This "Management's Discussion and Analysis of Financial Condition and Results of Operations" section and other sections of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, that are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and on management's beliefs and assumptions. In addition, other written or oral statements, which constitute forward-looking statements, may be made by or on behalf of the Company. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are based on current expectations of management and are not guarantees of future performance, and involve certain risks, uncertainties, and assumptions, which are difficult to predict. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, the general economic conditions in the markets in which the Company operates, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of product development agreements or the loss of customers and other factors described in the Company's filings with theSecurities and Exchange Commission , including the "Risk Factors" section as set forth in our Annual Report on Form 10-K for the year endedDecember 31, 2019 , as updated below in this Quarterly Report on Form 10-Q. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The forward-looking statements set forth herein speak only as of the date of this report. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law. The Company operates its business under one reportable segment.
Company Overview
Strategic Overview
Teligent, Inc. and its subsidiaries (collectively the "Company") is a specialty generic pharmaceutical company. All references to "Teligent ," the "Company," "we," "us," and "our" refer toTeligent, Inc. Our mission is to become a leader in the specialty generic pharmaceutical market. Our platform for growth is centered around the development, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, complex generics and ophthalmic generics (what we call our "TICO" strategy"), 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 generic injectable pharmaceutical products inthe United States andCanada . Inthe United States , we currently market thirty-eight generic topical pharmaceutical products and four branded injectable pharmaceutical products. We have received FDA approvals for thirty-six topical generic products from our internally developed pipeline and we have seventeen Abbreviated New Drug Applications, ("ANDAs") submitted to the FDA that are awaiting approval. InCanada , we sell thirty-six generic and branded generic injectable products and medical devices. In addition, we have 45 product candidates at various stages of our development pipeline. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide contract manufacturing services to the pharmaceutical, ("OTC"), and cosmetic markets. We operate our business under one 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 at105 Lincoln Avenue ,Buena, New Jersey . We have additional offices located inIselin, New Jersey ,Mississauga, Canada , andTallinn, Estonia .
The manufacturing and commercialization of generic specialty pharmaceutical markets is competitive, and there are established manufacturers, suppliers and distributors actively engaged in all phases of our business. We currently manufacture and sell topical generic pharmaceutical products under our own label.
The three large wholesale drug distributors are AmerisourceBergen Corporation ("ABC"); Cardinal Health, Inc. ("Cardinal"); andMcKesson Drug Company , ("McKesson").ABC , Cardinal and McKesson are key distributors of our products, as well as a broad range of health care products for many other companies. None of these distributors is an end user of our products. Generally, if sales to any one of these distributors were to diminish or cease, we believe that the end users of our products would likely find little difficulty obtaining our products either directly from us or from another distributor. However, the loss of one or more of these distributors, together with a delay or inability to secure an alternative distribution source for end users, could have a material negative impact on our revenue, business, financial condition and results of operations. There are generally three major negotiating entities in the US market.Walgreens Boot Alliance, Inc. consists of Walgreens, Amerisource 42 -------------------------------------------------------------------------------- Bergen's PRxO Generics program, and Econdisc members. Red Oak Sourcing consists of CVS and Cardinal's source program. Finally, ClarusOne consists of Walmart,RiteAid and McKesson's OneStop program. A loss of any of these major entities could result in a significant reduction in revenue. We consider our business relationships withABC , Cardinal and McKesson to be in good standing and have fee for services contracts with each of them. However, a change in purchasing patterns, a decrease in inventory levels, an increase in returns of our products, delays in purchasing products and delays in payment for products by one or more of these distributors could have a material negative impact on our revenue, business, financial condition and results of operations. We continue to analyze the market for other specialty generic drug products through internal research and development. In addition, we continue to explore business development opportunities to add additional products and/or capabilities to our existing portfolio. For the three months endedJune 30, 2020 , one customer accounted for 27% of the Company's revenue. For the three months endedJune 30, 2019 , two of the Company's customers accounted for 53% of the Company's revenue, consisting of 22% and 31%, respectively. For the six months ended, 2020, two of the Company's customers accounted for 30% of the Company's revenue, consisting of 19% and 11%, respectively. For the six months ended, 2019, two of the Company's customers accounted for 50% of the Company's revenue, consisting of 25% each respectively. Accounts receivable related to the Company's major customers comprised 45% of all accounts receivable as ofJune 30, 2020 and 64% as ofJune 30, 2019 , respectively. The loss of one or more of these major customers could have a significant impact on our revenues and harm our business and results of operations. Our customers in the contract manufacturing business generally consist of pharmaceutical companies, as well as cosmetic and OTC product marketers, who require product development/manufacturing support. For the three months endedJune 30, 2020 , approximately 31% of our contract manufacturing revenue was derived from pharmaceutical projects, as compared to 47% of total contract manufacturing revenue for the three months endedJune 30, 2019 . For the six months endedJune 30, 2020 , approximately 34% of our contract manufacturing revenue was derived from pharmaceutical projects, as compared to 62% of total contract manufacturing revenue for the six months endedJune 30, 2019 . None of our contract manufacturing services customers represented greater than 10% of total revenue for the three and six months endedJune 30, 2020 and 2019, respectively.
COVID-19 Pandemic Update
The current financial results and anticipated future results of the Company have been negatively impacted due to COVID-19.
