ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q4 2023 Earnings Conference Call February 29, 2024 8:30 AM ET
Company Participants
Judy DiClemente – Insight Communications, IR
Nikhil Lalwani – President and CEO
Stephen Carey – CFO
Conference Call Participants
Gary Nachman – Raymond James
Operator
Good day everyone, and welcome to today’s ANI Pharmaceuticals Inc. Fourth Quarter 2023 Earnings Results Call. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call is being recorded. [Operator Instructions].
It is now my pleasure to turn the conference over to Judy DiClemente, Investor Relations for ANI Pharmaceuticals.
Judy DiClemente
Thank you, Angela. Welcome to ANI Pharmaceuticals’ Q4 2023 earnings call. This is Judy DiClemente of Insight Communications Investor Relations for ANI. With me on today’s call, are Nikhil Lalwani, President and Chief Executive Officer and Stephen Carey, Chief Financial Officer. You can also access the webcast of this call to the Investor 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 projections, 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. The 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. ANI specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.
The archived webcast will be available on our website www.anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 29, 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.
Nikhil Lalwani
Thank you, Judy. Good morning, everyone. Thank you for your interest in the ANI Pharmaceuticals, and for joining our fourth quarter earnings call. First, I want to thank our customers, suppliers, partners, investors and the entire ANI team for their collaboration and significant contributions in delivering on our company’s purpose of serving patients, improving lives.
A strong fourth quarter tapped off a record year and we finished 2023 with $486.8 million in total revenue, an increase of 54% over 2022. Adjusted non-GAAP EBITDA was a record $133.8 million, up 140% year-over-year, and adjusted non-GAAP earnings per share for $4.71, an increase of 246% from 2022. Total revenues for the fourth quarter were $131.7 million, an increase of 40% over the fourth quarter of 2022. Our lead rare disease assets, Purified Cortrophin Gel generated $41.7 million in this quarter, a year-over-year increase of 137% and a sequential increase of 40% from Q3.
For the full year, Cortrophin generated sales of $112.1 million representing year-over-year growth of 169%. I continue to be tremendously pleased by the effort and output of our Rare Disease team in building our Cortrophin Gel franchise. New patient starts accelerated during Q4, with the strongest sequential quarter over quarter growth in revenue to date.
In addition to record new cases initiated and new patient starts, we saw a significant number of first time ACTH users as well as the return of APPs, who had not prescribed ACTH for several years. Our world class rare disease sales and marketing team continues to grow the overall ACTH market and overall awareness of ACTH treatment in the U.S. for appropriate patients. Total ACTH unit volume was up 15% in 2023, compared to 2022 according to IQUVIA.
While the number of patients being treated with ACTH therapy in the U.S., is significantly lower today than it was several years ago. Since the launch of portrayal Cortrophin Gel in the first quarter of 2022, the overall category, ACTH category has experienced seven consecutive quarters of year-over-year growth and the outlook for the category remains robust.
Next, let me share a commentary on performance across specialties. Cortrophin demand growth continued across our specialties targeted at the launch — targeted at launch, which were rheumatology, neurology and nephrology. In the second quarter of 2023, we expanded into pulmonology. And we quickly gained momentum in this therapeutic area during the fourth quarter, with positive physician responses and growth in new cases initiated a new patient starts
Let’s turn next to gout. Cortrophin Gel is the only ACTH product indicated for the treatment of acute gouty arthritis flares. During the quarter we launched a new 1-ml vial size Cortrophin Gel for the treatment of acute gouty arthritis flares. Physicians can now administer Cortrophin Gel in their office when a patient presents with an acute need.
While it is still early in the launch, we are optimistic about the potential of Cortrophin Gel for this indication, which represents a unique opportunity to introduce Cortrophin to new prescribers. As we look ahead to 2024 we expect Cortrophin revenues to grow 52% to 61% to $170 million to $180 million. We believe we are early in the trajectory of Cortrophin Gel and will continue to invest behind the franchise to drive greater adoption across current and new specialty areas.
We are taking several steps in 2024 to further support this important product. We are adding a second geographical reason to our pulmonology sales force, given the strong traction we have seen so far in the therapeutic area. We continue to expand our disease state coverage by adding a small targeted sales force in ophthalmology. This is a specialty where ACTH prescribing has gained traction over the past few years. We believe ophthalmology could be a meaningful growth contributor for profits. We are collaborating with top physicians and scientists to better delineate, Cortrophin Gel’s, activity and mechanism of action and help guide treatment decisions.
We are also continuing our efforts to better support the patient journey and are investing in enhancing the convenience and removing pain points for patients starting on ACTH as the healthcare providers who treat them. Expanding the scope and scale of our rare disease business, M&A and in licensing remains a high priority. We are currently evaluating opportunities with a focus on assets that are on or close to market, and that overlap with our current priority therapeutic areas of nephrology, neurology, rheumatology, pulmonology, and ophthalmology.
