This meeting is being recorded.
Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's 2022 first quarter results, followed by a Q&A session. As usual, you can find the slides to this earnings call on the investors page of our website at sanofi.com. Moving to slide three, I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC, and also our Document d'enregistrement universel for a description of these risk factors. With that, please advance to slide four. Our speakers on the call today are Paul Hudson, Chief Executive Officer, and John Reed, Global Head of R&D.
The Global Business Unit heads, Bill Sibold, Thomas Triomphe, Olivier Charmeil, and Julie Van Ongevalle, and Jean-Baptiste De Chatillon, Chief Financial Officer. For the Q&A, you have two options to participate. Option one, click the Raise Hand icon at the bottom of your screen, or option two, submit your question by clicking the Q&A icon at the bottom of the screen. With that, I'd like to turn the call over to Paul.
Well, thank you, Eva. Great introduction. Thanks to everyone for joining our call today. Delighted to be here, and together with the members of the executive team, to take you through the updates on our business and our financial performance. Let's start with Q1 sales review. Well, we're truly excited about the outstanding results in the first quarter. The strong performance of our businesses exceeded market expectations, with 8.6% growth on the top line and EPS up 16.1%. Our Specialty Care business continues to grow at a remarkable pace. Dupixent posted high double-digit growth in the U.S and strong ex-U.S sales now annualizing close to €2 billion. We have once again accelerated our critical milestones with several new indications submitted in both the U.S and EU in pursuit of our greater than €13 billion sales ambition for Dupixent.
Vaccines reported good business momentum with strong growth in PPH and a further recovery in sales of travel and endemic vaccines. In General Medicines, our Play to Win strategy continues to pay off. Divesting non-core products and investing in transplants and other selected assets resulted in another quarter of growth for our core assets. Likewise, the Consumer Healthcare business is executing on the strategy outlined at our capital markets day on February the 5th of last year. We delivered double-digit growth rates across all key franchises and more than doubled sales in cough and cold. Moving to slide seven, into the 3rd year now of executing on our Play to Win strategy, the strong set of 1st quarter results marks another proof point of our focus on growth. The constant improvement of our BOI margin puts us on a clear trajectory to deliver on our midterm financial targets.
In the first quarter of 2022, EPS grew at double-digit rates once again. R&D spend is now growing again as we rebuild the pipeline following a period of lower R&D investments due to the prioritization within specialty care and discontinuation of diabetes and cardiovascular activities. Over the last two years, we increased our spending in R&D by EUR 700 million in a cumulative way, funding the development of our priority assets and our recent bolt-on acquisitions, such as Principia, Kymab, Kiadis, and Tidal. In the area of immunology, we are striving for industry leadership with an exceptional pipeline. Our pipeline spans across our key priorities, tackling a broad spectrum of diseases with the most promising MOAs and offering modalities from injectable to oral to topical.
In addition to Dupixent as the foundation and the cornerstone in type 2 inflammatory diseases, we now have 10 molecules in development that could start to enter the market as early as 2025. These programs include potentially transformative medicines in specialty care areas such as dermatology and respiratory, representing highly attractive and growing markets with unmet needs, especially in COPD, where no new mechanisms for disease management have emerged for more than two decades. Our oncology and neurology portfolios continue to expand. We aim to build these into industry-leading pipelines similar to our position in immunology, both through in-house development and of course by targeted M&A and BD. Advancing to slide nine, I want to highlight some key R&D collaborations added during the quarter. I'll do that before I hand over to John to give us a quick update.
I would like to briefly mention the collaboration with Blackstone. This deal facilitates the development of Sarclisa's subcutaneous formulation, which serves as another example of prioritization. Partnering Sarclisa going forward allows us to reallocate R&D investments to further expand our pipeline and to strengthen our growth areas. In summary, a really strong first quarter for us here at Sanofi. John, over to you.
Thank you, Paul. We continue to expand our pipeline through deals that add best-in-class science to our existing capabilities. In Q1, we announced three external collaborations that further supplement our pipeline. First, to build on our momentum with the antibody drug conjugate molecule tusamitamab ravtansine, our potential first-in-class CEACAM5-targeting ADC that's now in phase III for advanced lung cancer, we announced an exclusive collaboration agreement with Seagen to design and develop ADCs with potent payloads for up to three cancer targets. This collaboration will synergistically combine our proprietary monoclonal antibody technology with Seagen's proprietary ADC technology. Second, with Exscientia, we established a strategic research collaboration to utilize machine learning technologies to accelerate the discovery of precision engineered medicines across oncology and immunology.
We expanded our existing relationship and are now accessing the Exscientia AI-based small molecule drug discovery and their precision medicine platform, spanning from chemical lead identification and optimization through to patient selection. With machine learning, this collaboration promises to accelerate our timeline for drug discovery, while also potentially pointing us to those subsets of patients most likely to benefit. Our third collaboration is with IGM Biosciences. Their technology platform offers an exciting approach to developing multivalent IgM antibodies that can efficiently bind and stimulate the activity of cell surface receptors. This unique platform has the potential to overcome historical limitations of conventional bivalent IgG antibodies when seeking agonists of some class of receptors. We've established an exclusive worldwide collaboration agreement to develop IgM antibody agonists against three oncology targets and three immunology inflammation targets.
For clarity, these are not T-cell engagers, but rather engineered IgM antibodies targeting, in each case, a single cell surface receptor that we wish to activate on certain types of immune cells. Advancing to slide 10. At Sanofi, we believe in the mission of chasing the miracles of science to improve people's lives. The collaborations depicted on this slide exemplify our journey towards this ambition in the context of childhood cancers. One year ago, Sanofi announced its new corporate social responsibility commitments, which are fully implemented in our Play to Win strategy. Within our strategic CSR pillar of innovating for vulnerable communities, we presented our ambition to develop innovative medicines to eliminate cancer deaths in children. Today, conducting clinical trials for pediatric cancers is challenging due to several factors, including broad heterogeneity in terms of prognosis, molecular features of the tumor pathobiology, current treatment strategies, and scientific objectives.
As a result, the design of clinical trials for pediatric cancers is challenged by several practical issues that must be addressed for ensuring trial feasibility for this vulnerable group of patients. That's why Sanofi has partnered with leading oncology institutions to advance innovative clinical trial designs. Aided by the leadership of Head of Oncology Development, Peter Adamson, who was previously head of the Children's Oncology Group, we move forward with a strong sense of purpose and with the objective of creating real impact for these young patients and their families. Speaking of progress in oncology, on slide 11, I'd like to summarize the advances we are making in building an innovative oncology portfolio, now with 14 molecules in development compared to only five molecules just a few years ago.
Starting with Sarclisa, combined with Revlimid, Velcade, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma patients, the event-driven IMROZ trial is expected to read out in the second half of this year. Initial data for frontline myeloma patients who are eligible for transplant was shared in a podium presentation at the ASH Congress last year, showing an unprecedented rate of MRD negativity pre-transplant. For amcenestrant, our oral selective estrogen receptor degrader or SERD, we're pursuing a broad program to assess efficacy and tolerability in different lines of therapy. We started our journey with exploratory phase 1b studies, where we observed excellent tolerability combined with strong efficacy and robust target engagement with a once daily 200 mg dose.
