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COLLEGIUM PHARMACEUTICAL INC

For the period ended Mar 31, 2024. Filed May 9, 2024.

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About this filing

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

Mar 31, 2024 · Filed May 9, 2024

COLL$24.47-1.0%Stored close · as of Nov 10, 2026

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Item 1. Condensed Consolidated Financial Statements (Unaudited)

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

​​​​​​​
​ · ​ · March 31, · ​ · December 31,
​ · ​ · 2024 · ​ · 2023
Assets​​
Current assets​​​​​​
Cash and cash equivalents​$228,610​$238,947
Marketable securities​​89,438​​71,601
Accounts receivable, net​​174,693​​179,525
Inventory​​31,276​​32,332
Prepaid expenses and other current assets​15,243​15,195
Total current assets​539,260​537,600
Property and equipment, net​15,457​15,983
Operating lease assets​​5,813​​6,029
Intangible assets, net​​387,191​​421,708
Restricted cash​​1,047​​1,047
Deferred tax assets​​30,671​​26,259
Other noncurrent assets​​954​​825
Goodwill​​133,857​​133,857
Total assets​$1,114,250​$1,143,308
Liabilities and shareholders' equity​​​​​​
Current liabilities​​​​​​
Accounts payable​$6,020​$8,692
Accrued liabilities​38,190​37,571
Accrued rebates, returns and discounts​​217,880​​227,331
Current portion of term notes payable​​183,333​​183,333
Current portion of operating lease liabilities​​1,013​​988
Total current liabilities​446,436​457,915
Term notes payable, net of current portion​​177,360​​221,713
Convertible senior notes​​262,425​​262,125
Operating lease liabilities, net of current portion​5,860​6,124
Total liabilities​892,081​947,877
Commitments and contingencies (refer to Note 14)​​​​​​
Shareholders’ equity:​​​​​​
Preferred stock, $0.001 par value; authorized shares - 5,000,000​​—​​—
Common stock, $0.001 par value; authorized shares - 100,000,000; 39,029,639 issued and 32,705,747 outstanding shares as of March 31, 2024 and 38,192,441 issued and 31,868,549 outstanding shares as of December 31, 2023​39​38
Additional paid-in capital​565,111​565,949
Treasury stock, at cost; 6,323,892 shares as of March 31, 2024 and 6,323,892 shares as of December 31, 2023​​(137,381)​​(137,381)
Accumulated other comprehensive (loss) income​​(124)​​14
Accumulated deficit​(205,476)​(233,189)
Total shareholders’ equity​222,169​195,431
Total liabilities and shareholders’ equity​$1,114,250​$1,143,308

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Product revenues, net$144,923​$144,767
Cost of product revenues​​​​​
Cost of product revenues (excluding intangible asset amortization)​18,950​​29,899
Intangible asset amortization​34,517​​37,466
Total cost of product revenues53,467​67,365
Gross profit​91,456​​77,402
Operating expenses​​​​​
Selling, general and administrative41,982​52,775
Total operating expenses41,982​52,775
Income from operations49,474​24,627
Interest expense(17,339)​(21,427)
Interest income​4,487​​2,747
Loss on extinguishment of debt​—​​(23,504)
Income (loss) before income taxes​36,622​​(17,557)
Provision for (benefit from) income taxes​8,909​​(131)
Net income (loss)$27,713​$(17,426)
​​​​​​
Earnings (loss) per share — basic$0.86​$(0.51)
Weighted-average shares — basic​32,326,589​​34,319,291
​​​​​​
Earnings (loss) per share — diluted$0.71​$(0.51)
Weighted-average shares — diluted​41,438,466​​34,319,291

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Net income (loss)$27,713​$(17,426)
Other comprehensive loss:​​​​​
Unrealized losses on marketable securities, net of tax​(138)​​—
Total other comprehensive loss​(138)​​—
Comprehensive income (loss)$27,575​$(17,426)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

​​​​​​
​Three Months Ended March 31,
​ · ​ · 2024 · ​ · 2023
Operating activities​​​​​
Net income (loss)$27,713​$(17,426)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:​​​​​
Amortization expense​34,517​​37,466
Depreciation expense​917​​817
Deferred income taxes​(4,412)​​(46)
Stock-based compensation expense7,475​6,035
Non-cash lease benefit​(22)​​(105)
Non-cash interest expense for amortization of debt discount and issuance costs1,780​2,287
Loss on extinguishment of debt​—​​23,504
Net amortization of premiums and discounts on investments​(415)​​—
Changes in operating assets and liabilities:​​​​​
Accounts receivable​4,832​​3,993
Inventory​1,056​​13,606
Prepaid expenses and other assets(177)​(238)
Accounts payable(2,536)​(502)
Accrued liabilities660​(12,131)
Accrued rebates, returns and discounts​(9,451)​​(29,589)
Net cash provided by operating activities61,937​27,671
Investing activities​​​​​
Purchases of property and equipment​(568)​(176)
Purchases of marketable securities​(39,110)​​—
Maturities of marketable securities​21,550​​—
Net cash used in investing activities(18,128)​(176)
Financing activities​​​​​
Proceeds from issuances of common stock from employee stock purchase plan​356​​169
Proceeds from the exercise of stock options4,205​3,848
Payments made for employee stock tax withholdings​(12,874)​​(7,736)
Repayment of term notes​(45,833)​​(25,000)
Proceeds from issuances of 2029 Convertible Notes, net of issuance costs of $5,846​—​​235,654
Repurchase of 2026 Convertible Notes, including premium​—​​(138,638)
Net cash (used in) provided by financing activities(54,146)​68,297
​​​​​​
Net (decrease) increase in cash, cash equivalents and restricted cash(10,337)​95,792
Cash, cash equivalents and restricted cash at beginning of period239,994​176,235
Cash, cash equivalents and restricted cash at end of period$229,657​$272,027
​​​​​​
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:​​​​​
Cash and cash equivalents$228,610​$269,480
Restricted cash​1,047​​2,547
Total cash, cash equivalents and restricted cash$229,657​$272,027
​​​​​​
Supplemental disclosure of cash flow information​​​​​
Cash paid for interest$17,468​$19,499
Cash paid for income taxes$173​$743
​​​​​​
​​​​​​
Supplemental disclosure of non-cash activities​​​​​
Note issuance costs in accounts payable and accrued liabilities$—​$434

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in thousands, except share and per share amounts)

1. Nature of Business

Collegium Pharmaceutical, Inc. (the “Company” or “Collegium”) was incorporated in Delaware in April 2002 and then reincorporated in Virginia in July 2014. The Company has its principal operations in Stoughton, Massachusetts. The Company’s mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company’s portfolio includes Belbuca, Xtampza ER, Nucynta ER and Nucynta IR (collectively the “Nucynta Products”), and Symproic.

The Company’s operations are subject to certain risks and uncertainties. The principal risks include the Company’s ability to continue successfully commercializing products, changing market conditions for products and development of competing products, changing regulatory environment and reimbursement landscape, product-related litigation, manufacture of adequate commercial inventory, inability to secure adequate supplies of active pharmaceutical ingredients, key personnel retention, protection of intellectual property, and patent infringement litigation.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited Condensed Consolidated Financial Statements include the accounts of Collegium Pharmaceutical, Inc. (a Virginia corporation) and its subsidiaries. The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete consolidated financial statements.

In the opinion of the Company’s management, the accompanying unaudited Condensed Consolidated Financial Statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to fairly present the financial position of the Company as of March 31, 2024, the results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the full year.

The preparation of the Condensed Consolidated Financial Statements in accordance with GAAP requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues, costs and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. Estimates in the Company’s consolidated financial statements include revenue recognition, including the estimates of product returns, discounts and allowances related to commercial sales of products, estimates related to the fair value of assets acquired and liabilities assumed, including acquired intangible assets and the fair value of inventory acquired, estimates utilized in the ongoing valuation of inventory related to potential unsaleable product, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, impairment of intangible assets and deferred tax valuation allowances. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. The consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s most recently filed annual report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”).

There were no significant changes in the Company’s significant accounting policies from those described in the Company’s Annual Report.

Subsequent Events

Redemption of 2026 Convertible Notes

On April 11, 2024, the Company announced that it called all $26,350 aggregate principal amount of its outstanding 2.625% convertible senior notes due in 2026 (the “2026 Convertible Notes”) for redemption on June 14, 2024 (the “Redemption Date”).

The redemption price will be equal to 100% of the principal amount of each 2026 Convertible Note called for redemption, plus accrued and unpaid interest on such 2026 Convertible Note to, but excluding, the Redemption Date for such 2026 Convertible Note (the “Redemption Price”). For each $1,000 principal amount of 2026 Convertible Notes, the Redemption Price is equal to approximately $1,008.68.

The sending of the notice of redemption to the holders of the 2026 Convertible Notes constituted a “Make-Whole Fundamental Change” under the Indenture, and therefore the conversion rate was required to be increased in accordance with the terms of the Indenture. The conversion rate reflecting such increase is 36.7815 shares of common stock per $1,000 principal amount of 2026 Convertible Notes. This conversion rate will remain subject to adjustment in accordance with the Indenture from time to time for certain events.

