Q2 2024 LENZ Therapeutics Inc Earnings Call
Good afternoon ladies and gentlemen and welcome to the Lenz Therapeutics second quarter 2024 conference call at this time all participants are in a listen only mode.
Operator: 24 conference call. At this time, all participants are in a listen-only mode.
Dan Ceballard: Following prepared remarks from management, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevillard, Chief Financial Officer. Please go ahead.
Operator: Following prepared remarks from management, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevalart, Chief Financial Officer. Please do so.
Dan Chevillard: Thank you. Good afternoon, and thank you to everyone for joining us today to discuss Lenz's second quarter 2024 financial results and recent highlights. My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Shimmel-Pennick, our President and Chief Executive Officer, and Shawn Olson, our Chief Commercial Officer.
Dan Ceballard: Thank you. Good afternoon and thank you to everyone for joining us today to discuss Lenz's second quarter 2024 financial results and recent highlights.
Dan Schövelard: My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics.
Speaker Change: We are joined today by Abe Chemilpenik, our President and Chief Executive Officer, and Shawn Olson, our Chief Commercial Officer. In addition, Dr. Mark Odrich, our Chief Medical Officer, will join us for the question and answer session.
Dan Chevillard: In addition, Dr. Mark Odrich, our Chief Medical Officer, will join us for the question and answer session. Before we begin, I would like to remind you that this call contains forward-looking statements regarding Lenz's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections, and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission and which can also be found on our website.
Speaker Change: 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.
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 and which can also be found on our website.
Dan Chevillard: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.
Speaker Change: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.
Abe Shimmel-Pennick: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter 2024 410Q, which was filed today. With that, I will now turn the call over to Dan. Thank you, Dan, and good afternoon, everyone. The first half of 2024 and recent period has been transformational for us.
Speaker Change: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter 2024 410Q, which was filed today.
Speaker Change: With that, I will now turn the call over to Abe.
Abe Shimmel-Pennick: In short succession, we made our debut on the public markets with a strong investor base and balance, delivered the results of our Phase 3 CLARI trials, which we believe support LNG-100 as the potential best-in-class treatment for presbyopia, concluded a $30 million financing, and importantly submitted our NDA to the FDA. I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only cyclone-based eyedrop for improvement of vision in people with Fresna opium.
Abe Chemilpenik: Thank you, Dan, and good afternoon, everyone.
Abe Chemilpenik: The first half of 2024 and recent period has been transformational for Lenz.
Abe Chemilpenik: In short succession, we made our debut on a public market with a strong investor base and balance sheet.
Abe Chemilpenik: Delivered the results of our phase 3 CLARI trials, which we believe support LMG100 as the potential best-in-class treatment for presbyopia.
Abe Chemilpenik: Conclued at a 30-million-five-financing and, importantly, submit at our NDA to the FDA.
Speaker Change: I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a second-and-based hydrox. For the improvement in the division and people with friends we are okay.
Abe Shimmel-Pennick: Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FBA in mid-2025, and if approved, a US launch as early as the second half of. Before I review our key achievements in more detail, and as a quick reminder, trespidopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 40. As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near-vision.
Speaker Change: Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-2025 and, if approved, U.S. launch as early as second half of 2025.
Speaker Change: Before I review our key achievements in more detail, and as a quick reminder, trespidopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45.
Speaker Change: As the Chris Landlands in our eyes hardens with age, the eyes less able to accommodate and focus the incoming lives for near vision on the retina.
Operator: At this time, all participants are in a listen-only mode.
Operator: Following prepared remarks from management, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded.
Abe Shimmel-Pennick: Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. To address the daily challenges faced by presbyopes, we are developing a once-daily eye drop that, in our clarity trials, has shown to be capable of improving their vision throughout the full workday without the need for reading glasses.
Speaker Change: resulting in blurry near-vision.
Abe Shimmel-Pennick: More specifically, in April, we reported positive phase 3 data, which we complemented with capstone data in June, in which LMZ100, our cyclin-based product candidate, continued to show strong performance and best-in-class potential. Highlighting some of the key results of the trial and, for the moment, focusing on the results of Clare U2 as this is the direct vehicle control trial, we saw a rapid onset effect with 71% of At three hours, our primary endpoint, we also observed a three-line or more responder rate of 71%.
Speaker Change: Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life, as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read texts or conduct close-up work.
Dan Jebelard: At this time, I would like to turn the call over to Dan Jebelard, Chief Financial Officer. Please go ahead. Thank you.
Dan Jebelard: Good afternoon and thank you to everyone for joining us today to discuss Lenz's second quarter 2024 financial results and recent highlights. My name is Dan Jebelard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Schimmelpenek, our President and Chief Executive Officer, and Sean Olson, our Chief Commercial Officer.
Abe Shimmel-Pennick: And we maintained these high levels for the full workday, with 40% of participants still achieving three lines or more of near-vision improvement at 10 hours, the last time point measured in our efficacy trial, and these three-line games turned out to be only the beginning. 4% of participants achieved at least a four-line game during the study, and a staggering 52% achieved at least five lines.
Speaker Change: To address the daily challenges faced by presbyos, we are developing a once daily eyedrop that in a cloudy trial says shown to be capable of improving their vision throughout the forward day, without the need for reading glasses.
Abe Shimmel-Pennick: We also saw a very impressive near-universal response to LNG-100, with 95% of participants achieving at least two lines of near-vision improved. This is an important measure because it is seen as clearly meaning. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. Interestingly, we also observed a statistically significant improvement of at least one line of distance vision across the population. In terms of safety, LMZ100 was seen to be well-tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three clarity trials. Of all reported adverse events, 95% were classified as mild, relatively transient, and consistent with those observed in previous trials.
Dan Jebelard: In addition, Dr. Mark Odrich, our Chief Medical Officer, will join us for the question-and-answer session. Before we begin, I would like to remind you that this call will contain forward-looking statements regarding Lenz's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations. Cash runway projections and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities Exchange Commission, in which can also be found on our website.
Abe Shimmel-Pennick: We also sorted in the rare cases, more specifically 7.6% placebo-corrected, that participants noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphalactic and, for most, stopped appearing with prolonged use of LNG-100.
Speaker Change: More specifically, in April we reported positive phase 3 data, which we complemented with capstone data in June , in which LMZ100, our cycloderm-based product candidate, continued to show strong performance and best-in-class potential.
Dan Jebelard: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter, 2024, 410Q, which was filed today.
Abe Shimmel-Pennick: These strong clinical results and the promise they bring for 128 million presbyopes in the U.S. alone allowed us to further strengthen our balance sheet with a $30 million investment from Richback Capital in July. We appreciate the significant support and confidence shown by the Ridgeback team and are pleased to add this additional capital as we aim to make LNG100 the best-in-class, if not the only-in-class, therapeutic option for the treatment of pres Lastly, I'm very excited to highlight that we have submitted our MBA for LNG 100s to the FDA, marking a key milestone for the company.
Speaker Change: Highlighting some of the key results of the trial.
Speaker Change: And for the moment, focusing on the results of Clarity 2, as this is the direct vehicle control trial, we saw a rapid onset effect with 71% of participants achieving three lights or more of near-vision improvement at 30 minutes on the very first day of use of the product.
Speaker Change: At three hours, our primary endpoint, we also observed a three-line or more responder rate of 71%.
Speaker Change: And we maintained these high levels for the full workday with 40% of participants still achieving three lines or more of near-vision improvement at 10 hours, the last time point measured in our efficacy trials.
Speaker Change: And these three-line gains turned out to be only the beginning. Eighty-four percent of participants achieved at least a four-line gain during the study and a staggering 52 percent at least five lines.
Dan Jebelard: With that, I will now turn the call over to Abe.
Speaker Change: We also saw a very impressive near-universal response to LNG-100, with 95% of participants achieving at least two lines of near-vision improvement.
Abe Schimmelpenek: Thank you, Dan and good afternoon, everyone. The first half of 2024 and recent period has been transformational for Lenz. In short succession, we made our debut on our public markets with a strong investor base and balance sheet. We levered the results of our Phase III Clary Trials, which we believe support NRG100 as the potential best-in-class treatment for Presbyopia, concluded a 30 million pipe financing and importantly submitted our NDA to the FDA.
Speaker Change: This is an important measure because it is seen as clinically meaningful.
Speaker Change: Notably, 69% of the participants still reported this improvement at the end of the day, ten hours after dosing.
Speaker Change: Interestingly, we also observed a statistically significant, at least one line of distance vision improvement across the population.
Abe Schimmelpenek: I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cycle-in-based eye drop for the improvement in their vision in people with Presbyopia. Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-2025. If approved, U.S, launch as early as second half of 2025.
Speaker Change: In terms of safety, LMZ100 was seen to be well-tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three clarity trials.
Speaker Change: Of all reported adverse events, 95% were classified as mild, believed to be transient, and consistent with those observed in previous trials.
Speaker Change: We also sorted in the rare cases, more specifically 7.6% placebo-corrected.
Speaker Change: The participant noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphalactic and for most, no longer appearing with prolonged use of LNG-100.
Abe Schimmelpenek: Before I review our key achievements in more detail, and as a quick reminder, Presbyopia is the inevitable loss of near-vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens inner eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near-vision on the retina. Now, resulting in blurry near vision. Although the progression of Presbyopia is gradual, Presbyopes often experience an abrupt change in their data life, as the symptoms become more pronounced starting in the mid-40s when reading glasses or other corrective aids are suddenly necessary to read texts or conduct close-up work.
Speaker Change: These strong clinical results and the promise they bring for 128 million presbyopes in the U.S. alone allowed us to further strengthen our balance sheet with a 30 million dollar investment from Richback Capital in July .
Speaker Change: We appreciate the significant support and confidence shown by the RISDAC team and are pleased to add this additional capital as we aim to make LNG100 the best in class, if not only in class, therapeutic option for the treatment of presbyopia.
Speaker Change: Lastly, I'm very excited to highlight that we have submitted our NDA for LNG100 to the FDA, marking a key milestone for the company.
Abe Schimmelpenek: To address the daily challenges faced by Presbyopes, we are developing a once daily eye-drop that in our Cloudy Trials has shown to be capable of improving near vision throughout the full workday without the need for reading glasses. More specifically, in April, we reported positive phase 3 data, which we complemented with capstone data in June, in which NZ100, our cyber and baseball candidate, continued to show strong performance and best in class potential.
Abe Shimmel-Pennick: Our NDA is the culmination of a development program that, along the way, incorporated feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data, and we look forward to working with the agency as they review our submission. A first step in this process and following a positive initial review would be the formal acceptance of our MBA within 60 days of submission.
Speaker Change: Our NDA is a culmination of a development program that along the way incorporated a value of feedback and guidance from the FDA.
Speaker Change: We believe that we have compiled a dossier with strong clinical manufacturing and quality data, and we look forward to working with the agency as they review our submission.
Abe Schimmelpenek: Highlighting some of the key results of the Clary II, as this is the direct vehicle control trial, we saw a rapid onset effect with 71 percent of participants achieving three lines or more of near vision improvement at 30 minutes on the very first day of years of the product. At three hours upon my end point, we also observed a three-line or more spun the rate of 71 percent. And we maintained these high levels for the full workday with 40 percent of participants still achieving three lines or more of near vision improvement at 10 hours, the last time point measured in our efficacy trials.
Speaker Change: A first step in this and following a positive initial review would be the formal acceptance of our NDA within 60 days of submission.
Abe Shimmel-Pennick: Once the FDA accepts our NDA, the agency must complete the review within 10 months. The date at the end of this period is referred to as the PDUFA date, and once the FDA has provided us with it, we will communicate this. As mentioned earlier, and in line with previous guidance, we believe that this PDUFA date could be in the middle of next year and, if our submission needs approval, could lead to the launch of LNG100 in the US in the second half of 2025. To highlight some of the key areas of focus as we begin to prepare for a potential launch, I will now hand the call over to Sean Olsen. Chief Commercial Officer
Speaker Change: Once the FDA accepts our NDA, the agency must complete their review within 10 months.
Speaker Change: The date at the end of this period is referred to as the PDUFA date, and once the FDA has provided us with it, we will communicate this with you.
Speaker Change: As mentioned earlier, and in line with previous guidance, we believe that this PDUFA date can be in the middle of next year and, if our submission leads to approval, could lead to launch of LNG100 in the U.S. in the second half of 2025.
Abe Schimmelpenek: And these three-line games turned out to be only the beginning. A four percent of participants achieved at least a four-line game during the study and a staggering 52 percent at least five lines. We also saw a very impressive near universal response to NZ100. With 95 percent of participants achieving at least two lines of near vision improvement, this is an important measure because it is seen as cleanly meaningful. Notably, 69 percent of the participants still reported this improvement at the end of the day, 10 hours after dosing.
Sean Olson: To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson Chief Commercial Officer Sean. Thank you, and thank you all for joining us today.
Sean Olson: Sean, thank you, Eve, and thank you all for joining us today. The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. As they stated, press the open tax estimated 128 million people in the U.S., an incident population that is nearly four times greater than those impacted by dry ice. It is also more than the combined population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma.
Sean Olson: The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities.
Sean Olson: As they stated, Presbyopia impacts an estimated 128 million people in the U.S.
Sean Olson: an incident population that is nearly four times greater than those impacted by dry eye. It is also more than the combined population suffering from dry eye, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma in the U.S.
Abe Schimmelpenek: Interestingly, we also observed a statistically significant at least one line of distance vision improvement across the population. In terms of safety, NZ100 was seen to be well-tolerated with no treatment related serious adverse events observed in the over 30,000 treatment days across all three clarity trials. Of all reported adverse events, 95 percent were classified as mild, believed to be transient and consistent with those observed in previous trials. We also saw it in the rare cases, more specifically 7.6 percent placebo corrected, that participant noticed a mostly mild and transient headache following insulation of the drop.
Sean Olson: The first eyedrop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eyedrop treatment, as evidenced by initial paid new scripts of $3,000 to $5,000 per week. However, long-term usage beyond the trial period of this product did not materialize as a pile of carbene, even at the high concentration of 1.25 percent, couldn't deliver the results the consumer required before. We believe this leaves the category wide open for a non-pylocarpene presbyopia eyedrop solution that can deliver what consumers desire.
Speaker Change: The first eyedrop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eyedrop treatment.
Speaker Change: as evidenced by initial paid new scripts of $3,000 to $5,000 per week.
Speaker Change: Long-term usage beyond the trial period of this product did not materialize as pile of carbene, even at the high concentration of 1.25 percent, couldn't deliver the consumer required performance.
Speaker Change: We believe this leaves the category wide open for a non-pylocarpene presbyopia eyedrop solution that can deliver what consumers desire.
Sean Olson: Unlocking this market requires an ideal presbyopia eye drop, and we are excited about the prospect of our acyclidene-based LNZ100. We believe the commercial potential of LNZ 100 was validated in our phase three clarity stuff study, with 90% of participants noticing an improvement in their vision and 75 participants indicating they would continue to use LMZ100 after the study, of which 81% plan to use the product four to seven days Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion market potential opportunity and in what could potentially be a category of one, in parallel to our recent effort toward our NDA submission.
Abe Schimmelpenek: This appears to be tech-of-electric and for most no longer appearing before long to use at NZ100. These strong clinical results and the promise they bring for 128 million presbyelps in the US alone allowed us to further strengthen our balance sheet with a $30 million investment from Richback Capital in July. We appreciate the significant support and confidence shown by the Richback team and are pleased to add this additional capital as we aim to make NZ100 the best in class if not only in class the Appearic option for the treatment of presbyelps.
Speaker Change: Unlocking this market requires an ideal presbyopia eye drop, and we are excited for the prospect of our cyclidine-based LNV100.
Speaker Change: We believe the commercial potential of LND 100 was validated in our Phase 3 Clarity Study.
Speaker Change: with 90% of participants noticing an improvement in your vision.
Speaker Change: and 75 participants indicating they would continue to use Lenz 100 after the study, of which 81% plan to use the product 4 to 7 days per week.
Speaker Change: Together, with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion market potential opportunity.
Abe Schimmelpenek: Lastly, I'm very excited to highlight that we have submitted our MBA for L&D 100 to the FDA, marking a key milestone for the company. Our MBA is a culmination of a development program that along the way incorporated a valuable feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data and we look forward to working with the agency as they review our submission.
Speaker Change: and in what could potentially be a category of one.
Sean Olson: Our commercial launch preparedness is well underway. In February of 2024, Lenz launches an unbranded IAM campaign to educate and excite eye care professionals about future presbyopia solutions. Over 50 key opinion leaders are involved in the campaign, of which many are featured at iamselective.com.
Speaker Change: In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway. In February of 2024, Lens launched its unbranded IAM campaign to educate and excite eye care professionals about future presbyopia solutions.
Speaker Change: Over 50 key opinion leaders are involved in the campaign, of which many are featured at iamselective.com. That is E-Y-E-AMSELECTIVE.COM.
Sean Olson: That is E-Y-E-I-A-M-S-E-L-E-C-T-I-V-E dot com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and expected early consumer adopters of Presbio B-Hydroxides. Continuing on that momentum, and to support the projected launch following potential FDA approval, Lenz has fully staffed its commercial leadership team across marketing, sales, and commercial operations with expertise in eye care, direct consumer, influencer, and consumer products. From an infrastructure standpoint, Lenz is actively building out its U.S. commercial capability
Abe Schimmelpenek: Our first step in this and following a positive initial review would be the formal acceptance of our MBA within 60 days of submission. Once the FDA accepts our MBA, the agency must complete their review within 10 months. The end, the date at the end of this period is referred to as the producer date and once the FDA has provided us with it, we will communicate this with you.
