For the transition period from to Table of Contents 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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Common Stock, par value $0.0001 ...

Financial Data and Key Metrics Changes - The company reported total revenue of $52.8 million for Q1 2023, with product revenue net at $46.8 million, reflecting a 15% increase from $40.7 million in Q1 2022 but a decline from $53.7 million in Q4 2022 [65][81] - The gross to net adjustment for Q1 2023 was approximately 21.2%, up from 17.8% in Q4 2022, primarily due to higher co-pay [52][81] - The company achieved a net income of $1.4 million or $0.03 per share in Q1 2023, compared to a net loss of $5.6 million or $0.12 per share in Q4 2022 [81][86] Business Line Data and Key Metrics Changes - NERLYNX sales totaled 2,849 bottles in Q1 2023, a 6% increase from Q1 2022 but a 14% decrease from Q4 2022 [51][99] - Approximately 64% of patients started NERLYNX on a lower daily dose in Q1 2023, consistent with Q4 2022 [46] - The company anticipates Q2 2023 net product revenue to be between $47 million and $50 million, indicating a year-over-year decline [47][60] Market Data and Key Metrics Changes - The company noted a 11% quarter-over-quarter growth in new patient enrollment, despite a year-over-year decline [99] - The specialty pharmacy channel accounted for approximately 75% of the business in Q1 2023, while the specialty distributor channel accounted for 25%, a shift from 78% and 22% respectively in Q4 2022 [104] Company Strategy and Development Direction - The company is focused on expanding its outreach to local and regional advocacy organizations to increase NERLYNX adoption [75][103] - Puma continues to evaluate several drugs for potential in-licensing to diversify its portfolio while maintaining net income and cash flow positivity [45][126] - The company plans to meet with the FDA in late Q2 2023 to discuss the registration pathway for alisertib in small cell lung cancer [50][102] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive net income and cash flow for the full year 2023, attributing this to expense reductions [86][114] - The company acknowledged the uncertainty regarding the impact of COVID-19 on sales and royalties, particularly in international markets [111] Other Important Information - The company reported cash and cash equivalents of approximately $71 million as of March 31, 2023 [57] - Research and development expenses were $12.7 million in Q1 2023, a decrease from $13.8 million in Q4 2022 [112] Q&A Session Summary Question: What are the assumptions behind the Q2 net product revenue guidance? - Management indicated that the guidance reflects expected inventory adjustments and market conditions [60] Question: What is the focus for neratinib moving forward? - The company will focus on continued execution in the extended adjuvant and metastatic breast cancer settings, while alisertib will be prioritized for expansion opportunities [19][18] Question: How is the company addressing the challenges in the Chinese market? - Management noted that payments in China can be lumpy due to manufacturing and distribution complexities [27] Question: What are the expectations for the upcoming biomarker data? - The company anticipates presenting biomarker data at the ASCO Annual Meeting in June, which could provide insights into treatment efficacy [41][72]

Puma Biotechnology Earnings Call Commercial Update May 4, 2023 Forward-Looking Safe-Harbor Statement Puma's Pharmacy and Distributor Network Copyright 2023 Puma Biotechnology 3 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 ...

☐ 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 Table of Contents 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 March 31, 2023 OR PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or othe ...

Patients Sites of Care Academic Hospitals Community Hospitals Physician Practices Others (VA, DOD) Hub Services Specialty Pharmacy Network (SP) Specialty Distributor Network (SD) Acaria Health Accredo CVS ONCO 360 Optum / Diplomat Biologics Cardinal Health McKesson ASD/Oncology Supply DMS Pharmaceutical Group Inc. 6.1 20.1 36.0 50.8 52.6 61.1 45.6 53.8 53.5 58.7 48.6 48.8 49.3 50.0 45.8 48.9 43.4 51.0 40.7 51.3 54.3 53.7 Bottles Sold (SP + SD) by Quarter ~64% of patients in Q4'22 started at a reduced dose* ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2022 Earnings Conference Call March 2, 2023 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director of IR Alan Auerbach - CEO, President and Chairman Maximo Nougues - CFO Jeff Ludwig - Chief Commercial Officer Conference Call Participants Dave Rao - Cowen and Company Sahil Kazmi - B. Riley Securities Operator Good afternoon. My name is Diego, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being reco ...