As is often the practice in oncology drug development, we took a swing at the late line population of second line, third line metastatic breast cancer patients, where most of these women have already failed an aromatase inhibitor combined with a CDK4/6 inhibitor and unfortunately have few treatment options. In the phase II trial we call AMEERA-3, we did not observe a clearly superior efficacy benefit for amcenestrant compared to other endocrine therapies. The full data will be presented at a conference in the second half of this year. Now in the frontline metastatic setting, the AMEERA-5 comparing CDK4/6 inhibitor palbociclib in combination with either amcenestrant or an aromatase inhibitor has fully enrolled ahead of schedule.
For early breast cancer in the adjuvant setting, we have joined forces with some of the world's leading oncology cooperative groups focusing on breast cancer to conduct a seminal trial in aromatase inhibitor-intolerant patients that have tumors with high-risk features. Our AMEERA-6 adjuvant study puts amcenestrant head-to-head against tamoxifen and has enrolled its first patients. While addressing a subset of the adjuvant population, this study design affords the opportunity to reach the market relatively quickly by adjuvant standards. Additionally, at this year's ASCO, we will present data for our ADC molecule tusamitimab, showing promising durability results for long-term treated non-small cell lung cancer patients. The treatment duration observed so far is really quite remarkable.
Tusamitimab aims to not only become the standard of care for patients with CEACAM5-high-expressing tumors in second-line lung post-immunotherapy, but also to become the cornerstone of therapy in first-line lung cancer in combination with a PD-1. In addition to lung and gastric cancer, additional basket trials in CEACAM5-expressing tumors, namely breast and pancreatic, are also ongoing and expected to read out in 2023. Finally, I draw your attention to SAR444245, our potential best-in-class, non-alpha IL-2 molecule that's being tested across five oncology indications as monotherapy and in combination with other medicines, leveraging 444245's impressive ability to selectively expand effector T-cells and natural killer cells without undue expansion of immunosuppressive regulatory T-cells or eosinophils that cause side effects.
We anticipate early efficacy data starting in the second half of this year to inform our decisions for planning pivotal phase III starts later in 2022. Now, in the aftermath of the recent decision by BMS and Nektar to discontinue their collaboration on their pegylated IL-2 molecule bempeg, I want to remind you of the information we presented at ASCO in 2020, taking a slide from that investor event where we compared the attributes of Nektar's bempeg to our differentiated non-alpha IL-2 SAR444245. Now without going into the details here, the bottom line is that we're not surprised that the Nektar molecule struggled to deliver. Unlike bempeg, our synthetic biology platform from the Synthorx acquisition allows for precision pegylation of IL-2 at a single site that selectively and permanently blocks engagement of the alpha chain of the IL-2 receptor.
Our pharmacodynamic data generated in the clinic thus far illustrate that SAR444245, unlike the Nektar molecule, does precisely what it was designed to do. Namely, SAR444245 selectively expands effector CD8 positive T-cell and natural killer cells without causing significant expansions of immunosuppressive regulatory T-cells or eosinophils that contribute to native IL-2's toxicity. Our clinical data show that the improved therapeutic index of SAR444245 allows us to dose more than four times higher and to dose more frequently than the Nektar molecule, which we believe will drive greater efficacy. We can dialogue during the Q&A about the best in class attributes of Sanofi's differentiated non-alpha IL-2, which now with the fall of the Nektar molecule, has the potential to become the first in class next generation engineered IL-2 for immuno-oncology. On my last slide 13, we provide a list of recent pipeline achievements in Q1.
What I'd like to highlight here is the external validation of our pipeline that we're receiving from health authorities, which have granted several accelerated reviews for our future medicines, 28 in total across the pipeline. With that, I hand over to Bill Sibold.
Thank you, John. Moving to our Specialty Care performance, it is exciting to see a strong start to the year with solid double-digit growth in the first quarter, up 18% with EUR 3.6 billion in sales. As mentioned by Paul earlier, Dupixent, our truly transformative immunology mega brand, is blazing the trail for our immunology portfolio. Dupixent delivered once again a stellar first quarter with sales of EUR 1.6 billion growing over 46% from last year's Q1. five years into Dupixent's launch of its first indication in atopic dermatitis in the U.S., we are still only at the beginning of our journey with approximately 8% market penetration in adults. Across all indications in age groups globally, there are now more than 430,000 patients on therapy.
As highlighted at our immunology event last month, we expect to add at least 1.5 million eligible patients by 2025 with our anticipated new indication expansions. More about the brand performance in just a minute. Our oncology franchise grew at 7% in the first quarter, driven by recent launches, including Sarclisa in key markets. As you know, the strong launch performance was offset by Jevtana LOE in Europe facing generic competition. As highlighted by John, we are excited about the rich news flow on our emerging oncology portfolio focused on best in class and first in class assets. Our rare disease business reported EUR 804 million of sales in the first quarter, driven by an increase in the underlying patient base across geographies.
Continued strong growth of our Pompe franchise, up 9%, was impacted by the effect of order phasing in the other rare disease franchises in the quarter. Rare blood disorders grew 2% despite lower industrial sales to our partner, Sobi, in the quarter. Of note, Cablivi sales were up 16%, mainly driven by the uptake in Europe. Neurology and immunology sales remained broadly stable versus last year. Kevzara had 61% sales growth due to higher demand in the U.S, which was offset by lower sales of Aubagio. Lemtrada sales were in line with last year. Moving to slide 16, let's focus on Dupixent's outstanding performance in the first quarter. Notably, Q1 2022 represents the biggest gain in sales Q1 over Q1 since its launch in 2017, with more than EUR 500 million of incremental sales compared to the same period last year.
A key driver of the strong growth this quarter was the performance ex-U.S, with sales up 70%, reaching almost half a billion EUR and annualizing at close to EUR two billion. In the U.S, I'd like to emphasize Dupixent's strong performance is even more impressive, considering we are still below 90% of physician offices reopened since the start of the pandemic. With this strong start, we are on track to fully exploit further growth opportunities, including the exciting regulatory progress we have made around the submissions for new indications, including prurigo nodularis, eosinophilic esophagitis, AD in six months to five-year-old children, as well as approval for six to 11-year-olds with severe asthma in Europe. Moving to slide 17, the panels on this slide demonstrate the impressive leadership position of Dupixent across type 2 inflammatory diseases.
Not only does the strong momentum for the brand persist in 2022, but also seems to benefit from the dynamics in the marketplace with new molecules entering the space and the impact of the COVID-19 pandemic subsiding. In fact, we believe that the additional treatment options for patients contribute to unlocking significant incremental growth potential for Dupixent through market expansion, as well as improved physician and patient awareness. We are extremely well-positioned to further strengthen Dupixent's leadership position in type 2 inflammatory diseases, given our unique mode of action selectively targeting IL-4 and IL-13. We continue to demonstrate the efficacy and safety of Dupixent, both in clinical and real-world settings, treating adults and younger patients.
