ANI Pharmaceuticals Q1 2026 Earnings Report

ANI Pharmaceuticals EPS Results

• Actual EPS: $2.05
• Consensus EPS: $1.28
• Beat/Miss: Beat by +$0.77
• One Year Ago EPS: $1.70

ANI Pharmaceuticals Revenue Results

• Actual Revenue: $237.46 million
• Expected Revenue: $207.63 million
• Beat/Miss: Beat by +$29.83 million
• YoY Revenue Growth: +20.50%

ANI Pharmaceuticals Announcement Details

• Quarter: Q1 2026
• Date: 5/8/2026
• Time: Before Market Opens
• Conference Call Date: Friday, May 8, 2026
• Conference Call Time: 8:00AM ET

ANI Pharmaceuticals (NASDAQ:ANIP) is a United States–based specialty pharmaceutical company focused on the development, manufacturing and commercialization of generic and branded prescription drugs. The company operates as an end-to-end provider, offering services that range from active pharmaceutical ingredient (API) production and formulation development to finished dosage form manufacturing and packaging.

ANI’s product portfolio encompasses injectable and oral therapies across several therapeutic areas, including endocrinology, oncology, pain management and respiratory care. Alongside its proprietary generics business, ANI provides contract development and manufacturing organization (CDMO) services, leveraging its integrated in-house capabilities in sterile and nonsterile production, analytical testing and regulatory support to meet the needs of pharmaceutical partners.

Primarily serving markets in North America, ANI maintains multiple U.S. manufacturing facilities certified for complex sterile and nonsterile operations. The company collaborates with major distributors, retail pharmacies, hospitals and healthcare systems, and continues to invest in process optimization and quality systems to expand its product pipeline and support evolving patient needs.

ANI Pharmaceuticals Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: ANI raised its 2026 guidance, now targeting $1.08B–$1.14B in revenue, $285M–$300M adjusted EBITDA and $9.19–$9.69 adjusted EPS, driven by rare disease strength.
• Positive Sentiment: Cortrophin Gel revenue grew 42% YoY to $75.1M in Q1, April saw the highest new patient starts since launch, and a 64‑rep commercial expansion into primary care and podiatry is being deployed to accelerate H2/2026 and 2027 growth.
• Positive Sentiment: ANI recognized a $15M upfront fee from an out‑license to Harmony Biosciences, expects an additional $10M in near‑term development milestones (Q2–Q3) and low‑single‑digit royalties on pitolisant (WAKIX), adding immediate cash and future royalty upside.
• Positive Sentiment: Generics continue to fund growth with Q1 generics revenue of $105.4M (up 7%), six new launches YTD and a steady 10–15 launch cadence, while management authorized a new $100M share repurchase program as part of disciplined capital allocation.
• Negative Sentiment: Q1 results were impacted by insurance reverification delays and weather‑related office closures that temporarily depressed early‑quarter Cortrophin volumes and contributed to a lower non‑GAAP gross margin (60.8%), and ILUVIEN still faces ongoing Medicare access challenges.

Presentation

[Operator]

Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. first quarter 2026 earnings results call. Please note this call is being recorded. After the speaker's prepared remarks, there will be a question-and-answer session. If you'd like to ask a question during this time, simply press star one one on your telephone keypad. If you'd like to withdraw your question, please press star one one on your telephone keypad again. It is now my pleasure to turn the conference over to Irina Koffler.

[Irina Koffler, VP of Investor Relations at ANI Pharmaceuticals, Inc]

Thank you, Liz. Welcome to ANI Pharmaceuticals' first quarter 2026 earnings results call. This is Irina Koffler, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey, Senior Vice President and 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 anipharmaceuticals.com. This call is accompanied by a slide deck that can be accessed by going to the events section of the Investors page of our website. You can turn to our forward-looking statements on slide two. Before we begin, I would like to remind everyone that some statements we make today may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

[Irina Koffler, VP of Investor Relations at ANI Pharmaceuticals, Inc]

ANI cautions that these forward-looking statements are subject to risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC that may cause actual results to 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. During this call, we will also refer to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered as an alternative to financial measures required by GAAP. The non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measures in a table available in the slide deck accompanying this call. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com.

[Irina Koffler, VP of Investor Relations at ANI Pharmaceuticals, Inc]

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 8th, 2026. Since then, ANI may have made announcements related to the topics discussed, please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to Nikhil Lalwani.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Thank you, Irina, and welcome again to ANI. Good morning, everyone, and thank you for joining us for ANI's first quarter 2026 earnings call. Starting on slide four. In the first quarter, we continued to deliver on our goal of accelerating our transformation into a leading rare disease company and meaningfully further our commitment to serving patients, improving lives. Specifically, in the first quarter, we grew total net revenues 20% year-over-year, driven by strong performance across our Rare Disease and Generics businesses, along with contributions from an innovative intellectual property out-licensing agreement that will provide us with royalty revenues for years going forward. We also grew adjusted EBITDA 24% year-over-year while making strategic investments into our Rare Disease business to accelerate its growth.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

