莫德納 (MRNA) 2026年第3季法說會：營收成長 29%，上修展望

重點摘要

• 莫德納公布 2026 年第三季營收為 13 億美元，年增 29%，主要受 COVID-19 疫苗銷售增加帶動。今年迄今營收達 18 億美元。
• 淨利改善至 1.6 億美元，或稀釋每股盈餘 0.38 美元，相較於去年同期為淨損 2.02 億美元，或每股虧損 0.51 美元。
• 管理階層將 2026 全年營收展望上調至成長 15%–25%，高於先前預期的最高成長 10%，主要歸因於美國與國際市場表現更為強勁。
• Intismeran autogene 搭配 pembrolizumab 將黑色素瘤復發或死亡風險降低了 42%，此結果來自第三期 INTerpath-001 試驗。兩年無復發存活率為 82.2%，相較之下單獨使用 pembrolizumab 則為 70.0%。
• 莫德納截至季末持有 80 億美元的現金與投資，此前該公司籌集了約 26 億美元的淨收益，來自 0% 可轉換公司債發行及上限買權交易。
• 該公司將 2026 年研發費用預測調降 2 億美元至 27 億美元，並將現金成本目標降至約 38 億美元。

主要財務業績

該季營收結構約為 美國占 60%、國際占 40%。莫德納表示，需求增強、營運執行力與出貨時程支撐了這兩個地區的表現。

今年迄今國際市場營收達到 9 億美元，已較該公司 2025 全年國際營收高出 2 億美元。管理階層將此成長部分歸因於在英國、加拿大與澳洲建立的策略夥伴關係。

業務與營運表現

莫德納持續擴展其呼吸道疫苗產品組合。FDA 核准了 mFLUSIVA 用於 50 至 64 歲成人，並加速核准用於 65 歲及以上成人。加拿大則核准 mFLUSIVA 與 mCOFLU（mCOMBRIAX 的當地品牌名稱）用於 60 歲及以上成人。

該公司亦取得 mNEXSPIKE 的年度病毒株更新核准，涵蓋美國、加拿大、日本與台灣的 2026–2027 接種季。莫德納表示，mNEXSPIKE 在美國的採用率有所提高，而整體疫苗接種率與去年同期相比維持相對穩定。

截至 10 月底，施打量約達 4,410 萬劑，涵蓋透過美國零售與長期照護通路施打的流感、COVID-19 及 RSV 疫苗，較去年同期成長 3%。其中流感疫苗接種量略增，而 COVID-19 疫苗接種量則略減。

在腫瘤學方面，第三期 INTerpath-001 試驗招募了超過 1,100 名接受過切除手術的 IIb 至 IV 期黑色素瘤患者。Intismeran 搭配 pembrolizumab 展現出無復發存活期風險比為 0.58，P 值小於 0.001。

一項預先設定的修正意向治療分析（僅限於接受預定疫苗或安慰劑注射的患者）顯示，降低了 49% 的復發或死亡風險。合併療法的兩年無復發存活率為 84.2%，相較之下單獨使用 pembrolizumab 則為 70.4%。

該合併療法耐受性普遍良好。接受合併療法的患者中有 36% 出現了受關注的 pembrolizumab 相關不良事件，而單獨接受 pembrolizumab 的患者此比例為 35%。最常見的 intismeran 相關不良事件包括發燒、注射部位疼痛與疲勞。

莫德納與默沙東正致力於在 2026 年提交 intismeran 的生物製劑許可申請（BLA）。管理階層表示，若審查流程按計畫進行，期望能在 2027 年獲得核准。

管理階層財測指引

該公司預計全年美國與國際營收將大致各占一半。若不計可轉換公司債的 26 億美元淨收益，預估年底現金將為 55 億至 57 億美元，高於先前架構預估的 47 億至 52 億美元。

管理階層表示，現金前景改善反映出預期營收提高、現金成本減少以及資本支出降低。

風險與觀察重點

諾羅病毒候選疫苗 mRNA-1403 的第三期試驗在期中分析中未達早期成功的統計標準。莫德納將不再招募額外的冬季受試群體，目前正就潛在的後續步驟諮詢衛生主管機關。

intismeran 針對腎細胞癌的研究屬於事件驅動型（event-driven），管理階層表示期中數據判讀可能落在 2026 年底或 2027 年初。該公司並未透露有關統計分析計畫或盲態事件進展的詳細資訊。

管理階層表示，胰臟癌的研究結果在免疫原性與安全性方面令人鼓舞，但亦指出該單臂第一期試驗尚處於早期階段且異質性較高，不足以確立療效訊號。

mCOMBRIAX 流感與 COVID-19 組合疫苗在美國的監管審查時程，仍取決於與 FDA 的進一步討論。

分析師問答重點

• Intismeran 定價：莫德納表示討論定價尚言之過早。該公司與默沙東打算考量該療法對醫療體系的價值。
• 腎細胞癌市場機會：管理階層提及腎細胞癌（RCC）對抗 PD-1 療法的敏感性、intismeran 在高腫瘤突變負荷與低腫瘤突變負荷黑色素瘤中的療效活性，以及其抗原選擇演算法中納入了插入缺失（indel）突變。正面的第二期試驗結果可為臨床實務提供參考，而遞交監管申請則將取決於數據的強度。
• Intismeran 技術護城河：莫德納表示，專有演算法與前端針對個別患者的設計流程是該產品不可或缺的核心部分。來自第三期黑色素瘤計畫與其他九項研究的數據，預計將進一步擴充該公司的新抗原與 T 細胞反應資料庫。
• 肺癌研發計畫：術後輔助治療的第三期 INTerpath-002 試驗已完成受試者招募。另外兩項第三期研究仍在招募中，包括一項針對前導性治療後未達到病理完全緩解的患者，另一項則針對高風險的第一期疾病。
• mRNA-2808：在美國血液學會（ASH）年會上的簡報預計將納入更多患者、更長的追蹤時間以及有關治療反應深度的數據，其中包括先前曾接受過 BCMA 與 GPRC5D 標靶治療的患者。
• 國際營收持久性：管理階層表示，策略夥伴關係占國際營收的一半以上，同時市占率提升與疫苗接種率趨穩也為成長提供了支撐。

完整財報電話會議逐字稿

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完整財報電話會議逐字稿

管理層陳述

Operator

Good day, and thank you for standing by. Welcome to Moderna's Third Quarter 2026 Conference Call. [Operator Instructions] Please be advised, today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.

