管理層發言
Good morning, ladies and gentlemen, and welcome to the LENZ Therapeutics Year End 2024 Financial Results Conference Call. This time all participants are in a listen-only mode. Following prepared remarks from the management, we will conduct a question-and-answer session where 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 Chevallard, Chief Financial Officer. Please go ahead.
Thank you. Good afternoon, and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Eef Schimmelpennink, our President and Chief Executive Officer; and Shawn Olsson, our Chief Commercial Officer, as well as Dr. Marc Odrich, 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 LENZ'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 Securities 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 2024 Form 10-K, which is being filed today. With that, I will now turn the call over to Eef.
Thank you, Dan, and good afternoon, everyone. 2024 has been a highly successful year for LENZ and I'm extremely proud of all we have accomplished. We are truly building something special and I strongly believe we have put ourselves in a position to have an even greater and transformational year in 2025, as we aim to emerge as a commercial company. On previous calls, I have mentioned the consistent pattern of execution by the team, and I would like to take a moment and acknowledge their efforts. We are a team that is the best when we are together. We go fast with purpose, we relish ingenuity, and we are relentless. On the back of these core values, we had a tremendous year in 2024, highlighted by our emergence as a public company in March and completion of our Phase 3 CLARITY study and announcement of stellar data for LNZ100 in April. This was followed by the execution of a $30 million PIPE financing with Ridgeback Capital in July, submission of our NDA in August, and its acceptance in October, all contributing to the significant progress and momentum as we work towards the potential approval and launch of LNZ100.
With all of the exciting progress we've made over 2024, the fourth quarter and most recent period has been a critical time as we have completely transitioned to a pre-commercial company and have entered 2025 in a position of financial strength, ending 2024 with over $209 million in cash. I'd now like to take a few minutes to highlight five key areas of corporate focus where we've seen excellent progress in recent months. Regulatory, manufacturing readiness, medical affairs, intellectual property, and pre-launch commercial planning. First, on the regulatory front, in what has been a very constructive and highly engaged process thus far, we continue to make encouraging progress with the FDA on our NDA review. In January of this year, we completed our mid-cycle review, which is a key milestone in the agency's review progress. We were very pleased that the agency noted no significant review issues and that they reiterated that they have no plans to request an advisory committee meeting.
Importantly, in light of the recent developments around federally funded agencies, FDA inspections on our clinical trial sites are now underway, and we are pleased to report that we have confidence that our NDA review has been uninterrupted and is making great progress. As such, we continue to believe that we are well-positioned for potential on-time approval in August 2025, which, if granted, will be immediately followed by commercial launch activities in the United States, with product anticipated to be available in the market in the fourth quarter of 2025. Second, on manufacturing readiness, I am particularly pleased with the progress the manufacturing operations team has made in recent months. Importantly, and signifying an important milestone, in February, we initiated the manufacturing of potential commercial products. The team, together with our manufacturing partners, has been working tirelessly to enable the achievement of this important landmark, and will continue to focus over the coming months on manufacturing adequate commercial sample and product inventory to support a successful launch.
For the time being, this product will be kept in bulk and, following label discussions and potential approval of our NDA, undergo final packaging. As a result, and following FDA approval, we expect to have commercial products available in the market in Q4 of this year. Third, I'm very excited to highlight key progress from our medical affairs team. We are seeing noteworthy eye care professional engagement nationwide, led by meaningful interactions by our all-optometrist medical science liaison team, who have been very active at state and national medical conferences, educating the ECP community on the importance of being pupil-selective and the differentiation of a ciliary-body-sparing mechanism of action, as well as on the data from the Phase 3 CLARITY study. Just a few weeks ago, the medical team held a fantastic event at SECO in Atlanta, where we hosted over a hundred ECPs at the College Football Hall of Fame.
