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Philippe Martin

Thank you, Scott. We have strong momentum advancing our Phase 3 programs, which is one of our key priorities this year. We previously mentioned that we would have six Phase 3 readouts in 2025. We've already had the first three readouts, and I'm pleased to report that all three are positive. These programs are now moving to the regulatory submission preparation phase.
Let's begin with the Phase 3 readout of our investigational MR-107A-02 program for the treatment of moderate to severe acute pain that we announced earlier today. The development of safe and effective alternative treatments to opioids is an important public health need. The improvement in pain we observed from our fast-acting meloxicam compared to placebo was statistically significant and clinically meaningful, building on an established mechanism of action and well-characterized safety profile.
All primary and secondary endpoints were met in both Phase 3 studies. These results were consistent across multiple post-surgical models of moderate to severe acute pain. We believe that when approved, this oral non-opioid analgesic option for the treatment of moderate to severe acute pain will get us closer to addressing this important public health need.
In addition to placebo, these trials included an opioid arm, Tramadol 50 milligram given every six hours to confirm the sensitivity of the pain model. Importantly, and in contrast to recently approved agents, our fast-acting meloxicam demonstrated superior pain control versus the opioid arm in both surgical models, further strengthening its value as a potential non-opioid option for acute, moderate to severe pain. For context, this regimen of Tramadol equals 40 year-old morphine equivalents, which is two-fold higher than hydrocodone 20 milligram.
Additionally, our fast-acting Meloxicam demonstrated a significant reduction in opioid usage across both studies. This was demonstrated by a significant reduction in opioid use versus placebo and a significantly higher number of opioid-free patients on fast-acting Meloxicam than placebo. Our fast-acting Meloxicam were generally well tolerated. In both studies, incidence of TEAEs was comparable to placebo in a post-surgical setting. Few severe TEAEs and SAEs were reported with a rate consistent with placebo. No TEAEs leading to death were reported.
These two pivotal studies optimally position our fast-acting meloxicam for potential first-line treatment for moderate to severe acute pain. The company is targeting to submit a new drug application to the FDA by the end of the year based on the positive data from these two Phase 3 studies and the supportive positive Phase 2 dose-ranging finding data in dental pain. We also anticipate that the full data set from both Phase 3 studies will be presented during the PAINWeek Medical Conference in September in Las Vegas.
Next, let me provide more details about the positive results from our investigational XULANE LO Phase 3 readout that we have also announced today. There are three important conclusions from the study. One, it confirmed the effectiveness of XULANE LO weekly patch for birth control in women of childbearing potential.
Two, it demonstrated a favorable safety and tolerability profile with most TEAEs reported as mild to moderate and no new safety concerns identified. And three, it demonstrated potential best-in-class patch performance with very few patches completely detaching over the seven-day wearing period, and less than 1% of trial subjects reporting severe local application site reactions.
Overall, we are pleased with the results, and believe XULANE LO also has the potential to address an important unmet need for women seeking a reversible birth control option with a lower dose of estrogen. We also design our patch with certain texture and sizing properties that we believe could be appealing to women who are seeking another weekly birth control patch option.
Viatris has a long history and strong track record of developing and manufacturing dermal patches at our R&D and manufacturing facilities in Vermont. We are looking forward to progressing this product toward regulatory submission, which we anticipate will be in the second half of this year. We also anticipate that the result from this Phase 3 study will be presented at the next American College of Obstetricians and Gynecologists Conference.
Our remaining Phase 3 readouts anticipated this year relate to our ophthalmology programs. We remain on track to receive three key Phase 3 registrational readouts in the first half of the year. These include Pimecrolimus for blepharitis, Phentolamine Ophthalmic solution for presbyopia and for visual loss in low-light condition associated with keratorefractive surgery.
As for other advancements in our pipeline, our regulatory team is hard at work advancing key submissions. We recently filed application to the Japanese health authorities for approval of EFFEXOR for the treatment of adults with generalized anxiety disorder.
There is no other treatment option currently approved for this indication in Japan. Our positive results from our previously announced Phase 3 efficacy and safety studies laid the foundations for our applications. We are also pleased that these results have been accepted as a poster presentation at the Japanese Society of Neurology and Psychiatry Conference. In addition, we are focused on preparing our submissions for Sotagliflozin in a number of ex-US markets. Our findings in UAE and Saudi Arabia have been submitted, and we expect to submit our findings in Canada soon.
Moving to Selatogrel and Cenerimod. Enrollment for both programs remains on schedule. We recently presented data at PANLAR that covered the multifaceted immunomodulatory properties of Cenerimod. Also, we are pleased to share the acceptance of our abstracts covering data from the additional analyses of the Phase 2 care study, providing information related to fatigue and quality of life at LUPUS 2025 and maintenance of response at EULAR 2025.
We look forward to continuing to engage with the rheumatology and LUPUS scientific and patient communities at several congresses throughout the year. For Selatogrel, we had very productive discussions at the recent American College of Cardiology Congress and continue to see strong interest in the trial within the cardiology community.
Lastly, regarding our best business portfolio, we are on track with the approvals required for us to deliver $450 million to $550 million of new product revenue this year, including our anticipated approval for Iron Sucrose, Octreotide, and Liraglutide. Overall, it's a strong start to the year. Our R&D strategy is driven by our deep in-house development capabilities and expertise. And we are very pleased with our steady discipline progress today.
I will now turn the call to Doretta.

