Theravance Biopharma Inc
For the period ended Dec 31, 2023. Filed Mar 1, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 1, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
1. Organization and Summary of Significant Accounting Policies
Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) is a biopharmaceutical company primarily focused on the discovery, development, and commercialization of medicines. The Company’s core purpose is to createmedicines that make a difference® in people's lives.
Basis of Presentation
The Company’s consolidated financial statements as of December 31, 2023 and 2022, and for the year ended December 31, 2023 and 2022 have been prepared in conformity with United States (“US”) Generally Accepted Accounting Principles ("GAAP"), and the US Securities and Exchange (“SEC”) regulations for annual reporting.
On July 20, 2022, the Company completed a monetization of its ownership interests in a significant equity method investment which had a major effect on the Company’s financial results for the year ended December 31, 2022 (see*“**Note 9. Sale of Equity Interests in Theravance Respiratory Company, LLC and Discontinued Operations”*). In accordance with GAAP, the transaction was accounted for as a sale of a financial asset, and the results of the sale were included as discontinued operations on these consolidated financial statements.
Certain prior period amounts in the*“Notes to Consolidated Financial Statements”* have been reclassified. The reclassifications had no impact on previously reported aggregate financial position, results of operations, cash flows, or disclosures.
Principles of Consolidation
The consolidated financial statements include the accounts of Theravance Biopharma and its wholly-owned subsidiaries, all of which are denominated in US dollars. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses, and related disclosures in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Due to the inherent uncertainty in making estimates, actual results in future periods could differ materially from those estimates.
Segment Reporting
The Company has determined that its chief executive officer is the chief operating decision maker (“CODM”). A single management team reports to the CODM who comprehensively manages the entire business. The Company’s business offerings have similar economics and other characteristics, including the nature of products, types of customers, distribution methods, and regulatory environment. As a result, the Company has concluded that it operates in a single segment which is the development and commercialization of human therapeutics.
Cash and Cash Equivalents
The Company considers all highly-liquid investments purchased with a maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents are carried at cost which approximates fair value due to their short-term nature.
Restricted Cash
The Company maintains restricted cash for certain lease agreements and letters of credit by which the Company has pledged cash and cash equivalents as collateral. See*“Note 5. Cash, Cash Equivalents, and Restricted Cash”* for more information.
Investments in Marketable Securities
The Company invests in marketable securities, primarily commercial paper, corporate notes, US government bonds and US government agency bonds. Marketable debt securities with original maturities of greater than three months and remaining maturities of less than 12 months are considered short-term investments. Marketable debt securities with maturities greater than 12 months are considered long-term investments. The Company determines the appropriate classification of the marketable securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its marketable securities as available-for-sale securities and reports them at fair value in cash and cash equivalents or marketable securities on the consolidated balance sheets.
Unrealized gains and losses are included as a component of accumulated other comprehensive income (loss) in shareholders’ equity of the consolidated balance sheets and as a component of total comprehensive income (loss) in the consolidated statements of operations and comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included as a component of interest and other income (loss) on the consolidated statements of operationsand comprehensive income (loss).
The cost of securities sold is based on the specific identification method. Realized gains and losses and interest and dividends on securities are included in interest and other income (loss). In circumstances where the Company intends to sell, or is more likely than not required to sell, the security before it recovers its amortized cost basis, the difference between fair value and amortized cost is recognized as a loss in the consolidated statements of operations, with a corresponding write-down of the security's amortized cost.
The Company accounts for credit losses on available-for-sale debt securities in accordance with Accounting Standards Codification (“ASC”), Topic 326,Financial Instruments – Credit Losses (“ASC 326”). Under ASC 326, the Company regularly reviews its debt securities in an unrealized loss position to determine if the unrealized loss was credit-related or noncredit-related. The factors considered in determining whether credit losses exist include, but are not limited to, the creditworthiness of the security issuers, the severity and duration of the unrealized losses, any adverse conditions specifically related to the security, an industry, or geographic area, and whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of the security’s amortized cost basis. The Company did not recognize any credit losses on available-for-sale debt securities for either the year ended December 31, 2023 or 2022.
Fair Value of Financial Instruments
The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. ASC Topic 820,Fair Value Measurements and Disclosures (“ASC 820”) establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels:
Level 1— Unadjusted quoted prices for identical instruments in active markets;
Level 2— Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable (e.g., interest rates, yield curves, etc.); and
Level 3— Unobservable inputs and little, if any, market activity which require the Company to develop its own assumptions.
The Company’s financial instruments include cash equivalents, marketable securities, receivables from collaborative arrangements, accounts payable, and accrued liabilities. Cash equivalents and marketable securities are carried at estimated fair value and remeasured on a recurring basis. The carrying value of receivables from collaborative arrangements, accounts payable, and accrued liabilities approximate their estimated fair value due to the relatively short-term nature of these instruments.
Receivables from Collaborative Arrangements
For the periods presented, the Company’s receivables from collaborative arrangements relate to amounts due arising from its collaboration (and licensing) agreements. When appropriate, the Company provides for an allowance for credit losses. The Company performs periodic credit evaluations of its customers and generally does not require collateral. For the periods presented, the Company did not have any material write-offs of receivables from collaborative arrangements.
Concentration of Credit Risks
The Company invests in a variety of financial instruments and, based on its policy, limits the amount of credit exposure with any one issuer, industry, or geographic area for investments other than instruments backed by the US federal government.
The Company’s future contingent milestone and royalty assets and receivables primarily relate to amounts due under its collaboration and other agreements. Accordingly, the Company may be exposed to credit risk generally associated with pharmaceutical companies or specific to its collaboration agreements. The Company performs periodic evaluations of its customers and generally does not require collateral. For the year ended December 31, 2023 and 2022, the Company did not experience any losses related to its receivables.
Property and Equipment
Property, equipment, and leasehold improvements are stated at cost, net of accumulated depreciation, and are depreciated using the straight-line method over the estimated useful lives as presented in the table below. Upon retirement or sale, the cost of the disposed assets and the related accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in the consolidated statement of operations in the period realized.
| | | |
|---|---|---|
| Leasehold improvements | Shorter of remaining lease terms or useful life | |
| Equipment, furniture and fixtures | | 5 - 7 years |
| Software and computer equipment | | 3 - 5 years |
Leases
The Company determines whether a contract is or contains a lease at inception of the arrangement. In evaluating whether a contract is indicative of a lease, the Company considers all relevant facts and circumstances to assess whether the arrangement has extended to the Company the right to both (i) obtain substantially all the economic benefits from use of an identified asset and (ii) direct the use of the identified asset. To the extent that the Company determines a contract represents a lease, the arrangement is classified as either an operating lease or a finance lease, with the classification affecting the presentation and pattern of expense recognition in the consolidated statements of operations. The Company did not have any finance leases at either December 31, 2023 or 2022.
Operating lease assets represent the Company’s right to use an underlying asset over the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the leasing arrangement. The Company records operating leases on the consolidated balance sheets through an operating lease asset and a corresponding short-term and long-term operating lease liability, as applicable. Lease liabilities are measured based on the present value of lease payments over the lease term discounted at the implicit interest rate at the commencement date of the leasing arrangement, when readily available or using the Company’s incremental borrowing rate, if the implicit rate is not determinable. The incremental borrowing rate is considered the estimated rate of interest
that the Company would have to pay to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. The Company measures its operating lease assets based on the corresponding operating lease liabilities adjusted for (i) prepayments made to the lessor at or before the commencement date, (ii) any initial direct costs incurred, and (iii) tenant incentives granted under the lease contract.
In calculating operating lease assets and liabilities, the Company may elect to combine lease and non-lease components based on the asset type. When combining lease and non-lease components, the Company would account for the lease and non-lease components as a single lease component. The Company’s lease terms may include options to extend the lease only when it is reasonably certain that such options will be exercised, and the Company recognizes lease expense on a straight-line basis over the lease term.
Operating lease assets and operating lease liabilities are remeasured upon reassessment events and modifications to leases using the present value of remaining lease payments and incremental borrowing rate at the time of remeasurement, as applicable. Operating lease assets are evaluated for possible impairment in accordance with the Company’s long-lived assets policy.
The Company recognizes variable lease payments as operating expenses in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company.
The Company has elected to not recognize operating lease assets or liabilities for leases that have a lease term of 12 months or less at commencement date, and the lease expense related to these short-term lease arrangements is recognized on a straight-line basis over the term of the lease.
Future Contingent Milestone and Royalty Assets
The fair value of consideration received in connection with TRC Transaction in July 2022 (see “Note 9. Sale of Equity Interests in Theravance Respiratory Company, LLC and Discontinued Operations”) included an estimated $194.2 million in future contingent milestones and royalties that were recorded as a contingent consideration asset (“Contingent Consideration”) on the Company’s consolidated balance sheets on the TRC Transaction date. The Contingent Consideration was initially measured at fair value utilizing a Monte Carlo simulation model to calculate the present value of the risk-adjusted cash flows estimated to be received from the Contingent Consideration. The fair value model involved significant unobservable inputs derived using Company estimates. The Company’s estimates were based in part on external data and reflected its judgements and forecasts. The primary significant unobservable input was the estimate of forecasted TRELEGY net revenues which is considered a Level 3 fair value input. The Company periodically reassesses the carrying value of the Contingent Consideration when indicators of impairment are identified, and the Company will recognize an impairment loss if the carrying value materially exceeds the reassessed fair value. The Company recognizes any increases in the carrying value of the Contingent Consideration only when such contingent gains are realized.
Future Royalty Payment Contingency
The Company treats contingent liabilities related to sale of future royalties (see “Note 10. Ampreloxetine Funding”) as debt financings, amortized under the effective interest method over the estimated life of the related expected royalty stream. The contingent liabilities related to sale of future royalties and the debt amortization are based on current estimates of the amount and timing of future royalty payments, including the potential for any future funding milestones. The Company periodically reassesses the amount and timing of estimated royalty payments based on internal sales projections and external information from market data sources, which are considered Level 3 inputs. To the extent the Company’s estimates of the amount and timing of future royalty payments are materially greater or less than previous estimates, the Company will prospectively adjust the amortization of the contingent liability and effective interest rate.
Impairment of Long-Lived Assets
The Company regularly reviews long-lived assets, including operating lease assets, to determine whether indicators of impairment may exist. If indications of impairment exist, the Company performs a test of recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset over its useful life to the carrying value of the long-lived asset. If the carrying value of the long-lived asset exceeds such estimated undiscounted cash flows, the Company would determine the estimated fair value of the long-lived assets generally using the estimated discounted future cash flows to recognize an impairment loss on the long-lived asset. The Company did not recognize any impairment losses related to its long-lived assets for either the year ended December 31, 2023 or 2022.
Revenue Recognition
The Company recognizes revenue under ASC Topic 606,Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, an entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company identifies the performance obligations in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Collaborative Arrangements under ASC 606
The Company enters into collaborative arrangements with partners that fall under the scope of ASC Topic 808,Collaborative Arrangements(“ASC 808”). While these arrangements are in the scope of ASC 808, the Company may analogize to ASC 606 for some aspects of these arrangements. The Company analogizes to ASC 606 for certain activities within collaborative arrangements for the delivery of a good or service (i.e., a unit of account) that is part of its ongoing major or central operations. Revenue recognized by analogizing to ASC 606 is recorded as “collaboration revenue” or “licensing revenue” whereas, revenue recognized in accordance with ASC 808 is recorded on a separate collaboration revenue line on the consolidated statements of operations.
