LENZ Therapeutics, Inc. (NASDAQ:LENZ) Q3 2024 Earnings Call Transcript

LENZ Therapeutics, Inc. (NASDAQ:LENZ) Q3 2024 Earnings Call Transcript November 6, 2024

Operator: Good morning, ladies and gentlemen, and welcome to the LENZ Therapeutics’ Third Quarter 2024 Conference Call. At this time, all participants are in a listen-only mode. Following prepared remarks from the management, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.

Dan Chevallard: Thank you. Good afternoon, and thank you to everyone for joining us today to discuss LENZ’s third quarter 2024 financial results and recent highlights. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Eef Schimmelpennink, our President and Chief Executive Officer; and Shawn Olsson, our Chief Commercial Officer, as well as Dr. Marc Odrich, our Chief Medical Officer will join us for the question-and-answer session. Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ’s future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections, and performance.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, and which can also be found on our website. In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our third quarter 2024 Form 10-Q, which was filed this morning. With that, I will now turn the call over to Eef.

Eef Schimmelpennink: Thank you, Dan and good afternoon everyone. The third quarter of 2024 has been highlighted by multiple significant corporate achievements. They reflect the consistent pattern of execution by the LENZ team as we continue to build momentum on our path towards the potential approval and launch of LNZ100. I’d like to take a moment to summarize our recent milestones and signal a clear and important transition in the profile of LENZ as we move from a late-stage clinical development biopharmaceutical company to a pre-commercial company, fully focused on what we believe is to come in 2025. The recent period has been pivotal in our advancements with significant achievements, most notably the acceptance by the FDA of our NDA for LNZ100 for the treatment of presbyopia.

And importantly, receipt of a PDUFA target action date of August 8th, 2025. With that, I’d like to provide a brief refresher on the widespread and inevitable problem we are aiming to solve. As we know, presbyopia is a loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens in our eye hardness with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurring near vision. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work.

To address the daily challenges faced by presbyopes, we are advancing the first and only aceclidine-based once-daily eye drop that in our Phase 3 CLARITY trials has shown to be capable of improving near vision throughout the full work day without the need for reading glasses. We are extremely excited about the LNZ100 product profile, which we believe has best-in-class potential. The profile of LNZ100 includes a rapid onset of response with 71% achieving three lines or greater of near vision improvement at 30 minutes and also 71% achieving three lines or greater of near vision improvement at 3 hours, which was a primary endpoint. An unprecedented long-lasting response rate measured out to at least 10 hours with 40% achieving three lines or greater near vision improvement, which was the last time measured in our efficacy trials.

And a very impressive near universal response to LNZ100 with 95% of participants achieving at least two lines of near vision improvement. This is an important measure because it seen as clinically meaningful and significant for most presbyopes. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. In addition, we observed a statistically significant at least one line of distance vision improvement across the population. And importantly, in terms of safety, LNZ100 was seen to be well-tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three CLARITY trials. Of all reported adverse events, 95% were classified as mild, believed to be transient, and in the rare cases of headache appear to be tachyphylactic and for most, no longer appearing with prolonged use of LNZ100.

Returning now to our recent news and exciting regulatory milestone announced a few weeks ago. We were pleased to receive our Day 74 letter, which signifies the official acknowledgment of acceptance by the FDA of our NDA for LNZ100 for the treatment of presbyopia, importantly, including our PDUFA target action date of August 8th, 2025. As I mentioned on our second quarter call, our NDA is the culmination of a development program that along the way incorporated valuable feedback and guidance from the FDA, and we believe that we have compiled the dossier with strong clinical, manufacturing and quality data. We look forward to continuing to collaborate with the agency as they review our submission, all of which we believe could result in a potential approval by the FDA in August of next year and a commercial launch in the United States as early as the fourth quarter of 2025.

