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spk05: Good day, everyone, and welcome to Pfizer's third quarter 2023 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DiMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.
spk20: Good morning and welcome to Pfizer's earnings call. I'm Francesca DiMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at Pfizer.com. Earlier this morning, we released our results for the third quarter of 2023. Our earnings materials can be accessed on the IR website at investors.pfizer.com. I'm joined today by Dr. Albert Bourla, our Chairman and CEO, Dave Denton, our CFO, and Dr. Michael Dolston, President, Pfizer Research and Development. Joining for the Q&A session, we will also have Angela Huang, Chief Commercial Officer and President, Global Pharmaceuticals Business, Amir Malik, our Chief Business Innovation Officer, Dr. Chris Boshoff, our Chief Oncology Research and Development Officer, and Doug Linkler, our General Counsel. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer on slide three. Additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC forms 10-K and 10-Q under risk factors and forward-looking information and factors that may affect future results. Forward-looking statements on the call are subject to substantial risks and uncertainty, speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. With that, I will turn the call over to Albert.
spk26: Thank you, Francesca. Hello, everyone, and thank you for joining us today. Pfizer continues to have a far-reaching and positive impact on human health. Through the first nine months of the year, more than 457 million patients around the world were treated with our medicines and vaccines. Compared with the first nine months of 2022, we have reached more patients in several key therapeutic areas, including oncology, cardiovascular disease, and anti-infectants. Patients will always be a North Star, and this figure serves as a testament to our leadership in innovation and our commitment to understanding and serving patients' needs. During the third quarter, we were encouraged by the continuous strong performance of Pfizer's non-COVID products, with revenue from these products growing 10% operationally compared with the year-ago quarter. We saw significant contributions from new launches and robust year-over-year growth for several key in-line brands. Our recently launched respiratory syncytial virus, the RSV vaccine, this is called Abrisvo, contributed $375 million in U.S. revenues. With the recent approval of the maternal indication, Pfizer is the only company with an RSV vaccine approved for preventing RSV in older adults and in infants via maternal immunization. We believe that Brisbane will be a significant and growing contributor to revenue, as many customers have indicated to us, that protecting both populations with one vaccine is desirable and a competitive advantage for a Brisbane. In the U.S. alone, there are approximately 80 million adults over age 60 who are eligible for RSV vaccination, and an estimated 1.5 million pregnant women are eligible for maternal immunization with a RSV vaccine between September 23 and January 24. NERTEC, Vaidura, and Oxbrita which were acquired in the fourth quarter of 2022, contributed 233 million and 85 million in global revenues, respectively. For Nurtek, in the US, oral CGRPs represent about 17% of the migraine market, and the unmet need is high. We believe oral CGRPs can ultimately be the first line therapy for migraine and could eventually account for as much as 40% of the overall migraine market. Primary care is a clear source of potential growth in the migraine marketplace. Year to date, Primer care health care providers wrote more than 6.1 million prescriptions for trapped times, compared with approximately 1 million for all our CGRPs, which highlights a significant potential opportunity for growth. Regarding Oxbrita, there is significant burden of illness and unmet need for patients suffering from sickle cell disease. An estimated 12 million people around the world have SCD, sickle cell disease, with the highest prevalence in countries with the lowest resources. While in the U.S. 95% of children survive to adulthood, 99% of children in other regions will die before they reach their fifth birthday, many without even ever being diagnosed. Our Vintakel family of products, including Vintakel, Vintamax, Vinmac, recorded 47% operational growth globally compared with the third quarter of 2022. This growth was driven largely by continued strong uptake of the transferretin amyloid cardiomyopathy in the case, primarily in the US and developed Europe. We estimate there are between 120,000 and 150,000 people suffering from ATTR cardiomyopathy, with the majority still not yet diagnosed. The largest unmet need continues to be the lack of general understanding and ability to diagnose this deadly disease, which is why we are focused on educational activities as the proven standard of care. Such efforts significantly contributed to this quarter's revenue increase in the U.S. And our prevenant family of products, prevenant 13 and prevenant 20, saw global revenue rise 15% operationally compared with a year-ago quarter. This increase was driven primarily by strong patient demand for Prevnar 20 adult in the U.S., the U.S. approval of Prevnar 20 pediatric and associated stocking, and growth of Prevnar 13 pediatric in certain emerging markets. These were partially offset by anticipated lower market share in the U.S. for Prevnar pediatric due to competitive entry. Of note, Prevener 20 adult remains the category-leading pneumococcal vaccine for adults in the U.S., with a 95% market share in the third quarter. Year-to-date revenues for our non-COVID products have grown 7% operationally, and we remain on track to deliver 6 to 8 operational revenue growth for these products for the full year. We continue to progress toward our goal of executing an unprecedented number of launches of new products or indications. Recent milestones include U.S. and EU approvals and launches of abridged or impregnated individuals, U.S. approval and launch of Erlexphere in relapsed refractory multiple myeloma, U.S. approval of our BRAFTOVI and MEKTOVI combination in BRAF-mutated metastatic non-small cell lung cancer. U.S. approval of VELCIPITY for moderate to severe ulcerative colitis. E.C. approval of LIPTHULO for severe alopecia areata. and U.S. approval of Canbria, the first and only pentavelan vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. To date, we have now executed 13 of the 19 originally identified potential launches, with four other products approved and preparations being made for their launch. In fact, five of the six remaining potential launches have been largely de-risked from a technical perspective. The only one remaining would be our mRNA flu candidate. Given our recent positive results from our next generation mRNA flu COVID combination candidate and pending results for our 65 and older first generation, first three standalone mRNA flu study, Timing of our standalone mRNA flu is now expected after 2024. If successful, our next generation mRNA flu-COVID combination candidate is expected to market in 2025. Michael will share more about these programs shortly. We remain excited about our proposed acquisition of SIDS and the dramatic impact we think this combination can have on human health. One in three people will be diagnosed with cancer in their lifetime. So conquering cancer would have an almost unimaginable impact on humanity. We recently gained unconditional antitrust clearance from the EC, and we continue to expect the transaction to close in late 2023 or early 2024, subject to customary closing conditions, including clearance by the US FTC. We have raised 31 billion in acquisition financing so far and continue to expect incremental 2030 risk-adjusted revenues in excess of 10 billion and expected cost efficiencies of 1 billion to be realized by the end of year three post-close without impacting any R&D problem. With that, I turn it over to Dave. And after Dave, Michael will provide an update on our R&D pipeline. So Dave.
