LENZ Therapeutics - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 execution remained disciplined ahead of the August 8 PDUFA; LENZ ended the quarter with $194.1M cash, cash equivalents, and marketable securities, and raised projected PDUFA cash to over $185.0M following a $16.3M April ATM block trade.
• OpEx ramped in-line with pre-launch plans: SG&A rose to $11.1M (sequential increase vs Q4), R&D was $5.8M, and net loss was $14.6M (EPS $(0.53)); management noted total OpEx up ~11% q/q and net cash burn of ~$15M, reflecting pre-approval build for launch.
• Regulatory momentum: mid-cycle review completed with no significant issues; late-cycle review moved forward to late May 2025; FDA continuity cited with no review team changes; CBP rulings confirm LNZ100 is U.S. origin and duty-free, removing tariff uncertainty.
• Commercial readiness advanced: >40% of 88 sales territories already accepted offers; full field team targeted by July 1; sampling logistics and e-pharmacy pathways built to drive rapid patient conversion at launch—DTC influencer campaign slated for early 2026 after ECP education in Q4 2025.
• Near-term stock catalysts: late-cycle review outcome, continued hiring milestones and sampling readiness updates, and affirmation of cash runway to post-launch positive operating cash flow; no Street consensus available for revenue/EPS to frame beats/misses this quarter (pre-commercial).

What Went Well and What Went Wrong

What Went Well

• “Upwardly revised anticipated cash balance at PDUFA to over $185.0 million; cash runway anticipated to extend to post-launch positive operating cash flow” (press release).
• FDA interactions remained constructive: “mid-cycle review… noting no significant review issues… late-cycle review meeting… scheduled for late May 2025… no plans to request an Advisory Committee Meeting” (CEO prepared remarks).
• Tariff/country-of-origin certainty: CBP confirmed U.S. origin and duty-free classification—“we are proud to say that LNZ100 is designated Made in the USA” (CEO).

What Went Wrong

• Operating costs continued to ramp ahead of launch: total OpEx rose to $16.9M (≈+11% q/q) driven by commercial build-out; SG&A increased ~19% sequentially to support hiring and pre-launch marketing.
• Net loss increased to $(14.6)M (EPS $(0.53)), reflecting manufacturing and commercial readiness spend; compares to $(12.7)M (EPS $(0.46)) in Q4 2024.
• No Street estimates available to benchmark performance, limiting near-term “beat/miss” narrative for trading-focused investors (S&P Global consensus data returned no quarterly revenue/EPS estimates for LENZ in Q1/Q4).

Transcript

Speaker 5

Afternoon, ladies and gentlemen, and welcome to the LENZ Therapeutics First Quarter 2025 Financial Results 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. 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.

Speaker 7

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 Abe Schimmelpennink, our President and Chief Executive Officer, and Shawn Olsen, our Chief Commercial Officer, as well as Dr. Marc 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 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, 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 first quarter 2025 Form 10-Q, which was filed today. With that, I'll now turn the call over to Abe.

Speaker 4

Thank you, Dan, and good afternoon, everyone. The first quarter of 2025 has been a focused and highly productive period for LENZ. With our PDUFA action date for LNZ100 now just three months away, we are entering into what we believe will be a defining chapter in our company's growth. Back in January, I said that 2025 had the potential to be a transformational year, and with each passing milestone, that's proving to be the case. In prior quarters, we emphasized our commitment to disciplined execution as we are advancing LNZ100 to launch and our belief in its potential as a category-defining treatment for presbyopia. That focus hasn't wavered, and we've been doing all of this while maintaining a strong financial foundation to support our growth.

The foundation in recent weeks has been further strengthened through a block trade as a result of an inbound from a high-quality investor eager to initiate a meaningful starting position in our stock. Their interest was, amongst others, triggered by our commercial day, which we hosted in April at the NASDAQ market site. Our objective was to provide a clear and comprehensive look at our commercial readiness and share our excitement for the upcoming potential launch of LNZ100. It was an outstanding event with many investors and sell-side analysts joining in person, hundreds more joining live online, and many others who have watched the replay since. The feedback has been extremely positive. We believe we accomplished what we set out to do, demonstrate the strength of our commercial strategy, and instill confidence in our ability to execute.