The Company performed an impairment analysis for the quarter endedMarch 31, 2020 , by comparing the expected future cash flows of the assets to the carrying value of the related intangible assets. As a result, the Company recorded an impairment charge of$8.4 million , related to trademarks and technology of$4.9 million and product acquisition costs of$3.5 million . There were no changes to the assumptions made at the first quarter of this year that would suggest further impairment. The Company did not have impairment triggers during the second quarter of 2020 related to the long-lived assets. The Company initiated a company-wide cost reduction initiative targeted at eliminating discretionary spending and ensuring that remaining expenditures are reduced in line with the lower demand for its products in light of COVID-19 impact to the business. Effective onMay 4, 2020 , the Company's Executive Leadership Team and all employees with annual salaries exceeding$100,000 accepted a 20% and 15% eight-week reduction in pay, respectively. Over the same eight-week period, the Company furloughed a portion of employees at itsBuena, NJ manufacturing facility. InMay 2020 , the Company modified one of its office lease agreements and obtained a deferral of 2 months rental payments amid the Pandemic. According to FASB Staff Q&A on Topic 842 and 841, because the amount of the total consideration paid under the modified lease agreement is substantially the same as the original agreement, except the deferral of the lease payments which only affect the timing of the payments, the Company accounted for the concession as if no changes to the lease contract were made and continues to recognize expenses during the deferral period. OnMay 15, 2020 , the Company received$3.4 million of proceeds from theU.S. Small Business Administration Paycheck Protection Program (the 'Government Grant Advance") and has been utilizing 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 Advance matures in 2 years with accrued interest at an annual rate of 1.00%, being deferred for payments until the date of forgiveness or 24 weeks from the date when the fund was received by the Company. According to ASC 450-30, Gain Contingencies, the Company recorded the$3.4 million of proceeds in the Government Grant Advance line on its Condensed Consolidated Balance 43 -------------------------------------------------------------------------------- Sheet as ofJune 30, 2020 . The Company will record the related earnings impact on its Condensed Consolidated Statement of Operations in the period when the associated conditions attached to the Advance are reasonably assured to be met. In order to preserve cash and align manufacturing-related resources with downward adjustments made to our production schedule, we initiated a reduction in force at ourBuena, NJ manufacturing facility effectiveJune 19, 2020 . In connection with the reduction, the Company terminated 53 employees and furloughed another 15 employees.The Company's employee base after these actions and a company-wide effort to reduce recruitment is down 31% from the start of the year. The Company provided terminated employees with a severance package and will continue to provide health insurance coverage to its furloughed employees. The associated one-time employee severance costs totaled$0.3 million and are reflected in primarily cost of revenues and the product development and research expenses in the Company's Condensed Consolidated Statement of Operations for the three and six months endedJune 30, 2020 . The Company markets a portfolio of FDA-approved medicines, including several generic alternatives inthe United States . These products include both injectable and topical prescription medicines. From late March to the end ofApril 2020 , several data sources suggested that patient visits to the dermatologist inthe United States were down more than 50% in comparison to the typical number of dermatologist visits realized prior to shelter-in-place guidelines. As a consequence of COVID-19, dermatology visits are still down vs. pre-pandemic levels. But, as shelter-in-place guidelines across the country were relaxed, several data sources reflected an increase in dermatology visits and thus patient demand for topical pharmaceutical products. Although estimates vary, beginning in late May and into early June, there have been positive signs that the market for dermatology pharmaceutical products is rebounding driven by increased 90-day prescription refills approved by the Pharmacy Benefit Managers and the emergence of stronger telehealth networks. In fact, since mid-June data sources have shown the category return to 80% of pre-pandemic levels.Teligent sales have mostly mirrored these increases, although percentages vary by product. The Company remains cautiously optimistic given the consequences of COVID-19 in some locations have proven to change rapidly. Due to the level of uncertainty and potential consequences of less stringent guidelines, it is still extremely challenging to predict the pace of the anticipated ramp and whether or not there might be a second wave of decline.
Product and Pipeline Approvals
There were no significant approvals announced in 2020 to date.
OnApril 4, 2019 , we announced approval of an ANDA for Fluocinonide Cream USP, 0.1%. This was our fourth approval of 2019, and our thirty-sixth approval from its internally developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the second half of 2021.
Results of Operations
Three months ended
We had a net loss of$14.3 million , or$2.56 per share, for the three months endedJune 30, 2020 (the "Current Period"), compared to a net loss of$4.0 million , or$0.74 per share, for the three months endedJune 30, 2019 (the "Prior Period"). Product Sales, net, include Company Product Sales and Contract Manufacturing Sales. Revenues: Three Months Ended June 30, Increase/(Decrease) Components of Revenue: 2020 2019 $ % Product sales, net$ 13,335 $ 18,256 $ (4,921) (27) % Research and development services and other income 251 85 166 195 % Total Revenues$ 13,586 $ 18,341 $ (4,755) (26) % Total revenues decreased by 26% to$13.6 million in the Current Period from the$18.3 million recorded in the Prior Period. The$4.8 million decrease in comparison to the Prior Period was driven primarily by a net reduction of$3.9 million in our US Sales due to lost contract volume and incremental price erosion and a$0.9 million decrease in Canadian revenues due to supply constraints. Research and development services and other revenues will not be consistent and will vary, from period to period, depending on the required timeline of each development project and/or agreement. 44 --------------------------------------------------------------------------------
