Q4 2024 Lenz Therapeutics Inc Earnings Call
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Operator: Good morning, ladies and gentlemen, and welcome to the Lenz Therapeutics Year-End 2024 Financial Results Conference. This time, all participants are in a listening-only mode.
Speaker Change: Good morning, ladies and gentlemen, and welcome to the lens Therapeutics year end 2024 financial results Conference call.
Time, all participants are in a listen only mode.
Operator: Following prepared remarks from the management, we will conduct a question and answer session with instructions will follow at that time. As a reminder, this call is being recorded.
Speaker Change: Following prepared remarks from the management, we will conduct a question and answer session with instructions will follow at that time.
Speaker Change: As a reminder, this call is being recorded.
Operator: This time I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead. Thank you.
Speaker Change: At this time I would like to turn the call over to Dan Shovel art.
Speaker Change: <unk> Financial Officer. Please go ahead.
Speaker Change: Thank you good afternoon, and thank you for joining US today My name is Dan shovel, our Chief financial Officer of lens Therapeutics we.
Daniel Chevallard: Good afternoon and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of Lenz Therapeutics.
Daniel Chevallard: We are joined today by Eve Schimmelpennink, our President and Chief Executive Officer, and Sean Olson, our Chief Commercial Officer, as well as Dr. Mark Odrich, Chief Medical Officer, who will join us for the question and answer session.
Speaker Change: We are joined today by extreme OPEC, our president and Chief Executive Officer, and Sean Olson, Our Chief commercial officer as well as Dr. Mark <unk>, Chief Medical Officer, who will join us for the question and answer session.
Daniel Chevallard: Before we begin, I would like to remind you that this call will contain forward-looking statements regarding Lenz's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections, and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, which can also be found on our website. In addition, any forward-looking statements represent only our views as of the day of this webcast and should not be relied upon as representing our views as of any subsequent date.
Speaker Change: Before we begin I would like to remind you that this call will contain forward looking statements regarding lenses future expectations plans prospects corporate strategy regulatory and commercial plans and expectations cash runway projections and performance.
Speaker Change: Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, which can also be found on our website.
Speaker Change: In addition, any forward looking statements represent only our views as of the day of this webcast and should not be relied upon as representing our views as of any subsequent date.
Daniel Chevallard: We specifically disclaim any obligations to update such statements.
Speaker Change: We specifically disclaim any obligations to update such statements.
Daniel Chevallard: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our 2024 Form 10-K, which is being filed today.
Speaker Change: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our 2024 Form 10-K, which is being filed today.
Operator: With that, I will now turn the call over. Thank you, Dan, and good afternoon, everyone.
Speaker Change: With that I'll now turn the call over to <unk>.
Speaker Change: Thank you Dan and good afternoon, everyone.
Eve Schimmelpennink: 2024 has been a highly successful year for Lenz, and I'm extremely proud of all we have accomplished. We are truly building something special, and I strongly believe we have put ourselves in a position to have an even greater and transformational year in 2025. as we aim to emerge as a commercial company.
Speaker Change: 24, it's been a highly successful year for lengths and I'm extremely proud of all we have accomplished.
Speaker Change: We are truly building something special and I strongly believe we have put ourselves in a position to have an even greater and transformational year in 2025.
Speaker Change: We aim to emerge as a commercial company.
Eve Schimmelpennink: On previous calls, I've mentioned the consistent pattern of execution by the team, and I would like to take a moment to acknowledge that effort. We are a team that are the best when we are together. We go fast with purpose. We relish ingenuity. And we are Lenz.
Speaker Change: On previous calls I've mentioned, the consistent pattern of execution by the team.
Speaker Change: Like to take a moment and acknowledge that efforts.
Speaker Change: We are a team that are best when we are together, we got past the purpose, we relish ingenuity we are relentless.
Eve Schimmelpennink: On the back of these core values, we had a tremendous year in 2024, highlighted by our emergence as a public company in March and completion of our phase three clarity study and announcement of stellar data for LNG 100 in April. This was followed by the execution of a $30 million pipe financing with Richback Capital in July. Submission of our NDA in August and its acceptance in October. all contributing to significant progress and momentum as we work towards the potential approval and launch of LMZ 100.
Speaker Change: On the back of these core values, we had a tremendous year and 'twenty four.
Speaker Change: Highlighted by our emergence as a public company in March and completion of our phase III clarity study announcement of stellar data quite Lindsay 100 in April.
Speaker Change: This was followed by the execution of a $30 million by financing with rich back capital in July.
Speaker Change: Mission of our Anda in August.
Speaker Change: Its acceptance in October.
Speaker Change: All contributing to the significant progress and momentum as we work towards the potential approval and launch of LNG one hundreds.
Eve Schimmelpennink: With all of the exciting progress we've made over 2024, the fourth quarter and most recent period has been a critical time as we have completely transitioned to a pre-commercial company and have entered 2025 in a position of financial strength. Ending 2024 with over $209 million in cash.
With all of the exciting progress we've made over 20000 for the fourth quarter. The most recent period that's been a critical time.
Speaker Change: As we have completely transitioned to a pre commercial company and have entered 2025 and a position of financial strength.
Speaker Change: I think 2024 with over two and a $9 million in cash.
Eve Schimmelpennink: I'd now like to take a few minutes to highlight five key areas of corporate focus where we've seen excellent progress in recent months. Regulatory, Manufacturing Readiness, Medical Affairs, Intellectual Property and Pre-launch Commercial Planning.
Speaker Change: I'd now like to take a few minutes to highlight five key areas of corporate focus.
Speaker Change: <unk> seen excellent progress in recent months.
Speaker Change: Regulatory.
Speaker Change: Manufacturing readiness medical affairs intellectual property and prelaunch commercial planning.
Eve Schimmelpennink: First, on the regulatory front, in what has been a very constructive and highly engaged process thus far, we continue to make encouraging progress with the FDA on our NDA review. In January of this year, we completed our mid-cycle review, which is a key milestone in the agency's review program. But we were very pleased that the agency noted no significant review issues and that they reiterated that no plans to request an advisory committee meeting. Importantly, in light of the recent developments around federally funded agencies, FDA inspections on our clinical trial sites are now underway. And we are pleased to report that we have confidence that our MDA review has been uninterrupted and is making great progress.
Speaker Change: First on the regulatory front and what it has been a very constructive and highly engaged process thus far.
Speaker Change: We continue to make encouraging progress with the FDA on our NDA review.
Speaker Change: In January of this year, we completed a mid cycle review, which is a key milestone in the agency's review progress.
Speaker Change: We were very pleased that the agency noted no significant review issues.
Speaker Change: They reiterated that no plans to request an advisory Committee meeting.
Speaker Change: Importantly in light of the recent developments around federally funded agencies FDA inspections on our clinical trial sites are now underway.
Speaker Change: And we are pleased to report that we have confidence that our NDA review has been uninterrupted and is making great progress as.
Eve Schimmelpennink: As such, we continue to believe that we are well-positioned for potential on-time approval in August 2025, which, if granted, will be immediately followed by commercial launch activities in the United States with products anticipated to be available in the market in the fourth quarter of 2025.
Speaker Change: As such we continue to believe that we are well positioned for a potential <unk> approval in August 2025.
Speaker Change: If granted will be immediately followed by commercial launch activities in the United States with products anticipated to be available in the market in the fourth quarter of 2025.
Eve Schimmelpennink: Second, on manufacturing readiness, I am particularly pleased with the progress the manufacturing operations team has made in recent months, importantly, and signifying an important milestone. In February, we initiated the manufacturing of potential commercial products. The team, together with our manufacturing partners, has been working tirelessly to enable the achievement of this important landmark, and will continue to focus over the coming months on manufacturing adequate commercial sample and product inventory to support a successful launch. For the time being, this product will be kept in bulk and, following label discussions and potential approval of our NDA, undergo final packaging.
Speaker Change: Second on manufacturing readiness, I am, particularly pleased with the progress the manufacturing operations team has made in recent months importantly, a cigna and signifying an important milestone.
Speaker Change: In February we initiated at the manufacturing of potential commercial products.
Speaker Change: The team together with our manufacturing partners has been working tirelessly to enable the achievement of this important landmark and will continue to focus over the coming months and manufacturing adequate commercial sample and product inventory to support a successful launch.
Speaker Change: For the time being this Brian will be kept in bulk and following label discussions and potential approval of our NDA undergo final packaging.
Eve Schimmelpennink: As a result, and following FDA approval, we expect to have commercial products available in the market in Q4 of this year.
Speaker Change: As a result, and following FDA approval, we expect to have commercial product available in the market in Q4 of this year.
Eve Schimmelpennink: Third, I'm very excited to highlight key progress from Medical Affairs Team. We are seeing noteworthy ICAP professional engagement nationwide. led by meaningful interactions by our all optometrists medical science liaison team who have been very active at state and national medical conferences. Educating the ECP community on the importance of being pupil selected and the differentiation of a psychedelic ciliary body sparing mechanism of action. as well as on the data from the Phase III Clarity Study. Just a few weeks ago, the medical team held a fantastic event at SECO in Atlanta, where we hosted over 100 ECPs at the College Football Hall of Fame.
Speaker Change: Third I'm very excited to highlight highlights key progress from our medical affairs team.
Speaker Change: We are seeing noteworthy I kept professional engagement nationwide.
Speaker Change: A meaningful interactions by our all optometrists medical science liaison team.
Speaker Change: <unk> been very active at state and National medical conferences.
Speaker Change: And the ACP community community on the importance of being pupil selected.
Speaker Change: And the differentiation of our cycle guidance ciliary body sparing mechanism of action.
As well as on the data from the phase III clarity study.
Speaker Change: Just a few weeks ago, the medical team held a fantastic event at CECO in Atlanta.
Speaker Change: At over 100, Ecp's at the College Football Hall of Fame and.
Eve Schimmelpennink: And since the beginning of Q4, we've had meaningful medical interactions with more than a thousand individual ECPs. Our intent is to have our MSL team engage with a majority of our key target ECPs ahead of our PDUFA date.
Speaker Change: Since the beginning of Q4, we've had meaningful medical interactions.
Speaker Change: More than a thousand individual acp's.
Speaker Change: Our intent is to have an MSL team engage with a majority of our key saga ecp's a half of <unk>.
Eve Schimmelpennink: Next, a foundational area of focus and recent progress has been on intellectual property. More specifically, a domestic and international patent estate for LNG 100. We have continued to strengthen our patent tickets and currently have seven granted patents in the United States that go out to 2039, with an additional 10 patents under review that aim to extend our patent protection to at least 2044. Together with the expected five years of NC exclusivity, we believe our product is extremely well protected and set up for longevity. In addition, we continue to extend our patent portfolio XUS to support the significant commercial opportunity we believe exists there.
