(EDGAR Online via COMTEX) -- Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our condensed consolidated financial statements and notes to those statements and other financial information appearing elsewhere in this Quarterly Report on Form 10-Q and in the 2020 Form 10-K. In addition to historical information, the following discussion and other parts of this Quarterly Report contain forward-looking information that involves risks and uncertainties.
We are a commercial-stage pharmaceutical company. Our lead product, TPOXX(R) ("oral TPOXX(R)"), is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration ("FDA") approved oral TPOXX(R) for the treatment of smallpox.
The COVID-19 pandemic has caused significant societal and economic disruption. Such disruption, and the associated risks and costs, are expected to continue for an indeterminate period of time. Given the uncertain future course of the COVID-19 pandemic, and the uncertain scale and scope of its future impact, the Company is continually reviewing business and financial risks related to the pandemic and seeking coordination with its government partners with respect to the performance of current and future government contracts. Additionally, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations that constitute our supply chain, with respect to actions and risks caused by the COVID-19 pandemic.
As of the filing date of this document, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts. Additionally, the Company's supply chain for the manufacture of TPOXX(R) has remained operational on current projects without material COVID-19 related disruption, and in the ordinary course of operations, the supply chain has secured sufficient raw materials to support manufacture and product delivery activities on current projects. With regard to day-to-day operations, the COVID-19 pandemic has at times slowed the daily pace of execution of government contracts as well as new contract generation, as U.S. and foreign government staff overseeing health security preparedness has been involved directly or indirectly in governmental responses to the pandemic, which has diverted government staff time that would normally be directed toward contract matters involving SIGA. The Company expects to experience delays, or slower-than-usual pace, in connection with certain research and development activities, such as those that involve clinical trials. The Company does not currently expect any pandemic-related delays in research and development activities to have a material adverse impact on the financial condition or annual financial results of the Company, or its long-term performance, but cannot give assurances as to the full extent of the impact at this time.
Overall, the COVID-19 pandemic has not adversely affected the liquidity position of the Company, nor is it currently expected to have a material adverse effect on the financial condition of the Company. Given that the pandemic has diverted foreign government staff time normally directed toward contract matters involving SIGA, the COVID-19 pandemic could affect the timing of international contract awards for oral TPOXX(R); otherwise, the pandemic is not currently expected to have a material adverse effect on the 2021 financial results of the Company. The pandemic has resulted in almost all of our employees working from home; however, the shift in location for employees has not had a material adverse impact on the day-to-day operations of the Company. If the general negative effect of the COVID-19 pandemic becomes more acute or is prolonged, there could be potential risks to our business and cash flows.
19C BARDA Contract
On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX(R) to the U.S. Strategic National Stockpile ("Strategic Stockpile"), and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of the intravenous (IV) formulation of TPOXX(R) ("IV TPOXX(R)"). Additionally, the contract includes funding from BARDA for advanced development of IV TPOXX(R), post-marketing activities for oral and IV TPOXX(R), and procurement activities. As of March 31, 2021, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance (five years as of the award date of September 10, 2018), approximately $127.1 million of payments are related to exercised options and up to approximately $423.7 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance.
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The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX(R) to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX(R) ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund advanced development of IV TPOXX(R); and payments of approximately $0.6 million for supportive procurement activities. As of March 31, 2021, the Company had received or billed for $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX(R) to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS and $9.7 million for other base period activities. IV BDS is expected to be used for the manufacture of 20,000 courses of IV FDP. The $3.2 million received for the manufacture of IV BDS has been recorded as deferred revenue as of March 31, 2021 and December 31, 2020; such amount is expected to be recognized as revenue when IV TPOXX(R) containing such IV BDS is delivered to the Strategic Stockpile or placed in vendor-managed inventory.