The terms of the Company’s collaborative arrangements typically include one or more of the following: (i) up-front fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; (iv) reimbursements or cost-sharing of research and development expenses; and (v) profit/loss sharing arising from co-promotion arrangements. Each of these payments results in collaboration revenues or an offset against research and development expense. Where a portion of non-refundable up-front fees or other payments received is allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as collaboration revenue when (or as) the underlying performance obligation is satisfied.
As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price may include such estimates as, forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the collaborative partner which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
*Up-front Fees:*If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes collaboration revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing collaboration revenue from the allocated transaction price. For example, when the Company receives up-front fees for the performance of research and development services, or when research and development services are not considered to be distinct from a license, the Company recognizes collaboration revenue for those units of account over time using a measure of progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue or expense recognition as a change in estimate.
*Milestone Payments:*At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the collaborative partner’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the collaborative partner’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment.
*Royalties:*For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
*Reimbursement, cost-sharing and profit-sharing payments:*Under certain collaborative arrangements, the Company has been reimbursed for a portion of its research and development expenses or participates in the cost-sharing of such research and development expenses. Such reimbursements and cost-sharing arrangements have been reflected as a reduction of research and development expense in the Company’s consolidated statements of operations, as the Company does not consider performing research and development services for reimbursement to be a part of its ongoing major or central operations.
Research and Development Expenses
Research and development (“R&D”) expenses are recorded in the period that services are rendered or goods are received. R&D expenses consist of salaries and benefits facility costs, and fees paid to third parties that conduct certain clinical study activities on behalf of the Company, net of certain external R&D expenses reimbursed under the Company’s collaborative arrangements.
As part of the process of preparing its consolidated financial statements, the Company is required to estimate and accrue certain R&D expenses. This process involves the following:
| • | identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost; |
| • | estimating and accruing expenses in the Company’s consolidated financial statements as of each balance sheet date based on facts and circumstances known to it at the time; and |
| • | periodically confirming the accuracy of the Company’s estimates with selected service providers and making adjustments, if necessary. |
Examples of estimated R&D expenses that the Company may accrue include:
| • | fees paid to investigative sites in connection with clinical studies; |
| • | fees paid to contract manufacturing organizations (“CMOs”) in connection with the production of clinical study materials; and |
| • | professional service fees for consulting and related services. |
The Company bases its expense accruals related to clinical studies on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions that conduct and manage clinical studies on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful enrollment of patients and the completion of clinical study milestones. The Company’s service providers typically invoice it monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the Company does not identify costs that it has begun to incur or if it underestimates or overestimates the level of services performed or the costs of these services, the Company’s actual expenses could differ from its estimates.
To date, the Company has not experienced significant changes in its estimates of accrued R&D expenses after a reporting period. However, due to the nature of estimates, there is no assurance that the Company will not make changes to its estimates in the future as it becomes aware of additional information about the status or conduct of its clinical studies and other R&D activities. Such changes in estimates will be recognized as R&D expenses in the period that the change in estimate occurs.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”) expenses are recorded in the period that services are rendered or goods are received. SG&A expenses consist primarily of salaries and benefits, facilities and overhead costs, and other costs related to areas such as legal, finance, information technology, sales and marketing, and medical affairs.
Advertising expenses within selling, general and administrative expenses, including promotional expenses, were $5.1 million and $8.0 million for the year ended December 31, 2023 and 2022, respectively.
Share-Based Compensation
The Company issues share-based awards to employees and non-employees, generally in the form of share options and restricted share units (“RSUs”). Share-based compensation expense is calculated based on awards ultimately expected to vest and is reduced for actual forfeitures as they occur. The Company expenses these share-based awards over the requisite service period on a straight-line basis, based on the grant date fair value of the awards.
The Company determines the fair value of RSUs to be the closing market price of the Company's common shares on the day of grant. The Company uses the Black-Scholes-Merton option pricing model to estimate the fair value of share options granted under its equity incentive plans and rights to acquire shares granted under its employee share purchase plan (“ESPP”). The Black-Scholes-Merton option pricing model requires the use of assumptions, including: (i) the expected term of the options and ESPP purchases; (ii) the share’s expected dividend yield; (iii) the expected share price volatility; and (iv) the risk-free interest rate. The expected share price volatility is based on the historical volatility, and the risk-free interest rate is based on the US Treasury rate commensurate with the expected term of the associated award. The Company previously used the “simplified” method as described in Staff Accounting Bulletin No. 107,Share-Based Payment, to estimate expected option term. However, during 2023, the Company concluded that it had sufficient
exercise data and transitioned to estimating the expected option term based on its historical option exercise behavior. The change in expected term methodology did not have a material impact to the financial statements.
The Company may also issue performance-contingent RSUs that settle in the Company’s ordinary shares. The fair value of the performance-contingent RSUs is determined on the day of grant using the number of shares expected to be vested and the ending market value of the shares on the grant date. The number of shares expected to vest is determined by assessing the probability that the performance criteria will be met and the associated targeted payout level that is forecasted will be achieved. For performance-contingent RSUs, the Company recognizes share-based compensation expense over the requisite service period using the accelerated attribution method when achievement of the performance criteria is considered probable based on the Company’s best estimate at the end of each reporting period.
The Company may also issue market-based RSUs that settle in the Company’s ordinary shares. Market-based RSUs vest upon the Company’s shares meeting certain market-based price targets followed by a service period. The fair value of the market-based RSUs is determined using a Monte-Carlo valuation model. Share-based compensation expense is recognized over the requisite service period regardless of whether or not the market-based price targets are deemed probable, and the share-based compensation expense is not reversed solely because the market-based price target is not achieved.
Income Taxes
The Company utilizes the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
The Company’s total gross unrecognized tax benefits associated with uncertain tax positions of$79.5 million and $76.0 million, as of December 31, 2023 and December 31, 2022, respectively, may reduce the effective tax rate in the period of recognition. The Company released its federal valuation allowance as of December 31, 2022. As a result, the statutes of limitations have started on the Company’s federal unrecognized tax benefits. The timing of the effective tax rate benefit is dependent on the expiration of these statutes of limitations, as well as any favorable settlement of the Company’s uncertain positions in the future.
The Company assesses all material positions, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50% likely to be realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether the factors underlying the sustainability assertion have changed and whether the amount of the recognized tax benefit is still appropriate.
The recognition and measurement of tax benefits requires significant judgment. The Company has taken certain positions where it believes that its position is greater than 50% likely to be realized upon ultimate settlement and for which no reserve for uncertain tax positions has been recorded. If the Company does not ultimately realize the expected benefit of these positions, it will record additional income tax expenses in future periods. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available.
Any tax levied or credited by a governmental taxing authority that is not based on the Company’s income is outside the scope of accounting for income taxes. Therefore, the Company records such items as a component of its loss before income taxes.
Net Income (Loss) per Share and Anti-dilutive Securities
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares outstanding during the period. Diluted net income (loss) per share is computed by increasing the weighted-
average number of shares outstanding for the dilutive effect of potential ordinary shares determined using the treasury stock method. Potential ordinary shares include outstanding share options, ordinary shares expected to be issued under the Company’s ESPP, RSUs, and performance-contingent RSUs for which the performance or market vesting conditions have been deemed probable. Performance-contingent RSUs with performance or marketing vesting conditions that have been deemed not probable as of the end of the period are not included in the diluted net income (loss) per share computation.
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands, except per share data) | 2023 | 2022 | ||||
| Numerator: | | | | | | |
| Net loss from continuing operations | | $(55,193) | | $(92,824) | ||
| Net income from discontinued operations | | | — | | | 964,956 |
| Net income (loss) | | | (55,193) | | | 872,132 |
| | | | | | | |
| Denominator: | | | | | | |
| Weighted-average ordinary shares outstanding | | | 55,303 | | | 73,591 |
| Less: weighted-average ordinary shares subject to forfeiture | | | — | | | — |
| Weighted-average ordinary shares outstanding - basic and diluted | | | 55,303 | | | 73,591 |
| | | | | | | |
| Net income (loss) per share: | | | | | | |
| Continuing operations - basic and diluted | | $(1.00) | | $(1.26) | ||
| Discontinued operations - basic and diluted | | $— | | $13.11 | ||
| Net income (loss) per share - basic and diluted | | $(1.00) | | $11.85 | ||
In accordance with ASC 260,Earnings Per Share, if a company incurred a net loss related to its continuing operations, then potential ordinary shares are considered anti-dilutive for the periods in which the net loss was recognized. For the year ended December 31, 2023 and 2022, the Company recognized net losses from continuing operations. As a result, the following potential ordinary shares were not included in the computation of diluted net loss per share for both continuing operations and discontinuing operations because including them would have had an anti-dilutive effect:
| | | | | |
|---|---|---|---|---|
| · · Year Ended December 31, | ||||
| (In thousands) · 2023 · 2022 | ||||
| Options | | 2,348 | | 2,601 |
| Restricted shares | | 1,523 | | 2,851 |
| Employee share purchase plan | | 45 | | 35 |
| Total | 3,916 | | 5,487 | |
Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net income (loss) and changes in unrealized gains and losses on the Company’s available-for-sale investments.
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 requires entities to provide additional information in their tax rate reconciliation and additional disclosures about income taxes paid by jurisdiction. ASU 2023-09 is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is also permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements income tax disclosures.
The Company has evaluated other recently issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its consolidated financial statements and related disclosures.
**2.**Revenue
Revenues from Collaborative Arrangements
Viatris
In January 2015, the Company and Viatris Inc. (“Viatris”) established a strategic collaboration (the “Viatris Agreement”) for the development and commercialization of revefenacin, including YUPELRI® (revefenacin) inhalation solution. The Company entered into the collaboration to expand the breadth of its revefenacin development program and extend its commercial reach beyond the acute care setting. In November 2018, YUPELRI was approved by the US Food and Drug Administration (the “FDA”) for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”).
In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris;35% to the Company). Outside the US (excluding China and adjacent territories), Viatris is responsible for development and commercialization and will pay the Company a tiered royalty on net sales at percentage royalty rates ranging from low double-digits to mid-teens. Viatris also holds exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories, which include the Hong Kong SAR, the Macau SAR, and Taiwan, and the Company is eligible to receive low double-digit tiered royalties on net sales of nebulized revefenacin in this region, if approved. Viatris is responsible for all aspects of development and commercialization in the China and adjacent territories, including pre- and post-launch activities and product registration and all associated costs. Viatris is the principal in the sales transactions, and as a result, the Company does not reflect the product sales in its consolidated financial statements.
As of December 31, 2023, the Company is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding China and adjacent territories) up to $205.0 million in the aggregate, with $160.0 million associated with YUPELRI monotherapy and $45.0 million associated with future potential combination products. Of the $160.0 million associated with monotherapy, $150.0 million relates to sales milestones based on achieving certain levels of US net sales and $10.0 million relates to regulatory actions in the European Union (“EU”). The Company is also eligible to receive additional potential development and sales milestones up to$52.5 million related to Viatris’ development and commercialization of nebulized revefenacin in China and adjacent territories with$45.0 million associated with YUPELRI monotherapy and$7.5 million associated with future potential combination products. Of the$45.0 million associated with monotherapy,$37.5 million relates to sales milestones based on achieving certain levels of net sales and$7.5 million relates to regulatory approval in China.