spk22: Thank you, Albert, and good morning. Before I review this quarter's results, I'll address a couple of topics that have been top of mind with investors since our announcement on October 13th. These topics relate to our future U.S. government Paxlovid revenue forecast, as well as our multi-year cost realignment program. With respect to revenue recognition associated with the amended agreement, the US government is expected to return an estimated 7.9 million EUA-labeled treatment courses And in return, we'll receive a volume-based credit at an approximate value of $4.2 billion at the end of 2023 for future treatment courses. Pfizer will also provide an additional 1 million treatment courses into the U.S. Strategic National Stock Market. As a result of all that, Pfizer has an obligation to deliver an estimated 8.9 million treatment courses for which we will record an approximately $4.2 billion of revenue beginning in 2024 as we deliver these treatment courses. It is important to note that there is no cash compensation for the estimated 8.9 million treatment courses delivered. Regarding our cost realignment program, I WANT TO REITERATE THAT WE EXPECT TO ACHIEVE AT LEAST $3.5 BILLION IN NET COST SAVINGS BY THE END OF 2024 VERSUS THE MIDPOINT OF OUR AUGUST 1, 2023 SINA AND RND GUIDANCE. WE EXPECT $1 BILLION OF TARGETED SAVINGS IN 2023 AND EXPECT AN ADDITIONAL SAVINGS OF AT LEAST $2.5 BILLION IN 2024. In a moment, when I review the components of our full year 2023 guidance, you will see that we have lowered the midpoints of both our SINA and R&D guidance ranges by $500 million, respectively. Now, turning to the quarter, our Q3 results, both top and bottom line, were significantly and negatively impacted by our COVID products. Revenues declined 41% operationally, the result of the decrease in both Paxlovid and Comergy cells, while adjusted diluted loss per share was also significantly impacted by $5.6 billion of non-cash inventory write-offs of COVID-related inventories. I want to emphasize, as Albert stated previously, that the operational revenue growth of our products in Q3, excluding both Paxlovid and Comirnaty, were strong at 10%. Contributing to this strong performance was our newly approved RSV vaccine and the families of products associated with both Prevnar and Vindicale. Additionally, our recently acquired products, NERTEC and Oxbrita, also contributed to this strong performance. Our reported diluted loss per share of 42 cents and adjusted diluted loss per share of 17 cents in the quarter are primarily the result of the decline in Paxlovid and Comirgity cells and the non-cash charge related to write-offs of COVID-related inventories. The inventory write-off of $4.7 billion for Paxlovid and $900 million for Comirnaty negatively affected adjusted loss per share by 84 cents. Foreign exchange movements had a de minimis unfavorable impact on third quarter revenues and increased adjusted diluted loss per share by 4 cents or 2% compared to LY. Now let me briefly touch on our full year guidance. Given we updated our full-year revenue EPS guidance on October 13th, I'm just going to hit a few of the highlights. Total company full-year 2023 revenues are expected to be in the range of $58 to $61 billion versus the previous range of $67 to $70 billion. Importantly, we continue to expect 6% to 8% full-year operational revenue growth for non-COVID products year over year. And as anticipated, the majority of this growth is occurring in the second half of the year, given the timing of new products and indicated launches. I want to remind you that beginning in Q4, we will overlap the acquisitions of both Biohaben and GBT, which were completed in October of 2022. Adjusted cost of sales and percentage of revenue is expected to be in the range of 41 to 43%, primarily the result of the $5.6 billion non-cash charge related to inventory write-offs for our COVID products. Adjusted SINA expenses are expected to be in the range of $13.3 to $14.3 billion, and adjusted R&D expenses to be within a range of $11.9 billion to $12.9 billion. The midpoints of both ranges are now $500 million lower than our original guidance. As a result of all these, the company now expects full-year adjusted diluted earnings per share to be in the range of $1.45 to $1.65 per share versus the original guidance range of $3.25 to $3.45. All additional components of our guidance are included in our press release that was issued earlier today. As discussed in prior quarters, our capital allocation strategy is based on three core pillars. First is reinvesting in our business. Second is growing our dividends over time. And third is making value-enhancing share repurchases. In the first nine months of 2023, we invested $7.9 billion in internal R&D, returned $6.9 billion to shareholders via our quarterly dividend, and allocated approximately $43 billion towards the proposed CGIN acquisition. Lastly, in addition to completing a $31 billion unsecured debt offering in Q2 of this year, we are ready to execute the remaining short-term financing to complete the proposed CGIN acquisition upon fulfillment of the required closing conditions. We expect to deliver our capital structure following the completion of this transaction And as we delever, we anticipate returning to a more balanced capital allocation strategy, inclusive of share with purchasers. In closing, I want to reiterate that our product portfolio remains very strong. We continue to be encouraged by the momentum of our non-COVID products in Q3 and are committed to the successful execution of our new product and indication launches. of our operating margin, enhancing long-term shareholder value. And with that, let me turn it over to Michael.
