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Cuộc họp báo cáo kết quả kinh doanh quý 3/2026 của Puma Biotechnology (PBYI): Định hướng Nerlynx và cập nhật về Alisertib

6 Th11 2026 00:15
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Puma Biotechnology ghi nhận tổng doanh thu quý 3/2026 đạt 55,1 triệu USD, với doanh thu thuần từ sản phẩm Nerlynx đạt 54,1 triệu USD. Lợi nhuận ròng theo GAAP đạt 6,0 triệu USD, trong khi lợi nhuận ròng non-GAAP đạt 8,0 triệu USD.

Ban lãnh đạo thu hẹp dự báo doanh thu thuần Nerlynx năm 2026 xuống 205 triệu – 208 triệu USD, đồng thời nâng dự báo lợi nhuận ròng lên 20 triệu – 22 triệu USD. Công ty tiếp tục triển khai các thử nghiệm lâm sàng đối với alisertib và duy trì kỷ luật tài chính nhằm kiểm soát chi phí.

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Điểm nhấn chính

  • Puma Biotechnology công bố tổng doanh thu quý 3/2026 đạt 55,1 triệu USD. Doanh thu thuần từ sản phẩm Nerlynx tăng lên 54,1 triệu USD từ mức 53,6 triệu USD trong quý 2/2026 và 51,9 triệu USD trong quý 3/2025.
  • Lợi nhuận ròng theo GAAP đạt 6,0 triệu USD, tương đương 0,11 USD trên mỗi cổ phiếu pha loãng. Lợi nhuận ròng non-GAAP đạt 8,0 triệu USD, tương đương 0,15 USD trên mỗi cổ phiếu cơ bản và pha loãng.
  • Nhu cầu Nerlynx tại Mỹ đạt tổng cộng 2.899 lọ, giảm khoảng 3% so với quý trước nhưng tăng 5% so với cùng kỳ năm trước. Số lượng bệnh nhân mới bắt đầu điều trị qua kênh thương mại giảm 13% so với quý trước và giảm 9% so với cùng kỳ năm trước.
  • Doanh thu tiền bản quyền giảm xuống còn 0,9 triệu USD sau khi Puma ghi nhận khoản giảm trừ lũy kế 2,1 triệu USD liên quan đến thị phần thuốc gốc Nerlynx tại Trung Quốc. Tỷ lệ tiền bản quyền thấp hơn sẽ áp dụng cho doanh số bán hàng tại Trung Quốc trong thời gian tới.
  • Ban lãnh đạo đã thu hẹp dự báo doanh thu thuần từ sản phẩm Nerlynx năm 2026 xuống 205 triệu - 208 triệu USD và nâng dự báo lợi nhuận ròng lên 20 triệu - 22 triệu USD.
  • Puma cho biết dữ liệu tạm thời từ thử nghiệm ALISCA-Breast1 ủng hộ việc đưa alisertib tiến tới nghiên cứu giai đoạn 3. Công ty dự kiến sẽ làm việc với các cơ quan quản lý toàn cầu về thiết kế thử nghiệm trong nửa đầu năm 2027.

