Good morning, ladies and gentlemen, and welcome to the LENZ Therapeutics corporate update conference call. At this time, all participants are in a listen-only mode. Following prepared remarks from management, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.
Thank you. Good morning, and thank you to everybody for joining us at this exciting moment for LENZ Therapeutics. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Evert Schimmelpennink, our President and Chief Executive Officer, Dr. Marc Odrich, Chief Medical Officer, and Shawn Olsson, our Chief Commercial Officer. 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, 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 SEC, and which can also be found on our website. With that, it is my pleasure to now turn the call over to Evert.
Thank you, Dan. Good morning, everyone, and thank you for joining us. Today marks a proud and defining moment for LENZ Therapeutics. Yesterday afternoon, we announced the FDA approval of LNZ100, now known commercially as BIS, the first and only ciliary-sparing eye drop for the treatment of presbyopia in adults. With this approval, BIS becomes the only once-daily eye drop with clinically proven near-vision improvement lasting up to 10 hours. This milestone reflects years of scientific development and disciplined execution, aimed at our mission to transform the treatment landscape for 128 million adults in the U.S. living with near-vision loss. This is the result of tremendous commitment and collaboration from the LENZ Therapeutics team and our development partners, with the dedication of our clinical investigators and the contributions of hundreds of participants in our clinical trials. I want to thank them all for their hard work.
I also want to acknowledge the review team within the Ophthalmology Division of the FDA for their consistently high engagement throughout our NDA review process. As you know, presbyopia is the gradual and inevitable loss of near vision that occurs with age. It happens to virtually all of us and often first presents itself as difficulty reading a menu, using a phone, or focusing on objects up close. For many, it's one of the earliest signs of aging and a daily source of frustration. Reading glasses or progressive lenses have been the default workaround, but they are inconvenient and, for most people, not a real solution. There is a true unmet need for a product that restores seamless vision near and far, and with BIS, people now have that alternative.
A once-daily eye drop designed to improve near vision while preserving distance vision for a full workday, offering a hassle-free and effective way to manage presbyopia. We believe yesterday's approval will establish a new standard of care in presbyopia, as we have shown that this is not only best in class, but frankly the only in a class of pupil-selective, ciliary-sparing myotics. This is clearly recognized by the FDA and reflected in our approval label, which reads, "BIS is a predominantly pupil-selective myotic that interacts with the iris with minimal ciliary muscle stimulation." This is uniquely engineered, highly differentiated, and designed to deliver quick onset and lasting benefit for the vast majority of presbyopes.
That's why we see this not just as a launch, but as the foundation of a new category, one defined by real-world efficacy, doctor and patient-centric messaging, coupled with seamless and broad access to samples and parts. With the approval in hand, we are activating our branded commercial launch plan immediately. Our 88-member sales force, fully hired and trained as of July 1, has begun field deployment earlier this month. This team was hand-selected from over 8,500 applicants and represents the top pharmaceutical sales spend in the country. It will be supported by our Optometry Select Medical Sales Liaison Team and our Insight Sales Team. In parallel, we've also kicked off our direct-to-eye care professional marketing campaign, which focuses on the unique mechanism of action of BIS, its impressive clinical results, and how it fits in eye care practices.
Together, they will engage an initial universe of 15,000 eye care professionals across the U.S., ensuring broad education and rapid awareness from day one. This approach allows us to first equip providers with the tools, confidence, and training they need, and allows them to start serving the roughly 40 million presbyopes they are already seeing annually in their practices. This phase is key to do before our expected rollout of our direct-to-consumer campaign in the first quarter of 2026, which will drive branded demand directly to consumers and tapping into the roughly 80 million presbyopes that currently are not seeing an eye doctor. The brand itself, BIS, was built with a vision of the Category 1 lifestyle brand in mind. It is clean, modern, and highly memorable.
It emerged from extensive consumer testing and market research and stands as one of only nine single-syllable brand names approved by the FDA in the past 15 years. We believe that's a testament to its clarity, its strength, and the premium positioning it conveys. Switching over to product availability, we expect samples to start to be available at targeted optometrist offices no later than October, with commercial product to be broadly available mid-Q4. Pricing of this will be $79 for a box of 25 vials with a three-month supply available for $198. What makes me proudest today is not just the approval, but the people behind it. We have purpose-built LENZ Therapeutics for this moment with the right team, the right strategy, and the financial strength to execute. We've built something bold, differentiated, and disruptive, and I'm incredibly proud of the team that brought us to this point.
Before we turn the call to Shawn to walk through our commercial rollout strategy, I'd like to first hand the call to Marc Odrich, our Chief Medical Officer. Marc will share additional perspectives on what today's approval means for the eye care professional community and why this represents a true advancement in presbyopia care. Marc.