Lavina Talukdar

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's third quarter 2026 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website.

On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; Jamey Mock, our Chief Financial Officer; and David Berman, our Chief Development Officer.

Before we begin, please note that this call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

With that, I will turn the call over to Stephane.

Stéphane Bancel

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start today with a review of our third quarter. Jamey will then cover our financial results and outlook, followed by Stephen with our current business updates in infectious disease. David will then review our clinical progress in oncology and rare diseases. And I will come back quickly for close on our key value drivers before Q&A.

The Moderna team delivered a great third quarter, generating $1.3 billion in revenues, representing 29% growth year-over-year. Importantly, this strong commercial performance translated into $200 million in net income for the quarter. We also ended the quarter with a strong balance sheet with $8 billion in cash and investments, reflecting a combination of solid operational and commercial execution, along with a highly successful convertible debt financing. And we continue to demonstrate financial discipline across the company, reducing cash cost by 10% compared to the third quarter of last year. Together, these strong results underscore our ability to deliver strong commercial performance while maintaining financial discipline and strengthening our financial position.

During the quarter, we achieved several important milestones across our pipeline and our business. U.S. FDA approval of mFLUSIVA, making Moderna's fifth approved product and the first mRNA-based influenza vaccine to reach the market. In Canada, we secured approvals of both mFLUSIVA and mCOFLU yesterday, the local brand name for mCOMBRIAX, further expanding our respiratory portfolio internationally.

In oncology, we are very proud to present positive Phase III data for intismeran autogene, our individualized cancer therapy being developed in partnership with Merck. The results demonstrated a significant clinical benefit with a 42% reduction in the risk of recurrence or death in patients with resected melanoma, and additional analysis suggesting an even greater benefit of 49% reduction in the risk of recurrence or death in patients who received at least 1 dose of intismeran as planned. Importantly, this marks the first combination immunotherapy regimen to demonstrate additional benefits of a KEYTRUDA alone in the adjuvant melanoma setting, representing a significant milestone for melanoma patients and their families around the world. David will discuss these results in greater details.

We also took an important step to further strengthen our financial position. During the quarter, we raised $3 billion for a 0% convertible note debt, securing long-term capital on highly attractive terms. After accounting for the purchase of capped call, designed to mitigate potential future dilution and fees, we raised approximately $2.6 billion in net proceeds. This financing strengthens our ability to invest in the growth of our oncology business, a key strategic priority for Moderna as we approach candidate important clinical milestones.

In Global Health, our Ebola vaccine candidate, mRNA-1469, developed in collaboration with CEPI, was selected to advance into a [ Phase II/III ] following a recommendation from the WHO Technical Advisory Group.

I am extremely proud of our performance delivered by the team in Q3. Strong sales growth, profitability, approval and quick launch of flu in the U.S., intismeran positive Phase III and the convertible debt financing.

I'm also very pleased and happy to welcome back Juan Andres to Moderna Executive Committee. Many of you will remember Juan for his previous time at Moderna, where he played a critical role in building and scaling our global manufacturing network during the pandemic. He also led the scale-out of individualized manufacturing for intismeran autogene. He knows our company, our technology and our culture extremely well.

As we enter this next phase of Moderna's growth with an expanded commercial portfolio and important opportunities ahead in oncology, having Juan back on the team will be invaluable. I am personally very excited to be working with him again. And I know the entire Moderna team is delighted to welcome him back.

With that, I'll turn to Jamey.

James Mock

Thanks, Stephane, and hello, everyone. Today I'll begin with a review of our third quarter financial performance, followed by an update on our 2026 financial framework. Let me start with our commercial performance on Slide 8.

We delivered a strong third quarter with revenue of $1.3 billion, bringing our year-to-date revenue to $1.8 billion. Our geographic mix for the quarter was approximately 60% U.S. and 40% international. Both the U.S. and international markets delivered stronger-than-expected revenue in 3Q, driven by a mix of increased demand, operational execution and timing of shipments between the third and fourth quarters.

As mentioned in prior calls, we forecasted 2 primary growth drivers in 2026: increased mNEXSPIKE adoption and growth in our strategic partnerships in the U.K., Canada and Australia. In the U.S., while the vaccination season is still ongoing, we have seen increased uptake of mNEXSPIKE, and vaccination rates have been relatively stable versus the prior year.

Internationally, our teams have executed well, particularly in the U.K. and Canada. Year-to-date, international revenue of $900 million is already $200 million ahead of the full year we delivered in 2025.

Based on the strong start to the season combined with the visibility we have into the fourth quarter, we are increasing our full year revenue framework to a range of 15% to 25% growth, which exceeds our prior framework of up to 10% growth. We continue to expect an approximately even split between U.S. and international revenue for the full year.

Now let me turn to our third quarter financial performance on Slide 9. As I just mentioned, total revenue was $1.3 billion for the quarter, up 29% from last year, primarily driven by higher COVID sales.