Importantly, unlike the new entrants in dermatology or respiratory, which have failed in type 2 inflammatory diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps, Dupixent continues to rapidly expand its leadership by adding new indications across the type 2 spectrum. Now, on slide 18, let me highlight some of the next exciting advances in our rare disease business. Our leadership position in rare has been further reinforced by two recently launched innovative products, Nexviazyme and Xenpozyme. Only about two quarters into the launch, half of the patients with late-onset Pompe disease in the U.S. are either already on Nexviazyme or are in the process of starting Nexviazyme, and we remain fully focused on making Nexviazyme the next standard of care for all appropriate patients.
As you may recall, last quarter I highlighted our launch opportunity with Xenpozyme, the world's first and only therapy indicated to treat acid sphingomyelinase deficiency, or ASMD. In late March, we obtained approval for Xenpozyme in Japan, Sanofi's first therapy to be approved under the Sakigake Designation, which is the Japanese government regulatory fast-track pathway to promote research and development of innovative new medical products addressing urgent unmet medical needs. We are now working with health authorities globally, including the EU and the U.S, to make this important medicine available for ASMD patients around the world. Both launches exemplify our relentless efforts to advance innovation and to bring life-changing treatments to patients suffering from rare diseases. Our continued success in patient accruals drives strong demand across the rare franchises.
This dynamic keeps us on a trajectory of mid-single-digit growth on an annual basis, despite the usual fluctuations quarter-over-quarter, mainly due to order phasing in our global markets. With that, I hand over to Thomas to update you on the vaccines business.
Thank you, Bill. Q1 delivered 6.8% growth, in line with our mid- to high single-digit guidance. This performance was driven by the PPH franchise, where Pentaxim in China bounced back. We also saw a strong recovery from the travel and the endemic vaccine franchise with the easing of travel restrictions. It is reassuring to witness the strength of our vaccines portfolio when normal life conditions are restored. However, the COVID-19 epidemiology remains unpredictable, and local lockdowns, like the current one in Shanghai, may temporarily impact our business. In the longer term, with COVID-19 becoming endemic, we are confident that our travel and booster vaccines will regain the level we enjoyed pre-pandemic. To conclude on this slide, I'd like to speak about flu and reiterate that we anticipate another record sales year for flu in 2022.
The 18% decline in Q1, which is traditionally a low quarter for flu sales, was mainly due to high base last year, when we benefited from extraordinary demand as some governments built safety stock due to COVID-19. In addition, Southern Hemisphere markets are mostly using standard dose vaccines, sometimes even with a trivalent formulation, while our strategy remains focused on differentiated high-value influenza vaccines that have demonstrated protection beyond flu. Next slide, please. I'm pleased with the tremendous progress made in the past few months to bring the first solution to protect all infants against RSV. Last month, the New England Journal of Medicine published the detailed results of nirsevimab pivotal trials. Besides the 74.5% efficacy already shared, we are thrilled by the analysis showing a reduction of RSV-related hospitalizations by 77%.
Knowing that RSV is the leading cause of hospitalization in all infants and the most common cause of LRTI, we do believe nirsevimab will have a significant impact on RSV disease by providing protection for all infants. As predicted last December during our vaccines event, maternal immunization is not a smooth ride. This was evidenced by the setback experienced by one of the maternal immunization vaccine candidates that had to stop all phase III clinical trials. Regulatory authorities have understood the benefits nirsevimab can bring and will review our dossier in an accelerated fashion, the first one being EMA. We expect to receive the EMA decision later this year, one year ahead of plan. Vaccine recommending bodies are also highly interested in nirsevimab.
In the U.S., ACIP, the Advisory Committee on Immunization Practices, has updated their charter to have their scope encompass monoclonal antibodies, putting them in a position to review and make recommendations on nirsevimab once licensed in the U.S. Lastly, I'm glad to share that our phase III B study will start in October of this year. It will generate data in a real-world setting to reinforce the strong data set supporting nirsevimab's benefits and showcase its ease of implementation in the pediatric immunization schedules. With that, I hand the call over to Olivier.
Thank you, Thomas. Moving to General Medicines on slide 21, we are very pleased with our performance in the first quarter. General Medicines sales were broadly stable to EUR 3.8 billion, which included sales from Industrial Affairs. Excluding the impact of divestiture and supply constraint, GenMed would have delivered slight growth in the first quarter. The execution of our strategy continues to deliver as planned, and the focus on our core asset has consistently generated positive results in the recent quarters. Our core assets grew 4.7%, driven by double-digit growth of Praluent, Multaq, Soliqua, Thymoglobulin, and the strong growth of Rezurock, which achieved EUR 41 million in sales, but impacted by the lower performance of Lovenox. Sales of non-core assets were lower in the quarter, in line with our expectations.
The decline of 4.2% reflected the impact of lower Lantus sales, as well as the impact of VBP wave five in China on Eloxatin and Taxotere sales and product divestiture, which are key to our ongoing strategic streamlining efforts. Excluding the impact of divestiture, non-core assets were down 2.8%. As you know, we are vigorously reducing the number of smaller product families with the objective to drive efficiencies and increase profitability. As I've mentioned before, moving to slide 22, let's focus on the performance of our core assets in the first quarter. Lovenox sales decreased 8.2% in the first quarter of 2022, impacted by a slowdown of COVID-related demand, especially in the rest of the world region, and comparing with a high base of comparison in 2021. Biosimilar competition and supply limitations are also impacting the performance.
Toujeo sales were up 6.3%, with strong growth in Europe and the rest of the world, partially offset by lower sales in the U.S. In China, the volume-based procurement for insulin is expected to be implemented in May 2022. As discussed earlier, Sanofi was among the bidding winners in the group A with Lantus and Toujeo. This will enable us to deliver higher volumes but at lower price. As announced at full-year results, we expected our total glargine sales, Toujeo and Lantus, to decrease by around 30% in China in 2022. Looking ahead, we aim to establish Toujeo as the basal insulin of choice in the large diabetes market in China and expect to make Toujeo one of our important growth driver in China in 2022 and beyond.
We will share the results of InRange, a head-to-head study comparing Toujeo and degludec using time in range as primary endpoint at ATTD tomorrow. Our well-established transplant franchise delivered a strong performance, with sales up 39% driven by Rezurock, as well as the strong performance of Thymoglobulin. We continue to be excited about Rezurock, our innovative new core asset. Launch performance reflects a rapidly expanding pool of prescribing institutions, as well as the pent-up demand from cGVHD patients who have already failed multiple systemic therapies. Healthcare professionals continue to report positive clinical experience. Praluent sales delivered continued strong growth due to its performance in Europe, where it was recently relaunched in Germany.
In conclusion, the performance of our core assets in the first quarter reinforce our confidence to deliver on our ambition to grow our core asset mid-single-digit CAGR over the period of 2020-2025, reach 20 General Medicines sales in 2025, excluding EUROAPI sales, and deliver roughly stable overall General Medicines sales in 2022, as announced at 2021 full year results. With that, I hand over the call now to Julie.