There are four key takeaways from that event I'd like to briefly touch on here. First, the perspective shared by eye care professionals. We heard from a number of respected KOLs who all expressed genuine enthusiasm about the clinical potential of LNZ100, particularly on how it could enhance patient care. As a reminder, while there are approximately 128 million Americans with presbyopia, fewer than half of them are believed to see an eye care doctor. That presents a substantial opportunity, and ECPs are very interested in how our direct-to-consumer marketing will help drive awareness and engagement among this large population. Second, we outlined the progress we have made in preparing for launch. As you know, our commercial strategy is structured around three pillars: enabling doctors to recommend us, empowering patients to address us by name, and ensuring a seamless path to access.

On the first pillar, our unbranded I Am Selected campaign continues to generate strong engagement. More than 50 KOLs are part of the effort, helping their peers take a fresh look at emerging options in presbyopia treatments. The campaign has reached over 12,000 ECPs and has delivered more than 2 million impressions online. Furthermore, our all-optometrist MSL team has been actively engaging with ECPs, with thousands of meaningful interactions to date. They are playing a key role in educating the community about the aceclidine mechanism of action and the importance of pupil selectivity. In parallel, our sales force build-out is progressing as planned, and Shawn will speak to that shortly. The second pillar, building brand awareness among patients post-approval and launch, is driven by a clear and targeted strategy. As shared at the commercial day, our goal is to establish a true Category 1.

We have defined our consumer targets, we know how and where to reach them, and we are building a campaign that will incorporate the right mix of influencer and ambassador engagement to drive visibility and recognition. Third, we have laid the foundation for a strong product access strategy that includes an extensive sampling approach and broad distribution through both traditional retail pharmacies and existing e-pharmacy channels, ensuring convenience and accessibility from the start. We also provided an update on our interactions with the FDA. Given the current regulatory environment, we felt it was important to reiterate that we are continuing to see a high level of engagement from the agency, with excellent continuity among the review team, which has seen no changes in personnel.

In fact, our late cycle review meeting has been moved forward to later this month, and we remain on track for our August 8 PDUFA date. Finally, I want to briefly speak to the topic of tariffs, which for obvious reasons continues to come up in conversations. As we shared at the commercial day, we are in a strong and well-defined position. On November 7 of last year, U.S. Customs and Border Protection issued a definitive ruling establishing the United States as the country of origin for LNZ100. Then, on April 2, we received the second definitive ruling confirming that LNZ100 will be duty-free. Combined with the fact that our intellectual property is domiciled in the U.S., we are proud to say that LNZ100 is designated Made in the USA.

Across the organization, from medical and regulatory to manufacturing operations, quality, finance, HR, and commercial, every team is operating with urgency and alignment as we approach our target action date in August. These are truly cross-functional efforts, and I'm incredibly proud of what we have accomplished so far. With that, I will turn the call over to Shawn, our Chief Commercial Officer, who will share more on the progress we are making in our pre-commercial planning. Shawn.

Speaker 0

Thank you, Abe. Good afternoon, everyone. As we've 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 US, a population 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 more than the combined US population suffering from dry eye, Demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma. The first eye drop treatment for presbyopia was approved in 2021 and confirmed that there's a 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 this product did not materialize, as pilocarpine, even at the high concentration of 1.25%, cannot deliver the consumer-required performance. Extensive independent consumer market research suggests this 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're excited for the prospect of an aceclidine-based 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 the product four to seven days per week.

Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion-plus market, creating a potential Category 1. We continue to advance our commercial readiness as we progress towards August 8 PDUFA date, and I'd like to take just a moment to provide an update on the three pillars of our commercial strategy. The first pillar of our commercial strategy is doctors to recommend us. As Abe mentioned, our all-optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the phase 3 data. In addition, our unbranded campaign continues to drive awareness of an ideal presbyopia solution with over 2 million digital impressions. Following credentialed NDA approval, our sales force will immediately begin branded calls on approximately 15,000 ECPs, and I'm pleased to report that we have made substantial progress on the sales force over the past quarter.

As a reminder, we had already successfully hired our full sales leadership team, including both of our regional directors in 2024. In Q1, we expanded the team further with an additional 10 district managers. Collectively, this core leadership group brings nearly 150 years of eye care experience and more than 300 years of total sales experience. In March, we launched job postings for all 88 sales territories nationwide. The interest to join LENZ's sales force has been tremendous, with over 7,500 applications for the 88 positions. The quality applicants have been very high, and we're excited to share that we've begun extending offers to our field-based sales representatives. As of today, we've extended and received accepted offers for over 40% of our field sales team. In addition, 97% of these new team members have prior eye care or pharma experience and, on average, have over 10 years of sales experience.