Cost of sales for the quarter was $318 million, representing 24% of total revenue for the quarter. This was a 54% increase in our cost of sales from Q3 last year, primarily driven by higher product sales volume and other manufacturing-related costs. We remain on track to drive significant gross margin improvements in 2026, excluding the $900 million litigation charge.

R&D expenses for the quarter were $583 million, down 27% from last year, driven by completion and wind-down of studies in our infectious disease portfolio as well as efficiency gains across the organization. SG&A expenses for the quarter were $282 million, a 5% increase year-over-year. We continue to maintain cost discipline across the organization while investing for growth.

Our income tax provision was immaterial in both periods. Net income for the quarter was $160 million, an improvement of $362 million compared to last year. Diluted earnings per share was $0.38, compared to a loss per share of $0.51 last year.

We ended the quarter with cash and investments of $8 billion, up from $6.9 billion at the end of the second quarter. The increase was primarily driven by $2.6 billion of net proceeds from our convertible note issuance and capped call transaction, partially offset by a $950 million litigation settlement payment as well as the seasonal impact to working capital.

Now let's turn to our financial framework for 2026. For total revenue, as I mentioned in my earlier remarks, we are improving our revenue outlook to a range of 15% to 25% growth, which exceeds our prior framework of up to 10% growth. Cost of sales is unchanged at $1.7 billion, which includes $0.9 billion of expense related to the previously announced litigation settlement charge.

We are lowering our R&D expense by $200 million to $2.7 billion due to further wind-down of studies and continued operational efficiencies. SG&A expenses are still expected to be approximately $1 billion, flat versus the prior year. Similar to last year, we expect higher SG&A expenses in the fourth quarter primarily due to commercial related activity.

In aggregate, excluding the $0.9 billion litigation charge, we are expecting total GAAP operating expenses of $4.5 billion and $3.8 billion of cash costs, which excludes stock-based compensation, depreciation and amortization. Each reflects a $200 million improvement compared to our previous framework. We expect taxes to be negligible in 2026. And we are lowering our capital expenditure estimate to $200 million from our previous range of $200 million to $300 million.

Cash and investments are now projected to be between $8.1 billion and $8.3 billion at the end of 2026. Excluding the $2.6 billion net proceeds from the convertible note and capped call transaction, our cash projection would be $5.5 billion to $5.7 billion, which is an improvement from our previous framework of $4.7 billion to $5.2 billion. The increase in our cash projection is due to our improved revenue outlook and reductions in both our cash cost and CapEx projections. Our cash cost framework does not assume any additional drawdown from our remaining $0.9 million undrawn credit facility.

With that, I will now turn the call over to Stephen.

Stephen Hoge

Thank you, Jamey, and good morning or good afternoon, everyone. I'll now take you through our recent business updates. As a reminder, Slide 12 outlines our multiyear revenue growth strategy, which continues to be anchored in 2 key drivers: geographic expansion and portfolio expansion through continued pipeline advancement. We are building a more diversified portfolio with new opportunities across respiratory vaccines, oncology and rare diseases, while expanding our commercial footprint in markets around the world.

We're making tangible progress against this strategy with several important milestones achieved during the quarter. Starting with mFLUSIVA, we recently received FDA approval for adult age 50 to 64 and accelerated approval for adults age 65 and older in the U.S. In Canada, we secured approvals for both mFLUSIVA and mCOFLU, the local brand name for mCOMBRIAX, for adults aged 60 and older. For our mNEXSIPKE, we saw approvals for the annual strain updates in the United States, Canada, Japan and Taiwan for the 2026, 2027 vaccination season. And for mRESVIA, we continue to make progress in the U.S. and international markets.

We expanded our international presence with a 5-year agreement signed with a local manufacturer in Mexico to support COVID-19 vaccine supply. And finally, in oncology, we presented positive Phase III data for intismeran in adjuvant melanoma at the ESMO Presidential Symposium, as highlighted earlier. These milestones demonstrate continued execution against our strategy to drive revenue growth.

Turning to our approved infectious disease portfolio. We continue to make progress across our 5 commercial products. starting with our COVID vaccine. As I mentioned earlier, mNEXSPIKE received approval for the updated [ XFG strain ] for this coming vaccination season in the United States, Canada, Japan and Taiwan, with additional regulatory reviews and filings underway. Spikevax has also received approval for the updated strain in these markets and also in the European Union. Deliveries of our updated COVID-19 vaccines are now underway globally.

Turning to RSV, mRESVIA is approved in 44 countries. We also received published results from a Phase III study evaluating revaccination with mRESVIA in adults aged 60 and older who had previously received a protein-based RSV vaccine. This study demonstrated robust immune responses comparable to those seen following the initial vaccination with mRESVIA, with no new safety concerns identified, highlighting the potential for mRESVIA in revaccination. A link to the study can be found on this slide.

For mFLUSIVA, our seasonal influenza vaccine, we have approvals in the United States and now Canada with reviews ongoing in the European Union, Australia and Taiwan. In the U.S. the American Academy of Family Physicians has recommended mFLUSIVA for adults aged 65 and older as an enhanced influenza vaccine.

And finally, for mCOMBRIAX, our combination influenza and COVID-19 vaccine, we now have approvals in Europe and Canada. The product remains under review in Japan, the United Kingdom, Australia and Switzerland, with a decision on filing in the United States subject to further discussion with the FDA.

Turning to U.S. respiratory vaccination trends. Overall demand remains strong, as I said before. Through late October, approximately 44.1 million flu, COVID-19 and RSV vaccinations have been administered in the retail and long-term care channels, a 3% increase over the comparable period last year. Flu vaccinations are trending slightly ahead of last year, and COVID-19 vaccinations are trending slightly behind, but momentum in October suggests vaccinations may end up flat year-over-year in the channel. These trends demonstrate the healthy demand for seasonal respiratory vaccines in the United States.