The Viatris Agreement is considered to be within the scope of ASC 808,Collaborative Arrangements, as the parties are active participants and exposed to the risks and rewards of the collaborative activity with a unit of account provided to Viatris as a customer. Under the terms of the Viatris Agreement, which included the delivery by the Company of a license to Viatris to develop and commercialize revefenacin, Viatris was responsible for reimbursement of the Company’s costs related to the registrational program up until the approval of the first new drug application in November 2018; thereafter, R&D expenses are shared. Performing R&D services for reimbursement is considered a collaborative activity under the scope of ASC 808. Reimbursable program costs are recognized proportionately with the performance of the underlying services and accounted for as reductions to R&D expense. For this unit of account, the Company did not recognize revenue or analogize to ASC 606,Revenue Recognition, and, as such, the reimbursable program costs are excluded from the original transaction price.
The future potential milestone amounts for the Viatris Agreement were not included in the original transaction price, as they were all determined to be fully constrained following the concepts of ASC 606. As part of the Company’s evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals which are not within its control and uncertain at this stage. The Company expects that the sales-based milestone payments and royalty arrangements will be recognized when the sales occur or the milestone is achieved.
Following the FDA approval of YUPELRI in November 2018, net amounts payable to or receivable from Viatris each quarter under the profit-sharing structure are disaggregated according to their individual components. In
accordance with the applicable accounting guidance, amounts receivable from Viatris in connection with the commercialization of YUPELRI are recorded within the consolidated statements of operations as revenue from “Viatris collaboration agreement” irrespective of whether the overall collaboration is profitable. Amounts payable to Viatris, if any, in connection with the commercialization of YUPELRI are recorded within the consolidated statements of operations as a collaboration loss within selling, general and administrative expenses. Any reimbursement from Viatris attributed to the 65% cost-sharing of the Company’s R&D expenses is characterized as a reduction of R&D expense, as the Company does not consider performing research and development services for reimbursement to be a part of its ordinary activities. For the year ended December 31, 2023 and 2022, YUPELRI continued to be profitable for the Company.
The following YUPELRI-related amounts were recognized within revenue in the Company’s consolidated statements of operations:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands) · · 2023 · · 2022 | ||||||
| Viatris collaboration agreement – Amounts receivable from Viatris | | $57,201 | | $48,624 | ||
| Viatris royalties (Non-US) | | | 7 | | | 30 |
| Total | | $57,208 | | $48,654 | ||
While Viatris records total YUPELRI net sales within its own consolidated financial statements, Viatris collaboration agreement revenue on the Company’s consolidated statements of operations included the Company’s implied 35% share of total YUPELRI net sales, before deducting shared expenses, as presented below:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year Ended December 31, | ||||
| (In thousands) · 2023 · 2022 | ||||
| YUPELRI net sales (Theravance Biopharma implied 35%) | | $77,337 | | $70,653 |
Other Collaborative Arrangement Revenues
The Company’s other collaborative arrangement revenues consisted of:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands) · 2023 · 2022 | ||||||
| Viatris | | $216 | | $24 | ||
| Other | | | — | | | 168 |
| Total collaboration revenue | | $216 | | $192 | ||
All of the recognized revenues from the Company’s other collaborative arrangements presented in the table above were included in deferred revenue at the beginning of the respective periods.
Reimbursement of R&D Expenses
As noted above, under certain collaborative arrangements the Company is entitled to reimbursement of certain R&D expenses. Activities under collaborative arrangements for which the Company is entitled to reimbursement are considered to be collaborative activities under the scope of ASC 808. For these units of account, the Company does not analogize to ASC 606 or recognize revenue. The Company records reimbursement payments received from its
collaboration partners as reductions to R&D expense.
The following table summarizes the reductions to R&D expenses related to reimbursement payments:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year Ended December 31, | ||||
| (In thousands) · 2023 · 2022 | ||||
| Viatris | | $5,723 | | $6,682 |
Revenue from Licensing Arrangements
Pfizer
In December 2019, the Company entered into a global license agreement with Pfizer Inc. (“Pfizer”) for its preclinical skin-selective, locally-acting pan-JAK inhibitor program (the “Pfizer Agreement”). The compounds in this program are designed to target validated pro-inflammatory pathways and are specifically designed to possess skin-selective activity with minimal systemic exposure. Under the Pfizer Agreement, Pfizer had an exclusive license to develop, manufacture and commercialize certain compounds for all uses other than gastrointestinal, ophthalmic, and respiratory applications. The Company received an upfront cash payment of $10.0 million in 2019, and for the year ended December 31, 2022, the Company recognized$2.5 million in licensing revenue related to a development milestone payment from Pfizer for the dosing of the first patient in the Phase 1 clinical trial. In June 2023, the Company received notice from Pfizer terminating the Pfizer Agreement, effective as of October 7, 2023, at which time the skin-selective pan-JAK inhibitor program was returned to the Company.
3. Segment Information
The Company operates in a single segment, which is the development and commercialization of human therapeutics. The following table summarizes total revenue by geographic region based on the location of the Company’s customers or collaboration partners:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Year Ended December 31, | |||||
| (In thousands) · 2023 · 2022 | |||||
| US | | $57,201 | | $51,124 | |
| Europe | | 223 | | | 222 |
| Total revenue | | $57,424 | | $51,346 | |
The following table summarizes total revenue from each of the Company’s customers or collaboration partners who individually accounted for 10% or more of total revenue (as a percentage of total revenues) during the most recent three years:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year Ended December 31, · | ||||
| (% of total revenue) · 2023 · · 2022 | ||||
| Viatris | | 100% | | 95% |
Viatris accounted for 100% of the Company’s receivable from collaborative arrangements as of December 31, 2023 and 2022.
4. Sale of Velusetrag
Velusetrag is an oral, investigational medicine developed for gastrointestinal motility disorders. It is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor.
In 2012, the Company partnered with Alfasigma S.p.A. (“Alfasigma”) in the development of velusetrag and its commercialization in certain countries. In April 2018, Alfasigma exercised its option to continue to develop and commercialize velusetrag, and the Company elected not to pursue further development. Global rights to develop, manufacture and commercialize velusetrag were transferred to Alfasigma under the terms of the collaboration arrangement.
On June 30, 2022, the Company entered into an Asset Purchase Agreement (the “APA”) to sell all of its velusetrag assets to Alfasigma. In connection with the closing of the transaction, Alfasigma acquired, among other things, (i) intellectual property and (ii) books and records related to velusetrag. As consideration for the velusetrag sale, the Company received an upfront payment of $2.8 million in July 2022, and pursuant to the terms of the APA, the Company is eligible to receive up to $105.0 million in additional future developmental and sales milestones.
At the time of the sale, the velusetrag assets hadno remaining book value on the Company’s records, and all of the velusetrag assets were delivered to Alfasigma. For year ended December 31, 2022, the Company recognized a net gain of $2.7 million, after transaction costs, related to the sale of velusetrag within “interest income and other income, net” on the consolidated statements of operations.
5. Cash, Cash Equivalents, and Restricted Cash
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the current period and comparable prior year period consolidated balance sheets that sum to the total of the same such amounts shown on the consolidated statements of cash flows.
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| (In thousands) · · 2023 · · 2022 | ||||||
| Cash and cash equivalents | | $39,545 | | $298,172 | ||
| Restricted cash | | | 836 | | | 836 |
| Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows | | $40,381 | | $299,008 | ||
The Company maintains restricted cash for certain lease agreements and letters of credit by which the Company has pledged cash and cash equivalents as collateral. The cash-related amounts reported in the table above exclude the Company’s investments in short and long-term marketable securities that are reported separately on the consolidated balance sheets.
The Company periodically engages in foreign exchange transactions as a part of its operations. The Company recognized net realized and unrealized foreign currency gains of $0.06 million for the year ended December 31, 2023 and net realized and unrealized foreign currency losses of $0.9 million for the year ended December 31, 2022. These amounts are included in the Company’s consolidated statements of operations within “Interest income and other income, net”.
6. Investments and Fair Value Measurement****s
Available-for-Sale Securities
The estimated fair value of marketable securities is based on quoted market prices for these or similar investments obtained from a commercial pricing service. The fair market value of marketable securities classified within Level 1 is based on quoted prices for identical instruments in active markets. The fair value of marketable securities classified within Level 2 is based on quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; or model-driven valuations whose inputs are observable or whose significant value drivers are observable. Observable inputs may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, and reference data including market research publications.
Available-for-sale securities are summarized below:
| | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · December 31, 2023 | ||||||||||||||
| · · · · Gross · Gross · · | ||||||||||||||
| · · · · Amortized · · Unrealized · · Unrealized · · Estimated | ||||||||||||||
| (In thousands) · · · · Cost · · Gains · · Losses · · Fair Value | ||||||||||||||
| US government securities | | Level 1 | | $29,848 | | $— | | $(29) | | $29,819 | ||||
| US government agency securities | | Level 2 | | 4,428 | | | — | | | (8) | | 4,420 | ||
| Corporate notes | | Level 2 | | 28,670 | | | 4 | | | (32) | | 28,642 | ||
| Marketable securities | | | | | 62,946 | | | 4 | | | (69) | | | 62,881 |
| Money market funds | | Level 1 | | | 26,179 | | | — | | | — | | | 26,179 |
| Total | | | | $89,125 | | $4 | | $(69) | | $89,060 | ||||
| | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · December 31, 2022 | ||||||||||||||
| · · · · Gross · Gross · · | ||||||||||||||
| · · · · Amortized · · Unrealized · · Unrealized · · Estimated | ||||||||||||||
| (In thousands) · · · · Cost · · Gains · · Losses · · Fair Value | ||||||||||||||
| US government securities | | Level 1 | | $24,873 | | $8 | | $— | | $24,881 | ||||
| US government agency securities | | Level 2 | | 20,869 | | 4 | | — | | 20,873 | ||||
| Commercial paper | | Level 2 | | | 37,307 | | | — | | | (27) | | | 37,280 |
| Marketable securities | | | | | 83,049 | | | 12 | | | (27) | | | 83,034 |
| Money market funds | | Level 1 | | | 220,508 | | | — | | | — | | | 220,508 |
| Total | | | | $303,557 | | $12 | | $(27) | | $303,542 | ||||
As of December 31, 2023, all of the Company’s available-for-sale securities had contractual maturities withinsix months, and the weighted-average maturity of marketable securities was less than two months. There wereno transfers between Level 1 and Level 2 during the periods presented, and there have been no material changes to the Company’s valuation techniques during the year ended December 31, 2023 or 2022.
Available-for-sale debt securities with unrealized losses are summarized below:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||||||||||||
| · · Less than 12 Months · · Greater than 12 Months · · Total | ||||||||||||||||||
| · · · Gross · · · · Gross · · · · Gross | ||||||||||||||||||
| · · Estimated · · Unrealized · · Estimated · · Unrealized · · Estimated · · Unrealized | ||||||||||||||||||
| (In thousands) · · Fair Value · · Losses · · Fair Value · · Losses · · Fair Value · · Losses | ||||||||||||||||||
| US government securities | | $29,819 | | $(29) | | $— | | $— | | $29,819 | | $(29) | ||||||
| US government agency securities | | | 4,420 | | | (8) | | | — | | | — | | | 4,420 | | | (8) |
| Corporate notes | | | 23,641 | | | (32) | | | — | | | — | | | 23,641 | | | (32) |
| Total | | $57,880 | | $(69) | | $— | | $— | | $57,880 | | $(69) | ||||||
| · · · · · · · · · · · · · · · · · · | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2022 | ||||||||||||
| · · Less than 12 Months · · Greater than 12 Months · · Total | ||||||||||||
| · · · Gross · · · · Gross · · · · Gross | ||||||||||||
| | | Estimated | | Unrealized | | Estimated | | Unrealized | | Estimated | | Unrealized |
| (In thousands) | | Fair Value | | Losses | | Fair Value | | Losses | | Fair Value | | Losses |
| Commercial paper | | $37,280 | | $(27) | | $— | | $— | | $37,280 | | $(27) |
| Total | | $37,280 | | $(27) | | $— | | $— | | $37,280 | | $(27) |
The Company invests primarily inhigh credit quality and short-term maturity debt securities with the intent to hold such securities until maturity at par value. The Company does not intend to sell the investments that are currently in an unrealized loss position, and it is unlikely that it will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity. The Company reviewed its available-for-sale debt securities and determined that there wereno credit-related losses to be recognized as of December 31, 2023, and there were no individual securities that were in a significant unrealized loss position as of December 31, 2023.
