The accompanying notes are an integral part of the financial statements.
The accompanying notes are an integral part of the financial statements.
The accompanying notes are an integral part of the financial statements.
SCYNEXIS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. |
Description of Business and Basis of Preparation |
Organization
SCYNEXIS, Inc. (“SCYNEXIS” or the “Company”) is a Delaware corporation formed on November 4, 1999. SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, and is pioneering innovative medicines to potentially help millions of patients worldwide in need of new options to overcome and prevent difficult-to-treat and drug-resistant infections. The Company is developing its lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (“IV”)/oral agent for multiple fungal indications in both the community and hospital settings. In June 2021, the U.S. Food and Drug Administration (“FDA”) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (“VVC”), also known as vaginal yeast infection, and the Company has commenced the commercialization of BREXAFEMME in the U.S.
The Company has incurred significant losses and negative cash flows from operations since its initial public offering in May 2014 and expects to continue to incur losses and negative cash flows for the foreseeable future. As a result, the Company had an accumulated deficit of $364.9 million at March 31, 2022 and limited capital resources to fund ongoing operations. These capital resources primarily comprised cash and cash equivalents of $95.2 million at March 31, 2022. While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements, the Company's liquidity could be materially affected over this period by, among other things: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory events or unanticipated costs related to its development of ibrexafungerp; (4) its ability to commercialize BREXAFEMME and; (5) any other unanticipated material negative events or costs. One or more of these events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany balances and transactions are eliminated in consolidation.
New Jersey Technology Business Tax Certificate Transfer (NOL) Program
The New Jersey Technology Business Tax Certificate Transfer (NOL) program, administered by the New Jersey Economic Development Authority, enables approved biotechnology companies to sell their unused net operating losses (“NOLs”) and research and development tax credits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. For the three months ended March 31, 2022, the Company recognized a $4.7 million income tax benefit for the sale of a portion of the Company’s unused New Jersey NOLs and research and development credits.
Unaudited Interim Condensed Consolidated Financial Information
The accompanying unaudited interim condensed consolidated financial statements and notes have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”), as contained in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (the “Codification” or “ASC”) for interim financial information. In the opinion of management, the interim financial information includes all adjustments of a normal recurring nature necessary for a fair presentation of the results of operations, financial position, and cash flows. The results of operations for the three months ended March 31, 2022, are not necessarily indicative of the results for the full year or the results for any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 29, 2022.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. Significant estimates and judgements include: revenue recognition including gross to net estimates and the identification of performance obligations in licensing
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arrangements, determination of the fair value of stock-based compensation grants; the estimate of services and effort expended by third-party research and development service providers used to recognize research and development expense; and the estimates and assumptions utilized in measuring the fair values of the warrant and derivative liabilities each reporting period.
2. |
Summary of Significant Accounting Policies |
The accompanying unaudited condensed consolidated financial statements and notes follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2021, except as described below.
Basic and Diluted Net Loss per Share of Common Stock
The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share. Basic net loss per common share for the three months ended March 31, 2022 and 2021 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three months ended March 31, 2022 includes the outstanding pre-funded warrants to purchase 3,200,000 shares of common stock issued in the December 2020 Public Offering. Diluted net loss per common share for the three months ended March 31, 2022 and 2021 was determined as follows (in thousands, except share and per share amounts):
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Net loss |
|
$ |
(5,451 |
) |
|
$ |
(4,676 |
) |
Dilutive effect of warrant liability |
|
|
— |
|
|
|
(1,323 |
) |
Dilutive effect of convertible debt |
|
|
(584 |
) |
|
|
— |
|
Net loss allocated to common shares |
|
$ |
(6,035 |
) |
|
$ |
(5,999 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding – basic |
|
|
32,051,228 |
|
|
|
25,802,700 |
|
Dilutive effect of warrant liability |
|
|
— |
|
|
|
721,220 |
|
Dilutive effect of convertible debt |
|
|
1,138,200 |
|
|
|
— |
|
Weighted average common shares outstanding – diluted |
|
|
33,189,428 |
|
|
|
26,523,920 |
|
|
|
|
|
|
|
|
|
|
Net loss per share – diluted |
|
$ |
(0.18 |
) |
|
$ |
(0.23 |
) |
The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2022 and 2021, as the result would be anti-dilutive:
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Outstanding stock options |
|
|
2,050,094 |
|
|
|
1,371,606 |
|
Outstanding restricted stock units |
|
|
981,841 |
|
|
|
96,974 |
|
Warrants to purchase common stock associated with June 2016 public offering |
|
|
— |
|
|
|
421,867 |
|
Warrants to purchase common stock associated with March 2018 public offering – Series 2 |
|
|
798,810 |
|
|
|
798,810 |
|
Warrants to purchase common stock associated with December 2019 Public Offering |
|
|
— |
|
|
|
4,472,205 |
|
Warrants to purchase common stock associated with December 2020 Public Offering - Series 2 |
|
|
6,800,000 |
|
|
|
6,800,000 |
|
Warrants to purchase common stock associated with Loan Agreement |
|
|
198,819 |
|
|
|
— |
|
Warrants to purchase common stock associated with Solar loan agreement |
|
|
— |
|
|
|
12,243 |
|
Common stock associated with March 2019 Notes |
|
|
— |
|
|
|
1,138,200 |
|
Warrants to purchase common stock associated with Danforth |
|
|
50,000 |
|
|
|
— |
|
Total |
|
|
10,879,564 |
|
|
|
15,111,905 |
|
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13 require a financial asset (or group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. In November
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2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which revised the effective dates for ASU 2016-13 for public business entities that meet the SEC definition of a smaller reporting company to fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022, with early adoption permitted. As a smaller reporting company, the Company is currently evaluating the impact ASU 2016-13 will have on its unaudited interim condensed consolidated financial statements.
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity: Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share. The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years. As a smaller reporting company, the Company is currently evaluating the impact ASU 2020-06 will have on its unaudited interim condensed consolidated financial statements.