Since the beginning of Q4, we've had meaningful medical interactions with more than 1,000 individual ECPs. Our intent is to have our MSL team engage with a majority of our key target ECPs ahead of our PDUFA date. Next, a foundational area of focus and recent progress has been on intellectual property. More specifically, our domestic and international patent estate for LNZ100. We have continued to strengthen our patent tickets, and currently have seven granted patents in the United States that go out to 2039. There are an additional 10 patents under review that aim to extend patent protection to at least 2044. Together with the expected five years of NCE exclusivity, we believe our product is extremely well protected and set up for longevity. In addition, we continue to extend our patent portfolio ex-U.S. to support the significant commercial opportunity we believe exists there. And lastly, I'll turn to pre-launch commercial planning.
The commercial team has been hard at work, and before I turn it over to Shawn to step into more detail, I would like to highlight a few key items. First, the hiring of a sales force is in its final stage. Both of our regional directors were hired in Q4 and we've now hired all 10 of our district managers. We've been extremely pleased with the excellent quality of candidates we are attracting and the significant eye care experience across the board. As you may have seen last week, we launched a hiring campaign for our 88 territory sales force, our last sales hires, and as an indication of the anticipation we believe exists in the market, we received over 1,300 applications within the first 24 hours of posting the job profiles. We are looking forward to hiring only the best and most talented candidates to LENZ and having them fully onboarded ahead of our PDUFA date. This will ensure that they can be in the field promoting our product immediately after potential approval and get one or more core cycles in ahead of product being available in the market.
Second, we're very much looking forward to our upcoming commercial day on April 15th, where we'll have the opportunity to elaborate on our commercial strategy and pre-launch preparations, as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNZ100. Shawn will touch on this in more detail shortly. As I mentioned in my opening remarks, 2024 has been a highly successful year, and the recent period has continued to be extremely productive as we prepare for the potential approval of LNZ100. I will now hand the call over to Shawn Olsson, our Chief Commercial Officer, to provide additional comments on our pre-commercial planning efforts.
Thank you, Eef, and good afternoon, everyone. As we have discussed on previous calls, the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities in the United States. Presbyopia impacts an estimated 128 million people in the U.S., a population incidence that's nearly four times larger than those impacted by dry eye, and nearly six times larger than those impacted by Demodex Blepharitis. For further context, presbyopia impacts a population larger than the combined U.S. populations suffering from dry eye, Demodex Blepharitis, childhood myopia, macular degeneration, diabetic retinopathy and glaucoma combined. The first eye drop treatment for presbyopia was approved in 2021 and confirmed that there is strong consumer desire for an eye drop treatment as evidenced by initial paid new scripts of up to 6,000 per week. Long term usage beyond the trial period of that product did not materialize because pilocarpine, even at the high concentration of 1.25%, cannot 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 Vuity, we do not believe they will clear the consumer hurdle for performance or the ECP desire for a pupil-selective option. We continue to believe the category is wide open for an eye drop solution that can deliver what consumers desire: a once-a-day eye drop that provides seamless near vision for the full workday for the majority of presbyopes. Unlocking this market requires an ideal presbyopia eye drop and we are excited for the prospect of a site-leading LNZ100. We believe the commercial potential of LNZ100 was validated in our Phase 3 CLARITY study, with 90% of participants noticing an improvement in near vision and 75% of participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use 4 to 7 days per week. Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion-plus potential market opportunity.
Our commercial team continues to advance its commercial readiness as we progress towards our August 8th PDUFA. I would like to provide an update on the three primary pillars of our commercial strategy. First, we want to make sure doctors are there to recommend us. As Eef mentioned, our all-optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the Phase 3 data. In addition, one year ago, our marketing team launched the EYEAMSELECTIVE unbranded campaign at SECO 2024. This is driving ECP awareness and excitement for the future presbyopia solutions that can achieve the necessary sub-2 millimeter pupil size to restore near vision while not overstimulating the ciliary muscle. Awareness for this campaign continues and has over 50 KOLs and over 2 million digital campaign impressions targeting over 30,000 ECPs. Following potential NDA approval, our sales force will be calling on approximately 15,000 ECPs, with a potential best-in-class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering.
