Puma Biotechnology Barclays Global Healthcare Conference March 2021 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 results and expectations expressed in these forward-looking statements. These s ...

Part I [Business Overview](index=3&type=section&id=Item%201.%20Business) Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing its primary cancer care product, NERLYNX - Puma Biotechnology, Inc is a biopharmaceutical company focused on developing and commercializing innovative products to enhance cancer care, with **NERLYNX (neratinib) as its lead product**[15](index=15&type=chunk)[356](index=356&type=chunk)[518](index=518&type=chunk) - NERLYNX is an oral, potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through HER1, HER2, and HER4 receptors[15](index=15&type=chunk)[32](index=32&type=chunk)[356](index=356&type=chunk) - NERLYNX received **FDA approval in July 2017** for extended adjuvant treatment of early-stage HER2-overexpressed/amplified breast cancer and in February 2020 for metastatic HER2-positive breast cancer in combination with capecitabine[15](index=15&type=chunk)[35](index=35&type=chunk)[51](index=51&type=chunk) - The European Commission (EC) granted marketing authorization for NERLYNX in August 2018 for extended adjuvant treatment of early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer[18](index=18&type=chunk)[35](index=35&type=chunk) - The company commercializes NERLYNX in the US with a direct specialty sales force of approximately **68 sales specialists** and through exclusive sub-license agreements in various regions outside the US[18](index=18&type=chunk)[89](index=89&type=chunk)[91](index=91&type=chunk) - Puma Biotechnology is actively conducting Phase II clinical trials to evaluate neratinib's safety and efficacy for other indications, including HER2-mutated HER2-negative cancers and EGFR exon 18 mutated non-small cell lung cancer[21](index=21&type=chunk)[66](index=66&type=chunk)[69](index=69&type=chunk)[79](index=79&type=chunk) - The company's strategy includes executing the NERLYNX commercial plan, advancing neratinib development for other cancer indications, expanding the product pipeline, and evaluating commercialization strategies[25](index=25&type=chunk) - Puma Biotechnology **relies exclusively on third-party contractors** for drug formulation and manufacturing of NERLYNX and its drug candidates[132](index=132&type=chunk)[133](index=133&type=chunk) - The company holds a worldwide exclusive license from Pfizer for neratinib, with key US patents expiring between 2025 and 2031[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[104](index=104&type=chunk) - Research and development expenses totaled **$97.7 million in 2020**, a decrease from $132.9 million in 2019 and $164.9 million in 2018[191](index=191&type=chunk) NERLYNX Approvals by Country (as of December 2020) | Indication | Country | Approval Date | | :---------- | :------ | :------------ | | Extended adjuvant | United States | July 2017 | | Extended adjuvant | European Union | August 2018 | | Extended adjuvant | Australia | March 2019 | | Extended adjuvant | Canada | July 2019 | | Extended adjuvant | Argentina | August 2019 | | Extended adjuvant | Hong Kong | October 2019 | | Extended adjuvant | Singapore | November 2019 | | Extended adjuvant | Switzerland | March 2020 | | Extended adjuvant | Brunei | April 2020 | | Extended adjuvant | China | April 2020 | | Extended adjuvant | Chile | April 2020 | | Extended adjuvant | New Zealand | June 2020 | | Extended adjuvant | Taiwan | June 2020 | | Extended adjuvant | Ecuador | July 2020 | | Extended adjuvant | Malaysia | July 2020 | | Metastatic | United States | February 2020 | | Metastatic | Argentina | January 2021 | Workforce by Location (as of December 31) | Location | December 31, 2020 | December 31, 2019 | | :--------- | :------------------ | :------------------ | | Los Angeles | 86 | 83 | | South San Francisco | 67 | 70 | | Field | 114 | 116 | | **Total** | **267** | **269** | [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including operating losses, single-product dependency, and challenges in commercialization and financing - Puma Biotechnology has a history of operating losses, with an **accumulated deficit of approximately $1.3 billion** as of December 31, 2020[206](index=206&type=chunk) - The company is currently a single-product company, with **NERLYNX being the sole source of product revenue**, making its success almost entirely dependent on NERLYNX's commercial performance[209](index=209&type=chunk) - Commercial success of NERLYNX is uncertain and depends on market penetration, physician