Speaker Change: Next a foundational area of focus and recent progress has been on intellectual property.
Speaker Change: More specifically, our domestic and international patent estate for LNG one hundreds.
Speaker Change: We have continued to strengthen our patent patent tickets and currently have seven granted patents in the United States as.
Speaker Change: They go out to find it 39 additional 10 patents under review that aimed to extend our patent protection to at least 2044.
Speaker Change: Together with the expected five years of exclusivity, we believe our product is extremely well protected and setup for longevity.
Speaker Change: In addition, we continue to extend our patent portfolio ex U S to support the significant commercial opportunity we believe exists there.
Eve Schimmelpennink: And lastly, I'll turn to pre-launch commercial planning. The commercial team has been hard at work, and before I turn it over to Sean to step through in more detail, I would like to highlight a few key items. First, the hiring of a sales force is in its final stages. Both of our regional directors were hired in Q4, and we now hire all 10 of our district managers. We've been extremely pleased with the excellent quality of candidates we are attracting to significant eye care experiences across the board. As you may have seen, last week we launched a hiring campaign for our 88th Territory Sales Force, our last sales hires, and as an indication of the anticipation we believe exists in the market, received over 1,300 applications within the first 24 hours of posting the job profile.
Speaker Change: And lastly, I'll turn to pre launch commercial planning.
Speaker Change: The commercial team has been hard at work and before I turn it over to Sean to step through in more detail I would like to highlight a few key items first the hiring of our sales force is in its final stage.
Speaker Change: Both of our regional directors will hire in Q4 and went out Hyatt all 10 of our district managers.
Speaker Change: We've been extremely pleased with the excellent quality of candidates, we are attracting significant ikat experiences across the board.
Speaker Change: As you May have seen last week, we launched our hiring campaign for our 88 territory sales force.
Speaker Change: Sales highest and.
Speaker Change: As an indication of the anticipation we believe exists in the market.
Speaker Change: Received over 1300 applications within the first 24 hours of posting the job profiles.
Eve Schimmelpennink: We look forward to hiring only the best and most talented candidates to Lenz and have them fully onboarded ahead of our PDUFA day. This will ensure that they can be in the fields promoting our products immediately after potential approval and get one or more call cycles in ahead of product being available in the market.
Speaker Change: We are looking forward to hiring all the best and most talented candidates two lens.
Speaker Change: Fully on boarded ahead of <unk> dates.
Speaker Change: This will ensure that they can be in the field promoting our products immediately after potential approval.
Speaker Change: And get one or more cold cycles in ahead of product being available in the market.
Eve Schimmelpennink: Second, we're very much looking forward to our upcoming commercial day on April 15. We will have the opportunity to elaborate on our commercial strategy and pre-launch preparations as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNG 100.
Speaker Change: Second we're very much looking forward to our upcoming commercial day on April 15.
Speaker Change: Well, we will have the opportunity to elaborate on our commercial strategy and pre launch preparations as well as bring forward additional key opinion leader and ACP perspectives as we approach the potential approval and launch of LNG 100.
Eve Schimmelpennink: Something Sean will touch on in more detail shortly. As I mentioned in my opening remarks, 2024 has been a highly successful year, and the recent period has continued to be extremely productive as we prepare for the potential approval of LNG 100.
Speaker Change: Thanks, Sean will touch on in more detail shortly.
Speaker Change: As I mentioned in my opening remarks, 2024 has been a highly successful year in the recent period as we continue to be extremely productive as we prepare for a potential approval of LNG one hundreds.
Sean Olson: I will now hand the call over to Sean Olson, our Chief Commercial Officer, to provide additional comments on our pre-commercial planning efforts. Sean.
Speaker Change: I will now hand, the call over to Sean Olson, our chief commercial officer to provide additional comments on our pre commercial planning efforts Sean.
Sean Olson: Thank you, Ace, and good afternoon, everyone. As we have discussed on previous calls, the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities in the United States. Presbyopia impacts an estimated 128 million people in the US, a population incidence that's nearly four times larger than those impacted by dry eye and nearly six times larger than those impacted by demodex blepharitis. For further context, presbyopia impacts more than the combined population in the US, suffering from dry eye, demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma combined. The first eyedrop treatment for presbyopia was approved in 2021.
Sean Olson: Thank you Amy and good afternoon, everyone.
Sean Olson: As we have discussed on previous calls the commercial potential for an effective presbyopia treatment represents one of the largest ICM market opportunities in the United States.
Sean Olson: Presbyopia impact an estimated 129 people in the U S.
Sean Olson: Our population incidents that nearly four times larger than those impacted by dry eye and nearly six times larger than those impacted <unk> blepharitis.
Sean Olson: For further context presbyopia impacts more than the combined population in the U S suffering from dry eye <unk> blepharitis childhood, myopia, macular degeneration, diabetic retinopathy and glaucoma combines.
Sean Olson: First I drop treatment for Presbyopia was approved in 2021.
Sean Olson: and confirmed that there is strong consumer desire for an iDOT treatment as evidenced by initial paid new scripts of up to $6,000 per week. Long-term usage beyond the trial period of this product did not materialize as pylocarpine, even at the high concentration of 1.25%, cannot deliver the consumer-required performance. Other attempts at a lower dose BID strategies are being pursued, but given the efficacy profile is very similar to that of UTI, we do not believe they will clear the consumer hurdle for performance. or the ECP Desire for a pupil-selected honor. We continue to believe the category is wide open for an eyedrop solution that can deliver what consumers desire.
Sean Olson: And confirm that there is strong consumer desire.
Sean Olson: <unk> treatment as evidenced by initial paid new scripts of up to 6000 per week.
Sean Olson: Long term usage beyond the trial period. This product did not materialize as pilocarpine, even at the high concentration of 1.25% cannot deliver the consumer required performance.
Sean Olson: Other attempts at a lower dose DIY strategies are being pursued.
Sean Olson: Given the efficacy profile is very similar to that annuity we do not believe they will clear the consumer hurdle for performance.
Sean Olson: Or the ECP desire for a pupil selected option.
Sean Olson: We continue to believe the category is wide open for an eye drop solution that can deliver what consumers desire.
Sean Olson: A once-a-day eyedrop that provides seamless near vision for the full workday for the majority of presidents. Unlocking this market requires an ideal presbyopia eyedrop, and we are excited for the prospect of a cyclidine-based LNZ100. We believe the commercial potential of LMZ100 was validated in our Phase 3 clarity study. with 90% of participants noticing an improvement in their vision and 75% participants indicating they would continue to use LNC100 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 L&G 100 well for the estimated $3 billion plus potential market opportunity, creating a potential category of one.
Sean Olson: Once a day eye drop that provides seamless near vision for the full workday for the majority of presbyopia.
Sean Olson: Unlocking this market requires an ideal presbyopia eyedrop and we are excited for the prospect of a site leading based LNG 100.
Sean Olson: We believe the commercial potential of LNG 100 was validated in our phase III clarity study.
Sean Olson: With 90% of participants noticing the improvement near vision, and 75% participants, indicating they would continue to use the R&D 100 after the study.
Sean Olson: Of which 81% plan to use four to seven days per week.
Sean Olson: Together with our broad inclusion criteria. We believe this positions LNG 100, well for the estimated $3 billion plus potential market opportunity, creating a potential category of one.
Sean Olson: Our commercial team continues to advance its commercial readiness as we progress towards our August 8th PDUFA Day.
Sean Olson: Our commercial team continues to advance its commercial readiness as we progressed towards our honest eight <unk> date, and I would like to just take a moment to provide an update on the three primary pillars of our commercial strategy.
Sean Olson: And I would like to just take a moment to provide an update on the three primary pillars of our commercial strategy. First, we want to make sure doctors are there to recommend us. As Ace mentioned, our all optometrists MSL team is already engaging with ECPs on medical education and fielding questions on the Phase 3 data. In addition, one year ago, our marketing team launched the I Am Selective unbranded campaign at SECO 2021. This is driving ECP awareness and excitement for the future presbyopia solutions that can achieve the necessary sub two millimeter pupil size to restore near vision while not overstimulating the ciliary muscle.
Sean Olson: First we want to make sure our doctors are there to recommend us.
Sean Olson: As <unk> mentioned are all optometrists MSL team is already engaging with Ecp's on medical education and fielding questions on the phase III data.
Sean Olson: In addition, one year ago, our marketing team launched the Iam selective unbranded campaign at CECO 2024.
Sean Olson: This is driving ECP awareness and excitement for the future presbyopia solutions that can achieve the necessary sub two millimeter pupil size to restore near vision, while not over stimulating the ciliary muscle.
Sean Olson: Awareness continues for this campaign and has over 50 KOLs and over 2 million digital campaign impressions targeting over 30,000 ECPs. Lastly, and following potential NDA approval, our sales force will be calling on approximately 15,000 ECPs. with our potential best-in-class product to educate and equip them to recommend LNZ 100 and to integrate our solution into their patient offering. As we prepare for this, the hiring of our sales force has been a key focus over the recent months. Our full sales leadership team was hired in 2025, including both of our regional directors who joined Lenz in Q4.
Sean Olson: Awareness continues for this campaign and has over 50, Kols and over 2 million digital campaign impressions targeting over 30000 Ecp's.
Sean Olson: Lastly, and following potential NDA approval, our sales force will be calling on approximately 15000 ECP.
Sean Olson: With our potential best in class product to educate and equip them to recommend LNG 100 and to integrate our solution into their patient offerings.
Sean Olson: As we prepare for this the hiring of our sales force has been a key focus over the recent months.
Sean Olson: Our full sales leadership team was hired in 2025, including both of our regional directors, who joined lands in Q4.
Sean Olson: Since then, we've continued to grow our sales team and are happy to share that all 10 district managers are now also on board. This core leadership team within the Salesforce brings almost 150 years of eye care experience and over 300 years of total sales. Finally, we have now begun our field based sales rep hiring, with job postings currently available for all 88 territories across the United It's great to see the progress on our first pillar. And as a reminder of what was shared in the last earnings call, our primary market research survey of 426 ECPs yielded that an impressive 82% and 83% of ECPs already being likely to prescribe and sample LNZ100 if FDA approved, respectively, based on the phase 3.
Sean Olson: Since then we've continued to grow our sales team and are happy to share that all 10 district managers are now also onboard.
Sean Olson: This core leadership team within our sales force brings almost a 150 years of <unk> experience and over 300 years of total sales experience.