Before we transition to a commercial discussion, I would like to also take a moment to highlight the exciting results from Corxel, previously known as Ji Xing, our development and commercial licensing partner in China, which we jointly announced last week. We were very pleased with the top line data from the Phase 3 study performed by Corxel. It was a well-executed study as evidenced by the strong p-values of at least — of less than 0.0001. We believe it’s important to emphasize the relative strength and consistency of the data with that of the CLARITY study as the JX07001 clinical study was performed by a different company in a different country and importantly, with a patient population that was predominantly of a different ethnicity. We believe this further highlights the potential LNZ100 has as a global therapy, starting with potentially providing access to the estimated 400 million presbyopes in China.

We believe this to be an illustration of an ex-U.S. partnership that has an opportunity to create meaningful shareholder value. As the balance of the global rights to LNZ100 ex-China remain unpartnered, we believe opportunities to further partner globally could provide significant additional upside to our shareholders. As I mentioned in my opening remarks, these recent milestones signal an important transition in the focus and profile of LENZ as we have moved from a late-stage clinical development biopharmaceutical company to a pre-commercial company. With that, we would like to highlight a few key observations from a recent primary market research survey commissioned by LENZ of approximately 430 eye care professionals, comprised of approximately 80% optometrists and 20% ophthalmologists.

We believe the results will help illuminate some very interesting insights about the potential treatment of presbyopia with LNZ100, if approved. I will now hand the call over to Shawn Olsson, our Chief Commercial Officer, to step us through the results of this analysis. Shawn?

Shawn Olsson: Thank you, Eef, and good morning, everyone. It goes without saying that the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. Presbyopia impacts an estimated 128 million people in the U.S., a population incidence that is nearly 4 times larger than those impacted by dry eye. It is also more than the combined U.S. population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma. As we continue to advance towards potential approval by our PDUFA date of August 8th next year, we wanted to take this opportunity to share significant and insightful perspective gained from eye care professionals through primary market research, confirming what we have understood to be anecdotally true.

Reflecting on eye care professional patients, our survey found that most patients seen are presbyopic and the recommendation for a retinal eye exam is already built into their standard eye care exam process. Based on the feedback from 426 eye care professionals, the average ECP will see 300 to 400 patients per month. Of those, 61% are reported to be presbyopes. Further, the ECPs in the survey indicated that 80% — 87% of the annual eye exams they perform already include a retinal exam to evaluate retinal pathology. We anticipate such a retinal exam will be recommended by the FDA, and we believe it integrates seamlessly into the existing exam process and will not be a burden to prescribe. Next, we wanted to survey eye care professionals to get a sense if their prior experience with [Indiscernible] had impacted their interest levels in the treatment of presbyopia as well as their impressions of LNZ100.

The ECP surveyed were asked to review the LNZ100 Phase 3 safety and efficacy data. More specifically, we shared LNZ100’s 30-minute and 10-hour post-treatment three-line and two-line improvement rates from our CLARITY study, the adverse event table from our CLARITY study, in which all ocular AEs were mild and noted that there were no treatment-related serious adverse events across more than 30,000 patient treatment days. Following review, 78% of ECPs surveyed agreed with the statement that LNZ100 is an attractive presbyopia treatment as well as 78% agreed with the statement that LNZ100 is well-tolerated and safe. As we look forward to the adoption of LNZ100, we are excited to share that 83% and 82% of eye care professionals surveyed would be likely to sample and likely to prescribe LNZ100, respectively, confirming the sustained excitement for a non-pilocarpine presbyopia eye drop solution.

As we’ve discussed on previous calls, the first eye drop treatment for presbyopia was approved in 2021 and confirmed the strong consumer desire for an eye drop treatment as evidenced by initial paid new scripts of over 5,000 per week. Long-term usage beyond the trial period of this product did not materialize as pilocarpine, even at the high concentration of 1.25%, couldn’t deliver the consumer required performance. Other attempts at lower dose BID strategies are being pursued. But given the efficacy profile is very similar to that of beauty, we do not believe this will clear the consumer hurdle for performance or the eye care professional hurdle for a pupil selective option. We continue to believe the category is wide open for an eye drop solution that can deliver what consumers desire, a once-daily eye drop that works for the full workday for the majority of presbyopes.

