Q4 2024 ANI Pharmaceuticals Inc Earnings Call
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Please stand by, we're about to begin.
Good morning, everyone. Welcome to today's A&I Pharmaceuticals fourth quarter 2024 earnings results call.
Speaker Change: Please note this call is being recorded. After the speaker's opening remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 on your telephone. If you would like to withdraw your question, please press star 2. Now at this time, it's my pleasure to turn the call over to Ms. Lisa Wilson, Investor Relations at A&I Pharmaceuticals. Please go ahead, ma'am.
Speaker Change: Thank you. Welcome to A&I Pharmaceuticals Q4 2024 earnings results call. This is Lisa Wilson of Insight Communications, Investor Relations for A&I.
Nikhil Lalwani: With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey,
Speaker Change: Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of A&I's Rare Disease Business.
Thank you. Bye. Bye.
Speaker Change: You can also access the webcast of this call through the investor section of the A&I website at aanifarmaceuticals.com.
Speaker Change: Before we get started, I would like to remind everyone that any statement made on today's conference call that expresses a belief, expectation, projection, forecast, anticipation, or intent
Speaker Change: regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.
Speaker Change: These forward-looking statements are based on information available to A&I Pharmaceuticals Management as of today and involve risks and uncertainties included in those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance.
Speaker Change: Actual results may differ materially from those projected in the forward-looking statements.
Speaker Change: A&I specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website at www.anifarmaceuticals.com.
Speaker Change: For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 28, 2025.
Speaker Change: Since then, A&I may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Nikhil Lalwani.
Thank you for watching!
Thank you, Lisa.
Good morning, everyone, and thank you for joining us.
Speaker Change: Today I'll start by discussing our full year and fourth quarter performance and highlights and our 2025 guidance.
Speaker Change: This will provide additional color on our rare disease business, including our lead acid, cortophan gel, and eluvian in your cheek.
which we recently added to the Acquisition of Alameda.
Finally.
Speaker Change: Steve will review our fourth quarter results and 2025 guidance in more detail.
Following our remarks, we'll take your questions.
For more information, visit www.FEMA.gov
Speaker Change: We're pleased to report record fourth quarter and full year 2024 results and are raising our 2025 guidance for total revenues and adjusted non-GAAP EBITDA.
Speaker Change: The upward revision in our guidance is based on further confidence in higher demand for corticofen gel.
Speaker Change: A strong start for generics with the launch of Prokalo Pride with 180-day exclusivity and increased demand in the first quarter, as we have seen in the past, for our established brands portfolio.
Speaker Change: which is now referred to as BRANDS under our new segment reporting structure.
https://www.youtube.com
Speaker Change: We now expect 2025 revenue of $756 million to $776 million, which represents growth of 23% to 26% over 2024, versus our prior guidance of $739 million to $759 million.
versus our prior guidance of $182 million to $192 million.
Steve will provide more specifics on our financial guidance.
Speaker Change: 2024 was another year of strong execution for A&I, sapped by a record fourth quarter with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP value-to-DPS all coming in above our previously announced guidance for the full year.
Speaker Change: Rare disease was our primary driver of growth in 2024 with our lead rare disease acid, corticosteroids, generating close to 200 million dollars of sales in just the third year since launch.
Speaker Change: and our genetics business delivered 12% revenue growth driven by operational excellence and new product launches.
Speaker Change: making 2024 the third straight year of achieving double-digit top-line growth for this business.
Speaker Change: In addition, we expanded our rare disease franchise in 2024 with the acquisition of Alomera Sciences in September in keeping with our longer-term strategy to broaden our presence in the rare disease space.
Speaker Change: We also successfully executed the refinancing of our prior debt and put in place a more efficient and effective capital structure.
Turning now to our fourth quarter results.
Speaker Change: Our financial performance in the fourth quarter was the strongest in our history.
Speaker Change: Total revenues were $190.6 million, representing a year-over-year increase of 45% on an as-reported basis and 24% on an organic basis.
Speaker Change: driven by accelerating demand for Cortofan gel, continued strong growth for generics, a full quarter contribution of from Illuvian and Utique, and higher demand for brands.
Speaker Change: adjusted non-gap EBITDA was $50 million and adjusted non-gap EPS was $1.63
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Speaker Change: For Frost and Gel, generated $59.4 million in revenues during the quarter, up 42% over the fourth quarter of 2023.
Speaker Change: The quarter reflected continued momentum, with the highest number of both quarterly new patient starts and new cases initiated since we launched the product in January 2022.
Speaker Change: We saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology.
for Trophin Gel remains on a strong multi-year growth trajectory.
Thank you. Thank you.
Speaker Change: The overall ACTH category returned to growth in 2024 while the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion.
Speaker Change: We expect the strong momentum to continue in 2025 and our new guidance forecast for trophin gel revenues to grow between 34% and 38% to 265 million to 274 million in 2025.
Speaker Change: Chris will talk more about our initiatives to increase awareness of the benefits of ACTH therapy for appropriate patients.
and further drive demand for corticofen gel.
Thank you for watching.
Speaker Change: Our new ophthalmology products, Illuvian and Utique, generated revenues of $27.6 million in the fourth quarter. Our first full quarter of ownership following the acquisition of Alomera.
Speaker Change: Our expanded ophthalmology team also drove significant growth in new patient starts for cotrophin gel in ophthalmology, which doubled in Q4 versus Q3.
Speaker Change: A core strategic rationale for acquiring Alomera was to add assets that are synergistic with protrophin gel and leverage our rare disease infrastructure.
Speaker Change: and proven commercial execution capabilities in order to unlock the potential of Eluvian and Utique as well as accelerate the growth of corticofen, sorry, as well as accelerate the growth of corticofen gel in ophthalmology.
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Speaker Change: We believe there is significant room for both Illuvian and Utique, given the novel, long-acting nature of the products and size of the addressable market.
Speaker Change: We have taken steps and are continuing to execute on initiatives that will enable us to capture these growth initiatives.
Speaker Change: As a part of this expansion we agreed to partner with take rate to upgrade equipment on the existing manufacturing line in Irvine, California and significantly expand capacity through the addition of a second manufacturing line.
Speaker Change: Both the equipment upgrade and capacity expansion initiatives are on track.
Speaker Change: We have also been executing our strategy to transition the manufacturing of Utica to six <unk> in 2025.
Speaker Change: We submitted a prior approval supplement or P. S to the FDA to add new peaks indication of chronic non infectious uveitis affecting the posterior segment of the eye or Niu PFS. So the ILUVIEN label.
Speaker Change: No both ILUVIEN in your key are substantially similar ophthalmic implants with the same active ingredient fusin and I'll ask you Tonight.
Speaker Change: And almost identical strengths with ILUVIEN, having 0.19 milligram loosen alone and Ut, having 0.18 milligrams of <unk>.
