Product Approval and Commercialization - NERLYNX is currently approved in the United States for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed breast cancer and for use in combination with capecitabine for advanced HER2-positive breast cancer [17]. - As of December 31, 2022, NERLYNX has received approval in over 18 countries outside the United States, including the European Union, China, and Canada [19]. - The company relies on a direct sales force of approximately 40 sales specialists to market NERLYNX in the United States [19]. - The company has implemented a managed access program for NERLYNX to provide access to patients in countries with limited therapeutic options [20]. - The company aims to become a leading provider of advanced therapies for cancer treatment, focusing on the commercialization of NERLYNX in the U.S. and pursuing regulatory approvals in additional countries [23]. - NERLYNX was launched in the United States in July 2017, with subsequent approval in February 2020 for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer [93]. - The company aims to establish NERLYNX as the standard of care by educating healthcare providers and patients, ensuring broad insurance coverage, and providing co-pay support [94]. - NERLYNX received marketing authorization in the EU in August 2018 and was included in China's National Reimbursement Drug List in December 2021, enhancing access for patients [95]. - The company is focused on expanding its commercialization efforts for NERLYNX in Europe and other international markets [95]. Clinical Trials and Efficacy - The ExteNET trial demonstrated a 33% reduction in the risk of invasive disease recurrence or death for patients treated with neratinib compared to placebo, with a two-year disease-free survival (DFS) rate of 93.9% for the neratinib arm [33]. - For centrally confirmed HER2-positive patients, neratinib resulted in a 49% reduction in the risk of invasive disease recurrence or death, with a two-year DFS rate of 94.7% [34]. - The five-year invasive disease-free survival (iDFS) rate for the neratinib arm was 90.2%, compared to 87.7% for the placebo arm, indicating a 27% reduction in risk of recurrence or death [36]. - The NALA trial demonstrated a statistically significant improvement in progression-free survival (PFS) for neratinib plus capecitabine with a hazard ratio of 0.76 (p=0.0059) [55]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months compared to 18.7 months for lapatinib plus capecitabine [56]. - The NALA trial showed a cumulative incidence of CNS metastases of 22.8% for neratinib plus capecitabine versus 29.2% for lapatinib plus capecitabine (p=0.043) [57]. - The CONTROL trial showed that the incidence of grade 3 diarrhea was 13% for dose escalation regimen 1 (DE1) and 27% for regimen 2 (DE2), significantly lower than the historical control of 39.8% [48]. - The CONTROL trial indicated that the proportion of patients discontinuing neratinib due to diarrhea was 3% for DE1 and 6% for DE2, compared to 17% in the ExteNET trial [48]. Drug Development and Pipeline - The company has in-licensed alisertib, which is designed to disrupt mitosis in rapidly proliferating tumor cells, and plans to develop it for hormone receptor positive breast cancer and small cell lung cancer [21][22]. - Alisertib has shown activity in previous clinical trials across various cancer types, including hormone receptor positive breast cancer and small cell lung cancer, with over 1,300 patients tested in 22 trials prior to licensing [21]. - The company is focused on in-licensing or acquiring additional drug candidates to build a sustainable product pipeline, employing disciplined decision criteria [23]. - The company plans to maximize the value of its programs by evaluating various commercialization strategies for drug candidates, including independent commercialization and collaborative partnerships [23]. - The company anticipates meeting with the FDA in the first half of 2023 to discuss the clinical development plan for alisertib and its potential dosing schedule under Project Optimus [22]. Financial and Business Risks - The company faces risks related to its status as a single product company with limited commercial sales experience, which may hinder its ability to maintain profitability [11]. - The company is dependent on international third-party sub-licensees for the development and commercialization of NERLYNX in several countries, which poses a risk to its business [11]. - The company is obligated to make milestone payments totaling $187.5 million to Pfizer upon achieving certain milestones, with a one-time payment triggered by FDA approval of NERLYNX in July 2017 [112]. - Under the Pfizer Agreement, the company pays annual royalties between approximately 10% and 20% of net sales of licensed products, reduced to a fixed rate in the low to mid-teens as per a 2014 amendment [114]. - The company must use commercially reasonable efforts to develop and commercialize products in specified major-market countries under the Takeda Agreement [117]. Regulatory Environment - The FDA has a goal of ten months to review and act on a standard NDA for a new molecular entity, typically taking twelve months from submission [155]. - The FDA may grant orphan designation to drugs intended for rare diseases affecting fewer than 200,000 individuals in the U.S. [160]. - Orphan products receiving FDA approval are entitled to seven years of exclusivity for the same disease or condition, barring certain exceptions [161]. - The FDA's priority review aims to evaluate applications within six months, compared to ten months for standard reviews [165]. - The EU Clinical Trials Regulation (CTR) harmonizes clinical trial processes across EU member states, effective January 31, 2022 [178]. - The CTR allows for a single application submission for clinical trials across multiple EU member states, streamlining the approval process [179]. - The company is subject to comprehensive regulatory oversight by the EMA and must maintain a pharmacovigilance system for monitoring product safety [188]. Market Competition and Intellectual Property - The company faces significant competition from major pharmaceutical and biotechnology companies, including Genentech, Novartis, and Roche, in the cancer treatment market [88]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 4 pending U.S. patent applications related to neratinib [97]. - The company is pursuing patent term extensions and supplemental protection certificates in various jurisdictions to enhance its intellectual property protection [99]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 439 foreign patents related to alisertib, with a focus on developing and commercializing the drug [106]. - The company plans to pursue additional patents for alisertib covering formulations and therapeutic uses, enhancing its intellectual property portfolio [108]. Healthcare Policy and Pricing - Political and regulatory changes in the U.S. healthcare system, such as the ACA, could significantly affect the company's future business operations [203]. - The company may face increased levels of discounts and rebates required by state and federal governments, impacting revenue generation [202]. - The Inflation Reduction Act of 2022 (IRA) requires manufacturers of certain drugs to engage in price negotiations with Medicare starting in 2026, with prices subject to a cap [205]. - The IRA imposes rebates under Medicare Part B and Part D to penalize price increases that exceed inflation, with the first rebates due in 2023 [205]. - The cost of prescription pharmaceuticals in the U.S. remains a significant topic of discussion, with ongoing Congressional inquiries and legislative initiatives aimed at increasing pricing transparency [206].