Unlocking this market requires an ideal presbyopia eye drop, and we are excited for the prospect of aceclidine-based LNZ100. We believe the commercial potential of LNZ100 was validated in our Phase 3 CLARITY study with 90% of participants noticing an improvement in near vision and 75% of the participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use four to seven days per week. Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion-plus potential market opportunity, creating a potential category of one. Continuing on that momentum and to support the projected launch following potential FDA approval, LENZ has now fully staffed its commercial leadership team across marketing, sales and commercial operations with expertise in eye care, direct-to-consumer, influencer, and consumer product goods.

In addition, we have now hired our Regional Sales Directors for the East and West that will report to our Vice President of Sales. From an infrastructure standpoint, LNZ100 is actively building out its U.S. commercial capabilities, highlighted by the completion of our third-party logistics contracting, all in preparation for a potential launch of LNZ100 as early as fourth quarter of 2025. As we have discussed previously, in February of 2024, LENZ launched its unbranded Eye Am Selective campaign to educate and excite eye care professionals about future presbyopia solutions. Over 50 key opinion leaders are involved in this campaign, of which many are featured at eyemselective.com, that is E-Y-E-M-selective.com, where eye care professionals can learn about the importance of ideal pupil size, high-risk muscle selectivity, and expected early adopters of presbyopia eye drops.

As we think about the commercialization of LNZ100, we’d like to just take a moment to reiterate our commercial strategy based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals who represent over 85% of the VUITY scripts with potential best-in-class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering. Second, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct-to-consumer advertising. And third, we want to ensure ease of 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 is building out consumer sampling capabilities and commercial access with multiple channels, including traditional retail pharmacy as well as home delivery. Before I conclude, I’d like to highlight that we have turned our attention to key medical conferences with an aim to continue to get our data into relevant medical forums, including a presentation last month at Eyecelerator at AAO 2024 in Chicago; tomorrow at the American Academy of Optometry at Academy 2024 Indianapolis; and we are pleased to recently learn that we have been accepted for presentation at OIS in San Diego later in November. We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch.

With that, I’d now like to hand the call over to Dan Chevallard, our CFO, to step through our financial results.

Dan Chevallard: Thank you, Shawn. As both Eef and Shawn have highlighted, the third quarter and recent period has been very productive. In early July, we were very pleased to have completed a $30 million PIPE financing with Ridgeback, bringing a strong and well-respected investor into our shareholder base and further strengthening our balance sheet. To that end, we ended the third quarter 2024 with approximately $217.2 million in cash, cash equivalents, and marketable securities, which as we have guided previously, is anticipated to fund the company’s cash runway to post-launch positive operating cash flow. Turning now to our third quarter results. Our operating expenses and resulting cash burn for the third quarter were once again substantially in line with our plan.

Total operating expenses for Q3 2024 were approximately $12.9 million compared to $19.9 million for the same period in 2023. Our Q3 2024 cash burn, net of interest income was approximately $9 million. Sequentially, our total operating expenses decreased quarter-over-quarter by approximately 10% from $14.4 million in the second quarter of 2024. On previous earnings calls, we highlighted that we would anticipate a decline in our research and development expenses due to the conclusion of our positive Phase 3 CLARITY study, while shifting our research and development focus and spend towards pre-approval manufacturing activities, which we have seen in the third quarter. Total R&D expenses decreased to $6.5 million in Q3 2024 compared to $17 million for the same period in 2023.

Sequentially, research and development expenses decreased quarter-over-quarter by approximately 7% from $6.9 million in the second quarter of this year. Total SG&A expenses increased to $6.5 million in Q3 2024 compared to $2.9 million for the same period in 2023. This increase was driven primarily by increases in commercial headcount and pre-commercial planning activities. Sequentially, SG&A decreased quarter-over-quarter by approximately 12% from $7.4 million in the second quarter 2024, driven primarily by decreases in non-commercial G&A administrative expenses, including outside legal services and other corporate expenses. We expect our SG&A expenses or our sales and marketing expenses to be more specific to begin to ramp from here as we approach a mid-2025 approval for LNZ100.