The options that have been exercised to date provide for payments up to approximately $127.1 million. There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX(R); payments up to $101.3 million for the delivery of up to 363,070 courses of oral TPOXX(R); and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX(R). As of March 31, 2021, the Company has received the following payments in connection with exercised options: $112.5 million was received in connection with the deliveries made in 2020 of approximately 363,000 courses of oral TPOXX(R); and $6.5 million has been received or billed for in connection with post-marketing activities for oral TPOXX(R).
Unexercised options specify potential payments up to approximately $423.7 million in total (if all such options are exercised). There are options for the following activities: payments of up to $337.7 million for the delivery of up to approximately 1,089,000 courses of oral TPOXX(R) to the Strategic Stockpile; payments of up to $76.8 million for the manufacture of up to 192,000 courses of IV FDP, of which up to $30.7 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX(R); and payments of up to approximately $5.6 million for supportive procurement activities.
The options related to IV TPOXX(R) are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance ("IV BDS Options"), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product ("IV FDP Options"). BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 64,000 courses of IV TPOXX(R); and three separate IV FDP Options, each providing for 64,000 courses of final drug product of IV TPOXX(R). BARDA has the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). If BARDA decides to only exercise IV BDS Options, then the Company would receive payments up to $30.7 million; alternatively, if BARDA decides to exercise both IV BDS Options and IV FDP Options, then the Company would receive payments up to $76.8 million. For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP. The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.
Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA. The request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile. Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX(R), the Company estimates that approximately one million courses of smallpox antiviral treatment would need to be delivered to the U.S. Government between 2021 and 2023 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.
2011 BARDA Contract
On May 13, 2011, the Company signed a contract with BARDA pursuant to which BARDA agreed to buy from the Company 1.7 million courses of oral TPOXX(R). Additionally, the Company agreed to contribute to BARDA 300,000 courses at no additional cost to BARDA.
The 2011 BARDA Contract specifies approximately $508.4 million of payments, of which, as of March 31, 2021, $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX(R) and $45.7 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $2.9 million remains eligible to be received in the future for reimbursements of development and supportive activities.
The 2011 BARDA Contract expires in December 2024.
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International Procurement Contracts
Contract with Public Health Agency of Canada
On January 13, 2021, the Public Health Agency of Canada ("PHAC") awarded a contract to Meridian Medical Technologies, Inc. ("Meridian," a Pfizer Company) (the "Contract") for the purchase of up to approximately $33 million of oral TPOXX(R) (tecovirimat) within five years. The Contract specifies firm commitments for the cumulative purchase of approximately $17 million of oral TPOXX(R) by March 31, 2023; the remaining courses under the Contract are targeted for delivery after March 31, 2023 and are subject to option exercise by PHAC. For the three months ended March 31, 2021, SIGA recognized $3.4 million of revenue for the delivery of oral TPOXX(R). In April 2021, SIGA delivered $6.9 million of oral TPOXX(R) to PHAC. The contract award was coordinated between SIGA and Meridian under an international promotion agreement (as amended, the "International Promotion Agreement") that was entered into by the parties on June 3, 2019. As such, Meridian is the PHAC's counterparty under the Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX(R) purchased thereunder.
Canadian Military Contract
On April 3, 2020, the Company announced that the Canadian Department of National Defence ("CDND") awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND will purchase up to approximately $14 million of oral TPOXX(R) over four years. In the second quarter 2020, CDND purchased $2.3 million of oral TPOXX(R). The remaining purchases are at the option of the CDND, and are expected to occur after regulatory approval of oral TPOXX(R) in Canada. Meridian is the CDND's counterparty under the Canadian Military Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX(R) purchased thereunder. For the three months ended March 31, 2021, there were no deliveries under this contract.
International Promotion Agreement
Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX(R) in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the "Territory"), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory. SIGA retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX(R), and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX(R). SIGA's consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.
The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX(R) net of certain expenses, for years in which customer invoiced amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for years in which such net invoiced amounts exceed the specified threshold. Taking into account Meridian's fee and manufacturing costs of oral TPOXX(R), it is currently estimated by the Company that international sales of oral TPOXX(R) will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%.