Thank you, Eve, and good morning, everyone. As Eve mentioned, the FDA approval of LNZ100, or BIS, is not only a milestone for LENZ Therapeutics, but also a pivotal event for the eye care professional community. Presbyopia has long been a frustrating and difficult-to-treat condition. The ability to now offer patients a once-daily on-label treatment that is both well-tolerated and effective is something we believe will have a lasting clinical impact. The approval of BIS was based on three rigorous phase 3 trials: Clarity 1 and Clarity 2, which evaluated efficacy and safety in 466 participants dosed daily over 42 days, and Clarity 3, which assessed long-term safety in 217 participants over a six-month period. BIS achieved all primary and secondary endpoints, demonstrating meaningful near-vision improvement within 30 minutes of dosing, with durability extending to at least 10 hours. This benefit was consistent and reproducible across the program.
All of this was reflected well by the FDA in our label, which says that BIS is indicated for the treatment of presbyopia in adults. This reflects the broad inclusion of patients in our trials and the large market we can serve. The label describes the onset of the BIS effect on presbyopia from 30 minutes post-dose and lasting 10 hours. Notably, BIS is the only product that has shown efficacy for 10 hours, the last time point we measured in our trials. The label also describes the mechanism of action of Aceclidine as a predominantly pupil-selective myotic that interacts with the iris with minimal ciliary muscle stimulation. BIS causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision, clearly highlighting the unique mechanism of action of BIS. Equally important, BIS was well-tolerated.
Across more than 30,000 treatment days, there were no serious treatment-related adverse events. The most common reactions were mild, transient, and self-resolving. For patients, the clinical impact is compelling. In the Clarity trials, 93% of participants achieved near vision of 20/40 or better just 30 minutes after instillation. At one hour, that figure remained at 93%, and nearly 7 in 10 participants maintained 20/40 or better vision at 10 hours, all following a single daily dose. This level of rapid onset, durability, and consistency represents a meaningful advancement in the treatment of presbyopia. What gives me even greater confidence is what we've heard directly from the eye care professional community. Our 10-member all-optometrist medical science liaison team has conducted thousands of peer-to-peer conversations already this year.
Their insights have consistently reinforced what we see in the data, that there is a strong clinical appetite for a pupil-selective, ciliary-sparing myotic that fits into the daily workflow of eye care professionals and meets the needs of a large and diverse patient population. For many providers, BIS represents the first truly practical pharmacologic solution for presbyopia, one that doesn't compromise distance vision and that can be integrated into real-world practice. Before I hand the call over to Shawn Olsson, our Chief Commercial Officer, to walk through our launch strategy, I want to again recognize the broader LENZ Therapeutics team, our partners, our clinical investigators, and especially the patients who participated in the Clarity trials. We are grateful for their role in making this approval possible. Shawn?
Thank you, Marc, and good morning, everyone. As both Evert and Marc have shared, this is a proud and transformational moment for LENZ Therapeutics and one we've been building toward with a focus and urgency for the past several years. I'd like to start by thanking the entire LENZ Therapeutics team, from sales and marketing to medical affairs and operations, for the incredible work leading up to today. We have built a best-in-class commercial engine, and we are fully prepared for launch. With FDA approval in hand, we are immediately launching our sales activities, supported by our branded go-to-market efforts to bring BIS to eye care professionals across the country. Let me start with the commercial opportunity. Presbyopia is the largest unmet vision condition in the United States. It affects approximately 128 million people, a population nearly four times larger than those with dry eye.
In fact, presbyopia affects more Americans than dry eye, Demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma combined. Yet treatment today remains largely unchanged: reading glasses, progressive lenses, or simply struggling through. That is what makes this moment so unique. With BIS, we are bringing a once-daily, preservative-free eye drop to the market with rapid onset that is well-tolerated and with clinically proven efficacy lasting up to 10 hours. What makes BIS different and why we believe it can reshape the treatment landscape is its mechanism of action. Powered by Aceclidine, BIS is a predominantly pupil-selective myotic that interacts with the iris and avoids overstimulating the ciliary muscle. This results in a pinhole effect that improves depth of focus, allowing patients to see up close without compromising distance vision.
As Evert noted earlier, this differentiation is now clearly reflected in our approved FDA label, something we're very excited about. How are we bringing BIS to market? We've designed our commercial strategy not just to support a product launch, but to establish a new category. BIS stands alone as the first and only once-daily, FDA-approved Aceclidine-based treatment for presbyopia that lasts up to 10 hours and is effective across a broad population of presbyopes. We are positioned as a true Category of 1, and this is supported in our ECP surveys that highlighted 82% of ECPs were already likely to prescribe BIS based on the clinical data. This is now about introducing a disruptive, lifestyle-forward solution into a space where innovation has been long overdue. Our commercial strategy remains built on three pillars. First, we want doctors to recommend us.
We've now launched our Make It Visible campaign to support this pillar, aimed at driving awareness of BIS and educating eye care professionals on the unique mechanism of action, clinical profile, and practical fit of BIS. Our 88-member sales force, fully trained and deployed as of July 1, is laser-focused on targeted education, sampling, and early trial adoption across our initial target of 15,000 optometrists and ophthalmologists. In just a short time in the field, they have already completed more than 8,000 meetings with doctors focused on our unbranded message, a number that will increase rapidly as we now pivot to our branded BIS discussions. This effort is supported by our optometrist-led MSL team and Insight Sales Group, both of which are fully aligned and already engaging clinicians.