Speaker Change: where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity,
Speaker Change: and Expected Early Consumer Adopters of Presbiobia Hydroxides.
Speaker Change: continuing on that momentum and to support the projected launch following potential FD approval.
Abe Schimmelpenek: As mentioned earlier and in line with previous guidance, we believe that this producer date can be in the middle of next year and if our submission needs to approval could lead to a launch of L&D 100 in the US in the second half of 2025.
Speaker Change: Lenz has fully staffed its commercial leadership team across marketing, sales, and commercial operations with expertise in eye care, direct consumer, influencer, and consumer products goods.
Speaker Change: From an infrastructure standpoint, LEND is actively building out its U.S. commercial capabilities, highlighted by completion of our third-party logistics contracting, all in preparation for a potential launch of LND 100 as early as the second half of 2025.
Sean Olson: Highlighted by the completion of our third-party logistics contracting, all in preparation for a potential launch of LNZ 100 as early as the second half of 2020. As we think about the commercialization of LMZ100, our strategy is clear and based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals, who represent over 85% of the beauty market, with our potential best-in-class product to educate and equip them to recommend LNZ100 and integrate our solution into their patient offices. Second, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct-to-consumer advertising.
Sean Olson: To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson, Chief Commercial Officer. Sean, thank you, Ace, and thank you all for joining us today. The commercial potential for an effective Presbyopia treatment represents one of the largest eye care market opportunities. As they stated, Presbyopia impacts estimated 128 million people in the US. An incident population that is nearly four times greater than those impacted by dry eye.
Sean Olson: And third, we want to ensure ease of product access for consumers with a seamless journey. This requires enabling consumers to experience the product and move quickly from trial to use. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy as well as home delivery. We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch.
Speaker Change: As we think about the commercialization of LMV100, our strategy is clear and based on three primary pillars.
Speaker Change: First, we want doctors to recommend us.
Speaker Change: This requires calling on approximately 15,000 eye care professionals who represent over 85% of the beauty scripts.
Sean Olson: It is also more than the combined population suffering from dry eye, childhood myopia, macogeneration, diabetic retapapy, and bifonal in the US. The first eye drop treatment for Presbyopia was approved in 2021 and confirmed that strong consumer desire for an eye drop treatment. As evidenced by initial, paid new scripts of 3,000 to 5,000 per week, long-term usage beyond the trial period of this product did not materialize as pylocarbene, even at the high concentration of 1.25 percent, couldn't deliver the consumer required performance.
Speaker Change: With our potential best-in-class product, to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering.
Speaker Change: Second, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct-to-consumer advertising.
Speaker Change: And third, we want to ensure ease of product access for consumers with a seamless journey to use.
Speaker Change: This requires enabling the consumer to experience the product and move quickly from trial to usage.
Sean Olson: We believe this leaves the category wide open for a non-pylocarbene Presbyopia eye drop solution that can deliver what consumers desire. Unlocking this market requires an ideal Presbyopia eye drop, and we are excited for the prospect of our cycling-based LNZ 100. We believe the commercial potential of LNZ 100 was validated in our phase 3 clarity study. With 90 percent of participants noticing an improvement in your vision and 75 participants indicating they would continue to use LNZ 100 after the study of which 81 percent plan to use the product 4 to 7 days per week.
Speaker Change: To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy as well as home delivery.
Speaker Change: We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch. With that, I'd now like to hand the call over to Dan Chevard, our CFO , to step through our financial results.
Sean Olson: With that, I'd now like to hand the call over to Dan Chevillard, our CFO, to go through our financial results. Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter. On the financial front, we were very pleased to have completed the $30 million private investment in public equity, or PIPE, with Ridgeback in mid-July. I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor base in Lenz.
Speaker Change: Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter and recent period.
Speaker Change: On the financial front, we were very pleased to have completed the $30 million private investment in public equity, or PIPE, with Ridgeback in mid-July.
Sean Olson: Together with our broad inclusion criteria, we believe this positioned LNZ 100 well for the estimated $3 billion market potential opportunity, and in what could potentially be a category of one. In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway.
Abe Chemilpenik: I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor base in Lenz.
Sean Olson: Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately $226.2 million in cash, cash equivalents, and marketable securities, which is anticipated to fund the company's cash runway to post-launch positive operating cash. Turning now to our second quarter operating results, our operating expenses and resulting cash burn for the second quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14.4 million compared to $15 million for the same period in 2023.
Abe Chemilpenik: Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately 226.2 million in cash, cash equivalents and marketable securities.
Sean Olson: In February of 2024, Lenz launches unbranded IAM campaigning to educate and excite I care professionals about future of Presbyopia solutions. Over 50 key opinion leaders are involved in the campaign of which many are featured at IAMselective.com, that is EYEAMselective.com, where I care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and expected early consumer adopters of Presbyopia by drops. Continue on that momentum and to support the projected launch following potential approval, Lenz has fully staffed its commercial leadership team across marketing, sales, and commercial operations with expertise in I care, direct consumer, influencer, and consumer products goods.
Abe Chemilpenik: Which is anticipated to fund the company's cash runway to post launch positive operating cash flow
Speaker Change: Turning now to our second quarter operating results, our operating expenses and resulting cash burden for the second quarter were substantially in line with our plan.
Speaker Change: Total operating expenses for Q2 2024 were approximately $14.4 million compared to $15 million for the same period in 2023.
Dan Chevillard: sequentially, our total operating expenses decreased quarter over quarter by 11% from $16.1 million in the first quarter of 2024, as we moved away from costs associated with the recent merger transaction and reduced overall clinical development. On our first quarter call, we highlighted that we would anticipate a sharp decline in our research and development expenses in subsequent quarters due to the recent conclusion of our Phase III Clarity Study, which we certainly have realized in the second quarter.
Speaker Change: Sequentially, our total operating expenses decreased quarter over quarter by 11% from $16.1 million in the first quarter of 2024, as we moved away from costs associated with the recent merger transaction and reduced overall clinical development spend.
Sean Olson: From an infrastructure standpoint, Lenz is actively building out its U.S, commercial capabilities highlighted by completion of our third party logistic contracting, all in preparation for a potential launch of LNB 100 as early as the second half of 2025.
Speaker Change: On our first quarter call, we highlighted that we would anticipate a sharp decline.
Speaker Change: our research and development expenses in subsequent quarters due to the recent conclusion of our Phase 3 clarity study, which we certainly have realized in the second quarter.
Dan Chevillard: Total R&D expenses decreased to $6.9 million in Q2 2024 compared to $12.6 million for the same period in 2023. Sequentially, R&D expenses decreased quarter over quarter by 34% from $10.5 million in the first quarter of this year.
Sean Olson: As we think about the commercialization of LNB 100, our strategy is clear and based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 I care professionals who represent over 85 percent of the beauty scripts without potential best-in-class product to educate and equip them to recommend LNB 100 and to integrate our solution into their patient offering. Second, we want consumers to request us by name.
Speaker Change: Total R&D expenses decreased to $6.9 million in Q2 2024 compared to $12.6 million for the same period in 2023.
Speaker Change: Sequentially, R&D expenses decreased quarter over quarter by 34% from $10.5 million in the first quarter of this year.
Dan Chevillard: We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing. Similarly, and further to our go forward reallocation of capital towards the commercial organization, total SG&A expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023 and sequentially increased quarter over quarter by 32% from $5.6 million in the first quarter of this year.
Speaker Change: We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing activities.
Speaker Change: Similarly and further to our go-forward reallocation of capital towards the commercial organization.
Sean Olson: This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct to consumer advertise. And third, we want to ensure ease of product access for consumers with a seamless during use. This requires enabling consumer to experience the product and move quickly from trial to usage. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy, as well as home delivery. We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and march.
Speaker Change: total SG&A expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023, and sequentially increased quarter over quarter by 32% from $5.6 million in the first quarter of this year.
Dan Chevillard: This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre-commercial planning initiative. Finally, our net loss per share, both basic and diluted, was $0.40 per share in the second quarter 2024 on a net loss of $10.3 million compared to a net loss per share of $7.53 per share in the second quarter 2023 on a net loss of $14.7 million. As was noted on our first quarter call, we again wanted to remind you that these loss per share figures, calculated on a gap basis, consider only weighted average common shares outstanding, which were considerably different in the comparative period. For example, as a public company with a single class of stock outstanding, our Q2 2024 net loss per share was calculated on approximately 25.6 million weighted average common shares outstanding.
Speaker Change: This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre-commercial planning initiatives.
Abe Shimmel-Pennick: Comparing this to Q2 2023, when as a then private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding. Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27.4 million shares outstanding following that financial.
Speaker Change: Finally, our net loss per share, both basic and diluted, was $0.40 per share in the second quarter of 2024 on a net loss of $10.3 million, compared to a net loss per share of $7.53 per share in the second quarter of 2023 on a net loss of $14.7 million.
Dan Chevrolet: With that, I'd now like to hand a call over to Dan Chevrolet, RCFO, to step through our financial results. Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter in recent periods. On the financial front, we were very pleased to have completed the $30 million private investment in public equity or pipe with Ridgeback in mid-July. I would like to reiterate it's comments to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor base in Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately 226.2 million in cash, cash equivalents and marketable securities, which is anticipated to fund the company's cash runway to post-launch positive operating cash flow.
Speaker Change: As was noted on our first quarter call, we again wanted to remind you that these loss per share figures, calculated on a gap basis, consider only weighted average common shares outstanding, which were considerably different in the comparative periods.
Speaker Change: For example, as a public company with a single class of stock outstanding, Q2 2024 net loss per share was calculated on approximately 25.6 million weighted average common shares outstanding.
Speaker Change: Compare this to Q2 2023, when as a then-private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding.
Speaker Change: Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding.
Dan Chevrolet: Turning now to our second quarter operating results, our operating expenses and resulting cash burned for the second quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14.4 million, compared to $15 million for the same period in 2023. Sequentially, our total operating expenses decreased quarter over quarter by 11% from 16.1 million in the first quarter of 2024. As we moved away from costs associated with the recent merger transaction and reduced overall clinical development spend.
Speaker Change: To roll this forward to our July 2024 pipe, we had approximately 27.4 million shares outstanding following that financing.
Abe Shimmel-Pennick: With that, I'll conclude the financial update for what has been a very productive quarter in the recent period, and I'll now turn the call back over to Abe for final remarks. Thanks, Dan. In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been and promises to continue to be a very exciting time.
Speaker Change: With that, I'll conclude the financial update for what has been a very productive quarter in recent period, and I'll now turn the call back over to Abe for final remarks.
Abe Chemilpenik: Thanks, Dan.
Abe Chemilpenik: In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been, and promises to continue to be, a very exciting time at Lenz.
Operator: With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LNZ100. And 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. With that, I'd like to open up the call for questions. We will now begin the question and answer session. Our first question will come from the line of Pavan Patel with Bank of America. Please go ahead. Hey guys, this is Bhavan Patel on 4G Sinkerberry.
Speaker Change: With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LMZ100.
Dan Chevrolet: On our first quarter call, we highlighted that we would anticipate a sharp decline in our research and development expenses in subsequent quarters due to the recent conclusion of our phase three clarity study, which we certainly have realized in the second quarter. Total R&D expenses decreased to $6.9 million in Q2 2024, compared to $12.6 million for the same period in 2023. Sequentially, R&D expenses decreased quarter over quarter by 34% from $10.5 million in the first quarter of this year. We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing activities.
Speaker Change: And we believe we're well-positioned to deliver a once-daily, safe, and rapidly-acting treatment to the 128 million individuals living with presbyopia in the United States.
Speaker Change: With that, I'd like to open up the call for questions.
Speaker Change: We will now begin the question and answer session. Our first question will come from the line of Pawan Patel with Bank of America. Please go ahead. Thank you.
Pavan Patel: Congratulations on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect SG&A spend to pick up as you begin to incur more meaningful pre-launch investment in your P&L? And then our second question is, maybe you can remind us how you think about the market opportunity and identify the patients who would be good candidates for a pharmacotherapy treatment for loss of near vision versus reading glasses. Thank you. Thanks, well, great questions. I'll hand the first one over to Dan.
Bob: Hey guys, this is Bhavan Patel on 4G Sinkerberry. Congrats on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect
Speaker Change: SG&As then to pick up as you begin to incur more meaningful pre-launch investment on your P&L.
Dan Chevrolet: Similarly, and further toward GoFord reallocation of capital towards the commercial organization, total SGNA expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023. In sequentially increased quarter over quarter by 32% from $5.6 million in the first quarter of this year. This change was directly attributable to key personal additions within our commercial leadership team and increases in our pre-commercial planning initiatives.
Speaker Change: And then our second question is, maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses.
Speaker Change: Thank you.
Speaker Change: Thanks a very long time.
Dan Chevillard: Sure, yeah, thanks for the question. As we said, for this quarter, we did see a 32% quarter-on-quarter increase in SG&A, and I think that you should expect us to have a modest ramp over the balance of this year. I think where you'll really start to see it is as we move into 2025 and then subsequently prepare for commercialization, Salesforce, hiring, et cetera, as we approach the mid-year of next year.
Dan: Great questions. I'll hand the first one over to Dan.
Dan: Sure, thanks for the question. Kind of as we said for this quarter, we did see a 32% quarter-on-quarter increase in SG&A and I think that you should expect us to have a modest ramp over the balance of this year.
Dan Chevrolet: Finally, our net loss per share, both basic and deluded, was $0.40 per share in the second quarter of 2024 on a net loss of $10.3 million. Compared to a net loss per share of $7.53 per share in the second quarter of 2023, on a net loss of $14.7 million. As was noted on our first quarter call, we again wanted to remind you that these loss per share figures calculated on a gap basis consider only weighted average common shares outstanding, which were considerably different in the competitive periods.
Speaker Change: I think where you'll really start to see is as we move into 2025, and then subsequently preparing for commercialization, sales force, hiring, et cetera, as we approach the mid-year of next year.
Dan Chevillard: Thanks. And then, as for which patients we would prioritize, Sean? Yeah, so when we think about our product, we have a very broad inclusion criteria. So, you know, we want to develop a product that works for everyone. And that's why we were focused on an all eyes, all day solution. Now, that being said, there are people that are more prone to be early adopters of an eye drop solution.
Speaker Change: Thanks.
Speaker Change: And then as for which patients we would prioritize, Sean? Yeah, so looking at how we identify the patients that would be good candidates for this job.
Dan Chevrolet: For example, as a public company with a single class of stock outstanding, Q2 2024 net loss per share was calculated on approximately $25.6 million weighted average common shares outstanding. Compared this to Q2 2023, when as a then private company with multiple classes of preferring common stock outstanding, net loss per share was calculated on approximately $2 million weighted average common shares, outstanding. Putting the nuances of loss per share aside in the lack of culpability to 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27.4 million shares outstanding following that financing.
Speaker Change: So when we think about our product, we had a very broad inclusion criteria. So, you know, we want to develop a product that did work for everyone. And that's why we're focused on an all eyes, all day solution. Now, that being said, there are people that are more prone to be early adopters of an eyedrop solution.
Dan Chevillard: We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters. And those three groups fall into people that are in contacts now, entering Presbyopia, and want to stay in contacts. They've been in a glasses-free lifestyle and want to continue that, and a big reason for dropout of contacts is because of Presbyopia.
Speaker Change: We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters.
Speaker Change: And those three groups fall into people that are in contacts now, entering presbyopia, and want to stay in contacts. They've been in a glasses-free lifestyle and want to continue that.
Speaker Change: And a big reason for dropout of contacts is because of presbyopia. The second one are people that have had refractive surgery in the past. So again, people who paid for LASIK.
Sean Olson: The second one is people that have had refractive surgery in the past. So, again, people who paid for LASIK, invested in the Glasses-Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that have been to a Medi-Spa in the past 12 months. Each one of those groups is north of 10 million individuals.
Dan Chevrolet: With that, I'll conclude the financial update for what has been a very productive quarter in recent period, and I'll now turn the call back over to Dave for final remarks. Thanks, Dan. In summary, we are very pleased for the progress that the team has made on all fronts.
Speaker Change: invested in Glasses-Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that have been to a Medi-Spa in the past 12 months. Each one of those groups are north of 10 million individuals.
Igor Malkomovitz: Thanks, Sean. Great. Our next question will come from the line of Igor Malkomovitz with Citi. Please go ahead. Hi, team. Thanks for taking the questions. I had a few.
Abe Schimmelpenek: The recent period has been and promises to continue to be a very exciting time at Lenz. With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of L&Z100, and we believe we'll well-positioned to deliver a once-daily, safe, and rapidly acting treatments to the 128 million individuals living with Presbyopia in the United States.
Sean Olson: Thanks, Sean. Great.
ego knock-o-movits: Our next question will come from the line of Egon Malkomovitz with Citi. Please go ahead.