Costs and Expenses: Three Months Ended June 30, Increase/(Decrease) 2020 2019 $ % Cost of revenues$ 11,084 $ 9,800 $ 1,284 13 % Selling, general and administrative expenses 4,989 5,187 (198) (4) % Product development and research expenses 1,880 2,668 (788) (30) % Totals costs and expenditures 17,953 17,655 298 2 %
Cost of revenues increased by 13% to
Selling, general and administrative expenses in the Current Period decreased by$0.2 million to$5.0 million as compared to a$5.2 million in the Prior Period. The decrease was primarily due to i) a$0.2 million decline in professional and legal fees, ii) a$0.1 million decline in amortization expenses due to an impairment charge incurred in the first quarter of this year plus a$0.1 million of contribution expense in 2019 vs. none in 2020, and partially offset by iii) an increase of$0.3 million in personnel costs. Product development and research expenses decreased by$0.8 million to$1.9 million as compared to the$2.7 million reported in the Prior Period. The decrease in product development and research expenses was due primarily to (i) a$0.6 million decline in personnel costs, (ii) a$0.2 million decline in outside testing, iii) a$0.2 million decline in GDUFA fees and associated Abbreviated New Drug Applications filings, iv) a$0.1 million decline in occupancy and business insurances, partially offset by v) a$0.2 million increase in clinical studies, and (vi) a$0.2 million increase in exhibit and pilot batch costs. Other (Expense) Income, net: Three Months Ended June 30, (Increase)/Decrease 2020 2019 $ % Interest and other expense, net$ (7,520) $ (5,155) $ (2,365) (46) % Foreign currency exchange gain 2,124 553 1,572 284 % Change in the fair value of derivative liabilities (4,591) - (4,591) (100) %$ (9,987) $ (4,602) $ (5,385) (117) %
The net increase in interest and other expense in the Current Period is due
primarily to an increase in interest expense of
Foreign exchange gain of$2.1 million in the Current Period was mainly related to the foreign currency translation of our intercompany loans denominated inU.S. dollars to our foreign subsidiaries to be repaid inNovember 2022 . Depending on the changes in foreign currency exchange rates, we will continue to record a non-cash gain or loss on translation for the remaining term of these loans. The change in the fair value of derivatives of$4.6 million was related to a$3.5 million loss on the 2023 Series B Notes, a$0.3 million loss on the Senior Credit Facilities, and a$0.8 million loss on the Warrants in the Current Period ( Note 8). Net loss attributable to common stockholders (in thousands, except per share numbers): Three Months Ended June 30, Increase/(Decrease) 2020 2019 $ % Net loss attributable to common stockholders$ (14,332) $ (3,989) $ 10,343 259 % Basic and diluted loss per share $ (2.56)$ (0.74) $ 1.82 (246) % 45
-------------------------------------------------------------------------------- Net loss for the Current Period was$14.3 million as compared to a net loss of$4.0 million of the Prior Period. The decline was primarily due to a decrease in revenues of$4.8 million , an increase in interest expense of$2.4 million , the derivative liability increases of$4.6 million , a$0.3 million increase in cost and expenses, partially offset by a$1.6 million increase on foreign currency exchange gain, as discussed above.
Six months ended
We had a net loss of$41.2 million , or$7.50 per share, for the six months endedJune 30, 2020 (the "Current Year"), compared to a net loss of$12.7 million , or$2.36 per share, for the six months endedJune 30, 2019 (the "Prior Year"). Product Sales, net, include Company Product Sales and Contract Manufacturing Sales. Revenues: Six months ended June 30, Increase/(Decrease) Components of Revenue: 2020 2019 $ % Product sales, net$ 20,671 $ 31,293 $ (10,622) (34) % Research and development services and other income 362 170 192 113 % Total Revenues$ 21,033 $ 31,463 $ (10,430) (33) % Total revenues decreased by 33% to$21.0 million of the Current Year from the$31.5 million reported in the Prior Year. The decrease of$10.4 million was driven primarily by a net reduction of$8.0 million in US sales due to lost contract volume and incremental price erosion and a decrease of$2.4 million in Canadian revenues due to supply constraints. Research and development services and other revenues will not be consistent and will vary, from period to period, depending on the required timeline of each development project and/or agreement. Costs and Expenses: Six months ended June 30, Increase/(Decrease) 2020 2019 $ % Cost of revenues$ 19,694 $ 17,160 $ 2,534 15 % Selling, general and administrative expenses 11,706 10,700 1,006 9 % Impairment charges 8,373 - 8,373 100 % Product development and research expenses 3,680 5,657 (1,977) (35) % Totals costs and expenditures$ 43,453 $ 33,517 $ 9,936 30 % Cost of revenues increased by 15% to$19.7 million of the Current Year from a$17.2 million of the Prior Year. Gross margin decreased to 6% in the Current Year from 45% of the Prior Year. The decrease was attributable to an inventory reserve build of$1.9 million and decreased volume lowering fixed cost absorption and product mix changes continued from the first quarter of this year. Selling, general and administrative expenses in the Current Period increased by$1.0 million to$11.7 million as compared to$10.7 million reported in the Prior Period. The increase was primarily due to a$1.1 million increase in personnel costs and partially offset by a$0.2 million decline in professional and legal fees. An intangible assets impairment charge was recorded in the Current Year of$8.4 million related to trademark and technology of$4.9 million and product acquisition costs of$3.5 million . There were no impairment charges in the Prior Year. Product development and research expenses decreased by$2.0 million to$3.7 million as compared to$5.7 million reported in the Prior Year. The decrease in product development and research expenses was primarily due to (i) a$0.9 million decline in personnel cost, ii) a$0.7 million decline in outside testing and lab supplies, (iii) a$0.1 million decline in clinical studies, and (iv) a$0.3 million decline in GDUFA fees and associated Abbreviated New Drug Applications filings.
