NASDAQ:TARS Tarsus Pharmaceuticals Q3 2023 Earnings Report $42.96 -0.23 (-0.52%) As of 10:29 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Tarsus Pharmaceuticals EPS ResultsActual EPS-$1.28Consensus EPS -$1.40Beat/MissBeat by +$0.12One Year Ago EPSN/ATarsus Pharmaceuticals Revenue ResultsActual Revenue$1.87 millionExpected Revenue$0.72 millionBeat/MissBeat by +$1.15 millionYoY Revenue GrowthN/ATarsus Pharmaceuticals Announcement DetailsQuarterQ3 2023Date11/9/2023TimeN/AConference Call DateThursday, November 9, 2023Conference Call Time4:30PM ETUpcoming EarningsTarsus Pharmaceuticals' Q2 2025 earnings is scheduled for Wednesday, August 6, 2025, with a conference call scheduled on Thursday, August 7, 2025 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Tarsus Pharmaceuticals Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 9, 2023 ShareLink copied to clipboard.There are 12 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Tarsus Pharmaceuticals Third Quarter 2023 Financial Results Conference Call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to David Nagasoni, Head of Investor Relations to lead off the call. Please begin. Speaker 100:00:22Thank you. Before we begin, I encourage everyone to go to the Investors section of the Tarsus website to view the earnings release and related financial tables we will be discussing today. Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman Aziz Motiwala, our Chief Commercial Officer and Jeff Ferro, our Chief Financial Officer and Chief Strategy Officer. I'd like to draw your attention to Slide 3, which contains our forward looking statement. During this call, we will be making forward looking language statements that are based on our current expectations and beliefs. Speaker 100:00:59These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail. With that, I will turn the Speaker 200:01:13call over to Bobby. Bobby? Speaker 300:01:16Thank you, Dave, and thank you all for joining us for our first ever earnings call and our first opportunity to speak with you since the highly anticipated launch of Exevi, the only FDA approved treatment for devepinax nephritis. We are off to a great start and I am pleased to share our progress with you today. Pembinaic blepharitis is a pervasive and damaging island disease that affects approximately 25,000,000 Americans. Of these, more than 7,000,000 are seeking treatment for a complementary eye condition. Double clicking on that number, More than 1,500,000 people have already been diagnosed with seborrheitis and are highly motivated to find an effective treatment. Speaker 300:01:58As anticipated, this is the patient segment driving strong initial demand. And as the Xtendi launch progresses, we expect to expand further into that group of 7,000,000 patients. Xtendi was approved a month ahead of its scheduled PDUFA date and as planned, we made sure it was available to patients within a month of approval. Today, I'm proud to report that we are delivering on the expectations we set for ourselves and for the launch of XtendBI. Specifically, in the Q3, we generated $1,700,000 in net sales and we delivered XtendBI to more than 1700 patients eagerly awaiting a new solution for dermatitis lephuritis. Speaker 300:02:42These results speak to the 2 key advantages that make Xtendi launch unique. 1, Xtendi is the 1st and only FDA approved medicine to treat seminis prophritis, which has enabled us to build an entirely new market focused on islet health. 2, Xtensy offers a defined course of treatment that delivers strong and durable outcomes and provides value to payers, for eye care providers and patients. You will hear more about our progress on both fronts later in this call. For those of you who are not familiar with devinex lephritis, it's caused by an infestation of devinex mice, and the most common parasite found on humans. Speaker 300:03:26Patients with this disease need treatment. They can experience Importantly, the cost, quality of life burden and psychosocial effects are significant. Patient impact ranges from the inability to wear makeup to functional issues such as driving difficulty driving at night. And in the most advanced stages of disease, there may also be corneal involvement, which can negatively impact the patient's vision. Turning to the next slide, you'll see exactly what I mean. Speaker 300:04:05This is a photo gallery of patients who have been suffering for years with dimeric blepharitis and prior to their treatment with Xtandi. I'd like to draw your attention to one image in particular, the one in the upper right hand corner. This is Lucas. He is a very active gentleman, retired chemical engineer. In addition to keeping up with his 8 grandchildren, he is also a competitive fencer. Speaker 300:04:30I had the great chance to meet Lucas last week. He shared with me that his watery eyes, irritation and blurred vision not only made it hard for him to participate in competitive fencing tournaments, but also made it hard to read the newspaper every day. As you can see in this photo, his eyelashes are crusted with colorects to tell cell signs of demodex blepharitis. Fast forward 5 weeks, a little less than a full course of therapy with Xtendvii complete, a stark contrast, No colorants, no redness, but what stands out most to me is the impact Xtendvii has had on its daily activities. And this is only one of the many similar stories we heard and similar photos we saw from eye care providers or DCPs for short. Speaker 300:05:22During the recent American Academy of Optometry and American Academy of Ophthalmology conferences. So when I say I'm confident about the blockbuster The potential of Xtandi not just because of the $1,700,000 in net product sales we reported for our 1st 5 weeks of launch, It's also because of the impact we are having on patients like Lucas. Again, we are off to a great start. The momentum we're already generating in these early days is proof of the value proposition of this category creating product, our extensive disease educational efforts and the seasoned leadership of our commercial organization led by our Chief Commercial Officer, Aziz Motiwala. Finally, I know the XtendBI launch is top of mind, but I want to close by reminding everyone of the potential of our robust pipeline and the near term data readouts that will be important for our long term growth, all of which will be addressed by Jeff Farrell, our Chief Financial Officer and Chief Strategy Officer later in the call. Speaker 300:06:24I will now turn the call over to Aziz for more detail on our launch progress. Speaker 200:06:29Thanks, Bobby. As the initial launch metrics demonstrate, the enthusiasm for XENVY is truly remarkable. I've worked in the eye care industry for more than 20 years and I've never This kind of early response, which I believe speaks to our unique and differentiated approach. In July, we shared our strategic and deliberate launch plan and we are executing successfully on this plan. We have a driven best in class team comprised of eye care experts and product launch veterans that are exceeding expectations on a daily basis. Speaker 200:06:59So far, our near term accomplishments are delivering a solid foundation for the long term expectations we have set for ourselves and for Xtandi. That said, launching a 1st in class therapeutic is a marathon and not a sprint. And we are planning for a steady launch trajectory as we continue to build demand and secure high value payer contracts. Category creation requires both substantial disease education and behavioral change. Diagnosing demidex blepharitis is a simple task as it just requires patients to look down during every eye exam and looking for colorect, the sure sign of disease. Speaker 200:07:35And as it's simple as it sounds, Not every eye doctor is doing it, at least not yet. We recognize that a shift in behavior like this will take time, which is why we initiated disease state education campaigns for every eye care provider as well as for patients well in advance of approval. We have now transitioned our efforts to MITRE Vermont, a complementary branded campaign that highlights the benefits of Xtandi. As a result, recent market research indicates that nearly 70% of ECPs say they recognize the importance of screening for colorects in every eye exam and more than 90% of ECPs indicate intent to prescribe Xtendi. That is truly a remarkable number. Speaker 200:08:16And what it says to me is that ECPs understand both the importance of treating this disease and the value that Xtendi brings to their patients. This is further bolstered by the recent addition of Xtendi to the American Academy of Ophthalmology's practice guidelines as the first and only FDA approved treatment for demodex blepharitis. We've also been highly successful in our differentiated approach to distribution, reimbursement and patient access. Due to the