3. |
Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands):
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Prepaid research and development services |
|
$ |
753 |
|
|
$ |
247 |
|
Prepaid insurance |
|
|
206 |
|
|
|
505 |
|
Other prepaid expenses |
|
|
2,956 |
|
|
|
2,813 |
|
Other current assets |
|
|
4 |
|
|
|
4 |
|
Total prepaid expenses and other current assets |
|
$ |
3,919 |
|
|
$ |
3,569 |
|
Inventory consisted of the following (in thousands):
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Raw materials |
|
$ |
5,486 |
|
|
$ |
5,162 |
|
Work in process |
|
|
3 |
|
|
|
3 |
|
Finished goods |
|
|
115 |
|
|
|
127 |
|
Total inventory |
|
$ |
5,604 |
|
|
$ |
5,292 |
|
As of March 31, 2022 and December 31, 2021, the Company’s inventory consisted of $4.5 million and $4.8 million, respectively, of raw material that is not expected to be sold in one year and is classified as long term within other assets on the unaudited interim condensed consolidated balance sheet.
Accrued expenses consisted of the following (in thousands):
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Accrued research and development expenses |
|
$ |
1,210 |
|
|
$ |
1,498 |
|
Accrued employee bonus compensation |
|
|
505 |
|
|
|
2,012 |
|
Other accrued expenses |
|
|
1,893 |
|
|
|
1,352 |
|
Accrued co-pay rebates |
|
|
915 |
|
|
|
836 |
|
Total accrued expenses |
|
$ |
4,523 |
|
|
$ |
5,698 |
|
Loan Agreement
On May 13, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), as administrative agent and collateral agent (in such capacity, the “Agent”) and a lender, and Silicon Valley Bank, as a lender (“SVB,” and collectively with Hercules, the “Lenders”) for an aggregate principal amount of $60.0 million (the “Term Loan”). Pursuant to the Loan Agreement, the Term Loan is available to the Company in four tranches, subject to certain terms and conditions.
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Under the terms of the Loan Agreement, the Company received an initial tranche of $20.0 million from the Lenders on the Closing Date. The second tranche of the Term Loan, consisting of up to an additional $10.0 million, became available to the Company upon receipt of approval from the FDA of ibrexafungerp for the treatment of vaginal yeast infections (the “First Performance Milestone”) and was fully funded in June 2021. The third tranche of the Term Loan, consisting of an additional $5.0 million, became available to the Company upon (a) the First Performance Milestone and (b) the achievement of the primary endpoint from the Phase 3 study of ibrexafungerp in patients with recurrent vulvovaginal candidiasis, and was fully funded in March 2022. The fourth tranche of the Term Loan, consisting of up to an additional $25.0 million, will be available to the Company from January 1, 2022 through December 31, 2023 in $5.0 million increments, subject to certain terms and conditions, including in maintaining a ratio of total outstanding Term Loan principal to net product revenues for BREXAFEMME below a certain specified level for a given draw period. The Company estimated the fair value of the loan payable using a credit spread valuation model and Level 3 inputs which included an implied secured spread, risk free rate, and secured yield of 9.63%, 2.44%, and 12.07%, respectively. At March 31, 2022 and December 31, 2021, the fair value of the loan payable is $33.1 million and $29.2 million, respectively.
The Term Loan will mature on March 3, 2025 (the “Maturity Date”); provided that, the Maturity Date shall be automatically extended to May 1, 2025 subject to the occurrence of certain conditions set forth in the Loan Agreement. The Term Loan bears interest at a variable annual rate equal to the greater of (a) 9.05% and (b) the Prime Rate (as reported in the Wall Street Journal) plus 5.80% (the “Interest Rate”). The Company may make payments of interest only through November 1, 2023, which may be extended to May 1, 2024 upon the achievement of the First Performance Milestone prior to November 1, 2023, and which is further extendable in quarterly increments until the Maturity Date, subject to continued compliance with the financial covenant of the Loan Agreement (the “interest-only period”). After the interest-only period, the principal balance and related interest will be required to be repaid in equal monthly installments and continuing until the Maturity Date.
The Loan Agreement contains customary closing fees, prepayment fees and provisions, events of default, and representations, warranties and covenants, including a financial covenant requiring the Company to maintain certain levels of trailing three-month net product revenue solely from the sale of ibrexafungerp commencing on June 30, 2022. The financial covenant will be waived at any time in which the Company maintains unrestricted and unencumbered cash in accounts maintained with SVB equal to at least 50.0% of the total outstanding Term Loan principal amount, subject to certain requirements.
Future principal debt payments on the currently outstanding loan payable as of March 31, 2022 are as follows (in thousands):
2021 |
|
$ |
— |
|
2022 |
|
|
— |
|
2023 |
|
|
— |
|
2024 |
|
|
23,874 |
|
2025 |
|
|
11,126 |
|
Total principal payments |
|
|
35,000 |
|
Final fee due at maturity |
|
|
1,383 |
|
Total principal and final fee payment |
|
|
36,383 |
|
Unamortized discount and debt issuance costs |
|
|
(2,670 |
) |
Less current portion |
|
|
— |
|
Loan payable, long term |
|
$ |
33,713 |
|
April 2020 Note Purchase Agreement
On April 9, 2020, the Company entered into the April 2020 Note Purchase Agreement with Puissance Life Science Opportunities Fund VI (“Puissance”) and issued and sold to Puissance $10.0 million aggregate principal amount of its April 2020 Notes, resulting in net proceeds of approximately $9.5 million after deducting $0.5 million for an advisory fee and other issuance costs.
In January 2021, Puissance converted the remaining $6.0 million of the April 2020 Notes for 959,080 shares of common stock. Upon conversion of the $6.0 million of the April 2020 Notes, the Company recognized a $2.7 million extinguishment loss which represents the difference between the total net carrying amount of the convertible debt and derivative liability of $4.8 million and the fair value of the consideration issued of $7.5 million.
