Core Insights - Puma Biotechnology reported a return to profitability in Q2 2025, with non-GAAP EPS of $0.15 and GAAP revenue of $52.4 million, exceeding estimates [1][2] - The company reiterated its full-year guidance, projecting total GAAP revenue between $212 million and $222 million and net income of $23 million to $28 million [1][13] Financial Performance - Non-GAAP EPS was $0.15, surpassing the estimate of $0.09, and up from a loss of $0.05 in Q2 2024 [2][7] - GAAP revenue reached $52.4 million, an increase of 11.3% from $47.1 million in Q2 2024 [2][7] - Net product revenue from NERLYNX was $49.2 million, up 10.8% from $44.4 million in Q2 2024 [2][5] - Royalty revenue increased by 18.5% to $3.2 million compared to $2.7 million in Q2 2024 [2][6] - GAAP net income was $5.9 million, a turnaround from a loss of $4.5 million in Q2 2024 [2][7] Business Strategy - Puma focuses on developing and commercializing cancer therapies, particularly NERLYNX for HER2-positive breast cancer [3][4] - The company emphasizes market penetration, global partnerships, and patient education to drive NERLYNX sales [4][9] - Ongoing clinical programs for alisertib are part of Puma's strategy for future growth [4][10] Operational Highlights - The company achieved a 28% reduction in SG&A costs to $18.0 million, primarily due to lower legal expenses [7][8] - R&D expenses increased by 14% to $15.5 million, reflecting investments in alisertib trials [7][11] - Cash and equivalents totaled $96.0 million, with a reduction in debt to $34.0 million [8] Outlook - Management expects total revenue for Q3 2025 to be between $48 million and $51 million, with net income projected at $2 million to $4 million [13][14] - The company aims to diversify revenue sources beyond NERLYNX and is exploring new pipeline assets for potential acquisition [14]

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]

PART I – FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and controls and procedures [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements show a shift to net income and positive operating cash flow for the six months ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) The balance sheets show a decrease in total assets and liabilities, with an increase in stockholders' equity as of June 30, 2025 | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----- | :--------------------------- | :------------------------------- | | Total Assets | $194.9 | $213.3 | | Total Liabilities | $90.2 | $121.2 | | Total Stockholders' Equity | $104.7 | $92.1 | - Cash and cash equivalents decreased from **$69.2 million** to **$54.7 million**, while marketable securities increased from **$31.7 million** to **$41.4 million**[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) The statements of operations show increased revenue and a shift from operating loss to income for the three and six months ended June 30, 2025 | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :----- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Total Revenue | $52.4 | $47.1 | $98.4 | $90.8 | | Income (loss) from operations | $6.6 | $(2.2) | $10.6 | $(4.5) | | Net Income (loss) | $5.9 | $(4.5) | $8.8 | $(9.3) | | Basic EPS | $0.12 | $(0.09) | $0.18 | $(0.19) | | Diluted EPS | $0.12 | $(0.09) | $0.18 | $(0.19) | - Total revenue increased by **11.4%** for the three months and **8.4%** for the six months ended June 30, 2025, compared to the same periods in 2024[15](index=15&type=chunk) - Operating costs and expenses decreased by **7.0%** for the three months and **7.9%** for the six months ended June 30, 2025, compared to the same periods in 2024[15](index=15&type=chunk) [Condensed Consolidated Statements of Comprehensive Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) The statements show a positive shift in comprehensive income for the three and six months ended June 30, 2025, compared to prior year losses | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :----- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net income (loss) | $5.9 | $(4.5) | $8.8 | $(9.3) | | Unrealized loss on available-for-sale securities, net of tax | $(0.003) | $(0.006) | $(0.02) | $(0.028) | | Comprehensive income (loss) | $5.9 | $(4.5) | $8.8 | $(9.4) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) The statements detail changes in stockholders' equity, reflecting positive contributions from net income in 2025 compared to prior year losses | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | | :----- | :--------------------------- | :--------------------------- | | Total Stockholders' Equity (3 Months) | $104.7 | $48.5 | | Total Stockholders' Equity (6 Months) | $104.7 | $48.5 | | Additional Paid-in Capital (6 