As we prepare for this, the hiring of our sales force has been a key focus over the recent months. Our full sales leadership team was hired in 2024, including both of our regional directors who joined LENZ in Q4. Since then, we've continued to grow our sales team and are happy to share that all 10 district managers are now also on board. This core leadership team within the sales force brings almost 150 years of eye care experience and over 300 years of total sales experience. Finally, we have now begun our field-based sales rep hiring with job postings currently available for all 88 territories across the United States. It's great to see the progress on our first pillar. As a reminder of what was shared in the last earnings call, our primary market research survey of 426 ECPs yielded that an impressive 82% and 83% of ECPs were already likely to prescribe and sample LNZ100 if FDA approved respectively based on the Phase 3 data.
The second pillar of our commercial strategy is for consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and activate consumer response. LENZ is partnered with multiple New York and California-based advertising agencies to understand the consumer and develop a campaign that will connect emotionally, creating a desire for our brands. We have taken a consumer-centric focus in the development of this brand and have leaned into lifestyle creative. We are excited about the brand we have created and the proposed advertisements, which have been testing well in market research. Our creative is now locked, and the majority of the launch promotional materials are now completed pending final product insert language. Upon approval, we will launch the ECP materials, and once we feel ECPs are well educated, we'll turn on the direct-to-consumer advertising.
The third and final pillar will ensure ease of sample and 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 has built out consumer sampling capabilities and commercial access across multiple channels, including the traditional retail pharmacy as well as e-pharmacy home delivery. In our clinical trial, 95% of patients noticed a two-line improvement at hour one on day one. This immediate response lends itself incredibly well to product sampling. Our sample vendor has been contracted, and after approval samples will be rep-delivered to eye care professionals, allowing consumers to try the product. Our team has developed a five-day sample pack similar to the sample size for contacts, which following the initial trial can act as a bridge until the product is picked up at the pharmacy or delivered to the consumer's home.
We'll continue to drive these three pillars: doctors to recommend us, consumers to request us by name, and a seamless journey to use as we progress towards our PDUFA date. Before I conclude, we're looking forward to our upcoming commercial day on April 15th, where we will have the opportunity to elaborate on our commercial strategy and pre-launch preparations, as well as bring forward additional key opinion leader and ECP perspectives, as we approach the potential approval and launch of LNZ100. We feel this is an important event which will give investors, analysts, and others a thoughtful overview of our plans and progress towards the potential approval and launch of LNZ100. I'd now like to hand the call over to Dan Chevallard, our CFO, to step through our financial results.
Thank you, Shawn. As both Eef and Shawn have highlighted, the fourth quarter and recent period has been a critical time, as we have now pivoted to a pre-commercial company. We ended 2024 in a position of financial strength with approximately $209.1 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 fourth quarter financial results, our operating expenses and resulting cash burn were generally consistent with prior quarters and in line with our operating plan. Total operating expenses for Q4 2024 were approximately $15.2 million compared to $25 million for the same period in 2023. In general, this decrease was specifically driven by the fact that we were in the midst of our Phase 3 CLARITY study in Q4 of last year, which makes these figures less relevant to compare.
Perhaps more comparable, on a quarter-over-quarter and sequential basis, our total operating expenses increased by approximately 18% from $12.9 million in the third quarter. From a cash perspective, our Q4 2024 operating cash burn net of interest income was approximately $8.1 million, which was consistent with the $9 million in net cash burn last quarter. Total sales, general and administrative expenses increased to $9.4 million in Q4 2024 compared to $5.5 million for the same period in 2023, driven primarily by an increase in commercial headcount and other pre-commercial, pre-launch commercial planning activities. Sequentially, SG&A increased quarter-over-quarter by approximately 44% from $6.5 million in the third quarter due to significant relative increases in sales and marketing as we continue to ramp our allocation of spend to support our consumer-driven brand planning and the addition of key sales force leadership.
