LENZ Therapeutics Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 7, 2025
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Operator

afternoon, ladies and gentlemen, and welcome to the LENS Therapeutics First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. Following prepared remarks from management, As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevillard, Chief Financial Officer. Please go ahead.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Thank you. Good afternoon and thank you for joining us today. My name is Dan Chevillard, Chief Financial Officer of LENS Therapeutics. We are joined today by Abe Schimmelpennik, our President and Chief Executive Officer and Sean Olson, our Chief Commercial Officer, as well as Doctor. Mark Oedricht, Chief Medical Officer, who will join us for the question and answer session.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Before we begin, I would like to remind you that this call will contain forward looking statements regarding LINZESS 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 twenty twenty five Form 10 Q, which was filed today.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

With that, I'll now turn the call over to Abe.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Thank you, Dan, and good afternoon, everyone. The first quarter of twenty twenty five has been a focused and highly productive period for LEMS. But our PDUFA target action date for RMZ100, 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 has 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

That focus hasn't weighed, 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 LMZ100. 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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 NMC-one hundred, particularly on how it could enhance patient care.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

As a reminder, while there are approximately one hundred and twenty eight 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 request us by name, and ensuring a seamless path to access. On the first pillar, our unbranded I'm Selective campaign continues to generate strong engagement.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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 2,000,000 impressions online. Furthermore, our old optometrist MSL team has been actively engaging with ECPs with thousands of meaningful interactions to date. They're playing a key role in educating the community about the mechanism of action and the importance of pupil selectivity. And in parallel, our sales force build out is progressing as planned, and Sean will speak to that shortly.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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 seventh of last year, U.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

S. Customs and Border Protection issued a definite death ruling establishing The United States as the country of origin for LNG 100. Then on April 2, we received a second definitive ruling confirming that LNG 100 will be duty free. Combined with the fact that our intellectual property is domiciled in The US, we are proud to say that LNG one hundred is designated Make 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

It is a truly cross functional effort, and I'm incredibly proud of what we have accomplished so far. With that, I'll turn the call over to Sean, our Chief Commercial Officer, who will share more on the progress we are making in our

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

pre commercial planning. Sean?

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Thank you, Yves. 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Presbyopia impacts an estimated one hundred and twenty eight million people in the 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 one and a quarter percent 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 a cyclidine based LNZ100. We believe the commercial potential of LNZ100 was validated in our phase three CLARITY study, with ninety percent of participants noticing an improvement in near vision, and seventy five percent of participants indicating they would continue to use LNZ100 after the study, of which eighty one percent 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 3,000,000,000 plus market, creating a potential category of one. We continue to advance our commercial readiness as we progress towards August 8 PDUFA date.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 Eif mentioned, our all optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the phase three data. In addition, our unbranded campaign continues to drive awareness of an ideal presbyopia solution with over 2,000,000 digital impressions. Following Prudential NDA approval, our sales force will immediately begin branded calls on approximately 15,000 ECPs.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 a full sales leadership team, including both of our regional directors in 2024. In Q1, we expand the team further with additional 10 district managers. Collectively, this core leadership group brings nearly one hundred and fifty years of eye care experience and more than three hundred years of total sales experience. In March, we launched job postings for all 88 sales territories nationwide.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

The interest to join LENS' 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 ten years of sales experience. This marks a major milestone in our commercialization readiness and great progress towards our target to have a full field team in place by July 1.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

We're excited to progress our first pillar, doctors to recommend us. And as a reminder, our primary market research surveyed four twenty six eye care professionals. And it yielded an impressive eighty two percent and eighty three percent of ECP's already being likely to provide, prescribe and sample LNZ100 if FDA approved respectively, based on that phase three 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

The brand we've built is empowering, desirable and has tested exceptionally well in market research. On April 15, we hope 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 three users of LMC one hundred, 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, 90,210 and White Collar.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

As a presbyopia 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 finding. 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

For more information from the commercial day, a replay 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 products 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, ninety five percent of patients noticed at least two lines of improvement on hour one day one.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 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 dates. Doctors to recommend us, consumers to request us by name, and a seamless journey to use.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

I'd now like to hand the call over to Dan Chevillard, our CFO, to highlight our financial results.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Thank you, Sean. As has been mentioned, the first quarter of twenty twenty five has been a very productive and focused time for the company, with our PDUFA target action date for LNZ100 just over ninety days from now. We ended Q1 twenty twenty five in a position of financial strength and funded for success with approximately $194,100,000 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 shell limitations imposed upon us by the SEC, We became shelf eligible and filed our first S-three 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 $16,300,000 further strengthening our financial position.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

