Key Takeaways IRWD's growth is driven by its U.S. Linzess partnership with ABBV, which posted robust Q3 resultsStronger Linzess demand led IRWD to lift its 2025 revenue outlook following a solid Q3 performance.PBYI's Nerlynx posted $144.2M sales in the first nine months of 2025, up 2.5% year over year.Both Ironwood Pharmaceuticals (IRWD) and Puma Biotechnology (PBYI) are small biotechs, concentrating on the successful commercialization of their respective products with the goal of establishing leadership in ...

Perhaps against better judgment, I have continued to find optimism in the investment thesis of Puma Biotechnology ( PBYI ), having written multiple articles with Buy sentiments on the back ofI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this spac ...

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Key Takeaways Puma Biotechnology posted Q3 adjusted EPS of $0.21, which topped estimates but fell from last year's $0.45.Q3 revenues of $54.5 million beat expectations but declined 32.3% year over year on weaker royalty income.PBYI raised 2025 revenue guidance to $220-$223 million, while increasing Nerlynx product sales outlook.Puma Biotechnology (PBYI) reported third-quarter 2025 adjusted earnings of 21 cents per share, which beat the Zacks Consensus Estimate of 9 cents. In the year-ago quarter, the compan ...

Puma Biotech (PBYI) came out with quarterly earnings of $0.21 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.45 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +133.33%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.11 per share when it actually produced earnings of $0.15, delivering a surprise of +36.36%.Over the last four quar ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $54.5 million, with product revenue net at $51.9 million, an increase from $49.2 million in Q2 2025 but a decrease from $56.1 million in Q3 2024 [5][27] - Net income based on GAAP for Q3 2025 was $8.8 million, or $0.18 per basic share, compared to $5.9 million, or $0.12 per share in Q2 2025 [26] - Non-GAAP net income for Q3 2025 was $10.5 million, or $0.21 per share, reflecting an increase from the previous quarter [27] Business Line Data and Key Metrics Changes - Product revenue was impacted by approximately $3.1 million of inventory billed at specialty pharmacies and distributors [6] - Royalty revenue decreased to $2.6 million in Q3 2025 from $3.2 million in Q2 2025 and $24.4 million in Q3 2024 [6][29] - Nerlynx sales included U.S. net sales of $51.8 million in Q3 2025, up from $48.8 million in Q3 2024 [21][28] Market Data and Key Metrics Changes - New prescriptions for Nerlynx were down approximately 3% compared to Q2 2025, while total prescriptions decreased by about 1% [6] - Demand for Nerlynx increased by about 3% quarter-over-quarter and year-over-year, with stronger growth in the specialty distributor channel [23] Company Strategy and Development Direction - The company is focused on expanding its market presence for Nerlynx, particularly among patients at higher risk of recurrence [18] - Puma is evaluating several drugs for potential licensing or acquisition to diversify its portfolio [14] - The company aims to maintain positive net income while managing expenses effectively [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving year-over-year demand growth for Nerlynx in the U.S. for the first time since 2018 [37] - The company anticipates net income for the full year 2025 to be in the range of $27 million to $29 million, reflecting ongoing financial discipline [31] Other Important Information - The company reported cash burn of approximately $1.6 million in Q3 2025, with total outstanding principal debt reduced to approximately $33 million [34] - Anticipated net product