As we think about the year prior to launch and heading into the potential year of launch, we believe our sales and marketing spend is well aligned to deliver on our commercial plans. Importantly, our allocation of capital to sales and marketing, including our absolute dollar sales and marketing spend and sales and marketing spend as a percentage of total operating expenses all line up well to benchmark comparative analyses we have performed. Finally, our net loss per share, both basic and diluted, was $0.38 per share in the third quarter 2024 on a net loss of $10.2 million compared to a net loss per share of $9.62 per share in the third quarter 2023 on a net loss of $18.9 million. As was noted on previous earnings calls, please keep in mind that our net loss per share figures consider only weighted average common shares outstanding, which were considerably different in 2023.

Q3 2024 net loss per share was calculated on approximately 27.2 million weighted average common shares outstanding compared to Q3 of last year when as a then private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding. We ended Q3 2024 with approximately 27.5 million total common shares outstanding. That concludes my comments on our Q3 financial results. And with that, I’d like to turn the call back over to Eef for final remarks.

Eef Schimmelpennink: Thanks Dan. As you can see, the third quarter and recent period has been a very productive time, and we feel the team continues to build momentum into the end of the year. It goes without saying that it is an exciting time at LENZ. We have continued to execute in all facets of our organization. We remain highly confident that we are well on our way to deliver the first and only aceclidine-based eye drop for the improvement in near vision in people with presbyopia. We look forward to this next phase as a pre-commercial company as we prepare for a potential approval and commercialization of LNZ100 and believe we are well-positioned to deliver a once-daily, safe, and rapidly acting treatment to 128 million individuals living with presbyopia in the United States. With that, I’d like to open up the call for questions.

Operator: Thank you. We will now begin the question-and-answer session. [Operator Instructions] And your first question comes from the line of Yigal Nochomovitz with Citi. Please go ahead.

Q&A Session

Yigal Nochomovitz: Hi guys. Thank you very much for taking the questions. I had a few here. So, first off, you mentioned, I believe, the survey, there was 80% optometrists, 20% ophthalmologists. I’m just curious if the conclusions of the survey were consistent amongst those two subgroups? And then the second question, obviously, with this very, very large market, over 100 million potential patients, I’m curious what level of investment in the social media access. I think you mentioned influencers are you expecting for the launch? And then thirdly, just could you remind us as far as the manufacturing of the product, where is it manufactured? Is it within the United States? Or is it ex-U.S.? And do you have multiple suppliers? Thank you.

Eef Schimmelpennink: Thanks Yigal. Great questions. Let me kick off with the 80/20 and the manufacturing, and then I’ll hand it over to Shawn for the investments. So the 80/20 split between optometrists and ophthalmologists is obviously by design. We see that if you look at the VUITY scripts, that 80/20 split is how the VUITY scripts came about, and we expect that to be reflected for our commercial plan as well. That’s why we ended up with 80/20. And the feedback across those two groups is very consistent. So, you don’t see any changes between those two groups. Then on manufacturing, we are fully set up to produce at commercial scale. Actually, our Phase 3 trial was produced at that same commercial scale ready to support the launch as is.

Manufacturing setup is partly U.S., partly ex-U.S., all European-based. So, European and U.S. manufacturers, both for drug products as well as drug substance, all with ample capacity that we will continue to add to and build redundancy to as we launch.

Shawn Olsson: And turning to the interest from social and influencers to LNZ100. So, we see the potential of LNZ100 in this large untapped market, right, that has the potential to be north of $3 billion. And because of that, we will put the financials behind it from a direct-to-consumer strategy that would be commensurate with a product of that potential. What we saw with VUITY was when they turned on their direct-to-consumer campaign, it nearly doubled their scripts from 3,000 new scripts per week to up to 6,000 new scripts per week. And therefore, that supports our strategy behind a direct-to-consumer campaign. We are evaluating both influencer campaigns as well as a celebrity spokesperson. And we’ll continue to evaluate that as we get closer to launch. What we see is when you’re selecting influencers and celebrities, you do want to do that fairly close to launch just because they do tend to go in and out of favor over time.

