NASDAQ:LENZ LENZ Therapeutics Q2 2024 Earnings Report $29.37 +3.03 (+11.50%) Closing price 04:00 PM EasternExtended Trading$29.38 +0.02 (+0.05%) As of 04:05 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast LENZ Therapeutics EPS ResultsActual EPS-$0.40Consensus EPS -$0.49Beat/MissBeat by +$0.09One Year Ago EPSN/ALENZ Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ALENZ Therapeutics Announcement DetailsQuarterQ2 2024Date8/14/2024TimeN/AConference Call DateWednesday, August 14, 2024Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by LENZ Therapeutics Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 14, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Lens Therapeutics Second Quarter 2024 Conference Call. At this time, all participants are in a listen only mode. Following prepared remarks from management, we will conduct a question and answer session and instructions will follow at that time. Operator00:00:16As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevillard, Chief Financial Officer. Please go ahead. Speaker 100:00:26Thank you. Good afternoon and thank you to everyone for joining us today to discuss Lens' Q2 2024 financial results and recent highlights. My name is Dan Shevalard, Chief Financial Officer of LENS Therapeutics. We are joined today by Abe Schimmelpennik, our President and Chief Executive Officer and Sean Olson, our Chief Commercial Officer. In addition, Doctor. Speaker 100:00:50Mark Oedrich, our Chief Medical Officer, will join us for the question and answer session. Before we begin, I would like to remind you that this call will contain forward looking statements regarding LENS' future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, which can also be found on our website. In addition, any forward looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Speaker 100:01:48The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our Q2 2024 Form 10 Q, which was filed today. With that, I will now turn the call over to Abe. Speaker 200:02:03Thank you, Dan, and good afternoon, everyone. The first half of twenty twenty four and recent period has been transformational for Lance. In short succession, we made our debut on a public markets with a strong investor base and balance sheet, delivered the results of our Phase 3 CLARITY trials, which we believe support LNG-one hundred as the potential best in class treatment for presbyopia, concluded a $30,000,000 pipe financing and importantly submitted our NDA to the FDA. I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cyclinib based eye drop for the improvement in their vision and people with presbyopia. Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-twenty 25 and if approved U. Speaker 200:03:01S. Launch as early as second half of twenty twenty five. Before I review our key achievements in more detail and as a quick reminder, presbyopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision. Although the progression of presbyopia is gradual, presbyopia often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Speaker 200:03:51To address the daily challenges faced by presbyopes, we are developing a once daily eye drop that in our CLARITY trials has shown to be capable of improving their vision throughout the full work day without the need for reading glasses. More specifically, in April we reported positive Phase 3 data which we complemented with Capstone data in June in which LMG-one hundred, our cyclin based product candidate continued to show strong performance and best in class potential. Highlighting some of the key results of the trial and for the moment focusing on the results of CLARITY-two as this is the direct vehicle controlled trial, we saw a rapid onset effect with 71% of participants achieving 3 lines or more of near vision improvement at 30 minutes on the very first day of use of the product. At 3 hours, our primary endpoints, we also observed a 3 line or more responder rate of 71%. And we maintained these high levels for the full workday with 40% of participants still achieving 3 lines or more of near vision improvement at 10 hours, the last time point measured in our efficacy trials. Speaker 200:05:02And these three line gains turn out to be only the beginning. 84% of participants achieved at least a 4 line gain during the study and a staggering 52% at least 5 lines. We also saw a very impressive near universal response to LNG-one hundred with 95% of participants achieving at least two lines of near vision improvement. This is an important measure because it has seen as clinically meaningful. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. Speaker 200:05:40Interestingly, we also observed a statistically significant at least one line of distance vision improvement across the population. In terms of safety, LMG-one hundred was seen to be well tolerated with no treatment related serious adverse events observed in the over 30,000 treatment days across all three CLARITY trials. Of all reported adverse events, 95% were classified as mild, believed to be transient and consistent with those observed in previous trials. We also saw that in the rare cases, more specifically 7.6% placebo corrected that participant noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphylactic and for most no longer appearing before long to use of LNG100. Speaker 200:06:33These strong clinical results and the promise they bring for the 128,000,000 press release in the U. S. Alone allowed us to further strengthen our balance sheet with a $30,000,000 investment from Ridgeback Capital in July. We appreciate the significant support and confidence shown by the Ridgeback team and are pleased to add this additional capital as we aim to make LNZ100 the best in class, if not only in class therapeutic option for the treatment of presbyopia. Lastly, I'm very excited to highlight that we have submitted our NDA for LNG-one hundred to the FDA, marking a key milestone for the company. Speaker 200:07:14Our NDA is a combination of a development program that along the way incorporated a value of feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data and we look forward to working with the agency as they review our submission. The first step in this and following a positive initial review would be the formal acceptance of our NDA within 60 days of submission. Once the FDA accepts our NDA, the agency must complete their review within 10 months. The end the date at the end of this period is referred to as PDUFA date and once the FDA has provided us with it, we will communicate this with you. Speaker 200:08:02As mentioned earlier and in line with previous guidance, we believe that this PDUFA date can be in the middle of next year and if our submission needs to approval could lead to launch of LNG100 in the U. S. In the second half of twenty twenty five. To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson, Chief Commercial Officer. Sean? Speaker 200:08:29Thank you, Eef, and thank you all for joining us today. Speaker 300:08:32The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. As I've stated, Presbyopia impacts an estimated 128,000,000 people in the U. S. An incident population that is nearly 4 times greater than those impacted by dry eye. It is also more than the combined population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy and glaucoma in the U. Speaker 300:09:02S. The first eye drop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eye drop treatment, as evidenced by initial paid new scripts of 3,000 to 5,000 per week. Long term usage beyond the trial period of this product did not materialize as pilocarpine even at the high concentration of 1.25% couldn't deliver the consumer required performance. We believe this leaves the category wide open for a non pilocarpine presbyopia eye drop solution that can deliver what consumers desire. Unlocking this market requires an ideal presbyopia eyedrops and we are excited for the prospect of our acyclidine based LNZ100. Speaker 300:09:51We believe the commercial potential of LNZ100 was validated in our Phase 3 CLARITY study with 90% of participants noticing an improvement in your vision and 75 participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use the product 4 to 7 days per week. Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3,000,000,000 market potential opportunity and in what could potentially be a category of 1. In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway. In February 2024, LEMS launched its unbranded I'm campaign to educate and excite eye care professionals about future presbyopia solutions. Over 50 key opinion leaders are involved in the campaign, of which many are featured at iamselective.com that is eyeamselective.com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity and expected early consumer adopters of presbyopia eyedrops. Speaker 300:11:10Continuing on that momentum and to support the projected launch following potential FDA approval, Lens has fully staffed its commercial leadership team across marketing, sales and commercial operations with expertise in eye care, direct to consumer, influencer and consumer products goods. From an infrastructure standpoint, Lens is actively building out its U. S. Commercial capabilities, highlighted by completion of our 3rd party logistics contracting, all in preparation for a potential launch of LNZ100 as early as the second half of twenty twenty five. As we think about the commercialization of LNZ-one hundred, our strategy is clear and based on 3 primary pillars. Speaker 300:11:57First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals who represent over 85% of the beauty scripts with our potential best in class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering. 2nd, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct to consumer advertise. And third, we want to ensure ease of product access for consumers with a seamless journey to use. Speaker 300:12:41This requires enabling consumer to experience the product and move quickly from trial to usage. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy as well as home delivery. We look forward to providing further updates and progress on our pre commercial preparations in the quarters to come as we approach potential approval and launch. With that, I'd now like to hand the call over to Dan Chevouillard, our CFO to step through our financial results. Speaker 100:13:17Thank you, Sean. As has been mentioned, the team has continued organization in the Q2 in recent period. On the financial front, we were very pleased to have completed the $30,000,000 private investment in public equity or PIPE with Ridgeback in mid July. I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber adding to what is an already strong and supportive investor base in Lens. Inclusive of the $30,000,000 in proceeds on a pro form a basis, we ended the 2nd quarter with approximately 226,200,000 dollars in cash, cash equivalents and marketable securities, which is anticipated to fund the company's cash runway to post launch positive operating cash flow. Speaker 100:14:07Turning now to our 2nd quarter operating results. Our operating expenses and resulting cash burn for the 2nd quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14,400,000 compared to $15,000,000 for the same period in 2023. Sequentially, our total operating expenses decreased quarter over quarter by 11% from $16,100,000 in the Q1 of 2024 as we moved away from costs associated with the recent merger transaction and reduced overall clinical development spend. On our Q1 call, we highlighted that we would anticipate a sharp decline in our research and development expenses in subsequent quarters due to the recent conclusion of our Phase 3 CLARITY study, which we certainly have realized in the Q2. Speaker 100:15:03Total R and D expenses decreased to $6,900,000 in Q2 twenty twenty four compared to $12,600,000 for the same period in 2023. Sequentially, R and D expenses decreased quarter over quarter by 34% from $10,500,000 in the Q1 of this year. We anticipate R and D costs to continue to decline over the balance of the year, while shifting our development focus towards preapproval manufacturing activities. Similarly, and further to our go forward reallocation of capital towards the commercial organization, total SG and A expenses increased to $7,400,000 in Q2 2024 compared to $2,300,000 for the same period in 2023 and sequentially increased quarter over quarter by 32% from $5,600,000 in the Q1 of this year. This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre commercial planning initiatives. Speaker 100:16:07Finally, our net loss per share both basic and diluted was $0.40 per share in the Q2 of 2024 on a net loss of $10,300,000 compared to a net loss per share of $7.53 per share in the Q2 2023 on a net loss of $14,700,000 As was noted on our Q1 call, we again wanted to remind you that these loss per share figures calculated on a GAAP basis consider only weighted average common shares outstanding, which were considerably different in the comparative periods. For example, as a public company with a single class of stock outstanding, Q222 net loss per share was calculated on approximately 25,600,000 weighted average common shares outstanding. Compare this to Q2 2023, when as a then private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2,000,000 weighted average common shares outstanding. Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25,800,000 shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27,400,000 shares outstanding following that financing. Speaker 100:17:31With that, I'll conclude the financial update for what has been a very productive quarter in recent period. And I'll now turn the call back over to Eef for final remarks. Speaker 200:17:40Thanks, Dan. In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been and promises to continue to be a very exciting time at Lens. With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LNZ100. And we believe we're well positioned to deliver once daily safe and rapidly acting treatments to 128,000,000 individuals living with presbyopia in the United States. Speaker 200:18:17With that, I'd like to open up the call for questions. Operator00:18:21We will now begin the question and answer session. Our first question will come from the line of Pavan Patel with Bank of America. Please go ahead. Speaker 400:18:29Hey, guys. This is Pavan Patel on 4J Singerberry. Congrats on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect SG and A spend to pick up as you begin to incur more meaningful pre launch investment on your P and L? And then our second question is maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses? Speaker 400:19:05Thank you. Speaker 200:19:07Thanks, Pavel. Great questions. I'll hand the first one over to Dan. Speaker 100:19:13Sure. Yes, thanks for the question. Kind of as we said for this quarter, we did see a 32% quarter on quarter increase in SG and A. And I think that you should expect us to have a modest ramp over the balance of this year. I think where you'll really start to see is as we move into 2025 and approach the mid year of