Nature of the Business and Going Concern	6 Months Ended
Jun. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of the Business and Going Concern	Nature of the Business and Going Concern Nature of the Business Teligent, Inc. (the “Company”) is a generic pharmaceutical company. All references to "Teligent," the "Company," "we," "us," and "our" refer to Teligent, Inc. and its subsidiaries. To date, our platform for growth has been centered around the development, manufacturing and marketing of a portfolio of generic pharmaceutical products under our own label and private labeled for other pharmaceutical companies in topical and injectable dosage forms. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, will leverage our existing expertise and capabilities, and broaden our platform for more diversified strategic growth. We currently market and sell generic topical and generic and branded injectable pharmaceutical products in the United States and Canada. In the United States, we market 37 generic topical pharmaceutical products and 1 branded injectable pharmaceutical products. We have FDA approvals for a total of 39 topical generic products of which 3 products are currently discontinued, and we have 7 Abbreviated New Drug Applications ("ANDAs") on topical products and 3 New Drug Application ("NDA") Prior Approval Supplements ("PASs") for sterile injectable products submitted to the FDA that are awaiting approval. As a result of our remediation of certain issues identified in the FDA Warning Letter issued in November 2019 (discussed further below), we have paused the marketing and sale of 5 of our products, with tentative plans to return them to the market sometime in second quarter of 2022. Furthermore, in reaction to changing market forces, the Company is examining the potential discontinuance of an additional 5 products over the next 12-24 months. In Canada we market 24 generic injectable, 1 generic topical, and 3 generic ophthalmic products approved by Health Canada. We have 1 Abbreviated New Drug Submission (“ANDS”) pending at Health Canada. In the United States, approved ANDA generic drugs are usually interchangeable with the innovator drug. This means that the generic version may generally be substituted for the branded product by either a physician or pharmacist when dispensing a prescription. We also provide contract development and manufacturing services to the prescription and over-the-counter ("OTC") pharmaceutical and cosmetic markets. We operate our business under one operating segment. Our common stock is traded on the Nasdaq Global Select Market under the trading symbol “TLGT.” Our principal executive office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. We have additional offices located in Iselin, New Jersey, and Mississauga, Canada. In late 2020, we decided to reposition the research and development operation mainly performed at our Tallinn, Estonia office to our US manufacturing site at Buena, New Jersey, and consequently we have divested our limited assets in Estonia and are in the process of formally dissolving our Estonian operations. The manufacturing and commercialization of generic pharmaceutical products is competitive, and there are established manufacturers, suppliers and distributors actively engaged in all phases of our business. We currently manufacture and sell topical, injectable and ophthalmic generic pharmaceutical products under our own label in both the US and Canada. Liquidity and Capital Resources; Going Concern We have incurred significant losses and generated negative cash flows from operations in recent years, and we expect to continue to incur losses and generate negative cash flows from operations for the foreseeable future. We are not currently generating revenues from operations that are sufficient to cover our operating expenses, and our available capital resources are not sufficient for us to continue to meet our obligations as they become due, presenting substantial doubt as to our ability to continue as a going concern. Our cash and cash equivalents at June 30, 2021 were approximately $22.6 million, compared to approximately $5.9 million at December 31, 2020 and approximately $27.5 million at March 31, 2021. We continue to work diligently with our financial and strategic advisors to critically assess the strengths of the company which we can leverage moving forward. In the absence of additional liquidity, we anticipate that existing cash resources, after giving effect to $4.6 million in interim funding under the Second Lien Credit Agreement, with our continued focus on cash conservation, will result in our having sufficient operating cash until the end of 2021 or into the first quarter of 2022. We have been and are actively pursuing potential sources of additional liquidity, including: •Equity Financing. We completed the at-the-market offering on March 31, 2021 with aggregate gross proceeds of $38,712,036 from the sale of shares of our common stock at an average price of $0.993 per share. •Debt Financing. We have undertaken several deleveraging transactions to reduce our indebtedness and our related costs of capital. Additionally, we have worked with our lenders under the Senior Credit Facilities to obtain short-term financing to meet our immediate liquidity needs, including $4.6 million in interim funding under the Second Lien Credit Agreement. At the commencement of the ATM offering, we and Ares agreed to amendments of the Senior Credit Agreements to provide for an extension of relief from certain financial covenants (including, among others, our minimum liquidity covenant through March 31, 2022). There can be no assurances that our senior lenders will continue to provide interim financing or other relief from the covenants contained in our Senior Credit Agreements, from which we may need one or more additional waivers based on our currently expected results. In the event such waivers are not extended and we violate one or more of certain specified covenants in our Senior Credit Agreements, such violation may lead to one or more events of default under the Senior Credit Agreements, which may trigger certain cross-default provisions under the terms of any other indebtedness then in effect. We continue to engage with our business, financial and legal advisors to further analyze and explore new potential transactions to refinance or restructure our remaining outstanding debt. •Strategic Alternatives and Further Deleveraging. We expect to continually engage in such exploratory discussions with potential partners and counterparties in regard to strategic transactions and further deleveraging transactions as we and our board of directors determine are appropriate. We are continuing to diligently pursue with our financial and strategic advisors critical assessments of our asset base, operational and strategic strengths and how we can best leverage them moving forward, as well as potential transactions which could result in further deleveraging