Sean Olson: I'm just curious, with respect to the target prescriber audience, the optometrists, can you just give some perspective as to what percent of the optometrist pool in the United States are currently able to write prescriptions for Lenz 100? And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe Lenz 100? Thanks. Absolutely. So, this is Sean Olson again. So, when we think of L&P 100, you know, upon potential approval, those that are able to prescribe it when we think of optometrists, nearly all the optometrists across the U.S. will have the ability to prescribe LNV-100. So it falls into the category of meiotics.
ego knock-o-movits: Hi Eiffen team, thanks for taking the questions. I had a few. I'm just curious with respect to the the target prescriber audience, the optometrists...
ego knock-o-movits: Can you just give some perspective as to what percent of the palmistress pool in the United States are currently able to write?
ego knock-o-movits: prescriptions for Lenz 100? And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe Lenz 100? Thanks.
Operator: With that, I'd like to open up the call for questions. We will now begin the question and answer session.
Pauvin Patel: Our first question will come from the line at Pauvin Patel with Bank of America. Please go ahead. Hey guys, this is Pauvin Patel on 4G Singer Berry. Congrats on your recent NDA submission and things are taking their questions.
ego knock-o-movits: Absolutely. So, this is Sean Olson again. So, when we think of L&D 100, you know, upon potential approval,
Sean Olson: The first question is, can you give us an idea of when we should expect S-G&A to pick up as you begin to incur more meaningful pre-launch investment on your PNL? The second question is maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses, thank you. Thanks, Oval. Great questions.
ego knock-o-movits: Those that are able to prescribe it, when we think of the optometrists, nearly all the optometrists across the U.S. will have the ability to prescribe LNV-100. So it falls in the category of meiotics.
Sean Olson: And with the exception of a couple of states, they will have the ability to prescribe on day one. And so that really covers the vast majority of all optometry. In terms of doing retinol eye exams, retinol eye exams are going to be a very common process done for, again, nearly every optometrist across the U.S.
ego knock-o-movits: And with the exception of a couple of states, they will have the ability to prescribe on day one. And so that really covers the vast majority of all optometrists.
ego knock-o-movits: In terms of doing retinal eye exams, retinal eye exams are going to be a very common process done for, again, nearly every optometrist across the U.S. They will be able to do those retinal eye exams.
Sean Olson: I'll hand the first one over to Dan. Sure. Thanks for the question. As we said for this quarter, we did see a 32% quarter on quarter increase in S-G&A, and I think that you should expect us to have a modest ramp over the balance of this year. I think where you'll really start to see is as we move into 2025 and then subsequently preparing for a commercial, commercialization, sales force, hiring, etc, as we approach the mid-year next year.
Sean Olson: They will be able to do those retinol eye exams. So, in terms of access, we see ourselves in a very good position for access upon approval. Great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies and the data that supports the use of Lenz 100 in lower light conditions, for example, if you're out for a meal at a restaurant and you need to read the menu, for example, could you just talk about that aspect of the product profile?
ego knock-o-movits: So, in terms of access, we see ourselves in a very good position for access upon approval.
Speaker Change: Okay, great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies.
Speaker Change: and the data that supports the use of Lenz 100 in
Speaker Change: lower light conditions, for example, if you're out at a meal at a restaurant and you need to read the menu, for example. Could you just talk about that aspect of the product profile?
Sean Olson: Absolutely. So we did all our near vision measurements in what's called mesopic conditions. So mesopic is low light. Just to give you an idea of what that means, so we actually have one of our KOLs describe that very adequately in our KOL event, that basically means that you lower the light in the room to almost candlelight conditions.
Sean Olson: Thanks. And then ask for which patients we would prioritize, Sean. Yeah. So looking at how we identify the patients that would be good candidates for this drop. So when we think about our products, we had a very broad inclusion criteria. So we want to develop a product that did work for everyone, and that's why we're focused on all eyes all day solutions. Now, that being said, there are people that are more prone to the early adopters of an eye drop solution.
Speaker Change: Absolutely. So, we did all our near vision measurements in what's called mesopic conditions. So, mesopic is low light.
Speaker Change: Just to give you an idea of what that means, so we actually have one of our KOLs describe that very adequately in our KOL event.
Speaker Change: That basically means that you lower the lights in the room.
Sean Olson: So, it's very low light in the room, and then you have them read a backlit screen. So, these are truly low-light conditions that we've measured all eye-mirror vision in. So, if you will, it's the most challenging condition because we definitely wanted to avoid brightening the room in a way that it would impact near vision in a positive way that we could not ascribe to our product. So, again, very low-light, dim-lit conditions in the room.
Speaker Change: To almost candlelight conditions, so it's very low light in the room
Sean Olson: We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters. And those three groups fall into people that are in contacts now, entering Presbyopia, and want to stay in contacts. They have been looking for, they've been in a glasses' real lifestyle, and want to continue to... And a big region for recent, for dropout of, of contacts is because of Presbyopia.
Speaker Change: And then you have them read a backlit screen. So it's truly low-light conditions.
Speaker Change: that we've measured all our near vision in. So, if you will, it's the most challenging condition because we definitely wanted to avoid that we, you know, brighten the room in a way that it would impact positively.
Speaker Change: near vision, that would good enough.
Sean Olson: The second one are people that have had refractive surgery in the past, but again, people who have paid for LASIC, invested in glasses rely style and want to continue it. And thirdly, we found a high correlation to people that have been to a Medispa in the past 12 months. Each one of those groups are north of 10 million individuals. All right, thanks, Sean.
Speaker Change: Ascribe to our products. So again, very low light dim lit conditions in the room.
Sean Olson: And just to back up a little bit on Sean's statement on the retina exam, that's something that all optometrists pretty much do already. So, it's a very standard exam. So, it's not something that we need to train them on or that they need to add to their practice to be able to prescribe a drop.
Sean Olson: And just to back up a little bit into Sean's statement on the retina exam, that's something that all optometrists pretty much do already, so it's a very standard exam, so it's not something that we need to train them on or that they need to add to the practice to be able to prescribe a drop. Again, very common practice in optometry.
Ego Nakama: Our next question will come from the line of Ego Nakama, that's with city. Please go ahead. Hi, I have been team. Thanks for taking the questions. I had a few. I'm just curious with respect to the target prescriber audience, the optometrist, can you just give some perspective as to what percent of the optometrist pool in the United States are currently able to write prescriptions for Lenz 100. And then also what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe Lenz 100. Thanks.
Sean Olson: Again, very common practice in optometry. Okay. Thank you. Our next question comes from the line of Joseph Kadenzerra with Piper Sandler. Please go ahead. Hey, everybody. Thanks for taking my questions. Maybe two for me.
Speaker Change: Okay, thank you.
Speaker Change: Our next question comes from the line of Joseph Cadenzaro with Piper Sandler. Please go ahead.
Joseph Kadenzerra: First, as it relates to the NDA filing, can you just remind us whether there was any formal engagement with the FDA, like a pre-NDA meeting, ahead of the filing? And if so, any sort of feedback learnings you gleaned from those interactions? And then second question, related to early adopters, but less from a patient perspective and more so from a physician perspective, you know, what are you looking for there? Is it simply those who have written a VUIDI script in the past, or are there more things that you're honing in on that could potentially identify early writers?
Joseph Cadenzaro: Hey everybody, thanks for taking my questions, maybe two from me first as of relates to the NDA filing. Can you just remind us whether there was any?
Joseph Cadenzaro: formal engagement with the FDA, like a pre-NDA meeting ahead of the filing, and if so, any sort of feedback learnings you glean from those interactions.
Speaker Change: And then second question, I guess, related to.
Speaker Change: early adopters, but less from a patient perspective and more so from a physician perspective. You know, what are you looking for there? Is it simply those who have written a VUITY script in the past or are there more things that you're honing in on that could potentially identify early writers? Thanks.
Sean Olson: Absolutely. So this is Sean Olson again. So when we think of LND100, you know, upon potential approval, those that are able to prescribe it when we think of the optometrist, nearly all the optometrist across the US will have the ability to prescribe LND100. So it falls into the category of myodics. And with the exception of a couple of states, they will have the ability to prescribe on day one. And so that really covers the vast majority of all optometrists.
Abe Shimmel-Pennick: Thanks. Thanks, Joe. I'll take the first one, and then I'll get the next one over to Sean.
Speaker Change: Thanks, Joe. I'll take the first one and then I'll get the next one over to Sean.
Abe Shimmel-Pennick: So, yes, there was definitely an end-of-phase three and pre-submission meeting with the FDA. But more importantly, we've had many discussions and engagements with them throughout the years of our development, and that's where most of the feedback actually came from, the FDA. So, we were very well aligned with them, and especially our clinical program, manufacturing setup, basically everything that was relevant for the development. And that actually made the end of phase three meeting with them pretty benign. I think there were hardly any questions that we actually had left that we wanted to ask.
Sean Olson: So, yes, there's been definitely an end-of-phase 3 and pre-submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development, and that's where most of the feedback...
Sean Olson: In terms of doing retinal eye exams, retinal eye exams are going to be a very common process done for, again, nearly every optometrist across the US, they will be able to do those retinal eye exams. So in terms of access, we see ourselves in a very good position for access upon approval. Okay. Great.
Sean Olson: actually came from the FBA, so we're very well aligned with them, especially our clinical program.
Sean Olson: manufacturing setup, basically everything that was relevant for the development. And that actually then made the end of phase three meeting with them pretty benign. I think there was hardly any any questions actually that that we had left.
Sean Olson: And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies and the data that supports the use of LND100 in lower light conditions, for example, if you're out at a meal at a restaurant and you need to read the menu, for example, could you just talk about that aspect of the product profile? Absolutely. So we did all our near vision measurements in what's called mesopic conditions.
Abe Shimmel-Pennick: It was merely a confirmation that this is all the data that we've gathered, this is the number of patients that we have on both the efficacy and the safety side, and they once again confirmed that this was completely aligned with their expectations for our NDA. So we're very confident that the filing has, or the submission has everything in it that the FDA wants. And for your second question, when we were identifying early adopters from an eye care professional standpoint, again, we commissioned a very large study and took into account many factors.
Sean Olson: that we want to ask, it was merely a confirmation of.
Sean Olson: This is all the data that we've gathered. This is the amount of patients that we have from both the efficacy and the safety side.
Sean Olson: So mesopic is low light, just to give you an idea of what that means. So we actually have one of our KOLs described that very adequately in our KOL events. That basically means that you're low in the light in the room to almost kind of light conditions. So it's very low light in the room. And then you have them read a backlit screen screen. So it's truly low light conditions that we've measured all our near vision in.
Sean Olson: And they once again confirmed that that was completely aligned with their expectations for our NDA. So we're very confident that the filing has, or the submission has everything in it that the FDA wants to see.
Sean Olson: So if you will, it's the most challenging condition because we definitely wanted to avoid that we brighten the room in a way that it would impact positively near vision that we could not ascribe to our products. So again, very low light dimlit conditions in the room.
Speaker Change: And for your second question, when we were identifying early adopters from an eye care professional standpoint, again we commissioned a very large study and took in count many factors. We looked at the prescriptions of beauty,
Abe Shimmel-Pennick: We looked at the prescriptions of UOD. We looked at early adopters of other recent eye care launches. We also looked at the history of prescriptions for dry eye, as well as different locations such as urban city centers where we saw a lot of beauty scripts.
Speaker Change: We looked at early adopters of other recent eye care launches.
Speaker Change: We also looked at, you know, history of prescriptions for dry eye as well as different locations such as urban city centers where we saw a lot of the beauty scripts.
Sean Olson: Ultimately, when we did all the analysis, what came out and was the primary focus of the targeting was their actual propensity to write quality and how many scripts they wrote. And that's really where we came up with those 15,000 target ECPs that represent over 85% of all the views. Okay. Our next question will come from the line of Mark Goodman with Lear, Inc. Please go ahead.
Speaker Change: Ultimately, when we did all the analysis, what came out and was the primary focus of the targeting was their actual propensity to write VUIDI and how many scripts they wrote.
Speaker Change: And that's really where we come up with those 15,000 target ECPs that represent over 85% of all the beauty scripts.
Sean Olson: And I just do to back up a little bit into Sean's statement on the retina exam. That's something that all optometrist pretty much do already. So it's a very standard exam. So it's not something that we need to train them on or that they need to add to the practice to be able to describe it right again, very common practice in optometrium. Okay, thank you.
Speaker Change: Okay. Our next question will come from the line of Mark Goodman with Lyrinc. Please go ahead.
Mark Goodman: Yishai, could you please review what you've done on CMC and tell us what's left to do? Just give us an update there, please. Thanks. Absolutely. Thanks, Mark.
Mark Goodman: If I could you please review what you've done on CMC, what's left to do, just give us an update there please.
Sean Olson: So on the CMC side, on the manufacturing side, we've actually produced all our clinical phase 3 material at commercial scale. So we're fully set up to produce launch quantities at that scale. Our complete supplier network is in very good standing with the FBA, so we're very confident that our commercial network, commercial manufacturing, and clinical trials are all in place there. And that goes for both drug products as well as drug substance or API. Stability is all done; everything you need to do there.
Speaker Change: Absolutely. Thanks, Mark. Good question. So, on the CMC side, or the manufacturing side, we've actually produced all that clinical Phase III material at commercial scale.
Joseph Cadenzerro: All right, next question comes from the line of Joseph Cadenzerro with Piper Samler. Please go ahead. Hey everybody, thanks for taking my questions.
Dan Chevrolet: Maybe two from me versus it relates to the NDA filing. Can you just remind us whether there was any formal engagement with the FDA, like a pre-NDA meeting ahead of the filing? And if so, any sort of feedback learnings to sort of glean from those interactions?
Speaker Change: Our complete supplier network is in very good standing with the FBA, so we're very confident that our commercial network, commercial manufacturing is all in place there, and that goes for both the truck products as well as truck substance or API.
Sean Olson: And then second question, I guess related to early adopters, but but let's from a patient perspective and more so from a physician perspective, you know, what are you looking for there? Is it simply those who have written a beauty script in the past or are there more things that you're honing in on that could potentially identify early early writers? Thanks. Thanks, Joe.
Sean Olson: Yeah, so that is all done. All the stability data that we needed to submit our program, and this is generic for for any submissions you need to submit with at least 12 months of stability data on your registration batches, which, obviously, given the fact that we've submitted. We have that in place, and we submitted it, and Dale looks stellar.
Speaker Change: Stability all done. Everything you need to do there.
Speaker Change: Yep, so that is all done. So all the submissions that we needed to submit our program, and this is generic for any submissions, you need to submit with at least 12 months.
Dan Chevrolet: I'll pick the first one and then I'll pick the next one over to Sean. So yes, there's been definitely a end of phase three and pre-submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development. And that's one of most of the feedback actually came from the FDA. So we've very well aligned with them, on especially our clinical program, manufacturing setup, basically everything that was relevant for the development.
Dan Chevrolet: And that actually then made the end of phase three meeting with them pretty benign. I think it was hardly any any questions actually that we have left that we want to ask. It was merely a confirmation of this is all the data that we've gathered, these are the amount of patients that we have on both the efficacy and the safety side. And they once again confirmed that that was completely aligned with that expectations for our FDA. So we're very confident that the filing has or the submission is everything in that the FDA wants to see.
Speaker Change: of stability data on your registration badges, which obviously, given the fact that we've submitted, we have that in place and submitted, and that data all looks stellar.
Sean Olson: Great. And then just secondly, on the unbranded campaign, can you just go into a little bit of detail, a little more color just on, you know, what the discussion is like, maybe just give us a sense of what a session would be like and the feedback you're getting. Thank you. Yeah, absolutely.
Speaker Change: Great, and then just secondly on the unbranded campaign, can you just go into a little bit of detail, a little more color just on, you know, what
Speaker Change: what's the discussion, what it's like, maybe just give us a sense of what a session would be like and the feedback you're getting. Thank you.
Sean Olson: So we're really excited about this unbranded campaign. What's unique to presbyopia is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state.
Speaker Change: Yeah, absolutely. So we're really excited about this unbranded campaign. What's unique to Presbyopia is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. What we have to train people on is how to look for what an ideal Presbyopia eyedrop solution is.
Sean Olson: What we have to train people on is how to look for the ideal presbyopia eyedrop solution. So really, what we're talking about is what's the ideal pupil size, you know, the importance of an eyedrop that focuses on reducing the pupil but avoiding that ciliary muscle. And also, because there are so many people out there impacted by presbyopia, you know, who are the early adopters? So a lot of that's training on, you know, those three groups I talked about before, people in contacts, people who have had refractive surgery, and people who have been to a MediSpot. And overwhelmingly, what we see at the different conventions is excitement for the campaign.
Speaker Change: So, really what we're talking about is what's the ideal pupil size, you know, the importance of an eyedrop that focuses on reducing the pupil but avoiding that ciliary muscle.
Speaker Change: And then also, because there's so many people out there impacted by presbyopia, you know, who are the early adopters? So a lot of that's training on, you know, those three groups I talked about before. People in contacts, people have had refractive surgery, and people have been to a MEDISPAR.
Sean Olson: And for your second question, when we're identifying early adopters from an I care professional standpoint. Again, we commissioned a very large study and took and count many factors. We looked at the prescriptions of duty. We looked at early adopters of other recent I care launches. We also looked at history of prescriptions for dry eye as well as different set different locations such as urban city centers where we saw a lot of the beauty scripts.
Speaker Change: and overwhelmingly what we see at the different conventions.
Sean Olson: It's very ETP forward, so we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions, and we actually release a new one every week on LinkedIn. And we get calls from doctors saying, "Hey, when is my photo going out? Because I actually want to see my photo on LinkedIn. I want to like it." So it's going very well, and I think what's always really important with our product, you know, the first thing people want to know about the product, and this is separate from the unbranded because we can't commingle the two, but they want to know it's not pylocarbene. That's the really important thing that doctors care about.
