Puma Biotechnology NASDAQ: PBYI reported first-quarter 2026 total revenue of $44.8 million, driven primarily by NERLYNX product revenue net of $42.0 million and royalty revenue of $2.8 million, according to remarks on the company’s earnings call. Management attributed the quarter’s product revenue performance in part to a specialty pharmacy and distributor inventory drawdown and highlighted new interim clinical data from ongoing Phase II alisertib studies in small cell lung cancer and HER2-negative, hormone receptor-positive breast cancer.
Quarterly revenue trends and NERLYNX volumes
Chief Executive Officer Alan Auerbach said net product revenue, consisting entirely of NERLYNX sales, declined from $59.9 million in Q4 2025 and from $43.1 million in Q1 2025. He noted that Q1 2026 product revenue was impacted by approximately $7.9 million of inventory drawdown at specialty pharmacies and specialty distributors.
Royalty revenue was $2.8 million in Q1 2026, compared with $15.6 million in Q4 2025 and $2.9 million in Q1 2025. Auerbach said the Q4 2025 royalty figure was driven by a shipment to the company’s partner in China.
On unit metrics, Auerbach said Puma reported 2,328 bottles of NERLYNX sold in Q1 2026 versus 3,298 bottles in Q4 2025, and the company estimated inventory decreased by 439 bottles during the quarter. He also said new prescriptions increased about 25% compared with Q4 2025, while total prescriptions decreased about 4%.
Commercial execution and channel dynamics
Senior Vice President of Sales Roger Storms said the sales team remained focused on expanding healthcare provider reach and engagement. He reported Q1 2026 call activity increased 44% year-over-year and 14% quarter-over-quarter, attributing the increases to “continued emphasis put on executional excellence and increased field accountability.”
Storms described Puma’s distribution split for the quarter, saying about 58% of business was purchased through the specialty pharmacy channel and 42% through the specialty distributor (in-office dispensing) channel. He said Puma continued to see stronger growth in the specialty distributor channel, “driven mainly by increased sales in the group purchasing organizations or GPO segment.”
On demand and prescription metrics, Storms provided several quarter-over-quarter and year-over-year comparisons:
- Enrollments increased about 10% quarter-over-quarter and about 1% year-over-year.
- Commercial new patient starts (NRXs) increased about 25% quarter-over-quarter and about 11% year-over-year.
- Total prescriptions (TRXs) declined about 4% quarter-over-quarter and about 1% year-over-year.
- Commercial demand decreased about 6% quarter-over-quarter but increased about 7% year-over-year.
Storms said specialty distributor demand declined about 9% quarter-over-quarter due to Q4 “buy-ins,” while rising about 28% year-over-year. He also said dose-escalation uptake remained a commercial priority, noting approximately 78% of patients started NERLYNX at a reduced dose in Q1 2026, up from 75% in Q4 2025.
Internationally, Storms noted that NERLYNX was launched in Thailand during Q1 2026 in the extended adjuvant setting.
Senior Vice President of Marketing Heather Blaber said the marketing team remained focused on awareness of clinical data for NERLYNX and reinforcing unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. Blaber said Puma’s strategy aims to increase awareness of NERLYNX’s “dual indication” in HER2-positive breast cancer, describing the product’s role in early-stage disease and in the metastatic setting.
Alisertib interim data: small cell lung cancer (ALISCA-Lung1)
Auerbach presented interim results from the Phase II ALISCA-Lung1 study (PUMA-ALI-4201), which enrolls up to 60 patients with small cell lung cancer previously treated with platinum-based chemotherapy and immunotherapy, including second- and third-line patients. He said the trial began dosing at 50 mg BID (days 1–7 of a 21-day cycle), was amended to 60 mg BID, and Puma is “now in the process of increasing the dose to 70 mg BID.” Mandatory prophylactic G-CSF is used to reduce neutropenia.
In the interim analysis, Auerbach cited safety outcomes including all-grade neutropenia rates of 19.2% (50 mg arm) and 22% (60 mg arm), with Grade 3 or higher neutropenia of 13.5% and 11.1%, respectively. He compared these results with a previously published alisertib monotherapy Phase II study in small cell lung cancer (C14007), noting that C14007 did not mandate G-CSF prophylaxis and that prophylactic G-CSF “appeared to reduce” severe neutropenia rates.
For efficacy, Auerbach said that among 52 patients treated at 50 mg, four patients (11.5%) had a best response of partial response and 18 patients (34.6%) had stable disease, with median progression-free survival (PFS) of 1.7 months. In the first 15 patients treated at 60 mg, he reported one partial response (6.7%) and seven cases of stable disease (46.7%), with median PFS of 4.2 months, while cautioning it was early and additional follow-up is needed.
Auerbach also discussed biomarker analyses centered on c-MYC, including Kaplan-Meier PFS analyses by c-MYC H-score and by percent of tumor cells that are c-MYC positive. He said that across the combined 50 mg and 60 mg cohorts, patients with higher c-MYC H-scores (101–300) showed longer median PFS than those with lower H-scores (0–100). He added that in the 60 mg cohort, median PFS had not yet been reached for patients with c-MYC H-scores of 101–300.
Auerbach said Puma plans to continue dose escalation to 70 mg and “hope[s] to begin enrollment of the 70 mg cohort in the second half of 2026.” He also said Puma intends to initiate a second study, ALISCA-Lung2, evaluating alisertib in combination with paclitaxel with mandatory G-CSF prophylaxis, which the company hopes to start in the second half of 2026. Additional interim efficacy data from ALISCA-Lung1 is anticipated in the second half of 2026 or the first half of 2027.
