Biohaven Ltd. Q2 FY2021 earnings call

• NURTEC ODT became the first oral CGRP targeting drug approved for prevention of migraine in episodic patients and has a dual indication for acute migraine and prevention. Q2 net revenue was $93M, cumulative to-date ~$200M with over 875,000 prescriptions.
• United States Patent and Trademark Office awarded Biohaven a new patent for ODT formulation of NURTEC ODT, extending until March 2039.
• Over 10 CGRP clinical programs globally in migraine and non-migraine indications, including adolescent migraine, asthma, and psoriasis.
• Near-term milestones: top-line results for Verdiperstat in multiple system atrophy in Q3 2021, Phase 3 study of Verdiperstat in ALS to complete in Q4 2021, Troriluzole top-line data in Spinocerebellar Ataxia early 2022.
• Commercial success with NURTEC ODT, strong market share, and positive reception from prescribers, patients, and payers due to its efficacy, safety profile, and dual indication.

NURTEC ODT was the key segment. In Q2 2021, NURTEC ODT net revenue was $93 million, with cumulative net revenue to-date approximately $200 million. Over 875,000 prescriptions of NURTEC ODT have been achieved. NURTEC ODT's new-to-brand Rx market share is approximately 56%, reflecting strong demand from its dual indication for acute and prevention of migraine. The oral CGRP class as a whole is outperforming initial launch expectations, with oral CGRP antagonists driving growth in the overall CGRP targeting market.

• Expect continued market expansion of NURTEC ODT in migraine.
• Anticipate multiple pivotal trial readouts over the next year.
• Potential for multiple NDAs over the next couple of years.
• Remain focused on investing in long-term success of NURTEC ODT and growing the oral CGRP market.

• Volatility in pricing due to launch phase and potential changes in affordability programs.
• Uncertainty around regulatory processes and outcomes for EU filing and other trials.
• Competition in the migraine market and potential impact on market share.

Q: Good morning, everyone and congratulations on the strong quarter. A few commercial questions from us, please. Just first, with regard to the prevention launch. Can you maybe just update us on how you're positioning and messaging NURTEC among potential prescribers and patients ahead of a competitive launch coming down the road? And how would you characterize and quantify relative awareness of the different molecules at this point?

A: Thanks, Paul, and I'll turn it over to BJ to answer that question. I did want to highlight, though that because the prevention launch came late in the quarter, really the results you saw today are still from the growing acute market. And the early metrics looks so positive for the dual indication as reflected by the 56% NBRx today. But certainly I think you're going to see a lot more in the next quarter as we begin to realize more of those dual acting and prevention scripts. So BJ? BJ Jones: Thanks for the question, Paul. Messaging has been very clear, we've been communicating to both clinicians and patients, the fact that we are the first and only medication that can be utilized to treat and prevent migraine. And once again, as I mentioned, it allows us to really set ourselves up as the only medication in this space. So as you look at all the others, those that may be coming right through and pending PDUFA date, and as well as the mAbs and the rest of the market in generic space like we're the only ones in this space. And thus far, as Vlad just mentioned, we really have seen just tremendous receptivity to that messaging from clinicians and patients as well. So we feel very good about that. From an awareness standpoint it's very early but we're excited because we don't have to climb the hill of a brand new medication, we are well known, we're utilized the marketplace is well aware of NURTEC and so we're able to use that relative awareness, really to just launch us into what is a broad awareness around this dual indication. So thus far we like what we see.

Q: Congratulations, Vlad, you and the team really just fantastic performance, I guess my question is around the value per Rx that you're securing currently in the acute just kind of give us a sense, if you could, where that's going. And then BJ made a very nice commentary about payer access around prevention, I guess just wanted to drill down a little bit more here. Obviously, prevention is in essence, doubling the amount of pills and just wanted to understand how those payer discussions are going. I think you mentioned that at this point, there's no real step-through versus the injectables, but maybe how that will shake out when you feel that, we'll have this locked in and then maybe a sense of where the value per prescription on a blended basis will be going. And then Vlad, just back to you on ex-U.S., obviously wonderful performance here in the U.S., maybe talk about how we're thinking about ex-U.S. and pacing and decisions in terms of partnering?

