Q2 2026 Viatris Inc Earnings Call

August 6, 2026

Speaker #1: Good morning, everyone, and welcome to the Viatris Q2 2026 earnings call. All participants will be in a listen-only mode; should you need assistance, please signal a conference specialist by pressing the star key followed by 0.

Operator: Good morning, everyone, and welcome to the Viatris Q2 2026 Earnings Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one on your touch-tone phones. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Szablewski, Head of Capital Markets. Sir, please go ahead.

Speaker #1: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touchstone phones.

Speaker #1: To withdraw your questions, you may press star and 2. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Sablewski, Head of Capital Markets.

Speaker #1: Sir? Please go ahead.

Speaker #2: Good morning, everyone. Welcome to our Q2 2026 earnings call. With us today is CEO Scott Smith, Interim CFO Paul Campbell, Chief R&D Officer Philippe Martin, and Chief Commercial Officer Corinne Le Goff.

Bill Szablewski: Good morning, everyone. Welcome to our Q2 2026 earnings call. With us today is CEO Scott Smith, Interim CFO Paul Campbell, Chief R&D Officer Philippe Martin, and Chief Commercial Officer Corinne Le Goff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2026 and various strategic initiatives. These statements are subject to risk and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to most directly comparable GAAP measures. When discussing 2026 actual or reported results, we will be making certain comparisons to 2025 actual or reported results on an operational basis, which excludes the impact of foreign currency rates.

Speaker #2: During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2026 and various strategic initiatives. These statements are subject to risk and uncertainties.

Speaker #2: We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information.

Speaker #1: Good morning, everyone, and welcome to the Viatris Q2 2026 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Speaker #2: Including reconciliations of those non-GAAP measures to most directly comparable GAAP measures. When discussing 2026 actual or reported results, we will be making certain comparisons to 2025 actual or reported results, on an operational basis, which excludes the impact of foreign currency rates.

Speaker #1: will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touchstone phones. To withdraw your questions, you may press star and 2.

Speaker #2: When comparing our 2026 actual or reported results, to our expectations, we are making comparisons to our 2026 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Bill Szablewski: When comparing our 2026 actual or reported results to our expectations, we are making comparisons to our 2026 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Speaker #1: recorded. At this time, I'd like to turn the floor over to Bill Sablewski, Head of Capital Markets. Sir, please go ahead.

Speaker #3: Good morning, everyone. We're often exceptional start in 2026. We delivered another strong quarter that reinforces our confidence in the strategy we outlined earlier this year.

Scott Smith: Good morning, everyone. We're off to an exceptional start in 2026. We delivered another strong quarter that reinforces our confidence in the strategy we outlined earlier this year. In Q2, we delivered $3.8 billion in total revenues, representing 3.5% operational revenue growth year-over-year, adjusted EBITDA of $1.2 billion and adjusted EPS of $0.69 per share. These results exceeded our expectations and reflect the strong momentum across our businesses and continued improvement in operating leverage. Just as importantly, these results give us confidence to raise our outlook for the remainder of the year. Let me briefly highlight some of the progress we've made across our businesses. Commercial execution was excellent across our global portfolio during the quarter, led once again by Greater China, where the commercial investments in our portfolio of established brands are generating meaningful growth.

Speaker #2: everyone. Good morning, 2026 earnings call. With us today is CEO Scott Smith, Interim CFO Paul Campbell, Chief R&D Officer Philippe Martin, and Chief Commercial Officer Corinne Goff.

Speaker #3: In the second quarter, we delivered 3.8 billion dollars in total revenues, representing 3.5% operational revenue growth year over year, adjusted EBITDA of 1.2 billion dollars, and adjusted EPS of 69 cents per share.

Speaker #3: These results exceeded our expectations and reflect the strong momentum across our businesses, and continued improvement in operating leverage. Just as importantly, these results give us confidence to raise our outlook for the remainder of the year.

Speaker #2: We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information.

Speaker #3: Let me briefly highlight some of the progress we've made across our businesses. Commercial execution was excellent across our global portfolio during the quarter, led once again by greater China, where the commercial investments in our portfolio of established brands are generating meaningful growth.

Speaker #3: In North America, execution across our complex generics and transdermal products also drove solid growth. Our pipeline has progressed as expected. As we announced last week, we received U.S.

Scott Smith: In North America, execution across our complex generics and transdermal products also drove solid growth. Our pipeline is progressing as expected. As we announced last week, we received US regulatory approval for Gwyn Lo and expect to launch the product later this year. At the same time, launch preparations continue for fast-acting meloxicam as it progresses through FDA review. We're confident in the differentiated clinical profiles of both medicines and also in our commercial readiness. In Japan, we recently reported phase III results for Nefecon, while Pitolisant continues to progress through the final stages of regulatory review, underscoring the momentum we're building across our pipeline in this strategically important market. Beyond these opportunities, our phase III programs for Selatogrel and Cenerimod remain on track with important readouts expected in 2027, which, if successful, we believe will represent meaningful long-term blockbuster growth opportunities.

Speaker #3: regulatory approval for Gwenlon, and expect to launch the product later this year. At the same time, launch preparations continue for Fast Acting Meloxicam as a progresses through FDA review, where confident in the differentiated clinical profiles of both medicines and also in our commercial readiness.

Speaker #3: Good morning, everyone. We're often exceptional start in 2026. We delivered another strong quarter that reinforces our confidence in the strategy we outlined quarter, we delivered 3.8 billion dollars in total revenues, representing 3.5% operational revenue growth year over year, adjusted EBITDA of 1.2 billion dollars, and adjusted EPS of 69 cents per share.

Speaker #3: In Japan, we recently reported phase 3 results for Nefcon, while Pitolisin continues to progress through the final stages of regulatory review, underscoring the momentum we're building across our pipeline in the strategically important market.

Speaker #3: Beyond these opportunities, our phase 3 programs for Celadon and Sanerma remain on track with important readouts expected in 2027, which, if successful, we believe will represent meaningful long-term blockbuster growth opportunities.

Speaker #3: Taken together, these milestones provide a robust set of near-term catalysts with the potential to accelerate our long-term growth profile. As we prepare for our next phase of growth, we're prioritizing our capital talent and resources toward the opportunities we believe offer the greatest long-term growth potential.

Scott Smith: Taken together, these milestones provide a robust set of near-term catalysts with the potential to accelerate our long-term growth profile. As we prepare for our next phase of growth, we're prioritizing our capital, talent, and resources toward the opportunities we believe offer the greatest long-term growth potential. As part of that effort, we agreed to sell the global rights to Tyrvaya, reflecting a strategic shift away from eye care as a therapeutic area of focus. Turning to our enterprise-wide strategic review, we're delivering the savings we committed to earlier this year while reinvesting a portion of those savings to support future growth. We're beginning to see those actions translate into the real operating leverage we expected. That's creating a stronger Viatris with greater flexibility to invest in growth and create long-term value. Turning to capital allocation, we continue to take a balanced and opportunistic approach.

Speaker #3: Let me briefly highlight some of the progress we've made across our businesses. Commercial execution was excellent across our global portfolio during the quarter. Led once again by greater China, where the commercial investments in our portfolio of established brands are generating meaningful growth.

Speaker #3: As part of that effort, we agreed to sell the global rates to Turvaya, reflecting a strategic shift away from eye care as a therapeutic area of focus.

Speaker #3: In North America, execution across our complex generics and transdermal products also drove solid growth. Our pipeline is progressing as expected. As we announced last week, we received U.S.

Speaker #3: Turning to our enterprise-wide strategic review, we're delivering the savings we committed to earlier this year, while reinvesting a portion of those savings to support future growth.

Speaker #3: Regulatory approval for Gwenlon is expected, and we anticipate launching the product later this year. At the same time, launch preparations continue for fast-acting meloxicam as it progresses through FDA review.

Speaker #3: We're beginning to see those actions translate into the real operating leverage we expected. That's creating a stronger Viatris with greater flexibility to invest in growth and create long-term value.

Speaker #3: We're confident in the differentiated clinical profiles of both readiness. In Japan, we recently reported phase three results for NEFCON, while Pitolisin continues to progress through the final stages of regulatory review, underscoring the momentum we're building across our pipeline in the strategically important market.

Speaker #3: Turning to capital allocation, we continue to take a balanced and opportunistic approach. Supported by strong cash generation and the additional financial flexibility created through the monetization of our Biocon equity stake, we're executing across all our capital allocation priorities.

Scott Smith: Supported by strong cash generation and the additional financial flexibility created through the monetization of our Biocon equity stake, we're executing across all our capital allocation priorities. We continue to return significant capital to shareholders through our dividend and more recently through our continued share repurchases, together totaling approximately $550 million to date. At the same time, we're maintaining flexibility to pursue disciplined business development opportunities that we believe can play a significant role in accelerating our long-term growth. As we think about our performance so far this year and the outlook for the rest of the year, we're raising the midpoint of our 2026 financial guidance ranges across all key financial metrics. Our updated outlook incorporates all the business dynamics we expect in the second half, including certain intermittent manufacturing disruptions at our Nashik facility following the Q1 fire and the FDA's May 2026 inspection.

Speaker #3: Beyond these opportunities, our phase three programs for Celadon and Sanerma remain on track with important readouts expected in 2027, which, if successful, we believe will represent meaningful long-term blockbuster growth opportunities.

Speaker #3: We continue to return significant capital to shareholders through our dividend and more recently through our continued share repurchases together totaling approximately 550 million dollars to date.

Speaker #3: At the same time, we're maintaining flexibility to pursue disciplined business development opportunities that we believe can play a significant role in accelerating our long-term growth.

Speaker #3: As we think about our performance so far this year and the outlook for the rest of the year, we're raising the midpoint of our 2026 financial guidance ranges across all key financial metrics.

Speaker #3: Our updated outlook incorporates all the business dynamics we expect in the second half, including certain intermittent manufacturing disruptions that are not facility following the Q1 fire and the FDA's May 2026 inspection.

Speaker #3: As part of that effort, we agreed to sell the global race to Turvaya, reflecting a strategic shift away from eye care as a therapeutic area of focus.

Speaker #3: Turning to our enterprise-wide strategic review, we're delivering the savings we committed to earlier this year, while reinvesting a portion of those savings to support future growth.

Speaker #3: We are communicating with the FDA working closely with external experts and have initiated a comprehensive remediation plan to address the inspection observations. In summary, I'm very pleased with our execution through the first half of the year and the momentum we're carrying into the second half.

Scott Smith: We are communicating with the FDA, working closely with external experts, and have initiated a comprehensive remediation plan to address the inspection observations.

Speaker #3: We're beginning to see those actions translate into the real operating leverage we expected. That's creating a stronger Viatris, with greater flexibility to invest in growth and create long-term value.

Scott Smith: In summary, I'm very pleased with our execution through H1 of the year and the momentum we're carrying into H2. We're entering a catalyst-rich period with multiple upcoming launches, important Phase III milestones, and the financial flexibility to pursue disciplined, accretive business development. Together, we believe these opportunities position Viatris to accelerate long-term growth and create meaningful value for shareholders. With that, I'll turn it over to Philippe.

Speaker #3: We're entering a catalyst-rich period with multiple upcoming launches, important phase 3 milestones, and the financial flexibility to pursue disciplined accretive business development. Together, we believe these opportunities position Viatris to accelerate long-term growth and create meaningful value for shareholders.

Speaker #3: With that, I'll turn it over to Philip.

Speaker #4: Thank you, Scott. We have Danny Berta, strong first half of the year in R&D as we continue to execute with discipline against our ur strategy.

Philippe Martin: Thank you, Scott. We have delivered a strong H1 of the year in R&D as we continue to execute with discipline against our strategy. Starting with our value-added medicines, we were pleased to receive FDA approval for Gwyn Lo last week ahead of its PDUFA date. Gwyn Lo is a new, discreet, once-weekly transdermal hormonal contraceptive patch that offers women a non-invasive, reversible option with a low dose of estrogen. Importantly, the approved label reflects the strength of our clinical program, including demonstrated efficacy in women with a BMI of 25 to less than 30 kg per square meter, with no BMI-based limitation of use for this population. We are also working on addressing the unmet need for women with a BMI at or above 30 through our next contraceptive transdermal system, a progestin-only patch currently in development.

Speaker #4: Starting with our value-added medicines, we were pleased to receive FDA approval for Gwenlon last week, ahead of its PDUFA date. Gwenlon is a new, discrete, once-weekly transdermal hormonal contraceptive patch that offers women an non-invasive reversible option with a low dose of estrogen.

Speaker #4: Importantly, the approved label reflects the strength of our clinical program, including demonstrated efficacy in women with a BMI of 25 to less than 30 kilogram per square meter, with no BMI-based limitation of use for this population.

Speaker #3: Our updated outlook incorporates all the business dynamics we expect in the second half, including certain intermittent manufacturing the Q1 fire and the FDA's May 2026 inspection.

Speaker #3: We are communicating with the FDA, working closely with external experts, and have initiated a comprehensive remediation plan to address the inspection observations. In summary, I'm very pleased with our execution through the first half of the year and the momentum we're carrying into the second half.

Speaker #4: We are also working on addressing the unmet need for women with a BMI at or above 30 through our next contraceptive transdermal system. The progestin-only patch currently in development.

Speaker #4: This program has completed phase 3 enrollment, and we expect top-line results in the first half of 2027. As patients continue to seek convenient and non-invasive treatment options, we believe our deep expertise in developing and manufacturing transdermal drug delivery systems positions us well to advance additional opportunities across this platform.

Philippe Martin: This program has completed Phase III enrollment, and we expect top-line results in H1 2027. As patients continue to seek convenient and non-invasive treatment options, we believe our deep expertise in developing and manufacturing transdermal drug delivery systems position us well to advance additional opportunities across this platform. Regarding Fast-Acting Meloxicam, we continue to have positive engagement with FDA as the NDA review progresses and as we approach the mid-cycle point of the review. We continue to believe that the investigational profile of Fast-Acting Meloxicam, including its rapid absorption, clinically meaningful pain relief, and reductions in opioid use, positions the product as a meaningful addition to the evolving acute pain treatment landscape and in final labeling negotiations ahead of an anticipated FDA approval.

Speaker #3: We're entering a catalyst-rich period with multiple upcoming launches, important phase three milestones, and the financial flexibility to pursue disciplined accretive business development. Together, we believe these opportunities position Viatris to accelerate long-term growth and create meaningful value for shareholders.

Speaker #3: With that, I'll turn it over to Philip.

Speaker #4: Regarding Fast Acting Meloxicam, we continue to have positive engagement with FDA. As the NDA review progresses and as we approach the mid-cycle point of the review, we continue to believe that the investigational profile of Fast Acting Meloxicam including its rapid absorption clinically meaningful pain relief and reduction in opioid use positions the product as a meaningful addition to the evolving acute pain treatment landscape.

Speaker #4: Thank you, Scott. We have Danny Berta, strong first half of the year in R&D as we continue to execute with discipline against our ur strategy.

Speaker #4: Starting with our value-added medicines, we were pleased to receive FDA approval for Gwenlon last week, ahead of its PDUFA date. Gwenlon is a new, discrete, once-weekly transdermal hormonal contraceptive patch that offers women a non-invasive, reversible option with a low dose of estrogen.

Speaker #4: Pending final labeling negotiations, ahead of an anticipated FDA approval. Regarding our pipeline in Japan, we recently announced positive top-line phase 3 results evaluating the efficacy and safety of Nefcon in Japanese adults with primary IgA nephropathy.

Philippe Martin: Regarding our pipeline in Japan, we recently announced positive top-line Phase III results evaluating the efficacy and safety of Nefecon in Japanese adult with primary IgA nephropathy, a designated intractable disease in Japan. If approved, Nefecon has the potential to provide a meaningful disease-modifying treatment option for these patients. We are targeting submission of a new drug application in Japan by the end of 2026. In addition, our applications for pitolisant for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy remain on track and have reached the final stages of review. We anticipate regulatory decisions for both indications in H2 of this year. Turning to our innovative global Phase III programs. For solriamet, we continue to expect results from both Phase III SLE studies, OPUS 1 and 2, in H1 2027.

Speaker #4: A designated intractable disease in Japan. If approved, Nefcon has the potential to provide a meaningful disease-modifying treatment option for these patients, with our targeting submission of a new drug application in Japan by the end of 2026.

