[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Puma Biotechnology reported a **$3.4 million** net loss in Q1 2022, a reversal from **$16.5 million** net income in Q1 2021, primarily due to the absence of **$50 million** license revenue Condensed Consolidated Statements of Operations (Q1 2022 vs Q1 2021) | Financial Metric | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Total Revenue** | **$45,736** | **$98,169** | | Product revenue, net | $40,718 | $45,816 | | License revenue | $0 | $50,000 | | Royalty revenue | $5,018 | $2,353 | | **Total operating costs and expenses** | **$46,483** | **$78,023** | | (Loss) income from operations | ($747) | $20,146 | | **Net (loss) income** | **($3,403)** | **$16,528** | | Net (loss) income per share—basic | ($0.08) | $0.41 | | Net (loss) income per share—diluted | ($0.08) | $0.40 | Condensed Consolidated Balance Sheets | Balance Sheet Item | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Total Assets** | **$200,685** | **$226,585** | | Cash and cash equivalents | $63,913 | $63,131 | | Total current assets | $117,570 | $140,022 | | **Total Liabilities** | **$193,540** | **$229,031** | | Total current liabilities | $74,789 | $109,586 | | Long-term debt, net | $97,381 | $97,092 | | **Total stockholders' equity (deficit)** | **$7,145** | **($2,446)** | Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($26,895) | $15,661 | | Net cash provided by (used in) investing activities | $8,982 | ($5,301) | | Net cash provided by financing activities | $9,845 | $0 | | **Net (decrease) increase in cash** | **($8,068)** | **$10,360** | [Note 1: Business and Basis of Presentation](index=10&type=section&id=Note%201%E2%80%94Business%20and%20Basis%20of%20Presentation) Puma Biotechnology develops and commercializes NERLYNX® for cancer care, reporting a **$3.4 million** net loss and **$26.9 million** cash used in operations in Q1 2022 - The company's primary focus is the development and commercialization of NERLYNX® (neratinib), an oral tyrosine kinase inhibitor for HER2-positive breast cancer and other HER2 mutated cancers[24](index=24&type=chunk) - For the three months ended March 31, 2022, the company reported a net loss of approximately **$3.4 million** and used approximately **$26.9 million** in cash from operations[32](index=32&type=chunk) - Management believes that its cash, cash equivalents, and marketable securities of approximately **$73.9 million** as of March 31, 2022, along with product sales and sub-license payments, are sufficient to fund operations for at least one year[32](index=32&type=chunk)[33](index=33&type=chunk) [Note 2: Significant Accounting Policies](index=11&type=section&id=Note%202%E2%80%94Significant%20Accounting%20Policies) Key accounting policies cover revenue recognition for product and license sales, expensing R&D as incurred, and amortizing intangible assets related to the Pfizer license - Product revenue is recognized upon delivery to specialty pharmacies and distributors, net of estimated variable consideration such as rebates, chargebacks, and returns[45](index=45&type=chunk)[46](index=46&type=chunk)[49](index=49&type=chunk) - As of March 31, 2022, potential milestone payments due to the company under its sub-license agreements total approximately **$579.8 million**, though the timing and probability of achievement are uncertain[63](index=63&type=chunk) - Intangible assets related to the Pfizer license agreement are amortized to cost of sales. Amortization expense was **$2.0 million** for Q1 2022, with estimated future annual amortization of approximately **$8.0 million** from 2023 through 2029[104](index=104&type=chunk) [Note 8: Accrued Expenses](index=27&type=section&id=Note%208%E2%80%94Accrued%20Expenses) Total accrued expenses decreased to **$62.6 million** as of March 31, 2022, primarily due to a payment for the Hsu v. Puma class action lawsuit settlement Breakdown of Current Accrued Expenses | Expense Category | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Accrued legal verdict expense | $30,030 | $57,137 | | Accrued royalties | $8,477 | $8,829 | | Accrued variable consideration | $10,807 | $11,406 | | Accrued bonus | $1,496 | $5,083 | | Accrued compensation | $4,207 | $3,878 | | **Total Current Accrued Expenses** | **$61,837** | **$92,575** | - The company reached a settlement in the Hsu v. Puma Biotechnology, Inc. class action lawsuit. The first payment of **$27.1 million** was made in January 2022, with the balance due in June 2022[121](index=121&type=chunk) [Note 9: Debt](index=29&type=section&id=Note%209%E2%80%94Debt) The company's long-term debt totaled **$97.4 million** as of March 31, 2022, comprising **$100.0 million** in senior notes maturing in 2026 with variable interest - The company's long-term debt consists of **$100.0 million** in senior notes from the Athyrium Note Purchase Agreement, with a net carrying value of **$97.4 million** as of March 31, 2022[126](index=126&type=chunk)[135](index=135&type=chunk)[140](index=140&type=chunk) Future Minimum Principal and Exit Payments | Year | Amount ($ thousands) | | :--- | :--- | | 2022 (remaining) | $0 | | 2023 | $0 | | 2024 | $33,997 | | 2025 | $45,329 | | 2026 | $22,674 | | **Total** | **$102,000** | [Note 10: Stockholders' Equity](index=32&type=section&id=Note%2010%E2%80%94Stockholders%27%20Equity) Stockholders' equity improved to a positive balance in Q1 2022, primarily due to a private placement that raised **$10.0 million** from the sale of **3,584,228** common shares - On March 10, 2022, the company closed a private placement, selling **3,584,228 shares** of common stock at **$2.79 per share** for gross proceeds of approximately **$10.0 million**[145](index=145&type=chunk) - The purchasers in the private placement were CEO Alan H. Auerbach and Athyrium Opportunities IV Co-Invest 2 LP, each purchasing approximately **$5.0 million** worth of shares[145](index=145&type=chunk) [Note 12: Commitments and Contingencies](index=36&type=section&id=Note%2012%E2%80%94Commitments%20and%20Contingencies) The