March 2019 Note Purchase Agreement
On March 7, 2019, the Company entered into a Senior Convertible Note Purchase Agreement (the “March 2019 Note Purchase Agreement”) with Puissance. Pursuant to the March 2019 Note Purchase Agreement, on March 7, 2019, the Company issued and sold to Puissance $16.0 million aggregate principal amount of its 6.0% Senior Convertible Notes due
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2025 (“March 2019 Notes”), resulting in $14.7 million in net proceeds after deducting $1.3 million for an advisory fee and other issuance costs.
As of March 31, 2022 and December 31, 2021, the Company’s March 2019 Notes consists of the convertible debt balance of $10.4 million and $10.2 million, presented net of the unamortized debt issuance costs allocated to the convertible debt of $0.3 million, and the bifurcated embedded conversion option derivative liability of $0.4 million and $1.4 million, respectively. In connection with the Company’s issuance of its March 2019 Notes, the Company bifurcated the embedded conversion option, inclusive of the interest make-whole provision and make-whole fundamental change provision, and recorded the embedded conversion option as a long-term derivative liability in the Company’s balance sheet in accordance with ASC 815, Derivatives and Hedging, at its initial fair value of $7.0 million as the interest make-whole provision is settled in shares of common stock. The convertible debt and derivative liability associated with the March 2019 Notes are presented in total on the accompanying unaudited condensed consolidated balance sheets as the convertible debt and derivative liability. The derivative liability will be remeasured at each reporting period using the binomial lattice model with changes in fair value recorded in the statements of operations in other (income) expense. For the three months ended March 31, 2022 and 2021, the Company recognized gains of $1.0 million and $42,000, respectively, on the fair value adjustment for the derivative liability. For the three months ended March 31, 2022 and 2021, the Company recognized $0.2 million and $0.3 million, respectively, in amortization of debt issuance costs and discount related to the March 2019 Notes.
The Company estimated the fair value of the convertible debt and derivative liability for the March 2019 Notes using a binomial lattice valuation model and Level 3 inputs. At March 31, 2022 and December 31, 2021, the fair value of the convertible debt and derivative liability for the March 2019 Notes is $10.9 million and $12.3 million, respectively.
The March 2019 Notes were issued and sold for cash at a purchase price equal to 100% of their principal amount, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), due to the March 2019 Notes being issued to one financially sophisticated investor. The March 2019 Notes bear interest at a rate of 6.0% per annum payable semiannually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The March 2019 Notes will mature on March 15, 2025, unless earlier converted, redeemed or repurchased. The March 2019 Notes constitute general, senior unsecured obligations of the Company.
The holder of the March 2019 Notes may convert their March 2019 Notes at their option at any time prior to the close of business on the business day immediately preceding March 15, 2025 into shares of the Company’s common stock. The initial conversion rate is 73.9096 shares of common stock per $1,000 principal amount of March 2019 Notes, which is equivalent to an initial conversion price of approximately $13.53 and is subject to adjustment in certain events described in the March 2019 Note Purchase Agreement. The Holder upon conversion may also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of common stock. In addition, following certain corporate events that occur prior to the maturity date, the Company will, in certain circumstances, increase the conversion rate if the holder elects to convert its March 2019 Notes in connection with such a corporate event. Subject to adjustment in the conversion rate, the number of shares that the Company may deliver in connection with a conversion of the March 2019 Notes, including those delivered in connection with an interest make-whole payment, will not exceed a cap of 81 shares of common stock per $1,000 principal amount of the March 2019 Notes.
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On or after March 15, 2022, the Company has the right, at its election, to redeem all or any portion of the March 2019 Notes not previously converted if the last reported sale price per share of common stock exceeds 130% of the conversion price on each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice. The redemption price will be 100% of the principal amount of the March 2019 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If a “fundamental change” (as defined in the March 2019 Note Purchase Agreement) occurs, then, subject to certain exceptions, the Company must offer to repurchase the March 2019 Notes for cash at a repurchase price of 100% of the principal amount of the March 2019 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date.
Other Liabilities
In February 2021, the Company partnered with Amplity Inc. (“Amplity”) for the commercial launch of ibrexafungerp for the treatment of VVC. Under the terms of the 5-year agreement, the Company will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services. The Company will maintain full ownership of ibrexafungerp and control of all strategic aspects of the launch. Amplity is deferring a portion of its direct service fees (“Deferred Fees”) in the first two years (2021 and 2022), up to a cap, which the Company will repay over three years starting in 2023. As of March 31, 2022 and December 31, 2021, Deferred Fees of $4.1 million and $3.3 million, respectively, are recognized as long term other liabilities in the unaudited interim condensed consolidated balance sheet and represent a debt obligation.
The Deferred Fees will accrue until the earlier of (i) the cap is reached or (ii) December 31, 2022. The Deferred Fees will accrue interest at annual rate of 12.75% and will be compounded quarterly, at the end of each quarter. Interest expense is recognized using the effective interest method. The Company will repay the Deferred Fees plus accrued interest in quarterly installments at the end of each calendar quarter beginning in 2023. The total amount of Deferred Fees plus accrued interest as of December 31, 2022, will serve as the basis for repayment (the “Repayment Basis”), which shall be repaid in equal installments at the end of a given quarter calculated as follows: 15% of the Repayment Basis will be repaid in 2023; 50% of the Repayment Basis will be repaid in 2024; and 35% of the Repayment Basis will be repaid in 2025. As of March 31, 2022, the Company is obligated to repay $0.7 million in 2023, $2.1 million in 2024, and $1.5 million in 2025.
Amplity has the potential to earn a performance-based success fee (“Success Premium”) in the 2023-2025 time frame by exceeding certain revenue targets. The Company identified the Success Premium as a derivative under ASC 815 that qualified for a scope exception given the revenue targets are considered the predominant underlying of the Success Premium. For the three months ended March 31, 2022 and 2021, there was no expense recognized associated with the Success Premium, respectively.
