TELIGENT BUENA, N.J., July 28, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced its financial results for the second quarter ended June 30, 2016.
http://photos.prnewswire.com/prnvar/20151022/279641LOGO
Second Quarter 2016 Highlights
-- Total revenues of $17.1 million in the second quarter of 2016, an
increase of 93% 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 June 30,
2016 and 2015 of $11.1 million and $6.7 million, respectively.
-- Total revenues generated from contract manufacturing services and other
income for the three months ended June 30, 2016 and 2015 of $6.0 million
and $2.2 million, respectively.
-- Total international revenues for the three months ended June 30, 2016
and 2015 of $2.8 million and $0, respectively.
-- Gross margin for the three months ended June 30, 2016 equaled 56% as
compared to 41% in the same period of 2015.
-- Operating income was $1.1 million in the second quarter of 2016 compared
to operating loss of $1.9 million in the same period in 2015.
-- Our operating results in the second quarter of 2016 include $4.8 million
in research and development costs, compared to $3.4 million in the same
period in 2015.
-- Adjusted EBITDA (as defined and reconciled to GAAP) for the three months
ended June 30, 2016 and 2015 was $3.0 million and $(1.2 million),
respectively.
-- Adjusted earnings per fully diluted share (as defined and reconciled to
GAAP) for the three months ended June 30, 2016 and 2015 was $0.02 and
($0.05), respectively.
-- As a result of the fluctuation in foreign exchange rates during the
second quarter of 2016, we recorded a non-cash loss in the amount of
$0.6 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 second quarter, one for
Triamcinolone Acetonide Ointment USP, 0.1%, the Company's topical
product and one for Flurandrenolide Cream USP 0.5%, a partnered product.
Both products were launched in the second quarter.
-- The Company filed two ANDAs in the second quarter of 2016 with the FDA.
Full Year 2016 Revised Financial Guidance
-- The Company expects total revenue between $65.0 and $72.0 million for
the year ended December 31, 2016.
-- The Company anticipates gross margin of 54% to 56% for the year ended
December 31, 2016.
-- The Company intends to submit at least 15 ANDAs with the FDA in 2016.
The Company intends to submit 8 Abbreviated New Drug Submissions (ANDSs)
with 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 ended December 31, 2016.
Teligent's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "Our team continued to execute in the second quarter of 2016. During the quarter, we received approval from the FDA for two ANDAs, which included one Teligent product and one partnered product. Both products were launched in the same quarter as approval was received. On July 7, 2016, we received approval for two more Teligent generic topical products, which we will launch next month. During the second quarter of 2016, Teligent submitted two ANDAs to the FDA, bringing our total number of ANDAs currently pending at the FDA to thirty-three. Based on IMS Health data as of May 2016, the current total addressable market of these pipeline ANDAs is estimated at approximately $1.6 billion, excluding our three remaining partnered submissions. Significantly, 78% of this total addressable market is for products filed in Generic Drug User Fee Amendments (GDUFA) Year 3 or later, where FDA has committed to faster review cycles. We also have five applications pending with Health Canada for our Canadian injectable business, including one filed in 2016. We also received our license to distribute controlled substances in Canada during the second quarter, which allowed us to launch our first controlled-substance injectable product earlier this month.''
Mr. Grenfell-Gardner continued, "Our strategy is based on the implementation of GDUFA by the FDA. We believe that the six approvals by the FDA thus far in 2016 confirm to us that our strategy is working. Just one year ago, Teligent had seven topical generic products, and no generic injectable products in our US portfolio. With the product launches in August, we will now market twelve products in twenty-two 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 nineteen products in thirty-eight presentations in the Canadian injectable market."
"In June 2016, we hosted the ground-breaking ceremony for our expansion of our facility in Buena, New Jersey. The renovation and expansion continues to be on track to deliver our completed new facility by the end of 2017. In July we completed the first phase of the project, as we opened our new research and development lab. The expansion will increase our topical manufacturing capacity, as well as include new sterile injectable manufacturing capabilities for the product development and manufacturing of generic injectable prescription products."