Sean Olson: Finally, we have now begun our field based sales rep hiring with job postings currently available for all 88 territories across the United States.
Sean Olson: It's great to see the progress on our first pillar and as a reminder of what <unk> shared in the last earnings call. Our primary market Research survey of 426, Ecp's yielded that an impressive 82% and 83% of Etp's.
Sean Olson: Already being likely to prescribe and sample LNG 100, if FDA approved respectively based on the phase III data.
Sean Olson: The second pillar of our commercial strategy is for consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and activate consumer response. Lenz has partnered with multiple New York and California-based advertising agencies to understand the consumer and develop a campaign that will connect emotionally, creating a desire for our brand. We've taken a consumer centric focus in the development of this brand and have leaned into the lifestyle creative We're excited about the brand we have created and the proposed advertisements which have been testing well in market.
Sean Olson: The second pillar of our commercial strategy is for consumers to reclassify name District.
Sean Olson: This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and activate consumer response.
Sean Olson: <unk> partnered with multiple New York, and California based advertising agencies to understand the consumer and develop a campaign that will connect emotionally creating a desire for our brands.
Sean Olson: We've taken a consumer centric focus and the development of this brand and have leaned into the lifestyle creative.
Sean Olson: We're excited about the brand we've created and the proposed advertisements, which had been testing while in market research.
Sean Olson: Our creative is now locked, and the majority of the launch promotional materials are now completed, pending final product insert language. Upon approval, we will launch the ECP materials, and once we feel ECPs are well-educated, we will turn on the direct consumer advertising.
Sean Olson: Our creative is now locked in the majority of the launch promotional materials are now completed pending final product insert language.
Sean Olson: Upon approval, we will launch the ECB materials and once we feel etp's are well educated will turn on the direct to consumer advertising.
Sean Olson: The third and final pillar will ensure ease of sample and product access for patients with a seamless journey to you. This requires enabling the patient to experience the product and move from trial to usage as quickly as possible. To support this, our team has built out consumer sampling capabilities and commercial access across multiple channels, including the traditional retail pharmacy, as well as e-pharmacy home delivery. In our clinical trial, 95% of patients noticed a two lines of improvement on hour one, day one. This immediate response lends itself incredibly well to product sampling. Our sample vendor has been contracted, and after approval, samples will be rep-delivered to eye care professionals, allowing consumers to try the product.
Sean Olson: The third and final pillar will ensure ease a sample and product access for patients with a seamless journey to use.
This requires enabling the patient to experience the product and move from trial usage as quickly as possible to support. This our team has built out consumer sampling capabilities and commercial access across multiple channels, including the traditional retail pharmacy as well as E pharmacy home delivery.
Sean Olson: In our clinical trial, 95% of patients noticed a two line two lines of improvement on our one day one this.
Sean Olson: Immediate response lend itself incredibly well to product sampling.
Sean Olson: Our sample vendor has been contracted and after approval samples will be wrapped delivered to eye care professionals, allowing consumers to try the product.
Sean Olson: Our team has developed a five-day sample pack, similar to the sample size for contacts. which following the initial trial can act like a bridge until the product is picked up at the pharmacy or delivered to the consumer's home. We will continue to drive these three pillars, doctors to recommend us, consumers to request us by name, and a seamless journey to use.
Sean Olson: Our team has developed a five day sample pack similar to the sample size for contacts which following the initial trial can act like a bridge until the practice picked up at the pharmacy or delivered to the consumer's home.
Sean Olson: We will continue to drive these three pillars doctors recommend us consumers to requests by name and a seamless journey to use.
Sean Olson: As we progress towards our PDUFA Before I conclude, we're looking forward to our upcoming commercial day on April 15th. where we will have the opportunity to elaborate on our commercial strategy and pre-launch preparations, as well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of L&Z 100. We feel this is an important event which will give investors, analysts, and others a thoughtful overview of our plans and progress towards the potential approval and launch of L&Z 100.
Sean Olson: As we progress towards our <unk> date.
Sean Olson: Before I conclude we're looking forward to our upcoming commercially on April 15th.
Sean Olson: Where we will have the opportunity to elaborate on our commercial strategy and prelaunch preparations.
Sean Olson: As well as bring forward additional key opinion leader and ECP perspectives as we approach the potential approval and launch of LNG 100, we feel this is an important event, which will give investors analysts and others thought thoughtful overview of our plans and progress towards the potential approval and launch of LNG 100.
Daniel Chevallard: I'd now like to hand the call over to Dan Chevallard, our CFO, to step through our financials. Thank you, Sean. As both Abe and Sean have highlighted, the fourth quarter in a recent period has been a critical time as we have now pivoted to a pre-commercial company. We ended 2024 in a position of financial strength with approximately $209.1 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. Turning now to our fourth quarter financial results, our operating expenses and resulting cash burns were generally consistent with prior quarters and in line with our operating plan.
Sean Olson: I'd now like to hand, the call over to Dan <unk>, our CFO to step through our financial results.
Speaker Change: Thank you Sean as both AF and Sean have highlighted the fourth quarter and recent period has been a critical time as we have now pivoted to a pre commercial company.
Speaker Change: We ended 2024, and a position of financial strength with approximately $209 1 million in cash cash equivalents and marketable securities, which as we have guided previously is anticipated to fund the companys cash runway to post launch positive operating cash flow.
Speaker Change: Turning now to our fourth quarter financial results, our operating expenses and resulting cash burn we're generally consistent with prior quarters and in line with our operating plan.
Daniel Chevallard: Total operating expenses for Q4 2024 were approximately $15.2 million, compared to $25 million for the same period in 2023. In general, this decrease was specifically driven by the fact that we were in the midst of our phase three clarity study in Q4 of last year, which makes these figures less relevant to compare. Perhaps more comparable, on a quarter-over-quarter and sequential basis, our total operating expenses increased by approximately 18% from $12.9 million in the third quarter. From a cash perspective, our Q4 2024 operating cash burn net of interest income was approximately $8.1 million, which was consistent with the $9 million in net cash burn last quarter.
Speaker Change: Operating expenses for Q4, 2024 were approximately $15 2 million compared.
Speaker Change: Compared to $25 million for the same period in 2023.
Speaker Change: In General this decrease was specifically driven by the fact that we were in the midst of our phase III clarity study in Q4 of last year, which makes these figures less relevant to compare.
Speaker Change: Perhaps more comparable on a quarter over quarter and sequential basis. Our total operating expenses increased by approximately 18% from $12 9 million in the third quarter.
Speaker Change: From a cash perspective, our Q4 2020 for operating cash burn net of interest income was approximately $8 $1 million, which was consistent with the $9 million and net cash burn last quarter.
Daniel Chevallard: Total sales, general and administrative expenses increased to $9.4 million in Q4 2024 compared to $5.5 million for the same period in 2023, driven primarily by an increase in commercial headcount and other pre-commercial, pre-launch commercial planning activities. Sequentially, SG&A increased quarter over quarter by approximately 44% from $6.5 million in the third quarter due to significant relative increases in sales and marketing as we continue to ramp our allocation of spend to support our consumer-driven brand planning and the addition of key salesforce leadership. As we have discussed on previous calls, we expect our SG&A expenses and more specifically our sales and marketing expenses to continue to ramp from here as we approach our potential August 2025 approval for LNZ100.
Speaker Change: Total sales general and administrative expenses increased to $9 4 million in Q4, 2024 compared to $5 5 million for the same period in 2023.
Speaker Change: Driven primarily by an increase in commercial head count another crude commercial prelaunch commercial planning activities succumb.
Speaker Change: Sequentially SG&A increased quarter over quarter by approximately 44% from $6 5 million in the third quarter due to significant relative increases in sales and marketing as we continue to ramp our allocation of spend to support our consumer driven brand planning and the addition of key Salesforce leadership.
Speaker Change: As we have discussed on previous calls, we expect our SG&A expenses and more specifically our sales and marketing expenses to continue to ramp from here as we approach our potential August 2025 approval for <unk> hundred.
Daniel Chevallard: Importantly, and as a particular point of emphasis, we will continue to be measured in our spend on the general and administrative side of the organization. Our model will always be to staff appropriately and grow to support our commercial launch and organization at large, but remain a lean and highly efficient G&A team. Turning now to research and development, total R&D expenses decreased to $5.9 million in Q4 2024 compared to $19.5 million for the same period last year. Sequentially, quarter over quarter, R&D expenses once again decreased by approximately 9% from $6.5 million last quarter. The majority of our R&D expenses between now and the time of potential approval will be dedicated to our manufacturing operations team as we build pre-approval commercial product and sample inventory to support our launch.
Speaker Change: Importantly, and as a particular point of emphasis we will continue to be measured in our spend on the general and administrative side of the organization are.
Speaker Change: Our model will always be to staff appropriately and grow to support our commercial launch an organization at large but remain a lean and highly efficient G&A team.
Speaker Change: Turning now to research and development totaled.
Speaker Change: Total R&D expenses decreased to $5 9 million in Q4, 2024 compared to $19 5 million for the same period last year.
Speaker Change: Sequentially quarter over quarter R&D whats the R&D expenses once again decreased by approximately 9% from $6 5 million last quarter.
Speaker Change: The majority of our R&D expenses between now and the time of potential approval will be dedicated to our manufacturing operations team as we build preapproval commercial product and sample inventory to support our launch.
Daniel Chevallard: Finally, our net loss per share, both basic and diluted, was $0.46 per share in the fourth quarter of 2024 on a net loss of $12.7 million, compared to a net loss per share of $12.04 per share in the fourth quarter of 2023 on a net loss of $23.7 million. Q4 2024 net loss per share was calculated on approximately 27.5 million weighted average common shares outstanding, compared to Q4 2023, when as a then private company with multiple classes of preferred in common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding.
Speaker Change: Finally, our net loss per share both basic and diluted was <unk> 46 per share in the fourth quarter 2020 for on a net loss of $12 7 million compared to a net loss per share of $12 <unk> per share in the fourth quarter of 2023 on a net loss of $23 7 million.
Speaker Change: Q4, 2024 net loss per share was calculated on approximately 27 5 million weighted average common shares outstanding compared to Q4 2023, when as it than private company with multiple classes of preferred and common stock outstanding net loss per share was calculated on approximately 2 million weighted average common share.
Speaker Change: There is outstanding.
Daniel Chevallard: As a final point, as of December 31st, 2024, we had approximately 27.5 million shares of common stock outstanding.
Speaker Change: As a final point as of December 31, 2024, we had approximately 27 5 million shares of common stock outstanding.