Theodora Mistras

Thank you, Philippe, and good morning, everyone. I'm glad you could join us. Today I will walk you through the key drivers and takeaways for the quarter. The progress we're making against our capital allocation plan and our outlook for the remainder of the year.
Our first quarter results were in line with our expectations and reflect our well diversified global business. Total revenues for the quarter were $3.25 billion, down 2% versus the prior year. The impact from Indore in the first quarter was approximately $140 million, which was in line with our expectations. Excluding this impact, operational revenue would have increased 2% versus the prior year. As Scott mentioned, the remediation effort at Indore is progressing as planned.
Our revenues benefited from growth in our brands of 3%. This was primarily driven by the expansion of our cardiovascular portfolio in emerging markets and growth in greater China and developed markets. In developed markets, overall net sales were impacted by declines in our generics business, partially offset by growth in brands.
From a regional perspective, we continue to see consistent and durable growth from our European business, growing approximately 1% this quarter. The brand portfolio grew 2% led by Creon, Brufen, and our Thrombosis portfolio. Generics performance was flat year-over-year despite the Indore impact and continues to benefit from key markets, such as France.
Our North American business decreased 8% versus the prior year, primarily as a result of the Indore impact and competition on select generic products which was expected. This was partially offset by new product revenues and continued growth in Breyna. In emerging markets, net sales decreased approximately 5% versus the prior year, primarily driven by the Indore impact and customer buying patterns affecting the ARV generics business. Partially offsetting this performance was growth in brands across the cardiovascular portfolio in certain Latin American countries and continued strengths in the MENA and Eurasia regions.
In our JANZ segment, net sales decreased approximately 6%. Results were primarily driven by expected government price regulations in Japan and Australia and a change in reimbursement impacting off-patent brands in Japan. This was partially offset by volume increases in the generics portfolio. Lastly, we see continued positive momentum in greater China. Net sales grew 4%, which was as a result of our diversified model across e-commerce, retail, and private hospitals. This led to growth across the portfolio, particularly brands that are sensitive to proactive patient choice.
In looking at the P&L, adjusted gross margin of approximately 56% in the quarter was in line with expectations. As anticipated, margins declined versus the prior year due to price regulations and JANZ, the impact of Indore, and the increase in certain product supply costs. Operating expenses were roughly flat versus prior year. Cost savings initiatives benefiting SG&A were offset by investments in R&D to advance our innovative pipeline.
Finally, the company had a triggering event for goodwill impairment testing in the first quarter due to a decline in our share price and the increased uncertainty and volatility in the geopolitical and economic environments in which we operate. As a result, for US GAAP purposes, we recorded a non-cash goodwill impairment charge of $2.9 billion, driven by an increase in discount rate assumptions reflecting the increased business risk. Despite this, we remain confident in our base business outlook and in our ability to deliver on our expectations for the year.
Turning to free cash flow, for the quarter it was $493 million and would have been $535 million excluding transaction costs and taxes from the divestitures. Moving to capital allocation, we continue to prioritize capital return and since the beginning of the year, we have repurchased over $300 million worth of shares. Including our Q1 dividend payment, we are pleased to have already returned more than $450 million of capital to our shareholders.
Now, a few comments on our outlook and phasing for the rest of the year. Based on the performance in the first quarter and trends we are seeing across the business, we are reaffirming our outlook for the year. Within our guidance, the drivers of total revenue include no change to the base business outlook, including the estimated financial impact from Indore, and continued confidence in meeting our new product revenue range of $450 million to $550 million.
While foreign exchange has been volatile, we've seen spot rates move favorably over the past month. And if current rates hold for the remainder of the year, this could offset the 2% to 3% headwind we had previously incorporated in our full year revenue guidance.
Due to finalizing an agreement to expand our commercial rights for Cenerimod, adjusted EBITDA and adjusted EPS guidance reflects a $10 million impact from IPR&D. Adjusted EPS also reflects the benefit from share repurchases executed to date. It's important to note that our guidance does not account for any potential impact related to industry tariffs.
With regards to anticipated phasing for the rest of the year, total revenues are still expected to be higher in the second half at approximately 52% of our full year outlook. This reflects the estimated impact of Indore, normal product seasonality, and back-weighted launches of new products. Adjusted EBITDA and adjusted EPS are still expected to be higher in the second half. And as a reminder, free cash flow is expected to be lowest in Q2 due to timing of semi-annual interest payments and working capital requirements.
In conclusion, I want to take the opportunity to reiterate our confidence in the fundamentals of our business and the progress we continue to make executing against our strategic priorities. Our well-diversified global business and our strong cash flow enables us to continue delivering on returning capital to our shareholders. We believe we are well positioned to meet our expectations for the remainder of this year.
And with that, I'll hand it back to the operator to begin the Q&A.