Importantly, the feedback from the eye care professionals has been strongly positive, reinforcing our belief that BIS will resonate as a much-needed innovation in this space. We are confident that our focused and coordinated launch efforts are laying the groundwork for BIS to take its place as an effective treatment option for a broad population of presbyopes. Secondly, we want consumers to request us by name. We've developed a modern lifestyle brand grounded in consumer research, one that we believe will resonate strongly with consumers. It's worth noting how rare it is to receive FDA approval for a single-syllable brand name. In fact, as mentioned, BIS is only the ninth single-syllable brand name approved in the past 15 years and has tested exceptionally well with consumers on the memorability scale.
We believe that distinction underscores both the simplicity and strength of our brand, which we've intentionally designed to have the power to stand alone as a Category of 1. We expect our direct-to-consumer campaign to begin in Q1 of 2026, using high-impact creative and trusted personalities to introduce BIS as a modern, empowering alternative to readers. Third, we want to ensure a seamless journey to use. This includes broad sampling availability at doctors' offices, eye care professionals' offices, and commercial access through both retail pharmacies and e-pharmacy. Product samples are expected in market in October, with full commercial availability of product by mid-Q4. As stated earlier, BIS will be priced at $79 for a box of 25 single-use vials, with a three-month supply available from $198 through our e-pharmacy partner.
We believe this approach, physician-led adoption followed by consumer activation, gives BIS the best opportunity to establish early momentum and long-term leadership in this category. Our website, bisviz.com, is now live and will serve as an informational and experienced destination for both consumers and eye care professionals. It reflects the brand vision we've been building toward, a modern, premium consumer brand. In short, we've built the team, the tools, and strategy to deliver, and we look forward to updating you as we execute the launch. With that, I'll hand the call over to Dan Chevallard, our Chief Financial Officer, to speak to our financial position and launch support strategy. Dan?
Thank you, Shawn. Before I begin, I would just like to once again acknowledge all of the hard work that has gone into the approval of LNZ100, or as it will now be known, BIS, by the LENZ team and our partners. The team at LENZ is extremely strong, and today's announcement is a special moment for all of us. With the approval of BIS, I wanted to take a moment and highlight a few key financial points, priorities, and go-forward launch metrics. First, and as we have guided for the past five quarters, we are in a position of financial strength, and we anticipate our cash on hand will be sufficient to support our commercial and corporate operations through positive operating cash flow.
To that end, we are launching BIS with over $205 million in cash, which is a significant beat compared to the $190 million that we most recently guided on our first quarter earnings call. The primary driver of the incremental cash at launch, from our most recent guidance, includes upfront payments from our recent regional licensing transactions in Southeast Asia with Lotus and Canada with TAYA, respectively. Next, I'd like to highlight our initial commercial spend priorities. As Shawn mentioned, our 88-member sales force was fully hired as of July 1, is now fully trained, and will be in the market with our branded material immediately. Shawn has highlighted our initial emphasis on direct-to-ECP marketing, grounded in the first pillar of our commercial strategy of doctors to recommend us.
Our commercial launch spend over the remainder of 2025 will be almost entirely dedicated to support the sales force over these first months, emphasizing our sampling strategy, ECP education through the launch of our speaker program initiative, and preparing for our Q1 2026 direct-to-consumer campaign launch. This, in turn, will result in a ramp of our commercial spend into 2026, where we have guided a go-forward all-in commercial spend estimated to be $80 to $100 million per year in 2026 and beyond. Lastly, and to get in front of a question that we often receive, I would like to highlight a few key early launch metrics that we will be focused on. In the first quarters of launch, we believe an early measure of our success will be driven by the focused efforts of our sales representatives as they engage with their target call plans and initial prescriber conversion.
We anticipate this being something we can quantitatively measure as a predictive indicator of ECP engagement in several ways. Initially, we will focus on, one, how many unique ECPs have written a script of BIS, and two, how many ECPs have written multiple scripts within our target ECP universe. Once scripts begin to become meaningful, likely into the new year, our focus will then shift towards total new patient starts, or NRXs. This will further evolve as we get into 2026, where the emphasis on NRXs will continue, but then also shift to include total scripts, or TRXs, with an emphasis importantly on RRXs, or refill prescriptions, in the second quarter of next year. As you will recall, the third pillar of our commercial strategy is focused on the ease of access for the consumer.
As we have discussed previously, our sampling campaign is core to our commercial strategy, and we anticipate samples will be available in the market as early as October of this year. This will then be followed by commercial product being broadly available by mid-Q4 through both the traditional retail pharmacy and e-pharmacy channels. We like this commercial product distribution strategy as it will provide both LENZ and the consumer with multiple available channels for BIS, with an aim to reduce any barriers to product access. However, we would like to take this opportunity to caution immediately not to rely on weekly IQVIA data early in the launch phase. Script data will likely not flow accurately early on and have a substantial lag, principally between the e-pharmacy and IQVIA. We will be sure to help clarify channel mix and script levels in the first quarters of launch.
