UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~September 30, 2023~~March 31, 2024

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 001-37372

Collegium Pharmaceutical, Inc.

(Exact name of registrant as specified in its charter)

Virginia (State or other jurisdiction of incorporation or organization)		03-0416362 (I.R.S. Employer Identification Number)

100 Technology Center Drive Stoughton, MA (Address of principal executive offices)		02072 (Zip Code)

(781) 713-3699

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	COLL	The NASDAQ Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ◻

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.



Large accelerated filer ☒	Accelerated filer ◻	Non-accelerated filer ◻	Smaller reporting company ☐	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ⌧

As of ~~October 31, 2023,~~April 30, 2024, there were ~~32,610,873~~32,715,322 shares of Common Stock, $0.001 par value per share, outstanding.

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Forward-Looking Statements

Statements made in this quarterly report on Form 10-Q (“Quarterly Report”) that are not statements of historical or current facts, such as those under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. These statements may be preceded by, followed by or include the words “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “may,” “could,” “would,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning.

Forward-looking statements are inherently subject to risks, uncertainties and assumptions; they are not guarantees of performance. You should not place undue reliance on these statements. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct.

You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements:

●

our ability to commercialize and grow sales of our products;

●

our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of an approved product;

●

the size of the markets for our products, and our ability to service those markets;

●

the success of competing products that are or become available;

●

our ability to obtain and maintain reimbursement and third-party payor contracts with favorable terms for our products;

●

the costs of commercialization activities, including marketing, sales and distribution;

●

the rate and degree of market acceptance of our products;

●

changing market conditions for our products;

●

the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us;

●

the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid medications;

●

the performance of our third-party suppliers and manufacturers;

●

our ability to secure adequate supplies of active pharmaceutical ingredients for each of our products, manufacture adequate quantities of commercially salable inventory and maintain our supply chain;

●

our ability to effectively manage our relationships with licensors and to commercialize products that we in-license from third parties;

●

our ability to attract collaborators with development, regulatory and commercialization expertise;

●

our ability to obtain funding for our business development;

●

~~our ability to obtain regulatory approval for any product candidates we may acquire in the future;~~

●

our ability to comply with the terms of our outstanding indebtedness;

●

regulatory and legislative developments in the United States, including the adoption of opioid stewardship and similar taxes that may impact our business;

●

our ability to obtain and maintain sufficient intellectual property protection for our ~~products and any future product candidates;~~products;

●

our ability to comply with stringent government regulations relating to the manufacturing and marketing of pharmaceutical products, including U.S. Drug Enforcement Agency (“DEA”) compliance;

●

our customer concentration, which may adversely affect our financial condition and results of operations; ~~and~~

●

the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing; and

●

the other risks, uncertainties and factors discussed under the heading “Risk Factors” in this Quarterly ~~Report.~~Report on Form 10-Q.

In light of these risks and uncertainties, expected results or other anticipated events or circumstances discussed in this Quarterly Report on Form 10-Q (including the exhibits hereto) might not occur. We undertake no obligation, and specifically decline any obligation, to publicly update or revise any forward-looking statements, even if experience or future developments make it clear that projected results expressed or implied in such statements will not be realized, except as may be required by law.

These and other risks are described under the heading “Risk Factors” in this Quarterly ~~Report.~~Report on Form 10-Q. Those factors and the other risk factors described therein are not necessarily all of the important factors that could cause actual results or developments to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results. Consequently, there can be no assurance that actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Given these uncertainties, prospective investors are cautioned not to place undue reliance on such forward-looking statements.

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PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited).

Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)


	September 30,		December 31,		March 31,		December 31,
	2023		2022		2024		2023
Assets
Current assets
Cash and cash equivalents	$	258,532	$	173,688	$	228,610	$	238,947
Marketable securities		46,033		—		89,438		71,601
Accounts receivable, net		181,851		183,119		174,693		179,525
Inventory		34,125		46,501		31,276		32,332
Prepaid expenses and other current assets		16,545		16,681		15,243		15,195
Total current assets		537,086		419,989		539,260		537,600
Property and equipment, net		16,645		19,521		15,457		15,983
Operating lease assets		6,243		6,861		5,813		6,029
Intangible assets, net		456,222		567,468		387,191		421,708
Restricted cash		1,047		2,547		1,047		1,047
Deferred tax assets		25,738		23,950		30,671		26,259
Other noncurrent assets		740		100		954		825
Goodwill		133,857		133,695		133,857		133,857
Total assets	$	1,177,578	$	1,174,131	$	1,114,250	$	1,143,308
Liabilities and shareholders' equity
Current liabilities
Accounts payable	$	3,653	$	3,494	$	6,020	$	8,692
Accrued liabilities		31,651		36,129		38,190		37,571
Accrued rebates, returns and discounts		245,012		230,491		217,880		227,331
Current portion of term notes payable		183,333		162,500		183,333		183,333
Current portion of operating lease liabilities		963		1,112		1,013		988
Total current liabilities		464,612		433,726		446,436		457,915
Term notes payable, net of current portion		265,886		397,578		177,360		221,713
Convertible senior notes		261,823		140,873		262,425		262,125
Operating lease liabilities, net of current portion		6,384		7,112		5,860		6,124
Total liabilities		998,705		979,289		892,081		947,877
Commitments and contingencies (refer to Note 16)
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; 38,000,607 issued and 33,061,932 outstanding shares as of September 30, 2023 and 37,084,759 issued and 33,848,936 outstanding shares as of December 31, 2022		38		37
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		545,940		538,073		565,111		565,949
Treasury stock, at cost; 4,938,675 shares as of September 30, 2023 and 3,235,823 shares as of December 31, 2022		(101,924)		(61,924)
Accumulated other comprehensive loss		(52)		—
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		(265,129)		(281,344)		(205,476)		(233,189)
Total shareholders’ equity		178,873		194,842		222,169		195,431
Total liabilities and shareholders’ equity	$	1,177,578	$	1,174,131	$	1,114,250	$	1,143,308

See accompanying notes to the Condensed Consolidated Financial Statements.

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Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended March 31,
	2023		2022		2023		2022		2024		2023
Product revenues, net	$	136,709	$	127,013	$	417,022	$	334,313	$	144,923	$	144,767
Cost of product revenues
Cost of product revenues (excluding intangible asset amortization)		20,081		30,622		74,237		80,638		18,950		29,899
Intangible asset amortization		36,317		37,552		111,246		93,976		34,517		37,466
Total cost of product revenues		56,398		68,174		185,483		174,614		53,467		67,365
Gross profit		80,311		58,839		231,539		159,699		91,456		77,402
Operating expenses
Research and development		—		—		—		3,983
Selling, general and administrative		35,298		38,372		126,266		134,154		41,982		52,775
Total operating expenses		35,298		38,372		126,266		138,137		41,982		52,775
Income from operations		45,013		20,467		105,273		21,562		49,474		24,627
Interest expense		(20,768)		(19,046)		(64,058)		(42,638)		(17,339)		(21,427)
Interest income		4,538		11		11,312		20		4,487		2,747
Loss on extinguishment of debt		—		—		(23,504)		—		—		(23,504)
Income (loss) before income taxes		28,783		1,432		29,023		(21,056)		36,622		(17,557)
Provision for (benefit from) income taxes		8,149		975		12,808		(3,253)		8,909		(131)
Net income (loss)	$	20,634	$	457	$	16,215	$	(17,803)	$	27,713	$	(17,426)

Earnings (loss) per share — basic	$	0.61	$	0.01	$	0.47	$	(0.52)	$	0.86	$	(0.51)
Weighted-average shares — basic		33,744,209		34,058,802		34,226,488		33,912,832		32,326,589		34,319,291

Earnings (loss) per share — diluted	$	0.53	$	0.01	$	0.46	$	(0.52)	$	0.71	$	(0.51)
Weighted-average shares — diluted		42,058,821		34,570,319		35,149,154		33,912,832		41,438,466		34,319,291

See accompanying notes to the Condensed Consolidated Financial Statements.

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Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)


	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended March 31,
	2023		2022		2023		2022		2024		2023
Net income (loss)	$	20,634	$	457	$	16,215	$	(17,803)	$	27,713	$	(17,426)
Other comprehensive loss:
Unrealized losses on marketable securities		(14)		—		(52)		—
Unrealized losses on marketable securities, net of tax										(138)		—
Total other comprehensive loss		(14)		—		(52)		—		(138)		—
Comprehensive income (loss)	$	20,620	$	457	$	16,163	$	(17,803)	$	27,575	$	(17,426)

See accompanying notes to the Condensed Consolidated Financial Statements.

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Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)


	Nine Months Ended September 30,				Three Months Ended March 31,
		2023		2022		2024		2023
Operating activities
Net income (loss)	$	16,215	$	(17,803)	$	27,713	$	(17,426)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Amortization expense		111,246		93,976		34,517		37,466
Depreciation expense		2,547		1,859		917		817
Deferred income taxes		(1,815)		(7,313)		(4,412)		(46)
Stock-based compensation expense		20,134		17,204		7,475		6,035
Non-cash lease (benefit) expense		(258)		341
Non-cash lease benefit						(22)		(105)
Non-cash interest expense for amortization of debt discount and issuance costs		6,672		5,902		1,780		2,287
Loss on extinguishment of debt		23,504		—		—		23,504
Net amortization of premiums and discounts on investments		(667)		—		(415)		—
Changes in operating assets and liabilities:
Accounts receivable		1,268		(34,063)		4,832		3,993
Inventory		12,376		30,124		1,056		13,606
Prepaid expenses and other assets		42		998		(177)		(238)
Accounts payable		106		3,436		(2,536)		(502)
Accrued liabilities		(4,479)		(24,719)		660		(12,131)
Accrued rebates, returns and discounts		14,520		(12,040)		(9,451)		(29,589)
Operating lease assets and liabilities		—		3
Net cash provided by operating activities		201,411		57,905		61,937		27,671
Investing activities
Purchases of property and equipment		(297)		(682)		(568)		(176)
Acquisition of BDSI (net of cash acquired)		—		(572,069)
Purchases of marketable securities		(51,418)		—		(39,110)		—
Maturities of marketable securities		6,000		—		21,550		—
Net cash used in investing activities		(45,715)		(572,751)		(18,128)		(176)
Financing activities
Proceeds from issuances of common stock from employee stock purchase plan		460		337		356		169
Proceeds from the exercise of stock options		5,401		4,948		4,205		3,848
Payments made for employee stock tax withholdings		(8,128)		(3,999)		(12,874)		(7,736)
Repurchases of common stock, including the ASR agreement		(50,000)		(6,422)
Repayment of term notes		(116,667)		(50,000)		(45,833)		(25,000)
Proceeds from term note modification		—		517,682
Proceeds from issuances of 2029 Convertible Notes, net of issuance costs of $6,280		235,220		—
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)		—		—		(138,638)
Net cash (used in) provided by financing activities		(72,352)		462,546		(54,146)		68,297

Net increase (decrease) in cash, cash equivalents and restricted cash		83,344		(52,300)
Net (decrease) increase in cash, cash equivalents and restricted cash						(10,337)		95,792
Cash, cash equivalents and restricted cash at beginning of period		176,235		188,973		239,994		176,235
Cash, cash equivalents and restricted cash at end of period	$	259,579	$	136,673	$	229,657	$	272,027

Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:
Cash and cash equivalents	$	258,532	$	134,126	$	228,610	$	269,480
Restricted cash		1,047		2,547		1,047		2,547
Total cash, cash equivalents and restricted cash	$	259,579	$	136,673	$	229,657	$	272,027

Supplemental disclosure of cash flow information
Cash paid for interest	$	57,679	$	35,280	$	17,468	$	19,499
Cash paid for income taxes	$	17,293	$	10,037	$	173	$	743


Supplemental disclosure of non-cash activities
Acquisition of property and equipment in accounts payable and accrued liabilities	$	53	$	260
Note issuance costs in accounts payable and accrued liabilities					$	—	$	434

See accompanying notes to the Condensed Consolidated Financial Statements.

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Collegium Pharmaceutical, Inc.

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”), ~~Belbuca,~~ and Symproic.

Xtampza ER, an abuse-deterrent, oral formulation of oxycodone, was approved by the U.S. Food and Drug Administration (“FDA”) in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Company commercially launched Xtampza ER in June 2016.

The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol. Nucynta ER is indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta IR is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. The Company began shipping and recognizing product sales on the Nucynta Products in January 2018 and began marketing the Nucynta Products in February 2018.

On March 22, 2022 (the “Acquisition Date”), the Company acquired BioDelivery Sciences International, Inc. (“BDSI”), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions, pursuant to an Agreement and Plan of Merger, dated as of February 14, 2022, by and among the Company, Bristol Acquisition Company Inc., the Company’s wholly owned subsidiary, and BDSI (the “BDSI Acquisition”). Upon closing, the Company acquired the Belbuca and Symproic products. Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate. Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. The Company began shipping and recognizing product sales related to Belbuca and Symproic in March 2022.

The Company’s operations are subject to certain risks and uncertainties. The principal risks include ~~inability~~the Company’s ability to continue successfully commercializing products, changing market conditions for products and development ~~or introduction~~ 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.

The Company believes that its cash and cash equivalents as of September 30, 2023, together with expected cash inflows from the commercialization of its products, will enable the Company to fund its operating expenses, debt service and capital expenditure requirements under its current business plan for at least one year from the date the consolidated financial statements were issued.

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

~~Table of Contents~~

(“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 ~~September 30, 2023,~~March 31, 2024, the results of operations for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023, ~~and 2022,~~ and cash flows for the ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and ~~2022.~~2023. The results of operations for the three ~~and nine~~ months ended ~~September 30, 2023~~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, ~~2022~~2023 (the “Annual Report”).

~~Marketable Securities~~

As of September 30, 2023, the Company’s marketable securities consisted of investments in available-for-sale corporate debt, U.S. Treasury, and government-sponsored securities with readily determinable fair values. The Company classifies available-for-sale marketable securities as current assets on its consolidated balance sheets. The fair value of these securities is based on quoted prices for identical assets or inputs other than quoted prices that are observable for similar assets, either directly or indirectly.

The Company records interest earned and net amortization of premiums and discounts on investments within interest income on its consolidated statements of operations. The Company records unrealized gains (losses) on available-for-sale debt securities as a component of ~~Accumulated other comprehensive (loss) income,~~ which is a separate component of shareholders’ equity on its consolidated balance sheets, until such gains and losses are realized. Realized gains and losses are determined using the specific identification method.

For available-for-sale debt securities in unrealized loss positions, the Company is required to assess whether to record an allowance for credit losses using an expected loss model. A credit loss is limited to the amount by which the amortized cost of an investment exceeds its fair value. A previously recognized credit loss may be decreased in subsequent periods if the Company’s estimate of fair value for the investment increases. To determine whether to record a credit loss, the Company considers issuer specific credit ratings and historical losses as well as current economic conditions and expectations for future economic conditions.

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

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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 of five years, with automatic one-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 provide one 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.

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Accelerated Share Repurchase Program

~~Subsequent Events~~

In ~~November 2023,~~May 2024, the Company’s Board of Directors authorized an accelerated share repurchase program to repurchase ~~$25,000~~$35,000 of the Company’s common stock, as part of the ~~$100,000~~$150,000 repurchase program authorized in January ~~2023.~~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.

~~Following the cessation of the London Interbank Offered Rate (“LIBOR”) in the United States~~The Company has not been required to adopt any accounting standards that had a significant impact on ~~June 30, 2023, the Company elected to apply the optional expedient provided in FASB Accounting Standards Update (“ASU”) 2020-04,~~ ~~Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting~~ prospectively. Thus, debt previously referenced to LIBOR was transitioned to the Secured Overnight Financing Rate (“SOFR”) effective July 1, 2023, however, such transition did not have a material effect on the Company’sits condensed consolidated financial ~~statements.~~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 is one 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

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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.

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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, ~~Belbuca~~ 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 ~~the~~ 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 for returns to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period.~~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 beginning six 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.

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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) ~~to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period.~~. Variable consideration, including the risk of customer concessions, is included in the transaction price only to the extent that it is

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probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is subsequently resolved. ~~In particular, resolution of the unprocessed return claims includes the risk of concession for those that are outside of the Company’s return policy.~~

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 ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and ~~2022:~~2023:


Trade


Trade

Rebates and

Product

Allowances and

Rebates and

Product

Allowances and

Incentives (1)

Returns (2)

Chargebacks (3)

Incentives ⁽¹⁾

Returns ⁽²⁾

Chargebacks ⁽³⁾
Balance as of December 31, 2022

$
156,937

$
73,554

$
22,058
Balance as of December 31, 2023

$
149,826

$
77,505

$
20,917
Provision related to current period sales

325,725

31,904

112,550

92,569

9,697

39,013
Changes in estimate related to prior period sales

2

3,722

589

1,061

1,519

(53)
Credits/payments made

(315,170)

(31,662)

(113,263)

(105,228)

(9,069)

(39,245)
Balance as of September 30, 2023

$
167,494

$
77,518

$
21,934
Balance as of March 31, 2024

$
138,228

$
79,652

$
20,632




Trade



Trade

Rebates and

Product

Allowances and

Rebates and

Product

Allowances and

Incentives (1)

Returns (2)

Chargebacks (3)

Incentives ⁽¹⁾

Returns ⁽²⁾

Chargebacks ⁽³⁾
Balance as of December 31, 2021

$
142,379

$
54,617

$
13,226
Acquired from BDSI

38,074

18,187

7,575
Balance as of December 31, 2022

$
156,937

$
73,554

$
22,058
Provision related to current period sales

368,880

26,508

94,859

92,871

10,166

34,921
Changes in estimate related to prior period sales

(304)

(838)

(580)

36

571

92
Credits/payments made

(385,298)

(20,987)

(93,946)

(122,852)

(10,381)

(32,563)
Balance as of September 30, 2022

$
163,731

$
77,487

$
21,134
Balance as of March 31, 2023

$
126,992

$
73,910

$
24,508

(1) Provisions for rebates and incentives ~~includes~~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 ~~September 30, 2023,~~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.

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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

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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 September 30,

Nine Months Ended September 30,
Three Months Ended March 31,

2023

2022

2023

2022
2024

2023
Belbuca
$
45,447

$
38,802

$
132,795

$
84,413
$
50,663

$
44,212
Xtampza ER

39,800

38,859

128,914

103,567

45,813

47,869
Nucynta IR

24,906

27,274

80,963

83,163

25,960

27,899
Nucynta ER

22,634

17,133

62,941

53,473

19,186

21,136
Symproic

3,922

3,580

11,409

7,740

3,301

3,651
Other

—

1,365

—

1,957
Total product revenues, net
$
136,709

$
127,013

$
417,022

$
334,313
$
144,923

$
144,767

~~The Company began recognizing product revenues, net from sales of Belbuca and Symproic following the Acquisition Date (refer to Note 4,~~ ~~Acquisitions~~).

~~4. Acquisitions~~

~~On March 22, 2022, the Company closed the BDSI Acquisition,~~ with BDSI surviving as a wholly owned subsidiary of the Company. The BDSI Acquisition was completed to leverage the Company’s existing sales force and other operations to commercialize additional products that are typically marketed to similar physicians and to develop other synergies. The Company obtained control through the acquisition of shares in an all-cash transaction which closed on March 22, 2022.

~~The total consideration paid for the BDSI acquisition was approximately $669,431 consisting of the following (in thousands, except per share amounts):~~

Fair Value of Purchase Price Consideration
Amount
Fair value of purchase price consideration paid at closing:

Cash consideration for all outstanding shares of BDSI's common and preferred stock (103,235,298 shares acquired at $5.60 per share)
$
578,118
Cash consideration paid to settle RSUs and in-the-money options

28,309
Cash paid to settle BDSI debt

63,004
Total purchase consideration
$
669,431

The Company has accounted for the BDSI Acquisition as a business combination and, accordingly, has included the assets acquired, liabilities assumed and results of operations in its financial statements following the Acquisition Date.

The final allocation of the consideration transferred to the assets acquired and liabilities assumed has been completed. During the three months ended March 31, 2023, the Company recorded measurement period adjustments to increase accrued expenses by $134 and deferred tax liabilities by $28, with a corresponding increase to goodwill of $162.