Speaker #4: This program has completed phase three enrollment, and we expect top-line results in the first half of 2027. As patients continue to seek convenient and non-invasive treatment options, we believe our deep expertise in developing and manufacturing transdermal drug delivery systems positions us well to advance additional opportunities across this platform.

Speaker #4: In addition, our applications for Pitolisin for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy remain on track and have reached the final stages of review.

Speaker #4: We anticipate regulatory decisions for both indications in the second half of this year. Turning to our innovative global phase 3 programs. For Cinerimod, we continue to expect results from both phase 3 SLE studies Opus 1 and 2 in the first half of 2027.

Speaker #4: Regarding fast-acting meloxicam, we continue to have positive engagement with FDA. As the NDA review progresses and as we approach the mid-cycle point of the review, we continue to believe that the investigational profile of fast-acting meloxicam including its rapid absorption clinically meaningful pain relief and reduction in opioid use positions the product as a meaningful addition to the evolving acute pain treatment landscape.

Speaker #4: So far, most patients have elected to continue treatment in the open label extension study with a study treatment duration extending up to 5 years.

Philippe Martin: So far, most patients have elected to continue treatment in the open-label extension study with a study treatment duration extending up to five years. For filagral, we remain on track to reach full enrollment in our SOS MI phase III study around year-end and are maintaining an enrollment rate of approximately 1,200 patients per month. We continue to expect a data readout in H1 2027. Finally, turning to our generic pipeline. We continue to execute well across our pipeline and remain on track to achieve more than 100 new product approvals this year, with 70 approvals already secured in H1. The key area of focus remains our complex generics, including complex injectables, where we have established a meaningful expertise.

Speaker #4: Pending final labeling negotiations, ahead of an anticipated FDA approval. Regarding our pipeline in Japan, we recently announced positive top-line phase three results, evaluating the efficacy and safety of NEFECON in Japanese adults with primary IgA nephropathy.

Speaker #4: For Celadogrel, we remain on track to reach full enrollment in our SOS MI phase 3 study around year-end, and I'm maintaining an enrollment rate of approximately 1,200 patients per month.

Speaker #4: We continue to expect a data readout in the first half of 2027. And finally, turning to our generic pipeline, we continue to execute well across our pipeline and remain on track to achieve more than 100 new product approvals this year, with 70 approvals already secured in the first half.

Speaker #4: A designated intractable disease in Japan. If approved, NEFECON has the potential to provide a meaningful disease-modifying treatment option for these patients, with our targeting submission of a new drug application in Japan by the end of 2026.

Speaker #4: A key area of focus remains our complex generics, including complex injectables. Where we have established a meaningful expertise. Over the past 2 years, we have secured approval in the US for 11 complex injectables including Ocreotide, and recently were the first approved for all 3 strengths for both iron sucrose and ferric carboxymaltose injection.

Philippe Martin: Over the past two years, we have secured approval in the US for 11 complex injectables, including octreotide, and recently, we are the first approved for all three strengths for both iron sucrose and ferric carboxymaltose injection. Overall, the substantial progress we've made in H1 reflects both the disciplined execution of our teams and the breadth of capabilities we've built. With multiple regulatory, clinical, and scientific milestones ahead, we remain confident in our ability to execute our R&D strategy, advance meaningful medicines for patients, and continue strengthening our scientific leadership. With that, I'll turn it over to Paul.

Speaker #4: We anticipate regulatory decisions for both indications in the second half of this year. Turning to our innovative global phase three programs. For scenario mode, we continue to expect results from both phase three SLE studies Opus 1 and 2 in the first half of 2027.

Speaker #4: Overall, the substantial progress we've made in the first half of the year reflects both the discipline execution of our teams and the breadth of capabilities we've built.

Speaker #4: So far, most patients have elected to continue treatment in the open label extension study with a study treatment duration extending up to five years.

Speaker #4: With multiple regulatory clinical and scientific milestones ahead, we remain confident in our ability to execute our R&D strategy, advance meaningful medicines for patients, and continue strengthening our scientific leadership.

Speaker #4: For Celadogrel, we remain on track to reach full enrollment in our SOS MI phase three study around year-end, and I'm maintaining an enrollment rate of approximately 1,200 patients per month.

Speaker #4: With Paul.

Speaker #2: Thank you, Philip, and good morning, everyone. I'm pleased to report that we deliver another strong quarter. Reflecting the durability of our global portfolio and disciplined execution of our strategy.

Paul Campbell: Thank you, Philippe, and good morning, everyone. I'm pleased to report that we delivered another strong quarter, reflecting the durability of our global portfolio and disciplined execution of our strategy. This morning, I'll highlight the drivers of this strong Q2 performance, the progress we've made delivering on our capital allocation priorities, and details supporting our financial guidance raise for the year. Beginning with our Q2 results. Total revenues were $3.8 billion, representing operational growth of approximately 3.5% year over year. This performance was driven primarily by continued growth in our cardiovascular portfolio in Greater China and strong performance across our generics product category in developed markets, led primarily by our complex generics and transdermal products in North America. The commercial highlights for the quarter across each of our segments is as follows. In developed markets, net sales increased by 2% versus the prior year, exceeding our expectations.

Speaker #2: This morning, I'll highlight the drivers of this strong second quarter performance: the progress we've made delivering on our capital allocation priorities and detailed supporting our financial guidance raise for the year.

Speaker #4: The key area of focus remains our complex generics, including complex injectables. Where we have established a meaningful expertise. Over the past two years, we have secured approval in the US for 11 complex injectables including Ocreotide, and recently were the first approved for all three strengths for both iron sucrose and ferric carboxymaltose injection.

Speaker #2: Beginning with our second quarter results, total revenues were 3.8 billion dollars, representing operational growth of approximately 3.5% year over year. This performance was driven primarily by continued growth in our cardiovascular portfolio and greater China, and strong performance across our generics product category and developed markets.

Speaker #4: Overall, the substantial progress we've made in the first half of the year reflects both the discipline execution of our teams and the breadth of capabilities we've built.

Speaker #2: Led primarily by our complex generics and transdermal products in North America. The commercial highlights for the quarter across each of our segments is as follows.

Speaker #2: In developed markets, net sales increased by 2% versus the prior year exceeding our expectations. For North America, net sales grew 1%, driven by increased demand across our diverse generics portfolio.

Paul Campbell: For North America, net sales grew 1%, driven by increased demand across our diverse generics portfolio, including estradiol patches, as well as continued strength from Breyna. New product revenues also benefited from continued momentum across our more durable, higher margin complex injectable portfolio, including octreotide and iron sucrose. Within our branded product category, solid growth from YUPELRI was more than offset by anticipated competitive pressure within our established brands portfolio. In Europe, net sales increased 2% versus the prior year, primarily driven by strength in the generics portfolio across key countries, including France and Italy, as well as contributions from new product revenues. The brands portfolio declined slightly year over year as continued solid growth from Creon and Brufen was offset by anticipated competitive pressure on Dymista. Turning to emerging markets. Net sales declined 2% versus the prior year, coming in below our expectations.

Speaker #4: With that, I'll turn it over to Paul.

Speaker #2: Including estradiol patches, as well as continued strength from Brainot. New product revenues also benefited from continued momentum across our more durable, higher-margin complex injectable portfolio, including Ocreotide and iron sucrose.

Speaker #2: Within our branded product category, solid growth from Yupelri was more than offset by anticipated competitive pressure within our established brands portfolio. In Europe, net sales increased 2% versus the prior year, primarily driven by strength in the generics portfolio across key countries including France and Italy, as well as contributions from new product revenues.

Speaker #2: Beginning with our second quarter results, total revenues were $3.8 billion, representing operational growth of approximately 3.5% year over year. This performance was driven primarily by continued growth in our cardiovascular portfolio and Greater China, and strong performance across our generics product category and developed markets.

Speaker #2: The brands portfolio declined slightly year over year as continued solid growth from Creon and Brufen was offset by anticipated competitive pressure on Dymista. Turning to emerging markets, net sales declined 2% versus the prior year, coming in below our expectations.

Speaker #2: Led primarily by our complex generics and transdermal products in North America. The commercial highlights for the quarter across each of our segments are as follows:

Speaker #2: In developed markets, net sales increased by 2% versus the prior year, exceeding our expectations. For North America, net sales grew 1%, driven by increased demand across our diverse generics portfolio.

Speaker #2: The decline was primarily driven by continued supply constraints affecting our lower-margin ARV generics portfolio. Net sales in our brand product category increased 6% year over year, supported by stable growth across established brands.

Paul Campbell: The decline was primarily driven by continued supply constraints affecting our lower margin ARV generics portfolio. Net sales in our brand product category increased 6% year over year, supported by stable growth across established brands. Within JANZ, net sales were essentially flat versus the prior year, exceeding our expectations. This result reflects uptake from the launch of Effexor for generalized anxiety disorder and broad volume growth in generics, offset by the anticipated impact from government-driven price regulations in Japan and increased competition for certain brands in Australia. Lastly, we delivered another exceptional quarter in Greater China, with net sales increasing 16% year over year, once again ahead of our expectations. We continue to benefit from favorable market fundamentals in China, including an aging population and demand for our cardiovascular products.

Speaker #2: Including estradiol patches, as well as continued strength from BRANA. New product revenues also benefited from continued momentum across our more durable, higher-margin complex injectable portfolio, including Ocreotide and iron sucrose.

Speaker #2: Within JANZ, net sales were essentially flat versus the prior year, exceeding our expectations. This result reflects uptake from the launch of Effexor for generalized anxiety disorder and broad-volume growth in generics, offset by the anticipated impact from government-driven price regulations in Japan and increased competition for certain brands in Australia.

Speaker #2: Lastly, we deliver another exceptional quarter in greater China, with net sales increasing 16% year over year, once again ahead of our expectations. We continue to benefit from favorable market fundamentals in China including an aging population and demand for our cardiovascular products.

Speaker #2: The brands portfolio declined slightly year over year, as continued solid growth from Creon and Brufen was offset by anticipated competitive pressure on Dymista. Turning to emerging markets, net sales declined 2% versus the prior year, coming in below our expectations.

Speaker #2: In addition, our strategic investments in selling and marketing capabilities, including our e-commerce and retail platforms, have positioned us to capitalize on the strength of our well-recognized brands.

Paul Campbell: Our strategic investments in selling and marketing capabilities, including our e-commerce and retail platforms, have positioned us to capitalize on the strength of our well-recognized brands. We saw growth across all channels during the quarter, including e-commerce, where sales increased 36% versus the prior year. Now turning to the remainder of the P&L. Adjusted gross margin was 57.5% for the quarter, representing nearly 1% improvement versus the prior year. The increase was driven primarily by the strong performance in Greater China and the favorable product mix in our North American generics portfolio, as mentioned earlier. Operating expenses declined as a percentage of total revenues compared with the prior year, partially reflecting continued SG&A discipline and realization of the expected savings from our enterprise-wide strategic review. R&D investment progressed in line with our expectations, driven primarily by the ongoing phase III programs for Selatogrel and Cenerimod.

Speaker #2: As a result, we saw growth across all channels during the quarter, including e-commerce, where sales increased 36% versus the prior year. Now turning to the remainder of the P&L.

Speaker #2: Adjusted gross margin was 57.5% for the quarter. Representing nearly 1% improvement versus the prior year. The increase was driven primarily by the strong performance in greater China and the favorable product mix, in our North American generics portfolio, as mentioned earlier.

Speaker #2: Operating expenses declined as a percentage of total revenues compared with the prior year, partially reflecting continued SG&A discipline and realization of the expected savings from our enterprise-wide strategic review.

Speaker #2: Offset by the anticipated impact from government-driven price regulations in Japan, and increased competition for certain brands in Australia. Lastly, we deliver another exceptional quarter in greater China, with net sales increasing 16% year over year, once again ahead of our expectations.

Speaker #2: R&D investment progressed in line with our expectations, driven primarily by the ongoing phase 3 programs for Sildenafil and Syneramod. For free cash flow, we generated 329 million dollars of cash during the quarter.

Speaker #2: We continue to benefit from favorable market fundamentals in China, including an aging population and demand for our cardiovascular products. In addition, our strategic investments in selling and marketing capabilities, including our e-commerce and retail platforms, have positioned us to capitalize on the strength of our well-recognized brands.

Paul Campbell: For free cash flow, we generated $329 million of cash during the quarter, inclusive of transaction and restructuring-related costs and taxes. Excluding these items, free cash flow would have been $449 million. The year-over-year improvement was primarily driven by stronger operating performance and favorable working capital dynamics. Turning to capital allocation. Through early August, we have deployed approximately $1.4 billion of capital, consistent with our balanced capital allocation strategy, including the return of approximately $550 million of capital to shareholders through dividends and approximately $270 million of share repurchases. We continued to strengthen our balance sheet by repaying approximately $900 million of debt that matured in June while refinancing the remaining balance. We ended the quarter with a gross leverage ratio of approximately 2.9 times, below the midpoint of our long-term target range of 2.8 to 3.2 times.

Speaker #2: Inclusive of transaction and restructuring-related costs and taxes. Excluding these items, free cash flow would have been 449 million dollars. The year-over-year improvement was primarily driven by stronger operating performance and favorable working capital dynamics.

Speaker #2: As a result, we saw growth across all channels during the quarter, including e-commerce, where sales increased 36% versus the prior year. Now turning to the remainder of the P&L.

Speaker #2: Turning to capital allocation, through early August, we have deployed approximately 1.4 billion dollars of capital consistent with our balanced capital allocation strategy, including the return of approximately 550 million dollars of capital to shareholders.

Speaker #2: Adjusted gross margin was 57.5% for the quarter. Representing nearly 1% improvement versus the prior year. The increase was driven primarily by the strong performance in greater China, and the favorable product mix, in our North American generics portfolio, as mentioned earlier.

Speaker #2: Through dividends and approximately 270 million dollars of share reverses. Additionally, we continued to strengthen our balance sheet by repaying approximately 900 million dollars of debt that matured in June, while refinancing the remaining balance.

Speaker #2: As a result, we ended the quarter with a gross leverage ratio of approximately 2.9 times. Below the midpoint of our long-term target range of 2.8 to 3.2 times.

Speaker #2: R&D investment progressed in line with our expectations, driven primarily by the ongoing Phase 3 programs for Saladogro and Saneramod. For free cash flow, we generated $329 million of cash during the quarter.

Speaker #2: For the remainder of the year, we expect to have approximately 1.6 billion dollars in deployable capital. This includes approximately 380 million dollars of pre-tax proceeds from the sale of our equity stake in Biocon.

Paul Campbell: For the remainder of the year, we expect to have approximately $1.6 billion in deployable capital. This includes approximately $380 million of pre-tax proceeds from the sale of our equity stake in Biocon. Now a few comments on our updated financial guidance and phasing for the remainder of the year. Based primarily on our strong H1 performance and our continued confidence in the momentum of our businesses, we are raising our 2026 financial guidance for all key metrics. The midpoint of each of our revised guidance ranges represents expected operational growth of approximately 2% for total revenues, 5% for adjusted EBITDA, and 7% for adjusted EPS versus the prior year. To provide further visibility into the segments, our updated full year guidance for total revenues reflects the following expectations compared to the prior year. Low double-digit growth in Greater China. Developed markets roughly flat, with North America declining slightly.

Speaker #2: Now a few comments on our updated financial guidance and phasing for the remainder of the year. Based primarily on our strong first half performance and our continued confidence in the momentum of our businesses, we are raising our 2026 financial guidance for all key metrics.

Speaker #2: Turning to capital allocation, through early August, we have deployed approximately 1.4 billion dollars of capital, consistent with our balanced capital allocation strategy, including the return of approximately 550 million dollars of capital to shareholders.

Speaker #2: The midpoint of each of our revised guidance ranges represents expected operational growth of approximately 2% for total revenues, 5% for adjusted EBITDA, and 7% for adjusted EPS versus the prior year.

Speaker #2: Through dividends and approximately 270 million dollars of share purchases. Additionally, we continued to strengthen our balance sheet by repaying approximately 900 million dollars of debt, that matured in June, while refinancing the remaining balance.

Speaker #2: To provide further visibility into the segments, our updated full-year guidance for total revenues reflects the following expectations compared to the prior year. Low double-digit growth in greater China, developed markets roughly flat with North America declining slightly, low single-digit growth in emerging markets, and low single-digit decline in JANZ.

Speaker #2: As a result, we ended the quarter with a gross leverage ratio of approximately 2.9 times, below the midpoint of our long-term target range of 2.8 to 3.2 times.

