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 ( ...

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 ...

Financial Data and Key Metrics Changes - Puma reported total revenue of $53.4 million for Q2 2021, which includes U.S. net NERLYNX sales and license fees [8] - Net NERLYNX sales were $48.9 million in Q2 2021, up from $45.8 million in Q1 2021 and $48.8 million in Q2 2020 [8] - Royalty revenue increased to $4.3 million in Q2 2021 from $2.4 million in Q1 2021 and $1.1 million in Q2 2020 [8] - The company reported a GAAP net loss of $5.1 million or $0.13 per share for Q2 2021, compared to a net income of $16.5 million in Q1 2021 [44] - On a non-GAAP basis, net income was $13.1 million or $0.32 per diluted share for Q2 2021 [44] - Gross revenue from NERLYNX sales was $59.3 million in Q2 2021, compared to $56.5 million in Q1 2021 [45] - SG&A expenses were $39.4 million in Q2 2021, up from $28.2 million in Q1 2021 [49] Business Line Data and Key Metrics Changes - NERLYNX bottles sold increased to 3,354 in Q2 2021, a 3.3% increase from 3,247 bottles sold in Q1 2021 [9][39] - Approximately 39% of new patient starts initiated therapy at a lower dose in Q2 2021, a slight increase from Q1 2021 [40] - The majority of business, approximately 77%, flowed through the specialty pharmacy channel in Q2 2021 [37] Market Data and Key Metrics Changes - The company experienced challenges due to the COVID-19 pandemic and the Delta variant, impacting access to healthcare providers [9][34] - There was a greater than 20% increase in call activity with healthcare providers in Q2 2021 compared to Q1 2021 [35] Company Strategy and Development Direction - Puma aims to improve the position of NERLYNX in early-stage breast cancer and strengthen the risk-benefit perception with clinicians [25] - The company is focused on increasing adoption of dose escalation in early-stage breast cancer to improve tolerability and length of therapy [40] - Strategic collaborations are being formed globally to make NERLYNX available to more patients, with recent launches in Chile and Malaysia [41] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding improvements in access to healthcare providers due to vaccinations, but acknowledged the impact of the Delta variant [55] - The company anticipates NERLYNX net sales for fiscal year 2021 to be in the range of $200 million to $205 million, slightly lower than previous guidance [47] - Management remains focused on revenue and sales growth for NERLYNX in 2021 and beyond [56] Other Important Information - Puma ended Q2 2021 with $109 million in cash, cash equivalents, and marketable securities [52] - The company entered into a $125 million note purchase agreement to improve cash flexibility and support commercial activities [53][54] Q&A Session Summary Question: Can you comment on the utilization of the dose titration regimen following the label update? - Management noted that the dose escalation label was approved at the end of June, and they expect to see an acceleration in adoption moving forward [60][61] Question: Will the data reported in Q4 include Stage 2 data from the neratinib arm? - Management confirmed that both Stage 1 and Stage 2 data will likely be included in the presentation [62] Question: What are the dynamics driving the increase in gross-to-net adjustments? - Management indicated that the decline in gross-to-net impact was not as significant as in prior years, with increases in Medicaid and government pricing contributing to the dynamics [68] Question: How many patients are currently undergoing treatment in the SUMMIT basket trials? - Management estimated that around 20 to 25 patients are currently being treated in the cohort for EGFR exon 18 mutations [71] Question: What is the current status of the regulatory progress for non-small cell lung cancer? - Management confirmed that both cervical cancer and exon 18 lung data are still enrolling, with presentations planned for early 2022 [76][77]

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 ...