Question and Answer Session

Operator

Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions)
Chris Schott, JP Morgan.

Chris Schott

Great. Thanks so much. Just two questions for me. Maybe first on the meloxicam opportunity. Can you just help us frame out how you're thinking about the peak sales opportunity and kind of the ramp once approved for this drug? And how much of your existing infrastructure can you leverage to launch the product?
And then my second question was just on tariffs. Scott, I appreciate some of the comments in the opening remarks, but for the 50% of your sales in the US that aren't manufactured domestically, how should we think about the company's ability to mitigate the impact there? Maybe specifically, is there opportunity to take price tops off some of this, and is there capacity within the US manufacturing network to shift things to the US if needed? Thanks so much.

Scott Smith

Good morning, Chris, and thank you for the question. Let me answer the tariff question first, and then I'll kick it over to Corinne and to potentially Philippe to talk a little bit about meloxicam.
So yes, so more than 50% of our US revenues come from US-based manufacturing. We have eight manufacturing R&D packaging sites here. We already produce 8.5 billion doses here annually. The countries we import from into the US where we don't manufacture in the US are Ireland, the UK, and India.
And obviously, we don't know where tariffs are going to land, but we've been involved in a lot of mitigation strategies, both short-term and long-term, thinking about what it is that we can do. So we're focused on, of course, increasing production within the US network that we have already. We're looking at adjusting our inventory levels for the US market.
In the longer term, we're looking at things like transfers, leveraging third parties here in the US, investment potentially in a larger US network of manufacturing facilities. So, we can control only what we can control. I don't know where the tariffs are going to land, but we're looking at a wide variety of mitigation strategies to be able to handle any -- whatever comes at us from the tariffs.
And I will say though that, if there are significant tariffs enacted in the pharma sector, it's likely to have a financial impact on the company. I think, the degree to which I can't say, but we're doing everything we can to mitigate that. But from my perspective, just as important as that, or maybe more important as this idea of patient access, and I think the discussions that we're having with the administration and with Congress are around the ability of the generic industry particularly to be able to continue to provide access to patients for all medications.
So we're trying to get our messages across, but in the meantime we're very, very involved, I would say, on a daily basis talking about mitigation strategies to minimize any impact that may come both financially and for patients.
So I'll kick it over to Corinne.

