ANI Pharmaceuticals Q3 2023 Earnings Call Transcript

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November 8, 2023

There are 6 speakers on the call.

Operator

Good day, everyone, and welcome to the ANI Pharmaceuticals, Inc. 3rd Quarter 2023 Earnings Results Call. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask a question during the question and answer session. Please note this call is being recorded.

Operator

I will be standing by should you need any assistance and if At this time, it is my pleasure to turn the conference over to Judy DiClemente with Investor Relations for ANI. Please go ahead. Thank you, Jamie. Welcome to ANI Pharmaceuticals' This is Judy DiClemente of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Rawani, President and Chief Executive Officer and Stephen Carey, Chief Financial Officer.

Operator

You can also access the webcast of this call through the Investors section of the ANI website at www.anipharmaceuticals.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 ANI Pharmaceuticals' management as of today and involve risks and uncertainties, including 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.

Operator

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, anipharmaceuticals.com. For the benefit of those who may be To the replay or archived webcast, this call was held and recorded on November 8, 2023. 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.

Operator

Nikhil?

Speaker 1

Thank you, Judy. Good morning, everyone, and thank you for joining the ANI Pharmaceuticals 3rd quarter earnings call, Our time tested values of teamwork, Innovation, integrity, compliance, accountability, commitment to excellence and always putting the patient first Guide us every day as we keep striving for serving patients, improving lives. Turning now to our business performance for the Q3. Steve and I will share the details of our financial results, The momentum we've built across key business segments and our overall confidence in the company's ability to drive sustainable profitable growth. I'm delighted to share that clarity of strategy and very strong execution has enabled ANI to deliver another record quarter for revenue and adjusted non GAAP EBITDA.

Speaker 1

This record quarterly performance also allowed us full year 2020 fee guidance for the Q3 in a row. This morning, we reported record net Quarterly revenues of $131,800,000 an increase of 57% over the Q3 of 2022 and up 13% for the record we achieved last quarter. Equally impressive, our adjusted non GAAP EBITDA was $36,500,000 a 98% Year over year increase and our adjusted non GAAP diluted EPS was $1.27 representing a nearly 118% increase over the Q3 of 2022. These results and the Q4 outlook for all segments have allowed us to once again raise our full year 2023 guidance. We now expect Net revenues to be in the range of $468,000,000 to $478,000,000 adjusted non GAAP EBITDA to be between $128,000,000 $133,000,000 and adjusted non GAAP earnings per share to be between $4.29 to $4.57 The midpoint of the revised total company Guidance represents remarkable year over year growth in net revenues of approximately 49%, Adjusted non GAAP EBITDA of 133 percent and adjusted non GAAP earnings per diluted share of 226%.

Speaker 1

Now let's take a closer look at our performance and the progress made against strategic imperatives for our key business segments, Starting with our rare disease business. We believe our rare disease business will continue to be the largest driver of ANI's We will deliver this growth through the purified Cortrophin Gel launch momentum as anchor and by adding assets that leverage our rare disease an increase of 136% over the prior year and up 22% compared to the Q2 of 2023. We also saw increasing momentum with new unique prescribers, including many prescribers who were The company's efforts to increase effectiveness of the field sales force An improved awareness of ACTH therapy for appropriate patients have yielded results. The outlook for the overall ACTH category remains robust with 6 consecutive quarters of year over year growth according to IQVIA. We saw ongoing strength in our targeted specialties of neurology, nephrology and rheumatology.

Speaker 1

In addition, we made gains through positive patients in response to the company's entry into the pulmonology specialty. Also during the quarter, we announced the FDA approval and commercial availability of the new 1 ml vial size of Cortrophin Gel. The only approved For acute gouty arthritis flares is supported by ANI's existing sales force. And while it is Still early in the launch, we are already receiving positive physician response. Recently, the company received a specific J code for Cortrophin to support physician administration of the 1 ml vial.