Other (Expense) Income, net:
46 -------------------------------------------------------------------------------- Six months ended June 30, (Increase)/Decrease 2020 2019 $ % Interest and other expense, net$ (13,396) $ (10,102) $ (3,294) 33 % Foreign currency exchange gain/(loss) 528 (291) 819 (281) % Change in the fair value of derivative liabilities (5,849) - (5,849) 100 % Debt partial extinguishment of 2019 Notes - (185) 185 (100) %$ (18,717) $ (10,578) $ (8,139) 77 %
Interest and other expense, net increased in the Current Period primarily
resulted from an increase in interest expense of
Foreign exchange gain of$0.5 million in the Current Year was related to the foreign currency translation of our intercompany loans denominated inU.S. dollars to our foreign subsidiaries to be repaid inNovember 2022 . Depending on the changes in foreign currency exchange rates, we will continue to record a non-cash gain or loss on translation for the remaining term of these loans. The change in the fair value of derivatives of$5.8 million included a$5.6 million loss on the derivative liability pertaining to the our Senior Credit Facility, a$0.8 million loss on the Warrants, and partially offset by a$0.5 million gain on the 2023 Series B Notes in the Current Year (Note 8).
Debt partial extinguishment of the 2019 Notes was zero in the Current Year
compared to
Net loss attributable to common stockholders (in thousands, except per share numbers): Six months ended June 30, Increase/(Decrease) 2020 2019 $ % Net loss attributable to common stockholders$ (41,168) $ (12,713) $ 28,455 224 %
Basic and diluted loss per share
217 % Net loss for the Current Year was$41.2 million as compared to a net loss of$12.7 million reported in the Prior Year. The decline was due primarily to a decrease in revenues of$10.4 million , an increase in cost and expenses of$9.9 million , an increase in interest expense of$3.3 million , the derivative liability increase of$5.8 million , and a$0.8 million increase of foreign exchange gain, as stated above.
Liquidity and Capital Resources
The Company has incurred significant losses and generated negative cash flows from operations in recent years and expects to continue to incur losses and generate negative cash flow for the foreseeable future. As a result, we had an accumulated deficit of$162.6 million , total principal amount of outstanding borrowings of$195.8 million , and limited capital resources to fund ongoing operations atJune 30, 2020 . These capital resources were comprised of cash and equivalents of$6.5 million atJune 30, 2020 and the generation of cash inflows from working capital. The Company's available capital resources may not be sufficient for it to continue to meet its obligations as they become due over the next twelve months if the Company cannot improve its operating results or increase its operating cash inflows. In the event these capital resources are not sufficient, the Company may need to raise additional capital through the sale of equity or debt securities, enter into strategic business collaboration agreements with other companies, seek other funding facilities, or sell assets. However, the Company cannot provide assurances that additional capital will be available on acceptable terms or at all. Moreover, if the Company is unable to meet its obligations when they become due over the next twelve months through its available capital resources, or obtain new sources of capital when needed, the Company may have to delay expenditures, reduce the scope of its manufacturing operations, reduce or eliminate one or more of its development programs, make significant changes to its operating plan or cease its operations. Our liquidity needs have typically arisen from the funding of our new manufacturing facility, product manufacturing costs, research and development programs and the launch of new products. In the past, we have met these cash requirements through cash inflows from operations, working capital management, and proceeds from borrowings discussed in Note 7. Although the construction of our new manufacturing facility was substantially completed in October of 2018, additional investment was made in order to prepare the facility and our employees for a prior approval inspection from the FDA for our injectable line. In 47 -------------------------------------------------------------------------------- addition, we expect to continue to incur significant expenditures for the development of new products in our pipeline, and the manufacturing, sales and marketing of our existing product. While we rely heavily on cash flows from operating activities and borrowings from outside sources to execute our operational strategy, meet our financial commitments and other short-term financial needs, we cannot be certain that sufficient capital will be generated through operations or will be available to the Company to the extent required and on acceptable terms. The$9.7 million decrease in our cash during the six months endedJune 30, 2020 was mainly to support our operational activities, which included a$9.1 million build in inventory to help avoid failure-to-supply fees and normal timing differences in working capital balances. In addition, we had an accumulated deficit of$162.6 million as ofJune 30, 2020 , inclusive of a$41.2 million net loss in this year. In the beginning of 2019, the Company used a total of$2.7 million of proceeds from the Senior Credit Facilities to repurchase a portion of the remaining 2019 Notes. The repurchase of the 2019 Notes was considered a debt extinguishment under ASC 470-50. The 2019 Notes were accounted for under cash conversion guidance ASC 470-20, which required the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition. In accordance with the guidance above, the Company allocated a portion of the$2.7 million to the extinguishment of the liability component equal to the fair value of that component immediately before extinguishment and recognized a$0.2 million extinguishment loss in the Consolidated Statement of Operations to measure the difference between (i) the fair value of the liability component and (ii) the net carrying value amount of the liability component (which is already net of any unamortized debt issuance costs). The reduction of Additional Paid in Capital in connection with this extinguishment was immaterial. The Company settled the remaining 2019 Notes of$13.0 million in principal upon its maturity inDecember 2019 . The Initial Term Loan of$50.0 million and$15.0 million of the Revolver