MRK Q3 '26

Moments, ranked

1. 109:24 ETprepared -0.01%

   “In infectious disease, anticipated regulatory filings for Islachivir plus Lenacapivir, the potential first once-weekly oral two-drug treatment regimen for HIV.”

   Management, 0.4x volume, adj. next 5 min: +0.14% raw vs +0.15% sector

   New, abnormal minute +5 min after the statement

   low confidence

1. -0.04%0:00OperatorWelcome to the Merck & Co. EAMS, by New Jersey USA, third quarter sales and earnings conference call. At this time, all participants are in a listen-only mode until the question and answer session of the audience. At that time, to ask a question, press star 1 on your phone and record your name at the prompt. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations, so he may begin.
2. -0.04%0:33ManagementThank you, Julie, and good morning, everyone. Welcome to the third quarter 2026 conference call for Merck & Co. Incorporated, Rahway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Research Labs. Before we get started, I'd like to point out that we have items in our GAAP results, such as acquisition-related charges, restructuring costs, and certain other items, that we have excluded from our non-GAAP results. There is a reconciliation in our press release. I will also remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995.
3. -0.15%1:17ManagementSuch statements are made based on the current beliefs of our company's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A and the 2025 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck & Company, Inc., in Rodway, New Jersey, USA, undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release,
4. -0.15%1:59Managementtoday's prepared remarks, and our SEC filings are all posted to the investor relations section of our company's website. With that, I'd like to turn the call over to Rob. Thank you, Peter. Good morning, and thank you for joining today's call. 2026 continues to be a year of substantial progress for our company. We're executing well on all fronts, demonstrated particularly by the many new product launches now successfully underway, and the important clinical milestones we're achieving that are further de-risking the substantial progress and substantial long-term opportunity of our late-phase pipeline. This momentum extends across multiple therapeutic areas and modalities, and there is much more to come, with numerous significant readouts still to occur over the coming years.
5. -0.23%2:44ManagementI'm very pleased that the disciplined execution of our strategy over the past several years is increasingly translating into meaningful clinical, regulatory, and commercial results. The breadth of these achievements strengthens my confidence in the future of our company, and our ability to deliver long-term value for patients and shareholders. Turning to our third quarter results, we delivered solid performance with revenue of $18.1 billion, reflecting increased contributions from new products, as well as strength in oncology and animal health. Caroline will discuss our results in the full-year outlook in greater detail in a moment. We also achieved several important clinical and regulatory milestones. In oncology, last weekend's study, we achieved a record of over 1.5 million patients. We also achieved a record of over 1.5 million patients.
6. -0.15%3:29ManagementIn the end, we achieved a record of over 1.5 million patients. In the end, we achieved a record of over 1.5 million patients. We also achieved a record of over 1.5 million patients. The new COVID-19 vaccines ESMO meeting showcased potential practice changing advances for several innovative programs highlighted by the first positive phase three results from our expansive global TROs Fuse program for sac TMT in advanced or recurrent endometrial cancer. Additional data shared at the meeting from our partner, Kahlun, further support the potential of sac TMT in lung cancer and other tumor types. And we are encouraged by the landmark validation of a therapeutic cancer vaccine with positive positive response to the disease. We also achieved a record of over 1.5 million patients. We also achieved a record of over 1.5 million patients. This is because of phase three data presented for intismeron autogene as an adjuvant treatment for certain patients with melanoma. This new approach may offer a tangible opportunity to change the trajectory of a patient's cancer.
7. -0.15%4:14ManagementIn ophthalmology, we presented results from the Brunello study, evaluating Remigremig and diabetic macular edema a significant milestone for our rapidly advancing retinal disease portfolio. And finally, in pathology, we achieved a record In immunology, we presented encouraging Phase 2B results in HS and look forward to advancing our TL1A development program. This year's clinical and commercial progress underlines the ongoing transformation of our business and provides us with greater visibility into the trajectory of our emerging and expansive new product portfolio. The opportunity we have to drive strong long-term growth beyond the Katruta LOE period is becoming
8. -0.15%4:56Managementincreasingly clear as we achieve these scientific and commercial milestones. As we look ahead, we'll remain focused on successfully executing our launches, broadening and advancing our pipeline, and making meaningful investments to realize the full potential of these opportunities. I want to recognize and thank our dedicated global teams for their ongoing commitment to delivering value for patients, shareholders, and all of our stakeholders. And now, I'll turn the call over to Caroline. Thank you, Rob. Good morning. As Rob noted, we delivered solid performance in the quarter, driven by increasing contributions from our compelling array of important new products and continued strength in oncology and animal health.
9. -0.06%5:42ManagementStrong commercial and operational execution continues to propel our near-term performance while we invest to optimize our launches and advance our broad and deep pipeline to create long-term value for patients. Customers and shareholders. Now, turning to our third quarter results. Total company revenues were $18.1 billion, an increase of 5% or 4% excluding the impact of foreign exchange. The following revenue comments will be on an ex-exchange basis. In oncology, sales of the Katruta family of products, which includes Katruta and Katruta QLEX, increased 6%.
10. 0.00%6:26ManagementThe total revenue of the Katruta family of products was $8.6 billion, with global growth driven by strong uptake in earlier stage cancers and continued robust demand from metastatic indications. Key contributors to growth included strong utilization in tumors that primarily affect women, particularly cervical and breast cancers, as well as increased use of Katruta plus PADSF in urethelial cancer. We also saw continued uptake in earlier stage head and neck cancers. As expected, the timing of U.S. customer purchases last year created a headwind to growth, but this was largely offset by an increase in channel inventory, which we expect to unwind
11. +0.28%7:10Managementin the fourth quarter. Sales of Katruta QLEX were $830 million. We continue to see adoption increase, which supports our confidence in the trajectory of the product. In our broader oncology portfolio, we're looking at a growth of $8.6 billion, which is a significant increase in new and experienced clinical trials. The overall rate of U.S. sales had increased from $95.4 million to $37.3 million, which includes new and experienced clinical trials, improved performance, and increased attention. The value of the new model is low.