and patient acceptance, and the ability to manage side effects like diarrhea[210](index=210&type=chunk) - The company may not be able to secure additional financing on favorable terms, which could force delays or termination of product development or commercialization efforts[212](index=212&type=chunk)[214](index=214&type=chunk) - The credit facility with Oxford Finance LLC places restrictions on business operations and financial flexibility, including **minimum revenue covenants**[215](index=215&type=chunk)[216](index=216&type=chunk) - Reliance on international third-party sub-licensees for development and commercialization of NERLYNX outside the US poses risks if these partners fail to meet obligations[211](index=211&type=chunk)[269](index=269&type=chunk) - NERLYNX or other drug candidates may cause undesirable side effects, which could delay or prevent regulatory approval or limit commercial potential[248](index=248&type=chunk) - The company has no experience in drug formulation or manufacturing and **relies exclusively on third parties**, exposing it to risks of supply disruption and quality issues[272](index=272&type=chunk)[274](index=274&type=chunk) - The **COVID-19 pandemic** has harmed and could continue to harm business operations, financial condition, and ongoing clinical trials[277](index=277&type=chunk)[279](index=279&type=chunk) - The company depends significantly on intellectual property licensed from Pfizer, and termination of this license would severely harm its business[307](index=307&type=chunk) - The company is subject to securities litigation, including the **Hsu v. Puma Biotechnology, Inc., et al. class action lawsuit**, which could result in substantial damages[325](index=325&type=chunk)[337](index=337&type=chunk) [Unresolved Staff Comments](index=61&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved comments from SEC staff [Properties](index=61&type=section&id=Item%202.%20Properties) The company leases adequate office space in Los Angeles and South San Francisco for its corporate and operational needs - The company leases **65,656 sq ft** of office space in Los Angeles, CA (corporate headquarters) and **29,470 sq ft** in South San Francisco, CA[336](index=336&type=chunk) - Both leases terminate in March 2026, with the South San Francisco lease having a five-year extension option[336](index=336&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in several material legal proceedings, including class action lawsuits and a licensing dispute - In Hsu v. Puma Biotechnology, Inc., et al., a jury found liability on one of four alleged misstatements, with claimed damages ranging from **$24.8 million to $51.4 million**[337](index=337&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - In Eshelman v. Puma Biotechnology, Inc., et al., a jury found the company liable for defamation, awarding **$26.3 million** including interest, which the company has appealed[338](index=338&type=chunk)[123](index=123&type=chunk) - The company resolved a licensing dispute with CANbridge Biomed Limited, agreeing to pay a one-time termination fee of **$20.0 million** to regain all rights to NERLYNX in Greater China[339](index=339&type=chunk)[463](index=463&type=chunk)[123](index=123&type=chunk) - Puma Biotechnology filed a legal malpractice lawsuit against its former attorneys in the Eshelman case, seeking recovery of the awarded amount[340](index=340&type=chunk)[123](index=123&type=chunk) [Mine Safety Disclosure](index=62&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company has no mine safety disclosures as it is not subject to the relevant Dodd-Frank Act requirements Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=63&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on NASDAQ under 'PBYI', and it has not paid dividends and does not plan to - Puma Biotechnology's common stock has been quoted on the NASDAQ Global Select Market under the symbol **'PBYI'** since January 3, 2017[342](index=342&type=chunk) - As of February 18, 2021, there were nine holders of record and approximately **14,500 additional owners** holding common stock in 'Street Name'[343](index=343&type=chunk) - The company has **never declared or paid cash dividends** and does not anticipate doing so in the foreseeable future; dividend payments are also restricted under its credit facility[344](index=344&type=chunk)[332](index=332&type=chunk) Cumulative Total Return Comparison (December 31, 2015 = $100) | | 12/31/2015 | 12/31/2016 | 12/31/2017 | 12/31/2018 | 12/31/2019 | 12/31/2020 | | :----------------------- | :--------- | :--------- | :--------- | :--------- | :--------- | :--------- | | Puma Biotechnology, Inc | 100.00 | 39.16 | 126.08 | 25.96 | 11.16 | 13.09 | | Nasdaq Biotechnology Index | 100.00 | 78.65 | 95.67 | 87.19 | 109.08 | 137.90 | | Nasdaq Composite Index | 100.00 | 108.87 | 141.13 | 137.12 | 187.44 | 271.64 | [Selected Financial Data](index=65&type=section&id=Item%206.