Q4 2024 Journey Medical Corp Earnings Call
Ladies and gentlemen, thank you for standing by good afternoon, and welcome to journey Medicals.
Operator: Ladies and gentlemen, thank you for standing by.
Operator: Good afternoon and welcome to Journey Medical. 2024 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode.
2024 financial results and corporate update conference call. At this time all participants are in a listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.
Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes.
Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of this call will be available approximately one hour. After the end of the call for approximate approx.
Operator: A webcast replay of this call will be available approximately one hour after the end of the call for approximately 30 days.
Approximately 30 days.
Jaclyn Jaffe: I would now like to turn the call over to Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Please go ahead.
I would now like to turn the call over to Jacqueline Jaffe, the company's senior director of corporate operations. Please go ahead.
Jaclyn Jaffe: Good afternoon, and thank you for participating in today's conference call.
Murali: Good afternoon, and thank you for participating in today's conference call. Joining me from journey Medicals leadership team are well I'm Murali co founder President and Chief Executive Officer, and Joseph The Nash Chief Financial Officer, joining for the Q&A portion of the call will be ran <unk> General counsel and corporate Secretary.
Jaclyn Jaffe: Joining me from Journey Medical's leadership team are Claude Maraoui, Co-Founder, President and Chief Executive Officer, and Joseph Benesch, Chief Financial Officer.
Jaclyn Jaffe: Joining for the Q&A portion of the call will be Ramsey Allouche, General Counsel and Corporate Secretary, Dr. Srinivas Sidgiddi, Vice President of Research and Development, and Louis Donati, Director of Market Access. During this call, management will be making forward-looking statements, including statements that address, among other things, Journey Medical's expectations for future performance, operational results, financial condition, and the receipt of regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
Speaker Change: Terry Doctor Sweeney said Getty, Vice President of research and development and Louis did not eat director of market access.
Speaker Change: During this call management will be making forward looking statements, including statements that address among other things journey medical's expectation for future performance operational results financial condition and the receipt of regulatory approvals forward looking statements involve risks and other factors that may cause actual results to differ materially.
Speaker Change: Really from those statements for more information about these risks please refer to the risk factors described in journey medical is the most recently filed periodic reports on Form 10-K and Form 10-Q, the form 8-K filed with the SEC today and the company's press release that accompanies this call, particularly the cautionary statements in it.
Jaclyn Jaffe: For more information about these risks, please refer to the risk factors described in Journey Medical's most recently filed periodic reports on Form 10-K and Form 10-Q, the Form 8-K files with the SEC today, and the company's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes non-GAAP financial measures that Journey Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non-GAAP financial measure to net loss, it's most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release.
Speaker Change: Today's conference call includes non-GAAP financial measures that journey medical believes can be useful in evaluating its performance you should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP.
Speaker Change: For a reconciliation of this non-GAAP financial measure to net loss its most directly comparable GAAP financial measure. Please see the reconciliation table located in the company's earnings press release.
Jaclyn Jaffe: The content of this call contains time sensitive information that is accurate only as of today, Wednesday, March 26th, 2025.
Speaker Change: The content of this call contains time sensitive information that is accurate only as of today Wednesday March 26th 2025, except as required by law journey medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call. It is now my.
Jaclyn Jaffe: Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.
Claude Maraoui: It is now my pleasure to turn the call over to Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical. Thank you, Jaclyn, and good afternoon to everyone on the call today. 2024 was a pivotal year for Journey Medical as we delivered on all of our guidance ranges for the year and positioned the company to launch MROSI, our best-in-class oral treatment for rosacea. We reported annual revenue of $56 million in 2024. And the fourth quarter marked the sixth consecutive quarter that the company achieved positive non-gap adjusted EBIT. Additionally, we submitted our new drug application for Ambrosi in early 2024 and received an on-time first cycle approval from the FDA in November.
Climb Rally: Pleasure to turn the call over to climb rally co founder President and Chief Executive Officer of journey medical.
Climb Rally: Thank you Jaclyn and good afternoon to everyone on the call today.
Climb Rally: 'twenty 'twenty four was a pivotal year for journey medical as we delivered on all of our guidance ranges for the year and position the company to launch them Roshi are best in class oral treatment for rosacea.
Climb Rally: We reported annual revenue of $56 million in 2024.
Climb Rally: In the fourth quarter marked the sixth consecutive quarter that the company achieved positive non-GAAP adjusted EBITDA.
Climb Rally: Additionally, we submitted our new drug application for Umbro seat in early 2024 and received an on time first cycle approval from the FDA in November.
Climb Rally: In 2024, we also paid out a total of $22 million in F. D. A filing fees and milestone payments to Doctor ready labs. These.
Claude Maraoui: In 2024, we also paid out a total of $22 million in FDA filing fees and milestone payments to Dr. Reddy Labs. These one-time payments completed our financial obligations associated with AMROSI's regulatory fees and development milestones in the United States for the Rosacea Indication. As a result, this clears the way for Ambrosy's commercial debut and our ability to increase our product revenues and operating cash flow as the product gains traction in the market. Despite these payments, our balance sheet remains strong ahead of the Ambrosi launch with $20.3 million in cash as of December 31st. We believe that Journey is well positioned ahead of the Amorosi launch.
Climb Rally: These one time payments completed our financial obligations associated with the <unk> regulatory fees and development milestones in the United States for the rosacea indication.
Climb Rally: As a result, this clears the way for a morose use commercial debut and our ability to increase our product revenues and operating cash flow as the product gains traction in the market.
Climb Rally: Despite these payments our balance sheet remained strong ahead of the Ambrosi launch with $20 3 million in cash as of December 31.
Climb Rally: Yeah.
Climb Rally: We believe that journey is well positioned ahead of the <unk> watch given that our current commercial organization is already targeting the same dermatology prescribers that treat the vast majority of rosacea patients.
Claude Maraoui: Given that our current commercial organization is already targeting the same dermatology prescribers that treat the vast majority of rosacea patients. This means that Ambrosi sales have potential to generate significant operating leverage for the business. Given the market opportunity for MROSI, which is entering a billion-dollar-plus treatment category with superior Phase III clinical results against the current oral standard of care. We believe that the product can be transformational to our business. Other accomplishments in 2024 include presentations of MROSI clinical data at key medical congresses, such as the American Academy of Dermatology annual conference in March. The Dermatologic Education Foundation Nurse Practitioner and Physician Assistant Conference in July.
Climb Rally: This means that <unk> sales have potential to generate significant operating leverage for the business.
Climb Rally: Given the market opportunity firm Roshi, which is entering a billion dollar plus treatment category with superior phase three clinical results against the current oral standard of care.
Climb Rally: We believe that the product can be transformational to our business.
Climb Rally: Other accomplishments in 2024 include presentations of them Roche see clinical data.
Climb Rally: Key medical Congresses, such as the American Academy of Dermatology annual conference in March.