Speaker 1

With momentum from our initial 3 priority specialties And good progress made with the 2 new specialties, we are raising our full year revenue guidance for Cotrophin Gel to $100,000,000 to $107,000,000 up from the previous range of $90,000,000 to $100,000,000 The new range represents year over year revenue growth of between 140% 157% compared to the $42,000,000 recognized in 2022. As we approach the end of 2023 And moving to 2024, our company remains actively committed to increasing the scope and scale of our rare disease portfolio through M and A and in licensing by leveraging our financial strength and the rare disease infrastructure and capabilities that we have built. Turning now to our generics, established brands and other segments, which also delivered strong results during the quarter by growing by 43 year over year to $102,100,000 in the 3rd quarter. As with the Prior two quarters, we were able to leverage the company's operational excellence and U. S.-based manufacturing footprint to fill the gap In pharmaceutical shortages due to supply chain disruptions, while some of the market opportunities from the past three quarters have softened, We remain poised to capitalize on current and future opportunities as an established and reliable partner of choice for our Customers, our strong R and D organization continued to deliver with 5 new product launches, including colestipol hydrochloride tablets, estradiol gel 0.1% and thyroid tablets.

Speaker 1

In addition, We filed 3 new ANDAs and 2 new 505(2) applications during the quarter. We also retained the number 2 ranking in competitive generic therapy approvals. Going forward, Our aim for the generics established brands and other segments is to remain focused on driving growth to superior new product launch execution, Operational excellence, cost competitiveness and supply reliability with a patient first orientation. To support the ongoing growth of this segment, the company has invested in expanding the manufacturing footprint and capacities at the New Jersey site and expect these to be operational by early 2024. With all that we've put in place during 2023 across all areas of the business, we are confident in our ability to build a sustainable biopharmaceutical company, serving patients, improving lives.

Speaker 1

I'll now turn the call over to Steve, who will walk through our Q3 financial results and revised guidance in more detail. Steve?

Speaker 2

Thank you, Nikhil, and good morning to everyone on the call. As Nikhil indicated, we posted very strong results in the Q3 of 2023. We saw growth across our core businesses generating record 3rd quarter revenues of 131,800,000 This represents $48,000,000 or 57 percent growth over the 83,800,000 reported in the Q3 of 2022 and a 13% sequential increase From the $116,500,000 of revenues reported in the 2nd quarter, which had been the company's previous record. Revenues from Cortrophin reported in our rare disease segment were $29,700,000 in the quarter, up 136% from the prior year. Revenues of our generics, Established Brands and Other segment rose $30,900,000 to $102,100,000 an increase of 43% over the prior year.

Speaker 2

Net revenue gains across the segment increased volumes on the base business, annualization of 2022 launches and new product launches in 20 From a product perspective, performance was driven by revenues from year over year gains in products such as colestipol, Famotidine, mixedancetaminasealt extended release, nitrofurantoin and thyroid tempered by a decrease in revenues of Fenofibrate, nabivolol and pryzocin among others. As Mikhail mentioned earlier, our strong commitment to U. S.-based manufacturing and excellence in generic R and D, Procurement and sales and marketing have enabled ANI to meet market demand for key products in the face of competitive supply chain issues throughout the 1st 3 quarters of this year. The market conditions for specific molecules have changed recently. And as a result, we currently expect 4th quarter established brand revenues to be significantly lower than that that we are reporting this morning for the Q3 of 2023.

Speaker 2

We do expect Importantly, the steps that we have taken to enhance the capabilities of ANI have increased our ability to service Operating expenses during the Q3 increased by 28% to $113,900,000 For the 3 months ended September 30, 2023 compared to $88,800,000 in the prior year period. Cost of sales, excluding depreciation and amortization, increased by $15,200,000 to $48,100,000 in the Q3 of 2023 compared to $32,900,000 in the prior year period driven by significant growth in sales volumes of generic and rare disease pharmaceutical products. Research and development expenses were $11,100,000 in the Q3 of 2023, An increase of $3,500,000 from the prior year period, primarily due to $1,600,000 in expenses related to a 505(2) filing and a higher level of activity associated with ongoing and new projects in the current year period. Selling, general and administrative expenses increased by 40% for $42,000,000 in the Q3 of 2023 compared to $30,100,000 in the prior year period, Primarily due to increased employment related costs as well as an overall increase in activities required to support the significant growth in our business. Depreciation and amortization expense was $15,200,000 for the 3 months ended September 30, 2023, an increase of $1,000,000 from the prior year period.