unique high value proposition of Xtendi, we are already seeing initial non contracted coverage that has resulted in better than expected gross to net discounts of 73%. It's a very encouraging metric for us. Speaker 200:08:57But I also want to caution that as more prescriptions start to come through their systems, payers may put more short term and onerous prior authorizations in place until we can work through our ongoing contract negotiations. That said, based on our ongoing discussions with all the top payers, we still expect broad commercial coverage to build throughout 2024 and Medicare coverage to come online in 2025. Before I turn the call over to Jeff, I want to acknowledge our sales force, which has done a remarkable job of generating the initial demand for Xtendi. They've already called on 80% of our top 4 desktop prescribers, who in the vast majority of cases have been called on multiple times. As a result of these efforts and launch to date, more than 2,000 ECPs have started patients on Xtendi and nearly half of those ECPs are repeat prescribers. Speaker 200:09:46We're also seeing a positive trend in new ECPs writing every day. Now when we look specifically at the Q3 results, we're pleased to report that approximately 1700 bottles of Xtendi were delivered to patients. And we recognized better than anticipated gross to net discount of 73%. This encouraging Q1 after launch said to me that we have established a solid foundation for ongoing momentum that gives us great confidence in the potential of Xtandi. I'll now turn the call over to Jeff Farrell for additional commentary on our financials and our pipeline. Speaker 200:10:21Jeff? Thanks Aziz. Speaker 400:10:24I've been lucky enough to have been part of several companies who have brought innovative new solutions to patients in need. And based on that experience, I believe Tarsus is on the cusp of delivering blockbuster potential in an entirely new category of eye care. As Bobby noted, we had an exciting Q3 marked by $1,700,000 in net product sales. We also completed an equity raise of nearly $100,000,000 that will be used to support the ongoing launch of XtEMVI and other strategic priorities. As a reminder, we recognize revenue when we ship XtEMVI from our warehouse to the distributors, not just on bottles received by the patients. Speaker 400:11:08Looking forward, we are very encouraged by the meaningful numbers of bottles dispensed so far in the Q4. But as we are still in the early days of an uncharted new launch, I wanted to highlight the potential fluctuations in both demand and gross to net discounts we might see in the future due to prescribers being out of the office for the American Academy of Ophthalmology and Optometry Conferences, that payers may implement while we work to finalize contracts. Turning now to our pipeline. I'm pleased to provide an update on the multiple near term Phase 2 data readouts we anticipate in the coming months. Beyond XtEMVI, we are continuing to advance 3 novel therapeutics that target the root cause of the disease. Speaker 400:12:07All three are based on Lotelanor, the same active ingredient in XtEMVI, providing us with a pipeline in a product. We remain on track to report top line data from our Myobian Gland disease study by year end and top line data from our ROCATION study in the Q1 of 2024. Due to additional time required Fully enroll our Lyme disease prevention study, we now expect to report top line results in the Q1 of 2024. Again, great progress here and the potential to continue building long term value for the company and our shareholders. Finally, as you may have noted, earlier today, we filed a shelf registration statement in the amount of $300,000,000 This is merely a good housekeeping measure for Tarsus and we have no immediate plans for financing. Speaker 400:13:04I also want to take this opportunity to note that the potential $2,500,000 milestone we have with Lianne Bio is now likely to be recognized in the first half of twenty twenty four. I will close by saying we remain well capitalized with approximately This provides sufficient capital to support the ongoing launch of XtEMVI and the advancement of our clinical pipeline programs. And with that, I will turn the call back to Bobby. Speaker 300:13:42Thank you, Jeff. As you heard today, this is an incredibly important and exciting time for our company. With the launch of Xtandi, Tarsus is well on its way to becoming an eye care leader with the potential to deliver multiple therapies from our category creating pipeline. Operator, please open the line for questions. Operator00:14:03Thank One moment for our first question. Our first question comes from Jason Gerberry of Bank of America. Speaker 500:14:36Hey, guys. Thanks for taking my questions. Couple for me, just your comments in the PR about 1700 bottles that pretty closely lines up with the IQVIA Data. So, just curious your thoughts on data reliability with IQVIA relative to Symphony and if IQVIA is ultimately perhaps like the better data source for tracking here. And then, just your latest thoughts on the role Between optometrists and ophthalmologists, it looks like I think you guys kind of had communicated this will be like kind of a fifty-fifty split, but it looks like ODs are about 62% of scripts so far. Speaker 500:15:19So curious if based on early observations, maybe how you're thinking about the optometrists The thing may be a bigger role here. Speaker 200:15:29Hey, Jason, it's Aziz. I'll happy to answer those for you. So When we think about the syndicated data like IQVIA or Symphony, I think a couple of things to keep in mind here. One is we have a very unique distribution network with Ora Focus Pharmacies. And secondly, it's very early in the launch. Speaker 200:15:45Those two things really yield that these audits are a little bit more directional at best In early days. I'd say in more recent weeks where they're looking better is just the trend in trajectory. But on a week to week basis, we see a lot of fluctuations in what they're reporting versus what we see here internally. We've been giving them a lot Speaker 500:16:03of the data feeds. Speaker 200:16:04So we anticipate as the weeks go on that those data feeds will be getting more and more accurate. But I think for now, I would tell you that really focusing on the trajectory and the trend versus the week to week numbers because you're going to see Our goal is to just focus on driving volumes and as the volumes increase that those will sort of align better over time. To your second question around the split across specialties, we're seeing great feedback from both ophthalmology and optometry. We reported over 2,000 doctors to date who've gotten patients on therapy and that is coming from a mix of both, as you mentioned. I think near term, we are seeing a slight slant towards optometry, but I think over the long haul, it will start to even out. Speaker 200:16:43You'll see equal contribution from both ophthalmologists and optometry. Maybe at most it goes to 55 optometry, but we do anticipate that balancing out a little bit more over time. Speaker 300:16:54Okay. Thanks a lot. Operator00:16:57Thank you. One moment for our next question. And our next question comes from Tim Lugo of William Blair. Speaker 600:17:15Hey, guys. This is Lachlan on for Tim. Thanks for taking the questions. At AIO, we had a lot of discussion, not necessarily from doctors, but other companies in the field around your pricing. So I was just wondering if you can discuss the initial feedback you've had You've been hearing that particularly from payers. Speaker 600:17:32And then second, can you maybe just talk about how the education has been going around demodex mites lead to blepharitis and how that's been received with eye care professionals? And do you have any sense of kind of how many have incorporated looking forward to the existing practice? Speaker 200:17:54Yes. Hey, thanks for the question. It's Aziz again. So on the first one around price, I think we were very thoughtful and purposeful when we thought about the pricing for Xtandi really reflecting the value proposition the product brings. It's one course of therapy for 6 weeks, Yes, great outcomes across multiple measures of disease and it's the 1st and only approved product for the disease. Speaker 200:18:16All those things combined lead to a great value prop for physicians, patients and payers. So the feedback we've gotten has been very reasonable on that. I think that's reflected in some of the non contracted coverage we're seeing here in early days, And that's reflected in the better than expected gross to net discounts. So payers are covering this. We're having ongoing discussions with all the payers and we're not seeing a lot of pushback there. Speaker 200:18:38Of course, those Those are all negotiations and they're active negotiations, but I think