These strong first quarter results enabled us to raise our 2026 financial guidance for total revenue to the range of $1.08 billion-$1.14 billion and adjusted EBITDA to the range of $285 million-$300 million. I'm highly encouraged by our first quarter performance, which positions us well to drive meaningful growth in 2026 and beyond. Turning to slide five. Earlier this year, we outlined top three priorities for 2026, and I'm proud of all of the hard work our team has put in to generate strong momentum as we execute against these priorities. The first priority is to accelerate our transformation into a leading rare disease company. Central to this effort is maximizing the multi-year growth opportunity for Cortrophin Gel, our lead Rare Disease asset.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We delivered $75.1 million in Cortrophin Gel net revenues for the first quarter, up 42% year-over-year and consistent with the expectations we outlined during our last quarterly call. The fundamentals remain strong, we exited the quarter with clear traction across our target indications. We saw accelerating momentum across our new patient starts and monthly volumes dispensed in February and March. This momentum has persisted in the second quarter, with April having the highest number of new patient starts and monthly volumes dispensed since launch. We have also made significant strides this quarter in expanding our rare disease organization to capture the sizable and unique opportunity in acute gouty arthritis flares by targeting podiatry and primary care. We have recently hired and onboarded the majority of our new dedicated commercial team who will be in the field in the second quarter.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We expect to have our full organizational expansion completed and operational by the end of June. This, together with the continued strong demand across other core indications, provides a solid foundation to drive significant revenue growth in the back half of the year. We believe we are well-positioned to achieve our 2026 guidance of $540 million-$575 million in Cortrophin Gel revenues. For ILUVIEN, we delivered $19.3 million of revenue in the first quarter, up 20% year-over-year, as we continue to execute on the commercial and patient access initiatives we established in 2025. In particular, we made meaningful progress on generating and sharing clinical data with the retina community, including our recent publication of NEW DAY results in DME.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We're also on track to announce results from the phase IV SYNCHRONICITY clinical trial in NIU-PS at a medical conference in the third quarter of 2026. Over the long term, we continue to believe the addressable patient populations in DME and NIU-PS represent at least 10x the number of patients treated with ILUVIEN today, representing a significant and durable opportunity for value creation. Turning to slide six, we entered into a transaction with Harmony Biosciences, under which we exclusively license certain intellectual property to Harmony, which expands its intellectual property estate for pitolisant. In addition, we provided Harmony a co-exclusive license with which Harmony and Novitium, a subsidiary of ANI, intend to develop a novel formulation of pitolisant in broad CNS indications. In the first quarter, we received a $15 million upfront license fee.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Additionally, we have the potential to receive an additional $10 million milestone payment upon achievement of certain development milestones, and expect these development milestones to be achieved in the second and third quarters of 2026. We will also receive low single-digit royalties on pitolisant-based products. Harmony's guidance has WAKIX delivering net revenues of $1 billion-$1.04 billion in 2026. Turning to slide seven, our second priority is continued execution in our Generics business by leveraging our superior R&D capabilities, operational execution, and U.S.-based manufacturing footprint, as well as maintaining our current cadence of 10-15 launches annually. Similar to our Rare Disease franchise, we are able to report meaningful progress on this front. Year to date, we have already launched six new generics products and continue holding our position as the number two player in overall CGT approvals.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Our third priority is managing a disciplined capital allocation strategy. We continue to explore inorganic opportunities to expand the scope and scale of our Rare Disease business. We are also focused on driving organic growth by investing in our dedicated organization for Cortrophin in acute gouty arthritis flares and investing a high single-digit percentage of Generics revenues into Generics R&D. Our confidence in the business is further evidenced by our new $100 million share repurchase program authorized by our board. Turning to slide eight. We are encouraged by our first quarter performance and the important progress we've made against our strategic priorities. We are seeing strong momentum coming out of the quarter and are well-positioned to achieve our newly raised 2026 financial guidance.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

In 2026, we expect to deliver over $1 billion in revenue, representing 26% growth over 2025 at the midpoint of our guidance range. Rare Disease is expected to account for approximately 60% of our total revenues in 2026, with Cortrophin Gel growing 60% year-over-year. We also expect to expand the bottom line with adjusted EBITDA forecasted to grow 27% year-over-year. Our balance sheet is healthy, with the capacity to support future business development opportunities to expand scope and scale of our Rare Disease business. With all of this recent progress, we are continuing our virtuous cycle of growth, with which our Generics and Brands businesses generate meaningful cash flows to support our Rare Disease business as we accelerate our transformation into a leading rare disease company.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

I'll now turn the call over to Chris to discuss our Rare Disease business in more detail. Chris?

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

Thank you, Nikhil, and good morning, everyone. Starting with slide nine, Cortrophin grew 42% year-over-year to $75.1 million, in line with our expectations in the first quarter. We drove momentum across our under-penetrated specialty indications and made significant progress on our organizational expansion to capture the unique opportunity in acute gouty arthritis flares. As a reminder, consistent with prior years and typical industry dynamics, Cortrophin's performance in the first quarter reflected seasonality primarily related to the impact of insurance reverifications. In the first half of the quarter, insurance reverifications took slightly longer to clear as compared to the prior year due to increased Cortrophin patient volumes in the physician offices and, in some parts of the country, due to weather-related physician office closures that temporarily delay the reverification process. As physician offices worked through the reverification backlog, Cortrophin sales began to ramp back up.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

In fact, we saw an acceleration in February and March, which carried into April. April achieved the highest number of new patient starts and monthly volumes dispensed since launch. We are also pleased with the underlying fundamentals. We delivered year-over-year growth across all of our targeted specialties of rheumatology, nephrology, neurology, pulmonology, and ophthalmology. Prescribing for Cortrophin Gel and acute gouty arthritis flares remained a key driver this quarter. This indication is unique to Cortrophin Gel among ACTH therapies represented approximately 18% of total utilization. We also continued to realize meaningful revenue synergies in ophthalmology with first quarter Cortrophin volumes in ophthalmology doubling over the same period a year ago. I'm proud of our commercial team's execution this quarter that positions us for significant growth in 2026. To capture the multi-year growth potential of Cortrophin Gel, we continue to focus on three key strategic priorities.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

