Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $52.3 million, with product revenue net at $49.2 million, an increase from $43.1 million in Q1 2025 and $44.4 million in Q2 2024 [5][19][26] - Net income based on GAAP for Q2 2025 was $5.9 million or $0.12 per share, compared to $3 million or $0.06 per share in Q1 2025 [25][26] - Non-GAAP net income for Q2 2025 was $7.5 million or $0.15 per share, reflecting an increase from Q1 2025 [26][27] - Cash burn for Q2 2025 was approximately $2.9 million, a decrease from $7.8 million in Q1 2025 [32] Business Line Data and Key Metrics Changes - NERLYNX sales in Q2 2025 were $49.2 million, up from $43.1 million in Q1 2025, driven by an increase in bottles sold [19][26] - Total prescriptions (TRx) increased by 3% quarter over quarter but declined by 2% year over year [21] - New prescriptions (NRx) decreased by approximately 3% quarter over quarter and 1% year over year [21] Market Data and Key Metrics Changes - The specialty pharmacy channel accounted for 63% of the business, while the specialty distributor channel accounted for 37% in Q2 2025 [18] - Demand in the specialty distributor channel grew by 8% quarter over quarter and 17% year over year [22] Company Strategy and Development Direction - The company is focused on increasing awareness of NERLYNX and its clinical benefits for HER2 positive early breast cancer patients [13][15] - Future clinical development of alasertib will focus on patients with specific biomarkers in breast and lung cancers [9][10] - The company is evaluating potential in-licensing or acquisition of additional drugs to diversify its portfolio [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining positive net income and emphasized fiscal responsibility to shareholders [34] - The company anticipates net NERLYNX product revenue for the full year 2025 to be between $192 million and $198 million [28] - Management acknowledged the significant unmet medical need in oncology and the commitment to finding effective treatments [35] Other Important Information - The company expects to have interim data from ongoing clinical trials later in 2025 [10][12] - The gross to net adjustment for Q2 2025 was 20.8%, unchanged from Q1 2025 [27] Q&A Session Summary Question: What is the venue for upcoming data disclosures? - Management indicated that disclosures would likely be presented as corporate updates, possibly around November [36][37] Question: What are the criteria for advancing clinical trials? - The company highlighted the need for progression-free survival (PFS) and overall survival (OS) benefits to justify further advancement in trials [40][41] Question: How will meeting or falling short of clinical trial bars impact strategic views? - Management stated that they would be selective in pursuing additional products and would not want to jeopardize profitability [43][44]

Financial Performance - Puma Biotechnology reported net NERLYNX revenue of $49.2 million in Q2'25, an increase of approximately 11% compared to $44.4 million in Q2'24[6, 7, 9] - The company also saw an increase of about 14% in net revenue from Q1'25 ($43.1 million) to Q2'25 ($49.2 million)[9, 10] - Inventory change improved from -$2.3 million in Q2'24 to -$1.3 million in Q2'25[8] - Inventory change improved from -$4.7 million in Q1'25 to -$1.3 million in Q2'25[11] Sales Volume - Puma Biotechnology sold 2,608 ex-factory bottles of NERLYNX in Q2'25[12] - This represents an approximate 4% increase compared to the 2,515 bottles sold in Q2'24[16] - There was also an approximate 12% increase in bottles sold from Q1'25 (2,338 bottles) to Q2'25 (2,608 bottles)[14, 16] - Inventory change in bottles improved from -132 in Q2'24 to -72 in Q2'25[13] - Inventory change in bottles improved from -250 in Q1'25 to -72 in Q2'25[15] Dosage Trends - Approximately 71% of patients in Q2'25 started NERLYNX at a reduced dose (fewer than 6 pills per day)[17] Global Expansion - NERLYNX has received regulatory approvals and been commercially launched in various regions through partnerships, including Australia/SE Asia, Israel, Canada, Latin America, Europe, Greater China, Middle East, North and West Africa, South Africa, Turkey, and South Korea[22]

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]

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]