trials compared to the same quarter in the prior year.

Office and facilities expense increased as we continued to grow.

The overall increase in research and development expense is partially offset by a $4.9 million reimbursement by Gilead of certain applicable costs of developing zimberelimab, including $4.0 million of cost sharing reimbursement related to milestone expense incurred, in accordance with the Gilead Collaboration Agreement.

Research and development expenses increased $33.1 million, or 93%, from $35.7 million for the three months ended June 30, 2020 to $68.8 million for the three months ended June 30, 2021.

The increase in research and development expenses included an increase of $13.0 million in employee compensation costs driven by our growing headcount as well as our 2021 stock awards.

Of the total change in employee compensation costs, approximately $4.6 million consists of increased non-cash stock-based compensation.

Clinical costs for our ongoing studies and manufacturing costs increased $11.9 million and $8.8 million, respectively, as a result of the increased number of programs and clinical trials compared to the same quarter in the prior year.

We incurred an additional $2.0 million increase in lab supplies and equipment, $1.9 million in clinical consulting costs, and $1.0 million in office and facilities expense as we expanded our development efforts.

The overall increase is partially offset by a decrease of $5.0 million in milestone expense incurred and an increase of $1.2 million in reimbursements from collaboration partners.

We did not incur milestone expense in the three months ended June 30, 2021, compared to $5.0 million in the same quarter in the prior year.

We receive reimbursements from collaboration partners for shared expenses that reduce our research and development expense.

In the current quarter we recognized approximately $1.2 million receivable from Gilead for certain applicable costs of developing zimberelimab in accordance with the Gilead Collaboration Agreement, compared to an immaterial reimbursement from our collaboration partners in the same quarter in the prior year.

General and Administrative Expenses

General and administrative expenses increased $8.8 million, or 126%, from $7.0 million for the three months ended March 31, 2020 to $15.8 million for the three months ended March 31, 2021.

The increase in general and administrative expenses was primarily due to $6.8 million in employee compensation costs, approximately $4.9 million of which consists of non-cash stock-based compensation.

This increase is driven by our growing headcount as well as our 2021 stock awards.

Additional increases in finance and legal expenses were largely driven by costs incurred to support our growth and ongoing compliance with public company requirements.

We also incurred additional facilities expense due to our expanding headcount and office space.

General and administrative expenses increased $5.4 million, or 47%, from $11.4 million for the three months ended June 30, 2020 to $16.8 million for the three months ended June 30, 2021.

The increase in general and administrative expenses was primarily due to an increase of $6.3 million in employee compensation costs driven by our growing headcount as well as our 2021 stock awards.

Of the total change in employee compensation costs, approximately $4.3 million consists of increased non-cash stock-based compensation.

We also incurred approximately $0.9 million in additional facilities expense due to our expanding headcount and office space.

The overall increase is partially offset by a $1.9 million decrease in legal, accounting, and other consulting expenses compared to the same quarter in the prior year.

In 2020, we incurred significant costs related to our transaction with Gilead and other corporate development activities.

Non- O perating I ncome , Net

Non-operating income, net decreased $0.1 million or 45%, from $0.3 million for the three months ended June 30, 2020 to $0.2 million for the three months ended June 30, 2021.

The decrease was primarily due to lower interest income resulting from lower investment yields on our portfolio of marketable fixed-income securities during the quarter ended June 30, 2021 as compared to the same period in the prior year.

Six Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the six months ended June 30, 2021 and 2020 (in thousands):

Six Months Ended June 30,

Collaboration revenue

Total collaboration and license revenue

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Non-operating income, net

Non-operating income, net decreased $0.4 million or 76%, from $0.6 million for the three months ended March 31, 2020 to $0.2 million for the three months ended March 31, 2021.

The decrease was primarily due to lower interest income resulting from lower investment yields on our portfolio of marketable fixed-income securities during the quarter ended March 31, 2021 as compared to the same period in the prior year.

* Not meaningful

Collaboration and License Revenue

Collaboration and license revenue increased $15.4 million, from $3.5 million for the six months ended June 30, 2020 to $18.9 million for the six months ended June 30, 2021.

In the six months ended June 30, 2021, we recognized $15.4 million in collaboration revenues related to Gilead’s ongoing rights to access our intellectual property in accordance with the Gilead Collaboration Agreement, as well as $3.5 million under the Taiho Agreement.

In the six months ended June 30, 2020, we recognized $3.5 million under the Taiho Agreement.

Research and Development Expenses

Research and development expenses increased $76.4 million, or 130%, from $58.8 million for the six months ended June 30, 2020 to $135.2 million for the six months ended June 30, 2021.

The increase in research and development expenses included $23.5 million in employee compensation costs driven by our growing headcount as well as our 2021 stock awards.

Of the total change in employee compensation costs, approximately $9.0 million consists of increased non-cash stock-based compensation.

Clinical costs for our ongoing studies and manufacturing costs increased $20.9 million and $18.8 million, respectively, as a result of the increased number of programs and clinical trials compared to the same period in the prior year.

The increase in research and development expenses also included a $10.0 million increase in development milestone expenses incurred, consisting of $10.0 million incurred for a milestone payment due to WuXi Biologics pertaining to zimberelimab and $5.0 million incurred for a milestone payment due to Abmuno pertaining to domvanalimab.

In the same period in the prior year, we made a $5.0 million development milestone payment to Abmuno.

