ANI Pharmaceuticals - Q3 2023

Transcript

Operator (participant)

Good day, everyone, and welcome to the ANI Pharmaceuticals Inc. third 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. You may register to ask a question at any time by pressing star one on your telephone keypad. If you find that your question has been answered, you may remove yourself by pressing star two. Please note, this call is being recorded. I will be standing by should you need any assistance, and if any audio assistance is needed, you may press star zero. At this time, it is my pleasure to turn the conference over to Judy DiClemente with Investor Relations for ANI. Please go ahead.

Judy DiClemente (IR Coordinator)

Thank you, Jamie. Welcome to ANI Pharmaceuticals third quarter 2023 earnings results call. This is Judy DiClemente of In-Site 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 through 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, 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. 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 listening to the replay or archived webcast, this call was held and recorded on November 8th, 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. With that, I'll turn the call over to Nikhil Lalwani. Nikhil?

Nikhil Lalwani (President and CEO)

Thank you, Judy. Good morning, everyone, and thank you for joining the ANI Pharmaceuticals third quarter earnings call. Thank you for your interest in ANI Pharmaceuticals. First, I would like to express tremendous gratitude to our customers, suppliers, and investors for their strong support of our ANI team and our board as we work tirelessly to fulfill our purpose of serving patients, improving lives. 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 third quarter. 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. This record quarterly performance also allowed us to raise full year 2023 guidance for the third quarter in a row. This morning, we reported record net quarterly revenues of $131.8 million, an increase of 57% over the third quarter of 2022 and up 13% over the record we achieved last quarter. Equally impressive, our adjusted non-GAAP EBITDA was $36.5 million, a 98% year-over-year increase, and our adjusted non-GAAP diluted EPS was $1.27, representing a nearly 118% increase over the third quarter 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 million-$478 million. Adjusted non-GAAP EBITDA to be between $128 million-$133 million. Adjusted non-GAAP earnings per share to be between $4.29-$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%, and adjusted non-GAAP earnings per diluted share of 226%.

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 future growth... We will deliver this growth through the Purified Cortrophin Gel launch momentum as anchor, and by adding assets that leverage our rare disease infrastructure and capabilities. Revenues for Cortrophin Gel totaled $29.7 million in the third quarter, an increase of 136% over the prior year and up 22% compared to the second quarter of 2023. Cortrophin Gel continues to accelerate, with record quarterly new cases initiated and new patient starts. We also saw increasing momentum with new unique prescribers, including many prescribers who were naive to ACTH therapy.

The company's efforts to increase effectiveness of the field sales force and improve awareness of ACTH therapy for appropriate patients have yielded results. The outlook for the overall ACTH category remains robust, with six consecutive quarters of year-over-year growth, according to IQVIA. We saw ongoing strength in our targeted specialties of neurology, nephrology, and rheumatology. In addition, we made gains through positive physician 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 purified ACTH indicated for the treatment of acute gouty arthritis flares. The commercial launch of the 1-mL vial 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. With momentum from our initial three priority specialties and good progress made with the two new specialties, we are raising our full-year revenue guidance for Cortrophin Gel to $100 million-$107 million, up from the previous range of $90 million-$100 million. The new range represents year-over-year revenue growth of between 140% and 157%, compared to the $42 million recognized in 2022. As we approach the end of 2023 and move into 2024, our company remains actively committed to increasing the scope and scale of our rare disease portfolio through M&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 43% year-over-year to $102.1 million in the third 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&D organization continued to deliver with five new product launches, including Cholestyramine hydrochloride tablets, Estradiol gel 0.1%, and Thyroid Tablets. In addition, we filed three new ANDAs and two new 505(b)(2) applications during the quarter.

We also retained the number two 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 through 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. I'll now turn the call over to Steve, who will walk through our third quarter financial results and revised guidance in more detail. Steve?

Stephen Carey (CFO)

Thank you, Nikhil, and good morning to everyone on the call. As Nikhil indicated, we posted very strong results in the third quarter of 2023. We saw growth across our core businesses, generating record third-quarter revenues of $131.8 million. This represents $48 million, or 57% growth, over the $83.8 million reported in the third quarter of 2022, and a 13% sequential increase from the $116.5 million of revenues reported in the second quarter, which had been the company's previous record.... Revenues from Cortrophin, reported in our rare disease segment, were $29.7 million in the quarter, up 136% from the prior year.

Revenues of our generics, established brands and other segment rose $30.9 million to $102.1 million, an increase of 43% over the prior year. Net revenue gains across the segment reflect increased volumes on the base business, annualization of 2022 launches and new product launches in 2023. From a product perspective, performance was driven by revenues from year-over-year gains in products such as Colestipol, Promethazine, Mixed Amphetamine Salts Extended Release, Nitrofurantoin, and Thyroid, tempered by a decrease in revenues of Fenofibrate, Nebivolol, and Prazosin, among others. As Nikhil mentioned earlier, our strong commitment to U.S.-based manufacturing and excellence in generic R&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 first three quarters of this year.