Turning to our late-stage infectious disease pipeline and our norovirus vaccine program, mRNA-1403. As a reminder, as previously disclosed, the Phase III study did not meet the statistical criteria for early success at its interim analysis. Following a review of the program, we have decided not to enroll an additional cohort this coming winter season. Instead we are engaging with health authorities to determine the next steps for the program. And we'll provide further updates following those discussions.

With that, I'll now turn the call over to David to review our oncology and rare disease pipeline.

David Berman

Thank you, Stephen. Hello, everyone. I will review the progress across our oncology and rare disease pipeline, starting with intismeran autogene, our individualized cancer therapy, which is being developed in partnership with Merck.

Last month, we presented the positive Phase III INTerpath-001 melanoma results at the Presidential Symposium at ESMO, and I'll discuss these in greater detail shortly. A link to the ESMO presentation can be found at the bottom of the slide.

Beyond melanoma, our intismeran development program continues to advance across multiple tumor types and stages of disease. In non-small cell lung cancer, the adjuvant Phase III study is fully enrolled. Two additional Phase III studies in non-small cell lung cancer continue to enroll patients. One, Phase III, is in patients who did not have a pathologic complete response following neoadjuvant therapy. And the other Phase III is in Stage 1 disease evaluating intismeran both as a monotherapy and in combination with KEYTRUDA [ QLEX ]. Phase II studies in adjuvant renal cell carcinoma and muscle invasive bladder cancer are fully enrolled. Both of these studies are randomized against KEYTRUDA and are event-driven studies.

We continue to enroll Phase II clinical studies in non-muscle invasive bladder cancer, metastatic melanoma and metastatic squamous non-small cell lung cancer. Phase I studies in pancreatic and gastric cancer are fully enrolled.

At ESMO, we presented a poster highlighting encouraging translational data from the Phase I pancreatic cancer study. Despite the low tumor mutational burden typically seen in pancreatic cancer, we were able to generate neoantigen-specific T cell responses in all 19 evaluable patients. A link to the poster is at the bottom of the slide.

Now let's review the Phase III melanoma results. In the INTerpath-001 trial, the primary endpoint was relapse-free survival. Intismeran plus pembrolizumab demonstrated a significant 42% reduction in the risk of recurrence or death, compared with pembrolizumab alone. The hazard ratio was 0.58 and P value below 0.001. These remarkable results were observed at the first interim analysis of this large randomized Phase III trial enrolling more than 1,100 patients with resected Stage IIb through IV melanoma. At 2 years, recurrence-free survival was 82.2% in the combination arm, compared with 70% for pembrolizumab alone, representing a 12 percentage point absolute improvement.

These results represent 2 important firsts. The first positive Phase III trial for an individualized cancer vaccine and the first positive Phase III trial demonstrating benefit over anti-PD-1 therapy in adjuvant melanoma.

This is a summary of the Phase II results at 3 different follow-ups. That study also tested intismeran plus pembrolizumab versus pembrolizumab monotherapy and also had an RFS primary endpoint. What's particularly remarkable is the consistency between the Phase II hazard ratio of 0.56 and the Phase III hazard ratio of 0.58 at the primary analysis where both had similar follow-up. In our Phase II study, the RFS hazard ratio improved, from 0.56 to 0.51% at 3 years. And that benefit was maintained through 5 years of follow-up. We are optimistic about the potential to see similar strengthening of the treatment benefit in Phase III as the data matures.

This optimism is further supported by sensitivity analyses from the Phase III trial. In the Phase III trial, we conducted prespecified sensitivity analyses that provide additional insights into the treatment to benefit. One of these analyses evaluated the modified intent to treat or MITT population, which evaluates only patients who received the intended intismeran or placebo injection. Patients were randomized and received pembrolizumab but either relapsed or withdrew prior to the first dose of intismeran or placebo as planned were excluded.

In other words, while the ITT analysis shows the results of a Phase III clinical trial, the MITT analysis, by limiting to patients actually treated with the blinded vaccine, shows the true treatment effect of intismeran. In this MITT analysis, we observed an even greater treatment benefit with a 49% reduction in the risk of recurrence or death, compared with a 42% reduction observed in the primary ITT. Notably, the hazard ratio of 0.51 is consistent with what we observed in Phase II at the 3 and 5-year follow-ups.

At 2 years, the recurrence-free survival was 84.2% with the combination, compared with 70.4% for pembrolizumab alone, representing nearly a 14 percentage point absolute improvement. Together, the ITT and MITT analyses reinforce the strength and consistency of the efficacy between Phase III and Phase II.

The degree of benefit for the combination over pembrolizumab monotherapy, which itself is a great drug, is one reason that I am optimistic intismeran will work in other tumor types.

The combination of intismeran plus pembrolizumab was generally well tolerated with findings consistent with the known safety profiles of the individual therapies. Adding intismeran did not meaningfully increase pembrolizumab associated adverse events of interest, which occurred in 36% of patients receiving the combination, compared to 35% of patients receiving pembrolizumab alone. And adverse events associated with intismeran were also consistent with its expected safety profile. The most common adverse events in the combination arm were pyrexia, injection site pain and fatigue. These events were generally low-grade, transient and were managed with standard supportive care. These findings are encouraging, particularly in the context of the significant improvement in relapse-free survival demonstrated in the study.

I'll now turn to our broader oncology portfolio. Outside of intismeran we continue to advance a diversified portfolio of oncology programs across cancer antigen therapies, T-cell engagers and cell therapy enhancement.

