ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's A&I Pharmaceuticals, Inc., third quarter 2024 earnings results call. Please note that 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 the star and the number one on your telephone keypad. If you would like to withdraw your question, please press star two. It is now my pleasure to turn the conference over to Lisa Wilson. Please go ahead.

Thank you, Todd. Welcome to ANI Pharmaceuticals Q3 2024 Earnings Results Call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lawani, President and Chief Executive Officer, Steve Carey, Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. You can also access the webcast of this call through the investor section of the ANI website at anifarmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to A&I Pharmaceuticals Management as of today and involve risks and uncertainties, including 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. Actual results may differ materially from those projected in the forward-looking statements. ANI 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, anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held or recorded on November 8, 2024. Since then, ANI 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. Nikhil Lalwani Thank you, Lisa.

Good morning, everyone, and thank you for joining us. Today, I'll start by discussing our third quarter performance and highlights. You'll then hear from Chris Mutz, ANI's Head of Rare Disease. After Chris provides additional color on the progress of this segment of our business, including the integration of Almera, Steve will review the quarter and our updated guidance in more detail. Following our remarks, we'll take your questions. It's an exciting time here at ANI, and we're continuing to execute well this year against our purpose of serving patients, improving lives. In addition, our team delivered record performance during the quarter, for our lead rare disease asset, cortofan gel, and our generics business. We also put a new, more efficient and effective capital structure in place and completed the acquisition of Almera on September 16th. As you've heard me outline previously, Almera is highly synergistic to our rare disease business, and we believe our proven commercial execution capabilities can further unlock the potential for alluvion and butique to growing and durable assets, as well as accelerate the growth of cortofan gel in ophthalmology. Integration remains one of our key priority areas, and I'm pleased with our progress to date. In particular, we have a 45-person combined ophthalmology sales force who have been cross-trained and promoting all three products since mid-October. In addition, We have successfully retained talented Almera employees and taken actions to ensure we are on track to capture $10 million of synergies in 2025. The Almera acquisition is transformative for our rare disease business. We expect the transaction to create substantial shareholder value, driving $35 to $38 million in adjusted non-GAAP EBITDA in 2025, inclusive of the approximately $10 million of identified cost synergies and high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS. In addition, we expect our dedicated ophthalmology team to drive additional cortofan revenues in 2025. Turning to our third quarter financial performance, The company posted another strong quarter, with total revenues of $148.3 million, an increase of 13% over the third quarter of 2023, driven by accelerating demand for cortofan gel and continued strong growth for generics. Adjusted non-GAAP EBITDA was $35.1 million, and adjusted non-GAAP EPS was $1.34. Cortofan gel generated $52.6 million in revenues during the quarter, up 77% over the third quarter of 2023. The third quarter represented continued momentum with the highest number of both quarterly new patient starts and unique prescribers since launch in January 2022. We saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology, and are pleased to report that the prescribing momentum has continued in the fourth quarter with a number of monthly new cases initiated reaching a record high in October. Cortofin remains on a strong multi-year growth trajectory as the overall ACTH category has returned to growth and is expected to deliver more than 20% year-over-year growth in 2024. In addition, the number of patients on ACTH therapy today is still substantially lower than a few years ago. Our generics business delivered another strong quarter with revenues of 78.2 million, an increase of 11% over the third quarter of 2023, and 5.4% over the second quarter of 2024. The solid performance reflected strength in our base business, coupled with contribution from new product launches. During the quarter, we launched five new generics, including some into limited competition markets. Our R&D team continues to build momentum with one additional product launched already in Q4 and submission of several new ANDAs in the fourth quarter. Based on our strong third quarter results, the continued momentum across the business, and the addition of Illumine and Utique, we're pleased to raise our full year 2024 guidance, which Steve will discuss later in the call. I'll now turn the call over to Chris Mutz, our head of rare disease, to discuss cortrophin and our new ophthalmology franchise in more detail. Chris?