Thank you, Olivier. I'm very glad to report that in Q1, and for the second quarter in a row, we are trending above market growth. Let's remember that until last year, we were losing share, trending about five points below market in 2020. Since Q4, and on a rolling 12 months basis, as you can see on this slide, data shows that we have more than closed this gap. This is ahead of our 2021 commitment, which was to grow our priority brands above market as early as 2022 in key geographies. The execution of our three strategic priority is clearly paying off, and while progressing, we continue to raise the bar. I'll come back to that on the next page.
First, I would like to give you an update on the timelines of our Rx-to-OTC switches. For Cialis, understandably, in 2021, the FDA has been very busy with COVID-related priorities. Earlier this month, we received further feedback, and we will start our AUT before the end of Q2. No company has made it this far in the journey. This puts our estimated launch date in 2025. For Tamiflu, as shared, we were ready to go, but the prevalence of flu has continued to be very low. Several of our studies rely on enough people to contract the flu so that we can study their experience with the disease. We need a minimum two flu seasons. Given these circumstances, we will not be able to progress to an actual use trial in 2022 as originally planned.
Of course, we continue to accelerate all studies that can be done without influenza to keep the program progressing. As a result, we estimate to launch Tamiflu in the 2025-2026 flu season. Important to note is that the business opportunity for the switches remains the same. On the next page, looking at our Q1 net sales performance, I'm thrilled to announce that we have delivered a powerful 17% growth, doubling, more than doubling our cough and cold business, and with a strong double-digit growth in most of our categories and geographies, also growing versus pre-pandemic levels in Q1 2019 and 2020. This strong performance is driven by, first, both resource reallocations informed by our strategic priorities and data. Second, an increased consumer understanding and creativity in the way our brands engage with consumers.
Third, increased agility to capture market opportunities. I'm very proud how our teams are responding to the current supply challenges, ensuring maximum availability of our products given the current constraints. Last but not least, this growth includes a favorable price effect of three points. Looking ahead, after this very robust quarter, we expect the market to experience a more normalized growth now that the strong cough and cold season is ending. The next quarter, we'll also have a higher 2021 comparison base. I'm extremely proud of our Q1 achievements, and my team and I continue to focus on further delivering on our strategic priorities that have proven to be working. With that, I hand it over to our CFO, Jean-Baptiste.
Thank you. Thank you, Julie. In addition to higher sales in the quarter, we were able to deliver on the leveraged PNL. Gross margin improvement of 160 basis points at constant exchange rate, resulting from our favorable portfolio shift to Specialty Care products on growing efficiencies within Industrial Affairs. Within OpEx, SG&A grew at a significantly slower pace than sales, and the 16.1% growth in EPS is also supported by our lower effective tax rate of 19%. Turning to slide 27, in addition to the EUR 3.33 dividend proposed for 2020, 2021, we have created incremental shareholder value through the spin-off of EUROAPI, a leading player in active pharmaceutical ingredients.
The creation of EUROAPI, announced in February 2020, is in line with Sanofi's ambition to create a global leader in APIs to help secure API manufacturing and supply capacities in Europe and worldwide in the context of increasing shortages of medicines essential to patient care. With this project, EUROAPI will gain agility as an independent company and unlock its growth potential, particularly in the CDMO business. This transaction is also in line with Sanofi's Play to Win strategy to simplify its operations. It will be slightly positive on our BOI margin in 2022. Its independence will not only allow EUROAPI to grow and become more efficient, but the development of its CDMO capabilities will also support Sanofi in its own development and production. We have already signed a five-year manufacturing and supply contract and CDMO agreement in October 2021.
EUROAPI assets are now part of assets held for sale. We plan to host an accounting call on May 18 to provide further information on the deconsolidation going forward. Moving to slide 28. Well, Sanofi committed to fully embedding sustainability in our Play to Win strategy, and it is happening across the company. In 2020, the finance team had linked the renewal of our EUR eight billion revolving credit facility with some of our key ESG targets on eradicating polio, on reducing our carbon footprint. In March 2022, we are doing it again, issuing our first sustainability-linked bond. The coupon amount is linked to one of our ESG access KPIs this time.
While we continue to progress on our ESG ambitions, S&P Global Ratings has recognized us as one of the most sustainability committed companies with a specific distinction on our social profile, ranked as leading in the category of communities, highlighting the recent 2021 creation of its global health unit. Indeed, Sanofi Global Health aims to provide 30 of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries. It's a great work from all the teams. Now on slide 30, we update the outlook on expected business dynamics across sales and expenses for 2022.
On the last part of the slide, you can see expected drivers of sales across our GBUs, including the continuation of strong growth from Dupixent, record flu season, and maintain business momentum for the core product of CHC and GenMed. As communicated before, we expect CHC priority brands to grow both market and key geographies, resulting in growth for the entire business, but only progressively nearing market rates. At the same time, we also foresee overall GBU sales in GenMed to stabilize. EUROAPI's third-party sales are currently consolidated in this business. Upon the planned EUROAPI listing, GenMed sales will be reduced by that amount going forward. The consolidation is planned in May 2022. On the right part of the slide, we expect growth margin to continue to improve due to product mix and efficiencies on the full year basis.
However, it will be weighted in the first half of the year. R&D expenses are expected to continue to grow in line with our strategy. As we keep streamlining our GenMed and CHC business, we expect now to generate approximately EUR 600 million in capital gains, with the majority of the disposals happening in the second half of 2022. We estimate that our 2022 ETR to be around 19%, given the evolution of our product and geographic mix. This estimate is based on current tax legislation. On my final slide 31, we expect full year 2022 business EPS to grow in the low double digits at constant exchange rate. On our way to achieve our 2022 financial targets, we also guide to a FY margin of 30% for the year.
On foreign exchange, we see a positive currency impact of 4%-5% based on April 2022 average exchange rates. I'm now handing back the call to Paul.
Well, thanks, JB. On the final slide, before I touch on planned events, let's look back at Q1 that was rich with news flow. We presented our latest tolebrutinib data and our emerging neurology pipeline at ACTRIMS. I trust the 18-month data for tolebrutinib were compelling because feedback I received shows that the difference of our BTKI is becoming to be really well understood. We updated you on our immunology pipeline a few weeks ago and shared our strategy and ambition to more than quadruple the immunology franchise sales by the end of the decade. We are on our way to being recognized as the immunology company. Turning to upcoming events, we are looking forward to telling you about the progress we are making to deliver on our CSR strategy during our first ESG event planned for July 5.
Since the approval of our new contract with Société Générale, built in late 2020 within our organization, we have embraced these initiatives as part of our business priorities. We also plan to hold an in-person investor event on our hemophilia rare blood disease pipeline in mid-July. At this event, we want to highlight the full results of our positive pivotal trial with efanesoctocog alfa that has the potential to revolutionize factor treatment for hemophilia A patients. We'll also review the fitusiran data disclosed thus far, and the rilzabrutinib phase II ITP data just published in the New England Journal of Medicine. With that, let's open the call now for the Q&A.
Thank you. As a reminder, we would like to ask you to limit your questions to no more than two. You have two options to participate. Option one, click the raise hand icon at the bottom of your screen. You will be notified by us when your line is open to ask your question. At that time, please make sure you unmute your microphone. Option two, submit your question by clicking the Q&A icon at the bottom of the screen, and then your question will be read by our panelists. Now let's go to the first question.