High ROI commercial initiatives, investment to generate robust clinical evidence to support physician decision-making and confidence in Cortrophin Gel, and enhancing patient convenience. I want to focus my comments today on our investments in high ROI commercial initiatives. Turning to slide 10. Building on the commercial expansion we executed in 2025 and following a successful pilot program, we are taking the next step to capture the unique opportunity for Cortrophin Gel and acute gouty arthritis flares with our new 90% dedicated organization targeting primary care and podiatry. The majority of our commercial team has been recently hired and onboarded. They'll be in the field and meaningfully engaging with prescriber targets in the back half of the second quarter. Our sales team is equipped with new promotional materials focused on acute gouty arthritis flares that we believe will assist significantly with their educational efforts.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

We expect to have the full team deployed by the end of the second quarter, focusing on the 7,000 HCPs that treat the most severe patients outside of our prior call points in rheumatology and nephrology. While we anticipate the expansion to begin impacting Cortrophin Gel volumes in the second half of 2026, we expect a greater impact in 2027 as the team reaches full productivity. There are several reasons why we are confident about the opportunity in acute gouty arthritis flares. First, it represents a significantly under-penetrated market opportunity. There are roughly 10 million patients in the U.S. with gout. About 36% receive treatment annually. They have 1.5-2 flares on average per year. Only 8% of those patients receive an injectable flare treatment.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

This group of 285,000 patients represents our addressable patient population. Majority of them are treated in settings called on by our new team. Second, Cortrophin is the only approved ACTH therapy for acute gouty arthritis flares. Third, we have a proven track record in this indication. Prescribing for acute gouty arthritis flares represents approximately 18% of Cortrophin Gel use to date, driven primarily by use in rheumatology and nephrology. Last year, we ran successful pilots across 10 territories in primary care and podiatry. We continue to see momentum in these territories. This data gave us further confidence to expand our organization to capture the broader opportunity in gout. Finally, our organization build-out further enables us to continue expanding the ACTH market, which is pictured on slide 11.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

Already, prescribers who were previously naive to ACTH represent approximately half of our total Cortrophin Gel prescriber base, and this cohort will continue to grow. The ACTH market is expected to reach over $1.3 billion in sales in 2026, with Cortrophin expected to grow 55%-65% year-over-year. On slide 12, turning to our retina franchise, we're advancing several initiatives to support ILUVIEN sales. We're committed to generating clinical data for the overall retina community. We're pleased that last month, the results of our NEW DAY study of ILUVIEN in patients with DME were published in Ophthalmology, a leading globally respected peer-reviewed journal. We also expect to share results from our SYNCHRONICITY phase IV study of YUTIQ, now promoted under the ILUVIEN label in chronic NIU-PS at a medical meeting in the third quarter.

[Chris Mutz, SVP and Head of Rare Disease at ANI Pharmaceuticals, Inc]

In addition, our commercial teams focus on educating and engaging the retina community. They are conducting peer-to-peer educational programs and field activities with updated marketing materials to enhance physician understanding of ILUVIEN and its two indications. We also continue to work with physician practices as they navigate ongoing Medicare market access challenges that have persisted since January 2025, including exploring alternate access pathways. I'm proud of all of the progress our team made this quarter and believe we are well-positioned to accelerate our transformation into a leading rare disease company. With that, I will now turn the call over to Steve to detail our financials.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

Thanks, Chris, and good morning to everyone on the call. I'll now review our first quarter results and 2026 guidance in more detail. Starting with slide 13, ANI total net revenues were $237.5 million in the first quarter, up 20% over the prior year period. Revenues from Cortrophin Gel in the first quarter were $75.1 million, up 42% from the prior year period, performing in line with our expectations. As Chris noted, first quarter 2026 results were impacted by seasonality related to the impact of insurance reverifications that took slightly longer to clear in January and February. ILUVIEN net revenues were $19.3 million in the first quarter, up 20% from the prior year period. As Nikhil mentioned, in January, we entered into a licensing transaction with Harmony Biosciences.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

We recognized $21.5 million of associated revenues in the first quarter, consisting of the $15 million upfront license fee and the initial royalty income on sales of WAKIX. Revenues from Generics in the first quarter were $105.4 million, an increase of 7% over the prior year. Driven by the continued strength in the partner generic launch that commenced in the third quarter of 2025. Contribution from new product launches and commercial and operational outperformance. Turning to slide 14. Non-GAAP cost of sales increased 28% to $93.1 million in the first quarter of 2026 compared to the prior year period, primarily due to net growth in sales volumes and significant growth of royalty-bearing products.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

Non-GAAP gross margin in the first quarter was 60.8%, a decrease of approximately 230 basis points from the prior year period, principally due to higher sales of royalty-bearing products, including Cortrophin Gel, the partnered generic product launch that occurred in the third quarter of 2025, the non-recurrence of prior year revenues from prucalopride, as well as lower brand sales year-over-year. These effects were somewhat tempered by the initial revenue recognition under the Harmony agreement. Non-GAAP research and development expenses were $10 million in the first quarter, essentially flat with the prior year period.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