the payers do recognize the value proposition Xcebi brings. They do acknowledge The unique aspect of the drug and the fact that it's the first and only. So we feel really good about that and stay committed to the idea of building commercial coverage through 24 and having Part D comment on 25. And then when it comes to education, this has been a focus of ours even prior to the launch. We had multiple campaigns Educating the physicians and patients on the disease. Speaker 200:19:09Our disease campaign was essentially as having physicians screened for the disease by having patients look down. We're seeing that momentum continue to build now that the product is approved. As we stated in our prepared comments, 70% of doctors we survey say that it's And furthermore, we know that if they're looking for colorects, they understand that colorects are pathognomonic for diabetic spelarthritis. So They are making the link. I think in early days, it's still important to build that habit and make it a routine in every exam. Speaker 200:19:40And that's our focus going forward, right? You can see the sales force and our Medifarious team are continuing to educate on disease. The sales force is out there linking the disease to the benefits of the product And that's going to be a continued focus for us, right? We're building a new category. It will take some time, but we are seeing great momentum there. Speaker 300:19:55And I just want to add to that, Aziz. This is Bobby Zameen. I've been in the field as has our executive team roughly monthly and I've seen that education take place. I was once in a very urban environment and next in a more suburban environment. And just as Aziz said, you see some doctors that are immediately prescribing And doing multiples and then you see some doctors that need a couple of visits and start to understand the value proposition, start to look for patients and then come online and start prescribing. Speaker 300:20:26So we're seeing that really week in week out in terms of that education taking up. Operator00:20:34Thank you. One moment for our next question. And our next question comes from Eddie Higdon of Guggenheim Securities. Speaker 700:20:48Hi, good afternoon and congrats on the launch so far. Thanks for taking my questions. Just 2 from me. Can you give any additional color on what went into that 73% Gross to net discount and how you think that will track over the next few quarters given it's already better than where we thought it would start. How many of those 1700 bottles were reimbursed And how does the limiting sampling work for this project product? Speaker 700:21:10And then if you can give us sort of any data benchmark on the upcoming MGD study and sort of what you're hoping to Speaker 400:21:20Hi, it's Jeff. I'll start with the gross to net question. So We did do better than we anticipated. We ended up with overall gross to net discount of about 73%. I think we were anticipating closer to The vast majority of that discounting was related to our bridging program. Speaker 400:21:39But what the delta between our expectations and What we ultimately saw was a little more coverage than what we were expecting from the commercial side in particular. We do think over time that as we start to get payer coverage in 2024 with commercial, we'll see that gross to net improve. And then ultimately in 2025, once Medicare comes on, we'll get to a steady state of about 50% gross to net discount. I think the thing we're cautioning folks on, as I mentioned earlier, is in the Q4, now that some of these payers are seeing More scripts come through. They're trying to manage their budgets if we are not currently contracted with them. Speaker 400:22:20So we're anticipating somewhat of a flat Gross to net discount from the Q3 because of that. We're starting to see more owners' prior offs. Again, that will be short term, And we do expect to see that improve over time starting in Q1 of 2024. Speaker 300:22:39And then the second question was about the upcoming MGD study. Jeff, do you want to take that one as well? Sure. Speaker 400:22:44Yes. On the MGD study, we anticipate Releasing the data here in the next month and a half prior to year end. It includes data from Two doses, 2 dose types. 1 is BID, 1 is TID. And so we'll be able to release that top line data sometime later this year. Speaker 200:23:09Thank you. Operator00:23:10Thank you. One moment for our next question. And our next question comes from Oren Livnat of H. C. Wainwright. Speaker 800:23:29Thanks. I have a couple of questions. Just to revisit this issue of the evolving Payer pushback, I guess, in the immediate term. First, can you just help us understand what kind of early experiences You're hearing about physicians having in terms of getting better patient access early on. Do they need to fill out letters of medical necessity now or is it just going through specialty pharmacy that's handling all that adjudication for them on the back end so that they don't experience any of that Friction per se. Speaker 800:24:03And going forward, I guess, obviously, gross to nets are going to potentially be volatile. But What about volumes? Do you suspect that if there's an incremental pushback in reaction to your very strong volume out of the gates here that it could actually get harder In the near term for Summit to get a patient on and what do you have to do to make sure that that doesn't then potentially sour any doctors on the experience going forward? Thanks. Speaker 200:24:31Sure, Oren Khazid. So I think when you think about that access right now, as Jeff mentioned earlier, Through the end of the year, right, we can expect that these folks as they start to see volume, the payers will put some restrictions in place. We've seen this in pockets. I think that this is something that the doctors can navigate through. The doctors typically initiate the PA, but through our FOCUS pharmacy network, they do get some assistance in that process. Speaker 200:24:53But clearly, the doctor has to initiate that they have the patient records. It varies by plan what the expectations are. So in some cases, it's a very simple PA. In other cases, we are seeing a little bit more onerous DAs. Mind you that all this coverage is not contracted right now. Speaker 200:25:05So as contracts come online, we would push for a more straightforward PA to label that aligned with a first and only type of product. So we see that evolving over time. In terms of impact to volumes, I think what Jeff is saying is we're continuing to see steady uptake from the physicians. We're seeing that the doctors are getting access to the drug. They're great success with the drugs and we continue to see that build. Speaker 200:25:28I think that you have to just keep in mind that that's more of a headwind. We don't see it as something that would keep the prescription flat, But it does sort of give us a little bit of a headwind as we are building that acceptance with physicians. And I think the doctors are sensitive to that. They know and understand that new products Take time to build coverage and I think it speaks to the value proposition of Xtandi that people are committed. They're seeing these patients. Speaker 200:25:49They don't have another option. So the doctors are putting the effort in and of course our programs are there to help that process along. So we think we'll continue to build volume steadily, but certainly Changes in policy or short term PA adjustments can be a slight headwind as we're ending the year here. Speaker 800:26:05And just so I'm clear, We're not covered or we're pushback is insurmountable. Is that bridging program still getting drug into Patients' hands in any and all cases essentially such that we'll continue to see the demand reflected in the prescriptions going forward? It's just a question of The economics that you realize in gross to net? Speaker 200:26:28That's exactly right, Alain. Speaker 800:26:31Perfect. Thanks. I'll get back in the queue. I appreciate it. Operator00:26:35Thank you. One moment for our next question. And our next question comes from Balaji Prasad of Barclays. Speaker 900:26:52Hi, everyone. This is Mikaela on for Balaji. Thanks for taking our questions. Just thinking about your pipeline, at what point might you look to expand this further and are there any areas in particular that would be of interest? Thanks so much. Speaker 300:27:04Thank you, Mikaela. We do look Actively at the entire eye care landscape, as you can imagine with a great early launch trajectory with a commercial platform, Eventually, we want to add more products to our pipeline and to our commercial force. Right now, we can only be so modest, but With continued success, we would look to add further products. And so stay tuned. There's nothing to report today, but stay tuned. Operator00:27:37Thank you. One moment for our next question. And we