• Like a specialized Genentech focused on HER2-positive breast cancer.
• A smaller, targeted Amgen for oncology.

• Nerlynx (neratinib): An oral irreversible tyrosine kinase inhibitor used for the extended adjuvant treatment of early-stage HER2-positive breast cancer and for HER2-positive metastatic breast cancer.

Major Customers of Puma Biotechnology (PBYI)

• McKesson Corporation (NYSE: MCK)
• AmerisourceBergen Corporation (now Cencora, Inc. NYSE: COR)
• Cardinal Health, Inc. (NYSE: CAH)

• Dishman Carbogen Amcis Ltd. (Symbol: DISHMAN)
• Thermo Fisher Scientific (Symbol: TMO)

Alan H. Auerbach, Chief Executive Officer, President, and Chairman

Mr. Auerbach is the Founder of Puma Biotechnology, Inc. He has served as its Executive Chairman since October 2011 and as Chief Executive Officer, President, and Secretary since September 2010. Prior to founding Puma, he founded Cougar Biotechnology Inc. in May 2003, serving as its Chief Executive Officer, President, and a board member until its acquisition by Johnson & Johnson in July 2009 for approximately $1 billion. Before founding Cougar, Mr. Auerbach was a Vice President and Senior Research Analyst at Wells Fargo Securities, covering small and mid-capitalization biotechnology companies with a focus on oncology. He is also noted as a Private Equity Partner at Burrill Private Equity.

Maximo F. Nougues, Chief Financial Officer

Mr. Nougues joined Puma Biotechnology as Chief Financial Officer in November 2018. Before Puma, he worked at Getinge AB, a global medical device company, from January 2008 to October 2018, holding leadership positions including regional chief financial officer for North America and the Americas. Earlier in his career, Mr. Nougues held finance roles in Boston Scientific's cardiac surgery division (which was acquired by Getinge in 2008) and at The Clorox Company from 1998 to 2007.

Douglas Hunt, Chief Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Law Officer

Mr. Hunt has been Puma Biotechnology's Chief Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Law Officer since April 2024. Prior to this role, he served as Senior Vice President, Regulatory Affairs at Puma Biotechnology. His previous experience includes serving as Vice President Regulatory Affairs and Quality Assurance at ArmaGen Inc.

Heather J. Blaber, Senior Vice President, Marketing

Ms. Blaber is the Senior Vice President of Marketing at Puma Biotechnology.

Gordon Esplin, Chief Accounting Officer

Mr. Esplin serves as the Chief Accounting Officer for Puma Biotechnology.

The following are the key risks to Puma Biotechnology (PBYI):

1. Heavy Reliance on NERLYNX and Intense Market Competition: Puma Biotechnology's financial health is predominantly tied to the sales of its single commercial product, NERLYNX, for HER2-positive breast cancer. This creates a significant vulnerability as approximately 95.2% of its total revenue in Q3 2025 came from NERLYNX product sales. The market for HER2-positive breast cancer treatments is highly competitive, with numerous established therapies and newer, more potent antibody-drug conjugates (e.g., trastuzumab deruxtecan) posing a constant threat to NERLYNX's market share. This intense competition and the potential for declining new patient enrollments could limit future revenue growth. Furthermore, international royalty revenue, a component of overall revenue, experienced a sharp decline in Q3 2025, dropping from $24.4 million in Q3 2024 to $2.6 million in Q3 2025, primarily due to reduced product supply to international licensees.

2. Uncertainty and Development Risk of Pipeline Drug Alisertib: Puma Biotechnology's long-term growth strategy relies heavily on the successful development and commercialization of its pipeline drug, alisertib, an Aurora kinase A inhibitor. However, alisertib is in early-stage development, and its commercial viability remains unproven, contingent on positive data from ongoing Phase II ALISCA-Breast1 and ALISCA-Lung1 trials, with key interim data readouts anticipated in the first half of 2026. Alisertib has a "spotty development history," and concerns exist regarding its clinical viability due to previous clinical failures by Takeda. Failure of these ongoing clinical studies could lead to significant delays, increased expenditures, or even the cessation of further development, jeopardizing a crucial future revenue stream for the company.

3. Legal and Regulatory Challenges, particularly Patent Invalidity: Puma Biotechnology is exposed to legal and regulatory risks that could impact its commercial prospects. A significant development occurred in August 2024 when a federal court ruled that some of Puma's patents ('314 and '162), which are exclusively licensed to Puma and cover aspects of NERLYNX, were invalid in a dispute with AstraZeneca. The court found these patents invalid due to a lack of enablement and written description for a specific claim limitation. While Puma retains contractual rights to monetary damages from the AstraZeneca litigation, this partial loss of patent validity could expose the company to increased competition and limit its ability to protect its intellectual property for NERLYNX. Additionally, the company faces ongoing risks related to obtaining and maintaining orphan drug designations and navigating extensive and evolving regulatory requirements in the United States and internationally for all its drug candidates.