12. +0.28%7:55ManagementIt has high risk and closed long-term drug use. Even though U.S. sales were highly successful, it has saved us money in the form of revenue. However, as we looked at the growth of the product, sales of Katruta QLEX increased 58 percent to $307 million, driven by increased use in previously treated patients and as adjuvant treatment for certain patients with renal cell carcinoma in the U.S., as well as continued uptake from ongoing launches in international markets. In vaccines and infectious diseases, Gardasil sales were $2 billion, an increase of 14 percent. In the U.S., sales grew 18 percent and increased by a quarter. sales grew 18%, benefiting from a significant CDC purchase and price, while international markets increased 6%. In New McCockle, capvaxib sales were $263 million, an increase of 7%, driven by ongoing launches in certain international markets. In the U.S., sales declined 13% as increased market share was more than offset by lower adult New McCockle vaccination rates. In RSV, Inflonsia sales of $187 million reflect seasonal demand and associated inventory build.
13. +0.20%8:38ManagementIn cardiometabolic and respiratory, Winrever continued its momentum with global sales of $694 million, an increase of 94%, reflecting strong demand and associated inventory build. In the U.S., sales of $694 million, an increase of demand and associated inventory build. In the U.S., sales of $694 million, an increase of nearly 1,600 new patients received a prescription, approximately 30% of whom were on background therapies that did not include a prosper cyclin. Outside the U.S., we continue to progress with ongoing launches. Otivare sales were $184 million, reflecting continued demand from adults with
14. +0.20%9:20ManagementCOPD, partially offset by a small headwind from the timing of specialty pharmacy purchases. While early, we are encouraged by the initial launch of LipFendra. Prescription trends and physician feedback has been positive. Additionally, we have established programs to support access and affordability for eligible patients. As expected, broad access will take time to build, and we remain confident in the long-term opportunity for this important treatment option for adults with elevated LDL cholesterol. Our animal health business delivered growth of 3%.
15. +0.19%10:01ManagementCompanion animal sales increased 6%, driven by new product launches. Livestock sales grew 2% due to higher demand for poultry products. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Today, we will now walk you through the remainder of our P&L, and my comments will be on a non-GAP basis. Gross margin decreased slightly to 81.4%. Operating expenses increased 12% to $7.4 billion, reflecting increased investments to support our launches and advance our diverse early and late-phase pipeline. This increase was partially offset by benefits from our ongoing multi-year optimizations efforts, and we are committed to improving our up-to-date optimizations efforts. We are committed to improving our up-to-date optimizations efforts, and we are committed to improving our up-to-date optimizations efforts. This increase was partially offset by benefits from our ongoing multi-year optimization efforts. Thank you. Thank you. Thank you. Thank you.
16. +0.19%10:43Managementand the recognition of a portion of the external funding for SEC TMT development. There was also a $400 million upfront charge related to the license agreement with CyBranch compared with a $300 million business development charge a year ago. Other expense increased to $420 million, primarily reflecting financing costs related to recent business development transactions. Our tax rate was 10.9%, reflecting a benefit from certain discrete items.
17. +0.19%11:20ManagementTaken together, earnings per share were $2.49, which includes a charge of $0.12 per share related to the CyBranch license agreement. Now turning to our 2026 non-GAAP guidance. We have narrowed the range and raised the midpoint of both our full-year revenue and EPS guidance. We now expect revenue to be between $66.8 and $67.3 billion, representing growth of 3% to 4%, including a positive impact from foreign exchange of approximately one percentage point using mid-October rates. Our growth margin assumption remains approximately 81%.
18. 0.00%12:05ManagementOperating expenses are expected to be between $42.4 and $42.9 billion. Other expense is still expected to be approximately $1.4 billion. We now expect a full-year tax rate between 32% and 33%. We assume approximately 2.48 billion shares outstanding. Taken together, we expect EPS of $2.77 to $2.82, including a positive impact from foreign exchange of approximately 15%. This range also includes the CyBranch charge.
19. 0.00%12:48ManagementAs you consider your models, there are a few items to keep in mind. Third quarter sales benefited by approximately $550 million from favorable purchase timing in the U.S. We expect the benefit related to Keytruda and WinRiver to fully unwind in the fourth quarter, while the majority of the benefit to vaccines, primarily related to Gardasil, is expected to unwind next year. As we look forward to 2027, we recently noted an expectation for modest revenue growth. For Keytruda, moderating growth reflects the success we have had in reaching the eligible patients
20. 0.00%13:32Managementas we now approach peak revenues for certain approved indications. Additionally, we expect the German market to be impacted by policies, and we expect the U.S. to be able to continue to grow in the future. For Bridion, we expect competition from multiple generics that have now entered the market. For vaccines, we are watching broader market trends given increased hesitancy and reduced utilization. Finally, we also expect underlying operating expenses to increase at a mid-to-high single-digit rate, reflecting our conviction in the significant opportunity from our expanding market to expand our market. For the third quarter,
21. 0.00%14:13Managementwe intend to have a full-scale start to the laufenation of the GDP. We are aiming to get rid of the P&O on both the strategy and commodity side of the GDP zone. Forении, for you. Thank you for listening. For the third quarter, we expect the United States to be able to continue to grow in the long term. We expect the U.S. to be able to continue to grow in the long term. For the third quarter, we expect the U.S. to be able to continue to grow in the long term. within a strong investment grade credit rating to pursue additional science-driven value-enhancing transactions. We remain on track for approximately $3 billion in share repurchases this year.
22. 0.00%14:56ManagementTo conclude, as we head into the fourth quarter, we remain confident in the outlook for our business. Demand for our diverse portfolio of human and animal health products remains strong, and our recent launches are making increasingly meaningful contributions to growth. Our compelling, innovative portfolio of pipeline assets continues to progress, leaving us very well positioned to deliver outstanding value for patients, customers, and shareholders now and into the future. With that, I'd like to turn the call over to Dean. Thank you, Caroline. Good morning, everyone. The third quarter was markedly
23. 0.00%15:40Managementby a number of significant clinical and regulatory milestones. Today, I will provide updates in oncology, cardiometabolic and respiratory, immunology, and ophthalmology. I will close by highlighting upcoming milestones. Starting with oncology, as Rob noted, data from several pivotal studies were presented at ESMO, which exemplify our clinical development approach and reflect how Katruta is informing our pipeline progress. ESMO marked the first presentation of detailed phase three findings from our expansive global TROPHUSE development program for SAC-TMT, our TROP2-directed ADC with a unique bifunctional linker.