revenue for Q4 2025 is projected to be between $54 million and $56 million [32] Q&A Session Summary Question: What is the evaluation bar for the breast cancer interim? - Management indicated that the previous trial, TBCRC41, will serve as a comparison for evaluating alisertib in combination with endocrine therapy [40][41] Question: Would the company consider going negative with data if it supports a pivotal program? - Management noted that while they aim to remain profitable, they are open to staggering indications to control expenses while pursuing pivotal trials [42][45]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $54.5 million, with product revenue net at $51.9 million, an increase from $49.2 million in Q2 2025 but a decrease from $56.1 million in Q3 2024 [5][20][27] - Net income based on GAAP for Q3 2025 was $8.8 million, or $0.18 per basic share, compared to $5.9 million, or $0.12 per share in Q2 2025 [25] - Non-GAAP net income for Q3 2025 was $10.5 million, or $0.21 per share, reflecting an increase from the previous quarter [26] - Gross-to-net adjustment in Q3 2025 was approximately 25.9%, up from 20.8% in Q2 2025, primarily due to higher Medicare rebates [27] Business Line Data and Key Metrics Changes - Product revenue from Nerlynx sales was $51.9 million in Q3 2025, up from $49.2 million in Q2 2025 but down from $56.1 million in Q3 2024 [5][20] - Royalty revenue decreased to $2.6 million in Q3 2025 from $3.2 million in Q2 2025 and $24.4 million in Q3 2024 [6][27] - Total prescriptions for Nerlynx declined approximately 1% compared to Q2 2025 and 4% year over year [22] Market Data and Key Metrics Changes - U.S. net sales of Nerlynx in Q3 2025 were $51.8 million, compared to $48.8 million in Q3 2024 [27] - The specialty pharmacy channel accounted for about 65% of the business, while the specialty distributor channel made up 35% in Q3 2025 [19] Company Strategy and Development Direction - The company is focused on expanding its market presence for Nerlynx and enhancing clinical education through marketing initiatives [15][16] - Ongoing clinical trials for alisertib are being prioritized, with a focus on identifying biomarkers that may predict better outcomes [10][11] - The company is evaluating potential acquisitions to diversify its portfolio and leverage existing infrastructure [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive net income for the full year 2025, driven by disciplined financial management [34][35] - The company anticipates a demand increase for Nerlynx in the U.S. for the first time since 2018 [34] - Future guidance includes expectations for net product revenue in Q4 2025 to be between $54 million and $56 million [30] Other Important Information - The company reported cash burn of approximately $1.6 million in Q3 2025, with total outstanding principal debt decreasing to about $33 million [32] - Anticipated R&D expenses are expected to increase by 20-25% year over year due to faster enrollment in clinical trials [32] Q&A Session Summary Question: What is the evaluation bar for alisertib in combination with endocrine therapy? - Management indicated that the previous trial TBCRC41 will serve as a comparison for efficacy, focusing on the third-line treatment space for HER2-negative breast cancer [38][39] Question: Would the company consider going negative with data if it supports a pivotal program? - Management noted that while they aim to remain profitable, they are open to staggered spending on indications to control cash burn [40][41] Question: Will a pivotal phase three trial require a partner? - Management stated that they do not anticipate a large trial and believe it can be managed within their financial framework, especially as debt is paid down [42][43]