The first question should come from Laura Sutcliffe at UBS. Laura?
Hello. Hopefully you can hear me.
Yep.
Great. Thanks for taking my questions. Firstly, are there any next steps in your dispute with the EMA over whether avalglucosidase is a new active substance, or is this kind of the end of the road there? Secondly, maybe just if you have any thoughts on what the past few months have taught on the appetite for COVID booster vaccines, and the potential characteristics of the ongoing booster market, that would be great. Thanks.
Okay. Thanks, Laura. I'll come back to avalglucosidase in a moment. Thomas, appetite for COVID booster vaccines.
Thank you, Laura. Well, as you know very well, the world, and it's been clear for everyone now, is indeed having a bigger amount of supply than demand when it comes to COVID-19 vaccines. Where the price is now is to get the right level of COVID-19 boosters. As you've seen that we have had strong results in our first generation COVID-19 boosters. We are going to come with a second generation COVID-19 boosters data this quarter in Q2 2022. Second generation being based on the beta variant, on which we are going to show data across multiple variants, and that's coming very soon. We believe that first and foremost, we are going to provide our supply to the countries with whom we have partnerships. That's very important moving forward to start by those partnerships.
Of course, we'll make our booster available once licensed to all the different markets. Once the markets are interested, of course, we will make it available and supply it to them. So that's as far as we go when it comes to COVID-19 boosters.
Thank you, Thomas. Bill, any comments on avalglucosidase?
No, thank you. Good question. You know, first of all, look, we are in complete disagreement with what they have said so far. We're looking at all options, exploring all opportunities and, you know, we believe that we are on the right side of the science, right side of the data, and we believe that this is gonna become the standard of care for Pompe disease.
Great. Thanks, Bill Sibold. The next question.
Next question comes from Graham Parry at Berenberg. Graham, if you would speak, please.
Great. Yeah, thanks for taking my questions. The first one's just on the guidance. You've obviously had a strong quarter. Your capital gains guidance was upgraded by EUR 100 million, but you didn't shift your full year guidance at all. Is that just an, you know, geopolitical uncertainty? I notice you're also flagging sort of your gross margin benefits more first half than second half. Just what's sort of behind caution on the full year at the moment? Then secondly, on AMEERA-3, it looks as if that's not coming until ESMO now. I think you said it didn't show clearly superior efficacy. Does that imply that there was some numerically positive trend there?
Just anything that we should be looking out for, I guess, from AMEERA-3 in ESMO to read into the AMEERA-5, AMEERA-6 settings. Thank you.
Thanks, Graham. JB, guidance, capital gains, and gross margin.
Come on, Graham. It's only Q1. I love your confidence, and there's nothing special to raise, effectively. It's early in the year, and I love the confidence you show in the team, and you're right to do so. We are navigating crisis, but you can count on us to deliver in 2022 and beyond. No, nothing really to signal on this.
Okay. Thanks, JB. John, a quick comment on AMEERA-3.
Yeah, Graham. The data are being submitted for presentation in a meeting later this year, and of course, once those are disclosed, you'll be able to see all the nuances and the subsets, like ER, wild type versus mutant, et cetera, et cetera. We really have nothing else to report at this point other than what was already shared in the press releases, that we do not see a statistically significant difference between the standard of care selected by physicians and amcenestrant in that late-line population, which I think, you know, the experience now is showing more and more that these patients may most of them may become estrogen receptor independent in their cancer journey.
Thank you, John. You know, as we head towards earlier lines, of course, what we're watching out for later this year is the relative tolerability profiles. That'll be very informative because we know that's a key differentiator as we go earlier. Next question.
Next question comes from Wimal Kapadia at Bernstein.
Well, great. Thank you very much for taking my question. So my first question is just on the nirsevimab trial, please. So you failed to achieve statistic reduction in hospitalization for RSV-associated lower respiratory tract infection. So just curious if and how that really impacts your thinking or commercial potential for the molecule, and you know, what feedback you've had so far as a result of that specific data point. Be interested to hear. Then my second question is just on Russia-Ukraine. You mentioned, you know, the COPD-MS trials, so just curious how data timelines, you know, delayed data timelines will not translate into shifts in defining timelines. So just maybe if you could elaborate a little bit on that would be great.
Okay. Wimal, thank you. We're very excited about the nirsevimab data, chance to protect all infants. Thomas?
Thanks for the question, Wimal. Indeed, very positive phase III trial, so let me restate the data, and I'll come back then to the perception of the different folks we've talked to. Again, we have succeeded by showing 77% reduction against hospitalization in a pre-specified phase 2B plus phase III endpoint. You know very well, as we did say multiple times, that the phase III alone was not powered in order to be able to demonstrate outcome on the secondary endpoint of hospitalization. We knew that when we were doing phase II plus phase III, that it was possible, and that's why we had pre-specified. We've shared that data with regulators, with the advisory committee. Very, very positive feedback.
Again, there's not so many drugs where from year one, if you implement this in a full birth cohort, from year one, you're gonna see three quarters less of hospitalization in newborns in the number one cause of hospitalization. That lends very well with payers or with advising committees. There are not so many products where you can show that from year one. That's where we're at. Very happy to show the data, and it's not finished. We are having very soon a very exciting ESPID Congress in May 2022, so next door. There will be some more data showing nirsevimab potential. Again, very excited about the journey, expecting market authorization in the EMA at the end of the year and moving forward for launch in 2023.
Thank you, Thomas. Yeah, I mean, from my own learning experience as well on this and talking to people, there's very few population health interventions that deliver that type of impact that fast, so you can see why people are very excited about what that looks like. John, Russia-Ukraine. Submission timelines are on track, but of course, there's been some challenges for all the companies actually in running clinical trials in such a difficult circumstance.
Indeed. We are obviously conducting global studies for our MS molecules, tolebrutinib. About roughly 11% of our sites are in Ukraine and Russia. We're staying on track with our submissions through a combination of really heroic efforts that our teams are making to keep patients on study in those affected territories. In Ukraine, for example, moving patients into the western parts of the country or into neighboring countries, into clinical sites where we have the study active.
We've taken mitigation efforts as well to expand recruitment outside those territories to add extra patients in case we lose data. So far so good, I would say. We are still on track with the submissions that we've shared previously.
Yeah. Thank you, John. I think John has mentioned already, but it's a Herculean effort by everybody, and not least to make sure the patients get the supervision that they need, but also to stay on track. I had a great privilege of being invited by Bill and John to one of our investigator meetings, global investigator meetings just a few weeks ago, to remind people of how important it is to deliver this and these studies. Everybody in the company doing what we can to make sure that not only do we help patients, but of course, we don't miss a timeline. Next question.
Next question comes from Richard Vosser at JPMorgan. Richard.
Hi. Thanks for taking my questions. Two, please. Just on the mRNA vaccine development for flu, can you give us an update of what's going on there? Are we gonna see an update on the program before the end of the year? I don't think that was mentioned. Secondly, just on consumer, perhaps you could talk about the development of the market in more detail. Clearly a very easy comp and easy flu cough and cold season. You know, how do you anticipate the market growth being pressured by the pressure on the consumer going forward? And what sort of levels should we think about? Thanks very much.
