ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's A&I Pharmaceuticals, Inc., third quarter 2024 earnings results call. Please note that this call is being recorded. After the speaker's opening remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star and the number one on your telephone keypad. If you would like to withdraw your question, please press star two. It is now my pleasure to turn the conference over to Lisa Wilson. Please go ahead.

Thank you, Todd. Welcome to ANI Pharmaceuticals Q3 2024 Earnings Results Call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lawani, President and Chief Executive Officer, Steve Carey, Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. 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 in 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 or recorded on November 8, 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 Lalwani Thank you, Lisa.

Good morning, everyone, and thank you for joining us. Today, I'll start by discussing our third quarter performance and highlights. You'll then hear from Chris Mutz, ANI's Head of Rare Disease. After Chris provides additional color on the progress of this segment of our business, including the integration of Almera, Steve will review the quarter and our updated guidance in more detail. Following our remarks, we'll take your questions. It's an exciting time here at ANI, and we're continuing to execute well this year against our purpose of serving patients, improving lives. In addition, our team delivered record performance during the quarter, for our lead rare disease asset, cortofan gel, and our generics business. We also put a new, more efficient and effective capital structure in place and completed the acquisition of Almera on September 16th. As you've heard me outline previously, Almera is highly synergistic to our rare disease business, and we believe our proven commercial execution capabilities can further unlock the potential for alluvion and butique to growing and durable assets, as well as accelerate the growth of cortofan gel in ophthalmology. Integration remains one of our key priority areas, and I'm pleased with our progress to date. In particular, we have a 45-person combined ophthalmology sales force who have been cross-trained and promoting all three products since mid-October. In addition, We have successfully retained talented Almera employees and taken actions to ensure we are on track to capture $10 million of synergies in 2025. The Almera acquisition is transformative for our rare disease business. We expect the transaction to create substantial shareholder value, driving $35 to $38 million in adjusted non-GAAP EBITDA in 2025, inclusive of the approximately $10 million of identified cost synergies and high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS. In addition, we expect our dedicated ophthalmology team to drive additional cortofan revenues in 2025. Turning to our third quarter financial performance, The company posted another strong quarter, with total revenues of $148.3 million, an increase of 13% over the third quarter of 2023, driven by accelerating demand for cortofan gel and continued strong growth for generics. Adjusted non-GAAP EBITDA was $35.1 million, and adjusted non-GAAP EPS was $1.34. Cortofan gel generated $52.6 million in revenues during the quarter, up 77% over the third quarter of 2023. The third quarter represented continued momentum with the highest number of both quarterly new patient starts and unique prescribers since launch in January 2022. We saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology, and are pleased to report that the prescribing momentum has continued in the fourth quarter with a number of monthly new cases initiated reaching a record high in October. Cortofin remains on a strong multi-year growth trajectory as the overall ACTH category has returned to growth and is expected to deliver more than 20% year-over-year growth in 2024. In addition, the number of patients on ACTH therapy today is still substantially lower than a few years ago. Our generics business delivered another strong quarter with revenues of 78.2 million, an increase of 11% over the third quarter of 2023, and 5.4% over the second quarter of 2024. The solid performance reflected strength in our base business, coupled with contribution from new product launches. During the quarter, we launched five new generics, including some into limited competition markets. Our R&D team continues to build momentum with one additional product launched already in Q4 and submission of several new ANDAs in the fourth quarter. Based on our strong third quarter results, the continued momentum across the business, and the addition of Illumine and Utique, we're pleased to raise our full year 2024 guidance, which Steve will discuss later in the call. I'll now turn the call over to Chris Mutz, our head of rare disease, to discuss cortrophin and our new ophthalmology franchise in more detail. Chris?