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~~The following tables set forth the final allocation of the BDSI Acquisition purchase price to the estimated fair value of the net assets acquired at the Acquisition Date:~~

Amounts Recognized at the Acquisition Date
Assets Acquired

Cash and cash equivalents

$
97,362
Accounts receivable

55,495
Inventory

77,382
Prepaid expenses and other current assets

6,125
Property and equipment

1,242
Operating lease assets

481
Intangible assets

435,000
Total assets

$
673,087
Liabilities Assumed

Accounts payable

$
12
Accrued expenses

18,249
Accrued rebates, returns and discounts

56,261
Operating lease liabilities

481
Deferred tax liabilities

62,510
Total liabilities

$
137,513
Total identifiable net assets acquired

535,574
Goodwill

133,857
Total consideration transferred

$
669,431

The valuation of the acquired intangible assets is inherently subjective and relies on significant unobservable inputs. The Company used an income approach to value the $435,000 of intangible assets. The valuation for each of these intangible assets was based on estimated projections of expected cash flows to be generated by the assets, discounted to the present value at discount rates commensurate with risk. The Company amortizes the identifiable intangible assets on a straight-line basis over their respective useful lives (refer to Note 10, ~~Goodwill and Intangible Assets~~~~). In addition, the acquired inventory was recognized at its acquisition-date fair value, which resulted in an increase of $54,700 compared to its preacquisition book value.~~

The excess of the purchase price over the fair value of identifiable net assets acquired represents goodwill. This goodwill is primarily attributable to synergies of merging operations. The acquired goodwill is not deductible for tax purposes.

~~5. License Agreements~~

~~Shionogi license and supply agreement~~

Prior to the BDSI Acquisition, BDSI and Shionogi Inc. (“Shionogi”) entered into an exclusive license agreement (the “Shionogi License Agreement”) for the commercialization of Symproic in the United States including Puerto Rico (the “Shionogi Territory”) for opioid-induced constipation in adult patients with chronic non-cancer pain (the “Shionogi Field”).

Pursuant to the terms of the Shionogi License Agreement, tiered royalty payments on net sales of Symproic in the Shionogi Territory are payable quarterly based on a royalty rate that ranges from 8.5% to 17.5% (plus an additional 1% of net sales on a pass-through basis to a third-party licensor of Shionogi) based on volume of net sales and whether Symproic is being sold as an authorized generic. Unless earlier terminated, the Shionogi License Agreement will continue in effect until the expiration of the royalty obligations, as defined therein. Upon expiration of the Shionogi License Agreement, all licenses granted for Symproic in the Shionogi Field and in the Shionogi Territory survive and become fully-paid, royalty-free, perpetual and irrevocable.

BDSI and Shionogi also had entered into a supply agreement under which Shionogi will supply Symproic at cost plus an agreed upon markup. In the event that Symproic is sourced from a third-party supplier, Shionogi would continue to supply naldemedine tosylate for use in Symproic manufacturing at cost plus such agreed upon markup for the duration of the Shionogi License Agreement.

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6.4. 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 ~~anti-dilutive.~~antidilutive.

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

Three Months Ended September 30,

Nine Months Ended September 30,
Three Months Ended March 31,

2023

2022

2023

2022
2024

2023
Numerator:

Net income (loss)
$
20,634

$
457

$
16,215

$
(17,803)
$
27,713

$
(17,426)
Adjustment for interest expense recognized on convertible senior notes

1,645

—

—

—

1,622

—
Net income (loss) - diluted
$
22,279

$
457

$
16,215

$
(17,803)
$
29,335

$
(17,426)
Denominator:

Weighted-average shares outstanding — basic

33,744,209


34,058,802

34,226,488


33,912,832

32,326,589


34,319,291
Effect of dilutive securities:

Stock options

222,355

191,454

263,513

—

468,057

—
Restricted stock units

583,153

320,063

659,153

—

1,134,716

—
Performance share units

—

—
Convertible senior notes

7,509,104

—

—

—

7,509,104

—
Weighted average shares outstanding — diluted

42,058,821

34,570,319

35,149,154

33,912,832

41,438,466

34,319,291

Earnings (loss) per share — basic
$
0.61

$
0.01

$
0.47

$
(0.52)
$
0.86

$
(0.51)
Earnings (loss) per share — diluted
$
0.53

$
0.01

$
0.46

$
(0.52)
$
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.

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

Three Months Ended September 30,

Nine Months Ended September 30,
Three Months Ended March 31,

2023

2022

2023

2022
2024

2023
Stock options
749,443

1,061,235

395,405

2,156,501
—

1,443,996
Restricted stock units
979,200

523,991

977,250

1,960,160
1,050

2,455,919
Performance share units
503,880

447,770

503,880

447,770
511,680

503,880
Employee stock purchase plan
19,094

11,553

19,094

—
17,320

—
Warrants
—

1,041,667

—

1,041,667
Convertible senior notes
—

4,925,134

7,509,104

4,925,134
—

7,509,104

For PSUs, these securities were excluded from the calculation of diluted earnings per share as the ~~performance-based or~~ 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.

~~As discussed in Note 14,~~ ~~Equity~~, the forward contract in connection with the Company’s ASR Agreement was outstanding as of September 30, 2023. As the Company is entitled to receive additional shares of its common stock in connection with the outstanding forward contract, the receipt of additional shares of common stock would be

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~~antidilutive. Therefore, no adjustments were made in the computation of earnings per share for the period the forward contract was outstanding.~~

7.5. Fair Value of Financial Instruments

Disclosures of fair value information about financial instruments are required, whether or not recognized in the consolidated balance sheets, for financial instruments with respect to which it is practicable to estimate that value. 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~~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~~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~~liability.

~~Transfers are calculated on values as of the transfer date.~~ The Company invests in instruments within defined credit parameters to minimize credit risk while ensuring liquidity.

There were no transfers between Levels 1, 2, and 3 during the ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and ~~2022.~~2023.

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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 ~~September 30, 2023~~March 31, 2024 and December 31, ~~2022:~~2023:

Significant

Significant

Quoted Prices

other

Significant

Quoted Prices

other

Significant

in active

observable

unobservable

in active

observable

unobservable

markets

inputs

inputs

markets

inputs

inputs



Total


(Level 1)


(Level 2)


(Level 3)


Total


(Level 1)


(Level 2)


(Level 3)
September 30, 2023

March 31, 2024

Cash equivalents:

Money market funds

$
104,250

$
104,250

$
—

$
—

$
69,772

$
69,772

$
—

$
—
Marketable securities:

Corporate debt securities

17,813

—

17,813

—

62,501

—

62,501

—
U.S. Treasury securities

23,740

—

23,740

—

24,442

—

24,442

—
Government-sponsored securities

4,480

—

4,480

—

2,495

—

2,495

—
Total assets measured at fair value

$
150,283

$
104,250

$
46,033

$
—

$
159,210

$
69,772

$
89,438

$
—

December 31, 2022

December 31, 2023

Cash equivalents:

Money market funds

$
172,590

$
172,590

$
—

$
—

$
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

$
172,590

$
172,590

$
—

$
—

$
153,629

$
77,299

$
76,330

$
—

The Company’s cash equivalents, ~~and marketable securities~~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 ~~September 30, 2023,~~March 31, 2024, the fair value of the Company's 2.625% convertible senior notes due in 2026 was ~~$25,033~~$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 ~~$212,602, which were estimated utilizing market quotations,~~$272,798 and ~~are considered Level 2.~~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 ~~September 30, 2023,~~March 31, 2024, the ~~outstanding principal balance~~carrying amount of the term notes ~~of $458,334~~ reasonably approximated the estimated fair value.

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As of ~~September 30, 2023,~~March 31, 2024, and December 31, ~~2022,~~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.

8.6. Marketable Securities

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

September 30,

March 31,

December 31,

2023

2024

2023
Cash and cash equivalents

$
—

$
—

$
4,729
Marketable securities

46,033

89,438

71,601
Total

$
46,033

$
89,438

$
76,330

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The following table summarizes the available-for-sale securities held as of ~~September 30,~~March 31, 2024 and December 31, 2023:

Amortized Cost

Gross Unrealized (Losses) Gains

Fair Value
March 31, 2024

Amortized Cost

Gross Unrealized Gains

Gross Unrealized Losses

Fair Value
Corporate debt securities

$
17,858

$
(45)

$
17,813

$
62,618

$
10

$
(127)

$
62,501
U.S. Treasury securities

23,741

(1)

23,740

24,448

—

(6)

24,442
Government-sponsored securities

4,486

(6)

4,480

2,496

—

(1)

2,495
Total

$
46,085

$
(52)

$
46,033

$
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 ~~September 30,~~March 31, 2024 and December 31, 2023:

September 30,

March 31,

December 31,


2023

2024

2023
Matures within one year

$
40,116

$
60,015

$
61,672
Matures after one year through five years

5,917

29,423

14,658
Total

$
46,033

$
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 were no 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 ~~and nine~~ months ended ~~September 30, 2023.~~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 ~~September 30,~~March 31, 2024 and December 31, 2023.

~~The Company did not hold marketable securities as of December 31, 2022.~~
There were no sales of marketable securities during the three and nine months ended September 30, 2023. 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.

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9.7. Inventory

Inventory as of ~~September 30, 2023~~March 31, 2024 and December 31, ~~2022~~2023 consisted of the following:

September 30,

December 31,

March 31,

December 31,

2023

2022

2024

2023
Raw materials

$
14,393

$
5,600

$
9,265

$
10,384
Work in process

9,186

24,672

8,706

6,740
Finished goods

10,546

16,229

13,305

15,208
Total inventory

$
34,125

$
46,501

$
31,276

$
32,332

The aggregate charges related to excess and obsolete inventory for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023 were ~~$563~~$373 and ~~$1,624,~~$906, respectively. These expenses were recorded as a component of cost of product revenues. ~~The aggregate charges related to excess and obsolete inventory for the three and nine months ended September 30, 2022 were immaterial.~~

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~~10.~~8. Goodwill and Intangible Assets

~~The following tables summarizes~~As of March 31, 2024 and December 31, 2023, the ~~changes in the carrying amount of goodwill:~~

Amount
Balance as of December 31, 2022

$
133,695
Measurement period adjustments from BDSI Acquisition

162
Balance as of September 30, 2023

$
133,857

Company’s goodwill balance was $133,857. The Company’s goodwill resulted from the ~~BDSI Acquisition.~~ ~~Refer to Note 4,~~ ~~Acquisitions~~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 ~~September 30, 2023~~March 31, 2024 and December 31, ~~2022:~~2023:

September 30, 2023

December 31, 2022

March 31, 2024

December 31, 2023

Amortization Period
(Years)

Cost

Accumulated Amortization

Carrying Amount

Cost

Accumulated Amortization

Carrying Amount

Cost

Accumulated Amortization

Carrying Amount

Cost

Accumulated Amortization

Carrying Amount
Belbuca
4.8

$
360,000

$
(114,973)

$
245,027

$
360,000

$
(58,428)

$
301,572

$
360,000

$
(152,669)

$
207,331

$
360,000

$
(133,821)

$
226,179
Nucynta Products ⁽¹⁾
8.5

521,170

(368,865)

152,305

521,170

(319,628)

201,542

521,170

(396,555)

124,615

521,170

(382,710)

138,460
Symproic
9.6

70,000

(11,110)

58,890

70,000

(5,646)

64,354

70,000

(14,755)

55,245

70,000

(12,931)

57,069
Elyxyb
—

—

—

—

5,000

(5,000)

—
Total intangibles

$
951,170

$
(494,948)

$
456,222

$
956,170

$
(388,702)

$
567,468
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 for the three ~~and nine~~ months ended ~~September 30, 2023~~March 31, 2024 and ~~2022:~~2023:

Three Months Ended September 30,

Nine Months Ended September 30,
Three Months Ended March 31,

2023

2022

2023

2022

2024

2023
Belbuca
$
18,850

$
18,848

$
56,545

$
39,581
$
18,848

$
18,849
Nucynta Products ⁽¹⁾

15,646

16,795

49,237

50,385

13,845

16,796
Symproic

1,821

1,821

5,464

3,825

1,824

1,821
Elyxyb

—

88

—

185
Total amortization expense
$
36,317

$
37,552

$
111,246

$
93,976
$
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

1817

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~~As of September 30, 2023, the remaining amortization expense expected to be recognized is as follows:~~

Years ended December 31,
Belbuca

Nucynta Products ⁽¹⁾

Symproic

Total
2023
$
18,848

$
13,845

$
1,821

$
34,514
2024

75,393

55,384

7,285

138,062
2025

75,393

55,384

7,285

138,062
2026

75,393

27,692

7,285

110,370
2027

—

—

7,285

7,285
Thereafter

—

—

27,929

27,929
Remaining amortization expense
$
245,027

$
152,305

$
58,890

$
456,222

~~(1)~~ During the three months ended September 30, 2023, the FDA granted New Patient Population exclusivity for Nucynta IR which extends the period of U.S. exclusivity for Nucynta IR to July 3, 2026, resulting in an extension of the estimated useful life of the underlying intangible asset from 8.0 years to 8.5 years. This change in estimate resulted in a decrease of amortization expense of $1,149 and an increase in net income of $855 during the three months ended September 30, 2023. The impact to earnings per share — basic and earnings per share — diluted was $0.03 and $0.02, respectively, during the three months ended September 30, 2023.

~~11.~~9. Accrued Liabilities

Accrued liabilities as of ~~September 30, 2023~~March 31, 2024 and December 31, ~~2022~~2023 consisted of the following:

September 30,

December 31,
March 31,

December 31,

2023

2022
2024

2023
Accrued income taxes
$
14,077

$
2,136
Accrued royalties
$
7,483

$
13,770

7,141

14,198
Accrued inventory

6,446

—
Accrued product taxes and fees

5,128

4,352

5,525

5,013
Accrued bonuses

4,103

6,347
Accrued sales and marketing

1,621

2,130

1,754

1,198
Accrued incentive compensation

1,290

1,507

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 interest

1,112

1,410

944

2,853
Accrued audit and legal

1,062

1,957
Accrued payroll and related benefits

941

1,208
Accrued other operating costs

2,465

3,448

2,088

3,600
Total accrued liabilities
$
31,651

$
36,129
$
38,190

$
37,571

~~12.~~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

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Loan bore interest at a rate based ~~upon~~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 ~~upon~~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 ~~September 30, 2023,~~March 31, 2024, the contractual interest rate was ~~13.2%~~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

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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.

~~During~~The following table presents the ~~three and nine months ended September 30, 2023, the Company recognized~~total interest expense ~~of $18,567 and $57,897, respectively,~~recognized related to the 2022 Term ~~Loan. During~~Loan during the three ~~and nine~~ months ended ~~September 30, 2022,~~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 ~~Company recognized~~effective interest ~~expense of $17,879 and $36,293, respectively, related to~~rate on the 2022 Term ~~Loan.~~Loan was 14.6%.

As of ~~September 30, 2023, future required~~March 31, 2024, principal repayments under the 2022 Term Loan are as follows:

Years ended December 31,
Principal Payments
Principal Payments
2023
$
45,834
2024

183,333
$
137,500
2025

183,333

183,333
2026

45,834

45,834
Total before unamortized discount and issuance costs
$
458,334
$
366,667
Less: unamortized discount and issuance costs

(9,115)

(5,974)
Term notes carrying value
$
449,219
$
360,693

~~13.~~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

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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;

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(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 ~~September 30, 2023,~~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 ~~any~~the 2026 Convertible Notes for redemption ~~will constitute~~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.

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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 ~~(“ASC”)~~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

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financing costs of $2,264. ~~After giving effect to the repurchase, the~~The total remaining principal amount outstanding under the 2026 Convertible Notes as of ~~September 30, 2023~~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.

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As of ~~September 30, 2023,~~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

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(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 ~~(xiii)~~(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 ~~September 30, 2023~~March 31, 2024 as convertible senior notes.

As of ~~September 30, 2023,~~March 31, 2024, the outstanding balance of the Convertible Notes consisted of the following:

2026 Convertible Notes

2029 Convertible Notes

Total Convertible Notes
2026 Convertible Notes

2029 Convertible Notes

Total Convertible Notes
Principal
$
26,350

$
241,500

$
267,850
$
26,350

$
241,500

$
267,850
Less: unamortized issuance costs

(401)

(5,626)

(6,027)

(317)

(5,108)

(5,425)
Net carrying amount
$
25,949

$
235,874

$
261,823
$
26,033

$
236,392

$
262,425

The Company determined the expected life of the 2026 Convertible Notes and 2029 Convertible Notes was equal to the six-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 ~~September 30, 2023,~~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 of~~amount.

The following table presents the total interest expense recognized related to the Convertible ~~Notes.~~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

2322

Table of Contents

~~The following table presents the total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2023, and 2022:~~

Three Months Ended September 30,

Nine Months Ended September 30,

2023

2022

2023

2022
Contractual interest expense
$
1,909

$
943

$
5,297

$
2,830
Amortization of debt issuance costs

302

228

863

678
Total interest expense
$
2,211

$
1,171

$
6,160

$
3,508

As of ~~September 30, 2023,~~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
2026 Convertible Notes

2029 Convertible Notes

Total Convertible Notes
2023
$
—

$
—

$
—
2024

692

6,943

7,635
$
346

$
3,471

$
3,817
2025

692

6,943

7,635

692

6,943

7,635
2026

26,696

6,943

33,639

26,696

6,943

33,639
2027

—

6,943

6,943

—

6,943

6,943
2028

—

6,943

6,943
Thereafter

—

251,915

251,915

—

244,972

244,972
Total minimum payments
$
28,080

$
279,687

$
307,767
$
27,734

$
276,215

$
303,949
Less: interest

(1,730)

(38,187)

(39,917)

(1,384)

(34,715)

(36,099)
Less: unamortized issuance costs

(401)

(5,626)

(6,027)

(317)

(5,108)

(5,425)
Convertible Notes carrying value
$
25,949

$
235,874

$
261,823
$
26,033

$
236,392

$
262,425

~~Table of Contents~~

~~14.~~12. Equity

The changes in shareholders’ equity for the three ~~and nine~~ months ended ~~September 30,~~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, 2023
38,192,441

$
38

$
565,949

(6,323,892)

$
(137,381)

$
(233,189)

$
14

$
195,431
Exercise of common stock options
200,200

—

4,205

—

—

—

—

4,205
Issuance for employee stock purchase plan
18,538

—

356

—

—

—

—

356
Vesting of RSUs and PSUs
1,000,357

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, 2024
39,029,639

$
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




Accumulated Other

Total


Additional




Total

Common Stock

Paid- In

Treasury Stock

Accumulated

Comprehensive

Shareholders’
Common Stock

Paid- In

Treasury Stock

Accumulated

Shareholders’

Shares


Amount

Capital

Shares

Amount

Deficit

Loss

Equity
Shares


Amount

Capital

Shares

Amount

Deficit

Equity
Balance, December 31, 2022
37,084,759

$
37

$
538,073

(3,235,823)

$
(61,924)

$
(281,344)

$
—

$
194,842
37,084,759

$
37

$
538,073

(3,235,823)

$
(61,924)

$
(281,344)

$
194,842
Exercise of common stock options
234,132

—

3,848

—

—

—

—

3,848
234,132

—

3,848

—

—

—

3,848
Issuance for employee stock purchase plan
11,329

—

169

—

—

—

—

169
11,329

—

169

—

—

—

169
Vesting of RSUs and PSUs
775,904

1

—

—

—

—

—

1
775,904

1

—

—

—

—

1
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(289,281)

—

(7,736)

—

—

—

—

(7,736)
(289,281)

—

(7,736)

—

—

—

(7,736)
Stock-based compensation
—

—

6,035

—

—

—

—

6,035
—

—

6,035

—

—

—

6,035
Net loss
—

—

—

—

—

(17,426)

—

(17,426)
—

—

—

—

—

(17,426)

(17,426)
Balance, March 31, 2023
37,816,843

$
38

$
540,389

(3,235,823)

$
(61,924)

$
(298,770)

$
—

$
179,733
37,816,843

$
38

$
540,389

(3,235,823)

$
(61,924)

$
(298,770)

$
179,733
Exercise of common stock options
72,405

—

1,251

—

—

—

—

1,251
Vesting of RSUs and PSUs
73,805

—

—

—

—

—

—

—
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(9,655)

—

(220)

—

—

—

—

(220)
Stock-based compensation
—

—

7,072

—

—

—

—

7,072
Other comprehensive loss, net of tax
—

—

—

—

—

—

(38)

(38)
Net income
—

—

—

—

—

13,007

—

13,007
Balance, June 30, 2023
37,953,398

$
38

$
548,492

(3,235,823)

$
(61,924)

$
(285,763)

$
(38)

$
200,805
Exercise of common stock options
21,185

—

302

—

—

—

—

302
Issuance for employee stock purchase plan
15,176

—

291

—

—

—

—

291
Vesting of RSUs and PSUs
18,207

—

—

—

—

—

—

—
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(7,359)

—

(172)

—

—

—

—

(172)
Share repurchases from Accelerated Share Repurchase ("ASR") agreement
—

—

—

(1,702,852)