Eef Schimmelpennink: Thank you, Shawn.

Yigal Nochomovitz: Okay. Thank you.

Operator: Your next question comes from the line of Marc Goodman with Leerink Partners. Please go ahead.

Marc Goodman: Yes. Two questions. One is, can you remind us what the incentive is for the optometrist has to recommend the product? And then second of all, thinking about the VUITY launch, help us with expectations for how to think about your launch for the ramp in prescriptions and sales? I mean, should we be expecting it to do as well or not as well or better? Or just help us kind of set the expectations right now. Thank you.

Shawn Olsson: This is Shawn Olsson, Chief Commercial Officer. [Technical Difficulty] presbyopia are really looking for an ideal solution for presbyopia. So our eye drop provides the opportunity for more patients to be [Technical Difficulty] patients that are buying reading glasses off the shelves. [Technical Difficulty] The other benefits in one of our target groups are contact lens. [Technical Difficulty] Ultimately, the product did not work, but they did drive 3,000 new scripts per week in the beginning, and then they increased that to 5,000 new scripts per week after DTC. Obviously, we are not the size of Allergan, but we’re going to put the potential marketing power behind this product to have a launch. I think anything in that realm would be good.

Eef Schimmelpennink: And just to maybe add on that a little bit, Marc. So, if you think about timing of that launch before we talk about REM, with our PDUFA date now obviously being set for August 8th next year, we’ve tightened our guidance as to when we expect to launch, as you’ve heard us talk about to the fourth quarter of next year. That’s the logical and I see everywhere time that will take to we expect it will take to get those product out of the door. So. early in that quarter, we’ll start with samples. It is a product that lends itself obviously extremely well for sampling with that very rapid onset. So remember that our clinical trial was truly a day one endpoints on that same day one. So first product, first time that a patient actually obviously use the product within 30 days, we hit those very high efficacy results that we’ve shared before.

So we look at that Q4 truly as a rollouts quarter. Well, we’ll start with heavy sampling that then will lead to that transition where patients are going to start filling scripts.

Marc Goodman: Thanks.

Operator: Your next question comes from the line of Joe Catanzaro with Piper Sandler. Please go ahead.

Joe Catanzaro: Great. Hi, everybody. Thanks for taking my questions. Congrats on the progress here. So within the ECP survey, you queried physicians on how often they perform retinal exams. And Shawn, I think you mentioned expectations around requirement for retinal exam. So wondering where those expectations stem from relative to the safety profile you observed in comparison to VUITY? And maybe more generally, how the language around retinal risk might compare to VUITY? Thanks. And I have a follow-up.

Eef Schimmelpennink: I’ll take that one. So our expectation is that our label will be very similar to that of VUITY, which has a general recommendation, not a requirement, but a general recommendation for an eye exam when using a presbyopia eye drop. And you could argue that, if you look at our safety data and knowing that a second in very different from pilocarpine is actually pupil selective, does not stimulate the Ciliary Body and we know that the Ciliary Body is overstimulation, Ciliary Body is what’s often connected to the retinal side effects. So we believe that our data shows and MOA shows that we don’t have that impact. At the same time, we believe that the FDA will not go as far as to not have that same general, again, recommendation on our label.

We actually believe that that’s a good thing. One of the questions earlier was what’s in it for eye care professionals. I think that eye exam is one, as we know, that’s actually a catch pay for most patients if you do a non-dilated eye exam. So that’s a positive for eye care professionals and also a positive actually for patients to just make sure they have your eye checked out on annual base. And as we stated or as we found in the survey, it is standard practice. So your annual standard eye exam almost always includes a retina exam. So it’s not something that needs to get done in addition. It’s not something new, something that all if not most eye care professionals already do. So again, we feel that it’s not a hurdle actually positive in there.

