LENZ Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Lens Therapeutics Third Quarter 2024 conference call. At this time, all participants are in a listen-only mode. Following prepared remarks from the management, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevalard, Chief Financial Officer. Please go ahead.

Thank you. Good morning and thank you for joining us today to discuss Lens' third quarter 2024 financial results and recent highlights. My name is Dan Chevalard, Chief Financial Officer of Lens Therapeutics. We are joined today by Abe Schimmelpennig, our President and Chief Executive Officer, and Sean Olson, our Chief Commercial Officer, as well as Dr. Mark Odrich, Chief Medical Officer, who 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 LINZ's 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 Security and Exchange Commission and 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. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our third quarter 2024 Form 10-Q, which was filed this morning. With that, I will now turn the call over to Abe.

Thank you, Dan, and good morning, everyone. The third quarter of 2024 has been highlighted by multiple significant corporate achievements. They reflect the consistent pattern of execution by the LEMS team as we continue to build momentum on our path towards the potential approval and launch of LNG 100. I'd like to take a moment to summarize our recent milestones. and signal a clear and important transition in the profile of LENS as we move from a late-stage clinical development by a pharmaceutical company to a pre-commercial company, fully focused on what we believe is to come in 2025. The recent period has been pivotal in our advancement, with significant achievements, most notably the acceptance by the FDA of our MDA for LNG100 for the treatment of presbyopia. and importantly, receipt of a PDUFA target action date of August 8th, 2025. With that, I'd like to provide a brief refresher on the widespread and inevitable problem we are able to solve. As we know, presbyopia is a loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eye partners with age, the eye is less able to accommodate and focus the incoming life for near vision on the retina, resulting in blurry near vision. Although the progression of presbyopia is gradual, presbyopes often experience a 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. To address the daily challenges faced by presbyopes, we are advancing the first and only a psychogen-based one daily eyedrop that in our Phase III clarity trials has shown to be capable of improving near vision throughout the full workday without the need for reading glasses. We are extremely excited about the LNG100 product profile, which we believe has best-in-class potential. The profile of LNG100 includes a rapid onset of response, with 71% achieving three lines or greater of near vision improvement at 30 minutes, and also 71% achieving three lines or greater of near-vision improvement at three hours, which was our primary endpoint. An unprecedented, long-lasting response rate measured out to at least 10 hours, with 40% achieving three lines or greater near-vision improvement, which was the last time but measured in our efficacy trials. And a very impressive near-universal response to LNG100 with 95% of participants achieving at least two lines of near vision improvements. This is an important measure because it's seen as clinically meaningful and significant for most presbyopes. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. In addition, we observed a statistically significant at least one line of distance vision improvement across the population. And importantly, in terms of safety, LNG-100 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 in the rare cases of headache, appeared to be tachycolectic, and for most, no longer appearing with prolonged use of LNG-100. Returning now to our recent news, an exciting regulatory milestone announced a few weeks ago. We were pleased to receive our Day 74 letter, which signifies the official acknowledgement of acceptance by the FDA of our MDA for LNZ100 for the treatment of presbyopia. Importantly, including our PDUPA target action date of August 8th, 2025. As I mentioned on our second quarter call, Our NDA is the culmination of a development program that along the way incorporated valuable feedback and guidance from the FDA, and we believe that we've compiled a dossier with strong clinical manufacturing and quality data. We look forward to continuing to collaborate with the agency as they review our submission, all of which we believe could result in a potential approval by the FDA in August of next year and a commercial launch in the United States as early as the fourth quarter of 2025. Before we transition to a commercial discussion, I would like to also take a moment to highlight the exciting results from Coexcel, previously known as Yijing, our development and commercial licensing partner in China, which we jointly announced last week. We were very pleased with the top-line data from the Phase III study performed by Coexcel. It was a well-executed study as evidenced by the strong p-values of at least of less than 0001. We believe it's important to emphasize the relative strength and consistency of that data with that of the CLARITY study, as the JX07001 clinical study was performed by a different company in a different country, and importantly, with a patient population that was predominantly of a different ethnicity. We believe this further highlights the potential LNZ100 has as a global therapy. starting with potentially providing access to the estimated 400 million presbyopes in China. We believe this to be an illustration of an ex-US partnership that has an opportunity to create meaningful shareholder value. As the balance of the global rights around G100 ex-China remain unpartnered, we believe opportunities to further partner globally could provide significant additional upside to our shareholders. As I mentioned in my opening remarks, these recent milestones signal an important transition in the focus and profile of LENS, as we have moved from a late-stage clinical development by a pharmaceutical company to a pre-commercial company. With that, we would like to highlight a few key observations from a recent primary market research survey commissioned by LENS of approximately 430 eye care professionals, comprised of approximately 80% optometrists. and 20% ophthalmologists. We believe the results will help illuminate some very interesting insights about the potential treatment of presbyopia with LNZ100, if approved. I will now hand the call over to Sean Olson, our Chief Commercial Officer, to step us through the results of this analysis. Sean?

