Sanofi SA

PAR:SAN

Earnings Call Transcript 2022-Q1

[Eva Schaefer-Jansen, executive]

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 3. 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 4. 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 2 options to participate. Option 1, click the raise hand icon at the bottom of your screen. Or option 2, submit your questions by clicking the Q&A icon at the bottom of the screen.

With that, I'd like to turn the call over to Paul.

[Paul Hudson, executive]

Well, thank you, Eva. Great introduction. And 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 view. 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 EUR 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 EUR 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 noncore products and investing in transplant and other selected assets resulted in another quarter of growth for our core assets.

Likewise, the Consumer Health business is executing on the strategy outlined at our Capital Markets Day on February 5 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 7. Into the third year now of executing on our Play to Win strategy, the strong set of first 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 2 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 2 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 9. I wanted 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 subcu formulation, which serves as another example of prioritization. Partnering Sarclisa going forward allows us to reallocate R&D investments to further expand on our pipeline and to strengthen our growth areas. So in summary, a really strong first quarter for us here at Sanofi.

John, over to you.

[John Reed, executive]

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 3 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 CCAM5-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 3 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 time line for drug discovery while also potentially pointing us to those subsets of patients most likely to benefit.

Our third collaboration is with IGM Bioscience. Their technology platform offers an exciting approach to developing multivalent IgM antibodies that can efficiently bind and stimulate the activity of cell service 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 3 oncology targets and 3 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 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 embedded 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 our Head of Oncology Development, Peter Adamson, who was previously Head of the Pediatric 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 5 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 pretransplant.

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 the exploratory Phase Ib studies, where we observed excellent tolerability combined with strong efficacy and robust target engagement with a once-daily 200-milligram dose.

Then 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 the 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 study comparing CDK4/6 inhibitor palbociclib in combination with either amcenestrant or an aromatase inhibitor has fully enrolled ahead of schedule. And then 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, tusamitamab, showing promising durability results for long-term treated nonsmall cell lung cancer patients. The treatment duration observed so far is really quite remarkable. Tusa aims to not only become the standard of care for patients with CCAM5 high-expressing tumors in second-line lung of 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 CCAM-expressing tumors, namely breast and pancreatic, are also ongoing and expected to read out in 2023.

Then finally, I draw your attention to SAR'245, our potential best-in-class non-alpha interleukin-2 molecule that's being tested across 5 oncology indications as monotherapy and in combination with other medicines, leveraging 245'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 SAR'245. Now without going into 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 SAR'245, unlike the Nektar molecule, does precisely what it was designed to do, namely, 245 selectively expands effector CD8-positive T cells and natural killer cells without causing significant expansions of immunosuppressive regulatory T cells or of eosinophils that contribute to native IL-2's toxicity.

Our clinical data show that the improved therapeutic index of SAR'245 allows us to dose more than 4x 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, 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.

[William Sibold, executive]

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 and 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 uptick 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 '22 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 EUR 0.5 billion and annualizing at close to EUR 2 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 6 months to 5-year-old children as well as approval for 6- 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 2 recently launched innovative products, Nexviazyme and Xenpozyme. Only about 2 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 governance 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 drive 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.

[Thomas Triomphe, executive]

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 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, South Hemisphere markets are mostly using standard dose vaccines, sometimes even with the 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. And 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 vaccines candidate that had to stop all Phase III clinical trials.

Regulatory authorities have understood the benefit nirsevimab can bring. And we'll review our dosing in an accelerated fashion, the first one being EMA. We expect to receive the EMA decision later this year, 1 year ahead of plan.

Vaccines recommending body are also highly interested by 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 IIIb study will start in October of this year. It will generate data in a real-world setting to reinforce the strong data sets supporting nirsevimab benefits and showcase its ease of implementation in the pediatric immunization schedules.

With that, I hand the call over to Olivier.

[Olivier Charmeil, executive]

Thank you, Thomas. Moving to General Medicine 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 affair.

Excluding the impact of divestiture and supply constraint, Gen Med 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 noncore 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 5 in China on Eloxatin and Taxotere sales and product divestiture, which are key to our ongoing strategic streamlining efforts.

