ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's A&I Pharmaceuticals, Inc., fourth quarter 2023 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 star 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Judy DiClemente, Investor Relations for A&I Pharmaceuticals.

Thank you, Angela. Welcome to A&I Pharmaceuticals Q4 2023 earnings 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 to 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. But 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 on our website, www.anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 29, 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?

Nikhil Lalwani Thank you, Judy. Good morning, everyone. Thank you for your interest in ANI Pharmaceuticals and for joining our fourth quarter earnings call. First, I want to thank our customers, suppliers, partners, investors, and the entire ANI team for their collaboration and significant contributions in delivering on our company's purpose of serving patients, improving lives. A strong fourth quarter capped off a record year, and we finished 2023 with $486.8 million in total revenue, an increase of 54% over 2022. Adjusted non-GAAP EBITDA was a record $133.8 million, up 140% year over year. And adjusted non-GAAP earnings per share was $4.71, an increase of 246% from 2022. Total revenues for the fourth quarter were $131.7 million, an increase of 40% over the fourth quarter of 2022. Our lead rare disease asset, purified cortofan gel, generated 41.7 million in the quarter, a year-over-year increase of 137%, and a sequential increase of 40% from Q3. For the full year, cortofan generated sales of 112.1 million, representing year-over-year growth of 169%. I continue to be tremendously pleased by the effort and output of our rare disease team in building our cortofan gel franchise. New patient starts accelerated during Q4 with the strongest sequential quarter over quarter growth in revenue to date. In addition to record new cases initiated and new patient starts, we saw a significant number of first time ACTH users, as well as the return of ACPs who had not prescribed ACTH for several years. Our world-class rare disease sales and marketing team continues to grow the overall ACTH market and overall awareness of ACTH treatment in the US for appropriate patients. total ACTH unit volume was up 15% in 2023 compared to 2022, according to IQVIA. While the number of patients being treated with ACTH therapy in the U.S. is significantly lower today than it was several years ago, since the launch of corticofan gel in the first quarter of 2022, the overall category, ACTH category, has experienced seven consecutive quarters of year-over-year growth and the outlook for the category remains robust. Next, let me share commentary on performance across specialties. Portrophin demand growth continued across our specialties, targeted at launch, which were rheumatology, neurology, and nephrology. In the second quarter of 2023, we expanded into pulmonology, and we quickly gained momentum in this therapeutic area during the fourth quarter, with positive physician responses and growth in new cases initiated and new patient starts. Let's start next to gout. Portrophan gel is the only ACTH product indicated for the treatment of acute gouty arthritis flares. During the quarter, we launched a new 1 ml vial size of cortofan gel for the treatment of acute gouty arthritis flares. Physicians can now administer cortofan gel in their office when a patient presents with an acute need. While it is still early in the launch, we are optimistic about the potential of cortofan gel for this indication, which represents a unique opportunity to introduce cortofan to new prescribers. As we look ahead to 2024, we expect Cortrofen revenues to grow 52% to 61%, to $170 million to $180 million. We believe we are early in the trajectory of Cortrofen gel and will continue to invest behind the franchise to drive greater adoption across current and new specialty areas. We are taking several steps in 2024 to further support this important product. We are adding a second geographical region to our pulmonology sales force, given the strong traction we have seen so far in this therapeutic area. We continue to expand our disease state coverage by adding a small targeted sales force in ophthalmology. This is a specialty where ACTH prescribing has gained traction over the past few years. We believe ophthalmology could be a meaningful growth contributor for portrophin. We are collaborating with top physicians and scientists to better delineate portrophin gel's activity and mechanism of action and help guide treatment decisions. We are also continuing our efforts to better support the patient journey and are investing in enhancing the convenience and removing pain points for patients starting on ACTH and the healthcare providers who treat them. Expanding the scope and scale of our rare disease business through M&A and in licensing remains a high priority. We are currently evaluating opportunities with a focus on assets that are on or close to market and that overlap with our current priority therapeutic areas of nephrology, neurology, rheumatology, pulmonology, and ophthalmology. We are also considering assets outside of our priority therapeutic areas that would leverage our rare disease platform. Starting now to our genetics business, which delivered another strong quarter. We generated 71.8 million in revenue during Q4, an increase of 24% over the last year, and 2% over the strong revenue we reported in Q3. As with the prior three quarters, we were able to leverage ANI's exceptional new product launch execution, operational excellence, and U.S.-based manufacturing footprint to achieve this growth. For the full year, our genetics business generated sales of $269.4 million, representing year-over-year growth of 28%. Three key factors will enable our genetics business to continue delivering robust growth. First, our high-performance R&D team. In 2023, we delivered 11 new product launches and 20 new product filings. In addition, we retained the number two ranking for competitive generic therapy approvals. Second, our strong operational backbone and US-based manufacturing footprint. During 2023, we supplied over 1.5 billion doses of therapeutics to patients in need. In addition, our efforts to expand the manufacturing footprint at our New Jersey site are on track to get the site operational by this quarter. The company continues to maintain a strong compliance track record with successful FDA audits across sites. Most recently, our New Jersey site successfully concluded both a pre-approval and a pharmacovigilance inspection with the FDA with zero observations. Third, our systematic and relentless approach to reducing costs, whether it be for raw materials, finished goods, or corporate spend. Overall, our genetics business remains 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 our 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. 2023 was a record year for ANI, and we're already off to a strong start in 2024. We look forward to continuing the momentum as we remain focused on serving patients, improving lives. I'll now turn the call over to Steve, who will walk through our fourth quarter financial results in more detail and discuss our guidance for 2024. Steve?