or increased liquidity. However, the outcome of these activities is uncertain at this time and there can be no assurance that we will be able to identify any appropriate transaction or strategy, or consummate any such potential transaction or strategic shift which may be identified on terms that are acceptable to us, if at all. It has been very difficult to estimate our liquidity requirements, future cash burn rates and future operating results, during the last 15 months due to the COVID-19 pandemic. Further, it has been difficult to determine when our operating environment will change to allow us to return to more normalized operations, including in respect of the effects of the COVID-19 pandemic. By way of example, the COVID-19 pandemic resulted in a significant decrease in elective visits to dermatologists in the United States, which has led to a reduction in the volume of prescriptions written for topical products customarily supplied by us, which has negatively impacted our revenue. While the easing of COVID-19 precautions has, to an extent, allowed some improvement in elective visits to dermatologists, the continuing uncertainty in regard to the sustainability of the level of these visits given the emergence of new strains of COIVD-19 and the resurgence of social distancing precautions is leading to continuing uncertainty on prescription volumes for topical products we supply and an inability to reliably forecast our revenues. Further, the FDA Warning Letter (discussed further below) has prevented us from launching our new sterile injectable product line to be produced at our new facility, and due to regulatory and inventory production requirements, as well as certain issues of non-conformance with respect to certain products identified during our review undertaken in connection with the FDA Warning Letter (including, among other matters, product recalls, long-term production pauses, short-term clear path to market production pauses, and continued production with minor process correction), we anticipate continuing to experience a significant delay in the launch of such product line even after the restrictions imposed by the FDA Warning Letter are rescinded (if such restrictions are rescinded at all). We also continue to experience significant pressures on our liquidity related to remediation efforts arising in respect of the FDA Warning Letter. While we believe we have made substantial progress in remediating the issues identified in the FDA Warning Letter and in subsequent internal reviews, as discussed in further detail below, the FDA is currently performing a Current Good Manufacturing Practices (“CGMP”) inspection and reinspection to follow-up on FDA Warning Letter remediation actions and we cannot predict at this time when it will be completed, when the results of the inspection will be made available to us, what those results may be and how those results may impact the restrictions imposed on the Company by the FDA Warning Letter. As a result, there can be no assurances as to when, whether and to what extent the FDA will agree to remove the restrictions imposed by the FDA Warning Letter following such re-inspection. As a result, we continue to have uncertainty as to whether or when the restrictions imposed by the FDA Warning Letter will be removed or if removed, how long it will take for our increased ability to operate following such removal to generate sufficient liquidity to achieve more normalized operating results. Further, given the substantial doubts of our ability to proceed as a going concern and the significant operational challenges we face in the near- and long-term, there can be no assurances that any or all these potential sources of liquidity will be available to us on commercially acceptable terms, if at all. FDA Warning Letter The Company received a warning letter from the FDA in November 2019 arising from an inspection of its Buena, New Jersey manufacturing facility, as well as an additional comment letter from the FDA in August 2020 (the “FDA Warning Letter”). As part of our efforts to remediate the issues identified in the FDA Warning Letter and to strengthen our quality systems, we undertook a comprehensive review of all of our products. This review was completed in December 2020. While the review did not identify material issues with many of our products, it identified certain issues of non-conformance with respect to certain products which have resulted in recalls and halting the production of certain products, that we are actively reviewing and remediating. We have experienced and may continue to experience, among other matters, product recalls, long-term production pauses, short-term clear path to market production pauses, and continued production with minor process corrections. The Company has also provided the FDA with a series of detailed submissions outlining additional changes in its quality practices, submitting additional documentation to support previous and ongoing independent assessments and remediation actions, providing updates to the Company’s organizational structure, and providing all further detail in regard to ongoing remediation projects (including comprehensive product quality assessments) to ensure all of our products are safe, effective and compliant. The Company is continuing to work diligently to remediate all issues cited by the FDA and those resulting from its comprehensive quality review, and has continued to have active communications with the FDA regarding its progress. As stated at the end of the first quarter of 2021, the Company was of the belief that it had made substantial progress in remediating the issues identified in the FDA Warning Letter and in subsequent internal reviews and that it would, based on its assessment of these remediation efforts, be ready to inform the FDA of its inspection readiness during the third quarter of 2021. However, prior to the Company so informing the FDA, it was informed that the FDA 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 is still on-going as of this time and we cannot predict at this time when it will be completed, when the results of the inspection will be made available to us, what those results may be, and how those results may impact the restrictions imposed on the Company by the FDA Warning Letter. We will have no further comment on this matter until such time as the results of the FDA’s inspection and reinspection are formally made available to us and we have had the opportunity to review and analyze the same with our consultants and advisors. We believe the foregoing disruptions with respect to certain of our products, the diversion of resources to remediate the product quality issues, and the uncertainty as to the results of the FDA's on-going inspection and reinspection and whether and when this may or may not result in the removal or abating of the restrictions imposed on the Company by the FDA Warning Letter will continue to have a negative impact on our