Hi, good morning, and welcome to day two of the Jefferies Healthcare Conference. My name is Dennis Thinnes, PEC Pharma analyst here at Jefferies. I have the great pleasure of having Beatrice here, the CFO, Doretta, and the CMO, Corinne, here up with me. Welcome. Before we kind of talk a little bit more about the business, I would love to understand your take on the broader macro and regulatory environment that's going on with regards to the generics and things like that, and how Beatrice is necessarily thinking about all the different dynamics that are going on in the environment right now.
Thanks, Dennis. It's great to be here, and thank you for having us. Yes, it's certainly an evolving and dynamic market. I know you have a lot of questions, and I'll get into that, but I thought it would be great if I could just take a step back and give a quick update on where we are, because I think that will also impact kind of how we think about the macro environment. Because kind of this year is really a focus on execution for us. We reported first quarter earnings a few weeks ago, and we're really off to a solid start executing against our strategic priorities. Our sales were in line with our expectations across all segments, really highlighted by operational growth in China and in Europe.
If you exclude the impact from Indore, we actually grew approximately 2% on a device-adjusted operational basis in spite of the evolving policy dynamics. We had four positive phase three milestones with positive data readouts from meloxicam, Xulane low dose, MR-142, and we also filed Effexor GAD in Japan. Our free cash flow was very strong in the first quarter, which really enabled us to execute against our capital allocation plan. We returned approximately $450 million to shareholders via both dividends and share purchases. With respect to Indore, it comes up, we remain on track to submit a request for reinspection mid-year. Finally, we did reaffirm our outlook based on the trends that we saw in the first quarter for the year, which does include approximately 3% growth excluding Indore for the year.
We were able to do all of that with respect to the kind of ongoing policy dynamics. We understand it's an evolving situation. I know we have some questions around tariffs, et cetera, that we'll get into, but our real focus in light of everything going on is really to continue to focus on what we can control, which is our execution.
Sure. Maybe you can talk a little bit about the tariff situation. How is Beatrice thinking about tariffs in general? What is the exposure to the company? How are you kind of scenario planning on if tariffs were 25%, 50%, or maybe no tariffs at all? How are you thinking about those scenarios?
Yeah. To your point, there is still a lot of unknowns with respect to where and what type of tariffs may be levied on the pharmaceutical sector. We have been engaged in a lot of conversations with a number of stakeholders. That includes the administration, that includes Congress, really focused on kind of the impact that tariffs could have on patient access. To your point, a little bit of background about our business. About 25% of our overall sales are in the US. Within that, a little over 50% of our US sales are actually produced here in the US. The main countries where we get imports from are Ireland and India. In the US, we have about eight sites across manufacturing, R&D, and packaging. We actually produce approximately 8.5 billion doses annually here in the US.
The U.S. is a critical part and is a really important part of our manufacturing. Specifically, as it relates to generics, we did participate in the 232 investigation process. Our focus was articulating, one, the value proposition that generics play to patient access, the fact that over 90% of U.S. prescriptions are generic, but they only represent a little over 1% of U.S. healthcare costs. The challenges associated with kind of increasing domestic manufacturing in the short term, as well as the potential risks that tariffs may cause to supply shortages. Our focus right now is on education. Internally, we are, to your point, also focused on exploring potential mitigation strategies as well.
Can you kind of outline some of your initial thoughts around mitigation strategies? Maybe talk a little bit about manufacturing capacity in the US and how much room there is left to ramp up or scale up?
Yeah. To your point, we do have eight facilities here in the US spread across our network. We are looking at a number of mitigation strategies. That includes, number one, to your point, increasing production at our existing US facilities. In the short term, adjusting our inventory levels here in the US market. We are also looking at exploring opportunities to optimize our global network. That includes looking at site transfers. That includes leveraging additional third-party manufacturers. That also looks at potentially exploring opportunities to further invest in our US manufacturing footprint. I do not know, Corinne, if you would add anything as well.
Yeah, we're also looking at the possibility of passing on price increases to customers. Now, as you know, from a pricing point of view, the generic market, and specifically the legacy generics in the US, is a very competitive market, and our customers are very focused on pricing. In the short term, we see maybe limited possibilities to address price because we have limitations with our contractual terms and notice requirements. In the mid to long term, and we would do this in collaboration with our customers in partnership with them, we might be able to increase prices where it fits, and with also the goal of limiting supply shortages. Not an impact in the midterm, which potentially, if those tariffs happen, we could have reduced margins and impact on drug supplies. Maybe in the mid to long term, that's a possibility.