Non-GAAP selling, general, and administrative expenses increased 12% to $71.4 million in the first quarter, driven by initial marketing and recruitment expenses for our organizational expansion for Cortrophin in acute gouty arthritis flares, as well as an overall increase in activities to support the ongoing significant growth of our business. Adjusted non-GAAP diluted earnings per share was $2.05 for the first quarter, compared to $1.70 per share in the prior year period. Adjusted non-GAAP EBITDA for the first quarter was $63 million, up 24% compared to the prior year period. We ended the first quarter with $311.2 million in unrestricted cash, up $25.6 million as compared to $285.6 million as of the December 31st, 2025 balance sheet.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

Cash flow from operations was $58.4 million in the first quarter. As of March 31st, 2026, we had $625 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. At the end of the first quarter, our gross leverage was 2.6x, and our net leverage was 1.3x our trailing 12 months adjusted non-GAAP EBITDA of $242 million. Driven by first quarter performance, we are pleased to raise our 2026 financial guidance for total net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS, which reflects significant top and bottom line growth. Our guidance outlined on slide 15 is as follows.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

We now expect 2026 net revenue of $1.08 billion-$1.14 billion, up $25 million from previous guidance. We are reaffirming our guidance for Cortrophin Gel net revenue of $540 million-$575 million. From a quarterly cadence perspective, we expect second quarter Cortrophin Gel revenues to represent approximately 21%-23% of total 2026 Cortrophin revenues. We then expect further sequential gains in the third and fourth quarters, driven by continued performance of our portfolio, pulmonology, and ophthalmology teams, in addition to the full deployment of our commercial organization focused on acute gouty arthritis flares. Revenues associated with this expansion will first occur late in the second quarter and are expected to build momentum throughout the second half of the year.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

We are reaffirming our ILUVIEN net revenue guidance of $78 million-$83 million. We now expect non-GAAP adjusted EBITDA of $285 million-$300 million, up $10 million from our previous guidance. From a quarterly cadence perspective, we expect second quarter non-GAAP EBITDA to be essentially in line with first quarter as the increase in Cortrophin Gel revenues will be tempered by the non-recurrence of the $15 million upfront license fee recognized in the first quarter. We expect strong sequential growth in adjusted non-GAAP EBITDA in the third and first quarters, driven by Cortrophin Gel revenue gains. We now expect adjusted non-GAAP earnings per share between $9.19 and $9.69.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

We are also adjusting upward gross margin expectations and expect adjusted gross margin to be 59.9%-60.9% in 2026, up 60 basis points from our previous guidance. We continue to anticipate between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full-year non-GAAP diluted EPS and a full-year U.S. GAAP effective tax rate of approximately 26%-28%. We are pleased to announce a new three-year share repurchase program to repurchase up to $100 million in common stock. This reflects the strength of our balance sheet and our ongoing confidence in the business. This program provides us with another tool in our capital allocation strategy, which is centered on creating long-term value for our shareholders. With that, I'll turn the call back to Nikhil.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Thank you, Steve. Turning to slide 16. In closing, we are making meaningful progress against our strategic priorities to accelerate our transformation into a leading rare disease company, continuing to execute in Generics and deploying capital in a disciplined manner. Overall, we expect to deliver over $1 billion in revenue in 2026, with Rare Disease representing approximately 60% of total revenues. We are on track to achieve our raised 2026 financial guidance, which reflects significant top and bottom-line growth. Operator, please open up the line for questions.

[Operator]

As a reminder, if you'd like to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from David Amsellem with Piper Sandler.

[David Amsellem, Analyst at Piper Sandler]

Thanks. Just have a couple. First on the mix for Cortrophin. Can you talk to how much of your growth is coming from the non-gout settings like pulmonology/sarcoidosis and ophthalmology, and how much of the mix is in those other high-growth settings other than gout? That's number one. Also wanted to drill down on number of vials and duration of treatment in the various indications. My understanding is that in gout, it's a pretty short course. Pulmonology, ophthalmology, others, there's more vials, there's more duration. Help us better understand those dynamics. Last question is on payer access. As you gain more and more of a footprint overall, and particularly in gout, can you talk about how access dynamics might evolve? Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Good morning, and thank you, David. Your first question is, where is the growth coming from? Our previous year sales was $348 million, our guidance for this year is $540 million-$575 million. That growth of approximately 60%. Majority of that growth comes from the what we're able to refer to as core indications are the ones that we have been, you know, focusing on since since launch, which is rheumatology, nephrology, neurology, pulmonology, and ophthalmology. There is acute gouty arthritis flares as part of that, but coming from the prescribers being rheumatologists and nephrologists.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

When you think about, you know, the gout expansion, right, that we've done this year, as Chris mentioned in his remarks, we've, the team is pretty much hired and trained and is, you know, gonna be in the field starting the back half of this quarter. You'll see some revenue impact in this quarter, but it'll really ramp up towards Q3, Q4. There's a much greater impact that's gonna happen in 2027 from this expansion that we've done of, you know, a dedicated commercial organization for acute gouty arthritis flares, targeting primary care and podiatry. To summarize again, majority of that growth from $347 million going to $540 million-$575 million will come from our core indications, and with our prescribers, with those core indications.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

There's a subset of it, of the growth that's coming from the gout expansion that we're doing this year. We'll see the full-scale impact and operating leverage in 2027. That's the answer to question one. Regarding the vials per by different therapeutic areas and indications, you're absolutely right that there is a variance. You know, Cortrophin is prescribed by across specialties, and there is specialties like pulmonology and nephrology that have higher vials or PFS per patient. There is multiple sclerosis, gout, which have, you know, lower vials per flare.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