This marks a major milestone in our commercialization readiness and great progress towards our target to have the full field team in place by July 1. We're excited to progress our first pillar, doctors to recommend us, and as a reminder, our primary market research surveyed 426 eye care professionals, and it yielded an impressive 82% and 83% of ECPs already being likely to provide, prescribe, and sample LNZ100 if FDA approved, respectively, based on that phase 3 data. Our second pillar of our commercial strategy is consumers to request us by name. We've taken a consumer-first approach, leaning heavily into lifestyle creative that reflects the aspirations and daily experiences of our future consumers. The brand we've built is empowering, desirable, and has tested exceptionally well in market research.

On April 15th, we hosted our commercial day event in New York City, where we unveiled the visual identity of the brand, which is modern, clean, and sophisticated. We heard from phase 3 users of LNZ100, which highlighted the personal experience with the drop and the word-of-mouth potential. We shared our plan for advertising, including influencers and celebrities, to drive awareness. We even facilitated a live discussion with Tiffany Thiessen, who many of you may know from Saved by the Bell, 90210, and White Collar. As a presbyop herself, she shared her frustrations with presbyopia and desire for a better solution. All of this to help frame how we plan to ensure consumers will request us by name. Our brand creative is now fully locked, and the majority of our launch promotional materials are ready, pending final product insert language.

Once approved, we'll begin activating our eye care professional-facing materials to ensure providers are confident and well-equipped. Following that, and once the ECP education is firmly in place, we'll launch into our direct-to-consumer campaign with high-impact advertising, influencers, and celebrities that we believe will powerfully introduce our brand to the market. For more information from the commercial day, a replay of the event is available on our investor relations page under the IR calendar on our website. The third and final pillar, seamless journey to use, will ensure ease of sample and product access for patients. 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 at least two lines of improvement on hour one, day one. This immediate response and wow effect is incredibly important 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 products. Our team has developed a five-day sample pack similar to sample sizes for contact lenses, which, following the initial trial, can act like a bridge until product is picked up at the pharmacy or delivered to the consumer's home. We will continue to drive these three pillars as we continue to progress towards our PDUFA dates: doctors to recommend us, consumers to request us by name, and a seamless journey to use. I'd now like to hand the call over to Dan Chevallard, our CFO, to highlight our financial results.

Speaker 7

Thank you, Shawn. As has been mentioned, the first quarter of 2025 has been a very productive and focused time for the company, with our PDUFA target action date for LNZ100 just over 90 days from now. We ended Q1 2025 in a position of financial strength and funded for success, with approximately $194.1 million in cash, cash equivalents, and marketable securities. As you may have seen, now having passed the anniversary date of our merger in March 2024 and the corresponding Rule 145 shelf limitations imposed upon us by the SEC, we became shelf eligible and filed our first S-3 shelf registration statement in early April. Subsequent to quarter end, we received a meaningful inbound inquiry from a high-quality investor on our ATM, which ultimately resulted in a single block trade of 600,000 shares and net proceeds of $16.3 million, further strengthening our financial position.

As such, we have upwardly revised our projected cash at LENZ from over $170 million, which we disclosed at our commercial day, to now over $185 million, and again reiterated our cash on hand is anticipated to fund the company's cash runway to post-launch positive operating cash flow. Let's now turn to our first quarter results. As I noted on our most recent year-end call, we expected measured increases in our operating expenses as we exited 2024 between year-end and the time of our PDUFA date, which was exactly what we saw in the first quarter. Our total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4, but well within our operating plan.

From a cash perspective, we had a total net cash burn of $15 million in Q1 2025, which included approximately $3 million in one-time annual cash costs and is really reflective of closer to $12 million in operating cash burn compared to our Q4 2024 net operating cash burn for approximately $8.1 million. Total SG&A expenses increased to $11.3 million for Q1 2025 compared to $5.6 million for the same period in 2024, driven primarily by an increase in commercial headcount and other pre-launch commercial planning activities. Sequentially, SG&A increased quarter over quarter by approximately 19% from $9.4 million in the fourth quarter, driven primarily by increases in personnel-related expenses due to a growth in commercial headcount, pre-commercial marketing, advertising, and sales infrastructure, all continuing the pattern of a ramped commercial spend as we approach our potential August 2025 approval for LNZ100.

