Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was reported at $46 million, with product revenue net at $43.1 million, a decline from $54.4 million in Q4 2024 but an increase from $40.3 million in Q1 2024 [6][21] - Royalty revenue was $2.9 million in Q1 2025, down from $4.7 million in Q4 2024 and $3.5 million in Q1 2024 [7][36] - Net income based on GAAP for Q1 2025 was $3 million or $0.06 per share, compared to $19.3 million or $0.39 per share in Q4 2024 [34][35] Business Line Data and Key Metrics Changes - NERLYNX sales saw a decrease in bottle sales to 2,338 in Q1 2025, down from 2,964 in Q4 2024, with a 6% increase in new prescriptions compared to the previous quarter [8][22] - Demand for NERLYNX declined by 6% quarter over quarter but increased by 2% year over year [25] - The distribution model showed 67% of business through the specialty pharmacy channel and 33% through the specialty distributor channel [20] Market Data and Key Metrics Changes - Enrollment for NERLYNX increased by 6% quarter over quarter but declined by 8% year over year [24] - Total prescriptions decreased by 9% quarter over quarter and 3% year over year [24] - Stronger growth was noted in the specialty distributor channel, driven by increased sales in the GPO segment and 340B purchasing [20] Company Strategy and Development Direction - The company is focused on expanding NERLYNX utilization, particularly among patients at increased risk of recurrence, and has revised marketing strategies accordingly [18][26] - Puma is evaluating several drugs for potential in-licensing or acquisition to diversify its portfolio [17] - The company aims to maintain positive net income and is committed to financial discipline and expense management [43] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of seasonal inventory changes and higher gross to net expenses on revenue [21][36] - The company anticipates net NERLYNX product revenue for fiscal year 2025 to be in the range of $192 million to $198 million [38] - Management expressed optimism regarding the ongoing clinical trials and the potential for new data to be presented in the future [12][16] Other Important Information - The company reported cash burn of approximately $7.8 million in Q1 2025, compared to $4.3 million in Q4 2024 [41] - As of March 31, 2025, the company had approximately $93 million in cash, cash equivalents, and marketable securities [42] - The company is in the process of amending the protocol for the ELYSCA lung study to increase the dose of alisertib [16] Q&A Session Summary Question: Inquiry about Alosertib IP and Manufacturing - Management confirmed that the IP for Alosertib is licensed from Takeda, and manufacturing is primarily done in the U.S. [48][50] Question: Questions on ELYSCA lung cancer trial and NERLYNX Phase one data - Management stated that the protocol amendment for the lung cancer trial is underway, and they expect interim data later this year [58][60] - They noted better activity in certain tumor types with the combination of neratinib and ADCs, but more data is needed for specific expectations [61] Question: Impact of Medicare Part D redesign - Management indicated that co-pays for patients have declined, making NERLYNX more affordable and increasing the percentage of business going through Medicare [64]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was reported at $46 million, with product revenue net at $43.1 million, a decline from $54.4 million in Q4 2024 but an increase from $40.3 million in Q1 2024 [5][20][34] - Net income based on GAAP for Q1 2025 was $3 million or $0.06 per share, compared to $19.3 million or $0.39 per share in Q4 2024, which included a non-cash deferred income tax benefit [32][33] - Non-GAAP net income for Q1 2025 was $5 million or $0.10 per share [33] Business Line Data and Key Metrics Changes - NERLYNX sales in Q1 2025 were $43.1 million, down from $54.4 million in Q4 2024, with a significant impact from inventory changes [20][34] - The number of NERLYNX bottles sold in Q1 2025 was 2,338, a decrease of approximately 21% quarter over quarter [20][21] - Royalty revenue was $2.9 million in Q1 2025, down from $4.7 million in Q4 2024 [34] Market Data and Key Metrics Changes - In Q1 2025, new prescriptions (NRx) increased by approximately 6% compared to Q4 2024, while total prescriptions (TRx) decreased by approximately 9% [22][23] - Demand for NERLYNX declined by about 6% quarter over quarter but increased by about 2% year over year [24] Company Strategy and Development Direction - The company is focused on expanding the utilization of NERLYNX, particularly among patients at increased risk of recurrence, and has revised marketing strategies accordingly [17][25] - Puma is evaluating several drugs for potential in-licensing or acquisition to diversify its portfolio [16] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining positive net income and fiscal responsibility, attributing recent financial performance to expense reductions and financial discipline [40] - The company anticipates net NERLYNX product revenue for fiscal year 2025 to be in the range of $192 million to $198 million [35] Other Important Information - The company reported cash burn of approximately $7.8 million in Q1 2025, compared to $4.3 million in Q4 2024 [38] - As of March 31, 2025, the company had approximately $93 million in cash, cash equivalents, and marketable securities [39] Q&A Session Summary Question: Inquiry about Alosertib IP and manufacturing - Management confirmed that the IP for Alosertib is licensed from Takeda, and manufacturing is primarily done in the U.S. [43][44][46] Question: Questions regarding ELYSCA lung cancer trial and NERLYNX Phase one data - Management stated that the protocol amendment for the ELYSCA lung cancer trial is to increase the dose, and they expect interim data later this year [52][53] - For NERLYNX, better activity was observed in certain tumor types, and further data is anticipated [56][57][58] Question: Impact of Medicare Part D redesign - Management noted that co-pays for patients have declined, making NERLYNX more affordable and increasing the percentage of business through Medicare [60]

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 March 31, 2025 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 or othe ...