Okay, perfect. When you talk about mid to long term, are you thinking about a few years or how long are the contracts in place for?
Right. So our contracts are multi-year contracts. Now we know we have evaluating possibilities to re-enter the negotiations depending on the terms of the contracts. We need to take into consideration as well the PBM cycles, which usually are on a yearly basis. These are the constraints we are facing.
Okay, that's helpful. Around Indore, can you just remind us the situation there? I know you guys will or have submitted a request for a reinspection. Remind us, when do you expect that situation to resolve?
Yeah. To your point, we continue to make progress with respect to the remediation efforts. We have also engaged with third-party subject matter experts to help us with respect to remediation. We remain kind of on track. At this point, we are almost through our internal remediation process, and we anticipate being in a position to submit a request for reinspection around mid-year. With respect to the overall impact, we highlighted our anticipation for the full year of Indore to have about a $500 million impact for the year. That still remains the case. I would just remind people that we have highlighted that the impact is going to be a little bit more first half weighted versus second half weighted.
We saw about a $140 million impact in the first quarter, and we think the second quarter is going to be in and around kind of that same level from a revenue perspective.
Okay. Okay, that's helpful. Maybe walk us through the back of the envelope math around that $500 million estimate, maybe in broad strokes. I'm just wondering, what are the pushes and pulls on that? Is there upside in terms of if you guys are being overly conservative there, or if there's downside, if you guys are assuming more or less of an impact than you would expect?
Yeah. The way we've characterized the Indore impact, about 40% of it is due to lenalidomide. That was slated to go generic or have additional generic entrants in early 2026. We don't anticipate kind of recovery of that in the short or long term on lenalidomide. About $100 million of that is due to penalties and supply shortages that we're kind of actively working. Again, we don't anticipate that kind of continuing into next year, and we're actively working to help mitigate, but that also is one time. The remainder of the impact just has to do with kind of ongoing shortages, mainly with respect to our ARV business. It is a situation that we're kind of ongoing, we're continuing to work on. Everything is on track.
Like we did in the first quarter, we'll continue to keep people updated on the Indore impact as we move through the year.
Okay. Given some of the changes at the FDA, how have your conversations been with the agency recently? Have you noticed any changes in tone or maybe it takes them a little bit longer to respond given the changes? Just talk to us a little bit about that.
We continue to have an active dialogue with the FDA. Obviously, there's unknowns both with respect to as it relates to manufacturing inspections, but also on the part of regulatory approvals. We have not noticed a change to date, but it is the situation that we're actively monitoring. Discussions are ongoing.
Okay. Jefferies hosted yesterday Marty McCarry here for a great fireside. One of the things that he noted was just the disparity around CMC inspections in the U.S. versus outside of the U.S. He would really like that to be more equalized or closer to parity. I am just curious from your perspective, how would that impact maybe Indore or some of the other facilities ex-U.S. as you think about the next few years?
Yeah, it's hard to predict. We don't get notifications with respect to when FDA is going to inspect our facilities. To give you some color, we did have three FDA kind of significant inspections last year. One was in Indore, the other one was in Carroll Park, Australia, and the third was in Nashik, which was also in India. We can't predict where and when the FDA will inspect.
Okay. We talked a little bit about the business in 2025. Talk about the factors impacting some of the back cap weighted revenue cadence for this year.
Sure. As you look at our base business, as Doretta mentioned earlier, we actually in the first quarter delivered a 2% growth, so operational growth excluding the impact of Indore. We continue to expect a 3% operational growth for the rest of the full year. This was a function of a few things. First, in the US, we see a relatively stable pricing environment. We will see growth of some of our complex products like Breyna, like Xulane. We see as well that we're going to launch more complex products in the US. In Europe, we see growth across our diversified portfolio, notably good performance in countries and markets like France and growth of key brands like Creon, like Brufen, our thrombosis portfolio as well, doing very well. In Greater China region, in China, strong growth also. We anticipate that this growth will continue.