Paul Campbell: Low single-digit growth in emerging markets, low single-digit decline in JANZ. In addition, this takes into account the following expected H2 dynamics. Moderation in Greater China growth due to the implementation of a procurement policy change expected to negatively impact volumes in our hospital chain. Additional competitive pressure in developed markets, including for Breyna and Rexulti in North America, additional expected supply disruptions primarily resulting from our Nashik facility and primarily impacting our low-margin oral solid dose generics in emerging markets and certain generic products in Europe. We currently anticipate the impact of supply disruptions to be between $100 million and $150 million to total revenues in H2 2026. Lastly, as Scott mentioned, we reached an agreement to divest our global product rights for Tyrvaya. The transaction is expected to close in H2 2026, subject to customary closing conditions.

Speaker #2: In addition, this takes into account the following expected second half dynamics. Moderation in greater China growth due to the implementation of a procurement policy change expected to negatively impact volumes in our hospital channel.

Speaker #2: Additional competitive pressure in developed markets, including for Brina and Roxella in North America. And additional expected supply disruptions primarily resulting from our Naushik facility and primarily impacting our low-margin oral solid dose generics in emerging markets and certain generic products in Europe.

Speaker #2: Now, a few comments on our updated financial guidance and phasing for the remainder of the year. Based primarily on our strong first-half performance and our continued confidence in the momentum of our businesses, we are raising our 2026 financial guidance for all key metrics.

Speaker #2: We currently anticipate the impact of supply disruptions to be between 100 and 150 million dollars to total revenues in the second half of 2026.

Speaker #2: Lastly, as Scott mentioned, we reached an agreement to divest our global product rights for Tiruvaya. The transactions expected to close in the second half of 2026, subject to customary closing conditions.

Speaker #2: To provide further visibility into the segments, our updated full-year guidance for total revenues reflects the following expectations compared to the prior year: low double-digit growth in Greater China, developed markets roughly flat with North America declining slightly, low single-digit growth in emerging markets, and a low single-digit decline in JANZ.

Speaker #2: The anticipated impact of this transaction has been fully considered in our updated 2026 financial guidance. Turning to phasing for the remainder of the year, total revenues are expected to be weighted to the second half at approximately 51% of our full-year output.

Paul Campbell: The anticipated impact of this transaction has been fully considered in our updated 2026 financial guidance. Turning to phasing for the remainder of the year. Total revenues are expected to be weighted to H2 at approximately 51% of our full-year outlook. Adjusted EBITDA and adjusted EPS are now expected to be slightly lower in H2, and free cash flow is still expected to be more heavily weighted to H2. In closing, we are pleased with our performance through H1, reflecting strong execution against our strategy. As we look ahead, we believe our diversified portfolio, strong commercial execution, and financial flexibility positions us well to deliver sustainable revenue and earnings growth. With that, I will hand it back to the operator to begin the Q&A.

Speaker #2: Adjusted EBITDA and adjusted EPS are now expected to be slightly lower in the second half, and free cash flow is still expected to be more heavily weighted to the second half.

Speaker #2: In closing, we are pleased with our performance to the first half of the year, reflecting strong execution against our strategy. As we look ahead, we believe our diversified portfolio, strong commercial execution, and financial flexibility positions us well to deliver sustainable revenue and earnings growth.

Speaker #2: Additional competitive pressure in developed markets, including for Brainia and Nexela in North America. And additional expected supply disruptions, primarily resulting from our Naushik facility and primarily impacting our low-margin oral solid dose generics in emerging markets, as well as certain generic products in Europe.

Speaker #2: With that, I'll hand it back to the operator to begin the Q&A.

Speaker #2: We currently anticipate the impact of supply disruptions to be between 100 and 150 million dollars to total revenues in the second half of 2026.

Speaker #1: We will now begin the question and answer session. To ask a question, you may press star and then 1 on your touchstone phones. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

Operator: We will now begin the question and answer session. To ask a question, you may press star and then one on your touch-tone phones. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your questions, you may press star and two. Again, that is star and then one to join the question queue. We will pause momentarily to assemble the roster. Our first question today comes from Ash Verma from UBS. Please go ahead with your question.

Speaker #1: To withdraw your questions, you may press star and 2. Again, that is star and then 1 to join the question queue. We'll pause momentarily to assemble the roster.

Speaker #1: Our first question today comes from Ash Verma from UBS. Please go ahead with your question.

Speaker #3: Okay. Yep. Thanks for taking our questions. Congrats on the progress. Maybe just on China, it's so great to see solid operational growth here that you've seen in the first two quarters.

Ash Verma: Okay. Yeah, thanks for taking our questions. Congrats on the progress. Maybe just on China. Great to see solid operational growth here that you have seen in the first two quarters. I know you have noted e-commerce has been a big source of growth. Just help us understand what percentage of your revenue right now is coming from e-commerce, retail, or the government channel, where I know you mentioned some headwinds on the procurement in the hospital channel. If you can just give us a little bit of a breakdown, that would be helpful. Secondly, just to help us understand the guidance. At the midpoint of 2026 guide, you are raising revenue by $50 million, but EBITDA by $100 million. Is this because you are expecting some very high-margin products to launch, or is there a chance that your reiterated OpEx guides come towards the lower end? Thanks.

Speaker #2: Adjusted EBITDA and adjusted EPS are now expected to be slightly lower in the second half, and free cash flow is still expected to be more heavily weighted to the second half.

Speaker #3: I know you've noted e-commerce has been a big source of growth. Just help us understand what percentage of your revenue right now is coming from e-commerce, retail, or the government channel, where I know you mentioned some headwinds on the procurement in the hospital channel.

Speaker #2: In closing, we are pleased with our performance through the first half of the year, reflecting strong execution against our strategy. As we look ahead, we believe our diversified portfolio, strong commercial execution, and financial flexibility positions us well to deliver sustainable revenue and earnings growth.

Speaker #3: So if you can just give us a little bit of a breakdown, that would be helpful. And then secondly, just help us understand the guidance.

Speaker #3: So at the midpoint of 2026 guide, you're raising revenue by 50 million, but EBITDA by 100 million. Is this because you're expecting some very high-margin products to launch, or is there a chance that your retailer OPEX guides come towards the lower end?

Speaker #2: With that, I'll hand it back to the operator to begin the Q&A.

Speaker #1: We will now begin the question and answer session. To ask a question, you may press star and then one on your touchstone phones. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

Speaker #3: Thanks.

Speaker #4: Good. So thank you. Good morning, Ash, and thank you for the questions. Let me make some comments. I'll kick it over to Paul for some more detail.

Paul Campbell: Good. Thank you. Good morning, Ash, and thank you for the questions. Let me make some comments. I'll kick it over to Paul for some more detail. Relative to China, a really strong quarter for China. Our commercial team, I believe, is doing an outstanding job. I think we've got great leadership there. We've made the right investments in China and are participating very well in healthcare in China. There's a real focus right now in China on healthcare quality of life. There's a sizable aging middle class, et cetera, which really allows us to participate strongly in China. We're very pleased with the progress there. We continue to see what I believe is real and strong demand for the iconic brands that we have in China, which is really nice to see.

Scott Smith: Good. Thank you. Good morning, Ash, and thank you for the questions. Let me make some comments. I'll kick it over to Paul for some more detail. Relative to China, a really strong quarter for China. Our commercial team, I believe, is doing an outstanding job. I think we've got great leadership there. We've made the right investments in China and are participating very well in healthcare in China. There's a real focus right now in China on healthcare quality of life. There's a sizable aging middle class, et cetera, which really allows us to participate strongly in China. We're very pleased with the progress there. We continue to see what I believe is real and strong demand for the iconic brands that we have in China, which is really nice to see.

Speaker #4: Relative to China, a really strong quarter for China. Our commercial team, I believe, is doing an outstanding job. I think we've got great leadership there.

Speaker #1: To withdraw your questions, you may press star and two. Again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster.

Speaker #4: We've made the right investments in China. And our participating very, very well in healthcare in China. There's a real focus right now in China on healthcare quality of life.

Speaker #1: Our first question today comes from Ash Verma from UBS. Please go ahead with your question.

Speaker #4: There's a sizable aging middle class, etc., which really allows us to participate strongly in China. We're very, very pleased. But the progress there. And we've continued to see what I believe is real and strong demand for the economic brands that we have in China, which is really nice to see.

Speaker #3: Okay. Yeah, thanks for taking a questions. Congrats on the progress. Maybe just on China, so great to see solid operational growth here that you've seen in the first two quarters.

Speaker #4: Relative to the guidance, very pleased. Based on the strength of the first half and the strength that we see throughout the rest of the year, being able to raise guidance on all our key financial metrics and I think we're in really good shape as we sit here in August in '26 and are moving towards the second half of '26 and '27.

Paul Campbell: Relative to the guidance, very pleased, based on the strength of the H1 and the strength that we see throughout the rest of the year, being able to raise guidance on all our key financial metrics. I think we're in really good shape as we sit here in August 2026 and are moving towards the H2 2026 and 2027 and feel very good about the strength of the business. Now, I'll kick it over to Paul to comment specifically on China and also the guidance.

Scott Smith: Relative to the guidance, very pleased, based on the strength of the H1 and the strength that we see throughout the rest of the year, being able to raise guidance on all our key financial metrics. I think we're in really good shape as we sit here in August 2026 and are moving towards the H2 2026 and 2027 and feel very good about the strength of the business. Now, I'll kick it over to Paul to comment specifically on China and also the guidance.

Speaker #3: So if you can just give us a little bit of a breakdown, that would be helpful. And then secondly, just help us understand the guidance.

Speaker #4: And feel very, very good about the strength of the business. Now, I'll kick it over to Paul to comment specifically on China and also the guidance.

Speaker #2: Yeah, thanks. Thanks, Ash. So as far as China goes, I think it's important to note that we have seen growth across all channels. In the market, not just the retail platform or e-commerce.

Paul Campbell: Yeah, thanks. Thanks, Ash. As far as China goes, I think it's important to note that we have seen growth across all channels in the market, not just the retail platform or e-commerce. However, e-commerce is between 10% and 15% of the overall business, which is specifically why I know you didn't ask, in the H2 of the year, we expect some decline in the hospital channel growth as a result of the implementation of the policy. We do expect, I think in the Q1, we said it was too early. We do expect the growth overall to continue similar to the trajectory we saw in the H1. It's just going to be muted because of the policy issue. As far as the guidance goes, we ran ahead of expectations for the H1, both revenue and EBITDA.

Speaker #3: Thanks.

Speaker #4: Good. So thank you. Good morning, Ash, and thank you for the questions. Let me make some comments. I'll kick it over to Paul for some more detail.

Speaker #2: However, e-commerce is about between 10 and 15 percent of the overall business. Which is specifically why I know you didn't ask, but in the second half of the year, we expect some decline in the hospital channel growth as a result of the implementation of the policy.

Speaker #4: Relative to China, a really strong quarter for China. Our commercial team, I believe, is doing an outstanding job. I think we've got great leadership there.

Speaker #4: We've made the right investments in China. And our participating very, very well in healthcare in China. There's a real focus right now in China on healthcare quality of life.

Speaker #2: But we do expect I think in first quarter, expect the growth overall to continue similar to the trajectory we saw in the first half.

Speaker #2: It's just going to be muted because of the policy issue. As far as the guidance goes, so we ran ahead of expectations for the first half, both revenue and EBITDA.

Speaker #2: Adjusted EBITDA was approximately twice the growth or the increase in expectation over revenue, right? And a lot of that is because of the cost containment measures are on track and even ahead of schedule in certain instances.

Paul Campbell: Adjusted EBITDA was approximately twice the growth or the increase in expectation over revenue, right? A lot of that is because of the cost containment measures are on track and even ahead of schedule in certain instances. However, in the H2 of the year, we do see the challenges on the additional competition that we have in the North America products, which are high margin, and the China business, which is high margin, kind of muting that. If you also think about the revenue challenges from Nashik that we've talked about, the H2 of the year, they're lower margin generic products that are impacted. The revenue component of the guidance, we had to mute a little bit because of that, whereas EBITDA ran pretty strong in the H1 of the year.

Speaker #4: And feel very, very good about the strength of the business now. I'll kick it over to Paul to comment specifically on China and also the guidance.

Speaker #2: However, in the back half of the year, we do see the challenges on the additional competition that we have in the North America products, which are high margin, and the China business, which is high margin, kind of muting that.

Speaker #2: Yeah, thanks. Thanks, Ash. So as far as China goes, I think it's important to note that we have seen growth across all channels in the market, not just the retail platform or e-commerce.

Speaker #2: But if you also think about the revenue challenges from Nashik that we've talked about the back half of the year, they're lower margin generic products that are impacted.

Speaker #2: However, e-commerce is about 10 between 10 and 15 percent of the overall business. Which is specifically why I know you didn't ask, but in the second half of the year, we expect some decline in the hospital channel growth as a result of the implementation of the policy.

Speaker #2: So the revenue component of the guidance we had to mute a little bit because of that. Whereas EBITDA ran pretty strong in the first half of the year and even with the challenges in the second half of the year, we expect that that will for the full year exceed the midpoint to where we put it compared to revenue.

Paul Campbell: Even with the challenges in the H2 of the year, we expect that that will, for the full year, exceed the midpoint to where we put it, compared to revenue.

Speaker #2: But we do expect I think in first quarter, we said it was too early. We do expect the growth overall to continue similar to the trajectory we saw in the first half.

Speaker #4: Paul, hit on a I think an issue that I think it's good for us to expand on a little bit. And that's the enterprise-wide strategic review, which we've engaged in taking a look at the company, making sure we got the resources in the right place.

Scott Smith: Paul hit on an issue that is good for us to expand on a little bit, and that's the enterprise-wide strategic review, which we've engaged in, taking a look at the company, making sure we got the resources in the right place and we're executing that, we're delivering on that, and from that, we're seeing real EBITDA leverage here for the Q2 in a row. We're very pleased with the outcome of that particular enterprise-wide strategic review.

Speaker #2: It's just going to be muted because of the policy issue. As far as the guidance goes, so we ran a head of expectations for the first half, both revenue and EBITDA.

Speaker #4: And we're executing that. We're delivering on that. And from that, we're seeing real EBITDA leverage here. For the second quarter in a row. So we're very pleased with the outcome of that, particular enterprise-wide strategic review.

Speaker #2: Adjusted EBITDA was approximately twice the growth or the increase in expectation over revenue, right? And a lot of that is because of the cost containment measures.

Speaker #1: Our next question comes from Omer Ratiff from Evercore. Please go ahead with your question.

Operator: Our next question comes from Umer Raffat from Evercore. Please go ahead with your question.

Speaker #2: Our on track and even ahead of schedule in certain instances, however, in the back half of the year, we do see the challenges on the additional competition that we have in are high margin.

Speaker #5: Hi guys. Thanks for taking my question. I just wanted to ask a three-part question on Celadogrell, if I may. First, at what point in the patient's journey post an event are they initiating an oral antiplatelet?

Umer Raffat: Hi, guys. Thanks for taking my question. I just wanted to ask a three-part question on seladelpar, if I may. First, at what point in the patient's journey post an event are they initiating an oral antiplatelet? I understand in the trial, if you're on an active arm, you'll be on seladelpar perhaps right away. At what point, once you're in the hospital after the index event, are you initiating an oral antiplatelet, number one? Which sort of leads me into my second part, which is, I know what the half-life is, but what's the off time where no more platelet inhibition's in place? I ask because if I go by your EC50, which is 14 nanomolars, it looks like the 16-mg dose doesn't get to that EC50 until 8 to 10 hours post the dosing.

Speaker #2: And the China business, which is high margin, is kind of muting that. But if you also think about the revenue challenges from Nashik that we've talked about in the back half of the year, they're lower margin generic products that are impacted.

Speaker #5: I understand in the trial, if you're on an active arm, you'll be on Celadogrell perhaps right away. But at what point, once you're in the hospital, after the index event, are you initiating an oral antiplatelet, number one?

Speaker #5: Which sort of leads me into my second part, which is what I know what the half-life is, but what's the off time where no more platelet inhibition is in place?

Speaker #5: And I ask because if I go by your EC50, which is, I think, 14 nanomolars it looks like the 16-meg dose doesn't get to that EC50 until 8 to 10 hours post the dosing.