business, financial position, results of operations and cash flows during 2021, including reducing our revenue, negatively impacting operating/(loss), and possibly resulting in impairment and other charges. Further, we anticipate that the FDA’s pre-approval inspection for commercial production on the newly installed injectable line at the Buena, NJ facility will continue to be delayed until such time as the FDA Warning Letter is fully addressed. The continued failure to address the issues identified by the FDA in its warning letter and those subsequently identified by us in our comprehensive product quality review as well as the continued delay in obtaining the FDA’s pre-approval inspection for commercial production on the newly installed injectable line at the Buena, NJ facility will have a negative impact on our business, financial position, results of operations and cash flows. COVID-19 Pandemic Update As a pharmaceutical manufacturing facility, we are considered “essential” under applicable directives from the state of New Jersey. During the COVID-19 Public Health Emergency and State of Emergency we maintained our manufacturing operations and monitored conditions in order to maintain a safe workplace for our employees. Among other preventative measures, during the height of the pandemic we directed all employees that could perform their function remotely to work from home in accordance with applicable guidelines, implemented social distancing measures on-site at our manufacturing facility and associated administrative office spaces, provided daily personal protective equipment to our onsite employees upon their arrival to the site and 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 now implemented a ‘return to office’ protocol for all our locations under which we will maintain social distanced workspace and continue to sanitize our facilities. During the pandemic, we re-aligned our manufacturing-related resources with downward adjustments made to our production schedule, and in order to preserve cash, we initiated a reduction in force at our Buena, NJ manufacturing facility effective June 19, 2020. In connection with the reduction, we terminated 53 employees, furloughed another 15 employees and eliminated the 2nd shift packaging operation. Many of the furloughed employees have now been recalled and our employee base has stabilized and begun to rebound as we recruit and fill critical positions. In addition, we decided to shift our research and development operation being performed in our Tallinn, Estonia office to our US manufacturing site at Buena, New Jersey and subsequently to wind-down our Estonia operation. On September 30, 2020, we sold certain of our assets located in Estonia. Government Grant Advance On May 15, 2020, the Company received $3.4 million of proceeds from the U.S. Small Business Administration (the "SBA") Paycheck Protection Program (the "Government Grant Advance") and utilized the advance to balance its employee-related actions previously taken with the business needs to ensure a significant portion of the loan will be forgiven. The Government Grant Advance matures in 2 years with accrued interest at an annual rate of 1.00%, being deferred for payments on amounts not forgiven at the later of (a) 10 months following the borrower's covered period, or (b) when the SBA remits any amounts forgiven to the lender. According to IAS 20, Accounting for Government Grants and Disclosure of Government Assistance, the Company recorded $3.4 million in other income on the Consolidated Statements of Operations for the year ended December 31, 2020. Nasdaq Delisting Notice On April 9, 2021, the Company received a notice (the “Notice”) from The Nasdaq Stock Market informing the Company that for the prior 30 consecutive business days, the bid price of the Company’s securities had closed below $1.00 per share, which is the minimum required closing bid price for continued listing on Nasdaq pursuant to Listing Rule 5450(a)(1) (the “Bid Price Requirement”). The Notice has no immediate effect on the Company’s Nasdaq listing or trading of the Company’s common stock. The Company has 180 calendar days, or until October 6, 2021, to regain compliance. To regain compliance, the closing bid price of the Company’s securities must be at least $1.00 per share for a minimum of ten consecutive business days. If the Company does not regain compliance by October 6, 2021, the Company may be eligible for additional time to regain compliance or if the Company is otherwise not eligible, the Company may request a hearing before a Hearings Panel. The negative financial conditions described above raise substantial doubt about our ability to continue as a going concern as of June 30, 2021. To that end, and as described above, the Company is not currently generating revenues from operations that are sufficient to cover its operating expenses, and its available capital resources are not sufficient for it to continue to meet its obligations as they become due. As a result, the Company has engaged financial, strategic and legal advisors to assist it in, among other things, analyzing all available strategic alternatives to address its liquidity and capital structure. As part of these activities we are continuing to diligently pursue with our financial and strategic advisors critical assessments of our asset base, operational and strategic strengths and how we can best leverage them moving forward, as well as potential transactions which could result in potential increased liquidity. However, the outcome of these activities is uncertain at this time and there can be no assurance that we will be able to identify any appropriate transaction or strategy, or consummate any such potential transaction or strategic shift which may be identified on terms that are acceptable to us, if at all. Thus, the Company cannot provide assurances that additional liquidity and capital will be available when needed or that any strategic alternatives or restructuring pursued will be available on acceptable terms. If such additional liquidity or capital is not available and the Company is unable to successfully pursue strategic alternatives or a restructuring, it may be forced to pursue a plan of reorganization under Chapter 11 of the U.S. Bankruptcy Code and/or cease its operations. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Teligent, Inc. (the “Company”) is a generic pharmaceutical company. All references to "Teligent," the "Company," "we," "us," and "our" refer to Teligent, Inc. and its subsidiaries. To date, our platform for growth has been centered around the development, manufacturing and marketing of a portfolio of generic pharmaceutical products under our own label and private labeled for other pharmaceutical companies in topical and injectable dosage forms. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, will leverage our existing expertise and capabilities, and broaden our platform for more diversified strategic growth.