We are very pleased with our performance there. You ask about the phasing of our revenues. The second half of the year represents about 52% of the full year revenues. The new product launches are expected to be more in the back half of the year. That includes key products like octreotide, iron sucrose, lanreotide. We also have, like every year, the normal seasonality that we see in the second half versus the first half, notably InfluVac, which is our flu vaccine in Europe.
Okay. In terms of the new launches, can you just help frame the magnitude of revenue that we could expect in the second half from those launches or maybe even just the opportunity for those new launches?
Yeah, I do not know if we have, we do not highlight the specific revenue attributed to any one product. I think what we have talked about on an ongoing basis is we expect to generate between $450 million and $550 million of aggregate new product revenues per year. To Corinne's point, in light of some of the back half kind of weighting around some of our new products, we do expect kind of the ratio of the $450 million to be slightly second half weighted. There is no specific kind of numbers we ascribe to any one key product because of the portfolio approach we take.
Okay. Do you have any updated thoughts on FX for the year?
Yeah, it has been a volatile situation with respect to FX. As a reminder, our business, approximately 75% of our revenues comes from outside of the U.S. What we've talked about is if current rates hold, we kind of expect to offset the 2%-3% headwind with respect to FX that we had provided when we gave guidance. That is the magnitude of how we're thinking about FX.
Okay. Why don't we shift over to the pipeline as well as BD? Walk us through your thinking around BD and just around the cadence of deal flow. Should we expect another deal this year or just broad strokes in terms of the timelines?
Yes. BD is still a strategic priority for the company. Our focus really is on adding kind of and expanding our portfolio of in or near-to-market assets that can add durability and, importantly, accelerate our top-line growth. That does include regional BD where that could be immediately accretive that we can tuck into our base business and really kind of leverage our global network. We have always talked about kind of a 50/50 split between allocating our capital between BD as well as capital return. What we have talked about this year is prioritizing capital return a bit more than BD. As we have talked about our available cash flow for the year, kind of if you use the midpoint of our guidance of about $2 billion, we have about $1.7 billion of deployable cash flow.
Even factoring in what we've talked about from a kind of capital deployment perspective, we still have about $500 million-$600 million of strategic flexibility this year. It is important for us to maintain that strategic flexibility, just one, given the dynamic macro environment we're in. We are also going to continue to evaluate both opportunities to add to our portfolio, but also continue to evaluate ways to maybe be more aggressive on the capital return.
Is there a particular type of therapeutic area or asset or synergy that you guys are looking for when you're looking across the landscape and thinking about BD?
Yeah. I mean, I would characterize it in a couple of buckets. One, obviously kind of immediately accretive regional deals where we can leverage our existing kind of infrastructure and our global network. I would also say secondly, it's looking at where we kind of have additional opportunities. The most important thing to us is to find opportunities where we think we can be successful and have the right assets that are durable and will really contribute to our top-line growth. We have existing infrastructure in ophthalmology. We have a respiratory franchise. We have women's health. We've talked about dermatology as well as GI as areas. We really have the infrastructure to be kind of opportunistic in terms of where we play. The most important thing is to kind of leverage the skill set that we have and find ways where we can be successful.
Okay. On R&D, can you just remind us what are some of the key readouts that Viatris will have this year?
We had about, at the beginning of the year, we've talked about the six, we anticipated to have six phase three readouts this year. Four of them have already read out and have been successful. That includes Xulane low dose, that includes meloxicam that we reported out a few weeks ago, as well as MR-142 in ophthalmology just this past week. We also filed Effexor GAD in Japan. We have two more anticipated readouts in the first kind of this year. We've talked about the first half of this year, and those are both in ophthalmology.
Okay. Is there any particular readout or an asset that you think that investors should really focus on this year?
I would say, one, it's the kind of totality of the execution track record that we've been able to kind of achieve over the course of the first half of this year. We were very pleased with the meloxicam data that we reported and just the level of differentiation and the opportunity set there. I would also say we're also excited about the totality of the assets that we have in our ophthalmology franchise, whether it's in blepharitis with pimecrolimus, as well as some of our assets. We have a real opportunity to expand upon our existing ophthalmology footprint.
Okay. If we can kind of talk a little bit about meloxicam because I find that asset pretty interesting. So can you give a quick recap of the phase three data and just the opportunity that's out there for pain?