Thank you, Nikhil. And good morning, everyone. I'm looking forward to telling you a bit more about the exciting things happening in our rare disease business. First, cortrophin. We're pleased with the strong demand trends for cortrophin gel during the third quarter, which included continued momentum in adding new prescribers and robust growth of existing prescribers. Importantly, we saw demand growth across all targeted specialties of neurology, rheumatology, nephrology, pulmonology, and ophthalmology. Our ophthalmology sales team in particular drove significant growth in prescriptions and new patient starts in the third quarter, further reinforcing our confidence in the potential of the expanded team, which is now bolstered by the addition of the former Alamira reps and new reps we hired to complete the 45-person integrated ophthalmology sales force. As Nikhil mentioned, we believe cortofan gel remains on a strong multi-year growth trajectory. And the company has been taking important steps to further strengthen the cortofan gel franchise. Over the past 18 months, we've launched dedicated sales teams in pulmonology and ophthalmology. And with the Alamira acquisition, we now have an expanded sales team in ophthalmology. Moving now to our efforts toward improving patient and physician experience and convenience, We are pleased to announce that we've completed the development of a pre-filled syringe offering for cortofen gel and submitted a supplemental NDA for FDA approval in late October. We believe the pre-filled syringe will provide further benefits to patients and physicians by reducing the steps needed for self-administration and are excited about the potential for this new offering that we plan to launch in the first half of 2025. We are also exploring other ideas to enhance the convenience for patients starting on cortofan gel and the healthcare providers who treat them. And as a reminder, in the fourth quarter of 2023, we introduced the one milliliter version of cortofan gel to meet the needs of physicians who desired a smaller configuration of ACTH for certain patients. In particular, those with acute gouty arthritis flares for which cortofan gel is the only approved ACTH therapy. Physician demand for the one ML vial has steadily ramped up, including in the third quarter. We're also continuing to invest in scientific research that will provide additional support for the use of cortofan gel. At the end of October, we presented two abstracts at the American Society of Nephrology annual meeting. And earlier in Q3, research with cortofan gel was published in Frontiers in Pharmacology, authored by Ruzhan Gong from the University of Toledo, with collaborators. Overall, ANI believes in and remains committed to investing behind cortofan and delivering strong multi-year growth through purified cortofan gel. Turning now to the Alamira products, we are as excited as ever about the potential for our combined rare disease team to accelerate growth of alluvian, utique, and cortofan gel with retina and uveitis specialists, along with additional targeted ophthalmology subspecialties. As a reminder, Alluvian is used to treat diabetic macular edema, or DME, the leading cause of vision loss in diabetic patients, and Utique is used to treat chronic noninfectious UV edits affecting the posterior segment, or NIUPS. Both products are differentiated as long-term treatment options compared to other available products on the market. ANI has continued to make progress on the clinical studies, New Day and Synchronicity, which are ongoing for Alluvian and UT. New Day has the potential to expand the utilization of Alluvian for patients with early DME by investigating combination therapy consisting of Alluvian and supplemental anti-excessive treatment to improve patient outcomes. We expect top line data in the second quarter of 2025. The study is a multi-center, single-mass, randomized, and controlled trial designed to demonstrate the efficacy of alluvian as baseline therapy in patients by comparing alluvian plus supplemental anti-VEGF therapy to the current standard of care, anti-VEGF therapy alone. The New Day study was initiated in 2020, and it's fully enrolled with 306 treatment-naive or almost-naive DME patients in approximately 42 sites around the U.S. The planned treatment period in this study is 18 months, with the last patient, last visit in this study projected for next month. Having just attended the American Academy of Ophthalmology meeting in Chicago in mid-October, it's very clear that this data is highly anticipated by the retina specialist community. Synchronicity, the study is designed to provide retina and uveitis specialists with a broader sense of the utility of UT in patients with chronic NIUPS. The study is a multi-center, open-label study evaluating UT and chronic inflammation. The study has enrolled 110 patients in approximately 25 sites around the U.S., with the last patient last visit for this study projected for November 2025. Overall, the integration has been relatively seamless, and we're not only excited about the product, but also impressed by the caliber of talent that we welcomed into ANI. Integration and cross-training of the legacy ANI and Alamira ophthalmology sales reps is complete, and a combined team of 45 began promoting cortofan gel, Iluvian, and UT compositions in mid-October. We expect the enhanced team to drive greater awareness of all three products and the identification of more patients that can benefit from treatment. In 2025, we expect ANI's rare disease business will be both the company's largest business unit and the largest driver of growth, and we look forward to keeping you updated on our progress. With that, I'll turn the call over to Steve for the financial update. Steve?

