ANI Pharmaceuticals Reports Record Third Quarter and Year-To-Date 2017 Results and Narrows Full Year Guidance

BAUDETTE, Minn., Nov. 2, 2017

For the third quarter 2017:

• Net revenues of $48.2 million, an increase of 25% as compared to the same period in 2016
• GAAP net income of $4.7 million and diluted GAAP earnings per share of $0.40
• Adjusted non-GAAP EBITDA of $20.7 million
• Adjusted non-GAAP diluted earnings per share of $1.11

ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported its financial results for the three and nine months ended September 30, 2017, and reaffirmed its 2017 financial guidance. The Company will host its earnings conference call this morning, November 2, 2017, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 95990267.

Financial Summary

(in thousands, except per share data)		Q3 2017		Q3 2016 ARIVA.DE Börsen-Geflüster Kurse ANI Pharmaceuticals 65,28 $ +0,51%		YTD 2017		YTD 2016
Net revenues		$ 48,164		$ 38,525		$ 129,556		$ 90,417
Net income		$   4,720		$   2,543		$   8,553		$   5,014
GAAP earnings per diluted share		$     0.40		$     0.22		$     0.73		$     0.43
Adjusted non-GAAP EBITDA(a)		$ 20,662		$ 16,354		$ 54,503		$ 43,178
Adjusted non-GAAP diluted earnings per share(b)		$     1.11		$     0.77		$     2.83		$     2.05

Arthur S. Przybyl, President and CEO, stated,

"This was a record quarter for ANI, with revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share increasing 25%, 26%, and 44%, respectively, as compared to the prior year. These increases are the direct result of the launches of InnoPran XL® and Inderal® XL in February 2017 and the continued impact of generic products launched in 2016 and 2017.

ANI continues to grow its branded product revenue base, an important strategic objective for the Company. To that end, we continue to advance the development and subsequent commercialization of two branded products, Vancocin® oral solution and Cortrophin® gel. Both of these drugs are FDA approved products, but will require ANI to file a prior approval supplement with the FDA prior to commercialization."

ANI Narrows Guidance for the Full Year 2017

ANI estimates are based on projected results for the twelve months ending December 31, 2017 and reflect management's current beliefs about product pricing, prescription trends, inventory levels, cost of sales, operating costs, timing of research and development spend, taxes, and the anticipated timing of future product launches and events. ANI is updating its full year 2017 guidance range to narrow its previously published guidance for net revenues and adjusted non-GAAP EBITDA. In conjunction with this change, ANI is narrowing and making a modest upward revision in its projected full year adjusted non-GAAP diluted earnings per share and improvement in its cost of sales as a percentage of revenues (excluding the impact of inventory step-up). The changes to guidance reflect better than previously-forecast product mix and gross profit pull through on net revenues.

Cortrophin® Gel Re-commercialization Update

In the third quarter of 2017, ANI executed a long-term commercial supply agreement with its Cortrophin® gel fill/finish contract manufacturer ("CMO"), specializing in aseptic parenteral manufacturing using mobile isolator technology. ANI plans to initiate manufacturing Cortrophin® gel development batches in the fourth quarter of 2017, using the active pharmaceutical ingredient ("API") from its recently manufactured intermediate scale batches. Combined with its current relationships with raw material suppliers for porcine pituitary glands and purified corticotropin powder (the API), ANI has now reached a very important milestone by securing its Cortrophin® gel supply chain.    

ANI has continued to advance the manufacture of corticotropin API, successfully manufacturing its first intermediate scale batch of API. This intermediate scale batch of corticotropin API was five times larger than its initial successful small-scale API batch and resulted in proportional increases in both yield and potency. ANI initiated manufacturing a second intermediate scale batch in the third quarter and expects to complete manufacturing of intermediate scale API batches two and three by the end of this year.  ANI expects to be able to demonstrate lot-to-lot consistency as it continues to build its comprehensive characterization package. ANI plans to initiate commercial scale API manufacturing in early 2018. 

ANI has continued to modernize the corticotropin characterization package by developing and implementing new and current analytical technologies that were not part of the original Cortrophin® gel NDA. These molecular biology techniques have been successfully developed to analyze both corticotropin as well as other related peptides. ANI has also developed a variety of methods to characterize in-process samples after completion of critical stages of corticotropin API manufacturing. These methods are being used to better control the API manufacturing process and identify its critical process parameters. These methods are being utilized throughout the API manufacturing process as a means of establishing lot-to-lot consistency and process control and demonstrating comparability to historically manufactured commercial lots of API.

ANI intends to request a meeting with the FDA in the fourth quarter of 2017 to present its Regulatory Filing Plan.

For further details, please see ANI's Cortrophin® Gel Re-commercialization Milestone Update in Table 5.

Vancocin® Oral Solution Update

ANI is currently advancing a commercialization effort for Vancocin® oral solution. Following completion of ongoing formulation and manufacturing optimization, ANI intends to file a prior approval supplement ("PAS") in the second half of 2018. This product will be manufactured at ANI's site in Baudette, MN. The launch of this product will fulfill a currently unmet patient need for an FDA approved liquid oral dosage form of the vancomycin molecule. This product will compete in a market that currently exceeds $450 million annually. When launched, ANI estimates that Vancocin® oral solution could achieve peak sales potential of $50 million.

Third Quarter Results

Net Revenues		Three Months Ended
(in thousands)		September 30,
		2017			2016			Change			% Change
Generic pharmaceutical products		$	30,546		$	30,191		$	355		1%
Branded pharmaceutical products			15,688			6,834			8,854		130%
Contract manufacturing			1,829			1,427			402		28%
Contract services and other income			101			73			28		38%
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