have time for one more question. One moment. Our next question comes from Patrick Dolesale of LifeSci Capital. Speaker 1000:28:10Hi, this is Corey on for Patrick. Thanks for taking our questions. In the call you mentioned that more than 2,000 ECPs have Prescribed Xtampi so far. So it sounds like prescriber adoption has been quite broad as opposed to a really narrow focused Group of prescribers leading most of the volume. We'd love to hear more about your strategy and How you've been prioritizing ECP targeting? Speaker 1000:28:39And I guess also on that note, how are you thinking about marketing in Both the near and long term, it seems like marketing has primarily been directed towards prescribers. Can you speak to the relevance of Consumer directed marketing in demodex blepharitis and what might your strategy be in that regard? Speaker 200:29:01Hey, Cory, it's Aziz. And yes, I think we've been really pleased with the physician acceptance and receptivity. We just came back from both the Academy of Ophthalmology and Academy of Optometry, got a lot of first hand feedback. So we're real delighted With the uptake we're seeing among the physician community, we're seeing broad updates to your point. And that's been our strategy, right? Speaker 200:29:20We didn't want to niche the product. We wanted to go to a broad Audience of prescribers, that's why we built the sales force the way we did. We're targeting over 15,000 doctors in our efforts. So we're making great progress in penetrating that marketplace. How we prioritize that, as I think we've shared before, we take a very data driven and informed approach. Speaker 200:29:39We think about where patient volumes are, we look at claims data and we look at who has historically been early adopters of other products and that really helps focus our efforts. We also mentioned earlier that we've already talked to 80% of our top decile doctors. So we've been real thoughtful about where we're deploying the sales force time. And I think that the physician receptivity and the number of doctors that have written and repeat written, which is really important, I think reflects that very thoughtful approach. I think in terms of the marketing efforts that you asked about, we've been real intentional here. Speaker 200:30:09I think early days, we really have focused on the physician education, building that understanding that scientific platform, if you will. That will continue to be the focus along with building coverage. And the way you can think about it is once we have great physician penetration, which we're already on a good And as more payer coverage comes in, that's probably going to signal a great time to think about activating the consumer more purposefully. We do have some consumer education ongoing right now. We've done some smaller campaigns. Speaker 200:30:34But in terms of broad based DTC, which I think you're referring to, I think that comes online when we've got even more adoption among the physician community and even enhanced coverage with our contracts coming online in 2024 and early 2025. Speaker 1000:30:49Excellent. Thanks for taking our questions and congrats on the progress. Operator00:30:54Thank you. One moment for our last question. This question is from Frank Brisebois of Oppenheimer. Speaker 1100:31:14Hi. Thanks for taking the questions and congrats on the start here. I was just wondering, we talked a little bit in previous questions about Optometrists versus Ophthalmologists. And I was wondering, can you just help us understand how the pitches are going and the reception is going between the 2 different types of docs and if there's any sticky points or is it a very different pitch between both of them? So Any color on that would be helpful. Speaker 1100:31:42And then you talked about entering the guidelines here. I was wondering how important that is for for physicians to then prescribe? Thank you. Speaker 200:31:52Yes, Frank, thanks for the question. I think the pitch is very similar overall, Our sales messaging is very consistent. You can think about it in really three tranches. We focus on the disease state, building awareness, Continue to promote diagnosis by looking at Lids. Secondly, we focus on the value proposition XENBI brings, the unique effects that XEMBI brings across tolerance, mites and redness. Speaker 200:32:15And third, we focus on our pull through with our pharmacy network getting the prescription in and the process to get the prescription, which is of course really important in early days when we don't have contracts in place. So that's pretty consistent. I think sometimes you do have nuances, The optometry versus, say, a very busy surgical practice, you do take a slightly different approach. But I think, again, we're seeing great receptivity on both. Again, primary optometry sees a lot of medical visits that they're incorporating this in. Speaker 200:32:41We are hearing from ophthalmologists that they are certainly going to look for a clean, healthy lid before they do a cataract or LASIK surgery. So those things are starting to take hold. And when you think about things like the guidelines, I think that validates the approach, which gives physicians a lot of confidence. And I think more so being in those guidelines also helps our discussions with the payers, right? It really positions the product at A standard of care, if you will, in eye care. Speaker 200:33:06And I think that helps us in those care negotiations that are ongoing as well. I think in terms of the day to day feedback, I've been out in the field. I'm hearing that Personally, I know, Bobby, you mentioned you've been out in the field, maybe you have a couple other insights software as well here. Speaker 300:33:19Yes. I would just add, I mean, we came back from both Major academies, optometry and ophthalmology in the last several weeks. And the value proposition is very strong, Whether it was our booth or advisory boards for commercial or medical affairs, there's tremendous interest. And I think as you're seeing In the data, there is a little more demand from optometry out of the gates. They've been already looking at the list probably a little bit more than the ophthalmologist. Speaker 300:33:47But we know how collaborative these doctors work together. So when we talk about that hybrid approach, it's really because In a given clinic, you'll see optometrists and ophthalmologists working together. That was very striking to me being out in the field. So And then there was one question about guidelines, I think you had Frank. Did you want to cover that, Adi? Speaker 300:34:08Yes. I think Speaker 200:34:09what we said on the guidelines was that I think that's important Validation for the physician, but again, I think, really does validate for the payers as well. So, we're delighted. I think we anticipate incorporating in other guidelines as well, But the AAO practice patterns, I think, are really important. I mean, I think just for reference to add to that is those aren't updated very often, right? Those are updated every handful of years. Speaker 200:34:31So to be included this year right after launch is a real testament to the medical efforts that we had, the scientific platform we've had out there and I think it's reflected in that. Speaker 1100:34:42Thank you. Speaker 300:34:44Thank you, Frank. Operator00:34:46Thank you. This concludes the Q and A session. I would like to now turn it back to Bobby Azamian for closing remarks. Speaker 300:34:55Thank you all again for your time and interest. We really look forward to keeping you updated on our progress as we work diligently to deliver on the promise of Xtandi. Hope everyone has a great day.Read morePowered by Key Takeaways Xtandi delivered $1.7 M in Q3 net sales within its first five weeks, reaching over 1,700 patients and being prescribed by more than 2,000 eye care providers, with better-than-expected gross-to-net discounts of ~73%. Targeting a sizable market of ~25 M Americans with blepharitis (7 M seeking treatment, 1.5 M diagnosed segment), Xtandi is the first-and-only FDA-approved therapy for demodex blepharitis, launched a month ahead of schedule and immediately available. Extensive disease education has driven prescriber engagement, with ~70% of eye care professionals recognizing the need for routine screening and >90% indicating intent to prescribe, and Xtandi’s inclusion in AAO practice guidelines further validates its standard-of-care position. Tarsus anticipates broad commercial coverage builds throughout 2024 and Medicare coverage in 2025, supported by initial non-contracted payer coverage and a focus on specialty pharmacy infrastructure to streamline patient access despite short-term prior authorization headwinds. Beyond Xtandi, Tarsus is advancing three Lotelobar-based therapeutics with top-line Phase 2 readouts expected by early 2024, and strengthened its