Speaker Change: The Dermatology Education Foundation.
Climb Rally: Nurse practitioners and physician assistant conference in July.
Claude Maraoui: and the Fall Clinical Dermatology Conference in October. And in November 2024, our licensed partner, QDA Therapeutics, received regulatory approval to market Amzik in China, which triggered a $1 million milestone payment to Journey.
Speaker Change: In the fall clinical Dermatology conference in October.
Speaker Change: And in November 2024.
Speaker Change: Our license partner Judea Therapeutics received regulatory approval to market <unk>, Zeke in China, which triggered a 1 million dollar milestone payment to journey.
Speaker Change: Continuing the business momentum from last year 2025 is off to a strong start.
Claude Maraoui: Continuing the business momentum from last year, 2025 is off to a strong start.
Speaker Change: Earlier this month, we hosted an exhibit booths at the 2025 AAD conference in Orlando, Florida.
Claude Maraoui: Earlier this month, we hosted an exhibit booth at the 2025 AAD Conference in Orlando, Florida. The AAD meeting attracts more than 20,000 attendees, including top dermatology KOLs and high prescribing physicians, nurse practitioners, and physician assistants. Our exhibit booth at the conference was very productive in terms of foot traffic and the time that attendees spent in our exhibit to learn about Ambrosie's recent FDA approval and our superior head-to-head Phase III results against aeration. Notably, dermatologists were interested in Ambrosy's low-dose modified release formulation. comprised of 10 milligram immediate release and 30 milligrams of extended release minocyte. as well as the product's favorable safety and tolerability profile.
Speaker Change: The AAD meeting attracts more than 20000 attendees, including top dermatology Kols and high prescribing physicians nurse practitioners and physician assistance.
Speaker Change: Our exhibit booth at the conference was very productive in terms of foot traffic and the time that attendees spent in our exhibit to learn about <unk> recent FDA approval and our superior head to head phase III results against duration.
Speaker Change: Notably dermatologists were interested in <unk> low dose modified release formulation comprised of 10 milligram immediate release and 30 milligrams of extended release minutes cycling.
Speaker Change: As well as the products favorable safety and Tolerability profile.
Speaker Change: We also observed significant attendee interest in the before and after photos of patients in our phase III clinical trials.
Claude Maraoui: We also observed significant attendee interest in the before and after photos of patients in our Phase III clinical trial. which were a focal point in our exhibit. Many dermatologists already know Journey, our current products, and the strong customer service that we provide, including our co-pay assistance and access program.
Speaker Change: Which where our focal point in our exhibit.
Speaker Change: Many dermatologists to already know journey, our current products and the strong customer service that we provide including our co pay assistance and access programs.
Claude Maraoui: We believe that the AAD meeting was highly successful and generated significant customer interest heading into the Ambrosi launch. Our national sales meeting kicks off next week, and with our launch quantities in place, we recently began shipping Amrosi inventory into the distribution channel and have already begun seeing prescriptions dispensed. As a result, we are well prepared to execute on a robust launch in early April. On our pre-commercial update call in February, we noted approximately 12% commercial payer coverage for MROSI at the time. Due to our initial market access efforts, which began immediately after MROSI's FDA approval last November.
Speaker Change: We believe that the AGM meeting was highly successful and generated significant customer interest heading into the <unk> launch.
Speaker Change: Our national sales meeting kicks off next week and with our launch quantities in place. We recently began shipping <unk> inventory into the distribution channel and have already begun seeing prescriptions dispensed.
Speaker Change: As a result, we are well prepared to execute on a robust launch in early April.
Speaker Change: On our pre commercial update call in February we noted approximately 12% commercial payer coverage for them Roche seat at the time.
Speaker Change: Due to our initial market access efforts, which began immediately after and received FDA approval last November.
Claude Maraoui: As an update, we now have coverage of approximately 20% of the 188 million commercial lives and 4% of the 58 million Medicare lives, enabling those patients access to AMROSI through their health insurance plan. We expect the number of payers and covered lives to increase substantially throughout the remainder of this year and into 2026. So far, we believe that the early progress is promising, and we expect to report on the ramp-up in payer coverage throughout the year.
Speaker Change: As an update we now have coverage of approximately 20% of the 188 million commercial lives and 4% of the 58 million Medicare lives, enabling those patients access to them roshi through their health insurance plans.
Speaker Change: We expect the number of Payors and covered lives to increase substantially throughout the remainder of this year and into 'twenty 'twenty six.
Speaker Change: So far we believe that the early progress is promising and we expect to report on the ramp up in payer coverage throughout the year.
Speaker Change: Earlier this month, our phase III results from Ambrosi were published in a peer reviewed article in the journal of the American Medical Association or Jama Dermatology, one of the most well recognized journals and medicine.
Claude Maraoui: Earlier this month, our Phase 3 results from EMBROSI were published in a peer-reviewed article in the Journal of the American Medical Association, or JAMA, Dermatology, one of the most well-recognized journals in medicine. Notably, this journal has among the highest impact factors in the dermatology field. The paper focused on the head-to-head clinical superiority of MROSI on both of our co-primary endpoints against oratia and placebo with very high statistical significance. As well, the publication noted that MROSI's Phase III results met all of the secondary endpoints, including a statistically significant benefit in reducing erythema, or the redness associated with rosacea compared to placebo.
Speaker Change: Notably this journal has among the highest impact factors in the dermatology field.
Speaker Change: The paper focused on the head to head clinical superiority of them Rowsey on both of our co primary endpoints against oil ratio and placebo with very high statistical significance.
Speaker Change: As well the publication noted the <unk> phase III results met all of the secondary endpoints, including a statistically significant benefit in reducing erythema or redness associated with rosacea compared to placebo.
Claude Maraoui: The publication also noted the favorable safety profile of Ambrosia. We believe that the JAMA publication is a significant positive that coincides well with our launch and can create additional awareness of Ambrosie's benefits as we roll the drug out into the market. In addition to the JAMA article, we anticipate two more publications on AMROSI this year. with one focusing on the microbiology study that we conducted.
Speaker Change: The publication also noted the favorable safety profile of <unk>.
Speaker Change: We believe that the Jama publication as a significant positive that coincides well with our launch and can create additional awareness of <unk> benefits as we roll the drug out into the market.
Speaker Change: In addition to the Jama article.
Speaker Change: We anticipate two more publications on Ambrosi this year.
Speaker Change: With one focusing on the microbiology study that we conducted.
Claude Maraoui: which demonstrates the drug's sub-antimicrobial effects and the other on the quality of life improvement for patients taking Ambrosie to treat their rosacea symptoms. As well, Journey is planning to attend, exhibit, and present at additional dermatology-focused medical congresses throughout 2025.
Speaker Change: Which demonstrates the drugs sub anti microbial effects and the other on the quality of life improvement for patients taking <unk> to treat their rosacea symptoms.