were drawn by the Company onDecember 13, 2018 . OnDecember 21, 2018 , the Company drew$20.0 million of the Delayed Draw Term Loan A. InJanuary 2019 , the Company drew$5.0 million and subsequently the remaining$5.0 million under the Revolver were drawn down by the Company inApril 2019 . OnSeptember 18, 2019 , pursuant to the Protective Advance clause in the Company's First Lien Credit Agreement with Ares Capital, the Company borrowed an incremental$2.5 million from its existing revolving credit facility. Consistent with the terms of the revolving credit facility, Protective Advances are secured by the Administrative Agent's liens, constitute Obligations pursuant to the First Lien Credit Agreement, and bear interest at the rate applicable to the outstanding revolving credit facility balances, however, the Protective Advance is repayable on demand. The liability was subsequently paid off inNovember 2019 along with repayment fee of$0.1 million . The Company drew down the remaining$10 million under its borrowing capacity of Delayed Draw Term Loan A before its expiry in December of 2019. The$15 million Delayed Draw Term Loan B expired upon the issuance of the Series B Notes, prior to the Company drawing down any monies. The Term Loans are governed by the Second Lien Credit Agreement. The Term Loans include a 24-month paid-in-kind interest option available to the Company should it choose to defer cash payments in order to maintain the liquidity needed to continue launching new products, and preparing for an FDA prior approval inspection of its new injectable manufacturing facility. The Company has elected the paid-in-kind interest option and increased the principal balance of Term Loans by$4.8 million and$15.7 million for the three months and since inception through the period endedJune 30, 2020 , respectively. OnApril 6, 2020 (the "Amendment Closing Date"), the Company entered (i) Amendment No. 2 of the Revolver (the "Amendment 2") and Amendment No. 4 of the Term Loans (the "Amendment 4"), effective as ofDecember 31, 2019 . The amendments collectively among other things, (i) increase the interest rates, (ii) reset certain prepayment premiums and modify the terms of certain mandatory prepayments and (iii) modify certain financial covenant levels inclusive of the disposition of prior covenants as of and for the period endedDecember 31, 2019 . The additions and changes to financial covenants set forth in both Amendments are: (i) a new minimum net revenue covenant is added that is tested on the last day of each fiscal quarter fromMarch 31, 2020 until the quarter endingDecember 31, 2020 , (ii) resets a minimum consolidated adjusted EBITDA covenant that is tested on the last day of each fiscal quarter ending during the period fromMarch 31, 2021 to maturity, (iii) eliminates a total net leverage covenant and (iv) adds a minimum liquidity covenant tested at all times during the term of the Senior Credit Facilities. Effective onApril 6, 2020 , the Revolver bears interest, amended pursuant to Amendment No. 2, at a fluctuating rate of interest equal to the one, two, three or six-month LIBOR plus a margin of 5.5% or a rate based on the prime rate plus a margin of 4.5%, with a LIBOR floor of 1.5%. Effective onApril 6, 2020 , the Term Loans bear interest, amended pursuant to Amendment No. 4, at a fluctuating rate of interest equal to the one, two, three or six-month LIBOR plus a margin of 13.0% or a rate based on the prime rate plus a margin of 12.0%, with a LIBOR floor of 1.5%. Interest on the Senior Credit Facilities is payable in cash quarterly in arrears (or more frequently in connection with customary LIBOR interest provisions), provided, that the Company may elect (and has covenanted to the lenders under its Senior Credit Facilities and subsequent amendments thereto) to pay interest on the Term Loans in kind throughDecember 13, 2021 but only if the following occurs: (1) the Company receives a "warning letter close-out letter" from theFederal Drug Administration in response to corrective actions taken by the Company 48 -------------------------------------------------------------------------------- since receipt of the warning letter inNovember 2019 and (2) the Company receives a written recommendation from theFederal Drug Administration setting forth its approval decision in respect of the pre-approval inspection for commercial production on the newly installed injectable line at the Company'sNew Jersey facility. If only one of those items occurs byDecember 13, 2020 , then the Company may still elect to pay interest in kind during 2021, but only from the time the second condition has been satisfied untilDecember 13, 2021 . Thereafter, a portion of interest on the loans accruing at a rate of 4.25% per annum may continue to be paid in kind. Both amendments provide that in the event of receipt of net proceeds from a disposition triggering a mandatory prepayment, net proceeds of such disposition will be applied as follows: (i) first, to be retained by the Company or applied to amounts outstanding under the First Lien Credit Agreement until such time as liquidity of the Company and its subsidiaries equals$10.0 million , (ii) next to amounts outstanding under the Revolver (without a permanent reduction in the revolving loan commitments of the lenders) until such amounts are paid in full (with the first lien administrative agent having the right to waive such prepayment, in which event, such net proceeds are applied to amounts outstanding under the Second Lien Credit Agreement), and (iii) finally, to amounts outstanding under the Term Loans. In addition, pursuant to the Revolver, the Company has agreed at all times to maintain book cash of the Company and its subsidiaries not in excess of$10.0 million with any excess being required to prepay the outstanding obligations under the Revolver. After the modification, the effective interest rates, inclusive of the debt discounts and issuance costs for the Initial Term Loan and Delayed Draw Term Loan A were between 16.6% and 17.7% and for the various borrowing tranches of the Revolver, were between 9.6% and 10.9%. In connection with the Term Loan Amendments datedApril 6, 2020 , the Company issued to the Term Loan lenders certain Warrants to purchase up to, in the aggregate, 538,995 of post reverse stock split shares of the Company's common stock at an exercise price of$0.01 per share. The Warrants initially were recorded at fair value upon issuance and classified as a liability as the Company did not have sufficient authorized