Speaker 2

During the quarter, we recognized a gain of $2,600,000 arising from the Nabidium contingent consideration fair value adjustment Compared to a loss of $2,500,000 in the prior year period, primarily due to a change in the anticipated cash flow, Specifically extending the timeframe over which cash flows will be generated by the product and the passage of time as well as an increase to the probability of payment for the product development based milestone payments. Regarding the closure of our Oakville, Ontario, Canada manufacturing plant, There was no P and L impact in the current year period as our restructuring activities are essentially complete. This is compared to $1,500,000 of restructuring expense recorded in the prior year period. On November 6, 2023, we entered into an agreement for the sale of the site for a total sale price of CAD17.85 million or approximately CAD13 1,000,000 Based on the current exchange rate, closing of the sale is currently expected to occur in the Q1 of 2024. Net income available to common shareholders Diluted GAAP earnings per share was $0.45 as compared to a $0.55 loss in the prior year period.

Speaker 2

On an adjusted non GAAP basis, we had diluted earnings per share of $1.27 for the quarter compared to Non GAAP EBITDA for the Q3 of 2023 reached a new company record of $36,500,000 and reflects gross profit pull through from the strong revenue performance. This is an increase of $18,100,000 compared to the $18,400,000 posted in the prior year period. Adjusted non GAAP EBITDA also rose $2,400,000 on a sequential basis, up from our previous record 34,100,000 recognized in the Q2 of 2023. From a balance sheet perspective, We ended the quarter with $193,100,000 in unrestricted cash, driven in part by cash flow from operations of $32,100,000 during the quarter ended September 30, 2023. On a 9 month year to date basis, we have generated $74,200,000 of cash flow from operations.

Speaker 2

We have $294,800,000 in face value of outstanding debt, which is due in November of 2027. As of the balance sheet, our gross leverage is 2.3 times And our net leverage is less than one time trailing 12 month adjusted non GAAP EBITDA of $126,900,000 Finally, as Nikhil mentioned And as outlined in this morning's press release, we are pleased to raise full year 2023 guidance as follows: $8,000,000 $478,000,000 up from the previously issued guidance of 425,000,000 and $445,000,000 representing approximately 48% to 51% growth as compared to the $316,400,000 recognized for full year 2022. We are raising total company adjusted non GAAP EBITDA to be between $128,000,000 and $133,000,000 up from previously issued guidance of $115,000,000 And $125,000,000 representing approximately 129% to 138% growth as compared to the $55,900,000 recognized in 2022. We are raising total company adjusted non GAAP earnings per share to $4.29 to 4 point representing approximately 2 15 percent to 2 36 percent growth as compared to the 1 point $0.36 reported in 2022. We are raising Cortrophin's specific revenue guidance to be in the range of $100,000,000 to $107,000,000 up from previously issued guidance Up $90,000,000 to $100,000,000 representing 140% to 157% growth as compared to the $41,700,000 recognized in 2022 And we now project total company non GAAP gross margin to be between 63% and 63.8 percent as compared to the previously issued guidance of 63% 64.8%.

Speaker 2

In addition, we currently anticipate between 19,200,000 19,300,000 The company will continue to tax effect adjustments for We will now open up the call to questions. Operator, please announce the instructions.

Operator

We'll take our first question from Les Luszky with Citrus Securities.

Speaker 3

Good morning. Thank you for taking my questions. First, I want to start off on the generics front. It seems to be that there is a shift in tone In gravitation towards a little bit of the weakness that you're seeing, can you just talk a little bit about that, which categories essentially? And then a follow-up to that is, what is the reasoning behind the And the manufacturing footprint, given the softness in the market or maybe it's a little bit exaggerated.

Speaker 3

Just Give me a

Speaker 2

little more color if you can.

Speaker 1

Sure. Good morning, Wes, and thank you for your question. I think first on the softness, look, the softness is that we've spoken to is with regards to the Specifically to opportunities that arose from specific product level opportunities that arose from supply chain disruptions, Right. We remember we had spoken about several structural factors such as product specific issues, manufacturing, site related issues arising from FDA audit Outcomes and company specific financial issues, all of these for our competitors that have resulted in opportunities for us. So when we're talking about softening, we're specifically speaking to specific Across multiple products, across generic and established brands, softening of These product level opportunities.