Speaker Change: As well journey is planning to attend exhibit and present at additional dermatology focus medical Congresses throughout 2025.
Joseph Benesch: With that, I will now turn the call over to our CFO, Joe Benesch, to review our financial results for 2024. Thank you, Claude, and hello, everyone. like to start by saying that we are pleased to have met all of our financial guidance ranges for 2024. As a reminder, for the full year, we anticipated product sales in the range of $55 to $60 million. SG&A expense in the range of $39 to $42 million. and R&D experts in the range of $9 to $10 million.
Speaker Change: With that I will now turn the call over to our CFO Jobin Ash to review our financial results for 'twenty 'twenty four.
Speaker Change: Thank you Claude.
Speaker Change: Hello, everyone.
Speaker Change: I'd like to start by saying that we are pleased to have met all of our financial guidance ranges for 2024.
Speaker Change: As a reminder for the full year, we anticipated product sales in the range of $55 million to $60 million.
Speaker Change: SG&A expense in the range of $39 million to $42 million.
Speaker Change: R&D expense in the range of $9 million to $10 million.
Speaker Change: For this year, given the upcoming launch of MLC and the variability that goes along with any drug launch.
Joseph Benesch: For this year, given the upcoming launch of MROSI and the variability that goes along with any drug launch, plan to offer 2025 financial guidance later in the year. After we assess initial MROSI prescription demand, we have conducted additional payer contract negotiations.
Speaker Change: Trying to offer 2025 financial guidance later in the year.
Speaker Change: After we assess initial ambrosi prescription demand now.
Speaker Change: We have conducted additional payer contract negotiations.
Speaker Change: Moving to our financial results for 2024.
Joseph Benesch: Moving to our financial results for 2024. Our total net product revenue in 2024 was $55.1 million. which compares to the $59.7 million that were reported in 2023. The decrease was primarily due to overall higher rebate costs across our product portfolio. and lower unit volumes mainly from our legacy products. Total revenues for 2024 were $56.1 million. This includes a $1 million milestone payment that was triggered upon QDF, receiving market authorization for Amzik in China. Under the CUNY agreement, Journey is also entitled to royalties on sales of Amzik in the licensed territory.
Speaker Change: Our total net product revenue in 2024 was $55 $1 million.
Speaker Change: This compares to the $59 $7 million that we reported in 2023.
Speaker Change: The decrease was primarily due to overall higher rebate costs across our product portfolio.
Speaker Change: Lower unit volumes, mainly from our legacy products.
Speaker Change: Total revenues for 2024 were $56 $1 million.
Speaker Change: This includes a $1 million milestone payment that was triggered upon QD res.
Speaker Change: Seating market authorization for <unk> in China.
Speaker Change: Under the QD agreement, Germany is also entitled to royalties on sales of ANZ in the licensed territory.
Speaker Change: Full year 2023, total revenues of $79 million includes a $19 million upfront licensing payment.
Joseph Benesch: Full year 2023, total revenues of $79 million. includes a $19 million upfront licensing payment. $500,000 in royalties that we received from our partner Marujo Limits. Our cost of goods sold decreased by $2 million, or 9%. $20.9 million for the full year 2024. The lower cost of goods was mainly due to decreased product royalties. Stemming from contractual royalty decreases in 2023 and the discontinuation of Zimino in 2023. Research and development expenses increased by $2.3 million to $9.9 million for the full year 2024. The increase was primarily driven by non-recurring payments of $4.1 million to the Ambrosia NDA filing fee in January 2024.
Speaker Change: $500000 in royalties that we receive from our partner Meru Hall limited.
Speaker Change: Our cost of goods sold decreased by $2 million or 9%.
$8 9 million for the full year 2024.
Speaker Change: The lower cost of goods was mainly due to decreased product royalties.
Speaker Change: Turning from contractual royalty decreases in 2023 and.
Speaker Change: And the discontinuation of the Minto in 2023.
Speaker Change: Research and development expenses increased by $2 $3 million to $9 $9 million for the full year 2024.
Speaker Change: The increase was primarily driven by nonrecurring payments of $4 $1 million.
Speaker Change: Yossi NDA filing fee in January 2024.
Joseph Benesch: and the $3 million contractual milestone payment to Dr. Reddy. which was triggered by the FDA's acceptance of our NDA application for AMROSI in March 2021. These increases were offset by lower clinical trial extensions.
Speaker Change: And the $3 million contractual milestone payments and Dr. Reddy is which was triggered by the fda's acceptance of our NDA application firm Rosy in March 2024.
Speaker Change: These increases were offset by lower clinical trial expenses.
Joseph Benesch: as the MROSI Phase III Clinical Program was concluded in 2023.
Speaker Change: Rosie Phase III clinical program was concluded in 2023.
Speaker Change: Looking now to our SG&A expenses.
Joseph Benesch: Looking now to our SG&A expense. STDs decreased by $3.7 million or 8%. $40.2 million for the full year 2020. The year-over-year decrease was mainly due to the full realization or expense optimization efforts that were completed in 2022.
Speaker Change: SG&A decreased by $3 7 million or 8%.
Speaker Change: $42 million for the full year 2024.
Speaker Change: Year over year decrease was mainly due to the full realization or expense optimization efforts that were completed in 2023.
Speaker Change: Continuing to our net loss for the periods.
Joseph Benesch: Continuing to our net loss for the period. Net loss to common shareholders was $14.7 million, or $0.72 per share basic and diluted for the full year 2020. This compares to a net loss to common shareholders of $3.9 million or $0.21 per share of basic and diluted for the full year of 2023. The net loss in 2023 includes the licensee revenue and product-related royalties of $19.5 million that we received from Maruha.
Speaker Change: Net loss to common shareholders was $14 $7 million 72 per share basic and diluted for the full year 2024.
Speaker Change: This compares to a net loss to common shareholders of $3 $9 million or 21 cents per share basic and diluted for the full year of 2023.
Speaker Change: The net loss in 2023 includes the license fee revenue and product related royalties of $19 $5 million that we received from Meru Hal.
Speaker Change: Turning now to our non-GAAP results.
Joseph Benesch: Turning now to our NOMGAP results. The non-GAAP-adjusted EBITDA for the full year 2024 was a positive $800,000. 4 cents per share basic and 3 cents per share diluted. This compares to positive adjusted EBITDA of $15.6 million. were $0.85 per share basic, $0.75 per share diluted for the full year of 2023. which includes the licensee revenue and product-related royalties of $19.5 million that we received from Maruha.
Speaker Change: non-GAAP adjusted EBITDA for the full year 2024 was a positive $800000 or <unk> <unk> per share basic and three cents per share diluted.
Speaker Change: This compares to positive adjusted EBITDA of $15 $6 million.
Speaker Change: Or <unk> 85 per share basic.
Speaker Change: 75 per share diluted for the full year of 2023.
Speaker Change: Includes the license fee revenue and product related royalties and $19 $5 million that we received from Meru Hal.