%20Selected%20Financial%20Data) This section presents a five-year summary of the company's key consolidated financial data Consolidated Statement of Operations Data (in millions, except share and per share data) | | 2020 | 2019 | 2018 | 2017 | 2016 | | :----------------------------------- | :----- | :----- | :----- | :----- | :----- | | Product revenue, net | $196.7 | $211.6 | $200.5 | $26.2 | $— | | License revenue | 22.7 | 60.3 | 50.5 | 1.5 | — | | Royalty revenue | 5.7 | 0.4 | — | — | — | | Cost of sales | 39.4 | 36.8 | 34.6 | 5.6 | — | | Selling, general and administrative | 118.4 | 141.6 | 146.2 | 106.7 | 53.8 | | Research and development | 97.7 | 132.9 | 164.9 | 207.8 | 222.8 | | Operating loss | (30.4) | (39.0) | (94.7) | (292.4) | (276.6) | | Net loss | (60.0) | (75.6) | (113.6) | (292.0) | (276.0) | | Net loss per common share—basic and diluted | (1.52) | (1.95) | (2.99) | (7.85) | (8.29) | | Weighted-average common shares outstanding—basic and diluted | 39,576,107 | 38,768,653 | 37,942,411 | 37,169,678 | 33,295,114 | Consolidated Balance Sheet Data (in millions) | | As of December 31, 2020 | As of December 31, 2019 | As of December 31, 2018 | As of December 31, 2017 | As of December 31, 2016 | | :-------------------------- | :---------------------- | :---------------------- | :---------------------- | :---------------------- | :---------------------- | | Total assets | $244.2 | $234.9 | $259.1 | $165.5 | $252.8 | | Total liabilities | 250.2 | 217.4 | 224.8 | 112.2 | 43.0 | | Total stockholders' (deficit) equity | (6.0) | 17.5 | 34.3 | 53.3 | 209.8 | Other Financial Data (in millions) | | Years Ended December 31, 2020 | Years Ended December 31, 2019 | Years Ended December 31, 2018 | Years Ended December 31, 2017 | Years Ended December 31, 2016 | | :--------------------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Net cash provided by (used in) operating activities | $0.8 | $22.4 | $(24.1) | $(172.5) | $(141.7) | | Net cash provided by (used in) investing activities | 23.4 | 5.2 | (57.6) | (15.4) | 142.2 | | Net cash provided by (used in) financing activities | 0.1 | (67.1) | 108.5 | 75.1 | 162.4 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial performance for 2020 and 2019, including revenue, expenses, and liquidity - Total revenue decreased to **$225.1 million in 2020** from $272.3 million in 2019, primarily due to a decrease in product and license revenue[370](index=370&type=chunk) - Product revenue, net, decreased by **$14.9 million (7.0%)** in 2020, driven by a 21% volume decrease in NERLYNX bottles sold[371](index=371&type=chunk) - License revenue decreased by **$37.6 million** in 2020 due to lower upfront payments and performance-based milestones from sub-license agreements[372](index=372&type=chunk) - Royalty revenue increased by **$5.3 million** in 2020, reflecting increased product sales by sub-licensees in international territories[373](index=373&type=chunk) - Total operating costs and expenses decreased by **17.9% to $255.5 million** in 2020 from $311.3 million in 2019[374](index=374&type=chunk)[376](index=376&type=chunk)[377](index=377&type=chunk) - Net loss for 2020 was **$60.0 million**, compared to $75.6 million in 2019[354](index=354&type=chunk)[388](index=388&type=chunk) - The company reported positive cash flows from operating activities of **$0.8 million in 2020**, down from $22.4 million in 2019[391](index=391&type=chunk) - As of December 31, 2020, the company had **$100.0 million in principal amounts outstanding** under its New Credit Facility, with an effective interest rate of 12.75%[402](index=402&type=chunk)[407](index=407&type=chunk) Revenue Breakdown (in millions) | Revenue Type | 2020 | 2019 | Change (2020 vs 2019) | | :------------- | :----- | :----- | :-------------------- | | Product revenue, net | $196.7 | $211.6 | $(14.9) | | License revenue | $22.7 | $60.3 | $(37.6) | | Royalty revenue | $5.7 | $0.4 | $5.3 | | **Total Revenue** | **$225.1** | **$272.3** | **$(47.2)** | Selling, General and Administrative Expenses (in thousands) | Category | 2020 | 2019 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Payroll and related costs | $41,313 | $41,415 | $(102) | -0.2% | | Professional fees and expenses | $42,935 | $49,060 | $(6,125) | -12.5% | | Travel and meetings | $4,726 | $10,987 | $(6,261) | -57.0% | | Facilities and equipment costs | $5,673 | $5,803 | $(130) | -2.2% | | Loss on impairment of asset | $— | $1,183 | $(1,183) | -100.0% | | Stock-based compensation | $17,778 | $27,892 | $(10,114) | -36.3% | | Credit loss expense | $1,000 | $— | $1,000 | 100.0% | | Other | $5,063 | $5,299 | $(236) | -4.5% | | **Total SG&A expenses** | **$118,488** | **$141,639** | **$(23,151)** | **-16.3%** | Research and Development Expenses (in thousands) | Category | 2020 | 2019 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Clinical trial expense | $31,428 | $51,545 | $(20,117) | -39.0% | | Internal R&D | $38,736 | $39,603 | $(867) | -2.2% | | Consultant and contractors | $8,689 | $12,268 | $(3,579) | -29.2% | | Stock-based compensation | $18,797 | $29,435 | $(10,638) | -36.1% | | **Total R&D expenses** | **$97,650** | **$132,851** | **$(35,201)** | **-26.5%** | Liquidity and Capital Resources (in thousands) | Category | December 31, 2020 | December 31, 2019 | | :------------------------------------------------- | :------------------ | :------------------ | | Cash and cash equivalents | $85,293 | $60,037 | | Marketable securities | $8,096 | $51,607 | | Working capital | $31,884 | $75,459 | | Stockholders' (deficit) equity | $(5,951) | $17,463 | | Net cash provided by (used in) operating activities | $773 | $22,376 | | Net cash provided by (used in) investing activities | $23,403 | $5,163 | | Net cash provided by (used in) financing activities | $68 | $(67,067) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $24,244 | $(39,528) | Contractual Obligations (as of December 31, 2020, in thousands) | Contractual Obligations | Total | Less than 1 year | 1 - 3 years | 3 - 5 years | More than 5 years | | :---------------------- | :---- | :--------------- | :---------- | :---------- | :---------------- | | Operating lease obligations | $29,776 | $5,365 | $11,114 | $13,297 | $— | | Debt obligations (principal and interest) | $126,509 | $23,194 | $78,214 | $25,101 | $— | | **Total** | **$156,285** | **$28,559** | **$89,328** | **$38,398** | **$—** | [Quantitative and Qualitative Disclosures About Market Risk](index=79&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure relates to interest rate changes affecting its cash equivalents and term loans - The company's primary market risk exposure is to **changes in interest rates**, affecting cash equivalents and outstanding term loans[440](index=440&type=chunk)[442](index=442&type=chunk) - Excess cash is invested in cash equivalents with objectives of liquidity and principal preservation[440](index=440&type=chunk) - A **10% increase in interest rates** is not expected to materially affect the realized value of cash equivalents[441](index=441&type=chunk) - As of December 31, 2020, outstanding term loans totaled **$100 million**, bearing variable interest, and a 100 basis point increase in interest rates would not have materially affected interest expense for 2020[442](index=442&type=chunk) [Financial Statements and Supplementary Data](index=79&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This item refers to the consolidated financial statements and supplementary data presented elsewhere in the Annual Report [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=79&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with accountants on accounting and financial disclosure matters [Controls and Procedures](index=79&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2020 - As of December 31, 2020, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective**[446](index=446&type=chunk) - There were **no material changes** in internal control over financial reporting during the year ended December 31, 2020[447](index=447&type=chunk) - Management assessed the effectiveness of internal control over financial reporting as of December 31, 2020, based on the COSO 2013 framework, and concluded it was effective[450](index=450&type=chunk) - KPMG LLP, the independent registered public accounting firm, issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of December 31, 2020[451](index=451&type=chunk)[453](index=453&type=chunk) [Other Information](index=81&type=section&id=Item%209B.