Speaker #5: And then finally, for patients that do end up needing a more intensive procedure like a CABG, I guess how is that being handled in the trial in terms of how they're taken out of the blood thinner or the timing post initial Celadogrell administration?

Umer Raffat: Finally, for patients that do end up needing a more intensive procedure like a CABG, I guess, how is that being handled in the trial in terms of how they're taking all the blood thinner or the timing post initial seladelpar administration? Thank you.

Speaker #5: Thank you.

Speaker #4: Hey, Omer. Before we get to answer the technicalities of your question, first of all, good morning and thank you for the question. We're really excited about Celadogrell.

Scott Smith: Umer, before we get to answer the technicalities of your question, first of all, good morning, and thank you for the question. We're really excited about seladelpar. We expect the readout when we get into H1 2027 on this. We've enrolled a lot of patients. Philippe can give you some context on that, and I think we've been very, very pleased with the execution and enrollment and progress of this particular trial. If positive, we see real blockbuster opportunities for seladelpar here and a major expansion. I say the same thing for Cenerimod. There's a lot of attention on seladelpar, which is great, very unique product. We're also really excited about the progress, execution, and the potential of Cenerimod as well. We really appreciate the question.

Speaker #4: We expect the readout when we get into the first half of '27 on this. We've enrolled a lot of patients Philippe can give you some context on that.

Speaker #1: Our next question comes from Omer Ratiff from Evercore. Please go ahead with your question.

Speaker #5: Hi guys. Thanks for taking my question. I just wanted to ask a three-part question on Selado Grow, if I may. First, at what point in the patient's journey post an event, are they initiating an oral antiplatelet?

Speaker #4: And I think we've been very, very pleased with the execution and enrollment and progress of this particular trial. We see if positive, we see real blockbuster opportunities for Celadogrell here and major expansion.

Speaker #4: I say the same thing for SonaraMod. There's a lot of attention on Celadogrell, which is great. Very unique product, but we're also really excited about the progress execution.

Speaker #5: I understand in the trial, if you're on an active arm, you'll be on Selado Grow, perhaps right away. But at what point, once you're in the hospital, after the index event, are you initiating an oral antiplatelet, number one?

Speaker #4: And the potential of SonaraMod as well. So we really appreciate the question. Love talking about new interesting products that can help drive our revenue future.

Speaker #5: Which sort of leads me into my second part, which is what I know what the half-life is, but what's the off time where no more platelet inhibition is in place?

Scott Smith: Love talking about new, interesting products that can help drive our revenue future. Let me kick it over to Philippe to give you some context.

Speaker #4: And let me kick it over to Philippe to give you some context.

Speaker #5: And I ask because if I go by your EC50, which is, I think, 14 nanomolars it looks like the 16-meg dose doesn't get to that EC50 until 8 to 10 hours post the dosing.

Speaker #6: Thanks, Scott. And thank you, Omer, for the question. So patients that are on the study, the vast majority are on dual antiplatelet therapy to begin with.

Philippe Martin: Thanks, Scott, and thank you, Umer, for the question. Patients that are on the study, the vast majority are on dual antiplatelet therapy to begin with. They're already on an oral clopidogrel for the most part is what we expect to see. While seladelpar is added on top of that. Now for those that are not necessarily on it, they could be post-treatment within 24 hours or so, the effect of seladelpar is no longer present, and therefore, treatment with an oral P2Y12 could be initiated at that point in time should it be required. With regards to the offset, as I said, I think we know that within 6 to 7 hours, we get to peak platelet inhibition, 80% platelet inhibition after 15 minutes, or more than 80% after 15 minutes is what we've seen in phase II.

Speaker #5: And then finally, for patients that do end up needing a more intensive procedure like a CABG, I guess how is that being handled in the trial in terms of how they're taking out the blood thinner or the timing post initial Selado Grow administration?

Speaker #6: So they're already on an oral clopidogrel for the most part is what we expect to see so that while Celadogrell is added on top of that.

Speaker #5: Thank you.

Speaker #4: Hey Omer, before we get to answer the technicalities of your question, first of all, good morning and thank you for the question. We're really excited about Selado Grow, we expect the readout and when we get into the first half of '27 on this, we've enrolled a lot of patients Philippe can give you some context on that.

Speaker #6: Now, for those that are not necessarily on it, they could be post-treatment within 24 hour or so the effect of Celadogrell is no longer present.

Speaker #6: And therefore, treatment with an oral P2Y12 could be initiated at that point in time should it be required. With regards to the offset as I said, I think we know that within six to seven hours, we get to peak platelet inhibition.

Speaker #4: I say the same thing for SonaraMod. There's a lot of attention on Selado Grow, which is great. Very unique product, but we're also really excited about the progress execution and the potential of SonaraMod as well.

Speaker #6: 80% platelet inhibition after 15 minutes or more than 80% after 15 minutes is what we've seen in phase two. The offset is, as I said, within 24 hours, Celadogrell is no longer present.

Speaker #4: So we really appreciate the question. Love talking about new interesting products that can help drive our revenue future. And let me kick it over to Philippe to give you some context.

Philippe Martin: The offset is, as I said, within 24 hours, seladelpar is no longer present. In terms of the CABG, I think CABG can be initiated at any point should it be deemed required. It is the current guidelines. There is no need to wait if it is deemed urgent. That being said, again, within post 8 hours post seladelpar injection, CABG can be initiated safely. Again, it is not a requirement to wait.

Speaker #3: Thanks, Scott. And thank you, Omer, for the question. So patients that are on the study, the vast majority are on dual antiplatelet therapy to begin with.

Speaker #6: Now, in terms of the CABG, I think CABG can be initiated at any point should it be required. Should it begin required, it's the current guidelines.

Speaker #3: So they're already on an oral clopidogrel for the most part, which is what we expect to see, so that while Selado Grow is added on top of that.

Speaker #6: There's no need to wait if it is deemed urgent. But that being said, again, within the post-eight hours CABG post-eight hour post-Celadogrell injection CABG can be initiated safely.

Speaker #3: Now, for those that are not necessarily on it, they could be post-treatment. Within 24-hour or so the effect of Selado Grow is no longer present.

Speaker #6: Again, it is not a requirement to wait.

Speaker #3: And therefore, treatment with an oral P2Y12 could be initiated at that point in time should it be required. With regards to the offset as I said, I think we know that within six to seven hours, we get to peak platelet inhibition.

Speaker #1: Our next question comes from Matt Delatorre from Goldman Sachs. Please go ahead with your question.

Operator: Our next question comes from Matt Dellatorre from Goldman Sachs. Please go ahead with your question.

Speaker #7: Great. Good morning and congrats on the progress. Maybe a couple on the branded pipeline. Starting with fast-acting meloxicam or FAM. Could you comment on any recent interactions with the FDA regarding the label being opioid-sparing?

Matt Dellatorre: Great. Good morning and congrats on the progress. Maybe a couple on the branded pipeline, starting with Fast-Acting Meloxicam or FAM. Could you comment on any recent interactions with the FDA regarding the label being opioid-sparing? Just remind us how this asset is factored into your longer-term guidance targets and the degree to which success could represent upside to those, either the base or bull case. On seladelpar, could you just remind us what magnitude of benefit you believe we need to see? I think you have disclosed in the past that the study is powered for a 20% benefit. I guess, what is the minimum benefit that could drive meaningful uptake? When we see the data, will there be any subtleties that we need to keep in mind, given it is a composite endpoint?

Speaker #3: 80% platelet inhibition after 15 minutes. More than 80% after 15 minutes is what we've seen in phase two. The offset is, as I said, within 24 hours, Selado Grow is no longer present.

Speaker #7: And then just remind us how this asset is factored into your longer-term guidance targets and the degree to which success could represent upside to those, either the base or bull case.

Speaker #7: And then on Celadogrell, could you just remind us what magnitude of benefit you believe we need to see? I think you've disclosed in the past that the study is powered for 20% benefit.

Speaker #3: Now, in terms of the CABG, I think CABG can be initiated at any point should it be required. Should it begin required, it's the current guidelines.

Speaker #7: So I guess what's the minimum benefit that could drive meaningful uptake? And then when we see the data, will there be any subtleties that we need to keep in mind given it is a composite endpoint, for instance, does it matter which of the components is driving the benefit?

Speaker #3: There's no need to wait if it is deemed urgent. But that being said, again, within the post-eight hours CABG post-eight hour post-Selado Grow injection CABG can be initiated safely.

Matt Dellatorre: For instance, does it matter which of the components is driving the benefit? It seems like they are all fairly serious, I just wanted to confirm. Thank you.

Speaker #7: It seems like they're all fairly serious, but I just wanted to confirm. Thank you.

Speaker #4: Thanks, Matt. First of all, on meloxicam fast-acting, we think it's going to be a significant contributor to our pipeline, to our revenue, to the US business between now and 2030.

Scott Smith: Thanks, Matt. First of all, on meloxicam fast-acting, we think it's going to be a significant contributor to our pipeline, to our revenue, to the US business, between now and 2030. I'm not getting into specific numbers at this point in time. We don't have a label yet, and there's some other things that we really need to look at, but we see it being a very significant contributor in the US to high margin branded portfolio in the United States. Philippe can talk a little bit about the label and the progression of discussions with the FDA and seladelpar, maybe we can loop back to Corinne to talk a little bit about the potential she sees in seladelpar.

Speaker #3: Again, it is not a requirement to wait.

Speaker #4: And so I'm not getting into specific numbers at this point in time. We don't have a label yet. And there's some other things that we really need to look at.

Speaker #1: Our next question comes from Matt Delator from Goldman Sachs. Please go ahead with your question.

Speaker #4: We see it being a very significant contributor in the US to high-margin branded portfolio in the United States. Philippe can talk a little bit about the label and the progression of discussions with the FDA and Celadogrell.

Speaker #6: Great. Good morning and congrats on the progress. Maybe a couple on the branded pipeline. Starting with fast-acting meloxicam or FAM, could you comment on any recent interactions with the FDA regarding the label being opioid-sparing?

Speaker #4: And then maybe we can loop back to Karim to talk a little bit about the potential she sees in Celadogrell.

Speaker #6: Yeah. Thank you. So with regards to meloxicam first and the progress of the review currently ongoing with FDA, we are reaching mid-cycle. Things are progressing as planned.

Speaker #6: And then just remind us how this asset is factored into your longer-term guidance targets and the degree to which success could represent upside to those, either the base or bull case.

Philippe Martin: Yeah. Thank you. We look out to meloxicam first and the progress of the review currently ongoing with FDA. We are reaching mid-cycle. Things are progressing as planned. FDA is very engaged. We're answering all the queries that they have and expect to get approval towards the end of the year at the time of the PDUFA. In terms of the labeling negotiations, there's interaction on the clinical data with the agency. Labeling negotiations won't start until October, November timeframe. This is when really we will start talking about the exact language around opioid sparing. As I previously mentioned, this was heavily discussed with the agency during phase II and during putting the protocol together for phase III. We've followed every recommendation that the agency had for us in order to be able to get this language included in the label section.

Speaker #6: And then on Selado Grow, could you just remind us what magnitude of benefit you believe we need to see? I think you've disclosed in the past the study is powered for 20% benefit.

Speaker #6: FDA is very engaged. We're answering all the queries that they have. And expect to get approval toward the end of the year at the time of the DUFA.

Speaker #6: So I guess what's the minimum benefit that could drive meaningful uptake? And then when we see the data, will there be any subtleties that we need to keep in mind, given it is a composite endpoint, for instance, does it matter which of the components is driving the benefit?

Speaker #6: In terms of the labeling negotiations, there's been I mean, there's interaction on the clinical data with the agency. Labeling negotiations won't start until October or November timeframe.

Speaker #6: It seems like they're all fairly serious, but I just wanted to confirm. Thank you.

Speaker #4: Thanks, Matt. First of all, on meloxicam fast-acting, we think it's going to be a significant contributor to our pipeline, to our revenue, to the US business, between now and 2030.

Speaker #6: So this is when really we will start talking about the exact language around opioid-sparing. As I previously mentioned, this was heavily discussed with the agency during phase two and during the putting the protocol together for phase three.

Speaker #4: And so I'm not getting into specific numbers at this point in time. We don't have a label yet. And there's some other things that we really need to look at.

Speaker #6: And we've followed every recommendation that the agency had for us in order to be able to get this language included in the label section.

Speaker #6: Where in the label section, in exactly what language? I can't tell you as of today, but we should get a better idea around the October/November timeframe.

Philippe Martin: Where in the label sections, in exactly what language? I can't tell you as of today, but we should get a better idea around the October, November timeframe.

Speaker #3: Yeah, thank you. So with regard to meloxicam first and the progress of the review, currently ongoing with FDA, we are reaching mid-cycle. Things are progressing as planned.

Speaker #2: And we see a lot of excitement about this product. We're getting very positive feedback from Carewell. Definitely, the results of the phase three program and notably on the opioid-sparing effect is seen as a real positive.

Corinne Le Goff: We see a lot of excitement about this product. We're getting very positive feedback from KOLs. Definitely, the results of the phase III program, and notably on the opioid sparing effect, is seen as a real positive. In terms of potential that we see for fast-acting meloxicam, FAM, as you call it, the potential is large. You know that acute pain is a broad market with about 80 million patients suffering from acute pain every year. Unfortunately, half of those patients already are dependent on opioids for pain relief. We see that this product has the right profile. This is generating a lot of interest, and we can imagine that with a market activity that could potentially go beyond three years as we are filing more patents. We could reach up to $500 million in peak sales with this asset.

Speaker #3: FDA is very engaged. We're answering all the queries that they have. And expect to get approval toward the end of the year, at the time of the DUFA.

Speaker #2: So in terms of potential that we see for fast-acting meloxicam FAM, as you call it, the potential is large. You know that pain is an acute pain is a broad market with about 80 million patients suffering from acute pain.

Speaker #3: In terms of the labeling negotiations, there's been I mean, there's interaction on the clinical data with the agency. Labeling negotiations won't start until October or November timeframe.

Speaker #2: Every year, and unfortunately, half of those patients already are dependent on opioids for pain relief. So we see that this product has the right profile.

Speaker #3: So this is when we will really start talking about the exact language around opioid-sparing. As I previously mentioned, this was heavily discussed with the agency during Phase 2 and during putting the protocol together for Phase 3.

Speaker #2: It is generating a lot of interest and we can imagine that with a market activity that could potentially go beyond three years as we are finding more patents.

Speaker #3: And we've followed every recommendation that the agency had for us in order to be able to get this language included in the label section.

Speaker #2: We could reach up to 500 million dollars in big sales with this asset. And that will contribute meaningfully to our long-term guidance.

Corinne Le Goff: That will contribute meaningfully to our long-term guidance.

Speaker #6: And then on your question on Celadogrell, so the actual benefit that the study is sized for is approximately a 20% risk reduction. We have discussed this obviously heavily with our Carewells and investigators.

Philippe Martin: Then, on your question on seladelpar. The actual benefit that the study is sized for is approximately a 20% risk reduction. I've discussed this obviously heavily with our KOLs and investigators. The minimal bar is much lower than that in the mind of the investigators and KOL. I think if we were to be able to show a risk closer to 10% to 15%, that would be very much acceptable and the lowest bar commercially to get this drug to patients. Again, the study is overpowered for that 20% risk reduction. That's really the minimal bar we're seeking at this point in time. In terms of the endpoint itself, as you know, the endpoint is ranked according to the outcome and according to their clinical importance. What we expect to see is that seladelpar is blunting acute MI from happening if injected at the right time.

Speaker #3: Where in the label section, in exactly what language? I can't tell you as of today, but we should get a better idea around the October/November timeframe.

Speaker #2: And we see a lot of excitement about this product. We're getting very positive feedback from Grow Else. Definitely, the results of the phase three program and notably on the opioid-sparing effect is seen as a real positive.

Speaker #6: The minimal bar is much lower than that in the mind of the investigators. And Carewell, I think if we were to be able to show risk closer 10 to 15%, that would be very much acceptable and the lowest bar commercially to get this drug to patients.

Speaker #6: So again, the study is overpowered for that 20% risk reduction. And that's the really the minimal bar we're seeking at this point in time.

Speaker #2: Every year, and unfortunately, half of those patients already are dependent on opioids for pain relief. So we see that this product has the right profile.

Speaker #2: It is generating a lot of interest and we can imagine that with a market activity that could potentially go beyond three years, as we are finding more patents.

