LENZ Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 19, 2025

There are 11 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to the Lens Therapeutics Year End twenty twenty four Financial Results Conference Call. At this time, all participants are in a listen only mode. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Shevalard, Chief Financial Officer. Please go ahead.

Speaker 1

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

Speaker 1

Before we begin, I would like to remind you that this call will contain forward looking statements regarding Lens' 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 day of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our 2024 Form 10 K, which is being filed today.

Speaker 1

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

Speaker 2

Thank you, Dan, and good afternoon, everyone. 2024 has been a highly successful year for Lens and I'm extremely proud of all we have accomplished. We are truly building something special and I strongly believe we have put ourselves in a position to have an even greater and transformational year in 2025 as we aim to emerge as a commercial company. On previous calls, I've mentioned the consistent pattern of execution by the team and I would like to take a moment and acknowledge their efforts. We are a team that are at best when we are together.

Speaker 2

We go fast with purpose. We relish ingenuity and we are relentless. On the back of these core values, we had a tremendous year in 2024 piloted by our emergence as a public company in March and completion of our Phase three CLARITY study and announcement of stellar data for LNZ100 in April. This was followed by the execution of a $30,000,000 pipe financing with Ridgeback Capital in July, submission of our NDA in August and its acceptance in October, all contributing to a significant progress and momentum as we work towards the potential approval and launch of LNZ100. With all of the exciting progress we've made over 2024, the fourth quarter and most recent period has been a critical time as we have completely transitioned to a pre commercial company and have entered 2025 in a position of financial strength, ending 2024 with over $2.00 $9,000,000 in cash.

Speaker 2

I'd now like to take a few minutes to highlight five key areas of corporate focus where we've seen excellent progress in recent months. Regulatory, manufacturing readiness, medical affairs, intellectual property and pre launch commercial planning. First, on the regulatory front, in what has been a very constructive and highly engaged process thus far, we continue to make encouraging progress with the FDA on our NDA review. In January of this year, we completed our mid cycle review, which is a key milestone in the agency's review progress. But we were very pleased that the agency noted no significant review issues and as they reiterated that no plans to request an advisory committee meeting.

Speaker 2

Importantly, in light of the recent developments around federally funded agencies, FDA inspections on our clinical trial sites are now underway. And we are pleased to report that we have confidence that our NDA review has been uninterrupted and is making great progress. As such, we continue to believe that we are well positioned for potential on time approval in August 2025, which granted will be immediately followed by commercial launch activities in The United States, with products anticipated to be available in the market in the fourth quarter of twenty twenty five. Second, on manufacturing readiness, I'm particularly pleased with the progress the manufacturing operations team has made in recent months. Importantly and signifying an important milestone, in February we initiated the manufacturing of potential commercial products.

Speaker 2

The team together with our manufacturing partners has been working tirelessly to enable the achievement of this important landmark and will continue to focus over the coming months on manufacturing adequate commercial sample and product inventory to support a successful launch. For the time being, this product will be kept in bulk and following label discussions and potential approval of our NDA undergo final packaging. As a result and following FDA approval, we expect to have commercial products available in the market in Q4 of this year. Third, I'm very excited to highlight key progress from our Medical Affairs team. We are seeing noteworthy eye care professional engagement nationwide led by meaningful interactions by our all optometrists medical science liaison team who have been very active at state and national medical conferences educating the ECP community on the importance of being pupil selective and the differentiation of a Cyclotence ciliary body sparing mechanism of action as well as on the data from the Phase three CLARITY study.

Speaker 2

Just a few weeks ago, the medical team held a fantastic event at CECO in Atlanta, where we hosted over 100 ECPs at the College Football Hall of Fame. And since the beginning of Q4, we've had meaningful medical interactions, with more than 1,000 individual ECPs. Our intent is to have our MSL team engage with the majority of our key target ECPs ahead of our PDUFA date. Next, a foundational area of focus and recent progress has been on intellectual property, more specifically our domestic and international patent estate for LNG100. We have continued to strengthen our patent tickets and currently have seven granted patents in The United States that go out to 02/1939 with an additional 10 patents on the review that aim to extend our patent protection to at least 02/1944.

Speaker 2

Together with the expected five years of NC exclusivity, we believe our product is extremely well protected and set up for longevity. In addition, we continue to extend our patent portfolio ex U. S. To support the significant commercial opportunity we believe exists there. And lastly, I'll turn to pre launch commercial planning.

Speaker 2

The commercial team has been hard at work. And before I turn it over to Sean to step through in more detail, I would like to highlight a few key items. First, the hiring of our sales force is in its final stage. Both of our regional directors were hired in Q4 and we now have hired all 10 of our district managers. We've been extremely pleased with the excellent quality of candidates we are attracting, the significant eye care experiences across the board.