We currently market and sell generic topical and generic and branded injectable pharmaceutical products in the United States and Canada. In the United States, we market 37 generic topical pharmaceutical products and 1 branded injectable pharmaceutical products. We have FDA approvals for a total of 39 topical generic products of which 3 products are currently discontinued, and we have 7 Abbreviated New Drug Applications ("ANDAs") on topical products and 3 New Drug Application ("NDA") Prior Approval Supplements ("PASs") for sterile injectable products submitted to the FDA that are awaiting approval. As a result of our remediation of certain issues identified in the FDA Warning Letter issued in November 2019 (discussed further below), we have paused the marketing and sale of 5 of our products, with tentative plans to return them to the market sometime in second quarter of 2022. Furthermore, in reaction to changing market forces, the Company is examining the potential discontinuance of an additional 5 products over the next 12-24 months.

In the United States, approved ANDA generic drugs are usually interchangeable with the innovator drug. This means that the generic version may generally be substituted for the branded product by either a physician or pharmacist when dispensing a prescription. We also provide contract development and manufacturing services to the prescription and over-the-counter ("OTC") pharmaceutical and cosmetic markets. We operate our business under one operating segment.

Our common stock is traded on the Nasdaq Global Select Market under the trading symbol “TLGT.” Our principal executive office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. We have additional offices located in Iselin, New Jersey, and Mississauga, Canada. In late 2020, we decided to reposition the research and development operation mainly performed at our Tallinn, Estonia office to our US manufacturing site at Buena, New Jersey, and consequently we have divested our limited assets in Estonia and are in the process of formally dissolving our Estonian operations.