Speaker Change: At December 31, 2024.
Joseph Benesch: At December 31, 2024, we had $20.3 million in cash and cash equivalents. compared to the $27.4 million at December 31, 2020.
Speaker Change: We had $23 million in cash and cash equivalents.
Speaker Change: To the $27 $4 million at December 31, 2023.
Joseph Benesch: Thank you very much.
Speaker Change: Thank you very much I will now turn the call back over to Claude.
Claude Maraoui: I will now turn the call back over to Clyde.
Speaker Change: Thank you Joe.
Claude Maraoui: Thank you, Joe. We executed well in 2024, ending the year on a high note and setting up our business for a transformational year in 2025. M-ROSI is now approved and ready for launch. And the entire company is energized as we prepare to go to market with a product that is clearly superior to the current standard of care and addresses an unmet need for improving the treatment of rosacea patients. As the first internally developed asset for the company, Ambrosi fits directly into our current dermatology commercial model, with no need to add to our sales force to promote the product.
Speaker Change: We executed well in 2024, ending the year on a high note and setting up our business for a transformational year in 2025.
Speaker Change: <unk> is now approved and ready for launch and the entire company is energized as we prepare to go to market with a product that is clearly superior to the current standard of care and addresses an unmet need for improving the treatment of rosacea patients.
Speaker Change: As the first internally developed asset for the company Ambrosi fits directly into our current dermatology commercial model with no need to add to our sales force to promote the product.
Claude Maraoui: As such, we have the financial and organizational resources in place to execute on a strong lawn. We believe that AMROSI will become a major growth driver for Journey Medical. given its potential to achieve peak annual sales of an estimated $200 million in the United States and $100 million internationally. providing significant operating leverage to our business.
Speaker Change: As such we have the financial and organizational resources in place to execute on a strong launch.
Speaker Change: We believe that <unk> will become a major growth driver for journey medical.
Speaker Change: Given its potential to achieve peak annual sales of an estimated $200 million in the United States and 100 million internationally provide.
Speaker Change: Providing significant operating leverage to our business.
Speaker Change: An exciting year lies ahead with several potential catalysts to create value.
Claude Maraoui: An exciting year lies ahead with several potential catalysts to create value. including the launch of Ambrosi and subsequent ramp and prescriptions for the product. Two additional peer-reviewed publications and medical conference presentations anticipated during the year. and Anticipated Entries in Covered Lives Gaining Access to AMROSI during 2025. Our financial progress as we drive the business towards sustainable, positive EBITDA and profitability. and the potential for business development activity, which may include licensing the commercial rights to our products outside the U.S. to create additional shareholder value.
Speaker Change: Including the launch of <unk>, and subsequent ramp and prescriptions for the product to.
Speaker Change: Two additional peer reviewed publications and medical conference presentations anticipated during the year.
Speaker Change: And anticipated increase in covered lives gaining access to amrozi during 2025.
Speaker Change: Our financial progress as we drive the business towards sustainable positive EBITDA and profitability.
Speaker Change: And the potential for business development activity, which may include licensing the commercial rights to our products outside the U S.
Speaker Change: Create additional shareholder value.
Speaker Change: We at journey medical are looking forward to a productive 2025, and we are laser focused on driving value for patients and our physician customers and our shareholders.
Claude Maraoui: We at Journey Medical are looking forward to a productive 2025, and we are laser-focused on driving value for patients, our physician customers, and our shareholders. Thank you.
Speaker Change: Thank you.
Operator: Operator, we are now ready to open the lines for Q&A. We will now begin the question and answer session. To ask a question, you may press star, then one on a touch-tone phone.
Speaker Change: Operator, we are now ready to open the lines for Q&A.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on a touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys if at any time. Your question has been addressed and you would like to withdraw your question. Please press star and then.
Operator: If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two.
Speaker Change: Two are.
Thomas Flaten: Our first question comes from Thomas Flaten with Lake Street Capital Markets. Please go ahead. Thank you. Hey, good afternoon. Thanks for taking the questions.
Speaker Change: Our first question comes from Thomas Flaten with Lake Street Capital markets. Please go ahead.
Thomas Flaten: Thank you Hey, good afternoon. Thanks for taking the questions just first on payer coverage. What do you think we should be expecting as you exit 2025, I know you said there'd be a nice ramp but relative to the 24 ish percent that you have now where do you think we should be ending the year.
Thomas Flaten: Claude, just first on payer coverage, what do you think we should be expecting as you exit 2025? I know you said there'd be a nice ramp, but you know, relative to the 24-ish percent that you have now, where do you think we should be ending the year?
Speaker Change: Yes, Hi, Thomas.
Claude Maraoui: Yeah, hi, Thomas. You know, our goal, obviously, is to obtain as many covered lives as possible. The expectation to peak commercial coverage should take anywhere from 12 to say 18 months.
Thomas Flaten: Our goal obviously is to obtain as many covered lives as possible.
Speaker Change: Expectation to peak commercial coverage should take anywhere from 12 to say 18 months.
Louis Donati: I do have our market access lead with us here, Louis Donati.
Speaker Change: Do you have our market access leave with us year boost annuity.
Louis Donati: I'm going to pass that to him and let him give you a little more. I appreciate the question, by the way, market actors team is working actively, obviously, on commercial coverage. as well as the Medicare line of business. So out of the 188 million lives commercially across the U.S. The anticipation is April 1, July 1, October 1, and so forth. We will have that ramp up period with peak coverage 12 to 18 months out. The anticipation, again, is based on a lot of the high demand through the field because the more demand, the better coverage we will get, and the head-to-head studies will back up that.
Speaker Change: Asset to him and let him give you a little more detail.
Speaker Change: I appreciate the question by the way our market access team is working actively obviously on commercial coverage.
Speaker Change: As well as the Medicare line of business. So how did the 188 million lives commercially across the U S. The anticipation that is April one July one October one and so forth, we will have that ramp up period, where peak coverage 12 to 18 months out.
Speaker Change: The anticipation again is based on a lot of the high demand through the field because the more more demand better coverage, we will get and the head to head studies will back up that.
Claude Maraoui: Demand also because the payers are very happy with the head-to-head studies.
Speaker Change: Demand also because the payers are very happy with the head to head studies, so to give you a specific target right now.
Claude Maraoui: So to give you a specific target right now Let's just wait a few months until we get more intel from the demand from the field. And I'm actively working with the GPOs and PBMs to obviously let them know of the head-to-head studies. So give us a few more months and we will report back. But again, peak coverage is 12, 18 months post launch. Great, I appreciate that.
Speaker Change: Let's just wait a few months until we get more Intel from the demand from the field and I'm actively working with the <unk> and Pbms to obviously, let them know of the head to head study yourself give us a few more months, we will report back but again peak coverage is 12 to 18 months post launch.
Speaker Change: Great I appreciate that and then from your interactions with Kols of other doctors at AAD.