Speaker #6: In terms of the endpoint itself, as you know, it is the endpoint is ranked according to the outcome and according to their clinical importance.

Speaker #2: We could reach up to 500 million dollars in big sales with this asset. And that will contribute meaningfully to our long-term guidance.

Speaker #6: What we expect to see is that Celadogrell is blunting acute MI from happening if injected at the right time. And we also expect to see that Celadogrell will reduce the severity of the MI that these patients are expecting making them a lot more manageable for the patient with a lot less sequelae over time, which leads to patients being in the hospital a lot less, a lot for much shorter amount of time, as well.

Speaker #3: And then on your question on Selado Grow, so the actual benefit that the study is sized for is approximately a 20% risk reduction. We have discussed this, obviously, heavily with our Grow Else and investigators.

Philippe Martin: We also expect to see that seladelpar will reduce the severity of the MIs that these patients are expecting, making them a lot more manageable for the patient with a lot less sequelae over time, which leads to patients being in the hospital a lot less, for much shorter amount of time as well. Adds a lot of benefits to the patient and to the payers overall.

Speaker #3: The minimal bar is much lower than that in the mind of the investigators. And, grossly, I think if we were to be able to show risk closer to 10 to 15%, that would be very much acceptable, and the lowest bar commercially to get this drug to patients.

Speaker #6: So adds a lot of benefits to the patient and to the payers overall.

Speaker #4: And these post-MI patients are very, very expensive for the healthcare system. They're very difficult to manage over time. And so being able to improve any particular outcome for a patient has not only tremendous benefits for that patient, but also on the healthcare system overall.

Scott Smith: These post-MI patients are very, very expensive for the healthcare system. They're very difficult to manage over time. Being able to improve any particular outcome for a patient has not only tremendous benefits to that patient, but also on the healthcare system overall. That's why part of the excitement that we feel about seladelpar being a unique drug in this space.

Speaker #3: So again, the study is overpowered for that 20% risk reduction. And that's the really the minimal bar we're seeking at this point in time.

Speaker #4: So that's why part of the excitement that we feel about Celadogrell being a unique drug in this space.

Speaker #1: Our next question comes from Glenn Santangelo from Barclays. Please go ahead with your question.

Speaker #3: In terms of the endpoint itself, as you know, it is the endpoint is ranked according to the outcome and according to their clinical importance.

Operator: Our next question comes from Glen Santangelo from Barclays. Please go ahead with your question.

Speaker #5: Oh, yeah. Good morning. And thanks for taking my question. Hey, Scott, I just had a couple of follow-up questions. I wanted to talk about this China dynamic.

Glen Santangelo: Yeah, good morning, and thanks for taking my question. Hey, Scott, I just had a couple of follow-up questions. I wanted to talk about this China dynamic. It seems like you're describing a situation that maybe has some durability in those commercial efforts beyond just 2026, because it seems like it's that market that gave you the ability to sort of raise guidance despite the fire-related disruptions you're sort of calling out in the back H2 of the year. I know it's a little bit too early to comment on 2027, but I was kind of curious if you could comment on the durability of the strength there and then should these fire-related disruptions be contained to just 2026? My follow-up was on meloxicam. It seems like meloxicam and the presbyopia solution are the two meaningful approvals you have left this year.

Speaker #5: It seems like you're describing a situation that maybe has some durability in those commercial efforts beyond just 2026 because it seems like it's that market that gave you the ability to sort of fire-related disruptions you're sort of calling out in the back half of the year.

Speaker #3: What we expect to see is that Selado Grow is blunting acute MI from happening if injected at the right time. And we also expect to see that Selado Grow will reduce the severity of the MI that these patients are expecting making them a lot more manageable for the patient with a lot less sequelae over time, which leads to patients being in the hospital a lot less, a lot for much shorter amount of time, as well.

Speaker #5: And so I know it's a little bit too early to comment on '27, but I was kind of curious if you could comment on the durability of the strength there and then should these fire-related disruptions be contained to just 2026?

Speaker #5: And then my follow-up was on meloxicam it seems like meloxicam and the presbyopia solution are the two meaningful approvals you have left. This year, at your analyst date, you sort of highlighted that value-added medicines pipeline would add about 1% to the growth algorithm in a previous question you just sort of highlighted that you think it can be a meaningful contributor.

Speaker #3: So adds a lot of benefits to the patient and to the payers overall.

Speaker #4: And if post-MI patients are very, very expensive for the healthcare system, they're very difficult to manage over time. And so being able to improve any particular outcome for a patient has not only tremendous benefits for that patient, but also on the healthcare system overall.

Glen Santangelo: At your Analyst Day, you sort of highlighted that value-added medicines pipeline would add about 1% to the growth algorithm. In a previous question, you just sort of highlighted that you think it can be a meaningful contributor. I'm just kind of curious when I think about that value-added pipeline, are you still thinking about it as a 1% contributor to the growth algorithm, or do you have maybe greater expectations at this point? Thanks so much.

Speaker #5: And I'm just kind of curious when I think about that value-added pipeline, are you still thinking about it as a 1% contributor to the growth algorithm or do you have maybe greater expectations at this point?

Speaker #4: So that's why part of the excitement that we feel about Selado Grow being a unique drug in this space.

Speaker #1: Our next question comes from Glenn Santangelo from Barclays. Please go ahead with your question.

Speaker #5: Thanks so much.

Speaker #4: Glenn, thank you very much for the question. So yeah, we're really pleased with the performance in China. There seems to be some good durability.

Scott Smith: Glen, thank you very much for the question. Yeah, we're really pleased with the performance in China. There seems to be some good durability. We had good performance last year. We see good performance this year. I think we see some of the investments that we've made in China in terms of the channels that we're going to, reaching to the patients, trying to restructure our business there, trying to make sure that we're over-investing in some of the demand for some of these iconic brands. There seems to be good durability there. The only thing you worry about in China is there's policy changes at times, and sometimes you see them coming and sometimes not. Sometimes they're inconsistently applied across provinces and things. We try and obviously work with the government in China to deliver the best healthcare we can.

Speaker #3: Oh, yeah. Good morning and thanks for taking my question. Hey, Scott, I just had a couple of follow-up questions. I wanted to talk about this China dynamic.

Speaker #4: We had good performance last year. We see good performance this year. I think we see some of the investments that we've made in China.

Speaker #3: It seems like you're describing a situation that maybe has some durability in those commercial efforts beyond just 2026 because it seems like it's that market that gave you the ability to sort of raise guidance despite the fire-related disruptions you're sort of calling out in the back half of the year.

Speaker #4: In terms of the channels that we're going to reaching to the patients, trying to restructure our business there, trying to make sure that we're over-investing in some of the demand for some of these iconic brands.

Speaker #4: There seems to be good durability there. The only thing you worry about in China is there's policy changes at times and sometimes you see them coming and sometimes not.

Speaker #3: And so I know it's a little bit too early to comment on '27, but I was kind of curious if you could comment on the durability of the strength there and then should these fire-related disruptions be contained to just 2026?

Speaker #4: Sometimes they're inconsistently applied across provinces and things. We try and obviously work with the government in China to deliver the best healthcare we can.

Speaker #4: But China seems to me to be a good engine for us moving forward. And I think it's not only China that allowed us to sort of beat and raise and to have a good outlook for this particular year.

Scott Smith: China seems to me to be a good engine for us moving forward. I think it's not only China that allowed us to sort of beat and raise and to have a good outlook for this particular year. There was some good strength in a number of other businesses as well. We see good strength in the value-added medicines that we're bringing in the United States and other places. We're very pleased with the business overall. You raised Nashik, and just to put that in perspective for you, we currently operate 26 manufacturing facilities around the world. We have inspections and observations and things all the time. Specific to Nashik, as I said in my prepared remarks, we're communicating with the FDA. We're working closely with the external experts and initiated comprehensive remediation plan to address all the issues or any issues that we see there.

Speaker #3: And then my follow-up was on meloxicam. It seems like meloxicam and the presbyopia solution are the two meaningful approvals you have left. This year, at your analyst date, you sort of highlighted that value-added medicines pipeline would add about 1% to the growth algorithm in a previous question you just sort of highlighted that you think it can be a meaningful contributor.

Speaker #4: There was some good strength in a number of other businesses as well. We see good strength in the value-added medicines that we're bringing in the United States and other places.

Speaker #4: So we're very pleased with the business overall. You raised NASHIC and just to put that in perspective for you, we currently operate 26 manufacturing facilities around the world.

Speaker #3: And I'm just kind of curious when I think about that value-added pipeline, are you still thinking about it as a 1% contributor to the growth algorithm or do you have maybe greater expectations at this point?

Speaker #4: We have inspections and observations and things all the time. Specific to NASHIC, as I said in my prepared remarks, we're communicating with the FDA.

Speaker #3: Thanks so much.

Speaker #4: Glenn, thank you very much for the question. So yeah, we're really pleased with the performance in China. There seems to be some good durability.

Speaker #4: We're working closely with the external experts and initiated comprehensive remediation plan to address all the issues or any issues that we see there. And we had a fire, as you said in Q1 and some inspection observations in May.

Speaker #4: We've had good performance last year. We've seen good performance this year. I think we see some of the investments that we've made in China.

Scott Smith: We had a fire, as you said, in Q1 and some inspection observations in May. We expect the remediations, as Paul was pointing out, to have some impact on H2 revenues, but it's fully baked into our guidance. As a reminder, we raised guidance for the year and for all key financial metrics. We see this being sort of intermittent as we remediate the fire and some of the things from the observations and the inspection, and we don't expect this to be long-term affecting the business, no.

Speaker #4: In terms of the channels that we're going to reach into the patients, trying to restructure our business there, trying to make sure that we're over-investing in some of the demand for some of these iconic brands.

Speaker #4: We expect the remediations as Paul was pointing out to have some impact and, second, have revenues but it's fully baked into our guidance. And as a reminder, we raised guidance for the year for all key financial metrics.

Speaker #4: There seems to be good durability there. The only thing you worry about in China is, there's policy changes at times, and sometimes you see them coming and sometimes not.

Speaker #4: We see this being sort of intermittent as we remediate the fire and some of the things from the observations and the inspection. And we don't expect this to be long-term affecting the business now.

Speaker #4: Sometimes they're inconsistently applied across provinces and things. We try and obviously work with the government in China to deliver the best healthcare we can.

Speaker #3: Yeah. Maybe if I could just add one thing too from a expectation perspective. We do see the impact being larger in Q3 and moderating a bit in Q4.

Paul Campbell: Maybe if I could just add one thing, too, from an expectation perspective. We do see the impact being larger in Q3 and moderating a bit in Q4. I think as Scott had intimated, we expect this supply disruption to be shorter term in nature and hopefully by exiting the end of the year into the beginning of next year, we will have gotten ourselves past it. That's our expectation.

Speaker #3: So I think as Scott had made it, we expect this supply disruption to be shorter-term in nature. And hopefully by the exiting the end of the year into the beginning of next year, we will have gotten ourselves past it.

Speaker #4: There was some good strength in a number of other businesses as well. We see good strength in the value-added medicines that we're bringing to the United States and other places.

Speaker #4: So we're very pleased with the business overall. You raised NASHIC and just to put that in perspective for you, we currently operate 26 manufacturing facilities around the world.

Speaker #3: That's our expectation.

Speaker #4: And NASHIC, just to characterize it as a lot of smaller products it's mainly emerging markets, GEMs, there's no one product there that's more than 20 million dollars in revenue.

Scott Smith: Nashik, just to characterize it, is a lot of smaller products. It's mainly emerging markets, JANZ. There's no one product there that's more than $20 million in revenue. It's a lot of little pieces. Again, as we remediate and get things online, we expect to see relatively short-term intermittent effects of that. The strength of the business allows us to get through that and again, be in a position to raise our guidance across all financial metrics. I think you had a question around meloxicam as well.

Speaker #4: We have inspections and observations and things all the time. Specific to NASHIC, as I said in my prepared remarks, we're communicating with the FDA.

Speaker #4: So it's a lot of little pieces. And again, as we remediate and get things online, we expect to see relatively short-term and intermittent effects of that.

Speaker #4: But the strength of the business allows us to get to get through that. And again, being in a position to raise our guidance across all financial metrics.

Speaker #4: We expect the remediations, as Paul was pointing out, to have some impact and, second, to drive revenues, but it's fully baked into our guidance. And as a reminder, we raised guidance for the year for all key financial metrics.

Speaker #4: I think you had a question around meloxicam as well.

Speaker #2: Yeah. And maybe I can address this again, Glenn. Good morning. Just to say that again, we'll remain very optimistic about meloxicam. We're expecting the date at the end of the year.

Corinne Le Goff: Yeah. Maybe I can address this again. Glen, hi. Good morning. Just to say that again, we remain very optimistic about meloxicam. We're expecting PDUFA date at the end of the year, so of course, we'll wait for the label to be available to finalize our pricing strategy and value proposition. Everything we are seeing so far and the feedback that we get from the market is very positive. We believe that there is room for another asset that is fast-acting, that would have a meaningful role in acute pain and really expand the utilization of NSAIDs that are with fast-acting meloxicam having a very well-characterized durability and safety profile. We are looking forward to launching this product. It will be a branded asset. We will deploy a specialty sales force, and I'm looking forward to talking about our launch at next fall.

Speaker #2: So of course, we'll wait for the label to be available to finalize our pricing strategy and value proposition. But everything we are seeing so far and the feedback that we get from the market is very positive.

Speaker #2: Yeah. Maybe if I could just add one thing too from a expectation perspective. We do see the impact being larger in Q3 and moderating a bit in Q4.

Speaker #2: So I think as Scott had made a we expect this supply disruption to be shorter-term in nature. And hopefully by the exiting the end of the year into the beginning of next year, we will have gotten ourselves past it.

Speaker #2: So we believe that there is room for another asset that is fast-acting that will have a meaningful role in acute pain. And really expand the utilization of NSAIDs that are with fast-acting meloxicam having a very well-characterized durability and safety profile.

Speaker #1: That's our expectation.

Speaker #4: And NASHIC, just to characterize it as a lot of smaller products it's mainly emerging markets, JANs, there's no one product there that's more than 20 million dollars in revenue.

Speaker #2: So we're looking forward to launching this product. It will be a branded asset. We will deploy a specialty sales force and I'm looking forward to talking about our launch at the next call.

Speaker #4: So it's a lot of little pieces. And again, as we remediate and get things online, we expect to see relatively short-term and intermittent effects from that.

Speaker #4: And I think one of the reasons we're so excited is not only the strength of the data relative to competitive setup there, but also the real market need.

Scott Smith: I think one of the reasons we're so excited is not only the strength of the data relative to competitive set out there, but also the real market need. I think Corinne hit on that earlier. The need for non-opioid solutions for patients with acute pain is really large, particularly in the US. We're excited about the profile, we're excited about the product, but we're also excited that it's going to fill a really significant need in the US.

Speaker #4: And I think Karina hit on that earlier, the need for non-opioid solutions for patients with acute pain is really large, particularly in the US.

Speaker #4: But the strength of the business allows us to get to get through that. And again, being in a position to raise our guidance across all financial metrics.

Speaker #4: And so we're excited about the profile. We're excited about the product. But we're also excited that it's going to fill a really significant need in the US.

Speaker #4: I think you had a question around meloxicam as well.

Speaker #5: Yeah. And maybe I can address this again, Glenn Harris, good morning. Just to say that again, we'll remain very optimistic about meloxicam. We're expecting the date at the end of the year.

Speaker #1: Our next question comes from Chris Schott from JP Morgan. Please go ahead with your question.

Operator: Our next question comes from Chris Schott from J.P. Morgan. Please go ahead with your question.

Speaker #5: So of course, we'll wait for the label to be available to finalize our pricing strategy and value proposition. But everything we're seeing so far and the feedback that we get from the market is very positive.

Speaker #6: Hi. This is Ethan on for Chris. Thanks for taking our questions. Just starting off, what are your latest thoughts on the M&A environment? Are you still seeing a good amount of assets in the marketplace or has that changed at all over the past couple of months?

[Analyst] (J.P. Morgan): Hi, this is Ethan on for Chris. Thanks for taking our questions. Just starting off, what are your latest thoughts on the M&A environment? Are you still seeing a good amount of assets in the marketplace, or has that changed at all over the past couple of months? Secondly, just thoughts on the latest headlines for potential US generic tariffs and maybe how you're thinking about the potential impact to Viatris specifically. Thank you.