Speaker 2

As you may have seen last week, we launched a hiring campaign for our 88 territory sales force, our last sales hires. And as an indication of the anticipation, we believe exists in the market received over 1,300 applications within the first twenty four hours of posting the job profiles. We're looking forward to hiring only the best and most talented candidates to Lens and have them fully onboarded ahead of our PDUFA date. This will ensure that they can be in the field promoting our products immediately after potential approval and get one or more call cycles in ahead of product being available in the market. Second, we're very much looking forward to our upcoming Commercial Day on April 15.

Speaker 2

We will have the opportunity to elaborate on our commercial strategy and pre launch preparations as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNZ100, something Sean will touch on in more detail shortly. As I mentioned in my opening remarks, 2024 has been a highly successful year and the recent period has continued to be extremely productive as we prepare for the potential approval of LNZ100. I will now hand the call over to Sean Olson, our Chief Commercial Officer to provide additional comments on our pre commercial planning efforts. Sean?

Speaker 3

Thank you, Aif and good afternoon everyone. As we have discussed on previous calls, the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities in The United States. Presbyopia impacts an estimated one hundred and twenty eight million people in The U. S. A population incidence that's nearly four times larger than those impacted by dry eye and nearly six times larger than those impacted by Demidex blepharitis.

Speaker 3

For further context, presbyopia impacts more than the combined population in The U. S. Suffering from dry eye, demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy and glaucoma combined.

Speaker 1

The first

Speaker 3

eye drop treatment for presbyopia was approved in 2021 and confirmed that there is strong consumer desire for an eye drop treatment as evidenced by initial paid new scripts of up to 6,000 per week. Long term usage beyond the trial period of this product did not materialize as pilocarpine even at the high concentration of one point two five percent cannot deliver consumer acquired performance. Other attempts at a lower dose BID strategies are being pursued, but given the efficacy profile is very similar to that of Vuity, we do not believe they will clear the consumer hurdle for performance or the ECP desire for a pupil selected option. We continue to believe the category is wide open for an eye drop solution that can deliver what consumers desire. A once a day eye drop that provides seamless near vision for the full work day for the majority of presbyokes.

Speaker 3

Unlocking this market requires an ideal presbyopia eye drop and we are excited for the prospect of acyclidine 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 your 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 four to seven days per week. Together with our broad inclusion criteria, we believe this positions LNG100 well for the estimated $3,000,000,000 plus potential market opportunity, creating a potential category of WOM. Our commercial team continues to advance its commercial readiness as we progress towards our August 8 PDUFA date.

Speaker 3

And I would like to just take a moment to provide an update on the three primary pillars of our commercial strategy. First, we want to make sure doctors are there to recommend us. As Dave mentioned, our all optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the Phase three data. In addition, one year ago, our marketing team launched the I'm selective unbranded campaign at CECO twenty twenty four. This is driving ECP awareness and excitement for the future presbyopia solutions that can achieve the necessary sub two millimeter pupil size to restore near vision, while not overstimulating the ciliary muscle.

Speaker 3

Awareness continues for this campaign and has over 50 KOLs and over 2,000,000 digital campaign impressions targeting over 30,000 ECPs. Lastly, and following potential NDA approval, our sales force will be calling on approximately 15,000 ECPs with our potential best in class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering. As we prepare for this, the hiring of our sales force has been a key focus over the recent months. Our full sales leadership team was hired in 2025, including both of our regional directors who joined Lens in Q4. Since then, we've continued to grow our sales team and are happy to share that all 10 district managers are now also on board.

Speaker 3

This core leadership team within the sales force brings almost one hundred and fifty years of eye care experience and over three hundred years of total sales experience. Finally, we have now begun our field based sales rep hiring with job postings currently available for all 88 territories across The United States. It's great to see the progress on our first pillar. And as a reminder of what was shared in the last earnings call, our primary market research survey of four twenty six ECPs yielded that an impressive eighty two percent and eighty three percent of ECPs already being likely to prescribe and sample LNZ100 if FDA approved respectively based on the Phase three data. The second pillar of our commercial strategy is for consumers to request us by name.

Speaker 3

This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and activate consumer response. Lens has partnered with multiple New York and California based advertising agencies to understand the consumer and develop a campaign that will connect emotionally, creating a desire for our brands. We have taken a consumer centric focus in the development of this brand and have leaned into the lifestyle creative. We're excited about the brand we have created and the proposed advertisements which have been testing well in market research. Our creative is now locked and the majority of the launch promotional materials are now completed pending final product insert language.

Speaker 3

Upon approval, we will launch the ECP materials and once we feel ECPs are well educated, we will turn on the direct to consumer advertising. The third and final pillar will ensure ease of sample and product access for patients with a seamless journey to use. This requires enabling the patient to experience the product and move from trial to usage as quickly as possible. To support this, our team has built out consumer sampling capabilities and commercial access across multiple channels, including the traditional retail pharmacy as well as e pharmacy home delivery. In our clinical trial, ninety five percent of patients noticed a two lines of improvement on hour one day one.