Kết quả tài chính cốt lõi

Chỉ sốQuý 3/2026So sánh và bối cảnh
Tổng doanh thu55,1 triệu USDBao gồm doanh thu từ sản phẩm Nerlynx và tiền bản quyền
Doanh thu thuần từ sản phẩm Nerlynx54,1 triệu USD53,6 triệu USD trong quý 2/2026; 51,9 triệu USD trong quý 3/2025
Doanh số thuần của Nerlynx tại Mỹ50,6 triệu USD53,6 triệu USD trong quý 2/2026
Doanh thu cung ứng sản phẩm quốc tế3,6 triệu USDKhoảng 17.000 USD trong quý 2/2026
Doanh thu tiền bản quyền0,9 triệu USD2,9 triệu USD trong quý 2/2026; bao gồm khoản giảm trừ lũy kế 2,1 triệu USD liên quan đến Trung Quốc
Lợi nhuận ròng theo GAAP6,0 triệu USD0,11 USD trên mỗi cổ phiếu pha loãng; lợi nhuận ròng quý 2 là 8,2 triệu USD
Lợi nhuận ròng non-GAAP8,0 triệu USD0,15 USD trên mỗi cổ phiếu cơ bản và pha loãng
Giá vốn hàng bán15,2 triệu USDBao gồm 2,4 triệu USD chi phí khấu hao tài sản vô hình từ giấy phép neratinib
Chi phí SG&A16,3 triệu USDGiảm từ mức 17,5 triệu USD trong quý 2/2026
Chi phí R&D18,3 triệu USDGiảm từ mức 18,9 triệu USD trong quý 2/2026
Mức tiêu hao tiền mặt14,7 triệu USD9,7 triệu USD trong quý 2/2026
Tiền, các khoản tương đương tiền và chứng khoán có thể giao dịch108,5 triệu USDTính đến ngày 30 tháng 9 năm 2026; 97,5 triệu USD vào cuối năm 2025

Hoạt động kinh doanh và vận hành

Doanh số xuất xưởng của Nerlynx đạt tổng cộng 2.818 lọ, giảm khoảng 4% cả so với quý trước và so với cùng kỳ năm trước. Lượng hàng tồn kho giảm ước tính 82 lọ, tương đương với mức giải phóng tồn kho khoảng 1,5 triệu USD.

Nhu cầu tại Mỹ đạt 2.899 lọ. Kênh nhà phân phối chuyên biệt đạt mức tăng trưởng 19% so với cùng kỳ năm trước, nhờ doanh số từ các tổ chức mua hàng theo nhóm và sự gia tăng mua hàng theo chương trình 340B. Các nhà thuốc chuyên biệt chiếm 61% hoạt động kinh doanh trong quý 3, trong khi các nhà phân phối chuyên biệt chiếm 39%.

Tổng số đơn thuốc qua nhà thuốc chuyên biệt giảm 5% so với quý 2 và đi ngang so với cùng kỳ năm trước. Số lượt đăng ký bệnh nhân mới giảm 12% so với quý trước và 6% so với cùng kỳ năm trước. Hoạt động tiếp cận khách hàng qua điện thoại giảm 9% so với quý trước và 8% so với cùng kỳ năm trước, phần lớn do tình trạng khuyết nhân sự tạm thời và thời gian vắng mặt tại các địa bàn bán hàng mà ban lãnh đạo kỳ vọng sẽ sớm bình thường hóa.

Puma tiếp tục chú trọng việc điều chỉnh tăng dần liều lượng Nerlynx và hỗ trợ bệnh nhân. Trong quý, 80% bệnh nhân đã bắt đầu điều trị ở liều giảm.

Đối với alisertib, Puma tiếp tục tuyển bệnh nhân tham gia các nhóm liều 40 mg và 50 mg trong thử nghiệm ALISCA-Breast1. Dữ liệu tạm thời cập nhật, bao gồm thời gian theo dõi dài hơn, dự kiến sẽ được công bố tại Hội nghị chuyên đề về ung thư vú San Antonio vào tháng 12. Thử nghiệm ALISCA-Lung1 đang tuyển bệnh nhân với liều 70 mg hai lần mỗi ngày, trong khi dữ liệu ban đầu của ALISCA-Lung2 và các kết quả tạm thời tiếp theo của ALISCA-Lung1 dự kiến sẽ có vào năm 2027.

Công ty cũng tiếp tục đánh giá các loại thuốc đang trong giai đoạn thương mại hóa và giai đoạn phát triển để xem xét tiềm năng cấp phép hoặc mua lại nhằm đa dạng hóa danh mục sản phẩm và tận dụng cơ sở hạ tầng hiện có.