As we have discussed on previous calls, we expect our SG&A expenses and more specifically our sales and marketing expenses to continue to ramp from here as we approach our potential August 2025 approval for LNZ100. Importantly, and as a particular point of emphasis, we will continue to be measured in our spend on the general and administrative side of the organization. Our model will always be to staff appropriately and grow to support our commercial launch and organization at large, but remain a lean and highly efficient G&A team. Turning now to research and development, total R&D expenses decreased to $5.9 million in Q4 2024 compared to $19.5 million for the same period last year. Sequentially, quarter-over-quarter, R&D expenses once again decreased by approximately 9% from $6.5 million last quarter. The majority of our R&D expenses between now and the time of potential approval will be dedicated to our manufacturing operations team as we build pre-approval commercial product and sample inventory to support our launch.
Finally, our net loss per share, both basic and diluted, was $0.46 per share in the fourth quarter of 2024 on a net loss of $12.7 million, compared to a net loss per share of $12.04 per share in the fourth quarter of 2023 on a net loss of $23.7 million. Q4 2024 net loss per share was calculated on approximately 27.5 million weighted average common shares outstanding, compared to Q4 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 million weighted average common shares outstanding. As a final point, as of December 31, 2024, we had approximately 27.5 million shares of common stock outstanding. That concludes my comments on our Q4 financial results. And with that, I'd like to turn the call back over to Eef for final remarks.
Thanks, Dan. As you can see, the fourth quarter and recent period has been an extremely productive time. And we're making significant strides in our pre-commercial preparations. As we are now less than five months from our PDUFA target action date, we 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 and very much looking forward to doing so. With that, I’d like to open up the call for questions.
分析師問答
And our first question comes from the line of Yigal Nochomovitz from Citigroup.
Appreciate all the updates. So first off, I think Shawn mentioned that the sales force is going to call on 15,000 ECPs. The digital campaign was targeting over 30,000. Could you just comment on how you’re filtering that down to focus on the 15,000? What are the parameters there?
Hi, Yigal. This is Shawn. Thanks for that question. It’s a really good question. So when you look across the landscape of eye care professionals, there’s obviously a lot out there. When you look at the 40,000 optometrists and 20,000 ophthalmologists, when we think of targeting in terms of our sales force, we’re looking at those that are high prescribers of Vuity and therefore we know that 15,000 ECPs represent roughly 85% or a little more than 85% of all the Vuity scripts. So that’s our focus for our sales force. But we also know that the other doctors and with presbyopia being so prevalent, driving early disease state awareness is helpful across a broader group of ECPs. And so that’s why you’ll see our unbranded promotion driving broader awareness, while the field will focus truly on the earliest adopters of eye care professionals and those who represented over 85% of all the Vuity scripts.
And then on this EYEAMSELECTIVE unbranded awareness campaign, I’d be super interested to get a better understanding quantitatively of how you’ve ratcheted up the awareness. Do you have data on the percent awareness before you started the campaign and how that’s improved today in terms of knowledge of not only presbyopia, but your Phase 3 data specifically?
Yes. So for the unbranded, we’re really focused on the disease state awareness and in general we’ve seen a lot of growth of interest in the concept at all of our conventions and across the board on LinkedIn. It’s great to see the feedback—attendees at conventions will come up and tell us they have been seeing our ads on LinkedIn about the EYEAMSELECTIVE campaign. We’re really pleased with how it’s coming along. We’ll continue to share more information at the upcoming commercial day.
And then just the last one on the timing of the launch, obviously the PDUFA August 8th. And then Eef mentioned that you’re going to have product available in the channel, I believe starting fourth quarter. Is the delta there a function of just needing more time to produce sufficient commercial material or training the sales force or are there other factors we should be aware of?
Great question, Yigal. This is Eef. That’s purely a factor of practicality. We believe this is going to be a very high-volume launch as you can imagine. As I shared in the prepared remarks, the manufacturing team has started production of the quantities that we believe will support a successful launch. That will all sit in bulk as we await final labeling discussions with the FDA and have a final approved label and insert. We will then start printing that, which would happen after approval, package all those quantities, ship them to our 3PLs, and get them into the field. So that time that we guide between PDUFA and a Q4 product in the market is purely determined by those steps. The sales force, importantly, will be trained up in general prior to the PDUFA date, with final training on final labeling, and then immediately hit the field. So you can expect that immediately upon approval, the sales force will be out there promoting the product. They can get a couple of sales cycles in, which we like, prepare the doctors for what's to come, and then start delivering samples as soon as we have them available for the field.