(40,000)

—

—

(40,000)
Forward contract on ASR agreement
—

—

(10,000)

—

—

—

—

(10,000)
Stock-based compensation
—

—

7,027

—

—

—

—

7,027
Other comprehensive loss, net of tax
—

—

—

—

—

—

(14)

(14)
Net income
—

—

—

—

—

20,634

—

20,634
Balance, September 30, 2023
38,000,607

$
38

$
545,940

(4,938,675)

$
(101,924)

$
(265,129)

$
(52)

$
178,873

2523

Table of Contents

~~The changes in shareholders’ equity for the three and nine months ended September 30, 2022 were as follows:~~


Additional




Total

Common Stock

Paid- In

Treasury Stock

Accumulated

Shareholders’

Shares


Amount

Capital

Shares

Amount

Deficit

Equity
Balance, December 31, 2021
35,806,119

$
36

$
502,095

(2,150,717)

$
(42,861)

$
(256,342)

$
202,928
Exercise of common stock options
190,074

—

3,261

—

—

—

3,261
Issuance for employee stock purchase plan
13,421

—

203

—

—

—

203
Vesting of RSUs and PSUs
563,050

—

—

—

—

—

—
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(191,667)

—

(3,382)

—

—

—

(3,382)
Share repurchases
—

—

5,000

(307,132)

(5,000)

—

—
Stock-based compensation
—

—

6,135

—

—

—

6,135
Net loss
—

—

—

—

—

(13,069)

(13,069)
Balance, March 31, 2022
36,380,997

$
36

$
513,312

(2,457,849)

$
(47,861)

$
(269,411)

$
196,076
Exercise of common stock options
102,283

—

1,545

—

—

—

1,545
Vesting of RSUs and PSUs
111,056

1

—

—

—

—

1
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(26,506)

—

(511)

—

—

—

(511)
Stock-based compensation
—

—

5,692

—

—

—

5,692
Net loss
—

—

—

—

—

(5,191)

(5,191)
Balance, June 30, 2022
36,567,830

$
37

$
520,038

(2,457,849)

$
(47,861)

$
(274,602)

$
197,612
Exercise of common stock options
10,395

—

142

—

—

—

142
Issuance for employee stock purchase plan
9,206

—

134

—

—

—

134
Vesting of RSUs and PSUs
17,644

—

—

—

—

—

—
Shares withheld for employee taxes upon vesting of RSUs and PSUs
(5,777)

—

(106)

—

—

—

(106)
Share repurchases
—

—

—

(366,213)

(6,422)

—

(6,422)
Stock-based compensation
—

—

5,377

—

—

—

5,377
Net income
—

—

—

—

—

457

457
Balance, September 30, 2022
36,599,298

$
37

$
525,585

(2,824,062)

$
(54,283)

$
(274,145)

$
197,194

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 ~~September 30, 2023,~~March 31, 2024, there were ~~1,859,087~~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 ~~and restricted stock units~~ generally vest ratably over a four-year period of ~~service. The stock options~~service and generally have a ten-year contractual ~~life and, upon~~life. Upon termination, vested stock options are generally exercisable for three 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 a four-year period of service. Beginning in 2024, RSUs granted by the Company vest ratably over a three-year period of service. Upon termination, unvested RSUs are forfeited immediately. Refer to Note ~~15,~~13, Stock-based Compensation, for more information.

ShareRepurchases
2023 Repurchase Program

In ~~August 2021,~~January 2023, the Company’s Board of Directors authorized ~~a share~~the repurchase ~~program to repurchase~~of up to $100,000 of ~~outstanding~~ shares of ~~the Company’s~~its common stock at any time or times through December 31, ~~2022~~2023 (the ~~“Prior~~“2023 Repurchase Program”). The ~~Prior~~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. ~~Shares~~

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 ~~Prior~~2023 Repurchase ~~Program~~Program. Repurchased shares were returned to the Company’s pool of authorized but unissued ~~shares available for reissuance.~~shares. The ~~timing and amount of any such repurchases were determined based on share price, market conditions, legal requirements, and other relevant factors.~~

~~Table of Contents~~

~~Through December 31, 2022, the Company repurchased 3,235,823 shares at a weighted-average price of $19.14 per share for a total of $61,924 under the Prior Repurchase Program and the~~ cost of repurchased shares were recorded as treasury stock in the consolidated balance sheet. ~~The Prior~~Shares repurchased under the 2023 Repurchase Program ~~expired on December 31, 2022.~~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

Table of Contents

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 ~~2023,~~2024, the Company’s Board of Directors authorized ~~a share~~the repurchase ~~program to repurchase~~of up to ~~$100,000~~$150,000 of the Company’s common stock through ~~December 31, 2023~~June 30, 2025 (the ~~“2023~~“2024-2025 Repurchase Program”). The ~~2023~~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 ~~repurchased~~purchased on the open market will be determined based on the Company’s evaluation of the market conditions, share price and other factors.

In July 2023, the Company’s board of directors authorized an accelerated share repurchase program (the “ASR Program”) to repurchase $50,000 of the Company’s common stock, as part of the Company’s existing 2023 Repurchase Program. Under the terms of the Company's ASR agreement with an investment bank (the “ASR Agreement”), 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 ASR Agreement was executed. The remaining shares repurchased 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 Company received an additional 462,442 shares in settlement of the ASR Agreement, bringing the total shares pursuant to the ASR Agreement to 2,165,294.

The ASR Agreement was accounted for as two separate transactions: (1) a repurchase of common stock in a treasury stock transaction recorded on August 7, 2023, and (2) a forward contract indexed to the Company’s own common stock which settled in the fourth quarter of 2023. The forward contract for the purchase of the remaining $10,000, representing remaining shares to be delivered by the investment bank under the ASR Agreement, was recorded as a reduction to stockholders’ equity as of September 30, 2023.

Forward contracts to repurchase a variable number of the Company’s equity shares that require physical settlement are accounted for in conformity with guidance in ASC 815-10-15. Under ASC 815-10-15-74, contracts issued or held by a company that are both (1) indexed to its own stock and (2) classified in stockholders’ equity in its statement of financial position are not considered to be derivative instruments. Based on the transaction structure, the Company concluded that the forward purchase contract portion of the Company’s ASR Agreement satisfied these criteria and accordingly was classified as an equity instrument. In accordance with ASC 260-10-55-88, the above-noted treasury stock acquisition resulted in an immediate reduction of 1,702,852 shares from the outstanding shares used to calculate the weighted-average common shares outstanding for both basic and diluted earnings per share. The forward contract was outstanding as of September 30, 2023. As the Company was entitled to receive additional shares of its common stock in connection with the outstanding forward contract as of September 30, 2023, the receipt of additional shares of common stock would be antidilutive. Therefore, no adjustments were made in the computation of earnings per share for the period the forward was outstanding.

As of September 30, 2023, the Company repurchased 1,702,852 shares at a weighted-average price of $23.49 per share for a total of $40,000 under the 2023 Repurchase Program and the cost of repurchased shares was recorded as treasury stock in the condensed consolidated balance sheet. As of September 30, 2023, $60,000 remained available for share repurchases under the 2023 Repurchase Program, which reflects the $10,000 forward contract that was not yet settled as of September 30, 2023.

The Company ~~has utilized, and~~ plans ~~to continue~~ to utilize existing cash on hand to fund ~~the 2023 Repurchase Program.~~share repurchases.

~~Table~~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 ~~Contents~~March 31, 2024.

~~15.~~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 ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and related information is as follows:

Weighted-Average

Weighted-Average

Shares

Grant Date Fair Value

Shares

Grant Date Fair Value
Outstanding as of December 31, 2022

447,770

$
28.71
Outstanding as of December 31, 2023

503,880

$
33.13
Granted

216,500

38.71

203,000

45.06
Vested

(223,170)

27.99

(314,921)

33.90
Forfeited

—

—

—

—
Performance adjustment

62,780

27.14

119,721

34.26
Outstanding as of September 30, 2023

503,880

$
33.13
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 ~~nine~~three months ended ~~September 30,~~March 31, 2024, and 2023 was $45.06 and ~~2022 was~~ $38.71, ~~and $24.12,~~ respectively.

~~Restricted Stock Units~~

The Company granted RSUs to employees during the nine months ended September 30, 2023. The Company’s RSUs generally vest ratably over a four-year period of service. A summary of the Company’s RSU activity for the nine months ended September 30, 2023 and related information is as follows:

Weighted-Average

Shares

Grant Date Fair Value
Outstanding as of December 31, 2022

2,047,571

$
19.67
Granted

1,268,907

26.27
Vested

(644,746)

19.90
Forfeited

(179,711)

21.85
Outstanding as of September 30, 2023

2,492,021

$
22.81

The weighted-average grant date fair value per share of RSUs granted for the nine months ended September 30, 2023 and 2022 was $26.27 and $17.48, respectively. The total fair value of RSUs vested (measured on the date of vesting) for the nine months ended September 30, 2023, and 2022 was $16,906 and $10,020, respectively.

2825

Table of Contents

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 a four-year period of service. Beginning in 2024, RSUs granted by the Company vest ratably over a three-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 a four-year period and generally have a ten-year contractual life. Upon termination, vested stock options are generally exercisable for three months following the termination date, while unvested options are forfeited immediately upon termination.

A summary of the Company’s stock option activity for the ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and related information is as follows:

Weighted-

Weighted-

Weighted-

Average

Weighted-

Average

Average

Remaining

Aggregate

Average

Remaining

Aggregate

Exercise Price

Contractual

Intrinsic

Exercise Price

Contractual

Intrinsic


Shares


per Share

Term (in years)


Value

Shares


per Share

Term (in years)


Value
Outstanding as of December 31, 2022

1,683,805

$
18.84

5.5

$
7,953
Outstanding as of December 31, 2023

1,176,750

$
19.48

4.3

$
13,297
Exercised

(327,722)

16.43

(200,200)

20.96

Cancelled

(8,923)

18.87

(1,000)

27.73

Outstanding as of September 30, 2023

1,347,160

$
19.43

4.7

$
4,952
Exercisable as of September 30, 2023

1,310,344

$
19.38

4.6

$
4,910
Outstanding as of March 31, 2024

975,550

$
19.17

4.0

$
19,172
Exercisable as of March 31, 2024

974,941

$
19.17

4.0

$
19,160

There were no stock options granted during the ~~nine~~three months ended ~~September 30, 2023~~March 31, 2024 and ~~2022.~~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 (1)~~on: (i) the first day of the purchase ~~period~~period; or ~~(2)~~(ii) the last day of the purchase period. During the ~~nine~~three months ended ~~September 30, 2023, 26,505~~March 31, 2024, 18,538 shares of common stock were purchased for total proceeds of ~~$460.~~$356. The expense for the three months ended ~~September 30,~~March 31, 2024 and 2023 was $65 and ~~2022 was $55 and $28, respectively. The expense for the nine months ended September 30, 2023 and 2022 was $155 and $88,~~$46, respectively.

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Stock-based Compensation Expense

A summary of the allocation of the Company’s stock-based compensation expense for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023 ~~and 2022~~ is as follows:

Three Months Ended September 30,

Nine Months Ended September 30,
Three Months Ended March 31,

2023

2022

2023

2022
2024

2023
Research and development
$
—

$
—

$
—

$
1,591
Selling, general and administrative

7,027

5,377

20,134

15,613
$
7,475

$
6,035
Total stock-based compensation expense
$
7,027

$
5,377

$
20,134

$
17,204
$
7,475

$
6,035

As of ~~September 30, 2023,~~March 31, 2024, there was approximately ~~$50,041~~$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 ~~2.6~~2.5 years.

~~16.~~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 of three 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 ~~filed~~filing the New Drug Application (“NDA”) for Xtampza ER as a 505(b)(2) application ~~which allows the Company to reference~~referencing data from an approved drug listed in the FDA’s Orange Book, in this case OxyContin. The 505(b)(2) process requires that the Company certify to the FDA that the Company does not infringe any of the patents listed forPurdue’s OxyContin ~~in the Orange Book, or that the patents are invalid. The process also requires that the Company notify Purdue Pharma, L.P (“Purdue”), as the holder of the~~ NDA, and ~~any other Orange Book-listed patent owners that it~~

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has made such a certification. On February 11, 2015, the Company made the required certification documenting why Xtampza ER does not infringe any of the 11 Orange Book-listed patents for OxyContin, five of which have been invalidated in court proceedings, and provided the required notice to Purdue. Underunder the Drug Price Competition and Patent Term Restoration Act of 1984, ~~Purdue had the option to sue the Company for infringement and receive~~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.

In response to these actions, Purdue sued the Company for infringement in the District of Delaware on March 24, 2015 asserting infringement of three 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), and accordingly, received a 30-month stay of FDA approval.

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 ~~asserting infringement of those patents with prejudice. Upon dismissal of those claims,~~which lifted the 30-month stay of FDA ~~approval was lifted. As a result,~~approval. Following this judgment, the Company ~~was able to obtain~~obtained final approval for Xtampza ER and ~~launch the product~~launched commercially.

Purdue subsequently filed two follow-on lawsuits asserting infringement of two patents that had been late-listed in the Orange Book and, therefore, could not trigger any stay of FDA approval: Purdue ~~filed suit asserting~~asserted infringement of Patent No. 9,073,933 in November 2015 and ~~asserted infringement of~~ Patent No. 9,522,919 in April 2017. In addition, Purdue ~~filed suit on~~invoked two non-Orange Book-listed patents, ~~that had not been listed in the Orange Book,~~ 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 ~~argues~~argued that the ʼ961 patent is invalid for lack of a written description, for lack of enablement, for indefiniteness, and as being anticipated by prior art. The PTAB held oral argument on the proceedings on July 10, 2019 and was scheduled to issue a decision on the patentability of the ʼ961 patent by no later than October 4, 2019. On September 15, 2019, Purdue commenced a voluntary case under chapter 11 of title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York. On September 24, 2019, Purdue gave the PTAB notice of its bankruptcy filing and sought the imposition of an automatic stay of the PGR proceedings. On October 2, 2019, the PTAB extended the one-year period for issuing its decision by up to six months.invalid.

In October 2017, and in response to the filing of the Company’s supplemental New Drug Application (“sNDA”) seeking to update the drug abuse and dependence section of the Xtampza ER label, Purdue filed another suit asserting infringement of the ʼ933 and ʼ919 patent. The Company filed a motion to dismiss that action, and the Court granted its motion on January 16, 2018.

~~A claim construction hearing was held on June 1, 2017.~~ 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 ~~granted in part a motion for summary judgment that the Company filed. Specifically, the Court~~ ruled that the Xtampza ER formulation does not infringe the ʼ497 and ʼ717 patents.

On September ~~18,~~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 ~~proceedings. On September 20, 2019,~~Court and the ~~matter was stayed~~PTAB granted Purdue’s requests to stay the pending ~~further order of the Court.~~matters.

On September 1, 2020, the Bankruptcy Court entered an Order, ~~Granting Motions for Relief from the Automatic Stay,~~ lifting the automatic stays in both the District of Massachusetts and ~~PTAB proceedings. The Company appealed the Bankruptcy Court’s Order, in part, and that appeal is stayed, on consent by Purdue, pending the outcome of any appeal of the~~ PTAB proceedings. On September 11, 2020, Purdue filed a motion to terminate the PTAB action on

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the basis that those proceedings had gone beyond the 18-month statutory period. ~~The Company opposed Purdue’s motion.~~ On November 19, 2021, the ~~PTAB~~PTAB: (i) denied Purdue’s motion to terminate the ~~PGR~~PGR; and (ii) issued its Final Written Decision, finding that the asserted claims ~~1-17~~ of the ʼ961 patent were invalid for lack of written description and anticipation. ~~On December 17, 2021,~~ Purdue ~~filed a Request for Director Review. That request was denied on February 7, 2022. On February 16, 2022, Purdue filed a~~appealed the decision to Federal Circuit, ~~notice~~which issued its decision on November 21, 2023, affirming the authority of ~~appeal. On April 12, 2022,~~ the ~~Company filed a Motion~~PTAB to ~~Dismiss~~issue its Final Written Decision and upholding the ~~Appeal as Untimely. On May 20, 2022,~~PTAB’s finding of invalidity relative to the ~~Federal Circuit denied~~’961 patent. Purdue has exhausted all possibility of appeal and the ~~Motion to Dismiss and directed~~judgment of invalidity of the ~~parties to address jurisdiction during merits briefing. Oral arguments in the appeal were heard on September 5, 2023.~~‘961 patent is final without further right of appeal.

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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, which was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval.~~10,407,434. The Company responded to Purdue’s complaint ~~asserting the ’434 patent~~ with a motion to dismiss. On May 21, 2021, and in response to the Company’s motion to dismiss, Purdue filed an amended ~~complaint asserting the ’434 patent.~~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 ~~October 5, 2021, the Court held a claim construction hearing for the ʼ961 patent and the ʼ434 patent. On~~ May 15, 2023, the Court issued an order ~~that~~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~~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 ~~PTAB’s order invalidating that~~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. The parties agreed, however, that litigation concerning the ʼ961 patent is stayed pending resolution of Purdue’s Federal Circuit appeal of the PTAB decision invalidating the claims of the ʼ961 patent. 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. Specifically, Purdue~~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. ~~Purdue has made a demand for monetary relief in its complaint but has not quantified its alleged damages.~~

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 ~~the~~ Purdue’s claims were barred by the doctrine of patent exhaustion. On June ~~18, 2019, the Court heard oral argument on the Company’s Rule 12(c) Motion for Judgment on the Pleadings. On June~~ 19, 2019, the Court issued an order ~~stating that “judgment in Collegium’s favor is warranted under~~calling for discovery on a factual predicate for the ~~doctrine of~~ patent exhaustion ~~to the extent Collegium’s alleged infringing activities resulted from sales~~defense and noted that fall within the scope of that covenant.” The Court explained, however, that based on the current record, it was not possible “to determine whether title of the Nucynta Products was transferred to Collegium” from sales authorized by Purdue’s covenant not to sue. The Court ordered discovery on this issue and 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 ~~gave~~notified the Court ~~notice~~ of its bankruptcy filing and sought ~~the imposition of~~ an automatic stay of ~~the proceedings.~~proceedings, which was granted. The Nucynta litigation iscurrently remains subject to the ~~automatic~~ bankruptcy stay.

~~Pending resolution of the bankruptcy action, the~~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.

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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 ~~United States~~ District Court for the Southern District of New York ~~captioned~~ ~~Stein v. BioDelivery Sciences International, Inc., et al.~~~~, No. 1:22-cv-01600,~~ naming as defendants BDSI and each member of its Board of Directors as of the date of the Merger Agreement (“Stein Action”). On February 28, 2022, two additional cases were filed by purported individual stockholders of BDSI in the same ~~court, captioned~~ ~~Sanford v. BioDelivery Sciences International, Inc., et al~~~~., No. 1:22-cv-01676 (“~~court: the “Sanford Action”), and ~~Higley v. BioDelivery Sciences International, Inc., et al.~~~~, No. 1:22-cv-01658 (“~~the “Higley ~~Action”). On~~Action.” In March ~~2, 2022 and March 5,~~ 2022, two additional cases were filed by purported individual stockholders of BDSI in the ~~United States~~ District Court for the Eastern District of New ~~York, captioned~~ ~~Justice II v. BioDelivery Sciences International, Inc., et al.~~~~, No. 1:22-cv-01145 (“~~York: the “Justice Action”) and the~~Zomber v. BioDelivery Sciences International, Inc., et al., No. 1:22-cv-01220 (“~~~~Zomber~~ “Zomber Action”~~; together~~ (together with the Stein, Sanford, ~~Higley~~, and ~~Justice~~Higley 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

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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 by allegedly failing to disclose purportedly material information relating to the sale process leading to the Merger, BDSI’s financial projections, and the analyses performed by Moelis & Company LLC in connection with the Merger.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. ~~Additionally, the~~ ~~Stein, Higley, Justice~~~~, and~~ ~~Zomber~~ ~~complaints assert violations of Section 14(d) of the Exchange Act and Rule 14d-9 promulgated thereunder.~~ 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, onbetween February ~~24, 2022, February 28, 2022,~~ and March 7,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”). OnIn March ~~4, 2022, March 9, 2022, and March 11,~~ 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”).