Speaker Change: So that alone.
In fact, the clinical trials for both Niu PFS Nvme were run on implants with 0.18 milligrams of <unk>.
Speaker Change: As of Tonight.
Speaker Change: The newer manufacturing process used exclusively for ILUVIEN, resulting a strength of <unk> 109 milligrams per plant.
Speaker Change: Pardon plant.
Speaker Change: We engaged with the FDA prior to the submission in order to understand the regulatory requirements and submit an application aligned with FDA guidance.
Since submission we have been engaged with the agency during the review period and expect action on the PFS in the second quarter.
Speaker Change: Following approval, we plan to transition commercialization efforts for both the <unk> and chronic <unk> indications.
Speaker Change: Indications to a single product ILUVIEN.
Speaker Change: As a reminder, ILUVIEN is already approved and marketed for both DMV.
Speaker Change: <unk> outside the U S, including in seven European countries and the Middle East.
Speaker Change: Operationally.
Speaker Change: Bulk initiatives will significantly enhance supply security for Boe.
Speaker Change: ILUVIEN and Utica.
Speaker Change: Resisting the franchise for a strong multiyear growth trajectory.
Speaker Change: In conjunction with these initiatives.
Speaker Change: And I point have agreed to non renewal of the current supply agreement for <unk> with an effective date of May 31 2025.
Speaker Change: Yeah.
Speaker Change: Moving now to our 2025 guidance for ILUVIEN in Utica.
Speaker Change: Q4, net sales for ILUVIEN, and <unk> was $27 6 million.
Speaker Change: Typical Q4, Q1 impact driven by insurance resets resets and purchasing patterns for products, such as ILUVIEN and Ut causes Q1 to be lower than Q4 by levels that are similar to other products.
Speaker Change: In addition, Q1 2025 for ILUVIEN and Utica will have the added impact of the change in U S market access dynamics. Since early January that has produced access for Medicare patients, which is particularly important for ILUVIEN and <unk> indication.
Speaker Change: We are working with Hcp's, so understand their response to the market access changes and refining our commercial approach accordingly.
Speaker Change: Stepping back to the overall picture.
Speaker Change: There are currently fewer than 5000 patients on therapy for each of the Logan in UTC and we estimate that the addressable patient population for each drug is approximately six to 10 times higher based on epidemiological data.
Speaker Change: So while there are near term topics to walk through we remain confident of the growth prospects for our for our products in both <unk> and PFS.
Speaker Change: As we strengthen the foundation of our ophthalmology business through this transition and market dynamics in 2025, we expect to deliver $97 million to a $103 million in sales for ILUVIEN in your teeth, and we remain enthusiastic about the products long term runway for growth.
Speaker Change: Chris will further detail, our commercial and clinical initiatives that we expect will drive significant quarter on quarter growth through 2025 and beyond.
Speaker Change: Turning now to our generics business.
Speaker Change: We delivered another solid quarter with revenues of $78 6 million, an increase of 9% over the fourth quarter of 2023.
Speaker Change: The performance reflected strength in our base business, coupled with contributions from new product launches.
Speaker Change: We continue to leverage our U S based manufacturing footprint to deliver over 1 billion doses to patients in the U S.
Speaker Change: Our R&D team with highly productive in 2024.
Speaker Change: Bidding multiple new Andas, and securing 17, new product approvals, including two with competitive generic therapy or CGT designation.
Speaker Change: We are proud that we became the number two ranking in CG key approvals in 2024.
Speaker Change: One of these approvals was for calibrate tablets, which we launched in.
Speaker Change: Late December early January into.
Speaker Change: <unk> hundred $68 million branded market with 180 days of exclusivity.
Our ability to be first to market with this important generic products is a testament to the quality of our R&D team.
Speaker Change: We expect another year of low double digit growth for our generics business in 2025 supported by our high performing R&D engine operational excellence and U S based manufacturing footprint.
Speaker Change: Our brands portfolio, which we previously referred to as established brands continues to address patient needs with reliability of supply a unique set of commercial capabilities and opportunistic business development to expand the portfolio.
Speaker Change: Our overall portfolio of businesses is strengthened by this high gross margin lower working capital and strong cash flow generation business.
Speaker Change: During the fourth quarter of 2024 and into the first quarter of 2025, we experienced an increase in demand for some of our brand portfolio as we have pre riyadh equally seen in the past.
Speaker Change: Our new 2025 guidance reflects this increased demand in the first quarter, followed by a return to a more normalized run rate in the second quarter.
Speaker Change: As I reflect on our year of accomplishments and look forward to 2025, I would like to thank our customers suppliers.
Speaker Change: <unk> investors and the entire Eni team for their collaboration and significant contribution in delivering on our company's purpose of.
Speaker Change: Serving patients improving lives.
Speaker Change: I'll now turn the call over to Chris <unk>, our head of rare disease Chris.
Chris: Thank you Nicole and good morning, everyone.
Chris: Our rare disease team drove strong demand for <unk> gel in the fourth quarter.
Chris: We're pleased to see demand growth across all targeted specialties, neurology, rheumatology, nephrology pulmonology and ophthalmology.
Chris: Prescribing momentum continued across both existing and new prescribers and the number of initiated cases in new patient starts reached record levels in the quarter.
Chris: We saw particularly strong growth from our newer therapeutic areas.
Chris: Ophthalmology, the number of new patient starts roughly doubled from the third quarter as our new larger ophthalmology sales team expanded our promotional activities to a broader group of physicians.
Chris: Prescribing for acute gouty arthritis, flares for which courts rofin gel is the only approved ACTH therapy also continues to ramp and now represents approximately 15% of course shelf and jellies.
Chris: Notably serving as a gateway indication for many physicians that are new to ACTH therapy.
Chris: Approximately 15% of healthcare professionals prescribing <unk> gel for the first time, our gout patient as their first patient on therapy.
Chris: We expect the God indication for me a key growth driver for quartz rofin gel in 2025.
Chris: As Vicki mentioned, we believe quite self NGL is on a strong multi year growth trajectory.
Chris: The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 based on the reported sales for <unk> gel and the guidance given for the other ACTH product by our competitor.
Chris: We believe the growing recognition of cortisol. Thank Joe is a safe and effective treatment option for appropriate patients as reflected by the recent growth dynamics for the overall ACTH category.
Chris: While the market is growing ACTH prescribing is still well below historical levels based on our analysis of claims data. We believe the number of patients on ACTH therapy now has approximately half the level of patients on therapy. When the category previously peaked in 2017.
Chris: Treatment of flares in exacerbations continues to be a significant unmet need for autoimmune disorders and inflammatory diseases. We've.
Chris: We believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago.
Chris: Our belief is anchored in the prevalence of and need for alternative treatment options for the autoimmune disorders that cultural fit is indicated for.
