On May 7, 2021 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ: ANIP) reported business highlights and financial results for the three months ended March 31, 2021 (Press release, ANI Pharmaceuticals, MAY 7, 2021, View Source [SID1234579484]).
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"We continue to make good progress on our Term Loan B in support of the Novitium transaction, and receiving our inaugural ratings from Moody’s and S&P represents another milestone in the maturation of the Company"
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First Quarter and Recent Business Highlights:
Continued efforts to assemble a robust re-filing package for Cortrophin Gel in preparation for second-quarter 2021 submission to the U.S. Food and Drug Administration ("FDA").
Signed a definitive agreement to acquire Novitium Pharma LLC ("Novitium"), a privately held, New Jersey-based high-growth pharmaceutical company. The transaction is expected to close in the second half of this year, pending Federal Trade Commission ("FTC") clearance and shareholder approval of the equity issuances for the transaction. Upon close, Novitium will diversify ANI’s commercial portfolio, add a proven best-in-class R&D engine, enhance our North American manufacturing footprint, and yield compelling financial benefits.
Acquired the new drug applications ("NDAs") for OXISTAT Lotion, VEREGEN Ointment, and Pandel Cream and the abbreviated new drug application ("ANDA") for ApexiCon E Cream from Sandoz Inc. Collectively, these dermatology products generated net revenues of $13.2 million in 2020. Strengthened leadership team with the addition of key pharmaceutical executives: Christopher K. Mutz as Chief Commercial Officer and Head of Rare Diseases and Ori Gutwerg as Senior Vice President of Generics.
Received inaugural ratings from the two major rating agencies, Moody’s and S&P. Moody’s assigned a B2 rating with a stable outlook, and S&P Global Ratings assigned a B+ rating with a positive outlook.
First Quarter 2021 Financial Highlights:
Net revenues were $54.5 million compared to $49.8 million in Q1 2020.
GAAP net income was $0.1 million, and diluted GAAP earnings per share was $0.01.
Adjusted non-GAAP EBITDA was $18.9 million.
Adjusted non-GAAP diluted earnings per share was $1.04.
Cash and cash equivalents were $25.1 million, net accounts receivable was $91.9 million, and face value of debt was $184.6 million as of March 31, 2021.
"During the first quarter, we made excellent progress on our stated goal of building a sustainable biopharma company well positioned for growth and serving patients in need. Our dedicated Cortrophin technical team is finalizing our sNDA file for resubmission, and Chris has made strong additions to the commercial team to ensure that we are prepared for a successful launch. The pending Novitium acquisition and product acquisitions from Sandoz represent significant steps toward our goals and are aligned with our four pillars for accelerating growth. Since we signed the Novitium deal in March, Novitium has launched several products, including limited competition opportunities such as Gx Famotidine solution, and continues to build momentum in advance of officially joining the ANI family. At the same time, our operational and commercial teams have seamlessly transitioned the Sandoz product assets into the ANI portfolio," stated Nikhil Lalwani, President and CEO.
"Similar to many of our industry peers, we have seen a combination of pandemic-related and seasonal factors that have contributed to softness in prescription levels. Despite these challenges, we are at an inflection point, and I believe that the Novitium transaction and sizable market opportunity for Cortrophin have the potential to be transformational for ANI. We remain focused on the work to be done to unlock value for all of our stakeholders and to continue to serve patients in need," concluded Lalwani.
"We continue to make good progress on our Term Loan B in support of the Novitium transaction, and receiving our inaugural ratings from Moody’s and S&P represents another milestone in the maturation of the Company," stated Stephen Carey, CFO.
