LENZ Therapeutics, Inc. (NASDAQ:LENZ) Q1 2025 Earnings Call Transcript

LENZ Therapeutics, Inc. (NASDAQ:LENZ) Q1 2025 Earnings Call Transcript May 9, 2025

Operator: Good 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 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 Chevallard, Chief Financial Officer. Please go ahead.

Dan Chevallard : 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, 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 Eef.

Eef Schimmelpennink : 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 target 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 I believe 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. There 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 prospective 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, few and 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 request us by name and ensuring a seamless path to access.

On the first pillar, our unbranded EYEAMSELECTIVE 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 treatment. 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 Aceclidine’s mechanism of action and the importance of pupil-selectivity. And 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 of one. 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. And third, we’ve 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, US 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 a second definitive ruling confirming that LNZ100 will be duty-free. Combined with the fact that our intellectual property is domiciled in the US, we are proud to say that LNZ100 is designated and 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.

It is a truly cross-functional effort 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?

Shawn Olsson: Thank you, Eef. 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, population nearly 4 times larger than those impacted by dry eye and nearly 6 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 is 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 Aceclidine-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 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 of water [ph]. 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 Eef mentioned, our all optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the Phase III data. In addition, our unbranded campaign continues to drive awareness of an ideal presbyopia solution with over 2 million digital impressions. Following prudential 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 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 physicians. 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 1st. 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 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 Tiffani Thiessen who many of you may know from Saved by the Bell, 90210, and White Collar. As a presbyopia herself, she shared her frustrations with presbyopia and desire for a better solution. All of this helped 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 trials, 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 contacted 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 path 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 date; 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.

Dan Chevallard: 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 [ph], 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 PDUFA 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 onetime 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 of 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 increasing commercial headcount and other prelaunch 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 and 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 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 and 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 Eef for final remarks.

Eef Schimmelpennink: Thanks, Dan. As you can see, we’re off to a great start in 2025 and 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 treatment to 128 million individuals living with presbyopia in the United States. We’re looking forward to the exciting months ahead. With that, I’d like to open up the call for questions.

Q&A Session

Operator: [Operator Instructions] Your first question comes from the line of Stacy Ku from TD Cowen. Please go ahead.

Stacy Ku: Hi. Thanks so much for taking our questions. Congrats on the progress. So 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. So 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’s the first question. And then the second is somewhat related. Maybe talk about the type of preparation the team is doing to drive continued use in 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? And then 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.

Shawn Olsson: Great. Thanks, Stacy. This is Shawn. So for your first question, you asked me about where are we in our readiness and ability to sample right out of the gate for LNZ100. I think I got that right. So we see sampling as a critical component to our commercial strategy. So we’ve been out in front of this for a long time. So we actually contracted our sampling distributor back in 2024. And what we’re doing in terms of progress, obviously, internally, we’re running all of our policies for how the reps deliver the samples. And then also, 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.

So 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. And really, our plan is to have the majority of our samples rep delivered, and we see that as very important. We see that opens the door to go and talk to the eye care professionals and 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. So we have a lot of work going on already to ensure that we’re ready to go. So as you can imagine with over 40% of the sales force 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. So we need to get training them day one and in terms of preparations to make sure that appropriate information is passed along to the eye care professional and we prepared our Q&A documents as well as key messages to have that conversation with the doctors.

Stacy Ku: Got it. And then the last comment on what type of metrics you might disclose?

Shawn Olsson: Yeah. So in terms of the metrics so what we see there is this product will be distributed both through the retail pharmacy as well as the e-pharmacy. So I think where most people will be looking for us in terms of metrics early on everyone will be going to the IQVIA data looking at that 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. And then 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.

Marc Odrich: 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’s really that — our idea is that that sample will be confident with a script. At that moment the patient can choose to fill that script as Shawn mentioned through e-pharmacy. This is the — what we’re like accustomed to now leave the doctor’s office and the text will pop-up on your phone and that product will then be delivered to your doorstep or if you want to go to more traditional route you can pick the actual product up at the retail pharmacy. And then the second part of that question was what we think about stickiness. Hard to say at the moment I think what’s different from our product and Shawn highlighted that sample use and we know that 95% of patients hit at least two lines of near vision improvement to expect that people see that improvement on the sample.

