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 ...

For the transition period from to 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Common Stock, par value $0.0001 ...

Financial Data and Key Metrics Changes - The company reported total revenue of $52.8 million for Q1 2023, with product revenue net at $46.8 million, reflecting a 15% increase from $40.7 million in Q1 2022 but a decline from $53.7 million in Q4 2022 [65][81] - The gross to net adjustment for Q1 2023 was approximately 21.2%, up from 17.8% in Q4 2022, primarily due to higher co-pay [52][81] - The company achieved a net income of $1.4 million or $0.03 per share in Q1 2023, compared to a net loss of $5.6 million or $0.12 per share in Q4 2022 [81][86] Business Line Data and Key Metrics Changes - NERLYNX sales totaled 2,849 bottles in Q1 2023, a 6% increase from Q1 2022 but a 14% decrease from Q4 2022 [51][99] - Approximately 64% of patients started NERLYNX on a lower daily dose in Q1 2023, consistent with Q4 2022 [46] - The company anticipates Q2 2023 net product revenue to be between $47 million and $50 million, indicating a year-over-year decline [47][60] Market Data and Key Metrics Changes - The company noted a 11% quarter-over-quarter growth in new patient enrollment, despite a year-over-year decline [99] - The specialty pharmacy channel accounted for approximately 75% of the business in Q1 2023, while the specialty distributor channel accounted for 25%, a shift from 78% and 22% respectively in Q4 2022 [104] Company Strategy and Development Direction - The company is focused on expanding its outreach to local and regional advocacy organizations to increase NERLYNX adoption [75][103] - Puma continues to evaluate several drugs for potential in-licensing to diversify its portfolio while maintaining net income and cash flow positivity [45][126] - The company plans to meet with the FDA in late Q2 2023 to discuss the registration pathway for alisertib in small cell lung cancer [50][102] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive net income and cash flow for the full year 2023, attributing this to expense reductions [86][114] - The company acknowledged the uncertainty regarding the impact of COVID-19 on sales and royalties, particularly in international markets [111] Other Important Information - The company reported cash and cash equivalents of approximately $71 million as of March 31, 2023 [57] - Research and development expenses were $12.7 million in Q1 2023, a decrease from $13.8 million in Q4 2022 [112] Q&A Session Summary Question: What are the assumptions behind the Q2 net product revenue guidance? - Management indicated that the guidance reflects expected inventory adjustments and market conditions [60] Question: What is the focus for neratinib moving forward? - The company will focus on continued execution in the extended adjuvant and metastatic breast cancer settings, while alisertib will be prioritized for expansion opportunities [19][18] Question: How is the company addressing the challenges in the Chinese market? - Management noted that payments in China can be lumpy due to manufacturing and distribution complexities [27] Question: What are the expectations for the upcoming biomarker data? - The company anticipates presenting biomarker data at the ASCO Annual Meeting in June, which could provide insights into treatment efficacy [41][72]