company faces significant commitments, including potential **$187.5 million** milestone payments to Pfizer, and is involved in multiple legal proceedings, including a **$54.2 million** class action settlement and patent infringement lawsuits - The company has reached a settlement in principle in the Hsu v. Puma class action lawsuit for approximately **$54.2 million**, payable in two installments. The first payment of **$27.1 million** was made in January 2022[163](index=163&type=chunk) - In the Eshelman v. Puma defamation case, the U.S. Court of Appeals vacated a **$22.4 million** damages award against the company, remanding the case for a new trial on damages. The company estimates the high end of potential damages could be approximately **$2.9 million**[165](index=165&type=chunk) - The company has filed patent infringement lawsuits against AstraZeneca regarding its product Tagrisso® and against Sandoz regarding its ANDA for a generic version of NERLYNX[170](index=170&type=chunk)[172](index=172&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=40&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenue decreased significantly in Q1 2022 due to the absence of a **$50.0 million** license fee in Q1 2021, while operating expenses declined due to headcount reductions and reduced clinical activity - The COVID-19 pandemic continues to impact operations by reducing the sales force's access to healthcare providers and potentially disrupting clinical trial enrollments, which has adversely impacted NERLYNX sales[186](index=186&type=chunk)[188](index=188&type=chunk) - In March 2022, the company raised approximately **$10.0 million** in gross proceeds through a private placement of common stock to its CEO and an affiliate of its lender, Athyrium[184](index=184&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) Total revenue decreased to **$45.7 million** in Q1 2022 from **$98.2 million** in Q1 2021, primarily due to the absence of a **$50.0 million** license fee, while operating expenses also declined Revenue Breakdown (Q1 2022 vs Q1 2021) | Revenue Source | Q1 2022 ($ millions) | Q1 2021 ($ millions) | | :--- | :--- | :--- | | Product revenue, net | $40.7 | $45.8 | | License revenue | $0.0 | $50.0 | | Royalty revenue | $5.0 | $2.4 | | **Total Revenue** | **$45.7** | **$98.2** | Operating Expenses Breakdown (Q1 2022 vs Q1 2021) | Expense Category | Q1 2022 ($ millions) | Q1 2021 ($ millions) | | :--- | :--- | :--- | | Cost of sales | $10.8 | $29.6 | | Selling, general and administrative | $20.4 | $28.2 | | Research and development | $15.2 | $20.2 | - The decrease in SG&A expenses was primarily due to lower professional fees (**$3.1 million**), reduced payroll costs (**$2.9 million**), and lower stock-based compensation (**$1.4 million**) following headcount reductions in 2021[205](index=205&type=chunk) - The decrease in R&D expenses was driven by lower internal R&D costs (**$2.5 million**) and stock-based compensation (**$1.3 million**) due to lower headcount, as well as reduced consultant and clinical trial expenses[207](index=207&type=chunk)[211](index=211&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company held **$63.9 million** in cash and equivalents, with working capital increasing to **$42.8 million**, despite **$26.9 million** cash used in operations due to a legal settlement Liquidity Summary | Metric | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $63,913 | $63,131 | | Marketable securities | $9,994 | $18,975 | | Working capital | $42,781 | $30,436 | - Cash used in operating activities was **$26.9 million**, primarily driven by a net loss of **$3.4 million** and a **$30.9 million** decrease in accrued expenses, which included a **$27.1 million** legal settlement payment[216](index=216&type=chunk) - Cash provided by financing activities was **$9.8 million**, representing net proceeds from the March 2022 private placement with the CEO and an affiliate of Athyrium[220](index=220&type=chunk) - The company's **$100 million** debt facility with Athyrium requires compliance with covenants, including minimum product revenue targets. As of March 31, 2022, the company was in compliance with all covenants[231](index=231&type=chunk)[233](index=233&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its **$100.0 million** variable-rate Athyrium Notes, where a **100 basis point** increase would raise interest expense by **$1.0 million** - The company's primary market risk is interest rate fluctuations affecting its variable-rate debt under the Athyrium Notes[247](index=247&type=chunk) - A **100 basis point** increase in interest rates during the quarter ended March 31, 2022, would have increased the company's interest expense by **$1.0 million**[247](index=247&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting during Q1 2022 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2022[249](index=249&type=chunk) - No material changes were made to the internal control over financial reporting during the three months ended March 31, 2022[250](index=250&type=chunk) [PART II – OTHER INFORMATION](index=54&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in significant legal proceedings, including a **$54.2 million** class action settlement, a vacated **$22.4 million** defamation damages award, and multiple patent infringement lawsuits - **Hsu v. Puma:** A settlement for ~**$54.2 million** was reached. The first payment of **$27.1 million** was made in January 2022, with the balance due in June 2022. A final settlement hearing is set for July 28, 2022[253](index=253&type=chunk) - **Eshelman v. Puma:** The U.S. Court of Appeals affirmed the liability verdict but vacated the **$22.4 million** damages award as excessive, remanding the case for a new trial on damages[254](index=254&type=chunk) - **Patent Litigation:** The company is actively pursuing patent infringement lawsuits against AstraZeneca, Sandoz, and Shanghai Acebright to defend its intellectual property for NERLYNX and related compounds[258](index=258&type=chunk)[259](index=259&type=chunk)[261](index=261&type=chunk) [Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors were reported for the period, consistent with the Annual Report on Form 10-K - No material changes to risk factors were reported for the period[263](index=263&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during Q1 2022, apart from the previously disclosed private placement - No unregistered sales of equity securities occurred during the quarter, other than what was previously reported on Form 8-K[264](index=264&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including amended bylaws, CEO/CFO certifications, and Inline XBRL data files

