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ENANTA PHARMACEUTICALS INC

For the period ended Jun 30, 2024. Filed Aug 7, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 7, 2024

ENTA$11.00+9.1%Stored close · as of Nov 6, 2026

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Notes to Condensed Consolidated Financial Statements (unaudited)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(amounts in thousands, except per share data)

  1. 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). The Company’s existing financial resources, as well as the retained portion of its royalties from the AbbVie collaboration, provide funding to support the Company’s wholly-owned research and development programs, which have been 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 June 30, 2024 and for the three and nine months ended June 30, 2024 and 2023 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 June 30, 2024 and results of operations for the three and nine months ended June 30, 2024 and 2023 and cash flows for the nine months ended June 30, 2024 and 2023 have been made. The results of operations for the three and nine months ended June 30, 2024 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 $87,222 for the nine months ended June 30, 2024 and $133,816 for the year ended September 30, 2023. As of June 30, 2024, the Company had an accumulated deficit of $294,217. 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 June 30, 2024, the Company had $272,595 in cash, cash equivalents and short-term and long-term marketable securities. The Company expects that its cash, cash equivalents and short-term and long-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.

  1. 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 June 30,
20242023
(in thousands)
Options to purchase common stock5,2364,455
Unvested rTSRUs9281
Unvested PSUs9281
Unvested restricted stock units436423

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, and interim periods within the fiscal year beginning October 1, 2025, on a retrospective basis 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.

  1. 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 June 30, 2024 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 June 30, 2024 Using:
Level 1Level 2Level 3Total
(in thousands)
Assets:
Cash equivalents:
Money market funds$35,519$—$—$35,519
Marketable securities:
U.S. Treasury notes233,824——233,824
Corporate bonds—2,996—2,996
$269,343$2,996$—$272,339
Liabilities:
Series 1 nonconvertible preferred stock$—$—$1,423$1,423
$—$—$1,423$1,423
Fair Value Measurements as of September 30, 2023 Using:
Level 1Level 2Level 3Total
(in thousands)
Assets:
Cash equivalents:
Money market funds$55,357$—$—$55,357
U.S. Treasury notes29,755——29,755
Marketable securities:
U.S. Treasury notes236,782——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 and nine months ended June 30, 2024 and 2023 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 June 30, 2024 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
June 30,September 30,
Unobservable Input20242023
Probabilities of payout0%-65%0%-65%
Discount rate7.25%7.25%

There wereno changes in the fair value of nonconvertible preferred stock during thethree and nine months ended June 30, 2024 and 2023.

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 June 30, 2024 and is based on current estimates of future royalties expected to be paid to OMERS over the next 8 years, which are considered Level 3 inputs. See Note 8 for a rollforward of the liability.

  1. Marketable Securities

As of June 30, 2024 and September 30, 2023, the fair value of available-for-sale marketable securities, by type of security, was as follows:

AmortizedCostGrossUnrealizedGainsGrossUnrealizedLossesCredit LossesFair Value
(in thousands)
U.S. Treasury notes$234,092$11$(279)$—$233,824
Corporate bonds2,997—(1)—2,996
$237,089$11$(280)$—$236,820
AmortizedCostGrossUnrealizedGainsGrossUnrealizedLossesCredit LossesFair Value
(in thousands)
U.S. Treasury notes$236,880$12$(110)$—$236,782
Corporate bonds27,127—(692)—26,435
Commercial paper21,305———21,305
$285,312$12$(802)$—$284,522

As of June 30, 2024, marketable securities consisted of investments that mature withinone year, with the exception of certain U.S. Treasury notes, which have maturities betweenone andtwo years and an aggregate fair value of $42,510. As of September 30, 2023, marketable securities consisted of investments that mature withinone year.

  1. Property and Equipment, Net

Property and equipment, net consisted of the following as of June 30, 2024 and September 30, 2023:

June 30,September 30,
20242023
(in thousands)
Laboratory and office equipment$15,849$15,891
Leasehold improvements13,97513,804
Purchased software1,4441,444
Furniture3,1172,290
Computer equipment1,083962
Construction in progress14,7951,273
50,26335,664
Less: Accumulated depreciation and amortization(25,212)(23,745)
$25,051$11,919

As of June 30, 2024, construction in progress related primarily to leasehold improvements for thenew laboratory and office space located at 4 Kingsbury Avenue in Watertown, Massachusetts.

  1. Accrued Expenses

Accrued expenses and other current liabilities consisted of the following as of June 30, 2024 and September 30, 2023:

June 30,September 30,
20242023
(in thousands)
Accrued professional fees$2,006$1,632
Accrued payroll and related expenses4,7937,037
Accrued research and development expenses2,7116,120
Accrued pharmaceutical drug manufacturing1,5813,083
Accrued other1,739467
$12,830$18,339
  1. 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$1,312,000 through June 30, 2024. 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.

  1. 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 June 30, 2024, the estimated future cash flows resulted in an effective annual imputed interest rate of approximately 5.6%.

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(9,796)
Payments on royalty sale liability(19,120)
Interest expense, net of capitalized interest8,595
Balance - June 30, 2024$174,184
  1. Series 1 Nonconvertible Preferred Stock

As of June 30, 2024,1,930 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.

