Puma Biotechnology(PBYI) - 2025 Q2 - Quarterly Results

Executive Summary Puma Biotechnology reported significant financial improvements for Q2 2025, transitioning from a net loss to net income on both GAAP and non-GAAP bases, driven by increased NERLYNX® sales and improved operating cash flow and positive clinical development updates Second Quarter 2025 Financial Highlights Puma Biotechnology reported significant financial improvements for Q2 2025, transitioning from a net loss to net income on both GAAP and non-GAAP bases, driven by increased NERLYNX® sales and improved operating cash flow Q2 2025 Financial Highlights | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------------- | :------ | :------ | :----------- | | Product Revenue, Net | $49.2M | $44.4M | +$4.8M | | GAAP Net Income (Loss) | $5.9M | ($4.5M) | +$10.4M | | GAAP EPS (Basic & Diluted) | $0.12 | ($0.09) | +$0.21 | | Non-GAAP Adjusted Net Income (Loss) | $7.5M | ($2.5M) | +$10.0M | | Non-GAAP Adjusted EPS (Basic & Diluted) | $0.15 | ($0.05) | +$0.20 | | Net Cash Provided by Operating Activities | $14.1M | $1.0M | +$13.1M | - Product revenue, net, for the first six months of 2025 increased to $92.3 million, up from $84.6 million in the first six months of 2024[3] - Net income for the first six months of 2025 was $8.8 million ($0.18 per share), a significant improvement from a net loss of $9.3 million ($0.19 per share) in the prior year period[4] CEO Commentary & Business Update The CEO expressed satisfaction with revenue growth and positive net income, attributing growth to NERLYNX® demand and progress in alisertib's clinical development for breast and small cell lung cancer. Key clinical milestones are anticipated in Q4 2025 - Revenue growth in Q2 2025 and positive net income were driven by increased NERLYNX® demand[7] - Progress is being made in the clinical development of alisertib for chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer[7] - Anticipated key milestones in the next 12 months include interim data presentations for ALISCA™-Breast1 (Q4 2025) and ALI-4201/ALISCA™-Lung1 (Q4 2025)[7] Financial Performance Analysis Puma Biotechnology's Q2 2025 financial performance shows increased total revenue and a shift to net income, driven by NERLYNX® sales and reduced operating expenses, despite higher R&D investments Revenue Total revenue for Q2 2025 increased by 11.3% year-over-year, primarily driven by higher net product revenue from NERLYNX® sales, complemented by a rise in royalty revenue Q2 Revenue (Millions) | Revenue Type | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :---------------- | :----------------- | :----------------- | :----------- | | Product revenue, net | $49.2 | $44.4 | +$4.8 | | Royalty revenue | $3.2 | $2.7 | +$0.5 | | Total revenue | $52.4 | $47.1 | +$5.3 | H1 Revenue (Millions) | Revenue Type | H1 2025 (Millions) | H1 2024 (Millions) | Change (YoY) | | :---------------- | :----------------- | :----------------- | :----------- | | Product revenue, net | $92.3 | $84.6 | +$7.7 | | Royalty revenue | $6.1 | $6.2 | -$0.1 | | Total revenue | $98.4 | $90.8 | +$7.6 | Operating Costs and Expenses Total operating costs and expenses decreased in Q2 2025 and the first six months of 2025, primarily due to a significant reduction in selling, general and administrative expenses, despite increases in cost of sales and research and development Q2 Operating Costs and Expenses (Millions) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Total operating costs and expenses | $45.8 | $49.3 | -$3.5 | | Cost of sales | $12.3 | $10.7 | +$1.6 | | Selling, general and administrative | $18.0 | $25.0 | -$7.0 | | Research and development | $15.5 | $13.6 | +$1.9 | H1 Operating Costs and Expenses (Millions) | Metric | H1 2025 (Millions) | H1 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Total operating costs and expenses | $87.8 | $95.3 | -$7.5 | | Cost of sales | $22.9 | $21.4 | +$1.5 | | Selling, general and administrative | $35.6 | $46.7 | -$11.1 | | Research and development | $29.3 | $27.2 | +$2.1 | Cost of Sales Cost of sales increased in Q2 and H1 2025, driven by higher royalty expenses and product costs from increased worldwide net sales - Cost of sales increased by $1.6 