Excluding the impact of divestitures, noncore 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 endpoints 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.

Q1 performance reflects the rapidly expanding pool of prescribing institutions as well as the pent-up demand from CGVHD patients, who have already failed multiple systemic therapies. Healthcare professional 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 2020 General Medicine 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.

[Julie Van Ongevalle, executive]

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 5 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 3 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 time lines 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 on this journey, and 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, and we needed a minimum 2 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-'26 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 '19 and 2020. This strong performance is driven by, first, bold resource reallocations informed by our strategic priorities and data; second, an increased consumer understanding and creativity in the way our brands engage with consumers; and 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 3 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 will 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.

[Jean-Baptiste de Chatillon, executive]

Thank you, Julie. So in addition to higher sales in the quarter, we were able to deliver on the leverage P&L. Gross margin improvement of 160 bps at constant exchange rate, resulting from our favorable portfolio shift to Specialty Care products and 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 2021, we have created incremental shareholder value through the spinoff 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 operation. It will be slightly positive on our BOI margin in 2022.

The independence will not only allow EUROAPI to grow and become more efficient, but the development of its CDMO capabilities will also support Sanofi on its own development on production. So we have already signed a 5-year manufacturing and supply contract on CDMO agreements in October 2021. EUROAPI assets are now part of assets held for sales. 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 8 billion revolving credit facility with some of our key ESG targets on eradicating polio and 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 KPI this time.

And 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 left 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 CSG and Gen Med. As communicated before, we expect CHC priority brands to grow above market in 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 Gen Med to stabilize. So EUROAPI third-party sales are currently consolidated in this business. Upon the planned EUROAPI listing, Gen Med 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 gross 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.

And as we keep streamlining our Gen Med 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, 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 BOI margin of 30% for the year. On foreign exchange, we see a positive currency impact of 4% to 5% based on April 2022 average exchange rates.

I'm now handing back the call to Paul.

[Paul Hudson, executive]

Well, thanks, J-B. On the final slide, before I touch on planned events, let's look back to Q1 that was rich with news flow. We presented our latest tolebrutinib data and our emerging neurology pipeline at ACTRIMS. And 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 society 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.

[Eva Schaefer-Jansen, executive]

Thank you. [Operator Instructions] You have 2 options to participate. So option 1, 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.

Or option 2, submit your questions by clicking the Q&A icon at the bottom of your screen and then your question will be read by our panelists.

Now let's go to the first question.

[Operator]

The first question should come from Laura Sutcliffe at UBS.

[Laura Sutcliffe, analyst]

Hopefully, you can hear me.

[Paul Hudson, executive]

Yes.

[Laura Sutcliffe, analyst]

Great. 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?

And then 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.

[Paul Hudson, executive]

Okay. Thanks, Laura. I'll come back to avalglucosidase in a moment. Thomas, appetite for COVID booster vaccines?

[Thomas Triomphe, executive]

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. Well, the price is now is to get the right level of COVID-19 boosters. And as you've seen that we have had strong results in our first-generation COVID-19 boosters.

We are going to come with the 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. And 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.

[Paul Hudson, executive]

Thank you, Thomas. Bill, any comments on avalglucosidase?

[William Sibold, executive]

Thank you for the question. First of all, look, we are in complete disagreement with what they have said so far. We're looking at exploring all opportunities, and we believe that we are on the right side of the science, right side of the data. And we believe that this is going to become the standard of care for Pompe disease.

[Paul Hudson, executive]

Great. Thanks, Bill.

[Operator]

Next question comes from Graham Parry at BofA.

[Graham Parry, analyst]

Great. So the first one is just on the guidance. So 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 geopolitical uncertainty? I noticed you're also flagging sort of your gross margin benefits more first half than second half. So just what's sort of behind caution on the full year at the moment?

And then secondly, on AMEERA-3, it looks as if that's not coming until ESMO now. And I think he said it didn't show clearly superior efficacy. So does that imply that there was some numerically positive trend there? So 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?

[Paul Hudson, executive]

Thanks, Graham. J-B, guidance, capital gains and gross margin.

