Akorn, Inc. Provides Fourth Quarter And Full Year 2016 Results And Outlines Full Year 2017 Guidance

- Q4 2016 Revenue Increase to $284 Million -

- Q4 2016 GAAP Diluted EPS Decrease of 4% to $0.26; Q4 2016 Adjusted Diluted EPS Decrease of 3% to $0.58 -

- FY 2016 Revenue Increase of 13% to $1,117 Million -

- FY 2016 GAAP Diluted EPS Increase of 20% to $1.47; FY 2016 Adjusted Diluted EPS Increase of 11% to $2.25 -

- Conference Call and Webcast to Be Held March 1, 2017 at 10:00 a.m. EST -

LAKE FOREST, Ill., March 01, 2017 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty generic pharmaceutical company, today announced its financial results for the fourth quarter 2016 and full year 2016, and provided full year 2017 guidance.

Q4 2016 Operating Highlights:

  • Received three Abbreviated New Drug Application (“ANDAs”) approvals:
    - Ibuprofen 100mg/5mL Oral Suspension that launched in November 2016
    - Azelastine Hydrochloride Ophthalmic Solution, 0.05% that launched in January 2017
    - Triamcinolone Acetonide Topical Aerosol, 0.147 mcg/mL that the Company is planning to launch in 2017 
  • Expanded R&D footprint with October opening of new R&D center in Cranbury, NJ
  • Submitted 12 ANDAs to the Food and Drug Administration ("FDA")
  • Received favorable ruling from the Patent Trial and Appeal Board ("PTAB") in the inter partes review (IPR) proceeding finding all of the claims of the Durezol® patent to be obvious; the decision has subsequently been appealed as expected
  • Received FDA NAI status (No Action Indicated), the highest status level available, for the Company's Decatur facility, following the December 2016 re-inspection.  The Company's three other FDA approved manufacturing sites are in good standing following 2016 FDA inspections.
  • Made significant progress at Akorn India; on track with plan to resume exhibit batch production in Q3 2017

Raj Rai, Akorn’s Chief Executive Officer, commented, “We are pleased with our performance in 2016. First and foremost, we completed the restatement of our 2014 financials and became current with our SEC filings, which in itself was a major accomplishment.  In 2016, we achieved record revenues, surpassing a billion dollars and solidifying Akorn’s position among the top specialty generics companies with manufacturing roots in the United States. This would not have happened without the collective efforts and dedication of all Akorn employees.”

Rai further added, “Our focus in 2017 and beyond remains consistent with our growth strategy of diversifying our portfolio, thus reducing product concentration through harvesting and replenishing our pipeline, deploying capital to consummate smart acquisitions through business development efforts and continuing to invest in our infrastructure. Finally, we remain optimistic about both the short and long-term prospects of our business despite the headwinds in our industry.”

Summary Financial Results for the Quarter Ended December 31, 2016:

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