Joe Catanzaro: Great. That’s really helpful. Maybe my follow-up, so I guess maybe if you have any updated thinking on ex-US, ex-China opportunities or where that stands, whether you pursue that on your own, look for partnerships and any sort of gating factors you see there to pursuing that?

Eef Schimmelpennink: Yes. Great question. What we can definitely say is that following first our results and frankly now seeing Oxtell repeat that ex-US, there’s definitely a lot of interest for markets beyond US and China. We are phasing those discussions in appropriate way. Obviously, our focus is to make sure that we get to the market in the US in the best way possible. But you can imagine that those discussions are ongoing. Timing of which is DVD, those discussions usually take a little bit of time and we’ll keep the market updated as we progress there.

Joe Catanzaro: Okay, great. Thanks for taking my question.

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

Pavan Patel: Hey, guys. Thanks for taking my questions. Just two for us. You speak to the recent Phase 3 study readout in China? What’s the timeline for approval and how big do you model the opportunity beyond the 400,000 addressable patient population that you’ve mentioned? And then the second question, maybe if you could speak to commercial launch readiness ahead of the August 2025 PDUFA date. At the time of launch, how many other approved eye drop treatments for presbyopia do you expect on the market? And if you could frame how you expect LNZ100 to be positioned among those competitors? Thank you.

Dan Chevallard: Sure. This is Dan Chevallard. So I’ll take the majority of that question and perhaps Marc Odrich can speak to the data if you wanted clarity around that and how we think about it. But how we think about the economics and modeling of the opportunity. First of all, there are $15 million in development milestones that are outstanding, that are in the agreement as well as $80 million in commercial milestones that are to be obtained based upon net sales in the region. In addition to that, royalties in the 5% to 15% range on net sales in China. So those are the economic terms that are in the agreement. The overall projections and revenue, we’re not guiding there at this time. And as far as timeline for their approval, we would guide you to keep an eye on their website, where they’ll be providing updates on their regulatory guidance.

We will not be guiding on their behalf. The first part of your question was about the data specifically from CORXEL. So if Marc would like to add any comments, go ahead.

Marc Odrich: Yes. Thank you, Dan. The data really was very validating. Overall, incredibly similar, very strong data and really no surprises whatsoever. So it’s good to see that in a somewhat different world, different population, we had the same result, very clinically similar and relevant. I really don’t have any more to say than that.

Shawn Olsson: And then turning to the commercial launch readiness, we’re very well positioned from our commercial launch readiness here at LENZ. So as we shared, our commercial leadership team is in place. We’ve now hired both of our regional directors for our sales team reporting to our Vice President and we’ll continue to build out that sales organization as we progress to the potential approval and PDUFA date next year. Other things that will continue to progress is our commercial operations. We highlighted that we have contracted with our third party logistics supplier. We’ll continue our wholesaler negotiations, again, all working towards that potential approval date. In terms of competition, really we see ourselves as the next product to be approved and it’s a presbyopia eye drop with our PDUFA data out there.

And really in terms of competition, as the only aceclidine-based eye drop, we see our product as a potential category of one and really the best in class potential as we look towards our potential approval.

Eef Schimmelpennink: So just adding a little additional color there. So if you look at what’s obviously, VUITY is still on the market, but Allergan or AbbVie stopped promoting that product about nine months, maybe 12 months after launch a couple of years ago now following a — as we noted earlier, actually very strong initial launch, very interesting and promising run rate for then patients and doctors called on that the product bank doesn’t work. So it’s not the target profile that patients are after. So if you think about the target profile as a presbyopia1 is a product that works rapidly. So you put in your eye, it works almost immediately. It needs to work or it needs to be a once a day product. So set it, forget it, you don’t want to be messing with adding drops throughout your work day.