If they are converting to a script they should be motivated to continue to use that. We would expect relatively high stickiness once people have converted into a script.

Stacy Ku: Wonderful. Okay, I will leave the floor. Thank you.

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

Pawan Patel: Hi, guys. This is Pawan 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? And what’s the expected conversion rate from sample to paid prescription? And then 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? And then one follow-up if I may.

Eef Schimmelpennink: Absolutely. Shawn, do you want to take the sample pack?

Shawn Olsson: Yeah, great. Great to hear from you Pawan. So the five-day sample pack when we think about how that will be managed and tracked. So what will happen is obviously our sample vendor will hold all of the actual bulk samples in their location. And then how that we manage every month that product will be shipped to each rep right? So every month there will be a shipment that goes to the rep. They’ll hold their products in their storage locker. And then that shipment will be dependent on the number of targets and then the expected amount of samples they’d be dropping off so that will be replenished every single month. 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 the eye care professional.

And then every subsequent visit they’ll be checking in on how many samples were written — or sorry 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. But when we have more insight we’ll share more on that.

Eef Schimmelpennink: Thanks, Shawn. Just to add to that before I go to the inventory question we do the math on the 15000 doctors and 88 reps you get to about a three-week call cycle. So every three weeks the rep’s 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. So on the inventory you are right that we started production of our to be commercial products in Q1. I don’t 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.

Pawan Patel: Great. And then just 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.

Shawn Olsson: Yes, 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, right? So there’s really been this growth in the use of e-pharmacies. What’s great about that is it really creates like a closed system which is helpful. So 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. So it should be seamless to send it on to 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 product.

So the e-pharmacy shoots the text to the patient’s phone right? At that point it’s just a link to click in. And 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. So it definitely creates a nice close environment where you have a strong relationship with the consumer. And then one other question which you asked earlier that I think I missed the 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 decile users of the Vuity box. So our reps are going to those practices, which have already shown a high volume of Vuity use early on and therefore that way the samples are going to the right accounts.

Pawan Patel: Thanks, guys.

Operator: Your next question comes from the line of Yigal Nochomovitz with Citi. Please go ahead.

Yigal Nochomovitz: 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? And then 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 breakeven for you or would you need to be higher or lower? And 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.

Shawn Olsson: 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. So 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? So 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. So 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. So we’re not beholden to when we have coverage by the PDMs to turn on DTC. So we can turn on faster than other products that are covered by insurance. So 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 had enough time to meet with the doctors, a few times each, make sure they’re comfortable with the products 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 are finding these people over 45, they’re spending the majority of time on Facebook, Instagram, YouTube and Pinterest. So those are really going to be the avenue that we focus to drive that awareness.

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

Yigal Nochomovitz: Got it. Got it.

Eef Schimmelpennink: Thanks, Shawn. I’ll take a question on the modeling Yigal, and thanks for dialing in. You’ll appreciate that at this state 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. And as we’ve shared previously, that’s based upon eight million ultimate users in the U.S. alone using the product five refills a year, at what would be yearly pricing. So, with that in mind and the fact that we’re guiding to be cash flow positive, I think many of the models including yours, are actively at least giving a sense of when that could happen. But again, we’re not guiding to what we have in our plans.

Yigal Nochomovitz: Okay. Got it. Thank you.

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

Lachlan Hanbury-Brown: Good morning guys. Thanks for taking my question. So, Shawn, just on the DTC marketing, I mean you’ve obviously had a pretty comprehensive unbranded campaign prior to approval. So, I was curious how you think about the transition from that to branded campaign to DTC? Does that 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? And then 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 weeks training, what can they do in terms of the interactions with target ECPs before an approval, if anything? Because I know there are obviously a lot of restrictions around what they can and can’t say and do. So, could you just elaborate on what they can do in that, say, five weeks before the PDUFA?