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2021 Earnings Conference Call March 3, 2022 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, IR Alan Auerbach - Chairman, President & CEO Jeff Ludwig - Chief Commercial Officer Maximo Nougues - CFO Conference Call Participants Edward White - H.C. Wainwright Carly Kenselaar - Citi Marc Frahm - Cowen Alex Hammond - Bank of America Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timest ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934exhibit For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 ( ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q3 2021 Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, Investor Relations Alan Auerbach - Chairman, President and Chief Executive Officer Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Carly Kenselaar - Citi Marc Frahm - Cowen Alex Hammond - Bank of America Sheldon Fan - Barclays Operator Good afternoon. My name is Melinda, and I will be your ...

Table of Contents ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or ...

Puma Biotechnology Earnings Call Commercial Update August 5, 2021 Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These sta ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, IR Alan Auerbach - Founder, Chairman, President, CEO & Secretary Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - CFO & Principal Accounting Officer Conference Call Participants Carly Kenselaar - Citigroup Marc Frahm - Cowen and Company Alex Hammond - Bank of America Merrill Lynch Sheldon Fan - Barclays Bank Paul Choi - Goldman Sachs Group Oper ...

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or orga ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, IR Alan Auerbach - Founder, Chairman, President, CEO & Secretary Jeff Ludwig - Chief Commercial Officer Maximo Nougues - CFO & Principal Accounting Officer Conference Call Participants Carly Kenselaar - Citigroup Marc Frahm - Cowen and Company Kennen MacKay - RBC Capital Markets Alec Stranahan - Bank of America Merrill Lynch Sheldon Fan - Barclays Bank Oper ...

PART I – FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial statements and management's analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements of Puma Biotechnology, Inc. and its subsidiaries for the periods ended March 31, 2021, and December 31, 2020, including balance sheets, statements of operations, comprehensive income (loss), stockholders' equity (deficit), and cash flows, along with detailed notes explaining the company's business, accounting policies, and specific financial line items [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details the company's financial position, including assets, liabilities, and equity, at specific reporting dates | Metric | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------ | | Total Assets | $258,659 | $244,220 | | Total Liabilities | $242,222 | $250,171 | | Total Stockholders' Equity (Deficit) | $16,437 | $(5,951) | | Cash and cash equivalents | $95,653 | $85,293 | | Current Liabilities | $140,408 | $114,255 | | Long-term debt | $76,346 | $84,025 | - The company's total assets increased by **$14.4 million**, and total liabilities decreased by **$7.9 million**, leading to a significant improvement in stockholders' equity from a deficit of **$(5.951) million** to a positive **$16.437 million**[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Reports the company's revenues, expenses, and net income or loss over specific periods | Metric | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------------- | :------------------------------------- | :------------------------------------- | | Total Revenue | $98,169 | $51,217 | | Product revenue, net | $45,816 | $48,609 | | License revenue | $50,000 | $2,000 | | Royalty revenue | $2,353 | $608 | | Total operating costs and expenses | $78,023 | $65,468 | | Income (loss) from operations | $20,146 | $(14,251) | | Net income (loss) | $16,528 | $(16,933) | | Net income (loss) per share—basic | $0.41 | $(0.43) | | Net income (loss) per share—diluted | $0.40 | $(0.43) | - Total revenue significantly increased by **91.7%** year-over-year, primarily driven by a substantial increase in license revenue from **$2.0 million** to **$50.0 million**. This led to a shift from an operating loss of **$(14.251) million** to an operating income of **$20.146 million**, and a net income of **$16.528 million** compared to a net loss of **$(16.933) million** in the prior year[15](index=15&type=chunk) [Condensed Consolidated Statements of Comprehensive Income (Loss)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20%28Loss%29) Presents the net income or loss alongside other comprehensive income or loss components | Metric | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------- | :------------------------------------- | :------------------------------------- | | Net income (loss) | $16,528 | $(16,933) | | Other comprehensive income (loss) | $0 | $(60) | | **Comprehensive income (loss)** | **$16,528** | **$(16,993)** | - The company reported comprehensive income of **$16.528 million** for the three months ended March 31, 2021, a significant improvement from a comprehensive loss of **$(16.993) million** in the