%20Other%20Information) The company amended its agreement with Pierre Fabre to extend NERLYNX rights to Greater China and terminated its agreement with CANbridge - On February 24, 2021, Puma Biotechnology entered into the Second Pierre Fabre Amendment, extending **NERLYNX commercial rights to Greater China**[461](index=461&type=chunk)[649](index=649&type=chunk) - Under the Pierre Fabre amendment, the company will receive a **$50.0 million upfront payment** and up to $240.0 million in additional milestone payments, plus royalties[461](index=461&type=chunk)[649](index=649&type=chunk) - Concurrently, the company terminated its sub-license agreement with CANbridge BIOMED Limited for Greater China, paying a one-time termination fee of **$20.0 million** to regain all rights[463](index=463&type=chunk)[649](index=649&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=81&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This item incorporates by reference information from the company's 2021 Proxy Statement [Executive Compensation](index=81&type=section&id=Item%2011.%20Executive%20Compensation) This item incorporates by reference information regarding executive compensation from the company's 2021 Proxy Statement [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=81&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This item incorporates by reference information regarding security ownership from the company's 2021 Proxy Statement [Certain Relationships and Related Transactions, and Director Independence](index=81&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This item incorporates by reference information regarding related transactions and director independence from the company's 2021 Proxy Statement [Principal Accounting Fees and Services](index=81&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This item incorporates by reference information regarding accounting fees and services from the company's 2021 Proxy Statement Part IV [Exhibits, Financial Statement Schedules](index=82&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K - The report includes the Report of Independent Registered Public Accounting Firm, Consolidated Financial Statements, and Notes to Consolidated Financial Statements[471](index=471&type=chunk) - Consolidated Financial Statement Schedules have been omitted as they are not required or applicable[472](index=472&type=chunk) - An Exhibit Index is provided, listing various agreements, plans, and certifications, including the License Agreement with Pfizer Inc and the Loan and Security Agreement with Oxford Finance LLC[472](index=472&type=chunk)[476](index=476&type=chunk)[477](index=477&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk) [Form 10-K Summary](index=83&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company states that no Form 10-K Summary is included in this report

Financial Data and Key Metrics Changes - Total revenue for Q4 2020 was reported at $52.6 million, which includes net U.S. NERLYNX sales and royalty fees from sublicensees [9] - Net U.S. NERLYNX sales were $50 million in Q4 2020, a slight increase from $49.3 million in Q3 2020, but a decrease from $58.7 million in Q4 2019 [9] - Royalty revenue for Q4 2020 was $2.6 million, compared to $200,000 in Q4 2019 [9] - The company reported a GAAP net loss of $15 million or $0.38 per share for Q4 2020, an improvement from a GAAP net loss of $31.5 million in Q3 2020 [41] - Non-GAAP net loss for Q4 2020 was $5.5 million or $0.14 per share [42] Business Line Data and Key Metrics Changes - NERLYNX sales gross revenue was $60.1 million in Q4 2020, up from $58.6 million in Q3 2020 [43] - Approximately 79% of NERLYNX sales were through the specialty pharmacy channel, with 21% through the specialty distributor channel [25] - The number of NERLYNX bottles sold in Q4 2020 was 3,585, a slight decrease from 3,611 in Q3 2020 [30] Market Data and Key Metrics Changes - The company anticipates that NERLYNX net sales for fiscal year 2021 will be in the range of $205 million to $210 million [45] - The gross-to-net adjustment for Q4 2020 was approximately 16.8%, an increase from 15.8% in Q3 2020 [44] - The company expects Q1 2021 NERLYNX net sales to be in the range of $42 million to $43 million [47] Company Strategy and Development Direction - The company is focusing on the extended adjuvant setting for NERLYNX, aiming to prevent patients from becoming metastatic, as this market is significantly underpenetrated [24][59] - Puma has extended its licensing agreement with Pierre Fabre to include commercialization rights for NERLYNX in Greater China, with an upfront payment of $50 million and potential milestone payments of up to $240 million [19][21] - The company is adapting to a virtual environment due to the COVID-19 pandemic and is hopeful that changes to its commercial infrastructure will positively impact NERLYNX sales growth [52][53] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the COVID-19 pandemic on achieving sales growth and emphasized the need for improvement