Product Approval and Commercialization - NERLYNX is currently approved in the United States for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed breast cancer and for use in combination with capecitabine for advanced HER2-positive breast cancer [17]. - As of December 31, 2022, NERLYNX has received approval in over 18 countries outside the United States, including the European Union, China, and Canada [19]. - The company relies on a direct sales force of approximately 40 sales specialists to market NERLYNX in the United States [19]. - The company has implemented a managed access program for NERLYNX to provide access to patients in countries with limited therapeutic options [20]. - The company aims to become a leading provider of advanced therapies for cancer treatment, focusing on the commercialization of NERLYNX in the U.S. and pursuing regulatory approvals in additional countries [23]. - NERLYNX was launched in the United States in July 2017, with subsequent approval in February 2020 for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer [93]. - The company aims to establish NERLYNX as the standard of care by educating healthcare providers and patients, ensuring broad insurance coverage, and providing co-pay support [94]. - NERLYNX received marketing authorization in the EU in August 2018 and was included in China's National Reimbursement Drug List in December 2021, enhancing access for patients [95]. - The company is focused on expanding its commercialization efforts for NERLYNX in Europe and other international markets [95]. Clinical Trials and Efficacy - The ExteNET trial demonstrated a 33% reduction in the risk of invasive disease recurrence or death for patients treated with neratinib compared to placebo, with a two-year disease-free survival (DFS) rate of 93.9% for the neratinib arm [33]. - For centrally confirmed HER2-positive patients, neratinib resulted in a 49% reduction in the risk of invasive disease recurrence or death, with a two-year DFS rate of 94.7% [34]. - The five-year invasive disease-free survival (iDFS) rate for the neratinib arm was 90.2%, compared to 87.7% for the placebo arm, indicating a 27% reduction in risk of recurrence or death [36]. - The NALA trial demonstrated a statistically significant improvement in progression-free survival (PFS) for neratinib plus capecitabine with a hazard ratio of 0.76 (p=0.0059) [55]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months compared to 18.7 months for lapatinib plus capecitabine [56]. - The NALA trial showed a cumulative incidence of CNS metastases of 22.8% for neratinib plus capecitabine versus 29.2% for lapatinib plus capecitabine (p=0.043) [57]. - The CONTROL trial showed that the incidence of grade 3 diarrhea was 13% for dose escalation regimen 1 (DE1) and 27% for regimen 2 (DE2), significantly lower than the historical control of 39.8% [48]. - The CONTROL trial indicated that the proportion of patients discontinuing neratinib due to diarrhea was 3% for DE1 and 6% for DE2, compared to 17% in the ExteNET trial [48]. Drug Development and Pipeline - The company has in-licensed alisertib, which is designed to disrupt mitosis in rapidly proliferating tumor cells, and plans to develop it for hormone receptor positive breast cancer and small cell lung cancer [21][22]. - Alisertib has shown activity in previous clinical trials across various cancer types, including hormone receptor positive breast cancer and small cell lung cancer, with over 1,300 patients tested in 22 trials prior to licensing [21]. - The company is focused on in-licensing or acquiring additional drug candidates to build a sustainable product pipeline, employing disciplined decision criteria [23]. - The company plans to maximize the value of its programs by evaluating various commercialization strategies for drug candidates, including independent commercialization and collaborative partnerships [23]. - The company anticipates meeting with the FDA in the first half of 2023 to discuss the clinical development plan for alisertib and its potential dosing schedule under Project Optimus [22]. Financial and Business Risks - The company faces risks related to its status as a single product company with limited commercial sales experience, which may hinder its ability to maintain profitability [11]. - The company is dependent on international third-party sub-licensees for the development and commercialization of NERLYNX in several countries, which poses a risk to its business [11]. - The company is obligated to make milestone payments totaling $187.5 million to Pfizer upon achieving certain milestones, with a one-time payment triggered by FDA approval of NERLYNX in July 2017 [112]. - Under the Pfizer Agreement, the company pays annual royalties between approximately 10% and 20% of net sales of licensed products, reduced to a fixed rate in the low to mid-teens as per a 2014 amendment [114]. - The company must use commercially reasonable efforts to develop and commercialize products in specified major-market countries under the Takeda Agreement [117]. Regulatory Environment - The FDA has a goal of ten months to review and act on a standard NDA for a new molecular entity, typically taking twelve months from submission [155]. - The FDA may grant orphan designation to drugs intended for rare diseases affecting fewer than 200,000 individuals in the U.S. [160]. - Orphan products receiving FDA approval are entitled to seven years of exclusivity for the same disease or condition, barring certain exceptions [161]. - The FDA's priority review aims to evaluate applications within six months, compared to ten months for standard reviews [165]. - The EU Clinical Trials Regulation (CTR) harmonizes clinical trial processes across EU member states, effective January 31, 2022 [178]. - The CTR allows for a single application submission for clinical trials across multiple EU member states, streamlining the approval process [179]. - The company is subject to comprehensive regulatory oversight by the EMA and must maintain a pharmacovigilance system for monitoring product safety [188]. Market Competition and Intellectual Property - The company faces significant competition from major pharmaceutical and biotechnology companies, including Genentech, Novartis, and Roche, in the cancer treatment market [88]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 4 pending U.S. patent applications related to neratinib [97]. - The company is pursuing patent term extensions and supplemental protection certificates in various jurisdictions to enhance its intellectual property protection [99]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 439 foreign patents related to alisertib, with a focus on developing and commercializing the drug [106]. - The company plans to pursue additional patents for alisertib covering formulations and therapeutic uses, enhancing its intellectual property portfolio [108]. Healthcare Policy and Pricing - Political and regulatory changes in the U.S. healthcare system, such as the ACA, could significantly affect the company's future business operations [203]. - The company may face increased levels of discounts and rebates required by state and federal governments, impacting revenue generation [202]. - The Inflation Reduction Act of 2022 (IRA) requires manufacturers of certain drugs to engage in price negotiations with Medicare starting in 2026, with prices subject to a cap [205]. - The IRA imposes rebates under Medicare Part B and Part D to penalize price increases that exceed inflation, with the first rebates due in 2023 [205]. - The cost of prescription pharmaceuticals in the U.S. remains a significant topic of discussion, with ongoing Congressional inquiries and legislative initiatives aimed at increasing pricing transparency [206].