The market conditions for specific molecules have changed recently, and as a result, we currently expect fourth quarter established brand revenues to be significantly lower than that that we are reporting this morning for the third quarter of 2023. We do expect to see ongoing sequential growth in generic revenues. However, it will be tempered by declines in certain molecules. Importantly, the steps that we have taken to enhance the capabilities of ANI have increased our ability to service these supply chain disruptions, and our business is well poised to meet current and future opportunities as they arise. Operating expenses during the third quarter increased by 28% to $113.9 million for the three months ended September 30th, 2023, compared to $88.8 million in the prior year period.

Cost of sales, excluding depreciation and amortization, increased by $15.2 million to $48.1 million in the third quarter of 2023, compared to $32.9 million in the prior year period, driven by significant growth in sales volumes of generic and rare disease pharmaceutical products. Research and development expenses were $11.1 million in the third quarter of 2023, an increase of $3.5 million from the prior year period, primarily due to $1.6 million in expenses related to a 505(b)(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% to $42 million in the third quarter of 2023, compared to $30.1 million 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 $16.2 million for the three months ended September 30th, 2023, an increase of $1 million from the prior year period.

During the quarter, we recognized a gain of $2.6 million arising from the Novitium contingent consideration fair value adjustment, compared to a loss of $2.5 million in the prior year period, primarily due to a change in the anticipated cash flows, specifically extending the time frame 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&L impact in the current year period as our restructuring activities are essentially complete. This is compared to $1.5 million 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 CAD 17.85 million, or approximately $13 million, based on the current exchange rate. Closing of the sale is currently expected to occur in the first quarter of 2024. Net income available to common shareholders for the third quarter of 2023 was $9.5 million, as compared to a net loss of $9 million in the prior year period. Diluted GAAP earnings per share was $0.45, as compared to a $0.55 loss in the prior year period. On an adjusted non-GAAP basis, we had diluted earnings per share of $1.27 for the quarter, compared to $0.58 per share in the prior year period.

Adjusted non-GAAP EBITDA for the third quarter of 2023 reached a new company record of $36.5 million and reflects gross profit pull-through from the strong revenue performance. This is an increase of $18.1 million compared to the $18.4 million posted in the prior year period. Adjusted non-GAAP EBITDA also rose $2.4 million on a sequential basis, up from our previous record, $34.1 million, recognized in the second quarter of 2023. From a balance sheet perspective, we ended the quarter with $193.1 million in unrestricted cash, driven in part by cash flow from operations of $32.1 million during the quarter ended September 30, 2023. On a nine-month year-to-date basis, we have generated $74.2 million of cash flow from operations.

We have $294.8 million in face value of outstanding debt, which is due in November of 2027. As of the balance sheet date, our gross leverage is 2.3x, and our net leverage is less than 1x trailing 12-month adjusted non-GAAP EBITDA of $126.9 million.

Finally, as Nikhil mentioned, and as outlined in this morning's press release, we are pleased to raise full year 2023 guidance as follows: We are raising total company expected net revenues to be between $468 million and $478 million, up from the previously issued guidance of $425 million and $445 million, representing approximately 48%-51% growth as compared to the $316.4 million recognized for full year 2022.

We are raising total company adjusted non-GAAP EBITDA to be between $128 million and $133 million, up from previously issued guidance of $115 million and $125 million, representing approximately 129%-138% growth as compared to the $55.9 million recognized in 2022. We are raising total company adjusted non-GAAP earnings per share to $4.29 to $4.57, up from the previously issued guidance of $3.62 to $4.11, representing approximately 215%-236% growth as compared to the $1.36 reported in 2022.

We are raising Cortrophin's specific revenue guidance to be in the range of $100 million-$107 million, up from previously issued guidance of $90 million-$100 million, representing 140%-157% growth as compared to the $41.7 million recognized in 2022. We now project total company non-GAAP gross margin to be between 63%-63.8%, as compared to the previously issued guidance of 63%-64.8%. In addition, we currently anticipate between 19.2 million and 19.3 million shares outstanding for purpose of calculating EPS and a U.S. GAAP effective tax rate of between 9%-13%.

The company will continue to tax effect adjustments for computation of adjusted non-GAAP diluted earnings per share at a tax rate of 24%. We will now open up the call to questions. Operator, please announce the instructions.

Operator (participant)

Thank you. Ladies and gentlemen, at this time, if you would like to ask a question, please press the star key followed by the digit one on your telephone keypad. Again, if you find that your question has been answered, you may remove yourself by pressing star two. Once again, that's star one to ask a question and star two to remove yourself. We will pause for just a moment to assemble our question queue. We'll take our first question from Les Sulewski with Truist Securities.