Speaker 3

This immediate response lends itself incredibly well to product sampling. Our sample vendor has been contracted and after approval samples will be rep delivered to eye care professionals, allowing consumers to try the product. Our team has developed a five day sample pack, similar to the sample size for contacts, which following the initial trial can act like a bridge until the product is picked up at the pharmacy or delivered to the consumer's home. We'll continue to drive these three pillars doctors to recommend us, consumers to request us by name and a seamless journey to use as we progress towards our PDUFA date. Before I conclude, we're looking forward to our upcoming commercial day on April 15, where we will have the opportunity to elaborate on our commercial strategy and pre launch preparations, as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNZ100.

Speaker 3

We feel this is an important event, which will give investors, analysts and others a thoughtful overview of our plans and progress towards the potential approval and launch of LNZ100. I'd now like to hand the call over to Dan Chevallard, our CFO to step through our financial results.

Speaker 1

Thank you, Sean. As both Aith and Sean have highlighted, the fourth quarter in a recent period has been a critical time as we have now pivoted to a pre commercial company. We ended 2024 in a position of financial strength with approximately $209,100,000 in cash, cash equivalents and marketable securities, which as we have guided previously is anticipated to fund the company's cash runway to post launch positive operating cash flow. Turning now to our fourth quarter financial results. Our operating expenses and resulting cash burn were generally consistent with prior quarters and in line with our operating plan.

Speaker 1

Total operating expenses for Q4 twenty twenty four were approximately $15,200,000 compared to twenty five million dollars for the same period in 2023. In general, this decrease was specifically driven by the fact that we were in the midst of our Phase three CLARITY study in Q4 of last year, which makes these figures less relevant to compare. Perhaps more comparable on a quarter over quarter and sequential basis, our total operating expenses increased by approximately 18% from $12,900,000 in the third quarter. From a cash perspective, our Q4 twenty twenty four operating cash burn net of interest income was approximately $8,100,000 which was consistent with the $9,000,000 in net cash burn last quarter. Total sales, general and administrative expenses increased to $9,400,000 in Q4 twenty twenty four compared to $5,500,000 for the same period in 2023, driven primarily by an increase in commercial headcount and other pre commercial pre launch commercial planning activities.

Speaker 1

Sequentially, SG and A increased quarter over quarter by approximately 44% from $6,500,000 in the third quarter due to significant relative increases in sales and marketing as we continue to ramp our allocation of spend to support our consumer driven brand planning and the addition of key sales force leadership. As we have discussed on previous calls, we expect our SG and A expenses and more specifically our sales and marketing expenses to continue to ramp from here as we approach our potential August 2025 approval for LNZ100. Importantly, and as a particular point of emphasis, we will continue to be measured in our spend on the general and administrative side of the organization. Our model will always be to staff appropriately and grow to support our commercial launch and organization at large, but remain a lean and highly efficient G and A team. Turning now to research and development, total R and D expenses decreased to $5,900,000 in Q4 twenty twenty four compared to $19,500,000 for the same period last year.

Speaker 1

Sequentially quarter over quarter, R and D expenses once again decreased by approximately 9% from $6,500,000 last quarter. The majority of our R and D expenses between now and the time of potential approval will be dedicated to our manufacturing operations team as we build pre approval commercial product and sample inventory to support our launch. Finally, our net loss per share both basic and diluted was $0.46 per share in the fourth quarter twenty twenty four on a net loss of $12,700,000 dollars compared to a net loss per share of $12.04 per share in the fourth quarter of twenty twenty three on a net loss of $23,700,000 Q4 20 20 4 net loss per share was calculated on approximately 27,500,000.0 weighted average common shares outstanding compared to Q4 twenty twenty three when as a then private company with multiple classes of preferred in common stock outstanding, net loss per share was calculated on approximately 2,000,000 weighted average common shares outstanding. As a final point, as of 12/31/2024, we had approximately 27,500,000.0 shares of common stock outstanding. That concludes my comments on our Q4 financial results.

Speaker 1

And with that, I'd like to turn the call back over to Aif for final remarks.

Speaker 2

Thanks, Dan. As you can see, the fourth quarter and recent period has been an extremely productive time. And we're making significant strides in our pre commercial preparations. As we are now less than five months from our PDUFA target action date, we believe we are well positioned to deliver a once daily safe and rapidly acting treatments to 128,000,000 individuals living with presbyopia in The United States and very much looking forward to doing so. With that, I'd like to open up the call for questions.

Operator

Thank you. And our first question comes from the line of Egon Lachowicz from Citigroup. Your line is open.