Claude Maraoui: And then from your interactions with KOLs and other doctors at AAD, you know, how important did they view the erythema data? And depending on that, you know, what are you doing to get that data into the hands of physicians, given that it didn't end up in the label? Yeah, I guess a couple things there. First of all, the AAD had significant interest from our providers and PAs as well. The erythema, interesting enough, was not the key subject at all. The head-to-head performance really is catching people and saying, okay, let me listen to more. Tell me about the safety.
Speaker Change: How important do they view the erythema data and depending on that what are you doing to get that data into the hands of physicians given that it didn't end up in the label.
Speaker Change: Yeah, I guess, a couple of things there first of all the AAD had significant interest from our providers and Tas as well.
Speaker Change: The erythema interesting enough was not the key subject at all.
Speaker Change: <unk> had performance really is catching people and saying, Okay. Let me listen to more tell me about the safety they did not hit the erythema whatsoever.
Claude Maraoui: They did not hit the erythema whatsoever.
Srinivas Sidgiddi: Outside of that, we also have held already today, Thomas, we've done three AAD boards. We've done a scientific AAD board already. And overwhelmingly, the response, again, the head-to-head is really what's capturing people's interest and why they want to prescribe MROSI moving forward. And that's really one of the reasons why we believe we anticipate this to becoming the new standard of care. In terms of erythema, to answer your question, we have our head of medical affairs on as well.
Speaker Change: Outside of that.
Speaker Change: We also have held our ready to date Thomas we've done three AD boards, we've done a scientific AD board already and overwhelmingly the response again the head to head is really what's capturing people's interest and why they want to prescribe.
Speaker Change: <unk> moving forward and Thats really.
Speaker Change: One of the reasons why we believe we anticipate this to becoming the new standard of care.
Speaker Change: In terms of.
Speaker Change: Erythema to answer your question, we have our head of medical affairs on as well.
Srinivas Sidgiddi: And that's Dr. Srinivas Sidgiddi. And he can speak more about that. Sure, Claude. Thank you so much. I hope I'm audible. Thomas, thanks for the question. First of all, we are very pleased with the JAMA publication and the data presented there. As Claude mentioned in his presentation, the JAMA publication covers the co-primary endpoints as well as all the secondary endpoints. And erythema was one of the secondary endpoints which showed success against placebo. And that data being in a journal like JAMA term is really very important and we are fortunate to get this out at the right time.
Speaker Change: Dr Shreve us should giddy.
Speaker Change: And he can speak more about that.
Speaker Change: Okay.
Speaker Change: Sure. Thank you so much I hope I'm audible.
Thomas Flaten: Thomas Thanks for the question.
Speaker Change: First of all we are very pleased with the Jama publication and the data presented there.
Speaker Change: As Claude mentioned in his presentation, the Jama publication, Carlos the co primary endpoints as well as all of the secondary endpoints.
Speaker Change: And added demand was one of the secondary endpoints, which showed success against placebo.
Speaker Change: And that data being in the Chilean Unlike jam-up zama dumb.
Speaker Change: <unk>.
Speaker Change: Really very important that would be out of watching it to get this out at the right time.
Srinivas Sidgiddi: With the high impact factor, the high credibility, and the wide readership of Chama dermatology, there will be natural visibility of the erythema data from the Phase III studies. And the Medical Affairs Group is well-trained to answer specific questions related to erythema from the dermatology prescribers about the Phase III results on erythema or any other clinical data related to those studies. As a result, we expect that the JAMA DERM publication will have a huge impact in disseminating the erythema data.
Speaker Change: With the high impact factor the high credibility and a wide readership of Jama dermatology, there will be natural visibility off the air demand data from the phase III studies.
Speaker Change: The Medical Affairs group is well trained to answer specific questions related to the demand from the dermatology prescribers about big phase III results on the EDA demand or any other clinical data related to those studies as a result, we expect that the jama dump application.
Speaker Change: We'll have a huge impact and disseminating the entity my data.
Greg: The one for you Greg.
Srinivas Sidgiddi: The one last thing, the other part I would invite you if you haven't yet and as well as all the other listeners, the MROSI website really has phenomenal before and after photos and I would invite you to take a look and see the baseline versus the finished results of the patients at week 16. It's pretty dramatic and there's really great indication of how powerful it is to your question specifically. Thanks for taking the questions. I appreciate it.
Speaker Change: I'm sorry, yes.
Speaker Change: The other part I would invite you if you haven't yet and as well as all the other listeners.
Speaker Change: <unk>.
Speaker Change: Website really has phenomenal before and after photos and I would invite you to take a look and see the baseline versus the finished results of the patients at week 16, its pretty dramatic.
Speaker Change: There is really great indication of how powerful it is.
Speaker Change: To your question specifically.
Speaker Change: Got it thanks for taking the questions I appreciate it.
Scott Henry: And the next question comes from Scott Henry with a G. P. Please go ahead.
Scott Henry: And the next question comes from Scott Henry with AGP. Please go ahead. Thank you and good afternoon.
Scott Henry: Thank you and good afternoon.
Scott Henry: I don't know if I missed it, or if your plan is to do it later, but do you have any thoughts on 2025 guidance or a plan for initiating that? Yeah, give us a few more months. This is really mostly related to the 2024 and us hitting all of our guidance that we gave. So we're going to let the launch of MROSI really begin here. We've got our national sales meeting set up next week, and then we'll have the full force of the commercial team out there for physicians to hear their voice and learn about MROSI.
Scott Henry: I don't know if I missed it but.
Scott Henry: Or if your plan is to do it later, but do you have any thoughts on 2025 guidance or a plan.
Scott Henry: We're initiating that.
Scott Henry: Yes. It gives us a few a few more months. This is really mostly related to the 'twenty 'twenty four and us hitting all of our guidance that we gave so we're going to let the launch of <unk> roshi really begin here.
Scott Henry: We've got our National sales meeting set up next week and then we'll have the full force of the commercial team out there.
Scott Henry: For physicians to hear their voice and learned about Roche. So we're going to wait a little bit before we give guidance. So at this point just please be patient with that.
Scott Henry: So we're going to wait a little bit. Just please be patient. Okay, fair enough. And then...
Scott Henry: Okay fair enough.
Scott Henry: And then.
Scott Henry: As far as the early days.
Claude Maraoui: As far as the early days, because you have filled some prescriptions, would you say that the reimbursement environment, has it been in line with expectations? Has it been better? Has it been worse? I know you have very few data points, but I'd like to ask the question just to see if there's anything there to focus. Yeah, definitely. You know, the distribution into the pharmacy channel is there, so we're glad to say that we've got that checked off and ready to go for the full launch year in the next couple weeks. In terms of coverage and reading into that, it's just too early to tell.
Scott Henry: Cause you have felt some prescriptions.