A: Thanks a lot, Ken. I appreciate the comments. In a minute I'll turn it over to Jim to talk about value for Rx and then BJ on the payer front. I would just generally say that, as you know, we don't guide towards value per Rx. But I'll let Jim comment just on the favorability that we've been seeing in pricing. But the good news is it's not just favorable in pricing, but continued growth is driving this value. Jim do you want to? Jim Engelhart: Yes, thanks, Vlad and thanks again, Ken for the question. So as Vlad mentioned, we don't guide you our net price. But I will say as I commented in my prepared script, that we were pleased to see the improvements in the second quarter. And we had provided in the past some context that this would improve. So we were really pleased about that. One of the big drivers obviously, as we've talked about is these patient affordability programs that we have in place, and over time, we will start to pull those back. And certainly as we do that, that will improve the price. Just one thing we want to just keep people mindful of though, as we said in the past, this is we're still in a launch phase. And certainly now with the approval of prevention, we will see some volatility in pricing in the future, but we are confident and believe that we'll continue to have success and strong performance. Turn over to BJ. BJ Jones: All right, Ken thanks for the question. So as it relates to payer access, and those discussions, as you can imagine, we're in constant dialogue at this point in time, and really our ability to communicate what is NURTEC's clinical profile, it's unique dual indication, dosing flexibility, where continued safety has really been received extremely well. And so we're excited about those discussions thus far. I can't get ahead of ourselves and communicate exactly what the outcome will be. But we feel confident that within say, the next 60 days or so, we will have some commitments for what will be 2022 and that's what we're focusing on. We have not thus far though run into situations. So we believe again, our current PI -- PA criteria is consistent with that for the mAbs which is best possible criteria. And again, these active negotiations are ongoing, and we feel confident again about what is we believe will be an extension of the current UMN and PA criteria.

Q: Hey, thanks. Just a question on the mix of prescribers. Some of our checks have indicated that you guys have seen a lot of traction among PCPs. I'm wondering, just generally you can talk about the mix there between primary care doc's versus headache specialists. And also maybe second part of that question, if you can outline are there any access considerations at the PCP level versus specialists that you can talk to, especially now with the prevention level?

A: Thanks, Chris. BJ? BJ Jones: Yes, thanks for question, Chris. As it relates to kind of specialist versus primary care as one would expect and we've seen in the data, specialists are the ones that adopt more rapidly. They see more patients, obviously per clinician, but we do see a nice transition, if you will, over time, where we're starting to see really strong pickup in primary care. And we see that actually for NURTEC, but certainly for class as a whole, we expect over time for primary care just because if there's so many of them they see so many patients with migraine is that that will be the bulk of this category in the not too distant future. And so we're excited again about what is even a re-energize excitement with our dual indication that we see even in this early stage from primary care as well specialists. As it relates to access issues, I would say that nothing is really sticking out. We do have strong access to primary care. There is, if you will, kind of just overarching concern around not only the class, but the broader industry as it relates to delve in impact from an access standpoint. But thus far we're excited we're getting into see most important clinicians and communicating effectively with it.

Q: Hey guys, this is Ari for Vamil. Yes, just wondering first, if you can talk a bit about Zavegepant expected Phase 3 readout this year. Just wondering what's your expectations are and how you would position the product. And secondly, just also wondering whether if you have any more color with regards to the EU filing?