Speaker 4

Hi guys. Thank you. I appreciate all the updates. So first off, I think Sean mentioned that the sales force is going to call on 15,000 ECPs. The digital campaign was targeting 30,000 or over 30,000.

Speaker 4

Could you just comment on how you're filtering that down to focus on the 15,000? What are the parameters there?

Speaker 3

Hi, Yigal. This is Sean. Thanks for that question. It's a really good question. So when you look across the landscape of eye care professionals, there's obviously a lot out there.

Speaker 3

When you look at the 40,000 optometrists and 20,000 ophthalmologists, when we think of targeting in terms of our sales force, we're looking at those that are high prescribers of Beauty and therefore we know that 15,000 ECPs represent roughly 85% or a little more than 85% of all the beauty scripts. So that's our focus for our sales force. But we also know that the other doctors and with presbyopia being so prevalent, driving early disease state awareness is helpful across a broader group of ECPs. And so that's why you'll see our unbranded promotion is driving more broader awareness, while the field will focus truly on the earliest adopters of eye care professionals and those who represented over 85% of all the beauty scripts.

Speaker 4

Okay, okay, got you. And then on this I'm selective unbranded awareness campaign, I'd be super interested to get a better understanding quantitatively of how you've ratcheted up the awareness. Do you have data on the percent awareness before you started the campaign and how that's improved today in terms of knowledge of not only presbyopia, but your Phase three data specifically?

Speaker 3

Yes. So for the unbranded, we're really focused on the disease state awareness and we've just in general, we've seen a lot of interest growth in the sorry, a lot of growth of interest in the concept at all of our conventions and across the board on LinkedIn. It's great to see actually is the fact that we'll be at our convention and people come up and I don't know, can't tell you how many times it comes to that. I've been seeing all of your ads on LinkedIn about your I'm selective campaign. And so we're really pleased with how it's coming along.

Speaker 3

We'll continue to share more information at the upcoming commercial days.

Speaker 4

Okay. And then just the last one on the timing of the launch, obviously the due for August 8. And then I just mentioned that you're going to have product available in the channel, I believe starting fourth quarter. Is the delta there a function of just needing more time to produce the commercial sufficient commercial material or training the sales force or are there other factors we should be aware of?

Speaker 2

Great question, Yigal. This is Avan. Thanks for allowing us to double click on that a little bit. That's purely a factor of practicality. This we believe is going to be a very high volume launch as you can imagine.

Speaker 2

As I've shared in the prepared remarks, the manufacturing team has started production of the quantities that we believe will support a successful launch. That will all sit in bulk as we await final labeling discussions with the FDA and have a final approved label in certain and cotton. We will then obviously start printing that which would happen after approval, package all those quantities, shift them to our 3PLs and get them into the field. So that's purely that time that we guide there between PDUFA and a Q4 product in the market is again purely determined by those steps. The sales force importantly will be trained up in general prior to PDUFA date final training on final labeling and then immediately hit the field.

Speaker 2

So you can expect that immediately upon approval, the sales force will actually be out there promoting the product. They can get a couple of sales cycles in which we like, prepare the doctors for what's to come and then start delivering samples as soon as we have them available for the field.

Speaker 4

All right. Thank you. Perfect.

Operator

Thank you. Our next question comes from the line of Mark Goodman from B. W. Inc. Partners.

Operator

Your line is open.

Speaker 5

Hi, this is Madhu on the line for Mark. Just a couple from us today. First, how long do you expect the like significant sampling to go on for until most of those target ECPs have gotten experienced with LNZ100? And then the second question is, what haven't you been asked about on the regulatory process or the launch that you would like people to be more focused on? Thanks.

Speaker 2

Great. Thank you for those questions. So from a sampling perspective, this product lends itself extremely well for sampling. If you look at the clinical data that we generated in our Phase III studies, you'll see that these are obviously the patients endpoint is our three day one. But within thirty minutes, which is the first time point that we've measured, you see that we have seventy one percent of patients hitting three lines, ninety five percent of patients hitting two lines of improvement.

Speaker 2

Because it lends itself so well for sampling, we feel that this is a unique tool that we have as a company that we will use widely. We don't really look at this as something that we will only do initially to give doctors the experience, but truly something that allows patients or consumers a very easy test or sample point to see does the product work for them, which again looking at the clinical data, I think we can be highly confident that the answer should be yes. And then do they like to continue to use that. That's why we've got that sample pack of five out there that to re answer your question will continue to pull through as the years pass by. Also because there's actually 4,000,000 new presby ops every year.

Speaker 2

So there's a large volume of new patients that we will continue to reach with those samples. Just on the sampling side, on the regulatory side, just reiterating a little bit what I mentioned in the prepared remarks. We're very pleased with how things are going with the FDA. We've had very engaged discussions with them frankly from like three years ago as we were talking through the setup of a clinical trial with them and obviously since we've submitted the NDA. I've mentioned those interactions continue to be very productive.

