ENANTA PHARMACEUTICALS INC
For the period ended Dec 31, 2023. Filed Feb 8, 2024.
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Dec 31, 2023 · Filed Feb 8, 2024
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Notes to Condensed Consolidated Financial Statements (unaudited)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts in thousands, except per share data)
- Nature of the Business and Basis of Presentation
Enanta Pharmaceuticals, Inc. (collectively with its subsidiary, the “Company”), incorporated in Delaware in 1995, is a biotechnology company that uses its robust, chemistry-driven approach and drug discovery capabilities to discover and develop small molecule drugs with an emphasis on virology and immunology indications. The Company discovered glecaprevir, the second of two protease inhibitors discovered and developed through its collaboration with AbbVie for the treatment of chronic infection with hepatitis C virus (“HCV”). Glecaprevir is co-formulated as part of AbbVie’s leading direct-acting antiviral (“DAA”) combination treatment for HCV, which is marketed under the tradenames MAVYRET® (U.S.) and MAVIRET®(ex-U.S.) (glecaprevir/pibrentasvir). Royalties from the Company’s AbbVie collaboration and its existing financial resources provide funding to support the Company’s wholly-owned research and development programs, which are primarily focused on the following disease targets: respiratory syncytial virus (“RSV”), SARS-CoV-2, hepatitis B virus (“HBV”) and Chronic Spontaneous Urticaria (“CSU”).
The Company is subject to many of the risks common to companies in the biotechnology industry, including but not limited to, the uncertainties of research and development, competition from technological innovations of others, dependence on collaborative arrangements, protection of proprietary technology, dependence on key personnel and compliance with government regulation. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approvals, prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance reporting capabilities.
Unaudited Interim Financial Information
The condensed consolidated balance sheet as of September 30, 2023 was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited condensed consolidated financial statements as of December 31, 2023 and for the three months ended December 31, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2023.
In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of December 31, 2023 and results of operations for the three months ended December 31, 2023 and 2022 and cash flows for the three months ended December 31, 2023 and 2022 have been made. The results of operations for the three months ended December 31, 2023 are not necessarily indicative of the results of operations that may be expected for subsequent quarters or the year ending September 30, 2024.
The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. All amounts in the condensed consolidated financial statements and in the notes to the condensed consolidated financial statements, except per share amounts, are in thousands unless otherwise indicated.
The accompanying condensed consolidated financial statements have been prepared based on continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company began reporting a net loss in fiscal 2020 and reported a net loss of $33,407 for the three months ended December 31, 2023 and $133,816 for the year ended September 30, 2023. As of December 31, 2023, the Company had an accumulated deficit of $240,402. The Company expects to continue to generate operating losses for the foreseeable future as the Company continues to advance its wholly-owned programs. As of December 31, 2023, the Company had $337,151 in cash, cash equivalents and short-term marketable securities. The Company expects that its cash, cash equivalents and short-term marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements. The Company may seek additional funding through equity offerings, non-dilutive financings, collaborations, strategic alliances or licensing agreements. The Company may not be able to obtain sufficient financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.
- Summary of Significant Accounting Policies
For the Company’s Significant Accounting Policies, please refer to its Annual Report on Form 10-K for the fiscal year ended September 30, 2023. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, management’s judgments with respect to its revenue arrangements; liability related to the sale of future royalties; valuation of stock-based awards and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience.
Net Loss per Share
Basic net loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. In periods in which the Company has reported a net loss, diluted net loss per common share is the same as basic net loss per common share since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Therefore, the Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss as its effect would have been anti-dilutive:
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Options to purchase common stock | 5,213 | 4,511 |
| Unvested rTSRUs | 129 | 151 |
| Unvested PSUs | 129 | 151 |
| Unvested restricted stock units | 455 | 439 |
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. This amendment is effective for the Company in the fiscal year beginning October 1, 2024, with early adoption permitted. The Company is currently evaluating the potential impact that ASU 2023-07 may have on its financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company in the fiscal year beginning October 1, 2025, with early adoption permitted. The Company is currently evaluating the potential impact that ASU 2023-09 may have on its financial statement disclosures.
- Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of December 31, 2023 and September 30, 2023, and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value:
| Fair Value Measurements as of December 31, 2023 Using: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| (in thousands) | ||||
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $38,905 | $— | $— | $38,905 |
| Marketable securities: | ||||
| U.S. Treasury notes | 264,537 | — | — | 264,537 |
| Corporate bonds | — | 26,706 | — | 26,706 |
| Commercial paper | — | 5,975 | — | 5,975 |
| $303,442 | $32,681 | $— | $336,123 | |
| Liabilities: | ||||
| Series 1 nonconvertible preferred stock | $— | $— | $1,423 | $1,423 |
| $— | $— | $1,423 | $1,423 | |
| Fair Value Measurements as of September 30, 2023 Using: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| (in thousands) | ||||
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $55,357 | $— | $— | $55,357 |
| U.S. Treasury notes | 29,755 | — | — | 29,755 |
| Marketable securities: | ||||
| U.S. Treasury notes | 236,782 | — | — | 236,782 |
| Corporate bonds | — | 26,435 | — | 26,435 |
| Commercial paper | — | 21,305 | — | 21,305 |
| $321,894 | $47,740 | $— | $369,634 | |
| Liabilities: | ||||
| Series 1 nonconvertible preferred stock | $— | $— | $1,423 | $1,423 |
| $— | $— | $1,423 | $1,423 | |
During the three months ended December 31, 2023 and 2022, there wereno transfers between Level 1, Level 2 and Level 3.
The fair value of Level 2 instruments classified as marketable securities were determined through third-party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, and current spot rates.
The outstanding shares of Series 1 nonconvertible preferred stock as of December 31, 2023 and September 30, 2023 are measured at fair value. These outstanding shares are financial instruments that might require a transfer of assets because of the liquidation features in the contract and are therefore recorded as liabilities and measured at fair value. The fair value of the outstanding shares is based on significant inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The Company utilizes a probability-weighted valuation model which takes into consideration various outcomes that may require the Company to transfer assets upon liquidation. Changes in the fair values of the Series 1 nonconvertible preferred stock are recognized in other income (expense) in the condensed consolidated statements of operations.
The recurring Level 3 fair value measurements of the Company’s outstanding Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs:
| Range | ||
|---|---|---|
| December 31, | September 30, | |
| Unobservable Input | 2023 | 2023 |
| Probabilities of payout | 0%-65% | 0%-65% |
| Discount rate | 7.25% | 7.25% |
There wereno changes in the fair value of nonconvertible preferred stock during thethree months ended December 31, 2023 and 2022.
In April 2023, the Company entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which the Company was paid a $200,000 cash purchase price in exchange for 54.5% of future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. The Company accounted for the upfront payment as a liability related to the sale of future royalties. The carrying value of the liability related to the sale of future royalties approximates fair value as of December 31, 2023 and is based on current estimates of future royalties expected to be paid to OMERS over the next 10 years, which are considered Level 3 inputs. See Note 7 for a rollforward of the liability.
- Marketable Securities
As of December 31, 2023 and September 30, 2023, the fair value of available-for-sale marketable securities, by type of security, was as follows:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | Credit Losses | Fair Value | |
|---|---|---|---|---|---|
| (in thousands) | |||||
| Corporate bonds | $27,043 | $— | $(337) | $— | $26,706 |
| Commercial paper | 5,975 | — | — | — | 5,975 |
| U.S. Treasury notes | 264,350 | 207 | (20) | — | 264,537 |
| $297,368 | $207 | $(357) | $— | $297,218 | |
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | Credit Losses | Fair Value | |
|---|---|---|---|---|---|
| (in thousands) | |||||
| Corporate bonds | $27,127 | $— | $(692) | $— | $26,435 |
| Commercial paper | 21,305 | — | — | — | 21,305 |
| U.S. Treasury notes | 236,880 | 12 | (110) | — | 236,782 |
| $285,312 | $12 | $(802) | $— | $284,522 | |
As of December 31, 2023 and September 30, 2023, marketable securities consisted of investments that mature withinone year.