"Revenue from the Teligent portfolio of injectable and topical products was $11.1 million for the quarter, a 66% increase over the same quarter last year. This growth has been driven by both our entry into the specialty generic injectable market in addition to the successful launches of four Teligent product launches in 2016. In the second quarter of 2016, just over 23% of our revenue was from our Teligent injectable products in both the United States and Canada compared to zero in the second 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, July 28, 2016 to discuss the second 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 June 30, Six months ended June 30,
--------------------------- -------------------------
2016 2015 2016 2015
---- ---- ---- ----
Revenues:
Product sales, net $17,025 $8,647 $32,447 $19,157
Research and
development
services and other
income 113 246 348 407
--- --- --- ---
Total revenues 17,138 8,893 32,795 19,564
Costs and Expenses:
Cost of revenues 7,582 5,227 15,284 10,270
Selling, general
and administrative
expenses 3,712 2,141 7,119 4,041
Product development
and research
expenses 4,768 3,436 8,479 6,066
----- ----- ----- -----
Total costs and
expenses 16,062 10,804 30,882 20,377
Operating income
(loss) 1,076 (1,911) 1,913 (813)
Other Income (Expense):
Change in the fair
value of
derivative
liability - 14,519 - 23,144
Foreign currency
exchange (loss)
gain (622) - 931 -
Interest and other
expense, net (3,332) (3,232) (6,650) (6,400)
------ ------ ------ ------
(Loss) income
before income tax
expense (2,878) 9,376 (3,806) 15,931
Income tax expense 23 - 45 -
--- --- --- ---
Net (loss) income $(2,901) $9,376 $(3,851) $15,931
======= ====== ======= =======
Basic earnings
(loss) per share ($0.05) $0.18 ($0.07) $0.30
Diluted earnings
(loss) per share ($0.05) ($0.03) ($0.07) ($0.02)
Weighted average shares of common stock outstanding:
Basic 53,059,799 52,861,167 53,045,576 52,851,587
Diluted 53,059,799 67,125,905 53,045,576 67,174,546
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
June 30, 2016 December 31,
(Unaudited) 2015*
---------- ----
ASSETS
Current assets:
Cash and cash equivalents $81,201 $87,191
Accounts receivable, net 15,511 14,028
Inventories 11,047 8,985
Prepaid expenses and other receivables 2,850 6,597
----- -----
Total current assets 110,609 116,801
Property, plant and equipment, net 16,376 8,706
Debt issuance costs, net 3,627 4,027
Intangible assets,net 56,006 54,320
Goodwill 460 426
Other 450 482
--- ---
Total assets $187,528 $184,762
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,972 $3,955
Accrued expenses 8,887 6,267
Deferred income, net 1 476
Capital lease obligation, current - 70
--- ---
Total current liabilities 12,860 10,768
Convertible 3.75% senior notes, net of debt discount (face of $143,750) 110,669 106,991
Deferred tax liability 261 244
Total liabilities 123,790 118,003
------- -------
Stockholders' equity:
Common stock, $0.01 par value, 60,000,000 shares authorized;
53,065,107and 53,000,689 shares issued and outstanding
as of June 30, 2016 and December 31, 2015, respectively 550 549
Additional paid-in capital 100,797 99,258
Accumulated deficit (36,769) (32,918)
Accumulated other comprehensive loss, net of taxes (840) (130)
---- ----
Total stockholders' equity 63,738 66,759
------ ------
Total liabilities and stockholders' equity $187,528 $184,762
======== ========
*Derived from the audited December 31, 2015 financial statements
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six months ended June 30, 2016 and 2015
(in thousands)
June 30, June 30,
2016 2015
---- ----
Cash flows from operating
activities:
