TELIGENT 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.
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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.
Contact: Jenniffer Collins
Teligent, Inc.
(856) 697-4379
www.teligent.com
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except shares and per share information)
(Unaudited)
Three months ended September 30, Nine months ended September 30,
-------------------------------- -------------------------------
2016 2015 2016 2015
---- ---- ---- ----
Revenues:
Product sales, net $15,709 $11,375 $48,156 $30,532
Research and
development services
and other income 442 240 790 647
--- --- --- ---
Total revenues 16,151 11,615 48,946 31,179
Costs and Expenses:
Cost of revenues 8,137 5,538 23,421 15,808
Selling, general and
administrative
expenses 3,694 2,433 10,813 6,474
Product development
and research
expenses 4,017 3,253 12,496 9,319
Total costs and
expenses 15,848 11,224 46,730 31,601
------
Operating income
(loss) 303 391 2,216 (422)
Other Income (Expense):
Change in the fair
value of derivative
liability - - - 23,144
Foreign currency
exchange gain 364 - 1,295 -
Interest and other
expense, net (3,347) (3,279) (9,997) (9,679)
------ ------ ------ ------
(Loss) income before
income tax expense (2,680) (2,888) (6,486) 13,043
Income tax expense 23 - 68 -
--- --- --- ---
Net (loss) income $(2,703) $(2,888) $(6,554) $13,043
======= ======= ======= =======
Basic earnings (loss)
per share ($0.05) ($0.05) ($0.12) $0.25
Diluted earnings
(loss) per share ($0.05) ($0.05) ($0.12) ($0.02)
Weighted average shares of common stock outstanding:
Basic 53,093,368 52,869,529 53,061,630 52,857,624
Diluted 53,093,368 52,869,529 53,061,630 67,173,250
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
September 30, 2016 December 31,
(Unaudited) 2015*
---------- ----
ASSETS
Current assets:
Cash and cash equivalents $74,632 $87,191
Accounts receivable, net 17,242 14,028
Inventories 12,485 8,985
Prepaid expenses and other
receivables 2,570 6,597
----- -----
Total current assets 106,929 116,801
Property, plant and
equipment, net 20,192 8,706
Debt issuance costs, net 3,416 4,027
Intangible assets,net 55,375 54,320
Goodwill 455 426
Other 794 482
--- ---
Total assets $187,161 $184,762
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,799 $3,955
Accrued expenses 8,810 6,267
Deferred income, net 1 476
Capital lease obligation,
current - 70
--- ---
Total current liabilities 12,610 10,768
Convertible 3.75% senior
notes, net of debt discount
(face of $143,750) 112,597 106,991
Deferred tax liability 259 244
Total liabilities 125,466 118,003
------- -------
Stockholders' equity:
Common stock, $0.01 par value, 100,000,000 shares authorized;
53,095,107and 53,000,689 shares issued and outstanding
as of September 30, 2016 and
December 31, 2015,
respectively 550 549
Additional paid-in capital 101,739 99,258
Accumulated deficit (39,472) (32,918)
Accumulated other
comprehensive loss, net of
taxes (1,122) (130)
------ ----
Total stockholders' equity 61,695 66,759
------ ------
Total liabilities and
stockholders' equity $187,161 $184,762
======== ========
*Derived from the audited December 31, 2015 financial statements
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended September 30, 2016 and 2015
(in thousands)
September 30, September 30,
2016 2015
---- ----
Cash flows from operating activities:
Net (loss)
income $(6,554) $13,043
Non-cash
expenses
(income) 11,057 (15,330)
Changes in
operating
assets and
liabilities (1,463) 4,108
------ -----
Net cash
provided by
operating
activities 3,040 1,821
Net cash used
in investing
activities (15,598) (11,751)
Net cash used
in financing
activities (71) (3,254)
--- ------
Effect of
exchange rate
on cash and
cash
equivalents 70 -
Net decrease in
cash and cash
equivalents (12,629) (13,184)
Cash and cash
equivalents at
beginning of
period 87,191 158,883
------ -------
Cash and cash
equivalents at
end of period $74,632 $145,699
======= ========
TELIGENT, INC. AND SUBSIDIARIES
GROSS TO NET CALCULATION
(in thousands)
Three months ended September 30, Nine months ended September 30,
-------------------------------- -------------------------------
2016 2015 2016 2015
---- ---- ---- ----
Gross product sales $64,943 $23,167 $136,329 $73,347
Reduction to gross product sales:
Chargebacks and
billbacks 43,161 9,072 82,564 37,160
Sales discounts and
other allowances 7,881 5,381 19,580 12,703
----- ----- ------ ------
Total reduction to
gross product sales 51,042 14,453 102,144 49,863
Product sales, net 13,901 8,714 34,185 23,484
Contract
manufacturing
product sales 1,808 2,661 13,971 7,048
----- ----- ------ -----
Total product sales,
net $15,709 $11,375 $48,156 $30,532
======= ======= ======= =======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP MEASURES
(in thousands)
Three months ended September 30, Nine months ended September 30,
-------------------------------- -------------------------------
2016 2015 2016 2015
---- ---- ---- ----
Net (loss) income $(2,703) $(2,888) $(6,554) $13,043
Depreciation and
amortization expense 283 164 679 454
Amortization of
intangibles 709 30 2,146 90
Interest expense, net 1,209 1,377 3,780 4,147
Non-cash interest
expense 2,139 1,902 6,217 5,532
Provision for income
taxes 23 - 68 -
--- --- --- ---
EBITDA 1,660 585 6,336 23,266
Inventory step-up,
related to
acquisition - - 530 -
Foreign currency
exchange gain (364) - (1,295) -
Stock-based
compensation expense 767 802 2,294 1,708
Change in the fair
value of derivative
liability - - - (23,144)
Acquisition costs - - - -
--- --- --- ---
Adjusted EBITDA 2,063 1,387 7,865 1,830
Product development
and research
expenses 4,017 3,253 12,496 9,319
----- ----- ------ -----
Adjusted EBITDA,
before R&D costs $6,080 $4,640 $20,361 $11,149
====== ====== ======= =======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP ADJUSTED NET INCOME
(in thousands, except share and per share information)
Three months ended September 30, Nine months ended September 30,
-------------------------------- -------------------------------
2016 2015 2016 2015
---- ---- ---- ----
Net (loss) income $(2,703) $(2,888) $(6,554) $13,043
Non-cash interest
expense 2,139 1,902 6,217 5,532
Provision for income
taxes 23 - 68 -
Amortization of
intangibles 709 30 2,146 90
Inventory step-up,
related to
acquisition - - 530 -
Foreign currency
exchange gain (364) - (1,295) -
Non-cash stock-
based compensation
expense 767 802 2,294 1,708
Change in the fair
value of derivative
liability - - - (23,144)
--- --- --- -------
Adjusted net income
(loss) $571 $(154) $3,406 $(2,771)
==== ===== ====== =======
Non-GAAP adjusted
net income (loss)
per diluted share $0.01 $(0.00) $0.05 $(0.04)
===== ====== ===== ======
Weighted average shares of common stock outstanding:
Basic 53,093,368 52,869,529 53,061,630 52,857,624
Diluted 67,478,451 52,869,529 67,400,694 67,173,250
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SOURCE Teligent, Inc.