Daniel Chevallard: That concludes my comments on our Q4 financial results.
Speaker Change: That concludes my comments on our Q4 financial results and with that I'd like to turn the call back over to <unk> for final remarks.
Eve Schimmelpennink: And with that, I'd like to turn the call back over to Abe for final remarks. Thanks, Dan. As you can see, the fourth quarter and recent period has been an extremely productive. and we're making significant strides in our pre-commercial preparation. As we are now less than five months from our Purdue target action date, we believe we are well positioned to deliver a once-daily, safe, and rapidly acting treatment to the 128 million individuals living with presbyopia in the United States. I'm very much looking forward to doing so.
Speaker Change: Thanks, Dan.
Speaker Change: As you can see the fourth quarter and recent period has been an extremely productive time.
Speaker Change: And we're making significant strides in our pre commercial preparations.
As we are now less than five months Purdue flip socket action dates. We believe we are well positioned to deliver a once daily safe and rapidly acting treatment with 128 million individuals living with presbyopia in the United States and very much looking forward to doing so.
Operator: With that, I'd like to open up the call for questions. Thank you.
Speaker Change: With that I'd like to open up the call for questions.
Speaker Change: Thank you.
Operator: If you would like to ask a question, please press star and the number one on your telephone keypad. Again, that is star and the number one on your telephone.
Speaker Change: If you would like to ask a question. Please press star and the number one on your telephone keypad again that is star <unk>.
Speaker Change: And the number one on your telephone keypad.
Yigal Nochomovitz: And our first question comes from the line of Yigal Nochomovitz from Citigroup. The line's open. Hi, guys. Thank you. I appreciate all the updates. So first off, I think Sean mentioned that the Salesforce is going to call on 15,000 ECPs. The digital campaign was targeting 30,000 or over 30,000. Could you just comment on how you're filtering that down to focus on the 15,000? What are the parameters there?
Speaker Change: And their first question comes from the line of Egon, Let's all of its Fran.
Speaker Change: Citigroup.
Speaker Change: Your line is open.
Hi, guys. Thank you I appreciate all the updates.
Speaker Change: So first off I think Sean mentioned that the sales force is going to call on 15000 ECP is.
Speaker Change: The digital campaign was targeting 30000 are over 30000.
Speaker Change: Could you just comment on how you are filtering that down to focus on the 15000 what are the what are the parameters there.
Speaker Change: Okay.
Sean Olson: Hi, Yigal. This is Sean. Thanks for that question. It's a really good question. So, when you look across the landscape of eye care professionals, there's obviously a lot out there. You know, when you look at the 40,000 optometrists and 20,000 ophthalmologists, when we think of targeting in terms of our sales force, we're looking at those that are high prescribers of beauty. And therefore, we know that 15,000 ECPs represent roughly 85 percent or a little more than 85 percent of all the beauty scripts. So, that's our focus for our sales force. But we also know that there are other doctors, and with presbyopia being so prevalent, you know, driving early disease state awareness is helpful across a broader group of ECPs.
Speaker Change: Hi, This is Shawn thanks for that question. It's a really good question. So when you look across the landscape of eyecare professionals Theres, obviously, a lot out there.
Speaker Change: You look at the 40000, optometrists and 20000 ophthalmologists when we think of targeting in terms of our sales force. We're looking at those that are high prescribers of beauty and therefore, we know that 15000, ecp's represent roughly 85% or a little more than 85% of all the beauty.
Speaker Change: So that's our focus for our sales force, but we also know that there are other doctors and with presbyopia being filled prevalent.
Speaker Change: Driving early disease state awareness is helpful across a broader group of Ecp's and so that's why you'll see our unbranded promotion is driving more broader awareness, while the field will focused truly on the earliest adopters of eyecare professionals and those who represented over 85% of all the beauty scripts.
Sean Olson: And so, that's why you'll see our unbranded promotion is driving more broader awareness, while the field will focus truly on the earliest adopters of eye care professionals and those who represented over 85 percent of all the beauty. Yeah, so for the unbranded, we're really focused on on the disease state awareness. And we've just in general, we've seen a lot of interest, growth in the, sorry, a lot of growth of interest in the concept at all of our conventions and across the board on LinkedIn, you know, it's great to see, actually, is the fact that we'll be at our convention and people come up.
Speaker Change: Okay. Okay got you and then on this I I am selective unbranded awareness campaign.
Speaker Change: Super interested to get a better understanding quantitatively of how you've ratcheted up the awareness do you have data on 8% awareness that before you started the campaign and how that's improved.
Speaker Change: Today in terms of knowledge of not only presbyopia, but your phase III data specifically.
Speaker Change: Yeah. So for the unbranded, we're really focused on the disease state awareness and we've just in general we've seen a lot of interest growth.
Speaker Change: Sorry, a lot of growth of interest in the concept at all of our conventions and across the board on Linkedin.
Speaker Change: Great to see actually is the fact that there will be at our convention and people come up and I don't know Ken tell you always had the comfort I have been seeing all of your ads only Dan about your I am selected campaign.
Sean Olson: And I don't know, can't tell you how many times it comes to that. I've been seeing all of your ads on LinkedIn about your I am selective campaign. And so we're really pleased with how it's coming along.
Speaker Change: And so we're really pleased with how it's coming along we'll continue to share more information at the upcoming commercial days.
Sean Olson: We'll continue to share more information at the upcoming commercial day.
Yigal Nochomovitz: Okay, and then just the last one on the timing of the launch. Obviously, the Dufa is August 8th. And then I mentioned that you're going to have product available in the channel, I believe, starting fourth quarter.
Speaker Change: Okay, and then just the last one on the timing of the launch obviously the the difference August.
Speaker Change: And then I just mentioned that youre going to have product available in the channel I believe starting fourth quarter is the delta there a function of just needing more time to produce the commercial submission commercial material or training the sales force or are there other factors, we should be aware of.
Eve Schimmelpennink: Is the Delta there a function of just needing more time to produce the commercial, sufficient commercial material or training the sales force, or are there other factors we should be aware of?
Eve Schimmelpennink: Great question, Yigal.
Speaker Change: Doug Great question Yigal. This is Dave thanks for allowing us to to double click on that a little bit.
Eve Schimmelpennink: This is Abe, and thanks for allowing us to double click on that a little bit. That's purely a factor of practicality. This, we believe, is going to be a very high volume launch, as you can imagine. As I've shared in the prepared remarks, the manufacturing team has started production of the quantities that we believe will support a successful launch. That will all sit in bulk. As we await final labeling discussions with the FDA and have a final approved label, insert, and cotton. We will then obviously stop printing that, which would happen after approval. Thank you to all those quantities, shift them to our 3PLs and get them into the field.
Speaker Change: Just purely.
Speaker Change: A a factor of practicality.
Speaker Change: This we believe is going to be a very high volume launches you can imagine.
Speaker Change: Sure in the prepared remarks, the manufacturing team has started production.
Speaker Change: The quantities that we believe will support a successful launch.
Speaker Change: That will sit in bulk.
Speaker Change: As we await final labeling discussions with the FDA and have a final approved label.
Speaker Change: And cotton.
Speaker Change: We will then obviously start printing that which would happen after approval.
Speaker Change: Thank you to all of those quantities shipped them, two or three pls and get them into the field.
Eve Schimmelpennink: So that's purely, you know, that time that we got there between PDUFA and a Q4 product in the market is again, you know, purely determined by those steps.
Speaker Change: That's purely that time that we got there between <unk> and our Q4 product in the market is again purely determined by dose steps. The Salesforce importantly will be trained up.
Eve Schimmelpennink: The sales force, importantly, will be trained up in general prior to PDUFA date, final training on final labeling, and then immediately hit the field. So you can expect that immediately upon approval, the sales force will actually be out there promoting the product. They can get a couple of sales cycles in, which we like, prepare the doctors for what's to come, and then start delivering samples as soon as we have them available for the field.
Speaker Change: In general prior to Purdue for date final training on final labeling and then immediately hit the field. So you can expect that.
Speaker Change: Immediately upon approval to Salesforce will actually be out there promoting the product.
Speaker Change: If I can get a couple of <unk>.
Speaker Change: Sales cycles, which we like but better doctors for what's to come and then start delivering samples as soon as we have them.
Speaker Change: Available for the after the field.
Yigal Nochomovitz: All right, thank you. Perfect.
Speaker Change: Alright, Thank you perfect.
Operator: Thank you.
Speaker Change: Thank you.
Madhu: Our next question comes from the line of Mark Goodman from Viewing Partners. The line's open. Hi, this is Madhu on the line for Mark. Just a couple from us today. First, how long do you expect the like significant sampling to go on for until, you know, most of those target ECPs have gotten experience with LMZ100? And then the second question is, what haven't you been asked about on the regulatory process or the launch that you would like people to be more focused on? Thanks. Great. Thank you for those questions. So from a sampling perspective, this product lends itself extremely well for sampling.
Speaker Change: Our next question comes from the line of Marc Goodman from Leerink partners.
Speaker Change: Your line is open.
Matthew: Hi, This is Matthew online for Mike just a couple from us today and how.
Matthew: How long do you expect the significant sampling to go onshore until most of those target ECP has gotten experience with R&D 100, and then the second question as well.
Speaker Change: But haven't you've been asked about the regulatory process to launch that you would like people to be more focused on thanks.
Speaker Change: Great. Thank you for those questions. So from Assembly perspective.
Speaker Change: This product lends itself extremely well with simply if you look at the.
Eve Schimmelpennink: If you look at the clinical data that we generated in our phase 3 studies, you'll see that these are obviously the patients. Endpoint is hour 3, day 1. But within 30 minutes, which is the first time point that we've measured, you see that we have 71% of patients hitting three lines, 95% of patients hitting two lines of improvement. Because it lends itself so well for sampling, we feel that this is a unique tool that we have as a company that we will use widely. We don't really look at this as something that we will only do initially to give doctors the experience, but truly something that allows patients, consumers, a very easy test or sample point to see if it does the right work for them.
Speaker Change: The clinical data that we generated in our phase III studies Youll see that these are obviously patients end point is our three day one.
Speaker Change: Within 30 minutes, which is the first time point that we can measure. It you see that we have 71% of patients had a <unk> 95% of patients through lines of improvements.
Speaker Change: Because it lends itself so well for sampling we feel that this is a unique tool that we have as a company that we will use widely.
Speaker Change: We don't really look at there is something that we will only do initially to give doctors the experience, but truly something that allows patients gives us a very easy test or simple points to theory doesn't work for them, which again looking at the clinical data I think what can be highly confident that.
