Financial Performance - Total revenue for Q1 2024 was $43,766,000, a decrease of 17.1% compared to $52,775,000 in Q1 2023[16] - Product revenue decreased to $40,279,000 in Q1 2024 from $46,794,000 in Q1 2023, representing a decline of 13.9%[16] - Net loss for Q1 2024 was $4,815,000, compared to a net income of $1,401,000 in Q1 2023, indicating a significant shift in financial performance[18] - Royalty revenue for the three months ended March 31, 2024, was $3.5 million, compared to $6.0 million for the same period in 2023, reflecting a decrease of approximately 41.7%[65] - Total revenue for Q1 2024 was approximately $43.8 million, a decrease from $52.8 million in Q1 2023, primarily due to a $6.5 million decrease in product revenue and a $2.5 million decrease in royalty revenue[191] Cash Flow and Liquidity - Cash and cash equivalents decreased to $76,751,000 as of March 31, 2024, down from $84,585,000 at the end of 2023[14] - The company reported a net cash provided by operating activities of $11,246,000 for Q1 2024, compared to $2,643,000 in Q1 2023, showing improved cash flow from operations[23] - Cash provided by operations was approximately $11.2 million for the three months ended March 31, 2024, with total cash and cash equivalents and marketable securities amounting to approximately $107.2 million[31] - Cash used in investing activities was approximately $19.1 million in Q1 2024, compared to $17.5 million in Q1 2023, primarily for the purchase of available-for-sale securities[203] - As of March 31, 2024, cash and cash equivalents were $76.8 million, down from $84.6 million as of December 31, 2023[200] Assets and Liabilities - Total assets decreased to $214,149,000 as of March 31, 2024, compared to $230,528,000 at the end of 2023, reflecting a reduction of 7.1%[14] - Total liabilities decreased to $163,167,000 as of March 31, 2024, down from $177,086,000 at the end of 2023, a decline of 7.8%[14] - Total accounts receivable decreased from $48.7 million as of December 31, 2023, to $25.6 million as of March 31, 2024, representing a decline of approximately 47.4%[111] - Accrued expenses decreased from $52.8 million as of December 31, 2023, to $37.8 million as of March 31, 2024, a reduction of about 28.4%[124] - Total long-term debt, net, is reported at $54.7 million as of March 31, 2024, after accounting for debt issuance costs and current portion[127] Research and Development - Research and development expenses increased to $13,587,000 in Q1 2024 from $12,706,000 in Q1 2023, an increase of 6.9%[16] - R&D expenses increased to approximately $13.6 million in Q1 2024, up 6.9% from $12.7 million in Q1 2023, driven by a 39.9% increase in clinical trial expenses[197] - The company is commercializing NERLYNX® for HER2-positive breast cancer and has recently in-licensed alisertib for global development and commercialization[24] - The company initiated the ALISCA-Lung1 Phase II trial for alisertib in February 2024 and plans to commence the ALISCA-Breast 1 trial in the second half of 2024[176] - Research and development expenses include clinical manufacturing costs, clinical trial expenses, and consulting costs, with payments dependent on achieving certain milestones[67] Stock and Compensation - The weighted-average shares of common stock outstanding increased to 48,189,256 in Q1 2024 from 46,636,083 in Q1 2023, reflecting an increase of 3.3%[16] - Total stock-based compensation expense for the three months ended March 31, 2024 was $2.377 million, compared to $2.838 million for the same period in 2023[141] - As of March 31, 2024, 4,776,926 stock options were outstanding with a weighted average exercise price of $46.54[142] - The total estimated unrecognized employee compensation cost related to non-vested stock options was approximately $2.7 million, expected to be recognized over 1.4 years[142] - The weighted average grant date fair value of options granted during the three months ended March 31, 2024 was $4.57 per share[142] Legal and Regulatory Matters - The Company is involved in multiple legal proceedings, including a lawsuit against AstraZeneca for patent infringement, with a jury trial scheduled for May 13, 2024[156] - The Company has filed lawsuits against Acebright and Aosaikang in China for patent infringement related to its NERLYNX product, with ongoing appeals and administrative determinations[158][161] - The Company can terminate the license agreement with Pfizer at will or for safety concerns, with specified advance notice[150] - The Company has the right to enforce its patents in civil litigation in China against generic competitors[161] - The CNIPA declined to accept the company's request for administrative determination regarding certain patents, stating they are not eligible for registration in the Chinese Orange Book[167] Future Obligations and Milestones - The Company has significant contractual obligations to make payments to Pfizer upon achieving certain milestones related to NERLYNX[28] - The Company is obligated to make milestone payments totaling approximately $187.5 million upon achieving certain milestones, with a one-time payment of $12.5 million triggered by worldwide net sales of $250 million in 2022[150] - As of March 31, 2024, the total potential milestone payments due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $579.8 million[63] - Future minimum lease payments as of March 31, 2024, total $11.9 million, with the largest payment of $5.98 million due in 2025[118] - Future minimum principal and exit payments under the Athyrium Notes total $102.0 million, with $33.997 million due in 2024, $45.329 million in 2025, and $22.674 million in 2026[133]