Yeah. We were very pleased with the top-line results of our phase three program for fast-acting meloxicam. As a reminder, fast-acting meloxicam has been specifically designed for rapid onset of action and is being developed for moderate to severe acute pain. We have hit on all our primary and secondary endpoints across the different trials. We have demonstrated that we can have statistical significance in terms of pain improvement versus placebo and reduction of pain that is clinically meaningful versus the background and the baseline. Importantly, what we have shown as well is that the safety profile was excellent. We showed that repeatedly in all our phase three programs, which confirmed the phase two data that we had as well. One thing I want to add is that in the trial design, we also had a comparative arm versus an opioid, tramadol.
What we demonstrated here is that fast-acting meloxicam, in fact, had a better and a superior pain control than tramadol. That is a very important data point, especially as we look at the possibility for opioid-sparing capacity. We should demonstrate this in our phase three program. Also, we had a higher number of patients who were completely opioid-free versus the placebo group. Of course, we just had the readout of this data. It is still maybe very early to talk about how we are going to position this product. I can see that with the data that we have in hand, this product is well positioned to play an important role in the management of moderate to severe acute pain.
If I give you a bit of how we consider the commercial opportunity, if you look at the US, there are about 70-80 million cases of acute pain annually. The majority, maybe half of those patients, still receive opioids, so despite the addictive properties of opioids. We believe that fast-acting meloxicam has the potential to be a real good alternative for these patients. We have designed the development program so that potentially we could have a broad label. We will be discussing, obviously, the data with the FDA. Potentially, we could treat patients post-surgery in inpatient setting, outpatient setting. We also have data in dental pain.
We are evaluating the opportunity, but we will commercialize this product as a branded asset and exploring capitalizing first on the capabilities that we have, notably in the hospital setting, in institutions in terms of contracting, but also establishing a specialty sales force to be able to compete appropriately in this market.
Sure. When will you submit this to the FDA? Which [crosstalk] way to submit it?
Our regular timeline is that we are going to submit to the FDA in the second half of this year.
Okay. And to be clear, meloxicam is a non-opioid?
It's a non-opioid.
Okay. Excuse me. How should we think about broadly the No Pain Act and where meloxicam could capitalize on some of the reimbursement tailwinds there?
Yes. No, absolutely. The No Pain Act will be an important lever for us as we commercialize these products in Medicare and Medicaid. States will have the possibility. I think to date, 11 states already passed the act to favor the reimbursement of non-opioids. I think it will be a favorable policy as we launch meloxicam. I think the No Pain Act is supposed to be in place until 2028, I believe.
Yeah. Okay. Right now, Vertex is launching their non-opioid acute pain product. Is there any kind of takeaways or learnings that Viatris has from looking at that launch and how you guys could apply that to meloxicam?
No, we'll be obviously watching what the competition is doing. But we're very pleased with our data, which I believe compare very favorably to Suzetrigine. I will repeat that I really think that fast-acting meloxicam can play a strong role in those patients post-surgery after very painful surgeries like bunionectomy, for instance. That's where we generated our data, but also in other settings, dental care mentioned, but in other areas of acute pain.
I would just add, it really highlights, one, the size of the market, right, and the real need for non-opioid kind of treatment options generally. I think the success bodes well for kind of the class in general.
Okay. You guys will be looking at a broad label, not just necessarily bunionectomy?
That's correct. I mean, I think, as I said, our development program has been designed in such a way that we could potentially have a broad label.
Okay. Good. In the last one or two minutes, do you guys have any final messages for investors and shareholders who are interested in the space and in Viatris?
Yes. Thank you for the time and allowing us the opportunity to share some of our updates. I would just say that this year, really, as I started, is a year of execution and us delivering on the strategic priorities that we set at the beginning of the year. That includes really driving strong commercial execution, including base business growth, excluding the impact from Indore, really advancing our pipeline where we've already had four positive phase three readouts, prioritizing capital return with the focus on share buybacks, but also targeting accretive business development, completing the remediation of our Indore facility and requesting for resubmission, and also conducting our enterprise-wide strategic review. We look forward to updating our investors on updates and the progress that we have through the rest of the year and just maintaining an active dialogue.
Perfect. Thank you so much for the time. Thank you for being here. We are all excited about the outlook ahead. Hope you guys have a great conference.
Thank you.
Thank you.