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 - The company reported adjusted earnings per share of $2.46, which is $0.10 above the guidance midpoint [7][45] - Total net revenues exceeded $13.3 billion, reflecting robust growth of 9.8% on an operational basis, excluding a 1.4% unfavorable impact from foreign exchange [7][45] - The adjusted operating margin ratio was 42.3% of sales, including a 1.9% unfavorable impact from acquired IPR&D expense [46] Business Line Data and Key Metrics Changes - Immunology revenues were over $6.2 billion, with Skyrizi and Rinvoq contributing $5.1 billion in combined sales, reflecting growth of more than 65% [14][20] - Oncology revenues reached $1.6 billion, with Imbruvica global sales at $738 million (down 11.9%) and Venclexta global revenues at $665 million (up 12.3%) [20][21] - Aesthetics delivered global sales of $1.1 billion, down 10.2% on an operational basis, with BOTOX Cosmetic revenues at $556 million (down 10.7%) and Juvederm sales at $231 million (down 20%) [23][24] - Neuroscience revenues were approximately $2.3 billion, up 17% on an operational basis, with VRAYLAR global sales at $765 million (up 10.3%) [26][27] Market Data and Key Metrics Changes - The company anticipates total net revenues of approximately $59.7 billion for the year, an increase of $700 million from previous estimates [47] - Skyrizi global revenues are now expected to be $16.5 billion, an increase of $600 million, while Rinvoq global sales are projected at $8.2 billion, an increase of $300 million [48] - US Humira revenues are expected to decrease to $3.5 billion, reflecting higher erosion from biosimilar competition [49] Company Strategy and Development Direction - The company plans to invest over $10 billion in the US over the next decade to support volume growth and expansion into new areas such as obesity [10][54] - The company is focusing on advancing its internal pipeline and pursuing strategic acquisitions to drive growth, including the acquisition of Nimble Therapeutics [11][12] - The company aims for a high single-digit revenue CAGR through 2029, indicating a clear runway for growth [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance across therapeutic areas and raised full-year adjusted EPS guidance by $0.10 [9][45] - The company is preparing for potential impacts from sectoral tariffs but believes any related impact would be in line with peers due to its extensive US manufacturing presence [10][53] - Management highlighted the importance of a balanced approach to drug pricing and innovation, emphasizing the need for policies that support the biopharmaceutical industry [91][92] Other Important Information - The company is making significant progress in its pipeline, with several important data readouts and regulatory submissions expected throughout 2025 [44] - The company is also exploring the potential of its amylin analog for obesity treatment, with positive interim results from ongoing studies [42][43] Q&A Session Questions and Answers Question: Can you elaborate on the indications most attributable to the upside for Skyrizi and Rinvoq? - The company raised Skyrizi guidance by $600 million, with $200 million attributed to psoriasis and $400 million to IBD indications. Rinvoq was raised by $300 million across all approved indications [60][61] Question: How is the company thinking about the tail for Humira in light of erosion? - Management noted faster erosion from biosimilars and expects the Humira tail to step down further, with deeper visibility anticipated over the year [66] Question: Can you elaborate on potential mitigation strategies regarding tariffs? - The company plans to manage inventory, secure alternate sources of API, and look for cost efficiencies as potential mitigation strategies [75][76] Question: What are the expectations for the amylin program regarding dosing and efficacy? - The company is exploring higher doses in ongoing studies and anticipates larger sample sizes in future phases, with a focus on tolerability and weight loss efficacy [83][84] Question: How does the company view its manufacturing footprint in relation to US investments? - The company maintains a robust US manufacturing network and plans to invest over $10 billion to expand its production capabilities, ensuring supply assurance [123][126]