퓨마 바이오테크놀로지(PBYI) 2026년 3분기 실적 발표 콘퍼런스콜: 널링스 가이던스 및 알리세르팁 업데이트
퓨마 바이오테크놀로지는 2026년 3분기 총매출 5,510만 달러, GAAP 기준 순이익 600만 달러, Non-GAAP 기준 순이익 800만 달러를 기록했다고 밝혔다. 주력 제품인 너링크스의 순제품 매출은 5,410만 달러였으며, 미국 내 수요는 전 분기 대비 3% 감소했으나 전년 동기 대비 5% 증가했다. 중국 내 제네릭 복제약 점유율 반영으로 로열티 매출은 90만 달러로 감소했다. 경영진은 2026년 너링크스 순제품 매출 가이던스를 2억 500만~2억 800만 달러로 좁히고, 순이익 가이던스는 2,000만~2,200만 달러로 상향 조정했다. 또한 알리세르팁 임상 데이터가 임상 3상 진입을 뒷받침한다고 밝혔으며, 2027년 상반기 규제 당국과 임상 설계를 논의할 예정이다.
핵심 요약
- 퓨마 바이오테크놀로지(Puma Biotechnology)의 2026년 3분기 총매출은 5,510만 달러를 기록했다. 너링크스(Nerlynx) 순제품 매출은 2026년 2분기 5,360만 달러, 2025년 3분기 5,190만 달러에서 5,410만 달러로 증가했다.
- GAAP 기준 순이익은 600만 달러(희석 주당 0.11달러)를 기록했다. Non-GAAP 기준 순이익은 800만 달러(기본 및 희석 주당 0.15달러)였다.
- 미국 내 너링크스 수요는 총 2,899병으로 전 분기 대비 약 3% 감소했으나 전년 동기 대비로는 5% 증가했다. 상업용 신규 환자 유입은 전 분기 대비 13%, 전년 동기 대비 9% 감소했다.
- 중국 내 너링크스 제네릭 복제약 점유율과 관련해 210만 달러의 누적 차감액을 반영하면서 로열티 매출은 90만 달러로 감소했다. 향후 중국 내 매출에는 인하된 로열티율이 적용된다.
- 경영진은 2026년 너링크스 순제품 매출 가이던스를 2억 500만~2억 800만 달러로 좁혔으며, 순이익 가이던스는 2,000만~2,200만 달러로 상향 조정했다.
- 퓨마는 ALISCA-Breast1 임상 중간 데이터가 알리세르팁(alisertib)의 임상 3상 진입을 뒷받침한다고 밝혔다. 회사는 2027년 상반기 글로벌 규제 당국과 임상 설계에 대해 논의할 계획이다.
핵심 재무 실적
| 지표 | 2026년 3분기 | 비교 및 세부 내용 |
|---|---|---|
| 총매출 | 5,510만 달러 | 너링크스 제품 매출 및 로열티 포함 |
| 너링크스 순제품 매출 | 5,410만 달러 | 2026년 2분기 5,360만 달러, 2025년 3분기 5,190만 달러 |
| 미국 너링크스 순매출 | 5,060만 달러 | 2026년 2분기 5,360만 달러 |
| 해외 제품 공급 매출 | 360만 달러 | 2026년 2분기 약 1만 7,000달러 |
| 로열티 매출 | 90만 달러 | 2026년 2분기 290만 달러, 중국 관련 누적 차감액 210만 달러 포함 |
| GAAP 순이익 | 600만 달러 | 희석 주당 0.11달러, 2분기 순이익은 820만 달러 |
| Non-GAAP 순이익 | 800만 달러 | 기본 및 희석 주당 0.15달러 |
| 매출원가 | 1,520만 달러 | 네라티닙(neratinib) 라이선스 무형자산 상각비 240만 달러 포함 |
| 판관비 | 1,630만 달러 | 2026년 2분기 1,750만 달러에서 감소 |
| 연구개발비 | 1,830만 달러 | 2026년 2분기 1,890만 달러에서 감소 |
| 현금 소진액 | 1,470만 달러 | 2026년 2분기 970만 달러 |
| 현금 및 현금성 자산과 시장성 유가증권 | 1억 850만 달러 | 2026년 9월 30일 기준, 2025년 말 기준 9,750만 달러 |
사업 및 운영 실적
너링크스의 공장도 출하량은 총 2,818병으로 전 분기 및 전년 동기 대비 모두 약 4% 감소했다. 재고는 약 82병 감소했으며, 이는 약 150만 달러 규모의 재고 소진에 해당한다.