~~On April 14, 2022, plaintiff~~Plaintiffs in the Higley, Zomber, and Justice ~~Action~~Actions each filed a notice of voluntary dismissal of ~~the complaint. On May 15, 2022, plaintiff~~their complaint in the ~~Zomber~~ ~~Action filed a notice~~second quarter of ~~voluntary dismissal of the complaint. And, on June 24, 2022, plaintiff in the~~ ~~Justice~~ ~~Action filed a notice of voluntary dismissal of the complaint. In the remaining~~ ~~Stein~~ ~~and~~ ~~Sanford~~ ~~Actions, on July 20, 2022, the respective Courts entered an Order for plaintiff to serve a summons and complaint by August 3,~~ 2022. On July 28, 2022, plaintiff in the Sanford Action filed a partial voluntary dismissal of the individual named defendants, ~~but not BDSI from that action~~ and ~~filed a waiver of service as to BDSI. On~~on October 26, 2022, ~~plaintiff in the~~ ~~Sanford~~ ~~Action~~ filed a notice of voluntary dismissal of the ~~complaint as to Defendant~~ BDSI ~~as well.~~defendant. On February 17, 2023, the ~~Court in the~~ Stein Action ~~entered an order dismissing that 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.

As set forth in the Supplemental Disclosures, nothing therein shall be deemed an admission of the legal necessity or materiality under applicable law of the Supplemental Disclosures. To the contrary, the Company and BDSI specifically deny all allegations that any of the Supplemental Disclosures, or any other additional disclosures, were or are required. The Company intends to defend the Merger Litigations vigorously. In connection with the Supplemental Disclosures, however, the Company has agreed to pay certain fees based on the purported benefit that the stockholders brought to the Company and its other stockholders through the Actions, Inspection Letters, and Demand Letters.

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~~Opioid Litigation~~

As a result of the opioid epidemic, numerous state and local governments, healthcare providers, and other entities brought suit against manufacturers, wholesale 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. Of the 21 MDL cases that named the Company as a defendant, the allegations against it were previously dismissed or withdrawn in 13 cases as of December 31, 2021. The remaining eight MDL cases that named the Company were dismissed as of April 19, 2022. In addition, the Company had been previously dismissed from three non-MDL cases filed in Pennsylvania and Arkansas state courts.

~~Outside of the MDL, there were several cases filed against the Company in state courts in Pennsylvania and Massachusetts:~~

●

In Pennsylvania, six lawsuits naming the Company were consolidated for discovery purposes in the Delaware County Court of Common Pleas as part of a consolidated proceeding of similar lawsuits brought by numerous Pennsylvania counties against other pharmaceutical manufacturers and distributors. These included lawsuits filed between May 2018 and July 2019, alleging claims related to opioid marketing and distribution, including negligence, fraud, unjust enrichment, public nuisance, and violations of state consumer protections laws.

●

In Massachusetts, there were lawsuits by 13 municipalities, all of which were consolidated before the Business Litigation Session of the Superior Court. The actions alleged a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, violations of Mass Gen. Laws ch. 93A, Section 11, unjust enrichment and civil conspiracy.

On December 24, 2021, the Company entered into a settlement framework with Scott+Scott Attorneys at Law, LLP, the law firm representing plaintiffs in each of the 27 cases, including the 8 remaining MDL cases and 19 state court cases described above. Pursuant to the terms of the settlement framework, which were later memorialized in a final settlement agreement, the Company agreed to pay $2,750 in exchange for the dismissal, with prejudice, of each plaintiff’s lawsuit against the Company and a release of claims related to such lawsuits. The settlement agreement was executed by the Company and all 27 plaintiffs, and the amounts subject to the settlement agreement were paid. As of April 19, 2022, the Company was dismissed, with prejudice, from each of the 27 cases.

~~The Company entered into this settlement to efficiently resolve this litigation and does not admit any liability or acknowledge any wrongdoing in connection with the settlement agreement.~~

~~Aquestive Litigation~~

On October 29, 2013, 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 against BDSI relating to its Bunavail product in the United States District Court for the Eastern District of North Carolina (“EDNC”) for alleged patent infringement. Bunavail is a drug approved for the maintenance treatment of opioid dependence. This case was dismissed, but the RB Plaintiffs subsequently filed an action against BDSI, on September 22, 2014, relating to Bunavail product in the United States District Court for the District of New Jersey for alleged patent infringement. The RB Plaintiffs claimed that Bunavail, whose formulation and manufacturing processes have never been disclosed publicly, infringes its U.S. Patent No. 8,765,167 (the “’167 Patent”).

~~On January 13, 2017, Aquestive filed a complaint in the United States District Court for the District of New Jersey alleging Belbuca infringes the ’167 Patent.~~

On March 8, 2023, the parties filed a stipulation of dismissal. The RB Plaintiffs dismissed their claims with prejudice, and BDSI dismissed its counterclaims without prejudice. 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.~~

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~~Chemo Research, S.L~~

~~On March 1, 2019, BDSI filed a complaint for patent infringement in~~ ~~United States 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 its Orange Book-listed patents for BELBUCA, including U.S. Patent Nos. 8,147,866 (“’866 patent”) and 9,655,843, (“’843 patent”) both expiring in July of 2027, and U.S. Patent No. 9,901,539 (“’539 patent”) expiring December of 2032 (collectively, “the BEMA patents”). This complaint follows a receipt by BDSI on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it has filed with the FDA an abbreviated New Drug Application (“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. Because BDSI initiated a patent infringement suit asserting the patents identified in the Notice Letter within 45 days after receipt, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. On March 15, 2019, BDSI filed a complaint against the Chemo Defendants in the Federal District Court for the District of New Jersey asserting the same claims for patent infringement made in the Delaware lawsuit. On April 19, 2019, Defendants filed an answer to the Delaware complaint wherein they denied infringement of the ’866, ’843 and ’539 patents and asserted counterclaims seeking declaratory relief concerning the alleged invalidity and non-infringement of such patents.

~~On April 25, 2019, BDSI voluntarily dismissed the New Jersey lawsuit given Defendants’ consent to jurisdiction in Delaware.~~

The trial to adjudicate issues concerning the validity of the Orange Book-listed patents covering BELBUCA was held from March 1-3, 2021. Chemo did not participate in the bench trial. Instead, on February 26, 2021, Chemo agreed to be bound by the decision of the Court with respect to the validity of the BEMA patents from the March 1-3, 2021 trial with Alvogen. On December 20, 2021, the Court issued an opinion upholding the validity of certain claims in BDSI’s ʼ866 patent, which expires in 2027, and certain claims in the ’539 patent, which expires in 2032, to which Chemo is bound. This holding was affirmed on appeal by the Federal Circuit on December 21, 2022. The bench trial to adjudicate issues concerning the Chemo Defendants’ infringement of the Orange Book patents was set to commence on April 25, 2022. On March 30, 2022, the Court vacated the trial and has not yet set a new trial date.

On August 1, 2022, BDSI received a second Paragraph IV certification notice letter from Chemo indicating that Chemo has 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 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 district 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.

The Company plans to litigate these cases 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.

Alvogen

On September 7, 2018, BDSI filed a complaint for patent infringement in ~~United States~~ 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 ~~infringes~~infringed BDSI’s Orange Book-listed patents for ~~BELBUCA,~~Belbuca, including U.S. Patent Nos. 8,147,866, 9,655,843 and ~~9,655,843, both expiring in July of 2027, and U.S. Patent No.~~ 9,901,539 ~~expiring in December of 2032~~ (collectively, “the BEMA patents”). This complaint followed receipt by BDSI on July 30, 2018 of a Paragraph IV Patent Certification from Alvogen stating ~~that Alvogen~~it had filed an ~~ANDA~~ abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of ~~BELBUCA~~Belbuca Buccal Film ~~(75~~in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 ~~mcg). Because BDSI initiated a patent infringement suit asserting the patents identified in the Paragraph IV notice within 45 days after receipt of the Paragraph IV Certification,~~

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~~the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid.~~mcg.

~~The Court scheduled a bench trial to adjudicate issues concerning the validity of the BEMA patents.~~ A three-day bench trial ~~against Alvogen~~ was ~~conducted commencing on~~held from March 1,1-3, 2021.

On December 20, 2021, the Court issued an opinion upholding the validity of certain claims in BDSI’s ʼ866 patent ~~which expires in 2027,~~ and certain claims in the ’539 ~~patent, which expires in 2032. Alvogen conceded infringement of those claims prior to the trial.~~patent. The Court entered final judgment on January 21, ~~2022. The final judgment entered in this case~~2022 upholding the validity of claims of the ’866 and ’539 ~~Orange Book-listed~~ patents ~~extends~~and thereby extended the effective date of any final approval by the FDA of Alvogen’s ANDA until December 21, 2032, ~~which is the~~(the expiration date of the ’539 ~~patent,~~patent) and ~~enjoins Alvogen and those acting in concert with~~enjoining Alvogen from commercially ~~manufacturing, using, selling, or offering for sale Alvogen’s~~launching its ANDA products until December 21, 2032. Alvogen filed a motion to stay certain provisions of the final ~~judgment in the Court.~~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 entered on January 21, 2022.~~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 ~~November 1, 2022, the Federal Circuit held oral argument on the parties’ appeal and issued its decision on~~ December 21, ~~2022. In that decision,~~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.

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

~~Opioid-Related Request~~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 ~~Subpoenas~~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 ~~like a number of other pharmaceutical companies, has received subpoenas or civil investigative demands related~~plans to opioid sales and marketing. The Company has received such subpoenas or civil investigative demands from the Offices of the Attorney General of each of Washington, New Hampshire, Maryland and Massachusetts.

~~On December 16, 2021,~~litigate this case vigorously. At this stage, the Company ~~entered into~~is unable to evaluate the likelihood of an ~~Assurance~~unfavorable outcome or estimate the amount or range of ~~Discontinuance with the Massachusetts Attorney General (the “AoD”). The Company is currently cooperating with each of the remaining states in their respective investigations.~~potential loss, if any.

~~17.~~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 ~~and nine~~ months ended ~~September 30, 2023~~March 31, 2024 and ~~2022:~~2023:


	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended March 31,
	2023			2022			2023			2022			2024			2023
Provision for (benefit from) income taxes	$	8,149		$	975		$	12,808		$	(3,253)		$	8,909		$	(131)
Effective tax rate		28.3	%		68.1	%		44.1	%		15.4	%		24.3	%		0.7	%

The provision for income taxes for the three months ended ~~September 30, 2023~~March 31, 2024 reflects the estimated annual effective tax rate as adjusted for discrete ~~tax benefits from~~ excess tax benefits from ~~equity~~stock-based compensation awards. The provision for income taxes for the ~~nine~~three months ended ~~September 30,~~March 31, 2023 was impacted by discrete nondeductible costs associated

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with the debt extinguishment that occurred in the three months ended March 31, 2023, partially offset by discrete excess tax benefits related to ~~stock compensation.~~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

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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 ~~September 30, 2023.~~March 31, 2024.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report, and in conjunction with management’s discussion and analysis and our audited consolidated financial statements included in our Annual Report. The following discussion contains forward-looking statements that involve risks uncertainties and assumptions. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of many factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Quarterly Report, including those set forth under “Forward-looking Statements” and “Risk ~~Factors”,~~Factors,” as revised and supplemented by those risks described from time to time in other reports which we file with the SEC.

~~OVERVIEW~~Overview

We are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We commercialize our pain portfolio, consisting of Belbuca, Xtampza ER, Nucynta ER and Nucynta IR (collectively the ~~Nucynta Products, Belbuca,~~“Nucynta Products”), and Symproic, in the United States.

Xtampza ER, an abuse-deterrent, oral formulation of oxycodone, was approved by the ~~FDA~~United States Food and Drug Administration (“FDA”) in April 2016 for the management of severe and persistent pain ~~severe enough to require~~that requires an extended treatment period with a daily ~~around-the-clock, long-term~~ opioid ~~treatment~~analgesic and for which alternative treatment options are inadequate. We commercially launched Xtampza ER in June 2016.

The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol. Nucynta ER is indicated for the management of severe and persistent pain ~~severe enough to require~~that requires an extended treatment period with a daily ~~around the clock, long-term~~ opioid ~~treatment,~~analgesic, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta IR is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in ~~adults.~~adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg. We began shipping and recognizing product sales on the Nucynta Products in January 2018 and began marketing the Nucynta Products in February 2018. In August 2023, the

FDA granted New Patient Population exclusivity in pediatrics for Nucynta IR. This grant extended the period of U.S. exclusivity

for Nucynta IR from June 27, 2025 to July 3, 2026.

On March 22, 2022, we acquired ~~BDSI,~~BioDelivery Sciences International, Inc. (“BDSI”), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic ~~conditions.~~conditions (the “BDSI Acquisition”). Upon closing of the BDSI Acquisition, we acquired ~~the~~ Belbuca and ~~Symproic products.~~ Symproic.

Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for ~~use in patients~~severe and persistent pain that requires an extended treatment period with ~~pain severe enough to require~~a daily ~~around-the-clock, long-term~~ opioid ~~treatment~~analgesic and for which alternative options are inadequate. Symproic was approved by the FDA in March 2017 for the treatment of ~~OIC~~opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. We began shipping and recognizing product sales related to Belbuca and Symproic in March 2022.

Outlook

We believe that our cash and cash equivalents as of ~~September 30, 2023,~~March 31, 2024, together with expected cash inflows from the commercialization of our products, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the foreseeable future.

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Our business was impacted by the COVID-19 pandemic and certain trends that emerged from the pandemic, including depressed pain patient office visits compared to pre-COVID periods, which may have accounted for fewer patients beginning therapy with our products, and labor disruptions that impacted pain offices, which in turn impacted our access to, and quality of interactions with, such offices. Although the federal public health emergency for COVID-19 expired in May 2023 in the United States, we expect the trends that emerged as a result of the pandemic to persist in the near to medium term.

~~CRITICAL ACCOUNTING POLICIES AND ESTIMATES~~Critical Accounting Policies and Significant Judgments and Estimates

We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results. For a description of critical accounting policies that affect our significant judgments and estimates used in the preparation of our consolidated financial statements, refer to our Annual Report.

There were no changes in our critical accounting policies from those described in our Annual Report.

~~RESULTS OF OPERATIONS~~Results of Operations


	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended March 31,
	2023		2022		2023		2022		2024		2023






	(in thousands)				(in thousands)				(in thousands)
Product revenues, net	$	136,709	$	127,013	$	417,022	$	334,313	$	144,923	$	144,767
Cost of product revenues
Cost of product revenues (excluding intangible asset amortization)		20,081		30,622		74,237		80,638		18,950		29,899
Intangible asset amortization		36,317		37,552		111,246		93,976		34,517		37,466
Total cost of product revenues		56,398		68,174		185,483		174,614		53,467		67,365
Gross profit		80,311		58,839		231,539		159,699		91,456		77,402
Operating expenses
Research and development		—		—		—		3,983
Selling, general and administrative		35,298		38,372		126,266		134,154		41,982		52,775
Total operating expenses		35,298		38,372		126,266		138,137		41,982		52,775
Income from operations		45,013		20,467		105,273		21,562		49,474		24,627
Interest expense		(20,768)		(19,046)		(64,058)		(42,638)		(17,339)		(21,427)
Interest income		4,538		11		11,312		20		4,487		2,747
Loss on extinguishment of debt		—		—		(23,504)		—		—		(23,504)
Income (loss) before income taxes		28,783		1,432		29,023		(21,056)		36,622		(17,557)
Provision for (benefit from) income taxes		8,149		975		12,808		(3,253)		8,909		(131)
Net income (loss)	$	20,634	$	457	$	16,215	$	(17,803)	$	27,713	$	(17,426)

Comparison of the three months ended ~~September 30,~~March 31, 2024 and March 31, 2023 ~~and September 30, 2022~~

Product revenues, net

Product revenues, net were ~~$136.7~~$144.9 million for the three months ended ~~September 30, 2023~~March 31, 2024 (the ~~“2023~~“2024 Quarter”), compared to ~~$127.0~~$144.8 million for the three months ended ~~September 30, 2022~~March 31, 2023 (the ~~“2022~~“2023 Quarter”). The ~~$9.7~~$0.1 million increase is primarily due to ~~increases in~~increased revenue for Belbuca of ~~$6.6~~$6.4 million, partially offset by decreased revenue for the Nucynta Products of ~~$3.1~~$3.9 million, ~~and~~ Xtampza ER of ~~$941,000, partially offset by decreases in other revenue~~$2.1 million, and Symproic of ~~$1.4~~$0.3 million.

The increase in revenue for Belbuca of ~~$6.6~~$6.4 million is primarily due to higher sales volume and gross price, partially offset by higher gross-to-net adjustments primarily related to provisions for chargebacks.

The decrease in revenue for the Nucynta Products of $3.9 million is primarily due to lower sales volume and higher gross-to-net adjustments primarily related to provisions for rebates, partially offset by higher gross price.

The decrease in revenue for Xtampza ER of $2.1 million is primarily due to lower sales volume, partially offset by higher gross price and lower gross-to-net adjustments primarily related to provisions for rebates.

The decrease in revenue for Symproic of $0.3 million is primarily due to lower sales volume and higher gross-to-net adjustments primarily related to provisions for rebates and chargebacks, partially offset by higher gross price.

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The increase in revenue for the Nucynta Products of $3.1 million is primarily due to lower gross-to-net adjustments primarily related to provisions for rebates and returns and higher gross price, partially offset by decreased sales volume.

The increase in revenue for Xtampza ER of $941,000 is primarily due to lower gross-to-net adjustments primarily related to provisions for rebates and higher gross price, partially offset by lower sales volume and higher gross-to-net adjustments related to provisions for returns.

Cost of product revenues

Cost of product revenues (excluding intangible asset amortization) was ~~$20.1~~$19.0 million for the 2024 Quarter, compared to $29.9 million for the 2023 ~~Quarter, compared to $30.6 million for the 2022~~ Quarter. The ~~$10.5~~$10.9 million decrease was primarily related to the ~~2022~~2023 Quarter including higher cost of product revenues related to the step-up basis in inventory acquired from BDSI as well as lower sales volume in ~~2023~~the 2024 Quarter for Xtampza and the Nucynta Products.

Intangible asset amortization was ~~$36.3~~$34.5 million for the 2024 Quarter, compared to $37.5 million for the 2023 ~~Quarter, compared to $37.6 million for the 2022~~ Quarter. The ~~$1.3~~$3.0 million decrease was primarily a result of the FDA granting New Patient Population exclusivity for Nucynta IR to July 3, 2026 in Q3 2023, resulting in an extension of the estimated useful life of the underlying intangible asset and a reduction of amortization expense recognized during the ~~2023 Quarter of $1.1 million.~~2024 Quarter. Intangible asset amortization expense is recognized in connection with our intangible assets. The intangible assets are amortized on a straight-line basis over the respective estimated useful lives.

Operating Expenses

Selling, general and administrative expenses were ~~$35.3~~$42.0 million for the 2024 Quarter, compared to $52.8 million for the 2023 ~~Quarter, compared to $38.4 million for the 2022~~ Quarter. The ~~$3.1~~$10.8 million decrease was primarily related to:

●

a decrease in audit and legal expenses of $10.1 million, primarily due to an $8.5 million litigation settlement during the 2023 Quarter and lower litigation related expenses;

●

a decrease in sales and marketing expenses of ~~$3.0~~$1.4 million, primarily due to the timing of marketing related expenses; ~~and~~

●

~~a decrease in audit and legal expenses of $1.9 million, primarily due to lower litigation related expenses;~~ partially offset by

●

an increase in salaries, wages, and benefits of ~~$1.9~~$0.7 million, primarily due to higher stock-based compensation ~~expenses.~~expense.

Interest expense and Interest income

Interest expense was ~~$20.8~~$17.3 million for the 2024 Quarter, compared to $21.4 million for the 2023 ~~Quarter, compared to $19.0 million for the 2022~~ Quarter. The ~~$1.8~~$4.1 million ~~increase~~decrease was primarily due to lower interest expense associated with the 2022 Term Loan as a result of scheduled principal payments, partially offset by higher interest expense due to the additional principal from the issuance of the 2029 Convertible Notes in February 2023, ~~as well as~~and higher interest rates impacting our variable rate term loan debt.

Interest income was $4.5 million for the ~~2023~~2024 Quarter, compared to ~~$11,000~~$2.7 million for the ~~2022~~2023 Quarter. The ~~$4.5~~$1.8 million increase was primarily due to higher interest rates earned on cash equivalents and marketable securities and due to a higher overall balance invested in the ~~2023~~2024 Quarter compared to the ~~2022~~2023 Quarter.

