ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. First Quarter 2024 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. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star and two. Please note this call is being recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Lisa Wilson.

Thank you, Shelby. Welcome to A&I Pharmaceuticals Q1 2024 Earnings Results Call. This is Lisa Wilson, 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 ANI website at 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 May 10, 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 Lawan.

Nikhil Lawan Thank you, Lisa. Good morning, everyone, and thank you for your interest in ANI Pharmaceuticals and for joining our first quarter earnings call. The company remains committed to our purpose serving patients, improving lives. On behalf of all of A&I, we are grateful for the continued support of our customers, suppliers, partners, and shareholders. We remain focused on driving growth, continued growth through our rare disease business and our genetics business, both supported by strong cash flow from our established brands business. We're pleased to report record first quarter results and are reiterating our full year guidance for total revenues, cortofan gel revenues, adjusted EBITDA, and adjusted EPS, which Steve will further highlight. Total revenues for the first quarter were 137.4 million, an increase of 29% over the first quarter of 2023. Adjusted non-GAAP EBITDA was $37.6 million, up 14% from the prior year period. Adjusted non-GAAP EPS was $1.21, an increase of 3% over the first quarter of 2023. Our lead rare disease asset, purified cortofan gel, generated $36.9 million of revenue in the quarter, a year-over-year increase of 126%. Our rare disease team continued to execute on successful cortofan gel commercialization in the first quarter, driving prescribing growth across our core specialties of neurology, rheumatology, and nephrology, as well as traction in our newer specialties of pulmonology and ophthalmology. We are pleased to report that the prescribing momentum has carried into the second quarter, and we achieved the highest number of new patient starts since launch during the month of April. On our fourth quarter call, we discussed several investments to support the corticofin gel franchise with the goal of driving greater adoption across current and new specialty areas. I'm proud to update you on the progress made on these initiatives. First, given the strong traction that we have seen in pulmonology, we've announced plans to add a second geographical regions to our pulmonology sales force. This team is now in place and the increased focus is paying off with record new patient starts in the first quarter for pulmonology. We also deployed a small targeted ophthalmology sales force in the first quarter. We see ophthalmology as a meaningful driver of future cortofan gel growth. For both pulmonology and ophthalmology, we also gain traction with new to ACTH prescribers. As you might recall, in the fourth quarter, we launched a new 1 mL vial of cortofan gel for the treatment of acute gouty arthritis flares. We believe that bringing the only ACTH product to market with this indication presents a promising growth opportunity for the Cortofen franchise. We believe Cortofen Gel remains on a strong multi-year growth trajectory, driven both by increased market penetration within core and new indications, as well as further expansion of the total ACTH category. While we have gained significant traction with cortofan gel after a little over two years on the market, the number of patients on ACTH therapy today remains substantially lower than a few years ago. Our prescriber engagement activities and investments to drive growth continue to boost higher utilization by 5%. continue to boost higher utilization by first-time and returning ACTH prescribers as more physicians use cortofan gel therapy for appropriate patients. While we have ample opportunity ahead to maximize cortofan gels potential, expanding the scope and scale of our rare disease business through M&A and in licensing remains a high priority. We are actively evaluating opportunities with a focus on commercial assets that overlap with our current priority therapeutic areas of nephrology, neurology, rheumatology, pulmonology, and ophthalmology, as well as assets outside of these areas that would leverage our rare disease platform. Turning now to our generics business. which delivered another solid quarter with revenue of $70.2 million, an increase of 10% over the first quarter of 2023. A strong new launch execution and operational excellence contributed to this performance. We launched six new products during the quarter, including a competitive generic therapy product with 180-day exclusivity. Notably, we retain the number two ranking for competitive generic therapy approvals and are a top 15 manufacturer in number of product approvals. Overall, our genetics business remains a key growth driver as we leverage our high-performance R&D team, operational excellence, and US-based manufacturing footprint. We remain 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 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. With these results and almost $230 million of cash on hand, the first quarter has set a solid foundation for 2024. We have many important initiatives and opportunities to execute on this year, and we look forward to continuing the momentum. I now turn the call over to Steve, who will walk through our first quarter financial results and 2024 guidance in more detail. Steve?