For the year ended December 31, 2023, the Company sold marketable securities for total proceeds of$71.4 million. The sales were based on the specific identification method, and the realized net gain from the sale was immaterial. For the year ended December 31, 2022, the Company didnot sell any marketable securities.
- Property and Equipment
Property and equipment are held predominantly in the US and consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| (In thousands) · 2023 · 2022 | ||||||
| Computer equipment | | $1,883 | | $1,921 | ||
| Software | | | 762 | | | 1,088 |
| Furniture and fixtures | | | 1,738 | | | 1,674 |
| Laboratory equipment | | | 60 | | | 15,445 |
| Leasehold improvements | | | 26,207 | | | 24,583 |
| Subtotal | | | 30,650 | | | 44,711 |
| Less: accumulated depreciation | | | (21,582) | | | (32,836) |
| Property and equipment, net | | $9,068 | | $11,875 | ||
For the year ended December 31, 2023 and 2022, depreciation expense for property and equipment was $1.9 million and $2.6 million, respectively.
As a result of strategic actions announced in February 2023 (see “Note 16. 2021 Restructuring and 2023 Strategic Actions”), the Company completed an auction of certain R&D laboratory equipment in 2023 with a carrying value of $2.7 million. The Company received net proceeds of $1.5 million and recognized a non-cash loss of $1.2 million resulting from the auction.
8. Leases
South San Francisco Lease and Subleases
As of December 31, 2023, the Company leased approximately 162,000 square feet of office and laboratory space intwo buildings in South San Francisco, California, under a non-cancelable operating lease that ends in May 2030 (“SSF Lease”). The lease includes a tenant improvement allowance that expires in November 2024 and had a remaining balance of $6.8 million and $8.9 million, as of December 31, 2023 and 2022, respectively.
In June 2022, the Company entered into a non-cancelable agreement under which it subleased approximately 78,000 square feet of its South San Francisco office and laboratory space to an unaffiliated company. The sublease term continues through May 2030, consistent with the remaining lease term of the SSF Lease, and the subtenant hasno option to extend the sublease. Under the terms of the sublease, the Company is entitled to receive an initial monthly base rent of $0.5 million which will be subject to annual increases of 3%, as well as the subtenant’s proportionate share of the property’s operating expenses. As part of the sublease terms, the subtenant was allocated $6.5 million of the Company’s $8.9 million remaining tenant improvement allowance in June 2022. The Company expects to receive a total of $51.7 million in base rent over the sublease term which represents a $13.5 million premium (before sublease execution-related costs) over its proportionate lease payment obligations under the SSF Lease. Under the terms of the SSF Lease,50% of the sublease premium, equal to approximately $6.7** **million, shall be shared with the landlord and 50% shall be retained by the Company.
In July 2021, the Company entered into a non-cancelable agreement under which it subleased approximately 21,000 square feet of its South San Francisco office and laboratory space to another unaffiliated company. Under the terms of the sublease agreement, the sublease term continues through September 2028, and the parties haveno option to extend the sublease. Either the Company or the subtenant may terminate the sublease by giving the other party ten days prior written notice. The Company is entitled to receive an initial monthly base rent of $0.1 million, with annual base rent increases of 3% and the subtenant’s proportionate share of the building’s operating expenses. The Company expects to receive a total of $13.1 million over the sublease term which represents a $4.2 million premium (before sublease execution-related costs) over its proportionate lease payment obligations under the SSF Lease. Under the terms of the head SSF Lease,50% of the sublease premium, equal to $2.1** **million, shall be shared with the landlord and 50% shall be retained by the Company.
The Company recognizes the sublease income on a straight-line basis over the term of itstwo subleases which is reflected as a reduction of R&D expense and selling, general and administrative expenses in the consolidated statements of operations. No lease modification was deemed to have occurred by entering into the sublease agreements because the Company was not released, either fully or in part, from its obligations under the SSF Lease.
See*“**Note 16. 2021 Corporate Restructuring Completion and 2023 Strategic Actions”*for information regarding the impairment evaluation related to additional South San Francisco office and laboratory space that is available for sublease as of December 31, 2023.
Dublin Lease
In April 2017, the Company leased approximately 6,100 square feet of office space in Dublin, Ireland, under a non-cancelable operating lease that expires in April 2027 (“Dublin Lease”). In May 2022, the Company entered into an agreement under which it assigned the Dublin Lease (“Lease Assignment”) to an unaffiliated company. The Company determined that the Lease Assignment would be accounted for as a lease modification under ASC 842,Leases. As a result of the lease modification, the Company reduced the value of its operating lease assets and liabilities in the consolidated balance sheets by $1.4 million and $1.5 million, respectively, in the second quarter of 2022. Under the Lease Assignment, the Company sold furniture and equipment located in the Dublin office to the unaffiliated company and recognized a net loss of $0.1 million from the sale.
Following the execution of the Lease Assignment, in May 2022, the Company entered into a new operating lease agreement for approximately 700 square feet of office space in Dublin, Ireland, effective June 2022. The lease has atwo-year term ending in May 2024, and the Companymay terminate the lease by providing three months prior written notice. Under the new lease, the Company will incur total base rent expense of approximately $0.4 million (or $0.2 million annually) which is recognized on a straight-line basis over thetwo-year lease term. The Company’s annual straight-line base rent for its previous Dublin Lease was approximately $0.4 million.
The Company has evaluated its existing leases and determined that they were all operating leases. The present values of the remaining lease payments and corresponding right-of-use assets were as follows, and the difference between the right-of-use assets and lease liabilities was primarily due to office-related deferred rent payments that are payable in future periods and tenant improvement reimbursements.
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| (In thousands) · Classification · December 31, 2023 · December 31, 2022 | |||||||
| Assets | | | | | | | |
| Operating lease assets | Operating lease assets | | $36,287 | | $40,126 | ||
| | | | | | | | |
| Liabilities | | | | | | | |
| Current: | | | | | | | |
| Operating lease liabilities | Operating lease liabilities | | $3,923 | | $6,753 | ||
| Non-current: | | | | | | | |
| Operating lease liabilities | Long-term operating lease liabilities | | 45,236 | | 45,407 | ||
| Total operating lease liabilities | | | $49,159 | | $52,160 | ||
In 2023, the Company recognized an increase to other assets and other current liabilities of $6.5 million for lessor tenant improvement allowances that have been assigned to its sublessees. The assigned tenant improvement allowance recorded as other assets is amortized over the lease term, and the assigned tenant improvement allowance recorded as a current liability will expire in November 2024.
Lease expense and sublease income were included within operating expenses in the consolidated statements of operations as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · Year Ended · · Year Ended · · · | ||||||||||
| (In thousands) · Classification · December 31, 2023 · December 31, 2022 · · | ||||||||||
| Operating lease expense (1) | Selling, general and administrative expense | | $8,548 | | $8,314 | | | | ||
| | | | | | | | | | | |
| | | | Year Ended | | Year Ended | | | | ||
| (In thousands) | Classification | December 31, 2023 | December 31, 2022 | | | |||||
| Operating sublease income | Selling, general and administrative expense | | $8,361 | | $5,420 | | | | ||
| (1) | Represents operating lease expense before sublease income. Excludes short-term leases which were not material and office lease service-related charges. |
Supplemental information related to leases for the periods reported was as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · · Year Ended · · Year Ended · | ||||||||
| (In thousands, except weighted average amounts) · · December 31, 2023 · December 31, 2022 · | ||||||||
| Operating cash flows from operating leases | | | $9,966 | | $9,312 | | ||
| Weighted average remaining lease term | | | | 6.4 years | | | 7.4 years | |
| Weighted average discount rate | | | | 8.64% | | 8.63% | ||
The Company determined that an implicit interest rate of its leases were not determinable and, therefore, used an incremental borrowing rate to determine the present value of its lease liabilities. The Company’s incremental borrowing rate was primarily derived from the 9.0% interest rate on its previously issued Non-Recourse 2033 Notes in November 2018 and did not involve any significant assumptions.
As of December 31, 2023, the maturities of the Company’s lease liabilities were as follows:
| | | | | |
|---|---|---|---|---|
| (In thousands) | | | | |
| Year ending December 31: · · · | ||||
| 2024 | | | $3,897 | |
| 2025 | | | | 10,940 |
| 2026 | | | | 11,198 |
| 2027 | | | | 11,479 |
| 2028 | | | | 11,739 |
| Thereafter | | | | 16,837 |
| Total operating lease payments | | | $66,090 | |
| Less: Estimated tenant improvement allowance | | | | (6,838) |
| Less: Imputed interest | | | | (10,093) |
| Present value of operating lease liabilities | | | $49,159 | |
As of December 31, 2023, the undiscounted cash flows to be received related to the Company’s subleases were as follows:
| | | | | |
|---|---|---|---|---|
| (In thousands) | | | | |
| Year ending December 31: · · · | ||||
| 2024 | | | $7,944 | |
| 2025 | | | | 8,181 |
| 2026 | | | | 8,425 |
| 2027 | | | | 8,675 |
| 2028 | | | | 8,412 |
| Thereafter | | | | 10,089 |
| Total operating sublease receipts | | | $51,726 | |
**9.**Sale of Equity Interests in Theravance Respiratory Company, LLC and Discontinued Operations
Background
In May 2014, the Company entered into the TRC LLC Agreement with Innoviva, Inc. (“Innoviva”) that governed the operation of Theravance Respiratory Company, LLC (“TRC”). Under the TRC LLC Agreement, Innoviva was the manager of TRC, and the business and affairs of TRC were managed exclusively by the manager, including (i) day to day management of the drug programs in accordance with the existing GSK agreements; (ii) preparing an annual operating plan for TRC; and (iii) taking all actions necessary to ensure that the formation, structure and operation of TRC complied with applicable law and partner agreements. The Company was responsible for its proportionate share of TRC’s administrative expenses incurred as communicated to the Company, by Innoviva.
Through the Company’s 85% equity interest in TRC, the Company was entitled to receive an 85% economic interest in any future payments made by GSK under the strategic alliance agreement and under the portion of the collaboration agreement assigned to TRC (net of TRC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters). The primary drug program assigned to TRC is Trelegy.