Speaker Change: is excitement for the campaign. It's very ECP forward, so we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions.
Speaker Change: And we actually release a new one every week on LinkedIn and we're getting calls from doctors saying, hey, when is my photo going out because I actually want to, I want to see my photo on LinkedIn. I want to like it.
Sean Olson: Ultimately, when we did all the analysis, what came out and with the primary focus of the targeting was their actual propensity to write beauty and how many scripts they wrote. And that's really where we come up with those 15,000 target ECPs that represent over 85% of all the beauty scripts. Okay.
Speaker Change: So, it's going very well. I think what's always really important with our product...
Speaker Change: You know, the first thing people want to know about the product, and this is separate from the unbranded because we can't commingle the two, but they want to know it's not pylocarcaine. That's the really important thing that doctors care about.
Sean Olson: As soon as they know it's a non-pylocarbene solution on the medical side, you know, they're very excited to learn more about the product and engage. So we've seen this as a very good success, and we've seen a lot of traction, and a lot of eye care professionals coming to us that want to share their excitement for the future of presbyopia solutions. They want us to tell them more. Our next question comes from the line of Tim Lugo with William Blair. Please go ahead. Hey guys, this is Lachlan on for Tim.
Mark Goodman: Our next question will come up on the line of Mark Goodman with leering. Please go ahead. If I could you please review what you've done on CMC. What's left to do. Just give us an update there. Please. Thanks. Absolutely. Thanks. Thanks Mark. Good question.
Speaker Change: As soon as they know it's a non-pylocarpene solution on the medical side, you know, they're very excited to learn more about the product and engage.
Speaker Change: So we've seen this as a very good success. We've seen a lot of traction and a lot of ECPs coming to us.
Speaker Change: that want to share their excitement for the future of Presbyopia solutions. They want us to tell them more.
Mark Goodman: So on the CMC side of the manufacturing side, we've actually produced all like clinical phase three material at commercial scale. So we're fully set up to produce low-inch quantities at that scale. A complete supply and network is a very good standing with the FDA. So a very confident that our commercial network, commercial manufacturing is all in place there and it goes for both the truck products as well as the truck substance or API.
Speaker Change: Thanks.
Speaker Change: Our next question comes from the line of Tim Lugo with William Blair. Please go ahead.
Tim Lugo: Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research? And secondly, I believe at KOL day, one of the physicians said or suggested that most patients would first try the drop in the office. Is that sort of correct, or is that what you're expecting? Thanks, Larry. I'm good to hear from you. So, I'm the first one.
Lachlan: Hey guys, this is Lachlan on for Tim. Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research? And secondly, I believe at the KOL day, one of the physicians said or suggested that they would
Mark Goodman: Stability all done, everything you need to do there. Yeah, Stability is all done, so all the stability that we need it to submit our program and it is generic for any submissions. You need to submit with at least 12 months of stability data on your registration batches, which obviously given the fact that we've submitted and we have that in place and submit it and that day all looks look stellar.
Speaker Change: you know, most patients would first try the drop in the office. Is that sort of correct or is that what you're expecting?
Sean Olson: And, you know, I'll keep that very brief because, obviously, I want to make sure that, one, we don't talk about anything that's not on the label yet that we've not studied. But, for sure, the medical community is talking and thinking about uses for how they could see this product being used outside of near vision. So, yeah, that's something that, in that context, is discussed. That's something for me to elaborate on.
Speaker Change: Thanks, thanks a lot. I'm good too. So I'm that first one. And, you know, I'll keep that very brief because obviously I want to make sure that one, we don't talk about anything that's that's not on the label yet on that that we've not started but
Speaker Change: For sure, you know, the medical community is talking and thinking about uses of how they could see this product being used outside of near vision. So, yeah, that's something that in that context.
Sean Olson: Great, and then just secondly on the unbranded campaign, you can just go into a little bit of detail, a little more color just on, you know, what's the discussion, what it's like, maybe just, you know, give us a sense of what a session would be like and feedback you're getting. Thank you. Yeah, absolutely.
Speaker Change: discussed, not something for me to elaborate on.
Sean Olson: And in terms of the use of the product, you know, we meet with a lot of different eye care professionals across optometry. You know, many of them want the patient to experience it in the office. And what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect, you know, right off the bat when they put it in. Now, some doctors, especially those that go for the dilated eye exam, are gonna want them to take the samples home and try it at home. But we see that, you know, how the ECPs run their practice will decide whether or not they do it in the office or outside of the office.
Speaker Change: And in terms of the use of the product, we meet with a lot of different eye care professionals across optometry. Many of them want the patient to experience in the office, and what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect.
Sean Olson: So we're really excited about this unbranded campaign. What you need to price the OBI is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. Well, we have to train people on is how to look for what an ideal press the OBI drop solution is. So really what we're talking about is what's the ideal pupil size, you know, the importance of a eye drop that focuses on reducing the pupil but avoiding that silly airy muscle.
Speaker Change: right off the bat when they put it in. Now, some doctors, especially those that go for the dilated eye exam, are going to want them to take the samples home.
Speaker Change: try it at home, but we see that, you know, how the ECPs run their practice will decide whether or not they do it in office or outside of the office. It will be a good mix.
Sean Olson: It will be good. Thanks. Just one thing to add there, like on the data side, just thinking about it some more on what you just asked. One of the things that we've realized that we shared during that KOL event is that what the data shows is that SEOpresbyopia gets worse; your actual impact keeps up with that.
Sean Olson: And then also because there's so many people out there impacted by a press the OBI, you know, who are the early adopters. So a lot of that's training on, you know, those three groups I talked about before, people in contacts, people have had refractive surgery and people have been to a many spot. And overwhelmingly, what we see at the different conventions is excitement for the campaign. It's very ETP forward. So we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions.
Speaker Change: Thanks.
Speaker Change: Just one thing to do at the like under on the data side just think about it some more on what you just just asked one of the things that we've realized that we shared during that KOL event that
Speaker Change: What the data shows is that SEL presbyopia gets worse.
Sean Olson: So the worse your Presbyopia is, the more lines you gain. That's certainly something that we've heard resonate really well in the medical community. So when maybe people initially were thinking about a presbyopia eye drop as something that, you know, could have an effect early on in some months, on the presbyopia journey, it's very clear now that actually our drop, uniquely, because it is unique to our product, keeps up with how your presbyopia, I guess, gets worse. So if your Presbyopia is 20 over 80 or 20 over 100, and you would need four or five, maybe six lines, that's what the product actually delivers for you.
Speaker Change: the actual impact keeps up with that. So the worse your presbyopia, the more lines you gain. That's certainly something that we've heard resonate really well in the medical community.
Sean Olson: And we actually released a new one every week on LinkedIn and we're getting calls from doctors saying, hey, when is my photo going out? Because I actually want to, I want to see my photo on LinkedIn, I want to like it. So it's going very well. And I think it's always really important with our product. You know, the first thing people want to know about the product is separate from the unbranded because we can't come into the tube, but they want to know it's not pylocarpine.
Speaker Change: what maybe people initially were thinking about.
Speaker Change: a presbyopia eye drop as something that could have an effect early on in someone's presbyopia journey.
Speaker Change: It's very clear now that actually our drop uniquely because it is unique to our product.
Sean Olson: That's the really important thing and the doctors care about. As soon as they know, if the mountain pylocarpine solution on the medical side, you know, they're very excited to learn more about the product and engage. So we've seen this is a very good success. We've seen a lot of traction and a lot of ETPs coming to us that want to share their excitement for the future of Presbyopia solutions. They want us to, they want us to tell them more. Thank you.
Speaker Change: Keeps up with how you are. Presbyopia, I guess, gets worse. So...
Speaker Change: If your price will be 20 over 80 or 20 over 100 and you would need four, five, maybe six lines, that's what the product actually delivers for you. So it ties into that very broad age range that we've tested in our trial.
Sean Olson: So it ties into that very broad age range that we've tested in our trial. Very interesting. Thanks. Our next question comes from the line of Matthew Caulfield with H.C. Wainwright. Please go ahead. Hi, Ocean Team.
Speaker Change: Very interesting. Thanks.
Tim Lugo: Our next question comes from the line of the Tim Lugo with William Blair. Please go ahead. Hey guys, this is a lock on the Tim. Thanks for taking the questions. As you've shared the data with the wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research?
Speaker Change: Our next question comes from the line of Matthew Caulfield with HC Wainwright. Please go ahead.
Matthew Caulfield: Some very exciting developments for the quarter. So, our question was, considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved? Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient, kind of based on their scheduling? Any clarity there or thoughts there could be helpful. I'm excited to see the progress. Thanks. Great, Thank you. This is Sean again.
Matthew Crawford: Hi, OSINT team. Some very exciting developments for the quarter.
Matthew Crawford: So our question was, considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved?
Tim Lugo: And secondly, I believe that the KOL, they, one of the physicians said or suggested that they would, you know, most patients would first try the drop in the office. Is that sort of correct or is that what you're expecting? Thanks. Like I'm good to.
Matthew Crawford: Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient, kind of based on their scheduling? Any clarity there or thoughts there could be helpful, and I'm excited to see the progress. Thanks.
Sean Olson: A couple of comments on that. In terms of what we found in our market research, people are looking for an everyday eyedrop that lasts all day. And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients want to use it four to seven times a week. When we actually look at the patient-reported outcomes from our Phase 3, eighty-one percent of the patients that would continue to use the product after the study plan to use it four to seven days a week.
Matthew Crawford: Great, thank you. This is Sean again. So a couple comments on that. So in terms of what we found in our market research, people are looking for an everyday eyedrop that lasts all day.
Sean Olson: So I'm on that first one and you know I'll keep that very brief because obviously I want to make sure that one we don't talk about anything that's that's not on the label yet on that that we've not studied. But for sure, you know, the medical community is talking and thinking about uses of how that could suit us by like being used outside of off me a vision. So yeah, that's that's something that in that context is discussed, not something for me to to elaborate on.
Matthew Crawford: And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients wanted to use it four to seven times a week, when we actually look at the patient-reported outcomes from our Phase 3.
Matthew Crawford: 81% of the patients that would continue to use the product after the study plan to use it four to seven days a week. So we do see that it's much more like contacts where people want to use it every day.
Sean Olson: So, we do see that it's much more like Contax, where people want to use it every day. Now, that being said, all medicines, you know, most medicines are not 100 percent compliant, right? If you look across the board, for Contax, it's about an 89 percent compliance rate for daily use. Trivia had about a 65 percent refill rate.
Sean Olson: In terms of the use of the product, you know, we meet with a lot of different eye care professionals across optometry. You know, many of them want the patient to experience in the office and what's great about our product is because you have that immediate response that we saw in our trial. People can have that wild effect, you know, right off the bat when they put it in. Now some doctors, especially those that go for the dilated eye exam, are going to want them to take the sample home and try it at home. But we see that, you know, how the ECPs run their practice will decide whether or not they do it in office or outside of the office, it will be a good mix. Okay, thanks.
Matthew Crawford: Now, that being said, all medicines, you know, most medicines are not 100% compliant, right? If you look across the board, you know, for contacts, it's about 89% compliance rate for daily contacts.
Sean Olson: General medicines, about 50 percent. So when you look at that $3 billion market cap, or $3 billion market size, it assumes a conservative five fills a year, or a 42% refill rate. So that's what's built into that $3 billion number.
Speaker Change: Jirvaya had about a 65% refill rate. General Medicine's about 50%.
Speaker Change: So when you look at that $3 billion market cap, or $3 billion market size, it assumes a conservative, you know, 5 fills a year, or a 42% reflow rate.
Sean Olson: However, when we speak to consumers, they're looking for an everyday eyedrop, probably four to seven days per week. Very helpful. And just to confirm, I heard that right. You said five times per year, as sort of an average from your analysis? Yeah, so if you think of average medicines, 50% compliance. Five refills a year would just be a little bit conservative to that. That'd be a 42% refill rate.
Speaker Change: So that's what's built into that $3 billion number. However, when we speak to consumers, they're looking for an everyday eyedrop, looking at probably four to seven days per week.
Abe Schimmelpenek: Just one thing to do at that, like under on the data side, just think about it some more on what you just just asked. One of the things that we've realized that we shared during that K level event that what the data shows is that as your Presbyopia gets worse, you actually in fact, keeps up with that. So the worse your Presbyopia, the more lines you gain, that's certainly something that we've heard resonate really well in the medical community.
Speaker Change: Very helpful. And just to confirm, I heard that right, you said five times per year as sort of an average from your analysis?
Speaker Change: Yeah, so if you think of average medicines are 50% compliance.
Speaker Change: Five refills a year would just be a little bit conservative to that, that'd be a 42% refill rate.
Sean Olson: Gotcha. Okay. Understood. Thank you for that. Thanks, Matt.
Speaker Change: Gotcha. Okay. Understood. Thank you for that.
Abe Schimmelpenek: So when maybe people initially were thinking about a Presbyopia I drop as something that, you know, could have an effect early on. And in some months, Presbyopia journey, it's very clear now that actually our drop uniquely because it is unique to our product, keeps up with how your Presbyopia, I guess gets worse. So if you're Presbyopia, you get over 80 or 20 or over 100 and you could, you would need four or five, maybe six lines, that's what the product, I think, delivers for you. So it ties into that very broad age range that we've tested in our trial. Very interesting.
Operator: And that concludes our question and answer session, as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Please wait. The conference will begin shortly. Please wait. The conference will begin shortly. Please wait.
Speaker Change: Thanks, Matt.
Speaker Change: And that concludes our question and answer session as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
Abe Schimmelpenek: Thanks.
Operator: The conference will begin shortly. [Music] Good afternoon, ladies and gentlemen, and welcome to the Lenz Therapeutics' second quarter 2024 conference call. At this time, all participants are in a listen-only mode.
Matthew Callfield: Our next question comes from the line of Matthew Callfield with H.C. Lanewright. Please go ahead.
Operator: Following prepared remarks from management, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevalart, Chief Financial Officer. Please do so.
Sean Olson: Hi, I was in team. Some very exciting developments for the quarter. So our question was considering filling a perspective monthly prescription. Have you shared how many refills per year could be anticipated among Presbyopia patients if for when ultimately approved? Is the baseline assumption that patients could be using the drops daily, or more likely on select days per month per patient, kind of based on their scheduling? Any clarity there or thoughts there could be helpful and excited to see the progress.
Dan Chevillard: Thank you. Good afternoon, and thank you to everyone for joining us today to discuss Lenz's second quarter 2024 financial results and recent highlights. My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Shimmel-Penick, our President and Chief Executive Officer, and Shawn Olson, our Chief Commercial Officer.
Sean Olson: Thanks. Great. Thank you. This is Sean again. So a couple comments on that. So in terms of what we found in our market research, people are looking for an everyday eye drop that lasts all day, today. And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients wanted to use it four to seven times a week. When we actually look at the patient reported outcomes from our phase three, 81% of the patients that would continue to use the product after the study plan to use it four to seven days a week.
Sean Olson: So we do see this much more like contacts where people want to use it every day. Now that being said, all medicines, you know, most medicines are not 100% compliant. Right? If you look across the board, you know, for contacts, about 89% compliance rate for daily contacts, your via had about a 65% refill rate general medicines about 50%. So when you look at that $3 billion market cap, or $3 billion market size, assumes a conservative, you know, five fill the year, or a 42% refill rate.
Sean Olson: So that was built into that $3 billion number. However, when we speak to consumers, they're looking for an everyday eye drop looking at probably four to seven days per week. Very helpful. And just to confirm, I heard that right. You said five times per year. That's sort of an average from your analysis. But yeah. So if you think of average medicines are 50% compliance, five refills a year would just be a little bit conservative to that.
Sean Olson: That'd be a 42% refill rate. Gotcha. Okay. Understood. Thank you for that. Thanks, Matt. And that concludes our question and answer session. If I'm showing no further questions at this time, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Please wait.
Operator: The conference will begin shortly. Thank you. Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz Lenz[inaudible] Lenz Lenz Lenz[inaudible] Thank you.
Speaker Change: know
Speaker Change: Thank you.
Speaker Change: [music]
Dan Chevillard: In addition, Dr. Mark Odrich, our Chief Medical Officer, will join us for the question and answer session. Before we begin, I would like to remind you that this call contains forward-looking statements regarding Lenz's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections, and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission and which can also be found on our website.
Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Lens Therapeutics second quarter 2024 conference call. At this time, all participants are in a listen-only mode.
Speaker Change: Following prepared remarks from management, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevillard, Chief Financial Officer. Please go ahead.
Dan Chevillard: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.
Dan Chevalard: Thank you. Good afternoon and thank you to everyone for joining us today to discuss Lenz's second quarter 2024 financial results and recent highlights.
Dan Shevelard: My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics.
Speaker Change: We are joined today by Abe Schimelpenik, our President and Chief Executive Officer, and Shawn Olson, our Chief Commercial Officer.
Speaker Change: In addition, Dr. Mork-Odrich, our Chief Medical Officer, will join us for the question and answer session.
Speaker Change: Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LIMS's 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 and which can also be found on our website.
Speaker Change: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.
Speaker Change: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter 2024 4-10Q, which was filed today.
