ANI Pharmaceuticals, Inc.

Good morning, everyone, and welcome to ANI's second quarter 2020 earnings conference 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 the star and the 1 on your touch-tone phone. If you would like to withdraw your question, please press the pound key. Please note, this call may be recorded. It is now my pleasure to turn today's program over to Lisa Wilson, Investor Relations for A&I Pharmaceuticals. Ms. Wilson, please go ahead.

Thank you, Christy. Welcome to A&I Pharmaceuticals Q2 2020 Earnings Results Call. This is Lisa Wilson of Insight Communications, Investor Relations for A&I. With me on today's call are Patrick Walsh, Interim President and Chief Executive Officer of 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 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 August 6, 2020. 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 Patrick Walsh.

Thank you, Lisa. Good morning, everyone, and thank you for joining our call today. The COVID-19 pandemic has affected all of us. It has altered our personal lives and has had an impact on our industry. I'd like to personally express my appreciation for our dedicated employees and contract manufacturing network and in our ability to continue supply of medicines critical to patients and caregivers. Let me first start off with a brief overview of our business, including second quarter events and the ways in which ANI is adapting to the pandemic-related headwinds. In the second quarter, both A&I and the broader pharmaceutical industry experienced depressed overall demand for prescription drugs, reflecting declining physician visits, lower hospital admissions across the country. And while our business felt those dampening effects, we are proud of the way we have managed through these challenges. We've kept our manufacturing facilities open, ensuring continuous supply of our medicines, and of course, we've worked tirelessly to keep our employees safe. That said, our products have continued to perform well, albeit at lower levels due to COVID. While some of this weakness is likely to persist into the third quarter, we do anticipate that our portfolio will begin to rebound to pre-COVID levels by year end, assuming resumption of normal patient physician activity, and there's not a significant second wave of COVID. We reported second quarter 2020 net revenues of $48.5 million. Adjusted Non-Gap EBITDA of $15.4 million and Adjusted Non-Gap Diluted Earnings per Share of $0.69. During the second quarter, we continued to expand our commercial portfolio. We announced our sixth generic launch of the year, Mexelatine Hydrochloride Capsules. The annual U.S. market for this product is about $16 million, and this was the first product launch of an ANI product at our Oakville, Canada site. In early June, we acquired Fluconazole tablets for $3 million. The annual U.S. market for this product is approximately $40 million. This product, previously manufactured for a contract client, is also manufactured at our Oakville, Canada site. Let me now turn to cortropin gel and the steps we are taking to resubmit our SMBA application to the FDA. In collaboration with a prominent consulting firm, we completed a comprehensive gap assessment. In parallel, we made significant changes to the leadership team working on this project. And I am confident that we have the right people in place to construct a robust submission. Our first step was to prioritize any deficiencies identified, the majority of which have already been remediated in our gap assessment. And we have established timelines for completing any of the remaining tasks, including additional data to bolster analytical comparability to the legacy drug product. With greater clarity on our path forward, I am confident we can resubmit the SMBA no later than in Q1 of 2021. Importantly, our team is confident about the quality of our filing. As announced earlier this week, we are delighted to welcome Nikhil Lalwani as our new president and chief executive officer, effective September 8th. The depth and breadth of his pharmaceutical industry experience spans generics and specialty pharma, where he has a proven track record in strategic planning, acquisitions, product development, and commercialization. He's delivered results throughout his career, most recently as CEO of CIPLA USA, and we are confident that he will be instrumental in executing our growth strategy at ANI. We also just announced the addition of two talented pharmaceutical executives to our board of directors. Jean Thoma, President and Chief Executive Officer of SPI Pharma, Inc., and Tony Perra, former President of Parr Pharmaceutical. Jean brings deep experience in pharma operations as well as a breadth of pharmaceutical supply chain experience. Tony's strong background in commercial product launch, generic sales and marketing strategy, and a documented track record of successful acquisitions further adds to the board's depth and experience. This further aligns our director representation skill set with the company's strategy and also reflects our commitment to diversity across race, ethnicity, and gender. Collectively, these three individuals strengthen our capability to manage through challenges and to execute on the business development front and to achieve our desired growth goals. Finally, for the benefit of our customers, investors, patients, and other key constituents, We recently overhauled our website and engaged a healthcare-focused investor relations agency to manage our shareholder communications program and outreach with investors. Before I turn the call over to Steve to review the financials, I just want to say a few words about the emergent acquisition recently completed this past January. It is ANI's largest acquisition to date and has increased our commercial portfolio and late-stage generic pipeline. We are pleased with the performance of the emerging portfolio to date, which is running ahead of expectations, and we continue to advance the numerous pipeline products acquired in the transaction. I will now turn the call over to our CFO, Stephen Carey, to discuss our second quarter results. Steve?