PUMA BIOTECHNOLOGY INC 2026 Q2 Earnings Call

Thank you, Daryl. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2026. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President, and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for the second quarter of 2026. That news release, the slides that Roger will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, August 6th, 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our second quarter 2026 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Marianne, and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2026 of $56.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sub-licensees. Product revenue net was $53.6 million in the second quarter of 2026, an increase from $42 million reported in Q1 of 2026 and $49.2 million reported in Q2 of 2025. As a reminder to investors, Puma's reported NERLYNX sales includes both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Product revenue for the second quarter of 2026 included approximately $1.3 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the second quarter of 2026, compared to $2.8 million in Q1 2026 and $3.2 million in Q2 of 2025.

We reported 2,929 bottles of NERLYNX sold in the second quarter of 2026, compared to 2,328 bottles sold in Q1 2026. In Q2 2026, we estimate that inventory decreased by 57 bottles. In Q2 2026, new prescriptions were down approximately 6% compared to Q1 2026, and total prescriptions were up approximately 7% compared to Q1 2026. Roger will provide further details in his comments and slides. I will now provide updates from Puma's ongoing phase II trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as ALISCA-Lung1 and ALISCA-Breast1. Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the second quarter of 2026.

As investors are aware, Puma has two ongoing phase II trials of our investigational drug, alisertib. ALISCA-Breast1, which is a phase II trial of alisertib in combination with endocrine therapy in patients with HER2-negative hormone receptor-positive recurrent or metastatic breast cancer, and ALISCA-Lung1, a phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative hormone receptor-positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting, have had previous treatment with a CDK4/6 inhibitor, and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

Patients were initially being dosed with alisertib, given at either 30 mg, 40 mg, or 50 mg twice daily, BID, on days one to three, eight to 10, and 15 to 17, on a 28-day cycle in combination with endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. Interim data from this trial was presented on the company's first quarter conference call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Breast1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role.

Based on the feedback that we have received from breast cancer key opinion leaders on this interim data, the trial has been amended such that now we are only continuing enrollment in the 40 milligram and 50 milligram dose groups. That amendment to the protocol has been submitted to the FDA and the EU authorities and is being submitted to the IRBs as well. We are hoping to begin enrollment under that amended protocol in Q3. We will also be updating interim data from the ALISCA-Breast1 trial, including longer-term patient follow-up in the fourth quarter of this year. With respect to the ALISCA-Lung1 study, as investors are aware, Puma has an ongoing phase II trial of our investigational drug, alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer.

Interim data from this trial was presented on the company's first quarter earnings call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with the biomarkers where the Aurora kinase pathway is playing a role. As was also discussed on that call, the company previously amended the trial to increase the dose from 50 milligrams BID to 60 milligrams BID. Dosing in the trial was further increased to 70 milligrams BID, and the company is currently enrolling patients at the 70 milligram BID level. There are currently 92 patients in the trial, with 36 of the patients enrolled at the 60 milligram BID dose and four patients enrolled at the 70 milligram dose.

As was also mentioned on the recent earnings call, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, Alliska Lung 02, where the drug will be given in combination with paclitaxel, similar to the phase II randomized trial that was previously published in the Journal of Thoracic Oncology. The company anticipates that enrollment in the Alliska Lung 02 trial will start in Q3, and the company will provide investors with further information on this trial in the future. The company anticipates that it will have additional interim data from ALISCA-Lung1 and the initial data from Alliska Lung 02 in 2027.

As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial stage and development stage drugs to potentially in-license or acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.

Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX, as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with healthcare professionals through both personal and non-personal promotion. Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression.

Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post adjuvant treatment, but we continue to adopt new prescribers year-over-year who recognize the unmet need in HER2-positive early-stage breast cancer and how NERLYNX may help their patients reduce their risk of recurrence. In summary, we are excited and committed to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer in both the early and metastatic settings. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the second quarter.