Chris: It's worth noting that approximately 40% of core children's health prescribers are new to the ACTH category, which illustrates the need for our therapy in certain patients and our ability to expand the market are.
Chris: Our messaging has resonated with physicians, who see patients with severe autoimmune disorders, who need alternative therapies for continued flares and exacerbations.
Chris: We've also taken important steps to strengthen and grow the court surfing gel franchise over the last several quarters.
Chris: We launched a dedicated sales teams in Pulmonology and ophthalmology and with the <unk> acquisition. We now have a much larger ophthalmology sales team is already driving greater prescribing in this important therapeutic area.
Chris: We've also seen continued strong growth in our initially targeted therapeutic areas of rheumatology neurology and nephrology.
Chris: Given our view on the unmet need in these areas and the utility of ACTH therapy. We recently increased the size of our sales team to help expand our promotional efforts to additional physicians.
Chris: The largest sales team has already contributed to growing the number of courts roofing gel prescribers in the first quarter.
Chris: And the number of new cases initiated reached a new monthly all time high in February despite the quarter tending to be seasonally low for quartz rofin gel and other rare disease therapies due to insurance resets and market dynamics.
Chris: We're also investing in initiatives to improve patient and physician convenience, we have a pre filled syringe under FDA review that we expect to launch in the second quarter of 2025.
Chris: The pre filled syringe will provide benefits to patients and physicians by reducing the steps needed for self administration.
Chris: We're excited about the potential of this new presentation and look forward to making the Cortez Hills NGL Prefilled syringe available in the second quarter as we can see.
Chris: We need to advance our rare disease portfolio.
Chris: We're also exploring other ideas to enhance convenience for patients starting on <unk> gel and the health care providers, who treat them and we look forward to sharing more details on these initiatives in the future.
Chris: Overall, we believe in and are committed to investing in our core children's health franchise, and continuing to deliver strong multiyear growth for the product.
Chris: Turning now to our new ophthalmology products ILUVIEN in your cake.
Chris: As a reminder, ILUVIEN and you take our both novel long acting inter vitriol implants in the U S. ILUVIEN is used to treat diabetic macular edema or <unk>, the leading cause of vision loss in diabetic patients and you seek is used to treat chronic non infectious uveitis affecting the posterior segment of the eye.
Chris: Niu PFS.
Chris: ILUVIEN and you take our the only long term durable therapies available that can reduce disease recurrence through extended disease control for up to three years.
Speaker Change: We believe there is significant room for growth for both products as.
Speaker Change: As we move through 2025, we expect to increasingly deploy the same commercial acumen with ILUVIEN and you keep that has driven our success with <unk> in jail.
Speaker Change: In sales, we are fully transitioned to the new larger footprint of 46 territories and key customer Handoffs are now complete.
Speaker Change: We also are beginning to see meaningful increase in call activity, which we expect to drive performance in both ILUVIEN and you keep throughout the remainder of 2025 and.
Speaker Change: In marketing, we are making significant investments in increasing peer to peer education as well as conference in Congress engagements.
Speaker Change: They're amplifying awareness of Ani's commitment to the ophthalmology space. Additionally.
Speaker Change: Additionally, in the coming weeks, we are launching new and enhanced the marketing materials informed by a significant investment and market research to help physicians better identify appropriate patients for a long acting in plants.
Speaker Change: We've continued to make progress on our clinical trials new day in synchronicity.
Speaker Change: New day is investigating the use of ILUVIEN in combination with the current standard of care anti suggests for the treatment of DNA <unk>.
Speaker Change: Today is fully enrolled with 306 patients at approximately 42 sites. The last patient last visit occurred in early January and we expect topline results in the second quarter of this year.
Speaker Change: Hey, Chronicity is designed to provide retina and uveitis specialists with a broader sense of the utility of your teeth across a variety of patients with chronic <unk>.
Speaker Change: Cynical trial has enrolled 110 patients and approximately 25 sites around the U S. We expect preliminary topline results also in the second quarter of this year.
Speaker Change: Looking across our overall rare disease business. We are pleased with the continued strong performance of quartz rofin gel. Furthermore, we remain excited about the long term growth runway for ILUVIEN in Utah, and we are laser focused on optimizing our commercial strategy and increasing supply security for these products.
Speaker Change: Our new ophthalmology sales team has been promoting all three products since mid October and we expect the team to drive greater awareness of the products and the patients that can benefit from treatment.
Speaker Change: For 2025, we expect our rare disease business, which includes CT soften gel ILUVIEN and you'd see the largest growth driver.
That I will turn the call over to Steve for the financial update Steve.
Steve: Thanks, Chris.
Steve: And good morning to everyone on the call.
Steve: I'll review, our fourth quarter results.
Steve: Then discuss our 2025 guidance in detail.
Steve: Eni generated fourth quarter revenues of $196 million up 45% over the prior year period.
Steve: Beginning with this reporting period, we have redefined our reporting segments.
Steve: We continue to have two segments. However, they are now defined as a rare disease and brands and generics than other.
Steve: This change reflects how we analyze the business post the <unk> acquisition.
Steve: The new segment presentation can be found in our earnings release, MD&A and our Form 10-K, and the footnotes to our financial statements filed this morning.
Steve: Prior period disclosures have been recast to be consistent with the go forward presentation.
Steve: Okay.
Steve: Revenues from rare disease, and brands were $106 9 million in the fourth quarter up 97% from the prior year period as reported and 24% on an organic basis driven by gains in both rare disease and brands.
Steve: Rare disease revenues more than doubled to $87 million.
Steve: Revenues from core Trophy Zelle were $59 4 million up 42% from the prior year period, driven primarily by increased volume and a record number of new patient starts.
Steve: Revenues from our new ophthalmology products ILUVIEN in Utica were $27 6 million.
Steve: As a reminder, we completed the acquisition of the Almere on September 16th and therefore, the fourth quarter represents our first full quarter of owning these assets.
Steve: Yeah.
Steve: Revenue for brands were $19 8 million in the quarter, an increase of 59% over the prior year period.
Steve: <unk> benefited from higher demand related to changes in market dynamics for certain products similar to what this portfolio has experienced in the past.
Steve: Yes.
Steve: Revenues for our generics and other segment were $83 7 million, an increase of 8% over the prior year period, driven by increased volumes and contributions from new product launches in 2024.
Steve: In the full year impact of products launched in 2023.
Steve: Yeah.
Steve: Now to move down the P&L.
Steve: As a reminder, when I speak to our operating expenses for the purposes of this earnings call I will be referring to our non-GAAP expenses, which are detailed on table three of our press release.
Steve: Generally our non-GAAP operating expense expenses exclude depreciation and amortization.
Steve: Stock based compensation and certain costs related to litigation and M&A activity.
Steve: Please refer to table three for a reconciliation to our GAAP expenditures.
Steve: Yeah.