We are also considering assets outside of our priority therapeutic areas that would leverage our Rare Disease platform.
Turning now to our genetics business, which delivered another strong quarter. We generated $71.8 million in revenue during Q4, an increase of 24% over the last year, and 2% over the strong revenue we reported in Q3. As to the prior three quarters, we were able to leverage ANI’s exceptional new product launch execution, operational excellence and U.S.-based manufacturing footprint to achieve this growth.
For the full year, our generics business generated sales of $269.4 million representing year-over-year growth of 28%. Three key factors will enable our Jeunesse business to continue delivering robust growth. First, our high-performance R&D team. In 2023, we delivered 11 new product launches and 20 new product filings. In addition, we’ll retain the number two ranking for competitive genetic therapy approvals.
Second, our strong operational backbone and U.S.-based manufacturing footprint. During 2023, we supplied over 1.5 billion doses of therapeutics to patients in need. In addition, our efforts to expand the manufacturing footprint at our New Jersey site are on track to get the site operational by this quarter. The company continues to maintain a strong compliance track record with successful FDA audits across sites. Most recently, on New Jersey site successfully completed both a pre-approval and a pharmacovigilance inspection with the FDA with zero observations.
Third, our systematic and relentless approach to reducing costs, whether it be for raw materials, finished goods or corporate spent. Overall, our generics business remains an established and reliable partner of choice for our customers.
Our established brands business continues to address patient needs, with reliability of supply, a unique set of commercial capabilities, and our opportunistic business development to expand the portfolio. Our overall portfolio is strengthened by this high gross margin, low working capital and strong cash flow generation business. 2023 was a record year for ANI and we’re already off to a strong start in 2024. We look forward to continuing the momentum as we remain focused on serving patients, improving lives.
I’ll now turn the call over to Steve, who will walk through our fourth quarter financial results and in more detail and discuss our guidance for 2024. Steve?
Stephen Carey
Thank you, Nikhil. Good morning to everyone on the call. We posted another strong quarter to close out 2023 with fourth quarter revenues of $131.7 million up to 40%, over the prior year period. Revenues from Cortrophin Gel reported in our Rare Disease segment was $41.7 million, up 137% from the prior year, and 40% from the third quarter driven by increased volume.
Fourth quarter revenues in our generic established brands and other segments were $89.9 million, an increase of 17% over the prior year period. Within this segment, generic revenues for the quarter were $71.8 million, an increase of 24% over the prior year period, and 2% over the third quarter, driven by increased volumes in the base business and contributions for new products launched in both 2022 and 2023.
To continue with this segment, net revenues for established brands and other revenues were $18.1 million in the quarter, a decrease of 3% from the prior year period driven by lower volume. The performance was in line with our expectations as described on the third quarter earnings call, when we noted that the market conditions for specific molecules had recently changed.
Cost of sales, excluding depreciation and amortization, increased 47% to $53.4 million in the fourth quarter of 2023, compared to the prior year period, primarily due to significant growth in sales volumes of both generic and rare disease pharmaceutical products. Non-GAAP gross margin was 59.6%, a decrease of approximately 200 basis points versus the prior year, primarily due to unfavorable product mix.
Research and development expenses increased 89% to $9.9 million in the fourth quarter of 2023, primarily due to a higher level of activity associated with ongoing and new products. Selling, general and administrative expenses increased by 34% to $44.5 million in the fourth quarter of 2023, primarily due to increased employment related costs, rare disease sales and marketing costs, legal expenses, and patient assistance program costs, as well as an overall increase in activities to support growth. Net income available to common shareholders for the fourth quarter of 2023 was $0.7 million as compared to net loss of $4.7 million in the prior year period.
Fourth quarter diluted GAAP earnings per share was four cents, as compared to a $0.28 loss in the prior year period. On an adjusted non-GAAP basis, diluted earnings per share was $1 for the quarter, compared to $0.76 per share in the prior year period. Adjusted non-GAAP EBITDA for the fourth quarter of 2023 was $30.2 million, an increase of 29% over the prior year period.
From a balance sheet perspective, we ended the quarter with $221.1 million in cash. This balance is net of $12.5 million of contingent consideration paid to selling shareholders in the Novitium in the fourth quarter. We generated cash flow from operations of $44.7 million during the fourth quarter, and $119 million for the full year. We have $294 million in face value of outstanding debt, which is due in November of 2027. At the end of the fourth quarter, our gross leverage was 2.2 times and our net leverage was approximately a half a turn of our trailing 12-month adjusted non-GAAP EBITDA of $133.8 million.