Speaker 2

The mid cycle review was a very benign just like you like it. And importantly, we now have seen them starting the inspections of our clinical trials. So showing that that progress continues to be made. So all in, very pleased with how the FDA interactions are going and continue to be very confident that we're working nicely towards that August 8

Speaker 5

for Dufa Day.

Operator

Thank you. Our next question comes from the line of Joe Catarozho from Piper Sandler. Your line is open.

Speaker 6

Hey, perfect. Thanks everybody. Thanks for the update. Thanks for taking the questions. Maybe two questions interrelated on the competitive landscape.

Speaker 6

So, Sean, you made some brief comments on Vuity and pilocarpine and pilocarpine BID. There's been some recent Phase three data for carbocol based product. Wondering if you guys have any thoughts there on that product's profile and maybe how it compares and contrasts to LNZ100? And then maybe relatedly on the other side of a potential approval, I'm wondering if there's any Phase four trials that you maybe have in mind that could reinforce that competitive profile best in class that you might have with LNZ100? Thanks.

Speaker 3

Hi, Joe. This is Sean. Thanks for the question. When we look at this area and opportunity for eye drops or presbyopia, we have said before, we really see this as a category of one and we continue to see this as a category of one. If you really want to drive the efficacy and the near vision improvement that the consumers desire the consumers desire requires two key things.

Speaker 3

It really requires a pupil size below two millimeters, which we achieved. And when you look at our commercial data, it's very clear the capabilities of our product. And what's really important is that you have the right meiotic to do it, which is a cyclodine, which is pupil selective and it's the only pupil selective meiotic. So when I look at this space, when I look at the competition, I really see this as a category of one and we're really defined instead of part by our ability to achieve the performance with the sub two millimeter pupil and acyclidine puts us in that place where we can be the only one with that opportunity.

Speaker 2

Maybe just adding to that, Joe, just building on what Sean said, the an online successful product is a once a day, fast acting, long lasting hydro. So do you overlay that on the clinical data that's out there? We truly believe that our data is the only ones that show that. You mentioned Cabacol and just to for everyone on the call that used to be VISUS that product is now owned by 10 points. We've not seen that Phase three data.

Speaker 2

The press release highlighted that they met the clinical trial endpoints, but did not disclose or they choose not to show any of that data, which is therefore a little unsure what that means. If you go by the Phase II data, which is available again, we feel that that doesn't meet what the consumers are after. So that's just to answer your question on the Phase three data from Carpal.

Speaker 6

Thanks. That's helpful. And then maybe on the follow-up on like Phase four studies that you maybe could potentially perform, if they're even necessary again to kind of sort of reinforce the competitive profile you have here?

Speaker 2

Yes. No, we're obviously focused on bringing this to the market. Phase four studies can be part of that. We know that there's ophthalmologists and other doctors out there that have interest in testing the product. We'll work with them as appropriate to do Phase four studies.

Speaker 2

I will report on that as we are starting them.

Speaker 6

Okay, perfect. Thanks for taking my questions.

Operator

Thank you. Our next question comes from the line of Stacy Ku from TD Cowen. Your line is open.

Speaker 7

Great. Congrats on the progress and thanks so much for taking our questions. We have three. So the first question is around kind of your last year around the educational campaign. Maybe talk about your 15,000 target ECPs.

Speaker 7

Where are we in the campaign? What's the level of awareness of lens and LNZ100? Obviously, you're not able to promote specifically, but just help us understand level of awareness. And obviously in our KOL techs, all the optometrist consultants were familiar with the asecline MOA and people selectivity, and they believe this confers low risk of retinal detachment. So curious your own progress.

Speaker 7

That's the first question. The second question, Sean, you made some comments around maybe finalizing the marketing messages around LNZ100 clinical profile. So just help us understand maybe early thoughts. How do you make sure consumers and patients have the right expectations for the product? Is it up to ten hours?

Speaker 7

How you talk about the durability for a once a day product? So that's question two. And then for our third question, can you discuss in a little more detail the background of the sales force hired so far? This is a unique launch that requires both therapeutic and consumer locks experience. So are they coming from recent launches?

Speaker 7

Are they able to navigate the current consumer profile? Any additional details would be appreciated.

Speaker 3

Cool. So thank you for the question, Stacy. I appreciate it. Again, this is Sean. So looking at the educational campaign, so we've been really pleased by this educational campaign.