Shawn Olsson: Thanks, Lachlan, great questions. Yeah, happy to cover those topics, so, first thing, when does the unbranded stop? So, right now, the unbranded campaign — obviously, it’s a 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. So, 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. And so, what that transition will look like to DTC marketing. So, 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. So, we’ll actually bring on branded messaging to the doctors. So, 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. And then, 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. And 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.

So, 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. So, what can happen after their training before approval? So, that’s again where the unbranded campaign comes in. The unbranded campaign is fair game for sales force to talk about, so they can actually start their call cycles. So, they can start to meet the eye care professionals, confirm routings, confirm emails, get to know the doctor — just the discussion will be limited to the EYEAMSELECTIVE campaign. And then upon approval, they can then immediately switch to the branded calls. So, that’s how to think of that transition from hiring until product approved.

Lachlan Hanbury-Brown: Okay. Thanks. That’s useful.

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

Denis Reznik: Hey, guys. This is Denis Reznik on for Gary Nachman. Thanks for taking our questions and congrats on 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 type of patents they are and your confidence in the overall IP estate? And then, 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? And just elaborate a little bit more there. And then I’ve got one follow-up.

Eef Schimmelpennink: Absolutely, great questions. If you think about the current patent estate, we have seven granted patents that go out to 2039 already. This fall roughly in two buckets: one around the use of Aceclidine to treat Presbyopia, so very strong patents around that another suite of product formulation patents and very strong patents that go out to 2039. And 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 products.

Ahead of that sits because it is a new chemical entity for the US at least five years of data exclusivity upon approval is what we expect to get. And on the back end, because it’s a self-pay product, you’ll never see your traditional generic switch for a product like this because there’s no insurance involved. So there’s no insurance pushing the pharmacists 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.

Shawn Olsson: And this is Shawn, for the second question on the process to select e-pharmacy. So we spend 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 didn’t want to select a pharmacy that’s not already established in the eye care offices because obviously that takes work to set up all their EMR systems. So that was a key criteria another key criteria was actually the interface for the consumer, right? With this being consumer products, we want something that was sleek, easy to use and a partner that had good follow-up to ensure compliance.

So other factors that were behind those two, 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’s 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 involved evaluating e-pharmacy given the fact that this is a cash pay product.

Denis Reznik: That’s super helpful. And then 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? And then would that cause you to focus on certain geographies over others? Congrats on all the progress.

Dan Chevallard: Yeah. So Denis, this is Dan Chevallard. I’ll start the first part of that question and then I’ll pass it to Shawn to conclude it. So the topic of recession is one that we’ve certainly looked at. And 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. And I think reference time points where you could look back to, to say, well gosh, how did those profiles or how do those categories behave. You don’t have to go too far back to see how do these categories behave in the COVID era and then prior to that in the Global Financial Crisis era of 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.

So that’s one way to look at it. I think that it’s fair to say that discretionary spend will always potentially be impacted. But 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 being 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.

Shawn Olsson: And 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 rep field force, we believe is rightsized and it’s really focused on 85% of all of beauty scripts. So 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. So, I don’t see that call point changing.

Q – Denis Reznik: Super helpful. Thanks, guys.

Operator: Your next question comes from the line of Matthew Caufield from H.C. Wainwright. Please go ahead.

Q – Matthew Caufield: 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.

Eef Schimmelpennink: Great question, Matt. I think Shawn and I might tag team, 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 with [indiscernible] at least a very significant part of the thing. We’ve seen that with Beauty that was not the case which was a high-dose aceclidine [ph] that clearly did not deliver that expectation on that expectation. And therefore, after our initial good launch, people didn’t refill, because it didn’t work. These are not products that you get people to say, 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.

And the liking it, truly comes down to does it work. So 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. And 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. And because of that what you see us do is, very heavy sampling which is different than what others are doing. So I’ll leave it, with that. We — it’s hard to see that, you’ll step in with one product and then if you will graduate to something else. Sampling is going to be key and people pick the ones that they will like.

Shawn Olsson: Yeah. And just to add on to that, Minor League. 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.

Q – Matthew Caufield: Excellent very helpful and definitely looking forward to the PDUFA. Thanks, guys. Congrats.

Eef Schimmelpennink: Thanks, Matt.

Operator: 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.