Starting with mRNA-4359, our cancer antigen therapy. We have an ongoing Phase II study in first-line metastatic melanoma, second-line or later metastatic melanoma and first-line metastatic non-small cell lung cancer. Our mRNA-4194 program is progressing in a Phase I/II study in Lynch syndrome with Phase I dose escalation ongoing. We all continue to advance mRNA-4106 and mRNA-4200 with Phase I studies dosing patients currently.

Turning to our T-cell engager program, mRNA-2808, is in a Phase I study in multiple myeloma. The initial clinical results have been selected for an oral presentation at the upcoming ASH Annual Meeting in December, and we look forward to presenting the data and advancing this program.

Finally, in collaboration with Immatics, we continue dosing in the Phase I study of our cell therapy enhancer, mRNA-4203 in combination with anzu-cel. Across these programs, we're evaluating several distinct therapeutic approaches and continue to generate clinical evidence to guide further development.

Turning briefly to our rare disease pipeline, our registrational trial in propionic acidemia, or PA, is on track. And we look forward to the results later this year. For methylmalonic acidemia, or MMA, we've deferred the decision to initiate a pivotal trial until after the PA readout.

With that, I'll hand the call back to Stephane.

Stéphane Bancel

Thank you, David, Stephen and Jamey. Looking ahead, we continue to see important value drivers across our commercial business, financial performance and pipeline. We have raised our full year 2026 revenue growth expectations to between 15% and 20% growth, exceeding our previous revenue growth expectation of up to 10%. We also continue to execute with financial discipline, lowering our adjusted cash cost target by another $200 million to approximately $3.8 billion for fiscal year '26. And we have raised our year-end cash and investment outlook to between $8.1 billion and $8.3 billion. On the commercial side, we continue to pursue additional regulatory approvals to expand the global reach of our respiratory vaccine portfolio.

Turning to our pipeline. 2026 has been a landmark year for oncology, highlighted by our positive Phase III melanoma result for intismeran and the presentation of encouraging early pancreatic cancer data at ESMO. Looking ahead, key milestone includes our events-driven Phase II renal cancer readout, the intismeran BLA submission, the presentation of mRNA-2808 at ASH and our registrational readout in propionic acidemia, or PA, our most advanced regenerative disease program.

Our priorities remain clear: grow our commercial business, maintain financial discipline and advance our pipeline towards important clinical and regulatory milestones. I'm very proud of what our team has accomplished this year and excited about the opportunities ahead for Moderna.

We look forward to hosting the investment community next week at our upcoming Analyst Day on November 12. The event will be held in person at our intismeran manufacturing site in Marlborough, Massachusetts, where attendees will have also the opportunity to tour the site. A webcast of our presentation will be available for those joining remotely.

I want to close thanking our teams around the world for their dedication and execution. This has been an important year for Moderna and our progress reinforce what we can accomplish when we combine both science with disciplined execution. Our platform is delivering. Five approved infectious disease vaccines around the world, positive Phase III for intismeran and the new modality with mRNA-2808 proof of concept in multiple myeloma T-cell engagers. Our mission remains at the heart of everything we do: to deliver the greatest possible impact to people for mRNA medicine.

With that, we'll be happy to take your questions.

Operator

[Operator Instructions] Our first question comes from Salveen Richter with Goldman Sachs.

分析師問答

Salveen Richter

Two questions for me. One is, could you frame your confidence into the interim data in renal cell carcinoma, particularly as we think about the statistical plan with regard to a number of events that needs to be hit around that interim? And then if you could also touch on the fact that there've been some questions in the contribution of the [ LNP ] to immunogenicity with regard to the melanoma trial, and maybe just help frame that for us as well?

David Berman

In terms of the timing, it's event driven for the RCC trial, so it could be end of this year or early next year. In terms of the confidence of that, why I'm confident, I would say probably a couple of reasons. First is that we know that RCC is an anti-PD-1 sensitive tumor, anti-PD-1s work by T cells, by reactivating T cells. We work by generating novel T cells. And so it's a T cell sensitive disease, and so that's confidence number one.

Confidence number two derives from the fact that in our Phase II trial, we saw efficacy in the melanoma population at both that was equivalent for high-TMB and for low-TMB patients. And if you overlap the low-TMB spectrum in the melanoma, it actually does overlap with RCC.

And then finally, the treatment benefits that we saw in the primary analysis has a ratio of 0.58 versus pembrolizumab alone, that was the same treatment effect that pembrolizumab alone saw versus placebo in their [ KEYNOTE 54 ], and then we know KEYTRUDA went on to be positive in RCC as well. So those are the reasons why I have confidence or believe that we are likely potentially to have a positive result. I don't say anything more about the statistical analysis plan.

In terms of the LNP immunogenicity question, this is a question that's been going on for a while just [indiscernible] that came up a few years ago when MD Anderson published a retrospective analysis. And it wasn't a randomized trial. It was just observation. And they suggested that patients who got the mRNA LNP vaccine had better outcomes to immunotherapy. That has -- that data from MD Anderson has subsequently been repeated and not been repeated by different groups.

And in fact, most recently, Memorial Sloan Kettering, which is the other large cancer center in the U.S., came out with their own analysis showing that actually there was no treatment effect by the addition of mRNA LNP. So I don't think that that answer is clear. I don't think the evidence is strong enough to claim it. And I don't think LNP T can generate such an incredibly strong hazard ratio in the adjuvant setting.

Operator

Our next question comes from Terence Flynn with Morgan Stanley.

Terence Flynn

Great. I was just wondering, I know you're not going to guide on price at this point for INT, but I was just wondering if you could talk through some of the inputs that you and Merck are considering as you think about pricing that therapy? And then the second question I had is just on the Phase II RCC study, if those data are positive, do you think that can support a registration in that setting?