balance sheet with ~$100 M in equity financing plus a $300 M shelf registration to fund ongoing launches and R&D. A.I. generated. May contain errors.Conference Call Audio Live Call not available Earnings Conference CallTarsus Pharmaceuticals Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Tarsus Pharmaceuticals Earnings HeadlinesTarsus Pharmaceuticals at H.C. Wainwright: Expanding Horizons with XdemvyMay 21 at 5:51 PM | investing.comTarsus Pharmaceuticals: The "Get Big Fast" Approach Could Pay OffMay 12, 2025 | seekingalpha.comAI Bloodbath Coming on June 1st?If you have any money in the markets, especially in AI stocks… Please click here to see Elon Musk’s new invention… This could send many popular AI stocks crashing, including Nvidia. And it could happen starting as soon as June 1st.May 22, 2025 | Paradigm Press (Ad)Tarsus to Participate in Upcoming Investor ConferencesMay 8, 2025 | globenewswire.com6 Analysts Assess Tarsus Pharmaceuticals: What You Need To KnowMay 5, 2025 | benzinga.comTarsus Pharmaceuticals, Inc. (TARS): Among the Best Breakout Stocks to Buy According to AnalystsMay 5, 2025 | insidermonkey.comSee More Tarsus Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Tarsus Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Tarsus Pharmaceuticals and other key companies, straight to your email. Email Address About Tarsus PharmaceuticalsTarsus Pharmaceuticals (NASDAQ:TARS), a commercial stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutic candidates for eye care in the United States. The company's lead product candidate is XDEMVY, a novel therapeutic for the treatment of blepharitis caused by the infestation of Demodex mites, as well as to treat meibomian gland disease. It is developing TP-04 for the treatment of rosacea; and TP-05 for Lyme prophylaxis and community malaria reduction. In addition, the company develops lotilaner to address diseases across therapeutic categories in human medicine, including eye care, dermatology, and other infectious disease prevention. 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There are 12 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Tarsus Pharmaceuticals Third Quarter 2023 Financial Results Conference Call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to David Nagasoni, Head of Investor Relations to lead off the call. Please begin. Speaker 100:00:22Thank you. Before we begin, I encourage everyone to go to the Investors section of the Tarsus website to view the earnings release and related financial tables we will be discussing today. Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman Aziz Motiwala, our Chief Commercial Officer and Jeff Ferro, our Chief Financial Officer and Chief Strategy Officer. I'd like to draw your attention to Slide 3, which contains our forward looking statement. During this call, we will be making forward looking language statements that are based on our current expectations and beliefs. Speaker 100:00:59These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail. With that, I will turn the Speaker 200:01:13call over to Bobby. Bobby? Speaker 300:01:16Thank you, Dave, and thank you all for joining us for our first ever earnings call and our first opportunity to speak with you since the highly anticipated launch of Exevi, the only FDA approved treatment for devepinax nephritis. We are off to a great start and I am pleased to share our progress with you today. Pembinaic blepharitis is a pervasive and damaging island disease that affects approximately 25,000,000 Americans. Of these, more than 7,000,000 are seeking treatment for a complementary eye condition. Double clicking on that number, More than 1,500,000 people have already been diagnosed with seborrheitis and are highly motivated to find an effective treatment. Speaker 300:01:58As anticipated, this is the patient segment driving strong initial demand. And as the Xtendi launch progresses, we expect to expand further into that group of 7,000,000 patients. Xtendi was approved a month ahead of its scheduled PDUFA date and as planned, we made sure it was available to patients within a month of approval. Today, I'm proud to report that we are delivering on the expectations we set for ourselves and for the launch of XtendBI. Specifically, in the Q3, we generated $1,700,000 in net sales and we delivered XtendBI to more than 1700 patients eagerly awaiting a new solution for dermatitis lephuritis. Speaker 300:02:42These results speak to the 2 key advantages that make Xtendi launch unique. 1, Xtendi is the 1st and only FDA approved medicine to treat seminis prophritis, which has enabled us to build an entirely new market focused on islet health. 2, Xtensy offers a defined course of treatment that delivers strong and durable outcomes and provides value to payers, for eye care providers and patients. You will hear more about our progress on both fronts later in this call. For those of you who are not familiar with devinex lephritis, it's caused by an infestation of devinex mice, and the most common parasite found on humans. Speaker 300:03:26Patients with this disease need treatment. They can experience Importantly, the cost, quality of life burden and psychosocial effects are significant. Patient impact ranges from the inability to wear makeup to functional issues such as driving difficulty driving at night. And in the most advanced stages of disease, there may also be corneal involvement, which can negatively impact the patient's vision. Turning to the next slide, you'll see exactly what I mean. Speaker 300:04:05This is a photo gallery of patients who have been suffering for years with dimeric blepharitis and prior to their treatment with Xtandi. I'd like to draw your attention to one image in particular, the one in the upper right hand corner. This is Lucas. He is a very active gentleman, retired chemical engineer. In addition to keeping up with his 8 grandchildren, he is also a competitive fencer. Speaker 300:04:30I had the great chance to meet Lucas last week. He shared with me that his watery eyes, irritation and blurred vision not only made it hard for him to participate in competitive fencing tournaments, but also made it hard to read the newspaper every day. As you can see in this photo, his eyelashes are crusted with colorects to tell cell signs of demodex blepharitis. Fast forward 5 weeks, a little less than a full course of therapy with Xtendvii complete, a stark contrast, No colorants, no redness, but what stands out most to me is the impact Xtendvii has had on its daily activities. And this is only one of the many similar stories we heard and similar photos we saw from eye care providers or DCPs for short. Speaker 300:05:22During the recent American Academy of Optometry and American Academy of Ophthalmology conferences. So when I say I'm confident about the blockbuster The potential of Xtandi not just because of the $1,700,000 in net product sales we reported for our 1st 5 weeks of launch, It's also because of the impact we are having on patients like Lucas. Again, we are off to a great start. The momentum we're already generating in these early days is proof of the value proposition of this category creating product, our extensive disease educational efforts and the seasoned leadership of our commercial organization led by our Chief Commercial Officer, Aziz Motiwala. Finally, I know the XtendBI launch is top of mind, but I want to close by reminding everyone of the potential of our robust pipeline and the near term data readouts that will be important for our long term growth, all of which will be addressed by Jeff Farrell, our Chief Financial Officer and Chief Strategy Officer later in the call. Speaker 300:06:24I will now turn the call over to Aziz for more detail on our launch progress. Speaker 200:06:29Thanks, Bobby. As the initial launch metrics demonstrate, the enthusiasm for XENVY is truly remarkable. I've worked in the eye care industry for more than 20 years and I've never This kind of early response, which I believe speaks to our unique and differentiated approach. In July, we shared our strategic and deliberate launch plan and we are executing successfully on this plan. We have a driven best in class team comprised of eye care experts and product launch veterans that are exceeding expectations on a daily basis. Speaker 200:06:59So far, our near term accomplishments are delivering a solid foundation for the long term expectations we have set for ourselves and for Xtandi. That said, launching a 1st in class therapeutic is a marathon and not a sprint. And we are planning for a steady launch trajectory as we continue to build demand and secure high value payer contracts. Category creation requires both substantial disease education and behavioral change. Diagnosing demidex blepharitis is a simple task as it just requires patients to look down during every eye exam and looking for colorect, the