Months) | $1,410.8 | $1,403.0 | | Accumulated Deficit (6 Months) | $(1,306.1) | $(1,354.5) | - Net income of **$5.9 million** for the three months and **$8.8 million** for the six months ended June 30, 2025, contributed positively to equity, contrasting with net losses in the prior year[19](index=19&type=chunk)[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) The cash flow statements show increased cash from operating activities and a significant rise in cash used for financing activities in 2025 | Activity | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :------- | :------------------------------------------ | :------------------------------------------ | | 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 | $(14.6) | $(17.4) | | Cash, cash equivalents and restricted cash, end of period | $56.8 | $69.2 | - Net cash provided by operating activities increased by **$5.4 million**, or **44.2%**, for the six months ended June 30, 2025, compared to the same period in 2024[24](index=24&type=chunk) - Cash used in financing activities increased significantly due to higher debt payments in 2025[24](index=24&type=chunk) [Note 1—Business and Basis of Presentation](index=11&type=section&id=Note%201%E2%80%94Business%20and%20Basis%20of%20Presentation) This note outlines the company's core business, financial performance highlights, and management's assessment of liquidity for the upcoming year - The Company commercializes NERLYNX® (neratinib) for HER2-positive breast cancer and is developing alisertib for various cancer types[25](index=25&type=chunk)[31](index=31&type=chunk) - The Company reported net income of approximately **$8.8 million** and cash provided by operations of approximately **$17.7 million** for the six months ended June 30, 2025[32](index=32&type=chunk) - Management believes existing cash, cash equivalents, marketable securities (**$96.0 million** total at June 30, 2025), product sales, and sub-license payments are sufficient to meet operating cash needs for at least one year[32](index=32&type=chunk)[33](index=33&type=chunk) [Note 2—Significant Accounting Policies](index=13&type=section&id=Note%202%E2%80%94Significant%20Accounting%20Policies) This note details the company's key accounting policies, including segment reporting, revenue recognition, and the evaluation of new accounting standards - The Company operates as a single reporting segment, focusing on the development and commercialization of cancer care products, with NERLYNX® generating global product, license, and royalty revenue[38](index=38&type=chunk) - Revenue recognition for product sales is recorded net of variable consideration, including trade discounts, product returns, chargebacks, government and payor rebates, and patient assistance programs[53](index=53&type=chunk) - The Company is evaluating the impact of new FASB ASUs on income tax disclosures (ASU 2023-09, effective after Dec 15, 2024) and expense disaggregation (ASU 2024-03, effective after Dec 15, 2026)[110](index=110&type=chunk)[111](index=111&type=chunk) [Note 3—Accounts Receivable, Net](index=30&type=section&id=Note%203%E2%80%94Accounts%20Receivable%2C%20Net) This note details the composition of net accounts receivable and the recorded recovery to the provision for credit losses | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----- | :--------------------------- | :------------------------------- | | Trade accounts receivable | $22.5 | $26.4 | | Royalty revenue receivable | $3.6 | $6.0 | | Total accounts receivable, net | $25.9 | $32.0 | - A recovery to the provision for credit loss of **$0.3 million** and **$0.2 million** was recorded for the three months ended June 30, 2025 and 2024, respectively, and **$0.1 million** for each of the six months ended June 30, 2025 and 2024[113](index=113&type=chunk) [Note 4—Prepaid Expenses and Other](index=30&type=section&id=Note%204%E2%80%94Prepaid%20Expenses%20and%20Other) This note outlines the changes in current and long-term prepaid expenses, highlighting increases in prepaid taxes and other long-term amounts | Category | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :------- | :--------------------------- | :------------------------------- | | Current Prepaid Expenses | $3.9 | $5.9 | | Long-term Prepaid Expenses | $1.8 | $0.3 | | Totals | $5.7 | $6.2 | - Prepaid Taxes increased significantly from **$21 thousand** to **$722 thousand** in current prepaid expenses[114](index=114&type=chunk) - Other long-term prepaid amounts increased from **$119 thousand** to **$1.7 million**, primarily for commercial copay support programs[114](index=114&type=chunk) [Note 5—Leases](index=30&type=section&id=Note%205%E2%80%94Leases) This note details lease