BAUDETTE, Minn., Nov. 3, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported record financial results for the three and nine months ended September 30, 2016, and reaffirmed and narrowed its 2016 financial guidance. The Company will host its earnings conference call this morning, November 3, 2016, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 93840986.
(in thousands, except per share data)
GAAP earnings per diluted share
Adjusted non-GAAP EBITDA(a)
Adjusted non-GAAP net income per diluted share(b)
See Table 2 for US GAAP reconciliation.
See Table 3 for US GAAP reconciliation.
Arthur S. Przybyl, President and CEO, stated,
"ANI had another record quarter, with revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP net income per diluted share increasing 93%, 41%, and 36%, respectively, as compared to the prior year quarter. These increases are the direct result of our nine product launches in the first three quarters of 2016. We expect to launch at least one additional product before year end, for a total of eleven."
ANI Reaffirms and Narrows Guidance for the Full Year 2016
ANI's estimates are based on projected results for the twelve months ending December 31, 2016 and reflect management's current beliefs about product pricing, prescription trends, inventory levels, cost of sales, operating costs, taxes, and the anticipated timing of future product launches and events.
- Net revenues for 2016 to be between $128 million and $134 million.
- Reported (US GAAP) diluted EPS to be between $0.60 and $0.75, assuming 11,625 thousand weighted average shares outstanding.
- Adjusted non-GAAP EBITDA to be between $59 million and $63 million.
- Adjusted non-GAAP net income per diluted share to be between $4.00 and $4.25.
ANI will provide guidance for 2017 when the Company announces its fourth quarter 2016 results.
Corticotropin Re-commercialization Update
ANI has assembled a Corticotropin re-commercialization team of scientists and subject matter experts who have extensive experience with the development and manufacturing of animal-derived pharmaceutical products. ANI has also established a laboratory exclusively for Corticotropin analytical method development. The team has already achieved several key milestones, including identifying and initiating the development of analytical methods that will be required to re-commercialize Corticotropin, a critical portion of the sNDA filing. At the same time, ANI has also secured the supply of porcine pituitaries necessary for both small and commercial-scale active pharmaceutical ingredient manufacturing, which is also pivotal for the re-launch of Corticotropin. Finally, ANI has contracted with an accomplished contract manufacturer and initiated manufacturing of Corticotropin active pharmaceutical ingredient. Due to these efforts, the project is tracking ahead of ANI's internal timeline. ANI remains dedicated to the re-commercialization of Corticotropin and will provide updates regarding further progress as appropriate.
Third Quarter Results
Three Months Ended
Generic pharmaceutical products
Branded pharmaceutical products
Contract services and other income
Total net revenues
For the three months ended September 30, 2016, ANI reported net revenues of $38.5 million, an increase of 93% from $20.0 million in the prior year period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 100%, to $30.2 million from $15.1 million in the prior period, primarily due to sales of the ten products launched over the previous twelve months.
- Revenues from sales of branded pharmaceuticals increased 203%, to $6.8 million from $2.3 million in the prior period, primarily due to sales of Inderal® LA, which was launched in Q2 2016.
- Contract manufacturing revenue increased by 12% to $1.4 million from $1.3 million in the prior year period, primarily as a result of the timing of customer orders.
- Contract services and other income decreased by 95%, to $0.1 million from $1.3 million, primarily because sales of Vancomycin in the ANI label have replaced the royalties previously received on the product.
Operating expenses increased to $30.6 million for the three months ended September 30, 2016, from $11.5 million in the prior year period.
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