in NERLYNX sales [52] - The company remains committed to addressing the unmet needs of women battling breast cancer and is focused on finding more effective ways to assist these patients [54] - Management expressed optimism about the second half of 2021, anticipating a more favorable commercial promotional environment as vaccination efforts progress [67] Other Important Information - The company reported cash burn of $15.6 million in Q4 2020, which included a $10.1 million milestone payment to Pfizer [50] - As of the end of Q4 2020, the company had $93.4 million in cash, cash equivalents, and marketable securities [51] Q&A Session Summary Question: Next steps on ongoing litigation regarding T790M patent in the EU and feedback on competition in the metastatic setting - Management indicated that the T790M patent is a sensitive legal matter and could not provide much detail. They noted that while the metastatic setting is competitive, their focus remains on the extended adjuvant setting where they see less competition [56][58] Question: Bar for success in EGFR exon 18 lung cancer and guidance assumptions for NERLYNX sales in 2021 - Management stated that the interim data showed a 40% response rate for EGFR exon 18, which compares favorably to existing data. They also noted that guidance for NERLYNX sales in 2021 considers the impact of the pandemic, with expectations for growth in the second half of the year as conditions improve [64][67] Question: Accelerated approval for HER2-mutant hormone receptor positive breast cancer cohort of the SUMMIT trial - Management explained that they are focusing on isolating the contribution of neratinib in combination therapies and are hopeful for a favorable response from the FDA based on the data [70][76] Question: Market for neratinib in Asia and go-to-market strategy for additional geographies - Management expressed optimism about the partnership with Pierre Fabre in Asia, highlighting their existing commercial infrastructure and plans for a launch in China. They also mentioned ongoing partnerships across various regions and potential for further expansions [81][84] Question: Current revenue breakdown from extended adjuvant versus metastatic settings - Management indicated that approximately 6% of new patient starts are in the metastatic setting, with expectations for this to remain consistent as the focus is on the extended adjuvant market [98]

Background Results HER2 activation results in enhanced tumor growth in preclinical models Aberrant HER2 activation HER2 amplification or overexpressionHER2 (ERBB2) somatic mutations P P P P P P P P P Activation of downstream signal transduction pathways Subset of HER2 mutations result in constitutive kinase signaling, oncogenic transformation and enhanced tumor growth in preclinical models1 Biliary tract cancer and HER2 mutations Biliary tract cancer is a heterogeneous and rare disease with poor prognosis; ...

Financial Performance - Net NERLYNX revenue reached approximately $49.3 million in Q3 2020[10] - Approximately 3,600 ex-factory bottles of NERLYNX were sold in Q3 2020[15] NERLYNX Usage - Around 33% of patients in Q3 2020 started NERLYNX at a reduced dose (fewer than 6 pills per day)[18, 20] Global Expansion & Regulatory Milestones - Australia/SE Asia: Approved in Australia (March 2019), Singapore (December 2019), Brunei, Malaysia, New Zealand (Q2/Q3 2020)[23] - Israel: Launched in Q1 2020; Approved for metastatic breast cancer in Q3 2020[24] - Canada: Approved in July 2019; Metastatic sNDS accepted by HC in September 2020[24] - Greater China: Approved in Hong Kong (November 2019), China (April 2020), and Taiwan (August 2020)[24] - Latin America: Launched in Argentina (Q1 2020); Approved in Chile (Q2 2020) and Ecuador (Q3 2020); Expecting approvals in Brazil, Colombia, Mexico, and Peru in 2021[25] - Europe: Launched in Germany, United Kingdom, and Austria (Q4 2019); Launched in Sweden and approved in Switzerland (Q1 2020); Planned launch in Finland (Q4 2020)[26] - South Korea: NDA filed in October 2020[28]

Puma Biotechnology, Inc. (PBY) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants Mariann Ohanesian – Senior Director-Investor Relations Alan Auerbach – Chief Executive Officer, President, and Chairman of the Board Jeff Ludwig – Chief Commercial Officer Maximo Nougues – Chief Financial Officer Conference Call Participants Ed White – H.C. Wainwright & Company Samantha Semenkow – Citi Kennen MacKay – RBC Capital Markets Laura Christianson – Cowen and Company Operator Greetings ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or other jurisdiction ...