Corinne Le Goff

Yes, so good morning, Chris. Before I give you a bit of some color on how we see the positioning of fast-acting meloxicam, I just would like to ask first, Philippe, to comment a bit on the data.

Philippe Martin

Yes. So -- thank you. I think the profile that we've seen we're very happy with from both Phase 3 studies. The results were very consistent across two studies. We made all primary and key secondary endpoints. And importantly, we were also able to show a superior profile versus our opioid comparator, which, as I said in my remark, is a highly potent comparator which has been shown to be highly efficacious in these two models of hernia and bunionectomy in clinical trials.
And it's about two-fold more potent than (inaudible) 20 milligrams. So we feel very strongly about our data versus this opioid comparator. On top of it, we were able to demonstrate significantly lower opioid usage than placebo in this study, which could be extremely important going forward. The safety profile was also well-tolerated. Incidence of TEAEs were comparable to placebo. Fewer TEAEs and SAEs were reported with a rate consistent with placebo as well. So overall, the benefit-risk profile emerging from these Phase 3 study positions is very well for first-line treatment.

Corinne Le Goff

So, Chris, obviously we are very pleased with the data. Just to give you an idea of how we look at the potential of this asset, it is potentially a large addressable market. There are about over 70 million acute pain cases annually in the United States. More than 80 million patients take pain medication for acute pain on a yearly basis, and we still see an over-reliance on opioids despite addiction risk. So the market demands for safer alternatives, non-saving alternatives, strong efficacy products with an established safety profile. And we believe that the novel fast-acting meloxicam can fit what the market is asking for.
So potentially, this asset could fit seamlessly both into the inpatient and outpatient care pathways. It will be a good treatment alternative for acute care management and has a very competitive profile. And we're in the process of refining our forecasts, so I cannot disclose any data at this point, but we'll make sure that we'll keep you abreast of our progress here.

Scott Smith

And just one final comment from me, Chris, and that is, I've been involved directly in a number of pain launches over my many years. When I take a look at this data, and it's really fresh and new data for us, it's very, very compelling. I think we have a really nice opportunity to have a major position in the acute market going forward here.

Operator

Ash Verma, UBS.

Ashwani Verma

Thanks for taking your questions. Maybe just on the share repurchases, I see you've done $300 million already and aiming for $500 million to $650 million. Is there more appetite here to go up substantially on the repo given where the stock is?
Then secondly, on MR-107, can you help us understand how fast acting is this? For example, how quickly does this get static benefit in terms of hours, let's say, on the primary endpoint on the Slide 15? And then can you get a fast-acting claim on the label versus, let's say, MOBIC. Thanks.

Scott Smith

So, good morning, Ash. And thank you for the question. And I'll take the first one on capital allocation. Philippe can talk a little bit more about the Meloxicam and the data. We've already, as you noted, repurchased more than $300 million to this point in time. We're going to -- we're firmly committed to our goal of $500 million to $650 million.
Given the environment and the volatility in the macro environment, we want to -- and tariff uncertainty and things -- we don't -- we want to keep a little bit of strategic flexibility in terms of our capital allocation. It's potential -- potentially we may lean in even more and do more than $650 million, but we're going to sort of let the year play out, given the uncertainty and see where we are. But give them where the share price is. This is the year where we've talked about really leaning into the share repurchases as an important part of our capital allocation plan.

Theodora Mistras

And importantly, I would also say nothing has changed in terms of our expectations of the ability to generate free cash flow for the year and have about $1.7 billion of deployable cash flow. And so, to Scott's point, we do have the strategic flexibility as we move forward to the year. We have multiple levers that we can push and play with.

Philippe Martin

Okay. Thank you, Ash. On the question about our fast-acting meloxicam in terms of time of response. We measured it in both Phase 3 studies. We looked at median time to meaningful pain relief and median time to perceptible pain relief. And we saw a fast-acting meloxicam to put this data in context against others and you have that data in the slide that we provided. But to put that data in context, we also did a post-hoc analysis where we looked at 2 points or more reduction in NPR from baseline, which has been demonstrated with others, and we were very fast with 95 minutes versus a placebo of 338 minutes.
So we feel that the fast-acting properties of -- our fast-acting meloxicam have been demonstrated in Phase 3 twice in both studies. As to whether we are able to get a claim, I think I don't want to speculate on what FDA may or may not do, but we certainly have the conversation with the agency.