Eve Schimmelpennink: Which again, looking at the clinical data, I think we can be highly confident that the answer should be yes. And then do they like to continue to use that?
Speaker Change: The answer should be yes.
Speaker Change: Like to continue to use that that's why we've kept that simple back of five out bad debt to answer your question, we'll continue to pull through.
Eve Schimmelpennink: That's why we've got that sample pack of five out there that, to re-answer your question, will continue to pull through as the years pass by. Also, because there's actually four million new presbyopes every year. So there's a large volume of new patients that we will continue to reach with those samples.
Speaker Change: Yes.
Speaker Change: Also because there is actually 4 million new <unk> every year. So there's a large volume of new patients that we will continue to reach with those samples.
Eve Schimmelpennink: That's on the on the sampling side. On the regulatory side, just reiterating a little bit what I mentioned in the prepared remarks, we're very pleased with how things are going with the FDA. We've had very engaged discussions with them, frankly, from like three years ago as we were talking through the setup of a clinical trial with them. And obviously, since we've submitted the NDA, the mentioned those interactions continue to be very productive. The mid-cycle review was very benign, just like you like it. and importantly, we now have seen them. starting the inspections of our clinical trials, so showing that that progress continues to be made.
Speaker Change: So that's on the on the sampling side.
Speaker Change: On the regulatory side, just reiterating a little bit what I mentioned in the prepared remarks, we're very pleased with how things are going with the FDA. We've had very engaged discussions with them frankly from like three years ago. As we were talking through the setup of a clinical trial with them on and off.
Speaker Change: <unk> submitted the NDA dimension those interactions continue to be very productive.
Speaker Change: The mid cycle review was very benign just like you like it.
Speaker Change: And importantly, we now have seen them.
Speaker Change: Got it.
Speaker Change: <unk> of our clinical trials, so showing that that progress continues to be made.
Eve Schimmelpennink: So all in, very pleased with how the FDA interactions are going, and continue to be very confident that we're working nicely towards that August 8th, BDUFA Day.
Speaker Change: So all in very pleased with how the FDA interaction are growing and continue to be very confident that we're working nicely towards that overstated.
Eve Schimmelpennink: Thanks. Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thank you.
Joe Pateranzo: Our next question comes from the line of Joe Pateranzo from Piper Sandler. The line's open. Hey, perfect. Thanks, everybody. Thanks for the update. Thanks for taking the questions.
Speaker Change: Our next question comes from the line of Joe Powder Anja.
Speaker Change: Piper Sandler your line is open.
Speaker Change: Okay perfect.
Speaker Change: Thanks, everybody. Thanks for the update thanks for taking the questions maybe maybe two questions interrelated on the competitive landscape. So Sean you made some some brief comments on beauty in pilocarpine in Pilocarpine PID. There has been some recent phase III data for carbo called based products wondering if you guys have any thoughts there.
Sean Olson: Maybe two questions interrelated on the competitive landscape. So, Sean, you made some brief comments on VUITY and pilocarpine and pilocarpine BID. There's been some recent phase three data for carbacol-based product. Wondering if you guys have any thoughts there on that product's profile and maybe how it compares and contrasts to LNZ100. And then maybe relatedly, you know, on the other side of a potential approval, I'm wondering if there's any phase four trials that you maybe have in mind that could reinforce that competitive profile best in class that you might have with LNZ100. Thanks.
Speaker Change: There on that.
Speaker Change: Products profile and maybe how it compares and contrasts to LNG 100, and then maybe relatedly on the other side of a potential approval I'm wondering if there's any phase four trials that you maybe have in mind that could.
Speaker Change: Reinforce that competitive profile best in class assets that you might have with LNG 100. Thanks.
Sean Olson: Hi, Joe, this is Sean. Thanks for the question. So, when we look at this area and opportunity for eyedrops or presbyopia, we have said before, we really see this as a category of one and we continue to see this as a category of one. If you really want to drive the efficacy and the near vision improvement that the consumers desire, it requires two key things. It really requires a pupil size below two millimeters, which we achieved. And when you look at our commercial data, it's very clear the capabilities of our product. And what's really important is that you have the right myotic to do it, which is a cyclidine, which is pupil selective.
Speaker Change: Hi, Joe This is Shawn thanks for the question.
Speaker Change: When we look at this area and opportunity for eye drops your presbyopia.
Speaker Change: We have said before we really see this as a category of one and we continue to see this as a category of one if you really want to drive the efficacy and the near vision improvement that the consumer's denier.
Speaker Change: The consumers desire requires two key things it really achieve required a pupil size below two millimeters, which we achieved and when you look at our commercial data, it's very clear the capabilities of our product.
Speaker Change: And what's really important is that you have the right miotic to do it which is a cycling which is pupils selective and it's the only people selective miotic.
Eve Schimmelpennink: And it's the only pupil selective myotic. So when I look at this space, when I look at the competition, I really see this as a category of one. And we're really defined and set apart by our ability to achieve the performance with a sub-2 millimeter pupil and a cycle that even puts us in that place where we can be the only one with that opportunity. Maybe just adding to that, Joe, just building on what Sean said, the, in our mind, successful product is a once a day, fast acting, long lasting hydra. So, if you overlay that on the clinical data that's out there, we truly believe that our data is the only ones that show that.
Speaker Change: So when I look at this space when I look at the competition I really see this as a category of one and we're really defined and set apart by our ability to achieve the performance of the sub 10 nanometer pupil and recycling and puts us in that place, where we can be the only one with that opportunity.
Speaker Change: Maybe just adding to that Joe.
Speaker Change: Australia, but shouldnt be an online successful product is a once a day fast acting long lasting hydro <unk>.
Speaker Change: So can you overlay that on the clinical data that's out there we truly believe that our data is the only ones that show that you've mentioned comical than just due for everyone on the call.
Eve Schimmelpennink: You mentioned Carvacol and just to, for everyone on the call, that used to be visors, that products now owned by TenPoint, we've not seen that phase three data. The press release highlighted that they met the clinical trial endpoints, but did not disclose, or they choose not to show any of that data, which is therefore a little unsure what that means. If you go by the phase two data, which is available again, we feel that that doesn't meet what the consumers are after. So that's just to answer your question on the phase three data from Carvacol.
Speaker Change: Use of advisors that <unk> now owned by by 10 points.
Speaker Change: We've not seen that phase III data.
Speaker Change: A press release highlighted that they met the clinical trial endpoints, but did not disclose so they chose not to show any of that data.
Speaker Change: Which is therefore, a little unsure what that what that means.
Speaker Change: If you go by the Phase II data, which is available again, we feel that that doesn't meet what the issue was on OXXO.
Speaker Change: So just to answer your question on the phase III data from comparable.
Eve Schimmelpennink: Thanks, that's helpful. And then maybe on the on the follow up on like phase four studies that you maybe could potentially perform, if they're even necessary, again, to kind of sort of reinforce the competitive profile you have here. Yeah, no, we're obviously focused on bringing this to the market. You know, phase four studies can be part of that. We know that there's, you know, ophthalmologists and other doctors out there that have interest in testing the product. You know, we'll work with them as appropriate to do those four phase four studies. I will report on that as we are starting them.
Speaker Change: Thanks, that's helpful and then maybe on the on the follow up Unlike phase four studies that you may be could potentially perform if theyre, even necessary again to kind of sort of re in fat reinforced our competitive profile you have here.
Speaker Change: Yes.
Speaker Change: Now, we're obviously focused on bringing this to the market phase four studies can be part of that we noticed as ophthalmologists doctors out there that have interest in testing the product.
Speaker Change: We'll work with them as appropriate to.
Speaker Change: To do dose for phase four studies.
Speaker Change: We'll report on that as well.
Speaker Change: We are starting them.
Joe Pateranzo: Okay, perfect. Thanks for taking my questions. Thank you.
Speaker Change: Okay perfect. Thanks for taking my questions.
Speaker Change: Thank you.
Stacey Pooh: Our next question comes from the line of Stacey Pooh from TD Cowan. The line is open. Great. Congrats on the progress and thanks so much for taking our questions. We have three. So the first question is around kind of your last year around the educational campaign. Maybe talk about your 15,000 target ECPs. Where are we in the campaign? What's the level of awareness of Lenz and LNV-100? Obviously, you're not able to promote specifically, but just help us understand level of awareness. And obviously, in our KOL text, all the optometrists were familiar with the acyclonitin MOA and pupil selectivity.
Speaker Change: Our next question comes from the line of Stacy <unk> from TD Cowen.
Speaker Change: Your line is open.
Stacy: Great and congrats on the progress and thanks, so much for taking our questions.
Speaker Change: Three.
Speaker Change: So the first question is around kind of here.
Speaker Change: Last year around the educational campaign.
Speaker Change: Maybe talk about your 15000 target ECP is where are we.
Speaker Change: Campaign, what's the level of awareness of lens and allergy 100, obviously youre not able to promote specifically, but just help us understand the level of awareness.
Speaker Change: And obviously in our cable attacks all the optometrists catan were familiar with this equity MLA people fill activity and liberate disconfirm furbish certain attachment. So curious your own program. That's the first question.
Stacey Pooh: And they believe this confers low risk of retinal attachment. So curious, your own progress.
Stacey Pooh: That's the first question.
Stacey Pooh: The second question, Sean, you made some comments around maybe finalizing the marketing messages around LNV-100's clinical profile. So just help us understand maybe early thoughts. How do you make sure consumers and patients have the right expectations for the product? Is it up to 10 hours? How do you talk about the durability for a once-a-day product?
Speaker Change: Second question, Shawn you made some comments around that.
Speaker Change: May be finalizing our marketing messages.
Speaker Change: LNG is 100 clinical profile. So just help us understand maybe early thoughts.
Speaker Change: How do you make sure consumers and patients have the right expectation for the product you said up to 10 hours. How you talk about the durability for once a day product and so that's question too.
Stacey Pooh: So that's question two.
Stacey Pooh: And then for our third question, can you discuss in a little more detail the background of the salesforce hired so far? This is a unique launch that requires both therapeutic and consumer locks experience. So are they coming from recent launches? Are they able to navigate the current consumer profile? Any additional details would be appreciated. Cool. So thank you for the question, Stacey. I appreciate it. Again, this is Sean. So, you know, looking at the educational campaign, so we've been really pleased by this educational campaign. Now, when we were looking at what we want to do to drive awareness of the important things to look for in the future, presbyopia eye drops, we really wanted to bring force, bring forward the eye care professionals as the voice of that campaign.
Speaker Change: For our third question can you discuss in a little more detail the background of the sales force hired so far and this is a.