We have incurred significant losses and generated negative cash flows from operations in recent years, and we expect to continue to incur losses and generate negative cash flows from operations for the foreseeable future. We are not currently generating revenues from operations that are sufficient to cover our operating expenses, and our available capital resources are not sufficient for us to continue to meet our obligations as they become due, presenting substantial doubt as to our ability to continue as a going concern. Our cash and cash equivalents at June 30, 2021 were approximately $22.6 million, compared to approximately $5.9 million at December 31, 2020 and approximately $27.5 million at March 31, 2021. We continue to work diligently with our financial and strategic advisors to critically assess the strengths of the company which we can leverage moving forward.

•Debt Financing. We have undertaken several deleveraging transactions to reduce our indebtedness and our related costs of capital. Additionally, we have worked with our lenders under the Senior Credit Facilities to obtain short-term financing to meet our immediate liquidity needs, including $4.6 million in interim funding under the Second Lien Credit Agreement. At the commencement of the ATM offering, we and Ares agreed to amendments of the Senior Credit Agreements to provide for an extension of relief from certain financial covenants (including, among others, our minimum liquidity covenant through March 31, 2022). There can be no assurances that our senior lenders will continue to provide interim financing or other relief from the covenants contained in our Senior Credit Agreements, from which we may need one or more additional waivers based on our currently expected results. In the event such waivers are not extended and we violate one or more of certain specified covenants in our Senior Credit Agreements, such violation may lead to one or more events of default under the Senior Credit Agreements, which may trigger certain cross-default provisions under the terms of any other indebtedness then in effect. We continue to engage with our business, financial and legal advisors to further analyze and explore new potential transactions to refinance or restructure our remaining outstanding debt.

•Strategic Alternatives and Further Deleveraging. We expect to continually engage in such exploratory discussions with potential partners and counterparties in regard to strategic transactions and further deleveraging transactions as we and our board of directors determine are appropriate. We are continuing to diligently pursue with our financial and strategic advisors critical assessments of our asset base, operational and strategic strengths and how we can best leverage them moving forward, as well as potential transactions which could result in further deleveraging or increased liquidity. However, the outcome of these activities is uncertain at this time and there can be no assurance that we will be able to identify any appropriate transaction or strategy, or consummate any such potential transaction or strategic shift which may be identified on terms that are acceptable to us, if at all.

It has been very difficult to estimate our liquidity requirements, future cash burn rates and future operating results, during the last 15 months due to the COVID-19 pandemic. Further, it has been difficult to determine when our operating environment will change to allow us to return to more normalized operations, including in respect of the effects of the COVID-19 pandemic. By way of example, the COVID-19 pandemic resulted in a significant decrease in elective visits to dermatologists in the United States, which has led to a reduction in the volume of prescriptions written for topical products customarily supplied by us, which has negatively impacted our revenue. While the easing of COVID-19 precautions has, to an extent, allowed some improvement in elective visits to dermatologists, the continuing uncertainty in regard to the sustainability of the level of these visits given the emergence of new strains of COIVD-19 and the resurgence of social distancing precautions is leading to continuing uncertainty on prescription volumes for topical products we supply and an inability to reliably forecast our revenues.