And obviously, it needs to work long. You really need to cover you for the full work day. That’s the profile that patients and doctors are looking forward to the profile that obviously we hit. Clearly, VUITY didn’t. And as we all know closely recently or got approved over a year ago, but recently announced that they will be launching with what is, you just look at the public data effectively a similar clinical profile. So a twice a day product that works for some patients, but not many for a limited amount of time. So while they’ll be out there and we expect them to be out there when we launch, we don’t foresee any a very different outcome for them if you compare to VUITY.

Pavan Patel: Thank you.

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

Lachlan Hanbury-Brown: Okay. Thanks for taking the question and congrats on the progress this quarter. I know you’ve been running education awareness campaigns with doctors for a while now. But I was wondering sort of how that will escalate or change as you get into launch over the next 10 months? And then somewhat related, that’s just one of the three pillars that you outlined to the launch. Wondering what or how much if anything you can do on the other two pillars prior to an approval? Or do they sort of require the approval so you have the brand name and the product to work on access?

Eef Schimmelpennink: Great. Thanks, Lachlan. So I’ll take the very first part of the question on what we’re currently doing and then Shawn will provide more color on our three key elements of the commercial strategy and what we can do prior to launch, which is actually quite a bit, but we have assembled now a medical sales liaisons team. So obviously, as we all know, that team can be and is out there currently talking to ECPs. So really sharing the MOA of the product. So how is aceclidine different than pilocarpine? And that’s what we continue to hear over and over again that people are not enthusiastic about another pilocarpine product given their experience with BOE and the fact that it’s not pupil selective. But on the contrary, are very excited about the aceclidine profile.

So we educate our MSL team educates doctors on the MOA, on the profile. Then we obviously talk about our clinical data. That team, again, in a medical to medical discussion can talk about aceclidine and its clinical data. And thirdly, we’ll start to talk about patient populations that initially would be the most attractive to use or to get on to the product. Again, that’s a medical to medical discussion, the one that only the MSL team can have, and that’s completely firewall off from the rest of the organization, and Shawn will talk to you about what we can do there prior to approval.

Shawn Olsson: Yes. So as we continue to progress towards that potential approval, our unbranded campaign will continue to accelerate. So currently, the team actually this week is at the American Academy of Optometry at the convention with our unbranded booth and continuing to share that story on those three key pillars. You can expect that we’ll be continuing to be present at upcoming conventions as well as continue to grow our presentation opportunities at those conventions as we announced earlier on the call. When you think of those three pillars, that really aligns to the doctors to recommend us and the prework we can do on the unbranded side. The patients request us by name, the second pillar and the access, the third pillar.

Really just diving a little bit more on the access side. Again, this will be less forward in terms of what people see externally. But on the back-end side, as we continue to highlight on these calls, we’re putting a lot of that infrastructure in place well ahead of launch. So that way, when the product is available, very quickly, we can get the product into the consumers’ hands so they can actually try it and so the eye care professionals can get comfortable with it. Really, those are the two that we’ll focus on ahead of approval, the doctors to recommend us as well as the access the patients to request us by name. Again, this is something where we want to make sure the doctors have some time with the product before we turn on direct-to-consumer advertising.

So they’re comfortable and aware of it, and then we’ll come forward with the patients to request us by name with those different DTC strategies we talked about earlier.

Lachlan Hanbury-Brown: Thanks. That’s helpful.

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

Gary Nachman : Hi. Thanks. Good morning. So in terms of your key targeted presbyopes that you’ll be going after when you launch, are you still thinking about certain groups like contact lens wearers, people that had refractive surgery or people that go to med spas. So how are you thinking about hitting those different groups once you activate the DTC? And then just back to the sampling with aggressive sampling at launch, how long do you think it will take for that transition to usage to occur? So how much is that going to play into the initial revenue ramp? How long will the sampling go before people start using it? Thanks.