I would just remind that, you know, in some cases, the patients do come back and, you know, they may have used Cortrophin a couple of years ago, but then will come back the next time, you know, an exacerbation or a flare comes up. That's a bit of the color that we can give you on vials or duration across indications. Obviously, there's a continuum there across different specialties and different indications. Then on third is payer access. You know, we've, you know, we brought competition to a category that had no competition in ACTH when we launched in 2022 and have been focused on expanding access, and you know, serving the significantly under-penetrated addressable market across indications.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

What you'll see, with the 30% growth implied in our and our competitors' guidance is that we're both focused on reaching the patients that can, for who ACTH therapy is appropriate and expanding the access as we are doing that. I'm trying to keep it a bit general because as you would expect, there's stuff that is competitively sensitive that we need to just balance while sharing information that's helpful for investors. Thank you, David.

[Operator]

Our next question comes from Vamil Divan with Guggenheim Partners.

[Vamil Divan, Analyst at Guggenheim Partners]

Great. Thanks, thanks for all the information today, and thanks for taking my question. I guess I have a couple questions related to the guidance increase. I guess ties into the Harmony deal. Just to confirm, it sounds like you already recognized $15 million upfront license fee. I'm assuming that's already included in your guidance expectations. There's this $10 million in development milestones you're expecting in 2Q and 3Q. My question is that already included in your guidance as well? If it is, that sort of accounts for the $25 million guidance range, you know, for the company as a whole. I'm wondering how you're thinking about the royalties that you'd get on top of that. Is that included in your guidance or not?

[Vamil Divan, Analyst at Guggenheim Partners]

If that is, then I'd almost wonder why the guidance and especially the EBITDA guidance maybe not is not going up by more, given the impact of this acquisition. My second question. Oh, sorry, that was a long question. The second one's on Cortrophin, I understand the reauthorizations, you know, took longer than expected in the first half of the first quarter. The prescription data that we're seeing publicly through IQVIA and, you know, those sources still looked very, very strong. I'm just wondering if you can maybe help explain the disconnect there. I would think that if the reauthorization was taking longer, it would lead through to in terms of the prescription data, but maybe it doesn't and maybe I'm wrong on that.

[Vamil Divan, Analyst at Guggenheim Partners]

If you can just clarify how we should think about interpreting any of the publicly available prescription data? Thanks.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Sure. Good morning, and thank you, Vamil. I'll take your second on Cortrophin and IQVIA first, then I'll come back to the guidance. Look, in the past, IQVIA has been directionally in line with our performance. However, we can't comment on the recent disconnect as it is third-party data, and we do not have insight into all their inputs. That's why what we've tried to do is share internal metrics that are useful for investors. As you would expect, operationally, we remain focused on our internal metrics and leading indicators we use to manage the business while obviously watching the external metrics too. What we have shared is that we exited the quarter and began Q2 with significant momentum across our target indications.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We saw accelerating momentum across monthly volumes dispensed and new patient starts in February and March. We've spoken to some of that when we reported it in February. This momentum has persisted in the second quarter, with April having the highest number of new patient starts and monthly volumes dispensed since launch. That's the answer on Cortrophin and related to the IQVIA clarification that you had sought. On the guidance, look, we, you know, our guidance included when we had issued the guidance, it included the Harmony deal, right?

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Our initial guidance, which we issued in January, included Cortrophin at $540 million-$575 million, ILUVIEN at $78 million-$83 million, revenues from the out-licensing agreement, gross margin at 59.3%-60.3%, and adjusted EBITDA at $275 million-$290 million. Our newly raised 2026 guidance retains Cortrophin and ILUVIEN revenue guidance. For the guidance increase is really driven by high Generics revenues on the back of first quarter and visibility into new product launches for the rest of the year. That's one. Second is clarity around the milestone achievement of the $10 million. The development milestones that is there in the Harmony agreement. We have more clarity around when that can be achieved.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

I think Steve had spoken that that will be achieved in the second and third quarter, that $10 million will be achieved across the second and third quarter of this year. Third is just refinement of the royalties revenues expected for this year based on the updated 2026 guidance issued by Harmony Biosciences.

[Vamil Divan, Analyst at Guggenheim Partners]

Okay.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Thank you for your question, Vamil.

[Vamil Divan, Analyst at Guggenheim Partners]

Yep. Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Yeah.

[Operator]

Our next question comes from Dennis Ding with Jefferies.

[Dennis Ding, Analyst at Jefferies]

Hey, guys. Thanks for taking my questions, and congrats on a very good Q1. you know, on the Q2 soft guidance, it seems to imply $117 million-$128 million for Cortrophin at the midpoint. Maybe talk about the pushes and pulls on that number and what's driving your confidence today in achieving that, and how much visibility do you have on orders over the next 45 days? That's question one. question number two, you know, if I think about Cortrophin guidance for the year, I feel like what I'm really trying to get comfortable with is maybe around an incremental $50 million in second half gout revenue.