We are looking forward to the tremendous months ahead as we launch BIS, supported by our fantastic sales force, as they work to prepare the ECP community for samples and commercial product availability in the months ahead. With that, I will conclude my remarks, and I'll turn the call back over to Evert for final remarks.
Thanks, Dan. As you can see, our team is ready for this moment. The commercial team has locked and loaded the sales force as world-class, and we've built the company for this moment on a foundation of financial strength. We're very confident in our abilities to execute the successful launch of BIS, and I'm thrilled to bring forward the first and only daily, up to 10-hour lasting presbyopia solution to the market. With that, I'd like to open up the call for questions.
We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to be sure a question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue. Our first question comes from the line of Stacy Ku with TD Cowen. Your line is open.
Great. Good morning. Thanks for taking our questions. Congrats on the BIS approval. By the way, the website is very nice. We have a few questions. First, in the time before now and the October sampling, maybe, Shawn, can you talk about that full 88 fully trained sales force and what type of outreach is possible? Maybe talk about prescribers that are, are you going back to the prescribers that are already familiar with LNZ100 in addition to Vuity? Just how long will it take to educate your target 1,500 ECPs? Are you going to be able to target them multiple times before October comes around? Help us set expectations there as you talk about hitting the ground running. That's question number one. Question number two is really about expectation setting.
As we think about maybe that phase from then sampling to commercial launch, David and Marc, maybe talk about the right expectation setting as you all collaborate. What considerations may be important as you think about consumer launch versus maybe a health care launch and what considerations you all are taking there, especially as it relates to what you're setting in terms of maybe the BIS website. I see it saying up to 10 hours, and the commentary today all suggests that that's what you all are using. Once daily durability is probably already sufficient at eight hours with pretty high patient satisfaction. Help us understand how you all are thinking about things here. Of course, related to expectations on efficacy, when it comes to the safety profile, our KOL checks suggest that patients will defer to the prescriber opinion.
Is that the case for you all as you're doing much deeper diligence? That's the second question. Really appreciate, Dan, all the different metrics that you've talked about. Maybe in the beginning, Dan or Shawn, what kind of users do you expect to see in the beginning? Obviously, we have patients that have some experience from the Clarity trials. Are the early patients going to be ones that want to use this more frequently with less dabblers, or are you kind of expecting to see kind of the full mix? Help us set expectations in terms of the early launch as we think about kind of samples to launch to commercial launch. Thanks so much.
Thanks, Stacy. Thanks for the congrats. A lot of questions in there. Let's try to group them a little bit. We'll talk a little bit, and Shawn will kick that off. Initial sales tactics, how we're rolling out the sales force. Shawn, if you can end that question, maybe also address the question of who do we initially see in the patient group as the early adopters. I keep talking about expectation settings a little bit there as well. On the safety profile, I'll take that one. Your assumption there of how you stated, Stacy, that patients will defer mostly to the ECP is correct. I think that's how most patients will get their information. The good thing is, as you know, and as we've shown in our clinical trials, this is a very well-tolerated product. We've seen that throughout our trials. We see it in our AE profiles.
The treatment-related AEs, as we've spoken about before, are all mild, short-living, and resolve therefore quickly. Importantly, especially as we've been talking through with the MSL force and with the doctors, that notion of Aceclidine not being ciliary-sparing reads very well or translates very well into discussions. The doctors immediately translate that and understand that that is likely to solve for many of the more serious AEs, and they're obviously coming up as a question. We feel that that discussion is one that will continue to obviously have, and our sales force will probably be the place. Let me label the plan to talk about that now, and that will form a great basis for that confidence that doctors have in our product. With that, Shawn, maybe you can talk a little bit about the sales force.
Absolutely. Stacy, thank you for the question. Happy to give a lot more color around that sales force in the early months. As we stated, we have the 88 outside field reps. In terms of their call points, it continues to remain those 15,000 eye care professionals that we've seen in the past that have prescribed Vuity multiple times. They're calling on those people that we know in the past have had the experience with Vuity and were willing to prescribe it. That's where they'll start. In terms of how things move forward, in July alone, that team already did over 8,000 doctor call visits. As we think between now and sample availability in mid-October, you know that field will be out there calling on their targets, and I would expect multiple visits per doctor prior to that mid-October date.
That's because it's roughly about a three-week call cycle for our field. When we think about those visits, what that looks like is obviously the first visit they're going to be introducing BIS itself. That follow-on visit, they'll be reinforcing the messages and also carrying along consumer pieces that will live within that eye care practice, right? Preparing the doctor for their expectations of the samples arrival and making sure that when they get the samples, you know they have enough to try it on multiple patients to get a good analysis of that product. We absolutely want to cite the right expectations, which goes into your next question. We were very deliberate in the up to 10 hours. We saw in our product at 10 hours, nearly 7 out of 10 patients were still 20/40 or better. This is definitely a category in a consumer product.
