ANI Pharmaceuticals, Inc.

Good morning, everyone, and welcome to ANI's first quarter 2020 earnings call. At this time, our participants are in a listen-only mode. It is now my pleasure to turn today's program over to Mr. Arthur Prisval, President and CEO of ANI Pharmaceuticals. Please go ahead, sir.

Thank you, Pasha. Good morning, everyone, and welcome to ANI's earnings conference call for the first quarter 2020. My name is Art Prisval. I am the CEO, and joining me today is Stephen Carey, our chief financial officer, and Patrick Walsh, an ANI board member who will be stepping in as interim CEO upon my departure. Before we begin, I want to refer everyone to the forward-looking statements language in this morning's press release and ask each of you to review it carefully as important context for this conference call. Discussions will also include certain financial measures that were not prepared in accordance with generally accepted accounting principles. Reconciliation of those non-GAAP financial measures can be found in our earnings release dated today. ANI reported first quarter 2020 net revenues of $49.8 million, adjusted non-GAAP EBITDA of $17.6 million, or 35% of net revenues, and adjusted non-GAAP diluted earnings per share of $1.04. Our first quarter numbers met our internal expectations. and Steve will provide you with additional commentary on our financial results. In January, we closed our acquisition of Amerigen's marketed products and pipeline. The acquisition increased our commercialized generic product portfolio by nine products from 35 to 44. Throughout the first quarter, we launched five generic products, further expanding our generic product offerings to 49 and our total commercialized offerings, including brands, In March, we filed our prior approval supplement for quaterofan gel and received the PDUFA date of July 23, 2020. After that filing, as announced, we received a refusal to file letter from the FDA, and as a result, we will request a Type A meeting with the FDA in order to discuss the deficiencies identified in the refusal to file letter and our plan to address each of them. As you know, Friday is my last day as CEO of ANI. I would like to take this opportunity to welcome Pat Walsh as the interim CEO of ANI. Pat joined the ANI board in 2018 and has extensive pharmaceutical industry experience, both as a CEO and as a board member. This experience will serve to complement and enhance our commercialization efforts. Finally, I want to sincerely thank my senior staff and all of our employees for their contributions to our success during my 11-year tenure as CEO. Together, we have built ANI from a small private company to a thriving public specialty pharmaceutical business. During that timeframe, we have reported record annual net revenues since 2013, increasing revenues from $30 million in 2013 to nearly $207 million in 2018. At the same time, adjusted non-GAAP EBITDA has increased from $7.5 million in 2013 to over $83 million in 2019. We have a solid balance sheet, continue to generate positive cash flows while maintaining reasonable leverage levels. These results are a further testament to the team at ANI as they were generated against the backdrop of a tough business environment for generic pharmaceuticals. Finally, we continue to have a compelling portfolio opportunity for Cortrophin Gel that still remains transformational for ANI. As I depart, I continue to remain excited about ANI's future. I will now turn the conference call over to our Chief Financial Officer, Stephen Carey, who will provide you with more details on our financial results.