- Accrued Expenses
Accrued expenses and other current liabilities consisted of the following as of December 31, 2023 and September 30, 2023:
| December 31, | September 30, | |
|---|---|---|
| 2023 | 2023 | |
| (in thousands) | ||
| Accrued pharmaceutical drug manufacturing | $1,099 | $3,083 |
| Accrued research and development expenses | 3,707 | 6,120 |
| Accrued payroll and related expenses | 4,310 | 7,037 |
| Accrued other | 2,487 | 2,099 |
| $11,603 | $18,339 | |
- AbbVie Collaboration
The Company has a Collaborative Development and License Agreement (as amended, the “AbbVie Agreement”), with AbbVie to identify, develop and commercialize HCV NS3 and NS3/4A protease inhibitor compounds, including paritaprevir and glecaprevir, under which the Company has received license payments, proceeds from a sale of preferred stock, research funding payments, milestone payments and royalties totaling approximately$1,296,000 through December 31, 2023. Since the Company satisfied all of its performance obligations under the AbbVie Agreement by the end of fiscal 2011, all milestone payments received since then have been recognized as revenue when the milestones were achieved by AbbVie.
The Company is receiving annually tiered royalties per Company protease product ranging from ten percent up to twenty percent, or on a blended basis from ten percent up to the high teens, on the portion of AbbVie’s calendar year net sales of each HCV regimen that is allocated to the protease inhibitor in the regimen. Beginning with each January 1, the cumulative net sales of a given royalty-bearing protease inhibitor product start at zero for purposes of calculating the tiered royalties on a product-by-product basis.
- Liability Related to the Sale of Future Royalties
In April 2023, the Company entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which the Company was paid a $200,000 cash purchase price in exchange for 54.5% of future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price.
Because the royalty sale agreement will be paid back to OMERS up to a capped amount as well as the Company’s significant continuing involvement in the generation of future cash flows under its AbbVie Agreement, the Company recorded the proceeds from the transaction as a liability on its condensed consolidated balance sheets which will be amortized as interest expense in the condensed consolidated statements of operations under the effective interest rate method over the life of the royalty sale agreement. The Company will continue to record the full amount of royalties earned on MAVYRET/MAVIRET sales as royalty revenue in the condensed consolidated statements of operations.
The Company’s liability related to the sale of future royalties is estimated based on forecasted worldwide MAVYRET/MAVYRET royalties to be paid to OMERS over the course of the royalty sale agreement. This estimate requires significant judgment, including the amount and timing of royalty payments up until the end of the royalty sale agreement, which is estimated to be the stated term of June 30, 2032. As royalties are earned by OMERS, the liability is reduced on the Company’s condensed consolidated balance sheets.
At December 31, 2023, the estimated future cash flows resulted in an effective annual imputed interest rate of approximately 7.05%.
The following table summarizes the activity of the liability related to the sale of future royalties:
| Liability related to the sale of future royalties | |
|---|---|
| (in thousands) | |
| Balance - September 30, 2023 | $194,505 |
| Royalty payable to purchaser | (9,822) |
| Interest expense | 3,441 |
| Balance - December 31, 2023 | $188,124 |
- Series 1 Nonconvertible Preferred Stock
As of December 31, 2023,1,930 shares of Series 1 nonconvertible preferred stock were issued and outstanding. The outstanding shares are financial instruments that might require a transfer of assets because of the liquidation features in the contract and are carried at fair value as a liability on the Company’s condensed consolidated balance sheets.
- Stock-Based Awards
The Company grants stock-based awards, including stock options, restricted stock units and other unit awards under its 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by its stockholders on February 28, 2019 and amended in March 2021, March 2022 and March 2023. The Company also has outstanding stock option awards under its 2012 Equity Incentive Plan (the “2012 Plan”) but is no longer granting awards under this plan.