Our next question comes from the line of Marc Goodman from Leerink Partners.
Hi. This is Madhu on the line for Marc. Just a couple from us today. First, how long do you expect the significant sampling to go on for until most of those target ECPs have gotten experience with LNZ100? And then the second question is, what haven't you been asked about on the regulatory process or the launch that you would like people to be more focused on? Thanks.
Great. Thank you for those questions. From a sampling perspective, this product lends itself extremely well to sampling. If you look at the clinical data that we generated in our Phase 3 studies, our primary patient endpoint is three lines improvement on day one. But within 30 minutes, which is the first time point that we've measured, you see that we have 71% of patients hitting three lines and 95% of patients hitting two lines of improvement. Because it lends itself so well to sampling, we feel that this is a unique tool that we will use widely. We don't really look at this as something that we will only do initially to give doctors the experience, but truly something that allows patients or consumers a very easy test or sample point to see whether the product works for them, which, again looking at the clinical data, we can be highly confident that the answer should be yes. And then whether they would like to continue to use it—that's why we've got that sample pack of five out there that will continue to be used as the years pass by.
Also, because there are actually 4 million new presbyopes every year, there's a large volume of new patients that we will continue to reach with those samples. On the regulatory side, reiterating what I mentioned in the prepared remarks, we're very pleased with how things are going with the FDA. We've had very engaged discussions with them, frankly, for the last several years as we were talking through the setup of the clinical trial with them. Since we've submitted the NDA, those interactions continue to be very productive. The mid-cycle review was very benign, and importantly, we now have seen them starting the inspections of our clinical trials, which shows that progress continues to be made. All in, very pleased with how the FDA interactions are going and we continue to be confident that we’re working nicely towards that August 8th PDUFA date.
Our next question comes from the line of Joe Catanzaro from Piper Sandler.
Maybe two questions interrelated on the competitive landscape. So, Shawn, you made some brief comments on Vuity and pilocarpine and pilocarpine BID. There’s been some recent Phase 3 data for a carbachol-based product. Wondering if you guys have any thoughts there on that product’s profile and maybe how it compares and contrasts to LNZ100? And then relatedly on the other side of a potential approval, I’m wondering if there’s any Phase 4 trials that you might have in mind that could reinforce that competitive profile or best-in-class status that you might have with LNZ100?
Hi, Joe. This is Shawn. Thanks for the question. When we look at this area and opportunity for eye drops for presbyopia, we have said before that we really see this as a category of one and we continue to see it as a category of one. If you want to drive the efficacy and the near vision improvement that consumers desire, it requires two key things. It requires a pupil size below two millimeters, which we achieved, and you need the right miotic to do it. Aceclidine is pupil-selective and it's the only pupil-selective miotic we have, and that puts us in a unique place. When I look at the competition, I really see this as a category of one and we’re defined by our ability to achieve the performance with the sub-2 millimeter pupil and aceclidine puts us in that place where we can be the only one with that opportunity.
Maybe just adding to that, Joe, building on what Shawn said: a successful product is a once-a-day, fast-acting, long-lasting eye drop. When you overlay that on the clinical data that’s out there, we truly believe our data is the only one that shows that profile. You mentioned carbachol—formerly a Visus product now owned by 10point—and we’ve not seen their Phase 3 data. Their press release highlighted that they met clinical trial endpoints but did not disclose the data, which makes it unclear what that means. If you go by the Phase 2 data that is available, we feel that it doesn’t meet what consumers are after. So that addresses your question on the carbachol-related Phase 3 data.
And then maybe a follow-up on Phase 4 studies that you might potentially perform, if they’re even necessary, to reinforce the competitive profile?