[Analyst] (JPMorgan): Hi, this is Ethan on for Chris. Thanks for taking our questions. Just starting off, what are your latest thoughts on the M&A environment? Are you still seeing a good amount of assets in the marketplace, or has that changed at all over the past couple of months? Secondly, just thoughts on the latest headlines for potential US generic tariffs and maybe how you're thinking about the potential impact to Viatris specifically. Thank you.

Speaker #6: And then secondly, just thoughts on the latest headlines for potential US generic tariffs and maybe how you're thinking about the potential impact to Beatrice specifically?

Speaker #5: So we believe that there is room for another asset that is fast-acting that will have a meaningful role in acute pain. And really expand the utilization of NSAIDs that are with fast-acting meloxicam having a very well-characterized durability and safety profile.

Speaker #6: Thank you.

Speaker #4: So maybe M&A environment is obviously pretty active right now. It's a good environment. There's a lot of things going on. Certainly, there's a lot of assets still out there.

Scott Smith: I think the M&A environment is obviously pretty active right now. It's a good environment. There's a lot of things going on. Certainly, there's a lot of assets still out there. Certainly, I still get a lot of inbound. I talk about getting inbound virtually every day, sometimes multiple times a day. We're looking hard at business development, adding things in-market, accretive things to the portfolio. We're going to be disciplined, though. We're going to try and find the right assets, the ones that we can be good owners of at the right price to bring them in. We're looking at a lot of things. We're excited about our ability to use our capital not only to pay back to shareholders, dividends, share buybacks, but also really build a portfolio of assets.

Speaker #5: So we're looking forward to launching this product. It will be a branded asset. We will deploy a specialty sales force and I'm looking forward to talking about our launch at the next call.

Speaker #4: Certainly, I still get a lot of inbound. I talked about getting inbound virtually every day. Sometimes multiple times a day. And so we're looking hard at business development, adding things portfolio.

Speaker #4: And I think one of the reasons we're so excited is not only the strength of the data relative to competitive setup there, but also the real market need.

Speaker #4: We're going to be disciplined though. We're going to try and find the right assets, the ones that we can be good owners of at the right price to bring them in.

Speaker #4: And I think Corinne hit on that earlier, the need for non-opioid solutions for patients with acute pain is really large, particularly in the US.

Speaker #4: So we're looking at a lot of things. We're excited about our ability to use our capital not only to pay back to shareholders for dividends and share buybacks, but also really build a portfolio of assets and again, we're sort of focused on in-market, a creative assets right now.

Speaker #4: And so we're excited about the profile. We're excited about the product. But we're also excited that it's going to fill a really significant need in the US.

Scott Smith: Again, we're sort of focused on in-market accretive assets right now, and there's a lot of things out there that we're looking at for sure. The second part was tariffs. Yes. It's difficult for me to comment. We're still gathering information. The administration has not released any official policy details at all here. It's important to note that I think we're in a pretty good position regardless of how this goes, if it goes relative to tariffs. We currently have 8 manufacturing R&D distribution sites in the United States. Over half our US revenues are from products that are manifested in the US. We're planning, as we move forward, to manufacture higher margin products like complex generics, transdermal products, value-added products, and such in the United States.

Speaker #4: And there's a lot of things out there that we're looking at for sure. The second part was tariffs. Yes. I mean, it's difficult for me to comment.

Speaker #1: Our next question comes from Chris Schott from JP Morgan. Please go ahead with your question.

Speaker #4: We're still gathering information. The administration has not released any official policy details at all here. Just it's an important to note that I think we're in a pretty good position regardless of how this goes.

Speaker #4: If it goes relative to tariffs, we currently have eight manufacturing R&D distribution sites in the United States. Over half our US revenues are from products that are manifested in the US.

Speaker #4: We're planning as we move forward to manufacture higher margin products like complex generics, transdermal products value-added products and the such in the United States.

Speaker #4: And we'll always work to partner with the administration as we understand the details of what they're trying to do here from a policy perspective.

Scott Smith: We'll always work to partner with the administration as we understand the details of what they're trying to do here from a policy perspective and work with them to help better healthcare for Americans.

Speaker #4: And work with them to help better healthcare for Americans.

Speaker #1: Our next question comes from Dennis Ding from Jefferies. Please go ahead with your question.

Operator: Our next question comes from Dennis Ding from Jefferies. Please go ahead with your question.

Speaker #5: Hey. Good morning. Thanks for taking my questions. I have two pipeline questions. So one on lupus and one on saliva growth. So first in their mind, I appreciate that the phase three is enriching for high IFN1.

Dennis Ding: Good morning. Thanks for taking my questions. I have two pipeline questions, one on lupus and one on selatogrel. First, Cenerimod, I appreciate that the phase II is enriching for high IFN-1. We've seen with other lupus programs like Iberomide and Saphnelo that SRI-4 is consistently higher in this population versus low interferon 1. When I look at your phase II, this relationship breaks apart. It seems like the 4 milligrams goes with a clear outlier on both SRI-4 and also SRI-4. What is it about the prior data that really gives you confidence going into that readout outside of this high interferon 1 relationship? Question number 2 on selatogrel. I believe the CVOT was initially 14,000 patients, you upsized the trial by almost 50% to 25,000.

Speaker #5: And we've seen with other lupus programs like Iberomide and Saphnelo that SRI4 is consistently higher in this population versus low interferon 1. But when I look at your phase two, this relationship breaks apart.

Speaker #5: It seems like the 4 milligram dose was a clear outlier on both SRI4 and also slid eye. So what is it about the prior data that really gives you confidence going into that readout outside of this high interferon 1 relationship?

Speaker #5: And then question number two on saliva growth. I believe the CDL2 was initially 14,000 patients, but then you upsized the trial by almost 50% to 25,000.

Speaker #5: So I want to understand what went into that decision to add 11,000 patients and what are you seeing on blinded event rates? Is it tracking with what you initially planned or are they lower than expected?

Dennis Ding: I want to understand what went into that decision to add 11,000 patients and what are you seeing on blinded event rates? Is it tracking with what you initially planned, or are they lower than expected? Thanks so much.

Speaker #5: Thanks so much.

Speaker #4: Please.

Scott Smith: Philippe, please.

Speaker #5: Thank you for the questions. So with regard to scenario mode and the interferon 1 signature, in phase two, we saw that the 4 milligram dose, which was the highest dose tested, was the dose that was clinically meaningful improvement.

Philippe Martin: Thank you for the questions. With regard to Cenerimod and the interferon 1 signature. In phase II, we saw that the 4 milligram dose, which was the highest dose tested, was the dose that showed clinically meaningful improvement and a nominally statistically significant p-value. That was in the total population. In that 4 milligram arm dose, we had approximately 50%, actually 45%, of patients that were interferon 1 high. These interferon 1 high patients responded better than the interferon 1 low, with a delta versus placebo of about 24%, which is one of the highest delta reported for this population. We also saw, which is what is so much expected, that the interferon 1 high patients were the patients that were the most active in terms of their disease. This is the kind of patients we are actively enrolling in phase III.

Speaker #5: And the nominally statistically significant p-value. That was in the total population. And then in that 4 milligram arm dose, we had approximately 50%, actually 45% of patients that were interferon 1 high.

Speaker #5: This interferon 1 high patients responded better than the interferon 1 low. With the delta versus placebo of about 24%, which is one of the highest delta reported for this population.

Speaker #5: So and we also saw, which is what is somewhat expected that the interferon 1 high patients were the patients that were the most active in terms of their disease.

Umer Raffat: What are you seeing on blinded event rates? Is it tracking with what you initially planned, or are they lower than expected? Thanks so much.

Speaker #5: And this is the kind of patients we are actively enrolling in phase three. We are ensuring that we're getting patients with higher disease activity and higher interferon 1 high expression goal was to get to approximately 70% of patients that were interferon 1 high in phase three.

Scott A. Smith: Philippe, please.

You know, what are you seeing on blinded event rates? Is it tracking with what you initially planned, or are they lower than expected? Thanks so much.

Philippe Martin: Thank you for the question. With regard to cenerimod and the type I interferon signature, in phase II, we saw that the 4-milligram dose, which was the highest dose tested, was the dose that showed clinically meaningful improvement and a nominally statistically significant p-value. That was in the total population. In that 4-milligram arm dose, we had approximately 50%, actually 45%, of patients that were type I interferon high. These type I interferon high patients responded better than the type I interferon low with a delta versus placebo of about 24%, which is one of the highest delta reported for this population. We also saw, which is what is so much expected, that the type I interferon high patients were the patients that were the most active in terms of their disease. This is the kind of patients we are actively enrolling in phase III.

Philippe Martin: We are ensuring that we're getting patients with higher disease activity and higher IFN-1 high expression. Our goal was to get to approximately 70% of patients that were IFN-1 high in phase III, and we have exceeded that goal in both studies. That's the data from our phase II. We've also, just to finish on this, implemented a number of things in phase III that were different than phase II, obviously, that we believe will lead to better outcomes. First of all, the primary endpoint is at 1 year and not at 6 months, which will lead to, I believe, continued and better strength of the data as we've seen continued improvement in patients exposed to 1 year of Cenerimod.

Speaker #5: And we have exceeded that goal in both studies. So that's the data from our phase two. And then we've also just to finish on this implemented number of things in phase three that were different than phase two, obviously, that we believe will lead to better outcomes.

Please, please, thank you for the questions. Uh, so with regard to scenario mode and and the interferon 1 uh signature uh, in Phase 2. Um, we saw uh, that the 4 milligram dose, which was the highest dose tested, uh, was the dose that was, uh, clinically miniature, clinically meaningful Improvement and the nominees statistically significant, um, uh, P value. Um,

Speaker #5: First of all, the primary endpoint is at one year and not at six months. Which will lead to, we believe, continued and better strength of the data as we've seen continued improvement in patients exposed to one year to scenario mode.

Speaker #5: And then another important part I would mention is the fact that because the endpoint is at one year, we're able to implement a steroid sparing mandatory steroid sparing for patients that will lead to further differentiation versus placebo.

Philippe Martin: Another important part I would mention is the fact that because the endpoint is at 1 year, we're able to implement steroid-sparing, mandatory steroid-sparing for patients that will lead to further differentiation versus placebo. That's our strategy. We feel good about the data that we've generated so far. We are actively cleaning that data so that we can report our top-line results in 2027, early 2027. There's another question on

That was in the total population and then in that 4 migram on those, we had approximately 50% actually 45%, uh, of patients that were interfer on 1 high this, interfer on 1, high patients responded better than the interferon 1 low uh, with the Delta versus placebo of about 24%. Um, which is 1 of the highest Delta reported for these population,

Speaker #5: So that's our strategy. We feel good about the data that we've generated so far. And we're actively cleaning that data so that we can report our top line results in 2027, early 2027.

Philippe Martin: We are ensuring that we're getting patients with higher disease activity and higher type I interferon high expression. Our goal was to get to approximately 70% of patients that were type I interferon high in phase III, and we have exceeded that goal in both studies. That's the data from our phase II. We've also, just to finish on this, implemented a number of things in phase III that were different than phase II, obviously, that we believe will lead to better outcomes. First of all, the primary endpoint is at one year and not at six months, which will lead to, believe, continued and better strength of the data as we've seen continued improvement in patients exposed to one year of cenerimod.

Um so uh and we also saw which is what is so much expected uh that the interion 1 high patients, we had the patient. They were the most active uh in terms of of their disease, uh and this is the kind of patients. We are um actively and willing in in Phase 3. We are ensuring that we're getting.

Speaker #5: And then there's another question on.

Speaker #4: Saliva growth power.

Scott Smith: Seladelgrastat

Paul Campbell: Enrollment.

Speaker #5: Patient. Enrollment.

Scott Smith: Patient.

Speaker #4: Patient enrollment. 14 was the original.

Paul Campbell: Patient enrollment.

Scott Smith: Enrollment. 14 was the original.

Speaker #5: Oh, yeah, yeah, yeah. So yeah, the protocol always contemplated enrolling up to 21,000 patients. That's the that's where we were. It was anywhere between 14 to 21,000.

Philippe Martin: Oh, yeah. Yeah, the protocol always contemplated enrolling up to 21,000 patients. That's where we were. It was anywhere between 14,000 to 21,000. We are seeing an event rate that is what we accepted. That being said, what we're trying to do is to enroll patients all the way to the end. By that I mean all the way to the time point where we get all the needed events that we need. We're not going to stop and wait for the events to happen. We will continue to enroll through that. We may need a little bit more than 21,000 patients. That remains to be determined. We will continue to enroll through that. What's important is that we believe we'll get the events we need by the end of the year, early next year, so that we can get data in H1 of 2027.

Station with higher disease activity and higher. Interferon 1, high expression, goal was to get to approximately 70% of patients that were uh, interferon were high in Phase 3 and we have uh exceeded that exceeded that goal in uh in both studies.

Speaker #5: We are seeing the an event rate that is what we expected. That being said, what we're trying to do is to enroll patients all the way to the end.

Speaker #5: By that, I mean all the way to the time point where we get all the needed events that we need. We're not going to stop and wait for the events to happen.

Philippe Martin: Another important part I would mention is the fact that because the endpoint is at one year, we're able to implement mandatory steroid-sparing for patients that will lead to further differentiation versus placebo. That's our strategy. We feel good about the data that we've generated so far. We're actively cleaning that data so that we can report our top-line results in early 2027. There's another question on-

So, um, that's the, uh, that's the data from our Phase 2. Um, and then, you know, we've also just to to finish on this implemented number of things in Phase 3 that uh were different than Phase 2. Obviously that we believe will lead to better, uh, had outcomes. First of all, the primary endpoint, is that 1 year and not at 6 months, uh, which will lead to, uh, believe um, continue and better strength of the data as we see in continued Improvement, in patients exposed to 1 year of scenario mode.

Speaker #5: We will continue to enroll through that. And 21,000 patients. That remains to be determined. But we will continue to enroll through that. What's important is that we believe we'll get the events we need by the end of the year so that we can early next year so that we can get data in the first half of 2027.

Uh, and then another important part I would mention is, uh, the fact that in because the end point is that 1 year, we're able to implement this series, uh, sparing, uh, mandatory store experience for patients and that will lead to further differentiation versus placebo. So, that's the, that's our strategy, we feel. Uh, we feel good about the data, um, that we've generated so far.

Speaker #1: Our next question comes from Jason Gerberry from Bank of America. Please go ahead with your question.

Operator: Our next question comes from Jason Gerberry from Bank of America. Please go ahead with your question.

uh and we are actively uh cleaning that data so that we can report uh our Topline results uh, in 2027 early 2027,

Scott A. Smith: It's a lot about power.

Umer Raffat: Enrolment.

Scott A. Smith: Patient enrollment.

And then there's another question on Salotto Power.

Umer Raffat: Enrolment.

Scott A. Smith: 14 was the original.

Speaker #6: Hi guys. Thanks for taking my questions. Just two for me. Just wanted to follow up on the China policy question because I didn't quite understand.

Jason Gerberry: Hey, guys. Thanks for taking my questions. Just two for me. Just wanted to follow up on the China policy question because I didn't quite understand. It sounds like despite the policy change, you're still bullish on the market overall. Perhaps there might be a little bit of fluidity with the situation, with the comment about the variability at the province levels. I guess I'm just wondering, I look at H2 of the year, sort of an implied low single-digit growth. Is that sort of what we should think about, H1, the carryover into next year? Does that create tough comps for 2027, is ultimately what I'm trying to get at.

Philippe Martin: The protocol always contemplated enrolling up to 21,000 patients. That's where we were. It was anywhere between 14 to 21,000. We are seeing an event rate that is what we accepted. That being said, what we're trying to do is to enroll patients all the way to the end. By that I mean all the way to the time point where we get all the needed events that we need. We're not going to stop and wait for the events to happen. We will continue to enroll through that. We may need a little bit more than 21,000 patients. That remains to be determined. We will continue to enroll through that. What's important is that we believe we'll get the events we need by the end of 2024, early 2025, so that we can get data in H1 2027.

Speaker #6: So it sounds like despite the policy change, you're still bullish on the market overall. Perhaps there might be a little bit of fluidity with the situation with the comment about the variability at the province levels.