Stephen Hoge

Look, this is Stephen, I'll take the first part of it on price and then I think hand it over to David. On price, look, it's premature at this point. We're working on getting a submission done this year and obviously working towards approval. We will always look to price our products to represent the value they create in health care systems. And obviously, we're thrilled by the data, but it is premature at this point to say anything more. And we'll work closely with Merck on that process.

David Berman

Terence, in regard to your second question, look, it's a pretty large randomized, well-controlled Phase II with 282 patients. But it is a Phase II. So at a base case, I would say it can be practice-informing, especially with compendium listing, if it's positive. In an upside, if the results are very strong, I think we can consider taking it to FDA. But it will be data dependent.

Operator

Our next question comes from Ellie Merle with Barclays.

Eliana Merle

On the back of the pancreatic data at ESMO, can you elaborate on how you're thinking about potential next development steps here? Would you study in combo with PD-1, with chemo or both? And then just a quick one on RCC. If the study is not successful in the first interim, is that something you'd disclose if it moves on to additional analyses?

David Berman

Ellie, so with regard to the PDAC, look, the good news is that in this low-TMB tumor, we were able to generate cassettes from the patients. And in all of the evaluable patients, we were able to see T cell reacting to those neoantigens. So I think that's a really good sign. And we did it in combination with the standard of care, which is FOLFIRINOX. So it informed us that it can safely be given with chemotherapy, which I think we probably assumed it could, and that we can still generate T cell reactivity in the face of the addition of chemotherapy.

I think for next steps, we're actively discussing that with Merck right now. I think it could be in the same regimen that we studied, it could be in combination with the RAS inhibitor. I think we need to do a little more thinking about that because the standard of care is changing.

And in terms of the disclosure, I don't think we've decided yet how we're going to handle that.

Operator

Our next question comes from Edward Tenthoff with Piper Sandler.

Edward Tenthoff

Great. And congrats on all the progress. My questions are just on the BLA for intismeran. What still has to happen? And are you working collaboratively with Merck on that? Are they driving the bus? And then just trying to get a sense for when we might get data from the lung cancer studies. And maybe you can kind of break out sort of how those different studies might read out.

Stephen Hoge

Ted, it's Stephen. I'll take the first part of that and then hand it over to David to speak through the lung cancer work. So we're working intensely with our partner, Merck. As we said earlier, as Stephane mentioned a moment ago, we are working to make sure that submission with the BLA happens this year. And if everything goes well, as has been said before, we would hope to see approval next year.

There are lots of steps, as you know, pulling those things together, including getting ready for pre-approval inspections and everything. And I can assure you, working around the clock to make sure that not only the submission happens on time, but the review is facilitated with the FDA. Because our goal here ultimately is approval. But working very closely with Merck together on that as we speak. David?

David Berman

Thanks, Stephen. The lung cancer adjuvant program is actually really comprehensive. We announced that we have just about completed. We have completed enrollment in the intismeran -- in the INTerpath-002, which is adjuvant after chemotherapy, with no neoadjuvant therapy. In fact, this was the fastest enrolling -- one of Merck's fastest enrolling trials, just to give you a sense of the excitement.

We are still ongoing in enrollment in patients who had neoadjuvant pembro chemo and did not have pathologic complete response. That's still enrolling. So it's too soon to know what's going to happen in terms of timing there. And then we have the really exciting high-risk Stage I lung cancer Phase III, where the first time we're testing intismeran monotherapy in one of the arms, also still enrolling there.

In terms of readouts and timings, I think it's a little too soon. We just finished [ PREDICT ]. We just finished enrolling. And so now we need to start monitoring events and then we'll have a better idea about timing.

Operator

Our next question comes from Alec Stranahan with Bank of America.

Alec Stranahan

Two from us, one on 2808 and one financial question. Looking forward to the data at ASH, I guess, what will the update add beyond the first 11 response available patients in terms of more patients, higher dose, durability? And I guess, how does this program maybe reflect the broader oncology opportunity you see for the platform?

And quickly on your 2026 growth guidance increase, how much of this came from timing, meaning deliveries moved into 2026? And does any of it, I guess, pull revenue forward from 2027?

David Berman

Alec, with regard to program, thanks for highlighting 2808, it is actually one of the exciting early-stage programs we have. There have been, obviously, lots of T-cell engagers in myeloma. There have been some that are targeting 2 antigens. This, of course, is the first time ever that 3 antigens have been targeted, and that's why we're excited this is going to be an oral presentation.

The data cut is later for the oral than it was the abstract, so you can expect more patients, longer follow-up and evaluation of what -- whether we can get a deeper response and activity in patients who had prior BCMA and [ GPCR 5D ].

In terms of the broader implications, this is testing a hypothesis we have that one of the benefits of our platform is that we can multiplex. And so we're multiplexing care against different tumor antigens in the form of 3 T-cell engagers. But it can also show that we can multiplex on the other side, going after different T cell stimulation approaches as well. So the fact that this works shows that we can multiplex, we can generate systemic proteins to treat cancer. And I think that's been a very important proof of principle.

James Mock

Thanks, David. Yes. And Alec, thanks for the question. So we're encouraged that this is really broad-based growth this year. It is both U.S. and international. And I'll just go back to some of my prepared remarks, which was we came into the year with 2 key growth drivers, mNEXSPIKE is performing extremely well in the U.S. But in addition to that, in the U.S., vaccination rates are stable, which Stephen walked through on his chart.

Internationally, we came in thinking about the strategic partnerships, and those have all performed extremely well also. So when we look to 2027, I go back to what Stephen presented in terms of there are still 4 growth drivers out there. Flu is relatively immaterial right now for us in 2026, and we expect to grow next year. Europe opens up for us, Latin America partnerships, hopefully, we will have INT approved. So we're quite encouraged. So again, it was a broad-based growth in 2026, and the 2 primary growth drivers are going well for us.

