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]

Table of Contents For the transition period from to Commission File Number: 001-35703 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Exchange Act: | | Trading | | | --- | --- | --- | | Tit ...

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]