spk25: Thank you, Dave. Today, I will share important updates from our robust respiratory vaccine portfolio. Our respiratory vaccines are built upon three cutting-edge platforms that enable us to bring the right science to the right pathogen. These include our mRNA platform in partnership with BioNTech targeting highly variant viruses, our subunit platform targeting viruses that remain relatively consistent season to season, and our conjugate vaccine platform designed to help prevent bacterial infections. We have achieved FDA approvals of vaccines derived from each platform within the last year and aim to further expand our leadership with additional vaccine candidates in development. Today, I will provide information on our standalone flu vaccine candidate, flu COVID combination vaccine candidate, and next-gen pneumococcal vaccine candidate. We are pleased to announce that we achieved both primary endpoint in the 18 to 64-year-old cohort of our ongoing phase three flu trial. In the trial, our first-gen mRNA flu vaccine candidate demonstrated non-inferiority and superiority to a licensed flu vaccine at the time of the primary analysis. This represents the first and only demonstration of efficacy and superiority for an mRNA-based flu vaccine candidate. In this age cohort, efficacy was maintained through the trial's end-of-season analysis, with our candidate remaining non-inferior to the license compared to. Safety was similar to the standard flu vaccine. The primary and end-of-season efficacy analysis considered both influenza A and B cases collectively. The vast majority of cases recorded in our trial and during the 22-23 flu season overall were flu A cases. Immunogenicity data showed robust antibody responses against influenza A compared to licensed flu vaccine. Humoral responses against influenza B were lower than those achieved with a comparator. Recall that our standalone flu vaccine phase 3 study also includes a 65-year and older cohort that we previously shared encouraging T cell data for all four strains from the phase 2 study in this cohort. Our belief is that the ability of the vaccine candidate to induce tissue responses may contribute to the improved efficacy of the current seasonal flu vaccines, particularly in those 65 and older. We expect a readout from this age group later this year. To address the lower B responses seen with our first-gen standalone flu candidate, Pfizer created next-generation reformulations. These were incorporated into our mRNA flu candidates in combination with the Pfizer-BioNTech COVID-19 vaccine, which I will review now. In positive phase 1-2 top-line data announced last week, we observed that reformulation of the lead flu candidates resulted in improved immunicity against influenza B, allowing us to meet all criteria for advancement to phase 3. In the trial, our lead candidate formulations induced robust immune responses with point estimates for geometric mean titer ratios that were consistent with criteria applied to approved vaccines for all matched flu and SARS-CoV-2 strains. Notably, point estimates for geometric mean titer ratios with selected candidate formulations were greater than one relative to the licensed comparator for all matched flu vaccine strains. The safety profile of evaluated candidates were consistent with Pfizer-BioNTech's COVID-19 vaccine. Following these positive immunicity data, we plan to initiate a phase three study in the coming months. Successfully developing a broad seasonal vaccine franchise anchored around the ModFlu mRNA vaccine is a key priority. as it may allow us to tap into the nearly 50% annual flu vaccination rate in the US adults. We're taking a differentiated approach in pursuit of this goal, leveraging both mRNA and protein subunit technologies. Our development program includes double and triple combination vaccines to potentially help protect against flu, COVID-19, and RSV. Now, turning to Prevnar. I'll start by reminding you that this is the only PCV business with an FDA indication for pneumonia in adults. Providing protection specifically against pneumococcal pneumonia is critical. It's the most common form of pneumococcal disease in adults, leading to 150,000 US hospitalizations each year. The prevalence of non-bacterial pneumococcal pneumonia is more than 15-fold greater than that of invasive pneumococcal disease in U.S. adults 50 and older. Prevna's pneumonia indication is supported by the CAPITA trial, which was enabled by pneumococcal vaccine population and proprietary assay. These innovative characteristics make it challenging for others to conduct a similar study given the high level of pneumococcal vaccine coverage that exists today. Capita's innovative design and landmark results helped establish our leading and differentiated position in the PCV space. To solidify this position, we are committed to pursuing continued innovation Our goal is to potentially maximize valency and improve immunicity while maintaining coverage of the serotypes clinically demonstrated to protect against pneumonia. In line with this commitment, we have been developing a fourth generation PCV candidate that builds on the Prevna business 20 plus years of innovation. Our next-generation technology leverages cutting-edge conjugation, chemistry, carriers, and reformulation. Using these new proprietary vaccine technologies, we observed a several-fold improvement in select serotype immunicity in a monovalent phase 1 study. Based on this data, we're confident that when we move this technology into our multivalent fourth gen candidate, we have the potential to achieve increased valency with improved serotype immunicity. We are now advancing our fourth generation candidate into a first in human trial, which is expected to begin in the fourth quarter of 2023. Finally, I will leave you with our list of milestones and call out the recent approval of Velcipity for ulcerative colitis and Pembrea, the first pentavalent meningococcal vaccine. Pfizer has delivered more than a dozen regulatory approvals this year alone. I'll also note the recent launches of Abrisvo for maternal immunization and Elrexio in multiple myeloma. Thank you. Let me turn it back to Francesca to start the Q&A session.
spk20: Thanks, Michael. With that, let's start the Q&A session. We will answer as many questions as time permits, and IR will be available after the call to answer any follow-up questions. Operator, please assemble the queue.
spk05: At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. And our first question will come from Robin Karnascus with Truist Securities.
spk02: Hi, thanks for taking my question. I think I have a big picture question on your new launches, which is extremely important for your growth. Are you seeing any impact given, I think, vaccine fatigue that we've seen with COVID impacting RSV and pneumococcal vaccines? And how do you think about that impact, you know, as you think about 2023 and 2024, you think that will dissipate?
spk26: Thanks. Thank you for your questions. First of all, I think it's good when you have a portfolio. And, you know, we have a quite strong portfolio because we have RSV, we have COVID, and we have pneumococcal in the respiratory front. But I think the biggest impact will be when and if we have combination products. We think that combination products will, because of their convenience, because vaccines are preferred by pairs with zero copay, will increase basically the volumes and vaccination rates of all vaccines because of the convenience of one injection. And I think this is why you saw from Michael, all our efforts right now are in developing multiple combinations so that consumers and physicians will have choice which ones to administer. I think we can go to the next question. Thank you very much, Robin.