unissued shares for the Warrants' exercise. The Warrants were remeasured to fair value till the reverse stock split date, with any fair value adjustments recognized in the condensed consolidated statements of operations. The Warrants were reclassified as equity at their fair value upon the reverse stock split date and will not be remeasured subsequently. The estimated fair value of the Warrants on the date of issuance of$1.4 million was recorded as a debt discount. The Warrants had a fair value of$2.2 million as of the reverse stock split date which was reclassified to equity. The Warrants are exercisable at any time after the reverse stock split which occurred onMay 28, 2020 and will remain exercisable, in whole or in part, for a period of 5 years from the issuance date. As ofJune 30, 2020 , all 538,995 Warrants remain outstanding (Note 8). The number of shares issuable upon the exercise of the Warrants is subject to customary adjustments upon the occurrence of certain events, including (i) payment of a dividend or distribution to holders of shares of the Company's common stock payable in shares of the Company's common stock, (ii) a subdivision, capital reorganization or reclassification of the Company's common stock or (iii) a merger, sale or other change of control transaction. OnOctober 31, 2019 , the Company closed its offering of the 2023 Series B Notes in the aggregate principal amount of$34.4 million ("2023 Series B Notes" and together with the 2023 Notes, the "Notes"). The 2023 Series B Notes will mature inMay 2023 and are convertible at the option of the holder at any time prior to its maturity. The initial conversion price was$7.20 per share, subject to adjustment under certain circumstances. The 2023 Series B Notes and any shares of common stock issuable upon conversion of the 2023 Series B Notes (the "Conversion Shares") have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other jurisdiction's securities laws, and the 2023 Notes and the Conversion Shares may not be offered or sold inthe United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. The Company does not intend to file a registration statement for the resale of the 2023 Series B Notes or any Conversion Shares. As part of the offering, the Company entered into agreements with certain holders of its existing 2023 Notes to exchange$9.0 million of the 2023 Notes for$5.1 million of the 2023 Series B Notes. The gross cash proceeds of approximately$29.3 million from the financing were used to extinguish the Company's existing 2019 Notes inDecember 2019 and intended to pay amounts owing with respect to other indebtedness and to fund general corporate and working capital requirements. The net proceeds from the financing were$26.9 million after deducting a total of$2.3 million of the initial purchasers' discounts and professional fees associated with the transaction. The 2023 Series B Notes bear interest at a rate of 7.00% per annum if paid in cash, semiannually in arrears onMay 1 andNovember 1 of each year, beginning onMay 1, 2020 . The Company also has an option, and has agreed with its senior lender, to PIK the interest at 8.00% per annum, to defer cash payments. As ofJune 30, 2020 , the Company has elected the paid-in-kind interest option and increased the principal balance of the 2023 Series B Notes by$1.4 million as ofJune 30, 2020 . The effective interest rate of the 2023 Notes, inclusive of the debt discount and issuance costs is 27.4%. 49 -------------------------------------------------------------------------------- The Company was in compliance with its financial covenants as ofJune 30, 2020 . OnJuly 20, 2020 , the Company entered into (i) a Consent and Amendment No. 3 to First Lien Revolving Credit Agreement (the "First Lien Amendment"), and (ii) a Consent and Amendment No. 5 to Second Lien Credit Agreement (the "Second Lien Amendment"). The First Lien Amendment amends the First Lien Credit Agreement to, among other things, (i) permit the issuance of the New 2023 Notes and the other transactions contemplated by the Indenture, (ii) modify the terms of certain mandatory prepayments, (iii) modify certain negative covenants and (iv) modify certain financial covenants. The Second Lien Amendment amends the Second Lien Credit Agreement to, among other things, (i) permit the issuance of the New 2023 Notes and the other transactions contemplated by the Indenture, (ii) modify the terms of certain mandatory prepayments, (iii) modify certain negative covenants, (iv) modify certain financial covenants and (v) extend the time period in which the Company may elect to pay interest in kind. OnJuly 20, 2020 , the Company closed its Series C Senior Convertible Notes offering in the aggregate principal amount of$13.8 million . Interest on the New 2023 Notes initially accrues at the rate of 9.5%, is payable in kind by issuing additional principal amount of New 2023 Notes, and will be payable semiannually in arrears onMarch 1 andSeptember 1 of each year, beginning onSeptember 1, 2020 . The New 2023 Notes mature inMarch 2023 . After taking into account an original issue discount and other transaction fees (including fees payable to the purchasers in the form of additional New 2023 Notes), the Company received approximately$10.0 million of net cash proceeds, which will be used to fund general corporate and working capital purposes. If the Company fails to comply with its covenants, an event of default under the Credit Agreements would be triggered and its obligations under the Senior Credit Facilities or other agreements (including as a result of cross-default provisions) may be accelerated. The derivative liability associated with certain mandatory prepayment penalties and the recognition of future interest payments in the anticipation of a potential future default on its Senior Credit Facilities atJune 30, 2020 was$5.6 million (Note 8). OnMay 15, 2020 , the Company received$3.4 million of proceeds from theU.S. Small Business Administration Paycheck Protection Program ( the 'Government Grant Advance") and has been utilizing 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 Advance matures in 2 years with accrued interest at an annual rate of 1.00%, being deferred for payments until the date of forgiveness or 24 weeks from the date when the fund was received by the Company. According to ASC 450-30, Gain Contingencies, the Company recorded the$3.4 million of proceeds in the Government Grant Advance line on its Condensed Consolidated Balance Sheet as ofJune 30, 2020 . The Company