Verona Pharma PLC OhtuvayreTM FDA Approval Conference Call and Webcast Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Andrew Tsai - Jefferies Group LLC - Analyst : Hey, good morning. Thanks for taking my questions and congratulations on our side. Based on our doctor test, which seems to be consistent with your own [checks] pulmonologists seem very well aware of Ohtuvayre, and they consistently say or tell us their patients who are, especially on maximal therapies, are motivated to try a new therapy. So do you believe there could be some type of bolus of patients ready to go in Q3? And is there any way you can quantify that potential bolus? And then secondly, we know IMS scrips will be untrackable. There will be no sales for Q2. And then Q3 sales, you'll probably report later in November. But in the meantime, what kind of KPIs are the leading indicators do you plan to disclose during your Q2 EPS call in August to help us gauge the launch trajectory? And how granular could you get? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2024 / 12:30PM, VRNA.OQ - Verona Pharma PLC OhtuvayreTM FDA Approval Conference Call and Webcast

Question: Andrew Tsai - Jefferies Group LLC - Analyst : All right. Thanks, guys. Congrats again.

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Good morning, team and congratulations from this incredible achievement. I know you've worked incredibly hard to get here. Two questions to you. I guess the first question is on, I think there was a high anticipation on going into the label, whether exacerbation was going to be in it in the clinical section, and we have been talking greatly around maybe not the lack of importance there. But what we did find, which was interesting is

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Thank you so much. As usual very clear, very thoughtful comments and congrats again.

Question: Joon Lee - Truist Securities - Analyst : Congrats on the approval and this was definitely worth the wait. $2,950 per month pricing is pretty robust, but regarding your average six month on therapy assumptions, is that just in line with other COPD drugs? But given your closed-loop commercial strategy, and [tackling] products, is there an opportunity to increase that to maybe seven, eight or nine months out of the year because my understanding is that COPD's a chronic disease as the name implies? Then I have a follow-up question. Thank you.

Question: Joon Lee - Truist Securities - Analyst : Great. And then I have a question for Dr. Wells. Dr. Wells, what excites you the most about Ohtuvayre? And what percentage of your current COPD patients do you think you'll end up prescribing Ohtuvayre to eventually? Thank you. Michael Wells - University of Alabama Birmingham - Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine So thank you for the question. Based on my practice, I could see the vast majority of patients prescribing for -- me prescribing it to the vast majority of the patients that I see. Again, almost all of the patients that I see are very symptomatic. They may be -- most of them are on background therapy. And really, with the improvements in quality of life and symptoms and improvement in lung function, I think these are all things that are -- that we really strive to hit and achieve for our patients. And I think the fact that if it makes patients feel better, then I think they're more likely to use it. And I think that's also a really important factor and it also results in compliance and things with the intervention as well.

Question: Tom Shrader - BTIG LLC - Analyst : Good morning and congratulations. So I have a question for Dr. Wells on exacerbations. Is the paper enough for most of your colleagues? Will they be aware of this? And is there any issue with the fact that such a -- I think, a gaudy number for exacerbation reduction isn't in the label? Will they trust it? Just your sense on, is that enough? And then I have a follow-up for Chris. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2024 / 12:30PM, VRNA.OQ - Verona Pharma PLC OhtuvayreTM FDA Approval Conference Call and Webcast Michael Wells - University of Alabama Birmingham - Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine Yeah. No, I think the answer is yes. I mean I think if you look at the totality of the data that there's improvement in symptoms, improvement in lung function and the reduction in exacerbation. I think the fact that there two complementary studies that you see the same signal in across both studies I think is really important for pulmonologists to feel comfortable that it's a real signal. And I think -- and it's also -- and we know that with exacerbations, thinking about frequent exacerbations and [Gold E] we know that the trajectory of exacerbations varies quite a bit over time as well. And so I think that any time there's the potential that this is going to impact exacerbations. I think people are going to be excited about it.

Question: Tom Shrader - BTIG LLC - Analyst : And one quick follow-up. You said 75% of patients have a nebulizer. 75% of what patients? Is that symptomatic patients? Or is --

Question: Tom Shrader - BTIG LLC - Analyst : Thank you very much. Congratulations again.

Question: Ram Selvaraju - H.C. Wainwright & Co - Analyst : Thank you so much for taking my questions and congratulations once again on this landmark achievement. With respect to the clinical aspects here, maybe a couple of questions for Dr. Wells. Firstly, I was wondering if you specifically are thinking about the combinability of ensifentrine with specific existing approved drugs, in particular or if you really are agnostic to this? You talked earlier about patients who are symptomatic being on dual therapy or tri-therapy. And I was just wondering whether you have any preferences with respect to the kinds of drugs that you would want to combine ensifentrine with or if you're more agnostic on this front? Michael Wells - University of Alabama Birmingham - Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine So thank you for the question. So in my practice, because I work in a [luttonary referral] center, most, if not all, of the patients that I see are already on at least dual therapy and if not triple therapy. And so any of these patients, because of this the novel mechanism action of Ohtuvayre, there's the potential to use it on any of the patients. Now I know the data in the published studies suggest that it works whether it's a stand-alone therapy or on top of maintenance therapy. And so I think again, that is a compelling reason. So I guess, specifically to your question, if I'm agnostic, I guess I'm somewhat agnostic, I think, mostly because of the novel mechanism of action. But I do think that there's going to be utility regardless of what type of background therapy patients are on.

Question: Ram Selvaraju - H.C. Wainwright & Co - Analyst : Okay. And then just very quickly for Chris. I was wondering if you could comment on whether you expect trends to emerge on the reimbursement side regarding the extent to which patients have already been managed using either dual therapy or tri-therapy as a precursor or prerequisite to the application of ensifentrine? Or if you anticipate that this is really not going to be a factor, that it doesn't matter how long a patient may have been on, dual therapy or tri-therapy, before reimbursement agencies would permit the application of ensifentrine, and if really what matters is whether or not the patients are remaining symptomatic? Thank you.

Question: Ram Selvaraju - H.C. Wainwright & Co - Analyst : Thank you very much.