Dự báo của ban lãnh đạo

Hạng mục dự báoTriển vọng hiện tại
Doanh thu thuần từ sản phẩm Nerlynx năm tài chính 2026205 triệu - 208 triệu USD
Doanh thu tiền bản quyền năm tài chính 202618 triệu - 19 triệu USD
Lợi nhuận ròng năm tài chính 202620 triệu - 22 triệu USD
Khoản điều chỉnh từ doanh thu gộp sang thuần năm tài chính 202627,5% - 28,0%
Doanh thu thuần từ sản phẩm Nerlynx quý 4/202656 triệu - 58 triệu USD
Doanh thu tiền bản quyền quý 4/202611 triệu - 12 triệu USD
Lợi nhuận ròng quý 4/202610 triệu - 12 triệu USD
Khoản điều chỉnh từ doanh thu gộp sang thuần quý 4/2026Khoảng 28% - 29%

Puma dự kiến sẽ không có doanh thu cấp phép trong năm 2026. Ban lãnh đạo cũng dự báo chi phí SG&A năm tài chính 2026 sẽ đi ngang so với cùng kỳ năm trước, trong khi chi phí R&D sẽ tăng 28% - 30% khi các thử nghiệm lâm sàng tiến triển.

Triển vọng lợi nhuận ròng không bao gồm bất kỳ khoản hoàn nhập dự phòng giảm giá tài sản thuế tiềm năng nào bổ sung. Puma đang rà soát lại các tài sản thuế thu nhập hoãn lại của mình nhưng chưa xác định liệu có cần điều chỉnh hay không, cũng như thời điểm và quy mô dự kiến của khoản điều chỉnh này.

Rủi ro và các yếu tố trọng yếu cần theo dõi

  • Tỷ lệ tiền bản quyền tại Trung Quốc sẽ thấp hơn trong thời gian tới sau khi thị phần thuốc gốc Nerlynx đạt ngưỡng quy định trong hợp đồng vào năm 2025.
  • Nhu cầu suy giảm, việc giải phóng hàng tồn kho và khoản điều chỉnh từ doanh thu gộp sang thuần cao hơn đã khiến doanh số thuần của Nerlynx tại Mỹ giảm so với quý trước. Ban lãnh đạo cho rằng tỷ lệ điều chỉnh gộp sang thuần cao hơn chủ yếu do tỷ trọng thanh toán qua chương trình Medicaid gia tăng.
  • Số đơn thuốc mới, tổng số đơn thuốc, số lượt đăng ký và số bệnh nhân mới bắt đầu điều trị qua kênh thương mại đều giảm so với quý 2/2026.
  • Ban lãnh đạo dự kiến chi phí R&D sẽ tăng lên khi các thử nghiệm đối với alisertib tiến triển, trong khi các chương trình lâm sàng vẫn đang trong giai đoạn nghiên cứu và phụ thuộc vào các dữ liệu tiếp theo cũng như các cuộc thảo luận với cơ quan quản lý.
  • Puma hiện không kỳ vọng thuế quan sẽ ảnh hưởng trọng yếu đến chi phí sản phẩm hoặc kết quả hoạt động kinh doanh, song ban lãnh đạo cho biết các chính sách thương mại thay đổi nhanh chóng vẫn rất khó dự đoán.

Toàn văn biên bản cuộc gọi báo cáo kết quả kinh doanh


Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

[Operator Instructions]

As a reminder, this conference is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin the conference.

Mariann Ohanesian

Thank you, LaTanya. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the third 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 third 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, November 5, 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 third 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

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the third quarter of 2026 of $55.1 million. Total revenue includes product revenue, net, which consists entirely of Nerlynx sales, as well as royalties from our sublicensees. Product revenue, net was $54.1 million in the third quarter of 2026, an increase from $53.6 million reported in Q2 2026 and $51.9 million reported in Q3 2025.

As a reminder to investors, Puma's reported Nerlynx sales include both U.S. net sales of Nerlynx and product supply revenues of Nerlynx to Puma's ex-U.S. partners. Product revenue for the third quarter of 2026 included approximately $1.5 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was slightly below $1 million in the third quarter of 2026 compared to $2.9 million in Q2 2026 and $2.6 million in Q3 2025.