As I have highlighted on previous calls and in what will be a consistent objective, we will continue to be measured in our spend on the G&A side of the organization as we aim to remain a lean and efficient G&A team. Total research and development expenses decreased to $5.8 million in Q1 2025 compared to $10.5 million for the same period in 2024. Sequentially, however, R&D expenses were flat quarter over quarter, with a 1% net decrease from the fourth quarter. The majority of our research and development expenses in Q1 were dedicated to our manufacturing operations efforts as we build pre-approval commercial product and sample inventory to support our launch, which will continue through the approval of LNZ100, at which time much of our manufacturing costs will be prospectively reflected in cost of sales.

Finally, our net loss per share, both basic and diluted, was $0.53 per share in the first quarter of 2025 on a net loss of $14.6 million compared to a net loss per share of $3.53 per share in the first quarter of 2024 on a net loss of $16.6 million. Q1 2025 net loss per share was calculated on approximately 27.5 million weighted average common shares outstanding compared to Q1 of last year, which was the quarter in which we completed our reverse merger, where a net loss was calculated on approximately 4.7 million weighted average common shares outstanding. In total, we ended Q1 2025 with approximately 27.5 million shares of common stock outstanding.

In summary, we feel very good about where we stand financially as we approach the exciting period ahead and are pleased with the strength of our balance sheet and disciplined operating plan as we approach our August 8 PDUFA date. With that, I'll turn the call back over to Abe for the final remarks.

Speaker 0

Thanks, Dan. As you can see, we're off to a great start in 2025. I believe we have tremendous momentum as we are now about three months from our PDUFA target action date. We've never been more confident in our abilities to deliver once daily, well-tolerated, and rapidly acting treatments to 128 million individuals living with presbyopia in the United States. I'm looking forward to the exciting months ahead. With that, I'd like to open up the call for questions.

Speaker 5

At this time, if you would like to ask a question, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. To repeat, to ask a question, please press star one. Your first question comes from the line of Stacy Ku from TD Cowen. Please go ahead.

Speaker 6

Hi. Thanks so much for taking our questions, and congrats on the progress. We have a few. First, as we think about the LNZ100 initial launch, we do think it makes a lot of sense to maximize the prescriber and patient relationship with high-volume sampling. Just curious, do you have the infrastructure in place to get samples to all interested offices as quickly as possible post-launch? Can you discuss in more detail plans kind of right immediately after approval? That is the first question. The second is somewhat related. Maybe talk about the type of preparation the team is doing to drive continued use and refills of LNZ100 after that initial sample. How are you thinking about the level of stickiness of LNZ100 as it relates to setting expectations for the patient experience?

Last, if we could, as you approach the approval timing, what kind of metrics will you disclose to kind of show patient demand to the street? Thank you so much.

Speaker 0

Great. Thanks, Stacy. This is Shawn. For your first question, you're asking about where are we in our readiness and ability to sample right out the gate for LNZ100. I think I got that right. We see sampling as a critical component to our commercial strategy. We've been out in front of this for a long time. We actually contracted our sampling distributor back in 2024. What we're doing in terms of progress, obviously, internally, we're writing all of our policies for how the reps deliver the samples. We're already coordinating between our sample distributor as well as our CRM system and actually smoke testing those systems to make sure it will be seamless upon those samples being available. Once samples are available, we'll immediately begin shipping those samples to the reps.

They'll receive those samples and be out distributing them to their 15,000 ECP targets. Our plan is to have the majority of our samples rep-delivered. We see that as very important. We see that opens the door to go and talk to the eye care professionals. That allows us to have that conversation about LNZ100 with the eye care professional every time we show up. On your second question in terms of preparations for the field, we have a lot of work going on already to ensure that we're ready to go. As you can imagine, with over 40% of the salesforce already accepting offers, in the background ahead of that, we've been building out all the training modules for the sales team.

Once the sales team comes on, they have about a three-week training cycle where we take them through all those modules. All of them, except for the one on the product, are all ready to go and through the medical, legal, and regulatory review process. We need to get training them day one. In terms of preparations to make sure that appropriate information is passed along to the eye care professional, we prepared our Q&A documents as well as key messages to have that conversation with the doctors.