Thank you, Richard. Thomas, mRNA flu program update.
All in and full speed. As we had discussed before, we are going to go after the initial results that we provided last year to go into a phase I, II quadrivalent modified mRNA flu product, in H2 2022, starting the phase I, II trial. We are full speed on that, and we want to make sure that we take this opportunity to, between last year's results and this year's start by keeping, studying, more LNP and more codon optimization. Very excited about the science we're gathering in the mRNA center of excellence. As you know, when it comes to mRNA flu development, it's gonna be a journey. You probably have seen, Richard, the recent phase II data from some of our mRNA competitors.
They show that there are still some way to go, especially if I look at the systemic adverse event in terms of grade 3. That shows that there are still a lot of potential into the mRNA opportunity, but we need to find the right adjustment on the mRNA itself as well as the LNP, and that's the focus of our company.
Yeah. Thanks, Thomas. I mean, it shouldn't be lost on anybody, the vaccine day we had on December the first last year. You know, we laid everything out really clearly and transparently, and I think as I've said a couple of times, we've sort of predicted the challenges the competition would face. You know, and while we may have been a little bit later to the party on mRNA, certainly we feel like we've caught right up and actually understand what it takes to go forward and differentiate it. You know, we've come a long way in a year. I'm very proud of the team, actually, and I think, we're gonna positively surprise everybody, which is always a good thing. Now, Julie, market, consumer market development, as Richard is suggesting, you had a great quarter one, but what's next?
Thank you very much, Richard. It seemed to be an easy Q1, but still, I think what we can say is that, of course, as you mentioned, with the cough and cold season almost behind us, the strong market growth and the performance of Q2, Q3, and Q4 last year, we believe that the market will go more to normalized levels. Now for us specifically, what I can say is that even Q1 for us this year was also a high single digit growth versus Q1 2020, and even a double-digit growth versus Q1 2019. Again, we are above pre-pandemic levels, and this is where we wanna continue by focusing again on our core brands in key geographies. We remain quite optimistic. Yes, the market will go to more normal levels.
Thanks, Julie. Again, well done on quarter one. Okay, next question.
Next question is from Tim Anderson at Wolfe. Tim, please.
Thank you. A couple of questions, please. On your SERD, given the failure of AMEERA-3 and also the failure recently by Roche, are you just as confident as ever that this is a class of drugs that's viable and will ultimately make it to market? Or do those two failures add at least a bit more uncertainty to the class? Second question on consumer health. Given the durability of your underlying pharma and vaccines business across the decade would seem like a great setup to divest consumer health, what would be the reason for you not to get rid of it at this point? Is the delay in OTC switch here with at least one program a complicating factor to that? Will we get a definitive answer in 2022 on what your plans are?
Tim, thank you. Great questions. John, do you wanna have another go at the SERD answer?
Yeah. Tim, I mean, from the beginning, we felt that the sweet spot for the SERDs was gonna be in the early lines of therapy, where we're confident that the SG receptor is really an important driver of tumor growth. We remain very confident that that's the right place to use them. You know, we took a swing in the late line, knowing the risks associated with that, but really the early lines is where the real opportunity is, both, you know, for patients and for the company.
Yeah. You know, there's still a lot to learn, Tim, you know, as we get to the congresses in the second half of the year, we get more richness. I think it's clear. I think you said it, John. You know, the later lines were gonna be a challenge given the activity. It's gonna get really interesting on tolerability. There's no reason mechanistically why the class can't do well earlier, but it's gonna be really interesting. You know, for example, our nearest competitor, do they hold the same challenges to their tolerability into earlier lines? Those are the things that will differentiate going forward. If a class has efficacy in the earlier lines, you know, then won't it be interesting to see who the winner is? We look forward to that too.
Jean-Baptiste, you'd like to continue to answer the question on consumer, so I'll leave it over to you.
Thanks for the question, Tim. I think, of course, our position has not changed since December 2019. Looking back, you remember at the time, we had the same question on what happened since. Well, I think we are really working on building a stronger and better business. You've seen what Julie just exposed. We are really en route to really building a stronger asset. That's our position. It has not changed. Of course, in the meantime, we go on with our carving out, and it's happening well, bringing this level of autonomy in decision-making, really agility, which is really a huge necessity in this business.
We are glad with where we are right now, so no change.
Thanks, Jean-Baptiste. Okay, next question.
Next question is from Peter Verdult at Citi. Peter.
Thank you. Peter Verdult, Citi. Two questions. Just Dupixent first. A fantastic momentum globally. But in the U.S, our net price calculations suggest low double-digit pressure. Just wanted to better understand from the team how you're feeling about rebating going forward, especially considering the IL-13 launches. Perhaps a quick update on when your previously announced efforts to significantly improve COGS with Dupixent, when might we see that actually coming through in the PNL? Then the second quick one, a follow-up to Graham's question. I know you want full flexibility to invest in the business and focus on the pipeline, and you'll do that. But at the same time, I think everyone on the call knows that you're well set to comfortably sail past your midterm margin and free cash flow target.
The question is, are you planning a CMD later this year or early next? Would that be the platform where your midterm objectives could be revisited? Thank you.
Okay, Pete. Thank you very much. Dupixent, Bill?
Great. Peter Verdult, thanks for the question. You know, Q1 really, it's just the anticipated impact that you have from patient assistance programs and so forth on net sales. It's what we've historically seen in the first quarter, and you see it pretty regularly, obviously, throughout the industry. I mean, we are in a highly favorable position from an access perspective with Dupixent. We've planned for the long-term growth of the product, new indications, competitors, et cetera. So things are tracking as usual. There'll continue to be some downward pressure on gross to net, but that's expected, and there's nothing out of the ordinary here.
Yeah, if I remember, but we're, you know, probably a year away from the competition at least. Jean-Baptiste, I think you touched on it. Some competition is good in terms of the education and the noise in the market.
Yeah, I think it's a great point, Paul. I mean, we are counting on competition. We need competition to help grow the market. We need it in asthma, we need it in AD. We've seen it around the world where competitors have come into the market. It helps to accelerate growth. As the product with the best profile, guess who wins? That's what we're looking forward to.
Thank you, Bill. Jean-Baptiste, COGS and the C3.
Yeah. Nothing has changed on that front. Remember, it takes the time to deploy in our different sites the new process, and it will be delivered, as I said, deployed during 2022 and 2023. You will see in our PNL the full impact starting 2024.
Okay. Thank you. I hope I've got it right, but you're sort of suggesting we should have a CMD take, you know, to do some reflection and think about what the future could be. Good advice, Peter Verdult, as always from you. We'll update you in time for any new investor opportunities for conversation. But clearly, the next chapter for the company is coming around very fast. As excitement builds around what we're doing, you know, it's important that we try and point you in the right direction. Watch out for that. Okay. Next question.
Thank you.
Next question comes from Luisa Hector at Berenberg. Luisa.