[Jean-Baptiste de Chatillon, executive]

Come on, Graham. It's only Q1. So I love your confidence, and there's nothing special to raise. Effectively, it's early in the year, and I love the confidence you're showing the team, and you're right to do so. We are navigating crisis, but you can count on us to deliver in '22 and beyond. So nothing really to signal on this.

[Paul Hudson, executive]

Okay. Thanks, J-B. John, a quick comment on AMEERA-3?

[John Reed, executive]

Yes, Graham, the data are being submitted for presentation at 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 did not see a statistically significant difference between the standard of care selected by physicians and amcenestrant in that late-line population, which I think the experience now is showing more and more that these patients, most of them may become estrogen receptor independent in their cancer journey.

[Paul Hudson, executive]

Thank you, John. As we head towards earlier lines, of course, what we're watching out for later this year is the relative tolerability profiles. That will be very informative because we know that's a key differentiator as we go earlier.

[Operator]

Next question comes from Wimal Kapadia at Bernstein.

[Wimal Kapadia, analyst]

My first question is just on the nirsevimab trial, please. So you failed to achieve stat sig reduction in hospitalization for RSV-associated lower respiratory tract infection. So just curious if and how that really impacts your thinking on commercial potential for the molecule. What feedback you've had so far as a result of that specific data point? I'd be interested to hear.

And then my second question is just on Russia, Ukraine. You mentioned the COPD MS trial. So just curious how data timelines -- delayed data timelines will not translate into shifts into filing timeline. So just maybe if you could elaborate a little bit on that, that would be great.

[Paul Hudson, executive]

Okay. Wimal, thank you. We're very excited about the 7-month data, chance to protect all infants. Thomas?

[Thomas Triomphe, executive]

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 prespecified Phase IIb plus Phase III endpoint. You know very well as we said multiple times, but the Phase III alone was not powered in order to be able to demonstrate outcome on the secondary endpoint of hospitalization. But we knew that when we were doing Phase II plus Phase III that it was possible, and that's why we have prespecified.

And we've shared that data with regulators, with the advisory committee, very, very positive feedback. Again, there are not so many drugs work from year 1. If you implement this in a full birth cohort from year 1, you're going to see 3/4 less of hospitalization in newborns in the #1 cause of hospitalization.

That lends very well with payers or with advisory committees. There are not so many products where you can show that from year 1. So that's where we're at, very happy to show the data, and it's not finished. We are having very soon and 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 EMA at the end of the year and moving forward for the launch in 2023.

[Paul Hudson, executive]

Thank you, Thomas. Yes, 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. So submission time lines 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.

[John Reed, executive]

Indeed. We are obviously conducting global studies for our MS molecules, tolebrutinib. About roughly 11% of our sites are in U.K. and in 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 and clinical sites where we have the study active.

And then we've taken mitigation efforts as well to expand recruitment outside those territories to add extra patients in case if we lose some data. But so far, good day, I would say, and we are still on track with the submissions that we've shared previously.

[Paul Hudson, executive]

Yes, thanks, 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. Had a great privilege 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 these studies. So 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 the timeline.

[Operator]

Next question comes from Richard Vosser at JPMorgan.

[Richard Vosser, analyst]

Two, please. Just on the mRNA vaccine development for flu. Could you give us an update of what's going on there? And are we going to see an update on the program before the end of the year? I don't think that was mentioned.

And then 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. But how do you anticipate the market growth being pressured by the pressure on the consumer going forward? And what sort of level should we think about?

[Paul Hudson, executive]

Thank you, Richard. Thomas, mRNA flu program update?

[Thomas Triomphe, executive]

All in and full speed. So as we have 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 results and this year's start by keeping -- studying more LNPs and more code optimization. So very excited about the science we're gathering on the mRNA center of excellence.

As you know, when it comes to mRNA flu development, it's going to be a journey. You probably have seen, Richard, the recent Phase II data from some of our mRNA competitors. They show that there is still some way to go, especially if I look at the systemic adverse event in terms of Grade 3.