Dan Chevillard: The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter 2024 410Q, which was filed today. With that, I will now turn the call over to Dan. Thank you, Dan, and good afternoon, everyone. The first half of 2024 and recent period has been transformational for us.
Speaker Change: With that, I will now turn the call over to Abe.
Abe: Thank you, Dan, and good afternoon, everyone.
Abe: The first half of 2024 and recent period has been transformational for Lens.
Abe Shimmel-Pennick: In short succession, we made our debut on our public markets with a strong investor base and balance, delivered the results of our Phase 3 CLARI trials, which we believe support LMG100 as the potential best-in-class treatment for presbyopia, concluded a $30 million pipe financing, and importantly submitted our NDA to the FDA. I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only cyclone-based eye drop for improvement in vision in people with Fresna opium.
Abe: In short succession, we made our debut on the public markets with a strong investor base and balance sheet.
Abe: Delivered the results of our phase 3 CLARI trials, which we believe support LMG100 as the potential best-in-class treatment for presbyopia.
Abe: concluded a 30-million-pipe financing, and importantly, submitted our NDA to the FDA.
Abe: I am incredibly proud of the continued excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cyclone-based eyedrop for the improvement in their vision in people with Fresbia opia.
Abe Shimmel-Pennick: Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-2025 and, if approved, a U.S. launch as early as the second half of 2021. Before I review our key achievements in more detail, and as a quick reminder, trespidopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 40. As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near-vision.
Abe: Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid-2025 and, if approved, U.S. launch as early as second half of 2025.
Abe: Before I review our key achievements in more detail and as a quick reminder, trespiopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45.
Abe: As the crystalline lens in our eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina.
Abe Shimmel-Pennick: Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their life as the symptoms become more pronounced starting in the mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. To address the daily challenges faced by presbyopes, we are developing a once-daily eye drop that, in our clarity trials, has shown to be capable of improving their vision throughout the full workday without the need for reading glasses.
Abe: resulting in blurry near-vision.
Abe: Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work.
Dan Chevrolet: Good afternoon and thank you to everyone for joining us today to discuss Lenz's second quarter, 2024, financial results and recent highlights. My name is Dan Chevrolet, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Schimmelpenck, our President and Chief Executive Officer, and Sean Olson, our Chief Commercial Officer. In addition, Dr. Mark O'Drich, our Chief Medical Officer, will join us for the question and answer session.
Speaker Change: To address the daily challenges faced by presbyopes, we are developing a once-daily eyedrop that in our clarity trials has shown to be capable of improving their vision throughout the full workday without the need for reading glasses.
Abe Shimmel-Pennick: More specifically, in April, we reported positive phase 3 data, which we complemented with capstone data in June, in which LMZ100, our cycaderm-based product candidate, continued to show strong performance and best-in-class potential. Highlighting some of the key results of the trial, and for the moment, focusing on the results of CLARI-2, as this is the direct vehicle control trial, we saw a rapid onset effect, with 71% of participants achieving three lights or more of near vision improvement at 30 minutes on the very first day of use of the product.
Speaker Change: More specifically, in April we reported positive phase 3 data, which we complemented with capstone data in June , in which LMZ100, our cycadene-based product candidate, continued to show strong performance and best-in-class potential.
Dan Chevrolet: Before we begin, I would like to remind you that this call contains 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, in which it can also be found on our website.
Speaker Change: highlighting some of the key results of the trial.
Speaker Change: And for the moment, focusing on the results of Clarity 2 as this is the direct vehicle control trial, we saw a rapid onset effect with 71% of participants achieving three lights or more of near vision improvement at 30 minutes on the very first day of use of the product.
Abe Shimmel-Pennick: At three hours, our primary endpoint, we also observed a three-line or more responder rate of 71%. And we maintained these high levels for the full workday, with 40 percent of participants still achieving three lines or more of near-vision improvement at 10 hours, the last time point measured in our efficacy trial. But these three-line gains turned out to be only the beginning.
Speaker Change: At three hours at primary end point, we also observed a three line or more spun the rate of 71%.
Dan Chevrolet: In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically display any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our second quarter 2024 forward thank you, which was filed today.
Speaker Change: And we maintained these high levels for the full workday with 40% of participants still achieving three lines or more of near-vision improvement at 10 hours, the last time point measured in our efficacy trials.
Abe Shimmel-Pennick: Eighty-four percent of participants achieved at least a four-line gain during the study and a staggering 52 percent achieved at least a five-line gain. We also saw a very impressive near-universal response to LNG-100, with 95% of participants achieving at least two lines of near-vision improved. This is an important measure because it is seen as clinically meaningful. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing.
Speaker Change: And these three-line gains turned out to be only the beginning. Eighty-four percent of participants achieved at least a four-line gain during the study and a staggering 52 percent at least five lines.
Dan Chevrolet: With that, I will now turn the call over to Abe. Thank you, Dan and good afternoon, everyone.
Speaker Change: We also saw a very impressive near-universal response to LNG-100, with 95% of participants achieving at least two lines of near-vision improvement. This is an important measure because it is seen as clinically meaningful.
Abe Schimmelpenek: The first half of 2024 and recent period has been transformational for Lenz. In short succession, we made our debut on our public markets with a strong investor base and balance sheet. We levered the results of our Phase 3 Clary Trials, which we believe support LNG100 at the potential best in class treatment for Presbyopia, concluded a 30 million pipe financing and importantly submitted our NDA to the FDA. I am incredibly proud of the continued, excellent execution across the organization and highly confident that we are well on our way to deliver the first and only a cycle-in-based eye drop for the improvement in near vision in people with Presbyopia. Looking ahead and in line with our previous guidance, we continue to work towards a potential approval by the FDA in mid 2025 and if approved, US launch as early as second half of 2025.
Speaker Change: Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing.
Abe Shimmel-Pennick: Interestingly, we also observed a statistically significant improvement in at least one line of distance vision across the population. In terms of safety, LMZ100 was seen to be well tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three clarity trials. Of all reported adverse events, 95% of the class survivors were mild, believed to be transient, and consistent with those observed in previous trials. We also saw that in rare cases, more specifically 7.6% placebo-corrected, that participants noticed a mostly mild and transient headache following insulation of the drop. This appears to be tachyphylactic and, for most, no longer appears with prolonged use of LNG-100.
Speaker Change: Interestingly, we also observed a statistically significant, at least one line of distance vision improvement across the population.
Speaker Change: In terms of safety, LMZ100 was seen to be well-tolerated with no treatment-related serious adverse events observed in the over 30,000 treatment days across all three clarity trials.
Speaker Change: Of all reported adverse events, 95% were classified as mild, believed to be transient, and consistent with those observed in previous trials.
Speaker Change: i
Speaker Change: We also saw that in the rare cases, more specifically 7.6% placebo-corrected, that participants noticed a mostly mild and transient headache following installation of the drop. This appears to be tachyphalactic and for most, no longer appearing with prolonged use of LNG-100.
Abe Schimmelpenek: Before I review our key achievements in more detail and as a quick reminder, Presbyopia is the inevitable loss of near vision that impacts the daily lives of nearly all people over the age of 45. As the crystalline lens inner eyes hardens with age, the eye is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision. Although the progression of Presbyopia is gradual, Presbyopes often experience an abrupt change in their daily life, as the symptoms become more pronounced, starting in the mid-40s when reading glasses or other corrective aids are suddenly necessary to read texts or conduct close-up work.
Abe Shimmel-Pennick: These strong clinical results and the promise they bring for 128 million presbyopes in the U.S. alone allowed us to further strengthen our balance sheet with a $30 million investment from Richback Capital in July. We appreciate the significant support and confidence shown by the Ridgeback team and are pleased to add this additional capital as we aim to make LNG100 the best-in-class, if not the only-in-class, therapeutic option for the treatment of pres Lastly, I'm very excited to highlight that we have submitted our NDA for LNZ100 to the FDA, marking a key milestone for the company.
Speaker Change: These strong clinical results and the promise they bring for 128 million presbyopes in the U.S. alone allowed us to further strengthen our balance sheet with a $30 million investment from Richback Capital in July.
Speaker Change: We appreciate the significant support and confidence shown by the Ridgeback team, and are pleased to add this additional capital as we aim to make LNG100 the best-in-class, if not only-in-class, therapeutic option for the treatment of presbyopia.
Speaker Change: Lastly, I'm very excited to highlight that we have submitted our NDA for LNZ100 to the FDA, marking a key milestone for the company.
Abe Schimmelpenek: To address the daily challenges faced by Presby Oaks, we are developing a once daily eye drop that in our cloud trials has shown to be capable of improving their vision throughout the full work day without the need for reading glasses. More specifically, in April we reported positive phase three data, which we complemented with capstone data in June, in which NZ100, our target and base product candidate should continue to show strong performance and besting class potential.
Abe Shimmel-Pennick: The RMDA is the culmination of a development program that, along the way, incorporated feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data, and we look forward to working with the agency as they review our submission. The first step in this process, following a positive initial review, would be the formal acceptance of our MBA within 60 days of submission.
Speaker Change: Our NDA is a culmination of a development program that along the way incorporated a value of feedback and guidance from the FDA.
Speaker Change: We believe that we have compiled a dossier with strong clinical manufacturing and quality data and we look forward to working with the agency as they review our submission.
Abe Schimmelpenek: Highlighting some of the key results of the trial, and for the moment focusing on the results of Clary II, as is the direct vehicle control trial, we saw a rapid onset effect with 71% of participants achieving three lines or more of near-vision improvement at 30 minutes on the very first day of years of the product. At three hours, our primary end point, we also observed a three line or more spun the rate of 71%.
Speaker Change: A first step in this, and following a positive initial review, would be the formal acceptance of our NDA within 60 days of submission.
Abe Shimmel-Pennick: Once the FDA accepts our NDA, the agency must complete the review within 10 months. The date at the end of this period is referred to as the PDUFA date, and once the FDA has provided us with it, we will communicate this. As mentioned earlier, and in line with previous guidance, we believe that this PDUFA date could be in the middle of next year and, if our submission needs approval, could lead to the launch of LNG100 in the U.S. in the second half of 2025. To highlight some of the key areas of focus as we begin to prepare for a potential launch, I will now hand the call over to Sean Olsen. Chief Commercial Officer. Sean.
Speaker Change: Once the FDA accepts our NDA, the agency must complete their review within 10 months.
Speaker Change: The date at the end of this period is referred to as the PDUFA date, and once the FDA has provided us with it, we will communicate this with you.
Abe Schimmelpenek: And we maintained these high levels for the full work day with 40% of participants still achieving three lines or more of near-vision improvement at 10 hours, the last time point measured in our efficacy trials. And these three line gains turned out to be only the beginning. A four percent of participants achieved at least a four line gain during the study and a staggering 52% at least five lines. We also saw a very impressive near-universal response to NZ100 with 95% of participants achieving at least two lines of near-vision improvement.
Speaker Change: As mentioned earlier, and in line with previous guidance, we believe that this PDUFA date can be in the middle of next year and, if our submission needs approval, could lead to launch of LNG100 in the U.S. in the second half of 2025.
Speaker Change: To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olsen, Chief Commercial Officer. Sean? Thank you, Ace, and thank you all for joining us today.
Sean Olson: Thank you, Abe. And thank you all for joining us today. The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities. As they stated, Presbyopia impacts an estimated 128 million people in the U.S., an incident population that is nearly four times greater than those impacted by dry up. It is also more than the combined population suffering from dry eye, childhood myopia, macular degeneration, diabetic reti
Sean Olson: The commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities.
Abe Schimmelpenek: This is an important measure because it is seen as clinically meaningful. Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. Interestingly, we also observed a statistically significant at least one line of distance vision improvement across the population. In terms of safety, NZ100 was seen to be well-tolerated with no treatment related serious adverse events observed in the over 30,000 treatment days across all three clarity trials.
Speaker Change: As they stated, Presbyopia impacts an estimated 128 million people in the U.S.
Speaker Change: an incident population that is nearly four times greater than those impacted by dry ice.
Speaker Change: It is also more than the combined population suffering from dry eye, childhood myopia, macogeneration, diabetic retopathy, and blood phoneline urox.
Sean Olson: The first eyedrop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eyedrop treatment, as evidenced by initial paid new scripts of $3,000 to $5,000 per week. However, long-term usage beyond the trial period of this product did not materialize, as a pile of carbene, even at the high concentration of 1.25 percent, couldn't deliver the consumer required before.
Speaker Change: The first eyedrop treatment for presbyopia was approved in 2021 and confirmed that strong consumer desire for an eyedrop treatment.
Speaker Change: as evidenced by initial paid new scripts of 3,000 to 5,000 per week.
Abe Schimmelpenek: Of all reported adverse events, 95% were classified as mild, relatively transient and consistent with those observed in previous trials. We also saw that in the rare cases, more specifically 7.6% placebo corrected, that participant noticed and mostly mild and transient headache following insulation of the cases. This appears to be tech-of-electric and for most no longer appearing before long to use at NZ100. These strong clinical results and the promise they bring for 128 million pass reobs in the US alone allowed us to further strengthen our balance sheet with a 30 million dollar investment from Richback Capital in July.
Speaker Change: Long-term usage beyond the trial period of this product did not materialize, as pylocarbine, even at the high concentration of one and a quarter percent, couldn't deliver the consumer required performance.
Sean Olson: We believe this leaves the category wide open for a non-pylocarpene presbyopia eyedrop solution that can deliver what consumers desire. Unlocking this market requires an ideal Presbyopia eye drop, and we are excited for the prospect of our acyclidene-based LNV100. We believe the commercial potential of LNZ100 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 Lenz 100 after the study, of which 81% plan to use the product four to seven days per week.
Speaker Change: We believe this leaves the category wide open for a non-pylocarpene presbyopia eyedrop solution that can deliver what consumers desire.
Speaker Change: I'm mapping this market requires an ideal presbyl get eye drops, and we are excited for the prospect of our cycling based LND100.
Speaker Change: We believe the commercial potential of LNZ100 was validated in our Phase 3 Clarity Study.
Speaker Change: with 90% of participants noticing an improvement in your vision and 75 participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use the product four to seven days per week.
Abe Schimmelpenek: We appreciate the significant support and confidence shown by the Richback team and are pleased to add this additional capital as we aim to make NZ100 the best in class, if not only in class, the diputic option for the treatment of best reobs.
Sean Olson: Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion market potential opportunity and in what could potentially be a category of one. In parallel to our recent effort toward our NDA submission, our commercial launch preparedness is well underway. In February of 2024, Lenz launches an unbranded IAM campaign to educate and excite eye care professionals about future Presbyopia solutions. Over 50 key opinion leaders are involved in the campaign, of which many are featured at IamSelective.com.
Speaker Change: Together, with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion market potential opportunity.
Abe Schimmelpenek: Lastly, I'm very excited to highlight that we have submitted our MBA for NZ100 to the FDA, marking a key milestone for the company. Our NDA is a culmination of a development program that along the way incorporated a valuable feedback and guidance from the FDA. We believe that we have compiled a dossier with strong clinical manufacturing and quality data and we look forward to working with the agency as they review our submission.
Speaker Change: and in what could potentially be a category of one.
Speaker Change: In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway. In February of 2024, Lenz launched its unbranded IAM campaign to educate and excite eye care professionals about future presbyopia solutions.
Speaker Change: Over 50 key opinion leaders are involved in the campaign, of which many are featured at iamselective.com, that is e-y-e-amselective.com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and the importance of proper
Sean Olson: That is E-Y-E-I-A-M-Selective.com, where eye care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and expected early consumer adopters of Pres-BOBI drugs. Continuing on that momentum, and to support the projected launch following potential FDA approval, Lenz has fully staffed its commercial leadership team across marketing, sales, and commercial operations, with expertise in eye care, direct consumer, influencer, and consumer products. From an infrastructure standpoint, Lenz is actively building out its U.S. commercial capability.
Abe Schimmelpenek: The first step in this and following a positive initial review would be the formal acceptance of our NDA within 60 days of submission. Once the FDA accepts our NDA, the agency must complete their review within 10 months. The end, the date at the end of this period is referred to as the Bedoufort date and once the FDA has provided us with it, we will communicate this with you.
Speaker Change: and expected early consumer adopters of PREV-B OBI drops.
Abe Schimmelpenek: As mentioned earlier and in line with previous guidance, we believe that this Bedoufort date can be in the middle of next year and if our submission needs to approval, could lead to a launch of L&D-100 in the US in the second half of 2025.
Speaker Change: continuing on that momentum and to support the projected launch following potential FD approval.
Speaker Change: Lenz has fully staffed its commercial leadership team across marketing, sales,
Speaker Change: and commercial operations with expertise in eye care, direct consumer, influencer, and consumer products goods.
Speaker Change: From an infrastructure standpoint, LEND is actively building out its U.S. commercial capabilities, highlighted by completion of our third-party logistics contracting, all in preparation for a potential launch of LND 100 as early as the second half of 2025.
Sean Olson: Highlighted by the completion of our third-party logistics contracting, all in preparation for a potential launch of LNZ 100 as early as the second half of 2020. As we think about the commercialization of LNP-100, our strategy is clear and based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals, who represent over 85% of the beauty market, with our potential best-in-class product to educate and equip them to recommend LNZ100 and integrate our solution into their patient offices. Second, we want consumers to request us by name. This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct-to-consumer advertising.