The following table summarizes stock option activity, including performance-based options, for the year-to-date period ending December 31, 2023:
| SharesIssuable UnderOptions | WeightedAverageExercisePrice | WeightedAverageRemainingContractualTerm | AggregateIntrinsicValue | |
|---|---|---|---|---|
| (in thousands) · (in years) · (in thousands) | ||||
| Outstanding as of September 30, 2023 | 4,365 | $52.68 | 5.9 | $— |
| Granted | 1,092 | 8.99 | ||
| Exercised | — | — | ||
| Forfeited | (244) | 38.99 | ||
| Outstanding as of December 31, 2023 | 5,213 | $44.17 | 6.7 | $459 |
| Options vested and expected to vest as of December 31, 2023 | 5,213 | $44.17 | 6.7 | $459 |
| Options exercisable as of December 31, 2023 | 3,028 | $53.37 | 5.1 | $— |
Market and Performance-Based Stock Unit Awards
The Company awards both performance share units, or PSUs, and relative total stockholder return units, or rTSRUs, to its executive officers. The number of units granted represents the target number of shares of common stock that may be earned; however, the actual number of shares that may be earned ranges from 0% to 150% of the target number. The number of shares cancelled represents the target number of shares, less any shares that vested. The following table summarizes PSU and rTSRU activity for the year-to-date period ending December 31, 2023:
| PSUs | rTSRUs | |||
|---|---|---|---|---|
| Shares | WeightedAverageGrant Date Fair Value | Shares | WeightedAverageGrant Date Fair Value | |
| (in thousands) · (in thousands) | ||||
| Unvested as of September 30, 2023 | 81 | $58.58 | 81 | $45.82 |
| Granted | 48 | 9.21 | 48 | 9.89 |
| Vested | — | — | — | — |
| Unvested as of December 31, 2023 | 129 | $40.23 | 129 | $32.47 |
Restricted Stock Units
The following table summarizes the restricted stock unit activity for the year-to-date period ending December 31, 2023:
| Restricted Stock Units | Weighted Average Grant Date Fair Value | |
|---|---|---|
| (in thousands) | ||
| Unvested as of September 30, 2023 | 411 | $51.78 |
| Granted | 162 | 8.99 |
| Vested | (116) | 52.00 |
| Cancelled | (2) | 54.27 |
| Unvested as of December 31, 2023 | 455 | $36.45 |
Stock-Based Compensation Expense
During thethree months ended December 31, 2023 and 2022 the Company recognized the following stock-based compensation expense:
| Three Months Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Research and development | $2,055 | $2,532 |
| General and administrative | 6,044 | 4,607 |
| $8,099 | $7,139 | |
| Three Months Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Stock options | $4,462 | $5,046 |
| rTSRUs | 445 | 461 |
| Performance stock units | 1,579 | 367 |
| Restricted stock units | 1,613 | 1,265 |
| $8,099 | $7,139 | |
During the three months ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense for performance-based stock units for which vesting became probable upon achievement of performance-based targets that occurred during the performance period.
As of December 31, 2023, the Company had an aggregate of$60,806 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.2 years.
- Income Taxes
For the three months ended December 31, 2023, the Company recorded an income tax benefit of $622 due to interest recorded on a pending federal income tax refund. For thethree months ended December 31, 2022, the Company recorded an income tax benefit of $34 due to the release of a state tax reserve during the period.
- Commitments and Contingencies
Litigation and Contingencies Related to Use of Intellectual Property
From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business. Except as described below, the Company currently is not a party to any material threatened or pending litigation. However, third parties might allege that the Company or its collaborators are infringing their patent rights or that the Company is otherwise violating their intellectual property rights. Such third parties may resort to litigation against the Company or its collaborators, which the Company has agreed to indemnify. With respect to some of these patents, the Company expects that it will be required to obtain licenses and could be required to pay license fees or royalties, or both. These licenses may not be available on acceptable terms, or at all. A costly license, or inability to obtain a necessary license, would have a material adverse effect on the Company’s financial condition, results of operations or cash flows. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
In June 2022, the Company announced that it filed suit in the United States District Court for the District of Massachusetts on June 21, 2022, against Pfizer, Inc. seeking damages for infringement of U.S. Patent No. 11,358,953 (the ’953 Patent) in the manufacture, use and sale of Pfizer’s COVID-19 antiviral, Paxlovid™ (nirmatrelvir tablets; ritonavir tablets). The United States Patent and Trademark Office awarded the '953 Patent to the Company in June 2022 based on the Company's July 2020 patent application describing coronavirus protease inhibitors invented by the Company. The Company is seeking fair compensation for Pfizer’s use of a coronavirus protease inhibitor claimed in the ‘953 patent. The Company records all legal expenses associated with the patent infringement suit as incurred in the condensed consolidated statements of operations.
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to customers, vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from services to be provided to the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. In addition, the Company maintains directors’ and officers’ insurance coverage. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of December 31, 2023.
Leases
The Company leases laboratory and office space under various non-cancelable operating leases. There have been no material changes to the Company’s leases during the three months ended December 31, 2023. For additional information, please read Note 12, Leases, to the consolidated financial statements in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2023.
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