  1. 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, March 2023 and March 2024, and its 2024 Inducement Stock Incentive Plan, which was adopted by the Board of Directors in April 2024 for awards to new employees. 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 June 30, 2024:

SharesIssuable UnderOptionsWeightedAverageExercisePriceWeightedAverageRemainingContractualTermAggregateIntrinsicValue
(in thousands) · (in years) · (in thousands)
Outstanding as of September 30, 20234,365$52.685.9$—
Granted1,3579.98
Exercised(9)8.99
Forfeited(477)40.30
Outstanding as of June 30, 20245,236$42.826.5$4,189
Options vested and expected to vest as of June 30, 20245,236$42.826.5$4,189
Options exercisable as of June 30, 20243,229$51.795.1$498

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 June 30, 2024:

PSUsrTSRUs
SharesWeightedAverageGrant Date Fair ValueSharesWeightedAverageGrant Date Fair Value
(in thousands) · (in thousands)
Unvested as of September 30, 202381$58.5881$45.82
Granted559.69529.89
Vested(25)68.67——
Cancelled(19)51.14(41)47.25
Unvested as of June 30, 202492$27.9892$25.09

Restricted Stock Units

The following table summarizes the restricted stock unit activity for the year-to-date period ending June 30, 2024:

Restricted Stock UnitsWeighted Average Grant Date Fair Value
(in thousands)
Unvested as of September 30, 2023411$51.78
Granted1729.20
Vested(116)52.00
Cancelled(31)24.75
Unvested as of June 30, 2024436$36.81

Stock-Based Compensation Expense

During thethree and nine months ended June 30, 2024 and 2023, the Company recognized the following stock-based compensation expense:

Three Months Ended June 30,Nine Months Ended June 30,
2024202320242023
(in thousands)
Research and development$1,738$2,385$5,587$7,437
General and administrative3,6794,61313,49014,063
$5,417$6,998$19,077$21,500
Three Months Ended June 30,Nine Months Ended June 30,
2024202320242023
(in thousands)
Stock options$3,632$4,963$11,805$15,020
Restricted stock units1,5251,5954,5974,491
rTSRUs2604409631,447
Performance stock units——1,712542
$5,417$6,998$19,077$21,500

During the nine months ended June 30, 2024 and 2023, 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 June 30, 2024, the Company had an aggregate of$40,045 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.1 years.

  1. Income Taxes

For the three and nine months ended June 30, 2024, the Company recorded an income tax benefit of$395 and$1,380, respectively, due to interest recorded on a pending federal income tax refund as compared to income tax expense of$4,221 and$4,231 during the three and nine months ended June 30, 2023, due to $200,000 received in April 2023 from the royalty sale agreement with OMERS which was taxable for federal and state purposes.

  1. 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. On May 28, 2024, the Company and Pfizer each filed motions for summary judgment and a hearing on the motions was held on July 31, 2024. The timing for a ruling on each of the motions for summary judgment is currently uncertain. 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 June 30, 2024.

Leases

The Company leases laboratory and office space under various non-cancelable operating leases.

In May 2022, the Company entered into a new ten-year lease agreement with its existing landlord for laboratory and office space in Watertown, Massachusetts, adjacent to its 400 Talcott Avenue premises. The new laboratory and office space is located at Arsenal on the Charles in Watertown, Massachusetts at 4 Kingsbury Avenue. Construction of the facility shell was completed by the landlord and the Company gained access to the building to construct tenant improvements during the three months ended March 31, 2024. The estimated minimum lease payments for the 4 Kingsbury Avenue facility total $76,470 over the ten-year term. The lease also contains a tenant improvement allowance of $15,205. The Company recorded a right-of-use asset of $32,499 and lease liability of $31,939 upon commencement of the lease during the three months ended March 31, 2024.

In conjunction with the new lease agreement at 4 Kingsbury Avenue, the Company amended its 500 Arsenal Street lease to shorten the term of the lease from September 2027 to the date the 4 Kingsbury Avenue facility is ready for the Company’s occupancy which is expected to be by the end of November 2024. The Company remeasured the lease term and remaining lease payments for the 500 Arsenal Street facility during the three months ended March 31, 2024 when the Company gained access to the 4 Kingsbury Avenue building. The Company recorded an adjustment to the right-of-use asset and lease liability for 500 Arsenal Street of $9,322 during the three months ended March 31, 2024.

The non-cash change arising from the new 4 Kingsbury Avenue lease, net of the remeasurement of the 500 Arsenal lease liability totaled $22,617 during thenine months ended June 30, 2024.

Future annual minimum facility and equipment lease payments, net of the tenant improvement allowance under the Company’s 4 Kingsbury Avenue lease, as of June 30, 2024, are as follows:

Years ended September 30,(in thousands)
Remainder of fiscal 2024$1,753
20258,223
20268,467
20278,721
20288,983
Thereafter59,191
Total future minimum lease payments95,338
Less: imputed interest(33,786)
Less: tenant improvement allowance(10,985)
Total operating lease liabilities$50,567
ContentsView on SEC.gov

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