will record the related earnings impact on its Condensed Consolidated Statement of Operations in the period when the associated conditions attached to the Advance are reasonably assured to be met. InJune 2019 , the Company received a de-listing notice from the NASDAQ due to its share price being below$1.00 for 30 consecutive trading days. The notice specified that the Company's share price must trade above$1.00 per share for ten consecutive trading days prior toDecember 2, 2019 in order to prevent its common stock from being de-listed. For the 180 days precedingDecember 2, 2019 the Company's share price remained below$1.00 . The Company requested a second 180-day extension. NASDAQ denied its request and the Company chose to file for an appeal. The Company was granted a hearing date for the end ofJanuary 2020 . Subsequent to the appeal hearing, NASDAQ set a deadline ofApril 17, 2020 for the Company to regain compliance with NASDAQ's continuing listing requirements. In earlyMarch 2020 the COVID-19 global pandemic triggered a significant decline in global capital markets, including NASDAQ. In light of this significant decline, the Company requested NASDAQ to reconsider theApril 17, 2020 deadline. NASDAQ agreed to the Company's request and set a new deadline to regain compliance byJune 1, 2020 . In response to the COVID-19 pandemic and related extraordinary market conditions, NASDAQ provided additional temporary relief ("Relief") from the continued listing bid price and market value of publicly held shares listing requirements throughAugust 17, 2020 . Under the Relief, the company will have additional time to regain compliance with the NASDAQ throughAugust 17, 2020 . InJanuary 2020 , the Company's Board of Directors and shareholders approved a reverse stock split in the range of any whole number between five (5) and ten (10) to one (1). While the Company believes that the reverse stock split will ultimately increase its share price above$1.00 for the required ten consecutive trading days, it can provide no assurances that its shares will trade above$1.00 per share for the required time period. A de-listing from the NASDAQ would be a "Fundamental Change" under the Company's 2023 Series A and Series B Unsecured Convertible Notes which triggers a right by the holders to require the Company repurchase the Convertible Notes. In such an event, the Company would need to seek financing to repurchase the Convertible Notes and there is no guarantee that such financing would be available or on terms acceptable to the Company. If noteholders demanded a repurchase of the notes and the Company could not finance the repurchase, it would be in default under the Indentures governing the Convertible Notes, and in that event the lenders of the Ares Credit agreements would have the right, but not the obligation, to declare all of the outstanding balance under those agreements due and payable as well. Therefore, in the event of the Company's shares are de-listed from the NASDAQ, the Company would likely have to seek some combination of waivers from its lenders and noteholders and seek new capital through the sale of equity or debt securities. If the Company is unable to obtain such waivers or raise new capital to meet these obligations if they become due, it may have to seek other strategic alternatives, including ceasing operations. OnMay 28, 2020 , the Company effectuated a one-for-ten reverse stock split (Note 2). OnJune 18, 2020 , the Company received a written notice from the NASDAQ that it has regained compliance with the Bid Price Requirement. While the Company believes it will comply with the NASDAQ listing requirements, it can provide no assurances that it will be able to remain in compliance. 50 -------------------------------------------------------------------------------- OnJuly 28, 2020 , the Company received a notice (the "Notice") fromThe Nasdaq Stock Market stating that the Company was not in compliance with Nasdaq Listing Rule 5450(b)(3)(C) relating to the minimum Market Value of Publicly Held Shares (the "MVPHS Rule"). The notice stated that the Company failed to maintain a minimum market value of publicly held shares of$15.0 million for the 30 consecutive days preceding the date of the notice. The notice has no immediate effect on the Company's Nasdaq listing or trading of the Company's common stock. The Company has a compliance period for the MVPHS Rule of 180 calendar days, or untilJanuary 25, 2021 , in which to regain compliance. To regain compliance the Company's minimum market value of publicly held shares must equal$15.0 million or more for a minimum of 10 consecutive business days, Nasdaq will notify the Company that it has achieved compliance with the Rule. If the Company does not regain compliance byJanuary 25, 2021 , then Nasdaq will notify the Company that the Company's common stock will be delisted from the Nasdaq Global Market, unless the Company requests a hearing before aNasdaq Hearings Panel . The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The negative financial conditions described above raise substantial doubt about
our ability to continue as a going concern as of
Our cash flows from operating, investing and financing activities, as reflected in the condensed Consolidated Statements of Cash Flows, are summarized in the following table: Six months ended June 30, 2020 2019 Net cash provided by (used in) Operating Activities$ (11,143) $ (10,288) Investing Activities $ (2,369)$ (5,101) Financing Activities $ 3,371$ 7,199 Operating Activities Our operating activities used$11.1 million and$10.3 million of cash and cash equivalents in the six months endedJune 30, 2020 and 2019, respectively, mainly to support our operational activities, which included a$9.1 million build in inventory to help avoid failure-to-supply fees and normal timing differences in working capital balances. Investing Activities Our investing activities used$2.4 million of cash and equivalents during the six months endedJune 30, 2020 , compared to$5.1 million used during the same period last year, which was used for the continued facility expansion inBuena, NJ . Financing Activities OnMay 15, 2020 , we received$3.4 million of proceeds from theU.S. Small Business Administration Paycheck Protection Program and has been utilizing 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 (Note 1). During the six months endedJune 30, 2019 , our financing activities provided$7.2 million of cash and cash equivalents, which included$10.0 million of proceeds from the Revolver.