Steve: non-GAAP cost of sales, excluding depreciation and amortization increased 31% compared to the prior year period to $69 5 million in the fourth quarter of 2020 for.
Steve: Primarily due to net growth in sales volumes of pharmaceutical products.
Steve: Significant growth of <unk>.
Steve: Royalty bearing products.
Steve: And a full quarter of ILUVIEN and Utica sales.
Steve: non-GAAP gross margin was 63, 5% an increase of approximately three nine percentage points from the prior year period.
Steve: Primarily driven by favorable product mix due to higher revenues from core Trophy, Magellan brands and a full quarter of ILUVIEN and <unk> sales.
Steve: non-GAAP research and development expenses increased 68% to $16 2 million in the fourth quarter due to the inclusion of costs related to the new day in synchronicity clinical trials.
Steve: Element of the core Trofim gel pre filled syringe and ongoing investments in generic R&D programs.
non-GAAP selling general and administrative expenses increased 42% to $54 8 million in the fourth quarter driven by a full quarter of spend for our new larger ophthalmology sales force promoting core trofim gel ILUVIEN in Utica.
Steve: <unk> investment in rare disease sales and marketing activities.
Steve: Increased employment related cost, including incentive based compensation tied to our record financial performance in 2024, and an overall increase in activity is required to support the ongoing growth of our business.
Steve: Yeah.
Steve: Adjusted non-GAAP diluted earnings per share was $1 63 for the quarter compared to $1 per share in the prior year period.
Steve: Adjusted non-GAAP EBITDA for the fourth quarter was 50 billion compared to $30 2 million in the prior year period.
Steve: Yeah.
Steve: We ended the quarter with $494 3 million of debt debt.
Steve: Comprised of $144 9 million in the unrestricted cash and $639 2 million in principal value of outstanding debt inclusive of our senior convertible notes and our term loan.
Steve: Utilizing the midpoint of our revised 2025, adjusted non-GAAP EBITDA guidance at the end of the fourth quarter. Our net leverage is approximately 2.25 times on a forward basis.
Steve: Turning to our 2025 financial guidance as Nicole previewed we are raising our guidance for total revenue and adjusted non-GAAP EBITDA from the preliminary targets that we announced on January 13th based on recent strong trends for coach Rofin gel.
Steve: The continued evolution of our generics business and higher first quarter demand for our brands portfolio.
Steve: We now expect total revenue of 756 million to $776 million, which represents growth of 23% to 26% over 2024.
For core Trofim gel, we expect revenue of 265 million to 274 million representing growth of 34% to 38%.
Steve: We anticipate continued adoption of poor trofim gel in the therapeutic areas of rheumatology neurology and nephrology helped in part by our expanded commercial team.
Steve: And strong growth in ophthalmology as well as for the <unk> indication.
Steve: We also expect continued growth for the overall ACTH market in 2025.
Steve: As you consider the quarterly progression for core Trofim gel.
Steve: Note that the general pattern of revenue in 2025 is expected to be similar to that reported in 2024 with a quarter over quarter decline in the first quarter due to prescription re authorizations.
Steve: Followed by strong sequential growth in the second quarter.
Steve: This pattern is generally consistent with other rare disease drugs.
Speaker Change: We expect combined ILUVIEN in Utica net revenues of $97 million to $103 million, which reflects the impact of the first quarter dynamics outlined by Nick Killen, Chris early in the call.
Speaker Change: As well as the commercial and operational transitions they discussed.
Speaker Change: First quarter net revenues of ILUVIEN in Utica are expected to be impacted both by both the typical Q4 to Q1 drop.
Speaker Change: In rare disease products as well as the added impact of the change in U S market access dynamics since early January.
Speaker Change: We expect this franchise to return to sequential growth in the second quarter of 2025.
Speaker Change: Yeah.
Speaker Change: For generics, we anticipate low double digit revenue growth driven by strength in our base business and contribution from new launches, including the full launch of propel a pride in early January with 180 days exclusivity.
Speaker Change: For brands, we saw increased demand in the fourth quarter for certain products as we have periodically experienced over the past two years.
Speaker Change: This increased demand has persisted in the first two months of 2025.
Speaker Change: Our guidance assumes that this increased demand does not persist beyond the first quarter and thus we assume normalized performance in quarters two through four.
Moving down the P&L.
Speaker Change: We expect total company non-GAAP gross margin to be between 63%, 64%, which reflects modest growth relative to 2024, driven primarily by higher sales for our rare disease franchise.
Speaker Change: We expect adjusted non-GAAP operating expenses of 293 million to $302 million, which reflect sales and marketing investments to drive greater disease growth and a full year of SG&A and R&D associated with ILUVIEN in Utica.
Speaker Change: Taking all of these factors into account, we expect 2025, adjusted non-GAAP EBITDA of 190 million to 200 million, which reflects 22% to 28% growth over 2024.
Speaker Change: And adjusted non-GAAP earnings per share between $6.12 and $6 49.
Speaker Change: We currently.
Speaker Change: We expect our U S GAAP effective tax rate to be approximately 25%.
Speaker Change: And consistent with the prior year, we will tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26%.
Speaker Change: That's the item being adjusted is non tax deductible in whole or part.
Speaker Change: We anticipate between $21 million and 24 million shares outstanding for purpose of calculating diluted EPS.
Speaker Change: With that I will.
Nick Killen: Turn the call back to Nick here.
Thank you Steve.
Speaker Change: We will open it up for questions. So operator could you please help us with the questions.
Speaker Change: Certainly Mr. Lou wanted ladies and gentlemen at this time, if you would like to ask a question. Please press star one just a reminder, if you find your question has been addressed you may remove yourself from the queue by pressing star to once again star one for questions well go first this morning to David M sell them at Piper Sandler.
David M: Thanks, So just got a couple first.
David M: On business development, and M&A, and obviously you've built out.
David M: The rare disease business and brand business. Overall can you just talk about your deal capacity right now and how high would you take our pro forma net leverage up to the.
David M: Execute on a deal and then also how are you thinking about.
David M: The sizing of the brand business or maybe the mix over time, I mean, right now it's sort of you know it.
David M: It has been kind of mirror.
David M: 60, 40, 50, 50 brands generics, but ultimately where you're looking to take the company longer term in terms of its terms of the brand's presence. So so that's number one and then secondly on <unk> just wanted to drill down a little more deeply on.
David M: The.
David M: The mix here how much of gout is in the mix you cited that as a higher growth opportunity I'm. Just wondering how we should think about that particular opportunity.
David M: And how much it could drive the business in 'twenty five and beyond thanks.
David M: Yeah.
David M.: Hey, good morning, David and thank you for your questions.
David M: Sure.
David M: First question on BD and M&A.
David M:
David M: As we assess shared before in.
David M: Terms of the areas, but focus our BD M&A as far as so on rare disease.
David M: Then your second part of the question was what is the deal capacity and where are we willing to take pro forma leverage so.