Exhibit 99.1 LOS ANGELES, Calif., May 2, 2024 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2024. Unless otherwise stated, all comparisons are for the first quarter 2024 compared to the first quarter 2023. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma's first commercial product. Product revenue, net in the first quarter of 2024 was $40.3 million, compared to product revenue, net of $4 ...

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 statements are based on our current expectations, forecasts and assum ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2023 Earnings Conference Call February 29, 2024 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, Investor Relations Alan Auerbach - Chief Executive Officer, President & Chairman Jeff Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Divya Rao - TD Cowen Operator Good afternoon. My name is Alicia, and I'll be your conference call operator today. At this time, all participants are in a listen-on ...

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 1934 For the fiscal year ended December 31, 2023 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 o ...

Exhibit 99.1 News Release Puma Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results LOS ANGELES, Calif., Feb. 29, 2024 — Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2023. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2023 compared to the fourth quarter and full year 2022. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Pum ...

Financial Data and Key Metrics Changes - Product revenue net for Q3 2023 was $51.6 million, unchanged from Q2 2023, and down $2.7 million from $54.3 million in Q3 2022 [5][91] - Net income based on GAAP for Q3 2023 was $5.8 million or $0.12 per share, compared to $2.1 million or $0.05 per share in Q2 2023 [79] - Total revenue for Q3 2023 was $56.1 million, which includes product revenue and royalties [86] Business Line Data and Key Metrics Changes - NERLYNX ex-factory bottle sales were 2,874 in Q3 2023, representing a 5% decline quarter-over-quarter and a 10% decline year-over-year [42] - New prescriptions (NRx) declined approximately 15% quarter-over-quarter and total prescriptions (TRx) were down about 7% compared to Q2 2023 [87] - The company reported an increase in inventory by about $600,000 in Q3 2023, compared to a $1.5 million drawdown in Q2 2023 [10][23] Market Data and Key Metrics Changes - Royalty revenue totaled $4.5 million in Q3 2023, up from $3 million in Q2 2023 and $2.8 million in Q3 2022 [72] - The gross to net adjustment in Q3 2023 was about 14.6%, compared to 17.9% in Q2 2023, primarily due to lower Medicare rebates [93] Company Strategy and Development Direction - The company remains focused on the extended adjuvant indication for NERLYNX, which generates about 90% of its business [90] - Puma plans to initiate a Phase 2 clinical trial of alisertib in small cell lung cancer before the end of the year and is committed to maintaining net income positivity [17][66] - The company is evaluating several drugs for potential in-licensing to diversify its portfolio [89] Management's Comments on Operating Environment and Future Outlook - Management noted a significant unmet need for patients battling breast cancer and lung cancer, emphasizing their commitment to improving patient outcomes [48] - The company expects Q4 2023 NERLYNX net product revenue to be in the range of $56 million to $59 million, with anticipated royalty revenues of $16 million to $19 million [94] Other Important Information - Cash burn for Q3 2023 was approximately $10.6 million, compared to $3.2 million in Q2 2023 [81] - The company had approximately $85 million in cash, cash equivalents, and marketable securities as of September 30, 2023 [25] Q&A Session Summary Question: What was the percent of free drug experienced this past quarter? - The company reported about 14% of free drug, consistent over the last several quarters [96] Question: What gives confidence in recovery for the fourth quarter? - Management noted improvements in enrollments month-over-month throughout Q3, with October enrollments aligning with Q1 and Q2 levels [43][52] Question: What is the anticipated design for the Phase 3 trial of alisertib in metastatic breast cancer? - The company indicated a preference for a trial design similar to previous studies, potentially involving combination therapy [34][58]