next year. Speaker 200:19:43Thanks. And then as for which patients we would prioritize, Sean? Speaker 300:19:49Yes. So looking at how we identify the patients that would be good candidates for this trial. So when we think about our products, we had a very broad inclusion criteria. So we want to develop a product that did work for everybody. And that's why we're focused on an all eyes, all day solution. Speaker 300:20:06Now that being said, there are people that are more prone to be early adopters of an eye drop solution. We commissioned a very large study to do market research in this space and we really found 3 groups of individuals that stood out as the earliest adopters And those 3 groups fall into people that are in contacts now entering presbyopia and want to stay in contacts. They've been looking for they've been in a glasses free lifestyle and want to continue that. And a big reason for dropout of contacts is because of presbyopia. The second one are people that have had refractive surgery in the past. Speaker 300:20:44So again, people who paid for LASIK, invested in Glasses Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that had been to a MediSpa in the past 12 months. Each one of those groups are north of 10,000,000 individuals. Speaker 200:21:04Thanks, Sean. Operator00:21:07Our next question will come from the line of Ygal Achnikomovitz with Citi. Please go ahead. Speaker 500:21:14Hi, Ef and team. Thanks for taking the questions. I had a few. I was just curious with respect to the target prescriber audience, the optometrists, can you just give some perspective as to what percent of the optometrists pool in the United States are currently able to write prescriptions for LENS 100? And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe ONCE-one hundred? Speaker 500:21:45Thanks. Speaker 300:21:47Absolutely. So this is Sean Olson again. So when we think of LND-one hundred, upon potential approval, those that are able to prescribe it when we think of the optometrists, nearly all the optometrists across the U. S. Will have the ability to prescribe LNV-one hundred. Speaker 300:22:06So it falls into the category of miotics and with the exception of a couple of states, they will have the ability to prescribe on day 1. And so that really covers the vast majority of all optometrists. In terms of doing retinal eye exams, retinal eye exams are going to be a very common process done for again nearly every optometrist across the U. S. They will be able to do those retinal eye exams. Speaker 300:22:31So in terms of access, we see ourselves in a very good position for access upon approval. Speaker 500:22:37Okay, great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies and the data that supports the use of LENS 100 in lower light conditions, for example, if you're out at a meal, at a restaurant and you need to read the menu, for example. Could you just talk about that aspect of the product profile? Speaker 200:23:01Absolutely. So we did all our near vision measurements in what's called mesopic conditions. So mesopic is low light. Just to give you an idea of what that means. So we actually have one of our KOLs describe that very adequately in our KOL event. Speaker 200:23:20That basically means that you lower the lights in the room to almost candlelight conditions. So it's very low light in the room and then you have them read a backlit screen. So it's truly low light conditions that we've measured all our near vision in. So if you will, it's the most challenging condition because we definitely wanted to avoid that we brighten the room in a way that it would impact positively near vision that we could not ascribe to our products. So again, very low light dim lit conditions in the room. Speaker 200:24:01And just to back up a little bit into Sean's statement on the retina exam, that's something that all optometrists pretty much do already. So it's a very standard exam. So it's not something that we need to train them on or that we need to that they need to add to the practice to be able to describe a drug. And again, very common practice in optometry. Speaker 500:24:25Okay. Thank you. Speaker 100:24:27Thank you. Operator00:24:28Our next question comes from the line of Joseph Catanzaro with Piper Sandler. Please go ahead. Speaker 500:24:34Hey, everybody. Thanks for taking my questions. Maybe 2 for me. First as it relates to the NDA filing. Can you just remind us whether there was any formal engagement with the FDA like a pre NDA meeting ahead of the filing? Speaker 500:24:47And if so, any sort of feedback learnings you glean from those interactions? And then second question, I guess related to early adopters, but less from a patient perspective and more so from a physician perspective. What are you looking for there? Is it simply those who have written a Vuity script in the past or are there more things that you're honing in on that potentially identify early writers? Thanks. Speaker 200:25:16Thanks, Joe. I'll take the first one and then I'll take the next one over to Sean. So yes, there's been definitely an End of Phase 3 and pre submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development. And that's where most of the feedback actually came from the FDA. Speaker 200:25:42So are very well aligned with them on especially our clinical program, manufacturing setup, basically everything that was relevant for the development. And that actually then made the end of Phase 3 meeting with them pretty benign. I think it was hardly any questions actually that we have left that we want to ask. It was merely a confirmation of this is all the data that we've gathered. This is the amount of patients that we have on both the efficacy and the safety side. Speaker 200:26:17And they once again confirmed that, that was completely aligned with their expectations for our NDA. So we're very confident that the filing has or the submission has everything in it that the FDA wants to see. Speaker 300:26:33And for your second question, when we're identifying early adopters from an eye care professional standpoint, Again, we commissioned a very large study and took into account many factors. We looked at the prescriptions of Vuity. We looked at early adopters of other recent eye care launches. We also looked at history of prescriptions for dry eye as well as different locations such as urban city centers where we saw a lot of the beauty scripts. Ultimately, when we did all the analysis, what came out and what's the primary focus of the targeting was their actual propensity to write Vuity and how many scripts they wrote. Speaker 300:27:12And that's really where we come up with those 15,000 target ECPs that represent over 85% of all the Beauty scripts. Speaker 200:27:25Okay. Operator00:27:25Our next question will come from the line of Mark Goodman with Leerink. Please go ahead. Speaker 600:27:32If I could you please review what you've done on CMC, what's left to do? Just give us an update there please. Thanks. Speaker 200:27:40Absolutely. Thanks, Mark. Good question. So on the CMC side or the manufacturing side, we've actually produced all our clinical Phase 3 material at commercial scale. So we're fully set up to produce launch quantities at that scale. Speaker 200:28:01Our complete supplier network is in very good standing with the FDA. So very confident that our commercial network, commercial manufacturing is all in place there. And that goes for both drug products as well as drug substance or API. Speaker 600:28:22Stability all done, everything you need to do there? Speaker 200:28:25Yes. Stability