The Company elected to settle all conversions of the 2026 Convertible Notes in cash. The cash paid to the holders to settle the conversions that is in excess of the carrying amount of the 2026 Convertible Notes, along with unamortized debt issuance costs, will be recognized as a loss on extinguishment of debt in the Company’s Condensed Consolidated Statement of Operations in the second quarter of 2024.

Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc.

On April 26, 2024, the Company entered into an Authorized Generic Agreement (the “AG Agreement”) with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which the Company granted to Hikma certain rights relating to an authorized generic version of the Company’s Nucynta IR product (the “Nucynta IR Authorized Generic”) and the Company’s Nucynta ER product (the “Nucynta ER Authorized Generic” and, collectively, the “Nucynta AG Products”) in the United States.

Under the terms of the AG Agreement, the Company granted Hikma the exclusive right to market the Nucynta AG Products in the United States. Hikma agreed to launch the Nucynta IR Authorized Generic and the Nucynta ER Authorized Generic 30 days prior to loss of exclusivity for each product or earlier under certain circumstances as set forth in the AG Agreement. Hikma will pay the Company a percentage of Net Profits (as defined in the AG Agreement) on sales of the Nucynta AG Products, with the Company’s profit share percentage beginning in the mid-80% range, and declining based on the number of third-party generic equivalents sold for each Nucynta AG Product, if any. During the term of the AG Agreement, the Company will supply Hikma with its requirements of the Nucynta AG Products at Collegium’s fully burdened manufacturing cost and Hikma will purchase the Nucynta AG Products exclusively from the Company. In addition, Hikma agreed that it will not market any generic equivalent of Nucynta IR or Nucynta ER at the same time it is marketing the Nucynta AG Products.

The AG Agreement has an initial term offive years, with automaticone-year renewals unless notice of termination is provided by either party prior to expiration. The AG Agreement may be terminated by either party in the event of uncured material breach by the other party or certain bankruptcy or insolvency events experienced by the other party. In addition, if Hikma elects to launch its own generic equivalent for either (or both) of Nucynta IR or Nucynta ER and terminate the AG Agreement, it must provideone years’ notice prior to doing so, and may only provide such notice on or after the first anniversary of the first Nucynta AG Product launch.

The foregoing description of the AG Agreement does not purport to be complete and is qualified in its entirety by reference to the AG Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2024.

Accelerated Share Repurchase Program

In May 2024, the Company’s Board of Directors authorized an accelerated share repurchase program to repurchase $35,000 of the Company’s common stock, as part of the $150,000 repurchase program authorized in January 2024.

Recently Adopted Accounting Pronouncements

New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as required by the specified effective dates.

The Company has not been required to adopt any accounting standards that had a significant impact on its condensed consolidated financial statements during the three months ended March 31, 2024.

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB issued ASU 2023-07*, Segment Reporting (Topic 280).*The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for fiscal years beginning after December 15, 2023 for the Company’s annual report, and interim periods within fiscal years beginning after December 15, 2024. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740). The amendments in this update expand income tax disclosure requirements, including additional information pertaining to the rate reconciliation, income taxes paid, and other disclosures. This update is effective for annual periods beginning after December 15, 2024. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements.

Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.

3. Revenue from Contracts with Customers

The Company’s revenue to date is from sales of the Company’s products, which are primarily sold to wholesalers (“customers”), which in turn sell the product to pharmacies or other outlets for the treatment of patients.

Revenue Recognition

The Company recognizes revenue when a 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 with a customer, the Company 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. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the assets isone year or less.

Performance Obligations

The Company determined that performance obligations are satisfied, and revenue is recognized, when a customer takes control of the Company’s product, which occurs at a point in time. This generally occurs upon delivery of the products to

customers, at which point the Company recognizes revenue and records accounts receivable. Payment is typically received 30 to 90 days after satisfaction of the Company’s performance obligations.

Transaction Price and Variable Consideration

Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). The transaction price for product sales includes variable consideration related to sales deductions, including: (i) rebates and incentives, including managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances; (ii) product returns, including return estimates; and, (iii) trade allowances and chargebacks, including fees for distribution services, prompt pay discounts, and chargebacks. The Company will estimate the amount of variable consideration that should be included in the transaction price under the expected value method for all sales deductions other than trade allowances, which are estimated under the most likely amount method. These provisions reflect the expected amount of consideration to which the Company is entitled based on the terms of the contract. In addition, the Company made a policy election to exclude from the measurement of the transaction price all taxes that are assessed by a governmental authority that are imposed on revenue-producing transactions.

The Company bases its estimates of variable consideration, which could include estimates of future rebates, returns, and other adjustments, on historical data and other information. Estimates include: (i) timing of the rebates and returns incurred; (ii) pricing adjustments related to rebates and returns; and (iii) the quantity of product that will be rebated or returned in the future. Significant judgment is used in determining the appropriateness of these assumptions at each reporting period.

Rebates and Incentives

Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the related sales. As the Company’s rebates and incentives are based on products dispensed to patients, the Company is required to estimate the expected value of claims at the time of product delivery to wholesalers. Given that wholesalers sell the product to pharmacies, which in turn dispense the product to patients, claims can be submitted significantly after the related sales are recognized. The Company’s estimates of these claims are based on the historical experience of existing or similar programs, including current contractual and statutory requirements, specific known market events and trends, industry data, and estimated distribution channel inventory levels. Accruals and related reserves required for rebates and incentives are adjusted as new information becomes available, including actual claims. If actual results vary, the Company may need to adjust future estimates, which could have an effect on earnings in the period of the adjustment.

Product Returns

Provisions for product returns, including returns for Belbuca, Xtampza, the Nucynta Products, and Symproic, are based on product-level returns rates, including processed as well as unprocessed return claims, in addition to relevant market events and other factors. Estimates of future product returns are made at the time of revenue recognition to determine the amount of consideration to which the Company expects to be entitled (that is, excluding the products expected to be returned). At the end of each reporting period, the Company analyzes trends in returns rates and updates its assessment of variable consideration. To the extent the Company receives amounts in excess of what it expects to be entitled to receive due to a product return, the Company does not recognize revenue when it transfers products to customers but instead recognizes those excess amounts received as a refund liability. The Company updates the measurement of the refund liability at the end of each reporting period for changes in expectations about the amount of refunds with the corresponding adjustments recognized as revenue (or reductions of revenue).

The Company provides the right of return to its customers for an 18-month window beginningsix months prior to expiration and up until twelve months after expiration. The Company’s customers short-pay an existing invoice upon notice of a product return claim. Adjustments to the preliminary short-paid claims are processed when the return claim is validated and finalized. The Company’s return policy requires that product is returned and that the return is claimed within the 18-month window.

Trade Allowances and Chargebacks

Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and chargebacks processed relating to sales recognized.

At the end of each reporting period, the Company updates the estimated transaction price (including updating its assessment of whether an estimate of variable consideration is constrained). Variable consideration, including the risk of customer concessions, is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is subsequently resolved.

Significant judgment is required to determine the variable consideration included in the transaction price as described above. Adjustments to the estimated variable consideration included in the transaction price occur when new information indicates that the estimate should be revised. If the value of accepted and processed claims is different than the amount estimated and included in variable consideration, then adjustments would impact product revenues, net and earnings in the period such revisions become known. The amount of variable consideration ultimately received and included in the transaction price may materially differ from the Company’s estimates, resulting in additional adjustments recorded to increase or decrease product revenues, net.

The following tables summarize activity in each of the Company’s product revenue provision and allowance categories for the three months ended March 31, 2024 and 2023:

​​​​​​​​​​
​ · ​ · ​ · ​ · ​ · Trade
​ · ​ · Rebates and · ​ · Product · ​ · Allowances and
​ · ​ · Incentives (1) · ​ · Returns (2) · ​ · Chargebacks (3)
Balance as of December 31, 2023​$149,826​$77,505​$20,917
Provision related to current period sales​​92,569​​9,697​​39,013
Changes in estimate related to prior period sales​​1,061​​1,519​​(53)
Credits/payments made​​(105,228)​​(9,069)​​(39,245)
Balance as of March 31, 2024​$138,228​$79,652​$20,632
​​​​​​​​​​
​ · ​ · ​ · ​ · Trade
​ · ​ · Rebates and · ​ · Product · ​ · Allowances and
​ · ​ · Incentives (1) · ​ · Returns (2) · ​ · Chargebacks (3)
Balance as of December 31, 2022​$156,937​$73,554​$22,058
Provision related to current period sales​​92,871​​10,166​​34,921
Changes in estimate related to prior period sales​​36​​571​​92
Credits/payments made​​(122,852)​​(10,381)​​(32,563)
Balance as of March 31, 2023​$126,992​$73,910​$24,508
(1)Provisions for rebates and incentives include managed care rebates, government rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s consolidated balance sheets.
(2)Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s consolidated balance sheets.
(3)Provisions for trade allowances and chargebacks include fees for distribution service fees, prompt pay discounts, and chargebacks. Trade allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s consolidated balance sheets.

As of March 31, 2024, the Company did not have any transaction price allocated to remaining performance obligations and any costs to obtain contracts with customers, including pre-contract costs and set up costs, were immaterial.