same period of 2020. Other comprehensive income (loss) was negligible in the current period[16](index=16&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) Outlines changes in the company's equity, including net income, stock-based compensation, and other adjustments | Metric | Balance at December 31, 2020 (in thousands) | Net Income (in thousands) | Stock-based Compensation (in thousands) | Balance at March 31, 2021 (in thousands) | | :-------------------------- | :---------------------------------- | :------------------------ | :------------------------------------ | :--------------------------------- | | Total Stockholders' Equity (Deficit) | $(5,951) | $16,528 | $5,860 | $16,437 | - Stockholders' equity transitioned from a deficit of **$(5.951) million** at December 31, 2020, to a positive **$16.437 million** at March 31, 2021, primarily driven by the net income of **$16.528 million** and stock-based compensation of **$5.860 million** during the quarter[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------- | :------------------------------------- | :------------------------------------- | | Operating activities | $15,661 | $(11,540) | | Investing activities | $(5,301) | $34,377 | | Net increase in cash, cash equivalents and restricted cash | $10,360 | $22,837 | | Cash, cash equivalents and restricted cash, end of period | $107,814 | $96,047 | - Cash flow from operating activities significantly improved, generating **$15.661 million** in Q1 2021 compared to using **$(11.540) million** in Q1 2020. Investing activities shifted from providing **$34.377 million** in Q1 2020 to using **$(5.301) million** in Q1 2021, primarily due to purchases of available-for-sale securities[21](index=21&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1—Business and Basis of Presentation](index=9&type=section&id=Note%201%E2%80%94Business%20and%20Basis%20of%20Presentation) Describes the company's biopharmaceutical business and the basis for preparing its financial statements - Puma Biotechnology, Inc. is a biopharmaceutical company focused on developing and commercializing innovative products for cancer care, primarily NERLYNX (neratinib) for HER2-positive breast cancer and HER2 mutated cancers[23](index=23&type=chunk) - NERLYNX received FDA approval in July 2017 for extended adjuvant treatment of early-stage HER2-overexpressed/amplified breast cancer and in February 2020 for advanced or metastatic HER2-positive breast cancer in combination with capecitabine. The European Commission granted marketing authorization in 2018[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The company has entered into exclusive sub-license agreements for NERLYNX commercialization in various international regions, including Europe, Australia, Canada, China, Southeast Asia, Israel, Mexico, South Korea, and Central/South America[28](index=28&type=chunk) - For the three months ended March 31, 2021, the company reported net income of approximately **$16.5 million** and cash flows from operations of approximately **$15.7 million**. Management believes existing cash and marketable securities, along with future product sales and sub-license payments, are sufficient to satisfy operating needs for at least one year[29](index=29&type=chunk) [Note 2—Significant Accounting Policies](index=10&type=section&id=Note%202%E2%80%94Significant%20Accounting%20Policies) Outlines the key accounting principles and estimates used in preparing the financial statements - Revenue from product sales is recognized net of variable consideration, including trade discounts, product returns, chargebacks, government rebates, payor rebates, and patient assistance programs, which are estimated and established as reserves[39](index=39&type=chunk)[42](index=42&type=chunk) - License revenue from non-refundable upfront fees is recognized when the license term commences and the licensed data, technology, or product is delivered, or deferred if performance obligations are not satisfied. Royalty revenue is recognized when related sales occur[50](index=50&type=chunk)[57](index=57&type=chunk) - Stock-based compensation for options is valued using the Black-Scholes Option Pricing Method, and Restricted Stock Units (RSUs) are valued at the market price on the grant date, with expense recognized over the service period[63](index=63&type=chunk)[64](index=64&type=chunk) - The company adopted ASU 2019-12 (Income Taxes) and ASU 2020-10 (Codification Improvements) as of January 1, 2021, with no material effect on its financial position, results of operations, or disclosures[94](index=94&type=chunk)[95](index=95&type=chunk) [Note 3—Accounts Receivable, Net](index=19&type=section&id=Note%203%E2%80%94Accounts%20Receivable%2C%20Net) Details the composition and changes in the company's net accounts receivable | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :----------------------- | :----------------------------- | :------------------------------ | | Trade accounts receivable | $22,800 | $21,515 | | License revenue receivable | $2,000 | $2,500 | | Royalty revenue receivable | $2,358 | $2,528 | | Total accounts receivable | $27,158 | $26,543 | | Allowance for credit losses | $(1,000) | $(1,000) | | Total accounts receivable, net | $26,158 | $25,543 | - Total accounts receivable, net increased slightly to **$26.158 million** at March 31, 2021, from **$25.543 million** at December 31, 2020. The company recognized **$0** in credit loss expense for the three months ended March 31, 2021, compared to **$1.0 million** for the period ended December 31, 2020[96](index=96&type=chunk)[97](index=97&type=chunk) [Note 4—Prepaid Expenses and Other](index=20&type=section&id=Note%204%E2%80%94Prepaid%20Expenses%20and%20Other) Provides a breakdown of current and long-term prepaid expenses and other assets | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | **Current:** | | | | CRO services | $1,308 | $1,550 | | Other clinical development | $3,322 | $2,718 | | Insurance | $2,733 | $3,708 | | Professional fees | $1,083 | $651 | | Other | $3,143 | $2,635 | | **Total Current** | **$11,589** | **$11,262** | | **Long-term:** | | | | CRO services | $198 | $518 | | Other clinical development | $475 | $437 | | Other | $657 | $790 | | **Total Long-term** | **$1,330** | **$1,745** | | **Totals** | **$12,919** | **$13,007** | - Total prepaid expenses and other remained relatively stable at **$12.919 million** as of March 31, 2021. Current prepaid expenses increased slightly, with notable changes in other clinical development (increase) and insurance (decrease). Long-term prepaid expenses decreased[98](index=98&type=chunk) [Note 5—Other Current Assets](index=20&type=section&id=Note%205%E2%80%94Other%20Current%20Assets) Details the components and changes in other current assets | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | Deposit for manufacturing costs | $0 | $3,376 | | Deferred rent | $198 | $198 | | Other | $175 | $67 | | **Totals** | **$373** | **$3,641** | - Other current assets significantly decreased from **$3.641 million** at December 31, 2020, to **$0.373 million** at March 31, 2021, primarily due to the absence of a deposit for manufacturing costs in the current period[99](index=99&type=chunk) [Note 6—Leases](index=20&type=section&id=Note%206%E2%80%94Leases) Describes the company's operating lease arrangements and related financial impacts - The company holds operating leases for office space in Los Angeles (until March 2026) and South San Francisco (until March 2026, with a five-year extension option), and copier equipment. These leases include annual rent increases of approximately **3%**[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) | Lease Metric | Value | | :-------------------------- | :------ | | Operating cash flows used for operating leases (Q1 2021) | $1,380 thousand | | Weighted average remaining lease term | 5.0 years | | Weighted average discount rate (IBR) | 10.9% | | Total lease liabilities (March 31, 2021) | $21,930 thousand | | Total minimum lease payments to be received (sublease) | $2,496 thousand | - Operating sublease income of **$0.1 million** was recorded for the three months ended March 31, 2021[103](index=103&type=chunk) [Note 7—Property and Equipment, Net](index=22&type=section&id=Note%207%E2%80%94Property%20and%20Equipment%2C%20Net) Presents the company's property and equipment, net of accumulated depreciation | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :----------------------- | :----------------------------- | :------------------------------ | | Leasehold improvements | $3,779 | $3,779 | | Computer equipment | $2,192 | $2,192 | | Telephone equipment | $302 | $302 | | Furniture and fixtures | $2,359 | $2,359 | | Less: accumulated depreciation | $(6,349) | $(6,151) | | **Totals** | **$2,283** | **$2,481** | - Property and equipment, net decreased slightly to **$2.283 million** at March 31, 2021, from **$2.481 million** at December 31, 2020, reflecting **$0.2 million** in depreciation expense incurred during the quarter[105](index=105&type=chunk) [Note 8—Intangible Assets, Net](index=22&type=section&id=Note%208%E2%80%94Intangible%20Assets%2C%20Net) Details the company's intangible assets, net of accumulated amortization | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | Acquired and in-licensed rights | $90,000 | $90,000 | | Less: accumulated amortization | $(17,864) | $(15,860) | | **Total intangible asset, net** | **$72,136** | **$74,140** | - Intangible assets, net decreased to **$72.136 million** at March 31, 2021, from **$74.140 million** at December 31, 2020, due to **$2.0 million** in amortization expense incurred during the quarter. The estimated remaining useful life of these assets is **9.0 years**[106](index=106&type=chunk) [Note 9—Accrued Expenses](index=23&type=section&id=Note%209%E2%80%94Accrued%20Expenses) Provides a breakdown of current and long-term accrued expenses | Category | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | **Current:** | | | | Accrued legal verdict expense | $47,731 | $22,724 | | Accrued royalties | $7,934 | $8,604 | | Accrued CRO services | $1,795 | $3,474 | | Accrued variable consideration | $9,050 | $9,014 | | Accrued bonus | $2,039 | $7,788 | | Accrued compensation | $5,135 | $4,820 | | Accrued other clinical development | $1,512 | $1,904 | | Accrued professional fees | $1,424 | $1,420 | | Accrued legal fees | $1,599 | $383 | | Accrued manufacturing costs | $476 | $752 | | Other | $589 | $442 | | **Total Current** | **$79,284** | **$61,325** | | **Long-term:** | | | | Accrued legal verdict expense | $0 | $24,822 | | Accrued CRO services | $934 | $908 | | Accrued other | $206 | $233 | | **Total Long-term** | **$1,140** | **$25,963** | | **Totals** | **$80,424** | **$87,288** | - Total accrued expenses decreased to **$80.424 million** at March 31, 2021, from **$87.288 million** at December 31, 2020. Current accrued legal verdict expense significantly increased to **$47.731 million**, including **$22.9 million** for *Eshelman v. Puma Biotechnology, Inc., et al.* and **$24.9 million** for *Hsu v. Puma Biotechnology, Inc., et al.