Operator

Our next question comes from Myles Minter with William Blair.

Myles Minter

Congrats on the quarter and all of the updates for the INTerpath-001. I actually had just a question on norovirus. I think at your last quarterly update, you indicated you were going to enroll another cohort. Now you're not and you're going to the regulators. Just wondering what changed there and what you're hoping to get out of those regulatory discussions.

Stephen Hoge

Yes, Myles. At this point, I don't have much more to say than we already did. You're correct, we did not meet the criteria for early success, and we were going forward with a cohort initially. But as we reviewed the program, we think the most appropriate next step is not to go forward with that cohort, but instead consult with regulators. And at this point, it's premature for me to guide any further on that. But once we've had those discussions with them about the potential next steps of the program, we'll be able to provide an update more broadly. So for now, we'll have to have those conversations before I can offer anything more.

Operator

Our next question comes from Tyler Van Buren TD Cowen.

Tyler Van Buren

Congrats on the quarterly results. So the melanoma INT results are clearly stellar. But regarding the next readout in RCC, some KOLs have brought up research suggesting that RCC immunogens may be driven in part by [ HIF-regulated ] endogenous retroviral elements. So can the current INT antigen selection process, identify and incorporate those types of noncanonical antigens? And how might that impact the probability of success?

David Berman

Yes, it's an interesting hypothesis that has been put out there. I think it's a hypothesis and it's a question whether endogenous retrovirals play a role or not. What I do know is that our algorithm does include insertion deletions, indels, which are actually strongly demonstrated to be important in RCC, as well as neoantigens, and single-point neoantigens that is.

And then I'll also point you out to a publication recently from Dana-Farber, where they did their own personalized cancer vaccine, and were able to identify sufficient neoantigens without the addition of endogenous retroviral. So the ERVs are interesting, they're speculative, and I think more research needs to be made before we include them.

Operator

Our next question comes from Andrew Tsai with Jefferies.

Lin Tsai

As we think about the BLA submission for melanoma with INT, can you talk about whether you would need some kind of special FDA approval on the algorithm side on top of the drug side? And secondly, if the power of AI continues to improve rapidly, can you just maybe talk about why competitors, hypothetically speaking, can't catch up to you on the algorithm side? Why do you think you have a protective moat?

Stephen Hoge

So first of all, yes, obviously, the algorithm for selection and, in fact, the entire front-end process for designing an INT for an individual patient, is a part of the drug. Effectively, there is software in it. And that is a proprietary feature of our platform, our technology. It's not something that will be readily available.

The important question maybe is the one -- the second part of yours, which is then, how does that play forward? And we're incredibly excited by what we've learned in our clinical trials. And bear in mind, the randomized data we have on immunogenicity from Phase II was in about 150 people, about 100 people who received INT. They've now been followed through 5 years. And at ASCO this year, we presented some of the update data, recent ESMO event, we presented some of that. We learned a tremendous amount the 34 neoantigens that we put into those people in that study.

What is remarkable is with the melanoma study that just read out, we've taken the number of patients up that we have that experience with by almost a factor of 10. And if you look across the other 9 studies that are up and running, we'll go another factor of 5 again. So we're starting to develop a tremendous amount of real experience with what sorts of neoantigens are generating T cell clones, what are the features of that T cell clonality that we think is really valuable for a neoantigen vaccine and individualized neoantigen vaccine. And we are constantly looking to bring that back into how we predict and design INTs for individuals going forward.

That data is a gold mine. We had -- I think we presented this, 5,000 neoantigens across the 100-plus participants in that first study, in the Phase II, it's gone up by a factor of 10. And we will be, with our partner, Merck, we're deeply going through that data and continuing to treat that proprietary information as one of the really special sauces, as we continue to try and make INTs more and more effective going forward in the -- really in the decades ahead. So we think we're at the very beginning of scientific revolution, and we're excited to be in the lead and to have that proprietary information.

Operator

Our next question comes from Michael Yee with UBS.

Michael Yee

Two questions. On INT, the clinical trial protocols are available for renal cell and bladder cancer, and we understand that they are an alpha spend -- one-sided alpha of 0.10, very much like you nicely designed your Phase II melanoma study and very much the same assumptions. Do you stand by that protocol and can confirm that those assumptions are correct?

And the second question is as it relates to filing in melanoma, is there a general timing guidance for that just so we can think about the gating steps and all the things that need to be done there in terms of the filing?

David Berman

Michael, we're not aware of the protocols that you cite, and I obviously can't comment on it, so I'm going to have to pass on that. In terms of the BLA, we're obviously working closely with Merck on that, and stay tuned for our next message on that.

Operator

Our next question comes from Courtney Breen with Bernstein.

Courtney Breen

A couple for me. I did want to zoom back to the pancreatic cancer study, the Phase I data that you presented at ESMO this year. Obviously, we saw the neoantigen generation, the T cell expansion, et cetera, that you've spoken to. There was also a small swimmer plot of kind of performance for these patients and recurrent details for these patients. Can you just help us understand what you're taking from that efficacy data so far? We see it as relatively early compared to kind of what performance can be generated with FOLFIRINOX on its own. But just want to understand kind of what you're already able to take from those insights and the potential to move forward. Or do you need more time to assess that data before you would move forward?

And then just the second question, just a really practical one on the revenue generation. Can you just talk a little bit about the ex U.S. components here and how much of that is coming from kind of commitments, how much of that is coming from pure demand? And we're just trying to figure out how we kind of appropriately carry some of this forward.