is all done. So all the stability that we needed to submit our program and this is generic for any submissions, you need to submit with at least 12 months of stability data on your registration batches, which obviously given the fact that we've submitted, we have that in place and submitted and that data looks stellar. Speaker 600:28:49Great. And then just secondly on the unbranded campaign, can you just go into a little bit of detail, a little more color just on what's the discussion, what it's like, maybe just give us a sense of what a session would be like and the feedback you're getting? Thank you. Speaker 300:29:08Yes, absolutely. So we're really excited about this unbranded campaign. What's unique to presbyopia is the fact that when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. What we have to train people on is how to look for what an ideal presbyopia eyedrop solution is. Speaker 300:29:28So really what we're talking about is what's the ideal pupil size, the importance of a eye drop that focuses on reducing the pupil, but avoiding that ciliary muscle. And then also because there's so many people out there impacted by presbyopia, who are the early adopters? So a lot of that's training on those three groups I talked about before, people in contacts, people who have had refractive surgery and people who have been to a medi spa. And overwhelmingly, what we see at the different conventions is excitement for the campaign. It's very easy to feed forward. Speaker 300:30:04So we have over 50 people that are the face of the campaign across all of our presentations, all of our conventions. And we actually release a new one every week on LinkedIn and we're getting calls from doctors saying, hey, when is my photo going out because I actually want to see my photo on LinkedIn, I want to like it. So it's going very well. And I think what's always really important with our product, the first thing people want to know about the product and it's separate from the unbranded because we can't commingle the 2, but they want to know it's not pilocarpine. That's the really important thing and the doctors care about. Speaker 300:30:39As soon as they know it's a non pilocarpine solution on the medical side, they're very excited to learn more about the product and engage. So we've seen this as a very good success. We've seen a lot of traction and a lot of ECPs coming to us that want to share their excitement for the future of presbyopia solutions. They want us to tell them more. Speaker 500:31:02Thanks. Operator00:31:04Our next question comes from the line of Tim Lugo with William Blair. Please go ahead. Speaker 700:31:10Hey, guys. This is Lachlan on for Tim. Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, Are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research? And secondly, I believe at the KOL day, one of the physicians said or suggested that they would most patients would first try the drop in the office. Speaker 700:31:39Is that sort of correct or is that what you're expecting? Speaker 200:31:45Thanks, Liam. Good to hear you. So on that first one, and I'll keep that very brief because obviously, I want to make sure that, 1, we don't talk about anything that's not on the label yet or that we've not studied. But for sure, the medical community is talking and thinking about uses of how they could see this product being used outside of near vision. So yes, that's something that in-depth context is discussed, not something for me to elaborate on. Speaker 300:32:21In terms of the use of the products, we meet with a lot of different eye care professionals across optometry. Many of them want the patient to experience in the office. And what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect right off the bat when they put it in. Now some doctors, especially those that go for the dilated eye exam are going to want them to take the samples home and try it at home. But, we see that how the ECPs run their practice will decide whether or not they do it in office or outside of the office. Speaker 300:32:55It will be a good mix. Speaker 700:33:00Got it. Thanks. Speaker 200:33:02Just one thing to add there like on the data side, just thinking about it some more on what you just asked. One of the things that we've realized that we shared during that KOL event that what the data shows is that as your presbyopia gets worse, your actual impact keeps up with that. So the worse your presbyopia, the more lines you gain. That's certainly something that we've heard resonate really well in the medical community. So when maybe people initially were thinking about the presbyopiaide drop as something that could have an effect early on. Speaker 200:33:42And in some months, presbyopia journey, it's very clear now that actually our drop uniquely, because it is unique to our product keeps up with how you are. Presbyopia, I guess gets worse. So your Presbyopia 20 over 80 or 20 over 100 and you would need 4 or 5, maybe 6 lines, that's what the product actually delivers for you. So it ties into that very broad age range that we've tested in our trial. Speaker 700:34:17Very interesting. Thanks. Operator00:34:21Our next question comes from the line of Matthew Caufield with H. C. Wainwright. Please go ahead. Speaker 800:34:27Hi, Oates and team. Some very exciting developments for the quarter. So our question was considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved? Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient kind of based on their scheduling? Any clarity there or thoughts there could be helpful and excited to see the progress. Speaker 800:34:59Thanks. Speaker 300:35:01Great. Thank you. This is Sean again. So a couple of comments on that. So in terms of what we found in our market research, people are looking for an everyday eye drop that lasts all day. Speaker 300:35:13And we see this across multiple different studies. So not only in our consumer research did we see that the majority of patients wanted to use it 4 to 7 times a week. When we actually look at the patient reported outcomes from our Phase 3, 81% of the patients that would continue to use the product after the study plan to use it 4 to 7 days a week. So we do see that it's much more like contacts or people want to use it every day. Now that being said, all medicines, most medicines are not 100% compliant, right? Speaker 300:35:47If you look across the board for contacts, it's about 89% compliance rate for daily contacts. Terrvia had about a 65% refill rate, general medicines is about 50%. So when you look at that $3,000,000,000 market cap or $3,000,000,000 market size, it assumes a conservative 5 fills a year or a 42% refill rate. So that's what's built into that $3,000,000,000 number. However, when we speak to consumers, they're looking for an everyday eye drop, looking at probably 4 to 7 days per week. Speaker 800:36:26Very helpful. And just to confirm I heard that right, you said 5 times per year as sort of an average from your analysis? Speaker 300:36:32Yes. So if you think of average medicines are 50% compliance, 5 refills a year would just be a little bit conservative to that. That'd be a 42% refill rate. Speaker 800:36:45Got you. Okay, understood. Thank you for that. Speaker 200:36:50Thanks, Matt. Operator00:36:51And that concludes our question and answer session as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Please wait. Operator00:37:03The conference will begin shortly.