commitments, including a significant office lease amendment and future minimum lease payment obligations - The Los Angeles office lease was amended in July 2025, extending the term to August 31, 2031, with total future lease payments of approximately **$6.6 million** and the return of a **$1.0 million** letter of credit[116](index=116&type=chunk) | Metric | 6 Months Ended June 30, 2025 (in millions) | | :----- | :------------------------------------------ | | Operating cash flows used for operating leases | $3.1 | | Weighted-average remaining lease term | 0.8 years | | Weighted average discount rate | 10.9% | | Future Minimum Lease Payments (in millions) | Amount | | :----------------------------------------- | :----- | | 2025 | $3.0 | | 2026 | $1.5 | | Total minimum lease payments | $4.5 | [Note 6—Property and Equipment, Net](index=32&type=section&id=Note%206%E2%80%94Property%20and%20Equipment%2C%20Net) This note presents the net property and equipment balances and associated depreciation expenses for the reported periods | Asset Category | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :------------- | :--------------------------- | :------------------------------- | | Total property and equipment | $8.5 | $8.4 | | Less: accumulated depreciation | $(8.1) | $(7.9) | | Property and equipment, net | $0.4 | $0.5 | - Depreciation expense was **$0.1 million** for the three months and **$0.2 million** for the six months ended June 30, 2025 and 2024, respectively[124](index=124&type=chunk) [Note 7—Intangible Assets, Net](index=34&type=section&id=Note%207%E2%80%94Intangible%20Assets%2C%20Net) This note details the net intangible assets, including acquired rights, accumulated amortization, and projected future amortization expenses | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----- | :--------------------------- | :------------------------------- | | Acquired and in-licensed rights | $102.5 | $102.5 | | Less: accumulated amortization | $(56.2) | $(51.4) | | Total intangible assets, net | $46.3 | $51.1 | - Amortization expense was **$2.4 million** for the three months and **$4.9 million** for the six months ended June 30, 2025 and 2024, respectively[125](index=125&type=chunk)[126](index=126&type=chunk) - Estimated future amortization expense is approximately **$4.9 million** for the remainder of 2025, **$9.7 million** for each year from 2026-2029, and **$2.4 million** for 2030[126](index=126&type=chunk) [Note 8—Accrued Expenses](index=34&type=section&id=Note%208%E2%80%94Accrued%20Expenses) This note provides a breakdown of accrued expenses, highlighting changes in royalties, CRO services, variable consideration, bonus, and compensation | Category | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :------- | :--------------------------- | :------------------------------- | | Accrued royalties | $8.8 | $10.2 | | Accrued CRO services | $1.7 | $1.0 | | Accrued variable consideration | $8.4 | $10.8 | | Accrued bonus | $3.4 | $8.0 | | Accrued compensation | $5.8 | $4.4 | | Total current accrued expenses | $31.8 | $36.9 | - Accrued variable consideration and accrued bonus decreased significantly, while accrued compensation and CRO services increased[127](index=127&type=chunk) [Note 9—Debt](index=34&type=section&id=Note%209%E2%80%94Debt) This note details the company's debt structure, including the Athyrium Notes' terms, interest rates, and compliance with covenants | Metric | June 30, 2025 (in millions) | | :----- | :--------------------------- | | Total debt, inclusive of exit payment | $102.0 | | Current portion of long-term debt | $34.0 | | Long-term debt, net | $10.9 | | Principal balance outstanding (Athyrium Notes) | $44.5 | | Exit fees (Athyrium Notes) | $0.9 | - The Athyrium Notes bear interest at an annual rate of **8.00%** plus a SOFR-based component, with an effective interest rate of **12.99%** as of June 30, 2025[131](index=131&type=chunk) - The Company began quarterly principal payments of approximately **$11.1 million** (plus **2.0%** exit payment) in Q2 2024 and was in compliance with all covenants as of June 30, 2025[131](index=131&type=chunk)[133](index=133&type=chunk) [Note 10—Stockholders' Equity](index=38&type=section&id=Note%2010%E2%80%94Stockholders'%20Equity) This note outlines the authorized common stock, stock-based compensation expenses, and a significant CEO stock warrant - The Company has **100,000,000** shares of common stock authorized for issuance[136](index=136&type=chunk) - Stock-based compensation expense totaled **$1.6 million** for the three months and **$3.7 million** for the six months ended June 30, 2025[141](index=141&type=chunk) - A warrant allows the CEO to acquire **2,116,250** shares at **$16 per share** until