LAKE FOREST, Ill.
Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today announced that it has acquired the NDA and all rights to Betimol® (timolol ophthalmic solution) 0.25% & 0.5% from Santen. Akorn plans to begin shipping Betimol® in the first quarter of 2014.
Raj Rai, Chief Executive Officer, commented, “We are excited to add Betimol® to our portfolio of branded ophthalmic products. This acquisition further enhances our platform and growth opportunities in 2014.”
Financial Impact of the Transaction
This transaction is expected to add approximately $8 million to $9 million in revenues to 2014 and approximately $0.03 to $0.04 of adjusted net income per diluted share.
About Betimol
BETIMOL® is a prescription eye drop medicine used to reduce pressure inside the eye in patients with ocular hypertension or open-angle glaucoma. The active ingredient of BETIMOL® is timolol hemihydrate and is available in concentrations of 0.25% and 0.5%.
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.
About Santen
Founded in 1890, Santen is a global company headquartered in Osaka, Japan. Santen researches, develops and markets ophthalmic products for physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. For more information, visit http://www.santen.co.jp/.
Forward Looking Statements
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 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 acquisitions or agreements, 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.
Non-GAAP Financial Measure
In addition to providing financial information in accordance with U.S. generally accepted accounting principles (GAAP), the Company is also providing Adjusted net income per diluted share, which is a non-GAAP financial measure. Since Adjusted net income per diluted share is a non-GAAP financial measure, it should not be used in isolation or as a substitute for GAAP financial measures. In addition, the Company’s definition of Adjusted net income per diluted share may not be comparable to similarly titled non-GAAP financial measures reported by other companies.
Adjusted net income, as defined by the Company, is calculated as follows:
Net income, plus:
. The recorded provision for income taxes
. Intangible asset amortization
. Non-cash expenses, such as non-cash interest, share-based compensation expense, settlement of product liability warranty and deferred financing cost amortization
. Other adjustments, such as legal settlements and various acquisition related expenses
. Less an estimated cash tax provision.
Adjusted net income per diluted share is equal to Adjusted net income divided by the actual or anticipated diluted share count for the applicable period.
The Company believes that Adjusted net income per diluted share is a meaningful financial indicator, to both Company management and investors, in that it excludes non-cash income and expense items that have no impact on current or future cash flows, as well as other income and expense items that are not expected to recur and therefore are not reflective of continuing operating performance. Adjusted net income per diluted share provides the Company and investors with income figures that would be expected to be more aligned with cash flows than GAAP net income per share, which includes a number of non-cash income and expense items.
While the Company uses Adjusted net income per diluted share in managing and analyzing its business and financial condition and believes this non-GAAP financial measure to be useful to investors in evaluating the Company’s performance, this financial measure has certain shortcomings. Adjusted net income per share does not take into account non-cash expenses that reflect the amortization of past expenditures, or include stock-based compensation, which is an important and material element of the Company’s compensation package for its directors, officers and other key employees. Due to the inherent limitations of this non-GAAP financial measure, the Company’s management utilizes comparable GAAP financial measures to evaluate the business in conjunction with Adjusted net income per diluted share and encourages investors to do likewise.
CONTACT
At the Company:
Akorn, Inc.
Tim Dick, Chief Financial Officer
(847)
279-6150