Thank you, Abe, and good morning, everyone. It goes without saying that the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. Presbyopia impacts an estimated 128 million people in the US, a population incident that is nearly four times larger than those impacted by dry eye. It is also more than the combined US population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma. As we continue to advance towards potential approval by our PDUFA date of August 8th next year, We wanted to take this opportunity to share significant and insightful perspectives gained from eye care professionals through primary market research, confirming what we have understood to be anecdotally true. Reflecting on eye care professional patients, our survey found that most patients seen are presbyopic, and the recommendation for a retinal eye exam is already built into their standard eye care exam process. Based on the feedback from 426 eye care professionals, the average ECP will see 300 to 400 patients per month. Of those, 61% are reported to be presbyopes. Further, the ECPs in the survey indicated that 80%, 87% of the annual eye exams they perform already include a retinal exam to evaluate retinal pathology. We anticipate such a retinal exam will be recommended by the FDA, and we believe it integrates seamlessly into the existing exam process and will not be a burden to prescribe. Next, we wanted to survey eye care professionals to get a sense if their prior experience of beauty had impacted their interest levels in the treatment of presbyopia, as well as their impressions of LNZ100. The ECP surveyed were asked to review the LNZ100 Phase III safety and efficacy data. More specifically, we shared LNZ100's 30-minute and 10-hour post-treatment three-line and two-line improvement rates from our clarity study, the adverse event table from our clarity study, in which all ocular AEs were mild, and noted that there were no treatment-related serious adverse events across more than 30,000 patient treatment days. Following your view, 78% of ECPs surveyed agreed with the statement that LNZ100 is an attractive presbyopia treatment, as well as 78% agreed with the statement that LNZ100 is well tolerated and safe. As we look forward to the adoption of LNZ100, we are excited to share that 83% and 82% of eye care professionals surveyed would be likely to sample and likely to prescribe LNZ100 respectively, confirming the sustained excitement for a non-pylocarpine presbyopia eye drop solution. As we've discussed on previous calls, the first eye drop treatment for presbyopia was approved in 2021 and confirmed the strong consumer desire for an eye drop treatment, as evidenced by initial paid new scripts of over $5,000 per week. Long-term usage beyond the trial period of this product did not materialize, as pylocarpine, even at the high concentration of 1.25%, couldn't deliver the consumer-required performance. Other attempts at lower-dose BID strategies are being pursued. But given the efficacy profile is very similar to that of beauty, we do not believe this will clear the consumer hurdle for performance or the eye care professional hurdle for a pupil-selective option. we continue to believe the category is wide open for an eyedrop solution that can deliver what consumers desire, a once-daily eyedrop that works for the full workday for the majority of presbyopes. Unlocking this market requires an ideal presbyopia eyedrop, and we are excited for the prospect of a cycladine-based LNZ100. We believe the commercial potential of LNZ100 was validated in our Phase III clarity study with 90% of participants noticing an improvement in your vision and 75% of the participants indicating they would continue to use L&Z 100 after the study, of which 81% plan to use four to seven days per week. Together with our broad inclusion criteria, we believe this positions L&Z 100 well for the estimated $3 billion-plus potential market opportunity, creating a potential category of one. Continuing on that momentum and to support the projected launch following potential FDA approval, LENZ has now fully staffed its commercial leadership team across marketing, sales, and commercial operations with expertise in eye care, direct consumer, influencer, and consumer product goods. In addition, we have now hired our regional sales directors for the east and west that will report to our vice president of sales. From an infrastructure standpoint, L&Z 100 is actively building out its U.S. commercial capabilities, highlighted by the completion of our third-party logistic contracting, all in preparation for a potential launch of L&Z 100 as early as fourth quarter of 2025. As we have discussed previously, in February of 2024, Lens launched its unbranded IAM selective campaigns. to educate and excite eye care professionals about future presbyopia solutions. Over 50 key opinion leaders are involved in this campaign, of which many are featured at IAmSelective.com, that is E-Y-E-AmSelective.com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and expected early adopters of presbyopia eye drops. As we think about the commercialization of LNZ100, we'd like to just take a moment to reiterate our commercial strategy based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals who represent over 85% of the VOD scripts with potential best-in-class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering. Second, 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 advertising. And third, we want to ensure ease of product access for patients with a seamless journey to use. This requires enabling the patient to experience the product and move from trial to usage as quickly as possible. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including traditional retail pharmacy as well as home delivery. Before I conclude, I'd like to highlight that we have turned our attention to key medical conferences with an aim to continue to get our data into relevant medical forums, including a presentation last month at Icelerator at AAO 2024 in Chicago, tomorrow at the American Academy of Optometry at Academy 2024 Indianapolis, and we are pleased to recently learn that we have been accepted for presentation at OIS in San Diego later in November. 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 Chevalard, our CFO, to step through our financial results.