Disaggregation of Revenue

The Company discloses disaggregated revenue from contracts with customers into categories that depict how the nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factors. When selecting the type of category to use to disaggregate revenue, the Company considers how information about the Company’s revenue has been presented for other purposes as well as what information is regularly reviewed and used for evaluating financial performance. As such, the Company disaggregates its product revenues, net from contracts with customers by product, as disclosed in the table below.

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Belbuca$50,663​$44,212
Xtampza ER​45,813​47,869
Nucynta IR​25,960​​27,899
Nucynta ER​19,186​​21,136
Symproic​3,301​​3,651
Total product revenues, net$144,923​$144,767

4. Earnings Per Share

Basic earnings per share is calculated by dividing the net income or loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted earnings per share is computed by dividing the net income or loss by the weighted-average number of shares of common stock, plus potentially dilutive securities outstanding for the period, as determined in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security. For purposes of the diluted earnings per share calculation, stock options, restricted stock units (“RSUs”), performance share units (“PSUs”), and shares potentially issuable in connection with the Company’s employee stock purchase plan and convertible senior notes are considered potentially dilutive securities and included to the extent that their addition is not antidilutive.

The following table presents the computations of basic and dilutive earnings per common share:

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Numerator:​​​​​
Net income (loss)$27,713​$(17,426)
Adjustment for interest expense recognized on convertible senior notes​1,622​​—
Net income (loss) - diluted$29,335​$(17,426)
Denominator:​​​​​
Weighted-average shares outstanding — basic​32,326,589​34,319,291
Effect of dilutive securities:​​​​​
Stock options​468,057​​—
Restricted stock units​1,134,716​​—
Performance share units​—​​—
Convertible senior notes​7,509,104​​—
Weighted average shares outstanding — diluted​41,438,466​​34,319,291
​​​​​​
Earnings (loss) per share — basic$0.86​$(0.51)
Earnings (loss) per share — diluted$0.71​$(0.51)

The Company has the option to settle the conversion obligation for its convertible senior notes due in 2026 and 2029 in cash, shares or a combination of the two. On April 11, 2024, the Company announced that it called all $26,350 aggregate principal amount of its 2026 Convertible Notes for redemption on the Redemption Date (refer to Note 2,Summary of Significant Accounting Policies – Subsequent Events), which represented 902,799 shares included in the diluted earnings per share for the three months ended March 31, 2024. The Company uses the if-converted method for the convertible senior notes.

The following table presents dilutive securities excluded from the calculation of diluted earnings per share:

​​​​
​Three Months Ended March 31,
​ · 2024 · 2023
Stock options—​1,443,996
Restricted stock units1,050​2,455,919
Performance share units511,680​503,880
Employee stock purchase plan17,320​—
Convertible senior notes—​7,509,104

For PSUs, these securities were excluded from the calculation of diluted earnings per share as the market-based vesting conditions were not met as of the end of the reporting period. All other securities presented in the table above were excluded from the calculation of diluted earnings per share as their inclusion would have had an antidilutive effect.

5. Fair Value of Financial Instruments

Fair value measurements and disclosures describe the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, as follows:

​​
Level 1 inputs:Quoted prices (unadjusted) in active markets for identical assets or liabilities. An active market is defined as a market where transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2 inputs:Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.
Level 3 inputs:Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

The Company invests in instruments within defined credit parameters to minimize credit risk while ensuring liquidity.

There wereno transfers between Levels 1, 2, and 3 during the three months ended March 31, 2024 and 2023.

The following table presents the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument as of March 31, 2024 and December 31, 2023:

​​​​​​​​​​​​​
​​​​​​​​​Significant​​​
​​​​​​Quoted Prices​​other​​Significant
​​​​​​in active​​observable​​unobservable
​​​​​​markets​​inputs​​inputs
​ · ​ · Total · ​ · (Level 1) · ​ · (Level 2) · ​ · (Level 3)
March 31, 2024​​​​​​​​​​​​
Cash equivalents:​​​​​​​​​​​​
Money market funds​$69,772​$69,772​$—​$—
Marketable securities:​​​​​​​​​​​​
Corporate debt securities​​62,501​​—​​62,501​​—
U.S. Treasury securities​​24,442​​—​​24,442​​—
Government-sponsored securities​​2,495​​—​​2,495​​—
Total assets measured at fair value​$159,210​$69,772​$89,438​$—
​​​​​​​​​​​​​
December 31, 2023​​​​​​​​​​​​
Cash equivalents:​​​​​​​​​​​​
Money market funds​$77,299​$77,299​$—​$—
U.S. Treasury securities​​4,729​​—​​4,729​​—
Marketable securities:​​​​​​​​​​​​
Corporate debt securities​​41,612​​—​​41,612​​—
U.S. Treasury securities​​25,468​​—​​25,468​​—
Government-sponsored securities​​4,521​​—​​4,521​​—
Total assets measured at fair value​$153,629​$77,299​$76,330​$—

The Company’s cash equivalents, which consist of money market funds, are measured at fair value on a recurring basis using quoted market prices. Accordingly, these securities are categorized as Level 1.

Assets and Liabilities Not Carried at Fair Value

The Company’s convertible senior notes fall into the Level 2 category within the fair value level hierarchy. The fair value was determined based on data points other than quoted prices that are observable, either directly or indirectly, such as broker quotes in a non-active market. As of March 31, 2024, the fair value of the Company's 2.625% convertible senior notes due in 2026 was $37,624 and the net carrying value was $26,033. As of March 31, 2024, the fair value of the Company's 2.875% convertible senior notes due in 2029 was $272,798 and the net carrying value was $236,392.

The Company’s term notes fall into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. As of March 31, 2024, the carrying amount of the term notes reasonably approximated the estimated fair value.

As of March 31, 2024, and December 31, 2023, the carrying amounts of cash and cash equivalents, accounts receivable, inventory, prepaid expenses and other current assets, accounts payable, accrued liabilities, and accrued rebates, returns and discounts reasonably approximated their estimated fair values.

6. Marketable Securities

Available-for-sale debt securities were classified on the condensed consolidated balance sheets at fair value as follows:

​​​​​​​
​ · ​ · March 31, · ​ · December 31,
​ · 2024 · ​ · 2023
Cash and cash equivalents​$—​$4,729
Marketable securities​​89,438​​71,601
Total​$89,438​$76,330

The following table summarizes the available-for-sale securities held as of March 31, 2024 and December 31, 2023:

​​​​​​​​​​​​​
March 31, 2024 · ​ · Amortized Cost · Gross Unrealized Gains · Gross Unrealized Losses · ​ · Fair Value
Corporate debt securities​$62,618​$10​$(127)​$62,501
U.S. Treasury securities​​24,448​​—​​(6)​​24,442
Government-sponsored securities​​2,496​​—​​(1)​​2,495
Total​$89,562​$10​$(134)​$89,438
​​​​​​​​​​​​​
December 31, 2023​​​​​​​​​​​​
Corporate debt securities​$41,610​$47​$(45)​$41,612
U.S. Treasury securities​​30,189​​8​​—​​30,197
Government-sponsored securities​​4,517​​4​​—​​4,521
Total​$76,316​$59​$(45)​$76,330

The following table summarizes the contractual maturities of available-for-sale securities other than investments in money market funds as of March 31, 2024 and December 31, 2023:

​​​​​​​
​ · ​ · March 31, · ​ · December 31,
​ · 2024 · ​ · 2023
Matures within one year​$60,015​$61,672
Matures after one year through five years​​29,423​​14,658
Total​$89,438​$76,330

The unrealized losses on the Company’s available-for-sale securities were immaterial as of March 31, 2024 and December 31, 2023. In addition, there wereno sales of marketable securities during the three months ended March 31, 2024. Net unrealized holding gains or losses for the period that have been included in accumulated other comprehensive loss were not material to the Company’s condensed consolidated results of operations.

The Company did not record any allowances for credit losses to adjust the fair value of available-for-sale debt securities during the three months ended March 31, 2024. The Company reviews its investments for other-than-temporary impairment whenever the fair value of an investment is less than amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers whether it has the ability and intent to hold the investment until a market price recovery and considers whether evidence indicating the cost of the investment is recoverable outweighs evidence to the contrary. The Company generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position. As such, the Company did not hold any securities with other-than-temporary impairment as of March 31, 2024 and December 31, 2023.

7. Inventory

Inventory as of March 31, 2024 and December 31, 2023 consisted of the following:

​​​​​​​
​ · ​ · March 31, · ​ · December 31,
​ · ​ · 2024 · ​ · 2023
Raw materials​$9,265​$10,384
Work in process​​8,706​​6,740
Finished goods​​13,305​​15,208
Total inventory​$31,276​$32,332

The aggregate charges related to excess and obsolete inventory for the three months ended March 31, 2024 and 2023 were$373 and$906, respectively. These expenses were recorded as a component of cost of product revenues.

8. Goodwill and Intangible Assets

As of March 31, 2024 and December 31, 2023, the Company’s goodwill balance was $133,857. The Company’s goodwill resulted from the acquisition of BioDelivery Sciences International, Inc. (“BDSI”) on March 22, 2022 (the “BDSI Acquisition”).