Sean Olson: To highlight some of the key areas of focus as we begin to prepare for our potential launch, I will now hand the call over to Sean Olson, Chief Commercial Officer. Sean, thank you, Dave, and thank you all for joining us today.
Sean Olson: The commercial potential for an effective Presbyopia treatment represents one of the largest eye care market opportunities. As they stated, Presbyopia impacts estimated 128 million people in the US. An incident population that is nearly four times greater than those impacted by dry eye. It is also more than the combined population suffering from dry eye, childhood myopia, macogeneration, diabetic retapapy, and lymphoma in the US. The first eye drop treatment for Presbyopia was approved in 2021 and confirmed that strong consumer desire for an eye drop treatment.
Sean Olson: And third, we want to ensure ease of product access for consumers with a seamless journey. This requires enabling the consumer to experience the product and move quickly from trial to use. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy as well as home delivery. We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch.
Speaker Change: As we think about the commercialization of LMV100, our strategy is clear and based on three primary pillars.
Speaker Change: First, we want doctors to recommend us.
Speaker Change: This requires calling on approximately 15,000 eye care professionals.
Speaker Change: who represent over 85% of the beauty scripts.
Speaker Change: with our potential best-in-class product to educate and equip them to recommend LNZ100 and to integrate our solution into their patient offering.
Speaker Change: Second, we want consumers to request us by name.
Speaker Change: This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct-to-consumer advertise.
Sean Olson: As evidenced by initial paid new scripts of 3,000 to 5,000 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 percent, couldn't deliver the consumer required performance. We believe this leaves the category wide open for a non-pylocarpine Presbyopia eye drop solution that can deliver what consumers desire. Unlocking this market requires an ideal Presbyopia eye drop and we are excited for the prospect of our cycling-based LNV100.
Speaker Change: And third, we want to ensure ease of product access for consumers with a seamless journey to use.
Speaker Change: This requires enabling consumer to experience the product and move quickly from trial to usage.
Speaker Change: To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy, as well as home delivery.
Dan Chevalard: We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch. With that, I'd now like to hand the call over to Dan Chevalard, our CFO, to step through our financial results.
Sean Olson: With that, I'd now like to hand the call over to Dan Chevalard, our CFO, to go through our financial results. Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter. On the financial front, we were very pleased to have completed the $30 million private investment in public equity, or PIPE, with Ridgeback in mid-July. I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor base in Lenz.
Sean Olson: We believe the commercial potential of LNV100 was validated in our Phase 3 Clarity Study, with 90 percent of participants noticing an improvement in your vision and 75 participants indicating they would continue to use LNV100 after the study, of which 81 percent plan to use the product 4 to 7 days per week. Together with our broad inclusion criteria, we believe this positions LNV100 well for the estimated $3 billion market potential opportunity and in what could potentially be a category of 1.
Dan Chevalard: Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter in a recent period.
Dan Chevalard: On the financial front, we were very pleased to have completed the $30 million private investment in public equity, or PIPE, with Ridgeback in mid-July.
Speaker Change: I would like to reiterate Abe's comments to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor basin lens.
Sean Olson: Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately $226.2 million in cash, cash equivalents, and marketable securities, which is anticipated to fund the company's cash runway to post launch positive operating cash. Turning now to our second quarter operating results, our operating expenses and resulting cash burden for the second quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14.4 million, compared to $15 million for the same period in 2023.
Sean Olson: In parallel to our recent effort towards our NDA submission, our commercial launch preparedness is well underway. In February of 2024, LNV100 is unbranded IM campaigning to educate and excite eye care professionals about future pre-COVID solutions, over 50 key opinion leaders are involved in the campaign of which many are featured at IAMselective.com, that is EYEAMselective.com, where I care professionals can learn about the importance of ideal pupil size, iris muscle selectivity, and expected early consumer adopters of Presbyopia Adrops.
Speaker Change: Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately 226.2 million.
Speaker Change: in cash, cash equivalents, and marketable securities, which is anticipated to fund the company's cash runway to post-launch positive operating cash flow.
Dan Chevillard: sequentially, our total operating expenses decreased quarter over quarter by 11% from $16.1 million in the first quarter of 2024, as we moved away from costs associated with the recent merger transaction and reduced overall clinical development. On our first quarter call, we highlighted that we would anticipate a sharp decline in our research and development expenses in subsequent quarters due to the recent conclusion of our Phase III Clarity Study, which we certainly have realized in the second... Total R&D expenses decreased to $6.9 million in Q2 2024 compared to $12.6 million for the same period in 2023. sequentially, R&D expenses decreased quarter over quarter by 34% from $10.5 million in the first quarter of this year.
Speaker Change: Turning now to our second quarter operating results, our operating expenses and resulting cash burden for the second quarter were substantially in line with our plan.
Speaker Change: Total operating expenses for Q2 2024 were approximately $14.4 million compared to $15 million for the same period in 2023.
Sean Olson: Continue non-metal momentum, and to support the projected launch following potential FDA approval, Lenz has fully staffed its commercial leadership team across marketing, sales, and commercial operations, with expertise in eye care, direct consumer, influencer, and consumer products goods. From an infrastructure standpoint, Lenz is actively building out its U.S, commercial capabilities, highlighted by completion of our third party logistic contracting, all in preparation for a potential launch of LNB 100 as early as the second half of 2025.
Speaker Change: Sequentially, our total operating expenses decreased quarter over quarter by 11% from $16.1 million in the first quarter of 2024, as we moved away from costs associated with the recent merger transaction and reduced overall clinical development spend.
Speaker Change: On our first quarter call, we highlighted that we would anticipate a sharp decline.
Speaker Change: our research and development expenses in subsequent quarters due to the recent conclusion of our Phase 3 Clarity Study, which we certainly have realized in the second quarter.
Sean Olson: As we think about the commercialization of LNB 100, our strategy is clear and based on three primary pillars. First, we want doctors to recommend us. This requires calling on approximately 15,000 eye care professionals who represent over 85% of the beauty scripts, without the potential best in class product to educate and equip them to recommend LNB 100 and to integrate our solution into their patient offering. Second, we want consumers to request us by name.
Speaker Change: Total R&D expenses decreased to $6.9 million in Q2 2024 compared to $12.6 million for the same period in 2023.
Speaker Change: Sequentially, R&D expenses decreased quarter over quarter by 34% from $10.5 million in the first quarter of this year.
Speaker Change: We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing activities.
Dan Chevillard: We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing. Similarly, and further to our go forward reallocation of capital towards the commercial organization, total SG&A expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023 and sequentially increased quarter over quarter by 32% from $5.6 million in the first quarter of this year.
Speaker Change: Similarly, and further to our go-forward, reallocation of capital towards the commercial organization.
Sean Olson: This requires developing a product brand and consumer campaign that will elicit a strong emotional connection and promotional sensitivity to direct to consumer advertising. And third, we want to ensure ease of product access for consumers with a seamless journey use. This requires enabling consumer to experience the product and move quickly from trial to usage. To support this, our team is building out consumer sampling capabilities and commercial access with multiple channels, including the traditional retail pharmacy, as well as home delivery.
Speaker Change: total SG&A expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023, and sequentially increased quarter over quarter by 32% from $5.6 million in the first quarter of this year.
Dan Chevillard: This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre-commercial planning initiative. Finally, our net loss per share, both basic and diluted, was $0.40 per share in the second quarter 2024 on a net loss of $10.3 million compared to a net loss per share of $7.53 per share in the second quarter 2023 on a net loss of $14.7 million. As was noted on our first quarter call, we again wanted to remind you that these loss per share figures, calculated on a gap basis, consider only weighted average common shares outstanding, which were considerably different in the comparative period. For example, as a public company with a single class of stock outstanding, our Q2 2024 net loss per share was calculated on approximately 25.6 million weighted average common shares outstanding.
Dan Chevillard: Comparing this to Q2 2023, when as a then-private company with multiple classes of preferred and common stock outstanding, net loss per share was calculated on approximately 2 million weighted average common shares outstanding. Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27.4 million shares outstanding following that financing.
Speaker Change: This change was directly attributable to key personnel additions within our commercial leadership team and increases in our pre-commercial planning initiatives.
Speaker Change: Finally, our net loss per share, both basic and diluted, was $0.40 per share in the second quarter of 2024 on a net loss of $10.3 million, compared to a net loss per share of $7.53 per share in the second quarter of 2023 on a net loss of $14.7 million.
Sean Olson: We look forward to providing further updates and progress on our pre-commercial preparations in the quarters to come as we approach potential approval and launch.
Dan Chevrolet: With that, I'd now like to hand a call over to Dan Chevrolet, our CFO, to step through our financial results. Thank you, Sean. As has been mentioned, the team has continued to execute across the organization in the second quarter in recent periods. On the financial front, we were very pleased to have completed the $30 million private investment in public equity or pipe with Ridgeback in mid-July. I would like to reiterate, it's common to say that we're pleased to welcome an investor of Ridgeback's caliber, adding to what is an already strong and supportive investor base and lens.
Speaker Change: As was noted on our first quarter call, we again wanted to remind you that these loss per share figures, calculated on a gap basis, consider only weighted average common shares outstanding, which were considerably different in the comparative periods.
Dan Chevrolet: Inclusive of the $30 million in proceeds on a pro forma basis, we ended the second quarter with approximately 226.2 million in cash, cash equivalence, and marketable securities, which is anticipated to fund the company's cash runway to post-launch positive operating cash flow.
Speaker Change: For example, as a public company with a single class of stock outstanding, Q2 2024 net loss per share was calculated on approximately $25.6 million. Weighted average common share is outstanding.
Speaker Change: Compare this to Q2 2023 when as a then private company with multiple classes of preferred and common stock outstanding net loss for shareless calculator on approximately two million weighted average common shares outstanding.
Speaker Change: Putting the nuances of loss per share aside and the lack of comparability to 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding.
Dan Chevrolet: Turning now to our second quarter operating results, our operating expenses and resulting cash burn for the second quarter were substantially in line with our plan. Total operating expenses for Q2 2024 were approximately $14.4 million compared to $15 million for the same period in 2023. Sequentially, our total operating expenses decreased quarter over quarter by 11 percent from 16.1 million in the first quarter 2024 as removed away from costs associated with the recent contract transaction and reduced overall clinical development spend.
Speaker Change: To roll this forward to our July 2024 PIPE, we had approximately 27.4 million shares outstanding following that financing.
Dan Chevillard: With that, I'll conclude the financial update for what has been a very productive quarter in the recent period, and I'll now turn the call back over to Abe for final words. Thanks, Dan. In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been and promises to continue to be a very exciting time.
A: With that, I'll conclude the financial update for what has been a very productive quarter in a recent period, and I'll now turn the call back over to Abe for final remarks.
A: Thanks, Dan.
A: In summary, we are very pleased with the progress that the team has made on all fronts. The recent period has been, and promises to continue to be, a very exciting time at Lens.
Abe Shimmel-Pennick: With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LNZ100. And 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. With that, I'd like to open up the call for questions. We will now begin the question-and-answer session. Our first question will come from the line of Pawan Patel with Bank of America. Please go ahead. Hey guys, this is Bhavan Patel on 4G Sinkerberry.
Speaker Change: With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of LMZ100.
Dan Chevrolet: On our first quarter call, we highlighted that we would anticipate a sharp decline in our research and development expense expenses in subsequent quarters due to the recent conclusion of our phase three Clary study, which we certainly have realized in the second quarter. Total R&D expenses decreased to $6.9 million in Q2 2024 compared to $12.6 million for the same period in 2023. Sequentially, R&D expenses decreased quarter over quarter by 34 percent from $10.5 million in the first quarter of this year.
Speaker Change: And we believe we're well-positioned to deliver a once-daily, safe, and rapidly-acting treatment to the 128 million individuals living with presbyopia in the United States.
Speaker Change: With that, I'd like to open up the call for questions.
Speaker Change: We will now begin the question and answer session. Our first question will come from the line of Pavan Patel with Bank of America. Please go ahead.
Pawan Patel: Congratulations on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect SG&A spend to pick up as you begin to incur more meaningful pre-launch investment in your P&L? And then our second question is, maybe you can remind us how you think about the market opportunity and identify the patients who would be good candidates for a pharmacotherapy treatment for loss of near vision versus reading glasses. Thank you. Thanks, well, great questions. I'll have the first one over to Dan.
Speaker Change: Hey guys, this is Bhavan Patel on 4G Sinkerberry. Congrats on your recent NDA submission and thanks for taking our questions. The first question is, can you give us an idea of when we should expect SG&A spend to pick up as you begin to incur more meaningful pre-launch investment on your P&L?
Dan Chevrolet: We anticipate R&D costs to continue to decline over the balance of the year while shifting our development focus towards pre-approval manufacturing activities. Similarly, and further toward go forward reallocation of capital towards the commercial organization, total SGNA expenses increased to $7.4 million in Q2 2024 compared to $2.3 million for the same period in 2023. It sequentially increased quarter over quarter by 32 percent from $5.6 million in the first quarter of this year. This change was directly attributable to key personal additions within our commercial leadership team and increases in our pre-commercial planning initiatives.
Speaker Change #100: And then our second question is maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses. Thank you.
Speaker Change #101: Thanks, Ravel. Great questions. I'll hand the first one over to Dan.
Dan Chevillard: Sure. Yeah, thanks for the question. Kind of as we said for this quarter, we did see a 32% quarter-on-quarter increase in SG&A, and I think that you should expect us to have a modest ramp up over the balance of this year.
Dan: Sure, yeah, thanks for the question. Kind of as we said for this quarter, we did see a 32% quarter-on-quarter increase in SG&A, and I think that you should expect us to have a modest ramp over the balance of this year.
Dan Chevrolet: Finally, our net loss per share both basic and deluded was $0.40 per share in the second quarter of 2024 on a net loss of $10.3 million compared to a net loss per share of $7.53 per share in the second quarter of 2023 on a net loss of $14.7 million. As was noted on our first quarter call, we again wanted to remind you that these loss per share figures calculated on a gap basis consider only weighted average common shares outstanding which were considerably different in the comparative periods.
Dan Chevillard: I think where you'll really start to see is as we move into 2025 and then subsequently prepare for commercialization, the sales force, hiring, et cetera, as we approach the mid-year of next year. Thanks. And then as for which patients we would prioritize, Sean? Yeah, so looking at how we identify the patients that would be good candidates for this. So when we think about our product, we had a very broad inclusion criteria. So, you know, we want to develop a product that works for everyone.
Speaker Change #102: I think where you'll really start to see is as we move into 2025 and then subsequently preparing for commercialization, sales force, hiring, etc. as we approach the mid-year of next year.
Speaker Change #102: You
Speaker Change #102: Thanks.
Speaker Change #102: And then as for which patients we would prioritize, Sean? Yeah, so looking at how we identify the patients that would be good candidates for this trial.
Dan Chevrolet: For example, as a public company with a single class of stock outstanding, Q2 2024 net loss per share was calculated on approximately 25.6 million weighted average common shares outstanding. Compare this to Q2 2023 when as a then private company with multiple classes of preferring common stock outstanding net loss per share was calculated on approximately 2 million weighted average common shares outstanding. Putting the nuances of what of loss per share aside in the lack of probability of 2023, we ended Q2 of this year with approximately 25.8 million shares of common stock outstanding. To roll this forward through our July 2024 pipe, we had approximately 27.4 million shares outstanding following that financing.
Speaker Change #103: So, when we think about our product, we had a very broad inclusion criteria. So, you know, we want to develop a product that did work for everyone. And that's why we're focused on an all eyes, all day solution. Now, that being said, there are people that are more prone to be early adopters of an eyedrop solution.
Dan Chevillard: And that's why we're focused on an all eyes, all day solution. Now, that being said, there are people that are more prone to be early adopters of an eyedrop solution. We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters. And those three groups fall into people that are in contacts now, entering Presbyopia, and want to stay in contact. They've been enjoying a glasses-free lifestyle and want to continue that, and a big reason for dropout of contacts is because of Presbyopia.
Sean Olson: The second one is people that have had refractive surgery in the past. So again, people who paid for LASIK, invested in the Glasses-Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that have been to a Medi-Spa in the past 12 months. Each one of those groups is north of 10 million individuals.
Speaker Change #103: We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters.
Speaker Change #103: And those three groups fall into people that are in contact now, entering presbyopia, and want to stay in contact. They've been in a glasses-free lifestyle and want to continue that.
Speaker Change #104: And a big reason for dropout of contacts is because of presbyopia.
Speaker Change #104: The second one are people that have had refractive surgery in the past. So again people who paid for LASIK
Abe Schimmelpenek: With that, I'll conclude the financial update for what has been a very productive quarter in recent period and I'll now turn the call back over to Thanks Dan. In summary, we are very pleased with the progress that the team has made on all fronts.
Speaker Change #104: invested in Glasses-Free Lifestyle and want to continue it. And thirdly, we found a high correlation to people that have been to a Medi-Spa in the past 12 months. Each one of those groups are north of 10 million individuals.
Abe Schimmelpenek: The recent period has been and promises to continue to be a very exciting time at Lenz.
Egon Okomobitz: Great. Thanks, Sean. Our next question will come from the line of Egon Okomobitz with Citi. Please go ahead. Hi, Edson team.
Sean Olson: Thanks, Sean. Thanks, Sean.
Abe Schimmelpenek: With these important achievements and milestones, we now turn our full focus towards preparing for the potential approval and commercialization of L&Z-100. And we believe we will well-positioned to deliver one daily, safe and rapidly acting treatments to the 128 million individuals living with Presbyopia in the United States.