David Berman

Courtney, this is David. Thank you for the pancreatic question. It was very exciting data because we can generate T cells reactive to neoantigens that are present in the PDAC patients, which is something that actually was not really necessarily given.

In terms of the swimmer plot that you noticed, yes, I think I agree that it's probably too early, point number one. And point number two, this was a mix of patients. Some of them had neoadjuvant treatments, some of them didn't. And so it's really hard for us to discern an efficacy signal. I'm always careful about discerning efficacy signals in single-arm trial time-to-event analyses. I think the immunogenicity is data great, the safety is great, and we'll have to figure out the next step.

James Mock

Question on international. So I would say a significant portion is very durable. We've talked about the strategic partnerships, and it comprises over 50% of our revenue for sure. And then -- but I think what's also great about our international growth is, one, we're playing in a lot of other markets outside of these strategic partnerships, that we have been for some time. And we are increasing share, to some degree, as well as, I think as I mentioned earlier, the vaccination rates are improving in a lot of these markets as well. So I think we are seeing a shift year-over-year globally that vaccination rates have become more stable. So we hope that that is pretty durable moving forward.

Operator

Our next question comes from Alexandria Hammond, Wolfe Research.

Alexandria Hammond

So on INT, what learnings have you guys been able to take in regard to the optimal number of neoantigens coated? Do you think 34 is a sweet spot? Or do you think essentially next-generation assets or of your internal kind of platform could encompass more? I guess what kind of has the data demonstrated about how much of the breadth of these neoantigen payload matters. Is more always better or could a smaller number of newly highly immunogenic [indiscernible] be more favorable?

David Berman

I love the science question, and I'm happy to take it and expand on it. You're asking the exact question, right, which is what makes an optimal neoantigen, how many you need. These are things that we are now looking into because we have a randomized Phase III trial. And you need the efficacy in order to decode, go back to how many neoantigens you actually need.

So in melanoma, which has several hundred neoantigen [indiscernible] we know that 34 selected is enough. We can see that roughly 1 out of 3 of them generate a T cell response, although that may be higher. Actually, we're learning that we may actually have more immunogenicity than we actually thought we did.

So I'm not sure more is better because I'm not sure a hazard ratio of 0.58 or 0.51 in MITT is pretty good, against KEYTRUDA is really, really good. So would more have been better? It's hard to imagine more would have been better, but I don't know. These are things we now need to decode with our Phase III data.

Operator

Our next question comes from Jess Fye with JPMorgan.

Jessica Fye

Just following up on Alex's question there, you mentioned now you have this sort treasure trove of Phase III data. If I recall from the Phase II of the translational work we saw at ASCO, there were like 7 patients to work with, and it was like maybe a little hard to draw conclusions based on the small sample size. Do you have the actual like samples and data that you need to run that analysis to figure out those answers about sort of optimal number of neoantigens?

David Berman

Jess, so the 7 patients that you talk about is correct, the n=7. Because in order to do very deep immunological monitoring, you have to withdraw a decent amount of blood, and not all patients are willing to do that. And in this case, there were 7 patients willing to do that.

We do have more patients available from across the trials. So that's point number one. And secondly, we have developed really exciting novel ways to decode T cell reactivity from gene -- from just looking at the expression data from the cold blood gene analysis TCR beta. We have a way that we're beginning to learn to try to decode back neoantigen specificity. I mean that's part of the Holy Grail. So I am hopeful that we will be able to get insights from the Phase III that we didn't have in the Phase II. I think that it remains to be seen how far we can go, but that is certainly the goal.

Operator

Our next question comes from Luca Issi with RBC.

Luca Issi

Congrats on all the progress. Maybe, David, one more on RCC and the upcoming Phase II. Can you just maybe talk about the stratification strategy there? It looks like you're stratifying patients by either clear cell versus [ populari ] histology as well as by high versus low-disease risk. I guess what I'm trying to ask is, are there any specific subpopulations within RCC that are maybe more immunologically active that you're more optimistic that this approach can work? Or do you think this can work kind of across the board? And then maybe related to it, are you tracking the blinded event [indiscernible] and death? And are they on track with internal expectations or not?

And then maybe separately, Steve, any update on the ongoing conversations with the FDA and the time line for COVID plus flu in the U.S.?

David Berman

Yes. In terms of the tracking of the events, we don't comment on that. In terms of the what subpopulations, I think we believe this can work in multiple subpopulations. I think that was one of the insights we made from the Phase II and the Phase III studies, that pretty much all of the subsets we looked at have had a trend or a point estimate in favor of intismeran, including high-stage versus low-stage, high-TMB versus low-TMB. Some subtypes, papillary renal cell, obviously, is different than clear-cell RCC, but that's why we're stratifying against that. But as long as they have neoantigens we think that can generate novel T cell clones, and that can potentially have a benefit. So I don't think I would narrow down to a population right now.

Stephen Hoge

Just on the question on the flu/COVID combo vaccine for the U.S. We, as we said before, we are waiting for the approval in August. That was just 2 months ago, and then the launch of the flu and COVID vaccines in the U.S. And that was our key to then start the process of engaging with the FDA, that will take some time, there's a lot going on right now across our whole portfolio. And so we will, in the next number of months, be able to sit down and understand better what the U.S. FDA expects in terms of submission of the 1083 program. And once we have that information, we'll obviously provide an update.

Operator

Ladies and gentlemen, this does conclude the Q&A portion of today's program. I'd like to turn the call back over to Stephane for any further remarks.

Stéphane Bancel

Well, thank you, everybody, for joining us today. We really appreciate it. We're looking forward to seeing many of you in person next week for our Annual Analyst Day, November 12. And we are very excited for you to tour and to discover the intismeran manufacturing site. Have a nice weekend.

Operator

Thank you. Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.