The following table sets forth the cost, accumulated amortization, and carrying amount of intangible assets as of March 31, 2024 and December 31, 2023:

​​​​​​​​​​​​​​​​​​​
​ · ​ · March 31, 2024 · ​ · December 31, 2023
​​​Cost​​Accumulated Amortization​​Carrying Amount​​Cost​​Accumulated Amortization​​Carrying Amount
Belbuca​$360,000​$(152,669)​$207,331​$360,000​$(133,821)​$226,179
Nucynta Products​​521,170​​(396,555)​​124,615​​521,170​​(382,710)​​138,460
Symproic​​70,000​​(14,755)​​55,245​​70,000​​(12,931)​​57,069
Total intangible assets​$951,170​$(563,979)​$387,191​$951,170​$(529,462)​$421,708

The following table presents amortization expense recognized in cost of product revenues forthe three months ended March 31, 2024 and 2023:

​​​​​​
​Three Months Ended March 31,
​ · ​ · 2024 · ​ · 2023
Belbuca$18,848$18,849
Nucynta Products​13,845​​16,796
Symproic​1,824​​1,821
Total amortization expense$34,517​$37,466

As of March 31, 2024, the remaining amortization expense expected to be recognized is as follows:

​​​​​​​​​​​​
Years ended December 31, · Belbuca · ​ · Nucynta Products · ​ · Symproic · ​ · Total
2024$56,545​$41,539​$5,461​$103,545
2025​75,393​​55,384​​7,285​​138,062
2026​75,393​​27,692​​7,285​​110,370
2027​—​​—​​7,285​​7,285
2028​—​​—​​7,285​​7,285
Thereafter​—​​—​​20,644​​20,644
Remaining amortization expense$207,331​$124,615​$55,245​$387,191

9. Accrued Liabilities

Accrued liabilities as of March 31, 2024 and December 31, 2023 consisted of the following:

​​​​​​
​ · March 31, · ​ · December 31,
​ · 2024 · 2023
Accrued income taxes$14,077​$2,136
Accrued royalties​7,141​​14,198
Accrued product taxes and fees5,525​​5,013
Accrued sales and marketing​1,754​​1,198
Accrued incentive compensation​1,519​1,375
Accrued audit and legal​1,430​​700
Accrued bonuses​1,406​​4,987
Accrued inventory​1,338​​—
Accrued payroll and related benefits​968​​1,511
Accrued interest944​2,853
Accrued other operating costs​2,088​​3,600
Total accrued liabilities$38,190​$37,571

10. Term Notes Payable

2022 Term Loan

On March 22, 2022, in connection with the closing of the BDSI Acquisition, the Company entered into an Amended and Restated Loan Agreement by and among the Company, and BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (collectively “Pharmakon”), as amended (the “2022 Loan Agreement”). The 2022 Loan Agreement provided for a$650,000 secured term loan (the “2022 Term Loan”), the proceeds of which were used to repay the Company’s existing term notes and fund a portion of the consideration to be paid to complete the BDSI Acquisition. The 2022 Loan Agreement was accounted for as a debt modification and transaction fees of$173 were expensed. In connection with the 2022 Loan Agreement, the Company paid loan commitment and other fees to the lender of$19,818, which together with preexisting debt issuance costs and note discounts of$2,049 will be amortized over the term of the loan using the effective interest rate.

The 2022 Term Loan will mature on the 48-month anniversary of the closing of the BDSI Acquisition and is guaranteed by the Company’s material domestic subsidiaries. The 2022 Term Loan is also secured by substantially all of the assets of the Company and its material domestic subsidiaries. Prior to the cessation of LIBOR on June 30, 2023, the 2022 Term Loan bore interest at a rate based on LIBOR (subject to a LIBOR floor of 1.20%), plus a margin of 7.5% per annum. On June 23, 2023, the Company entered into an amendment to the 2022 Loan Agreement to adjust the interest terms of the 2022 Term Loan to transition from LIBOR to SOFR in anticipation of the cessation of LIBOR. Effective July 1, 2023, the 2022 Term Loan bears interest at a rate based on SOFR plus a spread adjustment of 0.26% (subject to a floor of 1.20%), plus a margin of 7.5% per annum. As of March 31, 2024, the contractual interest rate was 13.1%. The Company paid $100,000 in principal payments under the 2022 Term Loan during the first year and the remaining $550,000 balance is required to be paid in equal quarterly installments over the remaining three years.

The 2022 Loan Agreement permits voluntary prepayment at any time, subject to a prepayment premium. The prepayment premium is equal to 2.00% of the principal amount being prepaid prior to the second-year anniversary of the closing date, or 1.00% of the principal amount being prepaid on or after the second-year anniversary of the closing date. The 2022 Loan Agreement also includes a make-whole premium in the event of a voluntary prepayment, a prepayment due to a change in control or acceleration following an Event of Default (as defined in the 2022 Loan Agreement) on or prior to the second-year anniversary of the closing date, in each case in an amount equal to foregone interest from the date of prepayment through the second-year anniversary of the closing date. A change of control also triggers a mandatory prepayment of the 2022 Term Loan.

The 2022 Loan Agreement contains certain covenants and obligations of the parties, including, without limitation, covenants that limit the Company’s ability to incur additional indebtedness or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business. Failure to comply with these covenants would

constitute an Event of Default under the 2022 Loan Agreement, notwithstanding the Company’s ability to meet its debt service obligations. The 2022 Loan Agreement also includes various customary remedies for the lenders following an Event of Default, including the acceleration of repayment of outstanding amounts under the 2022 Loan Agreement and execution upon the collateral securing obligations under the 2022 Loan Agreement.

The following table presents the total interest expense recognized related to the 2022 Term Loan during the three months ended March 31, 2024 and 2023.

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Contractual interest expense$13,651​$17,655
Amortization of debt issuance costs​1,480​​2,024
Total interest expense$15,131​$19,679

As of March 31, 2024, the effective interest rate on the 2022 Term Loan was 14.6%.

As of March 31, 2024, principal repayments under the 2022 Term Loan are as follows:

​​​
Years ended December 31, · Principal Payments
2024$137,500
2025​183,333
2026​45,834
Total before unamortized discount and issuance costs$366,667
Less: unamortized discount and issuance costs​(5,974)
Term notes carrying value$360,693

11. Convertible Senior Notes

2026 Convertible Notes

On February 13, 2020, the Company issued 2.625% convertible senior notes due in 2026 (the “2026 Convertible Notes”) in the aggregate principal amount of $143,750, in a public offering registered under the Securities Act of 1933, as amended. The 2026 Convertible Notes were issued in connection with funding the acquisition of the Nucynta Products. Some of the Company’s existing investors participated in the 2026 Convertible Notes offering. In connection with the issuance of the 2026 Convertible Notes, the Company incurred approximately $5,473 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees.

The 2026 Convertible Notes are senior, unsecured obligations and bear interest at a rate of 2.625% per year payable semi-annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2020. Before August 15, 2025, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after August 15, 2025, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The 2026 Convertible Notes will mature on February 15, 2026, unless earlier repurchased, redeemed or converted. The initial conversion rate is 34.2618 shares of common stock per $1 principal amount of the 2026 Convertible Notes, which represents an initial conversion price of approximately $29.19 per share of common stock. The conversion rate and conversion price are subject to adjustment upon the occurrence of certain events.

Holders of the 2026 Convertible Notes may convert all or any portion of their 2026 Convertible Notes, in multiples of $1 principal amount, at their option only under the following circumstances:

(1)during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter;
(2)during the five consecutive business days immediately after any 10 consecutive trading day period (such 10 consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal amount of the 2026 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day;
(3)upon the occurrence of certain corporate events or distributions on the Company’s common stock;
(4)if the Company calls the 2026 Convertible Notes for redemption; or
(5)at any time from, and including, August 15, 2025 until the close of business on the scheduled trading day immediately before the maturity date.

As of March 31, 2024, none of the above circumstances had occurred and as such, the 2026 Convertible Notes could not have been converted.

The Company did not have the right to redeem the 2026 Convertible Notes prior to February 15, 2023. On or after February 15, 2023, the Company may redeem the 2026 Convertible Notes, in whole and not in part, at a cash redemption price equal to the principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on:

(1)each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and
(2)the trading day immediately before the date the Company sends such notice.

Calling the 2026 Convertible Notes for redemption constitutes a make-whole fundamental change, in which case the conversion rate applicable to the conversion of any 2026 Convertible Notes, if converted in connection with the redemption, will be increased in certain circumstances for a specified period of time.

The 2026 Convertible Notes have customary default provisions, including: (i) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest on any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture, if such default is not cured within 3 calendar days after its occurrence; (iv) a default with respect to the Company’s obligations under the indenture related to consolidations, mergers and asset sales; (v) a default in any of the Company’s other obligations or agreements under the indenture that are not cured or waived within 60 days after notice to the Company; (vi) certain payment defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for indebtedness for money borrowed of at least$20,000 or other defaults by the Company or certain subsidiaries with respect to such indebtedness that result in the acceleration of such indebtedness; (vii) default upon the occurrence of one or more final judgments being rendered against the Company or any of the Company’s significant subsidiaries for the payment of at least$20,000; and (viii) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of its significant subsidiaries.