*, while long-term accrued legal verdict expense became **$0**[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) [Note 10—Debt](index=24&type=section&id=Note%2010%E2%80%94Debt) Details the company's outstanding debt, including terms, covenants, and related costs | Debt Component | March 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | | Total debt | $100,000 | | Accretion of final interest payment | $3,675 | | Less: current portion of long-term debt | $(22,857) | | Less: deferred financing costs | $(4,472) | | **Total long-term debt, net** | **$76,346** | - As of March 31, 2021, the company had **$100.0 million** in term loans outstanding under its New Credit Facility, maturing on June 1, 2024. The effective interest rate was **12.75%**[112](index=112&type=chunk)[114](index=114&type=chunk)[119](index=119&type=chunk) - The New Credit Facility includes affirmative and negative covenants, including product revenue targets, and the company was in compliance with all covenants as of March 31, 2021[116](index=116&type=chunk)[119](index=119&type=chunk) - Deferred financing costs, net of accumulated amortization, totaled **$4.472 million**, with **$0.5 million** of related interest expense recognized in Q1 2021[121](index=121&type=chunk) [Note 11—Stockholders' Equity](index=25&type=section&id=Note%2011%E2%80%94Stockholders%27%20Equity) Describes the components of stockholders' equity and stock-based compensation - As of March 31, 2021, **40,324,263** shares of common stock were issued and outstanding. A warrant for **2,116,250** shares at **$16** per share, issued to the CEO, is exercisable until October 4, 2021[13](index=13&type=chunk)[125](index=125&type=chunk) | Stock-based Compensation Expense (in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Options - Selling, general, and administrative | $1,007 | $920 | | Options - Research and development | $228 | $841 | | Restricted stock units - Selling, general, and administrative | $2,594 | $3,772 | | Restricted stock units - Research and development | $2,031 | $3,374 | | **Total stock-based compensation expense** | **$5,860** | **$8,907** | - Total estimated unrecognized employee compensation cost was approximately **$8.4 million** for non-vested stock options (over **2.1 years**) and **$22.3 million** for non-vested RSUs (over **2.0 years**) as of March 31, 2021[129](index=129&type=chunk) [Note 12—401(k) Savings Plan](index=27&type=section&id=Note%2012%E2%80%94401%28k%29%20Savings%20Plan) Reports the company's contributions to its employee 401(k) savings plan - The company incurred **$0.6 million** in employer matching contributions to its 401(k) plan for the three months ended March 31, 2021, an increase from **$0.4 million** in the same period of 2020[132](index=132&type=chunk) [Note 13—Commitments and Contingencies](index=27&type=section&id=Note%2013%E2%80%94Commitments%20and%20Contingencies) Outlines the company's contractual obligations and potential legal liabilities - Under its license agreement with Pfizer, the company is obligated to make substantial milestone payments (up to **$187.5 million** if all achieved) and annual royalties (low-to-mid teens of net sales). A remaining milestone payment of approximately **$21.9 million** (including interest) is due to Pfizer by September 2021[136](index=136&type=chunk)[137](index=137&type=chunk) - In *Hsu v. Puma Biotechnology, Inc., et al.* (class action), the company faces claimed damages of **$50.5 million**, but estimates actual claims could range from **$24.9 million** to **$51.4 million** after challenges[211](index=211&type=chunk) - In *Eshelman v. Puma Biotechnology, Inc., et al.* (defamation), a jury awarded **$15.9 million** in compensatory and **$6.5 million** in punitive damages, totaling **$26.3 million** with pre-judgment interest. The company has appealed, with an estimated high end of potential damages at **$27.9 million**[212](index=212&type=chunk) - The company resolved an arbitration with CANbridge BIOMED Limited, agreeing to dismiss claims and pay a one-time termination fee of **$20.0 million** to regain NERLYNX rights in greater China[93](index=93&type=chunk)[213](index=213&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2021, compared to the same period in 2020. It covers the business overview, the impact of the COVID-19 pandemic, critical accounting policies, a detailed analysis of revenue and expenses, liquidity and capital resources, and a reconciliation of GAAP to non-GAAP financial measures [Overview](index=29&type=section&id=Overview) Provides a general description of the company's business, products, and recent strategic developments - Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing innovative products for cancer care, primarily the oral version of neratinib (NERLYNX) for HER2-positive breast cancer and HER2 mutated cancers[141](index=141&type=chunk) - NERLYNX received FDA approval in 2017 for early-stage HER2-positive breast cancer and in 2020 for advanced/metastatic HER2-positive breast cancer. It also received EC marketing authorization in the EU in 2018[142](index=142&type=chunk) - The company settled an arbitration with CANbridge BIOMED Limited, regaining NERLYNX rights in greater China, and subsequently amended its sub-license agreement with Pierre Fabre Medicament SAS for greater China rights, receiving a **$50 million** upfront payment and potential additional milestone payments up to **$240 million**, plus double-digit tiered royalties[144](index=144&type=chunk) [Impact of COVID-19](index=30&type=section&id=Impact%20of%20COVID-19) Discusses the effects of the COVID-19 pandemic on the company's operations, sales, and clinical trials - The COVID-19 pandemic has led to limited travel and virtual promotional activities for the U.S. sales force, potentially deterring cancer patients from doctor visits and adversely impacting NERLYNX sales. Similar actions have been taken by international sub-licensees[146](index=146&type=chunk) - Disruptions in patient enrollments have been observed in clinical trials (e.g., SUMMIT basket trial), which could materially impact clinical trial plans and timelines[146](index=146&type=chunk) - The company's ability to operate without significant negative impacts depends on the pandemic's length and severity, and its ability to protect employees and the supply chain. While operations were broadly maintained in Q1 2021, the pandemic could adversely affect revenue and compliance with loan covenants[147](index=147&type=chunk)[148](index=148&type=chunk) [Critical Accounting Policies](index=30&type=section&id=Critical%20Accounting%20Policies) Reaffirms and explains the key accounting policies and estimates used in financial reporting - No material changes to critical accounting policies and estimates occurred during the three months ended March 31, 2021, from those