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLENZ Therapeutics Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) LENZ Therapeutics Earnings HeadlinesLENZ Therapeutics, Inc. (LENZ) Q1 2025 Earnings Call TranscriptMay 11 at 12:38 PM | seekingalpha.comLENZ Therapeutics, Inc. 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Sign up for Earnings360's daily newsletter to receive timely earnings updates on LENZ Therapeutics and other key companies, straight to your email. Email Address About LENZ TherapeuticsLENZ Therapeutics (NASDAQ:LENZ), a biopharmaceutical company, focuses on developing and commercializing therapies to improve vision in the United States. Its product candidates include LNZ100 and LNZ101 which are in Phase III clinical trials for the treatment of presbyopia. 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There are 9 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Lens Therapeutics Second Quarter 2024 Conference Call. At this time, all participants are in a listen only mode. Following prepared remarks from management, we will conduct a question and answer session and instructions will follow at that time. Operator00:00:16As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevillard, Chief Financial Officer. Please go ahead. Speaker 100:00:26Thank you. Good afternoon and thank you to everyone for joining us today to discuss Lens' Q2 2024 financial results and recent highlights. My name is Dan Shevalard, Chief Financial Officer of LENS Therapeutics. We are joined today by Abe Schimmelpennik, our President and Chief Executive Officer and Sean Olson, our Chief Commercial Officer. In addition, Doctor. Speaker 100:00:50Mark Oedrich, our Chief Medical Officer, will join us for the question and answer session. Before we begin, I would like to remind you that this call will contain forward looking statements regarding LENS' future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, which can also be found on our website. In addition, any forward looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Speaker 100:01:48The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our Q2 2024 Form 10 Q, which was filed today. With that, I will now turn the call over to Abe. Speaker 200:02:03Thank you, Dan, and good afternoon, everyone. The first half of twenty twenty four and recent period has been transformational for Lance. In short succession, we made our debut on a public markets with a strong investor base and balance sheet, delivered the results of our Phase 3 CLARITY trials, which we believe support LNG-one hundred as the potential best in class treatment for presbyopia, concluded a $30,000,000 pipe financing and importantly submitted our NDA to the FDA. I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cyclinib based eye drop for the improvement in their vision and people with presbyopia. Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-twenty 25 and if approved U. Speaker 200:03:01S. Launch as early as second half of twenty twenty five. Before I review our key achievements in more detail and as a quick reminder, presbyopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision. Although the progression of presbyopia is gradual, presbyopia often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Speaker 200:03:51To address the daily challenges faced by presbyopes, we are developing a once daily eye drop that in our CLARITY trials has shown to be capable of improving their vision throughout the full work day without the need for reading glasses. More specifically, in April we reported positive Phase 3 data which we complemented with Capstone data in June in which LMG-one hundred, our cyclin based product candidate continued to show strong performance and best in class potential. Highlighting some of the key results of the trial and for the moment focusing on the results of CLARITY-two as this is the direct vehicle controlled trial, we saw a rapid onset effect with 71% of participants achieving 3 lines or more of near vision improvement at 30 minutes on the very first day of use of the product. At 3 hours, our primary endpoints, we also observed a 3 line or more responder rate of 71%. And we maintained these high levels for the full workday with 40% of participants still achieving 3 lines or more of near vision improvement at 10 hours, the last time point measured in our efficacy trials. Speaker 200:05:02And these three line gains turn out to be only the beginning. 84% of participants achieved at least a 4 line gain during the study and a staggering 52% at least 5 lines. We also saw a very impressive near universal response to LNG-one hundred with 95% of participants achieving at least two lines of near vision improvement. This is an important measure because it has seen as clinically meaningful. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. Speaker 200:05:40Interestingly, we also observed a statistically significant at least one line of distance vision improvement across the population. In terms of safety, LMG-one hundred was seen to be well tolerated with no treatment related serious adverse events observed in the over 30,000 treatment days across all three CLARITY trials. Of all reported adverse events, 95% were classified as mild, believed to be transient and consistent with those observed in previous trials. We also saw that in the rare cases, more specifically 7.6% placebo corrected that participant noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphylactic and for most no longer appearing before long to use of LNG100. Speaker 200:06:33These strong clinical results and the promise they bring for the 128,000,000 press release in the U. S. Alone allowed us to further strengthen our balance sheet with a $30,000,000 investment from Ridgeback Capital in July. We appreciate the significant support and confidence shown by the Ridgeback team and are pleased to add this additional capital as we aim to make LNZ100 the best in class, if not only in class therapeutic option for the treatment of presbyopia. Lastly, I'm very excited to highlight that we have submitted our NDA for LNG-one hundred to the FDA, marking a key milestone for the company. Speaker 200:07:14Our NDA is a combination of a development program that along the way incorporated a value of feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data and we look forward to working with the agency as they review our submission. The first step in this and following a positive initial review would be the formal acceptance of our NDA within 60 days of submission. Once the FDA accepts our NDA, the agency must complete their review within 10 months. The end the date at the end of this period is referred to as PDUFA date and once the FDA has provided us with it, we will communicate this with you. Speaker 200:08:02As mentioned earlier and in line with previous guidance, we believe that this PDUFA date can be in the middle of next year and if our submission needs to approval could lead to launch of LNG100 in the U. S. In the second half of twenty twenty five. To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson, Chief Commercial Officer. Sean? Speaker 200:08:29Thank you, Eef, and thank you all for joining us today. Speaker 300:08:32The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. As I've stated, Presbyopia impacts an estimated 128,000,000 people in the U. S. An incident population that is nearly 4 times greater than those impacted by dry eye. It is also more than the combined population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy and glaucoma in the U. Speaker 300:09:02S. The first eye drop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eye drop treatment, as evidenced by initial paid new scripts of 3,000 to 5,000 per week. Long term usage beyond the trial period of this product did not materialize as pilocarpine even at the high concentration of 1.25% couldn't deliver the consumer required performance. We believe this leaves the category wide open for a non pilocarpine presbyopia eye drop solution that can deliver what consumers desire. Unlocking this market requires an ideal presbyopia eyedrops and we are excited for the prospect of our acyclidine based LNZ100. Speaker 300:09:51We believe the commercial potential of LNZ100 was validated in our Phase 3 CLARITY study with 90% of participants noticing an improvement in your vision and 75 participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use the product 4 to 7 days per week. Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3,000,000,000 market potential opportunity and in what could potentially be a category of 1. In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway. In February 2024, LEMS launched its unbranded I'm campaign to educate and excite eye care professionals about future presbyopia solutions. Over 50 key opinion leaders are involved in the campaign, of which many are featured at iamselective.com that is eyeamselective.com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity and expected early consumer adopters of presbyopia eyedrops. Speaker 300:11:10Continuing on that momentum and to support the projected launch following potential FDA approval, Lens has fully staffed its commercial leadership team across marketing, sales and commercial operations with expertise in eye care, direct to consumer, influencer and consumer products goods. From an infrastructure standpoint, Lens is actively building out its U. S. Commercial capabilities, highlighted by completion of our 3rd party logistics contracting, all in preparation for a potential launch of LNZ100 as early as the second half of twenty twenty five. As we think about the commercialization of LNZ-one hundred, our strategy is clear and based on 3 primary pillars. Speaker 300:11:57First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals who represent over 85% of the beauty scripts with our potential best in class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering. 2nd, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct to consumer advertise. And third, we want to ensure ease of product access for consumers with a seamless journey to use. Speaker 300:12:41This requires enabling consumer to experience the product and move quickly from trial to usage. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy as well as home delivery. We look forward to providing further updates and progress on our pre commercial preparations in the quarters to come as we approach potential approval and launch. With that, I'd now like to hand the call over to Dan Chevouillard, our CFO to step through our financial results. Speaker 100:13:17Thank you, Sean. As has been mentioned, the team has continued organization in the Q2 in recent period. On the financial front, we were very pleased to have completed the $30,000,000 private investment in public equity or PIPE with Ridgeback in mid July. I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber adding to what is an already strong and supportive investor base in Lens. Inclusive of the $30,000,000 in proceeds on a pro form a basis, we ended the 2nd quarter with approximately 226,200,000 dollars in cash, cash equivalents and marketable securities, which is anticipated to fund the company's cash runway to post launch positive operating cash flow. Speaker 100:14:07Turning now to our 2nd quarter operating results. Our operating expenses and resulting cash burn for the 2nd quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14,400,000 compared to $15,000,000 for the same period in 2023. Sequentially, our total operating expenses decreased quarter over quarter by 11% from $16,100,000 in the Q1 of 2024 as we moved away from costs associated with the recent merger transaction and reduced overall clinical development spend. On our Q1 call, we highlighted that we would anticipate a sharp decline in our research and development expenses in subsequent quarters due to the recent conclusion of our Phase 3 CLARITY study, which we certainly have realized in the Q2. Speaker 100:15:03Total R and D expenses decreased to $6,900,000 in Q2 twenty twenty four compared to $12,600,000 for the same period in 2023. Sequentially, R and D expenses decreased quarter over quarter by 34% from $10,500,000 in the Q1 of this year. We anticipate R and D costs to continue to decline over the balance of the year, while shifting our development focus towards preapproval manufacturing activities. Similarly, and further to our go forward reallocation of capital towards the commercial organization, total SG and A expenses increased to $7,400,000 in Q2 2024 compared to $2,300,000 for the same period in 2023 and sequentially increased quarter over quarter by 32% from $5,600,000 in the Q1 of this year. This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre commercial planning initiatives. Speaker 100:16:07Finally, our net loss per share both basic and diluted was $0.40 per share in the Q2 of 2024 on a net loss of $10,300,000 compared to a net loss per share of $7.53 per share in the Q2 2023 on a net loss of $14,700,000 As was noted on our Q1 call, we again wanted to remind you that these loss per share figures calculated on a GAAP basis consider only weighted average common shares outstanding, which were considerably different in the comparative periods. For example, as a public company with a single class of stock outstanding, Q222 net loss per share was calculated on approximately 25,600,000 weighted average common shares outstanding. Compare this to Q2 2023, when as a then private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2,000,000 weighted average common shares outstanding. Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25,800,000 shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27,400,000 shares outstanding following that financing. Speaker 100:17:31With that, I'll conclude the financial update for what has been a very productive quarter in recent period. And I'll now turn the call back over to Eef for final remarks. Speaker 200:17:40Thanks, Dan. In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been and promises to continue to be a very exciting time at Lens. With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LNZ100. And we believe we're well positioned to deliver once daily safe and rapidly acting treatments to 128,000,000 individuals living with presbyopia in the United States. Speaker 200:18:17With that, I'd like to open up the call for questions. Operator00:18:21We will now begin the question and answer session. Our first question will come from the line of Pavan Patel with Bank of America. Please go ahead. Speaker 400:18:29Hey, guys. This is Pavan Patel on 4J Singerberry. Congrats on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect SG and A spend to pick up as you begin to incur more meaningful pre launch investment on your P and L? And then our second question is maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses? Speaker 400:19:05Thank you. Speaker 200:19:07Thanks, Pavel. Great questions. I'll hand the first one over to Dan. Speaker 100:19:13Sure. Yes, thanks for the question. Kind of as we said for this quarter, we did see a 32% quarter on quarter increase in SG and A. And I think that you should expect us to have a modest ramp over the balance