Patient patient. Enrollment enrollment 14 was the original. Oh yeah, yeah, yeah. So yeah, the the protocol always, um, contemplated enrolling uh, up to 21,000 patients. Uh, that's the um that's where we were. It was anywhere between 14 to 21,000. Um,

Speaker #6: But I guess I'm just wondering, I look at the back half of the year, sort of it implied low single-digit growth. Is that sort of what we should think about first half, the carryover into next year?

We have we are seeing the uh uh an event rate. That is what we uh accepted.

Speaker #6: Does that create tough comps for 2027? Is ultimately what I'm trying to get at. And then on saliva growth, I'm just curious, once you complete enrollment towards the end of the year, for the primary endpoint, I think you only need to assess the patient for like two to seven days to determine the impact.

Jason Gerberry: On seladelgrastat, just curious, once you complete enrollment towards the end of the year, for the primary endpoint, I think you only need to assess the patient for 2 to 7 days to determine the impact on mortality or the other measures. Could you just remind me the different lag factors that go into once you complete enrollment to actually, the time to which you can generate top-line data? Thanks.

Speaker #6: On mortality or the other measures. And so can you just remind me the different lag factors that go into once you complete enrollment to actually the time to which you can generate top line data?

Speaker #6: Thanks.

Speaker #4: So just on China first. Again, we're very, very pleased with the business. It's running very strong. We think it's going to obviously, we're going to have strong results in '26.

Scott Smith: Just on China first. Again, we're very, very pleased with business. It's running very strong. We think obviously we're going to have strong results in 2026, and we believe 2027 and beyond as well. There's good momentum there. It's a very important part of our company going forward. Good growth. In terms of policy, it's not finalized at this point in time. There's discussions with the government around different policy executions. We're being a little bit careful to try and understand that policy. We will be in a position, I think, in November to really talk about the policy, what it looks like with any changes, if we think it's going to impact our business or not, what that's going to look like. It's just an active discussion right now with the government, and we're not exactly sure how that policy's going to be executed.

Uh, that being said, what we're trying to do is to enroll patients all the way to, uh, to The End by that. I mean, all the way to the time point, where we, we get all the needed events that we need, we are not going to stop and wait for the events to happen. We will continue to enroll through that and we may need a little bit more than 21,000 patients that remains to be determined. Um, but we, um, we will continue to enroll through that. What's important is that we believe we'll get the events we need uh, by the end of the year, uh, so that we can um, early next year so that we can get uh, data in the first half of 2027.

Umer Raffat: Our next question comes from Jason Gerberry from Bank of America. Please go ahead with your question.

Speaker #4: And we believe '27 and beyond as well. There's good momentum there. So very important part of our company going forward. Good growth. In terms of policy, it's not finalized at this point in time.

Jason Gerberry: Hey, guys. Thanks for taking my questions. Just two for me. Just wanted to follow up on the China policy question because I didn't quite understand. It sounds like despite the policy change, you're still bullish on the market overall. Perhaps there might be a little bit of fluidity with the situation, with the comment about the variability at the province levels. I guess I'm just wondering, I look at the H2 of the year, sort of an implied low single-digit growth. Is that sort of what we should think about, H1, the carryover into 2025? Does that create tough comps for 2027 is ultimately what I'm trying to get at.

Our next question comes from Jason Gerbi from Bank of America. Please go ahead with your question.

Speaker #4: There's discussions with the government around different policy executions. So we're being a little bit careful to try and understand that policy. We will be in a position, I think, in November to really talk about the policy, what it looks like, any changes.

Uh, hey guys, thanks for taking my questions. Um, just 2 for me, just wanted to follow up on the China policy question because I didn't quite understand. So it sounds like, despite the policy changes still bullish on the market. Overall, perhaps there might be a little bit of fluidity with the situation with the comment about the variability at the Province levels.

Speaker #4: If we think it's going to impact our business or not, what that's going to look like. And so it's just an active discussion right now with the government.

Speaker #4: We're not exactly sure how that policy is going to be executed. And again, policy in China tends to get executed in this kind of spotty way.

Scott Smith: Again, policy in China tends to get executed in kind of a spotty way. Different execution in different provinces and things. We're taking a look at it. We're in active discussions. We think it could have some effect in H2 of the year. We'll have a much better view on the policy execution when we get to November.

Jason Gerberry: On selatogrel, just curious, once you complete enrollment towards the end of 2024, for the primary endpoint, I think you only need to assess the patient for 2 to 7 days to determine the impact on mortality or the other measures. Could you just remind me the different lag factors that go into once you complete enrollment to actually the time to which you can generate top-line data? Thanks.

But I guess I'm just wondering you. I, I look at the back half of of the Year, sort of an implied low single digit growth is that sort of what we should think about. You know, first half the carryover into next year. Does that create tough comps for 2027 is ultimately what I'm trying to get at.

Speaker #4: And different execution and different provinces and things. So we're taking a look at it. We're in active discussions. We think it could have some effect in the second half of the year.

Speaker #4: And we'll have a much better view on the policy execution when we get to November.

Speaker #5: Yeah. And let me just add, we've built all that into the forecast, right? So I would say from my perspective, we are hopeful we'll continue to see momentum and grow beyond '26.

Paul Campbell: Yeah. Let me just add, we've built all of that into the forecast, right? I would say from my perspective, we are hopeful we'll continue to see momentum and grow beyond 2026. As of right now, we don't see the 16%, 17% continued growth. Right? We do expect growth, but it'll moderate back down. That's our current expectation based on everything we know.

Scott A. Smith: Just on China first, again, we're very, very pleased with business. It's running very strong. We think, obviously, we're going to have strong results in 2026, and we believe 2027 and beyond as well. There's good momentum there. It's a very important part of our company going forward. Good growth. In terms of policy, it's not finalized at this point in time. There's discussions with the government around different policy executions. We're being a little bit careful to try and understand that policy. We will be in a position, I think, in November to really talk about the policy, what it looks like with any changes, if we think it's going to impact our business or not, what that's going to look like. It's just an active discussion right now with the government, and we're not exactly sure how that policy's going to be executed.

The ladder girl just curious once you complete enrollment towards the end of the year, you know, for the primary endpoint I think, you know, you only need to assess the patient for like 2 to 7 days to determine the impact on mortality or or the other um uh measures and so could you just remind me that the different lag factors that go into uh what you complete enrollment to actually you know, the time to which you can generate uh, Topline data? Thanks.

Speaker #5: But as of right now, we don't see the 16, 17 percent continued growth, right? And so we do expect growth, but it'll moderate back down.

Speaker #5: That's our current expectation based on everything we know.

Speaker #2: Right. And nothing to this just to say that and you mentioned it, the implementation of this new policy, which is a new procurement, new that concerns only public hospitals.

Corinne Le Goff: Right. I have nothing to add to this, just to say that, and you mentioned it, the implementation of this new policy, which is a new procurement rule that concerns only public hospitals, will be done at the provincial level. Right? There are 31 provinces in China. Some of our products that have high volume utilization might be impacted. We will know more as those 31 provinces adopt this policy. Definitely by the end of the year, we'll have a much better picture of the impact. Again, we are confident, as Paul said, that we're going to grow through this policy implementation.

Speaker #2: Will be done at the provincial level, right? So there are 31 provinces in China. And some of our products that have high volume utilization might be impacted.

Scott A. Smith: Again, policy in China tends to get executed in this kind of spotty way and different execution in different provinces and things. We're taking a look at it. We're in active discussions. We think it could have some effect in the second half of the year, and we'll have a much better view on the policy execution when-

Speaker #2: But who will know more as those 31 provinces adopt this policy? And definitely by the end of the year, we'll have a much better picture of the impact.

Speaker #2: But again, we are confident as Paul said that we're going to grow through this policy implementation.

So just on on China first. Um, again, we're we're very, very pleased that this is running very strong. Um, we think it's going to, obviously, we're going to have strong results in 26 and we believe, 27 and Beyond as well. There's good momentum there. It's a very important part of our company going forward. Good growth in terms of policy that, you know, it's it's, it's not finalized at this point in time. There's discussions with the government around different, uh, different policy executions. Uh, you know, so we're, uh, being a little bit careful to try and understand that policy. We will be in a position. I think in November to really talk about the policy, what it looks like, would any changes if we think it's going to impact our business or not what that's going to look like and so it's just an active discussion right now with the government and we're not exactly sure how that policy is going to be executed. And again policy in China tends to get executed and it's kind of spotty way, uh, and and, you know, the different execution of different provinces and things. So, um, we're taking a look at it. We're in active discussions. We think it could have some

Paul Campbell: Yeah

Scott A. Smith: We get to November.

Speaker #5: And then regarding your questions on your question on saliva growth, so yes, you are correct that the primary endpoint is at seven days for death and within two days of injections for the other types of MIs.

Paul Campbell: Yeah. Let me just add, we've built all of that into the forecast, right? I would say from my perspective, we are hopeful we'll continue to see momentum and grow beyond 2026. As of right now, we don't see the 16% to 17% continued growth, right? We do expect growth, but it'll moderate back down. That's our current expectation based on everything we know.

Philippe Martin: Regarding your question on Selatogrel. Yes, you are correct that the primary endpoint is at 7 days for this and within 2 days of injections for the other types of MIs. That being said, the secondary endpoint at 30 days, we need to get that data at 30 days. Remember, this is a very sizable study with 45 countries involved and close to 900 sites. We need to make sure that we gather all that data and clean all that data, which is why we're talking about a H1 data release. It takes some time to clean all that and bring that back, right?

The fact in the second half of the year and uh we'll have a much better view on the policy execution when we get to November. Yeah. And and let me just add, um,

Speaker #5: That being said, the secondary endpoint at our 30 days. So we need to get that data at 30 days. And then remember, this is a very sizable study with 45 countries, and close to 900 sites.

Corinne Le Goff: Right. I have nothing to add to this, just to say that, and you mentioned it, the implementation of this new policy, which is a new procurement rule that concerns only public hospitals, will be done at the provincial level, right? There are 31 provinces in China. Some of our products that have high volume utilization might be impacted. We will know more as those 31 provinces adopt this policy. Definitely by the end of the year, we will have a much better picture of the impact. Again, we are confident, as Paul said, that we are going to grow through this policy implementation.

you know, we built all of that into the forecast, right? So uh, I would say, from my perspective, we are hopeful, we'll continue to see momentum and grow Beyond 26, uh, but as of right now, you know, we don't see the 1617 percent continued growth, right? And so we do expect growth, but it will, it'll moderate back down. That's our current expectation based on everything. We know.

Speaker #5: So we need to make sure that we gather all that data and clean all that data, which is why we're talking about a first half data release takes some time to clean all that and bring that back, right?

Speaker #5: So

Speaker #4: Very large study, right? Large global study. So it takes some time to clean and prepare the data properly.

Scott Smith: It's a very large study, right? Large global study, it takes some time to clean and prepare the data properly.

Speaker #1: Our next question comes from David Amsulam from Piper Sandler. Please go ahead with your question.

Operator: Our next question comes from David Amsellem from Piper Sandler. Please go ahead with your question.

Speaker #7: Thanks. So two for me. First, on Sonarimod, my understanding is that background Benlista is allowed in the trial. So wondering about the thought process there and is it stratified?

David Amsellem: Thanks. Two for me. First on Cenerimod. My understanding is that background BENLYSTA is allowed in the trial. Wondering about the thought process there and is it stratified or the patient stratified for background BENLYSTA? That's number 1. Switching gears to complex generics. Wanted to ask about the hormonal patch business with the acceleration following the removal of the box warnings. Wanted to get your thoughts on how long you think that could be a relatively limited competition market for you, and how big of a growth driver for generics in developed markets, namely the US, that could be in 2027. Thank you.

Right? And and I have nothing, uh, to add to this. Just to say that, you know, and you mentioned it, the implementation of this, uh, new policy, which is, uh, a new product that you get concerns only, uh, public hospitals, uh, will be done at the provincial level, right? So there are 31 provinces in in China. Uh, and you know, some of our products that have, uh, high volume visualization might be infected. Uh, but who in the world? As those 31 provinces, adopt this policy and definitely, by the end of the year, we'll have a much better picture of the impact.

Philippe Martin: Regarding your question on selatogrel. Yes, you are correct that the primary endpoint is at 7 days for this and within 2 days of injections for the other types of MIs. That being said, the secondary endpoint are at 30 days, we need to get that data at 30 days. Remember, this is a very sizable study with 45 countries involved in and close to 900 sites. We need to make sure that we gather all that data and clean all that data, which is why we are talking about a H1 data release. It takes some time to clean all that and bring that back, right?

But again, we are confident as Paul said that we're going to grow through this policy implementation.

Speaker #7: Are the patients stratified for background Benlista? So that's number one. And then switching gears to complex generics, wanted to ask about the hormonal patch business with the acceleration following the removal of the box warnings.

Speaker #7: Wanted to get your thoughts on how long you think that could be a relatively limited competition market for you and how big of a growth driver for generics and developed markets namely the US that could be in '27.

And then regarding your questions on on your question, on C? Well, um, so yes, you are correct that. The primary endpoint is that, uh, 7 days for this and within 2 days of injections for the, uh, other types of Mis that being said, the secondary endpoint that are 30 days so we need to get that data at 30 days. Um and then remember this is a very sizable study with uh 45 countries uh involved it and uh close to 900 sites. Um, so we need to make sure that we gather all that data and and clean all that data, which is why we're talking about the first half.

Speaker #7: Thank you.

Speaker #4: So on your question about Belimumab, yes, Belimumab is considered standard of care and therefore is included in the medications that can be given in combination with Sonarimod as part of this trial.

Philippe Martin: On your question about belimumab. Yes, belimumab is considered standard of care and therefore is included in the medications that can be given in combination with Suneima as part of this trial. That being said, we don't expect a significant number of patients that will be on belimumab as part of the study. We expect it to be closer to 5% of the patients. This will have limited potential impact on the data. Second, the randomization ensures balance and mitigation bias. The effect that you could see on with belimumab, you see in both placebo and the treatment arm. It's important to generate this data just from a pure safety and clinical value to show that the efficacy of Suneima is seen on top of belimumab or BENLYSTA, and that it is safe to co-administer these two drugs.

Scott A. Smith: It is a very large study, right? Large global study. It takes some time to clean and prepare the data properly.

Um data that is take sometimes to clean all that and and bring that that back, right? So it's very large study, right? Large Global Studies that takes it takes some time to clean and prepare the data properly.

Operator: Our next question comes from David Amsellem from Piper Sandler. Please go ahead with your question.

David Amsellem: Two for me. First on cenerimod. My understanding is that background BENLYSTA is allowed in the trial, wondering about the thought process there and is it stratified or the patient stratified for background BENLYSTA? That's number one. Switching gears to complex generics. Wanted to ask about the hormonal patch business with the acceleration following the removal of the black box warnings. Wanted to get your thoughts on how long you think that could be a relatively limited competition market for you, and how big of a growth driver for generics in developed markets, namely the US, that could be in 2027. Thank you.

Our next question comes from David Amsalem from Piper Sandler. Please go ahead with your question.

Speaker #4: That being said, we don't expect a significant number of patients that will be on Belimumab as part of the study. We expect it to be closer to 5% of the patients.

Speaker #4: So this will have limited potential impact on the data. Second, the randomization ensures balance and mitigation bias. It is the effect that you could see with Belimumab, you see in both placebo and the treatment arm.

Um, thanks. So 2 for me, uh, first on scenario mod. Um, my understanding, is that background been Lista is allowed in the trial. So wondering, uh, about the thought process. Um, there and, um, is it stratified or the patient's stratified for background?

Speaker #4: And then it's important to generate this data just from a pure safety and clinical value to show that the efficacy of Sonarimod is seen on top of Belimumab or Benlista and that the safety it is safe to co-administer these two drugs.

Philippe Martin: On your question about belimumab. Yes, belimumab is considered standard of care and, therefore, is included in the medications that can be given in combination with cenerimod as part of this trial. That being said, we don't expect a significant number of patients that will be on belimumab as part of the study. We expect it to be closer to 5% of the patients. This will have limited potential impact on the data. Second, the randomization ensures balance and mitigation bias. The effect that you could see on with belimumab, you see in both placebo and the treatment arm. It's important to generate this data just from a pure safety and clinical value to show that the efficacy of cenerimod is seen on top of belimumab or BENLYSTA, and that it is safe to co-administer these two drugs.

Speaker #4: So that's part of the reason why we also included it in the clinical trial. And then should we see an effect? I mean, we have sensitivity analysis that we would be looking at.