7. |
Commitments and Contingencies |
Leases
On March 1, 2018, the Company entered into a long-term lease agreement for approximately 19,275 square feet of office space in Jersey City, New Jersey, that the Company identified as an operating lease under ASC 842 (the “Lease”). The lease term is eleven years from August 1, 2018, the commencement date, with total lease payments of $7.3 million over the lease term. The Company has the option to renew for two consecutive five-year periods from the end of the first term and the Company is not reasonably certain that the option to renew the Lease will be exercised. Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $0.3 million, which was reduced by fifty-five thousand dollars on the first anniversary of the commencement date. The security deposit will continue to be reduced by fifty-five thousand dollars every two years on the commencement date anniversary for eight years. The security deposit is classified as restricted cash in the accompanying unaudited condensed consolidated balance sheets.
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The consideration in the Lease allocated to the single lease component includes the fixed payments for the right to use the office space as well as common area maintenance. The Lease also contains costs associated with certain expense escalation, property taxes, insurance, parking, and utilities which are all considered variable payments and are excluded from the operating lease liability. The incremental borrowing rate utilized approximated the prevailing market interest rate the Company would incur to borrow a similar amount equal to the total Lease payments on a collateralized basis over the term of the Lease. The following table summarizes certain quantitative information associated with the amounts recognized in the unaudited condensed consolidated financial statements for the Lease (dollars in thousands):
|
|
|
Three Months Ended March 31, |
|
|
|
|
2022 |
|
|
2021 |
|
Operating lease cost |
|
|
$ |
166 |
|
|
$ |
166 |
|
Variable lease cost |
|
|
|
(3 |
) |
|
|
(2 |
) |
Total operating lease expense |
|
|
$ |
163 |
|
|
$ |
164 |
|
|
|
|
|
|
|
|
|
|
|
Cash paid for amounts included in the measurement of operating lease liability |
|
|
$ |
174 |
|
|
$ |
170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Remaining Lease term (years) |
|
|
7.34 |
|
|
|
7.59 |
|
Discount rate |
|
|
|
15 |
% |
|
|
15 |
% |
Future minimum lease payments for the Lease as of March 31, 2022 are as follows (in thousands):
|
|
March 31, 2022 |
|
2022 |
|
$ |
354 |
|
2023 |
|
|
715 |
|
2024 |
|
|
730 |
|
2025 |
|
|
744 |
|
2026 |
|
|
759 |
|
Thereafter |
|
|
2,030 |
|
Total |
|
$ |
5,332 |
|
The presentations of the operating lease liability as of March 31, 2022 are as follows (in thousands):
|
|
March 31, 2022 |
|
Present value of future minimum lease payments |
|
$ |
3,215 |
|
|
|
|
|
|
Operating lease liability, current portion |
|
$ |
77 |
|
Operating lease liability, long-term portion |
|
|
3,138 |
|
Total operating lease liability |
|
$ |
3,215 |
|
|
|
|
|
|
Difference between future minimum lease payments and discounted cash flows |
|
$ |
2,117 |
|
License Arrangement with Potential Future Expenditures
As of March 31, 2022, the Company had a license arrangement with Merck Sharp & Dohme Corp., or Merck, as amended, that involves potential future expenditures. Under the license arrangement, executed in May 2013, the Company exclusively licensed from Merck its rights to ibrexafungerp in the field of human health. In January 2014, Merck assigned the patents related to ibrexafungerp that it had exclusively licensed to the Company. Ibrexafungerp is the Company's lead product candidate. Pursuant to the terms of the license agreement, Merck was originally eligible to receive milestone payments from the Company that could total $19.0 million upon occurrence of specific events, including initiation of a Phase 3 clinical study, new drug application, and marketing approvals in each of the U.S., major European markets, and Japan. In addition, Merck is eligible to receive tiered royalties from the Company based on a percentage of worldwide net sales of ibrexafungerp. The aggregate royalties are mid- to high-single digits.
10
Table of Contents
In December 2014, the Company and Merck entered into an amendment to the license agreement that deferred the remittance of a milestone payment due to Merck, such that no amount would be due upon initiation of the first Phase 2 clinical trial of a product containing the ibrexafungerp compound (the “Deferred Milestone”). The amendment also increased, in an amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical trial of a product containing the ibrexafungerp compound. In December 2016 and January 2018, the Company entered into second and third amendments to the license agreement with Merck which clarified what would constitute the initiation of a Phase 3 clinical trial for the purpose of milestone payment. In January 2019, a milestone payment became due to Merck as a result of the initiation of the VANISH Phase 3 VVC program and was paid in March 2019. On December 2, 2020, the Company entered into a fourth amendment to the license agreement with Merck. The amendment eliminates two cash milestone payments that the Company would have paid to Merck upon the first filing of an NDA, triggered by the FDA acceptance for filing of the Company’s NDA for ibrexafungerp for the treatment of VVC, and first marketing approval in the U.S. Such cash milestone payments would have been creditable against future royalties owed to Merck on net sales of ibrexafungerp. With the amendment, these milestones will not be paid in cash and, accordingly, credits will not accrue. Pursuant to the amendment, the Company will also forfeit the credits against future royalties that it had accrued from a prior milestone payment already paid to Merck. All other key terms of the license agreement are unchanged.
Clinical Development Arrangements
The Company has entered into, and expects to continue to enter into, contracts in the normal course of business with various third parties who support its clinical trials, preclinical research studies, and other services related to its development activities. The scope of the services under these agreements can generally be modified at any time, and the agreement can be terminated by either party after a period of notice and receipt of written notice.
Authorized, Issued, and Outstanding Common Stock
The Company’s authorized common stock has a par value of $0.001 per share and consists of 100,000,000 shares as of March 31, 2022, and December 31, 2021; 29,221,158 and 28,705,334 shares were issued and outstanding at March 31, 2022, and December 31, 2021, respectively.