October 4, 2026, to maintain at least **20%** ownership[137](index=137&type=chunk)[138](index=138&type=chunk) [Note 11—401(k) Savings Plan](index=39&type=section&id=Note%2011%E2%80%94401(k)%20Savings%20Plan) This note describes the company's 401(k) matching policy and the employer contributions for the reported period - The Company matches **100%** of the first **3%** of wages deferred and **50%** of the next **2%** for participating employees in its 401(k) plan[144](index=144&type=chunk) - Employer matching contributions were approximately **$1.0 million** for the six months ended June 30, 2025, an increase from **$0.9 million** in the prior year[144](index=144&type=chunk) [Note 12—Commitments and Contingencies](index=41&type=section&id=Note%2012%E2%80%94Commitments%20and%20Contingencies) This note details the company's contractual obligations, license agreements, and ongoing legal and patent-related proceedings - Contractual obligations include agreements with CMOs and CROs, with variable costs and milestones that are difficult to predict[146](index=146&type=chunk) - The Company has license agreements with Pfizer for NERLYNX and Takeda for alisertib, involving milestone payments and royalties[147](index=147&type=chunk)[150](index=150&type=chunk) - The Company is involved in a legal malpractice suit and several patent-related proceedings, including the AstraZeneca litigation (US), multiple generic challenges in China (Acebright, Aosaikang, Convalife, Kelun, Demai), and a European patent opposition (Hexal)[152](index=152&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk)[159](index=159&type=chunk)[162](index=162&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Puma Biotechnology's financial performance, liquidity, and critical accounting policies, highlighting increased revenue and net income [Overview](index=48&type=section&id=Overview) This overview introduces Puma Biotechnology's focus on cancer care, its key commercial product NERLYNX, and the development of alisertib - Puma Biotechnology develops and commercializes innovative products for cancer care, with NERLYNX as its primary commercial product for HER2-positive breast cancer[171](index=171&type=chunk)[172](index=172&type=chunk) - The Company in-licensed alisertib from Takeda in 2022 and initiated Phase II trials for small cell lung cancer (ALISCA™ -Lung1) in February 2024 and hormone receptor-positive breast cancer (ALISCA™ -Breast1) in November 2024[174](index=174&type=chunk) - NERLYNX is approved in over **40** countries outside the US and commercialized through exclusive sub-license agreements[173](index=173&type=chunk) [Critical Accounting Policies](index=49&type=section&id=Critical%20Accounting%20Policies) This section confirms no material changes to critical accounting policies and estimates during the six months ended June 30, 2025 - No material changes to critical accounting policies and estimates occurred during the six months ended June 30, 2025, compared to the December 31, 2024, Annual Report on Form 10-K[178](index=178&type=chunk) [Summary of Income and Expenses](index=50&type=section&id=Summary%20of%20Income%20and%20Expenses) This section defines revenue recognition policies, outlines components of cost of sales, SG&A, and R&D expenses, and notes potential tax law impacts - Product revenue is net of variable consideration (discounts, returns, rebates), while license revenue is from satisfied performance obligations in sub-license agreements, and royalty revenue is from sub-licensee sales[179](index=179&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - Cost of sales includes manufacturing, freight, Pfizer royalties, and amortization of milestone payments. SG&A covers payroll, professional fees, and general corporate expenses. R&D includes CRO fees, consultants, and personnel costs[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) - The Company does not expect tariffs to materially impact product costs or results of operations but is evaluating the 'One Big Beautiful Bill' for potential tax law changes[186](index=186&type=chunk)[187](index=187&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) This section analyzes the company's revenue, selling, general and administrative, and research and development expenses for the reported periods - Total revenue increased by **$5.4 million** (**11.4%**) for the three months and **$7.6 million** (**8.4%**) for the six months ended June 30, 2025, compared to 2024[189](index=189&type=chunk)[202](index=202&type=chunk) - Selling, general and administrative expenses decreased by **$6.9 million** (**27.7%**) for the three months and **$11.1 million** (**23.7%**) for the six months, primarily due to lower legal fees