sure sign of disease. Speaker 200:07:35And as it's simple as it sounds, Not every eye doctor is doing it, at least not yet. We recognize that a shift in behavior like this will take time, which is why we initiated disease state education campaigns for every eye care provider as well as for patients well in advance of approval. We have now transitioned our efforts to MITRE Vermont, a complementary branded campaign that highlights the benefits of Xtandi. As a result, recent market research indicates that nearly 70% of ECPs say they recognize the importance of screening for colorects in every eye exam and more than 90% of ECPs indicate intent to prescribe Xtendi. That is truly a remarkable number. Speaker 200:08:16And what it says to me is that ECPs understand both the importance of treating this disease and the value that Xtendi brings to their patients. This is further bolstered by the recent addition of Xtendi to the American Academy of Ophthalmology's practice guidelines as the first and only FDA approved treatment for demodex blepharitis. We've also been highly successful in our differentiated approach to distribution, reimbursement and patient access. Due to the unique high value proposition of Xtendi, we are already seeing initial non contracted coverage that has resulted in better than expected gross to net discounts of 73%. It's a very encouraging metric for us. Speaker 200:08:57But I also want to caution that as more prescriptions start to come through their systems, payers may put more short term and onerous prior authorizations in place until we can work through our ongoing contract negotiations. That said, based on our ongoing discussions with all the top payers, we still expect broad commercial coverage to build throughout 2024 and Medicare coverage to come online in 2025. Before I turn the call over to Jeff, I want to acknowledge our sales force, which has done a remarkable job of generating the initial demand for Xtendi. They've already called on 80% of our top 4 desktop prescribers, who in the vast majority of cases have been called on multiple times. As a result of these efforts and launch to date, more than 2,000 ECPs have started patients on Xtendi and nearly half of those ECPs are repeat prescribers. Speaker 200:09:46We're also seeing a positive trend in new ECPs writing every day. Now when we look specifically at the Q3 results, we're pleased to report that approximately 1700 bottles of Xtendi were delivered to patients. And we recognized better than anticipated gross to net discount of 73%. This encouraging Q1 after launch said to me that we have established a solid foundation for ongoing momentum that gives us great confidence in the potential of Xtandi. I'll now turn the call over to Jeff Farrell for additional commentary on our financials and our pipeline. Speaker 200:10:21Jeff? Thanks Aziz. Speaker 400:10:24I've been lucky enough to have been part of several companies who have brought innovative new solutions to patients in need. And based on that experience, I believe Tarsus is on the cusp of delivering blockbuster potential in an entirely new category of eye care. As Bobby noted, we had an exciting Q3 marked by $1,700,000 in net product sales. We also completed an equity raise of nearly $100,000,000 that will be used to support the ongoing launch of XtEMVI and other strategic priorities. As a reminder, we recognize revenue when we ship XtEMVI from our warehouse to the distributors, not just on bottles received by the patients. Speaker 400:11:08Looking forward, we are very encouraged by the meaningful numbers of bottles dispensed so far in the Q4. But as we are still in the early days of an uncharted new launch, I wanted to highlight the potential fluctuations in both demand and gross to net discounts we might see in the future due to prescribers being out of the office for the American Academy of Ophthalmology and Optometry Conferences, that payers may implement while we work to finalize contracts. Turning now to our pipeline. I'm pleased to provide an update on the multiple near term Phase 2 data readouts we anticipate in the coming months. Beyond XtEMVI, we are continuing to advance 3 novel therapeutics that target the root cause of the disease. Speaker 400:12:07All three are based on Lotelanor, the same active ingredient in XtEMVI, providing us with a pipeline in a product. We remain on track to report top line data from our Myobian Gland disease study by year end and top line data from our ROCATION study in the Q1 of 2024. Due to additional time required Fully enroll our Lyme disease prevention study, we now expect to report top line results in the Q1 of 2024. Again, great progress here and the potential to continue building long term value for the company and our shareholders. Finally, as you may have noted, earlier today, we filed a shelf registration statement in the amount of $300,000,000 This is merely a good housekeeping measure for Tarsus and we have no immediate plans for financing. Speaker 400:13:04I also want to take this opportunity to note that the potential $2,500,000 milestone we have with Lianne Bio is now likely to be recognized in the first half of twenty twenty four. I will close by saying we remain well capitalized with approximately This provides sufficient capital to support the ongoing launch of XtEMVI and the advancement of our clinical pipeline programs. And with that, I will turn the call back to Bobby. Speaker 300:13:42Thank you, Jeff. As you heard today, this is an incredibly important and exciting time for our company. With the launch of Xtandi, Tarsus is well on its way to becoming an eye care leader with the potential to deliver multiple therapies from our category creating pipeline. Operator, please open the line for questions. Operator00:14:03Thank One moment for our first question. Our first question comes from Jason Gerberry of Bank of America. Speaker 500:14:36Hey, guys. Thanks for taking my questions. Couple for me, just your comments in the PR about 1700 bottles that pretty closely lines up with the IQVIA Data. So, just curious your thoughts on data reliability with IQVIA relative to Symphony and if IQVIA is ultimately perhaps like the better data source for tracking here. And then, just your latest thoughts on the role Between optometrists and ophthalmologists, it looks like I think you guys kind of had communicated this will be like kind of a fifty-fifty split, but it looks like ODs are about 62% of scripts so far. Speaker 500:15:19So curious if based on early observations, maybe how you're thinking about the optometrists The thing may be a bigger role here. Speaker 200:15:29Hey, Jason, it's Aziz. I'll happy to answer those for you. So When we think about the syndicated data like IQVIA or Symphony, I think a couple of things to keep in mind here. One is we have a very unique distribution network with Ora Focus Pharmacies. And secondly, it's very early in the launch. Speaker 200:15:45Those two things really yield that these audits are a little bit more directional at best In early days. I'd say in more recent weeks where they're looking better is just the trend in trajectory. But on a week to week basis, we see a lot of fluctuations in what they're reporting versus what we see here internally. We've been giving them a lot Speaker 500:16:03of the data feeds. Speaker 200:16:04So we anticipate as the weeks go on that those data feeds will be getting more and more accurate. But I think for now, I would tell you that really focusing on the trajectory and the trend versus the week to week numbers because you're going to see Our goal is to just focus on driving volumes and as the volumes increase that those will sort of align better over time. To your second question around the split across specialties, we're seeing great feedback from both ophthalmology and optometry. We reported over 2,000 doctors to date who've gotten patients on therapy and that is coming from a mix of both, as you mentioned. I think near term, we are seeing a slight slant towards optometry, but I think over the long haul, it will start to even out. Speaker 200:16:43You'll see equal contribution from both ophthalmologists and optometry. Maybe at most it goes to 55 optometry, but we do anticipate that balancing out a little bit more over time. Speaker 300:16:54Okay. Thanks a lot. Operator00:16:57Thank you. One moment for our next question. And our next question comes from Tim Lugo of William Blair. Speaker 600:17:15Hey, guys. This is Lachlan on for Tim. Thanks for taking the questions. At AIO, we had a lot of discussion, not necessarily from doctors, but other companies in the field around your pricing. So I was just wondering if you can discuss the initial feedback you've had You've been hearing that particularly from payers. Speaker 600:17:32And then second, can you maybe just talk about how the education has been going