Financial Performance - Total revenue for Q3 2025 was $54.475 million, a decrease of 32.3% compared to $80.542 million in Q3 2024[15] - Product revenue for Q3 2025 was $51.902 million, down from $56.136 million in Q3 2024, representing a decline of 7.3%[15] - Net income for Q3 2025 was $8.844 million, a decrease of 56.5% compared to $20.317 million in Q3 2024[15] - Net income for the nine months ended September 30, 2025, was approximately $17.7 million, compared to $10.973 million for the same period in 2024, representing a 61.9% increase[31] - Total revenue for the nine months ended September 30, 2025 was approximately $152.9 million, a decrease of $18.5 million (10.8%) from $171.4 million in the same period of 2024[206] - Product revenue, net for the nine months ended September 30, 2025 was approximately $144.2 million, an increase of $3.4 million (2.4%) from $140.8 million in the same period of 2024, due to a 3% increase in domestic sales[207] - Royalty revenue for Q3 2025 was approximately $2.6 million, a significant decrease of $21.8 million (89.4%) from $24.4 million in Q3 2024, mainly due to timing of sales in China[196] - Royalty revenue decreased to approximately $8.7 million for the nine months ended September 30, 2025, down from $30.6 million in the same period of 2024, primarily due to reduced sales to international licensees, particularly in China[208] Assets and Liabilities - Total current assets decreased to $143.580 million as of September 30, 2025, from $147.658 million at December 31, 2024, a decline of 2.3%[13] - Total liabilities decreased to $87.594 million as of September 30, 2025, down from $121.208 million at December 31, 2024, a reduction of 27.7%[13] - Stockholders' equity increased to $115.268 million as of September 30, 2025, compared to $92.125 million at December 31, 2024, an increase of 25.1%[13] - Cash and cash equivalents decreased to $53.525 million as of September 30, 2025, from $69.219 million at December 31, 2024, a decline of 22.7%[13] - The company had a total accumulated deficit of $1,297.213 million as of September 30, 2025, compared to $1,314.886 million at December 31, 2024, a reduction of 1.3%[13] - Total accounts receivable, net increased to $33.565 million as of September 30, 2025, compared to $32.011 million as of December 31, 2024[113] Research and Development - Research and development expenses for Q3 2025 were $15.912 million, up 26.4% from $12.547 million in Q3 2024[15] - R&D expenses for Q3 2025 increased to approximately $15.9 million, up $3.4 million (27.1%) from $12.6 million in Q3 2024, driven by increased clinical trial activity for alisertib[199] - The company has invested significantly in the development and commercialization of its lead product, NERLYNX, which is expected to constitute the majority of product revenue for the foreseeable future[94] - The company initiated the ALISCA™-Lung1 Phase II trial for alisertib in February 2024 and the ALISCA™-Breast1 Phase II trial in November 2024[179] Commercialization and Licensing - The company is commercializing NERLYNX® for HER2-positive breast cancer and has in-licensed alisertib for potential treatment of various cancer types[24] - The company entered into an exclusive license agreement with Takeda for alisertib, with an upfront fee of $7 million and potential future milestone payments of up to $287.3 million[30] - The company plans to continue pursuing commercialization of NERLYNX in regions outside the United States, pending regulatory approvals[29] - The company recognizes revenue from product sales when the specialty pharmacy or specialty distributor obtains control of the product, which occurs upon delivery[49] - The company recognizes license revenue when the license term commences and the licensed data, technology, or product is delivered[62] Operating Expenses - Total operating costs and expenses for the nine months ended September 30, 2025, were $132.7 million, a decrease of 13.7% from $153.8 million in 2024[39] - Selling, general and administrative (SG&A) expenses were approximately $52.5 million for the nine months ended September 30, 2025, compared to $63.5 million in 2024, reflecting a decrease of 17.4%[210] - Professional fees and expenses saw a significant decrease of 44.9%, dropping from $25.1 million in 2024 to $13.9 million in 2025[211] - Stock-based compensation decreased by 24.3%, from $4.3 million in 2024 to $3.3 million in 2025[211] Legal and Regulatory Matters - The Company is involved in ongoing legal proceedings related to patent infringement and legal malpractice, impacting its financial and operational strategies[156][157] - The Company filed a civil lawsuit against Acebright for infringement of the '789 patent, seeking a judgment to enjoin Acebright's offer for sale of a generic version of NERLYNX[161] - The Company has appealed CNIPA's decisions regarding Acebright's ANDA, which lifted the stay on Acebright's application to market a generic version of NERLYNX[160] Stock and Compensation - The Company issued 55,882 and 64,118 shares of common stock upon exercise of stock options during the nine months ended September 30, 2025 and 2024, respectively[137] - The total stock-based compensation expense for the nine months ended September 30, 2025 was $5.327 million, compared to $6.493 million for the same period in 2024[144] - As of September 30, 2025, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $3.8 million, expected to be recognized over a weighted-average period of 1.3 years[147]

Puma Biotechnology Earnings Call Commercial Update Puma's Pharmacy and Distributor Network Copyright 2025 Puma Biotechnology 3 November 6, 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 res ...

Exhibit 99.1 Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA™-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2026) and (ii) presentation of additional interim data from the ALI-4201/ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with exten ...