Scott Henry: Would you say that the reimbursement environment has it been in line with expectations has it been better hasn't been worse and I know you have very few data points, but I like to ask the question just to see if there's anything there to focus on.
Scott Henry: Yes definitely.
Scott Henry: The distribution into the pharmacy channel is there. So we're glad to say that we've got that checked off and ready to go for the full.
Scott Henry: Launch here in the next couple of weeks.
Scott Henry: In terms of coverage and reading into that.
Scott Henry: It's just too early to tell we're definitely seeing the prescriptions coming in we certainly have some coverage happening.
Claude Maraoui: We're definitely seeing the prescriptions coming in. We certainly have some coverage happening. I would tell you that, you know, around the 20 percent mark right now in terms of getting adoption on formularies is probably on target and what I would utilize at this point as of today.
Scott Henry: I would tell you that.
Scott Henry: Around the 20% Mark right now in terms of.
Scott Henry: Getting adoption on formularies is probably.
Scott Henry: On target and what I would utilize at this point as of today.
Scott Henry: Okay and should we expect reported revenues in Q1.
Scott Henry: Okay, should we expect reported revenues in Q1? I know you'll fill some scripts, but sometimes there's a lag there. Should we look for just modest, small amounts in Q1? That's correct, Scott. Just, I would tell you that Q2 will have a meaningful, you know, revenue starting to begin with MROSI in Q2. I wouldn't expect much. makes sense.
Scott Henry: I know you will sell some scripts, but sometimes there's a lag there.
Scott Henry: Should we look for just modest small amounts in Q1.
Scott Henry: Yeah, that's correct Scott just I would tell you that Q2 will have a meaningful.
Roche: Revenue starting to begin with I'm Roche in Q2, I wouldn't expect much in Q1.
Scott Henry: Makes sense.
Scott Henry: And then for fourth quarter, if by math is correct, the revenue was down sequentially from Q3, somewhat notably. I know you talked about some of the reasons. My question is, when we think about the base business, Is it more reflective of all the quarters in 2024, or is there, you know, a step down in fourth quarter 24 that we should think about continuing into 2025?
Scott Henry: And then for fourth quarter, if my math is correct.
Scott Henry: Yeah. The revenue was down sequentially from Q3, somewhat notably I know you talked about some of the reasons Mike.
Scott Henry: My question is when we think about the base business.
Scott Henry: Is it more reflective of all the quarters in 2024 or is there.
Scott Henry: You know a step down in fourth quarter 24 that we should think about continuing into 2025.
Scott Henry: Yeah.
Claude Maraoui: I'll start out and then I'm going to hand this off to Joe. You know, if you take a look at the last several years, I think the base business has been relatively steady. We've got some legacy brands that continue to erode. When we look at our base business, our core four, it's been pretty consistent. Joe, if you wanted to add to that, please. Yeah, and I think, you know, when we look at the first quarter, you know, the first quarter is always going to be a little bit lower, right, because of rate resets that go through our P&L.
Joe: I'll start out and then I'm going to hand, this off to Joe.
Joe: Take a look at the last several years I think the base business has been.
Joe: Relatively steady.
Joe: We've got some legacy brands that continue to erode when.
Joe: When we look at our base business, our core four it's been pretty consistent but Joe do you want to add to that please.
Joe: Yeah, and I think.
Joe: You know when we look at the first quarter.
Joe: The first quarter is always going to be a little bit lower right because of rate resets.
Joe: That goes through our P&L, but I think you can look at the full year 2024, and Thats more representative of the sugar business.
Joseph Benesch: But I think you can look at the full year 2024. And that's more representative of the true business.
Speaker Change: Okay. So so down to the products you would say you have.
Claude Maraoui: Okay, so none of the products you would say have kind of reset at lower levels. I mean, mostly I'm thinking Qbrexa and Accutane are the main drivers. Qbrexa continues to perform well for us. We continue to see script growth year over year. And it's holding very solid. It obviously has some new competition out there. But again, the prescriptions continue to show very good positive signs. Again, when you look year over year, we're growing that product. With Accutane, as we've stated in the past, there were a couple new entries towards the second and third quarter of 2024.
Joe: Kind of reset at lower levels, I mean, mostly I'm thinking keep Brexit and ask you to enter the main drivers there.
Speaker Change: Yeah.
Speaker Change: <unk> Q Brexit continues to perform well for us and we continue to see script growth year over year.
Speaker Change: And.
Speaker Change: It's holding very solid it obviously has some new competition out there, but again.
Speaker Change: The prescriptions.
Speaker Change: Continue to show very good positive signs again, when you look year over year, we're growing that product.
Speaker Change: Accutane as we've stated in the past there were a couple of new entries.
Speaker Change: Towards the second and third quarter of 2024, we did see some slowdown with Accutane, we've stabilized that business relatively well and we believe we're going to have good performance with with Accutane.
Claude Maraoui: We did see some slowdown with Accutane. We've stabilized that business relatively well. And we believe we're going to have good performance with Accutane.
Speaker Change: Okay, Great and just.
Scott Henry: Okay, great.
Scott Henry: And just one accounting question. I see the loss recovery of 4553. Was that in fourth quarter? Is that related to the cyber attack?
Speaker Change: One accounting question.
Speaker Change: I see the loss recovery of four five to five three.
Speaker Change: Was that in fourth quarter is that related to the cyber attack.
Joseph Benesch: And also on the accounting side, the 15 million approval milestone, how should we think about that being? I thought we may see it expensed in the fourth quarter, but it doesn't look like it. How should we account for that going forward? Right. So to your first question, Scott, the $4.6 million in crypto, it was the recovery. We received the cash in December, so we're happy to put that through our P&L. And for the second question, the $15 million, we were able to capitalize that as an intangible asset, and we will amortize that over the life of the patent, which is through 2039.
Speaker Change: And also on the accounting side, the $15 million approval milestone, how how should we think about that being I thought we may see it expense in the fourth quarter, but it doesn't look like and how should we account for that going forward.
Speaker Change: Alright, so so to your first question Scott.
Speaker Change: The $4 6 million crypto it was the recovery we received the cash in December.
Speaker Change: So we're happy to put that through our P&L answer. The second question the $15 million, we were able to capitalize that as an intangible asset and we will amortize that over the life of the patent which is two.
Speaker Change: 1039.
Speaker Change: Okay and will that be amortized through the acquired intangible assets line, which is now broken it out or it will come at lower down.
Joseph Benesch: Okay, and will that be amortized through the Acquired Intangible Assets line, which is now broken out, or will it be lowered down? Now it'll be it'll be right in that line. Okay, great. Thank you for taking the questions. You're welcome.
Speaker Change: It'll be it'll be right in that line.
Speaker Change: Okay, great. Thank you for taking the questions.
Speaker Change: Youre welcome.