Thank you, Sean. As both Ace and Sean have highlighted, the third quarter and recent period has been very productive. In early July, we were very pleased to have completed a $30 million pipe financing with Ridgeback, bringing a strong and well-respected investor into our shareholder base and further strengthening our balance sheet. To that end, we ended the third quarter of 2024 with approximately $217.2 million in cash, cash equivalents, and marketable securities, which, as we have guided previously, is anticipated to fund the company's cash runway to post-launch positive operating cash flow. Turning now to our third quarter results, our operating expenses and resulting cash burn for the third quarter were once again substantially in line with our plans. Total operating expenses for Q3 2024 were approximately $12.9 million compared to $19.9 million for the same period in 2023. Our Q3 2024 cash burn net of interest income was approximately $9 million. Sequentially, our total operating expenses decreased quarter over quarter by approximately 10% from $14.4 million in the second quarter of 2024. On previous earnings calls, we highlighted that we would anticipate a decline in our research and development expenses due to the conclusion of our positive phase three clarity study, while shifting our research and development focus and spend towards pre-approval manufacturing activities, which we have seen in the third quarter. Total R&D expenses decreased to 6.5 million in Q3 2024, compared to 17 million for the same period in 2023. Sequentially, research and development expenses decreased quarter over quarter by approximately 7% from $6.9 million in the second quarter of this year. Total SG&A expenses increased to $6.5 million in Q3 2024 compared to $2.9 million for the same period in 2023. This increase was driven primarily by increases in commercial headcount and pre-commercial planning activities. SG&A decreased quarter-over-quarter by approximately 12% from $7.4 million in the second quarter of 2024, driven primarily by decreases in non-commercial G&A administrative expenses, including outside legal services and other corporate expenses. We expect our SG&A expenses or our sales and marketing expenses to be more specific to begin to ramp from here as we approach a mid-2025 approval for L&Z 100. As we think about the year prior to launch and heading into the potential year of launch, we believe our sales and marketing spend is well aligned to deliver on our commercial plans. Importantly, our allocation of capital to sales and marketing, including our absolute dollar sales and marketing spend and sales and marketing spend as a percentage of total operating expenses all line up well to benchmark comparative analyses we have performed. Finally, our net loss per share. both basic and diluted, was $0.38 per share in the third quarter 2024 on a net loss of $10.2 million, compared to a net loss per share of $9.62 per share in the third quarter 2023 on a net loss of $18.9 million. As was noted on previous earnings calls, please keep in mind that our net loss per share figures consider only weighted average common shares outstanding, which were considerably different in 2023. Q3 2024, net loss per share was calculated on approximately 27.2 million weighted average common shares outstanding compared to Q3 of last year when as a then private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding. We ended Q3 2024 with approximately 27.5 million total common shares outstanding. That concludes my comments on our Q3 financial results. And with that, I'd like to turn the call back over to Abe for final remarks.

Thanks, Dan. As you can see, the third quarter and recent period has been a very productive time, and we feel the team continues to build momentum into the end of the year. It goes without saying that it is an exciting time at LEND. We have continued to execute in all facets of our organization. We remain highly confident that we are well on our way to deliver the first and only a zygotin-based eye drop for the improvement in near vision in people with presbyopia. We look forward to this next phase as a pre-commercial company as we prepare for a potential approval and commercialization of LNG100 and believe we are well positioned to deliver a once-daily, safe, and rapidly-acting treatment to 128 million individuals living with presbyopia in the United States. With that, I'd like to open up the call for questions.

Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. And your first question comes from the line of Igor Nokomovic with Citi. Please go ahead.

Hi, guys. Thank you very much for taking the question. I had a few here. So first off, you mentioned, I believe, the survey that was 80% optometrists, 20% ophthalmologists. I'm just curious if the conclusions of the survey were consistent amongst those two subgroups. And then the second question, Obviously, with this very, very large market, over 100 million potential patients, I'm curious what level of investment in the social media access, I think you mentioned influencers, are you expecting for the launch? And then thirdly, could you remind us, as far as the manufacturing of the product, where is it manufactured? Is it within the United States or is it ex-U.S.? And do you have multiple suppliers? Thank you.

Thank you, Gal. Great questions. Let me kick off with the 80-20 and the manufacturing, and then I'll hand it over to Sean for the last couple of investments. So the 80-20 split between ophthalmologists and ophthalmologists is obviously by design. We see that if you look at the VOD scripts, that 80-20 split is how the VOD script We expect that to be reflected for our commercial plan as well. That's why we ended up with 80-20. And the feedback across those two groups is very consistent. So you don't see any changes between those two groups. Then on manufacturing, we are fully set up to produce at commercial scale. Actually, our phase three trial was produced at that same commercial scale. They're ready to support the launch as is. Manufacturing setup is partly U.S., partly ex-U.S., all European-based. So European and U.S. manufacturers both for drug products as well as drug substance, all with ample capacity. that we will continue to add to and build redundancy to as we launch.

And turning to the interests from social and influencers to LNZ100. So we see the potential of LNZ100 in this large untapped market, right? That has the potential to be north of $3 billion. And because of that, we will put the financials behind it from a direct consumer strategy that would be commensurate with a product of that potential. What we saw with Vuity was when they turned on their direct-to-consumer campaign, it nearly doubled their scripts from 3,000 new scripts per week to up to 6,000 new scripts per week. And therefore, that supports our strategy behind a direct-to-consumer campaign. We are evaluating both influencer campaigns as well as a celebrity spokesperson. And we'll continue to evaluate that as we get closer to launch. What we see is when you're selecting influencers and celebrities, you do want to do that fairly close to launch just because they do tend to go in and out of favor over time. Thank you, Sean.

Okay. Thank you.

Your next question comes from the line of Mark Goodman with Learing Partners. Please go ahead.

Yes, two questions. One is can you remind us what the incentives for the optometrist has to recommend the product? And then second of all, you know, thinking about the Vuity launch, you know, help us with expectations for how to think about your launch for the ramp and prescriptions and sales. I mean, should we be expecting it to do as well or not as well or better or, you know, just help us, you know, kind of set the expectations right now. Thank you.

commercial officer. And what we see is the majority of presbyopia are really looking for an ideal solution for presbyopia. So our eye drop provides the opportunity for more patients to be going to the doctor. that are practicing surgery, no longer being optometrists, or patients that are buying reading glasses off the shelves. That then results in the sitting fees, as well as the rest. The other benefits in one of our target groups are contact work. So there are over 10 people that are Presbyopic. And eventually, they get these contacts due to presbyopia. And that's because they have reading glasses and they want to bifocal or multifocal. This gives an opportunity to keep those people in touch. And they continue to come to the practice for a year. So when they're very potential of value they have for the practice. Again, we think Acuity did a good job opening up this market. Ultimately, the product did not work, but they did drive 3,000 new scripts per week in the beginning, and then they increased that to 5,000 new scripts per week after DTC. Obviously, we are not the size of Allergan, but we're going to put the potential marketing power behind this product to have a launch. I think anything in that realm would be good.

Just to maybe add on that a little bit, Mark, so if you think about timing of that launch before we talk about REM, we're up a due date now being set for August 8th next year. We've tightened our guidance as to when we expect to launch, as you let us talk about, to the fourth quarter of next year. That's the logical and OAC everywhere time that we expect it will take to get first product out of the door. So early in that quarter, we'll start with samples. It's a product that lands itself obviously extremely well for sampling with that very rapid onset. So remember that our clinical trial was truly a day one endpoint. On that same day one, so first product, first time that a patient actually ever sees a product within 30 days. We had those very high-efficacy results that we've shared before. So we look at that fourth quarter truly as a roll-out quarter. We'll start with heavy sampling that then will lead to that transition where patients are going to start filling scripts. Thanks.