Operator

David Amsellem, Piper Sandler.

David Amsellem

Hey, thanks. So, a couple for me. On Indore, can you talk about 2026 and the potential for impact to spill over into 2026. How should we think about that? Also, there's another facility in India, and I apologize if I missed any commentary on this, but can you talk about your inspection at the other facility in India that happened last year and where things stand on that.
And then switching gears regarding strategic priorities and BizDev M&A, can you talk to your appetite for taking on assets that are in mid to late stage development along the lines of Cenerimod and Selatogrel. How are you thinking about development stage assets versus your appetite for commercial stage brand assets? Thank you.

Scott Smith

So, thank you. Good morning, David. Yes, so the remediation in Indore is coming along fine. We are at progress as expected. We expect to submit a request for a reinspection mid-year. We can only control what we can control. We can't control the timing of that inspection. So we're making sure that we also qualify other plants in the network outside of Indore to be able to supply the US network. I think we'll see significant rebound in Indore-related products as we move into 2026. Some, like lenalidomide sort of go away as we get into 2026, but we should see some restoration of our products from Indore in 2026, and we don't think it will have a significant impact on our overall financials.
In terms of Nashik, the same status it's been, that inspection happened approximately a year ago. We got a 483. We have not heard from the FDA relative to the classification of that inspection. And we have importantly completed all committed actions that we agreed to with the FDA on that plan. So we're waiting to see. We've also qualified other facilities in the network as well in case there is any action in a Nashik. But we're waiting to hear back from the FDA on that. And again, we've completed all committed actions at this point in time.

Theodora Mistras

And just to add some color and contextualize on the potential Indore impact, we've talked about approximately $500 million revenue impact from Indore. As Scott mentioned, about 40% of that is lenalidomide related. And so, we don't anticipate that to come back. But about $100 million of that is due to penalties and short-term supply disruptions, which we don't anticipate occurring in 2026. And the remainder to Scott's point, we're in the process of either moving and is subject to the re-inspection and reputation of Indore.

Scott Smith

Thank you. And your second question was relative to our BD priorities. And I believe you said mid to late stage development assets. And first of all, I'd like to say that, we could not be more excited to have Cenerimod and Selatogrel in the portfolio. In the pipeline, the development of them is going very well. We've been able to accelerate the development and the timing of those assets. We've taken more control over the development programs. We've expanded the geography for Cenerimod. We're very, very excited about those assets.
However, our business development focus right now is for in-market or very near-to-market assets. We want to be able to build short-term revenue and EBITDA. So we're looking at assets that are closest rather than mid-stage development, either very, very late stages that are close to launch or in market is what our focus is right now.

Operator

Jason Gerberry, Bank of America.

Jason Gerberry

Hey, guys. This is Bhavin Patel on for Jason Gerberry. First question is that, the first quarter showed brand resilience, the generic weakness. So maybe if you can elaborate on the volume versus price drivers for key brands like Lipitor in developed markets in greater China. And then for generics beyond the quantified Indore impact, what drove the decline there and how sustainable is the overall 2% underlying core business growth, ex-divesters, ex-Indore that you saw this quarter?
And then my second question is that, the guidance assumes a significant second half ramp in revenue, EBITDA, and earnings per share. So maybe if you can provide some more color on the expected timing and contribution cadence within the second half from the key launches, including Iron Sucrose, Octreotide LAR, glucagon, which may or may not be needed to hit the $450 million to $550 million new product revenue target. Thank you.

Scott Smith

So, thank you very much for the question. Doretta, do you want to take that questions?