Thanks, Chris, and good morning to everyone on the call. I'll review our third quarter results and then discuss our updated 2024 guidance. A&I generated third quarter revenues of $148.3 million, up 13% over the prior year period. Revenues from Cortofan Gel reported in our rare disease segment were $52.6 million up 77% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Based upon the continued strong execution of the rare disease team in driving growth, we are raising our full-year cortofan gel revenue guidance to $196 million to $200 million. The acquisition of Almera closed on September 16th, and therefore, our third quarter financial statements reflect approximately two weeks of revenue and expense activity. We are reporting combined revenues from these products under the heading Alluvian and Utique, which contributed 3.9 million of revenues to our rare disease segment during the two-week period. Revenues for our generics, established brands, and other segments were $91.9 million, a decrease of 10% over the prior year period. Generic revenues for the quarter were $78.2 million, an increase of 11% over the prior year period, driven by increased volumes on contributions from new product launches in 2024. and the full year impact of products launched in 2023. Net revenues for established brands and other were $13.7 million in the quarter, a decrease of 57% over the prior year, which was in line with our expectations. Starting today, when I speak to our operating expenses for purpose of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 in our press release. Generally, our non-GAAP operating expense excludes depreciation and amortization, stock-based compensation, and certain costs related to litigation and M&A activity. Please refer to Table 3 for a reconciliation to our GAAP expenditures. Non-GAAP cost of sales, excluding depreciation and amortization, increased 25% to $59.5 million in the third quarter of 2024 compared to the prior year period, primarily due to net growth in sales volumes of pharmaceutical products and significant growth of royalty-bearing products. Non-GAAP gross margin was 60%. a decrease of approximately 3.9 points from the prior year period, primarily driven by unfavorable product mix due to the reduction in established brand revenues. Non-GAAP research and development expenses decreased 20% to 8.7 million in the third quarter of 2024, principally due to the timing of spend. we continue to expect second-half 2024 R&D expenditures to be meaningfully higher than the first half of the year due to the timing of activities and the inherent phasing of R&D on a quarter-by-quarter basis. In addition, fourth-quarter R&D spend will include expenditures for Alluvian and UT, driven primarily by the New Day and Synchronicity Studies, Expenditures related to these studies are expected to continue throughout 2025. Non-GAAP selling, general, and administrative expenses increased 23% to $45 million in the third quarter of 2024. Due to increased employment-related costs, continued investment in rare disease sales and marketing activities, and an overall increase in activities required to support the growth of our business. We expect these expenses to be meaningfully higher in the fourth quarter, reflecting a full quarter of our integrated ophthalmology sales force promoting Cortofin, Alluvian, and Utique. We expect continued investment in our business and corresponding expenses to support the expanded sales force to continue in 2025. Adjusted non-GAAP diluted earnings per share was $1.34 for the quarter compared to $1.27 per share in the prior year period. Adjusted non-GAAP EBITDA for the third quarter was $35.1 million compared to $36.5 million in the prior year period. We ended the quarter with $145 million in unrestricted cash and have $641.3 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. At the end of the third quarter, our gross leverage was approximately 3.8 times and our net leverage was approximately three times our trailing 12-month adjusted non-GAAP EBITDA of approximately $167.7 million, which is pro forma for the Almera acquisition, inclusive of run rate synergies. Turning to our updated 2024 outlook, we're pleased to have closed the acquisition of Almera and are raising our full-year 2024 guidance to reflect continued strength in purified cortofen gel and the contribution from Alluvian and UT starting September 16th. Our updated guidance is as follows. Full year 2024 net revenues of $594 million to $602 million, up from our prior guidance of $540 million to $560 million, representing year-over-year growth of approximately 22% to 24%. For trophy net revenues of $196 million to $200 million, up from our prior guidance of $185 million to $195 million, representing growth of 75% to 78%. Combined Elluvian and Utique net revenues of $30 million to $32 million, which reflects revenues during the post-closed period of September 16th through December 31st. Adjusted non-GAAP EBITDA of $149 million to $153 million, up from our prior guidance of $140 million to $150 million. representing growth of approximately 11 to 14 percent, and adjusted non-GAAP earnings per share between $4.90 and $5.05, up from our prior guidance of $4.38 and $4.82. We now expect total company non-GAAP gross margin to be at the high end of our previously communicated range of between 61 and 62 percent. With the inclusion of SG&A and R&D associated with Illuvium and Utique, we anticipate full-year total adjusted non-GAAP operating expenses for 2024 of between $219 million and $223 million. Consistent with previous quarters, we will continue to tax-effect non-GAAP adjustments for the computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26 percent unless the item being adjusted is non-tax deductible in whole or part. The company now anticipates approximately 19.7 million and 19.9 million shares outstanding for the purpose of calculating adjusted non-GAAP diluted EPS for the full year 2024 and fourth quarter 2024, respectively. The company also expects its annual U.S. GAAP effective tax rate to be in the mid-single digits as compared to our previous expectation between 22 and 25%, driven by the non-deductible nature of certain expenses incurred in conjunction with the acquisition of Almera, applied against an annual forecasted gap pre-tax loss. With that, I'll turn the call back to Mikhil.