A: Thanks. I'm going to turn it over to Elyse. I'll just say that Zavegepant, we were, I mean nicely complimentary to NURTEC ODT and we'll have Elyse address that. Elyse? Elyse Stock: Yes, thank you for the question. We're very, very excited about Zavegepant, right? It is in both the intranasal and oral formulations. And what you're referring to of course is the intranasal formulation, which we're developing for ultra-rapid use. As you know, right with patients who have migraine frequently they have nausea and although an ODT is a big advance versus something that must be swallowed and doesn't disintegrate while now. Intranasal may be something that is appealing to those of course who may have more severe nausea, but also is extremely fast. So it will be something that can be used for patients who are suffering with migraine, who needs something immediately, and can't even wait as long as they do for our disintegrating tablet, which is also very quick. Yes, as you said that Phase 3 readout will take place. And we certainly expect the filing by the end of the year and we're really excited about that. And so stay tuned for that. With regard to our European filing, as you know, that's been filed and we are expecting or hoping for an approval, I should say at the beginning of next year. And that process is, as with the FDA a long process of approximately a year, and it is going exactly as we would have expected at this point. So I can't give you more details. We don't usually give details on the specifics around the regulatory process that's ongoing. But sufficed to say that it's going exactly as we would have predicted at this point in time.

Q: Yes, good morning Vlad and team. Very nice quarter. Congratulations. Thanks for taking our questions. Had a commercial question and one -- and one R&D or pipeline question. Regarding the commercial question I guess I'm wondering, if BJ you could provide a little bit more color on the new prescriptions? Are they coming from new prescribers or are they coming from our deeper prescribing within a practice?

A: Well, great question, Charles, and thanks for that. As you can imagine, we're looking at that every day to make that determination. And the quick answer is both, which is exactly what we would hope for and expect. We certainly see depth of prescribing for those who already believe and have had success. And so they're extending that utilization right into preventive. And then as it relates to we've also seen what has been acceleration in new prescribers as well. And so again, it's -- we're nine weeks in so I want to be careful and certainly not predicting going forward, but so far we see acceleration in both those categories, which is good news for us.

Q: Hey, thanks for taking my question and congrats on the quarter. I just have a couple for BJ and then one on Verdiperstat if I can. So on NURTEC for the PCPs that are prescribing, can you give us some color on whether they're specifically headache specialists, or just generally PCP broadly? And then can you also talk a little bit about how you're thinking about the EU market dynamics, what are some of the pushes and pulls as you expect, you would expect as you're planning for a potential commercial launch?

A: I'm happy to respond, Esther and I'll hand actually over to Elyse in a moment to talk about the EU. But as it relates to PCP, they're a very small segment, they're actually headache specialists, but the vast majority of them and the vast majority of those primary care providers are just general practitioners. And again, they are folks who see a lot of patients therefore; they see a lot of patients with migraine. And so we do again expect this area to be the one where there is tremendous adoption over time, just because that they see so many patients. Elyse? Elyse Stock: Yes. With regard to Europe, again, the filing took place at the end of last year, we're in the midst of discussions with regulators in the normal process that you would expect. And the physicians that we've spoken to in the field have been as excited about, about being able to hopefully at some point, right be approved and have it on their marketplaces. So, they've just been very excited. And I think the dynamics, once we're out there will be comparable to what we see in the U.S.

Q: Thanks for the question. Thanks for sneaking me in. Can you just comment on your cash position, you hold $368 million down from $200 million last quarter. And I know you have access to the Sixth Street and a Series B financings, but still seems to be maybe a bit thin giving how much investments going into NURTEC and all of the clinical programs, it's actually Europe, you can just talk about maybe some areas where you might want to partner or maybe BioShin could present -- produce some capital, if execute in Asia?

A: Yes, great question, Tim. And I think as you know, we've always demonstrated ability to appropriately from the company, and these are things we watch very closely. And we're also very cognizant of wanting to avoid dilution to our shareholders, especially when one understands the magnitude of this asset. And obviously, we want to work as quickly as possible to profitability, so we could sell funds, rather than having to go to the markets. There's not a lot we can say, at this point on some of the plans, ex-U.S. again, you're going to have to just be a little patient. So we can come up with the best strategy there and communicate that but Jim and team and myself will make sure that company is always well funded. Jim, anything you want to add to that? Jim Engelhart: No, I think you summed that up well, Vlad. We're very dilution sensitive, obviously for investors but I believe we're well capitalized and set up for success with that.