[Dennis Ding, Analyst at Jefferies]

When I do the math, that implies around, let's say, 1,500-2,000 flares that need to be treated in the second half. You're also going after 7,000 HCPs, so maybe only a small proportion then just needs to treat a single flare in the second half to bridge the $50 million in gout revenue. Do you agree with that math? Is there something that we're missing here? Thanks.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Right. Good morning, and thank you for your questions, Dennis. The first question is on the Cortrophin guidance and the quarterly evolution that we spoke to. You know, as we said, we exited the first quarter with significant momentum, right? Saw accelerating momentum across monthly volumes dispensed and new patient starts in February and March. Began Q2 with significant momentum. We shared that, you know, both in terms of volumes dispensed and new patient starts, April is the highest of all time, right? We believe that momentum will sustain, right? We are reaffirming our guidance for Cortrophin of $540 million-$575 million.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

What you have in the third and fourth quarters is, this goes back to the question that the first question that I asked for David, is that the third and fourth quarters will have continued performance of our portfolio, pulmonology and ophthalmology teams. In addition to that is the full deployment of our commercial organization. We have completed that hiring and training for the most part. It will be fully complete by the end of June. The revenues associated with this expansion will first occur late in the second quarter, and then are expected to build momentum through the second half of the year, which is in the third quarter and fourth quarter. I mean, you know, for reference, we're adding 64 new sales reps.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

You know, as you're thinking about, you know, number of patients, the number of enrollments, number of physicians, I think I would just zoom out a little bit and say, you know, there are 285,000 patients that we believe are in the addressable market, and we believe that they have an unmet need where Cortrophin Gel may be an appropriate treatment. They are being treated by physicians that we are currently not reaching. Consistent with our mission of serving patients, improving lives, we've done an investment to reach these patients, first of all.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

It's, you know, as a consequence, also expand the ACTH market because we're reaching a completely new set of prescribers that for the most part, other than those 10 pilots that we had done last year and had seen significant success in and continue to see momentum in this year, you know, we were not really accessing. Really this is about reaching that much larger patient population through the, through the expanded sales force. Again, we remain confident with the addition of 64 reps, right, of seeing momentum build for that in the back half of the year, but also the bulk of the growth from, you know, $347 million to $540 million to $575 million coming from the core portfolio, pulmonology and ophthalmology team.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

When I say portfolio, I mean, reps that detail into nephrology, neurology and rheumatology. Thank you, Dennis.

[Operator]

Our next question comes from Glen Santangelo with Barclays.

[Glen Santangelo, Analyst at Barclays]

Yeah, thanks for taking my question. Hey, Nikhil, I just want to follow up on sort of your previous response regarding the guidance. I mean, you're making the case that the licensing fee was included in the original guidance, but it was unclear to me what you were saying about the milestone payments. Were they in the original guidance, or is that incremental now? I just want to make sure I'm clear on that. Then I had a follow-up.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Sure. Yeah, I think that when we gave the initial guidance, we had, you know, we take into account, you know, It took us time to figure out, you know, the timing of for the development of these, sorry, for the achievement of the milestone related to the development. That's, you know, that we baked that in into the revised guidance. Look, there are multiple factors that are impacting the raised guidance as I spoke about, right, you know, earlier, right? That was the higher Generics revenues on the back of first quarter and visibility into new product launches for the rest of the year. The second is the clarity around the achievement of the $10 million development milestones.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We're also retaining some flexibility to invest further across Rare Disease and Generics as we ramp through the year, right? We have tremendous growth opportunities across both, right? We're retaining some flexibility to invest further in the latter part of the year as needed. Thank you, Glen, and I think you have a follow-up. Please go ahead.

[Glen Santangelo, Analyst at Barclays]

Yeah. Maybe I'll shift gears and ask you a quick question on ILUVIEN. You know, based on, you know, your full year guidance and what you sort of did in 1Q, it doesn't seem to be that you're expecting any sort of sequential growth in this product throughout the year. I was wondering if you could just update us on your sort of commercial and patient access initiatives, because it seems like, you know, you're just sort of expecting $20 mil a quarter for the balance of the year.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Thank you for your question, Glen. We have, you know, we've deployed these commercial and patient access initiatives, you know, starting with towards the end of, 2025 and heading into 2026. We're seeing the impact from those as we, you know, in a strong Q1. You know, we're just calibrating, right, as we, as we look ahead. The foundation related access issues have not resolved. You know, we've obviously made some progress with alternate access pathways for patients that are, that do have the pharmacy benefit. You know, we're just, you know, we're calibrating as we give guidance and on what's what will come towards the rest of the year.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We have a lot to look forward to, right? We spoke about the release of the NEW DAY clinical study results in publishing of that in ophthalmology as well as, you know, in Q3 at a medical conference, releasing data on ILUVIEN in NIU-PS. The study's called SYNCHRONICITY. There's a number of things that we are working on, initiatives that we're working on, but we're just being calibrated on where the guidance is versus where we started. Thanks, Glen.

[Glen Santangelo, Analyst at Barclays]

Okay, thank you.

[Operator]

Our next question comes from Ekaterina Knyazkova with JPMorgan.