You want to set that expectation of up to 10 hours and then let them be delighted when it meets or even may exceed. That's how we want to make sure we set the right expectations. As we're setting, when we're providing the samples to the doctor, setting the expectations, and even though our product is very well tolerated, making sure they pass that information on to the consumer as well of what potential side effects could be so they have a delightful experience as well. Lastly, on the users that we expect, the first users we would expect since our initial promotion is direct to eye care professional, we expect our early adopters to be the ones that are already going into the practice. We've talked about the 40 million people that already get an eye exam.
We know from our market research, those that are most interested are those that are in contacts and want to stay in contacts. Those patients are already going to the doctor, and they're already getting their eye exam every year. In terms of as people start to adopt it, I'd expect the early users to be the ones that are already in that practice and already coming in. Thank you for the question, Stacy.
Thank you. Comes from the line of Yigal Nochomovitz with Citig roup. Your line is open.
Hey, guys. A big congratulations on the early approval. I guess the first question is, did you expect it a week early, and how much does this extra week help you in terms of getting a bit of a leg up on the pre-launch work?
Thank you, Gal. Yeah, we're definitely pleased to see, obviously, that approval coming through. I have to say, and I've tried to weave into that unbox as well, that our interactions with the FDA have been excellent. They've been highly engaged. We've shared in some of the previous calls. We've not seen any changes on the team, and they're very committed to that task and what we all know was and still is a turbulent time within the agency. Very pleased and thankful for that. From the beginning, they've indicated that since it is a new chemical entity, it would likely go the full time until the approval. As you would expect, you know over the last couple of weeks, things go a little bit more silent. We were frankly ready and expecting the approval to come in late next week.
Like I said, I was pleasantly surprised when that email hit my inbox yesterday. Great moment for the company that we briefly celebrated appropriately after they closed the market. How it helps us is, you know we've spoken before that we've manufactured a lot of old products in advance, and we expect this launch to be one of very high volume, initially focused on samples. We obviously could not start packaging final products until we had final label and product discussions and knew that that was all completed a lot. That's currently the case, logically. That's basically the team at the manufacturing facilities now ramping up those final stages of production, packaging, and then ensuring shipments, which is actually what's driving that gap between the approval today and then our guidance that samples will be in the market as early as October. Very pleased again with the approval.
The additional work, additional week definitely helps, and we're working hard to get the products into the market.
Got it. On the label, I was just curious if you could comment on if this was as we expected, specifically with respect to some of the statements on the label regarding the retina exam, the way the drug is stored, as well as the dosing instructions, if that was consistent with your expectations.
It definitely was. I don't think we've been very clear about that from the beginning that even though, and again, the FDA clearly recognizes that our MOA is different than the final product, we'd always expect it if the FDA looks at the retina exam as a class effect. We actually think that that's a good thing. I think it's a great way to include the ECP community in this, allow them to extend their patient population. We mentioned it in our prepared remarks, only about one reason for the field to actually see the eye doctor. Most others, and frankly, like me, turn to Amazon or wherever for their $2 readers. There's 80 million additional patients that can be brought into their practices. Nothing unexpected there. We like our label. We think it's nicely and clearly differentiated on important points.
It importantly highlights the fact that we have data up to 10 hours, which nobody else has, that it's ciliary-sparing and very easy product to use.
With regard to just the storage specifically on the refrigeration, is anything specific to say there? I know it mentioned that it can be stored at room temperature for 30 days, which seems fine.
Yes. No, that's something that was important to us and that we obviously designed the product for. The thing is for our scope, chain up to the whole saline, which is obviously very common for many, many eye drugs and many other products. As soon as it hits the consumer door, it can actually be room temp, which is important. You don't want to burden the consumer with having to keep this product in their fridge. We can ship from wholesaler to consumer room temperature as well. It's very important. Then there's just your normal eye drop that's on your counter or bathroom desk.
Are there any further details or expectations with respect to how you're going to build the social media campaign and when we might learn more about high-profile influencers that may participate in your marketing?
Hi, Yigal. Yes. When we think about the social media campaign, what you will expect is you'll start to see all of our pages turn on. That will include our pages on YouTube, our pages on Instagram, all of our pages on Facebook. You'll start to see all those come alive with the evergreen content. In terms of when we think about the influencers and celebrity, that's really going to take place in 2026 when we turn on that direct-to-consumer campaign. We're really going to focus in Q4. Q4, we're really going to focus on getting the practitioners, the eye doctors, comfortable with the product, using the samples, early prescribing. Once 2026 hits, that will be when we start to turn on the DTC and bring it through the celebrities.
All right. Congrats again.
Thank you. Thanks, Yigal.
Next question. Next question comes from the line of Marc Goodman with Leerink Partners. Your line is open.
Yeah, I was just curious. What is your competitor Qlosi kind of saying out there, their marketing pitch? How are you going to kind of counter-detail with your marketing pitch? It just seems kind of obvious how much your better product is, but I'm just curious, like what are they saying out there?