Speaker 3

When we were looking at what we want to do to drive awareness of the important things to look for in the future presbyopia eye drops, we really wanted to bring force bring forward the eye care professionals as the voice of that campaign. And that's how we came up with that concept of I'm And we allowed those doctors to really talk about what is it to them that's important and what makes them excited for the future of presbyopia solutions. In terms of reaching out to those 15,000 ECBs, we're making great progress. As we shared, we've had over 2,000,000 digital impressions with that campaign and targeting actually all the over 30,000 ECPs of the broader group, which means these eye care professionals are seeing the campaigns multiple times over. And that is driving a lot more awareness of lens itself and what's important, right?

Speaker 3

The pupil selectivity and the sub two millimeter pupil. And I think, although that's separate from the progress on awareness for LNZ100 and the efficacy of the drug, what we're really encouraged by was what we shared in our last earnings calls.

Speaker 2

We did a market research initiative

Speaker 3

of over four twenty eye care professionals. And by the way, those four twenty eye care professionals sit within our 15,000 target group, because when we designed that survey, we made sure that they had prescribed UITY and prescribed UITY multiple times and had an 80% split optometry versus ophthalmology. So that is a core signal of that group of our 15,000 targets. And we're really excited to see that over eighty percent of them were already excited to prescribe LNZ100 if approved. So we're really happy with that progress.

Speaker 2

Thanks, Sean. Just adding to that and Stacy, thanks for your initiation this week. We appreciate it and a lot of great insights that you did there. And I think you mentioned actually in your question and the survey work that you guys did, which was a lot. There was no shortage of awareness around LNG100 or CycloDent.

Speaker 2

I think that's reflective of all the unbranded work that's been done over the last year, as well as we touched upon it, the work that our MSL team has started to do and is in full force out there now doing. So over 1,000 individual meetings. So these are one on one meetings about twenty, thirty, forty minutes with MSLs or with the MSLs having a medical discussion really highlighting a product, the uniqueness of the Vicodin, the fact that it's pupil selective, tertiary sparing, importance of being below two millimeters and obviously our clinical profile. You mentioned that we're targeting the top deciles there first and again that's going really well. And I think all of that reflects in the fact that there is very high awareness of the second and ready in the market that we'll continue to build up.

Speaker 2

Okay.

Speaker 3

Fair enough. Moving on to your second question on, we said that and shared that we're working on final messaging on our campaigns. So we're very excited about where we're at in terms of our marketing materials. And we'll break them into two groups. One is for our eye care professional side and one is for our consumer side.

Speaker 3

When I speak to doctors and when we see what resonates with them and when we test what's important, I think one of the most important things they always bring up is this isn't pylo, is it, right? So when we think of our messaging to doctors, it's very important that we get across that this is not pilocarpine. So really when you think of promotion to doctors after approval, focus is going to be on MOA, which will lead heavily into the not pilocarpine, moves very quickly then into the efficacy and the safety profile. All that testing is continuing and we're looking forward to sharing more at the upcoming commercial day. On the consumer side, you are exactly right.

Speaker 3

What we don't want to do is over promise. What we saw from the previous launch with this space was promises were made that were not in line with the efficacy of the product, right. So it was a take one drop and it lasts all day, right, or one drop a day. What we really want to highlight here is we want to provide real expectations. So one example, which you just mentioned is how we're approaching it.

Speaker 3

Yes, in our data we see a lot of patients still having a very strong response at ten hours. That being said, in a strategy not to overpromise, we want to focus on a messaging of up to ten hours. And then we also shared that we're leaning into that lifestyle brand. So we spent a lot of time seeing with the consumers to invoke what's the emotion they feel that presbyopia has on them. And again, we don't refer to presbyopia to them, but they're blurry near vision and eliciting that actual feeling and turning that into a campaign.

Speaker 3

So when they see it, they want to click it and they want to learn about the product and they have a desire to be on the product. So that's really where we're at working on the messaging.

Speaker 7

Okay, that's wonderful. Thanks and looking forward to kind of the commercial day.

Speaker 2

Just wanted to touch in on last question there Stacy and we'll keep it brief, but the background of the sales force. Sean, you want to take that? You want me to?

Speaker 3

Yes. So we've had a tremendous amount of interest in joining Lens, which is exciting for us to see. We had a strong pool of candidates when we first brought on our regional directors in Q4. And then when we actually look at bringing on the district managers, which are now all 10 of them are on board, we are seeing that we're finding people that are in working in good jobs in eye care and in the pharma and are looking for the next better opportunity. So the candidate pool has been very, very great.

Speaker 3

What we're seeing are individuals are joining with decades of eye care experience as well as sales experience as well. So really great candidate pool.

Speaker 7

Thank you.

Operator

Thank you. Our next question comes from the line of Jason Gerberry from Bank of America. Your line is open.