Net
(loss)
income $(3,851) $15,931
Non-
cash
expenses
(income) 7,284 (18,208)
Changes
in
operating
assets
and
liabilities 2,123 (3,516)
----- ------
Net cash
provided
by
(used
in)
operating
activities 5,556 (5,793)
Net cash
used in
investing
activities (11,486) (2,795)
Net cash
used in
financing
activities (93) (74)
--- ---
Effect
of
exchange
rate on
cash
and
cash
equivalents 33 -
Net
decrease
in cash
and
cash
equivalents (6,023) (8,662)
Cash and
cash
equivalents
at
beginning
of
period 87,191 158,883
------ -------
Cash and
cash
equivalents
at end
of
period $81,201 $150,221
======= ========
TELIGENT, INC. AND SUBSIDIARIES
GROSS TO NET CALCULATION
(in thousands)
Three months ended June 30, Six months ended June 30,
--------------------------- -------------------------
2016 2015 2016 2015
---- ---- ---- ----
Gross product sales $44,563 $27,861 $71,386 $50,180
Reduction to gross product sales:
Chargebacks and
billbacks 27,059 15,576 39,404 28,088
Sales discounts and
other allowances 6,411 5,612 11,698 7,322
----- ----- ------ -----
Total reduction to
gross product sales 33,470 21,188 51,102 35,410
Product sales, net 11,093 6,673 20,284 14,770
Contract
manufacturing
product sales 5,932 1,974 12,163 4,387
----- ----- ------ -----
Total product sales,
net $17,025 $8,647 $32,447 $19,157
======= ====== ======= =======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP MEASURES
(in thousands)
Three months ended June 30, Six months ended June 30,
--------------------------- -------------------------
2016 2015 2016 2015
---- ---- ---- ----
Net (loss) income $(2,901) $9,376 $(3,851) $15,931
Depreciation and
amortization
expense 222 148 396 290
Amortization of
intangibles 732 30 1,437 60
Interest expense,
net 1,259 1,386 2,572 2,770
Non-cash interest
expense 2,073 1,845 4,078 3,630
Provision for
income taxes 23 - 45 -
--- --- --- ---
EBITDA 1,408 12,785 4,677 22,681
Inventory step-up,
related to
acquisition 187 - 530 -
Foreign currency
exchange loss
(gain) 622 - (931) -
Stock-based
compensation
expense 774 528 1,527 906
Change in the fair
value of
derivative
liability - (14,519) - (23,144)
--- ------- --- -------
Adjusted EBITDA 2,991 (1,206) 5,803 443
Product development
and research
expenses 4,768 3,436 8,479 6,066
----- ----- ----- -----
Adjusted EBITDA,
before R&D costs $7,759 $2,230 $14,282 $6,509
====== ====== ======= ======
TELIGENT, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP ADJUSTED NET INCOME
(in thousands, except share and per share information)
Three months ended June 30, Six months ended June 30,
--------------------------- -------------------------
2016 2015 2016 2015
---- ---- ---- ----
Net (loss) income $(2,901) $9,376 $(3,851) $15,931
Non-cash interest
expense 2,073 1,845 4,078 3,630
Provision for
income taxes 23 - 45 -
Amortization of
intangibles 732 30 1,437 60
Inventory step-up,
related to
acquisition 187 - 530 -
Foreign currency
exchange loss
(gain) 622 - (931) -
Non-cash stock-
based compensation
expense 774 528 1,527 906
Change in the fair
value of
derivative
liability - (14,519) - (23,144)
--- ------- --- -------
Adjusted net income
(loss) $1,510 $(2,740) $2,835 $(2,617)
====== ======= ====== =======
Non-GAAP adjusted
net income (loss)
per diluted share $0.02 $(0.05) $0.04 $(0.05)
===== ====== ===== ======
Weighted average shares of common stock outstanding:
Basic 53,059,799 52,861,167 53,045,576 52,851,587
Diluted 67,359,092 52,861,167 67,355,845 52,851,587
Logo - http://photos.prnewswire.com/prnh/20151022/279641LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/teligent-inc-announces-second-quarter-2016-results-300305942.html
SOURCE Teligent, Inc.