11
Table of Contents
The following table summarizes common stock share activity for the three months ended March 31, 2022 and 2021 (dollars in thousands):
|
|
Three Months Ended March 31, 2022 |
|
|
|
Shares of
Common Stock |
|
|
Common
Stock |
|
|
Additional
Paid-in
Capital |
|
|
Accumulated
Deficit |
|
|
Total
Stockholders’
Equity |
|
Balance, December 31, 2021 |
|
|
28,705,334 |
|
|
$ |
32 |
|
|
$ |
400,705 |
|
|
$ |
(359,479 |
) |
|
$ |
41,258 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,451 |
) |
|
|
(5,451 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
922 |
|
|
|
— |
|
|
|
922 |
|
Common stock issued, net of expenses |
|
|
487,610 |
|
|
|
— |
|
|
|
2,135 |
|
|
|
— |
|
|
|
2,135 |
|
Common stock issued through employee stock purchase plan |
|
|
3,120 |
|
|
|
— |
|
|
|
10 |
|
|
|
— |
|
|
|
10 |
|
Common stock issued for vested restricted stock units |
|
|
25,094 |
|
|
|
— |
|
|
|
(18 |
) |
|
|
— |
|
|
|
(18 |
) |
Vested Loan Agreement warrants |
|
|
— |
|
|
|
— |
|
|
|
71 |
|
|
|
|
|
|
|
71 |
|
Balance, March 31, 2022 |
|
|
29,221,158 |
|
|
$ |
32 |
|
|
$ |
403,825 |
|
|
$ |
(364,930 |
) |
|
$ |
38,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2021 |
|
|
|
Shares of
Common Stock |
|
|
Common
Stock |
|
|
Additional
Paid-in
Capital |
|
|
Accumulated
Deficit |
|
|
Total
Stockholders’
Equity |
|
Balance, December 31, 2020 |
|
|
19,663,698 |
|
|
$ |
20 |
|
|
$ |
349,351 |
|
|
$ |
(326,613 |
) |
|
$ |
22,758 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,676 |
) |
|
|
(4,676 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
398 |
|
|
|
— |
|
|
|
398 |
|
Common stock issued for conversion of April 2020 Notes |
|
|
959,080 |
|
|
|
1 |
|
|
|
7,452 |
|
|
|
— |
|
|
|
7,453 |
|
Common stock issued through employee stock purchase plan |
|
|
2,184 |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
|
|
6 |
|
Common stock issued for vested restricted stock units |
|
|
675 |
|
|
|
— |
|
|
|
(15 |
) |
|
|
— |
|
|
|
(15 |
) |
Balance, March 31, 2021 |
|
|
20,625,637 |
|
|
$ |
21 |
|
|
$ |
357,192 |
|
|
$ |
(331,289 |
) |
|
$ |
25,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Reserved for Future Issuance
The Company had reserved shares of common stock for future issuance as follows:
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Outstanding stock options |
|
|
2,050,094 |
|
|
|
1,542,126 |
|
Outstanding restricted stock units |
|
|
981,841 |
|
|
|
133,834 |
|
Warrants to purchase common stock associated with March 2018 Public Offering – Series 2 |
|
|
798,810 |
|
|
|
798,810 |
|
Warrants to purchase common stock associated with December 2020 Public Offering - Series 2 |
|
|
6,800,000 |
|
|
|
6,800,000 |
|
Prefunded warrants to purchase common stock associated with December 2020 Public Offering |
|
|
3,200,000 |
|
|
|
3,200,000 |
|
Warrants to purchase common stock associated with Loan Agreement |
|
|
198,819 |
|
|
|
170,410 |
|
Warrant to purchase common stock associated with Danforth |
|
|
50,000 |
|
|
|
50,000 |
|
For possible future issuance for the conversion of the March 2019 Notes |
|
|
1,138,200 |
|
|
|
1,138,200 |
|
For possible future issuance under 2014 Plan (Note 9) |
|
|
150,114 |
|
|
|
295,220 |
|
For possible future issuance under Employee Stock Purchase Plan |
|
|
3,714 |
|
|
|
3,893 |
|
For possible future issuance under 2015 Plan (Note 9) |
|
|
147,250 |
|
|
|
235,000 |
|
Total common shares reserved for future issuance |
|
|
15,518,842 |
|
|
|
14,367,493 |
|
12
Table of Contents
Common Stock Purchase Agreement and Sales Agreement
On April 10, 2020, the Company entered into the Common Stock Purchase Agreement with Aspire Capital pursuant to which the Company has the right to sell to Aspire Capital from time to time in its sole discretion up to $20.0 million in shares of the Company’s common stock over the next 30 months, subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement. The aggregate number of shares that we can sell to Aspire Capital under the Common Stock Purchase Agreement may in no case exceed 1,956,547 shares of the Company’s common stock (which is equal to approximately 19.99% of the common stock outstanding on the date of the Common Stock Purchase Agreement), including the 70,910 commitment shares (the Exchange Cap), unless either (a) shareholder approval is obtained to issue more, in which case the Exchange Cap will not apply, or (b) the average purchase price of all shares sold under the Common Stock Purchase Agreement exceeds $8.461; provided that at no time shall Aspire Capital (together with its affiliates) beneficially own more than 19.99% of the Company’s common stock. During the three months ended March 31, 2022, the Company sold 350,000 of its common stock under the Common Stock Purchase Agreement for gross proceeds of $1.5 million and did not sell any common stock during the three months ended March 31, 2021. During the months ended March 31, 2022, the Company sold 137,610 shares of its common stock and received net proceeds of $0.7 million, and did not sell any common stock during the three months ended March 31, 2021 under the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc.
Warrants Associated with the March 2018 and December 2020 Public Offerings
The outstanding warrants associated with the March 2018 and December 2020 public offerings contain a provision where the warrant holder has the option to receive cash, equal to the Black-Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity, requires that these warrants be classified as liabilities. The fair values of these warrants have been determined using the Black-Scholes valuation model, and the changes in the fair value are recorded in the accompanying unaudited interim condensed consolidated statements of operations. During the three months ended March 31, 2022 and 2021, the Company recognized gains of $10.0 million and $1.3 million on the warrant liabilities fair value adjustment. As of March 31, 2022 and December 31, 2021, the fair value of the warrant liabilities was $8.0 million and $18.1 million, respectively.