Thanks, Marc. I think that's a question that's passed off to Qlosi. I think that the focus of their product is obviously very different than ours. Although we take all competition seriously, we don't see that there's a lot of traction in the market, and it's not something that comes up importantly in any of the discussions that either our MSL team or the sales team has in the market. Frankly, one of the first questions that mostly come up, and again, not to drive a wedge, but is this is not another pilot company. The moment that we explain that it's not, that's where the discussion turns to great. Obviously, the MSL team is the only team to date that could actually talk about the data. The data is very impressive, and people see that, and it's very clear to compare products and see how different the data is.
Our messaging is not focused on how we're different. It's how our product works, how well it works, what it does for patients, and as Shawn said, set the right expectations for that. We're very focused on psyching in our product as we should be.
Dan, that 80 to 100 per year, is that including the cost of the field force?
Yes, that's inclusive for 2026.
Our next question comes from the line of Jason Gerberry with BofA Securities. Your line is open.
Hey, morning, and congrats on the approval and label. A couple for me. Just when we think about 4Q, how many samples do you expect to deliver into the market space? If you could estimate a conversion rate on that to actual paid script, that would be an interesting data point just in terms of how you're thinking about the sampling effort and maybe what that could yield. My second question is just on the pupil selectivity language in section 12 of the label, how obvious do you think that's going to be to HCPs that may confer a differentiated safety profile versus sort of the class safety warning that's in the label? I'm just kind of curious how much of an educational lift is going to be needed there with the HCPs.
My last question around the cash and the commentary about getting to break even, I think in the past, I recall maybe some comments about doing that within three quarters of the launch. Wondering if you could confirm if that's still an appropriate way to think about the time course to getting to break even on the launch. Thank you.
Thanks, Jason. We'll break those questions out, Marc, and then we'll take two and three. On the samples, our aim is to make sure that all those 15,000 doctors that we're targeting will ultimately have access to samples. We know that if you look at our data, 93% of patients are at least 20/40 within 30 minutes. We can frankly pretty much guarantee that if you're a presbyope and you put the spark into your eyes, you'll be able to see a text message on your phone again. That's that experience that we want to be able to make widely available. We want to make sure it's widely available in the market. That's going to allow doctors and patients to decide, hey, is this something for me?
While we're not going to give numbers on how many samples that means, you can expect that that's something that our sales force is going to be focused on to make sure that those samples are well stocked and well used in doctors' offices. The call cycle, that three-week call cycle that Shawn was talking about, gives them an opportunity to see how quickly doctors are going through samples and how that is converting into scripts. That conversion rate is something that we'll start to see at some point, but it's not something that we can and will share widely. The more important point is here that we will sample very, very broadly.
I can just follow up quickly on that point. The 15,000 targeted HCPs, I'd imagine that the 40 million that are in the treatment system, that HCP footprint is broader to cover the full 40 million, though, right? I mean, the 15,000 HCPs, I recall that's a mix of ODs and ophthalmologists that have more of a medical practice. Just maybe if you can clarify that point.
Yeah, no, I'm happy to do so. Yes, there's many more HCPs. That 15,000 is 80/20 on optometrists, ophthalmologists, really built around practice size, as well as focused on doctors that back in the day prescribed Vuity or prescribing other products. It's fair to assume that these are the doctors that are ultimately seeing the majority of general patients across the market. They are covering most of the eye exams in those 15,000. On the differentiation and how easy that is to understand, I'll pass it on to Marc. We're very pleased that the label differentiates there. Obviously, it's something that now our sales force can talk about. We have a lot of experience between the, frankly, up to 3,000 or 4,000 discussions that the MSL team already had, and the 8,000 or so that the sales force has.
Obviously, the sales force has not been able to talk about that just yet. Marc, maybe give your experience as the leader of the MSL team on how easy it is for an ECP to translate the difference in MOA into a different safety profile.
Thank you, Ethan. Thank you for the question. As you do point out in the PI or prescriber information, section 12.1, the mechanism of action clearly differentiates us from the other myotics. What it really speaks to is the selectivity of this particular agent. The experience has been through our MSL, our medical science liaisons, that this has great resonance with the eye care practitioners. They all understand immediately that a drug that does affect the iris sphincter predominantly and is ciliary-sparing is a unique opportunity. The traction that we see is all of them understanding immediately that the capability of this drug is to constrict the pupil and not induce both the side effects and the effects of ciliary muscle, which would mean that you would cause myopic shifts with those that do touch the ciliary muscle in addition to other issues.
It has great traction, and I think it's unique in its ability to speak to the eye care professionals in a way that really appeals to the science and the strategic difference of this drug.
Thanks, Marc.
Maybe I'll take that one question. Jason, you asked about the cash guidance there. A couple of just quick highlights. We're very pleased with our cash position and have been extremely consistent with how we've guided around cash runway and our ability to get all the way to positive cash flow. In fact, this is the fifth consecutive quarter we've guided in that way. If you actually reflect back as a newly public company, our ending cash or cash at PDUFA is remarkably similar to the cash that we had at the end of the first quarter of 2024 when we then stated we had cash to positive cash flow. As far as the revenue guidance and the time to break even, that's not something that has ever come from us. We've not guided on revenues and don't plan to for the foreseeable future. Thanks for the question.