Thank you, Steve.

The continued strong performance of our business in the third quarter underscores the strength of our strategy and highlights our solid execution. And we're excited about the potential of the new expanded rare disease business. We now have multiple growing and durable commercial rare disease assets and an augmented sales team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology. We look forward to seeing many of you in person later this month at the Guggenheim's inaugural Healthcare Innovation Conference in Boston and the Jeffries London Healthcare Conference. Thank you all for joining us today. Operator, please open the line for questions.

The floor is now open for your questions. If you have a question or comment at this time, please press star one on your telephone keypad. You may remove yourself by pressing star 2. Again, to ask a question, please press star 1. Our first question will come from David Amsum with Piper Sandler. Please go ahead.

Thanks. So, I have a couple of questions. First, can you talk about the payer landscape for Cortisone gel and how that has evolved, if it has evolved at all, and how that looks compared to Actargel. So that's number one. Number two is you've talked about the ACTH market returning to growth, but I am wondering out loud how much of your business is coming from practitioners who are moving away from Actargel versus... practitioners who are just new to the category. So you can help us understand the mix there for your product. And then lastly, on the generics business, you've had a steady cadence of new launches. I guess my question here is what does that mean for 25? How are you thinking about the pace of new launches and the extent to which you can continue to grow your generics business moving forward? Thank you.

Good morning, David, and thank you for your questions. I'll try to take them one by one. So, the first question on the payer landscape for Cortofan in the ACTH category. Look, we try to find a balance between sharing information that is relevant for investors and not revealing competitively sensitive information. So we maintain strong relationship with our partners in the market access space and believe that there is recognition of the value that Cortofan brings to this class. And as you think about the parallel landscape, I think the most important impactful market access change next year will be the increased affordability for seniors through the Medicare out-of-pocket cap, along with the smoothing mechanisms for that out-of-pocket cap. And our patient support team is prepared to educate patients and physicians about these new options, which we believe should improve patient access. Your second question regarding our growth and where does it come from, existing prescribers or new prescribers, I think the way I would look at it is, You know, when you look at total growth of A&I, we've been in the market for three years now and have achieved the growth that we have, right? Most recently growing from 112 million in 2023 to a guidance of 196 to 200 million in 2024. That growth has come from both overall market growth as well as share growth. And so when you sort of bring that down to the prescriber level, we're seeing both. We're seeing growth with share with prescribers that used to use the competitive product, as well as new prescribers that have been unique to PC, to cortofan gels. And the other thing to just highlight is there are indications that ANI has that the competitor does not have, including acute gouty arthritis flares. So as you think about, you know, the overall ACTH market, which, you know, if you take our guidance and the competitor's guidance, you know, implies more than 20% growth year on year and what the potential is and why we believe corticofenus has a strong multi-year growth trajectory. There's also, you know, beyond just the existing or the number of patients that were there on therapy a few years ago, And also the additional indications that we have that the competitor does not have. So that's on the second question on, you know, the drivers of our growth in Portrophine. And then on your third question on the cadence of new launches for generics and what does that imply for the trajectory for our generics business? We are a strong R&D team along with the operational excellence. and our U.S.-based manufacturing footprint with a strong FDA compliance track record will continue to deliver a cadence of new launches, and we believe that the combination of these different factors will enable the A&I genetics business to grow in the high single-digit, low double-digit range going forward as we have delivered over the past few years. Thank you, David. Thank you.

