Puma SE ( OTCPK:PUMSY ) ( OTCPK:PMMAF ) has a lot of tailwinds ahead as the company has large growth plans in the US market, and will benefit from their recent endorsements. Though their financial performance has been looking Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seekin ...

Puma SE ( PUMSY ) has gone down almost 50% this year. They have struggled with their profitability the past couple of years and investors has sent the company rocketing down. At the bright side, Puma is still growing its topline andHi, my name is Sander Pettersen Heio, I am from Norway. My primary focus is on foreign stocks, particularly within the Nordic market, where I analyze companies across various industries, from stable blue-chip firms to emerging market leaders. In addition to Nordic equities, I wri ...

Core Insights - The article emphasizes the importance of value investing and highlights Puma Biotechnology (PBYI) as a strong value stock opportunity [2][3][7] Company Metrics - Puma Biotechnology (PBYI) has a Zacks Rank of 2 (Buy) and a Value grade of A, indicating it is among the best value stocks currently available [3] - PBYI's PEG ratio is 1.38, significantly lower than the industry average of 3.07, suggesting it may be undervalued [4] - The company's P/B ratio stands at 2.06, compared to the industry average of 3.29, indicating a solid valuation relative to its book value [5] - PBYI's P/CF ratio is 4.22, which is attractive when compared to the industry's average of 13.37, further supporting the notion of undervaluation [6] Investment Outlook - The combination of PBYI's favorable metrics and strong earnings outlook positions it as a compelling value stock at this time [7]

Puma Biotechnology (PBYI) reported fourth-quarter 2024 adjusted earnings of 43 cents per share, which beat the Zacks Consensus Estimate of 14 cents. In the year-ago quarter, the company reported adjusted earnings of 31 cents per share.The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 39 cents compared with 26 cents in the year-ago quarter.For the fourth quarter, the company recorded a non-cash deferred tax income benefit of $7.1 m ...

Financial Data and Key Metrics Changes - Puma reported total revenue for Q4 2024 of $59.1 million, with product revenue net at $54.4 million, a decline from $56.1 million in Q3 2024 but an increase from $53.2 million in Q4 2023 [8][9] - Royalty revenue was $4.7 million in Q4 2024, down from $24.4 million in Q3 2024 and $19.0 million in Q4 2023 [9][42] - Net income based on GAAP for Q4 2024 was $19.3 million or $0.39 per share, compared to $20.3 million or $0.41 per share in Q3 2024 [38][39] - Non-GAAP net income for Q4 2024 was $21.1 million or $0.43 per share [40] Business Line Data and Key Metrics Changes - NERLYNX sales in Q4 2024 were impacted by a $3.7 million inventory increase at specialty pharmacies and distributors [9] - Total prescriptions (TRx) grew 4% quarter-over-quarter and 3% year-over-year, while new prescriptions (NRx) decreased 7% quarter-over-quarter but increased 10% year-over-year [30][31] - Approximately 74% of patients started NERLYNX at a reduced dose in Q4 2024, similar to 76% in Q4 2023 [32] Market Data and Key Metrics Changes - In Q4 2024, 75% of business was purchased through the Specialty Pharmacy channel and 25% through the Specialty Distributor channel [25] - NERLYNX received regulatory approval in Turkey and Thailand for extended adjuvant settings [34] Company Strategy and Development Direction - The company is focused on increasing NERLYNX utilization among high-risk patients and enhancing engagement with clinicians [21] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [18] - The company anticipates net NERLYNX product revenue for fiscal year 2025 to be between $192 million and $198 million [44] Management's Comments on Operating Environment and Future Outlook - Management highlighted a commitment to maintaining positive net income and financial discipline [53][54] - The company expects a net loss between $2 million and breakeven for Q1 2025, typically the lowest revenue quarter due to inventory burn-off [48] Other Important Information - Cash earned in Q4 2024 was approximately $4.3 million, with total outstanding principal debt increasing to approximately $67 million [50][51] - The company plans to keep investors updated on the progress of its clinical trials and potential new drug in-licensing opportunities [18][46] Q&A Session Summary Question: Expectations for Phase 1 MCI data presentation - Management expects interim data to be presented at either AACR or ASCO [58] Question: Current statistics on persistence and compliance - Management is working to educate customers on the benefits of completing therapy and has seen a 5% to 10% increase in patients remaining on therapy when starting at a lower dose [60][64] Question: Revenue guidance and price versus volume considerations - Management anticipates a decrease in product supply revenue and has implemented a 7% price increase in early Q1 2025 [67] Question: Royalty stream from China and its lumpiness - Management confirmed that royalties from China may be lumpy due to the distribution network and regulatory transitions [70][72] Question: Impact of IRA's Part D redesign on reimbursement - Management noted no significant impact on Medicare patient trends due to IRA reform [76] Question: Expectations for interim data from the alisertib breast cancer trial - Management indicated that interim data would include early response and duration data, with specifics to be shared in future calls [78]

