Puma Biotechnology Reports Q2 2026 Results: Full Earnings Call Transcript

On Thursday, Puma Biotechnology (NASDAQ: PBYI ) discussed second-quarter financial results during its earnings call. The full transcript is provided below. This content is powered APIs. 6 million, marking a significant increase from previous quarters.

The company is advancing its Phase 2 trials for alisertib in breast and lung cancer, with ongoing adjustments and plans for future Phase 3 trials contingent on continued positive data. Guidance for 2026 has been updated to anticipate net NERLYNX product revenue between $205 million and $209 million, with expected net income of $17 million to $20 million for the year. Puma Biotechnology remains debt-free following the final loan payment and is focusing on maintaining positive net income while evaluating business development opportunities.

Management emphasized the potential of alisertib and the continued strategic focus on increasing NERLYNX prescriptions and expanding market presence, particularly in the specialty distributor channel. Full Transcript Darrell, Operator Good afternoon. My name is Darrell and I will be your conference call operator today. At this time, all participants are in a listen-only mode.

After the speaker's formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you would like to withdraw your question, please press star 2. If you should require operator assistance during the conference, please press star zero.

As a reminder, this call is being recorded. I would now like to turn the conference call over to Marianne Ohansen, Senior Director of Investor Relations for Puma Biotechnology. You may begin your conference. Thank you.

Marianne Ohansen, Senior Director of Investor Relations 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 Noguez, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storm, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for the second quarter of 2026. 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 6, 2026. Puma undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, we may resort 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. Alan Auerbach, Chief Executive Officer, President and Chairman of the Board Thank you, Maryann, and thank you all for joining our call today. 5 million.

Total revenue includes product revenue, net, which consists entirely of NERLYNX sales as well as royalties from our sublicensees. 2 million reported in Q2 of 2025. S. S.

partners. 3 million of inventory drawdown at our specialty pharmacies and specialty distributors. 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 of 2026.

In Q2 2026, we estimate that inventory decreased by 57 bottles. 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 2 trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as ALISCA Lung-1 and ALISCA Breast-1.

Heather Blaber and Roger Storm will add additional color on NERLYNX's commercial activities. Maximo Noguez 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 2 trials of our investigational drug alisertib: ALISCA Breast-1, which is a Phase 2 trial of alisertib in combination with endocrine therapy in patients with HER2-negative, hormone receptor-positive recurrent or metastatic breast cancer; and ALISCA Lung-1, a Phase 2 study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.

As a reminder, the ALISCA Breast-1 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-naïve 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 1 to 3, 8 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 Breast-1 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 mg and 50 mg 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 Breast-1 trial, including longer-term patient follow-up, in the fourth quarter of this year. With respect to the ALISCA Lung-1 study, as investors are aware, Puma has an ongoing Phase 2 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 the presentation, the company believes that the data obtained to date from ALISCA Lung-1 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 mg BID to 60 mg BID. Dosing in the trial was further increased to 70 mg BID, and the company is currently enrolling patients at the 70 mg BID level. There are currently 92 patients in the trial, with 36 of the patients enrolled at the 60 mg BID dose and 4 patients enrolled at the 70 mg 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, ALISCA Lung-2, where the drug will be given in combination with paclitaxel, similar to the Phase 2 randomized trial that was previously published in the Journal of Thoracic Oncology. The company anticipates that enrollment in the ALISCA Lung-2 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 Lung-1 and the initial data from ALISCA Lung-2 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 Storm will follow with a review of our commercial performance during the quarter.

Heather Blaber, Senior Vice President of Marketing 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 setting. I will now turn the call over to Roger Storm to provide an overview on the commercial performance for the second quarter. Roger Storm (Senior Vice President of Sales) Thank you, Heather, and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements.

The sales team remains focused on increasing the use of NERLYNX with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy. Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the Specialty Pharmacy channel and the Specialty Distributor or in-office dispensing channel.

Regarding the overall distribution of our business in Q2 2026, about 61% of our business was purchased through the SP channel and the remaining 39% was purchased through the SD channel. We continue to see stronger growth in the SD channel driven by two main factors: increased sales in the group purchasing organizations, or GPO, segment and increasing 340B purchasing. 2 million we reported in Q2 of 2025. S.

S. partners. Please note that in Q2 2026 we reported minimal product supply revenue to our international partners versus about 100,000 in Q1 of 2026. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross-to-net expenses.

During Q2 2026, we estimate that inventory decreased by about 1 million. 9 million in Q1 of 2026. Slide 5 shows Q2 2026 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. As a reminder, ex-factory bottles include sales to our SP and SD channels.

In Q2 2026, NERLYNX ex-factory bottle sales were 2,929, which represents an approximate 26% increase quarter over quarter and 12% increase year over year. Let me specifically call out the inventory changes from a bottle perspective. In Q2 2026, we estimate that inventory decreased by 57 bottles. As a comparator, we estimate that inventory decreased by 439 bottles in Q1 of 2026 and decreased by 85 bottles in Q2 of 2025.

Slide 6 highlights our commercial demand for the quarter. S. demand was 2,986 bottles, which represents an approximate 8% increase quarter over quarter and 11% increase year over year. As mentioned earlier, we have seen stronger growth in the SD channel where we saw demand grow by about 12% quarter over quarter and 32% year over year.

The year-over-year and quarter-over-quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. Our Q2 2026 call activity increased 18% year over year and 2% quarter over quarter, and total prescriptions, or TRx, increased by 7% quarter over quarter and 3% year over year. Enrollments in the quarter grew 1% quarter over quarter and 12% year over year. Commercial new patient starts in the quarter declined 6% quarter over quarter and grew 8% year over year.

Continued messaging and adoption of dose escalation remains an important commercial priority, and 73% of patients started NERLYNX at a reduced dose. We believe dose escalation, coupled with patient education resources, will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide 7 highlights the strategic collaborations we formed across the globe. Most recently, in Q1 2026, NERLYNX was launched in Thailand, also in the extended adjuvant setting.

We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward. I'll close by sharing my sincere appreciation for the entire Puma Biotechnology team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating, and while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together. I will now turn the call over to Maximo for a review of our financial results.

Maximo Noguez (Chief Financial Officer) Thanks, Roger. I will begin with a brief summary of our financial results for the second quarter of 2026. Please note that I will make comparisons to Q1 2026, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our second quarter 2026 10-Q, which will be filed today and includes our consolidated financial statements.

16 per diluted share. 07 per share. 19 per diluted share for the second quarter of 2026. 5 million in Q1 2026.

2 million reported in Q2 2025. S. S. partners.

Please note that in Q2 2026 we reported product supply revenue to our international partners of around 23,000. S.