Financial Performance - Total revenue for Q1 2023 was $52.775 million, a 15.4% increase from $45.736 million in Q1 2022[17] - Product revenue increased to $46.794 million in Q1 2023, up from $40.718 million in Q1 2022, representing a 15.1% growth[17] - Net income for Q1 2023 was $1.401 million, compared to a net loss of $3.403 million in Q1 2022[18] - Royalty revenue for the three months ended March 31, 2023, was $6.0 million, compared to $5.0 million for the same period in 2022, reflecting a 20% increase[66] - Total revenue for Q1 2023 was approximately $52.8 million, an increase of 15.4% from $45.7 million in Q1 2022, driven by a $6.1 million increase in product sales and a $1.0 million increase in royalty revenue[193] - Product revenue, net was approximately $46.8 million for Q1 2023, up 15.0% from $40.7 million in Q1 2022, attributed to a 6.3% increase in bottles of NERLYNX sold and higher net selling prices[194] Cash and Liquidity - Cash and cash equivalents decreased to $61.394 million as of March 31, 2023, down from $76.201 million at the end of 2022[15] - The Company had cash and cash equivalents and marketable securities totaling approximately $71.2 million as of March 31, 2023[32] - Cash flows provided by operations were approximately $2.6 million for the three months ended March 31, 2023[32] - The company reported approximately $62.8 million in cash and cash equivalents exceeding insured limits as of March 31, 2023, indicating a concentration of credit risk[88] - The company intends to satisfy near-term liquidity requirements through existing cash and cash equivalents, marketable securities, and proceeds from product sales[181] Expenses and Costs - Research and development expenses for Q1 2023 were $12.706 million, down from $15.237 million in Q1 2022, a decrease of 16.6%[17] - SG&A expenses increased to approximately $22.5 million in Q1 2023, a 10.2% rise from $20.4 million in Q1 2022, mainly due to higher payroll costs and increased travel expenses[197] - Cost of sales rose to approximately $13.2 million in Q1 2023, up from $10.8 million in Q1 2022, primarily due to higher royalty expenses and increased intangible amortization related to a $12.5 million milestone payment to Pfizer[196] - Stock-based compensation expense for the three months ended March 31, 2023, was $2.838 million, compared to $3.148 million for the same period in 2022[143] Assets and Liabilities - Total assets decreased to $196.257 million as of March 31, 2023, from $222.059 million at the end of 2022[15] - Total liabilities decreased to $170.410 million as of March 31, 2023, from $200.451 million at the end of 2022[15] - The company has total long-term debt of $98.62 million as of March 31, 2023, which includes a $2.0 million exit payment[126] - Total accounts receivable decreased from $40.35 million as of December 31, 2022, to $31.16 million as of March 31, 2023, representing a decline of approximately 22.8%[108] Product Development and Commercialization - The company is currently commercializing NERLYNX for HER2+ breast cancer and has in-licensed alisertib for global development[24] - NERLYNX was approved by the FDA in July 2017 for the treatment of early stage HER2-overexpressed breast cancer and has since been commercialized in the U.S.[26] - The Company plans to continue pursuing commercialization of NERLYNX in various international markets, including Europe, Australia, and China[30] - The Company entered into an exclusive license agreement with Takeda for the worldwide research and development rights to alisertib in September 2022[31] - The company has invested significantly in the development and commercialization of its lead product, NERLYNX, which is expected to constitute the majority of product revenue for the foreseeable future[90] Legal and Regulatory Matters - The company filed a lawsuit against AstraZeneca for patent infringement, with trial currently scheduled to begin on or after May 13, 2024[159] - The company settled a patent infringement litigation with Sandoz, allowing Sandoz to sell a generic version of neratinib on or around December 8, 2030[161] - The company has filed petitions against ANDAs from Acebright, Aosaikang, Convalife, and Kelun, seeking administrative determinations regarding patent claims[165][166][168][171] - The CNIPA has declined to accept certain requests for administrative determination related to patents ZL200880118789.3 and ZL201710057547.9, citing eligibility issues[166][171] Future Outlook and Obligations - The Company has incurred significant operating losses since its inception and remains dependent on its ability to obtain sufficient funding to sustain operations[33] - The company has contractual obligations to make substantial payments to Pfizer upon achieving certain milestones[29] - The company is obligated to make milestone payments totaling approximately $187.5 million upon achieving certain milestones under the Pfizer License Agreement[152] - The company achieved aggregate worldwide net sales of $250.0 million in calendar year 2022, resulting in a payment of $12.5 million to Pfizer during Q1 2023[152]

Commercial Performance - Puma Biotechnology achieved approximately $54 million in net NERLYNX revenue in Q4 2022[21] - 3,323 ex-factory bottles of NERLYNX were sold in Q4 2022[16], including sales from the Commercial Specialty Pharmacy Network (SP) and Specialty Distributor Network (SD)[17] - The company's quarterly net revenue has fluctuated, with figures ranging from $2.68 million to $5.538 million across different periods[10] Dosage and Treatment - Approximately 64% of patients in Q4 2022 initiated treatment with a reduced dose of NERLYNX[4] Global Expansion - NERLYNX has received regulatory approvals in several regions, including Australia/SE Asia, Israel, Canada, Latin America, Europe, Greater China, Middle East, North and West Africa, South Africa, Turkey, and South Korea[19] - Commercial launches of NERLYNX have occurred in various countries, including Singapore, Malaysia, Brunei, New Zealand, Argentina, Chile, Peru, Brazil, Mexico, Germany, UK, Austria, Sweden, Finland, Scotland, Switzerland, Denmark, Hong Kong, China, Taiwan, Greece, Czech Republic, Ireland, Spain and South Korea[19] Distribution Network - Puma Biotechnology utilizes a pharmacy and distributor network that includes Specialty Pharmacies (SP) such as Acaria Health, Accredo, CVS ONCO 360, and Optum/Diplomat Biologics, and Specialty Distributors (SD) such as Cardinal Health, McKesson, ASD/Oncology Supply, and DMS Pharmaceutical Group Inc[1,8]

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2022 Earnings Conference Call March 2, 2023 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director of IR Alan Auerbach - CEO, President and Chairman Maximo Nougues - CFO Jeff Ludwig - Chief Commercial Officer Conference Call Participants Dave Rao - Cowen and Company Sahil Kazmi - B. Riley Securities Operator Good afternoon. My name is Diego, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being reco ...