reported at December 31, 2020[149](index=149&type=chunk) - License revenue is recognized under ASC 606, evaluating agreements for distinct performance obligations. Non-refundable upfront fees are recognized when the license term commences and the licensed data/product is delivered, or deferred if obligations are not satisfied. Estimates of transaction price, including variable consideration, are made to ensure no significant revenue reversal is probable[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - Legal contingencies are accrued when a loss is probable and estimable. Legal fees are expensed as incurred, and estimates are periodically adjusted based on available information[153](index=153&type=chunk) [Summary of Income and Expenses](index=31&type=section&id=Summary%20of%20Income%20and%20Expenses) Explains the primary drivers and components of the company's revenues and operating expenses - Product revenue, net, is derived from NERLYNX sales to specialty pharmacies and distributors, recorded net of variable consideration (discounts, returns, rebates)[154](index=154&type=chunk) - License revenue comes from satisfied performance obligations under sub-license agreements, while royalty revenue is earned from sub-licensees' product sales in their territories[155](index=155&type=chunk)[156](index=156&type=chunk) - Cost of sales includes third-party manufacturing, freight, overhead, Pfizer royalties, amortization of milestone payments, and inventory adjustments. Selling, general and administrative (SG&A) expenses cover payroll, professional fees, insurance, rent, and general legal activities. Research and development (R&D) expenses include clinical trial costs, consultant fees, and personnel costs[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Analyzes the period-over-period changes in the company's revenues and expenses | Revenue Category | Q1 2021 (in thousands) | Q1 2020 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------- | :--------------------- | :--------------------- | :-------------------- | :--------- | | Total revenue | $98,169 | $51,217 | $46,952 | 91.7% | | Product revenue, net | $45,816 | $48,609 | $(2,793) | -5.7% | | License revenue | $50,000 | $2,000 | $48,000 | 2400.0% | | Royalty revenue | $2,353 | $608 | $1,745 | 287.0% | - Product revenue, net, decreased by **5.7%** due to a **20%** volume decrease in NERLYNX bottles sold and an increase in variable consideration reserves (from **16%** to **19%** of product revenue), partially offset by higher gross selling prices[161](index=161&type=chunk) - Cost of sales increased significantly to **$29.6 million** in Q1 2021 from **$9.1 million** in Q1 2020, primarily due to a one-time license termination fee, increased amortization of intangible assets, and higher Pfizer royalty expense related to increased royalty revenue[164](index=164&type=chunk) | Expense Category | Q1 2021 (in thousands) | Q1 2020 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------- | :--------------------- | :--------------------- | :-------------------- | :--------- | | Selling, general and administrative | $28,238 | $30,937 | $(2,699) | -8.7% | | Research and development | $20,228 | $25,455 | $(5,227) | -20.5% | - SG&A expenses decreased by **$2.7 million**, mainly due to lower stock-based compensation (**$1.1 million** decrease), reduced travel and meetings (**$1.4 million** decrease due to COVID-19), and lower other expenses (**$0.4 million** decrease), partially offset by increased professional fees (**$0.3 million** increase, primarily legal expenses)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - R&D expenses decreased by **$5.2 million**, primarily due to a **$2.7 million** decrease in clinical trial expense (NALA close-out, studies nearing completion), a **$2.0 million** decrease in stock-based compensation, and a **$0.6 million** decrease in consultant and contractor expense[168](index=168&type=chunk)[172](index=172&type=chunk) - Total other expenses increased to **$(3.580) million** in Q1 2021 from **$(2.682) million** in Q1 2020, driven by a **$0.4 million** decrease in interest income and a **$0.4 million** increase in interest expense (due to milestone payment interest to Pfizer)[169](index=169&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, working capital, debt, and ability to meet future obligations | Metric | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | Cash and cash equivalents | $95,653 | $85,293 | | Marketable securities | $13,397 | $8,096 | | Working capital | $23,357 | $31,884 | | Stockholders' equity (deficit) | $16,437 | $(5,951) | | Cash Flow Activity | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :-------------------------- | :------------------------------------- | :------------------------------------- | | Operating activities | $15,661 | $(11,540) | | Investing activities | $(5,301) | $34,377 | | Net increase in cash, cash equivalents and restricted cash | $10,360 | $22,837 | - The company generated **$15.7 million** in cash from operating activities in Q1 2021, a significant improvement from using **$11.5 million** in Q1 2020. Investing activities used **$5.3 million** in Q1 2021, primarily for purchasing available-for-sale securities, compared to providing **$34.4 million** in Q1 2020[176](index=176&type=chunk)[179](index=179&type=chunk) - As of March 31, 2021, **$100.0 million** in term loans were outstanding under the New Credit Facility, with an effective interest rate of **12.75%**. The company was in compliance with all applicable covenants[185](index=185&type=chunk)[190](index=190&type=chunk) - While current cash and marketable securities are expected to satisfy operating needs for at least one year, the company anticipates continued significant losses and may require additional funding, which could be impacted by market conditions, the COVID-19 pandemic, and clinical trial results[192](index=192&type=chunk)[193](index=193&type=chunk) [Non-GAAP Financial