Further, the FDA Warning Letter (discussed further below) has prevented us from launching our new sterile injectable product line to be produced at our new facility, and due to regulatory and inventory production requirements, as well as certain issues of non-conformance with respect to certain products identified during our review undertaken in connection with the FDA Warning Letter (including, among other matters, product recalls, long-term production pauses, short-term clear path to market production pauses, and continued production with minor process correction), we anticipate continuing to experience a significant delay in the launch of such product line even after the restrictions imposed by the FDA Warning Letter are rescinded (if such restrictions are rescinded at all). We also continue to experience significant pressures on our liquidity related to remediation efforts arising in respect of the FDA Warning Letter. While we believe we have made substantial progress in remediating the issues identified in the FDA Warning Letter and in subsequent internal reviews, as discussed in further detail below, the FDA is currently performing a Current Good Manufacturing Practices (“CGMP”) inspection and reinspection to follow-up on FDA Warning Letter remediation actions and we cannot predict at this time when it will be completed, when the results of the inspection will be made available to us, what those results may be and how those results may impact the restrictions imposed on the Company by the FDA Warning Letter. As a result, there can be no assurances as to when, whether and to what extent the FDA will agree to remove the restrictions imposed by the FDA Warning Letter following such re-inspection.

As a result, we continue to have uncertainty as to whether or when the restrictions imposed by the FDA Warning Letter will be removed or if removed, how long it will take for our increased ability to operate following such removal to generate sufficient liquidity to achieve more normalized operating results. Further, given the substantial doubts of our ability to proceed as a going concern and the significant operational challenges we face in the near- and long-term, there

The Company received a warning letter from the FDA in November 2019 arising from an inspection of its Buena, New Jersey manufacturing facility, as well as an additional comment letter from the FDA in August 2020 (the “FDA Warning Letter”). As part of our efforts to remediate the issues identified in the FDA Warning Letter and to strengthen our quality systems, we undertook a comprehensive review of all of our products. This review was completed in December 2020. While the review did not identify material issues with many of our products, it identified certain issues of non-conformance with respect to certain products which have resulted in recalls and halting the production of certain products, that we are actively reviewing and remediating. We have experienced and may continue to experience, among other matters, product recalls, long-term production pauses, short-term clear path to market production pauses, and continued production with minor process corrections. The Company has also provided the FDA with a series of detailed submissions outlining additional changes in its quality practices, submitting additional documentation to support previous and ongoing independent assessments and remediation actions, providing updates to the Company’s organizational structure, and providing all further detail in regard to ongoing remediation projects (including comprehensive product quality assessments) to ensure all of our products are safe, effective and compliant. The Company is continuing to work diligently to remediate all issues cited by the FDA and those resulting from its comprehensive quality review, and has continued to have active communications with the FDA regarding its progress.

As stated at the end of the first quarter of 2021, the Company was of the belief that it had made substantial progress in remediating the issues identified in the FDA Warning Letter and in subsequent internal reviews and that it would, based on its assessment of these remediation efforts, be ready to inform the FDA of its inspection readiness during the third quarter of 2021. However, prior to the Company so informing the FDA, it was informed that the FDA 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 is still on-going as of this time and we cannot predict at this time when it will be completed, when the results of the inspection will be made available to us, what those results may be, and how those results may impact the restrictions imposed on the Company by the FDA Warning Letter. We will have no further comment on this matter until such time as the results of the FDA’s inspection and reinspection are formally made available to us and we have had the opportunity to review and analyze the same with our consultants and advisors.

We believe the foregoing disruptions with respect to certain of our products, the diversion of resources to remediate the product quality issues, and the uncertainty as to the results of the FDA's on-going inspection and reinspection and whether and when this may or may not result in the removal or abating of the restrictions imposed on the Company by the FDA Warning Letter will continue to have a negative impact on our business, financial position, results of operations and cash flows during 2021, including reducing our revenue, negatively impacting operating/(loss), and possibly resulting in impairment and other charges. Further, we anticipate that the FDA’s pre-approval inspection for commercial production on the newly installed injectable line at the Buena, NJ facility will continue to be delayed until such time as the FDA Warning Letter is fully addressed. The continued failure to address the issues identified by the FDA in its warning letter and those subsequently identified by us in our comprehensive product quality review as well as the continued delay in obtaining the FDA’s pre-approval inspection for commercial production on the newly installed injectable line at the Buena, NJ facility will have a negative impact on our business, financial position, results of operations and cash flows.

