EX-99.1 2 v451474_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

News From

 

Buena, NJ 08310

  

 

Release Date: October 27, 2016
Contact: Jenniffer Collins
  Teligent, Inc.
  (856) 697-4379
  www.teligent.com

 

TELIGENT, INC. ANNOUNCES THIRD QUARTER 2016 RESULTS

 

Teligent Product Portfolio Revenue Growth of 60% Over 2015

  

BUENA, NJ – (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.

   

 

 

   

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,
2015*		 
   (Unaudited)    
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; 53,095,107 and 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