million in Q2 2025 and $1.5 million in the first six months of 2025, primarily due to higher royalty expense and product costs resulting from increased worldwide net sales[10] Selling, General and Administrative Expenses SG&A expenses decreased significantly in Q2 and H1 2025, mainly due to lower legal fees related to prior year litigation - SG&A expenses decreased by $7.0 million in Q2 2025 and $11.1 million in the first six months of 2025, mainly due to lower legal fees associated with the AstraZeneca litigation in the prior year[11] Research and Development Expenses R&D expenses increased in Q2 and H1 2025, primarily driven by increased clinical study activity for alisertib - R&D expenses increased by $1.9 million in Q2 2025 and $2.1 million in the first six months of 2025, primarily driven by increased alisertib study activity[12] Total Other Income (Expenses) The company reported total other income of $0.4 million in Q2 2025, a significant improvement from total other expenses of $2.0 million in Q2 2024, primarily due to a lower debt balance Q2 Total Other Income (Expenses) (Millions) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Total other income (expenses) | $0.4 | ($2.0) | +$2.4 | H1 Total Other Income (Expenses) (Millions) | Metric | H1 2025 (Millions) | H1 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Total other income (expenses) | $1.2 | ($4.2) | +$5.4 | - The year-over-year decrease in other expenses for the first six months of 2025 was primarily due to a lower debt balance as the company continues to pay down its principal[13] Net Income (Loss) Puma Biotechnology achieved a net income of $5.9 million in Q2 2025, a substantial turnaround from a net loss of $4.5 million in Q2 2024, reflecting improved revenues and reduced operating expenses Q2 Net Income (Loss) (Millions) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Net income (loss) | $5.9 | ($4.5) | +$10.4 | | Net income (loss) per share—basic | $0.12 | ($0.09) | +$0.21 | | Net income (loss) per share—diluted | $0.12 | ($0.09) | +$0.21 | H1 Net Income (Loss) (Millions) | Metric | H1 2025 (Millions) | H1 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | Net income (loss) | $8.8 | ($9.3) | +$18.1 | | Net income (loss) per share—basic | $0.18 | ($0.19) | +$0.37 | | Net income (loss) per share—diluted | $0.18 | ($0.19) | +$0.37 | Financial Outlook Puma Biotechnology provides Q3 and full-year 2025 guidance, projecting continued revenue growth and positive net income, with consistent full-year estimates Third Quarter and Full Year 2025 Guidance Puma Biotechnology provided financial guidance for Q3 and the full year 2025, projecting continued revenue growth and positive net income, with consistent full-year estimates compared to previous outlooks Q3 and Full Year 2025 Guidance | Metric | Third Quarter 2025 | Full Year 2025 (current) | | :-------------------- | :----------------- | :----------------------- | | Net Product Revenue | $46-$48 million | $192–$198 million | | Royalty Revenue | $2-$3 million | $20–$24 million | | License Revenue | $0 million | $0 million | | Total Revenue | $48-$51 million | $212–$222 million | | Net Income/(Loss)* | $2-$4 million | $23–$28 million | | Gross to Net Adjustment | 22.5%–23.5% | 21.5%–22.0% | - The full year 2025 outlook for Net Product Revenue, Royalty Revenue, Total Revenue, and Net Income/(Loss) remains consistent with previous estimates[14] - The outlook does not include any adjustments for tax valuation allowance[16] Company Information Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing innovative cancer care products, with NERLYNX® as its primary commercial product and alisertib in Phase II clinical development About Puma Biotechnology Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing innovative cancer care products, with NERLYNX® as its primary commercial product and alisertib in Phase II clinical development for breast and lung cancers - Puma Biotechnology focuses on the development and commercialization of innovative products to enhance cancer care[18] - NERLYNX® (neratinib, oral) is approved for extended adjuvant treatment of early-stage HER2-positive breast cancer and in combination with capecitabine for advanced or