That shows that there is still a lot of potential into the mRNA opportunity. But we need to find the right adjustment on the mRNA cell as well as in the LNP, and that's the focus of our company.

[Paul Hudson, executive]

Yes. Thanks, Thomas. I mean, it shouldn't be lost on anybody the facts that we handed in December 1 last year. We laid everything out really clearly and transparently. And I think as we said a couple of times, we've sort of predicted the challenges the competition would face.

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. So we've come a long way in a year. I'm very proud of the team actually. And I think we're going to positively surprise everybody, which is always a good thing.

Now Julie, market -- consumer market development. I think Richard is suggesting you had a great quarter 1, but what's next?

[Julie Van Ongevalle, executive]

Thank you very much, Richard. It seemed to be an easy quarter 1, 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 '19. So again, we are above pre-pandemic levels, and this is where we want to continue by focusing again on our core brands and key geographies. So we remain quite optimistic, but yes, the market will go to more normal levels.

[Paul Hudson, executive]

Thanks, Julie. Again, well done on quarter 1.

[Operator]

Next question is from Tim Anderson at Wolfe.

[Timothy Anderson, analyst]

A couple of questions, please. So 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 2 failures add at least a bit more uncertainty to the class?

And 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? And is the delay in OTC switch here with at least one program a complicating factor to that? And will we get a definitive answer in 2022 on what your plans are?

[Paul Hudson, executive]

So Tim, thank you. Great questions. John, do you want to have another go at the SERD answer?

[John Reed, executive]

Yes. Tim, I mean, from the beginning, we felt that the sweet spot for the SERD was going to be in the early lines of therapy where we're confident that the estrogen receptor is really an important driver of tumor growth. So we remain very confident that, that's the right place to use them.

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 for patients and for the company.

[Paul Hudson, executive]

Yes. There's still a lot to learn. 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. And the later lines were going to be a challenge given the activity.

It's going to get really interesting on tolerability. There's no reason mechanistically why the class can't do well earlier. But it's going to be really interesting. For example, our nearest competitor, do they hold the same challenges to the tolerability into earlier lines. And those are the things that will differentiate going forward. So if the class has efficacy in the earlier lines, then, won't it be interesting to see who the winner is? We look forward to that, too.

Jean-Baptiste, you like to continue to answer the question on consumer so over to you.

[Jean-Baptiste de Chatillon, executive]

Yes. Well, thanks for the question, Tim. I think, of course, our position has not changed since December '19. But looking back, you remember at the time, we had the same question, and what happened since?

Well, I think we are really, really working on building a stronger and better business. And you've seen what Julie just exposed, we are really en route to really building a stronger asset. So that's our position. It has not changed.

And of course, in the meantime, we go on with our carving in. And it's happening, and it's happening well, bringing this level of autonomy in decision-making, really agility, which is really a huge necessity in this business. So yes, we are glad with where we are right now. So no change.

[Paul Hudson, executive]

Thanks, Jean-Baptiste.

[Operator]

Next question is from Pete Verdult at Citi.

[Peter Verdult, analyst]

Pete Verdult, Citi. Two questions. Just Dupixent first, fantastic momentum globally. But in the U.S., our net price calculation suggests low double-digit pressure. So I just wanted to better understand from team how you're feeling about rebating going forward, especially considering the IL-13 launches? And 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 P&L?

And 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. So the question is, are you planning at CMD later this year or early next? And would that be the platform where your midterm objectives could be revisited?

[Paul Hudson, executive]

Okay. Pete, thank you very much. Dupixent, Bill?

[William Sibold, executive]

Great. Pete, thanks for the question. 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 planned for the long-term growth of the product, new indications, competitors, et cetera. So things are tracking as usual though continue to be some downward pressure on gross to net, but that's expected. And there's nothing out of the ordinary here.

[Paul Hudson, executive]

Yes, we -- and if I remember, we're probably a year away from the competition at least. And which remind, I think you touched on it. Some competition is good in terms of the education and the noise in the market.

[William Sibold, executive]

Yes, 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 and as the product with the best profile, guess who wins? So that's what we're looking forward to.