Financial Performance - Product revenue for Q1 2025 was $43.1 million, a 6.9% increase from $40.3 million in Q1 2024[3] - Net income for Q1 2025 was $3.0 million, compared to a net loss of $4.8 million in Q1 2024, marking a significant turnaround[4] - Non-GAAP adjusted net income for Q1 2025 was $5.0 million, compared to a non-GAAP adjusted net loss of $2.4 million in Q1 2024[5] - Total revenue for Q1 2025 was $46.0 million, compared to $43.8 million in Q1 2024, reflecting a 5.0% increase[8] - Basic and diluted net income per share for Q1 2025 was $0.06, compared to a loss of $0.10 per share in Q1 2024[29] - Non-GAAP adjusted basic net income per share for Q1 2025 was $0.10, compared to a loss of $0.05 per share in Q1 2024[34] Operating Costs - Total operating costs and expenses decreased to $42.0 million in Q1 2025 from $46.1 million in Q1 2024, a reduction of 8.9%[9] - Selling, general and administrative expenses decreased by $4.2 million to $17.6 million in Q1 2025, primarily due to lower professional fees[11] - Research and development expenses slightly increased to $13.8 million in Q1 2025 from $13.6 million in Q1 2024[13] - Stock-based compensation represented approximately 6.4% of operating expenses in Q1 2025, slightly down from 6.7% in Q1 2024[32] Cash and Liquidity - Cash, cash equivalents, and marketable securities totaled $93.2 million as of March 31, 2025, down from $101.0 million at the end of 2024[6] - Cash and cash equivalents as of March 31, 2025, were $63.0 million, down from $69.2 million as of December 31, 2024[31] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $6.2 million for the three months ended March 31, 2025[31] Future Outlook - The company anticipates net product revenue for Q2 2025 to be between $48 million and $50 million, and for the full year 2025 to be between $192 million and $198 million[15] - Key upcoming milestones include interim data presentations from ongoing clinical trials in H2 2025[7]

Puma Biotech (PBYI) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Individ ...

Core Insights - Er-Kim has signed an agreement with Puma Biotechnology to commercialize NERLYNX in select Eastern European and Central Asian countries [1][2] - NERLYNX is a treatment for HER2-positive breast cancer, approved for both early-stage and metastatic cases [3][7] - Breast cancer is the most common cancer among women globally, with 2.3 million new cases and 670,000 deaths reported in 2022 [4] Company Overview - Er-Kim, established in 1981, partners with over 40 global leaders and has revenues exceeding EUR 260 million, reaching over 600 million patients [6] - Puma Biotechnology focuses on developing innovative cancer care products and has successfully commercialized NERLYNX since its FDA approval in 2017 [7] Market Context - The agreement aims to improve access to NERLYNX in Russia and the Commonwealth of Independent States, addressing the disparity in treatment availability for breast cancer [5] - The burden of breast cancer varies significantly across different regions, highlighting the need for targeted treatment solutions [4][5]

Investors in Puma Biotechnology, Inc. (PBYI) need to pay close attention to the stock based on moves in the options market lately. That is because the Jun 20, 2025 $5 Put had some of the highest implied volatility of all equity options today. What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could ...

Puma SE ( OTCPK:PUMSY ) ( OTCPK:PMMAF ) has a lot of tailwinds ahead as the company has large growth plans in the US market, and will benefit from their recent endorsements. Though their financial performance has been looking Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seekin ...

Puma SE ( PUMSY ) has gone down almost 50% this year. They have struggled with their profitability the past couple of years and investors has sent the company rocketing down. At the bright side, Puma is still growing its topline andHi, my name is Sander Pettersen Heio, I am from Norway. My primary focus is on foreign stocks, particularly within the Nordic market, where I analyze companies across various industries, from stable blue-chip firms to emerging market leaders. In addition to Nordic equities, I wri ...

Core Insights - The article emphasizes the importance of value investing and highlights Puma Biotechnology (PBYI) as a strong value stock opportunity [2][3][7] Company Metrics - Puma Biotechnology (PBYI) has a Zacks Rank of 2 (Buy) and a Value grade of A, indicating it is among the best value stocks currently available [3] - PBYI's PEG ratio is 1.38, significantly lower than the industry average of 3.07, suggesting it may be undervalued [4] - The company's P/B ratio stands at 2.06, compared to the industry average of 3.29, indicating a solid valuation relative to its book value [5] - PBYI's P/CF ratio is 4.22, which is attractive when compared to the industry's average of 13.37, further supporting the notion of undervaluation [6] Investment Outlook - The combination of PBYI's favorable metrics and strong earnings outlook positions it as a compelling value stock at this time [7]