spk05: Our next question will come from with UBS.
spk08: Oh, hi. Thanks for the questions. I have one on flu and then just one on . So on flu, can you confirm the comparator in the 18 to 64 and also the 64 age groups was the low-dose flu vaccines? Is there a risk FDA is going to need data against high dose flu vaccines? And from a commercial perspective, do you think you still need high dose flu data, the comparator against high dose flu data, given that's what's recommended by CDC in the older population? And then on Danu, should we just on the data that we expect before year end, what do you need to show in that in order to move it into phase three trials? Is something similar to the phase two we saw earlier this year enough to move it to phase three? Thanks very much.
spk26: Thank you. On the flu comparator, I can confirm that it is the low dose on the younger population because that's the only one that's allowed. So on the older population, we are having studies now with the low dose, but we will do also with the higher dose. So we have both. On Danube, there's not much to say. We need to wait to see the data. There is clearly when you are moving ahead with a program like that, you need to see the totality of the data. And we are working now intensively to be able to have those data presented before year end. Let's move to the next question.
spk05: Our next question will come from Umar Rafat with Evercore.
spk18: Hi, guys. Thanks for taking my question. I wanted to continue on the oral obesity theme for a second. I noticed there's a new molecule, 522, that you moved into phase one. And my question is, is the chemical structure and the chemical series akin to the Daniel and Lodi glipron programs? And also, Albert, you mentioned you want to wait to see the Daniel Glipron Phase 2 data, but I realize the trial's been wrapped up for a few weeks now. Have you not seen it yet? Thank you very much.
spk26: Michael, would you like to take the question about the new molecule and the Daniel?
spk25: Yeah, you know, we are building a platform around... the glip area and also obesity in general with multiple different mechanisms and compounds. We remain focused on the dinoglipron readout, as Albert mentioned, as our main opportunity here for getting data to review for obesity and type 2 diabetes. But, you know, there are many indications where GLIP may play a role outside the typical metabolic. So this one gives us just more option to explore and have interesting data. And you will see more new mechanism also coming from Pfizer. We have a pretty strong effort here. Thank you. Thank you very much. Let's go to the next call.
spk05: Next, we have Terrence Flynn with Morgan Stanley.
spk10: Hi. Thanks for taking the question. Maybe two for me. I was just wondering, on your RSV launch, how we should think about the potential for revaccination in 2024? And then on your DMD gene therapy program, I think you've previously talked about having interim data by year end. Is that still the case? And does the recent competitor data make you more or less optimistic in your program? Thank you.
spk26: Thank you very much. First of all, let me make a comment on the recent data that we saw about the DMD values. It's very, very bad news for patients. We are really, this is a patient population that doesn't have solutions. I hope there will be a solution for them with the discussion of the FDA, although I can't comment. Now, on our DMD program, I will ask Michael to... to comment on that. And then on the RSV, Angela. Michael, why don't you start with the DMT and then Angela go to RSV.
spk25: Yeah, I echo Albert's comment that we also always said and when someone fail a study. You know, we are very encouraged about getting to the readout. You are right. There is an opportunity for an interim analysis around year end with final analysis second half of next year. And overall, I think our gene therapy for DMD have shown a very consistent effect across biomarkers and functional endpoint. And what has been differentiated so far is that when you look at the functional data we've reported, it has been giving encouraging signals in both the younger and the slightly older boys. And that has not been seen with the other company you referred to. So in a way, I remain as earlier, very positive about looking forward to the readout and let the data tell the story. But of course, this makes our gene therapy in a way the main game in town.
spk26: Then there was a question, Angela, on the RSV.
spk12: Well, as you heard during the ACIP discussions, our recommendation for BRISVO today is really one around shared clinical decision-making. But we also were... Perhaps to bring additional data when they are ready. So just to confirm that we will have additional data and vaccine effectiveness in broader populations. We will have safety data also in broader populations. We will also have immunogenicity data in younger populations. All of this will be, I think, available in the next year. when we plan to bring this back to the CDC. In addition to that, actually I omitted to mention that we'll also have second season efficacy data. So we'll be able to bring this totality of data together to determine whether the recommendations will change, but also what the vaccination schedule will be. So that's to come in 2024. Thank you.
spk26: Let's go to the next question, please.
spk05: Next we have Steve Scala with TD Cowan.
spk09: Oh, thank you very much. As was just noted a couple of minutes ago, the DanU data has reached its primary completion. It was a while ago. Albert, when you were asked, you stressed the words totality of the data, implying that you could have seen some part of the data. Michael, when you were asked, you talked about different indications. These are not confidence-building statements. So I'm curious, what have you seen? And, Michael, you've said in the past you were absolutely encouraged and confident in the profile of Dan Yu. Are you still absolutely encouraged and confident? So that's the first question. Secondly, a competitor spoke to potentially COVID-derived decrease in diagnosis of inflammatory diseases such as UC. And I'm wondering if you've seen any of that. Thank you.
spk26: Steve, I think you likely misunderstood my comments on the totality. It has nothing to do with any data that I have seen, because I haven't, right? So the data have not been presented. I don't think the study has been completed yet. So I will ask also Michael to comment on that. But don't read, please, anything on the totality of the data. What I meant is that we are doing this, we are doing that. which will make it once a day. There are multiple things, but we need to wait and see. We see how competitors are doing before deciding what we will do. But the most important thing is to see what is the efficacy and safety of the study that will read out. So nothing to read in my comment on the target of the data.
spk25: So, Michael, do you want to add? Yeah, I can just echo what you said so well there, Albert. We and I remain, you know, very enthusiastic to look forward to see the data. We have not seen the final top line report coming yet. So today the study is still ongoing, but will be available before year end. Danu Glipron has shown, as you know, some really interesting profile as a full agonist, and it's our main opportunity and effort for obesity in type two diabetes. We got earlier today a question about new molecules that are coming in. And that's when I mentioned that there are additional indications to pursue for such new molecules. And we also have new mechanisms that are validated that are coming in in oral versions. So it just punctuates our big effort we have around both this class and obesity and other disorders.