from the AstraZeneca litigation[193](index=193&type=chunk)[196](index=196&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - Research and development expenses increased by **$1.8 million** (**13.4%**) for the three months and **$2.1 million** (**7.7%**) for the six months, mainly due to increased alisertib study activity[195](index=195&type=chunk)[197](index=197&type=chunk)[209](index=209&type=chunk)[214](index=214&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's liquidity and capital resources, including cash balances, working capital, debt, and future funding sufficiency | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----- | :--------------------------- | :------------------------------- | | Cash and cash equivalents | $54.7 | $69.2 | | Marketable securities | $41.4 | $31.7 | | 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 | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :----------------- | :------------------------------------------ | :------------------------------------------ | | 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 | $(14.6) | $(17.4) | - The Company believes its existing cash, cash equivalents, marketable securities (**$96.0 million** total at June 30, 2025), and future product sales/sub-license payments are sufficient for operating cash and capital needs for at least one year[229](index=229&type=chunk) [Non-GAAP Financial Measures](index=60&type=section&id=Non-GAAP%20Financial%20Measures) This section explains the use of non-GAAP financial measures, primarily by adjusting for stock-based compensation to highlight operational performance - Non-GAAP financial measures are used to enhance understanding of financial performance, focusing on operational performance by excluding stock-based compensation[232](index=232&type=chunk) - Stock-based compensation represented approximately **4.9%** and **5.6%** of operating expenses (excluding cost of sales) for the three and six months ended June 30, 2025, respectively[232](index=232&type=chunk) | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :----- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | GAAP net income (loss) | $5.9 | $(4.5) | $8.8 | $(9.3) | | Stock-based compensation (SG&A) | $1.0 | $1.4 | $2.2 | $2.9 | | Stock-based compensation (R&D) | $0.6 | $0.6 | $1.4 | $1.6 | | Non-GAAP adjusted net income (loss) | $7.5 | $(2.5) | $12.5 | $(4.9) | | GAAP basic EPS | $0.12 | $(0.09) | $0.18 | $(0.19) | | Non-GAAP adjusted basic EPS | $0.15 | $(0.05) | $0.25 | $(0.10) | [Off-Balance Sheet Arrangements](index=61&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of off-balance sheet arrangements as defined by SEC regulations - The Company has no off-balance sheet arrangements as defined by SEC regulations[238](index=238&type=chunk) [Contractual Obligations](index=61&type=section&id=Contractual%20Obligations) This section states that no material changes to contractual obligations have occurred since the prior annual report - No material changes to contractual obligations and commitments have occurred since the December 31, 2024, Annual Report on Form 10-K[239](index=239&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=62&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risk from interest rate fluctuations, impacting variable-rate debt and cash equivalents, with specific sensitivity to Athyrium Notes - The Company's investment activities prioritize liquidity and principal preservation, with excess cash invested primarily in money market instruments[240](index=240&type=chunk) - A **10%** increase in interest rates is not expected to materially affect the realized value of cash equivalents due to their short-term maturities[241](index=241&type=chunk) - A **100 basis point** increase in interest rates would increase interest expense on the **$44.5 million** outstanding Athyrium Notes by **$0.4 million** for the quarter ended June 30, 2025[242](index=242&type=chunk) [Item 4. Controls and Procedures](index=62&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[244](index=244&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[245](index=245&type=chunk) PART II – OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, exhibits, and signatures [Item 1. Legal Proceedings](index=63&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in a legal malpractice suit and various patent-related proceedings, including US, Chinese, and European litigations [Legal Malpractice Suit](index=63&type=section&id=Legal%20Malpractice%20Suit) This note details the re-filed legal malpractice lawsuit against former attorneys, its dismissal, and the ongoing appeal - The Company re-filed a legal malpractice lawsuit against former attorneys in June 2023, which