Les Sulewski (VP of Biotech Equity Research)

Good morning. Thank you for taking my questions. First, want to start off on the generics front. It seems to be that there's a shift in tone in gravitation towards a little bit of a 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 expansion and the manufacturing footprint? Given the softness in the market, or maybe it's a little bit exaggerated. Just give me a little more color if you can.

Nikhil Lalwani (President and CEO)

Sure. Good morning, Les, and thank you for your question. I think first on the, on the softness—look, the softness is, that we've spoken to is with regards to the, very 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, but that resulted in, you know, opportunities for us. So when we're talking about softening, we're specifically speaking to specific, you know, across multiple products, across generic and established brands, softening of, of these product-level opportunities. Now, the mix of current opportunities, you know, new opportunities and return of opportunities that have gone away is very dynamic and evolving.

Therefore, you know, we focus our guidance on sort of overall company numbers, right? And going to your second question, which is, so, 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 multi-year growth, right? So this is, you know, the addition of additional capacities in the New Jersey site to support the, you know, the next two, three 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, and the new products that we're going to bring to the market, so it's supporting that growth.

Les Sulewski (VP of Biotech Equity Research)

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

Nikhil Lalwani (President and CEO)

Yeah. So, we are 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. Some of those are softening is what we're speaking towards. Yeah. 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 you, I think you've seen the strength in what they're reporting, so.

Les Sulewski (VP of Biotech Equity Research)

I have. Yeah, and that's helpful. That is helpful. Thank you. Okay.

Nikhil Lalwani (President and CEO)

Yeah.

Les Sulewski (VP of Biotech Equity Research)

Just moving on. On the Cortrophin 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 a potential opportunity for this dosage?

Nikhil Lalwani (President and CEO)

Yeah, look, the launch of the 1-mL vial size and the commercial availability of that is for the adjunctive treatment of certain patients with acute gouty arthritis flares. Recently, the company received a specific J-code for Cortrophin to support physician administration of the 1-mL vial. So the 1-mL vial is for acute gouty arthritis flares and certain patients, or adjunctive treatment of certain patients with the acute gout, gouty arthritis flares. You know, while we've received positive initial physician response, we're very early into this launch, and we would love to share more at the next earnings or as the launch evolves.

Les Sulewski (VP of Biotech Equity Research)

Got it. Okay. And just to go back to generics, briefly. On the 3Q results, was the impact a lot driven primarily by seasonality, you'd say, the strength, some sort of perhaps inventory stocking or a just product channel mix? And then how do you envision essentially, given what we discussed earlier, the 2024 to kind of shape out? Thank you.

Nikhil Lalwani (President and CEO)

Yeah. I think the generics, the generics 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, you know, there's. You asked the question around seasonality. We don't believe that from the product portfolio we have, that there's a seasonality impact, you know, 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. But, you know, we continue to, as you would have seen, even in the R&D expense, we continue to, invest in, R&D for the generics business, to support the future growth.

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

Les Sulewski (VP of Biotech Equity Research)

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

Nikhil Lalwani (President and CEO)

Yeah. Thank you, Les.

Les Sulewski (VP of Biotech Equity Research)

Thank you.

Operator (participant)

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

Vamil Divan (Managing Director)

Great. Thanks for taking my questions, and, yeah, congrats on another strong quarter here. So a couple questions for me. First, on the Cortrophin side, I know you talked about the 1-mL. I'm curious about the gouty arthritis opportunity in particular, and that is sort of a unique one for you. Can you maybe just quantify, I guess, initially, any sort of feedback or, you know, kind of doctor interest in that indication? But also just sort of quantify what you see as the potential opportunity in that specific indication. And then my second question is kind of going back to some of the comments around the sort of softening that you're seeing. I think the main thing is really around 2024.

I know you're not going to give guidance till sort of end of February, but as I look at things right now, based on where you're planning to leave 2023, it looks like the 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. I'm just wondering if you can provide any color at all on how we should think about sort of the trajectory for the different businesses for next year at this point, understanding that we'll get more details, you know, 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.

Nikhil Lalwani (President and CEO)

All right. Good morning, Vamil, and thank you for your questions. I think first your question around gout. You know, like many of our other indications, right, multiple sclerosis, except, rheumatoid arthritis, et cetera, we're focused on patients for whom current treatments are not sufficient. You know, 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. 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, you know... And again, as we've done consistently, we try to find the balance between sharing information to assist the investment community while not, you know, giving away competitively sensitive data.

So, you know, please stay tuned, and we'll come back, you know, to share more about the gout launch. You should know that we have assumed no material revenues from gout 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, you know, the 2024 and how that links to the 2023 guidance. I mean, Vamil, 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 sort of more conservative while giving guidance.