[Paul Hudson, executive]

Thank you, Bill. Jean-Baptiste, COGS and the C3?

[Jean-Baptiste de Chatillon, executive]

Yes. 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 '22 and '23. So you will get and you will see in our P&L the full impact starting '24.

[Paul Hudson, executive]

Okay. Thank you. And I think I may -- I hope I get it right, but you're sort of suggesting we should have a CMD to do some reflection and think about what the future could be. Good advice, Pete, 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. And as excitement builds around what we're doing, it's important that we try and point you in the right direction. So watch out for that.

[Operator]

Next question comes from Luisa Hector at Berenberg.

[Luisa Hector, analyst]

I wonder if we could touch on China, where you had strong growth in the quarter, 13%. So perhaps a little bit of update on lockdowns and just outlook for the rest of the year because you do have the positive side from new launches, but then the incident pressure on your guidance there. So can we expect positive growth for the full year in China?

And perhaps just to touch on the Blackstone deal, very interesting there. Are there many other opportunities from your pipeline where we could see similar deals like this?

[Paul Hudson, executive]

Okay. Thank you, Luisa. J-B, China growth?

[Jean-Baptiste de Chatillon, executive]

Yes. Yes, we are quite a bit see that rebound. You've heard from vaccines some rebound. You've seen that we were also performing quite well across the board in our different business units. So this market is important to us, and we'll go on being a player of volume.

You remember that we have been playing the game of EBP quite successfully, winning where we wanted to win and really getting our growth in volume, which makes us stronger and stronger in China.

On maybe you had in mind is the negative impact of lockdowns and everything around Shanghai, and maybe I -- Thomas, you want to update us on this piece?

[Thomas Triomphe, executive]

Yes, absolutely. Thank you, J-B. So Luisa, you're right. We have -- you have seen a strong quarter on PPH and rest of the world, and as I said, it was driven by China.

You know that Pentaxim/pentavalent pair combination is doing well in China. We're gaining market share. And there is COVID-19 lockdowns, which is very difficult to predict duration and which city and for how long. Of course, you can expect that during the exact duration of the lockdown, people don't go to the point of vaccination center. And therefore, you have an immediate drop.

However, we're talking about pediatric immunization, less than 6-month-old babies. So as soon as the lockdown is removed, people go first and bring their newborns there. So it's going to be showing some shifts between quarter-to-quarter, but we catch up very quickly as soon as the lockdown is removed.

[Paul Hudson, executive]

Thank you. Luisa, as for Blackstone, clearly opportunistic, but we stay open-minded. I think I mentioned it in my upfront around staying agile for these things.

In many cases, we believe we have the best CD38, but of course, the market is moving to subcutaneous. We're going to produce more data, we hope differentiated.

So the question was really a simple one. What is an efficient way to be able to compete in a subcutaneous market over the upcoming years when our data will accumulate very positively and differentiated? I think we have to be realistic that we know how to get a return, but we also know when it's best to do it ourselves or when it's best to get some help to do it.

So I think it just shows how open-minded we are, frankly, but importantly, that we think there is some opportunities for Sarclisa. So we'll watch that as we go forward. It's quite exciting actually.

[Operator]

Next question is from Keyur Parekh at Goldman.

[Keyur Parekh, analyst]

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 are still very much a focus from a bolt-on perspective? So that's kind of question number one.

Question number two for Julie. The plus 3% price increases that you are seeing, seems like that's kind of fairly consistent across the broader consumer healthcare kind of universe has reported so far. But interested in your thoughts on how sustainable you think these price increases are going forward, especially as we look into 2023.

And 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?

[Paul Hudson, executive]

Okay. Thank you. Thank you, as always, Keyur. So as for M&A, well, nothing really changed for us. 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 assets. 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 business as usual. We spend a lot of time on it and for good reason. And 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. So they may cost us less, but it's still only about how good the opportunity is.

Julie, price sustainability?

[Julie Van Ongevalle, executive]

Sure. So thank you. Thank you for the question. We're obviously very closely monitoring the situation because, yes, we are increasing price. So we are hit by actual raw material increases, et cetera.