24. -0.30%16:24ManagementThe TROPHUSE program is guided by a two-prong development strategy. First, we are moving with speed and rigor to establish early leadership in multiple disease and treatment settings. Many of these first-mover opportunities are in gynecological and immunological care. We are also working with the U.S. Department of Health and Gynecologic cancers, where there remains significant unmet need. The TROPHUSE-005 study presented at ESMO evaluated SAC-TMT in patients with endometrial cancer whose disease has progressed following platinum chemotherapy and anti-PD-1-L1 immunotherapy, demonstrating a remarkable near seven-month improvement in median overall survival
25. -0.30%17:04Managementcompared to chemotherapy alone. Endometrial cancer is one of the few cancers with increasing incidence and mortality rates worldwide. These patients currently face a very poor prognosis, and we look forward to continuing to work with the FDA to deliver this potential new option as quickly as possible. Second, we are exploring the potential of SAC-TMT in certain types of breast and lung cancers where we believe we can be differentiated. In first line, PD-L1-negative non-squamous non-small cell lung cancer, results from the optotrope lung O6 study conducted by our partner, Keelan,
26. -0.30%17:45Managementshowed a meaningful improvement in progression-free survival for SAC-TMT plus Keytruda over Keytruda plus chemotherapy, raising the possibility that novel combinations may improve upon the high bar set by Keytruda plus chemotherapy. Our global TROPHUSE program includes five ongoing phase three studies in various non-small cell lung cancer settings. We plan to invest in the TROPHUSE-005 study in the next five years. We are also looking to investigate SAC-TMT in combination with MK-2010, our PD-1 VEGF bispecific, in first line non-small cell lung cancer. Engagement with the FDA has been productive, and we anticipate phase three studies in this setting in the first half of 2027.
27. -0.30%18:28ManagementNow, turning to antisemirad. Our deep understanding of tumor biology continues to inform the next generation of our oncology pipeline, including the development of an MRNA therapy for the cancer. We are also looking to investigate the development of an MRNA therapy for therapeutic cancer vaccine based on the unique mutational signature of a patient's tumor. ESMO marked the unveiling of landmark results for antisemirad, an investigational individualized neoantigen therapy developed in collaboration with Moderna plus Keytruda as adjuvant therapy for melanoma. Results of the InterPATH-001 study demonstrated clinically meaningful improvements in recurrence-free survival and distant metastasis. Results of the InterPATH-001 study demonstrated clinically meaningful improvements in recurrence-free
28. -0.30%19:10Managementsurvival for antisemirad plus Keytruda over standard of care Keytruda in patients with completely resected stage 2B24 melanoma. These results, building on the body of evidence from the phase 2B study, strengthen our confidence in the curative potential of antisemirad when given in combination with Keytruda. We are actively engaged with the FDA on regulatory submission. Additionally, we are progressing around the world in the field of antigen-free survival for antisemirad. robust interpath clinical development program across a range of immune-sensitive tumors, including indications in earlier stages of disease where Keytruda has established efficacy.
29. -0.30%19:52ManagementPhase 3 studies are ongoing in melanoma and non-small cell lung cancer, which are characterized by high mutational burden. Ongoing Phase 2 studies are also evaluating tumors with lower mutational burden, including certain bladder and renal cancers, to inform potential future expansion. I look forward to sharing further updates on these and other oncology programs. Now to a few regulatory updates. Subcutaneous pemberlizabab and barahyleronidase alpha was approved by regulatory authorities in Japan and China. In Europe, we received approval for Keytruda plus-passive as a perioperative treatment for resectable,
30. -0.30%20:34Managementmuscle-invasive bladder cancer. And in the U.S., the FDA approved Wellereg plus-Limvima for the treatment of patients with previously treated renal cell carcinoma. Regarding infinitumab, Dirextacan, together with Daiichi Sankyo, we made the decision to withdraw the biologic license or application seeking accelerated approval. Multiple studies of IDXD are ongoing in small cell lung cancer, prostate cancer, and other tumor types. Next, in cardiomyopathy, we received approval for Keytruda plus-passive as a perioperative treatment for patients with previously treated renal cell carcinoma. And in the U.S., the FDA approved a label update for Winrevere, incorporating results from the Phase III Hyperion study, providing further evidence to support its use earlier in the treatment journey for adults
31. 0.00%21:18Managementwith pulmonary arterial hypertension. With Winrevere, we introduced active and signaling inhibition, a novel mechanism targeting the underlying vascular remodeling that drives disease progression, building on the findings from the Phase II cadence trial. We are taking an important step to extend the application of active and signaling inhibition beyond Group I PAH. The upcoming Phase III core study will evaluate patients with combined post and precapillary pulmonary hypertension associated with heart failure with preserved ejection fraction. This distinct population within Group II pulmonary hypertension has similar vascular characteristics
32. 0.00%22:01Managementto PAH and no currently appropriate. We are taking an important step to extend the application of active and signaling inhibition beyond Group I PAH. The upcoming Phase III core study will evaluate patients with combined post and precapillary pulmonary hypertension associated with heart failure with preserved ejection fraction. This distinct population within Group I PAH. The upcoming Phase III core study will evaluate patients with combined post and precapillary pulmonary hypertension associated with heart failure with preserved ejection fraction. Next, in immunology. Last month at EADV, positive Phase IIb results were presented for Tulasocabart in patients with hydranitis superativa, making it the first anti-TL1a antibody to demonstrate positive clinical data in a dermatology indication. The study demonstrated promising clinical responses and encouraging safety profile. Based on these findings, we plan to advance Tulasocabart into Phase II PAH. Finally, to ophthalmology, as Rob mentioned, earlier this month, results were presented from the Phase IIb-3 Brunello study,
