The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: David Amsellem - Piper Sandler - Analyst
: So, first, I guess on the warning letter and the remediation, I guess any time there is a warning letter, you can't help but wonder are there potential
issues with quality control at other facilities. So I guess, can you just talk about your level of confidence that this is something that is contained, to
endure and not something that you're worried about in terms of 483s and potential warning letters at other sites. So, that's number one.
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FEBRUARY 27, 2025 / 1:30PM, VTRS.OQ - Q4 2024 Viatris Inc Earnings Call
Number two on Cenerimod and Selatogral, just given your comments on enrollment, can we assume that these are going to be '27 events in terms
of the data? It doesn't look like '26 may happen, but I just wanted to get your thoughts there regarding the timing of Phase III.
And then just lastly, just given your comments on capital deployment and your past comments and activity on M&A, I guess my question here is
going forward, what does Viatris want to be longer term? I mean, do you want to lean more into brands? Are you looking more at returning capital
to shareholders and comfortable with the current business? I guess just a bigger picture question in terms of where you want to take the company?
Question: Ash Verma - UBS - Analyst
: So I wanted to understand the implications for 2026. So typically, these type of warning letters can take a minimum of 2 years to resolve. I know
you said that (inaudible) was already going to go off, but did you have some offsets planned for it already? And then secondly, just with today's
update, I mean right now, the stock is trading 12% to 15%, down in pre-market. Why not be more aggressive on the buyback beyond what you've
guided here?
Question: Ash Verma - UBS - Analyst
: So with today's update right now, the stock is trading sort of mid-teens down in pre-market, why not be even more aggressive on the buyback
here beyond what you've guided.
Question: Chris Schott - JP Morgan - Analyst
: Maybe first, can you just elaborate on the scope, the size and timing of the enterprise review you mentioned on the call? I'm just wondering is this
something that's part of just ongoing efficiency efforts or something more substantial potentially?
And then my second question was on Indore and gross margins, can you just walk through a little bit when we think about the year-over-year step
down in gross margins, how much of that's coming from Indore and how much of that's coming from some of the factors that you cited?
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FEBRUARY 27, 2025 / 1:30PM, VTRS.OQ - Q4 2024 Viatris Inc Earnings Call
Question: Jason Gerberry - Bank of America - Analyst
: So just for me, maybe I missed this, but why does the Indore facility issues have an impact on revenues outside the United States? And then my
second question, just thinking about your generic pipeline assumptions for 2025, what are you thinking in terms of a, I know this isn't like a new
product issue, but like, is generic Symbicort a headwind in 2025 due to competition? And how would you frame maybe the risk profile and aggregate
of the pipeline contribution this year versus last year's pipeline contribution?
Question: Umer Raffat - Evercore - Analyst
: First, Scott, Doretta, for you. At the conference in January, you guys talked about for the Indore warning letter, you guys mentioned it's 11 products
and 4 of the 11 were exempt and more could get exempt, so most folks listening in just assuming what, hundreds of products in this company, 11
of them, so probably not so much. But the type of EBITDA hit we learned about today, considering also that you knew generic (inaudible) was one
of them, I'm just curious about the thought process around how you guys communicated that to investors previously.
And secondly, on the Idorsia deal, I'm just curious what's the new information you've learned perhaps on a blinded basis for the ongoing trials
which drove the decision to put in another $100 million which was technically what Idorsia was going to contribute to the R&D. And I acknowledge
they couldn't get their licensing deal done, but just curious about your thought process as well.
Question: Balaji Prasad - Barclays - Analyst
: Firstly, curious about the investor day, you have your task clear for you in getting Indore clear, new complex generics launches on track, and some
of the key pipeline events seem to be geared for late '25 or 2026. So what would the focus of the investor day be? Is it more of incremental updates
or are you envisaging a strategic shift? That is one.
Two, probably a minor follow up on Indore, it's reassuring to see that you're in control. Is there any commitment from the FDA on the timelines for
reinspection in terms of service level from the time you tell them that you're ready for an inspection?
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