around demodex mites lead to blepharitis and how that's been received with eye care professionals? And do you have any sense of kind of how many have incorporated looking forward to the existing practice? Speaker 200:17:54Yes. Hey, thanks for the question. It's Aziz again. So on the first one around price, I think we were very thoughtful and purposeful when we thought about the pricing for Xtandi really reflecting the value proposition the product brings. It's one course of therapy for 6 weeks, Yes, great outcomes across multiple measures of disease and it's the 1st and only approved product for the disease. Speaker 200:18:16All those things combined lead to a great value prop for physicians, patients and payers. So the feedback we've gotten has been very reasonable on that. I think that's reflected in some of the non contracted coverage we're seeing here in early days, And that's reflected in the better than expected gross to net discounts. So payers are covering this. We're having ongoing discussions with all the payers and we're not seeing a lot of pushback there. Speaker 200:18:38Of course, those Those are all negotiations and they're active negotiations, but I think the payers do recognize the value proposition Xcebi brings. They do acknowledge The unique aspect of the drug and the fact that it's the first and only. So we feel really good about that and stay committed to the idea of building commercial coverage through 24 and having Part D comment on 25. And then when it comes to education, this has been a focus of ours even prior to the launch. We had multiple campaigns Educating the physicians and patients on the disease. Speaker 200:19:09Our disease campaign was essentially as having physicians screened for the disease by having patients look down. We're seeing that momentum continue to build now that the product is approved. As we stated in our prepared comments, 70% of doctors we survey say that it's And furthermore, we know that if they're looking for colorects, they understand that colorects are pathognomonic for diabetic spelarthritis. So They are making the link. I think in early days, it's still important to build that habit and make it a routine in every exam. Speaker 200:19:40And that's our focus going forward, right? You can see the sales force and our Medifarious team are continuing to educate on disease. The sales force is out there linking the disease to the benefits of the product And that's going to be a continued focus for us, right? We're building a new category. It will take some time, but we are seeing great momentum there. Speaker 300:19:55And I just want to add to that, Aziz. This is Bobby Zameen. I've been in the field as has our executive team roughly monthly and I've seen that education take place. I was once in a very urban environment and next in a more suburban environment. And just as Aziz said, you see some doctors that are immediately prescribing And doing multiples and then you see some doctors that need a couple of visits and start to understand the value proposition, start to look for patients and then come online and start prescribing. Speaker 300:20:26So we're seeing that really week in week out in terms of that education taking up. Operator00:20:34Thank you. One moment for our next question. And our next question comes from Eddie Higdon of Guggenheim Securities. Speaker 700:20:48Hi, good afternoon and congrats on the launch so far. Thanks for taking my questions. Just 2 from me. Can you give any additional color on what went into that 73% Gross to net discount and how you think that will track over the next few quarters given it's already better than where we thought it would start. How many of those 1700 bottles were reimbursed And how does the limiting sampling work for this project product? Speaker 700:21:10And then if you can give us sort of any data benchmark on the upcoming MGD study and sort of what you're hoping to Speaker 400:21:20Hi, it's Jeff. I'll start with the gross to net question. So We did do better than we anticipated. We ended up with overall gross to net discount of about 73%. I think we were anticipating closer to The vast majority of that discounting was related to our bridging program. Speaker 400:21:39But what the delta between our expectations and What we ultimately saw was a little more coverage than what we were expecting from the commercial side in particular. We do think over time that as we start to get payer coverage in 2024 with commercial, we'll see that gross to net improve. And then ultimately in 2025, once Medicare comes on, we'll get to a steady state of about 50% gross to net discount. I think the thing we're cautioning folks on, as I mentioned earlier, is in the Q4, now that some of these payers are seeing More scripts come through. They're trying to manage their budgets if we are not currently contracted with them. Speaker 400:22:20So we're anticipating somewhat of a flat Gross to net discount from the Q3 because of that. We're starting to see more owners' prior offs. Again, that will be short term, And we do expect to see that improve over time starting in Q1 of 2024. Speaker 300:22:39And then the second question was about the upcoming MGD study. Jeff, do you want to take that one as well? Sure. Speaker 400:22:44Yes. On the MGD study, we anticipate Releasing the data here in the next month and a half prior to year end. It includes data from Two doses, 2 dose types. 1 is BID, 1 is TID. And so we'll be able to release that top line data sometime later this year. Speaker 200:23:09Thank you. Operator00:23:10Thank you. One moment for our next question. And our next question comes from Oren Livnat of H. C. Wainwright. Speaker 800:23:29Thanks. I have a couple of questions. Just to revisit this issue of the evolving Payer pushback, I guess, in the immediate term. First, can you just help us understand what kind of early experiences You're hearing about physicians having in terms of getting better patient access early on. Do they need to fill out letters of medical necessity now or is it just going through specialty pharmacy that's handling all that adjudication for them on the back end so that they don't experience any of that Friction per se. Speaker 800:24:03And going forward, I guess, obviously, gross to nets are going to potentially be volatile. But What about volumes? Do you suspect that if there's an incremental pushback in reaction to your very strong volume out of the gates here that it could actually get harder In the near term for Summit to get a patient on and what do you have to do to make sure that that doesn't then potentially sour any doctors on the experience going forward? Thanks. Speaker 200:24:31Sure, Oren Khazid. So I think when you think about that access right now, as Jeff mentioned earlier, Through the end of the year, right, we can expect that these folks as they start to see volume, the payers will put some restrictions in place. We've seen this in pockets. I think that this is something that the doctors can navigate through. The doctors typically initiate the PA, but through our FOCUS pharmacy network, they do get some assistance in that process. Speaker 200:24:53But clearly, the doctor has to initiate that they have the patient records. It varies by plan what the expectations are. So in some cases, it's a very simple PA. In other cases, we are seeing a little bit more onerous DAs. Mind you that all this coverage is not contracted right now. Speaker 200:25:05So as contracts come online, we would push for a more straightforward PA to label that aligned with a first and only type of product. So we see that evolving over time. In terms of impact to volumes, I think what Jeff is saying is we're continuing to see steady uptake from the physicians. We're seeing that the doctors are getting access to the drug. They're great success with the drugs and we continue to see that build. Speaker 200:25:28I think that you have to just keep in mind that that's more of a headwind. We don't see it as something that would keep the prescription flat, But it does sort of give us a little bit of a headwind as we are building that acceptance with physicians. And I think the doctors are sensitive to that. They know and understand that new products Take time to build coverage and I think it speaks to the value proposition of Xtandi that people are committed. They're seeing these patients. Speaker 200:25:49They don't have another option. So the doctors are putting the effort in and of course our programs are there to help that process along. So we think we'll continue to build volume steadily, but certainly Changes in policy or short term PA adjustments can be a slight headwind as we're ending the year here. Speaker 800:26:05And just so I'm clear, We're not covered or we're pushback is insurmountable. Is that bridging program still getting drug into Patients' hands in any and all