33. 0.00%22:46Managementthe first of two pivotal studies evaluating Remig-Remig, a novel Wnt agonist in adults with DME. Brunello achieved its primary endpoint with both doses of monthly Remig-Remig, demonstrating non-inferior best-corrected visual acuity compared to monthly 0.5 mg Ranibizumab at one year. While anti-VEGF therapies have transformed the treatment of DME, disease activity persists in many patients, highlighting the need for new therapeutic options. Brunello provides clinical evidence that activation of the Wnt pathway can achieve non-inferior efficacy to an anti-VEGF agent in DME. If confirmed in the companion Barolo trial,
34. -0.01%23:30ManagementRemig-Remig could introduce a promising new anti-VEGF agent. wzgl-Industries work well together to have a vision for the future ofSearch that sink into auger. helps devastated patients provide a corpus hypochemical and its own optimal shotgun relief opener, basically broth in optional mechanism, and help advance the field of ophthalmology toward therapeutic strategies involving multiple pathways. In closing, the breadth of these milestones reflects our progress in translating novel advances in the understanding of disease biology into potentially significant medicines across diverse therapeutic areas. Over the next 12 months, we anticipate several important clinical and regulatory milestones, including in immunology for Tulasocobar, we are compiling data from the phase 3 ATLAS-UC study
35. -0.01%24:10Managementand expect to share the results in the near term. In ophthalmology, the readout of the Barolo study of Remig-Remig. In cardiometabolic and respiratory, the initiation of the phase 3 CORE study. In infectious disease, anticipated regulatory filings for Islachivir plus Lenacapivir, the potential first once-weekly oral two-drug treatment regimen for HIV. Data from the phase 3 ANCHOR study evaluating MK1406, our investigational long-acting and strain-agnostic antiviral designed to prevent influenza, and the data from the phase 3 EXPRESSIV program
36. -0.01%24:48Managementof our investigational once-monthly oral HIV prep option, Alamatrover. And finally, in oncology, the potential approval of SAC-TMT in endometrial cancer and additional phase 3 readouts. The anticipated regulatory filing of Antisparan and additional readouts in multiple other programs. And now, I will turn the call back to Peter. Thanks, Dean. Before we get started with Q&A, I'm very pleased to introduce Yanni Osthazen and Brian Ford, who are with us this morning to help address questions. And as a reminder, Yanni serves as president of our oncology business unit, as well as the president of the
37. +1.19%25:30ManagementMSD International. And Brian serves as president of our specialty pharma and infectious diseases business unit. I'd also like to request that analysts limit themselves to a single question today so that we can get to as many different questioners as possible in the time that we have. So, Julie, if you could please start the Q&A session. Thank you.
38. +1.19%25:51OperatorJULIE WALSH, MSN, Thank you. Ladies and gentlemen, if you wish to ask a question, please press the button on your telephone keypad. You may withdraw your question at any time. If you are using a speakerphone, please pick up the handset before pressing the numbers. Once again, if you have a question, you may press star 1. One moment, please, for our first question. Our first question comes from Chris Schott with JPMorgan. Your line is open.
39. +1.02%26:21AnalystCHRIS SCHOTT, JPMorgan.com Great. Thanks so much for the question and congrats on all the progress. I guess my question is, you recently made some comments on 2027, both top line and spend. And I'm wondering if you could give us a little bit of a background on that. And I'm wondering if you could give us a little bit of a background on that. And I made just a two-part question. I'm just interested, do you feel that that's now appropriately reflected in consensus estimates? And then just given the R&D spend we are seeing for the company in the near term, as well as the longer term pipeline de-risking we've seen, is it now fair to think about earnings growing off of this type of level as we move through the key to LOE, I guess, that's a different way? Does this R&D spend effectively pull forward your trough earnings so we can think more about earnings growth from Merck as we look out to the 2030s? Thanks so much. JULIE WALSH, MSN, Great. Thanks.
40. +1.13%27:03ManagementThank you for the question. First, if I can maybe provide everybody the headlines around our comments on 2027, and then I'll answer the specific questions. For 2027, we see it as another year of investment, as we invest behind our expansive pipeline and our new product launches to drive long-term growth. Specifically in 2027, we expect moderate top line growth. JULIE WALSH, MSN, And that's as a result of the increase in the number of new products that are being launched. And that's a result of the increase in the number of new products, as well as the strong contributions we expect from our new product launches, as well as animal health, that will be partially offset by more than $2 billion of headwinds as a
41. +1.13%27:44Managementresult of generic competition and LOE, impacting Brideon, Genuvia family of products, as well as Odempus. We do expect Keytruda to continue to be an important contributor to our overall revenues, although we do see growth moderating. JULIE WALSH, MSN, Thank you. JULIE WALSH, MSN, Thank you. JULIE WALSH, MSN, Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. JULIE WALSH, MSN, Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. JULIE WALSH, MSN, Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. JULIE WALSH, MSN, That's as we've reached peak penetration in a number of indications. While we also expect headwinds to price in our XUS market, and we are watching the policy dynamics in Germany. From a vaccine perspective, we have seen a benefit of a CDC buy-in in
42. +1.77%28:23Management2026 of approximately $250 million that will unwind in 2027. Now, as we look at the rest of the , we have seen a decline in the information exchanges. We have seen a decline in financial free trade, and we've observed a decline in the shares trade, and we've seen Growth margin will increase given the roll-off of a royalty on Keytruda. As you've noted, we expect expenses to increase because we are fully investing behind our strong pipeline as well as our launches. And we do expect slightly higher interest expense and a slightly higher tax rate.
43. +1.77%28:54ManagementBut all in all, 27 marks a year of investment for strong growth in our future, which is all in part to drive our strategy of how our company grows beyond the Keytruda LOE. Now, as we look at that, we see the Keytruda LOE as really more of a hill on the overall revenues of our company as we will, in short order, then return to strong growth. As we look at consensus estimates for 2027, there are a number of different estimates from the different analysts, and some have incorporated the messaging that we've given. Many have not yet.