Taxes

The provision for income taxes was ~~$8.1~~$8.9 million for the ~~2023~~2024 Quarter, compared to ~~$975,000~~a benefit from income taxes of $131,000 for the ~~2022~~2023 Quarter. The tax provision for the ~~2023~~2024 Quarter primarily reflects federal and state income taxes incurred from earnings during the period ~~consistent with our statutory~~as adjusted for discrete excess tax ~~rate, after considering~~benefits from stock-based compensation awards. The tax benefit for the 2023 Quarter reflects the tax benefit of the loss during the period, as well as the impact of ~~nondeductible expenses. The tax provision for the 2022 Quarter reflects the impact of discrete nondeductible transaction costs and excess tax benefits.~~

~~Comparison of the nine months ended September 30, 2023 and September 30, 2022~~

~~Product revenues, net~~

Product revenues, net were $417.0 million for the nine months ended September 30, 2023 (the “2023 Period”), compared to $334.3 million for the nine months ended September 30, 2022 (the “2022 Period”). The $82.7 million increase is

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primarily due to increases in revenue for Belbuca of $48.4 million, Xtampza ER of $25.3 million, the Nucynta Products of $7.3 million, and Symproic of $3.7 million, partially offset by decreases in other revenue of $2.0 million.

The increase in revenue for Belbuca of $48.4 million and Symproic of $3.7 million is primarily due to nine months of revenue in the 2023 Period compared to approximately seven months of revenue in the 2022 Period due to the timing of the BDSI Acquisition.

The increase in revenue for Xtampza ER of $25.3 million is primarily due to lower gross-to-net adjustments primarily related to provisions for rebates and higher gross price, partially offset by lower sales volume and higher gross-to-net adjustments related to provisions for returns.

The increase in revenue for the Nucynta Products of $7.3 million is primarily due to lower gross-to-net adjustments primarily related to provisions for rebates and higher gross price, partially offset by lower sales volume.

~~Cost of product revenues~~

Cost of product revenues (excluding intangible asset amortization) was $74.2 million for the 2023 Period, compared to $80.6 million for the 2022 Period. The $6.4 million decrease was primarily related to the 2022 Period including higher cost of product revenues related to the step-up basis in inventory acquired from BDSI combined with lower cost of product revenues primarily due to lower sales volume for Xtampza and the Nucynta Products. This decrease was partially offset by higher royalties and cost of product revenues for products acquired from BDSI due to nine months of revenue in the 2023 Period compared to approximately seven months in the 2022 Period.

Intangible asset amortization was $111.2 million for the 2023 Period, compared to $94.0 million for the 2022 Period. The $17.2 million increase in intangible asset amortization was due to nine months of amortization expense recognized in the 2023 Period related to the intangible assets acquired from BDSI of which $435.0 million of consideration was allocated to our acquired intangible assets, compared to approximately seven months of amortization expense in the 2022 Period. This increase was partially offset by a decrease in amortization expense as a result of the FDA granting New Patient Population exclusivity for Nucynta IR to July 3, 2026, resulting in an extension of the estimated useful life of the underlying intangible asset. The intangible assets are amortized on a straight-line basis over the respective estimated useful lives.

~~Operating Expenses~~

We did not recognize research and development expenses in the 2023 Period, compared to $4.0 million recognized in the 2022 Period. The $4.0 million decrease was due to redirection of resources from research and development activities during 2022 as we shifted our focus to supporting our commercial products rather than research and development.

~~Selling, general and administrative expenses were $126.3 million for the 2023 Period, compared to $134.2 million for the 2022 Period. The $7.9 million decrease was primarily related to:~~

●

~~a decrease in acquisition related expenses classified as selling, general and administrative of $30.5 million; partially offset by~~

●

an increase in salaries, wages, and benefits of $9.5 million, primarily due to increases in personnel costs for employees retained following the BDSI Acquisition and higher stock-based compensation expenses;

●

~~an increase in audit and legal expenses of $6.3 million, primarily due to an $8.5 million litigation settlement;~~

●

~~an increase in sales and marketing expenses of $5.2 million, primarily due to expenses incurred to support the ongoing commercialization of products acquired from BDSI; and~~

●

~~an increase in regulatory expenses of $1.5 million, primarily due to nine months of expenses related to products acquired from BDSI.~~

~~Interest expense and Interest income~~

Interest expense was $64.1 million for the 2023 Period, compared to $42.6 million for the 2022 Period. The $21.5 million increase was primarily due to the 2022 Term Loan that we entered into in connection with the BDSI Acquisition, higher interest rates impacting our variable rate term loan debt, and higher interest expense due to the 2029 Convertible Notes.

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Interest income was $11.3 million for the 2023 Period, compared to $20,000 for the 2022 Period. The $11.3 million increase was primarily due to higher interest rates earned on cash equivalents and marketable securities and due to a higher overall balance invested in the 2023 Period compared to the 2022 Period.

~~Taxes~~

~~The provision for income taxes was $12.8 million for the 2023 Period, compared to a benefit from income taxes of $3.3 million for the 2022 Period. The tax provision for the 2023 Period was impacted by~~ discrete nondeductible costs associated with the debt extinguishment, ~~that occurred in the first quarter of 2023,~~ partially offset by discrete tax benefits from excess tax benefits related to ~~stock-based~~stock compensation. ~~The tax benefit for the 2022 Period reflects the tax benefit from the loss during the period, which includes the impact of discrete nondeductible transaction costs and excess tax benefits.~~

~~LIQUIDITY AND CAPITAL RESOURCES~~Liquidity and Capital Resources

Sources of Liquidity

Historically, we have funded our operations primarily through ~~the~~ private placements and/or public offerings of our preferred stock, common stock, and convertible notes; commercial bank debt; and cash inflows from sales of our products. We are primarily dependent on the commercial success of Belbuca, Xtampza, and the Nucynta Products.

As of September 30, 2023, we had total cash, cash equivalents and marketable securities of $304.6 million, which represented an increase of $130.9 million from $173.7 million as of December 31, 2022. We intend to rely on our existing cash, cash equivalents and marketable securities together with cash inflows from sales of our products as our primary sources of liquidity.

In March 2022, our debt balance increased significantly as we modified our 2020 Term Loan with Pharmakon to an increased principal balance of $650.0 million to fund a portion of the consideration paid to complete the BDSI Acquisition. We paid $100.0 million in principal payments during the first year of the 2022 Term Loan. The remaining ~~$550.0~~

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$550.0 million balance is required to be paid in equal quarterly installments over the remaining three years of the term note. As of ~~September 30, 2023,~~March 31, 2024, the outstanding principal balance of the 2022 Term Loan was ~~$458.3~~$366.7 million, of which $183.3 million in principal payments are due within the next twelve months.

As of ~~September 30, 2023,~~March 31, 2024, the outstanding principal balance of ~~our 2026 Convertible Notes and 2029~~the Convertible Notes was $267.9 million, of which $26.4 million ~~and $241.5 million, respectively. The outstanding principal balance of~~related to the 2026 Convertible Notes and $241.5 million related to the 2029 Convertible Notes. The $26.4 million principal balance in connection with the 2026 Convertible Notes was originally due in 2026. However, on April 11, 2024, we called all $26.4 million aggregate principal amount of our 2026 Convertible Notes for redemption on June 14, 2024 (the “Redemption Date”). Refer to Note 2, Summary of Significant Accounting Policies – Subsequent Events). The $241.5 million principal balance in connection with the 2029 Convertible Notes is ~~not~~ due ~~until 2026 and 2029, respectively.~~in 2029.

As of March 31, 2024, we had $318.0 million in cash, cash equivalents, and marketable securities. We believe that our cash, cash equivalents, and marketable securities as of ~~September 30, 2023~~March 31, 2024, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service, and capital expenditure requirements under our current business plan for the foreseeable future.

Borrowing Arrangements ~~and Equity Offerings~~

~~The following transactions represent~~There have been no material changes in our ~~material~~ borrowing arrangements ~~and equity offerings.~~

~~2022 Term Loan~~

Onduring the quarter ended March ~~22, 2022, in connection with the closing of the BDSI Acquisition,~~31, 2024. However, on April 11, 2024, we entered into the 2022 Loan Agreement. The 2022 Loan Agreement provided for the $650.0 million secured 2022 Term Loan, the proceeds of which were used to repay our 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 $173,000 were expensed. In connection with the 2022 Loan Agreement,announced that we paid loan commitment and other fees to the lender of $19.8 million, which together with preexisting debt issuance costs and note discounts of $2.0 million will be amortized over the term of the loan using the effective interest rate. Refer to Note 12, ~~Term Notes Payable~~~~, for more information.~~

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~~2026 Convertible Notes~~

On February 13, 2020, we issued the 2026 Convertible Notes in the aggregate principal amount of $143.8 million, 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 our existing investors participated in the convertible notes offering. The 2026 Convertible Notes are senior, unsecured obligations and accrue interest at a rate of 2.625% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. The notes will mature on February 15, 2026, unless earlier repurchased, redeemed or converted.

~~On February 10, 2023, we entered into privately negotiated transactions with certain holders of the 2026 Convertible Notes to repurchase $117.4~~called all $26.4 million aggregate principal amount of ~~the~~our 2026 Convertible Notes for ~~an aggregate of $140.1 million of cash, which includes accrued and unpaid interest~~redemption on the 2026 Convertible Notes to be repurchased. After giving effect to the repurchase, the outstanding principal balance of the 2026 Convertible Notes as of September 30, 2023 is $26.4 million. There are no principal repayment obligations due within the next twelve months.Redemption Date. Refer to Note ~~13,~~2, Summary of Significant Accounting Policies – Subsequent Events; Note 10, Term Notes Payable; and Note 11, Convertible Senior Notes,, for more information.

~~2029 Convertible Notes~~

On February 10, 2023, we issued the 2029 Convertible Notes in the aggregate principal amount of $241.5 million, 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.

The 2029 Convertible Notes are senior, unsecured obligations and accrue interest at a rate of 2.875% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. The 2029 Convertible Notes will mature on February 15, 2029, unless earlier repurchased, redeemed or converted. The outstanding principal balance of the 2029 Convertible Notes as of September 30, 2023 is $241.5 million. There are no principal repayment obligations due within the next twelve months. Refer to Note 13, ~~Convertible Senior Notes~~~~, for more information.~~

Cash Flows


	Nine Months Ended September 30,				Three Months Ended March 31,
	2023		2022		2024		2023

	(in thousands)




					(in thousands)
Net cash provided by operating activities	$	201,411	$	57,905	$	61,937	$	27,671
Net cash used in investing activities		(45,715)		(572,751)		(18,128)		(176)
Net cash (used in) provided by financing activities		(72,352)		462,546		(54,146)		68,297
Net increase (decrease) in cash, cash equivalents and restricted cash	$	83,344	$	(52,300)
Net (decrease) increase in cash, cash equivalents and restricted cash					$	(10,337)	$	95,792

Operating activities. Cash provided by operating activities was ~~$201.4~~$61.9 million for the 2024 Quarter, compared to $27.7 million for the 2023 ~~Period, compared to $57.9 million for the 2022 Period.~~Quarter. The ~~$143.5~~$34.2 million increase was primarily due to the increase in cash ~~flow~~flows from operating results, which reflects operating earnings, after adjustment for non-cash items that are included in net income (loss), including ~~higher intangible asset amortization as a result of the BDSI Acquisition and~~ recognition of a loss on extinguishment of debt in connection with the repurchase of a portion of our 2026 Convertible ~~Notes.~~Notes in the 2023 Quarter, combined with changes in working capital.

Investing activities. Cash used in investing activities was ~~$45.7~~$18.1 million for the ~~2023 Period,~~2024 Quarter, compared to ~~$572.8 million~~$176,000 for the ~~2022 Period.~~2023 Quarter. The ~~$527.1~~$18.0 million ~~decrease~~increase was primarily due to ~~the use of $572.1 million for the BDSI Acquisition, net of cash acquired, in the 2022 Period~~increased purchases, partially offset by ~~purchases~~maturities, of marketable ~~securities in the 2023 Period.~~securities.

Financing activities. Cash used in financing activities was ~~$72.4~~$54.1 million for the ~~2023 Period,~~2024 Quarter, compared to cash provided by financing activities of ~~$462.5~~$68.3 million in the ~~2022 Period.~~2023 Quarter. The ~~$534.9~~$122.4 million decrease was primarily due to:

●

the repayment of the outstanding balance of the 2020 Term Loan and establishment of the 2022 Term Loan in connection with the BDSI Acquisition, which was accounted for as a debt modification and resulted in $517.7 million in proceeds from the term note modification in the 2022 Period;

●

~~an increase in repayments of term notes of $66.7 million; and~~

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●

~~an increase in repurchases of common stock of $43.6 million, which includes $50.0 million related to the ASR Program in the 2023 Period; partially offset by~~

●

the repurchase of a portion of our 2026 ~~Convertibles~~Convertible Notes and issuance of our 2029 Convertible Notes which resulted in net proceeds of ~~$96.6~~$97.0 million in the 2023 ~~Period.~~Quarter;

●

an increase in repayments of term notes of $20.8 million; and

●

an increase in taxes paid for employee stock withholdings of $5.1 million.

Funding Requirements

We believe that our cash, cash equivalents, and marketable securities as of ~~September 30, 2023,~~March 31, 2024, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service, and capital expenditure requirements under our current business plan for the foreseeable future. However, we are subject to all the risks common

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to the commercialization and development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We have significant future capital requirements, including:

●

expected operating expenses to manufacture and commercialize our products and to operate our organization;

●

repayment of outstanding principal amounts and interest in connection with our 2022 Term Loan and Convertible Notes;

●

royalties we pay on sales of certain products within our portfolio;

●

operating lease obligations;

●

minimum purchase obligations in connection with our contract manufacturer; and

●

cash paid for income taxes.

In addition, we have significant potential future capital requirements, including:

●

we may enter into business development transactions, including acquisitions, collaborations, licensing arrangements and equity investments, that require additional capital;

●

any judgments rendered against us in connection with any of the litigation matters set forth in Note 14, Commitments and Contingencies, to our financial statements; and

●

asin January 2024, our Board of ~~September~~Directors authorized a new share repurchase program for the repurchase of up to $150.0 million of shares of our common stock through June 30, ~~2023,~~2025. Future share repurchases will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial conditions, the price of our common stock on the NASDAQ Global Select Market, and other factors that we ~~had $60.0 million remaining in authorization under our 2023 Repurchase Program.~~may deem relevant.

~~ADDITIONAL INFORMATION~~Additional Information

To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We ~~use these non-GAAP financial measures to understand, manage and evaluate our business as we~~ believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAAP, provide analysts, investors, lenders and other third parties insight into our view and assessment of our ongoing operating performance. In addition, we believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide ~~supplementary information that may be useful to~~ analysts, investors, lenders, and other third parties ~~in assessing~~with insights into how we evaluate normal operational activities, including our ~~performance~~ability to generate cash from operations, on a comparable year-over-year basis and ~~results from period to period. We report these~~manage our budgeting and forecasting. In addition, certain non-GAAP financial measures, primarily Adjusted EBITDA, are used to ~~portray the results~~measure performance when determining components of ~~our operations prior to considering certain income statement elements. These non-GAAP financial measures should be considered in addition to, and not as a substitute~~annual compensation for ~~or superior to, net income or other financial measures calculated in accordance with GAAP.~~substantially all non-sales force employees, including senior management.

~~In our quarterly and annual reports, earnings press releases and conference calls, we~~We may discuss the following financial measures that are not calculated in accordance with GAAP ~~to supplement~~in our ~~consolidated financial statements presented on a GAAP basis.~~quarterly and annual reports, earnings press releases and conference calls.

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income ~~(loss)~~or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.

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There are several limitations related to the use of adjusted EBITDA rather than net income ~~(loss),~~or loss, which is the nearest GAAP equivalent, such as:

●

adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;

●

we exclude stock-based compensation expense from adjusted EBITDA ~~although (a)~~although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation ~~strategy~~strategy; and ~~(b)~~(ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;

●

adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;

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●

adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;

●

adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;

●

we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the ~~assets~~asset(s) being impaired may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;

●

we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business;

●

we exclude litigation settlements from adjusted EBITDA, as well as any applicable income items or credit adjustments due to subsequent changes in estimates. This does not include our legal fees to defend claims, which are expensed as incurred;

●

we exclude acquisition related expenses as the amount and/or frequency of these expenses are not part of our underlying business. Acquisition related expenses include transaction costs, which primarily consisted of financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the acquisition, and miscellaneous other acquisition related expenses incurred;

●

we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense associated with sale of our products as part of our underlying business; and

●

we exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis.

Adjusted EBITDA for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023 ~~and 2022~~ was as follows:


									Three Months Ended
									March 31,
									2024		2023




	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022		(in thousands)
GAAP net income (loss)	$	20,634	$	457	$	16,215	$	(17,803)	$	27,713	$	(17,426)
Adjustments:
Interest expense		20,768		19,046		64,058		42,638		17,339		21,427
Interest income		(4,538)		(11)		(11,312)		(20)		(4,487)		(2,747)
Loss on extinguishment of debt		—		—		23,504		—		—		23,504
Provision for (benefit from) income taxes		8,149		975		12,808		(3,253)		8,909		(131)
Depreciation		835		488		2,547		1,859		917		817
Amortization		36,317		37,552		111,246		93,976		34,517		37,466
Stock-based compensation expense		7,027		5,377		20,134		17,204
Stock-based compensation										7,475		6,035
Litigation settlements		—		—		8,500		—		—		8,500
Acquisition related expenses		—		463		—		31,209
Recognition of step-up basis in inventory		198		10,519		15,116		23,760		—		10,170
Total adjustments	$	68,756	$	74,409	$	246,601	$	207,373	$	64,670	$	105,041
Adjusted EBITDA	$	89,390	$	74,866	$	262,816	$	189,570	$	92,383	$	87,615

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Adjusted EBITDA was ~~$89.4~~$92.4 million for the 2024 Quarter compared to $87.6 million for the 2023 ~~Quarter compared to $74.9 million for the 2022~~ Quarter. The ~~$14.5~~$4.8 million increase was primarily due to ~~higher revenues and~~ lower adjusted operating expenses.

Adjusted EBITDA was $262.8 million for the 2023 Period compared to $189.6 million for the 2022 Period. The $73.2 million increase was primarily due to higher revenues due to nine months of revenue in the 2023 Period compared to approximately seven months of revenue in the 2022 Period from products acquired from BDSI, partially offset by higher adjusted operating expenses.

Adjusted Operating Expenses

Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations.

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Adjusted operating expenses for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023 ~~and 2022~~ were as follows:


									Three Months Ended
									March 31,
									2024		2023




	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022		(in thousands)
GAAP operating expenses	$	35,298	$	38,372	$	126,266	$	138,137	$	41,982	$	52,775
Adjustments:
Stock-based compensation		7,027		5,377		20,134		17,204		7,475		6,035
Litigation settlements		—		—		8,500		—		—		8,500
Acquisition related expenses		—		463		—		31,209
Total adjustments	$	7,027	$	5,840	$	28,634	$	48,413	$	7,475	$	14,535
Adjusted operating expenses	$	28,271	$	32,532	$	97,632	$	89,724	$	34,507	$	38,240

Adjusted operating expenses were ~~$28.3~~$34.5 million in the 2024 Quarter compared to $38.2 million in the 2023 ~~Quarter compared to $32.5 million in the 2022~~ Quarter. The ~~$4.2~~$3.7 million decrease was primarily driven ~~by decreases in sales and marketing expenses and audit and legal expenses, primarily due to lower litigation related expenses.~~

~~Adjusted operating expenses were $97.6 million in the 2023 Period compared to $89.7 million in the 2022 Period. The $7.9 million increase was primarily driven~~ by:

●

~~an increase in salaries, wages, and benefits (excluding stock-based compensation) of $4.0 million primarily due to increases in personnel costs for employees retained following the BDSI Acquisition;~~

●

~~an increase in sales and marketing expenses of $5.2 million, primarily due to expenses incurred to support the ongoing commercialization of products acquired from BDSI; and~~

●

~~an increase in regulatory expenses of $1.5 million, primarily due to nine months of expenses related to products acquired from BDSI; partially offset by~~

●

a decrease in audit and legal expenses (excluding litigation settlements) of ~~$2.2 million.~~$1.6 million;

●

a decrease in sales and marketing expenses of $1.4 million, primarily due to the timing of marketing related expenses; and

●

a decrease in salaries, wages, and benefits (excluding stock-based compensation) of $0.7 million, primarily due to lower headcount.

Adjusted Net Income and Adjusted Earnings Per Share

Adjusted net income is a non-GAAP financial measure that represents GAAP net income ~~(loss)~~or loss adjusted to exclude significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of the tax effect of the adjustments. Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net income per share. Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security.