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was reported at $57.1 million, with product revenue net of $54.3 million, an increase from $51.3 million in Q2 2022 and $43.4 million in Q3 2021 [7][8] - Net loss based on GAAP for Q3 2022 was $0.4 million or $0.01 per share, compared to a net income of $9.4 million or $0.21 per share in Q2 2022 [28] - Non-GAAP net income for Q3 2022 was $2.5 million or $0.05 per share [29] - Gross to net adjustment in Q3 2022 was about 14.3%, down from 19% in Q2 2022 [30] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $0.5 million of inventory build in Q3 2022 [8] - New prescriptions (NRx) increased by approximately 17% compared to Q2 2022, while total prescriptions (TRx) were up about 5% [9][22] - Enrollments grew 7% quarter-over-quarter and 12% year-over-year [22] Market Data and Key Metrics Changes - Approximately 80% of NERLYNX business flowed through the specialty pharmacy channel in Q3 2022 [18] - NERLYNX received regulatory approval for metastatic breast cancer in Ecuador and Singapore, and was launched in Brazil and Spain [24] Company Strategy and Development Direction - The company continues to focus on increasing the adoption of NERLYNX through three strategic areas: communicating clinical data, engaging patients, and enhancing field force execution [16] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [15] Management Comments on Operating Environment and Future Outlook - Management noted that increased face-to-face interactions with healthcare providers (HCPs) have contributed to improved commercial results [37] - The company anticipates a seasonal decline in new patient starts in Q4 2022 due to the side effect profile of NERLYNX [32] Other Important Information - The company expects net NERLYNX product revenue for fiscal year 2022 to be in the range of $194 million to $196 million [31] - Cash burn for Q3 2022 was approximately $17.4 million, compared to $14 million in Q2 2022 [35] Q&A Session Summary Question: Change in timing for FDA meeting - The timing for the FDA meeting was moved to the first half of 2023 due to delays in submitting the packages [41] Question: Size of the sales team - The current size of the field force is deemed appropriate, with adjustments possible if access continues to improve [42][43] Question: Drivers of good commercial quarter - Increased live interactions with clinicians and improved access due to reduced COVID restrictions contributed to the positive commercial quarter [47][48] Question: Payer split and patient compliance - The payer split is approximately 65% commercial and 25% government, with dose escalation showing a 5% to 7% benefit in decreased discontinuations [54] Question: FDA discussion regarding alisertib - The company plans to proceed with the FDA discussions regardless of the availability of biomarker data [55]