44. +2.46%29:40ManagementSo hopefully this will provide clarity as to our expectations for 2027. And as we look at earnings as we move forward, we do expect to see our company have earnings. As we move forward, we do expect to see our company have earnings. As we move forward, we do expect to see our company have earnings. And we do expect, as I've noted, a shallow dip in revenues in the initial period post the price setting through IRA and the LOE, but to quickly return to growth. And we would expect the earnings profile to probably mirror that, given the expansive pipeline that we have and the continued studies that we will be doing and supporting.
45. +1.07%30:24ManagementAs well as the launches that are coming through year over year. So headline, confident in our future, confident in our pipeline that will drive long-term growth and patient benefit and enable us to offset over time the Keytruda LOE. Great. Thank you, Chris. Next question, please, Julie.
46. +1.07%30:47OperatorThank you. Our next question comes from Vamal Devon with Guggenheim Securities. Your line is open.
47. +1.07%30:54AnalystGreat, thank you for taking the question and congrats on the progress with the pipeline. Maybe just on Wynner here, if I could ask a couple of questions. One if you could quickly just quantify the one-time benefit you saw specifically for Wynner here. This quarter I know you kind of grouped it into the 550s overall for the pharma business. And then Dean, I specifically wanted to ask you on the Chorus trial, we did go through the listing there on clinical trials. If you can discuss how it's similar or different to what you did with the Phase II cadence trial in terms of the endpoint, in terms of the inclusion criteria, just to give us a sense of how the patients and the study will compare to each other.
48. +1.39%31:33ManagementThanks. Thank you, Vamil, for the question. In terms of the timing benefits that we saw in the quarter, if I may give the full picture inclusive of Wynner Affair so that we have it out there for all. We had a benefit in the third quarter. We had a benefit in the fourth quarter of $550 million as a result of the timing of purchases. $200 million of that relates to Keytruda, which we will expect to unwind in full in the fourth quarter. $50 million relates to Wynner Affair, which we expect to unwind in the fourth quarter. A further $300 million relates to our vaccines business, which is predominantly Gardasil. $50 million relates to the Pfizer vaccine.
49. +1.16%32:18Management$50 million relates to the Pfizer vaccine. $50 million relates to our vaccines, which is primarily Gardasil. That's $250 million to unwind in the fourth quarter and the remaining $250 million to unwind in 2027. Yeah, Vamil, thank you very much for the question. I'll just answer it in two parts. The first is I just want to call out for PH group one, not group two, that the field is increasingly moving to a concept of, with active and signaling inhibitor, the potential of remission. And you've seen that in the European guidelines that have come out, and we're hopeful that the similar sort of standard will take. This is really important because it suggests, similar to ACE inhibition and left heart failure, that in this right heart failure with PH group one, that physicians in the field can think
50. +0.73%33:03Managementdifferently about the treatment paradigm. The reason I want to bring that up is that you've asked me now about group two, which is a heart failure study. We have the cadence study. And what we're going to be doing in the core study... I just wanted to be pretty clear. We're not expanding the patient population in any substantive way. There are details in relationship to how we're going to execute on the trial. But we really think that, quote unquote, this patient population that was seen in the cadence has an incredibly high unmet need. There's no approved treatment. It's really poor prognosis. And it's also an orphan indication.
51. +0.73%33:47ManagementAnd so from the cadence... You know, we met primary endpoints, reduction in PVR, and important secondary endpoints. And we're going to initiate the phase three course this year with a 0.3 milligram per kilogram dose and with time to clinical worsening in the endpoints. And we enroll... We expect that this will be a very attractive trial for patients with group two pulmonary hypertension. Great. Thanks, Bob. Next question, please.
52. +0.34%34:19OperatorThank you. Our next question comes from Michael Yee with UBS. Your line is open.
53. +0.34%34:24AnalystGreat.
54. +0.34%34:25ManagementThanks. Maybe, Dean, if I could just follow up on, obviously, the very busy ESMO conference. Maybe here you could offer a view about the fact that you have greater confidence in China studies being further replicated across all of your global TROPHEW studies. And since I think we've discussed lung cancer enough, maybe you could just comment on where the one or two other SAC-TMT indications you think are most notable and that we may not be paying attention to. Thank you. Okay. So I had a hard time hearing, but I think the gist of your question relates to the TROPHEW ADC that we have, our SAC-TMT.
55. +0.46%35:07ManagementAnd I would just highlight what was said in the remarks, which is we've always had a two-part strategy. The first part is we had recognized that we had a very high risk of cancer. We had a very high risk of cancer. We had a very high risk of cancer. And we had a very high risk of cancer. So we realized that when we got into this field that there were two TROPHEWs that were ahead of us, but we were actually surprised that they did not move quickly to indications outside of breast and lung. And we thought that there would be an enormous opportunity to do so. And you see that in our clinical trials as we move very fast outside of lung and breast. There are trials that we have in lung and breast, but we've moved very fast outside of that.
56. +0.46%35:48ManagementAnd this most recent TROPHEWs 005 is an evidence of that. The reason why that's important is if you look at that TROPHEWs 005 as a proof point, I would just call your attention to, I think it was a presentation, I think in 2025 or 2026 with MK2870-001 or Keelin 264-01. That's the phase 1 slash 2 endometrial cohort. That was the informative information for us. And for us, looking at Chinese data that allowed us to figure out how to translate that in a TROPHEWs 005. So the bottom line is that experience, working closely with Keelin, it isn't like you're
57. +0.18%36:30Managementgoing to translate them exactly, but it gives you the signal as to how you might translate it into global. So that gives us confidence that the Keelin data is a really important signal for us and that we are confident that we can translate into the global. Thank you. Thank you. And we hope to replicate that in other indications outside of lung and breast, but clearly, as Marjorie and Elliot have talked recently, we plan to go quite aggressively in lung. Great. Thanks, Mike. Next question, please.
58. +0.65%37:04OperatorThank you. Our next question comes from Courtney Breen with Bernstein. Your line is open.