Repurchase of a Portion of the 2026 Convertible Notes

Contemporaneously with the offering of the 2029 Convertible Notes (as defined below), the Company entered into separate privately negotiated transactions with certain holders of the 2026 Convertible Notes to repurchase $117,400 aggregate principal amount of the 2026 Convertible Notes for an aggregate of $140,100 of cash, which includes accrued and unpaid interest on the 2026 Convertible Notes to be repurchased. This transaction involved a contemporaneous exchange of cash between the Company and holders of the 2026 Convertible Notes participating in the issuance of the 2029 Convertible Notes. Accordingly, the Company evaluated the transaction for modification or extinguishment accounting in accordance with Accounting Standards Codification Topic 470-50*, Debt – Modifications and Extinguishments* on a creditor-by-creditor basis depending on whether the exchange was determined to have substantially different terms. The repurchase of the 2026 Convertible Notes and issuance of the 2029 Convertible Notes were deemed to have substantially different terms based on the present value of the cash flows immediately prior to and after the exchange. Therefore, the repurchase of the 2026 Convertible Notes was accounted for as a debt extinguishment. The Company recorded a $23,504 loss on early extinguishment of debt on the condensed consolidated statements of operations during the three months ending March 31, 2023, which includes the recognition of previously deferred

financing costs of $2,264. The total remaining principal amount outstanding under the 2026 Convertible Notes as of March 31, 2024 was $26,350. On April 11, 2024, the Company announced that it called all $26,350 aggregate principal amount of its 2026 Convertible Notes for redemption on the Redemption Date (refer to Note 2,Summary of Significant Accounting Policies – Subsequent Events).

2029 Convertible Notes

On February 10, 2023, the Company issued 2.875% convertible senior notes due in 2029 (the “2029 Convertible Notes”) in the aggregate principal amount of $241,500, in a private offering to qualified institutional buyers pursuant to Section 4(a)(2) and Rule 144A under the Securities Act of 1933, as amended. The 2029 Convertible Notes were issued to finance the concurrent repurchase of a portion of the 2026 Convertible Notes, and the remainder of the net proceeds may be used for general corporate purposes. In connection with the issuance of the 2029 Convertible Notes, the Company incurred approximately $6,280 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees.

The 2029 Convertible Notes are senior, unsecured obligations and bear interest at a rate of 2.875% per year payable semi-annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2023. The 2029 Convertible Notes will mature on February 15, 2029, unless earlier repurchased, redeemed or converted. Before November 15, 2028, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after November 15, 2028, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate is 27.3553 shares of common stock per $1 principal amount of 2029 Convertible Notes, which represents an initial conversion price of approximately $36.56 per share of common stock. The conversion rate and conversion price are subject to adjustment upon the occurrence of certain events.

Holders of the 2029 Convertible Notes may convert all or any portion of their 2029 Convertible Notes, in multiples of $1 principal amount, at their option only under the following circumstances:

(1)during any calendar quarter commencing after the calendar quarter ending on June 30, 2023, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter;
(2)during the five consecutive business days immediately after any 10 consecutive trading day period (such 10 consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal amount of the 2029 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day;
(3)upon the occurrence of certain corporate events or distributions on the Company’s common stock;
(4)if the Company calls any or all of the 2029 Convertible Notes for redemption, but only with respect to the 2029 Convertible Notes called for redemption; or
(5)at any time from, and including, November 15, 2028 until the close of business on the scheduled trading day immediately before the maturity date.

As of March 31, 2024, none of the above circumstances had occurred and as such, the 2029 Convertible Notes could not have been converted.

The Company may not redeem the 2029 Convertible Notes prior to February 17, 2026. On or after February 17, 2026 and on or before the 40 th scheduled trading day before the maturity date, the Company may redeem the 2029 Convertible Notes, in whole or in part, at a cash redemption price equal to the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on:

(1)each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and
(2)the trading day immediately before the date the Company sends such notice.

However, the Company may not redeem less than all of the outstanding 2029 Convertible Notes unless at least $75,000 aggregate principal amount of the 2029 Convertible Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice.

Calling any 2029 Convertible Note for redemption will constitute a make-whole fundamental change with respect to that 2029 Convertible Note, in which case the conversion rate applicable to the conversion of that 2029 Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances for a specified period of time.

The 2029 Convertible Notes have customary default provisions, including: (i) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest on any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture, if such default is not cured within 3 business days after its occurrence; (iv) a default with respect to the Company’s obligations under the indenture related to consolidations, mergers and asset sales; (v) a default in any of the Company’s other obligations or agreements under the indenture that are not cured or waived within 60 days after notice to the Company; (vi) certain payment defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for indebtedness for money borrowed of at least $30,000 or other defaults by the Company or certain subsidiaries with respect to such indebtedness that result in the acceleration of such indebtedness; (vii) default upon the occurrence of one or more final judgments being rendered against the Company or any of the Company’s significant subsidiaries for the payment of at least $30,000; and (viii) upon the occurrence of certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of its significant subsidiaries.

The 2026 Convertible Notes and 2029 Convertible Notes (together, the “Convertible Notes”) are classified on the condensed consolidated balance sheets as of March 31, 2024 as convertible senior notes.

As of March 31, 2024, the outstanding balance of the Convertible Notes consisted of the following:

​​​​​​​​​
​ · 2026 Convertible Notes · ​ · 2029 Convertible Notes · ​ · Total Convertible Notes
Principal$26,350​$241,500​$267,850
Less: unamortized issuance costs​(317)​​(5,108)​​(5,425)
Net carrying amount$26,033​$236,392​$262,425

The Company determined the expected life of the 2026 Convertible Notes and 2029 Convertible Notes was equal to thesix-year term of each. The effective interest rate on the 2026 Convertible Notes and 2029 Convertible Notes is 3.34% and 3.28%, respectively. As of March 31, 2024, the if-converted value of the 2026 Convertible Notes exceeded the remaining principal amount by approximately $6,267. As of March 31, 2024, the if-converted value of the 2029 Convertible Notes did not exceed the remaining principal amount.

The following table presents the total interest expense recognized related to the Convertible Notes during the three months ended March 31, 2024, and 2023:

​​​​​​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Contractual interest expense$1,908​$1,479
Amortization of debt issuance costs​300​​263
Total interest expense$2,208​$1,742

As of March 31, 2024, the future minimum payments on the Convertible Notes were as follows:

​​​​​​​​​
Years ended December 31, · 2026 Convertible Notes · ​ · 2029 Convertible Notes · ​ · Total Convertible Notes
2024$346​$3,471​$3,817
2025​692​​6,943​​7,635
2026​26,696​​6,943​​33,639
2027​—​​6,943​​6,943
2028​—​​6,943​​6,943
Thereafter​—​​244,972​​244,972
Total minimum payments$27,734​$276,215​$303,949
Less: interest​(1,384)​​(34,715)​​(36,099)
Less: unamortized issuance costs​(317)​​(5,108)​​(5,425)
Convertible Notes carrying value$26,033​$236,392​$262,425

12. Equity

The changes in shareholders’ equity for the three months ended March 31, 2024 were as follows:

​​​​​​​​​​​​​​​​​​​​​​
​ · ​ · ​ · ​ · ​ · Additional · ​ · ​ · ​ · ​ · ​ · ​ · ​ · Accumulated Other · ​ · Total
​ · Common Stock · Paid- In · ​ · Treasury Stock · ​ · Accumulated · Comprehensive · ​ · Shareholders’
​ · Shares · ​ · Amount · Capital · ​ · Shares · ​ · ​ · Amount · Deficit · Income (Loss) · ​ · Equity
Balance, December 31, 202338,192,441​$38​$565,949​(6,323,892)​$(137,381)​$(233,189)​$14​$195,431
Exercise of common stock options200,200​​—​​4,205​—​​—​​—​​—​​4,205
Issuance for employee stock purchase plan18,538​​—​​356​—​​—​​—​​—​​356
Vesting of RSUs and PSUs1,000,357​​1​​—​—​​—​​—​​—​​1
Shares withheld for employee taxes upon vesting of RSUs and PSUs(381,897)​​—​​(12,874)​—​​—​​—​​—​​(12,874)
Stock-based compensation—​​—​​7,475​—​​—​​—​​—​​7,475
Other comprehensive loss, net of tax—​​—​​—​—​​—​​—​​(138)​​(138)
Net income—​​—​​—​—​​—​​27,713​​—​​27,713
Balance, March 31, 202439,029,639​$39​$565,111​(6,323,892)​$(137,381)​$(205,476)​$(124)​$222,169

The changes in shareholders’ equity for the three months ended March 31, 2023 were as follows:

​​​​​​​​​​​​​​​​​​​
​ · ​ · ​ · ​ · ​ · Additional · ​ · ​ · ​ · ​ · ​ · ​ · ​ · Total
​ · Common Stock · Paid- In · ​ · Treasury Stock · ​ · Accumulated · Shareholders’
​ · Shares · ​ · Amount · Capital · ​ · Shares · ​ · ​ · Amount · Deficit · Equity
Balance, December 31, 202237,084,759​$37​$538,073​(3,235,823)​$(61,924)​$(281,344)​$194,842
Exercise of common stock options234,132​​—​​3,848​—​​—​​—​​3,848
Issuance for employee stock purchase plan11,329​​—​​169​—​​—​​—​​169
Vesting of RSUs and PSUs775,904​​1​​—​—​​—​​—​​1
Shares withheld for employee taxes upon vesting of RSUs and PSUs(289,281)​​—​​(7,736)​—​​—​​—​​(7,736)
Stock-based compensation—​​—​​6,035​—​​—​​—​​6,035
Net loss—​​—​​—​—​​—​​(17,426)​​(17,426)
Balance, March 31, 202337,816,843​$38​$540,389​(3,235,823)​$(61,924)​$(298,770)​$179,733