Speaker Change: Okay. If you look at Eni's history, and as we built the company in two acquisitions.
Speaker Change: As well as launched our lead rare disease product.
Speaker Change: You will see that.
Speaker Change: This management team is there any talks are all about.
Speaker Change: The leverage ratio in the net leverage ratio and what we're willing to extend that to and historically it has.
Speaker Change: It has always been kept under three.
Speaker Change: Some points for short periods of time, such as during the launch of controlled Senate went.
Speaker Change: Slightly above, but then quickly de lever.
And as you look at you know.
Speaker Change: How we did.
Speaker Change: The <unk> acquisition and refinancing of the loan and putting in place a more efficient capital structure.
Speaker Change: I think that it's our intent and we believe it gives us the ability to pursue additional BD and M&A.
Speaker Change: While not straining the balance sheet. So that's how I would answer the question on <unk>.
Speaker Change: BD M&A your second question on.
Speaker Change: Where are we taking this company.
Speaker Change: Eni has.
Speaker Change: We are very strong as a strong portfolio of businesses.
Speaker Change: Both the rare disease business as well as the generics business are all growing.
Speaker Change: And the brands business.
Speaker Change: What we used to refer to as established brands plays a role in terms of being high margin strong.
Speaker Change: Cash flow generation and low working capital.
Speaker Change: But in terms of a focus area and capital allocation rare disease will be the primary driver of growth in the area in which we will continue to build right.
Speaker Change: Through BD through M&A, we will invest in.
Speaker Change: In R&D to fuel high single digit low double digit growth for the generics business.
Speaker Change: If you look over a period of time and just natural evolution central gravity.
Speaker Change: We'll shift with greater percentage coming from rare disease and brands.
Speaker Change: That's point number two and then the third question on on <unk> I think just two data points to share 15% of the volume of course rofin, partly is coming from <unk> and then as Chris talked about.
Speaker Change:
Speaker Change: Is ending up being a.
Speaker Change: Gateway in some ways with 15% of prescribers.
Speaker Change: Writing their first there were naive to ACTH, writing their first prescription in gout and then moving onto <unk>.
Speaker Change: Consider it for for other types of patients.
Thank you David.
Speaker Change: Thank you.
Speaker Change: Thank you. We'll go next now to mail <unk> at Guggenheim Securities.
Speaker Change: Great. Thanks for taking my questions. So a.
Speaker Change: Couple of that I have one just on the comments around the on their assets.
Speaker Change: Access issues since January.
Speaker Change: Maybe can just provide a little more incentive kind of all that.
Speaker Change: I guess your plans are there in terms of what we should look for in terms of time to resolution.
Speaker Change: The guidance this year suggests.
Speaker Change: The $100 million or so in the midpoint is not only much year over year growth from where you left in the fourth quarter. So how should we think about.
Speaker Change: The longer term impact of this access issue and.
Speaker Change: Year over year growth, maybe look into 2020 six 'twenty seven for example, and then the other question more on consultants you talked a lot about the seasonality obviously with the element of assets.
Speaker Change: For <unk>, how should we think about that.
Speaker Change: Given it sounds like.
Speaker Change: The growth has been very good and it looks like your initial trends are good for the year, if you're raising your guidance partially based on that so should we think about any sort of seasonality impact in on Q.
Speaker Change: Maybe you can just comment on sort of.
Speaker Change: How should we think about quarter over quarter growth for that franchise as well. Thanks.
Speaker Change: Yes, good morning, and thank you for your question first.
Speaker Change: First question on the.
Speaker Change: ILUVIEN Utica.
Speaker Change: Access issues.
Speaker Change: In the past Ah patients with Medicare and Medicare advantage plans that access to programs that assisted with offsetting the cost of that.
Speaker Change: Patient responsibility based on financial need and some of these programs have not received adequate funding yet in 2025.
Speaker Change: In terms of what Eni is doing about it first and foremost Eni has in place a patient assistance program that provides access for patients in financial need with three ILUVIEN in Utica as needed.
Speaker Change: And then secondly, we are spending time with our Hcp's, who understand their response to these market access changes and refining our commercial approach accordingly.
Speaker Change: And you asked a great question about what's the outlook and as we.
Speaker Change:
Speaker Change: Talked about there are currently in stepping back looking at the overall picture. There are currently fewer than 5000 patients on therapy for each of ILUVIEN and boutique and we estimate that the addressable patient population for each drug is approximately six to 10 times higher based on epidemiological data. So while this is.
Speaker Change: And near term topic to work through we remain confident of the growth prospects for our products in both <unk> and PFS.
Speaker Change: The second question was around seasonality and BCG.
Speaker Change: You will see typical.
Speaker Change: Q4 to Q1.
Speaker Change: Dynamic in <unk> also a cyclical for all rare disease drugs, driven by purchasing patterns as well as insurance resets, where we do have is that.
As we shared in February right, we've had the highest number of new cases to initiate it right. So we built momentum early and is one of the reasons why we raised our guidance that we had shared.
Speaker Change: A few weeks ago.
Speaker Change: And.
Speaker Change: You will see a drop but.
And then there will be sequential growth building on building on from there just again typical Q4 to Q1 type type.
Speaker Change: Dynamic core in terms of sales for.
Speaker Change: BCG.
Speaker Change: Thank you Amit.
Okay. Thank you.
Speaker Change: Thank you well go next now to Gary Nachman at Raymond James.
Gary Nachman: Hey, Thanks, and good morning, So yes back to ILUVIEN in U T. Can also trying to better understand the guidance of the 97 to 103 million given a lot of different moving parts that you have that you're working through in the near term. So are you anticipating any issue.
Gary Nachman: You sort of hiccups as you transition supply from I point to Cig freight is that factored in there at all.
Gary Nachman: And then I guess, how much do you think adding the uveitis indication for you'd seek will help.
Gary Nachman: Also with those additional datasets coming how much could dose helped and how soon do you think this could benefit the overall franchise and then I have one for Chris you often.
Gary Nachman: Got it.
Gary Nachman: Thank you Gary Thank you for your question.
Speaker Change: Yes. Your first question is on the guidance and you know as we've talked about that there are.
Several.
Speaker Change: Commercial clinical and operational initiatives that will drive b.
Speaker Change: Significant quarter on quarter ramp for the rest of 2025 and beyond.
Speaker Change: As we walk through the the access issues that we're seeing in early January as well as the transitions.
Speaker Change: <unk>.
Speaker Change: Commercially as you would expect with an acquisition integration like this we've made positive changes to Chris spoke a little bit about this and strengthened the peer to peer education programs for further increasing awareness of ILUVIEN, Utica and amplifying Eni commitment to ophthalmology.
Speaker Change: And retina.
Speaker Change: Marketing materials to help physicians identify appropriate patients and also continuing to refine our approach to selling three products across the U S. And then the international markets, we're investing in high ROI activities, such as expansion of the team in Germany, and providing increased support for our partner products.