59. +0.65%37:11AnalystHi, Marc team. Thanks so much for taking the question today. I just wanted to zoom into the subcutaneous or ketridoculex litigation that is ongoing. We're seeing kind of obviously reports out of Europe and kind of infringement claims that are being made. Can you just contextualize where we're at in Europe relative to the U.S.? Is this a definitive call? Are there likely paths to moving back towards the launch in these European countries? And is there any risk in the U.S. as we move forward, given that the path and the intention and the litigation that is ongoing? Thank you so much.
60. +0.65%37:54ManagementMaybe I'll start, Courtney, and then I'll turn it over to Yanni. Overall, I just want to emphasize, we feel very strongly that we have IP that gives us freedom to operate as it relates to Culex. That's why we actually pursued action against others in the field to ensure we could do that. So nothing has changed to our confidence. We see long term. The injunction you're seeing in Europe is just an injunction until the hearing is held. It doesn't speak to the merits of our belief. We continue to feel very, very good that we have a position both in the U.S. and in Europe. But maybe I'll let Yanni speak specifically to the implications of Europe and how we see that potentially resolving.
61. +0.46%38:39ManagementThank you, Rob. And thank you for the question, Courtney. In relation to the U.S., as Rob said, we feel really strong about our position in the U.S. And in fact, you saw the number 830 million of Culex. In the quarter or sub-Q in the quarter, which is the majority is the U.S. Since we received the permanent J code on April 1, it's really been a very positive trajectory. And we feel good about the objective of getting to that 30 to 40 percent adoption in the United States by the end of 2027. So the United States, we're really on a good path. In terms of XUS, we've always talked about a range of adoption from high adoption markets to much lower adoption. In a high adoption market, we've always talked about a range of adoption from high adoption markets to much lower adoption. In a high adoption market, we've always talked about a range of adoption from high adoption markets to much lower adoption. In a high adoption market, we've always talked about a range of adoption from high adoption markets to much lower adoption.
62. +0.35%39:20ManagementIn the high adoption markets, which is the U.K., Canada, Austria, we're actually able to supply. We're waiting for the launch in Canada. But these are the high adoption markets. And we actually see a high level of adoption in the U.K. already. So that is also very positive and not challenged by the injunction out of the Netherlands. In terms of Japan and China, also no issue from a supply and launch perspective. And we're waiting to launch in those two markets where there's significant volume and we have an ambition to get a high level of subcutaneous use. In Europe, where the Dutch ruling is valid for now, as Rob said, we do not disagree with the Dutch court, and we will continue to work
63. +0.35%40:03Managementto overturn this. So for now, we will not supply in Italy, Denmark, the Netherlands, France, Belgium, and Ireland. These, in general, are smaller volume markets, so it's immaterial in terms of our overall volume of sub-Q. But again, given that we have longer IP, if we would turn this decision positive, we will have time to get back and make this convenient formulation available to patients in these markets as well. So overall, we feel we're in a really good place in terms of subcutaneous adoption and trajectory of where we want to be. Excellent. Thank you, Courtney. Next question, please.
64. +0.35%40:46OperatorThank you. The next question comes from Akash Choukla. Akash Choukla with Jefferies. Your line is open.
65. +0.35%40:52AnalystHey, thanks so much. It looks like the primary endpoint for your KRAS G12C first-line NACLC trial was changed from PFS and OS to PFS only back in September, which cut your target enrollment and moved up your primary completion. Do you think this is a part of a larger stance that maybe the FDA is taking here, where hitting on OS is important but not gating towards initial filing? And how could that maybe apply to the design for your first-line SAC TMT PD-1 VEGF by specific trial you're aiming to start first half of next year? Thank you.
66. +0.22%41:23ManagementYeah, thank you very much for actually calling out Calderacib. I just step back so that other people who are listening understand that's our KRAS G12C inhibitor, and we think that MK1084 Calderacib is a very important molecule. It has the profile that we wish that, you know, any RAS molecule would have. It's extremely potent, it's extremely selective, and it can, uh, be well combined, for example, with Keytruda in the lung situation and with something like Cytuximab in the CRC, and we've seen really strong data. In relationship to our, our, uh, moving forward in relationship to this, I think, you know, part of that is discussions and feedback
67. -0.24%42:07Managementfrom, with the FDA. I, I do, uh, believe that all of those endpoints will be important. PFS, OS eventually will all be important, but yes, we are moving with speed, uh, and rigor to get this Calderacib in first-line lung with, um, with Keytruda, but especially sub-Q Keytruda, uh, moving quite fast. I should also emphasize that there is a difference of how we might have a philosophy in terms of clinical development versus others, uh, in this space, and for us, what's really important is, again, this is a place where we're thinking about Keynote 180.
68. -0.24%42:48ManagementKeynote 407 and asking ourselves, well, how do we displace that with those patients who have a KRAS G12C, uh, uh, mutation, which is the dominant, uh, mutation, uh, for RAS in that patient population, and our strategy is not to add it on top of Pembro plus chemo, but to use a Pembro plus that inhibitor by itself without the chemo so that we can create a chemo-free, uh, option for patients. Great. Thanks, Lakosh. Next question, please.
69. -0.18%43:24OperatorThank you. The next question comes from Dana Graybosh with LearRink Partners. Your line is open.
70. -0.18%43:30AnalystI have a follow-up that's right on RAS. You have two other RAS assets, one that you licensed out of China. I wonder if you could just step back, Dean, and talk about how you're thinking about the full portfolio across indications and combinations, uh, beyond, uh, Calderacib. Thank you.
71. -0.18%43:47ManagementYeah. So, uh, uh, thank you very much for that. Thank you for that question. Um, I think it shares a lot of similarities. So, our interest in, for example, KRAS G12D is whether we could, for example, replicate what we see in lung with a KRAS G12D, uh, in a very similar strategy. But as I said, we're using Calderacib and 1084 as a way to sort of measure what we do. The other place that we have, we think, quite good data is Calderacib. In relationship to CRC, especially in first-line CRC. Now, in Calderacib in CRC, KRAS G12C is a
72. -0.33%44:29Managementreally important target, but it's, it's the minority. It's, it's the distinct minority of RAS mutations. KRAS G12D is the sort of more dominant mutation. And so, our, our hope is that this KRAS G12D that we are, uh, we should have important clinical data in the next year or so. Uh, we'll replicate what we've done in KRAS G12C in, for example, lung and CRC. And also, you know, we would clearly look to see what it does in pancreas. But our focus has been, how do we use Calderacib and how do we look at the other isoforms of RAS or the other subtypes of RAS and how do we
73. -0.18%45:10Managementrecreate what we believe is a really good profile for KRAS G12C and how do we replicate it for the other subtypes? Great. Next question, please.