spk26: So in essence, he's still excited very much, Michael. Let's go to the next question, please.
spk05: Next, we have Louise Chen with Cantor.
spk03: Hi, thanks for taking my question. So I wanted to ask you on this fourth generation PCV, how much additional serotype coverage will you have? And then also on a breeze, will that be available to pregnant women in the pharmacy or do they have to go to their OBGYN? And then lastly, just on the end of the clip around again here, will you also have the modified release data before year end? Thank you.
spk26: Michael, you will take the PCV question and then Daniel, but also Angela very quickly.
spk12: Yes, it's going to be available in pharmacists, in doctor's offices, OBGYN offices. I think we have a real stocking advantage here, Louise, because anyone just needs to stock one product for two indications for both populations. So I think, you know, the uptake is to come. And certainly the next few months, being that it's the winter, is when we begin to we believe we'll see some good uptake.
spk25: And then Michael? On the PCV fourth generation, I hope you looked at today's data and what you could see is that we are really the first company that have been able to put in place a whole set of new technology that can bring immune responses to a higher level than have been seen. And that allow us to go with even more comprehensive coverage than the current 20%. I'm not going to give your curiosity and answer how many serotypes, I can just tell you it's considerable more than the 20. On Danu, we look upon Danu glypron as a once a day QD molecule because of the reformulation technologies that we have put in place and already generated some clinical data on and are now concluding. So that's really how we look upon the glipron and we'll have final data on the best formulation option early next year. But as Albert said, we're enthusiastic to look forward to the efficacy data later this year. So very exciting time. Thank you very much, Michael. Let's go to the next question.
spk05: Next, we have David Reisinger with Learink Partners.
spk11: Yes, thanks very much. So I have another question on Daniel LeBron, since it appears to be the company's number one pipeline candidate based upon your forecasts. So regarding the Phase 2B results that are expected soon, how should we expect Pfizer to share those results? And then with regard to the once daily formulation that you just mentioned, Michael, Will that be ready for the phase three start, assuming that the company moves to start phase three shortly after the phase two B results are generated? Thank you.
spk26: I mean, the first question, Michael, you want to take the second part of the question of David?
spk25: Yeah, I can first echo what Albert and I said. We look forward with, you know, NTCF to get the Danuglipron obesity data later this year. And of course, as Albert said, pending totality of reviewing everything we have, we have made a lot of progress and been able to accelerate the QD data. Now we're waiting for some more clinical data early next year, but I think it's within our reach if we decide to do, to start the pivotal study next year, to do it with a once a day molecule. Thank you very much, Michael.
spk26: Let's go to the next question.
spk05: Next, we have Chris Schott with JP Morgan.
spk15: Great. Thanks so much. Just two for me here. First, can you just comment a little bit more on what we're seeing with Neartech and the ramp relative to your expectations? And maybe just as part of that, just any color on pricing we're seeing within the market today and how we should think about that going forward? And then my second question was on 2024, and I know you're not giving guidance today, but as you look at where consensus has kind of shaken out post the COVID and cost restructuring updates, I think the earnings are in kind of the low $3 range at this point. I guess just are there any directional kind of pushes or pulls in the numbers that you feel the street isn't capturing properly and should be kind of thinking about before we get your kind of formal guidance as we look to early next year? Thank you.
spk26: Thank you, uh, David about 24 guidance that you are not going to tell us.
spk22: Right? So, uh, obviously it's a little early for 2024. I will just say that. Uh, clearly we had a, uh, clearing event as it relates to our covet expectations for this year. So a lot of that, uh, risk is behind us as we think about the balance this year. I do expect that the balance of this year will be very informative, particularly in the U.S., as we think about utilization trends, both for vaccination rates and, importantly, Paxlovid here in the U.S. That will allow us to have a better clarity cycling to 2024. Of the utilization around those specific products, which will still be meaningful to us at an enterprise level. Clearly, when we get to providing guidance, we'll give you a lot of information beneath that. So you can get a good sense of our importantly, our non code with products, which continue to trend very favorably and very well. And we can layer on, I'll say, the optionality associated with our COVID franchise as we cycle into next year. So obviously a lot more to come. We're looking forward to sharing those various details after the first year.
spk19: Yes.
spk12: So thanks for the question, Chris, because it's a great opportunity for us to share that we are seeing NERTEC perform just as we expected. In fact, with some really strong performance indicators that I'd like to share with you. First of all, from a TRX perspective, we grew 28% compared to last year this time. And sequentially, we grew 6% versus last quarter. In fact, on October 20th, we saw the highest week of TRXs and NRXs to date. That growth is also seen in the number of prescribers. Just this quarter alone, we had 73,000 prescribers write. And we are now moving at a clip of about 23,000 writers a week, which is 30% more than your BRELV and double that of Qualypto. Another good place to look is also in new-to-brand starts, right, MBRXs. And when you look at that, MBRX growth for NERTEC is higher than ubrovian colipter in all the deciles of physicians, but particularly in the decile 8 to 10s, which, as you know, is where the highest prescribers are or who are the highest prescribers. And then when you look at pill count, we see something interesting there too. We have been very intensely or intently driving our pill pack toward the larger pill pack size, which is the 16 pack, because of our prevention indication. And so when you look at the totality of all the pills or the total volume of pills, we have a leading market share there, more than 50%. And so I think when you look at all these indicators, at least from the way that we're looking at it, it's a very positive story. It's exactly how we see it. The expansion into primary care, as you heard in Albert's comments, is what it is that we're after. And today, only 17% of the entire market is oral CGRPs, which tells you that most of the market is still an opportunity for us and represents growth that we're really looking forward to. And I think that we put the right investments in the right places to generate this growth in the future. From a pricing perspective, obviously, this is a product that is rebated. And so I think the way to think about it is that from a patient perspective, which is where we really put a lot of focus, we want to make sure that our patients are able to get these scripts, are able to get access for NERTEC, especially as you consider that we're trying to mobilize people away from tapiramate and away from triptans onto all CGRPs. The growth-to-net effects here are significant, and you see that quarter over quarter, because we are making sure that we're able to provide access to patients who deserve and are eligible for Notex.