미국 내 수요는 2,899병에 달했다. 전문 유통업체 채널은 공동구매조직(GPO) 매출과 340B 구매 증가에 힘입어 전년 동기 대비 19% 성장했다. 3분기 매출 비중은 전문 약국이 61%, 전문 유통업체가 39%를 차지했다.
전문 약국의 총 처방 건수는 2분기 대비 5% 감소했고 전년 동기 대비로는 보합세를 보였다. 신규 등록 건수는 전 분기 대비 12%, 전년 동기 대비 6% 줄었다. 영업 활동은 전 분기 대비 9%, 전년 동기 대비 8% 감소했는데, 이는 주로 영업 인력의 일시적 공백과 담당 구역 이탈에 따른 것으로 경영진은 이것이 정상화될 것으로 예상하고 있다.
퓨마는 너링크스의 용량 점증과 환자 지원을 지속적으로 강조했다. 이번 분기 동안 환자의 80%가 감량된 용량으로 치료를 시작했다.
알리세르팁의 경우, 퓨마는 ALISCA-Breast1 임상의 40mg 및 50mg 투여군에서 환자 등록을 이어갔다. 더 긴 추적 관찰 기간을 포함한 업데이트된 중간 데이터는 12월 샌안토니오 유방암 심포지엄에서 발표될 예정이다. ALISCA-Lung1은 1일 2회 70mg 용량으로 환자를 등록 중이며, ALISCA-Lung2의 초기 데이터와 ALISCA-Lung1의 추가 중간 결과는 2027년에 나올 것으로 예상된다.
회사는 또한 포트폴리오를 다각화하고 기존 인프라를 활용하기 위해 상업화 단계 및 개발 단계의 의약품을 대상으로 잠재적 라이선스 도입이나 인수를 지속적으로 검토하고 있다.
경영진 가이던스
| 가이던스 항목 | 현재 전망 |
|---|---|
| 2026 회계연도 너링크스 순제품 매출 | 2억 500만~2억 800만 달러 |
| 2026 회계연도 로열티 매출 | 1,800만~1,900만 달러 |
| 2026 회계연도 순이익 | 2,000만~2,200만 달러 |
| 2026 회계연도 총매출-순매출 조정률 | 27.5%~28.0% |
| 2026년 4분기 너링크스 순제품 매출 | 5,600만~5,800만 달러 |
| 2026년 4분기 로열티 매출 | 1,100만~1,200만 달러 |
| 2026년 4분기 순이익 | 1,000만~1,200만 달러 |
| 2026년 4분기 총매출-순매출 조정률 | 약 28%~29% |
퓨마는 2026년에 라이선스 매출이 발생하지 않을 것으로 예상한다. 또한 경영진은 임상시험 진행에 따라 2026 회계연도 판관비는 전년 대비 보합세를 유지하는 반면, 연구개발비는 28%~30% 증가할 것으로 전망했다.
순이익 전망치에는 이연법인세 자산 평가충당금의 추가 환입 가능성은 제외되어 있다. 퓨마는 이연법인세 자산을 검토 중이지만 조정 필요 여부나 예상 시기 및 규모는 아직 결정하지 않았다.
리스크 및 주요 점검 사항
- 2025년 중 너링크스 제네릭 복제약의 시장 점유율이 계약상 기준치에 도달함에 따라 향후 중국 로열티율은 낮아질 예정이다.
- 수요 감소, 재고 소진 및 총매출-순매출 조정률 상승으로 인해 미국의 너링크스 순매출이 전 분기 대비 감소했다. 경영진은 총매출-순매출 조정률이 높아진 주된 원인으로 메디케이드(Medicaid) 비중 증가를 꼽았다.
- 신규 처방, 총 처방, 등록 건수, 상업용 신규 환자 유입 모두 2026년 2분기 대비 감소했다.
- 경영진은 알리세르팁 임상이 진행됨에 따라 연구개발비 지출이 늘어날 것으로 예상하고 있으나, 해당 임상 프로그램은 여전히 연구 단계에 있으며 추가 데이터 및 규제 당국과의 논의 결과에 따라 달라질 수 있다.
- 퓨마는 현재 관세가 제품 원가나 영업 실적에 중대한 영향을 미치지는 않을 것으로 보고 있으나, 경영진은 급변하는 무역 정책을 여전히 예측하기 어렵다고 밝혔다.
실적 발표 컨퍼런스 콜 전문
전체 실적 발표 컨퍼런스 콜 녹취록
경영진 발표
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.
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