TELIGENT 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.
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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
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.
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended March 31, 2016 and 2015
(in thousands, except shares and per share information)
(Unaudited)
March 31, March 31,
2016 2015
---- ----
Revenues:
Product sales, net $15,422 $10,510
Research and
development income 68 51
Licensing, royalty
and other revenue 167 110
--- ---
Total revenues 15,657 10,671
Costs and Expenses:
Cost of revenues 7,702 5,043
Selling, general and
administrative
expenses 3,407 1,900
Product development
and research
expenses 3,711 2,630
----- -----
Total costs and
expenses 14,820 9,573
Operating income 837 1,098
Other Income (Expense):
Change in the fair
value of derivative
liability - 8,625
Foreign currency
exchange gain 1,553 -
Interest and other
expense, net (3,318) (3,168)
------ ------
Income (loss) before
income tax expense (928) 6,555
Income tax expense 22 -
--- ---
Net income (loss) $(950) $6,555
===== ======
Basic earnings
(loss) per share ($0.02) $0.12
Diluted earnings
(loss) per share ($0.02) $0.01
Weighted average shares of common stock outstanding:
Basic 53,031,351 52,841,900
Diluted 53,031,351 67,210,177
The accompanying notes are an integral part of the condensed consolidated financial statements.
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
March 31, 2016 December 31,
(Unaudited) 2015*
---------- ----
ASSETS
Current assets:
Cash and cash equivalents $87,040 $87,191
Accounts receivable, net 13,159 14,028
Inventories 10,091 8,985
Prepaid expenses and other receivables 7,450 6,597
----- -----
Total current assets 117,740 116,801
Property, plant and equipment, net 11,125 8,706
Debt issuance costs, net 3,830 4,027
Intangible assets,net 54,916 54,320
Goodwill 459 426
Other 474 482
--- ---
Total assets $188,544 $184,762
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $4,437 $3,955
Accrued expenses 8,163 6,267
Deferred income, net 324 476
Capital lease obligation, current 40 70
--- ---
Total current liabilities 12,964 10,768
Convertible 3.75% senior notes, net of
debt discount (face of $143,750) 108,800 106,991
Deferred tax liability 261 244
--- ---
Total liabilities 122,025 118,003
------- -------
Stockholders' equity:
Common stock, $0.01 par value,
60,000,000 shares authorized;
53,059,273 and 53,000,689 shares issued
and outstanding as of March 31, 2016
and December 31, 2015, respectively 550 549
Additional paid-in capital 100,011 99,258
Accumulated deficit (33,868) (32,918)
Accumulated other comprehensive loss,
net of taxes (174) (130)
---- ----
Total stockholders' equity 66,519 66,759
------ ------
Total liabilities and stockholders'
equity $188,544 $184,762
======== ========
*Derived from the audited December 31, 2015 financial statements
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2016 and 2015
(in thousands)
March 31, March 31,
2016 2015
---- ----
Cash flows from operating
activities:
Net
income
(loss) $(950) $6,555
Non-
cash
expenses
(income) 2,198 (6,289)
Changes
in
operating
assets
and
liabilities 1,534 (380)
----- ----
Net
cash
provided
by
(used
in)
operating
activities 2,782 (114)
Net
cash
used
in
investing
activities (2,916) (1,711)
Net
cash
used
in
financing
activities (65) (27)
--- ---
Effect
of
exchange
rate
on
cash
and
cash
equivalents 48 -
Net
decrease
in
cash
and
cash
equivalents (199) (1,852)
Cash
and
cash
equivalents
at
beginning
of
period 87,191 158,883
------ -------
Cash
and
cash
equivalents
at
end
of
period $87,040 $157,031
======= ========
TELIGENT, INC. AND SUBSIDIARIES
GROSS TO NET CALCULATION
(in thousands)
Three months ended March 31,
2016 2015
---- ----
Gross product
sales $26,823 $22,307
Reduction to gross product sales:
Chargebacks and
billbacks 12,345 12,512
Sales discounts
and other
allowances 5,287 1,699
----- -----
Total reduction
to gross
product sales 17,632 14,211
Product sales,
net 9,191 8,096
Contract
manufacturing
product sales 6,231 2,414
----- -----
Total product
sales, net $15,422 $10,510
======= =======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP MEASURES
(in thousands)
Three months ended March 31,
----------------------------
2016 2015
---- ----
Net income (loss) $(950) $6,555
Depreciation and
amortization expense 174 143
Amortization of intangibles 705 30
Interest expense, net 1,313 1,384
Non-cash interest expense 2,005 1,785
Provision for income taxes 22 -
--- ---
EBITDA 3,269 9,897
Inventory step-up, related
to acquisition 343 -
Foreign currency exchange
gain (1,553) -
Stock-based compensation
expense 753 378
Change in the fair value of
derivative liability - (8,625)
Acquisition costs - -
--- ---
Adjusted EBITDA 2,812 1,650
Product development and
research expenses 3,711 2,630
----- -----
Adjusted EBITDA, before R&D
costs $6,523 $4,280
====== ======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP ADJUSTED NET INCOME
(in thousands, except share and per share information)
Three months ended March 31,
2016 2015
---- ----
Net income
(loss) $(950) $6,555
Non-cash
interest
expense 2,005 1,785
Acquisition
costs - -
Provision
for
income
taxes 22 -
Amortization
of
intangibles 705 30
Inventory
step-up,
related
to
acquisition 343 -
Foreign
currency
exchange
gain (1,553) -
Non-cash
stock-
based
compensation
expense 753 378
Change in
the fair
value of
derivative
liability - (8,625)
--- ------
Adjusted
net
income $1,325 $123
====== ====
Non-GAAP
adjusted
net
income
(loss)
per
diluted
share $0.02 $0.00
===== =====
Weighted average shares of common stock
outstanding:
Diluted 53,031,351 67,210,177
Contact: Jenniffer Collins
Teligent, Inc.
(856) 697-4379
www.teligent.com
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SOURCE Teligent, Inc.