Common Stock

In May 2015, the Company adopted the Amended and Restated 2014 Stock Incentive Plan (the “Plan”), under which an aggregate of 2,700,000 shares of common stock were authorized for issuance to employees, officers, directors, consultants and advisors of the Company, plus an annual increase on the first day of each fiscal year until the expiration of the Plan equal to 4% of the total number of outstanding shares of common stock on December 31 st of the immediately preceding calendar year (or a lower amount as otherwise determined by the Company’s board of directors (“Board of Directors”) prior to January 1 st). As of March 31, 2024, there were 2,016,363 shares of common stock available for issuance pursuant to the Plan. The Plan provides for granting of both Internal Revenue Service qualified incentive stock options and non-qualified options, restricted stock awards, restricted stock units and performance stock units. The Company’s qualified incentive stock options and non-qualified options generally vest ratably over afour-year period of service and generally have aten-year contractual life. Upon termination, vested stock options are generally exercisable forthree months following the termination date, while unvested options are forfeited immediately upon termination. The Company’s RSUs granted prior to 2024 generally vest ratably over afour-year period of service. Beginning in 2024, RSUs granted by the Company vest ratably over athree-year period of service. Upon termination, unvested RSUs are forfeited immediately. Refer to Note 13,* Stock-based Compensation*, for more information.

Share Repurchases

2023 Repurchase Program

In January 2023, the Company’s Board of Directors authorized the repurchase of up to $100,000 of shares of its common stock at any time or times through December 31, 2023 (the “2023 Repurchase Program”). The 2023 Repurchase Program permitted the Company to effect repurchases through a variety of methods, including open-market purchases (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act.

In July 2023, the Company’s Board of Directors authorized an accelerated share repurchase (“ASR”) program to repurchase $50,000 of the Company’s common stock, as part of the 2023 Repurchase Program. Under the terms of the Company's ASR agreement with an investment bank, the Company paid $50,000 on August 7, 2023, and received 1,702,852 shares, representing 80% of the upfront payment on a price per share of $23.49, the closing price on the date the agreement was executed. The remaining shares purchased by the Company were based on the volume-weighted average price of its common stock through October 31, 2023, minus an agreed upon discount between the parties. In October 2023, the ASR agreement settled and the Company received an additional 462,442 shares, bringing the total shares repurchased pursuant to the ASR agreement to 2,165,294.

In November 2023, the Company’s Board of Directors authorized a second ASR program as part of the 2023 Repurchase Program to repurchase $25,000 of the Company’s common stock. Under the terms of the Company's ASR agreement with an investment bank, the Company paid $25,000 on November 9, 2023, and received 865,426 shares, representing 80% of the upfront payment on a price per share of $23.11, the closing price on the date the agreement was executed. The remaining shares purchased by the Company were based on the volume-weighted average price of its common stock through December 29, 2023, minus an agreed upon discount between the parties. In December 2023, the ASR agreement settled and the Company received an additional 57,349 shares, bringing the total shares repurchased pursuant to the ASR agreement to 922,775.

Each ASR agreement was accounted for as two distinct transactions: (1) an immediate repurchase of common stock, recorded as a treasury stock transaction; and (2) a forward contract indexed to the Company’s own stock. The forward contracts, which represented the remaining shares to be delivered by the investment bank, were recorded as a reduction to stockholders’ equity. Both forward contracts associated with these ASR agreements were settled and not outstanding as of December 31, 2023.

The 2023 Repurchase Program expired on December 31, 2023. Through December 31, 2023, the Company repurchased 3,088,069 shares at a weighted-average price of $24.29 per share for a total of $75,000 under the 2023 Repurchase Program. Repurchased shares were returned to the Company’s pool of authorized but unissued shares. The cost of repurchased shares were recorded as treasury stock in the consolidated balance sheet. Shares repurchased under the 2023 Repurchase Program resulted in an immediate reduction of shares outstanding used to calculate the weighted-average common shares outstanding for both basic and diluted earnings per share. As the Company was entitled to receive

additional shares of its common stock in connection with the outstanding forward contracts, the receipt of additional shares of common stock was antidilutive. Therefore, no adjustments were made in the computation of earnings per share for the period the forwards were outstanding.

2024-2025 Repurchase Program

In January 2024, the Company’s Board of Directors authorized the repurchase of up to $150,000 of the Company’s common stock through June 30, 2025 (the “2024-2025 Repurchase Program”). The 2024-2025 Repurchase Program permits the Company to effect repurchases through a variety of methods, including open-market purchases (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act. The timing and amount of any shares purchased on the open market will be determined based on the Company’s evaluation of the market conditions, share price and other factors. The Company plans to utilize existing cash on hand to fund share repurchases.

The Company has not yet repurchased shares under the 2024-2025 Repurchase Program. Thus,$150,000 remained available for share repurchases under the 2024-2025 Repurchase Program as of March 31, 2024.

13. Stock-based Compensation

Performance Share Units

The Company periodically grants PSUs to certain members of the Company's senior management team. PSUs vest subject to the satisfaction of annual and cumulative performance and/or market conditions established by the Company’s Compensation Committee.

A summary of the Company’s PSU activity for the three months ended March 31, 2024 and related information is as follows:

​​​​​​
​ · ​ · ​ · ​ · Weighted-Average
​ · ​ · Shares · ​ · Grant Date Fair Value
Outstanding as of December 31, 2023​503,880​$33.13
Granted​203,000​​45.06
Vested​(314,921)​​33.90
Forfeited​—​​—
Performance adjustment​119,721​​34.26
Outstanding as of March 31, 2024​511,680​$37.66

The number of PSUs granted represents the target number of shares of common stock that may be earned. However, the actual number of shares earned may vary based on the satisfaction of performance criteria. The weighted-average grant date fair value of PSUs granted for the three months ended March 31, 2024, and 2023 was $45.06 and $38.71, respectively.

Restricted Stock Units

The Company granted RSUs to employees during the three months ended March 31, 2024. RSUs granted prior to 2024 generally vest ratably over afour-year period of service. Beginning in 2024, RSUs granted by the Company vest ratably over athree-year period of service.

A summary of the Company’s RSU activity for the three months ended March 31, 2024 and related information is as follows:

​​​​​​
​ · ​ · ​ · ​ · Weighted-Average
​ · ​ · Shares · ​ · Grant Date Fair Value
Outstanding as of December 31, 2023​2,443,907​$22.88
Granted​885,674​​33.70
Vested​(685,436)​​23.06
Forfeited​(80,392)​​25.83
Outstanding as of March 31, 2024​2,563,753​$26.47

The weighted-average grant date fair value per share of RSUs granted for the three months ended March 31, 2024 and 2023 was $33.70 and $26.82, respectively. The total fair value of RSUs vested (measured on the date of vesting) for the three months ended March 31, 2024, and 2023 was $23,112 and $14,779, respectively.

Stock Options

The Company’s qualified incentive stock options and non-qualified options generally vest ratably over afour-year period and generally have aten-year contractual life. Upon termination, vested stock options are generally exercisable forthree months following the termination date, while unvested options are forfeited immediately upon termination.

A summary of the Company’s stock option activity for the three months ended March 31, 2024 and related information is as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · ​ · ​ · Weighted- · ​ · ​
​ · ​ · ​ · ​ · Weighted- · Average · ​ · ​ · ​
​ · ​ · ​ · ​ · Average · Remaining · ​ · ​ · Aggregate
​​​​​Exercise PriceContractual​​Intrinsic
​ · Shares · ​ · per Share · Term (in years) · ​ · Value
Outstanding as of December 31, 20231,176,750​$19.484.3​$13,297
Exercised(200,200)​​20.96​​​​​
Cancelled(1,000)​​27.73​​​​​
Outstanding as of March 31, 2024975,550​$19.174.0​$19,172
Exercisable as of March 31, 2024974,941​$19.17​4.0​$19,160

There wereno stock options granted during the three months ended March 31, 2024 and 2023.

Employee Stock Purchase Plan

The Company’s 2015 Employee Stock Purchase Plan allows employees to purchase shares of the Company’s common stock. The purchase price is equal to 85% of the lower of the closing price of the Company’s common stock on: (i) the first day of the purchase period; or (ii) the last day of the purchase period. During the three months ended March 31, 2024,18,538 shares of common stock were purchased for total proceeds of $356. The expense for the three months ended March 31, 2024 and 2023 was $65 and $46, respectively.

Stock-based Compensation Expense

A summary of the allocation of the Company’s stock-based compensation expense for the three months ended March 31, 2024 and 2023 is as follows:

​ · ​ · ​ · ​ · ​ · ​
​Three Months Ended March 31,
​2024​2023
Selling, general and administrative$7,475​$6,035
Total stock-based compensation expense$7,475​$6,035

As of March 31, 2024, there was approximately $72,231 of unrecognized compensation expense related to unvested options, restricted stock units and performance stock units, which is expected to be recognized as expense over a weighted average period of approximately 2.5 years.