Speaker Change: A unique launch that requires both therapeutic and consumer lapse experience. So are they coming from recent launches are they able to navigate the current consumer profile and any additional details would be appreciated.
Sean Olson: Cool so thank you for the question Stacy I appreciate it Dan This is Shawn so looking at the educational campaign. So we've been really pleased by this educational campaign now when we were looking at what we want to do to drive awareness of the important things to look forward in the future Presbyopia eye drops we will.
Speaker Change: We wanted to bring for us going forward.
Speaker Change: Eyecare professionals is the voice that campaign and Thats, how we came up with that concept.
Sean Olson: And that's how we came up with that concept of I am, and we allowed those doctors to really talk about, you know, what is it to them? That's important. And what makes them excited for the future of presbyopia solutions. In terms of reaching out to those 15,000 ECBs, we're making great progress. As we shared, we've had over 2 million digital impressions with that campaign. and targeting actually over 30,000 ECPs of the broader group, which means, you know, these eye care professionals are seeing the campaigns multiple times over. And that is driving a lot more awareness of Lenz itself and what's important, right?
Speaker Change: And we allowed those doctors to really talk about what is it to them is important and what makes them excited for the future of Presbyopia solutions.
Speaker Change: In terms of reaching out to those 15000 Ecb's now.
We're making great progress as we shared we've had over 2 million digital impressions with that campaign.
Speaker Change: And targeting actually all the over 30000 ecp's of the broader group, which means these eyecare professionals are seeing the campaigns multiple times over and that is driving a lot more awareness lends itself.
Speaker Change: And what's important right that people selectivity in the sub two millimeter pupil.
Sean Olson: The pupil selectivity and the sub two millimeter pupil. And I think, you know, although that's separate from the progress on awareness for LNZ100 and the efficacy of the drug, what we're really encouraged by was what we shared in our last earning calls. You know, we did a market research initiative of 400, over 420 eye care professionals. And by the way, those 420 eye care professionals sit within our 15,000 target group. Because when we designed that survey, we made sure that they had prescribed duty and prescribed duty multiple times and had an 80% split optometry versus ophthalmology.
Speaker Change: And I think now although that's separate from the progress on awareness for LNG 100, and the efficacy of the drug what we're really encouraged by with what we shared in our last earning calls we did a market research initiative 400 over 420, eyecare professionals and by the way.
Speaker Change: Those 420 eyecare professionals sit within our 15000 target group.
Speaker Change: When we design that survey, we made sure that they had prescribed beauty and prescribed beauty multiple times and had an 80% split optometry versus ophthalmology. So that is a core signal of that group of our 15000 targets and we're really excited to see that over 80% of them were already excited to prescribe.
Sean Olson: So that is a core signal of that group of our 15,000 targets. And we're really excited to see that over 80% of them were already excited to prescribe LNZ 100 if approved. So we're really happy with that progress.
Speaker Change: LNG 100, if approved.
Speaker Change: Really happy with that progress.
Eve Schimmelpennink: Thanks Yigal, just adding to that and thank you for your initiation this week, we appreciate it and a lot of great insights that you did there. I think you mentioned, actually, in your question, in the survey work that you guys did, which was a lot, there was no shortage of awareness around LNG-100 or Cycadene. I think that's reflective of all the unbranded work that's been done over the last year, as well as, as we touched upon it, the work that our MSL team has started to do and is in full force out there now doing.
Thanks, Joe I, just just adding to that and certainly thanks for your initiation. This week, we appreciate it and a lot of great insights.
Speaker Change: Indicative Darren.
Speaker Change: Thank you you mentioned actually in your question in the survey work that you guys did which was a lot.
Speaker Change: There was no shortage of awareness around LNG and 100 or cycle, then I think that's reflective.
Speaker Change: All the unbranded work that's been done over the last year as.
Speaker Change: As well as as we touched upon it will work.
Speaker Change: MSL team started to do and is in full force out there now doing so over a thousand individual meetings. So these are one on one meeting so that 2030 40 minutes with <unk> or whether it be.
Eve Schimmelpennink: So, over a thousand individual meetings, so these are one-on-one meetings that are 20, 30, 40 minutes with MSLs, or with the MSLs having a medical to medical discussion, really highlighting a product, the uniqueness of a Cycadene, the fact that it's pupil selective, ciliary sparing, the importance of being below 2 millimeters, and obviously our clinical profile. You can imagine that we're targeting the top deciles, the first, and again, that's going really well. And I think all of that reflects in the fact that there is very high awareness of Cycadene already in the market that we will continue to build on.
Speaker Change: <unk>, having a medical medical discussion really highlighting.
Speaker Change: The uniqueness of a cycle in the fact that its pupils elective surgery sparing importance of being below two millimeters and obviously our clinical profile.
Speaker Change: Imagine that we're targeting the top decile stuff first and again, that's gone really well and I think all of that reflects in the fact that there is.
Speaker Change: Very high awareness of a cycle and already in the market that we will continue to build out.
Speaker Change: Okay.
Sean Olson: Okay, Gary, I'm moving on here. Moving on your 2nd question on, you know, we said that and shared that we're working on final messaging on our campaigns. So we're very excited about where we're at in terms of our marketing materials. And we'll break them into 2 groups. 1 is for our eye care professional side. And 1 is for our consumer side, you know, when I speak to to doctors, and when we see what resonates with them, and when we test, what's important. I think 1 of the most important things they always bring up is this isn't pilo.
Speaker Change: And then moving on here.
Speaker Change: Moving on to your second question on we said that and share that we're working on final messaging on our campaigns. So we're very excited about where we're at in terms of our marketing materials and we'll break them into two groups. One is for our eye care professional side and one is for a consumer side.
Speaker Change: When I speak to to doctors and when we see what resonates with them and when he tasked what's important.
Speaker Change: One of the most important things they always bring up is this isn't pai-loo is right. So when we think of our messaging a doctor and it's very important that we get across that this is not pilocarpine. So really the only think promotion to doctors. After approval focus is going to be an MLA with Lori lead heavily into the not pilocarpine.
Sean Olson: Is it right? So, when we think of our messaging and doctors, it's very important that we get across that. This is not pilocarpine. So, really, when we think of promotion to doctors after approval, focus is going to be on MOA, which will lead heavily into the not pilocarpine moves very quickly. Then into the efficacy and the safety profile, all that testing is continuing and we're looking forward to sharing more at the upcoming commercial day. On the consumer side, you're exactly right. What we don't want to do is over promise. What we saw from the previous launch with this space was promises were made that were not in line with the efficacy of the product, right?
Speaker Change: Moves very quickly then into the efficacy and the safety profile all of that testing is continuing and we're looking forward to sharing more at the upcoming commercial day.
Speaker Change: On the consumer side Youre exactly right, but we don't want to do is over promise what we saw from the previous launch with with.
Speaker Change: With this space was promises were made that were not in line with the efficacy of the product right. So it was a take one drop and it lasts all day Ryder one drop a day, but we really want to highlight here is we want to.
Sean Olson: So it was, hey, take one drop and it lasts all day, right? Or one drop a day. But we really want to highlight here is we want to provide real expectations. So one example, which you just mentioned, is how we're approaching it. Yes, in our data, we see a lot of patients still having a very strong response at 10 hours. That being said, in the strategy not to over promise, we want to focus on messaging up to 10 hours. And then we also shared that we're leaning into that lifestyle brand. So we spent a lot of time sitting with the consumers to invoke what's the emotion they feel that Presbyopia has on them.
Speaker Change: Provide real expectation. So one example, which you just mentioned is how we're approaching it.
Speaker Change: Yes.
Speaker Change: The data, we see a lot of patients still having a very strong response at 10 hours that being said in a strategy not to over promise, we want to focus on our messaging app.
Speaker Change: Up to 10 hours and then we also shared that we're leaning into that lifestyle brand. So we spent a lot of times seen with consumers.
Speaker Change: And what's the emotion they feel that presbyopia has on them.
Sean Olson: And again, we don't refer to it as Presbyopia to them, but they're blurry near vision. And enlisting that actual feeling and turning that into a campaign so when they see it, they want to click it and they want to learn about the product and they have a desire to be on the product. So that's really where we're at in working on the message.
Speaker Change: And again, we don't refer to as presbyopia to them, but they are blurry near vision and a listing that actual fuelling and turning that into a campaign. So when they see it they want to click it and they want to learn about the product and they have a desire to beyond the product. So thats really where were at and working on the messaging.
Sean Olson: Okay, that's wonderful. Thanks and looking forward to another commercial day.
Speaker Change: Okay. That's wonderful thanks, and let me kind of a commercial day.
Eve Schimmelpennink: Just wanted to touch on your last question there, Stacey, and we'll keep it brief, but the background of the, of the sales force, Sean, you want to take that or meet up? Yep. So we've had a tremendous amount of interest in joining Lenz, which is exciting for us to see. We had a strong pool of candidates when we first brought on our regional directors in Q4. And then when we actually look at bringing on the district managers, which are now all 10 of them are on board, you know, we are seeing that we're finding people that are working in good jobs in eye care and in pharma and are looking for the next better opportunity.
Speaker Change: Just wanted to touch on your last question, there Stacy and I will keep it brief but the background of the Salesforce.
Sean Olson: Sean you want to take a kilometer.
Sean Olson: So we've had a tremendous amount of interest in joining lens, which is exciting for us to see we had a strong pool of candidates. When he first brought on our R&D regional directors in Q4.
Sean Olson: And then when we actually look at bringing on the district managers, which are now all 10 of them are on board now we are seeing that we're finding people that are working in good jobs in eye care in an environment and are looking for the next better opportunity. So the candidate pool has been very very great.
Sean Olson: So the Canada pool has been very, very great. You know, what we're seeing are individuals that are joining with, you know, decades of eye care experience as well as sales experience. as well. So really great candidate pool. Thank you.
Sean Olson: We're seeing our individuals are joining with.
Sean Olson: Decades of eye care experience as well as sales experience.
Sean Olson: As well, so really great candidate pool.
Sean Olson: Yes.
Sean Olson: Thank you.
Sean Olson: [laughter].
Sean Olson: Thank you.
Jason Gareberry: Our next question comes from the line of Jason Gareberry from Bank of America. Your line is open. Hey, guys. Good afternoon, good evening. Thanks for taking the question.
Speaker Change: Our next question comes from the line of Jason <unk> from Bank of America.
Your line is open.
Speaker Change: Hey, guys.
Speaker Change: Good afternoon. Good evening, thanks for taking the question.