Our next question comes from the line of Biren Amin with Piper Sandler. Your line is open.
Yeah, hi, guys. Thanks for taking my questions and congrats on the approval. Maybe start on your DTC strategy. What's the driver that's starting in the first quarter of next year compared to initiating sooner during mid-four when the product would be fully available? I think that campaign's pretty much ready to go. Just your thoughts there in terms of timing. I guess, based on the second question on your MSL conversations this year with optometrists and ECPs, you mentioned that you had received strong feedback from those conversations. Were there any points of hesitancy that were brought up during those conversations? If so, what were they? Third question on the e-pharmacy to IQVIA lag. What's a typical lag that one should expect between e-pharmacy and reporting to IQVIA? Thank you.
Thanks, Biren. Great questions. Shawn will actually talk about the DTC and the lack of data from IQVIA and how well you can lean on that or maybe then we'll weigh into that. I'll start out with the feedback that we get from them as well as then Marc, please add to it. What we see and what I alluded to earlier is that the first question that comes up mostly is, is this pilot happening? When we say, no, it's not, it's very easy to start to have that discussion on how is the MOA different, what's the importance of getting below 2 millis, and then showing that data. What we see is that in the course of that discussion, people are maybe a little bit more skeptical early on. One meeting turned to, wow, the data is just very, very strong. Any hesitancy?
We wouldn't call it really hesitancy, but I think there's a question out there, which is the right one on, great, this all looks great. When can I get a product? When can I get a sample? When can I start using this on my patients to see what this does in the real world? That's where our confidence comes in, just looking at the product, looking at the profile, and frankly, looking at the feedback that we had from really hundreds of patients in our study and how they reacted to the product. We've shared some of that feedback in the commercial day. It's on the website now. I know many of you have spoken to investigators that were in our trials. Universally, people are saying that this thing works. People put a drop in their eye and they can see up close again, and they like that, obviously.
That's, I think, how most of those discussions are going. We've studied many of them, and again, very high confidence in what this will do in the doctor community. Anything to add to that, Marc?
No, I think the key is the initial conversation that you point out, Evert, with the eye care professionals. Once they hear it's not pilocarpine, and once they hear our clear messaging on what is the optimal pupil size and what we've done to pursue it and the data supporting that, they are very involved and interested. They are engaged. The engagement is really the unique feature here. The eye care professionals are looking for this. They're hungry for this. I think the patients will be hungry also once this becomes ubiquitous in the market.
Thanks, Marc. Shawn, if you can talk about why we've timed the DTC to Q1.
Yes, focusing in on why we focused on Q1 for the start of DTC. What we've learned in our discussions with eye care professionals is they want some time to get experience with the product before consumers are then driven into that practice. Our expectation is by Q1, we'll have enough visits and samples used by the doctor that it's the accurate and right time to turn on the direct-to-consumer campaigns. This is feedback we also learned in talking to doctors from the launch with Vuity, where that DTC came on a little bit too soon. It is great to hear you say that you see it looks like everything's ready for DTC, and you're right. Everything looks great and is ready to go.
It's more about a timing of when it's the right time to turn it on to make sure that the doctors are ready before we send more consumers into their office. A quick comment on the e-pharmacy. When you think of IQVIA data in general, you know they aggregate data that they buy from predominantly retail pharmacies. That would not include potentially data from our e-pharmacy. Because of that, you know they would be blind to that data. That reconciliation does happen, but I would think of that as months, not weeks, to get that all set up and talking to each other. That's why it's very important not to focus on the data coming through IQVIA early on. We can give more guidance on clarity of what's going on as that gets closer.
Great. Thank you.
Next question comes from the line of Lachlan Hanbury -Brown with William Blair. Your line is open.
Hey, guys. Thanks for the question and congrats on the approval. I guess the first question I have is on the dosing instructions. Calling for two drops instilled two minutes apart, was that your expectation and how it was done in the trial? Do you think that there could be a risk that patients might only instill one drop sometimes? If they do, do you have a sense of what that would do for the efficacy that they experience? A second question is just on a publication plan to get additional data out there so that MSL and so on can speak to that, like the two-line gain and the 20/40 and so on. Is that having already been presented at a conference, are they already able to speak about that, or are you looking to sort of publish stuff in peer-reviewed journals so they have that in hand? Great.
Thanks, Lachlan. On the dosing, yes, we expected that, and that's obviously exactly how we tested the product in our trials. It's a very easy dosing regimen. It's very easy to follow. We're pleased to see that. It's a great way to get the product to work the way that we want it to work. We've not tested it as a one-drop, so I can't elaborate on what that would do and how different that would be. Obviously, we've seen great data for the product as we've used it. We don't think that there's a risk around it. I don't quite know what that would be. These are single-use vials that have enough product in there for exactly a dosing regimen that you need. You can't close them out. I don't think there's any risk there. As to the publication strategy, yes, we are planning to formally publish.
