ANI Pharmaceuticals, Inc.

Good morning, and welcome to today's program. My name is Nicole, and I will be your conference operator. At this time, I would like to welcome everyone to the A&I Pharmaceuticals Third Quarter 2020 Earnings Results Conference 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 1 on your touch-tone phone. As a reminder, this call is being recorded today, November 5, 2020. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for ANI Pharmaceuticals. Please go ahead.

Thank you, Operator. Welcome to ANI Pharmaceuticals Q3 2020 Earnings Results Call. This is Lisa Wilson of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, our new President and Chief Executive Officer, and Stephen Carey, Chief Financial Officer of ANI. 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 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, 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 5th, 2020. 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.

Thank you, Lisa. Good morning, everyone, and thank you for joining our call. It is an honor to be with you today in my role as President and CEO of ANI Pharmaceuticals. Before we dive into our third quarter results and business update, I'd like to express my appreciation to essential workers, healthcare providers, first responders, teachers and scientists everywhere for their unstinted efforts during the COVID-19 pandemic. I'm also grateful for the strong commitment shown by our ANI team in conjunction with our customers, suppliers, and manufacturing partners to ensure that we continue to supply medicines to patients. Let me also share a little bit about my background, why I joined ANI, and some initial thoughts on ANI's promising opportunities. I've been in the healthcare industry for roughly two decades With the majority of that time spent on specialty pharmaceuticals. Prior to joining ANI in September, I held several roles at CIPLA, most recently as CEO of CIPLA USA, where I oversaw a period of rapid growth. My experience spans branded products, generics, and CDMO business lines. And functionally, my responsibilities have included multi-year strategic planning, accelerating growth through M&A and business development, portfolio development and commercialization, and overall P&L and balance sheet optimization. I've also worked very closely with the FDA on the launch of several complex products. These broad functional and leadership experiences in biopharma are immediately relevant here at ANI. I consider myself to be a growth-oriented leader, and I'm proud of my track record of building cohesive and productive teams that deliver results. all of which I believe align with ANI's goals. Which brings me to why I found the ANI opportunity so attractive. I see enormous capacity for growth, both organically and inorganically, and the potential to build on the core strengths of the business. ANI has a significant opportunity with cortofan gel. I will discuss that more in a few moments. A&I has a diverse portfolio of commercialized branded and generic products and a robust portfolio of AMDAs, several of which have limited competition. We also have a strong North American manufacturing footprint that has become more valuable and can be leveraged further both for serving commercial customers, CDMO clients, and the U.S. government. The manufacturing includes a high-potency hormone facility in Baudette, and lastly, we have a very strong track record in finding accretive inorganic branded generics and CDMO deals to support the organic growth. In my first two months since joining ANI, I've invested a great deal of time starting Cortrofen and familiarizing myself with the intricacies of the Supplemental New Drug Application or SNDA. Based on my observations to date, I can confirm that all stakeholders are working toward a successful refiling in Q1 of 2021 and a subsequent launch. In addition, I have worked diligently to better understand the drivers of operating performance, execution, capabilities, talent, and culture. I toured the Baudette, Minnesota facility in person, and due to COVID constraints, toured the Opal plant in Canada virtually. I have conducted dozens of one-on-ones and several small group discussions with our team. I have also been speaking with our commercial customers, CDMO clients, key suppliers and other stakeholders. This has allowed me to gain a preliminary understanding of where we are strong, where improvements need to be made, and what we need to do to realize the opportunities ahead of us. And importantly, Moving to third quarter results and business update, we have begun to see some rebound after Q2 in select parts of our branded and generic portfolios. We reported third quarter 2020 net revenues of $53 million, adjusted non-GAAP EBITDA of $17 million, and adjusted non-GAAP diluted earnings per share of $0.97. ANI has continued to monitor closely The impact of COVID-related dynamics on our business operations, and we have adapted our plans to deal with its impact. Steve will share a more detailed overview of our Q3 results in a few moments. Let me turn now to our work on the corticofin gel program. First, on the regulatory process, we are focused on resubmitting our S&DA in Q1 2021. We continue making significant progress in assembling a robust and compelling package to submit to the FDA. In parallel, we are working on the operational and commercial readiness for launch. We remain confident in both the quality of our SNDA filing and our market access, demand generation, and patient support plans for Corprofin. Before I turn the call over to Steve, I want to share a few final thoughts as I begin my tenure as CEO. First, I truly appreciate the trust placed in me in this role. Together with our board members, both the longstanding members and our new board members, we will be laser focused on driving shareholder returns. I will share our ambition, long-term strategy, and operational plan along with the full year 2020 results in February. That said, We are not waiting till February to get started. As I speak, we are evaluating strategic inorganic opportunities, working towards increasing the pace of new launches from our ANDA library, leveraging our manufacturing network further, and maximizing value capture from current products. And we remain focused on the corprosan gel refiling and commercialization, placing the necessary resources and attention required as a crucial priority for the company. I'll conclude by saying that I'm excited to be here. I believe I bring fresh energy and perspectives to ANI, and I will work tirelessly to bring value to our stakeholders, to build relationships between ANI and the investment community, and to ensure that patients and prescribers have access to our therapeutics. With that, I'll turn the call over to Steve.