Thank you, Art, and good morning to everyone on the call. The first quarter of 2020 has marked a period of significant activity at ANI. Throughout the quarter, our team was busy successfully integrating a sizable generic product acquisition. In March, our Cortrophin Development Team filed the SMDA for Cortrophin Gel and is currently in the process of requesting a Type A meeting with the FDA. to address the deficiencies identified in a recently received Refusal for File letter. And in recent months, our dedicated team of over 300 employees have rallied to continue to serve the public health care system in the midst of the COVID-19 pandemic. During this time, we also say goodbye to our departing President and CEO, Arthur Prisval, who after leading the growth of A&I over the past 11 years is departing the company effective this Sunday, May 10th. On behalf of the board of directors, senior management, and all employees of A&I, I thank Art for his numerous contributions to the company and wish him well in future endeavors. His legacy is highlighted by the organization he has assembled, and in such, he leads the company in the hands of a strong management team who remain tirelessly committed to A&I and its stakeholders. Our board of directors is currently conducting the search for arch replacement with Hydric and Struggles. And in the interim, we welcome Patrick Walsh, a member of our board to serve as interim CEO. In January of this year, we acquired the U.S. generic product portfolio of American Pharmaceuticals for $52.5 million. We separately purchased $4.3 million of inventory, resulting in a total day one consideration of $56.8 million. The U.S. GAAP allocation of purchase price resulted in the capitalization of $45.2 million of product-related intangible assets and $8.4 million of inventory, which includes a step-up in fair market value of $4.1 million, as well as a $3.8 million charge for in-process research and development. During the quarter, $2.7 million of the inventory step-up was expensed the cost of goods sold and this, along with the $3.8 million IPR and discharge, have been added back for the purpose of calculating our non-GAAP measures. Net revenues for the quarter ended March 31, 2020 were $49.8 million, down $3.1 million or 6% from prior year levels, driven by an $8.4 million reduction in our brand sales. Sales of our generic product offerings were up $5.9 million, or 19% over prior year levels, driven by the launch of vancomycin oral solution and the addition of the Amerigen portfolio. These gains were tempered by year-over-year declines in azetamide simvastatin, EES, and EEMT, all of which sustained competitive impacts over the past year. Gross profit adjusted for the $2.7 million impact of the purchase accounting and an $800,000 reserve against Pertilium finished goods inventory was $31.4 million, or 63% of net revenues, as compared to $38.2 million, or 72% of net revenues in the year-ago period. The approximate nine-point reduction in gross margin was principally the result of negative mix and increased royalties due to profit-sharing arrangements on the products acquired from Amerigen. Excluding the aforementioned IPR and recharges in the quarter, research and development expense was $2.6 million as compared to $4.4 million in the prior year, reflective of a decrease in expense related to the Cortrophin project, as we begin to complete our development efforts. During the quarter, we built an additional $4.6 million of Cortropin DAW material and API inventories to ensure that we have adequate launch quantities in anticipation of an FDA approval of our filing. These amounts were expensed to the P&L on a GAAP basis and added back for our non-GAAP measures. Adjusted non-GAAP EBITDA of $17.6 million was down $4.7 million from our prior year, principally due to the reduction in net revenues and corresponding gross profit. Our first quarter GAAP loss of 59 cents per diluted share includes $6.4 million of American purchase accounting-related charges. As detailed on Table 4 of this morning's press release, are adjusted non-GAAP diluted earnings per share is $1.04 for the quarter as compared to $1.30 in the year-ago period. As of the March 31st balance sheet date, we had $20.4 million of unrestricted cash. This balance is reflective of $55.5 million of cash paid in the quarter to purchase the emergent portfolio 1.5 million dollars of capital expenditures and 15 million dollars of borrowings under our revolving credit agreement. During the quarter, we generated 1.7 million dollars of cash from operations. This figure is lower than a typical quarter for ANI due to the fact that while we had significant initial sales of the Amerigen product portfolio, The lion's share of the receivables related to these sales will not be collected until the second quarter. The $15 million drawdown on the revolver was directly attributable to our purchase of Amerigen, and we currently anticipate paying this amount down as the year progresses. Total net debt on the balance sheet date increased to $181.2 million. as compared to $125.2 million as of December 31st of 2019, driven by the use of cash on hand to purchase Amerigen. This figure represents 2.3 times net leverage on a trailing 12-month basis. Looking forward, we continue to expect to reinvest our cash flow from operations in business development opportunities. In addition, $60 million of the $75 million revolver portion of our credit facility remains undrawn and provides us with flexibility in continuing to pursue further business development transactions in 2020. Regarding forward-looking guidance, we are closely monitoring the impact of the novel coronavirus pandemic on our business. While we did not incur significant disruptions during the three months ended March 31, 2020, we are unable to predict the future impact that the COVID-19 pandemic will have on our business, financial condition, and results of operations due to numerous uncertainties. These uncertainties include the scope, severity, and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impact, and the direct and indirect economic effects of the pandemic and containment measures, among others. Given these uncertainties, we are suspending financial guidance at this time. At this point, I would like to introduce Patrick Walsh, who currently serves on ANI's Board of Directors and will be stepping in as interim president and CEO.