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TPOXX Regulatory Summary
On July 13, 2018, the FDA approved oral TPOXX(R) for the treatment of smallpox.
For IV TPOXX(R), SIGA filed a new drug application ("NDA") with the FDA for IV TPOXX(R) on April 30, 2021. Based on its review of the NDA, the FDA will decide whether to approve IV TPOXX(R) and whether to impose any marketing restrictions or require additional post-approval clinical studies. This review process will typically take ten months. There can be no assurance that any approval will be granted on a timely basis, if at all.
The Company is also seeking regulatory approval of oral TPOXX(R) in Europe and Canada. In July 2020, the Company filed a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA") for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the name TPOXX(R). The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein. SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection. In December 2020, the Company filed an application for marketing authorization in Canada for oral tecovirimat. Based on a typical regulatory review timeline, SIGA estimates that the review processes for oral TPOXX(R) in both Europe and Canada will be completed by the first quarter of 2022. There can be no assurance that any approval will be granted on a timely basis, if at all.
Critical Accounting Estimates
The methods, estimates and judgments we use in applying our accounting policies have a significant impact on the results we report in our condensed consolidated financial statements, which we discuss under the heading "Results of Operations" following this section of our Management's Discussion and Analysis of Financial Condition and Results of Operations. Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Information regarding our critical accounting policies and estimates appears in Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations of our 2020 Form 10-K. Our most critical accounting estimates include revenue recognition over time, the valuation of stock-based awards including options and warrants granted or issued by the Company and income taxes.
Results of Operations
Three Months Ended March 31, 2021 and 2020
For the three months ended March 31, 2021, revenues from product sales and supportive services were $3.5 million, which primarily relate to the acceptance of courses of oral TPOXX(R) delivered to PHAC. There were no product deliveries for the three months ended March 31, 2020, during which period revenues from supportive services were $0.1 million.
Revenues from research and development activities for the three months ended March 31, 2021 and 2020, were $1.3 million and $2.5 million, respectively. The decrease in revenue of approximately $1.2 million, or 49%, primarily reflects a decrease in revenue in connection with a decrease in direct vendor-related costs for IV TPOXX(R) as well as a revenue decrease associated with variability related to post-marketing regulatory activities for oral TPOXX(R).
Cost of sales and supportive services for the three months ended March 31, 2021 and 2020 were $0.3 million and $0.1 million, respectively. Such costs in 2021 were associated with the manufacture and delivery of courses of oral TPOXX(R) to PHAC.
Selling, general and administrative ("SG&A") expenses for the three months ended March 31, 2021 and 2020 were $4.1 million and $3.2 million, respectively. The increase of approximately $0.9 million or 28% primarily reflects the commission expense associated with the sale of oral TPOXX(R) to PHAC in March 2021, as well as an increase in certain insurance costs.
Research and development ("R&D") expenses for the three months ended March 31, 2021 and 2020 were $2.3 million and $3.2 million, respectively, reflecting a decrease of approximately $0.9 million, or 27%. The decrease is primarily attributable to a decrease in direct vendor-related expenses supporting the development of IV TPOXX(R) and the performance of post-marketing regulatory activities for oral TPOXX(R).
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Patent expenses were $0.2 million for both the three months ended March 31, 2021 and 2020. These expenses reflect our ongoing efforts to protect our lead drug candidates in various geographic territories.
Interest expense for the three months ended March 31, 2020 was $3.0 million. The $3.0 million of interest for the three months ended March 31, 2020 included $0.9 million of accretion of unamortized costs and fees (prior to repayment of the Term Loan). There was no interest expense recognized for the three months ended March 31, 2021 as our Term Loan was paid off in March 2020.
Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the income statement. For the three months ended March 31, 2021, we recorded a gain of approximately $0.9 million, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. For the three months ended March 31, 2020, we recorded a loss of approximately $16,000.
There was minimal other income for the three months ended March 31, 2021. Other income of $0.4 million for the three months ended March 31, 2020 reflects interest income on the Company's cash and cash equivalent balances held in restricted and unrestricted accounts.
For the three months ended March 31, 2021 and 2020, we incurred pre-tax losses of $1.0 million and $11.6 million, respectively, and corresponding income tax benefits of $0.2 million and $2.7 million, respectively. The effective tax rates during the three months ended March 31, 2021 and 2020 were 22.3% and 23.3%, respectively. Our effective tax rates for the periods ended March 31, 2021 and 2020 differ from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under Internal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant.
Liquidity and Capital Resources
As of March 31, 2021, we had $106.5 million in cash and cash equivalents compared with $117.9 million at December 31, 2020.
We prepare our condensed consolidated statement of cash flows using the indirect method. Under this method, we reconcile net income/(loss) to cash flows from operating activities by adjusting net income/(loss) for those items that impact net income/(loss) but may not result in actual cash receipts or payments during the period. These reconciling items include but are not limited to stock-based compensation, loss on the extinguishment of the Term Loan, deferred income taxes, non-cash interest expense and changes in the fair value of our warrant liability, gains and losses from various transactions and changes in the condensed consolidated balance sheet for working capital from the beginning to the end of the period.
Net cash (used in)/provided by operating activities for the three months ended March 31, 2021 and 2020 was $(4.8) million and $3.3 million, respectively. For the three months ended March 31, 2021, net cash usage relates to support of ordinary working capital (accounts receivable, accounts payable, and prepaids, among other items) and customary operating activity. For the three months ended March 31, 2020, we incurred $2.1 million of cash interest expense on the Term Loan and used approximately $3.2 million in support of ordinary course working capital (accounts receivable, accounts payable, and prepaids, among other items). Additionally, cash was used for customary operating activities. These cash uses were more than offset by the receipt of approximately $11.2 million from BARDA in connection with the procurement of raw materials for the manufacture of at least 363,700 courses of oral TPOXX(R).
For the three months ended March 31, 2021 and 2020, we used cash in the amounts of $13,724 and $15,501, respectively, for capital expenditures.
Net cash used in financing activities for the three months ended March 31, 2021 was $6.5 million, which was substantially all attributable to our repurchase of approximately 1.0 million shares of common stock. Net cash used by financing activities for the three months ended March 31, 2020 was $86.9 million, which was attributable to our voluntary prepayment of the Term Loan, of which approximately $85.9 million was recorded as a financing activity, and our repurchase of approximately 0.2 million shares of common stock for approximately $1.0 million.
Future Cash Requirements
As of March 31, 2021, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $13.2 million.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements.
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Recently Issued Accounting Standards
For discussion regarding the impact of accounting standards that were recently adopted on the Company's condensed consolidated financial statements, see Note
Safe Harbor Statement
Certain statements in this Quarterly Report on Form 10-Q, including certain statements contained in the foregoing "Management's Discussion and Analysis of Financial Condition and Results of Operations," constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act, including statements relating to the progress of SIGA's development programs and timelines for bringing products to market, delivering products to the U.S. Strategic National Stockpile and the enforceability of the 2011 BARDA Contract and the 19C BARDA Contract (each as defined previously, and collectively, the "BARDA Contracts") with BARDA. The words or phrases "can be," "expects," "may affect," "may depend," "believes," "estimate," "project" and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties and any forward-looking information provided herein is not a guarantee of future performance. SIGA's actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA's control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contracts, not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contracts on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contracts are modified or canceled at the request or requirement of the U.S. government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to successfully market TPOXX(R) internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX(R) that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA's patent and other property rights, if adversely determined, could affect SIGA's business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA's products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products, (x) the risk . . .
May 06, 2021
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