NERLYNX Revenue and Sales - Net NERLYNX revenue for Q2 2020 was approximately $48.8 million[9] - Approximately 3,700 commercial bottles of NERLYNX were sold in Q2 2020[13] NERLYNX Dosing Trends - Approximately 31% of patients in Q2 2020 started NERLYNX at a reduced dose[17] Rest of World Partnerships - Regulatory and Launch Milestones - Australia/SE Asia: Approved in Australia (March 2019), Singapore (December 2019), Brunei, Malaysia, and New Zealand (Q2/Q3 2020)[22] - Israel: Launched in Q1 2020[22] - Canada: Approved in July 2019[22] - Greater China: Approved in Hong Kong (November 2019), China (April 2020), and Taiwan (August 2020)[22] - Latin America: Argentina-Launched (Q1 2020), Approved in Chile (Q2 2020), Ecuador (2H 2020), Brazil, Colombia, Mexico, Peru (2021)[22] - Europe Middle East North and West Africa South Africa Turkey: Germany-Launched (Q4 2019), United Kingdom-Launched (Q4 2019), Austria-Launched (Q4 2019), Sweden Launched (Q1 2020), Approved in Switzerland (Q1 2020), Rest of Territory (2020-2023)[22] - South Korea: NDA Filing expected by the end of 2020[22]

Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2020 of $70.6 million, which includes net U.S. NERLYNX sales and license and royalty fees [7] - Net U.S. NERLYNX sales were $48.8 million in Q2 2020, a slight increase from $48.6 million in Q1 2020 but a decrease from $53.8 million in Q2 2019 [7][8] - The company reported a GAAP net income of $3.4 million or $0.08 per diluted share for Q2 2020, compared to net losses of $16.9 million in Q1 2020 and $11.2 million in Q4 2019 [25] - On a non-GAAP basis, net income was $14 million or $0.35 per diluted share for Q2 2020 [25] - The gross to net adjustment in Q2 was 14.4%, down from 16.3% in Q1 2020 [26] Business Line Data and Key Metrics Changes - License fees increased by $20.7 million in Q2 2020, including a one-time payment due to regulatory approval of NERLYNX in mainland China [8] - Royalty revenue for the quarter was $1.1 million [8] - NERLYNX sales gross revenue was $57 million in Q2 2020, compared to $58 million in Q1 2020 [25] Market Data and Key Metrics Changes - The number of new patients signing up in April was flat compared to March, with a decline in May attributed to the COVID-19 pandemic [16] - Approximately 22% of total bottles sold in Q2 were through the specialty distribution channel, consistent with Q1 [17] - In Q2, 8% to 10% of new patient starts were in the metastatic setting, with the majority in the extended management setting [19] Company Strategy and Development Direction - The company is focused on improving NERLYNX sales growth and has made new hires in the commercial team to adapt to a virtual commercial environment due to COVID-19 [32][33] - Puma is committed to addressing the unmet needs of women battling breast cancer and aims to enhance the effectiveness of NERLYNX [33] - The company anticipates NERLYNX net sales for the full year 2020 to be in the range of $200 million to $210 million, a reduction from previous estimates [27] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that COVID-19 has negatively impacted commercial access and patient enrollment in clinical trials [16][11] - The company expects continued uncertainty regarding the impact of COVID-19 on sales, royalties, and license fees [27] - Management remains optimistic about the potential for NERLYNX to be approved in additional countries and is focused on expanding its market presence [20][21] Other Important Information - The company ended Q2 2020 with $107.3 million in cash, cash equivalents, and marketable securities [30] - Research and development expenses were $24.7 million in Q2 2020, a decrease from previous quarters [29] Q&A Session Summary Question: Contribution of metastatic revenues to overall NERLYNX picture - Management indicated that 8% to 10% of NERLYNX usage is in the metastatic setting, with anecdotal reports of off-label use in HER2-mutated breast cancer [35] Question: Guidance confirmation for adjuvant and metastatic settings - Management confirmed that the guidance provided is for both the adjuvant and metastatic settings [36] Question: Research on neratinib as a COVID-19 treatment - Management acknowledged awareness of research suggesting neratinib's potential as a COVID-19 treatment and indicated ongoing investigations [41] Question: HER2-mutant cervical cancer cohort update - Management did not have specific enrollment numbers but indicated plans to present more data in the future [42] Question: NERLYNX pricing strategy - Management refrained from commenting on future pricing strategies but emphasized the importance of maintaining a strong value proposition [46] Question: Impact of new language in NERLYNX package insert - Management noted that the ExteNET trial included a wide range of patients and plans to present data on specific cohorts at an upcoming meeting [50] Question: Salesforce and virtual interaction capabilities - Management discussed adapting the salesforce to virtual interactions due to COVID-19 and emphasized careful resource management [59][60] Question: Pre-NDA meeting preparations for HER2-mutated breast cancer - Management indicated that further analyses would depend on the data from the ongoing trials [61][62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 77-0683487 (I.R.S. Employer Identification Number) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition peri ...