Shawn Olsson: Great. So a couple of comments. So looking at those key targets for presbyopia, so we commissioned a large market research survey to look at the consumers most interested. I think what’s great to see is there’s broad interest across the full population of presbyopes. But at the same time, we do want to promote and go directly to pupil that over-index on interest for eye drops for presbyopia. As we previously shared, those are pupil that are in contact lenses. Those are pupil who have had refractive surgery and those that have been to a med spine in the past 12 months. So those will be the more primary targets of our DTC. And what we’ll do is we’ve partnered and continue to partner with agencies that work on how do you promote directly to those core groups.

So they look at different data that exists on their buying trends, on the websites they visit. So it will be a very digitally focused way on how we target those. We’ll also help target those buying our messaging to doctors. As you see in our unbranded campaign, we’re already helping doctors to understand which patients are most interested. Each one of those groups are north of 10 million people. So those are all very valuable groups that have a lot of people and highlight the potential of an eye drop for presbyopia. In terms of sampling, it’s very important to talk about the sampling of this product because it’s a little different than some other products. So with this product in terms of sampling, it is a five-day pack. So if you think about our product, it comes in those preservative-free single-dose vials.

So with this sample, they’re truly getting a five-day supply to use the product. That’s very different than, let’s say, products where they come in the multi-dose vial where it could be almost a month supply. So I think that’s very important. I think the other important thing here, too, is these samples will be given to the consumer at the optometrist and ophthalmologist location. So it’s not going through your retail pharmacy, right? So, they’ll actually receive those samples at the optometrist. They can immediately try it for five days. That’s very similar to how contacts work actually where you get a five-day supply. And then from there, we’ll move right into the actual prescription. So we don’t see this one having that same effect that other samples do when it’s a one-month supply or picked up at a retail pharmacy.

Gary Nachman : Okay. Great. And then just one more follow-up. Just on the hiring of the sales force. So just confirming that you’re not going to do that until after you have the approval? Will you have some contingency offers out there? And then just maybe the size and structure of the sales force, how you’re thinking about it? Thanks.

Shawn Olsson: Yes. So just to clarify on the sales force. So the sales force, we are already beginning to put that team in place. So we’ve already hired our Vice President of Sales. We’ve hired our two regional directors. We’ll continue to build that out ahead of the PDUFA date. So it won’t be brought on after PDUFA. They will be brought on before PDUFA. And what we’ve shared is that our sales force team will be roughly 100 reps calling on approximately 15,000 eye care professionals that actually represent over 85% of all the beauty scripts.

Gary Nachman : Okay. But you’ll have all the sales reps in before, even prior to the approval, the entire…

Shawn Olsson: Yes, prior.

Gary Nachman : Okay. Okay. All right. Thanks a lot.

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

Matthew Caufield: Hi. Great. Thank you guys and congrats on the progress towards the potential approval and launch, definitely exciting. We just had one follow-up on the Chinese market. Can you remind us if China had the same prescription experience with VUITY with a version to pilocarpine? Or are there any — is there any greater receptivity in that market for a novel mechanism? Thanks a lot.

Eef Schimmelpennink: Thanks, Matt. So VUITY was not launched anywhere beyond the U.S. So it wasn’t therefore beauty also not launched in China. So it’s really an open market there. Product pilocarpine obviously is a product that is known for its glaucoma use. So there’s definitely a great opportunity to highlight as our partner will do, just like we do here, the fact that aceclidine is very different from pilocarpine. It has that pupil selective mechanism. It has that very clean safety profile, at least shown in trials. And obviously, importantly, it works. So very different from [indiscernible], but beauty was never launched in China.

Matthew Caufield: Great. Very helpful.

Operator: Thank you guys and congrats again.

Eef Schimmelpennink: Thank you.

Operator: That concludes our question-and-answer session, as I am showing no further questions at this time. With that, I will hand the call back over to Eef Schimmelpennink, CEO for closing remarks.

Eef Schimmelpennink: Thank you, Tricia, and thanks, everyone, for dialing in today. Great to connect with you. And for everyone dialing in, have a great rest of your day. Thank you.

Operator: Ladies and gentlemen, that concludes today’s call. Thank you all for joining. You may now disconnect.