Sale of Equity Interests in TRC
On July 20, 2022, the Company completed the sale of its 2,125 Class B Units and 6,375 Class C Units (collectively, the “Issuer II Units”) of TRC to, and entered into a sale of future royalties from sales of ampreloxetine (see “Note 10. Ampreloxetine Funding”) with, Royalty Pharma Investments 2019 ICAV, an Irish collective asset-management vehicle (“Royalty Pharma”), pursuant to the Equity Purchase and Funding Agreement, dated as of July 13, 2022 (including the schedules and exhibits thereto, the “Purchase Agreement”), by and between the Company and Royalty Pharma (collectively with the other transactions contemplated by the Purchase Agreement, the “TRC Transaction”). The Issuer II Units represent the right to receive 85% of the royalty payments on worldwide net sales of Assigned Collaboration Products (as defined in the Purchase Agreement) pursuant to the terms of that certain Collaboration Agreement, dated as of November 14, 2002, by and between Innoviva, Inc. (formerly known as Theravance, Inc.), a Delaware corporation (“Innoviva”), and Glaxo Group Limited, a private company limited by shares registered under the laws of England and Wales (“GSK”) (as amended, the “Collaboration Agreement”). Assigned Collaboration Products is primarily comprised of Trelegy ELLIPTA (“TRELEGY”). Total consideration payable by Royalty Pharma under the terms of the TRC Transaction included initial consideration with a fair value of $1,326.6 million plus the right to receive additional payments as further described below.
At the closing of the TRC Transaction (the “Closing”), the Company received approximately $1.1 billion in cash. From and after January 1, 2023, for any calendar year starting with the year ended December 31, 2023 and ending with the year December 31, 2026, upon certain milestone minimum royalty amounts for the Assigned Collaboration Products being met, Royalty Pharma is obligated to make certain cash payments to the Company (the “Milestone Payments”), which are not to exceed $250.0 million in aggregate. For the year ended December 31, 2023, the minimum royalty amount was not achieved, and the remaining aggregate Milestone Payments available to the Company is $200.0 million.
Additionally, the Company will receive from Royalty Pharma 85% of the royalty payments on the Assigned Collaboration Products payable (a) for sales or other activities occurring on and after January 1, 2031 related to the Assigned Collaboration Products in the US, and (b) for sales or other activities occurring on and after July 1, 2029 related to the Assigned Collaboration Products outside of the US.
The Purchase Agreement contained customary representations and warranties of the Company and Royalty Pharma, including with respect to organization, authorization, intellectual property matters and tax matters, and certain covenants with respect to confidentiality, taxes and actions and conduct relating to preservation of TRC prior to the Closing. The Company and Royalty Pharma will each indemnify the other against damages arising from breaches of representations, warranties, and covenants under the Purchase Agreement.
Effective as of the Closing, the Company consented to certain amendments to the Collaboration Agreement and the Extension Agreement, dated as of March 3, 2014, by and between the Company and GSK, as well as the termination
of the Master Agreement, dated as of March 3, 2014, by and between Innoviva, the Company and GSK, and further released Innoviva, Innoviva TRC Holdings LLC, a Delaware limited liability company, Royalty Pharma and TRC for claims relating to TRC or the ownership of TRC by the Company or Innoviva prior to the Closing.
The Company evaluated the TRC Transaction under ASC 860,Transfers and Servicing of Financial Assets,(“ASC 860”) and determined that the future potential Milestone Payments and royalty payments are considered a form of continuing involvement between the Company and Royalty Pharma. The Company further evaluated the TRC Transaction under ASC 860 and concluded that (i) the equity interests in TRC have been isolated from the Company (even in the event of bankruptcy or other receivership); (ii) Royalty Pharma has the right to pledge or exchange the TRC assets it received from the Company without constraint; and (iii) the Company had surrendered control over its equity interests in TRC to Royalty Pharma. Based on the Company’s evaluation under ASC 860, the TRC Transaction was treated as a sale, and the Company recognized a gain from the sale of its equity interests in TRC of $1,141.1 million in 2022 based on the excess of the total net consideration allocated to the sale of the Company’s equity interests (based on relative fair value) of $1,301.6 million over the carrying value of the equity interests sold of $136.7 million, less transaction costs of $23.8 million. The total net consideration of $1,301.6 million included upfront cash of $1,107.4 million, plus an estimated $194.2 million representing the fair value of the future Milestone Payments and royalties (collectively, “Contingent Consideration”).
The Contingent Consideration was initially measured at fair value utilizing a Monte Carlo simulation model to calculate the present value of the risk-adjusted cash flows estimated to be received from the Contingent Consideration. The discount rate utilized in the valuation model was 7.83%. The fair value model involved significant unobservable inputs derived using management’s estimates. Management’s estimates were based in part on external data and reflected management’s judgements and forecasts. The primary significant unobservable input was the estimate of forecasted TRELEGY net revenues which is considered a Level 3 fair value input. The Company reassesses the carrying value of the Contingent Consideration when indicators of impairment are identified and will recognize any increases in the carrying value of the asset when such contingent gains are realized. As of December 31, 2023, there have been no changes to the carrying value of the Contingent Consideration since its initial measurement date in July 2022.
The Contingent Consideration is subject to counterparty credit risk, and the carrying value of the Contingent Consideration represents the maximum amount of potential loss due to credit risk. To date, the Company has not recorded any credit losses related to the Contingent Consideration. The Contingent Considerationis presented on the consolidated balance sheets asfuture contingent milestone and royalty assets.
Discontinued Operations
The TRC Transaction represented a monetization of a significant equity method investment that had a major effect on the Company’s financial results. In accordance with GAAP, the TRC Transaction was accounted for as a sale of a financial asset. For all periods presented, balances and the results related to TRC have been classified as discontinued operations on the Company’s consolidated financial statements.
The results of discontinued operations consisted of the following:
| | | | |
|---|---|---|---|
| · · Year Ended | |||
| | | | December 31, |
| (In thousands) | 2022 | ||
| Income from investments in TRC, LLC | | $53,237 | |
| Transaction-related legal expenses (prior to July 20, 2022) | | | (5,057) |
| Interest expense on 9.5% Non-recourse notes due 2035 | | | (21,312) |
| Loss on extinguishment of debt | | | (24,022) |
| Net gain from sale of equity interests in TRC, LLC | | | 1,141,084 |
| Provision for income tax expense | | | (178,974) |
| Net income from discontinued operations | | $964,956 | |
TRC Financial Information
Prior to the TRC Transaction, the Company analyzed its ownership, contractual and other interests in TRC to determine if it was a variable-interest entity (“VIE”), whether the Company had a variable interest in TRC and the nature and extent of that interest. The Company determined that TRC was a VIE. The party with the controlling financial interest, the primary beneficiary, is required to consolidate the entity determined to be a VIE. Therefore, the Company also assessed whether it was the primary beneficiary of TRC based on the power to direct TRC’s activities that most significantly impact TRC’s economic performance and its obligation to absorb TRC’s losses or the right to receive benefits from TRC that could potentially be significant to TRC. Based on the Company’s assessment, the Company determined that it was not the primary beneficiary of TRC, and, as a result, the Company did not consolidate TRC in its consolidated financial statements. The Company’s maximum exposure to loss, as a result of its involvement with TRC, were the amounts recorded in the consolidated balance sheets within “Amounts due from TRC, LLC” and “Equity in net assets of TRC, LLC”. TRC was recognized in the Company’s consolidated financial statements under the equity method of accounting.
For the year ended December 31, 2022, the Company recognized income from its investment in TRC of $53.2 million. As noted above, TRC is being recognized as discontinued operations as a result of the TRC Transaction.
TRC’s balance sheet as of July 20, 2022 and TRC’s statement of income for the period from January 1, 2022 to July 20, 2022, including the portion of equity interest that the Company did not own, were as follows:
| | | | |
|---|---|---|---|
| (In thousands) | July 20, 2022 | ||
| Assets | | | |
| Cash and cash equivalents | | $29,309 | |
| Related party receivables from collaborative arrangements | | | 42,720 |
| Total assets | | $72,029 | |
| | | | |
| Liabilities and LLC Members' Equity | | | |
| Accrued liabilities | | | — |
| LLC members' equity | | | 72,029 |
| Total liabilities and LLC members' equity | | $72,029 | |
| | | | |
| | | Period Ended | |
| (In thousands) | | July 20, 2022 | |
| Royalty revenue and gross profit | | $72,029 | |
| General and administrative expenses | | | (332) |
| Other income, net | | | 10 |
| Realized loss on equity and long-term investments | | | (39,385) |
| Changes in fair value of equity and long-term investments, net | | | (8,884) |
| Net Income | | $23,438 | |
10. Ampreloxetine Funding
Under the terms of the Purchase Agreement (see*“Note 9. Sale of Equity Interests in Theravance Respiratory Company, LLC and Discontinued Operations”*), the Company received $25.0 million in cash from Royalty Pharma in exchange for certain royalty rights to ampreloxetine and is entitled to receive an additional $15.0 million upon the first regulatory approval of any pharmaceutical product that contains ampreloxetine as an active pharmaceutical ingredient by either (a) the FDA or (b) the first of (i) the European Medicines Agency or (ii) all four of Germany, France, Italy and Spain. In exchange for the $25.0 million and potential $15.0 million in cash (the “Ampreloxetine Funding”), the Company will make quarterly royalty payments to Royalty Pharma equal to the amount of Ampreloxetine Net Sales (as defined in the Purchase Agreement) recognized during the applicable quarter multiplied by 2.5% for the first $500.0 million in Ampreloxetine Net Sales and 4.5% for Ampreloxetine Net Sales in excess of $500.0 million. These royalty payments from the Company to Royalty Pharma will continue until, on a country by country and product by product basis, the later of (a) the expiration of all valid and enforceable claims of any patent, or pending claim of a good faith patent application during thefive (5) years from the initial filing of such application, that cover the applicable
ampreloxetine product or the manufacture or use thereof in the applicable country and (b) the expiration of regulatory exclusivity granted by the FDA or equivalent organization in the applicable country. As the Ampreloxetine Funding and the TRC Transaction were part of the same Purchase Agreement, the Company evaluated the total consideration received from Royalty Pharma and determined that the consideration received for each of the individual transactions approximated their relative fair values.
The Company accounted for the Ampreloxetine Funding received from Royalty Pharma as a contingent liability because the Company has significant continuing involvement in generating the future revenue stream from which the contingent liability would be repaid to Royalty Pharma. If the regulatory approval milestone is achieved, the Company will recognize the $15.0 million milestone payment as an increase to the accumulated liability. If and when ampreloxetine obtains regulatory approval and is commercially launched, the Company will recognize the royalties paid to Royalty Pharma as a decrease to the accumulated liability due to Royalty Pharma and a corresponding reduction in cash. If ampreloxetine regulatory approval is not achieved or if ampreloxetine sales are never recognized, the contingent liability recognized would be extinguished as the Company would not be obligated to repay any of the funding amounts received from Royalty Pharma.
The carrying amount of the contingent liability for the future royalty payment was based on the upfront $25.0 million received and management’s estimate of (i) the risk-adjusted future contingent $15.0 million milestone; and (ii) the amount and timing of royalties to be paid to Royalty Pharma and then discounted over the life of the arrangement using an imputed rate of interest. The excess of future estimated royalty payments over the amount of cash funding received will be recognized as interest expense using the effective interest method. The balance associated with the contingent liability was initially recorded as $25.0 million, net of allocated transaction costs, in July 2022 and was reported on the consolidated balance sheets as future royalty payment contingency.
The Company periodically reassesses the amount and timing of estimated royalty payments. To the extent such payments are materially greater or less than the Company’s previous estimates, the Company will prospectively adjust the amortization of the contingent liability and the effective interest rate. The imputed effective rate of interest on the unamortized portion of the contingent liability was approximately 8.8% as of December 31, 2023.