We incurred an additional $5.0 million increase in lab supplies and equipment, and $2.6 million in office and facilities expense as we expanded our development efforts.

The overall increase is partially offset by an increase in reimbursements from collaboration partners for shared expenses that reduce our research and development expense.

In the six months ended June 30, 2021, we recognized approximately $6.1 million receivable from Gilead for certain applicable costs of developing zimberelimab, including $4.0 million of cost sharing reimbursement related to milestone expense incurred, in accordance with the Gilead Collaboration Agreement.

Reimbursement from our collaboration partners was immaterial in the same period in the prior year.

General and Administrative Expenses

General and administrative expenses increased $14.2 million, or 77%, from $18.4 million for the six months ended June 30, 2020 to $32.6 million for the six months ended June 30, 2021.

The increase in general and administrative expenses was primarily due to $ 13.1 million in employee compensation costs driven by our growing headcount as well as our 2021 stock awards.

Of the total change in employee compensation costs, approximately $ 9.2 million consists of increased non-cash stock-based compensation.

We also incurred approximately $1.9 million in additional facilities expense due to our expanding headcount and office space.

Additional increases in finance and recruiting expenses were largely driven by costs incurred to support our growth and ongoing compliance with public company requirements.

The overall increase is partially offset by a decrease of $1.3 million in legal and other consulting

expenses compared to the same quarter in the prior year.

In 2020, we incurred significant costs related to our transaction with Gilead and other corporate development activities.

Non-Operating Income, Net

Non-operating income, net decreased $0.6 million or 66%, from $0.9 million for the six months ended June 30, 2020 to $0.3 million for the six months ended June 30, 2021.

The decrease was primarily due to lower interest income resulting from lower investment yields on our portfolio of marketable fixed-income securities during the six months ended June 30, 2021 as compared to the same period in the prior year.

Liquidity and Capital Resources

To date, we have financed our operations primarily through net proceeds of approximately $677.1 million from equity offerings and proceeds of approximately $641.4 million from our collaboration and stock purchase agreements, including $220.4 million gross proceeds raised in February 2021 from the sale to Gilead of 5,650,000 shares of our common stock.

As of March 31, 2021, we had $884.9 million of cash, cash equivalents, and investments in marketable securities, compared to $735.1 million as of December 31, 2020.

As of June 30, 2021, we had $805.1 million of cash, cash equivalents, and investments in marketable securities, compared to $735.1 million as of December 31, 2020.

Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S.

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The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods presented below (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash (used in) provided by:

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Cash Used in Operating Activities

Net cash used in operating activities was $66.3 million for the three months ended March 31, 2021, as compared to $31.3 million for the same period in the prior year.

Net cash used in operating activities was $140.3 million for the six months ended June 30, 2021, as compared to $55.2 million for the same period in the prior year.

The change in cash flow from operating activities is primarily due to the $75.8 million increase in our net loss to $148.6 million.

The change in our net loss is primarily a result of our expanded clinical development activities and general and administrative costs incurred to support our operations.

The overall increase in cash used is partially offset by year-over-year changes in non-cash items, including $9.3 million of increased expense from stock-based compensation, and changes in our asset and liability balances due to the timing of payments to or from our vendors and collaborators.

The overall increase in cash used is partially offset by year-over-year changes in non-cash items, including $18.2 million increased expense from stock-based compensation, and changes in our asset and liability balances due to the timing of payments to or from our vendors and collaborators.

Cash Provided by Investing Activities

Cash provided by investing activities was a $62.8 million for the three months ended March 31, 2021 compared to $40.1 million for the same period in the prior year.

The change in cash flow from investing activities was primarily due to net maturities of our investments in fixed-income marketable securities.

Cash provided by investing activities was $65.8 million for the six months ended June 30, 2021 compared to $47.0 million used in investing activities for the same period in the prior year.

The change in cash flow from investing activities was primarily due to net proceeds from our investments in fixed-income marketable securities.

The overall cash provided by investing activities was partially offset by an increase in purchases of property and equipment, as we invested in our office and laboratory facilities.

Cash Provided by Financing Activities

Cash provided by financing activities was $222.1 million for the three months ended March 31, 2021 compared to $0.6 million in the same period in the prior year.

The increase in cash provided is primarily due to cash received from Gilead in February 2021 pursuant to the terms of the Amended and Restated Stock Purchase Agreement, as well as funds received during the three months ended March 31, 2021 for issuance of common stock pursuant to equity award plans.

Cash provided by financing activities was $224.4 million for the six months ended June 30, 2021 compared to $329.5 million in the same period in the prior year.

In February 2021 we received $220.4 million from Gilead pursuant to the terms of the Amended and Restated Stock Purchase Agreement.

In 2020, we received $326.2 million, net of direct offering costs, from our public offering.

Contractual Obligations and Commitments

There have been no material changes to our contractual obligations outside the ordinary course of business during the three months ended March 31, 2021, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020.

In April 2021, we entered into a lease amendment for our existing operating leases in Hayward, California, that, among other things, extends the terms of those leases.

The lease amendment includes approximately $43 million in additional undiscounted future minimum lease payments throughout the expected term and provides additional tenant improvement allowances totaling $5.8 million with options to increase the allowance by $10.9 million.

Other than the additional contractual obligations under this lease amendment, there have been no material changes to our contractual obligations outside the ordinary course of business during the six months ended June 30, 2021, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020.

Off-Balance Sheet Arrangements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis