Puma Biotechnology (PBYI) reported fourth-quarter 2024 adjusted earnings of 43 cents per share, which beat the Zacks Consensus Estimate of 14 cents. In the year-ago quarter, the company reported adjusted earnings of 31 cents per share.The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 39 cents compared with 26 cents in the year-ago quarter.For the fourth quarter, the company recorded a non-cash deferred tax income benefit of $7.1 m ...

Financial Data and Key Metrics Changes - Puma reported total revenue for Q4 2024 of $59.1 million, with product revenue net at $54.4 million, a decline from $56.1 million in Q3 2024 but an increase from $53.2 million in Q4 2023 [8][9] - Royalty revenue was $4.7 million in Q4 2024, down from $24.4 million in Q3 2024 and $19.0 million in Q4 2023 [9][42] - Net income based on GAAP for Q4 2024 was $19.3 million or $0.39 per share, compared to $20.3 million or $0.41 per share in Q3 2024 [38][39] - Non-GAAP net income for Q4 2024 was $21.1 million or $0.43 per share [40] Business Line Data and Key Metrics Changes - NERLYNX sales in Q4 2024 were impacted by a $3.7 million inventory increase at specialty pharmacies and distributors [9] - Total prescriptions (TRx) grew 4% quarter-over-quarter and 3% year-over-year, while new prescriptions (NRx) decreased 7% quarter-over-quarter but increased 10% year-over-year [30][31] - Approximately 74% of patients started NERLYNX at a reduced dose in Q4 2024, similar to 76% in Q4 2023 [32] Market Data and Key Metrics Changes - In Q4 2024, 75% of business was purchased through the Specialty Pharmacy channel and 25% through the Specialty Distributor channel [25] - NERLYNX received regulatory approval in Turkey and Thailand for extended adjuvant settings [34] Company Strategy and Development Direction - The company is focused on increasing NERLYNX utilization among high-risk patients and enhancing engagement with clinicians [21] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [18] - The company anticipates net NERLYNX product revenue for fiscal year 2025 to be between $192 million and $198 million [44] Management's Comments on Operating Environment and Future Outlook - Management highlighted a commitment to maintaining positive net income and financial discipline [53][54] - The company expects a net loss between $2 million and breakeven for Q1 2025, typically the lowest revenue quarter due to inventory burn-off [48] Other Important Information - Cash earned in Q4 2024 was approximately $4.3 million, with total outstanding principal debt increasing to approximately $67 million [50][51] - The company plans to keep investors updated on the progress of its clinical trials and potential new drug in-licensing opportunities [18][46] Q&A Session Summary Question: Expectations for Phase 1 MCI data presentation - Management expects interim data to be presented at either AACR or ASCO [58] Question: Current statistics on persistence and compliance - Management is working to educate customers on the benefits of completing therapy and has seen a 5% to 10% increase in patients remaining on therapy when starting at a lower dose [60][64] Question: Revenue guidance and price versus volume considerations - Management anticipates a decrease in product supply revenue and has implemented a 7% price increase in early Q1 2025 [67] Question: Royalty stream from China and its lumpiness - Management confirmed that royalties from China may be lumpy due to the distribution network and regulatory transitions [70][72] Question: Impact of IRA's Part D redesign on reimbursement - Management noted no significant impact on Medicare patient trends due to IRA reform [76] Question: Expectations for interim data from the alisertib breast cancer trial - Management indicated that interim data would include early response and duration data, with specifics to be shared in future calls [78]

Core Viewpoint - Puma Biotech reported quarterly earnings of $0.43 per share, significantly exceeding the Zacks Consensus Estimate of $0.14 per share, marking an earnings surprise of 207.14% [1][2] Financial Performance - The company achieved revenues of $59.1 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 14.02%, although this represents a decline from year-ago revenues of $72.2 million [2] - Over the last four quarters, Puma Biotech has consistently surpassed consensus EPS estimates [2] Stock Performance - Puma Biotech shares have declined approximately 9.2% since the beginning of the year, contrasting with the S&P 500's gain of 1.3% [3] - The current Zacks Rank for Puma Biotech is 3 (Hold), indicating expected performance in line with the market in the near future [6] Earnings Outlook - The consensus EPS estimate for the upcoming quarter is $0.06 on revenues of $43.77 million, while the estimate for the current fiscal year is $0.56 on revenues of $231.46 million [7] - The trend of estimate revisions for Puma Biotech is currently mixed, which may change following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Puma Biotech belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Puma Biotechnology Earnings Call Commercial Update February 27, 2025 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 ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was reported at $59.1 million, with product revenue net at $54.4 million, a decline from $56.1 million in Q3 2024 but an increase from $53.2 million in Q4 2023 [6][28] - Royalty revenue decreased significantly to $4.7 million in Q4 2024 from $24.4 million in Q3 2024, which included sales to China [6][30] - Net income based on GAAP for Q4 2024 was $19.3 million or $0.39 per share, compared to $20.3 million or $0.41 per share in Q3 2024 [27][28] Business Line Data and Key Metrics Changes - NERLYNX sales saw an increase in bottle sales to 2,964 in Q4 2024, up from 2,723 in Q3 2024, but new prescriptions (NRx) were down approximately 7% compared to Q3 2024 [7][22] - Product supply revenue was significantly lower at $800,000 in Q4 2024 compared to $7.4 million in Q3 2024 [20][30] - The company reported an increase in inventory of approximately $3.7 million in Q4 2024, compared to $600,000 in Q3 2024 [20][34] Market Data and Key Metrics Changes - The company noted a decline in enrollments of 7% quarter over quarter in Q4 2024, consistent with historical patterns due to holiday season effects [21][22] - Total prescriptions (TRx) grew by 4% quarter over quarter in Q4 2024, indicating some resilience in demand despite the decline in new patient starts [22][24] Company Strategy and Development Direction - The company is focused on increasing the utilization of NERLYNX, particularly among patients at higher risk of recurrence, and is enhancing engagement with clinicians [16][18] - Puma is exploring opportunities to diversify its portfolio by evaluating several drugs for potential licensing [13] - The company aims to maintain positive net income and is committed to financial discipline, including potential expense reductions if necessary [36][37] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the significant unmet need for patients with breast cancer and other solid tumors, emphasizing their commitment to improving patient outcomes [36][37] - The company anticipates a net income range of $23 million to $28 million for the full year 2025, with a focus on maintaining financial stability [31][34] Other Important Information - The company is currently conducting ongoing Phase II trials for its investigational drug, Alasertib, with interim data expected later in 2025 [9][11] - Regulatory approvals for NERLYNX were received in Turkey and Thailand for extended adjuvant settings, indicating expansion in international markets [26] Q&A Session Summary Question: Will interim data from the Phase one MCI trial be presented at a medical conference? - Management indicated that the data has been submitted for presentation at either AACR or ASCO [40][41] Question: What are the current statistics on persistence and compliance for NERLYNX? - Management highlighted efforts to educate customers on the benefits of completing therapy and noted improvements in patient retention when starting at a lower dose [42][44] Question: How does the company view the revenue guidance for the year in terms of price versus volume? - Management acknowledged a decrease in product supply revenue and a forecasted demand decline of about 2% year over year [45][46] Question: How should the royalty stream from outside the U.S. be viewed, particularly regarding China? - Management confirmed that royalties from China may be lumpy due to the distribution network and regulatory transitions affecting shipments [48][49] Question: What impact has the IRA Part D redesign had on patient reimbursement? - Management reported no significant changes in trends for Medicare patients following the IRA reform [53] Question: What are the expectations for interim data from the Allocertib breast cancer trial? - Management indicated that early response and duration data would be shared, with ongoing data expected [55]

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 [21]. - As of December 31, 2024, NERLYNX has received approval in over 40 countries outside the United States, including the European Union, China, and Canada [22]. - The commercialization strategy for NERLYNX includes a direct sales force of approximately 35 specialists in the U.S. and exclusive sub-license agreements for international markets [22]. - NERLYNX was launched in July 2017 and aims to establish itself as the standard of care for extended adjuvant treatment of early stage HER2-positive breast cancer [109]. - NERLYNX received marketing authorization in the EU in August 2018 for early stage hormone receptor positive HER2-overexpressed breast cancer, and was added to China's National Reimbursement Drug List in December 2021, broadening access to more women [113][114]. - The company is actively seeking regulatory or data exclusivity in jurisdictions outside the U.S. and Europe, including Chile and Taiwan [118]. - The company is pursuing patent term extensions for U.S. Patent No. 7,399,865, which is eligible for a five-year extension, expiring December 29, 2030 [118]. - The company has a total obligation of $187.5 million in milestone payments to Pfizer, triggered by FDA approval of NERLYNX in July 2017 [131]. - The annual royalty payments to Pfizer for net sales of licensed products range from approximately 10% to 20%, reduced to a fixed rate in the low to mid-teens as per the amendment in July 2014 [132][133]. Clinical Trials and Efficacy - Neratinib demonstrated a 33% reduction in the risk of invasive disease recurrence or death compared to placebo, with a two-year disease-free survival (DFS) rate of 93.9% for the neratinib arm versus 91.6% for the placebo arm [34]. - In the ExteNET trial, neratinib showed a 27% reduction in the risk of invasive disease recurrence or death after five years, with a five-year invasive disease-free survival (iDFS) rate of 90.2% for the neratinib arm compared to 87.7% for the placebo arm [38]. - The two-year DFS rate for centrally confirmed HER2-positive patients treated with neratinib was 94.7%, compared to 90.6% for the placebo group, indicating a 49% reduction in the risk of invasive disease recurrence or death [36]. - The Phase III NALA trial enrolled 621 patients, comparing neratinib plus capecitabine to lapatinib plus capecitabine [55]. - Neratinib plus capecitabine showed a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.76 (p=0.0059) compared to lapatinib plus capecitabine [56]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months, compared to 18.7 months for those treated with lapatinib plus capecitabine [57]. - The overall cumulative incidence of CNS metastases was 22.8% for the neratinib plus capecitabine arm, compared to 29.2% for the lapatinib plus capecitabine arm (p=0.043) [58]. - In the TBCRC 022 trial, 49% of patients experienced a CNS Objective Response by composite criteria, with a median overall survival of 13.5 months [65]. Adverse Events and Management - The most frequently observed adverse event in neratinib-treated patients was diarrhea, with about 39.9% experiencing grade 3 or higher diarrhea [33]. - The incidence of grade 3 diarrhea for patients receiving neratinib dose escalation regimen 1 (DE1) was 13%, significantly lower than the historical control of 39.8% from the ExteNET trial [47]. - The median cumulative duration of grade 3 diarrhea across the CONTROL DE study cohorts was 2 to 2.5 days, compared to 5.0 days for the ExteNET trial [47]. - The proportion of patients discontinuing neratinib due to diarrhea was reduced to 3% in DE1 and 6% in DE2, compared to 17% in the ExteNET trial [47]. - The CONTROL trial is investigating the use of antidiarrheal prophylaxis or dose escalation to reduce neratinib-associated diarrhea [45]. Research and Development - The company has in-licensed alisertib, which has shown activity in various cancers and was tested in over 1,300 patients across 22 trials prior to licensing [23]. - The company aims to advance alisertib development in hormone receptor positive breast cancer and small cell lung cancer, focusing on biomarker-driven populations [24]. - Alisertib showed a response rate of 19% in chemotherapy-sensitive small cell lung cancer patients, with a duration of response of 3.1 months [78]. - In a randomized Phase II trial, alisertib plus fulvestrant had a response rate of 20.0% compared to 19.6% for alisertib alone [88]. - The Phase II trial for alisertib in extensive stage small cell lung cancer will enroll up to 60 patients, with a primary endpoint of objective response rate [84]. - Approximately 72% of small cell lung cancer patient samples had c-Myc amplifications, and 60-80% had RB1 mutations [83]. - Alisertib monotherapy in HER2-negative, hormone receptor positive breast cancer resulted in a response rate of 23% and a PFS of 7.9 months [86]. - The Phase II ALISCATM-Breast1 trial is actively enrolling patients to evaluate alisertib in combination with endocrine therapy for chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer [97]. Regulatory and Compliance - The company must comply with extensive regulatory requirements throughout the drug development process, including pre-clinical tests and clinical trials [162]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with Good Manufacturing Practices (cGMP) and Good Clinical Practices (GCP) [175]. - The FDA has a goal of 10 months to review and act on a standard NDA for a new molecular entity, typically taking 12 months from submission [173]. - The FDA may issue a Complete Response Letter indicating deficiencies in the NDA, which may require additional clinical data or trials [176]. - The FDA offers various expedited review programs, including fast track designation, breakthrough therapy designation, priority review, and accelerated approval, aimed at expediting the drug approval process for serious diseases [181]. - Orphan Drug Designation can provide exclusivity for seven years if the product receives the first FDA approval for the designated disease [179]. - In the U.S., the FDCA provides a five-year non-patent data exclusivity period for new chemical entities, preventing other companies from submitting ANDAs during this time [189]. - In the EU, new products receive eight years of data exclusivity and an additional two years of market exclusivity, with potential extensions for new therapeutic indications [203]. Financial and Business Strategy - The company reported net income for the years ended December 31, 2024, 2023, and 2022, but cannot assure continued profitability [13]. - The company faces risks related to its single product status and limited commercial sales experience, which may impact future revenue generation [13]. - The company intends to evaluate options for commercialization of drug candidates, including joint marketing partnerships and out-licensing [24]. - The company is focused on maximizing the value of its programs while maintaining flexibility in commercialization strategies [24]. - The company relies on third parties for the formulation and manufacturing of its drug candidates, which poses risks to development and commercialization efforts [13]. - The company does not have its own manufacturing facilities and relies on third-party contractors for the production of its drug candidates, including NERLYNX and alisertib [160]. - The company anticipates establishing relationships with third-party manufacturers for commercial production if alisertib or other drug candidates obtain marketing approval [161].