Speaker Change #105: Our next question will come from the line of Egon Okomobitz with Citi. Please go ahead.
Sean Olson: Thanks for taking the questions. I had a few. I'm just curious, with respect to the target prescriber audience, the optometrists, can you just give some perspective as to what percent of the optometrist pool in the United States are currently able to write prescriptions for Lenz 100? And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe Lenz 100? Absolutely. So, this is Sean Olson again.
ego knock-a-mobbits: I have some team thanks for taking the questions. I had a few I'm just curious with respect to the the target prescriber audience the optometrists
Speaker Change #107: Can you just give some perspective as to what percent of the palmistress pool in the United States are currently able to write prescriptions for Lenz 100?
Operator: With that, I'd like to open up the call for questions. We will now begin the question and answer session.
Speaker Change #107: And then also, what percent of the optometrists have the basic ability to perform the retinal eye exam to prescribe MENS-100. Thanks.
Pauvin Patel: Our first question will come from the line of Paven Patel with Bank of America. Please go ahead. Hey guys, this is Paven Patel on 4G Singer Berry. Congrats on your recent NDA submission and thanks for taking your questions. The first question is, can you give us an idea of when we should expect SCNA to pick up as you begin to incur more meaningful pre-launch investment on your PNL? And then our second question is, maybe if you can remind us how you're thinking about the market opportunity and identifying the patients who would be good candidates for a pharmacotherapy treatment of loss of near vision versus reading glasses, thank you. Thanks a vote. Great questions.
Sean Olson: So, when we think of L&D 100, you know, upon potential approval, those that are able to prescribe it, we think of the optometrists. Nearly all the optometrists across the US will have the ability to prescribe LNZ 100, so it falls into the category of meiotics. And with the exception of a couple of states, they will have the ability to prescribe it on day one. And so that really covers the vast majority of all optometry. In terms of doing retinol eye exams, retinol eye exams are going to be a very common process done by, again, nearly every optometrist across the U.S.
Speaker Change #107: Absolutely. So, this is Sean Olson again. So, when we think of L&D 100, you know, upon potential approval,
Speaker Change #108: Those that are able to prescribe it, when we think of the optometrists, nearly all the optometrists across the U.S. will have the ability to prescribe LNV100. So it falls in the category of meiotics.
Speaker Change #108: And with the exception of a couple of states, they will have the ability to prescribe on day one. And so that really covers the vast majority of all optometrists.
Sean Olson: They will be able to do those retinol eye exams. So, in terms of access, we see ourselves in a very good position for access upon approval. Great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies and the data that supports the use of Lenz 100 in lower light conditions, for example, if you're out for a meal at a restaurant and you need to read the menu, for example, could you just talk about that aspect of the product profile? Absolutely. So we did all our near vision measurements in what's called mesopic conditions. So mesopic is low light.
Speaker Change #108: In terms of doing retinal eye exams, retinal eye exams are going to be a very common process done for, again, nearly every optometrist across the U.S. They will be able to do those retinal eye exams.
Dan Chevrolet: I'll hand the first one over to Dan. Sure. Thanks for the question. As we said for this quarter, we did see a 32% quarter on quarter increase in SCNA, and I think that you should expect us to have a modest ramp over the balance of this year. I think where you'll really start to see is as we move into 2025 and then subsequently preparing for commercial commercialization, sales force, hiring, etc, as we approach the mid-year next year. Thanks.
Speaker Change #108: So, in terms of access, we see ourselves in a very good position for access upon approval.
Sean Olson: Just to give you an idea of what that means. So we actually have one of our KOLs describe it very adequately at our KOL event. That basically means that you lower the light in the room to almost candlelight conditions.
Speaker Change #108: [inaudible]
Speaker Change #109: Okay, great. And then one other question we've been getting from investors is if you could talk a bit about how you ran your studies.
Speaker Change #109: and the data that supports the use of Lens 100 in...
Speaker Change #109: lower light conditions, for example, if you're out
Speaker Change #110: at a meal, at a restaurant, and you need to read the menu, for example. Could you just talk about that aspect of the product profile?
Sean Olson: And then ask for which patients we would prioritize, Sean. So looking at how we identify the patients that would be good candidates for this drop. So when we think about our products, we had a very broad inclusion criteria. So we want to develop a product that did work for everyone, and that's why we're focused on an all-wise, all-day solution. Now that being said, there are people that are more prone to the early adopters of an eye drop solution.
Speaker Change #111: Absolutely. So we did all our near-vision measurements in what's called mesopic conditions. So mesopic is low-light.
Speaker Change #111: Just to give you an idea of what that means, so we actually have one of our KOLs describe that very adequately in our KOL event.
Speaker Change #112: That basically means that you lower the lights in the room.
Sean Olson: So, it's very low light in the room, and then you have them read a backlit screen. So, it's truly low-light conditions that we've measured all eye-mirror vision in. So, if you will, it's the most challenging condition because we definitely wanted to avoid that we, you know, brighten the room in a way that it would impact positively near vision that we could not ascribe to our product.
Speaker Change #113: to almost candlelight conditions. So it's very low light in the room.
Sean Olson: We commissioned a very large study to do market research in this space, and we really found three groups of individuals that stood out as the earliest adopters. And those three groups fall into people that are in context now, entering price biopia, and want to stay in context. They have been looking for, they've been in a glasses relic style, and want to continue that. And a big reason for drop of context is because of price biopia.
Speaker Change #113: and then you have them read a backlit screen. So it's truly low-light conditions.
Speaker Change #113: that we've measured all our near vision in. So, if you will, it's the most challenging condition.
Speaker Change #113: Because we definitely wanted to avoid that we brighten the room in a way that it would impact positively.
Sean Olson: So, again, very low-light, dim-lit conditions in the room. And just to back up a little bit on Sean's statement on the retina exam, that's something that all optometrists pretty much do already. So, it's a very standard exam. So, it's not something that we need to train them on or that they need to add to their practice to be able to describe it right.
Speaker Change #113: near vision that we could not.
Sean Olson: The second one are people that have had refractive surgery in the past. So again, people who have paid for Lasit, invested in glasses relic style, and want to continue it. And thirdly, we found a high correlation to people that have been to a Medispa in the past 12 months. Each one of those groups are north of 10 million individuals. Thank you, Sean.
Speaker Change #113: Ascribed to our products. So again, very low light dim lit conditions in the room.
Sean Olson: And just to back up a little bit into Sean's statement on the retina exam, that's something that all optometrists pretty much do already, so it's a very standard exam, so it's not something that we need to train them on or that they need to add to the practice to be able to prescribe a drop. Again, very common practice in optometry.
Ego Nakama: Our next question will come from the line of Ego and Occamabits with City.
Sean Olson: Again, very common practice in optometry. Okay. Thank you. Our next question comes from the line of Joseph Cadenzaro with Piper Sandler. Please go ahead. Hey, everybody. Thanks for taking my questions. Maybe two for me.
Sean Olson: Please go ahead. Hi, I have been team. Thanks for taking the questions. I had a few. I'm just curious with respect to the target prescriber audience via tomatrist. Can you just give some perspective as to what percent of the tomatrist pool in the United States are currently able to write prescriptions for Lenz 100 and then also what percent of the optometrist have the basic ability to perform the retinal eye exam to prescribe Lenz 100.
Speaker Change #114: Okay, thank you.
Speaker Change #115: Our next question comes from the line of Joseph Cadenzaro with Piper Sandler. Please go ahead.
Joseph Cadenzaro: First, as it relates to the NDA filing, can you just remind us whether there was any formal engagement with the FDA, like a pre-NDA meeting, ahead of the filing? And if so, any sort of feedback learnings you gleaned from those interactions? And then, second question, I guess related to early adopters, but less from a patient perspective and more so from a physician perspective, what are you looking for there? Is it simply those who have written a VUITY script in the past? Or are there more things that you're honing in on that could potentially identify early writers?
Speaker Change #116: Hey, everybody. Thanks for taking my questions. Maybe two for me. First, as it relates to the NDA filing, can you just remind us whether there was any formal engagement with the FDA, like a pre-NDA meeting, ahead of the filing? And if so, any sort of feedback learnings you gleaned from those interactions?
Speaker Change #116: And then second question, I guess, related to.
Speaker Change #117: early adopters, but less from a patient perspective and more so from a physician perspective. You know, what are you looking for there? Is it simply those who have written a VUITY script in the past? Or are there more things that you're honing in on that could potentially identify early writers? Thanks.
Sean Olson: Thanks. Absolutely. So this is Sean Olson again. So when we think of Lenz 100, you know, upon potential approval, those that are able to prescribe it and we think of the optometrist nearly all the optometrist across the US will have the ability to prescribe Lenz 100. So it falls into the category of myodics and with the exception of a couple of states, they will have the ability to prescribe on day one and so that really covers the vast majority of all optometrist.
Abe Shimmel-Pennick: Thanks. Thanks, Joe. I'll take the first one, and then I'll get the next one over to Sean.
Speaker Change #117: Thank you. I'll take the first one and then I'll get the next one over to Sean.
Abe Shimmel-Pennick: So, yes, there was definitely an end-of-phase three and pre-submission meeting with the FDA. But more importantly, we've had many discussions and engagements with them throughout the years of our development, and that's where most of the feedback actually came from, the FDA. So, we were very well aligned with them on, especially our clinical program, our manufacturing setup, basically everything that was relevant for the development. And that actually then made the end-of-phase three meeting with them pretty benign. I think there were hardly any questions, actually, that we had left that we wanted to ask.
Sean Olson: So, yes, there's been definitely an end-of-phase 3 and pre-submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development, and that's where most of the feedback...
Sean Olson: In terms of doing retinal eye exams, retinal eye exam process done for, again, nearly every optometrist across the US, they will be able to do those retinal eye exams. So in terms of access, we see ourselves in a very good position for access upon approval.
Speaker Change #118: actually came from the FBA so we've very well aligned with them on especially our clinical program.
Speaker Change #118: manufacturing setup, basically everything that was relevant for the development. And that actually then made the end of phase three meeting with them pretty benign. I think it was hardly any any questions actually that we had left.
Sean Olson: Okay. Great. And then one other question we've been getting investors is if you could talk a bit about how you ran your studies and the data that supports the use of Lenz 100 in lower light conditions, for example, if you're out at a meal at a restaurant and you need to read the menu, for example, could you just talk about that aspect of the product profile? Absolutely. So we did all our near vision measurements in what's called misopic conditions.
Abe Shimmel-Pennick: It was merely a confirmation that this is all the data that we've gathered. This is the number of patients that we have on both the efficacy and the safety side. And they once again confirmed that that was completely aligned with their expectations for our NDA. So, we're very confident that the filing has, or the submission has everything in it that the FDA wants. And for your second question, when we were identifying early adopters from an eye care professional standpoint, again, we commissioned a very large study and took into account many factors.
Speaker Change #118: that we want to ask. It was merely a confirmation of.
Speaker Change #118: This is all the data that we've gathered. This is the amount of patients that we have from both the efficacy and the safety side.
Sean Olson: So misopic is low light just to give you an idea of what that means. So we actually have one of our KOLs described that very adequately in our KOL event. That basically means that you're low in the lights in the room to almost candle light conditions. So it's very low light in the room. And then you have them read a backlit screen screen. So it's truly low light conditions that we've measured all our near vision in.
Speaker Change #118: and they once again confirmed that that was completely aligned with their expectations for our NDA. So we're very confident that the filing has or the submission has everything in it that the FDA wants to see.
Sean Olson: So if you will, it's the most challenging condition because we definitely wanted to avoid that we brighten the room in a way that it would impact positively near vision that we could not ascribe to our products. So again, very low light dim lit conditions in the room.
Speaker Change #119: And for your second question, when we were identifying early adopters from an eye care professional standpoint, again, we commissioned a very large study and took and count many factors. We looked at the prescriptions of beauty.
Abe Shimmel-Pennick: We looked at the prescriptions for beauty. We looked at early adopters of other recent iCareLogic products. We also looked at the history of prescriptions for dry eye, as well as different locations such as urban city centers where we saw a lot of beauty scripts.
Speaker Change #119: We looked at early adopters of other recent eye care launches.
Speaker Change #119: We also looked at history of prescriptions for dry eye, as well as different locations, such as urban city centers where we saw a lot of the beauty scripts.
Sean Olson: Ultimately, when we did all the analysis, what came out and was the primary focus of the targeting was their actual propensity to write beauty and how many scripts they wrote. And that's really where we came up with those 15,000 target ECPs that represent over 85% of all beauty. Okay. Our next question will come from the line of Mark Goodman with Lear, Inc. Please go ahead. Yishai, could you please review what you've done on CMC? What's left to do? Just give us an update there, please.
Speaker Change #119: Ultimately, when we did all the analysis, what came out and was the primary focus of the targeting was their actual propensity to write beauty and how many scripts they wrote.
Sean Olson: And I just do to back up a little bit into shorn statements on the retina exam. That's something that all automatists pretty much do already. So it's a very standard exam. So it's not something that we need to train them on or that they need to add to the practice to be able to describe it up. Again, very common practice and optometry.
Sean Olson: Okay. Thank you.
Mark Goodman: Thanks. Absolutely. Thanks, Mark. Good question.
Speaker Change #119: Okay. Our next question will come from the line of Mark Goodman with Lear, Inc. Please go ahead.
Mark Goodman: Yes, hi, could you please review what you've done on CMC, what's left to do, just give us an update there, please.
Sean Olson: So on the CMC side, or the manufacturing side, we've actually produced all our clinical phase 3 material at commercial scale. So we're fully set up to produce launch quantities at that scale. Our complete supplier network is in very good standing with the FBA, so I'm very confident that our commercial network, commercial manufacturing, is all in place there, and that goes for both drug products as well as drug substance or API. Stability all done, everything you need to do there.
Speaker Change #120: Absolutely. Thanks. Thanks Mark. Good question. So on the CMC side of the manufacturing side we've actually produced all that clinical phase three material at commercial scale.
Joseph Cadenzerro: All right, next question comes from the line of Joseph Cadenzerro with Piper Samar.
Joseph Cadenzerro: Please go ahead. Hey, everybody. Thanks for taking my questions, maybe two from me versus it relates to the NDA filing. Can you just remind us whether there was any formal engagement with the FDA like a pre-NDA meeting ahead of the filing and if so, any sort of feedback learnings you sort of glean from those interactions? And then second question, I guess related to early adopters, but let's from a patient perspective and more so from a physician perspective, you know, what are you looking for there?
Speaker Change #120: Our complete supplier network is in very good standing with the FBA, so we're very confident that our commercial network, commercial manufacturing is all in place there, and that goes for both drug products as well as drug substance or API.
Joseph Cadenzerro: Is it simply those who have written a beauty script in the past or are there more things that you're honing in on that could potentially identify early, early writers? Thanks, Joe. I'll take the first one and then I'll take the next one over to Sean. So yes, there's been definitely an end of phase three and pre-submission meeting with the FDA. More importantly, we've had many discussions and engagements with them along the years of our development, and that's one most of the feedback actually came from the FDA.
Sean Olson: Yeah, so that is all done. So all the stability that we needed to submit our program, and this is generic for any submission you need to submit with at least 12 months of civility data on your registration badges, which, obviously, given the fact that we've submitted, we have that in place and submitted, and that data all looks stellar. Great. And then, just secondly, on the unbranded campaign, can you just go into a little bit of detail, a little more color just on, you know, what the discussion is like, what it's like, maybe just give us a sense of what a session would be like and the feedback you're getting.
Speaker Change #120: Stability all done, everything you need to do there.
Speaker Change #120: Yep, so that is all done. So all the submissions that we needed to submit our program, and this is generic for any submissions, you need to submit with at least 12 months.
Joseph Cadenzerro: So we've very well aligned with them, on especially our clinical program, manufacturing setup, basically everything that was relevant for the development, and that actually then made the end of phase three meeting with them pretty benign. I think it was hardly any questions actually that we had left that we wanted to ask. It was merely a confirmation of this is all the data that we've gathered, these is the amount of patients that we have on both the efficacy and the safety side, and they once again confirmed that that was completely aligned with our expectations for our FDA.
Speaker Change #120: of stability data on your registration badges, which obviously, given the fact that we've submitted, we have that in place and submitted, and that data all looks stellar.
Speaker Change #121: Great and then just secondly on the unbranded campaign, can you just go into a little bit of detail a little more color just on you know what
Speaker Change #122: what's the discussion, what it's like, maybe just, you know, give us a sense of what a session would be like and the feedback you're getting. Thank you.
Sean Olson: Thank you. Yeah, absolutely. So we're really excited about this unbranded campaign. What's unique to presbyopia is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state.
Speaker Change #123: Yeah, absolutely. So we're really excited about this unbranded campaign.
Speaker Change #124: What's unique to presbyopia is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. What we have to train people on is how to look for what an ideal presbyopia eyedrop solution is.
Sean Olson: What we have to train people on is how to look for what's the ideal presbyopia eyedrop solution. So, really, what we're talking about is, what's the ideal pupil size? You know, the importance of an eyedrop that focuses on reducing the pupil but avoiding the ciliary muscle. And then also, because there are so many people out there impacted by presbyopia, you know, who are the early adopters? So a lot of that's training on, you know, those three groups I talked about before: people in contacts, people who have had refractive surgery, and people who have been to a MediSpot. And overwhelmingly, what we see at the different conventions is excitement for the campaign.