PART I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q3 2023 and 2022, including balance sheets, statements of operations, comprehensive income, stockholders' equity, cash flows, and explanatory notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$203.6 million** by September 30, 2023, while total liabilities also decreased, and stockholders' equity increased to **$38.7 million** Balance Sheet Items (in thousands) | Balance Sheet Items (in thousands) | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $81,800 | $76,201 | | Total current assets | $125,354 | $134,281 | | Total assets | $203,605 | $222,059 | | Total current liabilities | $67,362 | $77,484 | | Total liabilities | $164,863 | $200,451 | | Total stockholders' equity | $38,742 | $21,608 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 2023 net income significantly improved to **$5.8 million** from a prior-year loss, despite a slight revenue decrease, while nine-month net income grew to **$9.3 million** Statements of Operations (in thousands, except EPS) | Metric (in thousands, except EPS) | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $56,116 | $57,102 | $163,459 | $162,356 | | Income from Operations | $8,585 | $2,393 | $17,842 | $13,704 | | Net Income (Loss) | $5,796 | $(360) | $9,323 | $5,608 | | Diluted EPS | $0.12 | $(0.01) | $0.20 | $0.13 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities for the nine months ended September 30, 2023, was **$16.6 million**, a significant turnaround from the prior year's cash usage Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash from operating activities | $16,554 | $(23,510) | | Net cash (used in) provided by investing activities | $(10,955) | $18,977 | | Net cash provided by financing activities | $0 | $9,792 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's cancer care business, accounting policies, debt, legal proceedings, and commitments, including license agreements and a recent workforce reduction - The company's business is focused on commercializing **NERLYNX®** for HER2-positive breast cancer and developing the newly in-licensed **alisertib** for various cancer types[24](index=24&type=chunk) - The company has substantial milestone and royalty obligations to Pfizer for NERLYNX, and an upfront payment of **$7.0 million** was made to Takeda for alisertib in October 2022, with potential future milestones up to **$287.3 million**[153](index=153&type=chunk)[154](index=154&type=chunk) - The company is involved in patent infringement litigation against AstraZeneca and has faced several ANDA filings for a generic version of NERLYNX® in China, with one generic approved in September 2023[160](index=160&type=chunk)[165](index=165&type=chunk) - A workforce reduction of approximately **5%** was implemented in October 2023, with expected related costs of **$0.4 million** to be recorded in Q4 2023[173](index=173&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance for Q3 and nine months ended September 30, 2023, analyzing revenue, expenses, liquidity, capital resources, debt covenants, and non-GAAP measures [Results of Operations](index=48&type=section&id=Results%20of%20Operations) Q3 2023 total revenue slightly decreased to **$56.1 million** due to lower NERLYNX sales, while nine-month revenue increased to **$163.5 million**, with improved operating income - Q3 2023 vs Q3 2022: Product revenue, net decreased by **$2.7 million** due to a **~10%** drop in NERLYNX bottles sold, while royalty revenue increased by **$1.7 million**, primarily from sales in China[195](index=195&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) - Nine Months 2023 vs 2022: Product revenue, net increased by **$3.6 million** due to higher net selling price, despite a **3.7%** decrease in bottles sold, and royalty revenue decreased by **$2.5 million**[205](index=205&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - SG&A expenses decreased by **$1.2 million** in Q3 2023 YoY, mainly due to a **$1.6 million** reduction in professional fees and expenses, including legal and consulting costs[199](index=199&type=chunk) - R&D expenses remained relatively flat at **$11.4 million** for Q3 2023 compared to **$11.3 million** in Q3 2022[201](index=201&type=chunk) [Liquidity and Capital Resources](index=54&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$81.8 million** in cash and **$58.0 million** in working capital, with **$100.0 million** in outstanding debt under Athyrium Notes Liquidity Metric (in thousands) | Liquidity Metric (in thousands) | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $81,800 | $76,201 | | Working capital | $57,992 | $56,797 | | Long-term debt | $76,634 | $98,307 | - Cash from operations for the nine months ended Sep 30, 2023 was **$16.6 million**, compared to cash used of **$23.5 million** in the same period of 2022, a positive swing driven by net income and changes in working capital[216](index=216&type=chunk)[217](index=217&type=chunk) - The company has **$100.0 million** in principal debt outstanding under the Athyrium Notes as of Sep 30, 2023, and was in compliance with all applicable covenants[228](index=228&type=chunk)[134](index=134&type=chunk) [Non-GAAP Financial Measures](index=57&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP adjusted net income for Q3 2023 was **$8.3 million** (**$0.17** per diluted share), significantly up from Q3 2022, reflecting operational performance excluding stock-based compensation Non-GAAP Metric (in thousands, except EPS) | Non-GAAP Metric (in thousands, except EPS) | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | GAAP net income (loss) | $5,796 | $(360) | $9,323 | $5,608 | | Stock-based compensation adjustment | $2,545 | $2,830 | $7,815 | $9,198 | | Non-GAAP adjusted net income | $8,341 | $2,470 | $17,138 | $14,806 | | Non-GAAP adjusted diluted EPS | $0.17 | $0.05 | $0.36 | $0.33 | [Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations, impacting its investment portfolio and variable-rate debt tied to SOFR, with a **1%** rate increase potentially raising interest expense by **$1.0 million** - The company's primary market risk is interest rate risk affecting its cash equivalents and its **$100.0 million** in variable-rate debt tied to the SOFR[241](index=241&type=chunk)[243](index=243&type=chunk) - A hypothetical **1%** increase in interest rates in Q3 2023 would have increased interest expense by **$1.0 million**[243](index=243&type=chunk) [Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during Q3 2023 - The CEO and CFO concluded that disclosure controls and procedures were effective as of September 30, 2023[245](index=245&type=chunk) - No material changes were made to internal control over financial reporting during Q3 2023[246](index=246&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=60&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing legal matters, including patent infringement litigation against AstraZeneca, challenges to NERLYNX patents in China, and a settled dispute with Sandoz - The company is suing AstraZeneca for infringement of two U.S. patents related to its product Tagrisso®, with a jury trial scheduled for May 2024[251](index=251&type=chunk) - Patent infringement litigation against Sandoz regarding a generic version of NERLYNX was settled in December 2022, permitting Sandoz to begin selling a generic version around December 8, 2030[252](index=252&type=chunk)[254](index=254&type=chunk) - Several companies (Acebright, Aosaikang, Convalife, Kelun) have filed for approval to market generic versions of NERLYNX in China, challenging the company's patents, with Acebright's generic version approved by the NMPA in September 2023[257](index=257&type=chunk)[258](index=258&type=chunk)[260](index=260&type=chunk) [Risk Factors](index=64&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the 2022 Annual Report on Form 10-K, referring readers to that document for a comprehensive discussion - No material changes to risk factors were reported since the 2022 Annual Report on Form 10-K[265](index=265&type=chunk) [Other Part II Information (Items 2, 3, 4, 5, 6)](index=64&type=section&id=Other%20Part%20II%20Information%20%28Items%202%2C%203%2C%204%2C%205%2C%206%29) This section confirms no unregistered equity sales, no defaults on senior securities, no mine safety disclosures, and no Rule 10b5-1 trading plan changes by directors or officers - No unregistered sales of equity securities or defaults on senior securities occurred during the period[266](index=266&type=chunk)[268](index=268&type=chunk) - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[270](index=270&type=chunk)

Puma Biotechnology Earnings Call Commercial Update Forward-Looking Safe-Harbor Statement Puma's Pharmacy and Distributor Network Copyright 2023 Puma Biotechnology 3 Q2'22 Q2'23 + $2.7 mil - $1.5 mil August 3, 2023 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 mat ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director, IR Alan Auerbach - Chairman, President and CEO Maximo Nougues - CFO Jeff Ludwig - CCO Conference Call Participants Ed White - H.C. Wainwright Divya Rao - TD Cowen and Company Alex Hammond - Bank of America Operator Good afternoon. My name is Victoria, and I will be your conference call operator today. At this time, all participants are in a listen-only m ...