Frankly, most, if not all, of our data is already out there. MSL can talk about all that data that's there. Similarly, sales force can, with the data that's in the label, talk about that. There will also be a very broad speaker program where we'll have upwards of 50 KOLs that are being trained on messaging that will expand that message to some of the different endpoints that we've made. Anything on your end, Marc, that you can add and want to add on how we can talk about, for example, two-line gain, 20/40, you and/or Shawn?
No, Shawn, I think you covered the question. I have nothing to add.
Yeah, from my side, a lot of this data you'll actually start to see roll out and be available. Publication strategies are obviously underway, but the ability to use them is still okay from our legal guidance.
Next question comes from the line of Gary Nachman with Raymond James. Your line is open.
Thanks, and my congrats as well on the early approval. With the initial physician marketing effort that's starting immediately, is there a reason you can't make samples available prior to October? Why are you waiting a couple of months for that, assuming the ECPs will want to see those as soon as possible once you start making noise with them? How will you be encouraging the conversion of samples to paid RXs? What tools will you have in place to do that? Lastly, what sort of patient assistance will you offer in terms of rebates and discounts to help with access? What should we anticipate average net pricing will be relative to the $79 and $198 pricing you mentioned?
Great question. Thanks, Gary. Last two, Shawn will address. I'll just very briefly reiterate what I said earlier. The gap between our approval and samples available in the market is purely a practical one. We had to wait for final label. This is not in College Park. We have got a couple of thousand vials that you can handpack. These are many, many, many sample packs and retail packs that had to be and are being finally finished. That's just driving the timing to get that logistically done, packaged up, shipped, and into the channel. We'll keep everybody abreast on when those samples are available. Shawn will talk about how we're driving the conversion of samples to script and how we secure pricing to patients.
Absolutely. Starting with the patient assistance first, what we really like about this market and this product is it's a cash pay market, right? Where other companies often have to worry about what exactly is the out-of-pocket and the volatility and timing of when it's covered by insurance, we can offer immediate access right away. Through our e-pharmacy partner, it will have the $79 price for that one-month 25-vial supply. For those that are super users, they have the option to go for a three-month supply, which is $198. It drops that per-month price substantially. For those that want to be available to pick it up in the retail, we will also have partnerships with GoodRx to make sure that we have consistent pricing at the retail channel.
When you think of the consumer out-of-pocket, it really should be focused around that $79 per one-month supply, potentially, depending on mix, the $198 for the three-month supply. Those are the patient programs we have available, and we're very happy how it creates a very clear pricing system. In terms of encouraging the conversion from samples to scripts, that falls right into our third pillar on ease of access. We want to have scripts out there because we know they work, right? When people try it, they feel it, and they know that they can see better. To help on that transition to scripts, our strategy would be working with the doctors to make sure they set the right expectations so there's that positive experience. Also, we want them to move forward with both the sample and the script, and therefore they move very quickly from trial to usage.
They can do that by sending the script to the e-pharmacy. The patient gets that text on their phone, and they fill the script when they're ready. That's how we'll help manage that trial-to-conversion step. Hopefully, that answers your question.
Yeah. If I could just squeeze in one follow-up, you know when you guys start the DTC campaign in early 2026, just how robust will it be? I'm curious what portion of the $80 to $100 million in annual spend will be going towards that and your confidence you'll get a good ROI on that investment. Maybe how long before you get good pull-through from the DTC campaign, maybe what your experience and marketing folks are telling you. Thanks.
Yeah, we'll give a brief answer. Sorry, Shawn. We've seen from Vuity and other launches that this is obviously a population that's highly motivated and you can activate well. You can think about that number, the 80 to 100 million, that a significant part of that will go to DTC. Thanks, Gary.
Next question comes from the line of Matthew Caufield with HC Wainwright. Your line is open.
Hi, thanks, and major congrats, guys. In our speaking with optometrists and ophthalmologists, KOLs, there's obviously been a strong desire for samples that you've discussed. There's also been mention of trying the product in-office while the patient basically waits in the waiting room and then reviewing the vis benefit and profile together. Is that something that you think could be realistic in-office and/or encouraged from the sales team strategically?
Great question. What we see is that, yes, there's a portion of doctors that want to do this in-office, and that's completely fine. We've obviously seen how the product works. You think of that 30 minutes as, frankly, just our first realistic time point that we could measure in a clinical trial. We could see, and we've seen, that the effect might start earlier than that. I think it's very well feasible for some doctors that want to drop in to the patient and to kind of let the patient see what it does. What they'll see is, and what they should see, is the same result that we've seen in our clinical trial, like a very rapid onset for almost every single patient. That's definitely something that can be done.
Excellent. Great to hear. Major congrats again, guys, to the team.
Thanks, Matt. Appreciate it. That
concludes our question and answer session, and I'm showing no further questions. Thank you for your participation, and we will now conclude today's conference call. You may now disconnect.