BUENA, N.J., April 28, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced its financial results for the first quarter ended March 31, 2016.
First Quarter 2016 Highlights
- Total revenues of $15.7 million in the first quarter of 2016, an increase of 47% 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 March 31, 2016 and 2015 of $9.2 million and $8.1 million, respectively.
- Total revenues generated from contract manufacturing services for the three months ended March 31, 2016 and 2015 of $6.5 million and $2.6 million, respectively.
- Gross margin for the three months ended March 31, 2016 equaled 51% as compared to 53% in the same period of 2015.
- Operating income was $0.8 million in the first quarter of 2016 compared to $1.1 million in the same period in 2015.
- Our operating results in the first quarter of 2016 include $3.7 million in research and development costs, compared to $2.6 million in the same period in 2015.
- Adjusted EBITDA (as defined and reconciled to GAAP) for the three months ended March 31, 2016 and 2015 was $2.8 million and $1.7 million, respectively.
- Adjusted earnings per fully diluted share (as defined and reconciled to GAAP) for the three months ended March 31, 2016 and 2015 was $0.02 and $0.00, respectively.
- As a result of the fluctuation in foreign exchange rates during the first quarter of 2016, we recorded a non-cash gain in the amount of $1.6 million related to the foreign currency translation of our intercompany loans to three of our wholly owned subsidiaries.
- The Company filed three abbreviated new drug applications, or ANDAs in the first quarter of 2016 with the US Food and Drug Administration (FDA).
- The Company received two product approvals in the first quarter of 2016 from the FDA.
- The Company launched Cefotan® (Cefotetan disodium for Injection) and lidocaine 5% ointment in March of 2016.
Teligent’s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “The Teligent team had a strong start to 2016. We received approval from the FDA for two products in the first quarter. We launched Cefotan® (Cefotetan disodium for injection) and lidocaine 5% ointment in March and anticipate launching desoximetasone ointment USP 0.25% during the second quarter. With these product launches, we now market nine products in sixteen presentations in our own label in the US generic topical market, and another four products in nineteen presentations in the US injectable market as well as eighteen products in thirty-four presentations in the Canadian injectable market. Our partner received approval for flurandrenolide cream, a product we developed for them and we anticipate manufacturing that product for our partner in the coming weeks.”
Mr. Grenfell-Gardner continued, “During the first quarter of 2016, Teligent submitted three ANDAs to the FDA bringing our total number of ANDAs pending at the FDA to thirty-four. Based on IMS Health data as of February, 2016, the current total addressable market of these pipeline ANDAs is estimated at $1.5 billion, excluding our three remaining partnered submissions. Notably, approximately 75% of the total addressable market in our pipeline relates to submissions filed in GDUFA Year 3 or later. Our recent approvals and the continued increased rate of review of our pending applications at the FDA, we believe, is evidence that the implementation of the GDUFA is working. We also have four applications pending with Health Canada for our Canadian injectable business.”
“We have also made significant progress on our facility expansion in Buena, New Jersey, to support our increased activity. The renovation and expansion of the facility is on track with construction work already started and long lead-time equipment ordered for delivery later this year.”
“Revenue from the Teligent portfolio of injectable and topical products was $9.2 million for the quarter, a 13.5% increase over the same quarter last year. This growth has been driven largely by our entry into the specialty generic injectable market. In the first quarter of 2016, just over 30 percent of our revenue was driven by our Teligent injectable products in both the United States and Canada compared to zero in the first quarter of 2015. The team continues to focus on the execution of our TICO strategy to expand our specialty generic pharmaceutical product portfolio in the topical, injectable, complex, and ophthalmic markets.”
The Company will hold a conference call at 4:15 pm ET today, Thursday, April 28, 2016 to discuss the 1st 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
Less: change in the fair value of derivative liability
Foreign currency exchange gain
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