Our capital resources were comprised of cash and cash equivalents of
In order to continue normal business operations and execution of the Company's growth strategy, the Company may exercise its ability to significantly defer or reduce planned discretionary investments in research and development and capital projects or seek other financing alternatives. Other financing alternatives may include raising additional capital through the sale of its equity, a strategic alliance with a third party or securing debt. If additional acquisition and growth opportunities arise, external financing will be required. OnNovember 12, 2018 , the Company secured a credit agreement for$120.0 million . The facility includes three tranches of funding, an asset based revolving credit facility of$25.0 million dueNovember 2022 ("Revolver"), a term loan of$80.0 million dueFebruary 2023 ("2023 Term Loan"), and a delayed draw term loan of$15.0 million also due inFebruary 2023 ("2023 Delayed Draw Term Loan"). The interest rate under the Revolver was calculated, at the option of the Company, at either the one, two, three or six-month LIBOR plus 3.75% or the base rate plus 2.75%. The interest rate on the 2023 Term Loan and the 51 -------------------------------------------------------------------------------- 2023 Delayed Draw Term Loan bore interest, at the option of the Company, at either the one, two, three or six-month LIBOR plus 8.75% or the base rate plus 7.75%, with a 24-month paid-in-kind interest option available to the Company should it choose to defer cash payments in order to maintain the liquidity needed to continue launching new products, build inventory, and prepare for the FDA prior approval inspection. OnApril 6, 2020 (the "Amendment Closing Date"), the Company entered (i) Amendment No. 2 of the Revolver (the "Amendment 2") and Amendment No. 4 of the Term Loans (the "Amendment 4"), effective as ofDecember 31, 2019 . The amendments collectively among other things, (i) increase the interest rates, (ii) reset certain prepayment premiums and modify the terms of certain mandatory prepayments and (iii) modify certain financial covenant levels inclusive of the disposition of prior covenants as of and for the period endedDecember 31, 2019 . The additions and changes to financial covenants set forth in both Amendments are: (i) a new minimum net revenue covenant is added that is tested on the last day of each fiscal quarter fromMarch 31, 2020 until the quarter endingDecember 31, 2020 , (ii) resets a minimum consolidated adjusted EBITDA covenant that is tested on the last day of each fiscal quarter ending during the period fromMarch 31, 2021 to maturity, (iii) eliminates a total net leverage covenant and (iv) adds a minimum liquidity covenant tested at all times during the term of the Senior Credit Facilities. Effective onApril 6, 2020 , the Revolver bears interest, amended pursuant to Amendment No. 2, at a fluctuating rate of interest equal to the one, two, three or six-month LIBOR plus a margin of 5.5% or a rate based on the prime rate plus a margin of 4.5%, with a LIBOR floor of 1.5%. Effective onApril 6, 2020 , the Term Loans bear interest, amended pursuant to Amendment No. 4, at a fluctuating rate of interest equal to the one, two, three or six-month LIBOR plus a margin of 13.0% or a rate based on the prime rate plus a margin of 12.0%, with a LIBOR floor of 1.5%. Interest on the Senior Credit Facilities is payable in cash quarterly in arrears (or more frequently in connection with customary LIBOR interest provisions), provided, that the Company may elect (and has covenanted to the lenders under its Senior Credit Facilities and subsequent amendments thereto) to pay interest on the Term Loans in kind throughDecember 13, 2021 but only if the following occurs: (1) the Company receives a "warning letter close-out letter" from theFederal Drug Administration in response to corrective actions taken by the Company since receipt of the warning letter inNovember 2019 and (2) the Company receives a written recommendation from theFederal Drug Administration setting forth its approval decision in respect of the pre-approval inspection for commercial production on the newly installed injectable line at the Company'sNew Jersey facility. If only one of those items occurs byDecember 13, 2020 , then the Company may still elect to pay interest in kind during 2021, but only from the time the second condition has been satisfied untilDecember 13, 2021 . Thereafter, a portion of interest on the loans accruing at a rate of 4.25% per annum may continue to be paid in kind. The Company has elected the paid-in-kind interest option and increased the principal balance of Term Loans by$4.8 million and$15.7 million for the three months and since inception through the period endedJune 30, 2020 , respectively. OnOctober 31, 2019 , the Company closed its offering of the 2023 Series B Notes in the aggregate principal amount of$34.4 million ("2023 Series B Notes" and together with the 2023 Notes, the "Notes"). The 2023 Series B Notes will mature inMay 2023 and are convertible at the option of the holder at any time prior to its maturity. The initial conversion price was$7.2 per share, subject to adjustment under certain circumstances. consider to remove the previous disclosure. The 2023 Series B Notes and any shares of common stock issuable upon conversion of the 2023 Series B Notes (the "Conversion Shares") have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other jurisdiction's securities laws, and the 2023 Notes and the Conversion Shares may not be offered or sold inthe United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. The Company does not intend to file a registration statement for the resale of the 2023 Series B Notes or any Conversion Shares. As part of the offering, the Company entered into agreements with certain holders of its existing 2023 Notes to exchange$9.0 million of the 2023 Notes for$5.1 million of the 2023 Series B Notes. The gross cash proceeds of approximately$29.3 million from the financing were used to extinguish the Company's existing 2019 Notes inDecember 2019 and intended to pay amounts owing with respect to other indebtedness and to fund general corporate and working capital requirements. The net proceeds from the financing were$26.9 million after deducting a total of$2.3 million of the initial purchasers' discounts and professional fees associated with the transaction. The 2023 Series B Notes bear interest at a rate of 7.00% per annum if paid in cash, semiannually in arrears onMay 1 andNovember 1 of each year, beginning onMay 1, 2020 . The Company also has an option, and has agreed with its senior lender, to PIK the interest at 8.00% per annum, to defer cash payments. The Company has elected the paid-in-kind interest option and increased the principal balance of the 2023 Series B Notes by$1.4 million as ofJune 30, 2020 . OnMay 15, 2020 , the Company received$3.4 million of proceeds from theU.S. Small Business Administration Paycheck Protection Program ( the 'Government Grant Advance") and has been utilizing 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 Advance matures in 2 years with accrued interest at an annual rate of 1.00%, being deferred for payments until the date of forgiveness or 24 weeks from the date when the fund was received by the Company. According to ASC 450-30, Gain Contingencies, the 52 -------------------------------------------------------------------------------- Company recorded the$3.4 million of proceeds in the Government Grant Advance line on its Condensed Consolidated Balance Sheet as ofJune 30, 2020 . The Company will record the related earnings impact on its Condensed Consolidated Statement of Operations in the period when the associated conditions attached to the Advance are reasonably assured to be met.
Off Balance Sheet Arrangements
We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our shareholders.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements are prepared in accordance withU.S. generally accepted accounting principles, which require management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from these estimates. Please refer to our Annual Report on Form 10-K for the year endedDecember 31, 2019 for a complete list of all Critical Accounting Policies and Estimates. See also Item 1 for our Condensed Consolidated Financial Statements.
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