ANI Pharmaceuticals, Inc.

Good morning and welcome to today's program. My name is Maria and I'll be your conference operator. At this time, I'd like to welcome everyone to ANI Pharmaceuticals' fourth quarter and year-end 2020 earnings results and business update call. 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 one on your touchtone phone. As a reminder, this conference call is being recorded today, March 9th, 2021. It's now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for A&I Pharmaceuticals. Please go ahead.

Thank you, Maria. Welcome to A&I Pharmaceuticals Q4 2020 Earnings Results Call. This is Lisa Wilson of Insight Communications, Investor Relations for A&I. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, and Steve Carey, Chief Financial Officer of ANI. You can also access the webcast of this call through the Investors 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 and many more. These forward-looking statements are based on information available to ANI 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 at ANIFarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, This call was held and recorded on March 9, 2021. 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 Lalwani. Nikhil Lalwani Thank you, Lisa.

Good morning, everyone, and thank you for joining our call. I am very pleased to be here to update you on our recent progress and to set forth for you my plan to drive sustainable growth for A&I. This morning, we announced the acquisition of Novidium Pharma. I'll share the details and the value of this important transaction in a few minutes. COVID-19 continues to impact just about every aspect of our personal and professional lives. The impact continues to be felt throughout the pharmaceutical industry and our team has been focused on managing our business through these challenges. I remain grateful and proud of the strong commitment shown by our A&I team in conjunction with our customers, suppliers and manufacturing partners to ensure that we continue to supply medicines to patients in need. Our established brands business experienced the greatest impact from the constraints imposed by the pandemic and our full year results reflect the significant depth seen commencing in March of last year. Steve will provide the full details of our financials, including 2021 guidance, in a few moments. As promised, I will now take you through my strategy to deliver sustainable future growth and create value for our shareholders, while most importantly, serving patients in need. During the past six months, I have taken time to understand the evolving biopharma market dynamics, potential market opportunities, the approaches developed by other players, and ANI's current competitive position. This has helped me crystallize how to build ANI into a successful and sustainable biopharma company and to maximize value for current shareholders. Let me now walk you through the four key pillars of our growth strategy. Our top priority is building a successful Cortropin franchise. Our goal is to submit as robust a package as possible, one that gives us the highest degree of confidence that it will be accepted and ultimately approved by the FDA. Over the past few months, we have actively engaged with the FDA to refine the regulatory path forward. Accordingly, we have made refinements to what we will submit. Based on the refinements, we now believe we are well positioned for resubmission in Q2 of 2021. In addition, we have increased our manufacturing batch size to match our commercial aspirations. Although this impacts our timeline by one quarter, We believe it will result in a more comprehensive and robust refiling to ultimately support approval of Cortrophin. In fact, as part of the Nuvidium acquisition, the Cortrophin refiling approach has been diligenced by a prominent regulatory firm outside of the one that we're currently using and other consultants, and they have each given a thumbs up to the Nuvidium sellers and Ampersand Capital partners. To strengthen our commercialization efforts around Cortrofen, we recently brought on Chris Mutz as Chief Commercial Officer and Head of Rare Diseases. He has been tasked with leading the Cortrofen commercial franchise, including our launch strategy and commercial plan. He brings deep experience in the successful commercialization of rare diseases at both Alexion and Merck, and we look forward to his leadership and guidance of this important franchise. The second pillar to our growth strategy is strengthening our generics business by enhancing development capabilities and enhancing increased focus on niche opportunities. The acquisition of Novidium Pharma announced this morning for 163.5 million is an important step towards achieving this goal. Let me share some of the compelling reasons that led us to doing this transaction. First, Novidium creates a sustainable generics growth engine with over 25 anticipated product launches in 2021 and 2022, including products with competitive generic therapy designation. Furthermore, they have 21 ANDAs on file with the FDA and more than 30 additional products under development. And their leadership team has an excellent track record of execution and efficiency from filing to launch. Importantly, they are currently advancing three 505 candidates in oncology and hypertension. These products will enable us to build on ANI's increasing focus on niche opportunities including a paragraph four filed in 2020 and the anticipated filing of injectable Xandas this year. The transaction will also serve to expand our manufacturing footprint and enhance the scale of our CDMO business. Nuvidium adds nine new customers to ANI's growing CDMO business. Nuvidium has a 50,000 square foot facility for finished doors, R&D, Commercial Manufacturing, and Packaging right here in New Jersey with a further 20,000 square feet expansion plan. Nuvidium's annual production capacity is approximately 2 billion units across tablets, capsules, liquid suspensions, solutions, powders for oral suspensions, control release, and potent compounds. The third component of our growth strategy is to maximize value within our established brands portfolio through continued programmatic business development and use of innovative market access and go-to-market strategies. The deal environment continues to provide good opportunities which can leverage our existing brand infrastructure. In addition, we have been adopting innovative programs that expedite the resolution of prior auth issues and digital tools for engaging prescribers and reducing patient burden. The fourth pillar of my growth strategy is to expand our CDMO business, leveraging our unique North America-based manufacturing capabilities. I just shared how the Novidium acquisition expands our customer base and enhances scale in manufacturing capacity. In addition, I believe we could leverage are fully contained high-potency facility that can manufacture hormonal, steroid, and oncolytic products in Baudet. Our ambition will be delivered by our collaborative, purposeful, and empowered team members with high performance orientation. Our strong internal talent pool complemented by targeted external hires will accelerate our growth. are recent hires of Chris Mutz, Ori Gutwerg, and Devinder Singh. They all hit the ground running from day one. Finally, we are taking steps to strengthen our capital structure with new credit facilities and a pipe. Steve will share the details with you shortly. This capital structure further facilitates achievements of ANI's aspirations. In summary, we have a clear goal strategy and have already taken a major step towards that goal with the acquisition of Novidium and a clear plan laid out for refiling cortofan gel in Q2 of 2021. With that, I'll turn the call over to Steve to discuss our Q4 financials as well as provide guidance for 2021. Steve?