As such, we have upwardly revised our projected cash at PDUFA from over $170,000,000 which we disclosed at our commercial day, to now over $185,000,000 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 twenty twenty five operating expenses increased to $16,900,000 an 11% increase over Q4, but well within our operating plan. From a cash perspective, we had a total net cash burn of $15,000,000 in Q1 twenty twenty five, which included approximately $3,000,000 in one time annual cash costs and is really reflective of closer to $12,000,000,000 in operating cash burn, compared to our Q4 twenty twenty four net operating cash burn for approximately $8,100,000 Total SG and A expenses increased to $11,300,000 for Q1 twenty twenty five compared to $5,600,000 for the same period in 2024, driven primarily by an increase in commercial headcount and other pre launch commercial planning activities.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Sequentially, SG and A increased quarter over quarter by approximately 19% from $9,400,000 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 what will be a consistent objective, we will continue to be measured in our spend on the G and A side of the organization as we aim to remain a lean and efficient G and A team. Total research and development expenses decreased to $5,800,000 in Q1 twenty twenty five compared to $10,500,000 for the same period in 2024. Sequentially, however, and 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 LMD one hundred, at which time much of our manufacturing costs will be prospectively reflected in cost of sales.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Finally, our net loss per share, both basic and diluted, was $0.53 per share in the first quarter of twenty twenty five, on a net loss of $14,600,000 compared to a net loss per share of $3.53 per share in first quarter of twenty twenty four on a net loss of 16,600,000.0. Q1 20 20 5 net loss per share was calculated on approximately 27,500,000.0 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 4,700,000.0 weighted average common shares outstanding. In total, we ended Q1 twenty twenty five with approximately 27,500,000.0 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, EBITDA. With that, I'll turn the call back over to Ef for final remarks.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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 treatments to one hundred and twenty eight million individuals living with presbyopia in The United States. I'm looking forward to the exciting months ahead. With that, I'd to open up the call for questions.

Operator

Your first question comes from the line of Stacy Ku from T. B. Cohen. Please go ahead.

Stacy Ku
Stacy Ku
Analyst at Cowen

Hi. Thanks so much for taking our questions, and 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?

Stacy Ku
Stacy Ku
Analyst at Cowen

Can you discuss in more detailed 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?

Stacy Ku
Stacy Ku
Analyst at Cowen

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
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Great, thanks Stacy, this is Sean. So for your first question, you're asking about you know, where are we in our readiness and ability to sample right out the gate for LNZ100. I think I got that right. So you know, we see sampling as a critical component to our commercial strategy. So we've been out in front of this for a long time.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

So we actually contracted our sampling distributor back in 2024. You know, and what we're doing in terms of progress, know, obviously internally we're running all of our policies for how the reps deliver the samples. And then also know 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, know 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

And really our plan is have the majority of our samples rep delivered. And we see that as very important. While we see that 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

So as you can imagine, with over 40% of the sales force already accepting offers, now in the background ahead of that, we've been building out all the training modules for the sales team. 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 he began 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 and A documents as well as key messages to have that conversation with the doctors.

Stacy Ku
Stacy Ku
Analyst at Cowen

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

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Yeah, so in terms of the metrics, so what we see there is, you know, 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, I'd rather 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 gonna be a lot about how are those refills coming through?

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

You know, given the e pharmacy, obviously that's often not picked up in IQVIA. Now we'll make sure that we can provide some guidance on how that's going, so the appropriate analysis can be made.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

That's Stacy, just adding to it. Think you had a question in there on how we would expect to go from samples to ultimately use. That's really that idea is that that sample will be accompanied with a script. At that moment, the patient may choose to fill that script, as Sean mentioned. Through e pharmacy, this is what we're all getting very 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Or if you want to go to more traditional routes, 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 this was different from our product, and Sean highlighted that sample use, and we know that ninety five percent of patients hit at least two lines of near vision improvements. You would expect that people see that improvement from the sample.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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

Stacy Ku
Stacy Ku
Analyst at Cowen

Wonderful. Incredibly helpful. Thank you.

Operator

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

Pavan Patel
Pavan Patel
Analyst at Bank of America

Hey, guys. This is Bhavan 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?

Pavan Patel
Pavan Patel
Analyst at Bank of America

And what's the expected conversion rate from sample to paid prescription? And then on the manufacturing supply chain, with the start of manufacturing in February of twenty twenty five, 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Yep, great. Great to hear from you Bhavan. 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 products will be shipped to each rep.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Right? So every month 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 the clear transfer of ownership to that eye care professional. And 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 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Thanks, Sean. Just to add to that before I go to the VM, sorry, question. If do the math on the 50,000 doctors and 88 reps plus the VMs you get to about a three week call cycle, so every three weeks the rep is in that office. On top of that, there's a mechanism for doctors, if there are other 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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

I don't think we're going 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.