First Quarter 2021 Financial Results
Net Revenues
(in thousands)
Three Months Ended
March March 31,
2021
2020
Generic pharmaceutical products
$
32,988
$
37,495
Branded pharmaceutical products
7,517
9,157
Contract manufacturing
2,573
1,974
Royalty and other income
11,443
1,148
Total net revenues
$
54,521
$
49,774
Net revenues for generic pharmaceutical products were $33.0 million during the three months ended March 31, 2021, a decrease of 12.0% compared to $37.5 million for the same period in 2020. Based upon an analysis of IQVIA/IMS data, during the three months ended March 31, 2021, the total market for generic prescriptions in the United States declined approximately 9% when compared to the three months ended March 31, 2020. We believe that this overall decline in prescription activity is principally due to the COVID-19 pandemic, and it negatively impacted the market for many of our generic pharmaceutical products. From a product perspective, the net decrease was driven by declines in sales of Ezetimibe Simvastatin, Methazolamide, Miglustat, and Diphenoxylate, somewhat tempered by increased revenues from sales of Paliperidone ER and Erythromycin Ethylsuccinate ("EES").
Net revenues for branded pharmaceutical products were $7.5 million during the three months ended March 31, 2021, a decrease of 17.9% compared to $9.2 million for the same period in 2020. The decrease primarily reflects lower unit sales of Inderal XL and InnoPran XL, tempered by increased sales of Casodex and Inderal LA.
Contract manufacturing revenues were $2.6 million during the three months ended March 31, 2021, an increase of 30.3% compared to $2.0 million for the same period in 2020, due to an increased volume of orders from contract manufacturing customers in the period.
Royalty and other revenues were $11.4 million during the three months ended March 31, 2021, an increase of $10.3 million from $1.1 million for the same period in 2020, primarily due to the recognition of royalties due ANI for patent rights related to Kite Pharma, Inc.’s oncology product, YESCARTA.
Operating expenses decreased to $51.5 million for the three months ended March 31, 2021, from $57.6 million in the prior year period.
Cost of sales, excluding depreciation and amortization, decreased by $1.8 million to $20.0 million in the first quarter of 2021, primarily as a result of the non-recurrence of $2.7 million in cost of sales representing the excess of fair value over cost for inventory acquired in the Amerigen acquisition and subsequently sold during the three months ended March 31, 2020.
Research and development expenses decreased to $3.0 million in the first quarter of 2021, a decrease of 53.2% from $6.3 million in the first quarter of 2020, primarily due to the non-recurrence of the $3.8 million in-process research and development expense from the Amerigen acquisition in the first quarter 2020.
Selling, general and administrative expenses rose by $3.9 million in the first quarter of 2021 to $17.6 million compared to $13.7 million in the comparable quarter in 2020. The increase primarily reflects $2.9 million of transaction expenses related to the pending Novitium acquisition incurred during the three months ended March 31, 2021, increased pharmacovigilance compliance costs in continued support of the expansion of our commercial portfolio, and increased legal, insurance, and other professional fees.
Depreciation and amortization decreased by $0.3 million in the first quarter of 2021 to $10.9 million compared to $11.2 million in the comparable quarter in 2020.
Net income for the first quarter of 2021 was $0.1 million as compared to net loss of $7.0 million in the prior year period. Diluted earnings per share for the three months ended March 31, 2021 was $0.01, compared to diluted loss per share of $0.59 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.04 in the first quarter of 2021 and 2020.
For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively.
Liquidity
As of March 31, 2021, the Company had $25.1 million in unrestricted cash and cash equivalents plus $91.9 million in net accounts receivable. The Company had $184.6 million (face value) in outstanding debt as of March 31, 2021.
Conference Call
As previously announced, ANI Pharmaceuticals management will host its first quarter 2021 conference call as follows:
A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for one week by dialing 800-934-5153 and entering access code 5412658.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cash stock-based compensation expense, expense from acquired in-process research and development, Novitium transaction expenses, Cortrophin pre-launch charges, asset impairments, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Net Income
ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, acquired in-process research and development ("IPR&D") expense, Novitium transaction expenses, asset impairments, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.
Adjusted non-GAAP net income is defined as net income, plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, expense from acquired in-process research and development, Cortrophin pre-launch charges, asset impairments, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted Earnings per Share
ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, acquired IPR&D expense, Novitium transaction expenses, asset impairments, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.
Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.