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.