cases essentially such that we'll continue to see the demand reflected in the prescriptions going forward? It's just a question of The economics that you realize in gross to net? Speaker 200:26:28That's exactly right, Alain. Speaker 800:26:31Perfect. Thanks. I'll get back in the queue. I appreciate it. Operator00:26:35Thank you. One moment for our next question. And our next question comes from Balaji Prasad of Barclays. Speaker 900:26:52Hi, everyone. This is Mikaela on for Balaji. Thanks for taking our questions. Just thinking about your pipeline, at what point might you look to expand this further and are there any areas in particular that would be of interest? Thanks so much. Speaker 300:27:04Thank you, Mikaela. We do look Actively at the entire eye care landscape, as you can imagine with a great early launch trajectory with a commercial platform, Eventually, we want to add more products to our pipeline and to our commercial force. Right now, we can only be so modest, but With continued success, we would look to add further products. And so stay tuned. There's nothing to report today, but stay tuned. Operator00:27:37Thank you. One moment for our next question. And we have time for one more question. One moment. Our next question comes from Patrick Dolesale of LifeSci Capital. Speaker 1000:28:10Hi, this is Corey on for Patrick. Thanks for taking our questions. In the call you mentioned that more than 2,000 ECPs have Prescribed Xtampi so far. So it sounds like prescriber adoption has been quite broad as opposed to a really narrow focused Group of prescribers leading most of the volume. We'd love to hear more about your strategy and How you've been prioritizing ECP targeting? Speaker 1000:28:39And I guess also on that note, how are you thinking about marketing in Both the near and long term, it seems like marketing has primarily been directed towards prescribers. Can you speak to the relevance of Consumer directed marketing in demodex blepharitis and what might your strategy be in that regard? Speaker 200:29:01Hey, Cory, it's Aziz. And yes, I think we've been really pleased with the physician acceptance and receptivity. We just came back from both the Academy of Ophthalmology and Academy of Optometry, got a lot of first hand feedback. So we're real delighted With the uptake we're seeing among the physician community, we're seeing broad updates to your point. And that's been our strategy, right? Speaker 200:29:20We didn't want to niche the product. We wanted to go to a broad Audience of prescribers, that's why we built the sales force the way we did. We're targeting over 15,000 doctors in our efforts. So we're making great progress in penetrating that marketplace. How we prioritize that, as I think we've shared before, we take a very data driven and informed approach. Speaker 200:29:39We think about where patient volumes are, we look at claims data and we look at who has historically been early adopters of other products and that really helps focus our efforts. We also mentioned earlier that we've already talked to 80% of our top decile doctors. So we've been real thoughtful about where we're deploying the sales force time. And I think that the physician receptivity and the number of doctors that have written and repeat written, which is really important, I think reflects that very thoughtful approach. I think in terms of the marketing efforts that you asked about, we've been real intentional here. Speaker 200:30:09I think early days, we really have focused on the physician education, building that understanding that scientific platform, if you will. That will continue to be the focus along with building coverage. And the way you can think about it is once we have great physician penetration, which we're already on a good And as more payer coverage comes in, that's probably going to signal a great time to think about activating the consumer more purposefully. We do have some consumer education ongoing right now. We've done some smaller campaigns. Speaker 200:30:34But in terms of broad based DTC, which I think you're referring to, I think that comes online when we've got even more adoption among the physician community and even enhanced coverage with our contracts coming online in 2024 and early 2025. Speaker 1000:30:49Excellent. Thanks for taking our questions and congrats on the progress. Operator00:30:54Thank you. One moment for our last question. This question is from Frank Brisebois of Oppenheimer. Speaker 1100:31:14Hi. Thanks for taking the questions and congrats on the start here. I was just wondering, we talked a little bit in previous questions about Optometrists versus Ophthalmologists. And I was wondering, can you just help us understand how the pitches are going and the reception is going between the 2 different types of docs and if there's any sticky points or is it a very different pitch between both of them? So Any color on that would be helpful. Speaker 1100:31:42And then you talked about entering the guidelines here. I was wondering how important that is for for physicians to then prescribe? Thank you. Speaker 200:31:52Yes, Frank, thanks for the question. I think the pitch is very similar overall, Our sales messaging is very consistent. You can think about it in really three tranches. We focus on the disease state, building awareness, Continue to promote diagnosis by looking at Lids. Secondly, we focus on the value proposition XENBI brings, the unique effects that XEMBI brings across tolerance, mites and redness. Speaker 200:32:15And third, we focus on our pull through with our pharmacy network getting the prescription in and the process to get the prescription, which is of course really important in early days when we don't have contracts in place. So that's pretty consistent. I think sometimes you do have nuances, The optometry versus, say, a very busy surgical practice, you do take a slightly different approach. But I think, again, we're seeing great receptivity on both. Again, primary optometry sees a lot of medical visits that they're incorporating this in. Speaker 200:32:41We are hearing from ophthalmologists that they are certainly going to look for a clean, healthy lid before they do a cataract or LASIK surgery. So those things are starting to take hold. And when you think about things like the guidelines, I think that validates the approach, which gives physicians a lot of confidence. And I think more so being in those guidelines also helps our discussions with the payers, right? It really positions the product at A standard of care, if you will, in eye care. Speaker 200:33:06And I think that helps us in those care negotiations that are ongoing as well. I think in terms of the day to day feedback, I've been out in the field. I'm hearing that Personally, I know, Bobby, you mentioned you've been out in the field, maybe you have a couple other insights software as well here. Speaker 300:33:19Yes. I would just add, I mean, we came back from both Major academies, optometry and ophthalmology in the last several weeks. And the value proposition is very strong, Whether it was our booth or advisory boards for commercial or medical affairs, there's tremendous interest. And I think as you're seeing In the data, there is a little more demand from optometry out of the gates. They've been already looking at the list probably a little bit more than the ophthalmologist. Speaker 300:33:47But we know how collaborative these doctors work together. So when we talk about that hybrid approach, it's really because In a given clinic, you'll see optometrists and ophthalmologists working together. That was very striking to me being out in the field. So And then there was one question about guidelines, I think you had Frank. Did you want to cover that, Adi? Speaker 300:34:08Yes. I think Speaker 200:34:09what we said on the guidelines was that I think that's important Validation for the physician, but again, I think, really does validate for the payers as well. So, we're delighted. I think we anticipate incorporating in other guidelines as well, But the AAO practice patterns, I think, are really important. I mean, I think just for reference to add to that is those aren't updated very often, right? Those are updated every handful of years. Speaker 200:34:31So to be included this year right after launch is a real testament to the medical efforts that we had, the scientific platform we've had out there and I think it's reflected in that. Speaker 1100:34:42Thank you. Speaker 300:34:44Thank you, Frank. Operator00:34:46Thank you. This concludes the Q and A session. I would like to now turn it back to Bobby Azamian for closing remarks. Speaker 300:34:55Thank you all again for your time and interest. We really look forward to keeping you updated on our progress as we work diligently to deliver on the promise of Xtandi. Hope everyone has a great day.Read morePowered by