Thank you. Our next question will come from Gary Nachman with Raymond James. Please go ahead.

Thanks. Good morning. So for Alluvian and UT, the guidance of 30 to 32 million is from the close of Alamira on September 16. So if I back out 4 million in the third quarter, it's 26 to 28 million for the fourth quarter. Is that a reasonable quarterly run rate to think about going into next year? And then just talk about with the integration in place, how you plan to accelerate those products, if we could see growth next year, and also how much you think the new day data could help potentially if it's positive, I guess, in terms of combination use. Great.

Good morning, Gary, and thank you for your questions. Yeah, so your first question on Illuvian and Utique and the the Q4 implied guidance. Since the deal closing, the commercial organization has been in a period of transition. We've hired and now have in place 45 ophthalmology-dedicated sales reps across the country. Some representatives have seen realignment of their territories. In addition, we've invested the time to cross-train this team across all three products, Alluvion, Utique, and Cortrofen. And post-training, the combined sales team has been in has been promoting all three products since mid-October. So the Q4 guidance reflects this period of transition, and we are confident that the underlying demand for Illuvian and Utique are aligned with our expectations and expect to achieve our growth goals for these assets. So we would expect growth over this run rate in 2025. And we remain confident that the Alamara acquisition to add incremental 35 to 38 million in incremental EBITDA in 2025 and anticipated to drive by single digit to a low double digit accretion in adjusted non-GAAP EPS. And then on the New Day Study, I'll turn that over to Chris to answer your question regarding the impact of the New Day Study. I will just say that from our perspective, the double digit growth that we've, or the growth expectations that we have for Elluvian and UT, have not hinged and neither did our deal model hinge on a positive readout of the New Day study. Having said that, you know, we look forward to updating you regarding, you know, as we get the top line results towards the end of quarter one and beginning of quarter two, the implications of that on, you know, the commercial implications of that on the growth trajectory for Illuvian. But, Chris, would you like to add anything?

Yeah. Yeah. So, as mentioned previously, the New Day clinical trial is designed to generate prospective data evaluating Luvian as baseline therapy in the treatment of DME and really compare it to current standard of care with anti-VEGF injections. You know, we think this study really has a significant opportunity for people to revisit how they're taking care of DME patients. Certainly, anti-VEGF therapy has been the standard of care in early DME and patients generally receive multiple anti-VEGF treatments before physicians consider eluvian for those patients. And I think, you know, from the feedback we've been getting from the retina community is that this is going to be the data that has been needed, really, to reconsider the way that the approach has been taken in taking care of these patients and really that the combination therapy of eluvian plus an anti-VEGF could potentially have a role based on this data.

Okay, thanks. Thank you, Gary. And then just on cortrophin, I know it's pretty early days, but are you seeing a real benefit yet within ophthalmology from the combined sales team with Alamira? What sort of impact do you expect in the coming year, you know, specifically in ophthalmology? And then just with the pre-filled syringe, available, I think you said, in the first half of next year. How much of a benefit do you think that'll be from a convenience standpoint to help quertrofen overall? Thanks. Yes.

Thank you for both those questions again, Gary. Regarding the pre-fill, I'll take your second question first, which is the pre-fill syringe. This is a new offering that we're bringing to the market for patients to make it easier for patients to increase the patient convenience versus when using the vial to make it easier from an administration standpoint to use our pre-filled syringe. So we do believe that this will be helpful for patients. This new offering will have an impact for patients that have you know, increase that convenience while using the, while administering the vials. So I think that's the first, so I guess that was your second question. And then regarding your question on the impact of PCG and ophthalmology, look, it's early days, right? We just said that the combined ophthalmology sales team is in the market since mid-October promoting all three products. And the early signs are positive. and we remain confident that there will be growth of cortofin and ophthalmology with this combined sales force. And what the early signs are promising, but again, it's been a few weeks, and we look forward to sharing further updates as we guide towards 2025 and inform on the updates on the progress made in this part of the business.

Thank you, Gary. Okay, great. Thank you.

Yep, thank you. Thank you. Our next question will come from Vamo Devon with Guggenheim Securities. Please go ahead.

