ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to the ANI Pharmaceuticals, Inc., third quarter 2023 earnings results call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask a question during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. If you find that your question has been answered, you may remove yourself by pressing star 2. Please note this call is being recorded. I will be standing by should you need any assistance, and if any audio assistance is needed, you may press star zero. At this time, it is my pleasure to turn the conference over to Judy DiComonte with Investor Relations for A&I. Please go ahead.

Thank you, Jamie. Welcome to A&I Pharmaceuticals' third quarter 2023 earnings results call. This is Judy DiClemente of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Rawani, 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 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 November 8, 2023. 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 Rawani. Nikhil?

Nikhil Rawani Thank you, Judy. Good morning, everyone, and thank you for joining the ANI Pharmaceuticals Third Quarter Earnings Call, and thank you for your interest in ANI Pharmaceuticals. I would like to express tremendous gratitude to our customers, suppliers, and investors for their strong support of our A&I team and our board as we work tirelessly to fulfill our purpose of serving patients, improving lives. Our time-tested values of teamwork, innovation, integrity, compliance, accountability, commitment to excellence, and always putting the patient first guide us every day as we keep striving for serving patients, improving lives. Turning now to our business performance for the third quarter. Steve and I will share the details of our financial results, the momentum we've built across key business segments, and our overall confidence in the company's ability to drive sustainable, profitable growth. I'm delighted to share that clarity of strategy and very strong execution has enabled ANI to deliver another record quarter for revenue and adjusted non-GAAP EBITDA. This record quarterly performance also allowed us to raise full-year 2020 fee guidance for the third quarter in a row. This morning, we reported record net quarterly revenues of $131.8 million. an increase of 57% over the third quarter of 2022 and up 13% over the record we achieved last quarter. Equally impressive, our adjusted non-GAAP EBITDA was $36.5 million, a 98% year-over-year increase, and our adjusted non-GAAP valued EPS was $1.27, representing a nearly 118% increase over the third quarter of 2022. These results and the Q4 outlook for all segments have allowed us to once again raise our full-year 2023 guidance. We now expect net revenues to be in the range of $468 million to $478 million. Adjusted non-GAAP EBITDA to be between $128 million and $133 million. And adjusted non-GAAP earnings per share to be between $4.29 to $4.57. The midpoint of the revised total company guidance represents remarkable year-over-year growth in net revenues of approximately 49%, adjusted non-GAAP EBITDA of 133%, and adjusted non-GAAP earnings per value to share of 226%. Now, let's take a closer look at our performance and the progress made against strategic imperatives for our key business segments. starting with our rare disease business. We believe our rare disease business will continue to be the largest driver of ANI's future growth. We will deliver this growth through the purified cortofan gel launch momentum as anchor and by adding assets that leverage our rare disease infrastructure and capabilities. Revenues for cortofan gel total 29.7 million in the third quarter, an increase of 136% over the prior year and up 22% compared to the second quarter of 2023. Arthrofen gel continues to accelerate with record quarterly new cases initiated and new patient starts. We also saw increasing momentum with new unique prescribers, including many prescribers who were naive to ACTH therapies. The company's efforts to increase effectiveness of the field sales force and improve awareness of ACTH therapy for appropriate patients have yielded results. The outlook for the overall ACTH category remains robust, with six consecutive quarters of year-over-year growth according to IQVIA. We saw ongoing strength in our targeted specialties of neurology, nephrology, and rheumatology. In addition, we made gains through positive physician response to the company's entry into the pulmonology specialty. Also, during the quarter, we announced the FDA approval and commercial availability of the new 1 mL vial size of cortofan gel, the only approved purified ACTH indicated for the treatment of acute gouty operitis flares. The commercial launch of the 1mL vial for acute gouty arthritis flares is supported by ANI's existing sales force. And while it is still early in the launch, we are already receiving positive physician response. Recently, the company received a specific J-code for control to support physician administration of the 1mL vial. With momentum from our initial three priority specialties, and good progress made with the two new specialties, we are raising our full-year revenue guidance for Kotrofen-Kell to $100 million to $107 million, up from the previous range of $90 million to $100 million. The new range represents year-over-year revenue growth of between 140% and 157% compared to the $42 million recognized in 2022. As we approach the end of 2023 and move into 2024, our company remains actively committed to increasing the scope and scale of our rare disease portfolio through M&A and in licensing by leveraging our financial strength and the rare disease infrastructure and capabilities that we have built. Turning now to our generics, established brands, and other segments, which also delivered strong results during the quarter. by going by 43% year over year to 102.1 million in the third quarter. As with the prior two quarters, we were able to leverage the company's operational excellence and US-based manufacturing footprint to fill the gap in pharmaceutical shortages due to supply chain disruptions. While some of the market opportunities from the past three quarters have softened, we remain poised to capitalize on current and future opportunities as an established and reliable partner of choice for our customers. Our strong R&D organization continued to deliver with five new product launches, including cholesterol hydrochloride tablets, estradiol gel 0.1%, and thyroid tablets. In addition, we filed three new ANDAs and two new 505B2 applications during the quarter. We also retained the number two ranking in competitive generic therapy approvals. Going forward, our aim for the generics established brands and other segments is to remain focused on driving growth to superior new product launch execution, operational excellence, cost competitiveness, and supply reliability with a patient-first orientation. To support the ongoing growth of this segment, the company has invested in expanding the manufacturing footprint and capacities at the New Jersey site and expect these to be operational by early 2024. With all that we've put in place during 2023 across all areas of the business, we are confident in our ability to build a sustainable biopharmaceutical company, serving patients, improving lives. I'll now turn the call over to Steve, who will walk through our third quarter financial results and revise guidance in more detail.