Brandon Folkes: And the next question comes from Brandon Folkes with Rodman and Renshaw. Please go ahead. Hi, thanks for taking my questions and congratulations on all the progress. Maybe just two from me. Firstly, you know, how do you think about pricing across the portfolio? You know, obviously talking about more the legacy portfolio here in 2025.
Speaker Change: And the next question comes from Brandon Folkes with Rodman and Renshaw. Please go ahead.
Brandon Folkes: Alright, Thanks for taking my questions and congratulations on all the progress.
Speaker Change: Maybe just two for me firstly.
Speaker Change: How do you think about pricing across the portfolio, obviously talking about more of the legacy portfolio. Yet in 2025, and then you know just kind of.
Joseph Benesch: And then, you know, just kind of With the Ambrosi launch, with the operating leverage you do have in your business, what do you think about capital allocation in 2025 and, you know, maybe beyond that as well? Thank you.
Speaker Change: With the Roissy launch with the operating leverage do you have in your business. How do you think about capital allocation in 2025, and maybe beyond that as well. Thank you.
Speaker Change: Sure.
Claude Maraoui: Joe, would you like to take that? Talbot, as far as capital allocation, you know, you know, we're good with cash. You know, we're very comfortable with our cash at this point. And can you talk, can you speak to the other part of the question, please? Pricing across the base business or legacy portfolio in 2025? Just sort of what are you seeing? You know, obviously there's competitor interactions. So maybe just, you know, whether you want to go product by product or just sort of holistically across the portfolio. You know, how do we think about kind of net pricing in 2025?
Speaker Change: Joe would you like to take that.
Speaker Change: Sure.
Speaker Change: Kelvin if as far as capital allocation.
Speaker Change: We're going to have cash yeah, we're very comfortable with our cash at this point.
Speaker Change: And can you can you talk can you speak to the other part of the question. Please.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Pricing across the base business the legacy portfolio in 2025, just sort of what are you seeing you know obviously they've competed tear interaction. So maybe just to you know whether you want to go product by product or just sort of holistically across the portfolio.
Speaker Change: Do we think about kind of net pricing in 'twenty five.
Speaker Change: So, yes, 25 got it got it.
Claude Maraoui: Go ahead, Claude. Yeah, I mean, just generally, Brandon, with our legacy brands, when we look at Exelderm and Targetox, I think our pricing is going to be holding steady. We don't see much of a difference between one year to the next. The fact is, you know, those brands do have their competitive generics out there, especially with Targetox. So, you know, there's some erosion in the volume of the scripts more so than it is a pricing game with them. The one benefit is, too, with Exelderm is we no longer have the obligation of paying royalties, so our margins for that product have actually gotten better.
Speaker Change: Yeah, I mean, just generally.
Brandon Folkes: Brandon with our with our legacy brands, when we look at actual derm and target ox.
Speaker Change: Our pricing is going to be holding steady.
Speaker Change: Don't see much of a difference between one year to the next.
Speaker Change: The fact is those brands.
Speaker Change: Do you have there competitive generic out there, especially with the with target ox. So there is some erosion in the volume of the scripts more so than it is a pricing game with that.
Speaker Change: The one benefit is to with actual burn as we no longer have the obligation of paying royalty. So are margins for that product have actually gotten better.
Speaker Change: And then in terms of our remainder are core for us I've been calling it in 2024.
Brandon Folkes: And then, you know, in terms of our remainder, our core four, as I've been calling it in 2024, we believe that net pricing should remain... the same as you've seen. Great, thanks very much.
Speaker Change: We believe that net pricing should.
Speaker Change: <unk>.
Speaker Change: The same as you've seen.
Speaker Change: Great. Thanks very much.
Jason Wittes: And the next question comes from Jason Wittes with Roth Capital. Please go ahead.
Jason Wittes: And the next question comes from Jason Wittes with Roth Capital. Please go ahead. Hi, thanks for taking the questions.
Jason Wittes: Hi, Thanks for taking the questions.
Jason Wittes: In terms of sort of the milestones for the MROC launch that, you know, you guys are looking for internally, at least the things that the, I guess the bottlenecks, I mean, reimbursement and getting in the formulary, I would think would be sort of The main things to track, obviously, at least from our checks with physicians, there seems to be a lot of interest in the drug from the physician's side, but I assume just the logistics of those other two items are kind of what's going to determine the outlook for 2025. Is that the right way to think about it?
Speaker Change: In terms of sort of the milestones are for Tomorrow's, who launch for.
Speaker Change: You guys are looking for internally.
Jason Wittes: At least the things that the.
Jason Wittes: I guess the bottlenecks are.
Jason Wittes: Reimbursement and getting on formularies or there are I would think would be sort of.
Jason Wittes: The main thing to track obviously.
Speaker Change: From our checks with physicians there seems to be a lot of interest in the drug from the physician side.
Jason Wittes: And I assume just the logistics of those other two items or kind of what's going to determine.
Speaker Change: The outlook for 2025 is that is that the right way to think about it.
Claude Maraoui: I think you're tracking correctly. I think there were two areas that we need to focus in on. One was supply, and we're glad to say that we've got ample supply and more supply on the way, so we feel real good with that. The distribution part has been taken care of, and the backup supplies, again, are in a good position there. So I think you can put that one on the side. Secondly, in terms of getting more formulary coverage, we feel really good, and the progress that we've done already I think shows a good indicator in where things are going.
Speaker Change: I think I think you're tracking correctly I think there were two areas that.
Speaker Change: We need to focus in on one was supply and we're glad to say that we've got ample supply and more supply on the way. So we feel real good that the distribution part has been taken care of and the backup supplies again, our order in a good position. There. So I think you can put that one on the side.
Speaker Change: Secondly in terms of getting more formulary coverage.
Speaker Change: We feel really good and the progress that we've done already.
Speaker Change: It shows a good indicator and where things are going.
Claude Maraoui: We've had great conversations with all the major plans, and I keep saying it, but it's so meaningful. These small molecules, there's not too many head-to-head comparisons, and when you're able to demonstrate statistical significance with a a highly efficacious product, the plans are certainly interested, and we feel very good in terms of being able to get on these formularies.
Speaker Change: We've had great conversations with all the major plans.
Speaker Change: <unk>.
Speaker Change: I keep saying it but it's still meaningful these small molecules, there's not too many.
Speaker Change: Comparisons and when you're able to demonstrate statistical significance with a.
Speaker Change: Highly efficacious product.
Speaker Change: The plans are certainly interested in we feel very good in terms of being able to get on these formularies.
Speaker Change: The one area as you like.
Claude Maraoui: The one area is, like... Like Louis just said earlier, it takes anywhere between 12 to 18 months, and we will see good progress on a quarterly basis and better coverage as we go. So have a little patience in this game, but on all accounts, it looks very promising.
Speaker Change: Lewis just said earlier it takes anywhere between 12 to 18 months and we will see good progress on a quarterly basis and better coverage as we go so it's a little patience and in the scheme, but on all accounts it looks very promising from that point as well.