14. Commitments and Contingencies

Legal Proceedings

From time to time, the Company may face legal claims or actions in the normal course of business. Except as disclosed below, the Company is not currently a party to any material litigation and, accordingly, does not have any other amounts recorded for any litigation related matters.

Xtampza ER Litigation

On March 24, 2015, Purdue sued the Company in the U.S. District Court for the District of Delaware asserting infringement ofthree of Purdue’s Orange Book-listed patents (Patent Nos. 7,674,799, 7,674,800, and 7,683,072) and a non-Orange Book-listed patent (Patent No. 8,652,497). The lawsuit was initiated in response to the Company filing the New Drug Application (“NDA”) for Xtampza ER as a 505(b)(2) application referencing data from Purdue’s OxyContin NDA, and under the Drug Price Competition and Patent Term Restoration Act of 1984, triggered a stay of up to 30 months before the FDA could issue a final approval for Xtampza ER, unless the stay was earlier terminated.

The Delaware court transferred the case to the District of Massachusetts. After the Company filed a partial motion for judgment on the pleadings relating to the Orange Book-listed patents, the District Court of Massachusetts ordered judgment in the Company’s favor on those three patents, and dismissed the claims which lifted the 30-month stay of FDA approval. Following this judgment, the Company obtained final approval for Xtampza ER and launched commercially.

Purdue subsequently filedtwo follow-on lawsuits asserting infringement oftwo patents that had been late-listed in the Orange Book and, therefore, could not trigger any stay of FDA approval: Purdue asserted infringement of Patent No. 9,073,933 in November 2015 and Patent No. 9,522,919 in April 2017. In addition, Purdue invoked two non-Orange Book-listed patents, filing suit in June 2016 asserting infringement of Patent No. 9,155,717 and in September 2017, asserting infringement of Patent No. 9,693,961.

On March 13, 2018, the Company filed a Petition for Post-Grant Review (“PGR”) of the ʼ961 patent with the Patent Trial and Appeal Board (“PTAB”). The PGR argued that the ʼ961 patent is invalid.

On November 21, 2017, the Court issued its claim construction ruling, construing certain claims of the ʼ933, ʼ497, and ʼ717 patents. The Court issued an order on September 28, 2018, in which it ruled that the Xtampza ER formulation does not infringe the ʼ497 and ʼ717 patents.

On September 15, 2019, Purdue commenced chapter 11 bankruptcy proceedings in the United States Bankruptcy Court for the Southern District of New York. Later in September 2019, Purdue gave the District Court of Massachusetts, as well as the PTAB, notice of its bankruptcy filing and sought the imposition of an automatic stay of proceedings. Both the Court and the PTAB granted Purdue’s requests to stay the pending matters.

On September 1, 2020, the Bankruptcy Court entered an Order, lifting the automatic stays in both the District of Massachusetts and PTAB proceedings. On September 11, 2020, Purdue filed a motion to terminate the PTAB action on

the basis that those proceedings had gone beyond the 18-month statutory period. On November 19, 2021, the PTAB: (i) denied Purdue’s motion to terminate the PGR; and (ii) issued its Final Written Decision, finding that the asserted claims of the ʼ961 patent were invalid for lack of written description and anticipation. Purdue appealed the decision to Federal Circuit, which issued its decision on November 21, 2023, affirming the authority of the PTAB to issue its Final Written Decision and upholding the PTAB’s finding of invalidity relative to the ’961 patent. Purdue has exhausted all possibility of appeal and the judgment of invalidity of the ‘961 patent is final without further right of appeal.

On April 2, 2021, the Court granted Purdue’s Motion to Lift the Stay in the District of Massachusetts that was entered following Purdue’s Notice of Bankruptcy. On April 9, 2021, Purdue filed another follow-on lawsuit asserting infringement of U.S. Patent No. 10,407,434. The Company responded to Purdue’s complaint with a motion to dismiss. On May 21, 2021, and in response to the Company’s motion to dismiss, Purdue filed an amended complaint. The Company renewed its motion to dismiss on June 4, 2021, arguing: (i) Purdue cannot, as a matter of law, state a claim for infringement under § 271(e)(2)(A); (ii) Purdue cannot, as a matter of law, state a claim for product-by-process infringement under §271(g); and (iii) Purdue has not alleged facts sufficient to support any indirect infringement theory under §271(b) or (c). The Court held a hearing on the Company’s motion to dismiss on October 13, 2021, and the motion is pending before the Court.

Like the prior follow-on lawsuits, the ’434 patent litigation was consolidated into the lead case and a scheduling order was entered. On May 15, 2023, the Court issued an order that: (i) vacated the existing deadlines with respect to the ʼ933, ʼ919, and ʼ434 patents and stayed the case pending the Federal Circuit’s decision in a different litigation that invalidated certain claims of the ʼ933 and ʼ919 patents; and (ii) continued the existing stay concerning the ʼ961 patent pending resolution of Purdue’s appeal rights relating to the decision invalidating the claims of the ʼ961 patent. The Court has not set a deadline for dispositive motions or trial.

The remaining patents-in-suit in the lead consolidated action in the District of Massachusetts are the ʼ933, ʼ919, ʼ434, and ʼ961 patents. Purdue has made a demand for monetary relief, and requested a judgment of infringement, an adjustment of the effective date of FDA approval, and an injunction on the sale of the Company’s products accused of infringement. The Company has denied all claims and has requested a judgment that the remaining asserted patents are invalid and/or not infringed; the Company is also seeking a judgment that the case is exceptional and has requested an award of the Company’s attorneys’ fees for defending the case.

The Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any.

Nucynta Litigation

On February 7, 2018, Purdue filed a patent infringement suit against the Company in the U.S. District Court for the District of Delaware, in which it argues that the Company’s sale of immediate-release and extended-release Nucynta infringes U.S. Patent Nos. 9,861,583, 9,867,784, and 9,872,836. On December 6, 2018, the Company filed an Amended Answer asserting an affirmative defense for patent exhaustion. On December 10, 2018, the Court granted the parties’ stipulation for resolution of the Company’s affirmative defense of patent exhaustion and stayed the action, with the exception of briefing on and resolution of the Company’s Motion for Judgment on the Pleadings related to patent exhaustion and any discovery related to that Motion.

Also, on December 10, 2018, the Company filed a Rule 12(c) Motion for Judgment on the Pleadings, arguing that Purdue’s claims were barred by the doctrine of patent exhaustion. On June 19, 2019, the Court issued an order calling for discovery on a factual predicate for the patent exhaustion defense and noted that the case remained “stayed with the exception of discovery and briefing on and resolution of the Company’s anticipated motion for summary judgment based on patent exhaustion.”

On September 19, 2019, Purdue notified the Court of its bankruptcy filing and sought an automatic stay of proceedings, which was granted. The Nucynta litigation currently remains subject to the bankruptcy stay.

The Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any.

Opioid Litigation

As a result of the opioid epidemic, numerous state and local governments and other entities brought suit against manufacturers, distributors, and pharmacies alleging a variety of claims related to opioid marketing and distribution practices. In late 2017, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of cases pending around the country in federal court against opioid manufacturers and distributors into a Multi-District Litigation (“MDL”) in the Northern District of Ohio. The Company was initially named as a defendant in 21 of the MDL cases. By April 19, 2022, all MDL cases naming the Company were dismissed or withdrawn.

Outside of the MDL, several cases were filed against the Company in Arkansas, Pennsylvania, and Massachusetts state courts with allegations similar to those in the MDL related to opioid marketing and distribution practices, as well as allegations including violations of state consumer protections laws.

On March 21, 2019, the Arkansas state court litigation was dismissed. On December 24, 2021, the Company entered into a settlement framework with Scott+Scott Attorneys at Law, LLP, the law firm representing plaintiffs in 27 jurisdictions filed either in Pennsylvania and Massachusetts state courts, or filed in other state courts and removed to the MDL. Pursuant to the terms of the settlement, the Company paid $2,750 in exchange for dismissal, with prejudice, of each plaintiff’s lawsuit and a release of claims related to such lawsuits. The Company is currently dismissed from all cases.

The Company settled to efficiently resolve these litigations and did not admit any liability or acknowledge any wrongdoing in connection with the settlement.

Opioid-Related Request and Subpoenas

The Company, like several other pharmaceutical companies, has received subpoenas or civil investigative demands related to opioid sales and marketing practices, from the Offices of the Attorney General of Washington, New Hampshire, Maryland, and Massachusetts.

On December 16, 2021, the Company entered into an Assurance of Discontinuance with the Massachusetts Attorney General’s Office. The Company is currently cooperating with each of the remaining states in their respective investigations.

Aquestive Litigation

On September 22, 2014, Reckitt Benckiser, Inc., Indivior PLC (formerly RB Pharmaceuticals Limited, “Indivior”), and Aquestive Therapeutics, Inc. (formerly MonoSol Rx, “Aquestive”) (collectively, the “RB Plaintiffs”) filed an action in the District Court in the District of New Jersey alleging patent infringement against BDSI related to its Bunavail product. The RB Plaintiffs claimed that Bunavail, whose formulation and manufacturing processes have never been disclosed publicly, infringed U.S. Patent No. 8,765,167.