Turning to 2024 guidance, we expect total revenue of $520 million to $542 million, which represents growth of 7% to 11% over 2023. For Cortrophin Gel, we expect revenue to be in the range of $170 million to $180 million, representing growth of 52% to 61%. As you consider the quarterly progression for Cortrophin Gel in 2024, please note that general pattern of revenue in 2024 is expected to be similar to that reported in 2023 with a modest quarter-over-quarter decline in the first quarter due to prescription reauthorizations followed by a strong return to growth in the second quarter. This pattern is generally consistent with other rare disease drugs.
For generics, we anticipate high-single digit to low-double digit revenue growth on top of our exceptionally strong performance of 28% year-over-year growth in 2023. We expect pricing dynamics were our base generics business to be similar to that experienced in 2023. Note that our generic guidance does not assume incremental benefit from future competitor supply shortages, which were a tailwind in 2023.
For established brands, given our performance in the first two months of the year, we believe that revenue in the first quarter of 2024 will be higher than that achieved in the fourth quarter of 2023. Despite that, we expect that the significant tailwind driven by competitive supply disruptions in 2023 will moderate on a full year basis in 2024, as our 2024 guidance does not assume any incremental supply tailwind we are currently seeing beyond the first quarter of the year.
Moving down the P&L, we expect total company non-GAAP gross margin between 62% and 63%, which reflects modest erosion relative to 2023, due in large part to product mix. The key factors impacting our 2024 gross margin outlook include higher contribution from Cortrophin Gel revenue, where the margin is meaningfully accretive to our corporate gross margin, offset by lower contribution from established brands, which is our highest gross margin segment.
Given the overall strength in the business, we will continue to invest in key growth initiatives in 2024. And expect total operating expenses to grow essentially in line with revenue growth and below 2023 expense growth. Contemplated in our guidance is increased investment in R&D to fuel generics growth through new product launches, along with further strengthening of the Cortrophin Gel franchise through the initiatives that Nikhil spoke of moments ago. We are also investing in high ROI initiatives, in Cortrophin sales and marketing.
Taking all of those factors into account, we expect full year adjusted non-GAAP EBITDA of $135 million to $145 million and adjusted non-GAAP earnings per share between $4.26 and $4.67 in 2024. We currently anticipate between 19.3 million and 19.7 million shares outstanding for the purpose of calculating diluted EPS, which is reflective of a full year of shares outstanding resulting from our May 2023 equity raise. We currently expect our U.S. GAAP effective tax rate to be between 20% to 22% as compared to 5.5% in 2023. The company will continue to tax effect adjustments utilized in the computation of its adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26%.
We will now open up the call to questions. Operator, please announce the instructions.
Question-and-Answer Session
Operator
[Operator Instructions] We’ll take our first question from Gary Nachman with Raymond James.
Gary Nachman
Hi, guys. Good morning. And congrats on all the progress. First on Cortrophin, the 2024 guidance. Just how much market growth are you assuming versus share gains from Axa [ph]? And any changes in net price anticipated over the course of the year? And what therapeutic areas you think should be the biggest contributors? I guess, looking out into this year since the guidance look pretty solid.
And then just in terms of looking at additional rare disease assets. Just talk about the market, Nikhil, and how many different opportunities you’re looking at currently? Are they mostly in your current therapeutic areas? I know you’re willing to consider assets outside those therapeutic areas as well? And then just in terms of size, how big are they? And are you confident you can get a deal done sometime this year? Thanks.
Nikhil Lalwani
Yeah. Thank you, Gary. Thank you for your question, and good morning. To your first question on Cortrophin Gel guidance in 2024, the overall category outlook remains robust. A number of patients being treated with ACTH treatments of course, for appropriate patients is significantly lower than where it was a few years ago. So the outlook for the category remains robust.
And as you’ve seen, there we have had seven quarters consecutively of quarter-on-quarter year-over-year growth in the number of units. So the growth opportunities in the category as a whole is significant.
Second, your question on price. We try to find a balance between sharing information that assists the investment community while not giving away competitively sensitive data, but publicly, you will see that both our competitor, and we took a 3% price increase on January 1, 2023.
And then third part of your question on Cortrophin was around the therapeutic areas. And look, we see strength in both the therapy that we initially launched with nephrology, neurology, and rheumatology as well as the newer therapeutic areas that we have begun investing in, which is pulmonology, ophthalmology and gout. And we see momentum.
Ophthalmology is clearly new, but we’ve seen momentum across these therapeutic areas. We have, as reported, a record number of new patient starts and new cases initiated in the fourth quarter of 2023. We see that momentum continuing in the first quarter and throughout 2024. And we also have seen growth across these therapeutic areas. So no one therapeutic area to sort of point out.
