ANI Pharmaceuticals, Inc.

Good morning, everyone. My name is Chelsea, and I will be your conference operator. At this time, I'd like to welcome everyone to A&I Pharmaceuticals' second quarter 2023 financial results. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. At that time, if you have a question, please press star and 1 on your telephone keypad. As a reminder, this conference call is being recorded today, August 9th, 2023. It is now my pleasure to turn the floor over to Ms. Judy DiClemente, Investor Relations for A&I Pharmaceuticals. Ma'am, please go ahead.

Thank you, Chelsea. Welcome to A&I Pharmaceuticals Q2 2023 Earnings Results Call. This is Judy DiClemente of Insight Communications, Investor Relations for A&I. 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 A&I website at www.anifarmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to A&I Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website, anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 9, 2023. Since then, A&I 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 Rawani. Nikhil?

Thank you, Judy. Good morning, everyone, and thank you for joining our call and for your interest in A&I Pharmaceuticals. I would like to start this morning's call by thanking the ANI family and our suppliers, customers, partners, and shareholders for all their efforts in enabling us to serve patients in need. I am very pleased to share that the strong momentum seen over the past several quarters has continued into the second quarter of 2023 and across all business segments. This morning, we reported net quarterly revenues of $116.5 million, an increase of nearly 58% over last year, and approximately 9% growth over the first quarter of 2023, which was also a record quarter. Our adjusted non-GAAP EBITDA of $34.1 million also represents a company record and a nearly 246% year-over-year increase. Our adjusted non-GAAP diluted EPF of $1.28 represents almost a tenfold growth over the second quarter of 2022. And the company generated cash of $42 million from operations during the first half of the year. These results and the outlook for all segments of our business have allowed us to once again raise our all-year 2023 guidance. We now expect net revenues to be in the range of $425 million to $445 million, adjusted non-GAAP EBITDA to be between $115 million and $125 million, and adjusted non-GAAP earnings per share to be between $3.62 to $4.11. Let's now take a closer look at the performance and progress made on our strategic imperatives in each segment, starting with our rare disease business. Our goal is to scale up our rare disease business with the successful launch of our lead asset, purified quercrofen gel, and to add assets that leverage the rare disease infrastructure we have built. Revenues for cortofan gel totaled $24.3 million in the first quarter, an increase of 138% over the prior year, and up 49% compared to the first quarter. During the quarter, we saw record numbers across several areas, including new patient starts, new cases initiated, and new unique prescribers. We also have continued growth in repeat prescribers. Growth was achieved across all targeted specialties, including neurology, nephrology, and hematology. Also, during the second quarter, our modest sales team expansion into pulmonology already began gaining momentum. The outlook for the overall ACTH category is also robust, with 12 consecutive months of year-over-year growth, from June 2022 to May 2023, and double-digit growth through all of 2023. We remain focused on continuing to improve how we service patients, physicians, and payers to increase access to ACTH therapy for patients in need. We are raising our full-year revenue guidance for cortofan gel to $90 million to $100 million, up from $80 million to $90 million. The new range represents year-over-year revenue growth of between 116% and 140%. Rare disease remains a critical focus area for ANI, and we expect it will be the largest driver of ANI's growth. Increasing the scope and scale of our rare disease portfolio is a key priority. following our recent successful equity raise, resulting in 80.6 million of net proceeds. In our strong cash flow generation, we believe we are well positioned to build upon the strength of our rare disease platform, and we are actively pursuing M&A and in-licensing opportunities. Turning now to our Genetics, Established Brands, and Others segment, which also delivered strong results during the quarter, growing by 45% year-over-year to $92.2 million in the second quarter. We have continued to build our reputation as a very reliable supplier by leveraging our U.S. manufacturing footprint, maintaining a strong GMP track record across sites, and maintaining healthy inventory levels for finished goods and raw materials. This enabled us to capture opportunities arising from numerous supply disruptions that continue to impact patient access to much-needed medicines across both generics and established brands. For our generics business, we remain focused on driving growth through superior new product launch execution, operational excellence, cost competitiveness, and supply reliability with a patient-first orientation always. During the quarter, our strong R&D organization received four abbreviated new drug applications or ANDA approvals, including cholesterol hydrochloride and nitrofurantoin oral suspension. In addition, we filed multiple new ANDAs and will continue investing in R&D with a focus on niche opportunities to fuel the growth of our generic business. The company also continued to be active on the business development front, acquiring three products from the Acorn Pharma auction. During the quarter, we also expanded commercialization efforts into new sales channels and will continue striving to take our more than 100 product families to patients in need. As previously announced, manufacturing operations ceased at the Oakville, Ontario site in January of 2023. with the successful relocation of the Oakville products to our U.S. facility, and discussions with potential buyers for the Oakville site remain ongoing. For our established brands business, we continue to innovate our commercialization efforts across products. These efforts, coupled with the supply reliability that we have spoken about earlier, have driven our success. As you've heard today, it was an impressive second quarter across multiple fronts, and we're excited to continue the momentum into the second half of the year. I'll now turn the call over to Steve, who will walk through our second quarter financial results and revise guidance in more detail.