Philippe Martin: That's part of the reason why we also included it in the clinical trial. Should we see an effect, we have sensitivity analysis that we would be looking at. Remember, we have two identical studies. This allows us to pool data across both studies to determine whether an effect that we would see is real or not. That gives us more robustness behind that data. Overall, I would say that we do not expect this to affect the study in any way.

Speaker #4: Remember, we have two identical studies that allows us to pull data across both studies to determine whether an effect that we would see is real or not.

Speaker #4: So that gives us more robustness behind that data. But overall, I would say that we do not expect this to affect the study in any way.

Speaker #2: And so regarding your question on estradiol patch, we have seen over the last year, over the past year, a strong increase in demand for estradiol patch for hormone replacement therapy.

Corinne Le Goff: Regarding your question on estradiol patch, we have seen over the past year, a strong increase in demand for estradiol patch for hormone replacement therapy. You're right, that the first reason for this is the market extension, which is due to the FDA removing a black box warning at the end of last year. We believe that this market expansion is here to stay. Now there is a secondary factor, a bit less important, but worth mentioning as well, which is the increased use of GLP-1s that has an impact on the utilization of patches because it's been demonstrated that there's a contraindication with the use of not only oral contraceptive but HRT products as well. We benefit from those two factors. Now, we have a leading position in the manufacturing of patches.

Speaker #2: And you're right. That's the first reason for this is the market exemption, which is due to the FDA removing a black box warning at the end of last year.

Uh, standard of care and, uh, therefore is included in the medications that can be given in combination with Cinema as part of the strap. That being said, uh, we don't expect a significant, uh, number of patients that will be on on Bill map as part of the study. We expect it to be closer to, uh, 5% of the patients. So this will have limited, uh, potential impact, uh, to on, on, on the data second, uh, Lorenzo, um, ensures balance and Recreation bias. Um, it is, uh, um, uh, the effect that you could see on with Bim, you feel in both Placebo and the, the, the treatment now. Um, and then, uh,

Speaker #2: And we believe that this market expansion is here to stay. Now there is a secondary factor, a bit less important, but worth mentioning as well.

Speaker #2: Which is the increased use of GLP-1s that has an impact on the utilization of patches because it's been demonstrated that they are contradication with the use of not only oral contraceptive, but HRT products as well.

Philippe Martin: That's part of the reason why we also included it in the clinical trial. Should we see an effect? We have sensitivity analysis that we would be looking at. Remember, we have two identical studies. This allows us to pool data across both studies to determine whether an effect that we would see is real or not. That gives us more robustness behind that data. Overall I would say that we do not expect this to affect the study in any way.

Speaker #2: So we benefit from those two factors. Now it's we have a leading position in the manufacturing of patches. We have our facility which is based out of Vermont.

It's important to generate this data just from a pure, uh, safety. Um, and clinical value to show that uh, the efficacy of Cinema is seen on top of billennium map and that the safety it is safe to go administer these 2 large. So that's part of the reason why we also uh included it in the uh clinical trials. And then should we see an effect? I mean, we have sensitivity analysis. Uh, that we would be looking at. Remember we have 2 identical studies, uh, that allows us

Corinne Le Goff: We have our facility, which is based out of Beaumont, that produces high tech, next generation transdermal systems. We continue to increase capacity there. We continue to drive efficiencies. We will continue to be a major leader in this market as we see the expansion forward.

Speaker #2: That produces high-tech next-generation transdermal systems. And we continue to increase capacity there. We continue to drive efficiencies so we will continue to be a major leader in this market as we see the expansion forward.

Corinne Le Goff: Regarding your question on estradiol patch, we have seen over the last year, over the past year, a strong increase in demand for estradiol patch for hormone replacement therapy. You're right, that the first reason for this is the market extension, which is due to the FDA removing a black box warning at the end of last year. We believe that this market expansion is here to stay. There is a secondary factor, a bit less important, but worth mentioning as well, which is the increased use of GLP-1s that has an impact on the utilization of patches because it's been demonstrated that there's a contraindication with the use of not only oral contraceptives, but all HRT products as well. We benefit from those two factors. Now, we have a leading position in the manufacturing of patches.

To probe data across both studies to to to to determine whether an effect that we would see is real or not. Um, so that gives us more robustness behind that, that data. Uh, but overall, I would say that, uh, we do not expect this to affect the study in any way.

Speaker #5: Yeah. And just to finalize the thought around estradiol, we do see it as an opportunity again, less about additional competition from my perspective. It is that demand has blown up.

Paul Campbell: Yeah. Just to finalize the thought around estradiol, we do see it as an opportunity. Again, less about additional competition from my perspective. It is that demand has blown up. We're currently as a data point, being able to fulfill about 70% of orders. Just as the demand is there, we're trying to ramp up production to meet that demand. I think there's opportunity there. As Corinne said, we are looking at our own plant. We're looking externally to see what's available to meet that demand in the future.

Speaker #5: We're currently as a data point being able to fulfill about 70% of orders. So just as the demand is there, we're trying to ramp up production to meet that demand.

Speaker #5: And I think there's opportunity there. And as Karun said, we are looking at our own plant. We're looking externally. To see what's available to meet that demand in the future.

Speaker #4: And certainly this is a place that we're willing to invest to go forward to meet what we see as sort of unprecedented increases in demand for the reasons that Karun was saying.

Scott Smith: Certainly, this is a place that we're willing to invest to go forward to meet what we see as sort of unprecedented increases in demand for the reasons that Corinne was saying. I think a real nice area of opportunity for us and one that we're going to invest in and likely to be a good driver of our revenues, at least through now to 2030.

Speaker #4: So I think a real nice area of opportunity for us and one that we're going to invest in and likely to be a good driver of our revenue is at least through now to 2030.

Corinne Le Goff: We have our facility, which is based out of Beaumont, that produces high-tech, next-generation transdermal systems. We continue to increase capacity there. We continue to drive efficiencies. We will continue to be a major leader in this market as we see the expansion forward.

And so regarding your question on Estrada patch, we have thin uh over the last year, over the past year or a strong increase in demand for uh, Estrada uh, patch for common replacement therapy and you're right. That's the first reason for this is the market exemption extension, which is due to the FDA, removing a black box warning, uh, at the end of last year, and we believe that this Market expression is here to stay, uh, there there. Now, there is a secondary factor a bit, a bit less important, but worth mentioning, as well, which is the increased use of vlp ones that has an impact on the organization of patches, because it's been demonstrated that, uh, they, uh, are, uh, are indication with the use of not only over 50 but all HRT products as well. So, we benefit from those 3 factors, uh, now it's, uh, we are we have a leading position in the manufacturing of

Speaker #1: And our next question comes from is a follow-up question from Umar Rifat from Evercore. Please go ahead with your question.

Operator: Our next question is a follow-up question from Umer Raffat from Evercore. Please go ahead with your question.

Speaker #6: Hi guys. Thanks for taking my follow-up. I wanted to touch up on something I meant to ask early on as well. I think it kind of came up on a question a few moments ago as well.

Umer Raffat: Hi, guys. Thanks for taking my follow-up. I wanted to touch up on something I meant to ask early on as well, and I think kind of came up on a question a few moments ago as well. Philippe, I think you mentioned the original sample size was 14 to 21,000, and I think ClinicalTrials.gov has it having gone from 14 to 25,000, even though in practice what's happened is it's gone from 14 to 21,000 to 25 to 35,000. Could you just speak to that if that was informed more by powering or more by sort of you're just letting it continue to enroll, so you just keep getting the events faster?

Paul Campbell: Yeah. Just to finalize the thought around EstroGel, we do see it as an opportunity. Again, less about additional competition from my perspective. It is that demand has blown up. We're currently, as a data point, being able to fulfill about 70% of orders. Just as the demand is there, we're trying to ramp up production to meet that demand, and I think there's opportunity there. As Corinne said, we are looking at our own plant. We're looking externally to see what's available to meet that demand in the future.

Speaker #6: So Felipe, I think you mentioned the original sample size was 14 to 21,000. And I think Clint Trials has it having gone from 14 to 25K, even though in practice what's happened is it's gone from 14 to 21K to 25 to 35K.

Batteries we have, uh, our facility, which is based out of Vermont. Um, that produces you know, high-tech, uh, Next Generation, uh, transdermal systems, and we continue to increase capacity. There. We continue to, uh, to drive this efficiencies. Uh, so we will continue to be, uh, a major leader in this market as we see the extension forward. Yeah. And just, just to, to finalize the the thought around Estrada. We do see it as a

Speaker #6: Could you just speak to that if that was informed more by powering or more by sort of you're just letting it continue to enroll so you just keep getting the events faster?

Speaker #4: That's exactly what the latter, right? Which is that we are letting it enroll. This is a sizable study. We've sent quite a bit of time.

Philippe Martin: That's exactly the latter, right? We are letting it enroll. This is a sizable study. We spend quite a bit of time and energy and money, quite frankly, in this study. We want to leverage it as best we can. Getting that data will be important for positioning of the drug, and therefore we believe it is important to let it run as close to the time point where we're going to lock the data. That will mean that we'll have more events than we need eventually, right? For the timing of the primary endpoint, that allows us to get there faster than if we were to stop now and wait for the events to occur, right? That's that strategy that you're seeing play. These numbers that we put on ClinicalTrials.gov are to give us flexibility in how many patients we want to enroll.

Scott A. Smith: Certainly, this is a place that we're willing to invest to go forward to meet what we see as unprecedented increases in demand for the reasons that Corinne was saying. I think a real nice area of opportunity for us, and one that we're going to invest in and likely to be a good driver of our revenues at least through now to 2030.

Speaker #4: And energy and money, quite frankly, in this study. So we want to leverage it as best we can getting that data will be important for positioning of the drug and therefore we believe it is important to let it run as close to the time point where we're going to lock the data so which will mean that we'll have more events that we need eventually, right?

An opportunity again, less about additional competition from my perspective. It is that demand is is is blown up. We're currently as a data point, being able to uh, fulfill about 70% of orders. So just as the demand is there, you know, we're trying to ramp up production uh, to meet that demand and I think there's opportunity there. And as KR said we are looking, you know at at our own plant we're looking externally to see what's available to meet that demand in the future. And certainly this is a place that we're willing to invest to go forward to meet. What we see as sort of unprecedented and increases in demand, for other reasons that Karen was saying. So I think a real nice uh, area of opportunity for us and 1 that we're going to invest in and likely to be a good driver of our revenue is always through now to 2030.

Operator: Our next question is a follow-up question from Umer Raffat from Evercore. Please go ahead with your question.

Umer Raffat: Hi, guys. Thanks for taking my follow-up. I wanted to touch up on something I meant to ask early on as well, and I think it kind of came up on a question a few moments ago as well. Philippe, I think you mentioned the original sample size was 14,000 to 21,000. I think ClinicalTrials.gov has it having gone from 14,000 to 25K, even though in practice what's happened is it's gone from 14,000 to 21K to 25K to 35K. Could you just speak to that, if that was informed more by powering or more by sort of you're just letting it continue to enroll, so you just keep getting the events faster?

And our next question comes from—this is a follow-up question from Ummer Refaat from Evercore. Please go ahead with your question.

Speaker #4: But for the timing of the primary endpoint, that allows us to get there faster than if we were to stop now and wait for the events to occur, right?

Speaker #4: So that strategy that you see in play. These numbers that we put on clinical trials dot gov are to give us flexibility in how many patients we want to enroll.

Hi guys. Thanks for taking my follow-up. I I wanted to touch up on something. I meant to ask early on as well. I think it kind of came up uh on a question few moments ago as well. So uh Filipe, I think you mentioned the original sample size was 14 to 21,000

Speaker #4: I don't want to have to change it 15 times. So we change it once, give a window, and then we'll end up somewhere there.

Philippe Martin: I don't want to have to change it 15 times. We change it once, leave a window, we'll end up somewhere there.

Philippe Martin: That's exactly the latter, right? Which is that we are letting it enroll. This is a sizable study. We spend quite a bit of time and energy and money, quite frankly, in this study, so we want to leverage it as best we can. Getting that data will be important for positioning of the drug and therefore we believe it is important to let it run as close to the time point where we're going to lock the data. Which will mean that we'll have more events that we need eventually, right? For the timing of the primary endpoint, that allows us to get there faster than if we were to stop now and wait for the events to occur, right? That's that strategy that you're seeing play. These numbers that we put on ClinicalTrials.gov are to give us flexibility in how many patients we want to enroll.

Speaker #1: And with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.

Operator: With that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.

Speaker #4: Thank you very much. And let me close with just three thoughts here. First, our second quarter performance and indeed sort of the strong first half results reinforced that the strategy we outlined early in the year is working.

Scott Smith: Thank you very much. Let me close with just three thoughts here. First, our Q2 performance, the strong H1 results reinforce that the strategy we outlined earlier in the year is working. Second, we're entering an important time period for our company. Over the coming quarters, we expect multiple regulatory milestones, important product launches, and continued progress across our pipeline. Finally, we're building a stronger company. We're improving the quality of our earnings, strengthening our operating model, sharpening our portfolio, and investing behind the opportunities we believe will drive sustainable long-term growth. We're excited about the opportunities ahead, confident in our ability to execute, and believe Viatris is well-positioned to deliver sustainable long-term value to shareholders. Thank you very much for your attention this morning.

Speaker #4: Second, we're entering an important time period for our company. Over the coming quarters, we expect multiple regulatory milestones important product launches and continued progress across our pipeline.

Exactly what, uh, the the, the last the latter, right? Which is that we are letting it enable. Uh, this is a sizable study, we spent quite a bit of time and energy in, um, and and Monique quite frankly in this study. So we want to leverage its uh, as as as best we can, uh, getting, uh, that data, um, will be important for, uh, positioning of the drug and and um,

Speaker #4: Finally, we're building a stronger company. We're improving the quality of our earnings, strengthening our operating model, sharpening our portfolio, and investing behind the opportunities we believe will drive sustainable long-term growth.

and therefore, uh,

we believe it is important to let it run as as

Speaker #4: We're excited about the opportunities ahead, confident in our ability to execute, and believe Viatris is well positioned to deliver sustainable long-term value to shareholders.

Speaker #4: Thank you very much for your attention this morning.

Operator: With that, we'll be concluding today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

Philippe Martin: I don't want to have to change it 15 times. We change it once, give a window, we'll end up somewhere there.

Scrolls through the time point where we're going to block the data, um, so which will mean that we'll have more events that we need eventually, right? But, uh, but for the timing of the primary endpoint that allows us to get there faster than if we were to stop now and wait for the events to occur, right? So that's, that's that strategy that you see, you see in play these numbers that we put on Pico trials, that gov are to give us flexibility in in uh, in how how many patients we want to enroll. I don't want to have to change it 15 times um so we change it once give a window and then we'll we'll end up somewhere there.

Operator: With that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.

Scott A. Smith: Thank you very much. Let me close with just three thoughts here. First, our Q2 performance, and indeed sort of the strong H1 results reinforce that the strategy we outlined earlier in the year is working. Second, we're entering an important time period for our company. Over the coming quarters, we expect multiple regulatory milestones, important product launches, and continued progress across our pipeline. Finally, we're building a stronger company. We're improving the quality of our earnings, strengthening our operating model, sharpening our portfolio, and investing behind the opportunities we believe will drive sustainable long-term growth. We're excited about the opportunities ahead, confident in our ability to execute, and believe Viatris is well-positioned to deliver sustainable long-term value to shareholders. Thank you very much for your attention this morning.

And with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to Scott Smith CEO for closing remarks.

Thank you very much and let me close with just 3, thoughts here first, our second quarter performance and indeed sort of the strong first, half results, reinforced that, the strategy we outlined earlier in the year is working.

Second, we're entering an important time period for a company. Over the coming quarters, we expect multiple regulatory Milestones important, product, launches, and continued progress our pipeline.

Finally, we're building a stronger company. We're improving the quality of our earnings. Strengthening our operating model sharpening. Our portfolio and investing behind the opportunities. We Believe will drive sustainable long-term growth.

Operator: With that, we'll be concluding today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

We're excited about the opportunities ahead, confident in our ability to execute, and believe Viatris is well positioned to deliver sustainable, long-term value to shareholders. Thank you very much for your attention this morning.

And with that we'll be concluding today's conference call and presentation. We thank you for joining you may now disconnect your lines.

Q2 2026 Viatris Inc Earnings Call

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