Warrants Associated with Loan Agreement
In connection with the entry into the Loan Agreement, the Company issued to each of Hercules and SVB a warrant (collectively, the “Warrants”) to purchase shares of the Company’s common stock, par value $0.001 per share (the “Shares”). The amount of shares that may be purchased for the Warrants, collectively between Hercules and SVB, will not exceed 0.04 multiplied by the aggregate amount of the term loan advances, divided by the exercise price of the Warrants. At the closing of the Loan Agreement, the Company issued 113,607 warrants to purchase shares of the Company’s common stock and recognized the initial warrants at their relative fair value in shareholder's equity.
13
Table of Contents
Upon the funding of the $10.0 million and $5.0 million for the second and third tranches in June 2021 and March 2022, respectively, the associated warrant liabilities of $0.3 million and $0.1 million, respectively, were reclassed to additional paid in capital at settlement. In June 2021 and March 2022, 56,803 and 28,409 warrants to purchase shares of the Company’s common stock were issued upon vesting of the second and third tranches, respectively.
9. |
Stock-based Compensation |
Pursuant to the terms of the Company’s 2014 Equity Incentive Plan (“2014 Plan”), on January 1, 2022 and 2021, the Company automatically added 1,148,213 and 786,547 shares to the total number shares of common stock available for future issuance under the 2014 Plan, respectively. As of March 31, 2022, there were 150,114 shares of common stock available for future issuance under the 2014 Plan.
As of March 31, 2022, there were 147,250 shares of common stock available for future issuance under the Company’s 2015 Inducement Award Plan (“2015 Plan”). During the three months ended March 31, 2022 and 2021, there were options to purchase 69,000 and zero shares of the Company’s common stock granted under the 2015 Plan, respectively. On April 30, 2021, the Company’s board of directors amended the 2015 Plan, and the share reserve for the 2015 Plan was increased from 90,000 to 500,000 shares of common stock.
The activity for the Company’s 2009 Stock Option Plan, 2014 Plan, and 2015 Plan, for the three months ended March 31, 2022, is summarized as follows:
|
|
Number of
Shares |
|
|
Weighted-
Average
Exercise
Price |
|
|
Weighted-
Average
Remaining
Contractual
Life (in years) |
|
|
Aggregate
Intrinsic
Value ($000) |
|
Outstanding — December 31, 2021 |
|
|
1,542,126 |
|
|
$ |
14.89 |
|
|
|
7.45 |
|
|
$ |
42 |
|
Granted |
|
|
550,500 |
|
|
$ |
4.59 |
|
|
|
|
|
|
|
|
|
Forfeited/Cancelled |
|
|
(42,532 |
) |
|
$ |
7.44 |
|
|
|
|
|
|
|
|
|
Outstanding — March 31, 2022 |
|
|
2,050,094 |
|
|
$ |
12.28 |
|
|
|
7.97 |
|
|
$ |
— |
|
Exercisable — March 31, 2022 |
|
|
793,216 |
|
|
$ |
21.77 |
|
|
|
6.01 |
|
|
$ |
— |
|
Vested or expected to vest — March 31, 2022 |
|
|
2,050,094 |
|
|
$ |
12.28 |
|
|
|
7.97 |
|
|
$ |
— |
|
Restricted stock unit (“RSU”) activity under the 2014 Plan and 2015 Plan for the three months ended March 31, 2022, is summarized as follows:
|
|
Number of
Shares |
|
|
Weighted
Average
Grant Date
Fair Value
Per Share |
|
Non-vested at December 31, 2021 |
|
|
133,834 |
|
|
$ |
7.98 |
|
Granted |
|
|
883,465 |
|
|
$ |
5.59 |
|
Vested |
|
|
(25,094 |
) |
|
$ |
7.92 |
|
Forfeited |
|
|
(10,364 |
) |
|
$ |
7.60 |
|
Non-vested at March 31, 2022 |
|
|
981,841 |
|
|
$ |
5.83 |
|
The fair value of RSUs is based on the market price of the Company’s common stock on the date of grant. RSUs generally vest 25% annually over a four-year period from the date of grant. Upon vesting, the RSUs are net share settled to cover the required withholding tax with the remaining shares issued to the holder. The Company recognizes compensation expense for such awards ratably over the corresponding vesting period.
Compensation Cost
The compensation cost that has been charged against income for stock awards under the 2014 Plan and the 2015 Plan was $0.9 million and $0.4 million for the three months ended March 31, 2022 and 2021, respectively. The total income tax benefit recognized in the statements of operations for share-based compensation arrangements was zero for each of the three months ended March 31, 2022 and 2021.
14
Table of Contents
Stock-based compensation expense related to stock options is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands):
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Research and development |
|
$ |
285 |
|
|
$ |
126 |
|
Selling, general and administrative |
|
|
637 |
|
|
|
272 |
|
Total |
|
$ |
922 |
|
|
$ |
398 |
|
15
Table of Contents
10. |
Fair Value Measurements |
The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their respective fair values due to the short-term nature of such instruments.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached as of March 31, 2022 and December 31, 2021 for financial instruments measured at fair value on a recurring basis (in thousands):
|
|
|
|
|
|
Fair Value Hierarchy Classification |
|
|
|
Balance |
|
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1) |
|
|
Significant
Other
Observable
Inputs
(Level 2) |
|
|
Significant
Unobservable
Inputs (Level 3) |
|
March 31, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
621 |
|
|
$ |
621 |
|
|
|
— |
|
|
|
— |
|
Restricted cash |
|
|
218 |
|
|
|
218 |
|
|
|
— |
|
|
|
— |
|
Money market funds |
|
|
94,589 |
|
|
|
94,589 |
|
|
|
— |
|
|
|
— |
|
Total assets |
|
$ |
95,428 |
|
|
$ |
95,428 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
$ |
7,961 |
|
|
|
— |
|
|
|
— |
|
|
$ |
7,961 |
|
Derivative liability |
|
|
378 |
|
|
|
— |
|
|
|
— |
|
|
|
378 |
|
Total liabilities |
|
$ |
8,339 |
|
|
|
— |
|
|
|
— |
|
|
$ |
8,339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
310 |
|
|
$ |
310 |
|
|
|
— |
|
|
|
— |
|
Restricted cash |
|
|
218 |
|
|
|
218 |
|
|
|
— |
|
|
|
— |
|
Money market funds |
|
|
104,187 |
|
|
|
104,187 |
|
|
|
— |
|
|
|
— |
|
Total assets |
|
$ |
104,715 |
|
|
$ |
104,715 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
$ |
18,062 |
|
|
|
— |
|
|
|
— |
|
|
$ |
18,062 |
|
Derivative liabilities |
|
|
1,358 |
|
|
|
— |
|
|
|
— |
|
|
|
1,358 |
|
Total liabilities |
|
$ |
19,420 |
|
|
|
— |
|
|
|
— |
|
|
$ |
19,420 |
|
The Company measures cash equivalents at fair value on a recurring basis. The fair value of cash equivalents is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets.