We reported 2,818 bottles of Nerlynx sold in the third quarter of 2026 compared to 2,929 bottles sold in Q2 2026. In Q3 2026, we estimate that inventory decreased by 82 bottles. In Q3 2026, new prescriptions were down approximately 13% compared to Q2 2026, and total prescriptions were down approximately 5% compared to Q2 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-Lung1, ALISCA-Lung2, and ALISCA-Breast1. Heather Blaber and Roger Storms will add additional color on Nerlynx commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the third quarter of 2026.

As investors are aware, Puma currently has three ongoing Phase 2 studies of our investigational drug, alisertib: ALISCA-Breast1, a Phase 2 trial of alisertib in combination with endocrine treatment in patients with HER2-negative, hormone receptor-positive, recurrent, or metastatic breast cancer; ALISCA-Lung1, a Phase 2 study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer; and ALISCA-Lung2, a Phase 2 trial of alisertib in combination with paclitaxel for the treatment of patients with advanced 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 to be eligible for the trial.

Patients were initially dosed with alisertib given at either 30 mg, 40 mg, or 50 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle in combination with endocrine therapy of the investigator's choice. Patients must not have previously been 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 feedback we have received from breast cancer key opinion leaders on this interim data, the trial has been amended such that we are only continuing enrollment in the 40 mg and 50 mg dose groups.

We began enrollment under that amended protocol during Q3. We are anticipating that updated interim data from the ALISCA-Breast1 study, including longer patient follow-up, will be presented at the San Antonio Breast Cancer Symposium in December. Based on our initial analysis of this data, we believe that the data from ALISCA-Breast1 is supportive of a Phase 3 trial of alisertib in patients with HER2-negative, hormone receptor-positive, recurrent, or metastatic breast cancer.

The company is looking to engage with global regulatory authorities regarding the design of this Phase 3 trial in the first half of 2027. With respect to the ALISCA-Lung1 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 extensive-stage 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 biomarkers where the aurora kinase pathway plays a role. As was also discussed on the call, the company previously amended the trial to increase the dose from 50 mg BID to 60 mg BID. Dosing in this trial was further increased to 70 mg BID, and the company is currently enrolling patients at this 70 mg BID dose level.

We have also initiated a second trial of alisertib in advanced small cell lung cancer, ALISCA-Lung2, where alisertib is given in combination with paclitaxel, similar to the Phase 2 randomized trial that was previously published in the Journal of Thoracic Oncology in February 2020. The company anticipates that they will have additional interim data from the ALISCA-Lung1 trial and initial data from ALISCA-Lung2 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.

Heather Blaber

Thank you, 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 Storms to provide an overview on the commercial performance for the third quarter.

Roger Storms

Thank you, Heather, and thanks to everyone for joining our third 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 committed to expanding the appropriate use of Nerlynx with a primary emphasis on patients at elevated risk of recurrence. The team continues to strengthen clinical education and healthcare provider engagement through non-personal promotional initiatives while leveraging patient support resources to encourage treatment adherence, persistence, and successful completion of Nerlynx therapy.

Let me now transition to some of the commercial slides that will 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 Q3 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: 1, increased sales in the group purchasing organizations, or GPO, segment, and 2, increasing 340B purchasing.

Nerlynx net product revenue in Q3 2026 was $54.1 million, an increase from the $53.6 million we reported in Q2 of 2026 and the $51.9 million we reported in Q3 of 2025. As a reminder to investors, Puma's reported Nerlynx sales include both U.S. net sales of Nerlynx and product supply revenues of Nerlynx to Puma's ex-U.S. partners. Please note that in Q3 2026, we reported $3.6 million of product supply revenue versus about $17,000 in Q2 of 2026. I'll provide some more details around inventory changes, and Maximo will provide some additional specifics around gross-to-net expenses during his update.