spk26: Thank you very much. Next question, please.
spk05: Next, we have Mohit Banzal with Wells Fargo.
spk23: Great. Thank you for taking my question. And I have a question regarding your S1C at ClassyMod. I would love to get your thoughts from the label. It seems like, I mean, you could avoid a lot of cardiac monitoring, but at the same time, there's this new requirement of eye exam as well as skin exam. How do you think about uptake considering these examinations before the start of the treatment, given that these doctors are not used to it?
spk26: All right. Michael, quite many questions.
spk25: Would you like to answer it, please? I'm happy to start on it. I think we have a very robust label for atresimod. It's the only S1P in this drug class for ulcerative colitis that have... a simple flat dosing and immediate start without any prior need for, let's say, cardiac rhythm exams like the other drug in this class. All S1P have various eye exams to monitor. And I think our label similarly has a recommendation to do that. So it's really nothing new. And our efficacy data in UC has been very favorable. So we are very optimistic that this can be
spk12: a true best in clause which is colitis sure i was just going to add to that that um if you i mean competitively we believe that we have an excellent efficacy and safety profile we don't have a need to titrate up as michael said um but also our assessments of standard you know versus our competitors at the initiation of therapy so i think that this is a level playing field that we're in. Certainly patient support is an area of focus for us, right, to ensure that patients are getting the assessments that they need. But we feel that this is pretty standard practice and we'll be able to launch this product as planned.
spk26: Thank you very much, Anto. Next question, please.
spk05: Next, we have Jeff Meacham with Bank of America.
spk14: Morning, everyone. Thanks for the question. Just have a couple of quick ones. First, I know CGEN obviously hasn't closed yet, but does all the emphasis on ADCs from ESMO, does it affect how you guys prioritize the pipeline or maybe investments you could make today commercially? And the second question on Dan, Michael, I know a lot's been asked on the upcoming data, you know, but from a commercial perspective, like where do you see the bigger opportunities for differentiation and metabolic? Is it really... just oral administration and obesity, or do you guys look more aggressively at related indications like cardio, renal, et cetera? Thank you.
spk24: Thank you very much. Obviously, we remain very confident that we will close season towards the end of this year, beginning next year. As you pointed out, there's a significant interest now in ADCs because of the potential that they could replace most of the communities. chemotherapeutics in the future for most cancer types. Segen obviously has a significant track record with four of the current approved ADCs from their laboratories. And as you've seen, three potential registration-based trials just read out with PADCIF to Kaiser, sorry, with PADCIF and with TIFTAC, but also with a small molecule to Kaiser They recently started two phase three studies, one with Desitamab, Vedotin, in combination with Femoralizumab, in advance metastatic HER2 positive or HER2 low bladder cancer. This is a program that we're very excited about. Already Desitamab received previously breakthrough therapy designation in the US. And they're also just about to start another phase three program in non-small cell lung cancer with their B6A program. Integrin beta-6 antibodies. So we remain very confident in their portfolio and the depth of expertise they're bringing to the development and discovery of ADCs. Thank you.
spk25: And then Michael? Yeah, I think you asked about how could... new oral GLIP into obesity be positioned for maximal attractiveness, and using Danner as one example, pending, of course, our excitement to see the data. Well, clearly as obesity and type 2 diabetes with overweight are moving from being treated from endocrinologists and metabolic physicians increasing in and out of primary care, particularly with the impressive effects of this drug class on obesity and body weight, all right agents in general are preferred. So I think once a day, drugs such as the new reformulated potential than gliprom would have an interesting role there. I think there is also a growing discussion among opinion leaders in the field that patients regain weight when they stop the injectable and in general they are only available for maybe a year. So an oral agent that could be taken for a longer period could also play a really interesting role to maintain body weight at the low level. And finally, you're absolutely right. The new data for this drug class suggests that patients could benefit from both cardiac and renal protection. And oral agents allow you to build combination with drugs that already are used in this population, such as S52 to protect the heart, et cetera. So I think that's why there is such a big interest in drugs in this class. So thank you for the question. Thank you. Next question, please.
spk05: Next, we have Tim Anderson with Wolf Research.
spk13: Thank you. I have a couple of questions on anaglipron. The early data set showed a QTC signal. Do you think that was a red herring that won't show up in later data? To me, when I just think about drug classes and seeing QTC signals, it seems like it often persists in later data sets. And then second question on mRNA flu, you mentioned that safety is the same as licensed vaccines. Does that mean tolerability was as well? I usually think of safety and tolerability as technically being different from each other. Thank you.
spk26: Very good. Thank you very much for the question. Michael, both questions for you. QTC, for Danu, and then tolerability.
spk25: Yeah. I mean, we have, I think, more than 1,400 patients on Danuglipron, and it's a very safe drug. It's a very safe drug, and we look forward to the readout and efficacy, as we have said, before year-end. So that's very straightforward. mRNA flu, you had a very good comment about Particularly in initial studies, tolerability is really what we focus on. And tolerability was similar to standard of care available vaccines or the other mRNA vaccines experienced from Pfizer. And we haven't really had any concerns about safety. So on both fallibility and safety, the statement stands that it looks like previous versions of our vaccines. Thank you, Michael.
spk26: Let's go to the next question.
spk05: Next, we have Chris Shibutani with Goldman Sachs.