74. -0.18%45:21OperatorThank you. The next question comes from Mohit Banzal with Wells Fargo. Your line is open.
75. -0.18%45:27AnalystGreat. Thank you very much for taking my question and congrats on all the progress. Uh, so just, uh, trying to speak to CL1A or . So, does that look like the field of IBD is moving towards combinations as we try to push remittance rates higher in earlier lines of setting? So, in that backdrop, how are you thinking about how to do that? So, do you think about building a combination strategy around CL1A? Do you think it is strategically important to have all the complementary mechanisms in-house or would you be comfortable partnering with some established market, uh, marketed product at this point to find the best combination?
76. +0.02%46:08ManagementThank you. Yeah. So, uh, you broke up a little bit, but I'll just answer in a more general way because I think you're asking a question that's a broader question in immunology. How do you think about that? I think you're asking a question that's a broader question than I do think about combinations and the such. You know, combinations have been done quite a lot in immunology. They were done back, I think, in the 2018, I can't remember, 2020 range. And those combinations have not generally given that much benefit. So, you do not see that combination strategy play out. I do have to give our credit to to a company who's more recently been doing that. And I think that's a great question. I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great question.
77. +0.02%46:51ManagementUh, advanced sort of combinations and we'll see how that data comes through. But the bottom line is combinations could be important. We believe combinations, for example, in oncology are really important. We think combinations of different mechanisms and ophthalmology is really important and combinations could be really important throughout immunology. However, I think each, each indication and each sort of compounds that are there will have to play out and we'll have to figure out how to do that. So, I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great question. I think it's a great 14 desde los低 how important and how effective combination therapies are throughout
78. -0.04%47:28ManagementING be potential combination partners but we also remain open on the business development front both in terms of products and development as well as commercialized products so we're we're looking at all fronts um and uh and remain confident that we are positioned to move depending on how we see the field evolve as dean said thank you mo next question please julie
79. -0.08%48:14Operatorthank you the next question comes from steve scala with td cowan your line is open
80. -0.08%48:18Analystoh thank you very much i'm curious what lip fendra sales were in the quarter and what percent of prescriptions are free drug despite lots of competitors lipitor generated over 800 million dollars in its first year on the market and i can't think of any reasons why the fendra shouldn't do at least that well and i'm wondering if you agree thank you so um
81. -0.08%48:45Managementappreciate the question you know we are as we uh highlighted in the opening comments as caroline laid out we are focused on affordability and access and the way we've structured this so we are using couponing and other other means i'll let brian speak to it i think what you're going to see right now is the script data is is quite strong we're not going to give specifics on on our revenue forecasts at the moment but uh i'll let uh brian get maybe give comments just you can get a sense of how we're seeing the scripts evolve yes thank you so much for your question sounds like you have uh similar excitement as we do in this particular space as well we are seeing really early positive uptake actually and i'll speak to a couple of the numbers in spite of the fact that we know that this is a marketplace but there is a significant
82. +0.12%49:27Managementamount of inertia and we've said that it'll be a gradual you know ascent as the prescriptions come in but i'll give you a couple of metrics to think about so in the third quarter we saw more than 11 000 prescriptions with over and this is coming from over 6 500 prescribers and those prescribers are broken down we're actually seeing not just in cardiologists but also in general practitioners which is which is really encouraging but probably what's even a little bit encouraging to that is we're seeing you know then signs that expanding beyond the pcs k9 marketplace the vast majority of prescriptions are coming from patients on other background lipid lowering therapies rather than switches off of injectable pcs k9s which is exactly what we had had hoped for now keep in mind as i think as rob had mentioned we have sampling and coupon programs that are out
83. -0.01%50:11Managementthere today that will affect revenue in the short term but we're also actively in discussions with payers and the whole goal there is to get as rapid access as possible commercial we expect as we had mentioned before large coverage of the access in the commercial space in 2027 time frame and then for medicare it's actually in the 2028 time frame as well now our teams are working really diligently to expedite that and bring it forward but as we said before you know this is a place that there is natural inertia in the marketplace and so we're cautious about the early uptake but early signs are positive for us and we see this again as we said as a meaningful growth driver for us in the future a multi-billion opportunity great thank you steve next question please julie thank you the next question comes from
84. -0.01%50:56Operatorumur rafat with evercore isi your line is open morning guys thanks for taking my question um dean
85. +0.26%51:03Analysti was thinking about the recently presented melanoma data for the cancer vaccine and my question is how does that efficacy break down for patients that had a lower number of new antigens and perhaps even more importantly patients that did not have a major driver mutation like anrus BRAF, et cetera. I'm just trying to think through the implications for the upcoming RCC readout.