In Q3 2026, we estimate that inventory decreased by about $1.5 million. As a comparator, we estimate that inventory decreased by about $1 million in Q2 of 2026. Slide 5 shows Q3 2026 ex-factory bottle sales and also provides both a year-over-year and quarter-over-quarter comparison. As a reminder, ex-factory bottle sales include sales to our SP and SD channels. In Q3 2026, Nerlynx ex-factory bottle sales were 2,818, which represents an approximate 4% decrease quarter-over-quarter and year-over-year. Let me specifically call out the inventory changes from a bottle perspective. In Q3 2026, we estimate that inventory decreased by 82 bottles. As a comparator, we estimate that inventory decreased by 57 bottles in Q2 of 2026 and increased by about 182 bottles in Q3 of 2025.

Slide 6 highlights our commercial demand for the quarter. In Q3 2026, U.S. demand was 2,899 bottles, which represents an approximate 3% decrease quarter-over-quarter and 5% increase year-over-year. As noted earlier, strong account management and pull-through drove 19% year-over-year growth in the SD channel, extending the growth and shift towards this channel seen in recent quarters. In the SP channel, total prescriptions, or TRxs, decreased by 5% quarter-over-quarter while remaining flat year-over-year.

Our Q3 2026 call activity decreased 8% year-over-year and 9% quarter-over-quarter, largely due to a temporary increase in vacancies and time off territory that are expected to normalize shortly. Enrollments in the quarter decreased by 12% quarter-over-quarter and 6% year-over-year. Commercial new patient starts decreased by 13% quarter-over-quarter and 9% year-over-year.

Continued messaging and adoption of dose escalation remains an important commercial priority, and 80% 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. The most recent launch remains the Q1 2026 Nerlynx launch in Thailand 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 expressing my heartfelt gratitude to the entire Puma team for their unwavering dedication to patients and families impacted by breast cancer. While significant progress has been made in the fight against this devastating disease, important challenges remain. Together, we have the opportunity to continue making a meaningful difference and advancing cancer outcomes for those who need it most. I will now turn the call over to Maximo for a review of our financial results.

Maximo F. Nougues

Thanks, Roger. I will begin with a brief summary of our financial results for the third quarter of 2026. I would like to note that I will make comparisons to Q2 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 third quarter 2026 Form 10-Q, which will be filed by Monday and includes our consolidated financial statements.

For the third quarter of 2026, we reported net income based on GAAP of $6 million, or $0.11 per diluted share. This compares to net income in Q2 2026 of $8.2 million, or $0.16 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $8 million, or $0.15 per basic and diluted share, for the third quarter of 2026.

Gross revenue from Nerlynx sales was $75.1 million in Q3 2026 and $74.3 million in Q2 2026. As I mentioned, net product revenue from Nerlynx sales was $54.1 million, an increase from $53.6 million reported in Q2 2026 and $51.9 million reported in Q3 2025. As a reminder to investors, Puma's reported Nerlynx sales include both U.S. net sales of Nerlynx and product supply revenue of Nerlynx to Puma's ex-U.S. partners. Please note that in Q3 2026, we reported product supply revenue to our international partners of about $3.6 million.

#4, U.S. net sales of Nerlynx in Q3 2026 were $50.6 million versus $53.6 million in Q2 2026. The reduction in net product revenue Q3 2026 versus Q2 2026 was driven by lower demand, an inventory decrease in Q3 of about $1.5 million versus an inventory decrease of $1 million in Q2, and higher gross-to-net in Q3.

Royalty revenue totaled $0.9 million in the third quarter of 2026 compared to $2.9 million in Q2 2026. Under our sublicense agreement covering China, the royalty rate payable to us is subject to reduction when the market share of generic versions of Nerlynx in China reaches a specific threshold. In October of 2026, the company received new third-party market data indicating that the market share of generic versions of Nerlynx in China reached a specific threshold during 2025. To reflect this, the company recorded a $2.1 million cumulative reduction to royalty revenue in Q3 2026. A reduced royalty rate will be applied to China sales going forward.