There are a number of factors that could materially affect the amount and timing of the contingent $15.0 million milestone and royalty payments, some of which are not within the Company’s control. Such factors include, but are not limited to, changes in the projected market size, the introduction of competing products, patent protection matters, and regulatory product approval. The contingent liability was recognized using significant unobservable inputs. These inputs were derived using internal management estimates and reflect management’s judgements and forecasts. The significant unobservable inputs include the forecasted revenues, the probability and timing of the regulatory milestone, and the expected term of the royalty stream, as well as the overall probability of ampreloxetine’s success. These estimates are considered Level 3 fair value inputs. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the contingent liability.
Changes to the contingent liability for sale of future royalties were as follows for the year ended December 31, 2023:
| · · · | ||
|---|---|---|
| (In thousands) | | |
| Balance at December 31, 2022 | | $25,438 |
| Non-cash interest expense accretion | | 2,350 |
| Balance at December 31, 2023 | | $27,788 |
11. Extinguishment of Debt
9.5% Non-Recourse Notes Due 2035
In February 2020, Theravance Biopharma R&D, Inc. (“Theravance R&D”), a wholly-owned subsidiary of the Company, and Triple Royalty Sub II LLC (the “Issuer II”), a wholly-owned subsidiary of Theravance Biopharma R&D, entered into certain note purchase agreements (“Note Purchase Agreements”) with certain note purchasers (“Note Purchasers”), relating to the private placement by Issuer II of $400.0 million 9.5% Fixed Rate Term Notes due on or
before 2035 (the “Non-Recourse 2035 Notes”). The Non-Recourse 2035 Notes were secured by all of Issuer II’s right, title and interest as a holder of certain membership interests in TRC. TRC held the right to receive upward-tiering royalties ranging from 6.5% to 10% on worldwide net sales of TRELEGY, and, prior to the closing of the TRC Transaction (see*“Note 9. Sale of Equity Interests in Theravance Respiratory Company, LLC and Discontinued Operations”*).
In connection with the TRC Transaction, the Company redeemed the outstanding Non-Recourse 2035 Notes on July 20, 2022 and paid certain other fees and expenses in conjunction with that redemption. The total repayment was comprised of$400.0 million of net principal,$4.7 million of accrued interest, an early redemption premium fee of$20.0 million, and$0.2 million of transaction costs. The$400.0 million of net principal included$30.7 million of issuance-to-date net interest shortfall. The repayments resulted in a net loss on extinguishment of debt of$24.0 million, which was included within discontinued operations in the accompanying consolidated statements of operations for the year ended December 31, 2022. The loss on extinguishment of debt was calculated as the difference between the carrying amount of the Non-Recourse 2035 Notes and the amounts paid to redeem the Non-Recourse 2035 Notes.
3.25% Convertible Senior Notes Due 2023
In November 2016, the Company completed an underwritten public offering of $230.0 million of 3.25% convertible senior notes, due 2023 (the "Convertible Senior 2023 Notes") for net proceeds of $222.5 million. The Company incurred $7.5 million in debt issuance costs, which were being amortized to interest expense over the estimated life of the Convertible Senior 2023 Notes. The Convertible Senior 2023 Notes bore an annual interest rate of 3.25%, payable semi-annually in arrears, on November 1 and May 1 of each year.
On July 26, 2022, subsequent to the closing of the TRC Transaction, the Company launched a tender offer to retire the Convertible Senior 2023 Notes (the “2023 Notes Tender Offer”). Pursuant to the terms of the 2023 Notes Tender Offer, the Company paid all accrued and unpaid interest on the purchased Convertible Senior 2023 Notes from and including the last interest payment date of May 1, 2022 up to, but not including, the settlement date for the 2023 Notes Tender Offer. The 2023 Notes Tender Offer expired on August 23, 2022 (the “Expiration Time”). As of the Expiration Time,$230.0 million in aggregate principal amount of the Convertible Senior 2023 Notes, representing 100% of the outstanding Convertible Senior 2023 Notes, were validly tendered and not validly withdrawn pursuant to the 2023 Notes Tender Offer. The Company accepted for purchase all of the Convertible Senior 2023 Notes and settled the 2023 Notes Tender Offer on August 25, 2022.
Total payments made by the Company under the 2023 Notes Tender Offer included$230.0 million of principal,$2.4 million of accrued interest, and$1.6 million of transaction costs. The repayments resulted in a net loss on extinguishment of debt of$3.0 million, which is included within “loss on extinguishment of debt” in the accompanying consolidated statements of operations for the year ended December 31, 2022. The loss on extinguishment of debt was calculated as the difference between the carrying amount of the Convertible Senior 2023 Notes and the amounts paid to settle the Convertible Senior 2023 Notes.
As December 31, 2023, the Company didnot have any long-term debt.
12. Share-Based Compensation
Theravance Biopharma Equity Plans
The Company hasthree equity compensation plans — the 2013 Equity Incentive Plan (the “2013 EIP”), the 2013 Employee Share Purchase Plan (the “2013 ESPP”) and the 2014 New Employee Equity Incentive Plan (the “2014 NEEIP”).
The 2013 EIP provides for the issuance of share-based awards, including restricted shares, restricted share units (“RSUs), options, share appreciation rights (“SARs”) and other equity-based awards, to Company employees, officers, directors, and consultants. Options may be granted with an exercise price not less than the fair market value of the ordinary shares on the grant date. Under the terms of the 2013 EIP, options granted to employees generally have a maximum term of 10 years and vest over afour-year period from the date of grant;25% vest at the end ofone year, and 75% vest monthly over the remaining three years. The Company may grant options with different vesting terms from
time to time. Unless an employee’s termination of service is due to disability or death, upon termination of service, any unexercised vested options will generally be forfeited at the end ofthree months or the expiration of the option, whichever is earlier.
At the Company’s Annual General Meeting of Shareholders on May 2, 2023, the Company’s shareholders approved an amendment and restatement of the 2013 EIP to effect the following material changes to the existing plan: (i) extend the term of the 2013 EIP by an additionalten years; (ii) eliminate the provision that provided for automatic annual increases in the number of shares available for issuance under the 2013 EIP; (iii) reduce the number of shares reserved for issuance by 3,808,287 shares; (iv) eliminate the Company’s ability to reprice options and share appreciation rights without first obtaining shareholder approval; and (v) remove certain provisions no longer necessary since the repeal of the exemption from the annual deduction limitation imposed by Section 162(m) of the Internal Revenue Code for performance-based compensation.
Under the 2013 ESPP, the Company’s officers and employees may purchase ordinary shares through payroll deductions at a price equal to 85% of the lower of the fair market value of the ordinary share at the beginning of the offering period or at the end of each applicable purchase period. As of January 1 of each year, commencing on January 1, 2015 and ending on (and including) January 1, 2033, the aggregate number of ordinary shares that may be issued under the 2013 ESPP shall automatically increase by a number equal to the least of 1% of the total number of ordinary shares outstanding on December 31 of the prior year,571,428 ordinary shares or a number of ordinary shares determined by the Company’s board of directors. The ESPP generally provides for consecutive and overlapping offering periods of 24 months in duration, with each offering period generally composed offour consecutivesix-month purchase periods. The purchase periods end on either May 15 or November 15. ESPP contributions are limited to a maximum of 15% of an employee’s eligible compensation, up to applicable regulatory limits. The 2013 ESPP also includes a feature that provides for the existing offering period to terminate and for participants in that offering period to automatically be enrolled in a new offering period when the fair market value of an ordinary share at the beginning of a subsequent offering period falls below the fair market value of an ordinary share on the first day of such offering period.
The 2014 NEEIP provides for the issuance of share-based awards, including restricted shares, RSUs, non-qualified options and SARs to the Company’s employees. Options may be granted with an exercise price not less than the fair market value of the ordinary shares on the grant date. Under the terms of the 2014 NEEIP, options granted to employees generally have a maximum term of 10 years and vest over afour-year period from the date of grant;25% vest at the end ofone year, and 75% vest monthly over the remaining three years. The Company may grant options with different vesting terms from time to time. Unless an employee’s termination of service is due to disability or death, upon termination of service, any unexercised vested options will generally be forfeited at the end ofthree months or the expiration of the option, whichever is earlier.
As of December 31, 2023, the total number of shares available for future issuance under each of the plans were:
| | | |
|---|---|---|
| 2013 EIP | | 5,339,942 |
| 2013 ESPP | | 2,453,502 |
| 2014 NEEIP | | 346,281 |
| Total | | 8,139,725 |
Market and Performance-Contingent Awards
The Company periodically grants market-based share awards to employees. For the year ended December 31, 2023, the Company granted 165,000 market-based restricted share units (“RSUs”). The 165,000 RSUs had a fair value of $1.4 million on the grant date that vest upon the Company’s ordinary shares meeting certain market-based price targets followed by a service period. The fair value of these market-based RSUs is being recognized through February 2027. For the year ended December 31, 2023, the Company recognized $0.7 million of share-based compensation expense related to the awards. There wereno market-based RSUs granted or expensed for the year ended December 31, 2022.
Separate from the market-based RSUs described above, the Company granted 367,000 and 43,000 of performance-contingent RSUs for the year ended December 31, 2023 and 2022, respectively. The 367,000 and 43,000 RSUs had a fair value of $3.7 million and $0.4 million, respectively, on grant date with performance vesting dates through February 2026. As of December 31, 2023, the Company concluded that 59,000 of the RSUs were probable of achievement, and as a result, the Company recognized $0.4 million of cumulative catch-up share-based compensation expense for the year ended December 31, 2023.
Share-Based Compensation Modifications
As a result of the Company’s corporate restructuring announcement in September 2021, the Board of Directors’ Compensation Committee approved the acceleration of certain equity awards for employees affected by the restructuring. The Company accounted for this acceleration as a Type III modification (improbable to probable). In 2022, the Company completed the 2021 restructuring that resulted in an equity award Type III modification fair value of $2.5 million which was recorded in “Restructuring and related expenses” within the consolidated statements of operations for the year ended December 31, 2022. The total cumulative compensation cost previously recognized for these modified awards of $0.8 million was reversed in the year ended December 31, 2022 within “Research and development” and “Selling, general and administrative” expenses. The acceleration resulted in a net incremental share-based compensation expense of $1.7 million for the year ended December 31, 2022 and impacted approximately 40 terminated employees that met the conditions of the acceleration.