On January 13, 2017, Aquestive filed a complaint in the District Court for the District of New Jersey against BDSI alleging Belbuca also infringed the ’167 Patent. On March 8, 2023, the parties filed a stipulation of dismissal after agreeing to settle the dispute. Under the terms of the settlement agreement, BDSI resolved both the Bunavail and Belbuca litigations in exchange for a one-time, lump-sum payment of $8,500 to Aquestive, which was recognized as an expense included in “selling, general and administrative expenses” in the consolidated statements of operations for the year ended December 31, 2023.

Litigation Related to the BDSI Acquisition

On February 25, 2022, in connection with the BDSI Acquisition, a purported individual stockholder of BDSI filed a complaint in the District Court for the Southern District of New York naming as defendants BDSI and each member of its Board of Directors as of the date of the Merger Agreement (“SteinAction”). On February 28, 2022, two additional cases were filed by purported individual stockholders of BDSI in the same court: the “SanfordAction” and the “HigleyAction.” In March 2022, two additional cases were filed by purported individual stockholders of BDSI in the District Court for the Eastern District of New York: the “JusticeAction” and the* “ZomberAction” (together with theStein*,Sanford, andHigley Actions, the “Actions”). The Actions and any similar subsequently filed cases involving BDSI, its officers or Board of Directors, or any committee thereof, and/or any of the Company’s officers or directors relating

directly or indirectly to the Merger Agreement, the BDSI Acquisition or any related transaction, are referred to as the “Merger Litigations.”

The Merger Litigations filed to date generally allege that the Schedule 14D-9 is materially incomplete and misleading. The Merger Litigations assert violations of Section 14(e) of the Exchange Act and violations of Section 20(a) of the Exchange Act against BDSI’s Board of Directors. The Merger Litigations seek, among other things: an injunction enjoining consummation of the Merger, rescission of the Merger Agreement, a declaration that BDSI and its Board of Directors violated Sections 14(e) and 20(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, damages, costs of the action, including plaintiffs’ attorneys’ fees and experts’ fees and expenses, and any other relief the court may deem just and proper.

In addition, between February and March of 2022, BDSI received demand letters from three purported stockholders of BDSI seeking to inspect certain books and records of BDSI related to the Merger (collectively, the “Inspection Letters”). In March 2022, BDSI received demand letters from four purported stockholders alleging that the Schedule 14D-9 omits purportedly material information relating to the Merger (collectively, the “Demand Letters”).

Plaintiffs in theHigley, Zomber, and JusticeActions each filed a notice of voluntary dismissal of their complaint in the second quarter of 2022. On July 28, 2022, plaintiff in theSanford Action filed a partial voluntary dismissal of the individual named defendants, and on October 26, 2022, filed a notice of voluntary dismissal of the BDSI defendant. On February 17, 2023, theStein Action was dismissed.

While the Company believes that the remaining Merger Litigations, Inspection Letters, and Demand Letters are without merit and that the disclosures in the Schedule 14D-9 comply fully with applicable law, solely in order to avoid the expense and distraction of litigation, BDSI previously determined to voluntarily supplement the Schedule 14D-9 with certain supplemental disclosures set forth in BDSI’s Schedule 14D-9 filed with the SEC on March 11, 2022 (the “Supplemental Disclosures”). The Company and BDSI believe that the Supplemental Disclosures mooted all allegations or concerns raised in the Merger Litigations, Inspection Letters, and Demand Letters.

Alvogen

On September 7, 2018, BDSI filed a complaint for patent infringement in District Court for the District of Delaware against Alvogen Pb Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen, Incorporated, and Alvogen Group, Incorporated (collectively, “Alvogen”), asserting that Alvogen infringed BDSI’s Orange Book-listed patents for Belbuca, including U.S. Patent Nos. 8,147,866, 9,655,843 and 9,901,539(collectively, “the BEMA patents”). This complaint followed receipt by BDSI on July 30, 2018 of a Paragraph IV Patent Certification from Alvogen stating it had filed anabbreviated New Drug Application (“ANDA”)with the FDA for a generic version of Belbuca Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg.

A three-day bench trial was held from March 1-3, 2021. On December 20, 2021, the Court issued an opinion upholding the validity of certain claims in BDSI’s ʼ866 patent and certain claims in the ’539 patent. The Court entered final judgment on January 21, 2022 upholding the validity of claims of the ’866 and ’539 patents and thereby extended the effective date of any final approval by the FDA of Alvogen’s ANDA until December 21, 2032, (the expiration date of the ’539 patent) and enjoining Alvogen from commercially launching its ANDA products until December 21, 2032. Alvogen filed a motion to stay certain provisions of the final judgment. BDSI filed an opposition to Alvogen’s request for a stay. The Court retained jurisdiction to decide BDSI’s motion for contempt, which was filed on September 21, 2021.

Alvogen filed a notice of appeal to the Federal Circuit seeking to reverse the Court’s final judgment. Separately, BDSI filed a cross-appeal to the Federal Circuit seeking to reverse the Court’s opinion that claims 3 and 10 of the ʼ866 patent and claims 8, 9 and 20 of the ’843 patent are invalid and thus, Alvogen is not liable for infringement of those claims, as well as any other ruling decided adversely to BDSI. On December 21, 2022, the Federal Circuit affirmed the district court judgment that certain claims of the ʼ866 and ʼ539 patent were not invalid as obvious. The Federal Circuit also vacated the district court’s judgment that certain claims of the ʼ866 and ʼ843 patent were invalid as obvious and remanded to the district court for further proceedings. The mandate issued on February 10, 2023.

As it has done in the past, the Company intends to vigorously defend its intellectual property against assertions of invalidity or non-infringement.

Chemo Research, S.L.

On March 1, 2019, BDSI filed a complaint for patent infringement in the District Court for the District of Delaware against Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, the “Chemo Defendants”), asserting that the Chemo Defendants infringe the BEMA patents. This complaint followed receipt by BDSI on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it had filed with the FDA an ANDA containing a Paragraph IV Patent Certification, for a generic version of Belbuca Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, and 900 mcg.

Chemo agreed to be bound by the decision of the Court with respect to the validity of the BEMA patents as disputed between BDSI and Alvogen. Accordingly, the December 20, 2021 ruling of the Court upholding the validity of certain claims of the BEMA patents is binding upon Chemo. In March 2022, the Court vacated the bench trial set to begin April 25, 2022 to address the remaining Chemo infringement claims. The Court has not yet set a new trial date.

On August 1, 2022, BDSI received a second Paragraph IV certification notice letter from Chemo indicating it amended its ANDA to: (i) withdraw its generic version of the 75 mcg and 150 mcg strengths of Belbuca; and (ii) include its generic version of the 600 mcg and 750 mcg strengths of Belbuca, in addition to the 300 mcg, 450 mcg, and 900 mcg strengths identified in the first Chemo Paragraph IV certification notice letter. In response, BDSI filed a complaint for patent infringement in Federal District Court for the District of Delaware. Chemo answered the complaint on December 1, 2022. The Court has not yet set a schedule for this litigation.

On August 24, 2022, the Court instructed the parties to update the Court at such time as the FDA addresses Chemo's July 29, 2022 response to the FDA. On February 8, 2023, the Court denied Chemo’s request for a trial date in the spring, and again instructed the parties to update the Court at such time as the FDA addresses Chemo’s July 29, 2022 response to the FDA. Chemo received a complete response letter with respect to its July 29, 2022 ANDA in April 2023. Chemo submitted a further amended ANDA to FDA in September 2023.

The Company plans to litigate this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any.

15. Income Taxes

The Company is subject to U.S. federal and state income taxes. The income tax provision for interim periods reflects the Company’s estimate of the annual effective tax rate expected to be applicable for the full fiscal year, adjusted for any discrete events which are recorded in the period in which they occur.

The following table presents information regarding the Company’s income tax expense (benefit) recognized for the three months ended March 31, 2024 and 2023:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​Three Months Ended March 31,
​ · 2024 · ​ · 2023
Provision for (benefit from) income taxes$8,909​​$(131)​
Effective tax rate​24.3%​​0.7%

The provision for income taxes for the three months ended March 31, 2024 reflects the estimated annual effective tax rate as adjusted for discrete excess tax benefits from stock-based compensation awards. The provision for income taxes for the three months ended March 31, 2023 was impacted by discrete nondeductible costs associated with the debt extinguishment that occurred in the three months ended March 31, 2023, partially offset by discrete excess tax benefits related to stock-based compensation awards. The nondeductible costs from the debt extinguishment that occurred in the three months ended March 31, 2023 were $21,238.

The Company provides a valuation allowance when it is more likely than not that deferred tax assets will not be realized. In determining the extent to which a valuation allowance for deferred tax assets is required, the Company evaluates all

available evidence including projections of future taxable income, carry back opportunities, reversal of certain deferred tax liabilities, and other tax planning strategies. The Company has maintained a valuation allowance on the portion of its deferred tax assets that are not more likely than not to be realized due to tax limitation or other conditions as of March 31, 2024.

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