Steve? Thank you, Nikhil, and good morning to everyone on the call. As Mikhil indicated, we posted very strong results in the second quarter of 2023, capitalizing on the groundwork we have laid over the past three years to build sustainable growth platforms and strengthen the capabilities of A&I. We saw growth across our core businesses, generating record second quarter revenues of $116.5 million. This represents $42.7 million or 58% growth over the 73.9 million reported in the second quarter of 2022 and is up 9% sequentially from the 106.8 million of revenues reported in our previous record first quarter of 2023. Revenues from Cortofin reported in our rare disease segment were $24.3 million in the quarter, up $14.1 million from the prior year. We believe our first half of 2023 performance creates a strong foundation for achieving our full-year quattrofen revenue goals, which we revised upwards this morning. Revenues of our generics, established brands, and the other segment rose $28.6 million to $92.2 million, an increase of 45% over the prior year. Net revenue gains across this segment reflect increased volumes driven by annualization of 2022 launches, current year launches, and our ability to quickly and effectively respond to evolving market needs. Our strong commitment to U.S.-based manufacturing, excellence in generic R&D, and informed and nimble procurement and sales marketing teams have enabled A&I to meet market demand for key products in the face of competitive supply chain issues. Operating expenses increased by 20% to $104.1 million for the three months ended June 30th, 2023, compared to $86.8 million in the prior year period. Cost of sales, excluding depreciation and amortization, increased by $7 million to $42.3 million in the second quarter of 2023, compared to $35.3 million in the prior year period, primarily due to a significant increase in sales volumes of generic and rare disease pharmaceutical products. Research and development expenses were $7.4 million in the second quarter of 2023, an increase of $3.2 million from the prior year period, primarily due to a higher level of activity associated with generic projects, coupled with an increase associated with projects related to cortosan gel in the current year period. Selling, general, and administrative expenses increased by 21% to $38.8 million in the second quarter of 2023, compared to $32 million in the prior year period, primarily due to increased employment-related costs and increased legal expenditures during the quarter. Depreciation and amortization expense was $14.7 million for the three months ended June 30th, 2023, an increase of approximately $900,000 from the prior year period. We recognized a contingent consideration fair value adjustment related to our 2021 acquisition of Nividium of $1 million of expense in the current year period as compared to $1.1 million of income in the prior year period. Regarding the closure of our Oakville, Ontario, Canada manufacturing plant, there was a de minimis P&L impact in the current year period as our restructuring activities are essentially wound down. This is compared to $2.6 million of restructuring expense recorded in the prior year period. The land and building remain for sale at this time. Net income available to common shareholders for the second quarter of 2023 was $5.8 million as compared to a net loss of $15.3 million in the prior year period. Diluted GAAP earnings per share was $0.29 as compared to a $0.94 loss in the prior year period. On an adjusted non-GAAP basis, we had diluted earnings per share of $1.28 for the quarter compared to $0.13 per share for the prior year period. Adjusted non-GAAP EBITDA for the second quarter of 2023 reached a new company record of $34.1 million and reflects gross profit pull-through from the strong revenue performance. This is an increase of $24.2 million compared to the $9.9 million posted in the prior year period. Adjusted non-GAAP EBITDA also rose $1.1 million on a sequential basis up from our previous record $33 million recognized in the first quarter of 2023. From a balance sheet perspective, we ended the quarter with $161.7 million in unrestricted cash driven in part by cash flow from operations of $20.6 million during the quarter ended June 30th, 2023. On a six-month year-to-date basis, we have generated $42 million of cash flow from operations. The ending cash balance also reflects net proceeds of $80.6 million raised in our secondary equity offering completed in May. This balance, along with expected second half cash flows and $40 million of untapped capacity in our revolving credit facility, placed us in a healthy position to pursue our strategic business development initiatives. We have 295.5 million in face value of outstanding debt, which is due in November of 2027. As of the balance sheet date, our gross leverage is 2.7 times, and our net leverage is 1.2 times trailing 12-month adjusted non-GAAP EBITDA of 108.9 million. Finally, 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 425 million and 445 million, up from previously issued guidance of 385 million to 410 million. representing approximately 34 to 41% growth as compared to the $316.4 million recognized in 2022. We are raising total company adjusted non-GAAP EBITDA to be between $115 million and $125 million, up from previously issued guidance of $97 million to $107 million. representing approximately 106 to 124% growth as compared to the 55.9 million recognized in 2022. We are raising total company adjusted non-GAAP earnings per share to $3.62 to $4.11, up from previously issued guidance of $2.99 to $3.45. representing approximately 166 to 202 percent growth as compared to the $1.36 reported in 2022. We are raising Cotrofin-specific revenue guidance in the range of $90 million to $100 million, up from previously issued guidance of $80 million to $90 million, representing 116% to 140% growth as compared to the 41.7 million recognized in 2022. And we now project total company non-GAAP gross margin of between 63% and 64.8% as compared to previously issued guidance of 60% and 62.5%. In addition, we currently anticipate between $19.1 million and $19.3 million of shares outstanding for second half EPS and a U.S. GAAP effective tax rate of between 6% and 10%. The company will continue to tax effect adjustments for computation of adjusted non-GAAP diluted earnings per share at our blended statutory rate of 24%. With that, we will now open the call to questions. Operator, please announce the instructions.