86. +0.26%51:24ManagementThank you. Yeah, so I want to be a little bit cautious of getting ahead of the data that was presented and the data that we are examining and will likely provide in some time. I think some people have said in the next year or so. So I don't want to get ahead of that. But I would just emphasize, and if you don't mind, I'm going to take a little bit of time here in relationship to that, which is, you know, there was a press conference or investor meeting that Moderna sponsored. And I would just call out the two really important experts that they had there,
87. +0.11%52:08Managementwhich was Georgina Long, who was important for this trial, and Antonio Ribas. And the reason I want to call that out is I've seen... some reports about melanoma and all of this. I just want to call out that Georgina Long was a senior investigator of Nadina, and Antonio Ribas was the senior author of SWOG 1801. And I would just quote Antonio Ribas saying, this is a landmark in cancer drug development. And so we are eager to present that to the FDA. And I do think the data as interpreted
88. +0.11%52:47Managementby those people who are scientific leaders is that this is a landmark study in its own right. And because of that, we would expect that, or we would hope, I should say, that upon approval, that the NCCN guidelines would potentially define this as a new standard of care. So thank you. So that's the melanoma question. The other question is melanoma itself. You can have a spectrum of TMB within melanoma, but in general, the spectrum of TMB in melanoma is just shifted. It's just shifted totally in favor of being high TMB. So I would be a little bit cautious for me
89. +0.09%53:29Managementto over-interpret any data in, for example, lower TMB in melanoma as a signal for RCC. I think the fundamental issue is that what you've seen is that at least in our hand, checkpoint inhibitors and IO agents, not just ours, but for example, IL-2 have worked, you know, that has been, you know, a place that RCC has been a good tumor in relationship to what you would call immunoresponsive. And, you know, I think TMB is important, but I also think TMB is not the answer. So I think that's a good question. And I think that's a good question. And I think that's a good question. And I think that's a good question. And I think that's a good question. And I think that's a good question. And I think that's a good question. I think that's the only determinant of immune responsiveness. And if you take that view, that's how I look at
90. -0.04%54:14Managementour upcoming study with RCC. I'm not so sure that parsing the TMB within melanoma will give me any increased or decreased confidence in relationship to RCC. Thank you, Umar. Next question, please.
91. -0.04%54:31OperatorThank you. The next question comes from Asad Hader with Goldman Sachs. Your line is open.
92. -0.04%54:37AnalystGreat. Thanks for taking the question. A lot of mine have been asked, but maybe one big picture, zooming out for you, Rob. Just given the developments over the course of this year, would it be great to get any updated framing on how you see the $70 billion revenue opportunity you've talked about by the mid-2030s? You've obviously had a lot of pipeline success over the course of the year. The company continues to transform its portfolio. Things are moving in the right direction to de-risk that number. So maybe just double-click on the pushes and pulls that have occurred to influence that and remind us on what wasn't incorporated into that framing and what surprised you to the positive side and what's still underappreciated. Thank you.
93. -0.09%55:13ManagementYeah, no, I appreciate that. So, you know, overall, the pride I have in what we've done as a company and how we're moving forward, given the fact that we've seen so much of our clinical data read out positive to date, you know, obviously these are studies, so every card's a new card and you have to wait until the next card's overturned. But that said, what we've seen, so far gives me great confidence and increased confidence in that 70 billion. And as such, as we've indicated, we expect now to be raising that number, not only because what we're seeing confidence in what we have, but what wasn't included, which is, I think, part of your question. And I would just remind you that when we gave that number, we did not have the turns acquisition included.
94. -0.09%55:57ManagementThat is going to be addition to that number. In addition to that, we really put nothing in for the PD-1 VEGF. Which now, given what you've heard coming out of several different conferences and other meetings, we have growing confidence in that as a combination agent for us, as we think about that with SAC-TMT and with everything else. So a lot of excitement there. SAC-TMT itself is probably going to have broader indications as we look forward with, given the fact that we're kicking off new studies there as well. And then lastly, and importantly, in Tismoron. You know, we had, in Tismoron,
95. -0.36%56:34Managementwe had a lot of And importantly, we have a lot more catalysts coming. As you look out over the next 12 to 24 months. So I think we need to continue to see those cards. But I feel very good about where we're sitting right now. Great. Thank you, Asad. Next question, please.
96. -0.25%57:16OperatorThank you. The next question comes from Terrance Flynn with Morgan Stanley. Your line is open.
97. -0.25%57:23AnalystGreat. Thanks for taking the question. Maybe a follow-up to a prior one. Dean, I recognize your comments on melanoma and what it means for other tumor types. What about the implications of the INT-PDAC poster that were presented at Asimov? If you could just help put that into context for us and the importance of that as you think about other tumor types. Thank you.
98. -0.25%57:46ManagementYeah. So I did not enjoy the balmy weather in Spain. And I had Elia and Marjorie out there. But I listened very carefully to some of the questions that were placed before them and also to our Moderna. Thank you. And I would also like to thank our Moderna colleagues. So I will just answer just in a more broad way. We have like four phase three interpaths and we have five phase twos. There is a strategy to broaden it from melanoma to lung to bladder to RCC within the conservative point of view in relationship of where we know that those are immune responsive
99. -0.56%58:30Managementand specifically our checkpoint inhibitor responsive. And specifically our Keytruda responsive and specifically Keytruda responsive in early stage. When you look at our trials, I think it's very important because people have asked different questions. And I'll get to your pancreatic study, but we have laid it out that what could it do without an IO agent? And so you see in stage one, non-small cell lung cancer in interpath 14, that's what we're doing in NMIBC. We're asking in the absence of checkpoint inhibitor. We're asking what happens? What happens in metastatic? That's first line melanoma.
100. -0.37%59:06ManagementThat's interpath 012 and first line squamous non-small cell lung cancer interpath 013. Specifically your question of something that's IO non-responsive, that's not where we've placed most of our phase three, phase two, but there are data from our other people moving field that suggests that we should look at it and that's it. We're testing whether or not with a checkpoint inhibitor. We're testing whether or not with a checkpoint inhibitor or even IO non-responsive tumors, how to think about it. But I also just want to make sure that everyone understands that there were questions in relationship to perioperative and all of this for melanoma. We also have questions of perioperative.
101. -0.37%59:50ManagementWe're not asking that question so much in melanoma, but we're asking that in non-small cell lung cancer, which is interpath 009. So I just want to give a sense that some of the questions that were asked that I've seen, we don't have every trial, but I hope that gives you a general sense of we have melanoma and we're trying to broaden the scope and we're trying to do the experiments that will teach us not just what tumor type, but how to think about the indication and the mechanism of action. DR. Great. Thank you, Terrance. And we know it's a busy day for all of you and we're at the top of the hour, so we're going to end it there. Thank you all for the very good questions and please follow up with the IR team for any follow-ups. DR.
102. -0.58%60:32OperatorThank you. Thank you for your participation. You may disconnect at this time.