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: Balaji Prasad - Barclays - Analyst
: Got it. Understood. We'll dig into each of these, Scott. The other major thing that you mentioned on the earnings call was also the
enterprise review that you're launching on. So could you comment on the scope, size, and timing of this enterprise review and what
do you aim to achieve there?
Question: Balaji Prasad - Barclays - Analyst
: Got it. We'll look forward to hearing more about it. And as we think about we are in the last couple of years, I think capital allocation
has been a big priority with you when every time I spoke to the team.
And on the call we discussed the buyback too, and you said you have a minimum range of buyback of $500 million to $650 million,
which coupled with the dividend, brings it to a goal of returning capital to shareholders of around 50%. It's been a few weeks in
earnings. Are there any incremental updates that either of you would like to provide?
Question: Balaji Prasad - Barclays - Analyst
: Got it. So maybe let's get into Indore. I think, clearly, top of mind for investors as your own incoming calls has been so has it been
with us. Help us understand the required requirements now from an FDA perspective, the key challenges for you as it stands, and
ultimately the bottom line impact of the business.
Question: Balaji Prasad - Barclays - Analyst
: Understood. So past 50% into remediation. And I think one of the things I did discuss with the team later on was if there is any service
level commitment from the FDA that once you let them know that you're ready for an inspection, would they visit you within two
months, four months, or is there a defined time frame?
Question: Balaji Prasad - Barclays - Analyst
: Got it. One of the things that I'd done a few years ago was look at 20 years of warning letter histories with the FDA, and I saw that
the average time to resolution was around 18 to 20 months. And it looks like there's a possibility that you could be ahead of that 18
months to take that December 24 as a (multiple speakers) --
Question: Balaji Prasad - Barclays - Analyst
: Got it. And I think within the $500 million of revenue impacted lenalidomide, this is one of the biggest components, and what are
the options for you in terms of tying up with a third-party provider or any other options that you have of salvaging as much of this
business?
Question: Balaji Prasad - Barclays - Analyst
: Got it. So maybe just one final question around this, that other facility inspected was Nashik facility. So could you comment around
that and when you expect to hear from the FDA on potential clearance there?
Question: Balaji Prasad - Barclays - Analyst
: Are the findings of the 483, the observations, are they comparable to Indore or?
Question: Balaji Prasad - Barclays - Analyst
: Got it. Maybe shifting from that towards the business itself, new product launches will be a big part of your business at least in
incremental launches. So could you discuss a bit more about the new product launches and the revenue potentially expect for 2025
and any pushes and pulls there?
Question: Balaji Prasad - Barclays - Analyst
: Got it. And I know that 2025 definitely there's a reset happening with this facility impact and investors we want to look at too. And
as we look at 2026, how should we think about the inherent growth in the business and potential margin trends too?
Question: Balaji Prasad - Barclays - Analyst
: Got it. And it's been a few years since you embarked on the global gateway model and an outcome of that is also that you are exposed
to macro far more than before. But can you comment around this impact on the business from new tariffs and of what could it mean
between China, Mexico, and Canada, what could the impact be to the business?
Question: Balaji Prasad - Barclays - Analyst
: Understood. And maybe just one on the outlook itself as we look at the year. Can you call out the phasing that we should expect
through the year and especially I've been getting questions around Q1 too.
Question: Balaji Prasad - Barclays - Analyst
: Got it. Thank you. That's helpful. Maybe in the few minutes left, I do want to discuss the pipeline side of things too. I mean, as you
got in selatogrel, cenerimod, and sota in the recent past too. So, help us understand how this fits within the global infrastructure of
the company and also, of course, the plans for commercialization of it.
Question: Balaji Prasad - Barclays - Analyst
: Understood. Maybe some quick comments around business development. I think we've seen a whole host of divestments and some
recent deals -- deals in the recent past. But what should we think about future BDs and what would the priority and preference be
for you?
Question: Balaji Prasad - Barclays - Analyst
: And reasonable to assume that, especially the smaller deals, that they're looking at could be near-term too?
Question: Balaji Prasad - Barclays - Analyst
: We're just out of time, Scott, but maybe I'll just invite you to make some closing remarks around how we think about the longer-term
direction for the company.
Question: Balaji Prasad - Barclays - Analyst
: Got it. We'll definitely look forward to that and look forward to incremental updates on the various parts of the business too. Scott
and Derotta, thank you so much for joining us.
Question: Balaji Prasad - Barclays - Analyst
: And I do wish you a very (multiple speakers) conference.
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