was dismissed by the Superior Court in March 2024 and is currently under appeal[153](index=153&type=chunk)[248](index=248&type=chunk) [Patent-Related Proceedings](index=63&type=section&id=Patent-Related%20Proceedings) This note outlines key patent litigations, including the AstraZeneca case, multiple Chinese generic challenges, and a European patent opposition - In the AstraZeneca litigation, a jury awarded Wyeth **$107.5 million** for Tagrisso® infringement, but the District Court later granted AstraZeneca's motion for judgment as a matter of law, invalidating certain patent claims. Wyeth has appealed this ruling[154](index=154&type=chunk)[249](index=249&type=chunk) - Multiple Chinese generic companies (Acebright, Aosaikang, Convalife, Kelun, Demai) have filed ANDAs for generic NERLYNX, leading to ongoing patent infringement lawsuits and administrative actions in China[156](index=156&type=chunk)[159](index=159&type=chunk)[162](index=162&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk)[251](index=251&type=chunk)[254](index=254&type=chunk)[257](index=257&type=chunk)[260](index=260&type=chunk)[262](index=262&type=chunk) - A European patent opposition against EP3000467 (NERLYNX) was upheld as amended after the first instance hearing, but Hexal, Generics [UK] Limited, and Wyeth have filed appeals[168](index=168&type=chunk)[263](index=263&type=chunk) [Item 1A. Risk Factors](index=68&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the last annual report, though new risks may emerge - No material changes to risk factors have occurred since the December 31, 2024, Annual Report on Form 10-K[265](index=265&type=chunk) - The Company acknowledges that additional risks and uncertainties, currently deemed immaterial or unknown, could affect future results[265](index=265&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=68&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales or purchases of equity securities by the issuer or affiliates occurred during the period - No recent sales of unregistered securities occurred[266](index=266&type=chunk) - No purchases of equity securities by the issuer or affiliated purchasers occurred[267](index=267&type=chunk) [Item 3. Defaults Upon Senior Securities](index=68&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - No defaults upon senior securities occurred[268](index=268&type=chunk) [Item 4. Mine Safety Disclosures](index=69&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item regarding mine safety disclosures is not applicable to the company - Mine Safety Disclosures are not applicable[269](index=269&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[270](index=270&type=chunk) [Item 6. Exhibits](index=70&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, encompassing corporate documents, lease amendments, certifications, and XBRL files - Exhibits include the Second Amended and Restated Certificate of Incorporation, Fifth Amended and Restated Bylaws, Sixth Amendment to Office Lease, and certifications from principal executive and financial officers[272](index=272&type=chunk) - XBRL instance document, taxonomy extension schema, calculation, definition, and label linkbase documents, and cover page interactive data file are also included[272](index=272&type=chunk) [Signatures](index=71&type=section&id=Signatures) The report was officially signed by the President and CEO, and the CFO on August 7, 2025 - The report was signed by Alan H. Auerbach (President and CEO) and Maximo F. Nougues (CFO) on August 7, 2025[276](index=276&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) 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](index=3&type=chunk) - 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](index=4&type=chunk) [CEO Commentary & Business Update](index=1&type=section&id=CEO%20Commentary%20%26%20Business%20Update) 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](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk) [Financial Performance Analysis](index=1&type=section&id=Financial%20Performance%20Analysis) 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](index=1&type=section&id=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](index=1&type=section&id=Operating%20Costs%20and%20Expenses) 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](index=2&type=section&id=Cost%20of%20Sales) 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](index=10&type=chunk) [Selling, General and Administrative Expenses](index=2&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) 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](index=11&type=chunk) [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) 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](index=12&type=chunk) [Total