We're looking at competitive behavior, consumer price elasticity. And we are adapting our prices where needed, but always staying as fair as possible to our consumers.

And so to answer your question, yes, I think what we have been doing now, the plus 3% -- the 3 points will be consistent in the coming months. But it's something we're, again, monitoring very closely, but it's something we're on.

[Paul Hudson, executive]

Thank you. Thank you, Julie. Brendan, you get the chance to answer a question. So -- and to talk about maybe just for a few seconds about why the partnership, and then you can answer his specific question on the dates, but the partnership is the important thing.

[Brendan O’Callaghan, executive]

Will do. Thank you. So 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.

So we've not met before, so maybe I'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 5 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. And of course, we work very closely with John and his colleagues in R&D 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 here: support -- supply product reliably, on time at the quality our patients expect and at the most competitive cost we can deliver. And it's in these key areas of priority that we focus our improvement efforts.

And so as 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. And 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 teamworks, best represented by the famous pit stop capability that we're also leveraging to help us maximize the utilization of our manufacturing asset base and 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. And 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.

And with their mindset, racing mindset, their focus on continuous improvement, McLaren will help us to bring a strong sense of speed and competitively driven teamwork internally to our efforts. So...

[Paul Hudson, executive]

Well, Brendan, thank you. You took your opportunity there. Just -- joking aside, 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. And we can bring a sense of fun and aspiration to it, too.

But at the heart of it will be a more efficient business, more agile, simplified portfolios and operational lines. And I think that is -- it's hard to probably articulate externally all the time how big these opportunities are. But as we move through R&D productivity and we move through our own internal opportunities, attention is on industrial affairs. And it can be exciting to do it, too. So a real big opportunity for us.

[Operator]

Next question comes from Florent Cespedes.

[Florent Cespedes, analyst]

Florent Cespedes from Societe Generale. 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? So some color would be great on this front.

And second question, maybe a follow-up on the situation in Ukraine regarding the clinical trials because I think you gave some examples on the multiple sclerosis market. But could you elaborate also on the COPD front because you have, I think, trials there for Dupixent, the [indiscernible] trial notice and also itepekimab with RFI 1 and 2. So any color on this front would be great.

[Paul Hudson, executive]

Great. Thank you. Olivier?

[Olivier Charmeil, executive]

Yes. So thank you, Florent. So 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 road map, both in terms of geographic simplification.

We now operate in roughly 50 countries through a distribution model. So it's not anymore -- no small products, no small countries. We have simplified drastically our geographic footprint. And of course, it's too early, but the preliminary signals that we get are far more -- 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. So 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. So really in line with the plan. And I think it's 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.

[Paul Hudson, executive]

Yes. Thank you, Olivier. 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 added to the bottom line into R&D. And I think we're really getting to a good cadence on that.

John, back to clinical trials, Ukraine and perhaps Russia, but with specifics to COPD, anything to add?

[John Reed, executive]

The answer is largely, I would say our exposure 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 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 just basically covered if we lose some patient data.

[Paul Hudson, executive]

Thank you.

[Operator]

Next question comes from Mark Purcell at Morgan Stanley.

[Mark Purcell, analyst]

So 2 for me. Firstly, could you help us understand the breadth of the CCAM5 opportunity in replacing chemotherapy in lung and breast cancer and pancreatic cancer? Is CCAM5 one of the targets in the Seagen collaboration? And when should we expect the first ADC from that collaboration to move into the clinic?

And then the second question, could you comment on the opportunity for efa alfa? I don't want to take any of the fun there from the 13th of July event, but the efficacy looks outstanding, over 50% of patients with 0 bleeds versus mid-teens for Elocta. What should we think about in terms of a market share target in the factor space for efa alfa? And how fast could you achieve that target?

[Paul Hudson, executive]

Thanks, Mark. John, breadth of the tusamitamab opportunity?

