The Company expects to lose two weeks of production from its Somerset, New Jersey ophthalmic plant as a result of Hurricane Sandy, which will impact both revenue and gross profit as a result of lost sales and lost manufacturing overhead absorption. As a result, the Company expects fourth quarter 2012 revenue, as a best case scenario, to be flat to third quarter.
The Company anticipates a $2.5 million increase in R&D expense in the fourth quarter compared with the third quarter. The anticipated increase is the result of the expected achievement of external development milestones, as well as the implementation of the new FDA Generic Drug User Fee Act (GDUFA) and the resulting ANDA backlog fees as well as fees on anticipated fourth quarter ANDA filings.
Factoring in the combined impact of Hurricane Sandy and increased fourth quarter R&D expense, the Company estimates 2012 non-GAAP adjusted net income per share consistent with its previously issued guidance of $0.50 to $0.52.2012 outlook excludes the impact of any new approvals after November 6, 2012. Akorn’s R&D Pipeline The Company has 45 ANDAs filed with the FDA with a combined annual market size of approximately $4.9 billion. The Company has completed development work on 14 additional products with a combined annual market size of approximately $0.5 billion and expects to file these products with the FDA shortly. Third Quarter 2012 Conference Call The Company will host a conference call at 10:00 a.m. Eastern Time on Tuesday, November 6, 2012, to discuss third quarter 2012 results followed by a Q&A session. The domestic call-in number is 888-389-5988 and the international call-in number is 719-325-2452. The confirmation code for all callers is 9897443. The URL for the webcast is http://www.videonewswire.com/event.asp?id=90009. A live broadcast of the conference call will also be available online at www.akorn.com under the Investor Relations tab and available for replay for 30 days. About Akorn, Inc. Akorn, Inc. is a niche pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois, Somerset, New Jersey and Paonta Sahib, India where the Company manufactures ophthalmic and injectable pharmaceuticals. Additional information is available on the Company’s website at www.akorn.com. Forward Looking Statement This press release includes statements that may constitute "forward-looking statements", including projections of certain measures of Akorn's results of operations, projections of sales, projections of certain charges and expenses, projections due to the closure of its Somerset, New Jersey manufacturing facility, the impact of Hurricane Sandy, projections related to the number and potential market size of ANDAs and other statements regarding Akorn's goals, regulatory approvals and strategy. Akorn cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. Factors that could cause or contribute to such differences include, but are not limited to: statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. These cautionary statements should be considered in connection with any subsequent written or oral forward-looking statements that may be made by the company or by persons acting on its behalf and in conjunction with its periodic SEC filings. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.