The second question was M&A. We are – we have been looking for assets for some period of time. We are — again, trying to find a balance between sharing information that’s helpful to the investment community, while not pave away sensitive data, in this case, to the companies that we’re engaged with. But there are companies that we’re engaged with and multiple ones. And they are both ones that they are aligned with our current priority therapeutic areas as well as ones — and therefore, leveraging our sales force and ones that are outside of our therapeutic areas but leverage the rest of our Rare Disease platform.
And of course, as I mentioned earlier, expanding the scope and scale of our Rare Disease business through BD and M&A remains a high priority for the company. Thank you, Gary.
Gary Nachman
Great. Thank you so much.
Operator
The next question comes from Vamil Divan with Guggenheim Securities.
Unidentified Analyst
Hi, this is Daniel on for Vamil. Thanks for taking my question. So based on our analysis of script trends for the fourth quarter, the control on sales were maybe a bit stronger than we had originally anticipated. So like what do you think is maybe the main driver of this? Are there any particular channels that aren’t captured in IQVIA or is it more like a pricing dynamic with improvements seen in net price?
And then a second question is more on the expense side. So I appreciate your overall commentary on what you maybe expect in 2024, but maybe you can give a little more detail on the right down between like SG&A and R&D going forward? Like how do you expect the growth in the more growth in one versus the other? Anything there would be helpful. Thank you.
Nikhil Lalwani
Yeah. Thank you, Daniel, and thank you for joining the call. Look, in your question in — on Q4 Cortrophin performance versus what the IQVIA data is showing, look, for us, revenues trended ahead and will continue to trend ahead due to increased volumes. Key factors driving these are further increase in effectiveness of our existing sales force, the record number of new patient starts and continued growth across specialties we targeted since launch and the new areas such as pulmonology, gout and now ophthalmology.
And then to your second question regarding expenses. We will continue to invest in key growth initiatives in 2024. And as Steve had mentioned, expect total operating expenses to essentially grow in line with the revenue growth and below the 2023 expense growth. And what’s contemplated in our guidance is investment in R&D to fuel the Generics growth, right? Our Generics business is larger, so we’re investing to continue fueling the generics growth through new product launches, right, to be able to deliver the high-single digits, low double digit growth on the Generics business.
And we’ve also talked about increased spend in — on the Cortrophin side to expand that franchise, the Cortrophin Gel franchise, where we are adding sales team members and marketing and sales efforts in our newer specialty areas of pulmonology, ophthalmology and gout. We’re further strengthening the patient support and operations to support the future growth, and there’s also modest R&D spending for Cortrophin on collaboration with top physicians and scientists to better delineate Cortrophin Gel’s activity and mechanism of action and help guide treatment decisions as well as to better support the patient journey and enhance the convenience as well as remove pain points for patients starting on ACTH.
You also asked about, look, what’s the specific, what — is it more in one area versus another? I think we’re investing in both, right? The Cortrophin related initiatives as well as the additional R&D spend to support the Generics business. Thank you, Daniel.
Unidentified Analyst
Hey, great. Thank you.
Operator
The next question comes from Les Sulewski with Truist Securities.
Unidentified Analyst
Hi. This is Jeremy on for Les. Regarding market normalization, what issues are mostly resolved or likely to be resolved this year versus what might still linger? And then also, just any color — more color on the progress in pulmonology from the sales force expansion and any early launch metrics on the 1 milliliter dose? Thanks.
Nikhil Lalwani
Good morning, and thank you, Jeremy. Thank you for joining our call. I think you asked three questions. One was on pulmonology. So on pulmonology, as we had mentioned, we have seen traction, increased number of new patient starts, increased number of new cases initiated and positive physician response seeing the momentum that we have from the first region, right? We had added a smaller sales force in the second quarter of 2023. We’re adding a second geographical region in pulmonology. So we are seeing the traction there and are investing to continue increasing the awareness in the pulmonology facility.
You also asked about the 1-ml vial in the gout therapeutic area. Look, we are optimistic about the potential for Cortrophin Gel for this indication. However, it is early in the launch, and we look forward to sharing updates in the future.
As far as market resolutions and overall market dynamics, the overall macro trend of supply-related tailwind continues. Having said that, what is contemplated in our guidance is for Generics. We have not contemplated any additional benefits from the supply tailwinds and for established brands. We have not contemplated additional tailwinds beyond what we’re already seeing in the first quarter of 2024.
Unidentified Analyst
Thank you.
Nikhil Lalwani
Thank you, Jeremy.
Operator
It appears we have no further questions at this time. I will now turn the program back over to Nikhil Lalwani for any additional or closing remarks.
Nikhil Lalwani
Yeah. Thank you, everybody. Thank you for – again, for spending time with us and for joining our call this morning and supporting the ANI team as we work to fulfill our purpose of Serving Patients, Improving Lives. We look forward to keeping you updated during the year ahead. Thank you.
Operator
This does conclude today’s program. Thank you for your participation. You may disconnect at any time.