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

The Cortrophin evolution, strong Cortrophin evolution, the rare disease M&A, the generics growth, and the status of the supply chain disruptions. We plan on releasing our 2024 financial guidance, as we move forward.

Vamil Divan (Managing Director)

Okay. All right, thanks. So just one quick follow-up, just again, on the sort of commentary around the 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 you can just sort of give us a little bit of directional sense on where you might be seeing more of the impact?

Nikhil Lalwani (President and CEO)

Sure. So, we are seeing impact across products, both in generics and in established brands. In generics, some of the, you know, 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 generics side.

Vamil Divan (Managing Director)

Okay. All right. That's helpful. Thank you.

Nikhil Lalwani (President and CEO)

Thank you, Vamil.

Operator (participant)

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

Oren Livnat (Managing Director)

Thanks for taking my questions. If I could just, I guess, approach this same discussion from a little bit different perspective. Obviously, you know, you've raised guidance dramatically from the beginning of the year, from initial guidance, I think about $100 million and 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? Do you have much visibility on these looking forward, or do you assume the ones that you already have in hand will end shortly, looking forward to be extremely conservative in your guidance? I guess what I'm asking is, you know, 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 expected new disruptions to come, you know, beneficial disruptions to come your way? I have a follow-up. Thanks.

Nikhil Lalwani (President and CEO)

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

I think to, you know, use words that Steve has used before when he's describing these. There's always more in the previous period of the supply chain of opportunities from the supply chain than 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, you know, to share that and continue our philosophy of saying what we'll deliver and deliver what we're saying. So.

Oren Livnat (Managing Director)

Okay. 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. You know, 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? And to the extent that that's moderating going forward, is that due to pricing dynamics? If it's price, is that due to dynamics softening in general, whether that's because of payers and contracting, et cetera, or is it purely a supply and demand issue, that as products, you know, leave the market and come back, prices adjust accordingly?

Nikhil Lalwani (President and CEO)

Yeah, no. Thank you for that question, Oren. It's all volume related, you know, in large portion relates to volume. It's not driven by pricing. So I think there's the second part of your question. Yeah.

Oren Livnat (Managing Director)

Can you comment on generics, I guess, portfolio, pricing trends in general? I mean, historically, we've gotten commentary from other players about, you know, double-digit year-over-year declines or not. Is that something you can comment across your portfolio?

Nikhil Lalwani (President and CEO)

Yeah, I think it's much like the larger players and their commentary. You know, we have seen some improvement in the degree of generic pricing decline. And yeah, I think that, versus what it was in past periods, we've seen some improvement. 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, you know, as they solve for that, there is lesser of a pricing decline, a pricing erosion on base products than we've seen in the past.

Oren Livnat (Managing Director)

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, you know, a pretty well-diversified portfolio. It's not enormous. It's spread pretty well. Can you talk about how that's changed this year with, you know, some of these benefits? Are there any one, two, or handful of products that have driven outsized gains? And, you know, what's maybe the largest single or handful of, revenue percentage, in your portfolio now?

Nikhil Lalwani (President and CEO)

Yeah, I think that, you know, the diversification of our product portfolio across the generics business persists. We, you know, we have multiple products in the generics business that have seen benefits from the supply chain disruptions. And, you know, not one has, you know, there are, there are different scales of it, but there are multiple products that have seen the benefits. And, you know, I'll let Steve sort of jump in with, you know, is there a specific product that is, I don't think so, that is, you know, disproportionately large of our, of our overall generic business. I think it's still, you know, up 10%, but Steve, you can just clarify.

Stephen Carey (CFO)

... You know, that's correct, Nikhil and Oren. On the generic side of the portfolio, the company has throughout the years, right, striven to diversify the generics. And at this moment in time, I would say we have quite a diverse portfolio, and you know, no single product you know taking any lion's share of the generics portfolio.

Oren Livnat (Managing Director)

All right. Just lastly, the rare disease business has been outperforming as well. I don't want to only focus on generics. Can you talk about the investment there? I think once upon a time, you told us you expected this year to have approximately 10% year-over-year spend, 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?

Nikhil Lalwani (President and CEO)

Yeah, thank you, Oren. No, I think that our, you know, we have invested from an SG&A perspective in line with, you know, in line with the numbers that you mentioned, which is 10%-ish year-over-year increase. And, yeah.

Oren Livnat (Managing Director)

All right. Thank you. Appreciate it. Congrats on another impressive beat.

Nikhil Lalwani (President and CEO)

Thanks, Oren.

Stephen Carey (CFO)

Thank you.

Operator (participant)

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.

Nikhil Lalwani (President and CEO)

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

Operator (participant)

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