Puma Biotechnology(PBYI) - 2021 Q1 - Quarterly Report

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) 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 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] Condensed Consolidated Statements of Operations 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] Condensed Consolidated Statements of Comprehensive Income (Loss) 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] Condensed Consolidated Statements of Stockholders' Equity (Deficit) 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] Condensed Consolidated Statements of Cash Flows 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] Notes to the Unaudited Condensed Consolidated Financial Statements Provides detailed explanations and disclosures supporting the condensed consolidated financial statements Note 1—Business and Basis of Presentation 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] - 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][26][27] - 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] - 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] Note 2—Significant Accounting Policies 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][42] - 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][57] - 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][64] - 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][95] Note 3—Accounts Receivable, Net 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][97] Note 4—Prepaid Expenses and Other 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] Note 5—Other Current Assets 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] Note 6—Leases 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][101][102] | 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] Note 7—Property and Equipment, Net 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] Note 8—Intangible Assets, Net 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] Note 9—Accrued Expenses 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][108][109] Note 10—Debt 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][114][119] - 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][119] - Deferred financing costs, net of accumulated amortization, totaled $4.472 million, with $0.5 million of related interest expense recognized in Q1 2021[121] Note 11—Stockholders' Equity 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][125] | 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] Note 12—401(k) Savings Plan 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] Note 13—Commitments and Contingencies 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][137] - 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] - 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] - 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][213] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - 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] - 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] Impact of COVID-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] - 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] - 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][148] Critical Accounting Policies 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] - 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][151][152] - 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] Summary of Income and Expenses 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] - 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][156] - 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][158][159] Results of Operations 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] - 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] | 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][166][167] - 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][172] - 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][171][172] Liquidity and Capital Resources 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][179] - 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][190] - 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][193] Non-GAAP Financial Measures 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][196] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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][204] - 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] Item 4. Controls and Procedures 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] - There were no material changes in the company's internal control over financial reporting during the three months ended March 31, 2021[208] PART II – OTHER INFORMATION Contains additional disclosures not included in the financial statements, such as legal proceedings and risk factors Item 1. Legal Proceedings 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] - 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] - 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] - A legal malpractice suit was filed against former attorneys for alleged negligent handling of the Eshelman case, seeking recovery of the awarded amount[214] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] - Neither the company nor any affiliated purchasers made any purchases of its equity securities during the quarter ended March 31, 2021[217] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[218] Item 4. Mine Safety Disclosures 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] Item 5. Other Information This section states that there is no other information to report - No other information is reported in this section[220] Item 6. Exhibits 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] 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]