Share-Based Compensation Expense
Share-based compensation expense included in the consolidated statements of operations was recognized as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands) · 2023 · 2022 | ||||||
| Research and development | | $8,048 | | $12,888 | ||
| Selling, general and administrative | | 16,966 | | 19,848 | ||
| Restructuring and related expenses | | | 357 | | | 6,998 |
| Total share-based compensation expense | | $25,371 | | $39,734 | ||
Share-based compensation expense included in the consolidated statements of operations by award type was as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands) · 2023 · 2022 | ||||||
| Options | | $2,294 | | $2,998 | ||
| RSUs | | | 21,817 | | | 35,726 |
| Performance RSUs | | | 1,087 | | | 237 |
| ESPP | | 173 | | | 773 | |
| Total share-based compensation expense | | $25,371 | | $39,734 | ||
As of December 31, 2023, the unrecognized share-based compensation cost, net of actual forfeitures, and the estimated weighted-average amortization period, using the straight-line attribution method, was as follows:
| | | | | | |
|---|---|---|---|---|---|
| · Unrecognized · · Weighted‑Average | |||||
| · Compensation · · Amortization Period | |||||
| (In thousands, except amortization period) · Cost · (Years) | |||||
| Options | | $2,600 | | 1.88 | |
| RSUs | | | 30,404 | | 2.36 |
| Performance RSUs (1) | | | 849 | | 1.26 |
| ESPP | | | 504 | | 1.05 |
| Total | | $34,357 | | | |
| (1) | Represents unrecognized share-based compensation cost associated with the Company’s market-based and performance-contingent awards described above that are probable of vesting. |
Compensation Awards
The following table summarizes option activity under the 2013 EIP and 2014 NEEIP for the year ended December 31, 2023:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · Weighted-Average · · · | ||||||||||
| · Number of Shares · · Weighted-Average · · Exercise Price of · · · Aggregate | ||||||||||
| · · Subject to · · Remaining Contractual · · Outstanding Options · · · Intrinsic Value | ||||||||||
| · · Outstanding Options · · Term (Years) · · (in dollars) · · · (in thousands) | ||||||||||
| Outstanding at December 31, 2022 | | 2,411,893 | | | | $19.53 | | | | |
| Granted | | 262,386 | | | | | 10.84 | | | |
| Exercised | | — | | | | | - | | | |
| Forfeited | | (368,403) | | | | | 18.85 | | | |
| Outstanding at December 31, 2023 | | 2,305,876 | | 5.32 | | | 18.65 | | $859 | |
| Exercisable at December 31, 2023 | | | | 4.48 | | | | | | 487 |
| Vested and expected to vest at December 31, 2023 | | | | 5.32 | | | | | | 859 |
The following table summarizes additional information for options under the 2013 EIP and 2014 NEEIP.
| · · · · · · | ||||
|---|---|---|---|---|
| · · 2023 · 2022 | ||||
| Weighted average fair value of options (in dollars) | | $5.74 | | $5.33 |
| Total intrinsic value of options exercised (in thousands) | | $— | | $— |
The following table summarizes total RSU activity (including market-based and performance-contingent RSUs) for the year ended December 31, 2023:
| | | | | |
|---|---|---|---|---|
| · Number of Shares · Number of Shares | ||||
| | | Subject to | | Outstanding Subject to |
| | | Outstanding RSUs | | Performance Conditions (RSAs) |
| Outstanding at December 31, 2022 | | 4,109,847 | — | |
| Granted | | 2,228,184 | | — |
| Released | | (1,651,141) | | — |
| Forfeited | | (691,140) | | — |
| Outstanding at December 31, 2023 | | 3,995,750 | — | |
The total estimated fair value of RSUs vested was $17.3 million and $37.2 million in 2023 and 2022, respectively.
Valuation Assumptions
The range of assumptions used to estimate the fair value of options granted and rights granted under the 2013 ESPP was as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| | 2023 | 2022 | ||||
| Options | | | | | | |
| Risk-free interest rate | | 3.46% - 4.18% | | | 1.5% - 3.8% | |
| Expected term (in years) | | 5.3 - 6.5 | | | 5.3 - 6.1 | |
| Volatility | | 53% - 55% | | | 55% - 70% | |
| Dividend yield | | — | | | — | |
| Weighted-average estimated fair value | | $5.74 | | $5.33 | ||
| 2013 ESPP | | | | | | |
| Risk-free interest rate | | | 4.06% - 5.39% | | | 1.5% - 4.57% |
| Expected term (in years) | | | 0.5 - 2.0 | | | 0.5 - 2.0 |
| Volatility | | | 32% - 58% | | | 41% - 72% |
| Dividend yield | | | — | | | — |
| Weighted-average estimated fair value | | $3.46 | | $3.86 | ||
13. Defined Contribution Plan
The Company sponsors a 401(k) retirement plan for eligible employees. Employees may contribute a percentage of their annual compensation to the plan, subject to statutory limitations. The Company makes matching contributions equal to 100% of the employee’s contribution up to $5,000 of their annual compensation. For the year ended December 31, 2023 and 2022, the Company recognized $0.5 million and $0.6 million, respectively, in compensation expense associated with its contributions to the 401(k) retirement plan.
14. Income Taxes
Theravance Biopharma was incorporated in the Cayman Islands in July 2013 under the name Theravance Biopharma, Inc. as a wholly-owned subsidiary of Innoviva and began operations subsequent to a spin-off with wholly-owned subsidiaries in the Cayman Islands, US, United Kingdom, and Ireland. Effective July 1, 2015, Theravance Biopharma became an Irish tax resident, therefore, the income (loss) before income taxes of Theravance Biopharma, the parent company, were included in Ireland in the tables below.
The components of the loss before income taxes from continuing operations were as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Year Ended December 31, | |||||||
| (In thousands) · 2023 · 2022 | |||||||
| Income (loss) before provision for income taxes: · · · · · | |||||||
| United States | | $1,151 | | $(40,556) | | ||
| Ireland | | | (50,420) | | | (52,168) | |
| United Kingdom | | | — | | | (91) | |
| Total | | $(49,269) | | $(92,815) | | ||
The components of provision for income tax expense from continuing operations were as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Year Ended December 31, | |||||||
| (In thousands) · 2023 · 2022 | |||||||
| Provision for income tax (expense) benefit: | | | | | | | |
| Current: | | | | | | | |
| United States | | $(2,881) | | $— | | ||
| Ireland | | | — | | | (8) | |
| United Kingdom | | | 164 | | | (1) | |
| Subtotal | | | (2,717) | | | (9) | |
| Deferred: | | | | | | | |
| United States | | | (3,207) | | | — | |
| Subtotal | | | (3,207) | | | — | |
| Total | | $(5,924) | | $(9) | | ||
| Effective tax rate | | | 12.02% | | (0.01)% | ||
The provision for income tax expense was $5.9 million and $9,000 for the year ended December 31, 2023 and 2022, respectively. The income tax expense for the year ended December 31, 2023 was primarily attributed to the Company’s profitability in the US jurisdiction which no longer had a valuation allowance offset for federal tax purposes due to the valuation allowance’s release in 2022. We expect to have an immaterial federal cash tax expense for the year ended December 31, 2023 which will be offset with a prior year overpayment.
Income tax expense related to discontinued operations for the year ended December 31, 2022 of $179.0 million was a result of the Company’s gain from the TRC Transaction, which was recognized as a discontinued operation.
No provision for income taxes has been recognized on undistributed earnings of the Company’s foreign subsidiaries because it considers such earnings to be indefinitely reinvested. In the event of a distribution of these earnings in the form of dividends or otherwise, the Company may be liable for income taxes, subject to an adjustment, if any, for foreign tax credits and foreign withholdings taxes payable to certain foreign tax authorities. As of December 31, 2023, there wereno undistributed earnings.
As a result of the Company becoming an Irish tax resident effective July 1, 2015, the tax rates reflect the Irish statutory rate of 25%. The differences between the Irish statutory income tax rate for non-trading income and the Company’s effective tax rates from continuing operations were as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · Year Ended December 31, | |||||
| · 2023 · 2022 | |||||
| Provision at statutory income tax rate | | 25.00% | 25.00% | ||
| Foreign rate differential | | (8.28) | (6.80) | ||
| Share-based compensation | | (3.00) | | (3.28) | |
| Non-deductible executive compensation | | (4.45) | | (2.79) | |
| Uncertain tax positions | | (7.31) | | (7.10) | |
| Research and development tax credit carryforwards | | 3.34 | | 2.65 | |
| Change in valuation allowance | | (16.00) | (1.01) | ||
| Other | | (1.32) | (6.68) | ||
| Effective tax rate | | (12.02)% | (0.01)% | ||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities were as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| (In thousands) | 2023 | | 2022 | |||
| Deferred tax assets: | | | | | | |
| Net operating loss carryforwards | $153,225 | | $141,674 | |||
| Capital loss carryforwards | | 21,482 | | 19,409 | ||
| Research and development tax credit carryforwards | | 16,910 | | 16,176 | ||
| Fixed assets and intangibles | | | 235,381 | | | 245,822 |
| Share-based compensation | | | 3,431 | | | 4,298 |
| Accruals | | | 1,186 | | | 1,795 |
| Operating lease liabilities | | | 10,946 | | | 11,239 |
| Prepaid assets | | | (248) | | | 304 |
| Other | | 4,982 | | 30 | ||
| Subtotal | | | 447,295 | | | 440,747 |
| Valuation allowance | | (429,850) | | (422,325) | ||
| Total deferred tax assets | | | 17,445 | | | 18,422 |
| | | | | | | |
| Deferred tax liabilities: | | | | | | |
| Operating lease assets | | | (8,076) | | | (8,634) |
| Future contingent milestone and royalty assets | | | (14,512) | | | (11,725) |
| Total deferred tax liabilities | | | (22,588) | | | (20,359) |
| Net deferred tax liabilities | | $(5,143) | | $(1,937) | ||
The Company follows the accounting guidance related to accounting for income taxes which requires that a company reduces its deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some portion or all of its deferred tax assets will not be realized. During the year ended December 31, 2022, the Company concluded that the valuation allowance related to its US federal assets was no longer needed primarily due to the gain and forecasted future taxable income from the TRC Transaction, and as a result, the Company released its valuation allowance against deferred tax assets for US federal tax purposes in 2022 as it was more like than not able to fully utilize such attributes. As of December 31, 2023, the Company continues to maintain its position that a valuation allowance against deferred tax assets for US federal tax purposes is not needed, as it is more like than not able to fully utilize such attributes. As of December 31, 2023, the Company continues to maintain a full valuation allowance in other jurisdictions.
The valuation allowance increased from $422.3 million, as of December 31, 2022, to $429.9 million as December 31, 2023, primarily as a result of activity in the foreign deferred tax assets, as well as the state deferred tax assets during 2023. Valuation allowances require an assessment of both positive and negative evidence when determining whether it is more likely than not that the deferred tax assets are recoverable. As required, the Company prepares its assessment of the realizability of deferred tax assets on a jurisdiction-by jurisdiction basis.
As of December 31, 2023, the Company has utilized all available US federal net operating loss carryforwards and federal research and development tax credit carryforwards. As of December 31, 2023, the Company had state net operating loss carryforwards of $103.8 million which generally begin to expire in 2034 and state research and development credit carryforwards of $25.9 million to be carried forward indefinitely.
As of December 31, 2023, the Company had Irish net operating loss carryforwards of $1.16 billion with no expiration date and capital loss carryforwards of $65.1 million to be carried forward indefinitely. The Company has additional Irish tax attributes of $1.04 billion which primarily consist of unused capital allowances. Net operating losses and capital allowances can be used to offset future income from Irish entities and income related to intellectual property.
Utilization of federal and state net operating loss and tax credit carryforwards may be subject to an annual limitation due to ownership change limitations provided by the Internal Revenue Code and similar state provisions. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have been utilized.
Uncertain Tax Positions
A reconciliation of the beginning and ending balances of the total amounts of unrecognized tax benefits were as follows:
| | | | |
|---|---|---|---|
| (In thousands) · · | |||
| Unrecognized tax benefits as of December 31, 2021 | | $75,023 | |
| Gross decrease in tax positions for prior years | | | (7,395) |
| Gross increase in tax positions for current year | | | 8,371 |
| Unrecognized tax benefits as of December 31, 2022 | | | 75,999 |
| Gross decrease in tax positions for prior years | | | (632) |
| Gross increase in tax positions for current year | | | 4,103 |
| Unrecognized tax benefits as of December 31, 2023 | | $79,470 | |
The total unrecognized tax benefits of $79.5 million and $76.0 million, as of December 31, 2023 and December 31, 2022, respectively, would reduce the effective tax rate in the period of recognition. As of December 31, 2023, the Company does not believe that it is reasonably possible that its unrecognized tax benefit will significantly increase or decrease in the next twelve months. The Company is not currently under Internal Revenue Service (“IRS”) examination.