Speaker Change: Asked about new day.
Speaker Change: So on the clinical front, we have continued to push forward with our key programs New day in Synchronicity, and we're pleased that both programs hold readout preliminary topline data in the second quarter of 2025, if the new day results are positive it could significantly expand the use of ILUVIEN earlier in the <unk> patient journey.
Speaker Change: And we have in place a robust plan for publishing in awareness building of the clinical results amongst the retina community who are eagerly awaiting those results.
Speaker Change: <unk> said that.
Speaker Change: We've been measured in our full year guidance and not presumed a tailwind from new day results in our 2025 guidance.
Speaker Change: And then I'll just come back to the earlier question. You also asked about the label combination and how that'll work commercially.
Speaker Change: I'll look to I think a couple of things first is I point is committed to working with us to support the transition and ensure patients.
Speaker Change: Sure continued supply security.
Speaker Change: That's from a supply perspective, and transition and obviously, we submitted the P. S. A while ago. We knew this transition was coming so we are building up ILUVIEN.
Speaker Change: Inventory to do that and we talked a lot about six freedom the capacity expansion there.
Speaker Change: I'm a commercial perspective.
Speaker Change: We will drive fast and broad awareness of the label consolidation during.
Speaker Change: During the you can label you've taken ILUVIEN transition period, we'll introduce the new consolidated label Wild gradually transitioning counts from Utica.
Speaker Change: To ILUVIEN for Niu PFS.
Speaker Change: And we will do this through the T L team marketing initiatives and distribute our communication to the accounts.
Speaker Change: And we will deliver succeed so think messaging on value add to customers on the retina community. When you look when you merge these when you add the uveitis label to ILUVIEN.
Speaker Change: You consolidate to one injector.
Speaker Change: Which is the only real difference between the two implants.
Speaker Change: And it also simplifies the ordering and processes for the office, so theres value out to the customers, which we will reinforce.
Speaker Change: Your next question was on Europe.
Speaker Change: You also had a question around the datasets, a new day and hopefully I answer that.
Speaker Change: Talking about the guidance and what's factored in and what's not factored in.
Speaker Change: Thank you Gary yes.
Speaker Change: Yeah, No that's great and then I just had a follow up on core Trofim I mean, you're seeing a nice benefit in ophthalmology and acceleration in gout.
Speaker Change: Just maybe just talk about how much did you add to the sales force.
Speaker Change: Across what indications and how you evaluate that ROI.
Speaker Change: If you think the market should really grow that much.
Speaker Change: At what point, you could add to that even further thank you.
Speaker Change: Yes. Thank you. Thank you for that question guys. So.
Speaker Change: The the increase in the quarter Olson Salesforce, we've added about 15% to 20 ish.
Speaker Change: Between reps and.
Speaker Change: Business Directors these are.
Speaker Change: Largely focused on the core.
Speaker Change: Core indications that we initially launched with.
Speaker Change: Rheumatology and nephrology and neurology.
Speaker Change: And.
Speaker Change: In terms of ROI I think as we've grown this product from over three years from zero to $200 million driven.
Speaker Change: Driven growth across both specialties, we targeted at launch as well as the witches, rheumatology neurology and nephrology as well as the north specialties off.
Speaker Change: Pulmonology and ophthalmology.
Speaker Change: We've developed and under Chris's leadership developed a good understanding of.
Speaker Change: Oh, how to drive sort of high R y.
Speaker Change: Commercial investments right leveraging the rare disease infrastructure that we also have in place.
Speaker Change: And also an understanding of the type of.
Speaker Change:
Speaker Change: Sales profile.
Speaker Change: He has been out with a product like <unk>.
Speaker Change: All of those come together and help us to continue.
Speaker Change: Sort of.
Speaker Change: Driving growth now having said that there's a number of other things that we're also doing too.
Speaker Change: To support the growth of this franchise right in.
Speaker Change: Where.
Speaker Change: Investing in R&D projects span for improving patient and physician convenience will share updates on these projects as we progress time, we've obviously, you're talking about the resource syringe and launching that in.
Speaker Change: Getting approval for that and launching that in the second quarter.
Speaker Change: We're investing in research to provide additional support for the use of <unk>.
Speaker Change: And then obviously, what we already talked about which is the high ROI commercial spend such as expansion of our port Rofin sales team to drive the growth of the core specialty is targeted at launch.
Speaker Change: Thank you again.
Speaker Change: Great. Thanks Heiko.
Speaker Change: Thank you. We'll go next now to five locker sheet at Leerink partners.
Speaker Change: Hey, good morning, guys. Thanks for taking me on the call sort of ask you spoke a little bit about their reimbursement changes with Medicare can you talk a little bit more about that and the impact is that just the kind of Medicare part D redesign and how does that affect the product and then are there other kind of product specific kind of factors that play with regard to.
Speaker Change: <unk> that we should be considering.
Speaker Change: Yes, good morning, Faisel and thank you for your question.
Speaker Change: This is not a redesign.
Speaker Change: What it is and as patients with Medicare and Medicare advantage plans that had access to programs that are associated with the offsetting the cost of the patient responsibility or the co pay based on financial need and these some of these programs have not received adequate funding yet in 2025.
Speaker Change: Al.
Speaker Change: <unk>.
Speaker Change: Yes.
Speaker Change: In terms of what we're doing about this Medicare book.
Speaker Change: The number of patients.
Speaker Change: The addressable market.
Speaker Change: Six two times 10 times higher than what is being treated right now right less than 5000 patients.
Speaker Change: As we've discussed with you on either ILUVIEN or or you cheat and so the addressable market is much much higher.
Speaker Change: And so while we're working through this in the short term.
Speaker Change: I understand you know how.
Speaker Change: Prescribers are thinking about this too.
But while this is a near term issue to work through we remain confident of the growth prospects for our products at both <unk> and <unk>.
Speaker Change: Got it and is this dynamic specific to when you take or is this impact Curt rofin as well.
Speaker Change: And all this does not impact quarter often.
Speaker Change: Because it's a.
Speaker Change: It's for part B and then the part B.
Speaker Change: As you know has some.
Speaker Change: Some of the positive tailwind.
Speaker Change: Tailwind from IR, a changes such as you know.
Speaker Change: Maximizing the co pay that $2000 and then allowing for smoothing. So that's.
Speaker Change: Those changes arent are impacting the part b of Medicare.
Speaker Change: However, this was Q2.
Speaker Change: Question.
Speaker Change: These programs provide assist with the cost setting the cost of patient responsibilities also for other products not just of ILUVIEN in Eugene.
Speaker Change: Yeah.
Speaker Change: Got it that's helpful. Thanks.
Speaker Change: Thanks accessory.
Speaker Change: Thank you we'll go next now to or Loopnet at H C. Wainwright.