spk06: Thank you 2 questions if I may on the cost savings program, you've been outlining what the. Plan is for 2024, but if we look at the pattern of the spending for R and D and in the quarter, you just reported. I would observe that the magnitude of reduction, the R and D spend was greater than expected relative to. How should we be interpreting this numbers or anything to read across in terms of the relative. amount of cost reductions coming from Sina versus R and D on the forward. And then a question on a Brisbane first quarter sales were solid. Can you just elaborate how much may have been attributable to, for instance, inventory stocking versus actual demand? And if we look at prescription data looks like from the retail setting, there's about a 30% market share. Is this similar to what you're observing in the broader market and how is this comparing with your expectation? Thank you.
spk26: Let me ask David to answer the question about the R&D and SMA expenses, and then Angela will take the prior brief.
spk22: Yeah. Hey, Chris, on the cost program, I would not read into the allocation of savings in 23 as it relates to 24. Obviously, we have a fairly robust program up and running today. We're working aggressively on those programs and beginning to implement those programs. As we cycle into 2024, we'll give you and the markets, the City of Color, on how to think about those cost savings as we wrap into next year.
spk12: Sure. So we're really pleased with our performance on a Brazil that has exceeded our expectations. You first asked whether this is all about stocking, and I can say that it isn't. Of course, there were stocking effects in the beginning because this was a new vaccine. But we're also closely tracking vaccination rates and uptake. And what you see is that there is very fast uptake. We were that really benefit from the fact that this was approved and in market prior to the vaccination season actually happening. So was able to ride off of the coattails of flu vaccinations, which, you know, are very high. Right. September, October. We have about a 70% co-administration rate. So the performance we're seeing on Brisbane is truly driven by vaccinations. To your comment about market share, yes, we are seeing a similar market share to what you have just said. That is because right now the retail setting is driving a lot of the vaccinations. But don't forget that that's not where all vaccinations are taking place. We also have non-retail settings such as health systems, doctor's offices. Those are also being engaged. And those particular settings, Pfizer actually has a leading preference for. They are smaller in proportion, but still. So I think we have to look at all channels of the market. Finally, I think that just from a momentum perspective, we expect things to continue. You know, the vaccinations really are happening throughout this time now. October, November, December are big vaccination months. From where we are right now, RSV is only 5% of the entire vaccination rate of the eligible population. So I think that the conclusion is we're very early in the innings of this launch. We're doing better than we thought. But that where we are going to be, I think, is a place where there's tremendous opportunity for driving uptake in older adults, but also maternal, which, as you know, we just got the approval for.
spk26: Thank you. Next question, please.
spk05: Next, we have Carter Gould with Barclays.
spk16: Great. Good morning. Thank you for taking the questions. Maybe to go back to Oral Danu, when we do get the Phase II data, what should our expectation be around communicating plans for a Phase III, which I guess is just a quicker way of saying what's a reasonable expectation for how quickly you could turn around the Phase II and start a Phase III and how much work Pfizer's already done on that front? And then maybe just coming out of ESMO, On the back of the EV302 data and the response, would Pfizer say that reaffirms their expectations or represents upside to their expectations when the deal was originally announced? Thank you.
spk26: No, thank you. Thank you very much. Daniel, let me take that so I can spare a little bit of Michael's time. We are expecting the data to show up before the end of the year. And of course, when we are ready with our phase three, and we hope that the data are good so that we can move in a phase three, and I hope that we are going to do it in an expedited manner because speed is of essence in this battle between competing molecules, but we will announce our plans for phase three. I know the interest is very high right now, but I want to be very prudent in not saying things without the data. The data are the king of the data. We haven't seen it yet. Now let me move to Chris so that we can discuss about the issue.
spk24: Thank you for raising 301. These were truly monumental data for the field of bladder cancer, neurothelial cancer. And as you pointed out, with overall survival and progressive free survival nearly doubled, moving median overall survival for this population now nearly towards longer than 31.5 months. So this just reaffirms our beliefs that antibody drug conjugates could become a standard of care across the treatment paradigm for many, many different tumor types.
spk26: Thank you very much. Next question.
spk05: Next, we have Akash Tiwari with Jefferies.
spk04: Good morning, this is Avion Burkash. Thanks for taking our questions. Our question is also on Janu Glypron. So for the once-daily modified release version, is there any possibility to do a bridging study for QT formulation? And also for Janu, I think as we've heard a lot of times on the call that the trial is marked as completed in October, I know you haven't seen the top-line data, so at this point, are we waiting for data from the slower four-week titration cohort? Also, would it be fair to say that you will have to continue the program already if there were any clinically significant serious issues with standing? Thanks.
spk26: Michael?
spk25: Yeah, on the once a day reformulated downward, We have initially tested a standard swellable core technology and could show that it worked very well with Danu. And now to be able also to incorporate a more sophisticated technology, we work on a matrix technology and all data suggests it's going to be a really intriguing alternative because as you know in diabetes for oral drugs and obesity you will over time end up with incorporating different drugs to prevent different downstream effects and that's the beautiful of having this type of novel technology that you have a potential in the future to go to fix those combinations. And we are really masters in developing sophisticated formulations. And we will have this available in 2024.
spk26: And there was a second part, I think. Or not. There was a second part from Daniel? Maybe I was wrong. Okay, let's move to the next question, please. Thank you, Akash, for your question.
spk05: Next, we have Kerry Holford with Barenburg.
spk00: Thank you. Two questions on vaccines for me, please. Firstly, on RSV, in August, GSK filed a lawsuit against Pfizer alleging patent infringement. So I wonder if you could just talk to the next steps here, perhaps a timeline that you anticipate for this, and should we think that this could ultimately result in some form of royalty payment from Pfizer to GSK. And then on Pembria, how does the recent ACIP recommendation sit against your expectations for the sales ramp and peak potential for this vaccine? If the vaccine is effectively only used for dose two of three, does that significantly reduce the commercial opportunity you had anticipated for the vaccine? Thank you.