Speaker Change: Okay. That's that's helpful. Thank you and.
Jason Wittes: Okay, that's helpful. Thank you.
Claude Maraoui: And I guess you put out $100 million international opportunity for Amorosi. Is that something that you're going to look to out-license at some point? I assume that's kind of the goal here, or how should we think about that? Yes, in terms of finding the right partner to out-license to is exactly what we're looking at. We certainly want to focus our efforts here in the United States. We've got a real good handle on that, and that's where our focus is going to be. But our business development strategy is to out-license this, and I think as we continue to see early success onward in 2025, I think it makes it even that much more tempting for partners outside to look at Amorosi as a very viable product.
Speaker Change: Yes. She met you you put out $100 million international opportunity from Rosie.
Speaker Change: Is that something that you're going to look to out license at some point.
Speaker Change: I assume that's kind of the go here or how should we think about that.
Speaker Change: Yes in terms of.
Speaker Change: Finding the right partner to out license to US exactly what were looking at we certainly want to focus our efforts here.
Speaker Change: In the United States, We've got a real good handle on that and that's where our focus is going to be but our business development strategy is to out license. This and I think as we continue to see early success onward in 2025, I think it makes it even that much more.
Speaker Change: Tempting for partners outside to look at <unk> as a very viable product on an international basis.
Brandon Folkes: International basis. Got it, thanks. I'll jump back in queue.
Speaker Change: Got it thanks, I'll jump back in queue.
Speaker Change: And the next question comes from <unk> Patel with B Riley Securities. Please go ahead.
Kalpit Patel: And the next question comes from Kalpit Patel with B-Riley Securities. Please go ahead. Yeah, hey, good afternoon. Thanks for taking the questions.
Speaker Change: Yeah, Hey, good afternoon, and thanks for taking the questions maybe a few on the market access and launch related.
Kalpit Patel: Maybe a few on the market access and launch-related questions. You mentioned that the peak coverage for MROSI, you would expect 12 to 18 months from the day of the launch. I guess what exactly is the peak coverage percentage? That's question number one.
Speaker Change: Questions.
Speaker Change: You mentioned that the peak coverage for Ambrosi, you would expect 12 to 18 months from the day of the launch.
Speaker Change: I guess, what exactly is the peak coverage percentage that's the.
Speaker Change: Question number one.
Louis Donati: And then the second question is, in terms of the covered lives, you gave a new updated 20% and 4% number for the different groups. What percentage of those are unrestricted versus single lives? Thanks Kalpit. Louis, would you like to take that one, please? Sure. Hi, Kalpit. It's Lou, by the way. Thanks for the call. And thanks for the question.
Speaker Change: And then the second question is in terms of covered lives you gave a new updated 20% and 4% number four.
Speaker Change: Or is it different.
Speaker Change: Groups.
Speaker Change: What percentage of those are unrestricted versus single step edits.
Speaker Change: Yeah.
Kelsey: Thanks Kelsey.
Speaker Change: Louis would you like to take that one please.
Louis: Sure Hi, calibrated slew by the way thanks for the call and thanks for the.
Speaker Change: Question. So peak coverage again trying to get ahead of it is maybe doing a disservice to what we're trying to do early on because I don't want to give you a number right now.
Louis Donati: So peak coverage, again, trying to get ahead of it is maybe doing a disservice to what we're trying to do early on, because I don't want to give you a number right now. 12 to 18 months down the road. All I can say is we've prepped the market early fall through today. And right now about 20% commercial coverage is where the forecast should be actually ahead of forecast, in my opinion. I expect M-ROSI because, again, we keep on talking about head-to-head studies and demand.
Speaker Change: 12 to 18 months down the road all I can say is we prep the market early fall through today and right now about 20% commercial coverage is where the forecast should be actually actually ahead of forecast in my opinion.
Speaker Change: I expect amrozi because again, we keep on talking about head to head studies in demand I really believe this will be a really good proud to the market in rosacea, and we will get the coverage that we anticipated, but just give us a few months to get out there with the field force and we can report back number one number two the 20% commercial coverage.
Louis Donati: I really believe this will be a really good product to the market, ROSACEA, and we will get the coverage that we anticipated, but just give us a few months to get out there with the field force, and we can report back, number one. Number two, the 20% commercial coverage, and that includes federal employees and health exchange, out of the 188 million lives. There's a mixed bag of unrestricted access and restricted access. So the good news is the payer response has been very positive. And there are some payers that are actually adopting EMROSI currently in an unrestricted position with no utilization management.
Speaker Change: And that includes federal employees and health exchange out of the 188 million lives.
Speaker Change: There is a mixed bag of unrestricted access and restricted access. So the good news is the payer response has been very positive.
Speaker Change: And there are some payers that are actually adopting amrozi currently in an unrestricted position with no utilization management and that is prior authorizations and no stop. So the response has been very well received again give us some give us some time as our market access team to get out there once we get the demand from the field that is definitely going to help our disc.
Louis Donati: And that is prior authorization and no steps. So the response has been very well received.
Kalpit Patel: Again, give us some time as a market access team to get out there once we get the demand from the field. That is definitely gonna help our discussions long-term. But just give us a few more months and we will report back, okay? Okay, got it.
Speaker Change: <unk> long term, but just give us a few more months and we will report back okay.
Speaker Change: Okay got it.
Kalpit Patel: And in a couple follow ups here is the stuff that it says being mandated, mandated by some of these payers. Should we assume that that's a generic ratio? Or does it also include off label Primarily, the payer response has been if to get to M-ROSI, if there's going to be a step at it, it's going to be through generic. and Generic Oral Agent. It could be menocycline and or doxycycline. The drug policies will vary, but generic oral agents would be the step. Got it, okay.
Speaker Change: A couple of follow ups here.
Speaker Change: The step edits that being mandated mandated by some of these payers.
Speaker Change: Should we assume that that's generic ratio or does it also include off label antibodies.
Speaker Change: Primarily the payer response has been to get to him rosy, if theres going to be a step at it it's going to be through generic.
Speaker Change: And generic oral agent it can be minocycline and or a doxycycline the drug policies will vary but generic oral agents would be the step.
Speaker Change: Got it Okay and then last question for me.
Kalpit Patel: And then last question for me, you know, after you guys announced your pricing and launched the drug here, has there been any pricing moves by Galderma for their brand name Oracion? Actually, we have not seen any market movement in terms of pricing, Kalpit, since we've launched, since we've announced. Got it. Thank you very much for being the question.
Speaker Change: After you guys announced your pricing and launch the drug here has there been any pricing moves by a gal derma for their brand name or ratio.
Speaker Change: Yeah actually we have not seen any market movement in terms of pricing Calvert since we've launched.
Speaker Change: Since we've announced.
Speaker Change: Got it. Thank you very much for taking the question.
Speaker Change: This concludes our question and answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Operator: This concludes our question and answer session. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.