Hello. Thank you for taking my questions. I wonder if we could touch on China, where you had strong growth in the quarter, 13%. Perhaps a little bit of an update on lockdowns and the outlook for the rest of the year, because you do have the positive side from new launches, but then the insulin pressure and your guidance there. Can we expect positive growth for the full year in China? Perhaps just to touch on the Blackstone deal, very interesting there. Are there many other opportunities from your pipeline that would
Okay.
Create similar deals like this? Thank you.
Thank you, Luisa. JB, China growth.
Yeah.[Inaudible]
Thank you, Felix. Good afternoon, team. Paul, one for you. Just would love your updated thoughts on kind of the broader capital allocation M&A priorities here. Clearly, biotech valuations seem to have corrected a fair bit this year. So just wondering how you're feeling about using your balance sheet more aggressively over the course of the rest of this year. Any interest in potentially bigger transactions or still very much a focus from a bolt-on perspective? That's kind of question number one. Question number two for Julie. The +3% price increases that you are seeing seems like that's kind of fairly consistent across the broader Consumer Healthcare kind of universe as reported so far.
Interested in your thoughts on how sustainable you think these price increases are going forward, especially as we look into 2023. Then just lastly, Paul, given the newly announced partnership with McLaren, are you guys planning to host an investor event either on the 30th of May or the 27th of May?
Okay. Thank you. Thank you as always, [Kir.] As for M&A, well, nothing really changed for us. You know, I think we've been pretty disciplined. We're looking to add to the pipeline. I think we're building it out right. We're doing it in the right areas. It's clear that some prices have fallen, but it's always been for us about picking the right target and the right asset. It's never been about size.
It's always been about the right thing, and that hasn't changed for us. I think that just stays, you know, business as usual. You know, we spend a lot of time on it and for good reason. You know, if we see the right thing, we'll move. That's been the same since the very beginning, at least since I've been here. They may cost us less, but it's still only about how good the opportunity is. Julie, price sustainability?
Thank you. Thank you for the question. We're obviously very closely monitoring the situation because, yes, we are increasing price. We are hit by actual raw material increases, et cetera. We're looking at competitor behavior, consumer price elasticity. And we are adapting our prices where needed, but always staying as fair as possible to our consumers. To answer your question, yes, I think what we have been doing now, the plus 3%, the three points, will be consistent in the coming months, but it's something we're again monitoring very closely, but something we're on.
Thank you. Thank you, Julie. Brendan, you get the chance to answer a question, to talk about maybe just a few seconds about why the partnership.
Mm-hmm.
You can answer Felix's specific question on the dates.
Sure.
Just the one, the partnership's the important thing.
Will do. Thank you. Good morning, good afternoon, everybody. Brendan O'Callaghan. I'm leading Industrial Affairs at Sanofi since Q4 of last year, before which I led the Biologics Manufacturing organization since 2015, primarily supporting Bill and the Specialty Care organization across the therapeutic areas that he's responsible for in immunology, oncology, rare disease, rare blood disease. We've not met before, maybe it'll take a few minutes just to give you some perspective on my new scope for reference. We're an organization that supplies almost 11 million patient doses every single day. Close to almost five billion doses in a year. We work with teams across more than 65 sites in 32 countries, supporting a portfolio of over 600 products and 20,000 SKUs supporting all of our business units.
Of course, we work very closely with John and his colleagues in R&D at CMC to make sure we deliver on-time launch and scale up of the pipeline assets right first time. Our priorities in industrial affairs are very clear. Supply product reliably, on time, at the quality our patients expect, and at the most competitive cost we can deliver. It's in these key areas of priority that we focus our improvement efforts. We looked at the various levers we have to drive improvements, we sought inspiration both internally as well as from external experts who can bring us a fresh perspective, mindset, and a set of capabilities to help us accelerate our improvement journey. That's where the partnership with McLaren came about.
As you know, they operate in one of the most competitive, fast-paced, and high-performance environments, where the ability to innovate rapidly, leveraging both data and technology insights, is key to make up the 2% difference that can separate first and last place on the racing grid. They've mastered skills in precision engineering, data analytics, and cross-functional teamwork, best represented by the famous pit stop capability, that we're also leveraging to help us maximize the utilization of our manufacturing asset base. Through that, to improve our productivity and clearly our cost efficiencies. We started last year with a pilot, delivered high single-digit improvements in a select number of sites. We're expanding that this year to over 100 of our production lines, taking learnings from that, which we'll then deploy across our full network, reaching out over almost 300 production lines.
With their mindset, racing mindset, their focus and continuous improvement, McLaren will help us to bring a strong sense of speed and competitively driven teamwork internally to our efforts.
Yeah, well, Brendan, thank you. You took your opportunity there.
I did.
Thank you. Joking aside, you know, it's quite important for people to realize as we go on this modernization effort as an organization, we have more opportunities than people fully appreciate externally to really improve productivity and efficiency and speed and cost internally. You know, we can bring a sense of fun and aspiration to it too, but at the heart of it will be, you know, a more efficient business, more agile, simplified portfolios and operational lines. I think that is, you know, it's hard to properly articulate externally all the time, you know, how big these opportunities are. As we move through R&D productivity, you know, and we move through our own internal opportunities, you know, attention is on Industrial Affairs. It can be exciting to do it too.
A real big opportunity for us. Next question.
Next question comes from Florent Cespedes. Florent, if you're there.
Good afternoon. I'm Florent Cespedes from Société Générale. Thank you very much for taking my questions. Two quick ones. First, for Olivier. Olivier, could you maybe give us an update on your simplification strategy in terms of this divestment or where you stand? Some color would be great on this front. Thanks. Second question, a follow-up on the situation in Ukraine regarding the clinical trials, because I think you gave some examples on the multiple sclerosis market. Could you elaborate also on the COPD front? Because you have, I think, trials there for Dupixent, the BOREAS trial, NOTUS, and also itepekimab with AERIFY-1 and 2. Any color on this front would be great. Thank you.
Great. Thank you, Olivier.
Yeah. Thank you. Thank you, Florent. Let me give you a little bit of color on how we progress in terms of simplification. I would say that we are in line in the plan, not to say a little bit in advance, to our roadmap, both in terms of geographic simplification. We now operate in roughly 50 countries through a distribution model. It's not anymore, you know, no small products, no small countries. We have simplified, you know, drastically our geographic footprint. Of course, it's too early, but the preliminary signals that we get from our relationship with the new distributors is positive.
Regarding the simplification of our portfolio, which is absolutely key, to simplify but also to decrease cost of goods, starting in 2020 or end of 2019, as you know, we had more than 350 product families. We are moving well in line with our plan, with the objective to go to 125 at the end of this year and 100 in 2025, through both, of course, divestiture, discontinuation of products, pruning. Really in line with the plan. I think it is an important element in order to drive down our cost of goods and make the life of my colleague, Brendan, and his people a little bit more easy.
Yeah. Thank you, Olivier. You know, again, just touched on it with industrial affairs. I think the teamwork that's going on between the business unit heads and industrial affairs is really important to give us the opportunity to redeploy resource either to the bottom line or into R&D. I think we're really getting to a good, you know, cadence on that. John, back to clinical trials, Ukraine, and perhaps Russia, but with specifics to COPD. Anything to add?