Sean Olson: On the sampling initiative and how you'll leverage the e-pharmacies, I'm wondering, ultimately, if the e-pharmacies will share with you kind of a sample conversion to patients opting in to monthly supply and, you know, if that's a metric that you'll be kind of sharing with the street just to kind of give some sense of how that's progressing with utilization and adoption.
Speaker Change: On the sampling initiative and how Youll leverage E pharmacies I'm wondering.
Speaker Change: Hum.
Speaker Change: Ultimately if the pharmacies will share with you kind of a sample conversion to patients opting in.
Speaker Change: Monthly supply in.
Speaker Change: It's a metric that you'll be kind of sharing with the street just to kind of give some sense of how thats progressing.
Speaker Change: With utilization and adoption.
Sean Olson: And then my second question, just with early adopters, curious from a patient perspective, you know, if you think that patients with other ocular comorbidities would be more or less likely to get treatment with a presbyopia drop therapy or if you think it's patients who probably have a low medication burden, just kind of curious how you're thinking about that dynamic. And at the commercial day, do you think you'll share any, you know, comps for launch ramp outside of the early view of the adoption dynamic? Those are my questions. Thanks. Great. Thanks, Jason.
Speaker Change: And then my second question just with early adopters curious from a patient perspective.
Speaker Change: If you think that patients with with other ocular comorbidities will be more or less likely to.
Speaker Change: To get to.
Speaker Change: With our presbyopia drop therapy or or if you think it's patients who probably have a little medication burden just kind of curious how you're thinking about that dynamic and at the.
Speaker Change: <unk> day.
Speaker Change: Do you think youll share any.
Speaker Change: Comps for launch ramp outside of the early view of the adoption dynamic.
Speaker Change: Those are my questions. Thanks.
Speaker Change: Great. Thanks, Jason This is Sean again, so yes, let me, let me dive deeper a little bit into the sampling process and strategy any pharmacy, because it's a great question. So when we think of the samples what will happen with the samples is those five day sample packs again very similar to how contacts I provided as samples they are really a bridge.
Sean Olson: This is Sean again. So yeah, let me, let me dive deeper a little bit into the sampling process and strategy in e-pharmacy because it's a great question. So when we think of the samples, what will happen with the samples is those five-day sample packs, again, very similar to how contacts are provided as samples. They're really a bridge until the consumer gets started. So those sample packs will be delivered to the optometrist by the rep, so by the representative. So the reps will show up on, at the optometrist, you know, let's, for example, say they leave 10 samples.
Speaker Change: <unk> until the consumer get started.
Speaker Change: So those sample packs will be delivered to the optometrist.
Speaker Change: Right. So by the representative so the reps will show up on at the Optometrist lets for example, say they leave 10 samples when they come back on their next visit will take a look at the samples and I'll make sure that they're well stocked and that they are appropriately being dispensed now the E pharmacy as disk.
Sean Olson: When they come back on their next visit, they'll take a look at the samples and, you know, make sure that, you know, they're well stocked and that they're appropriately being dispensed. Now, the e-pharmacy is disconnected from the samples. That's a separate process. So, you know, when the patient, you know, receives their sample and they're checking out with their optometrist. The optometrist will ask, where would you like your script to be sent? And they'll have two options there. It can be sent to the e-pharmacy or it can be sent to the retail pharmacy. Our preference is it's sent to the e-pharmacy, right?
Connected from the samples that's a separate process.
Speaker Change: When a patient receives their sample and they are checking out with their optometrist.
Speaker Change: The optometrist last where would you like your script to be.
Speaker Change: And they'll have two options. They are can be sent to the <unk> pharmacy or it can be sent to the retail pharmacy.
Speaker Change: Our preferences is sent to the <unk> the pharmacy right and we're sensitive E pharmacy, what actually happens is the patient gets a text on their phone and they can actually collect the tax pay.
Sean Olson: And when it's sent to the e-pharmacy, what actually happens is the patient gets a text on their phone. And they actually click the text, pay for their product, and that ships to their home every single month. So that's the way that e-pharmacy is set up. And now from the e-pharmacy, we'll get data directly from the e-pharmacy on a number of scripts and how often those are being ordered. The samples are separate from that. That's really delivered by the rep and separate from the e-pharmacy. The great thing about the samples are, since they're delivered at the optometrist location, they won't get caught up in any of your script data if you're monitoring script data for sale.
Speaker Change: Paid for their product and that shifts to their home every single every single month. So thats the way that E. Pharmacy is set up and now from the pharmacy.
Speaker Change: We'll get data directly from the pharmacy on a number of scripts.
Speaker Change: And how often those are being ordered the samples are separate from that that's really delivered by the rep and separate from the pharmacy. The great thing about the samples are since they are delivered at the optometrist location. They won't get caught up in any of your script data monitoring script data for sales.
Sean Olson: So very concretely, Jason, to your question, there's there's no correlation to be seen or will be shared between samples and conversion to script.
Speaker Change: So America greatly.
Jason: Jason to answer your question, there's no correlation to be seen or will be shared between the samples and conversion to scripts.
Jason: Okay.
Sean Olson: So second question was around the early adopter to the patient. So when we think about the first patients going into the doctor, so when we first get approval, our primary focus will be educating the. So, you know, our earliest patients will be those that are already going into the practice. And actually, this works out well, because if we think of comorbidities, right, one of the most important things that we see, when we look at consumers that are interested in this product, a group that really stands out are those that are in contact today and over 45.
Jason: So second question was around the early adopter to the patient. So when we think about the first patients going into the doctor. So when we first get approval our primary focus will be educating the doctors.
Jason: Our earliest patients will be those that are already going into the practice and actually this works out well because if we think of Comorbidities one of the most important things that we see when we look at consumers that are interested in this product.
Jason: Group that really stands out are those that are in context today and over 45 and the great thing about those patients they're already going into the Doctor every year for their annualized Ann So we're already going to be seeing those patients at the doctor already before we even turn on DTC and also what we saw.
Sean Olson: And the great thing about those patients, they're already going into the doctor every year for their annual eye exam. So, we're already gonna be seeing those patients at the doctor already before we even turn on DTC and also what we saw on our, our survey that we revealed last quarter, you know, those doctors are seeing over 200 presbios every single month already. And, you know, they're in a place where they're excited to prescribe LNC 100.
Jason: Our survey that we revealed last quarter.
Those doctors are seeing over 200 presbyopia every single month already and they are in a place where theyre excited to prescribe LNG 100.
Jason: Okay.
Sean Olson: The last question I had was on launch cups. So at the commercial day, we're not going to be talking about launch and launch ramping. I think you and others have done a very good job at putting your models together. So I think the consensus is what most people will look for and look at as we launch and in the quarters to follow. So we'll stick with that for now. Got it. Thanks, guys. Thank you.
Jason: And then the last question.
Jason: Launched comps.
Jason: Let the commercial day, we're not going to be talking about launching launch ramping I think you and others have done.
Speaker Change: Very good job at putting.
Jason: Putting your models together.
Jason: So I think the consensus is what most of the world will look for a look at as we launch them in the quarters two to follow.
Jason: So we'll stick with that for now.
Jason: Got it thanks guys.
Jason: Thank you.
Lachlan Hanbury Brown: Our next question comes from the line of Lachlan Hanbury Brown from William Blair. The line is open. Hey guys, thanks for taking the question. So I've heard across the industry that it's, it's been getting harder, at least in some places for sales reps to actually get in and see a doctor. I'm wondering if you have heard anything similar, particularly as it pertains to your target. And if so, what can you do, if anything, to get around those hurdles?
Speaker Change: Our next question comes from the line of Lachlan Hanbury Brown from William Blair.
Jason: Your line is open.
Speaker Change: Hey, guys. Thanks for taking the question.
Jason: I've heard across the industry.
Jason: Been getting hotter or at least in some places with sales reps to actually get in and see a doctor. So.
Jason: I'm wondering if you have.
Jason: But anything similar particularly as it pertains to your targets.
Jason: And if so like how what can you do if anything to.
Jason: Get around those hurdles.
Jason: Okay.
Sean Olson: Hi, Lachlan, this is Sean. Thanks for the question. So, in this area of the industry, particularly around optometry, access to the eye care professional hasn't been seen as being increasingly challenging for us. So, no, we're not seeing that on our end. Definitely when COVID came around, getting into the hospitals and the pharmacies became more difficult, but for the optometrists, we really don't see that growing. And I think what's really great about this product is with our samples, it's going to be another reason that they're going to want to see us, because obviously, as they provide the product to the patients, they're going to want to see us again so they can restock their samples.
Jason: Hi, Lachlan this is Shawn thanks for the question. So in this area of industries, particularly around optometry access to the eye care professional hasnt been seen as being increasingly challenging for us. So no. We're not seeing that on our end definitely when COVID-19 came around getting into the hospitals and the pharmacies.
Speaker Change: <unk> did more difficult.
Speaker Change: For the Optometrists, we really don't see that growing and I think what's really great about this product is with our samples is going to be another reason that they're going to want to see us because obviously now as they provide the product to the patients they're going to want to see us again, so they can restock their samples. So we see that as a great tool to make sure that that door remains open.
Sean Olson: So, we see that as a great tool to make sure that that door remains open for our sales force.
Speaker Change: Our sales force.
Speaker Change: Okay.
Unknown Executive: Thanks, and maybe a follow-up. I've seen in some prior... The Launches, you know, especially in the more sort of discretionary or aesthetic kind of areas, concern around, you know, macroeconomic conditions affecting.
Speaker Change: Got it thanks, and then maybe.
Speaker Change: Follow up I've seen in some trial.
Speaker Change: Launches, especially in the more discretionary or steady kind of.
Speaker Change: Areas of concern around.
Speaker Change: Macroeconomic conditions affecting.
Speaker Change: Affecting demand.
Speaker Change: Given there's been talk over the past month or so a potential recession I was just wondering if you have any.
Unknown Executive: Unknown Executive, Lachlan Hanbury, Lenz Yeah, great, great question, Lachlan, this is Ed. So, you know, two elements of that. One, if you'll look at a static and you look at how revenue or volume has been impacted or, frankly, not impacted by recessions, you see that, you know, take Votex, for example, hardly any impact in, you know, the big recession of the late or mid-2000s, definitely not over the last couple of years. So, you don't see that actually, which is partly, and this is, you know, as we've been speaking about quite a bit. Yes, there's 128 million presbyopes out there, we're talking about or projecting to get to a $3 billion plus potential market.
Speaker Change: Any thoughts on Macau.
Speaker Change: Clinically sensitive demand might be.
Speaker Change: On that one.
Speaker Change: Getting higher income customer.