We’re obviously focused on bringing this to market. Phase 4 studies can be part of that. We know that ophthalmologists and doctors have interest in testing the product. We'll work with them as appropriate to conduct Phase 4 studies. I will report on that as we start them.
Our next question comes from the line of Stacy Ku from TD Cowen.
Congrats on the progress and thanks so much for taking our questions. We have three. First, regarding your year-long educational campaign, maybe talk about your 15,000 target ECPs. Where are we in the campaign and what's the level of awareness of LENZ and LNZ100? Obviously, you're not able to promote specifically, but just help us understand the level of awareness. Second, Shawn, you made comments around finalizing the marketing messages around LNZ100 clinical profile. Help us understand early thoughts — how do you make sure consumers and patients have the right expectations for the product? Is it up to 10 hours? How do you talk about the durability for a once-a-day product? Third, can you discuss in a little more detail the background of the sales force hired so far? This is a unique launch that requires both therapeutic and consumer launch experience. Are they coming from recent launches? Are they able to navigate the current consumer profile? Any additional details would be appreciated.
Thank you for the question, Stacy. Looking at the educational campaign, we've been really pleased. When we planned to drive awareness of important attributes in future presbyopia eye drops, we wanted to bring forward eye care professionals as the voice of that campaign — hence EYEAM. We allowed those doctors to speak about what matters to them and what makes them excited for future presbyopia solutions. In terms of reaching the 15,000 ECPs, we're making great progress. As we shared, we've had over 2 million digital impressions with that campaign targeting over 30,000 ECPs, meaning these eye care professionals are seeing the campaign multiple times. That is driving a lot more awareness of LENZ itself and the important attributes such as pupil-selectivity and sub-2 millimeter pupil size. While that is separate from awareness of LNZ100's efficacy, we were encouraged by the market research of over 420 eye care professionals within our target group of 15,000, where over 80% were already excited to prescribe LNZ100 if approved.
On final messaging, we’re working on distinct campaigns for ECPs and consumers. For doctors, it’s important to highlight that this is not pilocarpine — the message will focus on mechanism of action, the not-pilocarpine distinction, the rapid onset, and the safety and efficacy profile. On the consumer side, we do not want to overpromise. Previous launches in this space made claims that didn't align with efficacy. We want to provide real expectations. For instance, though we see many patients with strong responses at ten hours in our data, we plan to communicate conservatively with language such as "up to ten hours" to avoid overpromising. We're also leaning into a lifestyle brand, invoking the emotion consumers feel about blurry near vision to create desire for the product. Regarding the sales force background, we've had tremendous interest. We had a strong pool of candidates when we brought on our regional directors in Q4, and all 10 district managers are now on board.
We're finding people who are currently in good eye care or pharma roles looking for the next opportunity. The candidates have decades of eye care and sales experience, so we feel good about the quality of the team.
Thanks, Stacy. To add briefly: there was no shortage of awareness around LNZ100 and aceclidine in the market, which reflects the unbranded work and our MSL team's activity. We're targeting the top deciles first and that’s going well with over 1,000 individual one-on-one meetings led by our MSLs. That level of engagement is driving high awareness.
Our next question comes from the line of Jason Gerberry from Bank of America.
On the sampling initiative and how you'll leverage e-pharmacies, I'm wondering if the e-pharmacies will share with you sample-to-conversion metrics for patients opting into monthly supply, and if that's a metric you'll be sharing publicly to give a sense of utilization and adoption? Second, regarding early adopters, do you think patients with ocular comorbidities would be more or less likely to get treatment with a presbyopia drop therapy, or are they patients with a lower medication burden more likely? And at the Commercial Day, will you share any comps for launch ramp outside of early adopter dynamics?
