Teligent, Inc. Announces Third Quarter 2016 Results

BUENA, N.J., Oct. 27, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced its financial results for the third quarter ended September 30, 2016.

Third Quarter 2016 Highlights

• Total revenues of $16.2 million in the third quarter of 2016, an increase of 39% over the same quarter in 2015.
• Total net revenues generated from the sale of our generic topical and injectable pharmaceutical products for the three months ended September 30, 2016 and 2015 of $13.9 million and $8.7 million, respectively, an increase of 60% over the same quarter last year.
• Total revenues generated from contract manufacturing services and other income for the three months ended September 30, 2016 and 2015 of $2.3 million and $2.9 million, respectively.
• Total international revenues for the three months ended September 30, 2016 and 2015 of $2.7 million and $0, respectively.
• Gross margin for the three months ended September 30, 2016 equaled 50% as compared to 52% in the same period of 2015.
• Operating income was $0.3 million in the third quarter of 2016 compared to operating income of $0.4 million in the same period in 2015.
• Our operating results in the third quarter of 2016 include $4.0 million in research and development costs, compared to $3.3 million in the same period in 2015.
• Adjusted EBITDA (as defined and reconciled to GAAP) for the three months ended September 30, 2016 and 2015 was $2.1 million and $1.4 million, respectively.
• Adjusted earnings per fully diluted share (as defined and reconciled to GAAP) for the three months ended September 30, 2016 and 2015 was $0.01 and $0.00, respectively.
• As a result of the fluctuation in foreign exchange rates during the third quarter of 2016, we recorded a non-cash gain in the amount of $0.4 million related to the foreign currency translation of our intercompany loans to three of our wholly-owned subsidiaries.
• The Company received approval from the US Food and Drug Administration ("FDA") of two Abbreviated New Drug Applications ("ANDAs") for topical generic prescription products during the third quarter, one for Triamcinolone Acetonide Lotion USP, 0.025%, and the other for Triamcinolone Acetonide Lotion USP, 0.1%. 
• The Company received five approvals during the third quarter from Health Canada's Therapeutic Products Directorate (TPD) for Gentamicin Injection USP, Baclofen Injection 0.05mg/mL, Baclofen Injection 0.5mg/mL, Baclofen Injection 2mg/mL, and Lidocaine Hydrochloride Topical Solution USP.  In addition, on October 5th, 2016, the Company received approval for Lidocaine Ointment USP 5% from Health Canada's TPD.
• The Company filed one ANDA with the FDA and one ANDS with Health Canada in the third quarter 2016.

Full Year 2016 Financial Guidance

• The Company expects total revenue between $65.0 and $72.0 million for the year ending December 31, 2016.
• The Company anticipates gross margin of 54% to 56% for the year ending December 31, 2016.
• The Company intends to submit at least 15 ANDAs with the FDA in 2016.  The Company intends to submit 8 applications to Health Canada in 2016.   In order to complete all of the development work required for the 2016 filings, the Company expects to spend between 28% and 32% of total revenue in research and development by the end of 2016.
• The Company expects operating income between $2.0 and $4.0 million for the year ending December 31, 2016.

''We delivered another strong quarter of growth, while also achieving regulatory approvals and executing product launches,'' said Jason Grenfell-Gardner, President and Chief Executive Officer. "During the quarter, we received approval from the FDA for two ANDAs, which we launched within sixty days of approval.  We also received approval of six products from Health Canada, all of which we plan to launch in the beginning of 2017.'' 

Mr. Grenfell-Gardner continued, "We are committed to executing our TICO strategy to expand our specialty generic pharmaceutical product portfolio in the topical, injectable, complex, and ophthalmic markets.  Revenue from our own portfolio of injectable and topical products increased 60% over the same quarter last year, and 25% over the second quarter of 2016.  We are pleased to see our sequential growth coming from both our specialty generic injectable portfolio, as well as six successful launches of Teligent products so far in 2016.  Just one year ago, Teligent had seven topical generic products and no generic injectable products in our US portfolio.  We now market twelve products in twenty-two presentations in the US generic topical market, and another four products in nineteen presentations in the US injectable market. We also market nineteen products in thirty-eight presentations in the Canadian injectable market. Our injectable business in the US and Canada represents 26% of our year-to-date revenue for the Company, compared to zero at this time last year."