Speaker 6

Got it. Then the last comment on what type of metrics you might disclose?

Speaker 0

Yeah. In terms of the metrics, what we see there is next product will be distributed both through the retail pharmacy as well as the e-pharmacy. I think where most people will be looking for us in terms of metrics early on, I'd really be going to the IQVIA data, looking at new script rates as well as that refill rate. I think early on, the focus of Q4 is going to be samples. Once we move into Q1, I think that focus is really going to be what are those new scripts per week. Moving into Q2, it's going to be a lot about how are those refills coming through. Given the e-pharmacy, obviously, that's often not picked up in IQVIA. We'll make sure that we can provide some guidance on how that's going so the appropriate analysis can be made.

Speaker 7

Stacy, just adding to it, I think you had a question in there on how we would expect to go from samples to ultimately use. That really, that idea is that that sample will be accompanied with a script. At that moment, the patient can either choose to fill that script as Shawn mentioned. For the e-pharmacy, this is what we're all getting very accustomed to now. You leave the doctor's office, and the text will pop up on your phone, and that product will then be delivered to your doorstep. If you want to go to more traditional reps, you can pick the actual product up at the retail pharmacy. The second part of that question was what we think about stickiness. Hard to say at the moment. I think it's different from our product. I'm sure I'm highlighted that sample use.

We know that 95% of patients hit at least two lines of near vision improvement. You would expect that people see that improvement from the sample. If they are converting to a script, they should be motivated to continue to use that. You would expect relatively high stickiness once people have converted into a script.

Speaker 6

Okay. Wonderful. Incredibly acceptable. Thank you.

Speaker 5

Your next question comes from the line of Pavan Patel with Bank of America. Please go ahead.

Speaker 1

Hey, guys. This is Pavan on for Jason Gerberry. First question is related to the five-day sample pack. I know that's a key part of the strategy. How will sample distribution be managed and tracked to ensure that they reach high potential prescribers and patients? What's the expected conversion rate from sample to paid prescription? On the manufacturing and supply chain, with the start of manufacturing in February of 2025, can you help us understand what's the current inventory level and what's the target inventory for launch? One follow-up, if I may.

Speaker 7

Absolutely. Shawn, you want to take the sample pack?

Speaker 0

Yep. Great. Great to hear from you, Bhavan. The five-day sample pack, when we think about how that will be managed and tracked, what will happen is, obviously, our sample vendor will hold all of the actual bulk samples in their location. How that will be managed, every month, that product will be shipped to each rep, right? Every month, there'll be a shipment that goes to the rep. They'll hold their products in their storage locker. That shipment will be dependent on the number of targets and then the expected amount of samples they'd be dropping off. That will be replenished every single month.

Now, once that rep goes to the actual doctor's office, to the eye care professional, every time samples are dropped off, we will make sure that they're signed for and fully accounted for to make sure that it's a clear transfer of ownership to that eye care professional. Every subsequent visit, they'll be checking in on how many samples were left and how many scripts were written to make sure it maintains the right ratio. In terms of the expected conversion from samples to full-time users, I think it's a little bit too early to tell on that. When we have more insight, we'll share more on that.

Speaker 7

Thanks, Shawn. Just to add to that before I go to the inventory question, we have a map on the 15,000 doctors and 88 reps plus the DMs. You get to about a three-week call cycle. Every three weeks, the rep is in that office. On top of that, there's a mechanism for doctors, if they run out of samples in that period, to request more. On the inventory, you were right that we started production of our to-be commercial product in Q1. I do not think we're going to be sharing at this moment what our inventory levels are other than we're confident that we can supply what we believe will constitute a successful launch.

Speaker 1

Great. For a follow-up, maybe if you can elaborate on the mechanics of the e-pharmacy partnership and how that will strengthen the patient journey from prescription to refill, including data capture on script conversion and adherence. Thank you.

Speaker 0

Yeah, absolutely. What we've really seen over the past few years are the growth of people that prefer their medicines to be delivered to their house, just like their Amazon packages. There's really been this growth in the use of e-pharmacies. What's great about that is it really creates a closed system, which is helpful. Our partner that we're going to be using for our e-pharmacy is already active in the eye care professional space. What that means and why that's important means when we go to when a doctor goes to enter the scripts into their EMR system, that e-pharmacy should already be loaded up within that computer. It should be seamless to send it on to the e-pharmacy. Once the e-pharmacy actually receives the scripts, they then take over the ownership and relationship with the patient to get them the products.

