ANI Pharma Reports Fourth Quarter And Full Year 2015 Results And Provides 2016 Guidance

BAUDETTE, Minn., Feb. 23, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ: ANIP) today reported financial results for the three and twelve months ended December 31, 2015, and provided its financial guidance for the 2016 year. The Company will host its earnings conference call this morning, February 23, 2016, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (844) 295-8236. The conference ID is 48813555.

Arthur S. Przybyl, President and CEO, stated,

“We are pleased with our progress during the past year and look forward to realizing the benefits of our 2015 business and product development activities in 2016. In 2015, we introduced six new products, significantly expanding our marketed product line, which now totals 17. We also acquired an additional 23 products and entered into an agreement to commercialize 18 more. To date in 2016, we have entered into two additional acquisitions for six products, bringing our total number of products under development to 85. Three of the acquired products are accretive to 2016 revenues and adjusted non-GAAP EBITDA, and are included in our financial guidance.

On January 4, 2016, we completed our acquisition of the two NDAs for Corticotropin and Corticotropin-Zinc, products which provide us with an opportunity to compete in a well-established and growing market that exceeds $1 billion and offer a less expensive alternative to both patients and payors. 2016 is an important year for this project as we begin the work we believe is necessary to recommercialize the products, including working closely with the FDA, building out our dedicated team, and re-establishing the supply chain.

The recommercialization of Corticotropin and Corticotropin-Zinc represents a compelling, strategic opportunity for ANI and our shareholders which, at the same time, will provide patients and their physicians with a valuable therapeutic option for a variety of critical, acute, and chronic diseases that afflict millions of Americans.”

2016 Financial Guidance

ANI’s estimates are based on projected results for the twelve months ended December 31, 2016 and reflect management’s current beliefs about product pricing, prescription trends, inventory levels, cost of sales, operating costs, and the anticipated timing of future product launches and events.

• Net revenues for 2016 to be between $105 million and $120 million.
• Adjusted non-GAAP EBITDA^(a), to be between $45 million and $53 million.
• Adjusted non-GAAP net income per diluted share^(b), to be between $2.94 and $3.31, assuming 11,552 thousand weighted average shares outstanding.
• Reported (US GAAP) diluted EPS to be between $0.30 and $0.65.

ANI’s 2016 guidance is based on certain assumptions including:

• Net 2016 revenues for current marketed products (17 products) to be between $92 million and $98 million.
• Net 2016 revenues for new product introductions (see table below) to be between $13 million and $22 million.
• EEMT market share is anticipated to remain stable at approximately 50%.
• Cost of sales^(c) of approximately 34%.
• Operating expenses^(d), inclusive of research and development costs, of between $24 and $25.5 million.
• Depreciation and amortization expense of approximately $18.7 million.
• Interest expense of approximately $11.2 million.
• Current tax provision of between $7.0 and $11.0 million.

^(a) See Table 2 for US GAAP reconciliation.
^(b) See Table 3 for US GAAP reconciliation.
^(c) Exclusive of depreciation and amortization.
^(d) Excludes non-cash stock compensation expense.

2016 New Product Introductions

^(e) Per IMS Health
^(f) FDA’s Target Action Date, per FDA communications

If the market conditions for these products remain as anticipated, the annualized effect of these products would be as follows:

• Annualized net revenues estimated to be between $52 million and $65 million.
• Annualized adjusted non-GAAP EBITDA^(a), estimated to be between $34 million and $40 million.

2015 Highlights Include:

• Net revenues of $76.3 million, an increase of 36% as compared to $56.0 million for the same period in 2014.
• Adjusted non-GAAP EBITDA of $43.5 million, an increase of 59% as compared to $27.3 million for the same period in 2014.
• Operating income of $32.7 million, an increase of 63% as compared to $20.0 million for the same period in 2014.
• Adjusted non-GAAP net income per diluted share of $2.72.
• Diluted earnings per share of $1.32.
• Launched six products: Etodolac, Propafenone, Oxycodone oral solution, Vancomycin, Nimodipine, and Flecainide.
• Acquired ANDAs for 23 generic products and an NDA for 1% Testosterone Gel.
• Entered into a distribution agreement with IDT Australia Limited to market 18 generic products in the U.S.
• Entered into an agreement to acquire two NDAs for Corticotropin and Corticotropin-Zinc. The transaction closed in January 2016.
• Established a common stock repurchase plan. In January 2016, we repurchased $2.5 million of our common stock under the plan.

For the three months ended December 31, 2015, ANI reported net revenues of $18.0 million, a decrease of 14% from $21.0 million in the prior year period, due to the following factors:

• Revenues from sales of generic pharmaceuticals increased 10%, to $14.0 million from $12.8 million in the prior period, primarily due to increased unit sales and pricing for EEMT, as well as a full quarter of sales from Methazolamide, Etodolac, and Propafenone, and a partial quarter of sales from Oxycodone oral solution and Vancomycin, both of which launched in the fourth quarter of 2015.
• Revenues from sales of branded pharmaceuticals decreased 52%, to $2.3 million from $4.9 million in the prior period, primarily as a result of lower unit sales of Reglan and Lithobid and increased Medicaid utilization for Lithobid and Vancocin.
• Contract manufacturing revenue decreased by 28% to $1.3 million from $1.8 million in the prior year period, primarily as a result of the timing and volume of customer orders.

• Contract services and other income decreased by 79%, to $0.3 million from $1.6 million, primarily due to recognition of only one month of royalties on sales of the authorized generic of Vancocin in 2015. In the fourth quarter of 2015, ANI’s authorized generic partner for Vancocin adjusted its estimates for chargebacks, rebates, and other deductions from gross sales, which resulted in a $0.2 million increase in royalty revenue

  To read full press release, please click here.