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Adjusted net income and adjusted earnings per share for the three ~~and nine~~ months ended ~~September 30,~~March 31, 2024 and 2023 ~~and 2022~~ were as follows:


									Three Months Ended
									March 31,
									2024		2023




	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022		(in thousands, except share and per share data)
GAAP net income (loss)	$	20,634	$	457	$	16,215	$	(17,803)	$	27,713	$	(17,426)
Adjustments:
Non-cash interest expense		2,124		2,467		6,672		5,902		1,780		2,287
Loss on extinguishment of debt		—		—		23,504		—		—		23,504
Amortization		36,317		37,552		111,246		93,976		34,517		37,466
Impairment expense		—		—		—		—
Stock-based compensation expense		7,027		5,377		20,134		17,204
Restructuring		—		—		—		—
Stock-based compensation										7,475		6,035
Litigation settlements		—		—		8,500		—		—		8,500
Acquisition related expenses		—		463		—		31,209
Recognition of step-up basis in inventory		198		10,519		15,116		23,760		—		10,170
Discrete deferred tax benefit from valuation allowance release		—		—		—		—
Income tax effect of above adjustments ⁽¹⁾		(11,300)		(14,290)		(42,274)		(43,698)		(12,653)		(18,874)
Total adjustments	$	34,366	$	42,088	$	142,898	$	128,353	$	31,119	$	69,088
Non-GAAP adjusted net income	$	55,000	$	42,545	$	159,113	$	110,550	$	58,832	$	51,662

Adjusted weighted-average shares — diluted ⁽²⁾		42,058,820		39,495,453		41,679,546		39,368,629		41,438,466		40,196,015
Adjusted earnings per share ⁽²⁾	$	1.34	$	1.10	$	3.91	$	2.88	$	1.45	$	1.32

(1)

The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the items that have a tax effect. The blended federal and state statutory rate for the three months ended ~~September 30,~~March 31, 2024 and 2023 were 26.6% and ~~2022 were 25.6% and 26.0%, respectively; and the blended federal and state statutory rate for the nine months ended September 30, 2023 and 2022 were 25.6% and 26.0%~~26.8%, respectively. As such, the non-GAAP effective tax rates for the three months ended ~~September 30,~~March 31, 2024 and 2023 were 28.9% and ~~2022 were 24.7% and 25.3%, respectively; and the non-GAAP effective tax rates for the nine months ended September 30, 2023 and 2022 were 22.8% and 25.4%~~21.5%, respectively.

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(2)

Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for our convertible notes in accordance with ASC 260, Earnings per Share. As such, adjusted weighted-average shares – diluted includes shares related to the assumed conversion of our convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income. For the three months ended ~~September 30,~~March 31, 2024 and 2023, ~~and 2022,~~ adjusted weighted-average shares – diluted includes 7,509,104 and ~~4,925,134, respectively, attributable to our convertible notes. For the nine months ended September 30, 2023 and 2022, adjusted weighted-average~~4,646,372 shares, ~~– diluted includes 6,530,392 and 4,925,134,~~ respectively, attributable to our convertible notes. In addition, ~~for the three and nine months ended September 30, 2023 and 2022,~~ adjusted earnings per share ~~also~~ includes other potentially dilutive securities to the extent that they are not ~~antidilutive given that non-GAAP adjusted net income was in an income position.~~antidilutive.

~~CONTRACTUAL OBLIGATIONS~~Contractual Obligations

There have been no material changes to the contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations from our most recently filed Annual Report.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Our primary exposure to market risk is interest rate sensitivity in connection with our investment portfolio and the 2022 Term Loan. None of these market risk sensitive instruments are held for trading purposes.

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Investment Portfolio

Our investment portfolio includes financial instruments that are sensitive to interest rate risks. Our investment portfolio is used to preserve capital, maintain liquidity sufficient to meet cash flow requirements, and maximize returns commensurate with our risk appetite. We invest in instruments that meet the credit quality, diversification, liquidity, and maturity standards outlined in our investment policy.

As of ~~September 30, 2023,~~March 31, 2024, our investment portfolio includes ~~$104.3~~$69.8 million of cash equivalents and ~~$46.0~~$89.4 million of marketable securities, which are primarily comprised of money market funds, U.S. Treasury securities, corporate debt securities, and government-sponsored securities. Our money market funds are short-term highly liquid investments, and our marketable securities have active secondary or resale markets to help ensure liquidity. We account for marketable securities as available-for-sale, thus, no gains or losses are realized due to changes in the fair value of our marketable securities unless we sell our investments prior to maturity or incur a credit loss. Furthermore, our investment policy includes guidelines limiting the term-to-maturity of our investments. Due to the nature of our investments, we do not believe that the fair value of our investments has a material exposure to interest rate risk.

2022 Term Loan

Prior to the cessation of LIBOR on June 30, 2023, the 2022 Term Loan had an underlying rate indexed to the 3-month LIBOR rate (subject to a floor of 1.20%), plus a margin of 7.5% per annum. On June 23, 2023, we 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, theThe 2022 Term Loan bears interest at a rate based upon ~~SOFR~~the Secured Overnight Financing Rate (“SOFR”) plus a spread adjustment of 0.26% (subject to a floor of 1.20%), plus a margin of 7.5% per annum. Based on the outstanding principal amount of the 2022 Term Loan as of ~~September 30, 2023~~March 31, 2024 of ~~$458.3~~$366.7 million and the applicable interest rate, a hypothetical 1% increase or decrease in interest rates would increase or decrease future interest expense by approximately ~~$4.6~~$3.7 million.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of ~~September 30, 2023.~~March 31, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of ~~September 30, 2023,~~March 31, 2024, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

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Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter covered by this Quarterly Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

Except as set forth in Note ~~16,~~14, Commitments and Contingencies, to our financial statements, which is incorporated herein by reference to the extent applicable, there are no other material changes from the legal proceedings previously disclosed in our most recently filed annual report on Form 10-K for the fiscal year ended December 31, ~~2022~~2023 (the “Annual Report”).

Item 1A. Risk Factors

Risk Factors Summary

Our business is subject to a number of risks and uncertainties, including those risks discussed at length below. These risks include, among others, the following principal risk factors that make an investment in our company speculative or risky. You are encouraged to carefully review our full discussion of the material risk factors relevant to an investment in our business, which follows the brief bulleted list of our principal risk factors set forth below:

●

We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results of operations;

●

Adverse developments affecting the financial services industry could adversely affect our business, financial condition, or results of operations;

●

If we cannot continue successfully commercializing our products and any products that we may acquire in the future, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline;

●

Despite receiving approval by the ~~U.S. Food and Drug Administration (“FDA”),~~FDA, additional data may emerge that could change the FDA’s position on the product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our ability to market our products successfully may be adversely affected;

●

Xtampza ER, the Nucynta ~~ER and Nucynta IR (collectively the “Nucynta Products”),~~Products, and Belbuca are subject to mandatory Risk Evaluation and Mitigation Strategy (“REMS”) programs, which could increase the cost, burden and liability associated with the commercialization of these products;

●

Failure to comply with ongoing governmental regulations for marketing our products, and in particular any failure to promote Xtampza ER’s abuse deterrent labeling in compliance with FDA regulations, could delay or inhibit our ability to generate revenues from their sale and could also expose us to claims or other sanctions;

●

Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products;

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If we are unable to obtain or maintain intellectual property rights for our technologies, products or any ~~future product candidates which~~products we may ~~develop,~~acquire, we may lose valuable assets or be unable to compete effectively in our market;

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We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets;

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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements;

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If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue;

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If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer;

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Our products ~~contain, and our future product candidates may~~ contain controlled substances, the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies;

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Current and future legislation may increase the difficulty and cost for us to continue to commercialize our products and may reduce the prices we are able to obtain for our products;

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rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain;

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Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for our products and may adversely impact external investor perceptions of our business;

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If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent claims that compete with our products, our sales could decline;

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If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business;

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Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us;

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We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and results of operations may be adversely affected;

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Our products could be subject to post-marketing requirements, which requirements may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control;

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We may not realize all of the anticipated benefits from future acquisitions, and we may be unable to successfully integrate future acquisitions;

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Our business ~~has been, and~~ may ~~continue to~~ be adversely affected by certain events or circumstances outside our control, including ~~the effects of the COVID-19 pandemic,~~ macroeconomic conditions and geopolitical turmoil;

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Litigation or regulatory action regarding opioid medications could negatively affect our business;

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We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products more successfully than we do;

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Commercial sales of our products ~~and clinical trials of any future product candidates we may develop or acquire,~~ may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all;

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Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings; and

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The price of our common stock may be volatile and you may lose all or part of your investment.

Risks Related to Our Financial Position and Capital Needs

Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products and any products ~~and future product candidates, if approved,~~ that we may ~~develop or~~ acquire in the future. Our failure to do so successfully could impair our growth strategy and plans and could have a material adverse effect on our business, financial position, and operating results.

Our ability to maintain profitability depends upon our ability to realize the full commercial potential of our products and to commercialize successfully any other products ~~and future product candidates, if approved,~~ that we may ~~develop,~~ in-license or acquire in the future. Our ability to generate revenue from our current or future products depends on a number of factors, including our ability to:

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realize a commercially viable price for our products;

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manufacture commercial quantities of our products at acceptable cost levels;

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sustain a commercial organization capable of sales, marketing and distribution for the products we sell;

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obtain coverage and adequate reimbursement from third parties, including government payors;

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acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and

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comply with existing and changing laws and regulations that apply to the pharmaceutical industry, including opioid manufacturers, and to our products specifically, including FDA post-marketing requirements.

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If we fail to maintain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

As of December 31, ~~2022,~~2023, we had a U.S. federal net operating loss (“NOL”) carryforward of approximately ~~$229.8~~$137.5 million and state NOL carryovers of approximately ~~$252.6~~$202.4 million. The U.S. federal and state NOL carryforwards expire at various dates through 2037. Federal NOLs and certain state NOLs incurred in 2018 and onward have an indefinite expiration under the Tax Cuts and Jobs Act of 2017 and applicable state statutes. We also had U.S. federal tax credits of approximately ~~$4.2~~$1.0 million, and state tax credits of approximately ~~$0.8~~$0.7 million. These tax attributes are generally subject to a limited carryover/carryback period and are also subject to the annual limitations that may be imposed under Section 382 of the Internal Revenue Code of 1986, as amended (“IRC 382”).

In 2021, we completed a study to assess the impact of ownership changes, if any, on our ability to use our NOL and tax credit carryovers as defined under IRC 382 (the “IRC 382 Study”). As a result of the study, we concluded that there were ownership changes that occurred during the years 2006, 2012 and 2015 that would be subject to IRC 382 limitations. These IRC 382 annual limitations may limit our ability to use pre-ownership change federal NOL carryovers and pre-ownership change federal tax credit carryovers, which may potentially limit our ability to reduce our future federal income tax liability by using these losses.

As part of the BDSI acquisition, ~~of BioDelivery Sciences International, Inc. (the “BDSI Acquisition”),~~ we acquired an estimated $234.7 million of federal NOL carryovers which are generally subject to a limited carryover/carryback period and are also subject to the annual limitations that may be imposed under IRC 382. We performed an IRC 382 study following the BDSI Acquisition in 2022 and concluded that there were ownership changes that occurred during the years 2006 and 2022 that would be subject to IRC 382 limitations. These IRC 382 annual limitations may limit our ability to use pre-ownership change federal NOL carryovers and pre-ownership change federal tax credit carryovers, which may potentially limit our ability to reduce our future federal income tax liability by using these losses. As of December 31, 2023, remaining net operating losses of $124.3 million are subject to limitation. Refer to Note ~~17,~~15, Income Taxes, ~~for more information.~~to our consolidated financial statements included in Part I of this Quarterly Report on Form 10-Q.

We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results of operations.

In March 2022, we entered into a $650.0 million secured term loan (the “2022 Term Loan”) pursuant to our Amended and Restated Loan Agreement with BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (as amended from time to time, the “2022 Loan Agreement”), of which ~~$458.3~~$366.7 million in principal was outstanding as of ~~September 30, 2023.~~March 31, 2024. In addition, we have $26.4 million in 2.625% ~~Convertible Senior Notes~~convertible senior notes due in 2026 (the “2026 Convertible Notes”) and $241.5 million in 2.875% ~~Convertible Senior Notes~~convertible senior notes due in 2029 (the “2029 Convertible Notes” and, together with the 2026 Convertible Notes, the “Convertible Notes”). On April 11, 2024, we announced that we called all $26.4 million aggregate principal amount of the 2026 Convertible Notes for redemption on June 14, 2024. Refer to Note 2, Summary of Significant Accounting Policies – Subsequent Events, to our consolidated financial statements included in Part I of this Quarterly Report on Form 10-Q.

We may also incur additional indebtedness to meet future financing needs. Our existing and future levels of indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, and among other things:

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requiring the dedication of a substantial portion of our cash flows from operations to service our indebtedness, which will reduce the amount of cash available for operations, working capital, capital expenditures, expansion, acquisitions or general corporate or other purposes;

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limiting our ability to obtain additional financing;

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limiting our flexibility to plan for, or react to, changes in our business;

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exposing us to the risk of increased interest rates as certain of our borrowings, including the 2022 Term Loan, are at variable rates of interest;

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diluting the interests of our existing shareholders as a result of issuing shares of our common stock upon conversion of the Convertible Notes;

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placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital; and

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increasing our vulnerability to downturns in our business, our industry or the economy in general.

Holders of our Convertible Notes, subject to a limited exception described in the notes, may require us to repurchase their notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any. In addition, upon conversion, we will satisfy part or all of our conversion obligation in cash unless we elect to settle conversions solely in shares of our common stock. We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the notes or pay the cash amounts due upon conversion. Applicable law, regulatory authorities and the agreements governing our other indebtedness may restrict our ability to repurchase the notes or pay the cash amounts due upon conversion, and any failure by us to repurchase notes or to pay the cash amounts due upon the conversion when required would constitute a default under the indenture.

Additionally, the indentures governing the Convertible Notes and our 2022 Loan Agreement contain certain covenants and obligations applicable to us, including, without limitation, covenants that limit our ability to incur additional indebtedness or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business, which could limit our ability to capitalize on business opportunities that may arise or otherwise place us at a competitive disadvantage relative to our competitors.

Failure to comply with covenants in the indentures governing the Convertible Notes or in the 2022 Loan Agreement would constitute an event of default under those instruments, notwithstanding our ability to meet our debt service obligations. A default under the indentures or a fundamental change could also result in a default under one or more of the agreements governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full. In such event, we may not have sufficient funds to satisfy all amounts that would become due. The 2022 Loan Agreement 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. In addition, because our assets are pledged as a security under the 2022 Loan Agreement, if we are not able to cure any default or repay outstanding borrowings, our assets would be subject to the risk of foreclosure by our lenders.

Further, amounts outstanding under our 2022 Loan Agreement historically bore interest at a rate based on ~~LIBOR,~~the London Interbank Offered Rate (“LIBOR”), and, effective July 1, 2023, bears interest at a rate based on ~~SOFR~~the Secured Overnight Financing Rate (“SOFR”) subject to a SOFR floor of 1.2%. We have not hedged our interest rate exposure with respect to our floating rate debt. Accordingly, our interest expense for any period will fluctuate based on SOFR and other variable interest rates, as applicable. To the extent the interest rates applicable to our floating rate debt increase, our interest expense will increase, in which event we may have difficulties making interest payments and funding our other fixed costs, and our available cash flow for general corporate requirements may be adversely affected.

Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition, or results of operations.

Events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. ~~Since March~~For example, in early 2023, several financial institutions ~~have been~~ closed and ~~been~~were taken into receivership by the Federal Deposit Insurance Corporation (“FDIC”). Although we assess our banking and customer relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial services industry or economy in general. Further, investor concerns regarding domestic or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all.

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Any decline in available funding or access to cash and liquidity resources could, among other risks, adversely impact our ability to meet our financial obligations, which could have material adverse impacts on our liquidity and our business, financial condition, or results of operations.

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Risks Related to our Products

Our business and future success are substantially dependent on our ability to continue successfully commercializing our products, including Xtampza ER, the Nucynta Products, Belbuca and ~~Symproic.~~Symproic, and any products that we may acquire in the future.

Our ability to continue successfully commercializing our products will depend on many factors, including but not limited to:

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our ability to manufacture commercial quantities of our products at reasonable cost and with sufficient speed to meet commercial demand;

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our ability to execute sales and marketing strategies successfully and continually;

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our success in educating physicians, patients and caregivers about the benefits, administration, use and coverage of our products;

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with respect to Xtampza ER, the perceived availability and advantages, relative cost, relative safety and relative efficacy of other abuse-deterrent products and treatments with similar indications;

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our ability to defend successfully any challenges to our intellectual property or suits asserting patent infringement relating to our products;

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the availability and quality of coverage and adequate reimbursement for our products;

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a continued acceptable safety profile of our products;

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our ability to acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and

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our ability to comply with applicable legal and regulatory requirements, including any additional manufacturing or packaging requirements that may become applicable to certain opioid products.

Many of these matters are beyond our control and are subject to other risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assure you that we will be able to continue successfully commercializing or to generate sufficient revenue from our products. If we cannot do so, or are significantly delayed in doing so, our business will be materially harmed.

Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our ability to market our products successfully may be adversely affected.

Xtampza ER was approved with label language describing abuse-deterrent properties of the formulation with respect to the nasal and IV routes of abuse, consistent with Guidance for Industry, “Abuse-Deterrent Opioids- Evaluation and Labeling.” In November 2017, the FDA approved a ~~supplemental New Drug Application (“sNDA”)~~sNDA for Xtampza ER to include comparative oral pharmacokinetic data from a clinical study evaluating the effect of physical manipulation by crushing Xtampza ER compared with OxyContin and a control (oxycodone hydrochloride immediate-release), results from an oral human abuse potential study and the addition of an oral abuse deterrent claim.

The FDA can require changes to the product labeling for any of our products at any time which can impact our ability to generate product sales. In particular, if the FDA determines that our post-marketing data for Xtampza ER does not demonstrate that the abuse-deterrent properties result in reduction of abuse, or demonstrates a shift to routes of abuse that present a greater risk, the FDA may find that product labeling revisions are needed, and potentially require the removal of our abuse-deterrence claims, which would have a material adverse effect on our ability to continue successfully commercializing Xtampza ER.

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Our opioid products are subject to mandatory REMS programs, which could increase the cost, burden and liability associated with the commercialization of these products.

The FDA has imposed a class-wide REMS on all IR, ER and long-acting opioid drug products (known as the Opioid Analgesic REMS). The FDA continually evaluates whether the REMS program is meeting its goal of ensuring that the benefit of these drugs continue to outweigh their risks, and whether the goals or elements of the program should be modified. As opioids, Xtampza ER, the Nucynta Products and Belbuca are subject to the Opioid Analgesic REMS.

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Any modification of the Opioid Analgesic REMS by the FDA to impose additional or more burdensome requirements could increase the costs associated with marketing these products and/or reduce the willingness of healthcare providers to prescribe these products, which would have a material adverse effect on our ability to continue to successfully commercialize and generate sufficient revenue from these products.

In addition to scrutiny by the FDA, advertising and promotion of any pharmaceutical product marketed in the United States is heavily scrutinized by, among others, the Department of Justice, the Office of Inspector General for the U.S. Department of Health and Human Services, state attorneys general, members of Congress and the public. Violations, including promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by government agencies.

In particular, Xtampza ER has FDA-approved product labeling that describes its abuse deterrent features, which allows us to promote those features and differentiate Xtampza ER from other opioid products containing the same active pharmaceutical ingredients. Because the FDA closely regulates promotional materials and other promotional activities, even though the FDA-approved product labeling includes a description of the abuse deterrent characteristics of Xtampza ER, the FDA may object to our marketing claims and product advertising campaigns.

Engaging in off-label promotion of our products, including Xtampza ER, could subject us to false claims liability under federal and state statutes, and other litigation and/or investigations, and could lead to the issuance of warning letters or untitled letters, suspension or withdrawal of our products from the market, recalls, fines, disgorgement money, operating restrictions, injunctions, and civil or criminal prosecution. Any of these consequences would harm the commercial success of our products, including Xtampza ER.

Further, ~~after product approval, subsequent~~ discovery of serious and unanticipated adverse events associated with the product; the emergence of other problems with the product, manufacturer or facility; or our failure to make required regulatory submissions may result in adverse regulatory actions, including withdrawal of the product from the market or the requirement to add or strengthen label warnings about the product. The failure to obtain or maintain requisite governmental approvals or the imposition of additional or stronger warnings could delay or preclude us from ~~further developing, marketing or~~ realizing the full commercial potential of our products.

Risks Related to Intellectual Property

Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products.