Our gross-to-net adjustment in Q3 2026 was about 28% and 27.9% in Q2 2026. The higher gross-to-net adjustment was mostly driven by higher Medicaid share. Cost of sales for Q3 2026 was $15.2 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q2 2026 was $12.5 million. Going forward, we will continue to recognize amortization of milestones to the licensor, about $2.4 million per quarter, as cost of sales.

For fiscal year 2026, Puma anticipates that net Nerlynx product revenue will be in the range of $205 million to $208 million, slightly lower than our prior guidance of $205 million to $209 million. We also anticipate that our gross-to-net adjustment for the full year 2026 will be between 27.5% and 28%, higher than our prior guidance, mostly due to Medicaid share. In addition, for fiscal year 2026, we anticipate receiving royalties from our partners around the world in the range of $18 million to $19 million, slightly lower than our prior guidance of $20 million to $23 million. As mentioned, the China royalty generic threshold has been reached and is reflected in our current guidance. We don't expect any license revenue in 2026.

We also expect that net income for the full year will be in the range of $20 million to $22 million, higher than our prior guidance of $17 million to $20 million. The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustment will be required or, if so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses.

At this time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shifting trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid to high single-digit percentage of our total cost of goods sold.

We anticipate that for Q4 2026, Nerlynx product revenue, net will be in the range of $56 million to $58 million. We expect Q4 royalty revenues will be in the range of $11 million to $12 million and no license revenue. We further estimate that the gross-to-net adjustment in Q4 2026 will be approximately 28% to 29%. We anticipate a Q4 net income between $10 million and $12 million.

SG&A expenses were $16.3 million in the third quarter of 2026 compared to $17.5 million in the second quarter of 2026. SG&A expenses included non-cash charges for stock-based compensation of $1.3 million for Q3 2026 and $1.2 million for Q2 2026. Research and development expenses were $18.3 million in the third quarter of 2026 and $18.9 million in Q2 2026. R&D expenses included non-cash charges for stock-based compensation of about $0.7 million in Q3 2026 and $0.8 million in Q2 2026.

On the expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to remain flat and R&D expenses to increase by 28% to 30% year-over-year. The higher increase in R&D is driven by the progress of our clinical trials.

In the third quarter of 2026, Puma reported cash burn of approximately $14.7 million. This compares to cash burn of approximately $9.7 million in Q2. Please note that during Q2 2026, we made our final quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result, Puma is now debt-free.

As of September 30, 2026, we had approximately $108.5 million in cash, cash equivalents, and marketable securities versus $97.5 million at year-end in 2025. Our accounts receivable balance was $32.8 million. Our accounts receivable terms ranged between 10 and 68 days, where our days sales outstanding are about 44 days. We estimate that as of September 30, 2026, our distribution network maintained approximately two weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of Nerlynx, the development of alisertib, and controlling our expenses.

Alan Auerbach

Thanks, Maximo. On past earnings calls, we have stressed that Puma senior management, in cooperation with the Board of Directors, continues to remain focused on Nerlynx sales trends and recognizes its responsibility to shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution thus far in 2026.

According to our current projections, 2026 will mark the second year-over-year demand increase for Nerlynx in the United States and the first time in the history of the launch of Nerlynx in the United States that we have seen two positive consecutive year-over-year increases in demand. We are pleased to report this demand-driven growth in the third quarter of 2026 and believe that the positive net income that the company is guiding to for the full year 2026 has resulted from both this increased demand as well as the continued financial discipline across the company over the last few years.

The company remains committed to continuing to achieve this positive net income in 2026 and will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to Mariann for closing remarks.

Mariann Ohanesian

Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.

Operator

Thank you, ladies and gentlemen. Thank you for participating in today's conference call. This concludes our program. Everyone, have a great day, and you may now disconnect.

This live transcript is auto-generated without human intervention or review.

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