[John Reed, executive]

We think the breadth is quite large because for starters, CCAM5 is expressed quite broadly in a number of adenocarcinomas, different percentages in 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 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 nonsmall cell lung cancer. So we're -- I think one of the things to watch for later this year is as we get some experience in frontline nonsmall cell lung cancer in combination with PD-1, where we are substituting CCAM for some of the chemotherapeutic agents, we'll have a much better foundation for thinking about how broad that opportunity could be. So 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 any 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.

[Paul Hudson, executive]

Thanks, John. Bill, efanesoctocog?

[William Sibold, executive]

Yes. So thanks. 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. So if you think about the market and the hem A prophylaxis segment, which the hem A 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 is going to be, how does it evolve? Will it become a market that is demanding normal? Or is it a market that is shifting towards convenience?

And fortunately, as a company, we have another asset, fitusiran, that covers the other side of the market as well. We -- I think our belief is that you want to 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. So we're extremely optimistic. We'll get into more detail as we come up to our event a little bit later this year.

[Paul Hudson, executive]

Yes. Well said, Bill. I think that's where we're going to be. It's quite interesting, isn't it, really, that it will go convenience or normal, which have never really been offered before. Monthly just won't look enough because to go beyond that on convenience with the new standard.

And then, of course, the other point is that on our nearest nonfactor competitor, they're weekly in 60% of the patients. And that's a nonfactor. So 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. So thanks for raising that, Mark.

[Operator]

Our next question goes to Seamus Fernandez at Guggenheim.

[Paul Hudson, executive]

Seamus, did we lose you?

[Operator]

If Seamus is not around, I would give it to Peter Welford at Barclays -- sorry, Peter...

[Paul Hudson, executive]

Jefferies.

[Eva Schaefer-Jansen, executive]

Jefferies.

[Operator]

Jefferies.

[Peter Welford, analyst]

It's all right though. So 2 questions. The first thing is just on the simplification. I think you said that you've raised the capital gains you like to talk this year to now around EUR 600 million. I'm curious, are most of those additional disposals you've got coming from the consumer health or from the Gen Med portfolio?

And should we think of this as disposals that you had planned in prior years brought forward because I think you've sort of guided there will be a cadence of these gains over the next few years. Or is this very much something that's going to be a -- what additional gains and additional simplification that you found that we should think of on top of what we should really have 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 rapid to the turnaround here, should we think about potential use of nirsevimab for the '22 to '23 winter season as possible? Or realistically by the time we get recommendations obviously from ACIP from various European countries, should we think of this as more of a '23 to '24? And how are you going, I guess, potentially laying the groundwork with some of the European countries to get into that?

[Paul Hudson, executive]

Thank you. Thank you, Peter. Jean-Baptiste, capital gains, disposals and cadence?

[Jean-Baptiste de Chatillon, executive]

Yes. Thank you. You just have to read through this update that we are deploying our strategy successfully. And the cadence is very much linked to the fact that we are signing almost a deal a month in a very good financial condition.

So effectively, the impact is a bit on the upside. But nothing else than the relentless execution on -- it's not necessarily more or less of Gen Med or CHC. It's both. We are really on top of our road map on executing fast.

[Paul Hudson, executive]

Yes. It's an important point, isn't it, because the -- everything is connected and the transformation of the company and 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. And I think -- I do think it will be a long-term strategy for us. It just makes sense.

Okay, Thomas, so maybe a comment from you on the nirsevimab and RSV season?

[Thomas Triomphe, executive]

I like to think about acceleration. And you know that on nirsevimab pillar, we're already accelerating from '24 to '23. So we are ready in 1 year.

I like the other question where you think -- realistically though, remember that we're going to submit the file in the U.S. 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. And then ACIP will look at the file.

So I would expect, knowing that RSV is a seasonal disease, that we are talking about launch in 2023 for the first sales of nirsevimab. And I will say from there on, it's on [ your ] part.

[Paul Hudson, executive]

Thanks, Thomas. I think that's probably a good place to bring us to a conclusion. Thank you to everybody for the questions and for the 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 coming together.

And 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 these productivity gains allows us to double down in R&D and to prepare for launches that perhaps didn't exist a few years ago. And I think that's getting -- that's very exciting for us because it means we can positively surprise. So thank you, everybody, for the time today.