The e-pharmacy shoots a text to the patient's phone, right? At that point, it's just a link to click in. From that link, they put in their credit card information and shipping information, and that product starts shipping to their door. Throughout that process, also, what's great about it is the opportunity for auto-refill, which means in terms of stickiness, right, that product showing up every single month to the door. If they didn't select the auto-refill, of course, the e-pharmacy will also follow up once they're at the end of their first box or second box to follow up and say, "Hey, it's time to order again." It definitely creates a nice closed environment where you have a strong relationship with the consumer. One other question, which you asked earlier, and I think I missed a spot on.

You want to make sure the samples go to those high-volume prescribers. Because our samples are rep-delivered, they're targeting those eye care professionals that we've identified as high-dosile users of the Vuity products. Our reps are going to those practices, which have already shown a high volume of Vuity use early on. Therefore, that way, the samples are going to the right accounts.

Speaker 1

Thanks, guys.

Speaker 5

Your next question comes from the line of Tomaso di Vignano with Citi. Please go ahead.

Speaker 3

Yeah. Hi. Thank you very much. Regarding the marketing plans, can you talk about when you're going to turn on the influencers and not who you're going to get, but kind of when that might happen and on what platforms? As far as the commercial model, in terms of how you're thinking about the launch, obviously, Vuity got to 6,000 scripts per week, I believe, and then it peaked out. I'm just wondering, if you get to that point, would that be break-even for you, or would you need to be higher or lower? How quickly do you think you could get to that 6,000-script high watermark that Vuity got to and then presumably exceed that? Thank you.

Speaker 0

Hi, Yigal. This is Shawn again. Thanks for that. I'll take the first question on the marketing plans and when to turn on the influencers. When we think of when we go to market, immediately upon the August 8 PDUFA date, if approved, the field will go out and start training ECPs. Our main goal ahead of the influencer campaign is to make sure the ECPs are aware of the product and comfortable with it, right? That's what we want to make sure is in place before we turn on the influencer campaign. That's important because what we heard about Vuity is if you turn on the influencers too quick, the doctors are caught off guard. I think it's safe to assume Q4 is really a focus on the eye care professionals. What's also great about our product is it's a cash-pay product.

We're not beholden to when we have coverage by the PBMs to turn on DTC. We can turn on faster than other products that are covered by insurance. When we start turning on influencer campaigns and really promoting DTC, that's going to happen in early 2026, I would expect. I think by that time, we'll have enough time to meet with the doctors a few times each, make sure they're comfortable with the product before turning on DTC. In terms of channels, we worked a lot on identifying the early adopters and where they spend their time. What we're finding, these people over 45, they're spending the majority of time on Facebook, Instagram, YouTube, and Pinterest. Those are really going to be the avenues that we focus to drive that awareness.

We're not finding that they're spending their time on linear TV, so your standard TV channels. So timing, early 2026, and channels Facebook, YouTube, Pinterest, and Instagram.

Speaker 1

Got it. Got it.

Speaker 7

Thanks, Shawn. I'll take a question on the modeling, Yigal, and thanks for dialing in. You'll appreciate that at this stage in the company and pre-launch, we're not guiding on revenue or volume. What we have shared is that ultimately, we can see this being a $3 billion-plus market. As we've shared previously, it's based upon 8 million ultimate users in the US alone, using the product five refills a year. What would be Vuity pricing? With that in mind and the fact that we're going to be cash flow positive, I think many of the models, including yours, are actively or at least giving a sense of when that could happen. Again, we're not guiding to what we have in our plans.

Speaker 3

Okay. Got it. Thank you.

Speaker 5

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

Speaker 0

Hey, guys. Thanks for taking the questions. Shawn, just on the DTC marketing, I mean, you've obviously had a pretty comprehensive unbranded campaign prior to approval. I was curious how you think about the transition from that to branded campaigns and DTC. If DTC starts in early 2026, does the unbranded campaign continue until then, or does it sort of slip over to something else upon approval or availability? Second, you sort of touched on this a little earlier, but with the sales force expected to all be hired by July 1, and presumably, at least some of them will have been through that three-week training, what can they do in terms of the interactions with target ECPs before an approval, if anything? I know there are obviously a lot of restrictions around what they can and can't say and do.