Pavan Patel
Pavan Patel
Analyst at Bank of America

Great. And then just for my 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
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Yeah, absolutely. You know, 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. So there's really been this growth in the use of e pharmacies. What's great about that is, know it really creates like a closed system, which is helpful. So you know our partner that we're going to be using for our e pharmacy is already active in the eye care professional space.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

What that means and why that's important means when we go to you know, when a doctor goes to enter the scripts into their EMR system, now that e pharmacy should already be loaded up within that computer. So it should be seamless to send it on 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. 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Throughout that process also, what's great about it is the opportunity for auto refill, which means in terms of stickiness, That product showing up every single month to the door. If they didn't select the auto refill, of course, the pharmacy will also follow-up once the once they're at the end of their first box or second box to follow-up and say, hey, now it's time to order again. So it definitely creates a nice closed environment where you have a strong relationship with the consumer. And then one other question, which you asked earlier, I think I missed a spot on, 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 beauty products.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

So our reps are going to those practices, which have already shown a high volume of beauty use early on, and therefore that way the samples are going to the right accounts.

Pavan Patel
Pavan Patel
Analyst at Bank of America

Thanks guys.

Operator

Your next question comes from the line of Ygal Nachomovitz with Citi. Please go ahead.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

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. 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 the beauty got to and then presumably exceed that?

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

Thank you.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Hi, this is Sean 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, you know, when we go to market, you know, 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Right? So that's what we want to make sure is in place before we turn on the influencer campaign. That's important because we heard about beauty 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 products is its cash pay products.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

So we're not beholden, so when we have coverage by the PBMs 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, So that's going to happen in early twenty twenty six. Would expect I think by that time, we'll 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 by identifying the early adopters and where they spend their time. What we're finding these people 45, they're spending the majority of time on Facebook, Instagram, YouTube and Pinterest.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

So 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 like linear TV, so your standard TV channels. So timing early twenty twenty six, and channels Facebook, YouTube, Pinterest, and Instagram.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

Got it.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Thanks, Sean. I'll take your 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 revenue or volume. What we have shared is that ultimately, we can see this being a $3,000,000,000 plus market, and as we've shared previously, it's based upon 8,000,000 users in The U. S.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Alone, using about five refills a year at what would be yearly pricing. So with that in mind, the fact that we're going to be cash flow positive, I think many of the models, including yours, are at least giving a sense of when that could happen. But again, one point I think to what we have in our plans.

Yigal Nochomovitz
Yigal Nochomovitz
Director at Citigroup

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
Biotech Equity Research Analyst at William Blair

Hey, guys. Thanks for taking the questions. So, Sean, just on the DTC marketing, I mean, you've obviously had, you know, pretty comprehensive unbranded campaign prior to approval. So I was curious how you think about the transition from that to branded campaigns in

Lachlan Hanbury-Brown
Biotech Equity Research Analyst at William Blair

DTC. You know, does that

Lachlan Hanbury-Brown
Biotech Equity Research Analyst at William Blair

if if DTC starts in early twenty twenty six, does the unbranded campaign continue until then, or does it sort of slip over to something else on approval or availability? And then second, you sort of touched on this a little earlier, but with the Salesforce 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 DCPs before an approval, if anything? Because I know there are obviously a lot of restrictions around what they 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
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Thanks, Lachlan. Great questions. Yeah, happy to cover those topics. So first thing, when did the unbranded stop? So right now that unbranded campaign, obviously it's you know a disease state awareness and looking for you know what's the ideal solution look like in presbyopia.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Our plan is to continue to run that up until potential approval, and then we would then we would sunset that campaign. So it's really you know what we can have out there, so you know 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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 twenty twenty six, the whole game resets in terms of how we target them. Because now that we're targeting consumer, know we're moving off of the platforms where doctors are focused for information back to that you know Pinterest, YouTube, Facebook, Instagram.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

And to do that, you know, we've brought on the right type of media by agencies that have those relationships to make sure that we have a 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. You know, some of them will be on before July 1. Right?

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

You spoke about the three weeks of training. So what can happen after their training, but before approval? So that's again where the unbranded campaign comes in. Know, the unbranded campaign is you know, fair game for Salesforce 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 I am selected campaign.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

And then upon approval, they can then immediately switch to the branded calls. That's how to think of that transition from hiring until product avail or product approved.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Okay, thanks. That's useful.

Operator

Your

Operator

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

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Hey, guys. This is Dennis Resnick on for Gary Nachman. Thanks for taking our questions and congrats on all

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

the progress. First, could you provide an update

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

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 IT 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?