The Company records liabilities related to uncertain tax positions in accordance with the income tax guidance which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Resolution of one or more of these uncertain tax positions in any period may have a material impact on the results of operations for that period.
The Company's policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The amount of tax expense related to interest or penalties was $0.6 million for the year ended December 31, 2023 and was not material for the year ended December 31, 2022. The Company will continue to accrue interest on the respective uncertain tax positions in accordance with applicable rules.
The Company’s $65.3 million net liability for unrecognized tax benefits relating to uncertain tax positions, as of December 31, 2023, can be relieved only if (i) the contingency becomes legally extinguished through either payment to the taxing authority or expiration of the statute of limitations; (ii) the recognition of the benefits associated with the position meets the more likely than not threshold; or (iii) the liability becomes effectively settled through the examination process. The Company considers matters to be effectively settled once the taxing authority has completed all of its required or expected examination procedures, including all appeals and administrative reviews. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in its income tax expense (benefit) calculation.
The Company is subject to taxation in Ireland, the US, and various other jurisdictions. The tax years 2015 and forward remain open to examination in Ireland, tax years 2015 and forward remain open to examination in the US, and the tax years 2012 and forward remain open to examination in other jurisdictions.
The Company’s future income tax expense may be affected by such factors as changes in tax laws, regulations, its business, tax rates, interpretation of existing laws or regulations, the impact of accounting for share-based compensation, the impact of accounting for business combinations and other transactions, its international organization, shifts in the amount of income before tax earned in the US as compared with other regions in the world, and changes in overall levels of income before tax.
15. Capital Return Program
In September 2022, the Company’s board of directors authorized a $250.0 million capital return program consisting of three elements as described below.
GSK Share Repurchase
On September 20, 2022, the Company repurchased 9,644,807 ordinary shares, par value $0.00001 per share, of the Company from GSK Finance (No.3) plc (“GSK Finance”), representing all of the ordinary shares of the Company owned by GSK Finance or its affiliates. The purchase price under the Share Repurchase Agreement was $9.75 per share, resulting in a total consideration of $94.0 million. The repurchased shares were accounted for as authorized shares that areno longer issued and outstanding upon the settlement date of the repurchase transaction.
Modified Dutch Auction Tender Offer
On September 28, 2022, the Company announced a “modified Dutch auction” tender offer (the “Offer”) to purchase up to $95.0 million of its ordinary shares. Upon the terms and subject to the conditions set forth in the Company's Offer to Purchase, dated September 28, 2022 (the "Offer to Purchase"), and the related Letter of Transmittal, the Company offered to purchase up to $95.0 million of its ordinary shares, at a purchase price not greater than $10.50 nor less than $9.75 per share, in cash, less any applicable withholding taxes and without interest. The Offer expired at midnight, New York City time, at the end of the day on November 17, 2022.
A "modified Dutch auction" tender offer allows shareholders to indicate how many shares and at what price or within the range described above they wish to tender their shares. Based on the number of shares tendered and the prices specified by the tendering shareholders, the Company determined the lowest per-share price that enabled it to purchase up to $95.0 million of all shares that were validly tendered and not validly withdrawn. All shares accepted in the Offer were purchased at the same price even if tendered at a lower price.
On November 22, 2022, the Company completed the Offer and purchased a total of 115,967 ordinary shares at a price of $10.50 per share, for an aggregate cost of $1.2 million, excluding fees and expenses relating to the Offer. The total of 115,967 shares that were accepted for purchase represented approximately 0.2% of the total number of shares outstanding as of November 21, 2022. The purchased shares were cancelled and ceased to be outstanding. The Company used the unused portion of the Offer to enlarge its previously announced, planned open market share repurchase plan which is described below.
Open Market Share Repurchase Plan
In December 2022, the Company initiated its open market repurchase plan to repurchase ordinary shares, and in February 2023, the Company’s board of directors authorized a $75.0 million increase to the $250.0 million capital return program bringing the total capital return program to $325.0 million.
The table below summarizes the share repurchases under the Company’s open market repurchase plan for the following periods:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| (In thousands, except per share amounts) · 2023 · 2022 | ||||||
| Shares repurchased | | | 18,634 | | | 2,978 |
| Amount repurchased (excluding fees and expenses) | | $196,608 | | $32,946 | ||
| Weighted average cost per share (excluding fees and expenses) | | $10.551 | | $11.062 | ||
In January 2024, the Company repurchased an additional 38,462 shares on the open market at an weighted average cost of $11.551 per share for an approximate aggregate cost of $0.4 million, excluding fees and expenses, to compete its capital return program. Since the initiation of the capital return program in September 2022 through January 2024, the Company repurchased 31.41 million of shares at a weighted average price of $10.354 per share for an approximate aggregate cost of $325.3 million, excluding fees and expenses.
16. 2021 Corporate Restructuring Completion and 2023 Strategic Actions
2021 Corporate Restructuring
In September 2021, the Company announced a strategic update and corporate restructuring (the “2021 Restructuring”) to focus on leveraging its expertise in developing and commercializing respiratory therapeutics. As part of the 2021 Restructuring, the Company initiated an approximate 75% reduction in workforce. A majority of the reduction in workforce occurred in November 2021, and the remainder was completed in February 2022.
For the year ended December 31, 2022, the Company incurred restructuring and related expenses of$12.8 million of which $5.9 million were related to R&D expenses and $6.9 million were related to selling, general and administrative expenses. Of the total $12.8 million recognized for the year ended December 31, 2022, cash-related expenses were $5.8 million and non-cash expenses were $7.0 million which were primarily related to the modification of equity-based awards for employees affected by the 2021 Restructuring and certain related awards for other employees.
Since the 2021 Restructuring was announced and through its completion in September 2022, the Company incurred total restructuring and related expenses of$33.0 million of which$16.5 million was each related to R&D expenses andselling, general and administrative expenses. Of the total $33.0 million, cash-related expenses were $17.4 million and non-cash expenses were $15.6 million. As of December 31, 2022, all of the 2021 Restructuring and related expenses were fully recognized by the Company.
2023 Strategic Actions
In February 2023, the Company announced new strategic actions (the*“2023 Strategic Actions”*) that included the discontinuation of its research activities, including the inhaled Janus kinase (JAK) inhibitor program, resulting in a 17% reduction in headcount in March 2023. In order to support the timely progression of the ampreloxetine Phase 3 study (CYPRESS) and the recently completed of the YUPELRI Peak Inspiratory Flow Rate (PIFR-2) Phase 4 study, the Company prioritized its R&D resource allocation to thesetwo programs.
As a result of the Company’s discontinued investment in research activities, the Company incurred restructuring and related expenses of$2.7 million for the year ended December 31, 2023, primarily related to R&D expenses. Of the total $2.7 million incurred forthe year ended December 31, 2023, cash-related expenses were $1.2 million and non-cash expenses were $1.5 million which was primarily related to the loss on the sale of R&D laboratory equipment and the modification of equity-based awards for employees affected by the reduction in headcount. The R&D laboratory equipment sold had a carrying value of $2.7 million, and the sale generated net cash proceeds of $1.5 million. The Company does not expect to recognize any additional employee-related expenses, including share-based compensation, related to the 2023 Strategic Actions.
Selected information relating to accrued cash-related restructuring expenses from the 2023 Strategic Actions was as follows:
| | | | |
|---|---|---|---|
| (In thousands) · · | |||
| Balance at December 31, 2022 | | $— | |
| Net accruals | | | 1,188 |
| Cash paid | | (1,188) | |
| Balance at December 31, 2023 | | $— | |
The Company also evaluated the impact of the 2023 Strategic Actions on the carrying value of its long-lived assets, such as property and equipment and operating lease assets, and in March 2023, the Company placed approximately 42,000 square feet of its vacant office and laboratory space in South San Francisco (“Sublease Assets”) on the market for sublease. The Company’s impairment evaluation process for the Sublease Assets consisted of comparing the estimated undiscounted future sublease income of the Sublease Assets to its carrying value. The Company estimated the sublease income using market participant assumptions, including the length of time to enter into a sublease and sublease payments, which the Company evaluated using recent sublease negotiations and current local subleasing trends. While the Company has not yet completed a new sublease, based on its evaluation, the Company determined that
the estimated undiscounted future sublease income exceeds the Sublease Assets’ carrying value, and as a result, the Company did not recognize an impairment charge as of December 31, 2023. The Company will continue to update its sublease cash flow estimates based on changes in market conditions, and the Company may record a non-cash impairment charge in future periods as these estimates change.
17. Commitments and Contingencies
Contract Obligations
In the ordinary course of business, the Company may enter into agreements with service providers to assist in the performance of its clinical trials and other operational activities. Subject to required notice periods and other varying provisions regarding termination, the Company can elect to terminate such agreements at any time.
Lease Commitments
The Company leases certain office and laboratory space. See*“Note 8.* Leases,” for further information on the terms of these non-cancelable lease agreements.
Indemnifications
The Company indemnifies its directors and officers for certain events or occurrences, subject to certain limits, that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The Company maintains director and officer liability insurance policies that may limit its exposure. Assuming the applicability of insurance coverage, and subject to certain retention, loss limits, and other policy provisions, the Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company hasnot recognized any liabilities relating to these indemnification obligations as of either December 31, 2023 or 2022. However, no assurances can be given regarding the amounts that may ultimately be covered by the insurers, and it is possible that the Company may incur substantial liabilities in the future resulting from these indemnification obligations.
Legal Proceedings
In the ordinary course of business, the Company may be subject to legal claims and regulatory actions that could have a material adverse effect on its business or financial position. The Company assesses it potential liability in such situations by analyzing the possible outcomes of various litigation, regulatory, and settlement strategies. If the Company determines that a material loss is probable and its amount can be reasonably estimated, it will accrue an amount equal to the estimated loss. As of December 31, 2023, the Company did not accrue any estimated losses related to its ongoing legal proceedings.
Litigation – Patent Infringement
During January 2023, the Company received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc. (collectively, the “generic companies”), that they have each filed with FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a paragraph IV certification with respect to five of the Company’s patents listed in FDA’s Orange Book for YUPELRI on the date of the Company’s receipt of the notice. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, the Company filed patent infringement suits against the generic companies in federal district court, including the United States District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, and the U.S. District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of the Company’s Orange Book listed patents. The Company is seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe its patents. As a result of this lawsuit, a stay of approval through May 2026 has been imposed by the FDA on the generic companies’ ANDAs pending any adverse court decision. Additional patents covering YUPELRI granted on July 4, 2023 and January 2, 2024 were subsequently listed in FDA’s Orange Book. The Company filed additional patent infringement suits in the U.S. District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the
above action. Further, the original complaint was amended during December 2023 to include certain patents not listed in the Orange Book.
As of February 28, 2024, the Company has settled all litigation with Accord Healthcare, Inc.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc. pursuant to individual agreements in which the Company granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements. As required by law, the settlements are subject to review by the U.S. Department of Justice and the Federal Trade Commission. The patent litigation against the three remaining generic companies, along with certain affiliates, remains pending.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.