Core Viewpoint - Puma Biotech reported quarterly earnings of $0.43 per share, significantly exceeding the Zacks Consensus Estimate of $0.14 per share, marking an earnings surprise of 207.14% [1][2] Financial Performance - The company achieved revenues of $59.1 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 14.02%, although this represents a decline from year-ago revenues of $72.2 million [2] - Over the last four quarters, Puma Biotech has consistently surpassed consensus EPS estimates [2] Stock Performance - Puma Biotech shares have declined approximately 9.2% since the beginning of the year, contrasting with the S&P 500's gain of 1.3% [3] - The current Zacks Rank for Puma Biotech is 3 (Hold), indicating expected performance in line with the market in the near future [6] Earnings Outlook - The consensus EPS estimate for the upcoming quarter is $0.06 on revenues of $43.77 million, while the estimate for the current fiscal year is $0.56 on revenues of $231.46 million [7] - The trend of estimate revisions for Puma Biotech is currently mixed, which may change following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Puma Biotech belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Puma Biotechnology Earnings Call Commercial Update February 27, 2025 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 ...

Puma Biotechnology (PBYI) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants Mariann Ohanesian - Senior Director of Investor RelationsAlan Auerbach - Founder, Chairman, President, CEO & SecretaryJeffrey Ludwig - Chief Commercial OfficerMaximo F. Nougues - CFO & Principal Accounting OfficerHang Hu - AVP - Biotech Equity Research Conference Call Participants Edward White - MD & Senior Biotechnology AnalystMarc Frahm - Biotechnology Equity Research Analyst Operator Good afternoon. My name ...