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was reported at $57.1 million, with product revenue net of $54.3 million, an increase from $51.3 million in Q2 2022 and $43.4 million in Q3 2021 [7][8] - Net loss based on GAAP for Q3 2022 was $0.4 million or $0.01 per share, compared to a net income of $9.4 million or $0.21 per share in Q2 2022 [28] - Non-GAAP net income for Q3 2022 was $2.5 million or $0.05 per share [29] - Gross to net adjustment in Q3 2022 was about 14.3%, down from 19% in Q2 2022 [30] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $0.5 million of inventory build in Q3 2022 [8] - New prescriptions (NRx) increased by approximately 17% compared to Q2 2022, while total prescriptions (TRx) were up about 5% [9][22] - Enrollments grew 7% quarter-over-quarter and 12% year-over-year [22] Market Data and Key Metrics Changes - Approximately 80% of NERLYNX business flowed through the specialty pharmacy channel in Q3 2022 [18] - NERLYNX received regulatory approval for metastatic breast cancer in Ecuador and Singapore, and was launched in Brazil and Spain [24] Company Strategy and Development Direction - The company continues to focus on increasing the adoption of NERLYNX through three strategic areas: communicating clinical data, engaging patients, and enhancing field force execution [16] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [15] Management Comments on Operating Environment and Future Outlook - Management noted that increased face-to-face interactions with healthcare providers (HCPs) have contributed to improved commercial results [37] - The company anticipates a seasonal decline in new patient starts in Q4 2022 due to the side effect profile of NERLYNX [32] Other Important Information - The company expects net NERLYNX product revenue for fiscal year 2022 to be in the range of $194 million to $196 million [31] - Cash burn for Q3 2022 was approximately $17.4 million, compared to $14 million in Q2 2022 [35] Q&A Session Summary Question: Change in timing for FDA meeting - The timing for the FDA meeting was moved to the first half of 2023 due to delays in submitting the packages [41] Question: Size of the sales team - The current size of the field force is deemed appropriate, with adjustments possible if access continues to improve [42][43] Question: Drivers of good commercial quarter - Increased live interactions with clinicians and improved access due to reduced COVID restrictions contributed to the positive commercial quarter [47][48] Question: Payer split and patient compliance - The payer split is approximately 65% commercial and 25% government, with dose escalation showing a 5% to 7% benefit in decreased discontinuations [54] Question: FDA discussion regarding alisertib - The company plans to proceed with the FDA discussions regardless of the availability of biomarker data [55]

Table of Contents 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, 2022 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 ...

Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2022 of $59.5 million, which includes product revenue net of $51.3 million, an increase from $40.7 million in Q1 2022 and $48.9 million in Q2 2021 [9][10] - Net income based on GAAP for Q2 2022 was $9.4 million or $0.21 per share, compared to a net loss of $3.4 million or $0.08 per share in Q1 2022 [45] - Gross revenue from NERLYNX sales was $63.4 million in Q2 2022, up from $51.5 million in Q1 2022 [46] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $2.7 million on inventory build at specialty pharmacies and distributors in Q2 2022 [9] - The company sold 3,200 bottles of NERLYNX in Q2 2022, an increase of 520 from Q1 2022 [11][32] - New prescriptions (NRx) were down approximately 8% compared to Q1, while total prescriptions (TRX) were up about 1.6% [11] Market Data and Key Metrics Changes - Approximately 79% of NERLYNX business went through the specialty pharmacy channel in Q2 2022, slightly down from 81% in Q1 2022 [29] - The extended adjuvant breast cancer market remains significantly under-penetrated, indicating potential growth opportunities [27] Company Strategy and Development Direction - The company remains focused on leveraging positive clinical data for NERLYNX, engaging patients, and enhancing field force execution [25] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio and leverage existing infrastructure [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty regarding the impact of COVID-19 on sales and revenue, but noted a positive trend in face-to-face interactions with healthcare providers [59] - The company anticipates Q3 2022 NERLYNX net sales in the range of $44 million to $47 million, with a net loss expected between $1 million and $2 million [50][52] Other Important Information - The company plans to submit final data from the SUMMIT trial to the FDA later this year [17] - Cash burn for Q2 2022 was approximately $14 million, down from $17 million in Q1 2022 [54] Q&A Session Summary Question: Changes in sales force structure due to increased live interactions - Management believes that a combination of live and virtual interactions will be the new normal, and they are currently satisfied with the size of the sales force [63][65] Question: Presentation of updated HER2-mutated breast cancer data - Management anticipates presenting updated data at the San Antonio Breast Cancer meeting, but the timing of FDA disclosures is uncertain [68] Question: Long-term profitability and cost management - Management reiterated the commitment to being net income positive and cash flow positive, with potential further cost cuts if necessary [77]