Great, thanks Jason. On sampling and e-pharmacy: the five-day sample packs will be rep-delivered to the optometrist and act as a bridge until the consumer gets started on a full supply. The e-pharmacy process is separate: when the patient receives a sample and checks out with their optometrist, the optometrist will ask where they'd like the script sent — to an e-pharmacy or a retail pharmacy. If sent to the e-pharmacy, the patient gets a text, clicks the link, pays, and then the product is delivered to their home every month. From the e-pharmacy, we'll get data on the number of scripts and refill frequency. The sample distribution at the clinic is separate and will not be captured in retail script data. Regarding early adopters, our initial focus will be on patients already visiting the practice. Contact lens wearers over 45 are an important group—these patients are already attending annual eye exams, so the doctor is a natural conduit. In our survey, doctors reported seeing over 200 presbyopes per month. For launch ramp comps, at the commercial day we will focus on strategy and readiness; we will not provide specific launch ramp projections at that event.
To be concrete, Jason: there’s no direct correlation we will share between samples and conversion to scripts, because samples are distributed at the office and script conversion is measured separately through pharmacy channels.
Our next question comes from the line of Lachlan Hanbury-Brown from William Blair.
I’ve heard across the industry that it’s been getting harder in some places for sales reps to actually get in and see a doctor. Have you heard anything similar for your targets? If so, what can you do to get around those hurdles? Also, given recent talk of a potential recession, do you have any thoughts on how economically sensitive demand might be, since this could be discretionary spending?
Hi, Lachlan. In optometry specifically, we have not seen access becoming more challenging. There was increased difficulty getting into hospitals and some retail during COVID, but for optometrists we don’t see that trend. Our samples will actually help keep doors open because reps will provide sample replenishment and practices will want to interact with reps for that reason.
On the macro sensitivity question: if you look at aesthetics and discretionary healthcare historically, revenue has been resilient even during downturns. Our projected market penetration is modest relative to the total presbyope population—we're modeling roughly a 6% penetration to reach that $3 billion-plus market estimate. We believe the target population for this product will be relatively robust to macro swings.
Our next question comes from the line of Gary Nachman from Raymond James.
Hey, guys. Good afternoon. This is Denis on for Gary. Congrats on the progress this quarter. Previously you've segmented the consumer market into lens wearers, refractive surgery patients, and med spa patients. Of those three, which do you think will be the easiest to activate and reach, and which will require more work? Any quick updates on commercialization plans for LNZ100 in the EU?
Great question. All three segments are accessible from a promotional standpoint. Pre-DTC, contact lens wearers are the easiest to access because they already visit optometrists annually. Med spa and refractive surgery patients can be targeted digitally—med spa patients in particular test highly in our research and are very motivated. We can utilize search histories and geo-targeting to reach them. Refractive surgery patients are reachable via ophthalmology channels and digital targeting. So all three are attractive and accessible targets.
On ex-U.S. strategy including Europe: we are focused on commercializing the product in the U.S. ourselves. Ex-U.S. territories will be licensed to appropriate commercial partners. There is significant inbound interest ex-U.S., and we will time those discussions to maximize value. The one exception is China: we licensed China early, and they may conduct their own clinical work. Their timeline is about 12 to 18 months behind us for filing and launch. We will keep everyone updated as we progress other ex-U.S. discussions.
Our next question comes from the line of Matthew Caufield from H.C. Wainwright.
Thanks for the update. From the commercial standpoint, do you foresee any tangible prescription resistance based on prior Vuity experiences or disappointment from that separate pilocarpine profile?
Hi, Matt. Great question. In our market research on the 15,000 target ECPs—with a subset survey of over 420 ECPs (80% optometry, 20% ophthalmology) who had prescribed Vuity—we found that over 88% were likely to prescribe LNZ100 if approved, about 2% to 4% were unlikely to prescribe. The key driver is that LNZ100 is not pilocarpine; it’s aceclidine-based and pupil-selective. In the research, the main reasons Vuity did not meet expectations were that it often didn’t work for many patients and when it did, it didn’t last long enough. We believe LNZ100 addresses both of those shortcomings, and the excitement in our research reflects that.
That concludes our question-and-answer session. As I am showing no further questions. Thank you for your participation, and we will now conclude today’s conference call. You may now disconnect.