spk26: Yes. Doug, can you please answer the question about this legal situation with CSK?
spk21: Yes. So it's very, very early stages with respect to the RSV litigation. We have patents. We feel strongly about our own intellectual property. And it's certainly too early to say whether one party or the other will be required to pay any royalties or otherwise. Very early stages in that regard.
spk26: Thank you. And Angela, about the development, how do you feel about it?
spk12: Sure. We continue to feel confident about the peak sales. The reason is that right now we have the first set of recommendations, but ACIP has also told us that we'll have the opportunity again to come back next year when we have additional data, which is when we'll have the opportunity to look at the schedule or how quads and Bs are being distributed. you know the schedule that they're being delivered today and uh we'll have an opportunity again to take a look at the uh the benefit of uh penbriar in this population so i think um i feel like it's great that we have an opportunity to get out now and to begin vaccinating our teenagers we'll have a second bite at the apple which will allow us to achieve our peak sales thank you next question please
spk05: Next, we have Andrew Baum with Citi.
spk07: Thank you. A couple of questions. Would you comment on your stake in RVT3101, the tier 1A, pending the approval of the licensing of the asset to Roche? Will you hang on to it or is that subject to divestment? And then second question for Chris, just looking at the recent EV302 data and with you seem to have the C-GEN portfolio. When you think about the combination of ADCs with PEMBRO or with a PD-1, do you believe the efficacy that you're seeing is associated with that hedging, or do you think it's true synergy through an immunologic mechanism and increased cell death? Thank you.
spk26: Amir, you want to speak a little bit about the ROS acquisition of TL1?
spk01: Yeah. So thanks for the question, Andrew. I think we're very pleased with the outcome of the TL1A program. When we created Televant, we did this as a R&D prioritization decision. Just as a reminder, this was a phase two program that required significant phase three investment. And so we held on to a 25% stake. We also had rights to royalties on U.S. sales, as well as the full ex-U.S. and ex-Japan rights. And we did that all without any R&D spend. So Roche's proposed acquisition of Talavant will give us access to about $1.75 billion of pre-tax cash, which is the translation of our stake. And we still retain all the other rights. So we're looking forward to having Roche as a partner. We're looking forward to the investments that they're going to make in advancing the clinical stage programs on TL1A and benefiting from the outcome of those.
spk24: And then Chris, about the synergies or not. Thanks, Andrew. That's a very good question. As you know, Segen pioneered the MMIE or orostatin-based payloads. And we see this potential synergy in combination with the PD-1, with Atsetris, with TIFDAC, and recently, as you've seen, with Atset. Although Segen does have the next generation of ADCs with TOPA1 that will enter the clinic this year and next year. We don't know yet if the TOPA1s are going to show the similar type of immunogenicity as what appears to happen with the MMAE or a statin-based payload. So I think we're very confident that that season has both TOPA1 as well as our statin-based payloads. In case with TOPA1s, we do not see what appears to be, you're correct, the type of...
spk26: Thank you very much, Chris. And let's go to the last question, please.
spk05: Our last question comes from Evan Segerman with the BMO Capital Markets.
spk17: Hi, guys. Thank you so much for taking my question. So, I have one on Danube and then a bigger picture one. So point of clarification on Daniel Glipron, Mikhail, is the ultimate goal to develop the fixed dose combination with, say, an SGLT2 or other anti-diabetes drugs? You kind of had mentioned that in your commentary. And taking a big step back, how should we think about how you risk adjusted your long-term revenue guidance? Did you plan on updating this figure if you have clinical or regulatory successes or failures, for example, with the approval of Estrazamod? Thank you.
spk26: Michael, can you please take Daniel's question?
spk25: Yeah, I mean, the near-term goal is really look at the data, as we have said, both Albert and myself, and pending review, of course, there's an option with a once-a-day Daniel to move forward in obesity and diabetes. I think we just commented that the upside with oral drugs are many in this sector, and that's why it has been such a big interest, and that includes with injectable. But we will keep it simple and clear. We'll review the data and take a decision about potential in obesity and diabetes once a day down the road. That's the near term.
spk26: Thank you very much. And also about your question, if we are going to change the 20 billion sorbets pending season acquisition, 20 billions of that. If you see the analyst expectations for these acquisitions at the end of 2030 are very, very close to what we have right now. And I think this is trending very nicely. When you see the internal launches that we are having from we declared 20 billions. There is a gap between what we believe and what the analysts believe. And this is where we are focusing our attention. Right now, it is very early with the launches. Some of them are doing better than what they thought. Some of them are doing worse than what we thought. And if we realize that the totality of 20 billions is not anymore what we think it will be, of course, we will update it.
spk22: But I think what is important to that is if you look at our business, our core business is performing nicely. We continue to make traction. We have obviously a lot of launches that we've completed and still several ahead of us. We're excited about what Segen could potentially bring to the company as we think about our focus now in oncology. And then importantly, I think we've re-baselined, if you will, the COVID franchise. Think about utilizations. half of this year and cycling to next year, we will then take a step back and look at what would be prudent as we think about the revenue in totality of this company as we cycle into 24 and beyond. So I think you look forward to as we begin going into 2024, those expectations and laying those out specifically.
spk26: Okay, thank you very much. I would like just to say that if you walk away from today's call with just one takeaway, it should be that I think Pfizer's future remains bright. We have rebased our COVID expectations and now I think it's very easy for everyone to be able to model what I think will be stable COVID revenues going forward. And with the recent, particularly with line and new products for you, excluding COVID, at 10% growth this quarter. And that position us to be able to have a growing business going forward. So I will now bring this call to an end. Thank you for joining us and have a great rest of your day.
spk05: Thank you, ladies and gentlemen. This concludes today's Pfizer third quarter 2023 earnings conference call. We appreciate your participation and you may disconnect at any time.
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