Theodora Mistras

Yes, so let's start with the brand resilience. And to your point, we feel good about the momentum that we've seen on the brand side. I would say, it was really driven in a couple of pieces. Number one, in China we continue to see good momentum and uptake in our brand portfolio. There we reported 4% growth this quarter. The other area is in Europe. We saw great growth in our portfolio there with Creon, Brufen, as well as our Thrombosis portfolio. And so overall, to your point, we are seeing good momentum in brands.
On the generic portfolio, that part of our portfolio has been the most impacted by Indore. If you ex the impact of Indore, I would say, expectations and the performance of our generic portfolio is actually performing in line with what we expect.
With respect to guidance in the second half, as we mentioned, we do expect our performance to be second half weighted. About 52% of our revenue we expect to hit in second half. There is a couple of pieces to that. Number one, the Indore impact is expected to be more acute in the first half versus the second half. The second piece of that is, just the ramp of new product launches. I'll have Philippe talk a little bit about how we think about that, but we do expect new product launches to be slightly more second half weighted. And we do have normal product seasonality that occurs in the second half, especially as it relates to some of our portfolio in Europe. And that's what's letting us to some of the trends that we're seeing between the first half and the second half.

Philippe Martin

Yes, and you mentioned a number of key launches. I just want to remind you that glucagon has been launched already. Iron Sucrose, Liraglutide and Octreotide are all scheduled for the second half of this year and so that's where we're on schedule with these three assets to get them approved in the second half.

Operator

Umer Raffat, Evercore.

Umer Raffat

Hi guys. Thanks for taking my questions. I have a few here if I may. First, if you could just remind us about your manufacturing network for your US business, the India facilities versus Morgantown and what percentage is made in US?
On meloxicam, I had a couple of questions if I may. First, your trials are obviously in acute setting, in surgery setting, where traditionally meloxicam takes a few hours to kick in. So congrats to you on the data. My question to you is, surgeons have historically hesitated doing NSAIDs for bleeding reasons in surgery setting, and to what extent do you see your products usage in acute setting versus in chronic settings like arthritis where meloxicam has been used?
Secondly, how do you think about potential risks with the [CMAX] because it definitely goes higher than the traditional meloxicam and if there's any potential bleeding risks. And finally, do you anticipate this being a hospital drug or not? Thank you.

Scott Smith

Thank you, Umar, for the questions, and nice to hear from you. The first one was relative to some facts around our US manufacturing network. We have 26 facilities in our network globally. We have eight facilities, manufacturing, packaging, R&D in the US. We manufacture approximately -- greater than 50% of our total revenues come from the US. The rest comes from combination of Ireland, the UK, and India. So that's a little bit of just a fact pattern of what our manufacturing footprint looks like. And obviously, given tariffs, we're looking at a number of short and long-term remediations if tariffs come and where they come from. So we're doing a lot of significant planning. We talk about it on a daily basis on things we can do to remediate, including taking a look at expanding our current US network, which again produces greater than 50% of our revenues.

Philippe Martin

Yes, and I will cover the three questions, I believe, on meloxicam. First of all, so first about the surgery setting. We studied in three clinical trials, one Phase 2 in post-surgery dental pain, bunionectomy and herniorrhaphy post-surgery. And we've seen no increased risk of bleeding as part of these three studies in our clinical studies. As a matter of fact, the safety profile was very much consistent with placebo, so we saw no increased risk in this post-surgery population.
In terms of CMAX, you're correct. The CMAX is higher. However, as I just said, it did not lead to -- in an acute setting, lead to additional -- any additional risk of bleeding. We have not seen any of it in the Phase 2 and Phase 3 program. So to the last question about hospital drug, I'll give that to Corinne to answer.

Corinne Le Goff

Yes, so we believe that this fast-acting meloxicam definitely could be used already in the hospital, as it was done in the clinical trial setting, but also, of course, for outpatient usage. And we're also looking at not only utilization of the product post-surgery, but also in any episode of acute care. And that could be dental acute pain or other type of acute pain, as we have also demonstrated very positive data in Phase 2 model in dental pain.

Operator

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

Scott Smith

Thank you very much, Stuard. In closing, we've had a really good start to the year. We've got operational performance in line with our expectations, significant pipeline progress, continued capital and return to our shareholders. We remain very optimistic about the future of Viatris.
Our growing pipeline, capital discipline, operational excellence, and significant global scope give us confidence in our ability to navigate through periods of volatility and uncertainty that our industry has been experienced for much of the year.
Thank you all very much for your attention this morning.

Operator

Ladies and gentlemen, the conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.