''During the third quarter of 2016, we submitted one ANDA to the FDA, bringing our total number of ANDAs currently pending at the FDA to thirty-four. Based on IMS Health data as of August 2016, the current total addressable market of these pipeline ANDAs is estimated at approximately $1.6 billion, excluding our three remaining partnered submissions. Significantly, 81% of this total addressable market is for products filed in Generic Drug User Fee Amendments (GDUFA) Year 3 or later, where the FDA has committed to faster review cycles. We also have three applications pending with Health Canada for our Canadian injectable business, including one filed in 2016,'' Mr. Grenfell-Gardner concluded.

The Company will hold a conference call at 4:30 pm ET today, Thursday, October 27, 2016 to discuss the third quarter 2016 results.

The Company invites you to listen to the call by dialing 1-888-346-3479. International participants should call 1-412-902-4260. Canadian participants should call 1-855-669-9657.  Participants should ask to be joined into the Teligent, Inc. call.

This call is being webcast by MultiVu (a PR Newswire Company) and can be accessed in the Investor Relations Section of Teligent Inc.'s website at www.teligent.com.

About Teligent, Inc.

Teligent is a specialty generic pharmaceutical company.  Our mission is to be a leading player in the specialty generic prescription drug market.  Learn more on our website www.teligent.com.

Forward-Looking Statements

This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue," "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions.  These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in Teligent, Inc.'s most recent Annual Report on Form 10-K,  Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission.  Teligent, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Non-GAAP Financial Measures

In addition to reporting financial information required in accordance with U.S. generally accepted accounting principles (GAAP), Teligent is also presenting EBITDA and Adjusted EBITDA which are non-GAAP financial measures. Since EBITDA, Adjusted EBITDA and Adjusted EBITDA before research and development costs are non-GAAP financial measures, they should not be used in isolation or as a substitute for consolidated statements of operations and cash flow data prepared in accordance with GAAP. In addition, Teligent's definition of Adjusted EBITDA may not be comparable to similarly titled non-GAAP financial measures reported by other companies.

Adjusted EBITDA, as defined by the Company, is calculated as follows:

Net income, plus:

Interest expense, net

Provision for income taxes

Depreciation and amortization

Amortization of intangibles

Inventory step up and acquisition costs related to acquisitions

Non-cash expenses, such as share-based compensation expense, and preferred stock dividend

Foreign currency exchange gain/loss

Less: change in the fair value of derivative liability

The Company believes that Adjusted EBITDA is a meaningful indicator, to both Company management and investors, of the past and expected ongoing operating performance of the Company. EBITDA is a commonly used and widely accepted measure of financial performance. Adjusted EBITDA is deemed by the Company to be a useful performance indicator because it includes an add back of non-cash and non-recurring operating expenses which have little to no bearing on cash flows and may be subject to uncontrollable factors not reflective of the Company's true operational performance (i.e. fair value adjustments to the derivative liability).

While the Company uses EBITDA, Adjusted EBITDA and Adjusted EBITDA before research and development costs in managing and analyzing its business and financial condition and believes these non-GAAP financial measures to be useful to investors in evaluating the Company's performance, it is open to certain shortcomings. EBITDA and Adjusted EBITDA do not take into account the impact of capital expenditures on either the liquidity or the financial performance of the Company and likewise omit share-based compensation expenses, which may vary over time and may represent a material portion of overall compensation expense.  Due to the inherent limitations of EBITDA, Adjusted EBITDA and Adjusted EBITDA before research and development costs, the Company's management utilizes comparable GAAP financial measures to evaluate the business in conjunction with EBITDA and Adjusted EBITDA and encourages investors to do likewise.

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SOURCE Teligent, Inc.

Related Links

http://www.teligent.com