Speaker Change #124: So really what we're talking about is what's the ideal pupil size, you know, the importance of a eye drop that focuses on reducing the pupil but avoiding that ciliary muscle.
Joseph Cadenzerro: So we're very confident that the filing has or the submission is everything in it that the FDA wants to see. And for your second question, when we're identifying early adopters from an eye care professional standpoint, again, we commissioned a very large study and took and count many factors. We looked at the prescriptions of the UTI, we looked at early adopters of other recent eye care launches. We also looked at history of prescriptions for dry eye, as well as different locations such as urban city centers where we saw a lot of the beauty scripts.
Speaker Change #124: And then also, because there's so many people out there impacted by presbyopia, you know, who are the early adopters? So a lot of that's training on, you know, those three groups I talked about before. People in contacts, people have had refractive surgery, and people have been to a Medi-Spa.
Speaker Change #124: And overwhelmingly, what we see at the different conventions is excitement for the campaign. It's very EPP forward, so we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions.
Sean Olson: It's very ECP forward. So we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions, and we actually release a new one every week on LinkedIn. And we get calls from doctors saying, hey, when is my photo going out? Because I actually want to see my photo on LinkedIn. I want to like it. So it's going very well. I think what's always really important with our product, you know, the first thing people want to know about the product, and this is separate from the unbranded because we can't commingle the two, but they want to know it's not pylocarpene.
Speaker Change #124: And we actually release a new one every week on LinkedIn and we're getting calls from doctors saying hey, when is my photo going out because I actually want to I want to see my photo on LinkedIn I want to like it.
Joseph Cadenzerro: Ultimately, when we did all the analysis, what came out, and with the primary focus of the targeting, was there actual propensity to write beauty and how many scripts they wrote? And that's really where we come up with those 15,000 target ECPs that represent over 85% of all of the beauty scripts. Okay.
Speaker Change #124: So it's going very well. I think what's always really important with our product...
Speaker Change #125: You know, the first thing people want to know about the product, and this is separate from the unbranded because we can't commingle the two, but they want to know it's not pylocarcane. That's the really important thing that doctors care about.
Dan Chevrolet: Our next question will come up on the line of Mark Goodman with Learing. Please go ahead. If I could you please review what you've done on CMC, what's left to do, just give us an update there, please. Thanks. Absolutely. Thanks, Mark. Good question. So on the CMC side of the manufacturing side, we've actually produced all our clinical phase dream material at commercial scale. So we're fully set up to produce low-inch quantities at that scale.
Speaker Change #125: As soon as they know it's a non-pylocarpene solution on the medical side, you know, they're very excited to learn more about the product and engage.
Speaker Change #125: So we've seen this as a very good success. We've seen a lot of traction and a lot of ECPs coming to us.
Speaker Change #125: that want to share their excitement for the future of presbyopia solutions. They want us to tell them more.
Sean Olson: That's the really important thing that doctors care about. As soon as they know it's a non-pylocarpene solution on the medical side, they're very excited to learn more about the product and get involved. So we've seen this as a very good success. We've seen a lot of traction and a lot of ECPs coming to us that want to share their excitement for the future of Presbyopia solutions. They want us to tell them more. Our next question comes from the line of Tim Lugo with William Blair. Please go ahead. Hey guys, this is Lachlan on for Tim.
Speaker Change #126: Thanks.
Speaker Change #126: Our next question comes from the line of Tim Lugo with William Blair. Please go ahead.
Tim Lugo: Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research? And secondly, I believe at KOL day, one of the physicians said or suggested that most patients would first try the drop in the office. Is that sort of correct, or is that what you're expecting? Thanks, Larry. I'm good to hear from you. So, I'm the first one.
Speaker Change #127: Hey guys this is Lachlan on for Tim. Thanks for taking the questions. As you've shared the data with a wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe
Dan Chevrolet: A complete supply network is a very good standing with the FDA, so a very confident that our commercial network, commercial manufacturing is all in place there. And it goes for both truck products, as well as truck substance or API. Stability all done, everything you need to do there. Yeah, so that is all done. So all the stability that we needed to submit our program, and it is generic for for any submissions, you need to submit where at least 12 months of stability data on your registration batches, which obviously given the fact that we submit it and we have that in place and submit it and that they all looks look seller.
Speaker Change #128: that hadn't really come through fully in your prior market research? And secondly, I believe at the KOL day, one of the physicians said or suggested that most patients would first try the drop in the office. Is that sort of correct or is that what you're expecting?
Sean Olson: And, you know, I'll keep that very brief because, obviously, I want to make sure that, one, we don't talk about anything that's not on the label yet that we've not studied. But for sure, the medical community is talking and thinking about uses for how they could see this product being used outside of near vision. And so, yeah, that's something that, in that context, is discussed, not something for me to elaborate on.
Speaker Change #129: Thanks, thanks a lot. I'm good too. So I'm that first one. And, you know, I'll keep that very brief because obviously I want to make sure that one, we don't talk about anything that's that's not on the label yet on that, that we've not started.
Speaker Change #130: For sure, you know, the medical community is talking and thinking about uses of how they could see this product being used outside of near vision. So, yeah, that's something that in that context.
Sean Olson: Great, and then just secondly on the unbranded campaign. Can you just go into a little bit of detail, a little more color, just on what's the discussion, what it's like, maybe just give us a sense of what a session would be like and feedback you're getting.
Sean Olson: And in terms of the use of the product, you know, we meet with a lot of different eye care professionals across optometry. You know, many of them want the patient to experience it in the office. And what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect, you know, right off the bat when they put it in. Now, some doctors, especially those that go for the dilated eye exam, are going to want them to take the samples home and try them at home. But we see that, you know, how the ECPs run their practice will decide whether or not they do it in the office or outside of the office. It will be good.
Speaker Change #130: It's discussed, not something for me to elaborate on.
Speaker Change #131: And in terms of the use of the product, we meet with a lot of different eye care professionals across optometry. Many of them want the patient to experience in the office, and what's great about our product is because you have that immediate response that we saw in our trial, people can have that wow effect.
Sean Olson: Thank you. Yeah, absolutely. So we're really excited about this unbranded campaign. What's unique to Presbyopia is the fact that, you know, when you think about it, everyone knows about reading glasses. We don't have to train them on the disease state. What we have to train people on is how to look for what an ideal Presbyopia I drop solution is. So really what we're talking about is what's the ideal pupil size, you know, the importance of a I drop that focuses on reducing the pupil, but avoiding that silly area muscle.
Speaker Change #131: right off the bat when they put it in. Now, some doctors, especially those that go for the dilated eye exam, are gonna want them to take the samples home and try it at home. But we see that how the ECPs run their practice will decide whether or not they do it in office or outside of the office, it will be a good mix.
Sean Olson: And then also because there's so many people out there impacted by Presbyopia, you know, who are the early adopters. So a lot of that's training on, you know, those three groups I talked about before, people in contacts, people have had refractive surgery and people have been to a many spot. And overwhelmingly what we see at the different conventions is excitement for the campaign. It's very ecp forward. So we have over 50 people that are, you know, the face of the campaign across all of our presentations, all of our conventions.
Sean Olson: Thanks. Just one thing to add there, like on the data side, just thinking about it some more on what you just asked, one of the things that we've realized that we shared during that KOL event is that what the data shows is that SEL presbyopia gets worse, and your actual impact keeps up with that. So the worse your presbyopia, the more Lenz you gain. That's certainly something that we've heard resonate really well in the medical community.
Speaker Change #131: Thanks.
Speaker Change #132: Just one thing to do at that I'm like under on the data side just think about it some more on what you just just want to one of the things that we've realized that we shed during that KLO event that
Speaker Change #133: What the data shows is that SEOpresbyopia gets worse.
Speaker Change #134: your actual impact keeps up with that. So the worse your presbyopia, the more lines you gain. That's certainly something that we've heard resonate really well in the medical community. So when maybe people initially were thinking about
Sean Olson: And we actually released a new one every week on LinkedIn and we're getting calls from doctors saying, hey, when is my photo going out? Because I actually want to I want to see my photo on LinkedIn. I want to like it. So it's going on very well. And I think it's always really important with our product. You know, the first thing people want to know about the product and separate from the unbranded because we can't call me go the two, but they want to know it's not pilot parking.
Sean Olson: So when maybe people initially were thinking about Presbyopia eye drop as something that could have an effect early on in someone's Presbyopia journey, it's very clear now that actually our drop, uniquely, because it is unique to our product, keeps up with how your Presbyopia, I guess, gets worse. So if your Presbyopia is 20 over 80 or 20 over 100 and you would need four, five, maybe six lines, that's what the product actually delivers for you.
Speaker Change #135: the presbyopia eyedrop as something that you know could have an effect early on and in some months presbyopia Jeremy
Speaker Change #135: It's very clear now that actually our drop uniquely because it is unique to our product.
Sean Olson: That's the really important thing and a doctor's care about as soon as they know if the man pilot parking solution on the medical side, you know, they're very excited to learn more about the product and engage. So we've seen this is a very good success. We've seen a lot of traction and a lot of ecp coming to us that want to share their excitement for the future of price yoga solutions. They want us to tell them more.
Speaker Change #135: Keeps up with how you are Presbyopia, I guess gets gets worse so
Sean Olson: Thank you.
Speaker Change #136: If your price will be 20 over 80 or 20 over 100, and you would need four, five, maybe six lines, that's what the product actually delivers for you. So it ties into that very broad age range that we've tested in our trial.
Matthew Caulfield: So it ties into that very broad age range that we've tested in our trial. Very interesting, thanks. Our next question comes from the line of Matthew Caulfield with HC Wainwright. Please go ahead. Hi, Ocean Team.
Speaker Change #137: Very interesting. Thanks.
Tim Lugo: Our next question comes from the line of Tim Lugo with William Blair. Please go ahead. Hey, guys, this is Loco and I'm for Tim. Thanks for taking the questions. As you've shared the data with the wider audience of physicians over the past few months, are there any new findings or sort of nuances that have emerged about how they're thinking of using it that maybe hadn't really come through fully in your prior market research?
Speaker Change #137: Our next question comes from the line of Matthew Caulfield with H.C. Wainwright. Please go ahead.
Sean Olson: Some very exciting developments for the quarter. So, our question was, considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved? Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient, kind of based on their scheduling? Any clarity there or thoughts there could be helpful. I'm excited to see the progress. Thanks. Great, Thank you. This is Sean again.
Matthew Crawford: Hi, Ocean Team. Some very exciting developments for the quarter.
Matthew Crawford: So, our question was, considering filling a prospective monthly prescription, have you shared how many refills per year could be anticipated among presbyopia patients if or when ultimately approved?
Tim Lugo: And secondly, I believe that the KOL day, one of the physicians said or suggested that they would, you know, most patients would first try the drop in the office. Is that sort of correct or is that what you're expecting? Thanks. Thank you. I'm good to.
Matthew Crawford: Is the baseline assumption that patients could be using the drops daily or more likely on select days per month per patient, kind of based on their scheduling? Any clarity there or thoughts there could be helpful, and I'm excited to see the progress. Thanks.
Sean Olson: A couple of comments on that. In terms of what we found in our market research, people are looking for an everyday eyedrop that lasts all day. And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients want to use it four to seven times a week. When we actually look at the patient-reported outcomes from our Phase 3, eighty-one percent of the patients that would continue to use the product after the study plan to use it four to seven days a week. So, we do see that it's much more like contacts, where people want to use them every day. Now, that being said, all medicines, you know, most medicines are not 100 percent compliant, right?
Sean Olson: So I'm on that first one and you know, I'll keep that very brief because obviously I want to make sure that one we don't talk about anything that's that's not on the label yet on that that we've not started. But for sure, you know, the medical community is talking and thinking about uses of how they could see this product being used outside of off me a vision. So, yeah, that's that's something that in depth context is discussed, not something for me to to elaborate on.
Speaker Change #138: Great, thank you. This is Sean again. So, a couple comments on that. So, in terms of what we found in our market research, people are looking for an everyday eye drop that lasts all day.
Speaker Change #138: And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients wanted to use it four to seven times a week, when we actually look at the patient-reported outcomes from our phase three. And we see that the majority of patients wanted to use it four to seven times a week, when
Speaker Change #138: Eighty-one percent of the patients that would continue to use the product after the study plan to use it four to seven days a week. So we do see that it's much more like contacts, where people want to use it every day.
Sean Olson: In terms of the use of the products, you know, we meet with a lot of different eye care professionals across optometry, you know, many of them want the patient to experience in the office and what's great about our product is because you have that immediate response that we saw in our trial. People can have that wild effect, you know, right off the bat when they put it in. Now, some doctors, especially those that go for the dilated eye exam, are going to want them to take the sample home and try it at home. But we see that, you know, how the ECPs run their practice will decide whether or not they do it in office or outside of the office, it will be a good mix. Thanks.
Sean Olson: If you look across the board, you know, for contacts, it's about an 89 percent compliance rate for daily contacts. Jirvaya had about a 65 percent refill rate. General medicines, about 50 percent. So when you look at that $3 billion market cap or $3 billion market size, it assumes a conservative, you know, five fills a year or a 42% refill rate. So that was built into that $3 billion number. However, when we speak to consumers, they're looking for an everyday eye drop, probably four to seven days per week.
Speaker Change #138: Now, that being said, all medicines, you know, most medicines are not 100% compliant, right? If you look across the board, you know, for contacts about 89% compliance rate for daily contacts.
Speaker Change #139: Tervaia had about a 65% refill rate. General medicines about 50%.
Speaker Change #140: So, when you look at that $3 billion market cap, or $3 billion market size, it assumes a conservative, you know, five fills a year, or a 42% reflow rate. So that's what's built into
Speaker Change #140: That $3 billion number. However, when we speak to consumers, they're looking for an everyday eyedrop looking at probably 4 to 7 days per week.
Abe Schimmelpenek: Just one thing to add there, like under on the data side, just think about it some more on what you just asked. One of the things that we've realized that we shared during that KLO event, that what the data shows is that as your Presbyopia gets worse, you actually in fact, keeps up with that. So the worse your Presbyopia, the more lines you gain, that's certainly something that we've heard resonate really well in the medical community.
Sean Olson: Very helpful. And just to confirm, I heard that right. You said five times per year, as sort of an average from your analysis. Yeah, so if you think of average medicines, 50% compliance. Five refills a year would just be a little bit conservative to that. That'd be a 42% refill rate.
Speaker Change #141: Very helpful and just to confirm I heard that right you said five times per year that's sort of an average from your analysis
Speaker Change #142: Yeah, so if you think of average medicines are 50% compliance.
Speaker Change #143: Five refills a year would just be a little bit conservative to that, that'd be a 42% refill rate.
Sean Olson: Gotcha. Okay. Understood. Thank you for that. Thanks, Matt. And that concludes our question and answer session, as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
Speaker Change #144: Gotcha. Okay. Understood. Thank you for that.
Abe Schimmelpenek: So maybe people initially were thinking about a Presbyopia eye drop as something that, you know, could have an effect early on. And in some months, Presbyopia journey, it's very clear now that actually our drop uniquely, because it is unique to our product, keeps up with how you are Presbyopia, I guess gets worse. So if you're Presbyopia, you get 20 over 80 or 20 over 100 and you would need four or five, maybe six lines, that's what the product actually delivers for you. So it ties into that very broad age range that we've tested in our trial. Very interesting. Thanks.
Speaker Change #144: Thanks, Matt.
Speaker Change #145: And that concludes our question and answer session as I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
Matthew Callfield: Our next question comes from the line of Matthew Callfield with H.C. Wayne Wright. Please go ahead.
Sean Olson: Hi, I'm some very exciting developments for the quarter. So our question was considering filling a perspective monthly prescription. Have you shared how many refills per year could be anticipated among Presbyopia patients if for when ultimately approved? Is the baseline assumption that patients could be using the drop daily or more likely on select days per month per patient kind of based on their scheduling? Any clarity there or thoughts there could be helpful and excited to see the progress.
Sean Olson: Thanks. Great. Thank you. This is Sean again. So a couple comments on that. So in terms of what we're going to do, we're going to have a couple of other questions that we're going to have. And we see this across multiple different studies. So not only in our consumer research do we see that the majority of patients wanted to use it four to seven times a week. When we actually look at the patient reported outcomes from our phase three, 81% of the patients that would continue to use the product after the study plan to use it four to seven days a week.
Sean Olson: So we do see this much more like contacts where people want to use it every day. Now that being said, all medicines, you know, most medicines are not 100% compliant, right? If you look across the board, you know, for contacts, about 89% compliance rate for daily contacts, your via had about a 65% refill rate, general medicines about 50%. So when you look at that $3 billion market cap, or $3 billion market size, this assumes a conservative, you know, five fills a year or a 42% refill rate.
Sean Olson: So that was built into that $3 billion number. However, when we speak to consumers, they're looking for an everyday eye drop, looking at probably four to seven days per week. Very helpful. And just to confirm, I heard that right. You said five times per year as sort of an average from your analysis. But yeah, so if you think of average medicines are 50% compliance, five refill a year would just be a little bit conservative to that, that'd be a 42% refill rate.
Sean Olson: Gotcha. Okay, understood. Thank you for that. Thanks, Matt. And that concludes our question and answer session. If I'm showing no further questions at this time, thank you for participating in today's conference. This does conclude the program.
Operator: You may now disconnect.