Speaker 1

Now the mix of current opportunities, new opportunities and return of opportunities that have On a way, it's very dynamic and evolving. Therefore, we focus our guidance on sort of overall company numbers, right? And going to your second question, which is so the softening again is related to specific supply chain disruption related opportunities that came up. As Steve mentioned in his remarks and so did I that we continue to believe in the growth of the generic business And the expansion at the New Jersey site is to support that growth, that multiyear growth, right? So this is the addition of additional In the New Jersey side to support the next 2, 3 years' worth of growth based on products that we have in our portfolio, Opportunities, so that's new, you know, existing products, opportunities in our pipelines that are new products that we're going to bring to the market.

Speaker 1

So it's supporting that growth.

Speaker 3

Nikhil, that's helpful. Perhaps I'll reframe the question in another way. Are you seeing market weakness or are you Seeing more of just the supply chain essentially kind of resolving and stabilizing.

Speaker 1

Yeah. So You're seeing specific resolution of certain supply chain related disruptions. We still think That the macro trends that give rise to the supply chain disruptions, which is the product specific issues, the manufacturing cycle related issues, The company specific financial issues, all of these are persisting. So the market macro trend is persisting. We're saying that specific opportunities that we had related to these trends are softening.

Speaker 1

Some of those are softening Is what we're speaking towards. Yes. So we're not talking about overall market weakness at all. Of course, you've Heard from many of our competitors in the generic space and I think you've seen the strength in what they're reporting.

Speaker 3

I have, yes, and that is helpful. Thank you. Okay, just moving on. On the control front side, so the 1 milliliter Dosage, is there a difference in shelf life? And would you see a prescriber appealing Prescribing this off label and what essentially is the appeal to prescribers and what's the kind of potential opportunity for this dosage?

Speaker 1

Yes. Look, the launch of the 1 ml vial size and the commercial availability of that It's for the adjunctive treatment of certain patients with acute girdle arthritis flares. And Recently, the company received a specific J code for Cortrophin

Operator

to support

Speaker 1

physician administration of the 1 ml vial. So the 1 ml vial is for Acute gouty arthritis layers and certain patients or adjunctive treatment of certain patients would be acute gouty arthritis layers. While we've received positive initial physician response, we're very early into this launch. We would love to share more At the next earnings or as the loan Chivals.

Speaker 3

Got it. Okay. And just to go back Generics briefly. On the 3Q results, was the impact driven primarily by seasonality, you'd say, the Strength, some sort of perhaps inventory stocking or just product channel mix? And then how do you envision essentially Given what we discussed earlier, the 24 to kind of shape out?

Speaker 3

Thank you.

Speaker 1

Yes. I think the The Cinex Q3 performance is driven by a combination of new product launches, Opportunities from the supply chain disruptions and continued strong performance with our base business. So it's there's You asked the question around seasonality. We don't believe that from the product portfolio we have, there's a seasonality impact on that. And then as far as 2024 goes, look, we're working through many moving parts and we'll plan on releasing Our 2024 financial guidance on our year end earnings call, which will occur towards the end of February, We continue to as you would have seen even in the R and D expense, we continue to invest in R and D for the Genex business to support the future growth.

Speaker 1

And that growth will come from new product launches, cost competitiveness and supply chain reliability. Thank you, Les.

Speaker 3

Got it. Yes, thank you for that. Congrats on the quarter again guys and good luck on the execution. Yes. Thank you, Les.

Speaker 2

Thank you.

Operator

We'll take our next question from Vamil Divan with Guggenheim Securities.

Speaker 4

Great. Thanks for taking my questions and congrats on another strong quarter here. So Couple of questions for me. First on the Cortrophin side, you mentioned you talked about the one in Mala. I'm curious about the gouty arthritis Opportunity in particular and that is sort of a unique one for you.

Speaker 4

Can you maybe just quantify, I guess initially any sort of Feedback or kind of thought your interest in that indication, but also just quantify what you see as a potential opportunity in that specific indication? And then my second question is going back to some of the comments around the softening that you're seeing. I mean, the main thing is really around, frankly, 4, And I know you're not going to give guidance until sort of end February, but as I look at things right now based on where you're planning to leave 2023, It looks like that sort of consensus numbers are assuming very minimal sales growth for next year and EPS is actually sort of below where you would leave this year. So just wondering if you can provide any color at all on how we should think about sort of trajectory for the different businesses for next year at this point, understanding that we'll give more detail A few months from now, but it does seem like there's a pretty big disconnect from the trajectory of the business and where consensus numbers are right now for next year.

