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 & Co. - Analyst
: Just a couple for me. First on CREXONT. Can you talk about how you see the payer landscape evolving, particularly Part D, just given the eventual
loss of exclusivity for Rytary? So just help us understand what you think access will look like, how restrictive do you think the landscape could be
with Rytary being available as a generic. So that's number one.
Then number two, just wanted to pick your brain on complex generics, particularly interested in what you're thinking regarding GLP-1 generics. I
think you called out an exenatide pen in your slides. Are there others, the obvious suspects here, that you're looking to file on down the road? I
wanted to get your thoughts there.
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Thanks, David. So as you know, Rytary has the highest coverage among the Parkinson's products, and we expect similar coverage for CREXONT or
even better. And initial discussions with all the payers have been good. We have a very smart strategy on the pricing to make -- as you know, we're
going after almost 30% of the market share.
Therefore, we have devised a great pricing plan where it's more affordable for seniors, especially the Part D. And with the new Part D out-of-pocket,
we expect the adoption for this product and the coverage would be even better. And the fulfillment of prescriptions will be better than previously.
We used to lose 20% to 30% prescriptions due to coverage or due to donut hole; we expect that to be much better going forward.
Joe, do you want to add anything?
Question: Les Sulewski - Truist Securities - Analyst
: Congrats on the approval of CREXONT. Just three questions for me. So maybe first, the focus on CREXONT now that it's approved. I would imagine
you have an improved profile across your lenders. Any consideration for a chunky BD plan, further advance your specialty portfolio? Or does the
focus remain on internal pipeline with some tuck-ins along the way?
Second question is on residual investments in CapEx, I believe you maintained $60 million to $70 million of guidance. I'm just kind of wondering
how that second half of the year plans out and then also 2025.
And then third, on the DHE auto-injector launch, I believe that was initially expected in kind of the earlier first half of next year. What's triggering
the delay into the second quarter?
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
So we are steadfastly focused on getting to 3 times, as Tasos mentioned, on a leverage profile. Until then, expect us to keep doing the R&D deals
and those are really good for us. We do have a large budget of R&D. And as my brother mentioned that we -- internally for Gx now, the spend has
gone down. It's still a good amount of spend but not as what it used to be in 2016, '17, '18, '19, right?
So we have more dollars available for R&D deals and we may acquire some of the commercial assets in the areas we operate, all on the branded
side. So that will remain as a BD plan. And then obviously, we'll be -- after we get to 3 times, we will be very engaged in very smart business
developments and acquisitions as we have -- our intention is to keep growing Amneal to the next level and next level. We have one of the best
team to do that and one of the best foundations in the industry. So we'll expect us to keep doing good business development over time.
Your second question on CapEx. CapEx will go up from next year and we'll share that detail. This year is in line. As we plan to expand, there's certain
specific areas which we'll share information when we have it. DHE auto-injector has always been a first half launch, and which allows us to -- specialty
team to focus on CREXONT. And we're completing stability in the fourth quarter. It's our own site. So we don't expect any delays anymore. And
after that, PAS, so four to six months after that.
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