Speaker Change: Thanks, I apologize in advance I have a really bad cough now so you might have to use the mute button, if I drop off.
Speaker Change: I wanted to talk about you've taken Olivia together.
Speaker Change: I'm just a little confused so hopefully you can help me understand this transition you mentioned transitioning you take rate is actually the state grid, which we had expected but also planning to start promoting the products. So I'm just trying to understand is this just supporting it at all.
Speaker Change: Ongoing supply as you transition or do you intend to continue long term manufacturing you take at Siegfried.
Speaker Change: Also.
Speaker Change: How close are you threading the needle regarding this.
Speaker Change: Supply agreement and with high points, and then this new indication and switch.
Sorry third part a few if I may.
Speaker Change: How disruptive could this be in terms of training and technique is there any difference is new.
Speaker Change: Applicators and new training required and do these have different costs or access, which maybe would cause some insurance transition.
Speaker Change: Happened as well.
Speaker Change: Just a follow up.
Speaker Change: Got it.
Speaker Change: Good morning, and thank you for your question and thank you for joining despite being under the weather.
Speaker Change: So I think the first question was on the.
Speaker Change: The transfer of manufacturing to succeed.
Speaker Change: Way, we are transferring the manufacturing to succeed is by adding the label.
Speaker Change: The indication of uveitis.
Speaker Change: Chronic non infectious uveitis affecting posterior segment of the eye to the ILUVIEN table.
Speaker Change: That is possible because these these two products are.
Speaker Change: Extremely similar in fact as I mentioned.
Speaker Change: Clinical trials were both one on the one eight milligram of <unk>. So the only real difference between the two is that ILUVIEN has a.
Speaker Change: Newer manufacturing process that.
Speaker Change: Has a slightly different strengths. So essentially that we will have one product which was ILUVIEN.
Speaker Change: That ILUVIEN product will have both indications on the label diabetic macular edema as well as chronic non infectious uveitis affecting posterior segment of the eye.
Speaker Change: <unk> already manufacturers ILUVIEN, and we will continue manufacturing ILUVIEN.
Speaker Change: Anticipating.
Speaker Change: This potential label consolidations.
Speaker Change: We extended the six freed Manny.
Speaker Change: Manufacturing agreement by five years to 2029.
Speaker Change: Upgrading the equipment on the existing manufacturing line as well as our adding a second manufacturing line and all of those initiatives are on track.
Speaker Change: We've known that this label consolidation is coming that's what we've been building up ILUVIEN inventory right to.
Speaker Change: Due to allow for the transition.
Speaker Change: As I said to you I point is.
Speaker Change: Committed to continue to work with us to ensure supply continuity.
Speaker Change: For patients right and worked with us through these changes.
Speaker Change: Having said that the agreement with them we've agreed for both I point and Eni have agreed for non renewal.
Speaker Change: Starting may 31 2025.
Speaker Change: We've talked through the.
Speaker Change: The inventory transition and have been preparing for it.
Speaker Change: And regarding the timing also right look we've engaged with the FDA, we knew exactly what they wanted to support the indication addition.
Speaker Change: Even before we submitted the.
Speaker Change: The PFS and then we've been having ongoing dialogue with them.
Speaker Change: Sure.
Speaker Change: That.
Speaker Change: Two we understand what they are asking for and look you know you can read the tea leaves them.
Speaker Change: <unk> been satisfactory asked answering the questions that <unk> been asking on the label. So that's why.
Speaker Change: Q2, we expect approval of this P S.
Speaker Change: And we will transition.
Speaker Change: You know from.
Speaker Change: From Utica.
Speaker Change: From selling both Utica and ILUVIEN to only selling ILUVIEN.
Speaker Change: And then Youll start up question was on physicians and what they actually use them. The fact that there are two implants.
Speaker Change: Look we believe.
Speaker Change: That there is significant value add to customers and simplicity, because theres consolidation to one injector.
Speaker Change: And our community and for the officers.
We'll buy and build this.
Speaker Change: We can simplify the ordering and processes. They don't have to excuse to maintain that can only maintain one. So we think that this is actually a value add to our customers and the retinal community.
Laura: Thank you Laura.
Laura: Okay, and just so I can get some clarity on that last point aside from the simplicity of having one product instead of two.
Laura: Is the procedure.
Laura: Aim for each relative indication.
Across different.
Laura: And I guess injectors is there any reason.
Laura: Patient with doctors, who are already using your cheek now for Niu switching to ILUVIEN has to do anything differently.
Laura: And not in any material. We're in there is slight difference, but nothing material and lot of the retina physicians.
Laura: Have.
Speaker Change: Uh huh.
Laura: Uh huh.
Speaker Change: The ability to use different kind of im sorry. This is not the only.
Laura: They do use different kinds of inserts.
Speaker Change: Sure.
Speaker Change: Our products so the ability to and these are substantially similar to.
Speaker Change: So the ability to sort of.
Speaker Change: Learned a slight tweak or change we don't think that that's material and obviously look again.
Speaker Change: To be clear Aloe Vera contemplated this even well before our acquisition if Eni had never acquired Altamira.
Speaker Change: This is exactly what they would have done and they obviously.
Speaker Change: We've just picked up from where they left off.
Speaker Change: In terms of.
Speaker Change: Merchant the consolidation of the two labels yep.
Speaker Change: And again to clarify is the insurance coverage and cost.
Speaker Change: <unk> alright identical for these products so the transition shouldnt be destructive on that front or in theory could there even be tailwind.
Speaker Change: With pricing differences.
Speaker Change: And the pricing is.
Speaker Change: Reasonably close for both the listed price and we do not foresee.
Speaker Change: Market access to be to cause any issues for me.
Speaker Change: Coverage perspective.
Speaker Change: Yes.
Speaker Change: Okay, and lastly, I appreciate all the time on quite profane how important is that one milliliter pre filled syringe launch assuming it's approved.
Speaker Change: Sure.
Speaker Change: <unk> similar self JAK trials, because achieved since launch and assuming some new uptake or switching from the five milliliter vial to your pre filled syringe would there be any material impact on average net selling price per patient potentially.
Speaker Change: Yeah. Thank you for your question look.
Speaker Change: We are introducing the pre fill syringe to enhance physician and patient convenience.
Speaker Change:
Speaker Change: So the five ml vial is a.
Speaker Change: Requires a multi step.
Speaker Change: Administration.
Speaker Change: And so what the Prefilled syringe.
Speaker Change: Reduce one step in the administration process for the patients and so that's helpful to them and so there is a subset of patients that have.
Speaker Change: For whom it is helpful to have one less staff and the administration process and.
Speaker Change: And that's that.
Speaker Change: The presentation that we're bringing to the market.
Speaker Change: We believe that this will continue as we have done with the one ml vial.
Speaker Change: <unk> got arthritis first we're focused on acute gouty arthritis letters.