Your next question comes from the line of Joe Catanzaro with Piper Sandler.

Please go ahead.

Great. Hey, everybody. Thanks for taking my questions. Congrats on the progress here. So within the ECP survey, you queried physicians on how often they perform retinal exams. And Sean, I think you mentioned expectations around requirement for a retinal exam. So wondering where those expectations stem from relative to the safety profile you observed in comparison to beauty. and maybe more generally how the language around retinal risk might compare to buity. Thanks, and I have a follow-up.

Thanks. I'll take that one. So our expectation is that our label will be very similar to that of buities, which has a general recommendation, not a requirement, but a general recommendation for an eye exam when using a presbyopia eye drop. And you could argue that if you look at our safety data and knowing that a psyched in very different from pilocop is actually pupil selected, does not stimulate the ciliary body. And we know that the ciliary body is, or overstimulation of the ciliary body is what's often connected to the retinal side effects. So we believe that our data shows and the MOA shows that we do not have that impact. At the same time, we believe that the FDA will not go as far as to not have that same general, again, recommendation on our label. We actually believe that that's a good thing. One of the questions earlier was what's in it for eye care professionals. I think that eye exam is one, as we know, that's actually a catchphrase for most patients. If you do a non-deleted eye exam. So that's a positive for eye care professionals. It's also a positive, obviously, for patients to just make sure that you have your eye checked out on an annual basis. And as we stated, or as we found in the survey, it is standard practice. So your annual standard eye exam is almost always includes a retina exam, so it's not something that needs to get done in addition. It's not something new. It's something that all, if not most, ICAP professionals already do. So again, we feel that it will actually be positive in there.

Great. That's really helpful. Maybe my follow-up. So I guess maybe if you have any updated thinking on ex-UX, ex-China opportunities or where that stands, whether you sort of pursue that on your own, look for partnerships and any sort of gating factors you see there to pursuing that.

Yeah, great question. What we can definitely say is that following first our results and frankly now seeing Goxel repeat that ex-UX, there's definitely a lot of interest. for markets beyond U.S. and China. We are phasing those discussions in an appropriate way. Obviously, our focus is to make sure that we get to the market in the U.S. in the best way possible. But you can imagine that those discussions are ongoing. Timing of purchase is immediate. Those discussions usually take a little bit of time, and we'll keep the market updated as we progress there.

Okay, great. Thanks for taking my question.

Your next question comes from the line of Baban Patel with Bank of America.

Please go ahead.

Hey, guys. Thanks for taking my questions. Just two for us. Can you speak to the recent phase three study readout in China? What's the timeline for approval and how big do you model the opportunity beyond the 400,000 addressable patient population that you've mentioned. And then the second question, maybe if you could speak to commercial launch readiness ahead of the August 2025 PDUFA date. At time of launch, how many other approved eye drop treatments for presbyopia do you expect on the market? And if you could frame how you expect LNZ100 to be positioned among those competitors. Thank you.

Sure, this is Dan Shovlar, so I'll take the majority of that question and perhaps Mark Odrich can speak to the data if you want clarity around that and how we think about it. But how we think about the economics and modeling of the opportunity, first of all, there are 15 million in development milestones that are outstanding, that are in the agreement, as well as 80 million in commercial milestones. that are to be obtained based upon net sales in the region. In addition to that, royalties in the 5% to 15% range on net sales in China. So those are the economic terms that are in the agreement. The overall projections and revenue, we're not guiding there at this time. And as far as timeline for their approval, we would guide you to keep an eye on their website where they'll be providing updates on their regulatory guidance. We will not be guiding on their behalf. The first part of your question was about the data specifically from QuarkCell, so if Mark would like to add any comments, go ahead.

Yes, thank you, Dan. The data really was very validating. Overall, incredibly similar, very strong data, and really no surprises whatsoever. So it's good to see that in a somewhat different world, different population, we had the same result, very clinically similar and relevant. I really don't have anything more to say than that.