Speaker 8

Hey guys. Good afternoon, good evening. Thanks for taking the question. On the sampling initiative and how you'll leverage the e pharmacies, I'm wondering, ultimately, if the e pharmacies will share with you kind of sample conversion to patients opting in to monthly supply and if that's a metric that you'll be kind of sharing with The Street just to kind of give some sense of how that's progressing with utilization and adoption? And then my second question just with early adopters, curious from a patient perspective, if you think that patients with other ocular comorbidities would be more or less likely to get treatment with presbyopia drop therapy or if you think it's patients who probably have a low medication burden, just kind of curious how you're thinking about that dynamic.

Speaker 8

And at the commercial day, do you think you'll share any comps for launch ramp outside of the early Vuity adoption dynamic? So those are my questions. Thanks.

Speaker 3

Great. Thanks, Jason. This is Sean again. So yes, let me dive deeper a little bit into the sampling process and strategy in e pharmacy because it's a great question. So when we think of the samples, what we'll have about the samples is those five day sample packs, again, very similar to how contacts are provided as samples.

Speaker 3

They're really a bridge until the consumer gets started. So those sample packs will be delivered to the optometrist by the rep, so by the representative. So the reps will show up on at the optometrist, let's for example, say they leave 10 samples. When they come back on their next visit, we'll take a look at the samples and make sure that they're well stocked and that they're appropriately being dispensed. Now the e pharmacy is disconnected from the samples.

Speaker 3

That's a separate process. So when the patient receives their sample and they're checking out with their optometrist, the optometrist will ask where would you like your script to be sent? And they'll have two options there. It can be sent to the e pharmacy or it can be sent to the retail pharmacy. Our preference is it sent to the e pharmacy, right.

Speaker 3

And when it's sent to the e pharmacy, what actually happens is the patient gets a text on their phone and they actually click the text, pay for their product and that ships to their home every single month. So that's the way that e pharmacy is set up. And now from the e pharmacy, we'll get data directly from the e pharmacy on a number of scripts and how often those are being ordered. The samples are separate from that. That's really delivered by the rep and separate from the e pharmacy.

Speaker 3

The great thing about the samples are, since they're delivered at the optometrist location, they won't get caught up in any of your script data if you're monitoring script data for sales.

Speaker 2

So very concretely, Jason, to your question, there's no correlation to be seen or will be shared between samples and conversion to scripts. So second question was around

Speaker 3

The early adopters to the patients. So when we think about the first patients going into the doctor, so when we first get approval, our primary focus will be educating the doctors. So our earliest patients will be those that are already going into the practice. And actually this works out well, because if we think of comorbidities, right, one of the most important things that we see when we look at consumers that are interested in this product, a group that really stands out are those that are in contacts today and over 45. And the great thing about those patients, they're already going into the doctor every year for their annual eye exam.

Speaker 3

So we're already going to be seeing those patients at the doctor already before we even turn on DTC. And also what we saw on our survey that we revealed last quarter, those doctors are seeing over 200 presbyls every single month already. And they're in a place where they're excited to prescribe LNC one hundred. And

Speaker 2

then last question here was on launch cups. So at the commercial day, we're not going to be talking about launch and launch ramping. I think you and others have done a very good job at at putting your models together. So I think the consensus is what most people will look for and look at as we launch and in the quarters to follow. So we'll stick with that for now.

Speaker 2

Got it. Thanks guys.

Operator

Thank you. Our next question comes from the line of Lachlan Hanbury Brown from William Blair. Your line is open.

Speaker 9

Hey guys, thanks for taking the question. So I've heard across the industry that it's been getting harder at least in some places for sales reps to actually get in and see a doctor. So I'm wondering if you sort of have heard anything similar particularly as it pertains to your targets. And if so, like how what can you do if anything to get around those hurdles?

Speaker 3

Hi, Lachlan. This is Sean. Thanks for the question. So in this area of the industry, particularly around optometry, access to the eye care professional hasn't been seen as being increasingly challenging for us. So we're not seeing that on our end.

Speaker 3

Definitely when COVID came around getting into the hospitals and the pharmacies became more difficult. But for the optometrists, we really don't see that growing. And I think what's really great about this product is with our samples, it's going to be another reason that they're going to want to see us because obviously as they provide the product to the patients, they're going to want to see us again so they can restock their samples. So we see that as a great tool to make sure that that door remains open for our sales force.

Speaker 9

Thanks. And then maybe

Speaker 2

a follow-up.

Speaker 9

I've seen in some prior launches, especially in the more sort of discretionary or aesthetic kind of areas concern around macroeconomic conditions affecting demand. And given there's been talk over the past month or so of potential recession, I was just wondering if you have any thoughts on like how sort of economically sensitive demand might be because you sort of outlined, you're going to be targeting higher income customers anyway. So just interested in sales there.

Speaker 2

Yes, great question, Akhil. This is So, two elements of that one. If you look at aesthetics and you look at how revenue or volume has been impacted or frankly not impacted by recessions, You see that take Votex for example, hardly any impact in the big recession of the late or mid-2000s, definitely not over the last couple of years. So you don't see that actually. This is partly and this is as we've been speaking about quite a bit.

