プーマ・バイオテクノロジー（PBYI）2026年第3四半期決算説明会：NerlynxのガイダンスとAlisertibの最新情報

主要ポイント

• ピューマ・バイオテクノロジー（Puma Biotechnology）が発表した2026年第3四半期の総売上高は5,510万ドルとなった。Nerlynxの製品純売上高は、2026年第2四半期の5,360万ドルおよび2025年第3四半期の5,190万ドルから増加し、5,410万ドルとなった。
• GAAPベースの純利益は600万ドル（希薄化後1株当たり0.11ドル）となった。Non-GAAPベースの純利益は800万ドル（基本的および希薄化後1株当たり0.15ドル）となった。
• 米国におけるNerlynxの需要は計2,899本となり、前四半期比で約3%減少したものの、前年同期比では5%増加した。民間保険適用の新規投与開始患者数は前四半期比で13%減、前年同期比で9%減となった。
• 中国におけるNerlynx後発医薬品（ジェネリック）の市場シェアに関連してピューマが210万ドルの累積減額を計上したため、ロイヤルティ収入は90万ドルに減少した。今後は中国での売上に対し、引き下げられたロイヤルティ料率が適用される。
• 経営陣は2026年のNerlynx製品純売上高ガイダンスを2億500万〜2億800万ドルに絞り込み、純利益ガイダンスを2,000万〜2,200万ドルに上方修正した。
• ピューマは、ALISCA-Breast1試験の中間データがアリセルチブの第3相臨床試験への進展を支持していると述べた。同社は2027年上半期に治験デザインについて世界各国の規制当局と協議を開始する予定である。

主要財務業績

事業および営業状況

Nerlynxの工場出荷ベースの販売数量は計2,818本となり、前四半期比および前年同期比でともに約4%減少した。流通在庫は推定82本減少し、約150万ドルの在庫取り崩しに相当する。

米国の実需要は2,899本に達した。共同購入組織（GPO）向け販売と340Bプログラムによる購入増に支えられ、専門卸チャネルは前年同期比19%の成長を達成した。第3四半期の売上構成比は専門薬局が61%、専門卸が39%となった。

専門薬局における総処方箋数は第2四半期比で5%減少し、前年同期比では横ばいとなった。新規登録数は前四半期比12%減、前年同期比6%減となった。営業コール活動は前四半期比9%減、前年同期比8%減となったが、これは主に一時的な欠員や担当エリアの不在によるものであり、経営陣は今後正常化すると見込んでいる。

ピューマは引き続き、Nerlynxの用量漸増アプローチと患者サポートを重視した。当四半期中、患者の80%が減量した用量で治療を開始した。

アリセルチブに関しては、ALISCA-Breast1試験の40mg群および50mg群で患者登録を継続した。より長期の追跡結果を含む最新の中間データは、12月のサンアントニオ乳がんシンポジウムで発表される見込みである。ALISCA-Lung1試験では1日2回70mg投与で患者登録が進められており、ALISCA-Lung2試験の初期データおよびALISCA-Lung1試験のさらなる中間結果は2027年に発表される予定である。

同社はまた、ポートフォリオの多角化と既存インフラの活用を目的に、ライセンス導入または買収の候補として商業化段階および開発段階の薬剤の評価を継続している。

経営陣による業績予想（ガイダンス）

ピューマは2026年にライセンス収入は見込んでいない。また経営陣は、2026年度の販管費（SG&A）が前年比で横ばいとなる一方、臨床試験の進展に伴い研究開発費（R&D）は28%〜30%増加すると予想している。

純利益の見通しには、繰延税金資産に対する評価性引当金の追加戻し入れの可能性は反映されていない。ピューマは繰延税金資産の見直しを進めているが、調整が必要となるか否か、またその時期や規模については決定していない。

リスク要因と主な注視点

• 2025年中に中国でNerlynx後発医薬品の市場シェアが契約上の基準値に達したため、同国でのロイヤルティ料率は今後低下する。
• 需要の減少、在庫の取り崩し、およびグロス・ツー・ネット調整比率の上昇により、米国のNerlynx純売上高は前四半期比で減少した。経営陣は、調整比率の上昇は主にメディケイドの比率上昇によるものだとしている。
• 新規処方箋数、総処方箋数、新規登録数、民間保険適用の新規投与開始患者数は、いずれも2026年第2四半期比で減少した。
• 経営陣はアリセルチブの治験進展に伴い研究開発費の増加を見込んでいるが、同臨床プログラムは依然として治験段階にあり、追加データや規制当局との協議に左右される。
• ピューマは現時点で関税が製品コストや業績に重大な影響を与えるとは見込んでいないが、経営陣は急速に変化する通商政策の予測は依然として困難であると述べている。

決算説明会 文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

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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