And then turning to the commercial launch readiness, we're very well positioned from our commercial launch readiness here at Lens. So as we shared, our commercial leadership team is in place. We've now hired both of our regional directors for our sales team, reporting to our vice president, and we'll continue to build out that sales organization as we progress to the potential approval and PDUFA dates next year. Other things that will continue to progress is our commercial operations. We highlighted that we have contracted with our third-party logistics supplier. We'll continue our wholesaler negotiations, again, all working towards that potential approval date. In terms of competition, you know, really, we see ourselves as the next product to be approved as a presbyopia eyedrop, you know, with our PDUPA data out there. And really, in terms of competition, you know, as the only acyclidine-based eyedrop, we see our product as a potential category of one and really the best in-class potential as we look towards our potential approval.

I mean, just adding a little additional color there. If you look at what's, you know, obviously, beauty is still on the market, but Allegan or AbbVie stopped promoting that product probably about nine months, maybe 12 months after launch, so a couple of years ago now, following a, as we noted earlier, actually very strong initial launch, very interesting and promising run rate. But then patients and doctors caught on that the That product doesn't work, so it's not the target profile that patients are after. So if you think about the target profile, as a presbyopia, what you want is a product that works rapidly, so you put it in your eye, it works almost immediately. It needs to be a once-a-day product, so set it, forget it. You don't want to be messing with adding drops throughout your workday. And obviously, it needs to work long. You really need to cover you for the full workday. That's the profile that patients and doctors are looking for. It's the profile that obviously we hit. Clearly, VUD didn't. And as we all know, Closy recently or got approved over a year ago, but recently announced that they will be launching with what is, if you just look at the public data, effectively a similar clinical profile. So a twice-a-day product that works for some patients but not many for a limited amount of time. So while they'll be out there and we expect them to be out there when we launch, we don't foresee a very different outcome for them if you compare it to beauty.

Thank you.

Your next question comes from the line of Lachlan Hanbury-Brown with William Blair. Please go ahead.

Thanks for taking the question and congrats on the progress this quarter. I know you've been running education awareness campaigns with doctors for a while now, but I was wondering sort of how that will escalate or change as you get into launch over the next 10 months and then somewhat related. That's just one of the three pillars that you outlined for the launch. I'm wondering what or how much, if anything, you can do on the other two pillars prior to an approval or do they sort of require the approval so you have the brand name and the product to work on access. Great.

Thanks, Lachlan. So I'll take the very first part of the question on what we're currently doing, and then Sean will provide more color on our three key elements of the commercial strategy and what we can do prior to launch, which is actually quite a bit. But we have assembled now a medical sales liaison team. So, obviously, as we all know, that team can be and is out there currently talking to ECPs. So, really, you know, sharing the MOA of the product. So, how is the cycling different than pilot carpet? And that's what we continue to hear over and over again, that people are not enthusiastic about another pilot carpet product, given their experience with VUE and the fact that it's not people-selected. But on the contrary, we are very excited about the acycadin profile. So we educate, our MSL team educates doctors on the MOA, on the profile. Then we obviously talk about our clinical data. That team, again, in the medical discussion, can talk about acycadin and its clinical data. And thirdly, they'll start to talk about, you know, patient populations that initially would be the most attractive to use or to get onto the product. Again, that's a medical-to-medical discussion, so one that only the MSL team can have, and that's completely firewalled up from the rest of the organization, and Sean will talk to you about what we can do there prior to approval.

Yeah, so as we continue to progress towards that potential approval, our unbranded campaign we'll continue to accelerate. So currently the team actually this week is at the American Academy of Optometry at the convention with our unbranded booth and continuing to share that story on those three key colors. You can expect that we'll be continuing to be present at upcoming conventions as well as continue to grow our presentation opportunities at those conventions as we announced earlier on the calls. When we think of those three pillars, that really aligns to the doctors to recommend us and the pre-work we can do on the unbranded side. The patient's request is by name, the second pillar, and the access, the third pillar. Really just diving a little bit more on the access side. Again, this will be less forward in terms of what people see externally, but on the back end side, as we continue to highlight on these calls, we're putting a lot of that infrastructure in place well ahead of launch. So that way, when the product is available, very quickly we can get the product into the consumer's hands so they can actually try it and so the eye care professionals can get comfortable with it. Really, those are the two that we'll focus on ahead of approval. The doctors recommend us as well as the access. The patients request us by name. Again, this is something where you want to make sure the doctors have some time with the product before we turn on the direct-to-consumer advertising so they're comfortable and aware of it. and then we'll come forward with the patients to request this by name with those different DTC strategies we talked about earlier.

Thanks.