Exhibit 99.1 News Release Puma Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results LOS ANGELES, Calif., Feb. 27, 2025 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2024. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2024 compared to the fourth quarter and full year 2023. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Pum ...

Core Viewpoint - Puma Biotechnology, Inc. (PBYI) has experienced a significant stock rally of 24% over the past three months, contrasting with a 9.7% decline in the industry, primarily driven by improved sales of its sole marketed product, Nerlynx [1][9]. Financial Performance - PBYI updated its financial guidance for 2024, now expecting Nerlynx's product sales to be between $187 million and $190 million, an increase from the previous estimate of $183 million to $190 million [2]. - For the fourth quarter of 2024, PBYI anticipates Nerlynx product sales to be in the range of $46 million to $48 million [13]. - In the first nine months of 2024, Nerlynx generated sales of $140.8 million, with third-quarter sales exceeding management's expectations [19]. Product Development - The ALISCA-Breast1 study is currently investigating alisertib in combination with endocrine therapy for treating HR+, HER2-negative recurrent or metastatic breast cancer [4]. - If successful, alisertib could enhance PBYI's position in the anticancer drug market and reduce its reliance on Nerlynx for revenue [5]. - PBYI has in-licensed global development and commercialization rights for alisertib from Takeda and is focusing on its development for various cancer indications [10]. Market Position and Competition - PBYI remains heavily dependent on Nerlynx, as it is the only approved product in its portfolio [6][12]. - The breast cancer market presents significant commercial potential; however, Nerlynx faces intense competition from established treatments like Roche's Herceptin and Novartis' Tykerb, as well as other emerging therapies [22]. Future Outlook - The successful development of alisertib and the improving sales of Nerlynx are expected to contribute to continued upward momentum for PBYI stock in 2025 [16]. - PBYI plans to meet with the FDA regarding a potential approval pathway for alisertib based on the outcomes of the ALISCA-Breast1 study [11].

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

Core Insights - Puma Biotechnology has initiated the phase II ALISCA-Breast1 study to evaluate alisertib for treating metastatic breast cancer [1][2] - The study focuses on hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer patients previously treated with CDK 4/6 inhibitors [2] - Initial data from the study is expected in 2025, with plans for a pivotal phase III study following the determination of the optimal dose [3][4] Study Objectives and Design - The main objective of the ALISCA-Breast1 study is to determine the optimal dose of alisertib in combination with selected endocrine therapy [3] - Primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival [6] - The company will conduct an interim analysis to investigate the safety and efficacy of the study [7] Development and Market Potential - Puma Biotechnology in-licensed alisertib from Takeda in 2022, positioning it for potential use in various cancers [8] - Alisertib shows promise in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer, and small cell lung cancer [9] - Successful development of alisertib could enhance the company's standing in the anticancer drug market [9] Stock Performance - Year to date, Puma Biotechnology's shares have declined by 34.4%, compared to the industry's decline of 10.9% [5]