Speaker Change: We believe that this will continue to.
Speaker Change: <unk> offer new presentations and options for different segments of patients and will drive overall growth of the ACTH market.
And that's how we see the launch of the approval and launch of the pre filled syringe and as we said that we're continuing to look into other explore other ideas.
Speaker Change: For improving patient and because it.
Speaker Change: Convenience and we'll look forward to sharing updates on these projects as we progress.
Speaker Change: Alright, thanks, so much.
Oren: Thank you Oren I hope you feel better.
Speaker Change: Thank you well go next now to less <unk> at <unk> Securities.
Julian: Good morning. Thank you for taking my questions. This is Julian on for less.
Julian: Are there any developments that could potentially disrupt a quick trophy market given its growth and.
Julian: Do you see potential for synthetic versions or other pipeline products potentially from overseas competitors.
Thank you.
Speaker Change: Yeah, no. Thank you Julian and good morning.
Julian: Yes.
Julian: The ACTH market has returned to growth.
Julian: The.
Speaker Change: Could you add or if you take our actuals and add the competitors' guidance today.
Speaker Change: Last reported in November.
Speaker Change: This market is seeing north of <unk>.
Speaker Change: Round, 25% growth to $660 million.
Speaker Change: And you know.
Speaker Change: You hear their rhetoric, and what we're saying and essentially we're all talking about were both talking about increasing awareness.
Speaker Change: Off the ACTH Cherokee.
Speaker Change: For the appropriate patients.
Speaker Change: And then the data point that we shared which is when you look at number of patients on therapy today.
Speaker Change: It's about half.
Speaker Change: The number of patients on therapy that were at the peak and from an epidemiological perspective were much lower than the addressable than what the addressable market was right. So the again the opportunity is very substantial.
Speaker Change: And.
Speaker Change: I think.
Speaker Change: Data point, a new data point that we shared for the first time today is that.
Speaker Change: Almost 40% of our prescribers.
Speaker Change: Our hcp's that were naive to ACTH.
Speaker Change: So our ability to get to you know when you talk about the epidemiological.
Speaker Change: Our addressable market and our ability to get through newer physicians.
Speaker Change: And to reach the appropriate patients I think it's proven as we over the last three years.
Speaker Change: So I think that tells you about sort of the why we continue to believe and continue to invest behind the long term multiyear growth trajectory.
Speaker Change: The ACTH market.
Speaker Change: And regarding competition look.
Speaker Change: I would say that for boats.
Speaker Change: For both products are the competitor and ours.
Speaker Change: And we've continued to see this over time that.
Speaker Change: It is.
Speaker Change: It's just tough to bring a.
Speaker Change: A generic or biosimilar to this product.
Speaker Change: That path to generics amortization in both the competitor and us have added.
Speaker Change: IP to strengthen.
Speaker Change: And so obviously, we keep tracking this from a competitive standpoint, we just we do see the outlook.
Speaker Change: For the ACTH category is.
Speaker Change: Is one where it'll be two of the two competitors trying to continue to build awareness and bring this therapy to patients in need.
Speaker Change: Thank you Gina.
Speaker Change: Thank you and just a quick reminder, ladies and gentlemen star one for further questions. This morning, We'll go next now to Glenn Santana Hello with Jefferies.
Speaker Change: Hi, guys. Good morning, Thanks for taking my question.
Speaker Change: Maybe I'll ask just a quick one on the generics business, it's always touched on that.
Speaker Change: Curious I mean, we've seen an uptick in form 40, threes and that's led to certain shortages and I'm just trying to reconcile some of your comments that you made with respect to the outlook for fiscal 'twenty five in terms of assuming continued double digit growth in what I was really hoping.
Speaker Change: That you could do is maybe just sort of unpack that growth algorithm for me.
Speaker Change: Give us a sense for maybe how much of that you expect to come from maybe organic volumes and price versus new product launches maybe fully appreciating. The comments you made on the timing on <unk>.
What's that you just recently launched and how that May impact the first half versus the second half. Thanks.
Yes.
Speaker Change: Thank you Glenn and thank.
Great to have you on our call for the first time, so I appreciate that.
Regarding the generics business.
Speaker Change: Look I think it's a combination of two or three things thats, helping us drive low double digit growth this year.
Speaker Change: First and foremost is the new product launch cadence that we have we launched 17 new products in 2024, we'll obviously see the full year impact of those launches.
Speaker Change: Because we launched them at different points in New York.
Speaker Change: Second is the launches that we will do this year.
Speaker Change: Including Coca Cola Pride, right, which gives us a.
Speaker Change: With 180 days of exclusivity, what you will see us.
Speaker Change: That the generics business sales because of the 180 days of exclusivity, we will see a.
Speaker Change: <unk>.
Speaker Change: Jump in in Q1 and Q2.
Speaker Change: And but so but there are other launches through through the year. So I think it's a combination of the annualized nation of 2017 2024 launches the new launches from 2025 and you balance the erosion that we will see in the.
Speaker Change: What I call the class of 2023 and before.
Speaker Change: Products from.
From additional.
Speaker Change: Additional competition and that's you know I think that's typical.
Speaker Change: <unk> pricing as you are well aware off now to your question.
Speaker Change: All of our growth will largely come from volumes.
Speaker Change: Rather new volumes, either from new product launches or from.
Speaker Change: From taking additional share in products that were already in the market for a market for but there is.
Speaker Change: In the in the guidance that we've shared with low double digit.
Speaker Change: There isn't any.
Speaker Change: Material.
Speaker Change: A positive benefit from.
Speaker Change:
Speaker Change: Warning letters, all 42, you take whatever the any supply related issues that competitors may have.
Speaker Change: Okay. Thanks, a lot.
Glenn: Thank you Glenn Thank you for joining.
Speaker Change: And ladies and gentlemen, it appears we have no further questions. This morning, Mr. <unk> I'll turn things back to you for any closing comments.
Speaker Change: Thank you both 2024 was a record year for our business and we expect to continue building on this momentum in 2025.
Speaker Change: Both core trough, Intel and generics and our ophthalmology franchise are already off to a.
Speaker Change: Good start.
Speaker Change: And our leading us to raise our 2025 outlook I am confident that Eni is well positioned to deliver another year of strong revenue growth and profitability in 2025.
Speaker Change: We look forward to seeing many of you in person next month, the Raymond James Annual Institutional Investor Conference in Orlando, and the Leerink Global Healthcare Conference in Miami Beach.
Speaker Change: Thank you for joining us today.
Speaker Change: Thank you.
Speaker Change: Thank you very much Mr. Leilani again, ladies and gentlemen that will conclude today's Eni pharmaceuticals fourth quarter 2024 earnings results call again, thanks, so much for joining US everyone and we wish you all a great day Goodbye.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yeah.
Yeah.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Mhm.
Speaker Change: Hum.