of this year. I think where you'll really start to see is as we move into 2025 and approach the mid year of next year. Speaker 200:19:43Thanks. And then as for which patients we would prioritize, Sean? Speaker 300:19:49Yes. So looking at how we identify the patients that would be good candidates for this trial. So when we think about our products, we had a very broad inclusion criteria. So we want to develop a product that did work for everybody. And that's why we're focused on an all eyes, all day solution. Speaker 300:20:06Now that being said, there are people that are more prone to be early adopters of an eye drop solution. We commissioned a very large study to do market research in this space and we really found 3 groups of individuals that stood out as the earliest adopters And those 3 groups fall into people that are in contacts now entering presbyopia and want to stay in contacts. They've been looking for they've been in a glasses free lifestyle and want to continue that. And a big reason for dropout of contacts is because of presbyopia. The second one are people that have had refractive surgery in the past. Speaker 300:20:44So again, people who paid for LASIK, invested in Glasses Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that had been to a MediSpa in the past 12 months. Each one of those groups are north of 10,000,000 individuals. Speaker 200:21:04Thanks, Sean. Operator00:21:07Our next question will come from the line of Ygal Achnikomovitz with Citi. Please go ahead. Speaker 500:21:14Hi, Ef and team. Thanks for taking the questions. I had a few. I was just curious with respect to the target prescriber audience, the optometrists, can you just give some perspective as to what percent of the optometrists pool in the United States are currently able to write prescriptions for LENS 100? And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe ONCE-one hundred? Speaker 500:21:45Thanks. Speaker 300:21:47Absolutely. So this is Sean Olson again. So when we think of LND-one hundred, upon potential approval, those that are able to prescribe it when we think of the optometrists, nearly all the optometrists across the U. S. Will have the ability to prescribe LNV-one hundred. Speaker 300:22:06So it falls into the category of miotics and with the exception of a couple of states, they will have the ability to prescribe on day 1. And so that really covers the vast majority of all optometrists. In terms of doing retinal eye exams, retinal eye exams are going to be a very common process done for again nearly every optometrist across the U. S. They will be able to do those retinal eye exams. Speaker 300:22:31So in terms of access, we see ourselves in a very good position for access upon approval. Speaker 500:22:37Okay, great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies and the data that supports the use of LENS 100 in lower light conditions, for example, if you're out at a meal, at a restaurant and you need to read the menu, for example. Could you just talk about that aspect of the product profile? Speaker 200:23:01Absolutely. So we did all our near vision measurements in what's called mesopic conditions. So mesopic is low light. Just to give you an idea of what that means. So we actually have one of our KOLs describe that very adequately in our KOL event. Speaker 200:23:20That basically means that you lower the lights in the room to almost candlelight conditions. So it's very low light in the room and then you have them read a backlit screen. So it's truly low light conditions that we've measured all our near vision in. So if you will, it's the most challenging condition because we definitely wanted to avoid that we brighten the room in a way that it would impact positively near vision that we could not ascribe to our products. So again, very low light dim lit conditions in the room. Speaker 200:24:01And just to back up a little bit into Sean's statement on the retina exam, that's something that all optometrists pretty much do already. So it's a very standard exam. So it's not something that we need to train them on or that we need to that they need to add to the practice to be able to describe a drug. And again, very common practice in optometry. Speaker 500:24:25Okay. Thank you. Speaker 100:24:27Thank you. Operator00:24:28Our next question comes from the line of Joseph Catanzaro with Piper Sandler. Please go ahead. Speaker 500:24:34Hey, everybody. Thanks for taking my questions. Maybe 2 for me. First as it relates to the NDA filing. Can you just remind us whether there was any formal engagement with the FDA like a pre NDA meeting ahead of the filing? Speaker 500:24:47And if so, any sort of feedback learnings you glean from those interactions? And then second question, I guess related to early adopters, but less from a patient perspective and more so from a physician perspective. What are you looking for there? Is it simply those who have written a Vuity script in the past or are there more things that you're honing in on that potentially identify early writers? Thanks. Speaker 200:25:16Thanks, Joe. I'll take the first one and then I'll take the next one over to Sean. So yes, there's been definitely an End of Phase 3 and pre submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development. And that's where most of the feedback actually came from the FDA. Speaker 200:25:42So are very well aligned with them on especially our clinical program, manufacturing setup, basically everything that was relevant for the development. And that actually then made the end of Phase 3 meeting with them pretty benign. I think it was hardly any questions actually that we have left that we want to ask. It was merely a confirmation of this is all the data that we've gathered. This is the amount of patients that we have on both the efficacy and the safety side. Speaker 200:26:17And they once again confirmed that, that was completely aligned with their expectations for our NDA. So we're very confident that the filing has or the submission has everything in it that the FDA wants to see. Speaker 300:26:33And for your second question, when we're identifying early adopters from an eye care professional standpoint, Again, we commissioned a very large study and took into account many factors. We looked at the prescriptions of Vuity. We looked at early adopters of other recent eye care launches. We also looked at history of prescriptions for dry eye as well as different locations such as urban city centers where we saw a lot of the beauty scripts. Ultimately, when we did all the analysis, what came out and what's the primary focus of the targeting was their actual propensity to write Vuity and how many scripts they wrote. Speaker 300:27:12And that's really where we come up with those 15,000 target ECPs that represent over 85% of all the Beauty scripts. Speaker 200:27:25Okay. Operator00:27:25Our next question will come from the line of Mark Goodman with Leerink. Please go ahead. Speaker 600:27:32If I could you please review what you've done on CMC, what's left to do? Just give us an update there please. Thanks. Speaker 200:27:40Absolutely. Thanks, Mark. Good question. So on the CMC side or the manufacturing side, we've actually produced all our clinical Phase 3 material at commercial scale. So we're fully set up to produce launch quantities at that scale. Speaker 200:28:01Our complete supplier network is in very good standing with the FDA. So very confident that our commercial network, commercial manufacturing is all in place there. And that goes for both drug products as well as drug substance