The continued and expanding market penetration and demonstrated superior efficacy of Enhertu (trastuzumab deruxtecan) in HER2-positive breast cancer. Enhertu, a next-generation antibody-drug conjugate from Daiichi Sankyo and AstraZeneca, has shown superior clinical outcomes in multiple trials, including direct comparisons with existing treatments. Its strong clinical profile across various lines of therapy in metastatic HER2-positive breast cancer and its ongoing development into earlier treatment settings are actively reshaping the standard of care for patients, thereby posing a direct and significant threat to the market share and utility of other HER2-targeted therapies, including Puma Biotechnology's lead product, NERLYNX (neratinib).

Puma Biotechnology's main product is NERLYNX (neratinib), an oral medication used to treat HER2-positive breast cancer. The global addressable market for neratinib was valued at approximately USD 1.3 billion in 2023 and is projected to grow to USD 3.8 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 12.7% during this forecast period.

North America currently holds the largest share of the neratinib market, with Europe also representing a significant portion. The Asia Pacific region is anticipated to experience the fastest growth in this market.

Puma Biotechnology (PBYI) is expected to drive future revenue growth over the next two to three years through several key initiatives and market dynamics:

1. Increased U.S. Demand and Sales Volume for NERLYNX: The company anticipates 2025 to be the first year since 2018 to see a year-over-year increase in demand for NERLYNX in the United States. This is supported by an 8% increase in NERLYNX bottle sales volume in the U.S. market in Q3 2025, alongside a higher net selling price. Management commentary indicates stronger growth in the specialty pharmacy (SD) channel due to increased sales in group purchasing organizations and 340B purchasing.
2. Strategic Commercial Efforts and Pricing Power for NERLYNX: Puma Biotechnology is focusing on enhancing its commercial execution in the U.S. market. This includes efforts to increase healthcare provider reach and engagement, prioritize NERLYNX for patients at higher risk of recurrence, and improve clinical education through promotional activities and patient support. The company has also demonstrated strong pricing power, indicated by a favorable gross-to-net adjustment.
3. Expansion of NERLYNX into New International Markets: Puma is actively pursuing partnerships to expand the global reach of NERLYNX. A recent collaboration with Er-Kim aims to distribute NERLYNX in ten countries across Europe, the Middle East, and Africa (EMEA), which is expected to support global revenue growth.
4. Advancement and Potential Approval of Alisertib in New Indications: The company is investing in its clinical pipeline, particularly with alisertib, an anti-cancer drug. Puma is conducting Phase II trials for alisertib as a monotherapy for extensive-stage small cell lung cancer (ALISCA-Lung1) and in breast cancer (ALISCA-Breast1). Interim data from the ALISCA-Lung1 study is anticipated in the first half of 2026. Successful outcomes and subsequent regulatory approvals for these new indications would open significant new market opportunities.
5. Enhanced Financial Flexibility from Becoming Debt-Free: While not a direct revenue driver, Puma Biotechnology anticipates becoming debt-free by mid-2026. This improved financial position is expected to enhance cash flow generation, which can then be strategically reinvested into research and development, supporting future clinical trials for pipeline products like alisertib, and further commercialization efforts for NERLYNX, thereby indirectly fueling future revenue growth.

Share Repurchases

• Puma Biotechnology did not report any share repurchases from 2020 to 2024.

Share Issuance

• The number of common shares outstanding for Puma Biotechnology increased from 39.88 million at the end of 2020 to 49.09 million at the end of 2024.
• As of November 3, 2025, the company had 50,391,107 shares of common stock outstanding.
• Historically, public offerings of common stock and sales of common stock in private placements have been sources of working capital for Puma Biotechnology.

Inbound Investments

• In September 2022, Puma Biotechnology entered into an exclusive license agreement for the global development and commercialization of the anti-cancer drug alisertib.
• This licensing deal included an upfront payment of $7.0 million, which was recognized as an in-process research and development expense in 2022.

Outbound Investments

• Puma Biotechnology reported no cash acquisitions of other companies from 2020 to 2024.

Capital Expenditures

• Capital expenditures were $0.0 million for the years 2020, 2021, and 2022.
• Capital expenditures were $0.1 million for both 2023 and 2024.