Level 3 financial liabilities consist of the warrant liabilities for which there is no current market such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, maturity, risk free rates, as well as volatility. The unobservable input for all of the Level 3 warrant liabilities includes volatility. The historical and implied volatility of the Company, using its closing common stock prices and market data, is utilized to reflect future volatility over the expected term of the warrants. At March 31, 2022, the range and weighted average of the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liabilities were 81.7% to 84.1% and 84.1%, respectively. The Company utilizes a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement warrants and allocated the probability of occurrence percentage to the fair values calculated.
The Company uses the binomial lattice valuation model to value the Level 3 derivative liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, dividend yield, risk-free rate, adjusted equity volatility, credit rating, market credit spread, and estimated effective yield. The unobservable inputs associated with the Level 3 derivative liabilities are adjusted equity volatility, market credit spread, and estimated yield. As of March 31, 2022, these inputs were 61.4%, 1,463 basis points, and 17.1%, respectively. The senior convertible notes are initially fair valued using the binomial lattice model and with the straight debt fair value calculated using the discounted cash flow method. The discount for lack of marketability, 2.9% as of March 31, 2022, is applied to the value of the March 2019 Notes. The residual difference represents the fair value of the embedded derivative liabilities and the fair value of the embedded derivative liabilities are reassessed using the binomial lattice valuation model on a quarterly basis.
16
Table of Contents
A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):
|
|
|
Warrant Liabilities |
|
Balance – December 31, 2021 |
|
|
$ |
18,062 |
|
Loan Agreement warrants |
|
|
|
(71 |
) |
Gain adjustment to fair value |
|
|
|
(10,030 |
) |
Balance – March 31, 2022 |
|
|
$ |
7,961 |
|
|
|
|
|
|
|
|
|
|
Derivative Liabilities |
|
Balance – December 31, 2021 |
|
|
$ |
1,358 |
|
Gain adjustment to fair value |
|
|
|
(980 |
) |
Balance – March 31, 2022 |
|
|
$ |
378 |
|
Product Revenue, Net
Net product revenue was $0.7 million for the three months ended March 31, 2022. Products are sold primarily to wholesalers and specialty pharmacies. Revenue is reduced from wholesaler list price at the time of recognition for expected chargebacks, rebates, discounts, incentives, and returns, which are referred to as gross to net (“GTN”) adjustments. These reductions are currently attributed to various commercial arrangements. Chargebacks and discounts are recognized as a reduction in accounts receivable or as accrued expenses based on their nature and settled through the issuance of credits to the customer or through cash payments to the customer, respectively. All other returns, rebates, and incentives are reflected as accrued expenses and settled through cash payments to the customer. Three wholesalers comprised 46%, 29%, and 21% of the Company’s gross revenue for the three months ended March 31, 2022.
The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of March 31, 2022 (in thousands):
|
|
Discounts and Chargebacks (1) |
|
|
Product Returns (2) |
|
|
Rebates and Incentives (3) |
|
|
Total |
|
Balance as of December 31, 2021 |
|
$ |
249 |
|
|
$ |
21 |
|
|
$ |
1,110 |
|
|
$ |
1,380 |
|
Provision related to current period revenue |
|
|
272 |
|
|
|
10 |
|
|
|
1,092 |
|
|
|
1,374 |
|
Changes in estimate related to prior period revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Credit/payments |
|
|
(122 |
) |
|
|
— |
|
|
|
(1,040 |
) |
|
|
(1,162 |
) |
Balance as of March 31, 2022 |
|
$ |
399 |
|
|
$ |
31 |
|
|
$ |
1,162 |
|
|
$ |
1,592 |
|
|
|
(1) |
Discounts and chargebacks include fees for wholesaler fees, prompt pay and other discounts, and chargebacks. Discounts and chargebacks are deducted from gross revenue at the time revenues are recognized and are included as a reduction in accounts receivable or as an accrued expense based on their nature on the Company’s unaudited interim condensed consolidated balance sheet. |
(2) |
Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited interim condensed consolidated balance sheet. |
(3) |
Rebates and incentives include rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited interim condensed consolidated balance sheets. |
License Agreement Revenue
In February 2021, the Company entered into an Exclusive License and Collaboration Agreement (the “Agreement”) with Hansoh (Shanghai) Health Technology Co., Ltd., and Jiangsu Hansoh Pharmaceutical Group Company Limited (collectively,
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“Hansoh”), pursuant to which the Company granted to Hansoh an exclusive license to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan (the “Territory”). The Company also granted to Hansoh a non-exclusive license to manufacture ibrexafungerp solely for development and commercialization in the Territory. Under the terms of the Agreement, Hansoh shall be responsible for the development, regulatory approval and commercialization of ibrexafungerp in the Territory.
Pursuant to the terms of the Agreement, the Company received as consideration for the licenses a nonrefundable upfront cash payment of $10.0 million and is entitled to an additional payment that was payable upon the transfer of certain data related to the manufacturing license. In addition, the Company will also be eligible to receive up to $110.0 million in potential development and commercial milestones. In addition, during the term of the licensing agreement, the Company is entitled to low double-digit royalties on net product sales. The obligation to pay royalties with respect to sales in a specified region will continue until the later of the date of expiration of all intellectual property and regulatory exclusivity for the product in the region and ten years from the first commercial sale, unless earlier terminated by Hansoh with advanced notice for convenience or under other specified circumstances. The Company is also eligible to receive a milestone related to the successful completion of a manufacturing batch by Hansoh.