or API. Speaker 600:28:22Stability all done, everything you need to do there? Speaker 200:28:25Yes. Stability is all done. So all the stability that we needed to submit our program and this is generic for any submissions, you need to submit with at least 12 months of stability data on your registration batches, which obviously given the fact that we've submitted, we have that in place and submitted and that data looks stellar. Speaker 600:28:49Great. And then just secondly on the unbranded campaign, can you just go into a little bit of detail, a little more color just on what's the discussion, what it's like, maybe just give us a sense of what a session would be like and the feedback you're getting? Thank you. Speaker 300:29:08Yes, absolutely. So we're really excited about this unbranded campaign. What's unique to presbyopia is the fact that when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. What we have to train people on is how to look for what an ideal presbyopia eyedrop solution is. Speaker 300:29:28So really what we're talking about is what's the ideal pupil size, the importance of a eye drop that focuses on reducing the pupil, but avoiding that ciliary muscle. And then also because there's so many people out there impacted by presbyopia, who are the early adopters? So a lot of that's training on those three groups I talked about before, people in contacts, people who have had refractive surgery and people who have been to a medi spa. And overwhelmingly, what we see at the different conventions is excitement for the campaign. It's very easy to feed forward. Speaker 300:30:04So we have over 50 people that are the face of the campaign across all of our presentations, all of our conventions. And we actually release a new one every week on LinkedIn and we're getting calls from doctors saying, hey, when is my photo going out because I actually want to see my photo on LinkedIn, I want to like it. So it's going very well. And I think what's always really important with our product, the first thing people want to know about the product and it's separate from the unbranded because we can't commingle the 2, but they want to know it's not pilocarpine. That's the really important thing and the doctors care about. Speaker 300:30:39As soon as they know it's a non pilocarpine solution on the medical side, they're very excited to learn more about the product and engage. So we've seen this as a very good success. We've seen a lot of traction and a lot of ECPs coming to us that want to share their excitement for the future of presbyopia solutions. They want us to tell them more. Speaker 500:31:02Thanks. Operator00:31:04Our next question comes from the line of Tim Lugo with William Blair. Please go ahead. Speaker 700:31:10Hey, guys. This is Lachlan on for Tim. Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, Are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research? And secondly, I believe at the KOL day, one of the physicians said or suggested that they would most patients would first try the drop in the office. Speaker 700:31:39Is that sort of correct or is that what you're expecting? Speaker 200:31:45Thanks, Liam. Good to hear you. So on that first one, and I'll keep that very brief because obviously, I want to make sure that, 1, we don't talk about anything that's not on the label yet or that we've not studied. But for sure, the medical community is talking and thinking about uses of how they could see this product being used outside of near vision. So yes, that's something that in-depth context is discussed, not something for me to elaborate on. Speaker 300:32:21In terms of the use of the products, we meet with a lot of different eye care professionals across optometry. Many of them want the patient to experience in the office. And what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect right off the bat when they put it in. Now some doctors, especially those that go for the dilated eye exam are going to want them to take the samples home and try it at home. But, we see that how the ECPs run their practice will decide whether or not they do it in office or outside of the office. Speaker 300:32:55It will be a good mix. Speaker 700:33:00Got it. Thanks. Speaker 200:33:02Just one thing to add there like on the data side, just thinking about it some more on what you just asked. One of the things that we've realized that we shared during that KOL event that what the data shows is that as your presbyopia gets worse, your actual impact keeps up with that. So the worse your presbyopia, the more lines you gain. That's certainly something that we've heard resonate really well in the medical community. So when maybe people initially were thinking about the presbyopiaide drop as something that could have an effect early on. Speaker 200:33:42And in some months, presbyopia journey, it's very clear now that actually our drop uniquely, because it is unique to our product keeps up with how you are. Presbyopia, I guess gets worse. So your Presbyopia 20 over 80 or 20 over 100 and you would need 4 or 5, maybe 6 lines, that's what the product actually delivers for you. So it ties into that very broad age range that we've tested in our trial. Speaker 700:34:17Very interesting. Thanks. Operator00:34:21Our next question comes from the line of Matthew Caufield with H. C. Wainwright. Please go ahead. Speaker 800:34:27Hi, Oates and team. Some very exciting developments for the quarter. So our question was considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved? Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient kind of based on their scheduling? Any clarity there or thoughts there could be helpful and excited to see the progress. Speaker 800:34:59Thanks. Speaker 300:35:01Great. Thank you. This is Sean again. So a couple of comments on that. So in terms of what we found in our market research, people are looking for an everyday eye drop that lasts all day. Speaker 300:35:13And we see this across multiple different studies. So not only in our consumer research did we see that the majority of patients wanted to use it 4 to 7 times a week. When we actually look at the patient reported outcomes from our Phase 3, 81% of the patients that would continue to use the product after the study plan to use it 4 to 7 days a week. So we do see that it's much more like contacts or people want to use it every day. Now that being said, all medicines, most medicines are not 100% compliant, right? Speaker 300:35:47If you look across the board for contacts, it's about 89% compliance rate for daily contacts. Terrvia had about a 65% refill rate, general medicines is about 50%. So when you look at that $3,000,000,000 market cap or $3,000,000,000 market size, it assumes a conservative 5 fills a year or a 42% refill rate. So that's what's built into that $3,000,000,000 number. However, when we speak to consumers, they're looking for an everyday eye drop, looking at probably 4 to 7 days per week. Speaker 800:36:26Very helpful. And just to confirm I heard that right, you said 5 times per year as sort of an average from your analysis? Speaker 300:36:32Yes. So if you think of average medicines are 50% compliance, 5 refills a year would just be a little bit conservative to that. That'd be a 42% refill rate. Speaker 800:36:45Got you. Okay, understood. Thank you for that. Speaker 200:36:50Thanks, Matt. Operator00:36:51And that concludes our question and answer session as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Please wait. Operator00:37:03The conference will begin shortly.Read morePowered by