Other Income (Expenses)](index=3&type=section&id=Total%20Other%20Income%20%28Expenses%29) 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](index=13&type=chunk) [Net Income (Loss)](index=6&type=section&id=Net%20Income%20%28Loss%29) 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](index=3&type=section&id=Financial%20Outlook) 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](index=3&type=section&id=Third%20Quarter%20and%20Full%20Year%202025%20Guidance) 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](index=14&type=chunk) - The outlook does not include any adjustments for **tax valuation allowance**[16](index=16&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) 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](index=3&type=section&id=About%20Puma%20Biotechnology) 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](index=18&type=chunk) - **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](index=18&type=chunk) - 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](index=19&type=chunk) [Product Information: NERLYNX](index=3&type=section&id=Product%20Information%3A%20NERLYNX) 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](index=22&type=chunk) - 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](index=22&type=chunk) - Key warnings and precautions include managing diarrhea, monitoring for hepatotoxicity, and advising on embryo-fetal toxicity[23](index=23&type=chunk) [Indications](index=3&type=section&id=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](index=22&type=chunk) - 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](index=22&type=chunk) [Important Safety Information](index=4&type=section&id=Important%20Safety%20Information) 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](index=23&type=chunk) - 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](index=23&type=chunk) - NERLYNX® can cause fetal harm, and patients are advised to use effective contraception[23](index=23&type=chunk) - Common adverse reactions (≥ 5%) for single-agent NERLYNX include diarrhea, nausea, abdominal pain, fatigue, and vomiting[27](index=27&type=chunk) - Common adverse reactions (≥ 5%) for NERLYNX in combination with capecitabine include diarrhea, nausea, vomiting, decreased appetite, and constipation[27](index=27&type=chunk) - 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](index=27&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) 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](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=6&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=7&type=section&id=Non-GAAP%20Financial%20Measures) 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)](index=7&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Adjusted%20Net%20Income%20%28Loss%29) 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](index=32&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides details on the Q2 2025 conference call, important forward-looking statements, and contact information for investor inquiries [Conference Call](index=3&type=section&id=Conference%20Call) 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](index=17&type=chunk) - 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](index=17&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=26&type=chunk) - 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](index=26&type=chunk) - 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](index=26&type=chunk) [Contacts](index=5&type=section&id=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](index=27&type=chunk) - Investor relations contacts from Russo Partners, David Schull and Olipriya Das, are also listed[27](index=27&type=chunk)

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]

Core Insights - Puma Biotechnology has an approved drug and decent sales but lacks market appreciation despite its ongoing pipeline [1] Company Overview - Puma Biotechnology is characterized as an "odd duck" in the biotech sector, having a unique position with an approved drug and reasonable sales figures [1] - The company has a continuing pipeline that suggests potential for future growth [1] Analyst Perspective - The author expresses cautious optimism regarding Puma Biotechnology, indicating that there are valid reasons for the current market sentiment [1] - The author has a background in biochemistry and extensive experience in analyzing clinical trials and biotech companies, which informs their perspective on the company [1]

Group 1 - Momentum investing focuses on "buying high and selling higher" rather than traditional "buying low and selling high" strategies [1] - Fast-moving trending stocks can lose momentum if their future growth does not justify their high valuations, leading to potential downside risks for investors [2] - A safer investment strategy involves identifying bargain stocks that exhibit recent price momentum, utilizing tools like the Zacks Momentum Style Score [3] Group 2 - Puma Biotech (PBYI) is highlighted as a strong candidate for momentum investing, with a recent price increase of 3.6% over the past four weeks [4] - PBYI has shown a significant price gain of 13.2% over the past 12 weeks, indicating its potential for sustained positive returns [5] - The stock has a beta of 1.29, suggesting it moves 29% more than the market, indicating fast-paced momentum [5] Group 3 - PBYI has a Momentum Score of B, suggesting it is an opportune time to invest in the stock to capitalize on its momentum [6] - The stock has received a Zacks Rank 2 (Buy) due to upward revisions in earnings estimates, which typically attract more investor interest [7] - PBYI is trading at a Price-to-Sales ratio of 0.71, indicating it is undervalued at 71 cents for each dollar of sales, providing room for growth [7] Group 4 - In addition to PBYI, there are other stocks that meet the criteria for fast-paced momentum at a bargain, which investors may consider [8] - Zacks offers over 45 Premium Screens tailored to different investing styles, aiding in the identification of potential winning stocks [9]

Core Viewpoint - Momentum investing focuses on "buying high and selling higher," contrasting with traditional strategies of "buying low and selling high" [1] Group 1: Momentum Investing Strategy - Momentum investing can be risky as stocks may lose momentum when their valuations exceed future growth potential [1] - Identifying the right entry point for momentum stocks is challenging, and investors may end up with expensive shares that have limited upside [1] Group 2: Bargain Stocks with Momentum - Investing in bargain stocks that have recently shown price momentum may be a safer strategy [2] - The Zacks Momentum Style Score helps identify strong momentum stocks, while the 'Fast-Paced Momentum at a Bargain' screen identifies fast-moving stocks that are still attractively priced [2] Group 3: Puma Biotech (PBYI) Analysis - Puma Biotech (PBYI) has a four-week price change of 13.2%, indicating strong recent price momentum [3] - PBYI gained 1.5% over the past 12 weeks, demonstrating its ability to deliver positive returns over a longer timeframe [4] - The stock has a beta of 1.29, suggesting it moves 29% higher than the market in either direction [4] Group 4: Valuation and Earnings Estimates - PBYI has a Momentum Score of A, indicating a favorable time to invest [5] - The stock has a Zacks Rank 2 (Buy) due to upward revisions in earnings estimates, which attract more investor interest [6] - PBYI is trading at a Price-to-Sales ratio of 0.73, meaning investors pay 73 cents for each dollar of sales, indicating a reasonable valuation [6] Group 5: Additional Investment Opportunities - Besides PBYI, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen [7] - Investors can explore over 45 Zacks Premium Screens tailored to different investing styles to find potential winning stocks [8]

It could be safer to invest in bargain stocks that have been witnessing price momentum recently. While the Zacks Momentum Style Score (part of the Zacks Style Scores system), which pays close attention to trends in a stock's price or earnings, is pretty useful in identifying great momentum stocks, our 'Fast-Paced Momentum at a Bargain' screen comes handy in spotting fast-moving stocks that are still attractively priced. There are several stocks that currently pass through the screen and Puma Biotech (PBYI) ...

Core Viewpoint - Puma Biotechnology (PBYI) is currently identified as a strong value stock based on its favorable valuation metrics and earnings outlook [3][7]. Valuation Metrics - PBYI has a PEG ratio of 1.38, significantly lower than the industry average of 2.45, indicating potential undervaluation [4]. - The stock's P/B ratio stands at 1.61, compared to the industry's average of 3.01, suggesting a solid market value relative to its book value [5]. - PBYI's P/CF ratio is 3.53, which is attractive when compared to the industry's average of 12.71, highlighting its strong cash flow outlook [6]. Performance Insights - Over the past 52 weeks, PBYI's PEG ratio has fluctuated between 1.38 and 1.79, with a median of 1.51, indicating stable valuation [4]. - The P/B ratio has ranged from 1.47 to 4.86 in the last 12 months, with a median of 2.04, reflecting variability in market perception [5]. - The P/CF ratio has seen a range from 3.24 to 9.59, with a median of 4.20, further supporting the notion of undervaluation [6].