Commitments and Contingencies |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2026 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies | 9. Commitments and Contingencies Operating Lease In March 2026, the Company entered into a noncancellable lease agreement (the “Yardley Lease”) for approximately 10,795 square feet of space in Yardley, Pennsylvania to be used as the Company's corporate headquarters. The contractual lease term is 65 months and is effective July 1, 2026. However, the Company gained early access to the premises on May 1, 2026 for the purpose of constructing and installing tenant improvements, for which the landlord has agreed to contribute up to approximately $0.3 million (the “Tenant Allowance”). During the three months ended September 30, 2026, the Company received $0.2 million of the Tenant Allowance in cash, and the remaining $0.1 million is being applied as a credit against the monthly base rent due for October, November and December 2026. The Tenant Allowance is accounted for as a lease incentive and therefore reduces the measurement of the right of use ("ROU") asset and the related lease liability. Since the Company gained control of the underlying assets on the date that early access was granted by the landlord, the accounting commencement date for the Company's new office headquarters is May 1, 2026 ("Commencement Date") and continues through November 30, 2031. Annual base rent is approximately $0.3 million, payable in monthly installments, and increases by approximately 2% on July 1 of each year beginning July 1, 2027. In addition, the monthly base rent for July 2026, August 2026, September 2027, September 2028 and September 2029 of the lease term was abated, and the base rent for September 2026 was paid upon execution of the Yardley Lease. The ROU asset was calculated using the present value of the lease payments, as offset by the Tenant Allowance, and utilizing the Company’s incremental borrowing rate based on the remaining lease term. The Company recorded a ROU asset and lease liability, current and noncurrent, for the Yardley Lease on the Commencement Date which had carrying values of $1.0 million and $1.3 million, respectively as of September 30, 2026. The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of September 30, 2026 (in thousands):
Manufacturing and Other Commitments and Contingencies The Company has entered into a number of contracts for the manufacture of its product candidate, MOLBREEVI. Some of these, as enumerated below, entail various royalties and manufacturing and development payments. FujiFilm Diosynth (“Fuji”) In February 2024, the Company entered into a master services agreement with Fuji to provide development and manufacturing services related to the active pharmaceutical ingredient (“API”) for the Company’s MOLBREEVI product candidate in accordance with the terms of separate scope of work agreements and to perform a manufacturing campaign for process performance qualification of the API of MOLBREEVI. As of September 30, 2026, the total estimated accumulated fees the Company will have paid this manufacturer for services under that master services agreement and related work orders and subsequent change orders is $75.4 million. Amounts payable for future services are subject to various cancellation fees ranging from ten percent (10%) to one hundred percent (100%) of the cost of the respective activity based upon the timing of the commencement date and status of the activity. PARI Pharma GmbH (“PARI”) The Company is also subject to certain contingent milestone payments of approximately $0.6 million, payable to PARI, the manufacturer of the proprietary nebulizer used to administer MOLBREEVI, upon the achievement of various development activities and regulatory approval of proprietary nebulizer utilized. In addition to these milestones, the Company will owe PARI a royalty of three and one-half percent (3.5%) based on net sales. Contract Research As part of its development of MOLBREEVI for the treatment of autoimmune PAP, the Company entered into a master services agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to clinical trials. Contemporaneously with entering the MSA in January 2021, a work order was executed with Parexel, under which it provides services related to the IMPALA-2 clinical trial. From inception of the original work order and subsequent change orders through trial close-out activities, the Company will have paid Parexel service fees, pass-through expenses, and investigator fees estimated to be approximately $51.3 million over the course of the IMPALA-2 clinical trial. In the second quarter of 2024, the Company initiated an open-label, multicenter clinical trial of MOLBREEVI in pediatric subjects with autoimmune PAP ("IMPACT") under a separate work order with Parexel. Pursuant to the IMPACT trial, Parexel has the opportunity to earn up to approximately $5.4 million dependent upon patient enrollment, site management, project oversight and the compliance with defined study protocols. Other MOLBREEVI Approval and Launch Support In the ordinary course of business, the Company has entered into agreements with third-party service providers supporting the approval and launch of MOLBREEVI that provide for contingent payments upon the achievement of specified milestones. As of September 30, 2026, no such milestones had been achieved, and no amounts have been accrued. Royalty Purchase and Sale Agreement On October 29, 2025, the Company entered into the Purchase Agreement with funds managed by RTW Investments, LP (the “Purchaser”). Under the terms of the Purchase Agreement, the Purchaser has agreed to pay the Company $75.0 million (the “Purchase Price”) upon approval of MOLBREEVI by the FDA on or before March 31, 2027 (the date of such payment, the "Closing Date") and subject to satisfaction of other customary closing conditions, in exchange for a true sale of assigned interests, including the right to receive royalty payments equal to a percentage of Net Sales (as defined in the Purchase Agreement) of MOLBREEVI in the U.S. The royalty rate is tiered, with the payments ranging from 7.0% to 1.0% of Net Sales in each calendar year, with the 7.0% tier increasing to 9.5% for a calendar year if the prior year’s Net Sales do not achieve a specified level. The royalty payments commence in the first calendar quarter in which there is a commercial sale of MOLBREEVI in the United States and end upon the receipt by the Purchaser of $187.5 million (the “Maximum Payment”). The Purchase Agreement includes a buy-back option that may allow the Company to pay a specified amount up to the Maximum Payment to terminate the Purchase Agreement and all obligations in the event of certain changes of control within two years of receipt of the Purchase Price. Unless otherwise agreed with the Purchaser, the Company is required to use a portion of the Purchase Price to repay all outstanding indebtedness. However, the Purchaser entered into an intercreditor agreement with the Lenders that allows amounts borrowed under the Hercules Loan Agreement, as amended, as described in Note 6, Debt Facility, to remain outstanding. The Purchase Agreement contains customary affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness (which restrictions are eliminated after the achievement by the Company of a specified amount of Net Sales), and other provisions customary for transactions of this nature, in each case subject to certain exceptions set forth in the Purchase Agreement. Under the Purchase Agreement, upon the occurrence of a Change of Control of the Company (as defined in the Purchase Agreement), the Company has the option to prepay (“Company Call”) and the Purchaser, in certain circumstances, has the option to demand the prepayment (“Buyer Put”) of a specified amount and terminate the Purchase Agreement. The revenue-based repayments to the Purchaser (“Revenue-Based Payment”) will be established on a schedule of royalty rates as a factor of Annual Net Sales, including applicable ratchets in the definition of a Royalty Rate, until the Maximum Payment is reached. The Company has identified the embedded features in the Purchase Agreement and concluded that the Buyer Put Option and the Company Call Option are embedded derivatives that must be bifurcated under ASC 815-10-15-83 and ASC 815-15-25-1, Derivatives and Hedging. Accordingly, the Company has recorded the royalty agreement derivative as of the date of issuance and determined its fair value to be approximately $0.2 million and $0.4 million as of September 30, 2026 and December 31, 2025, respectively, which is reflected in Accrued expenses and other current liabilities and subject to periodic fair value remeasurement. The Company has also capitalized the amount as deferred issuance costs, subject to straight line amortization up until the Closing Date, as reflected in Prepaid expenses and other current assets and similarly subject to periodic fair value remeasurement. In addition, direct and incremental Company issuance costs as well as reimbursed Purchaser expenses have been capitalized by the Company and amortized over the expected term of the arrangement. Upon the Closing Date, the remaining balance will be applied against the proceeds received and subsequently amortized using the effective interest method. |
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