Speaker Change: The estimate anyway.
So it's interesting.
Speaker Change: Yeah, Great Great question. This is Ed.
Speaker Change: So.
Speaker Change: Elements of that one.
Speaker Change: If you look at aesthetics. Thank.
Speaker Change: When you look at how revenue of Oems has been impacted at all frankly not impacted by recessions.
Speaker Change: See that take Botox for example, hardly any impacts in the big recession.
Speaker Change: Delayed.
Speaker Change: 2000.
Speaker Change: Definitely not.
Speaker Change: The last couple of years.
Speaker Change: So you don't see that actually.
Speaker Change: Which is partly in this.
Speaker Change: As we have been speaking about quite a bit.
Speaker Change: Yes, it was $128 million lastly, hopes out there.
Speaker Change: Okay about projecting to get to a 3 billion dollar plus.
Speaker Change: Potential market.
Unknown Executive: Only about a 6% penetration and one of the cuts in that is actually income. So I think this is at least we're rejecting this to go to a group of people for whom the discretionary spending is a little bit larger to begin with. So, again, we don't expect any, any impact on whatever the macro is going to do. Thank you.
Speaker Change: Only about a 6% penetration and one of the cuts and that is actually income.
Speaker Change: So I think this is at least one.
Speaker Change: Projecting this to go to a.
Speaker Change: A group of people for whom the discretionary spending is a little bit larger two to begin with so again, we don't expect any.
Speaker Change: Any impacts.
Speaker Change: Whatever the macro is going to do.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Thank you.
Gary Nachman: Our next question comes from the line of Gary Nachman from Raymond James. The line is open. Hey guys, good afternoon.
Speaker Change: Our next question comes from the line of Gary Nachman from Raymond James.
Speaker Change: Your line is open.
Speaker Change: Hey, guys. Good afternoon. This is Dennis <unk> on for Gary Nachman, Congrats on all the progress this quarter and thanks for taking the questions. So previously you've segmented the consumer market in a specific way, where you've talked about the patients that could be early first adopters being those who are lens wearers refractive surgery or those that go to med spas.
Dennis Resnick: This is Dennis Resnick on for Gary Nachman. Congrats on the progress this quarter and thanks for taking the questions. So previously you've segmented the consumer market in a specific way where you've talked about the patients that could be early first adopters being those who are Lenz wearers, refractive surgery, or those that go to med spas. Of those three, can you talk about which segment you think will be the easiest to activate and reach and which one will require more work? And then just any quick updates on how we should think about the commercialization plans for L&D 100s in the EU.
Speaker Change: Those three could you talk about which segment you think will be the easiest to activate our reach and which one will require more work and then just any quick update on how we should think about the commercialization plans for LNG one hundreds in the EU. Thanks, so much.
Sean Olson: Thanks so much. Great.
Speaker Change: Great. Thanks question. Thanks for the question Sean again, so when you think about the early adopters, we see all three of them as very great and accessible targets from a promotional standpoint in.
Eve Schimmelpennink: Thanks for the questions, Sean, again. So, when you think about the early adopters, right, we see all three of them as, you know, very great and accessible targets from a promotional standpoint. In terms of, you know, access, when we think of the early days of launch before we turn on DTC, I think, you know, we think of those people in contact lenses. The great news is they're already in the optometrist. So, the good news is we can get them early in terms of the doctor can be our conduit to start speaking to that subset. And then we think of those that have had, you know, refractive surgery in the past or those that get a med spa.
Speaker Change: In terms <unk>.
Speaker Change: Access when we think of the early days of launch before return on DTC.
Speaker Change: Now we think of those people in contact lens lenses. The great news is they're already in the optometrist. So the good news is we can get them early in terms of the doctor can be our conduit to start speaking to that subset.
Speaker Change: And then when you think of those that have had refractive surgery in the past are those that get a med spa and we see both of these are groups that we can target digitally and when we look at our media buy companies that we partnered with in our AD agencies now in terms of the port focusing on our med spa clients. We can look at there.
Sean Olson: And we see both of these are groups that, you know, we can target digitally. And when we look at our media buy companies that we've partnered with and our ad agencies, you know, in terms of if we're focusing on our med spa clients, you know, we can look at, you know, their search histories and geolocations to really target them with the right digital ads. You know, they are extremely motivated and they test very high. They actually test the highest in our analysis of interest for an eyedrop solution. And then for those that have had refractive surgery in the past, again, from here, we can target them as well as we can, as we reach out to ophthalmologists, you know, these are people that they've met in the past and worked on before.
Speaker Change: Search histories, and geolocation to really target them with the right digital ads.
Speaker Change: They are extremely motivated and they test very high they actually test the highest in our analysis of interest for an Eyedrop solution and then for those that have had refractive surgery in the past again from here, we can target them as well as we can as we reach out to ophthalmologists. These are people that they've met in the past and have worked out.
Sean Olson: So it's another avenue to get access to that population. So we really see this, all three groups is very accessible.
Speaker Change: Before there's another avenue to get access to that population. So we really see this all three groups is very accessible.
Sean Olson: Thanks, Shona.
Speaker Change: Okay.
Eve Schimmelpennink: Your second question was about Europe, so I'll take that a little bit broader and in general talk about the ex-US strategy. So what's clear or should be clear to all of you is that we are obviously focused on commercializing the product in the US ourselves. Ex-U.S. territories will all be outlicensing to the right commercial partner there. We do see that there's a significant actualized opportunity, and that's reflected in the amount of inbounds that we get from very interested parties wanting to understand what it would take to get a license to this product. We do want to make sure, obviously, that we drive the appropriate value for that.
Speaker Change: Thanks, Shawn Youre second question was about Europe. So I'll tell you that a little bit broader in general talk about the ex U S strategy.
Speaker Change: So let's clear it should be clear to all of all of you is that we.
Speaker Change: We are obviously focused on commercializing the product in the U S. Our subs.
Speaker Change: Ex U S territories will be licensing to the right commercial partner there.
Speaker Change: We do see that there's a significant ex U S opportunity and that's reflected in the amount of inbound that we get from very interested bodies on the strip wanting to understand what it would take to get a license to this product.
Speaker Change: We do want to make sure obviously that we drive the appropriate value for that.
Eve Schimmelpennink: And that's how we're timing those discussions. The one exception there being China, we've licensed China early, because they had to do their own clinical trial. But I've seen the results a couple of months ago, which were carbon copy of what we've seen in the US, which, again, was highly validating. So they're about, let's call it, 12 to 18 months or so behind us from a filing and launch perspective. And we'll keep everyone updated as we progress any other XUS discussions. Great. Thanks for the additional color and congrats on the progress. Thank you.
Speaker Change: And that's how we're timing those discussions.
Speaker Change: The one exception there being China, we've licensed China early just to add to do their own clinical trial, but I've seen the results couple of couple of months ago, which were carbon copy what we've seen in the U S, which was that it was highly validating.
So down about let's call it 12 to 18 months or so behind us.
Speaker Change: From a filing and launch perspective, and we'll keep everyone updated as we progress and the other ex U S discussions.
Speaker Change: Great. Thanks for that color and congrats on the progress.
Speaker Change: Thank you.
Matthew Caufield: Now our next question comes from the line of Matthew Caufield from H.C. Wainwright. The lines are. Great. Hi, guys. Thanks for the updates.
Our next question comes from the line of Matthew Coffee.
Speaker Change: H C Wainwright.
Speaker Change: Your line is open.
Speaker Change: Great Hi, guys. Thanks for the update.
Sean Olson: You kind of touched on this, but from the commercial standpoint, do you foresee any tangible prescription resistance based on former viewage experiences or disappointment from that separate pillocarpine profile? Thanks a lot.
Speaker Change: You kind of touched on this but from the commercial standpoint, do you foresee any tangible prescription resistance based on former viewed your experiences or disappointment from that separate pillow carpi profile. Thanks.
Speaker Change: Thanks, a lot.
Sean Olson: Hi Matt, this is Sean, and good question. So, when we look at this market, you know, what we really focused on, particularly in our last market research study was the excitement and interest for LNZ100. And so, when we look at those, those 15,000 ECP targets, we did the survey on a subset of them, right? Those 420 plus eye care professionals, again, 80% optometry, 20% ophthalmology. No, when we asked them about the willingness to prescribe LNZ100, what we saw was over 80% of them were already likely to prescribe. A few sat on the fence, and, you know, it's only about 2 or 4% that were unlikely to prescribe.
Speaker Change: Hi, Matt This is Sean and good question. So when we look at this market what we really focused on particularly in our last market research study what is the excitement and interest for LNG 100, and so when we look at those and those 15000 ECB targets. We did the survey on a subset of them right.
Speaker Change: Those 420, plus eyecare professionals get 80% of optometry and ophthalmology now when we ask them about the willingness to prescribe LNG 100, now what we saw was over 88% of them are already likely to prescribe <unk>.
Speaker Change: A few said on the fence and it was only about two or 4% that we're unlikely to prescribe.
Sean Olson: So, the fact that we're not pylocarpine based is really the key factor there. They're excited and ready for a solution for their patients. Their patients are still frustrated by the fact that they don't have a good solution. And the reason to believe for them and why they're so excited and open is the fact that we're not pylocarpene and that we're a cyclidine-based. And when we did our market research on, you know, why Doody failed, the number one reason that came out was for most people, it didn't work. And then for the second one, when it did work, it didn't work long enough.
Speaker Change: The fact that we're not pilocarpine based is really the key factor there.
Speaker Change: We're excited and ready for a solution for their patients their patients are still frustrated by the fact that they don't have a good solution.
Speaker Change: And the reason to believe for them and why they are so excited and open is the fact that we're not pilocarpine and that we're cycling based and when we did our market research on why beauty failed. The number one reason that came out was where most people didn't work and then for the second one when it didn't work it didn't work long enough. So we're.
Sean Olson: So, you know, we're really breaking the mold in what we're offering here. And, you know, the excitement that we're seeing in our market research, it doesn't have that hangover effect. Got it. Very helpful. Thank you, guys.
Speaker Change: It really breaking the mold and what we're offering here and the excitement that we're seeing in our market research and doesn't have the hangover effect.
Speaker Change: Got it very helpful. Thank you guys.
Operator: That concludes our question-and-answer session. As I am showing no further... Thank you for your participation.
Speaker Change: That concludes our question and answer session as I am showing no further questions.
Speaker Change: You for your participation and we will now conclude today's conference call you may now disconnect.
Operator: And we will now conclude today's conference call. You may now disconnect. [music]
Speaker Change: Yeah.
Speaker Change: [music].