Yes, sir. At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. And our first question will come from Vamil Devon with Guggenheim Securities.

Great. Thanks for taking my questions. So a couple if I could. One, just on the established brand segment, obviously very strong results again there. I'm just trying to get a better sense of what you see as the sustainability of this level of performance for the next couple quarters, even into next year, just to look at our model. That would be very helpful, obviously, a little bit. I prefer to see that externally, how that's performing, the details. And then the second one, just around your comments around rare diseases and picking up additional rare disease assets to build on what you built with cartropin. I'm wondering if you could just give a little bit more detail there in terms of kind of what you wish to expect in terms of the pace of doing deals or what kind of assets you're looking for and also your willingness to continue to use equity to do an acquisition as opposed to something more cash-based. Thank you.

Good morning, Wilma, and thank you for your question. I'll take the rare disease question first. Look, our corporate development team, led by Chad Gassert, and the executive team have been very active in evaluating the range of opportunities available to us. we remain focused on finding assets or companies that could provide significant synergy in terms of leveraging the infrastructure that we have built around purified protrophin gel. And that's both around the target specialties that we currently call on, as well as the infrastructure, like the rare disease infrastructure around specialty pharmacy distribution, market access, and the patient support hub, all of it, right? So basically assets that can leverage the sales force and the remaining rare disease infrastructure that we have in place. We are encouraged by the potential path forward. uh however you know we remain steadfast in ensuring that we are diligent and highly selective as we seek to deploy the capital towards this strategic imperative and that also you know drives our sort of choice in uh you know uh of how to fund it right obviously we did the equity raise uh earlier this year with the intent of fueling this expansion and expanding the scale and scope of our rare disease business. And that's what that was about, right? So that's that answer. The second is, look, your first question on established brands. You know, ANI's robust results in generic established brands and other segments just showcases our ability to leverage our U.S. manufacturing footprint and our agility in operations to deliver timely solutions to our customers. It's enabled us to capture market demand arising from supply disruptions impacting patient access to much-needed medicines. We see this as a positive trend impacting our business. And, you know, we expect this trend to continue. The degree is what we've factored into the guidance that we've given. And then, as I said earlier, on the established brand, in addition to the, you know, what's driving success is we continue to innovate our commercialization efforts across products and couple that with supply reliability. That's what's driven our success. Thank you, Mamal.

Okay, thank you. Thank you. Our next question will come from Les Saluski with Truist Securities.

Good morning. Thank you for taking my questions, and congrats on the progress. Which particular areas of the market are driving the ACTH growth, and how has the early uptake and control been on pulmonology? Any comments you can give around new patient starts, repeats, or dosing averages? and I guess what have been some of the internal levers that you've been able to pull to drive the growth. And I have a follow-up. Thank you.

Yeah, good morning, and thank you, Les. And, you know, welcome to the ANI call. I believe this is your first time here, so welcome. In terms of what drove the PCG growth, purified corticofan gel growth, it was driven by, you know, record number of new cases initiated, This growth came from a record number of new unique prescribers and continued growth in repeat prescribers. And to your question regarding which specialty, look, we would highlight that the growth was across all targeted specialties of rheumatology, nephrology, and neurology, and also early traction seen by our pulmonology sales team, right? So we've done a modest expansion of our pulmonology sales team, and we've seen early traction sort of strong traction for that team in that indication. And then in addition, we had spoken last quarter about the increased investment in patient support and our hub infrastructure, and we were able to translate the new case momentum to record number of new patient starts. So that's what's driven the growth in Court Proof of Job. I believe you had a follow-up, right?

Yeah, very helpful. Thank you for that. Thank you. And then in regards to some of the R&D pipeline, I mean, what is within generics, which therapeutic areas or product types specifically are of interest to you at this stage? Thank you.

Yeah. Looking in generics, we are continuing to invest in R&D with a focus on niche opportunities. So that's for competition areas. We haven't defined dosage forms, but we keep looking for niche opportunities. And we have a successful track record, and it's really the track record of the company we acquired, Nividium, two years ago, to fuel the growth of our generics business. And you've seen that in the launches that we've brought to the market and the continued growth that we've had in our generics business. We also continue to be active on the business development front opportunistically for smaller asset-level deals, and that's what will – the combination of the strong R&D organization with an established track record along with the smaller business development asset-type deals will drive the pipeline of the genetics business and fuel the growth of our genetics business.

All right, thank you. There are no further questions in the queue at this time, so I would like to turn the call back over to Nikhil Lawani for any additional or closing remarks.

Thank you, Chelsea, and thank you, everyone, for joining our call this morning. ANI is well positioned to continue delivering sustainable growth and serving patients in need. We look forward to updating you on our progress and we appreciate your time and interest in ANI. Thank you.

Thank you, ladies and gentlemen. This does conclude today's call, and we appreciate your participation. You may disconnect at any time.