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 [21]. - As of December 31, 2024, NERLYNX has received approval in over 40 countries outside the United States, including the European Union, China, and Canada [22]. - The commercialization strategy for NERLYNX includes a direct sales force of approximately 35 specialists in the U.S. and exclusive sub-license agreements for international markets [22]. - NERLYNX was launched in July 2017 and aims to establish itself as the standard of care for extended adjuvant treatment of early stage HER2-positive breast cancer [109]. - NERLYNX received marketing authorization in the EU in August 2018 for early stage hormone receptor positive HER2-overexpressed breast cancer, and was added to China's National Reimbursement Drug List in December 2021, broadening access to more women [113][114]. - The company is actively seeking regulatory or data exclusivity in jurisdictions outside the U.S. and Europe, including Chile and Taiwan [118]. - The company is pursuing patent term extensions for U.S. Patent No. 7,399,865, which is eligible for a five-year extension, expiring December 29, 2030 [118]. - The company has a total obligation of $187.5 million in milestone payments to Pfizer, triggered by FDA approval of NERLYNX in July 2017 [131]. - The annual royalty payments to Pfizer for net sales of licensed products range from approximately 10% to 20%, reduced to a fixed rate in the low to mid-teens as per the amendment in July 2014 [132][133]. Clinical Trials and Efficacy - Neratinib demonstrated a 33% reduction in the risk of invasive disease recurrence or death compared to placebo, with a two-year disease-free survival (DFS) rate of 93.9% for the neratinib arm versus 91.6% for the placebo arm [34]. - In the ExteNET trial, neratinib showed a 27% reduction in the risk of invasive disease recurrence or death after five years, with a five-year invasive disease-free survival (iDFS) rate of 90.2% for the neratinib arm compared to 87.7% for the placebo arm [38]. - The two-year DFS rate for centrally confirmed HER2-positive patients treated with neratinib was 94.7%, compared to 90.6% for the placebo group, indicating a 49% reduction in the risk of invasive disease recurrence or death [36]. - The Phase III NALA trial enrolled 621 patients, comparing neratinib plus capecitabine to lapatinib plus capecitabine [55]. - Neratinib plus capecitabine showed a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.76 (p=0.0059) compared to lapatinib plus capecitabine [56]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months, compared to 18.7 months for those treated with lapatinib plus capecitabine [57]. - The overall cumulative incidence of CNS metastases was 22.8% for the neratinib plus capecitabine arm, compared to 29.2% for the lapatinib plus capecitabine arm (p=0.043) [58]. - In the TBCRC 022 trial, 49% of patients experienced a CNS Objective Response by composite criteria, with a median overall survival of 13.5 months [65]. Adverse Events and Management - The most frequently observed adverse event in neratinib-treated patients was diarrhea, with about 39.9% experiencing grade 3 or higher diarrhea [33]. - The incidence of grade 3 diarrhea for patients receiving neratinib dose escalation regimen 1 (DE1) was 13%, significantly lower than the historical control of 39.8% from the ExteNET trial [47]. - The median cumulative duration of grade 3 diarrhea across the CONTROL DE study cohorts was 2 to 2.5 days, compared to 5.0 days for the ExteNET trial [47]. - The proportion of patients discontinuing neratinib due to diarrhea was reduced to 3% in DE1 and 6% in DE2, compared to 17% in the ExteNET trial [47]. - The CONTROL trial is investigating the use of antidiarrheal prophylaxis or dose escalation to reduce neratinib-associated diarrhea [45]. Research and Development - The company has in-licensed alisertib, which has shown activity in various cancers and was tested in over 1,300 patients across 22 trials prior to licensing [23]. - The company aims to advance alisertib development in hormone receptor positive breast cancer and small cell lung cancer, focusing on biomarker-driven populations [24]. - Alisertib showed a response rate of 19% in chemotherapy-sensitive small cell lung cancer patients, with a duration of response of 3.1 months [78]. - In a randomized Phase II trial, alisertib plus fulvestrant had a response rate of 20.0% compared to 19.6% for alisertib alone [88]. - The Phase II trial for alisertib in extensive stage small cell lung cancer will enroll up to 60 patients, with a primary endpoint of objective response rate [84]. - Approximately 72% of small cell lung cancer patient samples had c-Myc amplifications, and 60-80% had RB1 mutations [83]. - Alisertib monotherapy in HER2-negative, hormone receptor positive breast cancer resulted in a response rate of 23% and a PFS of 7.9 months [86]. - The Phase II ALISCATM-Breast1 trial is actively enrolling patients to evaluate alisertib in combination with endocrine therapy for chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer [97]. Regulatory and Compliance - The company must comply with extensive regulatory requirements throughout the drug development process, including pre-clinical tests and clinical trials [162]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with Good Manufacturing Practices (cGMP) and Good Clinical Practices (GCP) [175]. - The FDA has a goal of 10 months to review and act on a standard NDA for a new molecular entity, typically taking 12 months from submission [173]. - The FDA may issue a Complete Response Letter indicating deficiencies in the NDA, which may require additional clinical data or trials [176]. - The FDA offers various expedited review programs, including fast track designation, breakthrough therapy designation, priority review, and accelerated approval, aimed at expediting the drug approval process for serious diseases [181]. - Orphan Drug Designation can provide exclusivity for seven years if the product receives the first FDA approval for the designated disease [179]. - In the U.S., the FDCA provides a five-year non-patent data exclusivity period for new chemical entities, preventing other companies from submitting ANDAs during this time [189]. - In the EU, new products receive eight years of data exclusivity and an additional two years of market exclusivity, with potential extensions for new therapeutic indications [203]. Financial and Business Strategy - The company reported net income for the years ended December 31, 2024, 2023, and 2022, but cannot assure continued profitability [13]. - The company faces risks related to its single product status and limited commercial sales experience, which may impact future revenue generation [13]. - The company intends to evaluate options for commercialization of drug candidates, including joint marketing partnerships and out-licensing [24]. - The company is focused on maximizing the value of its programs while maintaining flexibility in commercialization strategies [24]. - The company relies on third parties for the formulation and manufacturing of its drug candidates, which poses risks to development and commercialization efforts [13]. - The company does not have its own manufacturing facilities and relies on third-party contractors for the production of its drug candidates, including NERLYNX and alisertib [160]. - The company anticipates establishing relationships with third-party manufacturers for commercial production if alisertib or other drug candidates obtain marketing approval [161].

Exhibit 99.1 News Release Puma Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results LOS ANGELES, Calif., Feb. 27, 2025 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2024. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2024 compared to the fourth quarter and full year 2023. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Pum ...