[Ekaterina Knyazkova, Analyst at JPMorgan]

Thank you so much. Just wanted to talk about the data generation strategy. Do you think that it makes sense generating additional data in some of the older indications as a kind of way to, you know, increase adoption? If so, what indications do you think would be the most interesting there? Second question is just on BD, just, you know, latest thinking in terms of appetite or priorities for the company. Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Good morning, thank you, Ekaterina. In terms of generating scientific and clinical evidence, it's something that we've been focused on right from year one of the launch. We've invested in generating preclinical evidence, you know, that shows the differentiated mechanism of action of Cortrophin Gel and, you know, supports the physician use of Cortrophin. We're continuing to explore, you know, and work collaboratively with physicians to identify areas where we can do that. You obviously know about the phase IV study that we have in acute gouty arthritis flares. We've also got other, you know, publications we've done in the other indications. We continue to sort of evaluate and make investments in generating scientific and clinical evidence.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

You know, we'll keep you updated. Obviously, there is a competitive angle to this and balancing what we're sharing from a competitively sensitive standpoint. It is an area, you know, generating scientific and clinical evidence is an area we're absolutely committed to for Cortrophin and supporting the growth of this franchise. When it comes to BD, you know, it is a critical and important part of our capital allocation strategy.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

We are exploring ways to expand scope and scale of our Rare Disease business, looking at commercial assets that can leverage the either the sales team that we have that go into multiple call points or the rest of the Rare Disease infrastructure that we have that support, you know, market access, especially pharmacy distribution, patient support, medical affairs, marketing, all of that Rare Disease infrastructure that we have in place that can support, you know, us reaching patients in rare indications. Identifying a commercial asset that can, you know, leverage these capabilities that ANI has in Rare Disease, to expand our scope and scale, we retain our focus on that, and is a critical priority for ANI. Thank you.

[Ekaterina Knyazkova, Analyst at JPMorgan]

Thank you.

[Operator]

Our next question comes from Les Sulewski with Truist.

[Les Sulewski, Analyst at Truist]

Good morning. Thank you for taking my questions. I have three. First, on the reverifications, can you color if do you expect any spillover of these lingering into 2Q, or is it now mostly resolved? Are you aware of the magnitude of these issues among your competitor? How should we expect similar reoccurrence in Q1 of next year? Just to clear up on the Harmony settlement, is the royalty tied to all WAKIX sales or just future indications or future formulations? Do you have ability to sell this royalty stream, and would you consider going this route? Just on the buybacks, is there an ASR component to the buybacks, and how should we think about priority of capital allocation strategy? Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Yeah. Thank you, Les, and good morning. I'll take the first one, and then I'll hand it over to Steve to answer your, the one on the share repurchase as well as the Harmony royalties. The headwinds that we saw related to Q1 seasonality and insurance reverifications taking longer to get through impacted the first half of the quarter. Physician offices have since worked through that backlog, and we saw the accelerating momentum across monthly volumes dispensed and new patient starts in February and March.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

I think that as we head into to your question on, you know, what will happen in 2027 Q1, as we get towards the end of the year and into 2027 Q1, we will work with the physician offices, and we already have as we've been working through these insurance reverifications on, you know, what can we do to collaborate to make these go, you know, go smoother. have identified a set of initiatives that we will deploy, and we will look forward to updating you as we get closer to that timeframe. Obviously, you know, there was some impact from the weather-related issues that happened in significant number or significant weather-related issues in those first, you know, half of Q1.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

You know, that's something obviously that we, that's mother nature and that will, that will decide. You know, in terms of the insurance reverification process, we do have ideas that we're exploring and we'll implement as we get towards the end of, end of this year and heading into next year to support the physician offices. I'll just turn it over to Steve to answer your question on Harmony Biosciences royalties as well as the buyback.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

I'll pick the buyback one first. Les, good morning. Thanks for the questions. Just to, you know, position the repurchase program a little bit, I'll get to your specific question. You know, as we said on the call, putting this in place at this time, you know, reflects our confidence in the balance sheet, you know, the cash generation that, you know, we've achieved to date with, you know, $311 million on the current balance sheet. You know, our overall confidence in the future prospects of the business, which includes, you know, an expectation for significant cash flow generation in 2026. To be clear, our principal goal for the excess cash on our balance sheet remains to support future business development and M&A.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

Within that framework, you know, the addition of the buyback program really just gives us another tool in our tool belt as we actively manage the capital allocation plans going forward. Our shareholders should expect us to judiciously allocate cash between investment behind the strategic growth and diversification of the business, de-levering our balance sheet, and return of any excess capital to shareholders. To your specific question, Les, at the current time, there is no plan for an ASR to be implemented within this buyback program. Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

On Harmony.

[Stephen Carey, SVP and CFO at ANI Pharmaceuticals, Inc]

On the Harmony royalties, it is, the royalty is due on all pitolisant products, including WAKIX and any future products that may be introduced, that is pitolisant-based. You know, in terms of, you know, whether we would sell that royalty stream or not, you know, we typically don't discuss any potential future BD. At the moment, you know, we're just very pleased with the collaboration with Harmony and look forward to executing our portion of that out-licensing deal.

[Operator]

Our next question comes from Brandon Folkes with H.C. Wainwright.

[Brandon Folkes, Analyst at H.C. Wainwright]

Hi. Thanks for taking the questions and congrats on a very good quarter. I just want to follow up on an earlier question regarding the prescription growth we are seeing where we sit versus reported revenue on Cortrophin. You know, a few sub-questions here. You know, as the ACTH category grows, you know, are you seeing any additional payer management across the board? On Cortrophin again, any changes in rebates or contract terms for 2026 versus 2025? Lastly, I guess, you know, was the level of patient support you provided in 1Q 2026, was that within what you would expect for a first quarter? Is it comparable to the prior year? You know, are you seeing any change in usage patterns in gout? A lot in there, but I appreciate it.