Could you just elaborate on what they can do in that, say, five weeks before the PDUFA?

Thanks, Lachlan. Great questions. Yeah, happy to cover those topics. First thing, when does the unbranded stop? Right now, the unbranded campaign, obviously, it's disease state awareness and looking for what's the ideal solution look like in Presbyopia. Our plan is to continue to run that up until potential approval, and then we would sunset that campaign. It's really what we can have out there so we can get the excitement going for future solutions in Presbyopia. Once we can transition to speaking about the brand, we want to immediately transition to that and make that the focus of all messaging. What that transition will look like to DTC marketing. Right now, in the unbranded campaign, a lot of that's focused on where do doctors spend their time as well as the conventions that they're going to in their publications.

When we move over to DTC for the direct-to-consumer, we'll actually first start with direct-to-practitioner. We'll actually bring on branded messaging to the doctors. We'll just transfer everything we're doing on the unbranded side, flip it over to branded materials directly at the doctors to really drive their awareness and make sure they're comfortable with the product. As we transition to then DTC after that in early 2026, the whole game resets in terms of how we target them. Because now that we're targeting a consumer, we're moving off of the platforms where doctors are focused for information back to that Pinterest, YouTube, Facebook, Instagram. To do that, we've brought on the right type of media buy agencies that have those relationships to make sure that we have hard-hitting, impactful messaging on those platforms. That's how we're really going to transition to DTC.

Now, the sales force, as we shared, over 40% of them have already accepted offers. Some of them will be on before July 1, right? You spoke about the three weeks of training. What can happen after their training but before approval? That is, again, where the unbranded campaign comes in. The unbranded campaign is fair game for sales force to talk about. They can actually start their call cycles. They can start to meet the eye care professionals, confirm routings, confirm emails, get to know the doctor. The discussion will be limited to the "I Am Selected" campaign. Upon approval, they can then immediately switch to the branded calls. That is how to think of that transition from hiring until product approved.

Okay. Thanks. That's useful.

Speaker 5

Your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.

Speaker 2

Hey, guys. This is Dennis Resnick on for Gary Nachman. Thanks for taking our questions and congrats on all the progress. First, could you provide an update on the work you're doing surrounding the additional patent protection for LNZ100? I believe you previously mentioned you had 10 currently under review. Just any additional color on what types of patents they are and your confidence in the overall IP estate? Can you talk a little bit more about the process that went into selecting the e-pharmacy you're working with? What specifically sets this e-pharmacy apart from others? Just elaborate a little bit more there. I've got one follow-up.

Speaker 7

Absolutely. Great questions. If you think about the current patent estate, we have seven granted patents that go out to 2039 already. It was four roughly in two buckets. One around the use of a psychedelic to treat presbyopia. It's a very strong patent around that. Another suite of product formulation patents. And very strong patents that go out to 2039. Then the patents that are currently under review, and I'm talking U.S. only here for the moment, that will extend that to at least 2044. Further patents in those two categories as well as use patents in different use cases that we have seen in our product. That's going to be, again, a very broad, very strong patent estate.

Just to complete that on the protection side for the product, ahead of that sits because this is a new chemical entity for the U.S., at least five years of data exclusivity upon approval is what we expect to get. On the back end, because this is a self-pay product, you'll never see your traditional generic switch for a product like this because there's no insurance involved. There's no insurance pushing the pharmacist to switch a brand over to a generic. That we feel on the back end, and now we're talking 2044 and beyond, will provide a very strong and long-lasting life cycle for the product.

Speaker 0

This is Shawn for the second question on the process to select an e-pharmacy. We spent a lot of time making sure we chose the right partner for e-pharmacy. One of the most important criteria is we wanted to make sure we selected an e-pharmacy that already existed within the eye care professional EMR ecosystem. What we did not want is to select a pharmacy that is not already established in the eye care offices because obviously that takes work to set up all their EMR systems. That was a key criteria. Another key criteria was actually the interface for the consumer, right? With this being a consumer product, we wanted something that was sleek, easy to use, and a partner that had good follow-up to ensure compliance.

Other factors that were behind those two, a speed of delivery, ability to handle high volume of actual scripts, and other partners, making sure that they work with other reputable partners as well, not necessarily in eye care, but other high-end pharma companies. What was not in the selection process that is different than many other companies is their ability for prior authorization or insurance claim adjudication. That was not something that we put into the factors as we were evaluating e-pharmacy, given the fact that this is a cash-pay product.