Speaker 2

Yes, there's 128,000,000 press release out there. We're talking about or projecting to get to a $3,000,000,000 plus potential market, only about a 6% penetration and one of the cuts in there is actually income. So I think this is at least we're projecting this to go to a group of people for whom the discretionary spending is a little bit larger to begin with. So again, we don't expect any impact on whatever the macro is going to do.

Speaker 9

Thanks.

Operator

Thank you. Our next question comes from the line of Gary Nachman from Raymond James. Your line is open.

Speaker 10

Hey guys, good afternoon. This is Dennis Resnick on for Gary Nachman. Congrats on the progress this quarter and thanks for taking the questions. So previously you've segmented the consumer market in a specific way where you've talked about the patients that could be early first adopters being those who are lenswares, refractive surgery or those that go to med spas. Of those three, could you talk about which segment you think will be the easiest to activate and reach and which one will require more work?

Speaker 10

And then just any quick updates on how we should think about the commercialization plans for LMT-100s in The EU? Thanks so much.

Speaker 3

Great. Thanks for the question. This is Sean again. So when you think about the early adopters, right, we see all three of them as very great and accessible targets from a promotional standpoint. In terms of access, when we think of the early days of launch before we turn on DTC, I think we think of those people in contact lenses.

Speaker 3

The great news is they're already in the optometrist. So the good news is we can get them early in terms of the doctor can be our conduit to start speaking to that subset. And then when you think of those that have had refractive surgery in the past or those that get a med spa. Again, we see both of these are groups that we can target digitally. And when we look at our media buy companies that we've partnered with and our ad agencies, in terms of if we're focusing on our med spa clients, we can look at their search histories and geolocations to really target them with the right digital ads.

Speaker 3

They are extremely motivated and they test very high. They actually test the highest in our analysis of interest for an eye drop solution. And then for those that have had refractive surgery in the past, again from here, we can target them as well as we can as we reach out to ophthalmologists, these are people that they've met in the past and have worked on before. So it's another avenue to get access to that population. So we really see this all three groups is very accessible.

Speaker 2

Thanks, Sean. Your second question was about Europe. So I'll take that a little bit broader and in general talk about the ex U. S. Strategy.

Speaker 2

So as clear or should be clear to all of you is that we are obviously focused on commercializing the product in The U. S. Ourselves. Ex U. S.

Speaker 2

Territories will all be up licensing to the right commercial partner there. We do see that there's a significant ex U. S. Opportunity and that's reflected in the amount of inbounds that we get from very interested parties, wanting to understand what it would take to get a license to this product. We do want to make sure obviously that we drive the appropriate value for that.

Speaker 2

And that's how we're timing those discussions. The one exception there being China, we've licensed China early, if they had to do their own clinical trial. But I've seen the results a couple of months ago which were carbon copy of what we've seen in The U. S. Which again was highly elevating.

Speaker 2

So they're about, let's call it twelve to eighteen months or so behind us from a filing and launch perspective. I will keep everyone updated as we progress any other ex U. S. Discussions.

Speaker 10

Great. Thanks for additional color and congrats on the progress.

Operator

Thank you. Our next question comes from the line of Matthew Coffee from H. C. Wainwright. Your line is open.

Speaker 8

Great. Hi, guys. Thanks for the update. You kind of touched on this, but from the commercial standpoint, do you foresee any tangible prescription resistance based on former Vuity experiences or disappointment from that separate pilocarpine profile? Thanks a lot.

Speaker 3

Hi, Matt. This is Sean and good question. So when we look at this market, what we really focused on particularly in our last market research study was the excitement and interest for LNZ100. And so when we look at those 15,000 ECP targets, we did the survey on a subset of them, right, those four twenty plus eye care professionals, again 80% optometry, twenty % ophthalmology. When we asked them about the willingness to prescribe LNZ100, what we saw was over 88% of them were already likely to prescribe a FUSET on the fence.

Speaker 3

And it was only about 2% or 4% that were unlikely to prescribe. So the fact that we're not pilocarpine based is really the key factor there. They're excited and ready for a solution for their patients. Their patients are still frustrated by the fact that they don't have a good solution. And the reason to believe for them and why they're so excited and open is the fact that we're not pilocarpine and that we're acipodine based.

Speaker 3

And when we did our market research on why Vuity failed, the number one reason that came out was for most people it didn't work. And then for the second one, when it did work, it didn't work long enough. So we're really breaking the mold in what we're offering here. And the excitement that we're seeing in our market research, it doesn't have that hangover effect.

Speaker 8

Got it. Very helpful. Thank you, guys.

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.

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Earnings Conference Call
LENZ Therapeutics Q4 2024
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