The Company evaluated the Agreement and concluded that it was subject to ASC 606 as the Company viewed the Agreement as a contract with a customer as the activities were central to its business operations. As such, the Company assessed the terms of the Agreement and identified one performance obligation for the licenses to research, develop, manufacture and commercialize ibrexafungerp in the Territory, including the underlying know-how related to such licenses. The Company also evaluated options for additional goods and services included in the Agreement related to (1) optional technical assistance related to development, regulatory or manufacturing activities and (2) an optional supply agreement for ibrexafungerp. Such options for additional goods or services were not considered to contain material rights as pricing approximated standalone selling prices and therefore the Company concluded that such options did not represent performance obligations and will be accounted for as separate transactions if and when they occur in the future.
The Company determined that the transaction price of $12.1 million included the fixed upfront cash payment of $10.0 million, an additional amount that was payable upon the transfer of certain data related to the manufacturing license, and $1.1 million related to withholding tax obligations that Hansoh remitted on behalf of the Company. The remaining amounts related to the successful completion of a manufacturing batch by Hansoh and potential development milestones represent variable consideration as it was concluded that it was not probable that a significant reversal in cumulative revenue recognized will not occur and therefore not included in the transaction price as of March 31, 2021. Potential commercial milestones and royalties on net product sales will be recognized in the same period that the underlying net product sales occur as they were determined to relate to the license. The transaction price was recorded in license agreement revenue during the three months ended March 31, 2021 at a point in time upon control of the license transferring to Hansoh. The Company will reevaluate the transaction price at the end of each reporting period as uncertain events or resolved, or as other changes in circumstances occur. For the three months ended March 31, 2022, there was no license agreement revenue recognized given the variable consideration was fully constrained as of March 31, 2022.
Additionally, pursuant to the Agreement, both the Company and Hansoh agreed to make reasonable efforts to account for applicable taxes, fees, duties, levies, or similar amounts imposed on net income, franchise taxes and profits arising directly or indirectly from the activities of the Agreement. To the extent Hansoh is required by applicable laws to withhold or deduct any tax on any payment to the Company, Hansoh agreed to make certain increases on payments to the Company to ensure that the Company receives a sum equal to what the Company would have received had there been no deduction or withholding. As a result, the Company has recorded revenue and tax withholding expense primarily associated with the up-front payment received by the Company on a gross basis. For the three months ended March 31, 2021, the Company recognized $1.1 million in license agreement revenue and $1.1 million in income tax expense to account for the tax withholding expense primarily on the $10.0 million up-front that the Company is responsible to remit under applicable tax law.
In July 2016, the Company entered into an asset purchase agreement with UK-based Cypralis Limited (or "Cypralis"), a life sciences company, for the sale of its cyclophilin inhibitor assets. Cypralis also acquired all patents, patent applications and know-how related to the acquired portfolio. In connection with the asset purchase agreement, the Company is eligible to receive milestone payments upon the successful progression of Cypralis clinical candidates into later stage clinical studies and royalties payable upon product commercialization. The Company retains the right to repurchase the portfolio assets from Cypralis if abandoned or deprioritized. For the three months ended March 31, 2022 and 2021, there was no revenue recognized associated with this agreement given the variable consideration associated with the sale of intellectual property to Cypralis was fully constrained as of March 31, 2022 and 2021, respectively. Additionally, in October 2014 the Company entered into a license agreement with Waterstone Pharmaceutical HK Limited (or “Waterstone”) and granted Waterstone an exclusive, worldwide license to develop and commercialize certain non-strategic compounds. The Company is entitled to receive potential milestones and royalties from Waterstone; however, there was no revenue recognized by the
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Company associated with this agreement given the variable consideration was fully constrained as of March 31, 2022 and March 31, 2021.
On April 22, 2022, the Company entered into an Equity Underwriting Agreement (the “Underwriting Agreement”) with Guggenheim Securities, LLC, as representative of the several underwriters (the “Underwriters”), relating to the offering, issuance and sale (the “Offering”) of (a) 3,333,333 shares of the Company’s common stock, par value $0.001 per share, (b) pre-funded warrants, in lieu of common stock, to purchase 11,666,667 shares of the Company’s common stock, par value $0.001 per share, and (c) warrants, which will accompany the common stock or pre-funded warrants, to purchase up to an aggregate of 15,000,000 shares of the Company’s common stock. The pre-funded warrants entitle the holders to purchase up to 11,666,667 shares of common stock and have an unlimited term and an exercise price of $0.001 per share. The warrants entitle the holders to purchase up to an aggregate of 15,000,000 shares of common stock and have a seven-year term and an exercise price of $3.45 per share. The warrants that accompany the pre-funded warrants have an additional provision entitling the holder thereof to purchase a pre-funded warrant rather than a share of common stock at the warrant exercise price less the exercise price of the pre-funded warrant purchased. There is not expected to be any trading market for the pre-funded warrants or warrants issued in the Offering. Each warrant is exercisable immediately upon issuance, subject to certain limitations on beneficial ownership. The price to the public in the Offering is $3.00 per share of common stock and accompanying warrants, or in the case of pre-funded warrants, $2.999 per pre-funded warrant and accompanying warrants. Pursuant to the Underwriting Agreement, the Underwriters agreed to purchase shares of common stock and accompanying warrants from the Company at a price of $2.82 per share of common stock, and to purchase pre-funded warrants and accompanying warrants from the Company at a price of $2.81906 per pre-funded warrant, which resulted in approximately $41.9 million of net proceeds to the Company after deducting the underwriting discount and estimated offering expenses. The shares of common stock will be listed on The Nasdaq Global Market. All of the shares, pre-funded warrants and warrants in the Offering were sold by the Company.
In addition, the Company granted to the Underwriters an option to purchase up 2,250,000 additional shares of common stock and/or warrants to purchase up to an aggregate of an additional 2,250,000 shares of common stock, in each case at their respective public offering prices, less underwriting discounts and commissions.
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