[Brandon Folkes, Analyst at H.C. Wainwright]

Thank you.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Yeah. Yeah. Good morning, Brandon, and thank you for your questions. Your first question on peer management and then your subsequent question on rebates. Look, we try to, you know, provide as much information as we can to be, you know, useful to investors, but some stuff is competitively sensitive and, you know, what's happening on the payer landscape as well as on rebates is competitively sensitive. Would not be able to give you specifics there. What I can say is that our efforts to, since we've launched, is to bring competition to a category that has not had competition and to reach more patients, right?

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Over half our prescribers are, you know, are ones that had, were naive to ACTH and had never considered ACTH before writing their first prescription of Cortrophin Gel. We're really trying to reach that larger addressable market. We believe that, you know, as, you know, with our efforts and also the competitors' efforts, you know, there are more patients that are appropriate for ACTH that are getting access to this therapy, right? I think that's what I could say in terms of expanding access and having patients access this therapy. That's on your first two questions.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

With regards to patient support. No, the patient support in 2026 Q, sorry, in 2025 Q4, and heading into 2026 Q1 was much more than the patient support that we had in 2024 Q4 going into 2025 Q1, 'cause we obviously knew there were a lot more patients on therapy, you know, in 2025 Q4 and that would need insurance reverifications. I believe that's where you were trying to understand. We made the expansion of our patient support team. There are three different, you know, stakeholders that play a role in insurance reverifications, and one of which is the physician offices.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

I think that's, you know, across the three where we had, you know, the volumes that went into those, some of those physician offices, and then it was exacerbated by the weather-related delays is what led to the insurance reverification issues. On gout, I think what I could share that would be useful is, you know, gout is a acute gouty arthritis flares as a percentage of Cortrophin volumes has grown to 18%, majority of which comes from rheumatology and nephrology, 'cause that's, you know, that's what we were originally focused on. That, you know, obviously is seeing a lot of momentum.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

The cities in which we did the pilots, those territories are also seeing momentum, and that momentum has persisted even after, you know, the pilot has concluded. Obviously, some of the pilots have just, you know, translated into this new acute gouty arthritis gout expansion team, and we're continuing to see momentum in that team too. Thank you, Brandon.

[Brandon Folkes, Analyst at H.C. Wainwright]

Great. Thank you very much, and congrat-

[Operator]

Our next question comes from Thomas Smith with Leerink Partners.

[Thomas Smith, Analyst at Leerink Partners]

Hey, guys. Good morning. Thanks for the updates and for taking our questions. On Cortrophin, could you just expand on some of those comments, Nikhil, with respect to the 10 primary care and podiatry centers where you executed the pilot programs last year? Maybe is there a way to quantify, I guess, the potential continued growth and maybe the uptake from those centers now that you're a bit removed from the pilot, what other learnings could you apply from that experience? On the Harmony licensing transaction, can you just talk about what a potential development path looks like for the novel formulation of pitolisant? Maybe a little bit of color on the timelines, how you think about potential value generation from that asset.

[Thomas Smith, Analyst at Leerink Partners]

Are there other, monetizable IP assets in that portfolio that could drive maybe similar transactions here over the next two years? Thanks so much.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Great. Thank you, Tom, for your questions. Good morning. On the pilots, look, we're continuing to see momentum, you know, in both the new patient starts and volumes dispensed and the momentum is significant, right? You know, obviously we keep monitoring that and that continues to give us confidence in this expansion that we've done. A lot of our expansion is architected based on what we learned from the pilots, right? You know, when you think about, you know, how do you identify primary care and podiatrist physicians to reach out to?

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

You know, we looked at the success of these pilots and were able to develop a set of criteria from claims data that have helped us identify who is the physicians, primary care and podiatrists, which are very large populations, and then really focusing on the, you know, the 7,000 HCPs that we are, you know, that are treating the patients with the most severe acute gouty arthritis flare indications. You know, a lot of that has been learning from there. Second is, you know, what is the cadence, right? This is a different prescriber group than, you know, than the ones that we've been going with initially or going to initially with our sales force.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

Really learning like, hey, what's the cadence that would be appropriate for them? What is the messaging that's appropriate? We have a whole slew of new marketing material that is tailored to acute gouty arthritis flares and what are the messages that resonate. A whole bunch of the architecture of our gout expansion really comes from the, you know, from the learnings from the 10 pilots. Your second question on the, you know, development timelines for Harmony, that's, you know, it's confidential to the collaboration and not one that I can speak to today.

[Nikhil Lalwani, President and CEO at ANI Pharmaceuticals, Inc]

The last one on monetizable IP, you know, we absolutely keep working on IP that we can monetize and collaborations that we can do from a development standpoint to create value for our shareholders. Harmony is one step in that direction. That's also part of the reason why, as Steve has highlighted, we now, you know, have these captured in a separate line under Cortrophin, under Rare Disease and Brands. Thank you, Thomas.

[Operator]

Thank you. That concludes today's question and answer session. This concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Chris Mutz, SVP and Head of Rare Disease
• Irina Koffler, VP of Investor Relations
• Nikhil Lalwani, President and CEO
• Stephen Carey, SVP and CFO

Analysts

• Brandon Folkes, Analyst at H.C. Wainwright
• David Amsellem, Analyst at Piper Sandler
• Dennis Ding, Analyst at Jefferies
• Ekaterina Knyazkova, Analyst at JPMorgan
• Glen Santangelo, Analyst at Barclays
• Les Sulewski, Analyst at Truist
• Thomas Smith, Analyst at Leerink Partners
• Vamil Divan, Analyst at Guggenheim Partners