Measures](index=36&type=section&id=Non-GAAP%20Financial%20Measures) Reconciles GAAP financial results to non-GAAP measures, primarily adjusting for stock-based compensation | Metric | Q1 2021 (in thousands) | Q1 2020 (in thousands) | | :-------------------------------- | :--------------------- | :--------------------- | | GAAP net income (loss) | $16,528 | $(16,933) | | Stock-based compensation (SG&A) | $3,601 | $4,692 | | Stock-based compensation (R&D) | $2,259 | $4,215 | | **Non-GAAP adjusted net income (loss)** | **$22,388** | **$(8,026)** | | Non-GAAP adjusted basic net income (loss) per share | $0.56 | $(0.20) | | Non-GAAP adjusted diluted net income (loss) per share | $0.55 | $(0.20) | - Excluding stock-based compensation, non-GAAP adjusted net income was **$22.388 million** in Q1 2021, a significant improvement from a non-GAAP adjusted net loss of **$(8.026) million** in Q1 2020. Stock-based compensation represented **12.1%** of operating expenses (excluding cost of sales) in Q1 2021, down from **15.8%** in Q1 2020[194](index=194&type=chunk)[196](index=196&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily focusing on interest rate fluctuations affecting its cash equivalents and outstanding borrowings - The company's investments in cash equivalents (e.g., money market investments) are subject to interest rate risk, but due to their short-term maturities, a **10%** increase in interest rates is not expected to materially affect their realized value[203](index=203&type=chunk)[204](index=204&type=chunk) - The **$100.0 million** outstanding under the loan and security agreement bears a variable interest rate (greater of **9.0%** or prime rate + **3.5%**), making the company's interest expense sensitive to changes in the prime rate[205](index=205&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms that management, including the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2021, concluding they were effective. It also states that no material changes in internal control over financial reporting occurred during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2021[207](index=207&type=chunk) - There were no material changes in the company's internal control over financial reporting during the three months ended March 31, 2021[208](index=208&type=chunk) PART II – OTHER INFORMATION Contains additional disclosures not included in the financial statements, such as legal proceedings and risk factors [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section provides updates on significant legal proceedings involving the company, including class action lawsuits, a defamation suit, a licensing dispute, and a legal malpractice claim - In *Hsu v. Puma Biotechnology, Inc., et al.* (class action), the claims administrator reported **$50.5 million** in claimed damages, but the company disputes this amount and estimates actual claims could range from **$24.9 million** to **$51.4 million** after challenges[211](index=211&type=chunk) - In *Eshelman v. Puma Biotechnology, Inc., et al.* (defamation), a jury awarded **$15.9 million** in compensatory and **$6.5 million** in punitive damages, totaling **$26.3 million** with pre-judgment interest. The company has appealed the verdict, with an estimated high end of potential damages at **$27.9 million**[212](index=212&type=chunk) - The company resolved an arbitration with CANbridge BIOMED Limited, dismissing all claims and paying a one-time termination fee of **$20.0 million** to regain NERLYNX rights in greater China[213](index=213&type=chunk) - A legal malpractice suit was filed against former attorneys for alleged negligent handling of the *Eshelman* case, seeking recovery of the awarded amount[214](index=214&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the company's Annual Report on Form 10-K for a comprehensive discussion of risk factors, stating that there have been no material changes to these risks since the prior filing - There have been no material changes in the company's risk factors subsequent to the filing of its Annual Report on Form 10-K for the year ended December 31, 2020[215](index=215&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms that the company did not engage in any unregistered sales of equity securities or purchases of its own equity securities during the three months ended March 31, 2021 - The company did not sell any of its equity securities without registration under the Securities Act of 1933 during the three months ended March 31, 2021[216](index=216&type=chunk) - Neither the company nor any affiliated purchasers made any purchases of its equity securities during the quarter ended March 31, 2021[217](index=217&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[218](index=218&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that the disclosure requirements for mine safety are not applicable to the company - Mine Safety Disclosures are not applicable to the company[219](index=219&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report - No other information is reported in this section[220](index=220&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, amendments to key agreements, and certifications required by SEC regulations - Key exhibits include the Fourth Amendment to Amended and Restated Loan and Security Agreement, Termination Agreement with CANbridge BIOMED Limited, Amendment No. 3 to the License Agreement with Pierre Fabre Medicament SAS, and certifications from the Principal Executive Officer and Principal Financial Officer (Sections 302 and 906 of Sarbanes-Oxley Act)[223](index=223&type=chunk) [Signatures](index=42&type=section&id=Signatures) This section contains the official signatures of the company's President and Chief Executive Officer, and Chief Financial Officer, certifying the accuracy and completeness of the Form 10-Q - The report was signed by Alan H. Auerbach, President and Chief Executive Officer, and Maximo F. Nougues, Chief Financial Officer, on May 6, 2021[227](index=227&type=chunk)