Table of Contents 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, 2022 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 (State or ...

Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2022 of $59.5 million, which includes product revenue net of $51.3 million, an increase from $40.7 million in Q1 2022 and $48.9 million in Q2 2021 [9][10] - Net income based on GAAP for Q2 2022 was $9.4 million or $0.21 per share, compared to a net loss of $3.4 million or $0.08 per share in Q1 2022 [45] - Gross revenue from NERLYNX sales was $63.4 million in Q2 2022, up from $51.5 million in Q1 2022 [46] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $2.7 million on inventory build at specialty pharmacies and distributors in Q2 2022 [9] - The company sold 3,200 bottles of NERLYNX in Q2 2022, an increase of 520 from Q1 2022 [11][32] - New prescriptions (NRx) were down approximately 8% compared to Q1, while total prescriptions (TRX) were up about 1.6% [11] Market Data and Key Metrics Changes - Approximately 79% of NERLYNX business went through the specialty pharmacy channel in Q2 2022, slightly down from 81% in Q1 2022 [29] - The extended adjuvant breast cancer market remains significantly under-penetrated, indicating potential growth opportunities [27] Company Strategy and Development Direction - The company remains focused on leveraging positive clinical data for NERLYNX, engaging patients, and enhancing field force execution [25] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio and leverage existing infrastructure [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty regarding the impact of COVID-19 on sales and revenue, but noted a positive trend in face-to-face interactions with healthcare providers [59] - The company anticipates Q3 2022 NERLYNX net sales in the range of $44 million to $47 million, with a net loss expected between $1 million and $2 million [50][52] Other Important Information - The company plans to submit final data from the SUMMIT trial to the FDA later this year [17] - Cash burn for Q2 2022 was approximately $14 million, down from $17 million in Q1 2022 [54] Q&A Session Summary Question: Changes in sales force structure due to increased live interactions - Management believes that a combination of live and virtual interactions will be the new normal, and they are currently satisfied with the size of the sales force [63][65] Question: Presentation of updated HER2-mutated breast cancer data - Management anticipates presenting updated data at the San Antonio Breast Cancer meeting, but the timing of FDA disclosures is uncertain [68] Question: Long-term profitability and cost management - Management reiterated the commitment to being net income positive and cash flow positive, with potential further cost cuts if necessary [77]

Table of Contents 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, 2022 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 (State or other ...

Puma Biotechnology Earnings Call Commercial Update May 5, 2022 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 statem ...

Call Start: 16:30 January 1, 0000 5:10 PM ET Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2022 Earnings Conference Call May 5, 2022 16:30 ET Company Participants Mariann Ohanesian - Senior Director of Investor Relations Alan Auerbach - Chairman, President & Chief Executive Officer Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Alex Hammond - Bank of America Operator Good afternoon. My name is Karen, and I will be your c ...

[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 ( ...