Great. Thanks for taking my questions. So two, if I could. So one, a little bit of a different angle on the Cortropin questions I asked before. You've continued to sort of beat and raise on this product through the course of this year. Can you maybe just talk about what parts are doing better? Is it more from certain segments? Is it volume? Is it price? Or what's been driving the upside over the course of 2024 just this week? Again, so think about how to model it out for next year. And then the second question, I want to make sure I caught something you said in your prepared remarks correctly, and it's something around rare disease being the biggest unit in 2025. If you can just clarify that that's what you said. And then when you're comparing that, are you comparing that to just generics on its own, or are you comparing it to to Merit's established brand and other altogether as a segment.

Thank you. Good morning, Vamil, and thank you for your question. Regarding growth and control fund, I think first you asked about its volume versus price. It's, you know, a majority of the growth, you know, almost all of the growth comes from growth and volumes. And where does that growth in volumes come from? We see growth across therapeutic areas, both the ones we focused on at launch, neurology, nephrology, and rheumatology, as well as the newer areas of ophthalmology, gout, and pulmonology. And we also see robust prescribing demand across both existing prescribers and new prescribers, as I had answered in the question for David up front. So that's where the, you know, we're seeing growth sort of pretty much across the board. And then the second clarification on rare disease, we see rare disease as the largest driver of growth for A&I as a company going forward. So that clarifies that part of the question. Thank you, Vado.

Okay. All right. Thank you.

Once again, if you would like to ask a question, please press star 1 at this time. Our next question comes from Liz Salusky with Truist Securities. Please go ahead.

Hey, this is Jeevan on for Les. Thanks for taking our questions. So as you look back on the recent Alimera acquisition and potentially consider future M&A, I'm just curious what learnings you take away from the transaction, if any, to prevent similar situations in regards to timely closure in the future? Thank you.

Yeah, good morning, Jeevan, and thank you for your question. Yeah, I think that's a great question regarding learnings. I think that as we look to pursue other M&A activities, I think we remain focused on what is strategically aligned and important for ANI. So the Alamira acquisition is a highly synergistic acquisition. It helps continue to expand the scope and scale of our rare disease business, which is right in line with with what we've been saying from day one, actually for almost over a year. And that's something that we have been pursuing. So sort of sticking to our strategy, that's one lesson that we want to continue gathering forward. And then the second is, you know, as you do an acquisition, there are bumps along the way. And to make sure that we can continue to stay and work through the challenges. And, you know, those challenges may vary from acquisition to acquisition. And, you know, to ensure that we understand the challenge, that we have the capability, experience, and expertise to address the challenge and to move forward from there. You know, and, you know, we believe that with the Alamira acquisition, there is a, you know, a challenge related to the supply of that has come up, and we are well-positioned to address that challenge. We have been working closely with I-Point since the deal signing to address the issues on the warning letter, and the work with and the collaboration and engagement with I-Point has become even closer since we closed the deal, and we remain confident that you know, that there will be, that I point will satisfactorily address the points raised by the FDA. In fact, they've been giving updates on the same as they've gone along. And we anticipate no impact on continuity of UTIC supply to patients in need. And look, it is standard practice for ANI to work towards creating redundancies in supply chain for high-value products. Accordingly, we are taking steps to increase supply security for both Illusion and UTIC. So, you know, going back to your question, Jeevan, you know, there will be bumps along the way as we do acquisitions and, you know, make sure that the experience and expertise that we have, we bring that to bear. You know, in this case, it was related to supply. It may be something else in a future acquisition. And look, we have significant capability and expertise in this area, given the three plants we run in the U.S. with strong FBA compliance track records and our experience in addressing points like these jointly with our suppliers. So those are the lessons that I would stick into our strategy and making sure that when bumps come along the way that we, you know, understand the bumps and address them. Thank you, Jeevan.

Great. Thank you.

Thank you. At this time, I show no further questions in queue. I will turn the call back to Nikhil Lalwani for closing remarks.

Yeah, thank you, everybody, for joining our call, and thank you for your interest in ANI. We look forward to continue updating you on our progress and look forward to seeing you at the conferences that we have coming up and engaging with you as we move forward. Thank you.

Thank you. This does conclude the ANI Pharmaceuticals, Inc. Third Quarter 2024 Earnings Results Call. You may disconnect your line at this time and have a wonderful day.