Speaker 1

Good morning, Valu, and thank you for your questions. I think first, your question around gout. Like many of our other indications, multiple sclerosis, rheumatoid arthritis, etcetera, we're focused on Patients for whom current treatments are not sufficient. In the case of gout flares, there are patients acute gouty arthritis flares. There are patients who might benefit from an additional option from the other therapeutics that are available.

Speaker 1

We have received positive initial Physician response at this so far, it's not something that we can we're able to quantify at this point or And again, as we've done consistently, we try to find the balance between sharing information to assist the investment community while not Giving away competitively sensitive data. So please stay tuned and we'll come back To share more about the GauC launch, you should know that we have assumed no material revenues From GAAP in the 2023 guidance. So I think that could be a pointer just to because it's early days in the launch. And then going back to your question, which your second question around the 2024 and how that links to the 2023 guidance. I mean, Bumble, you've been working with us long enough to know that We as we've done consistently, we deliver what we commit to and this is the continuation of that philosophy Of being more conservative while giving guidance.

Speaker 1

And in terms of 2024, We do see continued evolution of the PCG launch, right? Ongoing strong execution in our genetics business. We've also talked about the efforts that we're making to leverage the PCG launch So as our anchor asset in rare disease and build on that through M and A and in licensing and we've been actively working on that. So as you can see that there are multiple moving parts, right? Even the supply chain disruptions, right, As I've spoken about, there are opportunities that we've had.

Speaker 1

Some of them have gone away. There are new ones that are in the bucket. There are current ones that are persisting. So There are many moving parts that we're working through, the Cortrophin evolution, strong Cortrophin evolution, the rare disease M and The generics growth and the status of the supply chain disruptions, and we plan on releasing our 2024 financial guidance as we move forward.

Speaker 4

Okay. All right. Thanks. And then just one quick follow-up, just again on the sort of commentary Softening in specific markets you're seeing, would you say is that more on the generic side or more on established brands? Is there any way just sort of give us A little bit of directional sense on where you might be seeing what is the impact?

Speaker 1

Sure. So we are seeing impact Across products both in generics and in established brands, in generics, some of the as Steve mentioned in his remarks, The growth that we're seeing from the other products and the new launches is tempering some of that decline. So in The Q4 numbers, you will see the impact more on the established brand side than you will on the generic side.

Operator

We'll take our next question from Oren Livnat with H. C. Wainwright.

Speaker 5

Thanks for taking my questions. If I could just, I guess, approach the same discussion from a little bit different perspective. Obviously, you raised guidance dramatically from the beginning of the year from initial guidance, I think about $100,000,000 90% EPS raise, Mostly from the generics. When you issue guidance, I guess, how conservative are you being? How are you looking at the world with regards to all these disruptions and opportunities you have?

Speaker 3

Do you have to do

Speaker 5

you have much visibility on these looking forward? Or do you assume the ones that you already have in hand will And shortly looking forward to be extremely conservative in your guidance, I guess, what I'm asking is, it's not surprising that some of the Opportunities you've experienced this year are rolling off, right? They don't last forever. But when you give first time guidance next year or when you have given guidance each Quarter this year, what are you assuming for the durability of those opportunities? And do you build in really anything for

Speaker 1

you for your question. Look, I think we've spoken about this, which is that when we speak to guidance When we're giving guidance, we obviously bake in the performance of the previous quarter and then assume that with the many moving parts, our best Understanding of what subset of those opportunities will continue in the subsequent quarters, right? And we have some understanding, right? If there's a site related issue, it takes time to resolve those. If there's a product level Specific technical issue with 1 player in a 5 player market, then we know that that could be shorter.

Speaker 1

So we bake in that understanding As we're giving guidance and I think to use words that Steve has used before and he's describing these, There's always more in the previous period Supply chain of opportunities from the supply chain that we assume in the future, right? So our assumption When we were doing that, we're not assuming that these will persist forever and that's why we bake that in as we give guidance. Of course, as we learn more, we try to share that and continue our philosophy of seeing what we'll deliver and deliver what we're saying.

Speaker 5

Okay. And I think I appreciate you unless I misheard you, you said the biggest quarter over quarter Change in Q4 should be on the branded side. We're not used to seeing the legacy brands. We're not used to seeing Similar disruptions, I guess, on the brand side like we do in generics with products coming and going. Can you comment on whether the tailwinds you've had this year have been mostly a volume or a price benefit?