As a pharmaceutical manufacturing facility, we are considered “essential” under applicable directives from the state of New Jersey. During the COVID-19 Public Health Emergency and State of Emergency we maintained our manufacturing operations and monitored conditions in order to maintain a safe workplace for our employees. Among other preventative measures, during the height of the pandemic we directed all employees that could perform their function remotely to work from home in accordance with applicable guidelines, implemented social distancing measures on-site at our manufacturing facility and associated administrative office spaces, provided daily personal protective equipment to our onsite employees upon their arrival to the site and 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 now implemented a ‘return to office’ protocol for all our locations under which we will maintain social distanced workspace and continue to sanitize our facilities.

During the pandemic, we re-aligned our manufacturing-related resources with downward adjustments made to our production schedule, and in order to preserve cash, we initiated a reduction in force at our Buena, NJ manufacturing facility effective June 19, 2020. In connection with the reduction, we terminated 53 employees, furloughed another 15 employees and eliminated the 2nd shift packaging operation. Many of the furloughed employees have now been recalled and our employee base has stabilized and begun to rebound as we recruit and fill critical positions.

On May 15, 2020, the Company received $3.4 million of proceeds from the U.S. Small Business Administration (the "SBA") Paycheck Protection Program (the "Government Grant Advance") and utilized the advance to balance its employee-related actions previously taken with the business needs to ensure a significant portion of the loan will be forgiven. The Government Grant Advance matures in 2 years with accrued interest at an annual rate of 1.00%, being deferred for payments on amounts not forgiven at the later of (a) 10 months following the borrower's covered period, or (b) when the SBA remits any amounts forgiven to the lender. According to IAS 20, Accounting for Government Grants and Disclosure of Government Assistance, the Company recorded $3.4 million in other income on the Consolidated Statements of Operations for the year ended December 31, 2020.

On April 9, 2021, the Company received a notice (the “Notice”) from The Nasdaq Stock Market informing the Company that for the prior 30 consecutive business days, the bid price of the Company’s securities had closed below $1.00 per share, which is the minimum required closing bid price for continued listing on Nasdaq pursuant to Listing Rule 5450(a)(1) (the “Bid Price Requirement”). The Notice has no immediate effect on the Company’s Nasdaq listing or trading of the Company’s common stock. The Company has 180 calendar days, or until October 6, 2021, to regain compliance. To regain compliance, the closing bid price of the Company’s securities must be at least $1.00 per share for a minimum of ten consecutive business days. If the Company does not regain compliance by October 6, 2021, the Company may be eligible for additional time to regain compliance or if the Company is otherwise not eligible, the Company may request a hearing before a Hearings Panel.

The negative financial conditions described above raise substantial doubt about our ability to continue as a going concern as of June 30, 2021. To that end, and as described above, the Company is not currently generating revenues from operations that are sufficient to cover its operating expenses, and its available capital resources are not sufficient for it to continue to meet its obligations as they become due. As a result, the Company has engaged financial, strategic and legal advisors to assist it in, among other things, analyzing all available strategic alternatives to address its liquidity and capital structure. As part of these activities we are continuing to diligently pursue with our financial and strategic advisors critical assessments of our asset base, operational and strategic strengths and how we can best leverage them moving forward, as well as potential transactions which could result in potential increased liquidity. However, the outcome of these activities is uncertain at this time and there can be no assurance that we will be able to identify any appropriate transaction or strategy, or consummate any such potential transaction or strategic shift which may be identified on terms that are acceptable to us, if at all. Thus, the Company cannot provide assurances that additional liquidity and capital will be available when needed or that any strategic alternatives or restructuring pursued will be available on acceptable terms. If such additional liquidity or capital is not available and the Company is unable to successfully pursue strategic alternatives or a restructuring, it may be forced to pursue a plan of reorganization under Chapter 11 of the U.S. Bankruptcy Code and/or cease its operations. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.