Yeah. The answer is largely the same, although I would say our exposure to COVID-19 in terms of risk for COPD is quite a bit lower in terms of the percentage of patients that are found in Russia or Ukraine. So no change to submission timelines. We're, you know, doing our best to keep any patients we already have on study, as I talked about before, and making efforts to expand recruitment in other territories so that we're, you know, just basically covered if we lose some patient data.
Thank you.
Thank you very much.
Thank you. Thank you, Paul. Next question.
Next question comes from Mark Purcell at Morgan Stanley. Mark?
Yeah, thanks very much, Philippe. So two for me. Firstly, could you help us understand the breadth of the CEACAM5 opportunity in replacing chemotherapy in lung and breast cancer and pancreatic cancer? Is CEACAM5 one of the targets in the Seagen collaboration, and when should we expect the first ADC from that collaboration to move into the clinic? The second question, could you comment on the opportunity for efanesoctocog alfa? I don't want to take any of the thunder away from the thirteenth of July event, but the efficacy looks outstanding. Over 50% of patients with zero bleeds versus mid-teens% for ELOCTATE. What should we think about in terms of a market share target in the factor space for efanesoctocog alfa, and how fast could you achieve that target? Thank you.
Thanks, Mark. John, breadth of the tusamitamab opportunity.
We think the breadth is quite large because for starters, CEACAM5 is expressed quite broadly in a number of adenocarcinomas, different percentages and different tumor types. But for those that are historically sensitive to agents that target microtubules, lung cancer, gastric, pancreatic, breast, we think the opportunity is, it is quite extensive. Obviously, we're doing the pilot studies in some of those indications to really try to better understand that both as monotherapy and in combination with other agents, the most advanced being in the non-small cell lung cancer. We're
I think one of the things to watch for later this year is as we get some experience in front line non-small cell lung cancer in combination with PD-1, where we are substituting CEACAM5 for some of the chemotherapeutic agents, we'll have a much better foundation for thinking about how broad that opportunity could be. Watch for those phase II data towards the end of the year. In terms of Seagen, we have not disclosed what the targets are for that collaboration, so I can't say more about that, and it'd probably be very premature to hazard when we might think we'd have a molecule in the clinic, but we're dedicated to moving that fast as quickly as we possibly can into development.
Thanks, John. Bill, FNS Optico.
Thanks, Philippe. Thanks for the question, and I think you called it outstanding. We are of the same belief. I'll start with again, I agree with the New England Journal of Medicine with their statement that it would transform severe hemophilia A into a mild disease. We think that when you can offer normal for the first time bleeding in a hemophilia A population, that's something special. That's something the market hasn't seen before. If you think about the market and the hemophilia prophylaxis segment, which is the factor prophylaxis segment, hands down, there should be no other factor that offers anything even close to what EFA will have. The question on the market's gonna be, how does it evolve?
Will it become a market that is demanding normal, or is it a market that is shifting towards convenience? Fortunately, as a company, we have another asset, the fitusiran, that covers the other side of the market as well. You know, I think our belief is that you wanna have the best outcome for patients that you can. EFA is going to have the community start to think about what is possible in hemophilia A, hopefully a little bit differently than they ever have had to. We're extremely optimistic. We'll get into more detail as we come up to our event a little bit later this year.
Yeah. Well said, Bill. I think that's where we're gonna be. It's quite interesting, isn't it, really, that it'll go to convenience over normal, which have never really been offered before. Monthly just weren't frequent enough, because to go beyond that inconvenience will be the new standard. Then, of course, the other point is that on our nearest non-factor competitor, they're weekly in 60% of the patients.
Mm-hmm.
That's non-factor. The share, the real assumption, maybe I say that there's opportunity to put some pressure on you, Bill, that the share goes beyond factor ultimately, depending on what the goal is. Thanks for raising that, Mark. All right, next question.
Next question goes to Seamus Fernandez at Guggenheim. Seamus?
Seamus, did we lose you?
If Seamus is not around, I would give it to Peter Verdult at Jefferies. Sorry, Peter.
Jefferies.
Jefferies.
Jefferies.
All right. No worries at all. So, two questions. Firstly, just on the simplification, I think you said that you'd raised the capital gains that you'd like to book this year to now around EUR 600 million. I'm curious, are most of those additional disposals you've got coming from the Consumer Healthcare or from the GenMed portfolio? And should we think of this as disposals that you had planned in prior years brought forward? 'Cause I think you sort of guided there'll be a cadence of these gains over the next few years. Or is this very much something that is going to be a, you know.
It's more additional gains and additional simplification that you found, that we should think of on top of what we should have previously thought about. And then just going on to Nirsevimab, you mentioned the EMA decision in the second half, and obviously the U.S. ACIP change. Given we also obviously have the potential to have a U.S. breakthrough therapy, you know, rapid sort of turnarounds here, should we think about potential use of Nirsevimab for the 2022-2023 winter season as possible? Or realistically, by the time we get, you know, recommendations obviously from ACIP, from various European countries, should we think of this as more of a 2023-2024? And how are you going, I guess, potentially, laying the groundwork with some of the European countries to get into that? Thank you.
Thank you. Thank you, Peter. Jean-Baptiste, couple of gains, disposals, and cadence.
Yeah. Thank you. You just have to read through this update that we are deploying our strategy successfully. The cadence is very much linked to the fact that we are signing almost a deal a month, one in a very good financial condition. Effectively, the impact is a bit on the upside. Nothing else than the relentless execution, and it's not necessarily more or less of GenMed or CHC, it's both. We are really on top of our roadmap on executing it fast.
Yeah. It's an important point, though, isn't it? Because everything is connected, and the transformation of the company and the sort of jump, leapfrog to the future of Sanofi, it's we have to look at IA to GBU, to disposals, to efficiencies, to make sure that we can drive that simplification in the company and the accountability around it. I do think it'll be, you know, a long-term strategy for us. It just makes sense. Okay, Thomas, so maybe a comment from you on the nirsevimab and RSV season.
I like to think about acceleration and, you know that on nirsevimab, Peter, we already accelerating from 2024 to 2023, so we already gain one year. I like, though, the question the way you think. Realistically, though, remember that we're going to submit the file in the US in the second half of 2022. Time for the regulatory body to review it, and as you mentioned, ACIP has changed its charter, which is a very important outcome. ACIP will look at the file. I would expect knowing that RSV is a seasonal disease, that we are talking about a launch in 2023 for the first half of nirsevimab. I would say, from there on, it's on your part.
Thanks, Thomas. I think that's probably a good place to bring us to a conclusion. Thank you to everybody for their questions and for their interest today. Just by way of a few thoughts, strong performance in Q1. You've seen it again. Look forward to updating as we get further into the year. Pipeline progress again, so we're excited about what that's looking like and coming together. Although I don't think we deliberately set out to talk to you about how well we're now running as an organization, I think it's important to not miss the fact that all of this productivity gains allows us to double down on R&D and to prepare for launches that perhaps didn't exist a few years ago. I think that's very exciting for us because it means we can positively surprise.
Thank you to everybody for the time today.