Speaker 2

That's super helpful. Just given there's been some previous rumblings of recession, perhaps consumer sentiment being worse than people had anticipated, if that does end up occurring where there is a recession, how does that kind of change your initial call points, if at all? Would that cause you to focus on certain geographies over others? Thanks so much, guys. Congrats on all the progress.

Speaker 7

Yeah. Dennis, this is Dan Chevallard. I'll start the first part of that question, and I'll pass it to Shawn to conclude it. The topic of recession is one that we've certainly looked at. As you think about relative risks for a product with our profile, we evaluated the medical aesthetics field, beauty category, medical procedures like LASIK, dermatology, and others. I think reference time points where you could look back to to say, "Gosh, how did those profiles or how did those categories behave?" You don't have to go too far back to see how these categories behaved in the COVID era and then prior to that in the global financial crisis era 2007 through 2011.

Key takeaways, I think we would be naive to say that we're not immune, but historical precedent really suggests that the medical aesthetics category, and we'll use the neurotoxins and fillers as maybe the closest proxy to what we do, are a bit more insulated from a recession risk than higher-priced elective procedures such as cosmetic surgery. That is one way to look at it. I think that it's fair to say discretionary spend will always potentially be impacted. I think for a product like ours that impacts quality of life, that has such a large addressable market, and you could even kind of put it into a category like these medical aesthetics from the standpoint of consumerism, you could almost put this into a beauty-like view of this becoming something that is viewed as an essential, really, which I think could insulate us from significant downside risk.

Just to quantify that, you could look at the categories that we're highlighting as the closest proxies, and you get at the high-end single-digit negative impacts from a growth perspective at the peak of recession years, but on balance, coming through in an extremely strong way.

Speaker 0

Adding on to that in terms of the targets and given what was just shared by Dan, in terms of if a recession were to happen, our 88-reps field force, we believe, is right-sized, and it's really focused on 85% of all those Vuity scripts. I wouldn't see that changing. Again, given that minimal potential impact that Dan just highlighted, we're already also focused. When you look at those 88 reps in those territories, we're really focused in calling in those major metropolitan markets where you're focused on that higher-end consumer as well that has a little bit more resolve in those situations. I don't see that call point changing.

Speaker 2

Super helpful. Thanks, guys.

Speaker 5

Your next question comes from the line of Matthew Caufield from HC Wainwright. Please go ahead.

Speaker 4

Hi, guys. Thanks for taking our question. So we were curious with the recent developments in the space regarding others' NDA submission and a product launch. Do you foresee specific scenarios where a prescriber could ultimately suggest an alternative-approved eye drop first prior to utilizing LNZ100 pending approval? Thanks a lot.

Speaker 7

Great question, Matt. Shawn and I might back in a little bit on that. I think ultimately, with these products, it's all around, does it work? Yes or no? Do you achieve as a consumer what you're expecting, which is, can you go without your reading glasses? Or at least a very significant part of the thing. We've seen that with Vuity, that was not the case, which was a high-dose pilocarpine. That clearly did not deliver that expectation or on that expectation. Therefore, after our initial good launch, people didn't refill because it didn't work. These are not products that you can get people to say, "You can use it for three months, and maybe you notice an effect." It's on the very first day. You either like it or you don't like it. The liking it truly comes down to, does it work?

It's hard to believe how others currently on the market can achieve that. We'll see. We're very much focused on what we can deliver. That's where we know, again, if you just look at our clinical data, but especially also at the patient feedback, and we shared some of that at the commercial day, how they're talking about the product and how they've experienced that very first drop that went into their eyes. Because of that, what you see us do is very heavy sampling, which is different than what others are doing. I'll leave it with that. It's hard to see that you'll step in with one product and then people will graduate to something else. Sampling is going to be key, and people pick the ones that they will like.

Speaker 0

Yeah. And just to add on to that, Meyer Lee. So again, I've been out there at the conferences. I've spoken to the eye care professionals. I've seen the data of the products you're talking about. And I continue to see this as a category of one.

Speaker 4

Excellent. Very helpful. Definitely looking forward to the PDUFA. Thanks, guys. Congrats.

Speaker 0

Thanks, Matt.

Speaker 5

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.