metastatic HER2-positive breast cancer[18] - Puma is developing alisertib, an aurora kinase A inhibitor, with Phase II trials (ALISCA™-Lung1 and ALISCA™-Breast1) initiated for small cell lung cancer and HER2-negative, HR-positive metastatic breast cancer[19] Product Information: NERLYNX NERLYNX® (neratinib) is a kinase inhibitor indicated for specific HER2-positive breast cancer treatments, with important safety information regarding diarrhea, hepatotoxicity, and embryo-fetal toxicity, along with known drug interactions - NERLYNX® is indicated as a single agent for extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy[22] - It is also indicated in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens[22] - Key warnings and precautions include managing diarrhea, monitoring for hepatotoxicity, and advising on embryo-fetal toxicity[23] Indications NERLYNX® is indicated for extended adjuvant treatment of early-stage HER2-positive breast cancer and in combination with capecitabine for advanced or metastatic HER2-positive breast cancer - NERLYNX® is indicated as a single agent for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy[22] - NERLYNX® is indicated in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting[22] Important Safety Information Important safety information for NERLYNX® includes managing diarrhea, monitoring for hepatotoxicity, and precautions regarding embryo-fetal toxicity and drug interactions - Diarrhea is a common adverse reaction and requires management through dose escalation or loperamide prophylaxis; severe or persistent diarrhea may require withholding or permanent discontinuation[23] - Hepatotoxicity monitoring is required monthly for the first 3 months, then every 3 months; Grade 3 abnormalities require withholding, and Grade 4 require permanent discontinuation[23] - NERLYNX® can cause fetal harm, and patients are advised to use effective contraception[23] - Common adverse reactions (≥ 5%) for single-agent NERLYNX include diarrhea, nausea, abdominal pain, fatigue, and vomiting[27] - Common adverse reactions (≥ 5%) for NERLYNX in combination with capecitabine include diarrhea, nausea, vomiting, decreased appetite, and constipation[27] - Drug interactions include avoiding concomitant use with proton pump inhibitors, strong CYP3A4 inhibitors, P-gp and moderate CYP3A4 dual inhibitors, and strong or moderate CYP3A4 inducers[27] Financial Statements Puma Biotechnology's financial statements reflect a positive shift from net loss to net income, supported by increased revenue and improved liquidity, with positive cash flow from operations Consolidated Statements of Operations The consolidated statements of operations show a shift from net loss to net income for both the three and six months ended June 30, 2025, driven by increased total revenue and a reduction in total operating costs and expenses Consolidated Statements of Operations (Millions) - Three Months Ended June 30 | Metric (Millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | Total revenue | $52.4 | $47.1 | | Total operating costs and expenses | $45.8 | $49.3 | | Income (loss) from operations | $6.6 | ($2.2) | | Total other expenses, net | ($0.4) | ($2.0) | | Net income (loss) | $5.9 | ($4.5) | Consolidated Statements of Operations (Millions) - Six Months Ended June 30 | Metric (Millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $98.4 | $90.8 | | Total operating costs and expenses | $87.8 | $95.3 | | Income (loss) from operations | $10.6 | ($4.5) | | Total other expenses, net | ($1.2) | ($4.2) | | Net income (loss) | $8.8 | ($9.3) | Liquidity and Capital Resources Puma Biotechnology's liquidity position shows a decrease in cash and cash equivalents but an increase in marketable securities, resulting in a slight decrease in total cash, cash equivalents, and marketable securities compared to year-end 2024. Operating activities provided positive cash flow Liquidity and Capital Resources (Millions) | Metric (Millions) | June 30, 2025 | December 31, 2024 | | :---------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $54.7 | $69.2 | | Marketable securities | $41.4 | $31.7 | | Total Cash, Cash Equivalents and Marketable Securities | $96.1 | $100.9 | | Working capital | $57.5 | $51.5 | | Current portion of long-term debt | $34.0 | $45.3 | | Long-term debt | $10.9 | $21.7 | | Stockholders' equity | $104.7 | $92.1 | Cash Flow Activity (Millions) | Cash Flow Activity (Millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $17.7 | $12.3 |\ | Investing activities | ($9.7) | ($18.4) |\ | Financing activities | ($22.5) | ($11.3) |\ | Net decrease in cash, cash equivalents and restricted cash | ($14.5) | ($17.4) | Non-GAAP Financial Measures Puma Biotechnology presents non-GAAP adjusted net income (loss) by excluding stock-based compensation, offering a clearer view of core operational performance and facilitating period-over-period comparisons Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Loss) Puma Biotechnology provides non-GAAP adjusted net income (loss) by excluding stock-based compensation expense, which management believes offers a clearer view of operational performance and facilitates period-over-period comparisons Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Loss) (Millions) - Three Months Ended June 30 | Metric (Millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------------- | :------------------------------- | :------------------------------- | | GAAP net income (loss) | $5.9 | ($4.5) | | Stock-based compensation - SG&A | $1.0 | $1.4 | | Stock-based compensation - R&D | $0.6 | $0.6 | | Non-GAAP adjusted net income (loss) | $7.5 | ($2.5) | | GAAP net income (loss) per share—basic | $0.12 | ($0.09) | | Non-GAAP adjusted basic net income (loss) per share | $0.15 | ($0.05) | Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Loss) (Millions) - Six Months Ended June 30 | Metric (Millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------- | :----------------------------- | :----------------------------- | | GAAP net income (loss) | $8.8 | ($9.3) | | Stock-based compensation - SG&A | $2.2 | $2.8 | | Stock-based compensation - R&D | $1.4 | $1.6 | | Non-GAAP adjusted net income (loss) | $12.4 | ($4.9) | | GAAP net income (loss) per share—basic | $0.18 | ($0.19) | | Non-GAAP adjusted basic net income (loss) per share | $0.25 | ($0.10) | - Non-GAAP measures exclude stock-based compensation expense, which represented approximately 4.9% and 5.6% of operating expenses (excluding cost of sales and acquired in-process R&D) for the three and six months ended June 30, 2025, respectively[32] Additional Information This section provides details on the Q2 2025 conference call, important forward-looking statements, and contact information for investor inquiries Conference Call Puma Biotechnology hosted a conference call on August 7, 2025, to discuss Q2 2025 financial results, business updates, and outlook, with access provided via dial-in and webcast - A conference call was held on Thursday, August 7, 2025, at 1:30 p.m. PT/4:30 p.m. ET to report Q2 2025 financial results and provide a business update[17] - Access to the call was available via domestic and international dial-in numbers, and a live webcast with presentation slides was accessible on the company's investor relations website[17] Forward-Looking Statements This press release contains forward-looking statements regarding future milestones and financial results, which are subject to various risks and uncertainties that could cause actual results to differ materially from expectations - The press release includes forward-looking statements concerning anticipated milestones and estimates of future financial results for Q3 and full year 2025[26] - These statements involve risks and uncertainties, including regulatory approvals, clinical trial results, litigation, intellectual property changes, and global economic impacts, as detailed in SEC filings[26] - Readers are cautioned not to place undue reliance on these statements, and Puma assumes no obligation to update them except as required by law[26] Contacts Contact information for Puma Biotechnology's management and investor relations, as well as for Russo Partners, is provided for inquiries - Contact information for Alan H. Auerbach and Mariann Ohanesian from Puma Biotechnology, Inc. is provided for inquiries[27] - Investor relations contacts from Russo Partners, David Schull and Olipriya Das, are also listed[27]