Speaker 5

And to the extent that that's moderating going forward, is that due to pricing dynamics? If it's price, is that due to Softening in general, whether that's because of payers and contracting, etcetera? Or is it purely a supply and demand issue that products Leave the market and come back. Prices adjust accordingly.

Speaker 1

Yes. No, thank you for that question, Oren. It's all volume related Or but in large portion related to volume. It's not driven by pricing. So I think there's the second part of your question.

Speaker 1

Yes, it's

Speaker 5

helpful. And can you comment on generics, I guess, portfolio pricing trends

Speaker 3

in general? I mean,

Speaker 5

historically, we've gotten commentary from other Trends in general, I mean historically we've gotten commentary from other players about double digit year over year declines or not. Is that something you can comment Across your portfolio?

Speaker 1

Yes. I think it's much like the larger players and their commentary. We have Seeing some improvement in the degree of generic pricing decline. And Yes. I think that versus what it was in past periods, we've seen some improvement.

Speaker 1

These are not Separated from the macro trend of supply chain disruptions. And as our customers, right, their number one Objective is to ensure that product is available for their patients. And as they solve for that, There is lesser of a pricing decline, pricing erosion on base products than we've seen in the past.

Speaker 5

All right. That's encouraging. And then just last on the generics business. Are you able to comment on the, I guess concentration of your portfolio, I think historically you've had a pretty well diversified Portfolio is not enormous. It's spread pretty well.

Speaker 5

Can you talk about how that's changed this year with some of these benefits? Are there any 1, 2 or handful of Single or handful of revenue percentage

Speaker 1

And your portfolio now? Yes. I think that the diversification of our product portfolio across the GNAX In the generics business that has seen benefits from the supply chain disruptions and not one has There are different scales of it, but there are multiple products that have seen the benefit. And I'll let Steve sort of Jump in with, is there a specific product that is, I don't think so, that is disproportionately large of our overall generic business. I think it's still top 10%, but Steve, you can just clarify.

Speaker 2

That's correct, Nikhil and Oren. On the generic side of the portfolio, the company Throughout the years, rates driven to diversify the generics and At this moment in time, I would say we have quite a diverse portfolio and no single product

Speaker 5

And just lastly, the rare disease business has been outperforming as well. I don't want to only focus on generic. Can you talk about The investment there, I think once upon a time you told us you expected this year to have approximately 10% In year over year direct spend on that business, is it safe to assume that you've been investing more behind that than originally planned because of Outperformance and is that necessary to support the demand? Or are you actually investing more to drive more demand now and going forward?

Speaker 1

Yes. Thank you, Oren. No, I think that our

Speaker 3

we have From an SG and A perspective, in line with the numbers that you mentioned, which is 10% -ish year on year over year increase.

Operator

At this time, as we have no questions standing by, I will turn the conference back over to Nikhil Lalwani for any additional or closing comments.

Speaker 1

Thank you everyone for joining our call this morning. We believe that our efforts during 2023 have created a strong foundation For continued success and fulfilling our purpose of serving patients, improving lives. We look forward to updating you on our

Operator

Ladies and gentlemen, that does conclude today's conference. Thank you for your participation. You may disconnect at this time.

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Key Takeaways

  • Record Q3 results: Net revenues of $131.8 M (+57% YoY) and adjusted EBITDA of $36.5 M (+98% YoY) drove adjusted EPS of $1.27 (+118%), enabling ANI to raise full-year 2023 guidance for the third consecutive quarter.
  • Rare disease growth: Cortrophin Gel revenues jumped to $29.7 M (+136% YoY), supported by new prescriber momentum, expanded into pulmonology and a newly approved 1 mL vial for acute gout flares, with full-year guidance raised to $100 M–$107 M.
  • Generics and established brands: Q3 revenues reached $102.1 M (+43% YoY) backed by five new product launches, three ANDA and two 505(b)(2) filings, even as supply-chain tailwinds begin to normalize.
  • Operational investments: U.S. manufacturing footprint in New Jersey is being expanded to support multi-year generics growth with additional capacity expected online in early 2024.
  • Strong financial position: Quarter-end cash of $193.1 M, net leverage under 1x trailing EBITDA, and debt due 2027 at $294.8 M underpin confidence in sustainable, profitable growth.
A.I. generated. May contain errors.
Earnings Conference Call
ANI Pharmaceuticals Q3 2023
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