Alisertib interim data: ER-positive breast cancer (ALISCA-Breast1)
Auerbach also presented interim data from the Phase II ALISCA-Breast1 study (PUMA-ALI-1201), evaluating alisertib combined with endocrine therapy in patients with HER2-negative, hormone receptor-positive recurrent or metastatic breast cancer. He said eligible patients must be chemotherapy-naïve in the recurrent/metastatic setting, have received a CDK4/6 inhibitor, and have had at least two prior lines of endocrine therapy in the recurrent/metastatic setting. Dosing evaluated 30 mg, 40 mg, or 50 mg BID on days 1–3, 8–10, and 15–17 of a 28-day cycle.
Among 164 patients in the interim analysis, Auerbach said most were treated in the third-line or later setting. On safety, he highlighted Grade 3 or higher neutropenia rates of 8% (30 mg), 10.2% (40 mg), and 26.9% (50 mg), noting prophylactic G-CSF was not used. He also said these severe neutropenia rates appeared lower than those reported in a previously published Phase II study (TBCRC 041) in JAMA Oncology (2020).
For efficacy, Auerbach said best response rates were 5% (30 mg), 20% (40 mg), and 18.4% (50 mg). Median PFS was 2.04 months for the 30 mg arm, 5.45 months for 40 mg, and 5.59 months for 50 mg.
Auerbach described biomarker findings suggesting longer PFS in certain subgroups, including patients with c-MYC copy number gain and higher percentages of c-MYC-positive tumor cells. He also discussed analyses by ESR1 and PIK3CA status, including a subset analysis focusing on patients who were PIK3CA wild type and ESR1 mutated. He said that at the 50 mg dose in that subgroup, “no patient has yet progressed,” while cautioning that patient numbers were small and further follow-up is needed.
Auerbach added that many patients in the trial had been treated with newer oral SERDs, saying approximately 58% of ESR1-mutated patients had received oral SERDs including camizestrant, elacestrant, giredestrant, imlunestrant, or palazestrant.
Based on interim results, Auerbach said Puma plans to expand enrollment to obtain more data in biomarker-focused cohorts, with a focus on patients who are PIK3CA wild type, ESR1 mutant, or both, which the company expects to occur in the second half of 2026. Updated ALISCA-Breast1 data is also planned for the second half of 2026.
Financial results, guidance updates, and balance sheet
Chief Financial Officer Maximo Nougues reported a GAAP net loss of $3.8 million, or $0.07 per share, for Q1 2026, compared with GAAP net income of $13.4 million in Q4 2025. On a non-GAAP basis (adjusted to remove stock-based compensation), Puma reported a net loss of $1.9 million, or $0.04 per share.
Nougues said gross revenue from NERLYNX sales was $57.5 million in Q1 2026 versus $82.9 million in Q4 2025. U.S. net sales of NERLYNX were $41.9 million in Q1 2026 versus $55.2 million in Q4 2025, with the decrease driven by lower demand and the inventory reduction in Q1 compared with an inventory increase in Q4.
Gross-to-net adjustment was about 27% in Q1 2026 versus 27.8% in Q4 2025, with Nougues attributing the lower adjustment mostly to lower government chargebacks. Cost of sales was $10.4 million, including $2.4 million of amortization of intangible assets related to the neratinib license, and Nougues said Puma expects to continue recognizing about $2.4 million per quarter of milestone amortization as cost of sales.
Puma raised its full-year 2026 net NERLYNX product revenue guidance to $202 million–$206 million, up from $194 million–$198 million. The company also raised full-year net income guidance to $16 million–$19 million, up from $10 million–$13 million, and said guidance does not include any potential release of additional tax asset valuation allowance.
For Q2 2026, Nougues guided to NERLYNX product revenue of $50 million–$52 million and royalty revenue of $2 million–$3 million, with no license revenue expected. Puma expects Q2 gross-to-net adjustment of approximately 27%–28% and projected Q2 net income of $2 million–$4 million.
Operating expenses included SG&A of $18.4 million (flat versus Q4 2025) and R&D of $19.8 million (up from $16.8 million in Q4 2025). Nougues said Puma anticipates higher operating expenses in 2026 versus 2025, including an expected 1%–2% increase in SG&A and a 34%–37% increase in R&D due to clinical trial progress.
On the balance sheet, Nougues said Puma had approximately $101.5 million in cash, cash equivalents, and marketable securities as of March 31, 2026, compared with about $97.5 million at year-end 2025. He also said Puma made its eighth quarterly principal loan payment of $11.1 million to Athyrium during Q1, and that after quarter end the company made its final payment, leaving Puma “now debt-free.”
In the Q&A session, Auerbach said Puma is seeing a stronger signal in c-MYC-positive populations in both lung and breast studies and is considering how to incorporate c-MYC biology into future designs, while emphasizing the need for additional data to refine patient selection. He added that the company remains “all systems go” on both programs, and said the key to advancing development is additional patient numbers and longer duration of follow-up.
About Puma Biotechnology NASDAQ: PBYI
Puma Biotechnology, Inc is a late‐stage biopharmaceutical company dedicated to the development and commercialization of targeted therapies for oncology patients. Founded in 2010 and headquartered in Los Angeles, California, the company focuses on advancing molecularly defined cancer treatments that address significant unmet medical needs.
The company's lead product is neratinib, marketed under the brand name Nerlynx in the United States. Neratinib is an irreversible small‐molecule tyrosine kinase inhibitor designed to target the HER2 receptor, and it received FDA approval in 2017 for extended adjuvant treatment of early‐stage HER2-positive breast cancer.
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