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Update on FDA Inspection of Buena Facility
Assessing New Growth Opportunities in Injectables
Conference Call to Be Held on August 16, 2021 at 8:30 am Eastern Standard Time
(877) 407-0792 US Toll Free Number
(201) 689-8263 International Number
Confirmation Number: 13721972
BUENA, N.J., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based generics pharmaceutical company, today announced its financial results for the second quarter of 2021 and provided a business update.
“Product demand in our core business was impacted by a combination of factors, including remediation-related activities, the ongoing effects of the COVID-19 pandemic, and modest generic pricing erosion seen within the topicals segment,” said Tim Sawyer, Teligent’s President & Chief Executive Officer. “Looking ahead, we are assessing several new opportunities within the injectables segment of our end markets, which we believe will help strengthen the long-term growth prospects of our business. We look forward to providing further details on our assessment in our earnings call and updating our investors on these initiatives throughout the second half of 2021.”
Second Quarter 2021 - Financial Highlights
Total revenues were $10.4 million for the three-months ended June 30, 2021 versus $13.6 million in Prior Period for 2020. The decrease was driven primarily by lost contract volume due to remediation-related activities, the continuing effects of the COVID-19 pandemic, and modest product price erosion due to generic competition.
Cost of revenues increased $2.1 million to $13.1 million for the Current Period, versus $11.1 million for the Prior Period mainly attributable to the cost of inventory reserves as well as the ongoing cost of remediation and period expenses combined with lower absorption.
Selling, general and administrative expenses of $5.7 million for the Current Period, increased from $5.0 million for the Prior Period. The increase was primarily due to higher professional fees resulting from our debt restructuring, offset slightly by a decrease in personnel related costs.
Product development and research expenses were $2.2 million for the Current Period, versus $1.9 million for the Prior Period. The increase was primarily due to API related expenses offset by decreases in personnel costs, outside testing and pilot batch expenses.
Net loss attributable to common stockholders decreased by $1.5 million, or 10%, to $12.9 million for the Current Period, from $14.3 million for the Prior Period. The decrease was primarily due to a decrease in interest and other expenses of $4.5 million and a $4.6 million decrease in change in the fair value of derivative liabilities. Operating loss has increased by $6.3 million from period-to-period to $10.7 million as a result of lower net product revenues and higher overall costs and expenses discussed above.
Full Year 2021 Financial Guidance
As previously noted in our first quarter 2021 earnings release, the Company will not be providing financial guidance for the year ending December 31, 2021 at this time or in the immediate term. There are a number of factors which weigh on our inability to provide such financial guidance, including, but not limited to, the continuing macroeconomic volatility triggered by the COVID-19 global pandemic and its continued impact on the Company’s business plans, our efforts to resolve the Warning Letter issued by the FDA in November 2019, as well as the currently on-going inspection and reinspection of our facilities and the unknown results from such inspection and reinspection. An additional factor contributing to this inability is the uncertainty regarding the timing for the FDA to conduct the pre-approval inspection of our newly constructed sterile injectable manufacturing facility in Buena, New Jersey. We do, however, look forward to a time in the future when we can provide such financial guidance.
FDA Warning Letter Update
As previously reported, based on management’s assessment of our remediation efforts at the Buena NJ manufacturing facility, the Company issued prior guidance stating that it believed it would be ready to inform the FDA of its inspection readiness during the third quarter of 2021.
Prior to our informing the FDA of our inspection readiness, the Company was informed by the FDA that it would commence a periodic Current Good Manufacturing Practices (“CGMP”) inspection and reinspection to follow-up on FDA Warning Letter remediation actions in mid-July. This inspection and reinspection remain ongoing and no formal communication from the FDA to the Company regarding the outcome or providing the final results of the inspection and reinspection has been issued, nor is the timing of such communications determinable at this time. Therefore, until such time as the results of the FDA’s inspection and reinspection are formally made available to us and we have had ample opportunity to review and analyze the same with our consultants and advisors we will have no further comment on this matter.
COVID-19 Response Summary
In alignment with the directives in the state of New Jersey, as a Pharmaceutical manufacturing facility, we are considered "essential". During the COVID-19 Public Health Emergency and State of Emergency in order to continue to supply our products to the patients that need them, we maintained our manufacturing operations and monitored conditions in order to maintain a safe workplace for our employees. The Company has taken several preventative measures to help ensure business continuity, while maintaining safe and stable operations. We have implemented social distancing measures on-site at our manufacturing facility to protect employees and our products. Our employees are provided daily personal protective equipment upon their arrival to the site and we have implemented temperature monitoring services at our newly established single point of entrance. We have also implemented a more frequent sanitization process of the facility. As the Public Health Emergency, State of Emergency and restrictions have abated, we have implementing a phased ‘return to office’ protocol under which we will maintain social distanced workspace and continue to sanitize our facilities.
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.
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 successfully complete 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.
Source: Teligent, Inc.
TELIGENT, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
June 30, 2021
December 31, 2020
Cash and cash equivalents
Accounts receivable, net
Prepaid expenses and other receivables
Total current assets
Property plant and equipment, net
Intangible assets, net
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Capital lease obligation, current
Total current liabilities
Series C Senior Secured Convertible Notes, net of debt discount and debt issuance costs (face of $- and $50,323 as of June 30, 2021 and December 31, 2020, respectively)
Series D Senior Convertible Notes, net of debt discount and debt issuance costs (face of $277 and $3,352 as of June 30, 2021 and December 31, 2020, respectively)
Revolver, net of debt issuance costs (face of $25,000 and $25,000 as of June 30, 2021 and December 31, 2020, respectively)
2023 Term Loan, net of debt issuance costs (face of $86,605 and $102,905 as of June 30, 2021 and December 31, 2020, respectively)
Deferred tax liability
Other long term liabilities
Series D Preferred Stock, $0.01 par value, 1,000,000 shares authorized, 85,412 shares issued and outstanding as of June 30, 2021
Common stock, $0.01 par value, 100,000,000 shares authorized, 92,817,674 and 21,754,223 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively
Additional paid-in capital
Accumulated other comprehensive loss
Total stockholders’ deficit
Total liabilities, mezzanine equity and stockholders' deficit
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except shares and per share information)
Three months ended June 30,
Six months ended June 30,
Costs and expenses:
Cost of revenues
Selling, general and administrative expenses
Product development and research expenses
Total costs and expenses
Other income expense:
Foreign currency exchange gain (loss)
Interest and other expense, net
Gain on debt restructuring
Change in fair value of derivative liabilities
Loss before income tax expense
Income tax (benefit) expense
Loss attributable to common shareholders
Loss per share
Basic and diluted loss per share
Weighted average shares of common stock outstanding:
Basic and diluted shares
TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Six months ended June 30,
Cash flows from operating activities:
Changes in operating assets and liabilities
Net cash used in operating activities
Net cash used in investing activities
Net cash provided by financing activities
Effect of exchange rate on cash and cash equivalents
Net increase (decrease) in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
Cash, cash equivalents and restricted cash at end of period