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Just elaborate a little bit more there. And then I've got one follow-up.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Absolutely. Great questions. If you think about the current patent estate, we have seven granted patents that go out to 02/1939 already. This fall roughly in two buckets: one around the use of the Cyclidin to treat presbyopia, so very strong patents around that and a suite of product formulation patents, and very strong patents that go out to 2,039. The patents that are currently under review, and I'm talking US only here for the moment, that will extend that to at least 2,044, further patents in those two categories, as well as use patents in different use cases that we have seen in our product.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

That's going to be, again, a very broad, very strong data state, just to complete that on the protection side for the products. Ahead of that sits, because this 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 02/1944 and beyond, will provide a very strong and long lasting life cycle for the product.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

And this is Sean for the second question on the process to select an e pharmacy. So we spent a lot of time making sure we chose the right partner for e pharmacy. One of the most important criteria is we want to make sure we select an e pharmacy that already existed within the eye care professional EMR ecosystem. You know 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Another key criteria was actually the interface for the consumer. 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.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

That was not something that we put into the factors that we're involved evaluating e pharmacy, given the fact that this is a cash pay product.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

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? Thanks so much guys and congrats on

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

all the progress.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

Yeah, so Dennis, this is Dan Shetland. I'll start the first part of that question and I'll pass it to Sean to conclude it. So, the topic of recession is one that we 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. And I think reference time points where you could look back to say, well, gosh, how did those profiles or how did those categories behave?

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

You don't have go too far back to see how did these categories behave in the COVID era, and then prior to that, in the global financial crisis era, 02/2007 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 high price 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 can 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.

Dan Chevallard
Dan Chevallard
CFO at LENZ Therapeutics

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
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

And adding on to that in terms of the targets, and given what was just shared by Dan. So in terms of it for a session to happen, our 88 rep field force, we believe is right sized. And it's really focused on 85% of all of duty strips. So I wouldn't see that changing. Again, given that minimal potential impact that Dan just highlighted.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

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. You know, 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.

Denis Reznik
Denis Reznik
Senior Equity Research Associate at Raymond James

Super helpful. Thanks guys.

Operator

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

Matthew Caufield
VP - Senior Healthcare Analyst at H.C. Wainwright & Co.

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.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Quick question, Matt. I think Sean 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 with either reading glasses?

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

Or 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 biocarbon. That clearly did not deliver that expectation or upon that expectation, and 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, and 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 of it truly comes down to it doesn't work.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

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, that's why we know again, if you just look at clinical data, but especially also at the patient feedback, and we shared some of that at 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 I was doing. So I'll leave it with that.

Evert Schimmelpennink
Evert Schimmelpennink
President, CEO, Secretary & Director at LENZ Therapeutics

It's hard to see that you'll step in with one product and then you will graduate to something else, sampling is going be key, and people pick the ones that they will like.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Yeah, and just to add on to that minorly, 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.

Matthew Caufield
VP - Senior Healthcare Analyst at H.C. Wainwright & Co.

Excellent, very helpful and definitely looking forward to the PDUFA. Thanks, guys. Congrats.

Shawn Olsson
Shawn Olsson
Chief Commercial Officer at LENZ Therapeutics

Thanks, Bob.

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 call. You may now disconnect.

Executives
    • Dan Chevallard
      Dan Chevallard
      CFO
    • Evert Schimmelpennink
      Evert Schimmelpennink
      President, CEO, Secretary & Director
    • Shawn Olsson
      Shawn Olsson
      Chief Commercial Officer
Analysts
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Key Takeaways

  • The company is on track for its August 8, 2025 PDUFA target action date for LNZ100, with uninterrupted FDA review team engagement and a late-cycle meeting moved up to later this month.
  • They’ve built a three-pillar commercial strategy: driving doctors to recommend LNZ100 (unbranded “I’m Selective” campaign reached 12,000 ECPs with 2 million+ impressions), empowering patients to request it by name via targeted influencer and ambassador campaigns, and ensuring a seamless patient journey through 5-day sample packs plus retail and e-pharmacy distribution.
  • Phase 3 CLARITY data showed 90% of participants experienced improved near vision, 75% would continue use after the trial, and 81% planned to use LNZ100 four to seven days per week—supporting a potential $3 billion+ market.
  • First-quarter financials reflect a strong balance sheet with $194 million in cash and marketable securities, a net cash burn of $15 million, and a revised runway to over $185 million at PDUFA, sufficient to fund operations through post-launch positive cash flow.
  • Lens Therapeutics secured a duty-free “Made in the USA” designation for LNZ100, holds seven granted U.S. patents to 2039 and has additional filings expected to extend protection to at least 2044, plus five years of FDA data exclusivity upon approval.
AI Generated. May Contain Errors.
Earnings Conference Call
LENZ Therapeutics Q1 2025
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