Your next question comes from the line of Gary Nachman with Miller Human Chains. Please go ahead.

Hi, thanks. Good morning. So in terms of your key targeted presbyopes that you'll be going after when you launch, are you still thinking about certain groups like contact lens wearers, people that had refractive surgery, or people that go to med spas? So how are you thinking about hitting those different groups once you activate the DTC? And then, you know, just back to the sampling, with aggressive sampling at launch, How long do you think it'll take for that transition to usage to occur? So how much is that going to play into the initial revenue ramp? How long will the sampling go before people start using it? Thanks. Great.

So a couple comments. So looking at those key targets for presbyopia, so we commissioned a large market research survey to look at the consumers most interested. I think What's great to see is there's broad interest across the full population of presbyopes. But at the same time, we do want to promote and go directly to people that over index on interest for eye drops for presbyopia. As we previously shared, those are people that are in contact lenses. Those are people that have had refractive surgery and those have been to a med spa in the past 12 months. So those will be the more primary targets of our DTC. And what we'll do is, you know, we've partnered and continue to partner with agencies that work on, you know, how do you promote directly to those core groups. So they look at, you know, different data that exists on their buying trends, on the websites they visit. So it will be a very digitally focused way on how we target those. We'll also help target those by in our messaging to doctors. As you see in our unbranded campaign, we're already helping doctors understand which patients are most interested. Each one of those groups are north of 10 million people. So those are all very valuable groups that have a lot of people and highlight the potential of an eye drop for presbyopia. In terms of sampling, it's very important to talk about the sampling of this product because it's a little different than some other products. So with this product in terms of sampling, it is a five-day pack. So if you think about our product, it comes in those preservative-free single-dose vials. So at this sample, you know, they're truly getting a five-day supply to use the product. And it's very different than, let's say, products where they come in the multi-dose vial, where it could be almost a month's supply. So I think that's very important. I think the other important thing here, too, is these samples will be given to the consumer at the optometrist and ophthalmologist location. So it's not going through your retail pharmacy, right? So they'll actually receive those samples. At the optometrist, they can immediately try it for five days. That's very similar to how contacts work, actually, where you get a five-day supply. And then from there, we'll move right into the actual prescription. So we don't see this one having that same effect that other samples do when it's a one-month supply or picked up at a retail pharmacy.

Okay, great. And then just one more follow-up, just on the Hiring of the sales force. So just confirming that you're not going to do that until after you have the approval. Will you have some contingency offers out there? And just maybe the size and structure of the sales force, how you're thinking about it. Thanks.

Yeah. Yeah. So just to clarify on the sales force. So the sales force, we are already beginning to put that team in place. So we've already hired our vice president of sales. We've hired our two regional directors. We'll continue to build that out ahead of the PDUFA date. So it won't be brought on after PDUFA. They'll be brought on before PDUFA. And what we've shared is that our Salesforce team will be roughly 100 reps, calling on approximately 15,000 eye care professionals that actually represent over 85% of all the beauty scripts.

Okay, but you'll have all the sales reps in before, even prior to the approval, the entire process. Yeah, prior. Okay, okay. All right.

Thanks a lot.

Your next question comes from the line of Matthew Caulfield with HE Wainwright. Please go ahead.

Hi, great. Thank you, guys, and congrats on the progress towards the potential approval and launch. Definitely exciting. We just had one follow-up on the Chinese market. Can you remind us if China had the same prescription experience with Vuiti with aversion to pilocarpine, or is there any greater receptivity in that market for a novel mechanism? Thanks a lot. Thanks, Matt.

So Vuiti was not launched anywhere beyond the U.S. So it wasn't also not launched in China. So it's really an open market there. Now, Pylocarpin obviously is a product that is known for its glaucoma use, so it's definitely a great opportunity to highlight, as our partner will do, just like we do here, the fact that acycidin is very different from Pylocarpin. It has that pupil selective mechanism. It has that very clean safety profile, at least shown in trials. And obviously, importantly, it works. So very different from biocarbon, but PUD was never launched in China.

Great. Very helpful. Thank you, guys, and congrats again.

Thank you.

That concludes our question and answer session, as I am showing no further questions at this time. With that, I will hand the call back over to F. Skimeltening, CEO, for closing remarks.

Thank you, Trisha. And thanks, everyone, for dialing in today. Great to connect with you. And for everyone who is dialing in, have a great rest of your day. Thank you.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.