Our commercial success depends upon our ability to commercialize products without infringing the intellectual property rights of others. Our current or future products, or any uses of them, may now or in the future infringe third-party patents or other intellectual property rights. We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of our products.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing or commercializing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced,

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including by court order, to cease commercializing the infringing technology or product. In addition, in any such proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our products or force us to cease some of our business operations.

Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions or other post-grant review proceedings to patents in the United States, or litigation against our collaborators may be costly and time consuming and could have a material adverse effect on our operating results, our ability to raise capital needed

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to commercialize products and our overall financial condition. We expect that litigation may be necessary in some instances to determine the validity and scope of our proprietary rights. Litigation may be necessary in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the outcome of such litigation, including our pending litigation with Purdue, could compromise the validity and scope of our patents or other proprietary rights or hinder our ability to manufacture and market our products.

We depend on our ability to protect our proprietary technology. We rely on patent and trademark laws, unpatented trade secrets and know-how, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection. Our success depends in large part on our ability to obtain and maintain patent protection in the United States with respect to our proprietary technology and products.

The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights in the United States. The rights already granted under any of our currently issued patents and those that may be granted under future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking.

We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property rights against infringement and unauthorized use by competitors, and to protect our trade secrets, including in connection with our pending litigation against generic competitors that have filed Paragraph IV Certifications relating to certain of our products. In so doing, we may place our intellectual property at risk of being invalidated, rendered unenforceable or limited or narrowed in scope. This litigation is expensive and time consuming. Many of our current and potential competitors have the ability to dedicate substantially greater resources to defend their intellectual property rights than we can.

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs and diversion of management resources, which could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. In addition, an adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology and products, we rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States may be less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed

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by a competitor, we would have no right to prevent such competitor, or those with whom they communicate, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed or independently developed, our competitive position would be harmed.

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The United States Patent and Trademark Office (“USPTO”) requires compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees on issued patents are required to be paid to the USPTO in several stages over the lifetime of the patents. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our products, our competitive position would be adversely affected.

Risks Related to the Commercialization of Our Products

Our commercial organization continues to evolve and we cannot guarantee that we will continue to be successful in marketing our products. In addition, we compete with other pharmaceutical and biotechnology companies with extensive and well-funded sales and marketing operations to recruit, hire, train and retain sales and marketing personnel. If we are unable to continue to grow and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, including with respect to our recent acquisition of Belbuca and Symproic, we may not be able to generate sufficient product revenue and may not remain profitable. Factors that may inhibit our efforts to continue successfully commercializing our products in the United States include:

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our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

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the inability of sales personnel to reach adequate numbers of physicians who may prescribe our products; and

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unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing organization.

If we are not successful in retaining sales and marketing personnel or in maintaining our sales and marketing infrastructure or if we do not preserve strategic alliances with marketing collaborators, agreements with contract sales organizations or collaboration arrangements, we will have difficulty in continuing to commercialize our products. Under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), sponsors of approved drugs must provide six months notice to the FDA of any changes in marketing status, such as the withdrawal of the drug, and failure to do so could result in the FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed.

Additionally, our sales, marketing and distribution capabilities may continue to be hindered as a result of the ongoing effects of the COVID-19 pandemic, such as depressed pain patient office visits compared to pre-COVID periods, which may have accounted for fewer patients beginning therapy with our products, and labor disruptions that impacted pain offices, which in turn impacted our access to, and quality of interactions with, such offices. Although the federal public health emergency for COVID-19 expired in May 2023 in the United States, we expect the trends that emerged as a result of the pandemic to persist in the near to medium term. We will continue to equip our personnel with the tools and resources needed to effectively continue their sales and marketing efforts in a manner that complies with all relevant regulations, whether in person or from a remote setting. We face the risk, however, that limitations on activities within the healthcare sector and on economic activity generally will impede our ability to continue successfully commercializing our products.

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If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer.

Physicians and others in the medical community, patients, and healthcare payors may not continue to accept and use our products, or accept and use any new products that we may ~~develop or~~ acquire. Acceptance and use of our products will depend on a number of factors including:

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approved indications, warnings and precautions language that may be less desirable than competitive products;

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perceptions of physicians and other healthcare community members of the safety and efficacy of our products;

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perceptions by members of the healthcare community, including physicians, about the relevance and efficacy of our abuse deterrent technology;

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the availability of competitive products;

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the pricing and cost-effectiveness of our products relative to competing products;

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the potential and perceived advantages of our products over alternative treatments;

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the convenience and ease of administration to patients of our products;

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actual and perceived availability and quality of coverage and reimbursement for our products from government or other third-party payors;

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negative publicity related to our products or negative or positive publicity related to our competitors’ products;

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the prevalence and severity of adverse side effects;

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policy initiatives by FDA, ~~Department of Health and Human Services, U.S. Drug Enforcement Agency (“DEA”),~~HHS, DEA, or other federal or state agencies regarding opioids;

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our ability to comply with the Opioid Analgesic REMS; and

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the effectiveness of marketing and distribution efforts by us and any licensees and distributors.

If our products fail to have an adequate level of acceptance by the medical community, patients, or healthcare payors, we will not be able to generate sufficient revenue to remain profitable. Since we expect to rely on sales generated by Xtampza ER, the Nucynta Products, Belbuca, and Symproic for substantially all of our revenues for the foreseeable future, the failure of these products to maintain market acceptance would harm our business prospects.

Some of our products contain ~~and our future product candidates may contain,~~ controlled substances, and the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies.

Some of our products ~~contain, and our future product candidates may~~ contain controlled substances that are subject to state and federal laws and regulations regarding their manufacture, use, sale, importation, exportation and distribution. Xtampza ER’s active ingredient, oxycodone, and the Nucynta Products’ active ingredient, tapentadol, are both classified as Schedule II controlled substances under the Controlled Substances Act (“CSA”) and regulations of the DEA and the active ingredient in Belbuca, buprenorphine, is classified as a Schedule III controlled substance. A number of states also independently regulate these drugs, including oxycodone, tapentadol and buprenorphine, as controlled substances. We and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state and federal law enforcement and regulatory agencies and comply with state and federal laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances.

Furthermore, the amount of Schedule II substances that can be obtained for clinical trials and commercial distribution is limited by the CSA and DEA regulations. For more information, ~~see~~refer to the section in our Annual Report entitled “Business — Government Regulation — DEA and Opioid Regulation.” We may not be able to obtain sufficient quantities of these controlled substances in order to meet commercial demand. If commercial demand for Xtampza ER, or any of our other approved products, increases and we cannot meet such demand in a timely fashion because of our limited supply of its active pharmaceutical ingredient (in the case of Xtampza ER, ~~oxycodone)~~oxycodone or in the case of the Nucynta Products, tapentadol) then physicians may perceive such product as unavailable and may be less likely to prescribe it in the future.

In addition, controlled substances are also subject to regulations governing manufacturing, labeling, packaging, testing, dispensing, production and procurement quotas (for Schedule I and II substances), recordkeeping, reporting, handling, shipment and disposal. These regulations increase the personnel needs and the expense associated with ~~development and~~ commercialization of our products that include controlled substances. The DEA and some states conduct periodic inspections of registered establishments that handle controlled substances.

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Failure to obtain and maintain required registrations or to comply with any applicable regulations could delay or preclude us from ~~developing~~manufacturing and commercializing our products that contain controlled substances and subject us to enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature, these regulations could limit commercialization of our products containing controlled substances.

Current and future legislation may increase the difficulty and cost for us to continue to commercialize our products and may reduce the prices we are able to obtain for our products.

In the United States, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system generally, and the manufacturing, distribution, and marketing of opioids in particular, that could ~~prevent or delay marketing approval of future product candidates, restrict or regulate post-approval activities or~~ affect our ability to ~~profitably sell~~commercialize our ~~products for which we obtain marketing approval.~~products. For example, several states, including New York, have imposed taxes or fees on the sale of opioids. Other states, and even the federal government, could impose similar taxes or fees, and such laws

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and proposals can vary in the tax and fee amounts imposed and the means of calculation. Liabilities for taxes or assessments under any such laws could have an adverse impact on our results of operations.

California and several other states have enacted legislation related to prescription drug pricing transparency and it is unclear the effect this legislation will have on our business. Laws intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms may continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing of our products may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may subject us to more stringent product labeling and post-marketing testing and other requirements.

Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business. Such pricing regulations may address the rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain.

The regulations that govern marketing approvals, pricing and reimbursement for new drug products can vary widely. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Pricing limitations may hinder our ability to recoup our investment in our products.

Our ability to commercialize any product successfully will also depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors determine which medications they will cover and establish reimbursement levels and tiers of preference based on the perceived value and innovation of a given product. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications and establishing administrative hurdles that incentivize use of generic and/or lower cost products first. Increasingly, third-party payors are requiring that drug companies provide them with discounts and rebates from list prices and are challenging the prices charged for medical products. We have agreed to provide such discounts and rebates to certain third-party payors. We expect increasing pressure to offer larger discounts and rebates. Additionally, a greater number of third-party payors may seek discounts and rebates in order to offer or maintain access for our products. We cannot be sure that high-quality coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be and whether it will be satisfactory.

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Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from policy and payment limitations in setting their own reimbursement policies.

In August 2022, the Inflation Reduction Act ~~(“IRA”)~~ of 2022 (the “IRA”) was signed into law. This legislation contains substantial drug pricing reforms, including the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would subject manufacturers of some brand-name medications without generic or biosimilar competition to a price negotiation program that results in a negotiated “maximum fair price” (or pay an excise tax for noncompliance), the establishment of rebate payment requirements on manufacturers of drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and ~~revises~~revisions to the way manufacturers provide discounts on Part D drugs. The IRA also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000 per year, thereby eliminating the Medicare Part D coverage gap or “donut hole.” Substantial penalties can be assessed for noncompliance with the drug pricing provisions in the IRA. ~~There is pending litigation in the federal courts challenging the constitutionality of the drug price negotiation provisions of the IRA.~~ The IRA could have the effect of reducing the prices we can charge and reimbursement we receive for our products, thereby reducing our profitability, and

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could have a material adverse effect on our financial condition, results of operations and growth prospects. The effect of the IRA on our business and the pharmaceutical industry in general is not yet known.

Our inability to expand and maintain coverage and profitable reimbursement rates from both government-funded and private payors for our products could have a material adverse effect on our operating results, our ability to raise capital needed to continue to commercialize our products and our overall financial condition.

The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to continue to commercialize our products and affect the prices we may obtain.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably sell our products, including implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.

The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. There have been significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the Affordable Care Act, and the Affordable Care Act has also been subject to challenges in the courts. ~~See~~Refer to the section in our Annual Report entitled “Business — Government Regulation — Healthcare Reform.”

Further changes to and under the Affordable Care Act remain possible. It is unknown what form any such changes or any law proposed to replace the Affordable Care Act would take, and how or whether it may affect our business in the future. We expect that changes to the Affordable Care Act, the Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry.

Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private ~~payers.~~payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue and maintain profitability.

Law enforcement and regulatory agencies may apply policies and guidelines that seek to limit the availability or use of opioids. Such efforts may inhibit our ability to continue to commercialize our products.

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Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of oxycodone or other opioid drugs; the limitations of abuse-resistant formulations; the ability of people who abuse drugs to discover previously unknown ways to abuse opioid drugs, including Xtampza ER, the Nucynta Products and Belbuca; public inquiries and investigations into prescription drug abuse; litigation; or regulatory activity regarding sales, marketing, distribution or storage of opioid drugs could have a material adverse effect on our reputation. Such negative publicity could reduce the potential size of the market for our products, decrease the revenues we are able to generate from their sale and adversely impact external investor perceptions of our business. Similarly, to the extent opioid abuse becomes less prevalent or less urgent of a public health issue, regulators and ~~third party payers~~third-party payors may not be willing to pay a premium for abuse-deterrent formulations of opioids.

Federal laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use, including the Comprehensive Addiction and Recovery Act and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. These laws are described in more detail in our Annual Report under the caption “Business — Government Regulation — DEA and Opioid Regulation.”

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If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our products, our sales could decline.

Once ~~a New Drug Application (“NDA”),~~an NDA, including a Section 505(b)(2) application, is approved, the product covered thereby becomes a “listed drug” which can, in turn, be cited by potential competitors in support of approval of an ~~abbreviated New Drug Application (“ANDA”).~~ANDA. The Federal Food, Drug, and Cosmetic Act, FDA regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic substitutes. These generic equivalents would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Additionally, under ~~FDORA,~~the Food and Drug Omnibus Reform Act of 2022, FDA will assign therapeutic equivalence ratings for certain prescription drugs approved via the Section 505(b)(2) NDA pathway with respect to other approved drug products and it is unclear how assignment of these ratings will impact the market opportunity for our products. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically lost to the generic product. Accordingly, competition from generic equivalents to our products would substantially limit our ability to generate revenues and therefore, to obtain a return on the investments we have made in our products. In the past, we have initiated litigation with generic competitors that have filed Paragraph IV Certifications challenging certain of our patents. While we have entered into settlement agreements with certain competitors, we are currently pursuing litigation to defend against Paragraph IV Certifications related to Belbuca. Refer to Note ~~16,~~14, Commitments and Contingencies, ~~for more information.~~to our consolidated financial statements included in Part I of this Quarterly Report on Form 10-Q. We believe that we will continue to be subject to ANDA-related litigation, which can be costly and distracting and has the potential to impact the long-term value of our products.

We may seek FDA pediatric exclusivity for some of our products. Pediatric exclusivity, if granted, adds six months of

patent term and marketing exclusivity to ~~include~~existing exclusivity periods for all formulations, dosage forms, and indications for the active ~~moiety.~~moiety, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining. The regulatory exclusivity period for Nucynta IR in the United States has been extended through July 3, 2026, following the grant of New Patient Population exclusivity in pediatrics by the FDA in August 2023 based on data from pediatric trials which were submitted in response to the FDA's Pediatric Written Request (the “Written Request”) to evaluate the use of Nucynta as a treatment for pain in

pediatric patients aged 6 years and older. If the FDA deems these data to be responsive to its Written Request, the exclusivity of the entire Nucynta franchise could be extended an additional six months, to December 2025 for Nucynta ER and January 2027 for Nucynta IR. However, there is no guarantee that the FDA will agree that the Written Request has been satisfied and that we will receive this additional exclusivity, or that we will maintain such exclusivity, if granted.

In November 2017, the FDA issued a final guidance to assist the industry in the development of generic versions of approved opioids with abuse-deterrent formulations, including recommendations about the types of studies that companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. In the second half of 2018, the FDA posted three revised product-specific guidances related to generic abuse-deterrent opioid formulations, including one guidance specifically relating to Xtampza ER, which ~~recommend~~recommended specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. These guidances are part of the FDA’s wider focus on assisting developers of generic abuse-deterrent formulations in navigating the regulatory path to market more quickly. Earlier market entry of generic abuse-deterrent formulations could have a material adverse effect on our business.

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Risks Related to Our Dependence on Third Parties

We do not own any manufacturing facilities in drug development and commercial manufacturing. We currently have no plans to build our own clinical or commercial scale manufacturing facility and do not have the resources and expertise to manufacture and test, on a commercial scale, the technical performance of our products. We currently rely, and expect to continue to rely, on a limited number of experienced personnel and contract manufacturers for our products, as well as other vendors to formulate, test, supply, store and distribute our products, and we control only certain aspects of their activities.

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In 2020, we completed the build-out of a dedicated manufacturing suite for Xtampza ER at a site operated by our contract manufacturing organization, Patheon, part of Thermo Fisher Scientific. This facility requires the maintenance of regulatory approvals and other costs, all of which we absorb. We cannot guarantee that we will be able to continue to leverage the dedicated manufacturing suite in a profitable manner. If the demand for Xtampza ER and any future related products never meets our expectations and forecasts, or if we do not produce the output we plan, we may not be able to realize the return on investment we anticipated, which would have a negative impact on our financial condition and results of operations.

We have ~~completed the activities required to transition~~also transitioned commercial manufacturing for Nucynta ER from Janssen to Patheon. While we were successful in our regulatory approval and validation activities, we could encounter issues in obtaining commercial supply from Patheon's facility due to technical problems or challenges obtaining adequate and/or timely DEA procurement quota.

Although we have identified alternate sources for these services, it would be time-consuming, and require us to incur additional costs, to qualify these sources. Our reliance on a limited number of vendors and, in particular, Patheon as our single manufacturer for Xtampza ER and Nucynta ER, exposes us to the following risks, any of which could impact commercialization of our products, result in higher costs, or deprive us of potential product revenues:

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Our contract manufacturer, or other third parties we rely on, may encounter difficulties in achieving the volume of production needed to satisfy commercial demand, may experience technical issues that impact quality or compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical products, may be affected by natural disasters that interrupt or prevent manufacturing of our products, ~~including the COVID-19 pandemic,~~ may experience shortages of qualified personnel to adequately staff production operations, may experience shortages of raw materials and may have difficulties finding replacement parts or equipment;

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Our contract manufacturer could default on their agreement with us to meet our requirements for commercial supplies of our products and/or we could experience technical problems in the operation of our dedicated manufacturing suite;

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The use of alternate manufacturers may be difficult because the number of potential manufacturers that have the necessary governmental licenses to produce narcotic products is limited. Additionally, the FDA and the DEA must approve any alternative manufacturer of our products, before we may use the alternative manufacturer to produce commercial supplies;

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It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all. Our contract manufacturer and vendors may not perform as agreed or may not remain in the contract manufacturing business for the time required to produce, store and distribute our products successfully; and

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If our contract manufacturer were to terminate our arrangement or fail to meet our commercial manufacturing demands, we may be forced to delay our development and commercial programs.

Failure to obtain the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture our products could adversely affect our ability to continue to commercialize our products, which could in turn adversely affect our results of operations and financial condition. Likewise, the inability of any of our sole or limited suppliers to provide components that meet our specifications and requirements could adversely impact our ability to manufacture our

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products. In addition, DEA regulations, through the quota procurement process, limit the amount of DEA-controlled active pharmaceutical ingredient we have available for manufacture. Consequently, we are limited in our ability to maintain an appreciable safety stock of finished drug product.

Our reliance on third parties reduces our control over our ~~development~~manufacturing and commercialization activities but does not relieve us of our responsibility to ensure compliance with all required legal, regulatory and scientific standards. The FDA and other regulatory authorities require our products to be manufactured according to ~~current good manufacturing practices~~Current Good Manufacturing Practice regulations promulgated by the FDA (“cGMP”). Any failure by our third-party manufacturer to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of products in a timely manner, could lead to inspection deficiencies, a shortage of commercial product, or potential products liability exposure for any noncompliant distributed products. Such failure could also be the basis for the FDA to issue a warning or untitled letter, withdraw approvals for products previously granted to us, or take other regulatory or legal action, including recall or seizure, total or partial suspension of production, ~~suspension of ongoing clinical trials,~~ refusal to approve pending applications or

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supplemental applications, detention of product, refusal to permit the import or export of products, injunction, imposing civil penalties or pursuing criminal prosecution.

Any stock out, or failure to obtain sufficient supplies of any of our products, or the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture each of our products, could adversely affect our ability to commercialize such products, which could in turn adversely affect our results of operations and financial condition.

We currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredients of our products. We contract with these suppliers for commercial supply to manufacture our products. Further, our suppliers of the active pharmaceutical ingredients for Xtampza ER and the Nucynta Products ~~active pharmaceutical ingredients~~ also supply our primary competitor in the extended-release oxycodone space, Purdue. Identifying alternate sources of active pharmaceutical ingredients for our products is generally time-consuming and costly. Any changes that our suppliers make to the respective drug substance raw materials, intermediates, or manufacturing processes would introduce technical and regulatory risks to our downstream drug product supply. If our suppliers were to terminate an arrangement for an active pharmaceutical ingredient, or fail to meet our supply needs (including as a result of any disruptions in personnel or the global supply chain), we might incur substantial costs and be forced to delay our development or commercialization programs. Any such delay could have a material adverse effect on our business.

Global supply chain disruptions and shortages may limit manufacturing and commercial supply of our products and have a material impact on our business.

There are currently global supply chain disruptions and shortages caused by a variety of factors, including ~~the COVID-19 pandemic and~~ geopolitical turmoil, such as the Ukrainian War and current conflict in ~~Israel.~~Israel and Gaza. While we and our suppliers are still able to receive sufficient inventory of the key materials and components needed, we could experience pressure on our supply chain, including shipping delays, higher prices from suppliers, and reduced availability of materials, including excipients and packaging components. To date, supply chain pressure has not had a material impact on our results of operations. However, if these disruptions and shortages continue, we may in the future experience a material interruption to our supply chain. Such an interruption could have a material adverse impact on our business, including but not limited to, our ability to timely manufacture and distribute our products.

Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or limit commercial supply.

In our current commercial manufacturing operations, and as we scale up manufacturing of our products and conduct required stability testing, we may encounter product, packaging, equipment and process-related issues that may require refinement or resolution in order to ~~proceed with~~successfully commercialize our ~~planned clinical trials, obtain regulatory approval for commercial marketing and build commercial supplies.~~products. In the future, we may identify impurities, which could result in increased scrutiny by regulatory authorities, delays in our clinical programs and regulatory approval, increases in our operating expenses, failure to obtain or maintain approval or limitations in our commercial supply.

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A significant percentage of our product shipments are to a limited number of independent wholesale pharmaceutical distributors. Three of our wholesale pharmaceutical distributors represented greater than 90% of our product shipments for the ~~period~~quarter ended ~~September 30, 2023.~~March 31, 2024. Our loss of any of these wholesale pharmaceutical distributors’ accounts, or a material reduction in their purchases or a significant disruption to transportation infrastructure or other means of distribution of our products, ~~including as a result of the COVID-19 pandemic,~~ could have a material adverse effect on our business, results of operations, financial condition and prospects. The significance of each wholesale pharmaceutical distributor account to our business adversely impacts our ability to negotiate favorable commercial terms with each such distributor, and as a result, we may be forced to accept terms that adversely impact our results of operations.

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In addition, these wholesaler customers comprise a significant part of the distribution network for pharmaceutical products in the United States. This distribution network has undergone, and may continue to undergo, significant consolidation marked by mergers and acquisitions. As a result, a small number of large wholesale distributors control a significant share of the market. Consolidation of drug wholesalers has increased, and may continue to increase, competitive and pricing pressures on pharmaceutical products. We cannot guarantee that we can manage these pricing pressures or that wholesaler purchases will not fluctuate unexpectedly from period to period. In addition, due to unprecedented and significant disruptions in the processing of product returns by wholesale pharmaceutical distributors, as further disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” we formally denied a significant portion of unprocessed product claims under our return policy. We subsequently received payment for only a portion of the denied claims and vigorously pursued collections of the full amount of these short-pay receivables. Although we were able to formally settle a portion of the unprocessed product claims and receive payment therefor, payment for a significant portion of the unprocessed product claims has not been and is not expected to be received. There can be no assurance that similar disruptions in the wholesaler distribution network will not occur in the future or if they do, that we will be able to successfully manage such disruptions.

~~Our~~Certain of our opioid products are subject to post-marketing requirements or commitments, which ~~requirements~~ may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control.

~~Our opioid~~For certain of our products, we are subject to ~~a comprehensive regulatory scheme, including~~ post-marketing requirements ~~(“PMRs”)~~ to conduct epidemiological studies and clinical ~~trials. We~~trials, or, in some cases, to conduct post-marketing surveillance or observational studies to gather additional information about our products. For our opioid products, we generally intend to fulfill our ~~PMRs~~post-marketing requirements (“PMRs”) by virtue of our participation in the Opioid PMR Consortium (“OPC”). Although we retain discretion in how to discharge such PMRs, the scale and scope of the studies required by the FDA make it cost prohibitive to discharge these requirements other than by joining the OPC that was formed to conduct them. We are a member of the OPC and engage in decision-making as a member of that organization, but do not have a majority. If the OPC fails to conduct sufficiently rigorous studies or is unable to achieve the patient enrollment or other requirements established by the FDA, we may be unable to satisfy our PMRs and the FDA may choose to withdraw or otherwise restrict its approval of our opioid products. Additionally, there may be certain PMRs or post-marketing commitments that we fulfill on our own for our products, including via the conduct of post-marketing surveillance or observational studies. If such studies lead to the discovery of adverse findings regarding the safety or benefit profiles of our products, then the FDA may choose to withdraw or otherwise restrict the approval of our products or the FDA or we may determine that labeling changes are warranted based on their finding. Such withdrawal or restriction or labeling changes for our products would have an adverse impact on our business and financial condition.

We have historically relied on third parties to conduct our non-clinical and clinical trials, and may continue to rely upon third parties for any product candidates we develop or acquire in the future. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or if they terminate their agreement with us, we may not be able to maintain regulatory approval for our products and our business could suffer a material adverse effect.

We have relied upon and plan to continue to rely upon contract research organizations (“CROs”) to monitor and manage data for any non-clinical and clinical programs that we may conduct in the future, including the OPC PMR studies discussed above. We rely on these parties for execution of our non-clinical and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and clinical trials are conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. If we or any of our CROs fail to comply with applicable good clinical practices (“GCP”) and other regulations, including as a result of any recent changes in such regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. In addition, our clinical trials must be conducted with product produced under cGMP requirements. While we have agreements governing the activities

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of our CROs, we have limited influence over their actual performance. Failure to comply with applicable regulations in the conduct of the clinical trials for our products would have an adverse impact on our commercial efforts.

Risks Related to Our Business and Strategy

We may not realize all the anticipated benefits from our future acquisitions, and we may be unable to successfully integrate future acquisitions.

Our growth strategy will, in part, rely on acquisitions. We must plan and manage acquisitions effectively to achieve revenue growth and maintain profitability in our evolving market. We may not realize all the anticipated benefits from our future acquisitions, such as increased earnings, cost savings and revenue enhancements, for various reasons, including difficulties integrating operations and personnel, higher than expected acquisition and operating costs or other difficulties, inexperience with operating in new geographic regions, unknown liabilities, inaccurate reserve estimates and fluctuations in market prices.

In addition, integrating acquired businesses and properties involves a number of special risks and unforeseen difficulties can arise in integrating operations and systems and in retaining and assimilating employees. These difficulties include, among other things:

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operating a larger organization;

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coordinating geographically disparate organizations, systems, and facilities;

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integrating corporate, technological, and administrative functions;

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diverting management’s attention from regular business concerns;

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diverting financial resources away from existing operations;

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increasing our indebtedness; and

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incurring potential environmental or regulatory liabilities and title problems.

Any of these or other similar risks could lead to potential adverse short-term or long-term effects on our operating results. The process of integrating our operations could cause an interruption of, or loss of momentum in, the activities of our business. Members of our management may be required to devote considerable amounts of time to this integration process, which decreases the time they have to manage our business. If our management is not able to effectively

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manage the integration process, or if any business activities are interrupted as a result of the integration process, our business could suffer.

Our business ~~has been, and we~~ may ~~in the future continue to~~ be adversely affected by certain events or circumstances outside our control, including ~~the COVID-19 pandemic,~~ macroeconomic conditions and geopolitical turmoil.

Our business has been, and we may in the future continue to be, adversely affected by certain events or circumstances outside our control. For example, the COVID-19 pandemic has, and may continue to have, a substantial impact on the delivery of healthcare services in the United States. Our business was impacted by several trends which emerged from the pandemic, including depressed pain patient office visits compared to pre-COVID periods, which may have accounted for fewer patients beginning therapy with our products, and labor disruptions that impacted pain offices, which in turn impacted our access to, and quality of interactions with, such offices. Although the federal public health emergency for COVID-19 expired in May 2023 in the United States, we expect the trends that emerged as a result of the pandemic to persist in the near to medium term. These circumstances may result in reduced demand for our products and negatively impact our sales and results of operations.

~~In addition, other events~~Events or circumstances outside of our control, including macroeconomic conditions such as recession or depression, inflation, and declines in consumer-spending could result in reduced demand for our products. An economic downturn could result in business closures, higher levels of unemployment, or declines in consumer disposable income which could have an impact on the number of patients seeking and receiving treatment for conditions that might otherwise result in the prescription of our products, as patients may make efforts to avoid or postpone seeking non-essential medical care to allocate their resources to other priorities or essential items. These circumstances, in addition to the impact of geopolitical turmoil, such as the ongoing Ukrainian War and current conflict in Israel and Gaza (including any escalation or expansion), social unrest, political instability in the United States and elsewhere, terrorism, cyberwarfare or other acts of war, may result in reduced demand for our products and negatively impact our sales, results of operations, and liquidity.

~~Table~~Security breaches and other disruptions to our, or our vendors’, information technology systems may compromise our information and expose us to liability that could adversely impact our financial condition, operations, and reputation.

We, our collaborators, third-party providers, distributors, customers and other contractors utilize information technology systems and networks (“Systems”) to transmit, store and otherwise process electronic data in connection with our business activities, including our supply chain processes, operations and communications including, in some cases, our business proprietary information, and Electronic Data Interchange (“EDI”) on purchase orders, invoices, chargebacks, among other things. Our Systems, along with those of ~~Contents~~the third parties whom we rely on to process confidential and sensitive data in a variety of contexts, are potentially vulnerable to a variety of evolving threats that may expose this data to unauthorized persons or otherwise compromise its integrity. These threats may include, but are not limited to, social-engineering attacks (including through phishing attacks), business email compromise, online and offline fraud, malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, access attacks (such as credential stuffing), personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, and other similar threats.

We may expend significant resources to try to protect against these threats to our Systems. Certain data privacy and security laws, as well as industry best practice standards, may require us to implement and maintain security measures. While we have implemented security measures designed to protect our Systems and confidential and sensitive data, there can be no assurance that these measures will be effective. Threat actors and their techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. If we, or a third party upon whom we rely, experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences. These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms. Further, our insurance coverage may not be adequate or sufficient in type or amount to protect us from or to mitigate liabilities arising out of our privacy and security practices.

Litigation or regulatory action regarding opioid medications could negatively affect our business.

Beginning in 2018, lawsuits alleging damages related to opioids have been filed naming us as a defendant along with other manufacturers of prescription opioid medications. These lawsuits, filed in multiple jurisdictions, are brought by various local governments as well as private claimants, against various manufacturers, distributors and retail pharmacies. These lawsuits generally allege that we had engaged in improper marketing practices related to Xtampza ER and the Nucynta Products. In March 2022, we entered into a Master Settlement Agreement resolving 27 pending opioid-related lawsuits brought against us by cities, counties, and other subdivisions in the United States. As part of the Master Settlement Agreement, we paid $2.75 million to the plaintiffs and the cases were dismissed, with prejudice. In late March 2023, three new cases were filed in three federal courts, naming us as one of numerous defendants, from which we have been dismissed.

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Certain governmental and regulatory agencies are focused on the abuse of opioid medications, a concern we share, and we have received Civil Investigative Demands or subpoenas from four state attorneys general investigating our sales and marketing of opioids and seeking documents relating to the manufacture, marketing and sale of opioid medications. In December 2021, we entered into an Assurance of Discontinuance with the Massachusetts Attorney General pursuant to which we provided certain assurances and agreed to pay certain of the Massachusetts Attorney General’s costs of investigation, in exchange for closure of the investigation and a release of claims pertaining to the subject matter of the investigation. We are cooperating fully in the open investigations. Managing litigation and responding to governmental investigations is costly and may involve a significant diversion of management attention. Such proceedings are unpredictable and may develop over lengthy periods of time. An adverse resolution of any of these lawsuits or investigations may involve injunctive relief or substantial monetary penalties, either or both of which could have a material adverse effect on our reputation, business, results of operations and cash flows.

We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products more successfully than we do.

Competition in the pain and opioid market is intense. Our competitors include major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. Our products compete with oral opioids, transdermal opioids, local anesthetic patches, stimulants and implantable and external infusion pumps that can be used for infusion of opioids and local anesthetics. Products of these types are marketed by Actavis, Endo, Mallinckrodt, Purdue, Teva, and others. Some of these current and potential future competitors may be addressing the same therapeutic areas or indications as we are. Many of our current and potential future competitors have significantly greater research and development capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and managerial resources than we do, and have more institutional experience than we do. Our competitors have developed or may develop technologies that are, or may be, the basis for competitive products that are safer, more effective or less costly than our products. Moreover, oral medications, transdermal drug delivery systems, such as drug patches, injectable products and implantable drug delivery devices are currently available treatments for chronic pain, are widely accepted in the medical community and have a long history of use. These treatments will compete with our products and the established use of these competitive products may limit the potential for our products to receive widespread acceptance.

Commercial sales of our products and ~~clinical trials of~~ any ~~future product candidates~~products we ~~develop or~~ acquire, may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all.

We currently carry product liability insurance. Product liability claims may be brought against us by patients; ~~clinical trial participants;~~ healthcare providers; or others using, administering or selling our products. If we cannot successfully defend ourselves against claims that our products caused injuries, we could incur substantial liabilities. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Regardless of merit or eventual outcome, liability claims may cause us to incur significant costs to defend the litigation.

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Healthcare providers, physicians and payors play a primary role in the recommendation and prescription of our products. Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our ~~products and any product candidates for which we may obtain marketing approval.~~products. Even though we do not and will not control referrals of healthcare services or bill Medicare, Medicaid or other third-party payors directly, we may provide reimbursement guidance and support regarding our products to our customers and patients. Federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. If a government authority were to conclude that we provided improper advice to our customers and/or encouraged the submission of false claims for reimbursement, we could face action by government authorities. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

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We or the third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power outage, health epidemic ~~(such as the COVID-19 pandemic)~~ or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it might become difficult or, in certain cases, impossible for us to continue our business, and any disruption could last for a substantial period of time.

The disaster recovery and business continuity plans we have in place, and the technology that we may rely upon to implement such plans, may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, financial condition and results of operation.

Risks Related to Our Common Stock

The price of our common stock may be volatile and you may lose all or part of your investment.

The market price of our common stock is highly volatile and may be subject to wide fluctuations in response to numerous factors described in these “Risk Factors,” some of which are beyond our control. The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our business model, prospects or actual operating performance. The realization of any of these risks, or any of a broad range of other risks discussed in this report, could have a material adverse effect on the market price of our common stock.

We are subject to anti-takeover provisions in our second amended and restated articles of incorporation and amended and restated bylaws and under Virginia law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our shareholders.

Certain provisions of Virginia law, the state in which we are incorporated, and our second amended and restated articles of incorporation and amended and restated bylaws could hamper a third party’s acquisition of us, or discourage a third party from attempting to acquire control of us. These provisions could limit the price that certain investors might be willing to pay in the future for shares of our common stock. In addition, these provisions make it more difficult for our shareholders to remove our Board of Directors or management or elect new directors to our Board of Directors.

~~Table of Contents~~

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to report our financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting. We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. If we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is effective. We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. Further, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to capital markets.

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Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that these sales could occur, could cause a decline in the market price of our securities. Moreover, the exercise of options and other issuances of shares of common stock or securities convertible into or exercisable for shares of common stock will dilute your ownership interests and may adversely affect the future market price of our common stock.

Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that these sales could occur, could cause a decline in the market price of our securities. All of the shares of our common stock held by our current shareholders may be immediately eligible for resale in the open market either in compliance with an exemption under Rule 144 promulgated under the Securities Act, or pursuant to an effective resale registration statement that we have previously filed with the SEC. Such sales, along with any other market transactions, could adversely affect the market price of our common stock. As of ~~September 30, 2023,~~March 31, 2024, there were outstanding options to purchase an aggregate of ~~1,347,160~~975,550 shares of our common stock at a weighted average exercise price of ~~$19.43~~$19.17 per share, of which options to purchase ~~1,310,344~~974,941 shares of our common stock were then exercisable. The exercise of options at prices below the market price of our common stock could adversely affect the price of shares of our common stock. Additional dilution may result from the issuance of shares of our common stock in connection with collaborations or manufacturing arrangements or in connection with other financing efforts.

There can be no assurance that we will repurchase additional shares of our common stock at all or at favorable prices.

In August 2021, our Board of Directors authorized a repurchase program for the repurchase of up to ~~$100.0~~$100 million of shares of our common stock at any time or times through December 31, 2022 (the “Prior Repurchase Program”). We repurchased $61.9 million of shares pursuant to the Prior Repurchase Program prior to its expiration on December 31, 2022. In January 2023, our Board of Directors authorized a ~~new~~ share repurchase program for the repurchase of up to $100.0 million of shares of our common stock through December 31, 2023 (the “2023 Repurchase Program”). We repurchased $75.0 million of shares pursuant to the 2023 Repurchase Program prior to its expiration on December 31, 2023.

In January 2024, our Board of Directors authorized a new share repurchase program for the repurchase of up to $150.0 million of shares of our common stock through June 30, 2025 (the “2024-2025 Repurchase Program”). The ~~2023~~2024-2025 Repurchase Program permits us 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 August 2023, we entered into the ASR Program to repurchase $50.0 million of our common stock, as part of the 2023 Repurchase Program. As of September 30, 2023, we had repurchased an initial $40.0 million of shares under the 2023 Repurchase Program, and the remaining value of shares that may be repurchased pursuant to the 2023 Repurchase Program was $60.0 million, which included $10.0 million which has since been settled under the ASR Program. Additional share Share repurchases under the ~~2023~~2024-2025 Repurchase Program will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial condition, the price of our common stock on the NASDAQ Global Select Market, and other factors that we may deem relevant. We can provide no assurance that we will continue to repurchase shares of our common stock at favorable prices, if at all.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

~~RECENT SALES OF UNREGISTERED SECURITIES~~Recent Sales of Unregistered Securities

There were no unregistered sales of equity securities during the period covered by this quarterly report on Form 10-Q.

~~PURCHASES OF EQUITY SECURITIES~~Purchases of Equity Securities

The following table sets forth shares of common stock repurchased under our ~~2023~~2024-2025 Repurchase Program, as well as shares transferred to us from employees in satisfaction of minimum tax withholding obligations associated with the vesting of performance share units and restricted stock units during the three months ended ~~September 30, 2023:~~March 31, 2024:


Period	Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs ^{(1) (2)}		Maximum approximate dollar value of shares that may yet be purchased under the plans or programs		Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs ⁽¹⁾		Maximum approximate dollar value of shares that may yet be purchased under the plans or programs (in thousands)
July 1, 2023 through July 31, 2023	508		$	21.57	—		$	100,000
August 1, 2023 through August 31, 2023	1,708,331			23.49	1,702,852			60,000
September 1, 2023 through September 30, 2023	1,372			23.36	—			60,000
January 1, 2024 through January 31, 2024									750		$	32.63	—		$	150,000
February 1, 2024 through February 29, 2024									379,818			33.70	—			150,000
March 1, 2024 through March 31, 2024									1,329			37.50	—			150,000
Total	1,710,211	⁽³⁾	$	23.49	1,702,852	⁽³⁾	$	60,000	381,897	⁽²⁾	$	33.71	—	⁽²⁾	$	150,000

(1)

The ~~2023~~2024-2025 Repurchase Program was announced on January ~~4, 2023.~~3, 2024. The ~~2023~~2024-2025 Repurchase Program provides for the repurchase of up to ~~$100.0~~$150.0 million of outstanding shares of our common stock at any time or times through ~~December 31, 2023.~~June 30, 2025. The ~~2023~~2024-2025 Repurchase Program did not expire during the three months ended ~~September 30, 2023,~~March 31, 2024, nor do we currently plan to terminate the ~~2023~~2024-2025 Repurchase Program prior to expiration. However, there can be no assurance as to the timing or number of shares of any repurchases in the future.

(2)

As part of the 2023 Repurchase Program, on August 4, 2023 we entered into the ASR Agreement with an investment bank and announced the ASR Program on August 7, 2023. The ASR Agreement provided for the repurchase of up to $50.0 million of outstanding shares of our common stock through December 8, 2023. The ASR Program did not expire during the three months ended September 30, 2023, nor did we plan to terminate the ASR Program prior to its expiration. During the three months ended September 30, 2023, we repurchased 1,702,852 shares at a price of $23.49 per share for a total of $40.0 million under the 2023 Repurchase Program. For more information regarding the ASR Program, refer to Note 14, ~~Equity~~.

~~(3)~~

The difference, if any, between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program relates to common stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of performance share units and restricted stock units granted under our Amended and Restated 2014 Stock Incentive Plan.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

~~RULE~~Rule 10b5-1 ~~TRADING PLANS~~Trading Plans

The disclosure set forth in Part II – Item 2 above is incorporated herein by reference.

The following table shows the “Rule 10b5-1 trading arrangements” or “non-Rule 10b5-1 trading arrangements” (as each term is defined in Item 408(a) of Regulation S-K) adopted, amended, or terminated by our directors and officers during the three months ended ~~September 30, 2023:~~March 31, 2024:

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Trading Arrangement

Name

Title

Action

Effective Date

Rule 10b5-1

Non-Rule 10b5-1

Scheduled Expiration Date of Trading Plan ⁽¹⁾

Maximum Shares Subject to Trading Plan

~~Scott Dreyer~~Joseph Ciaffoni

~~Executive Vice~~Director, President and Chief ~~Commercial~~Executive Officer

Adoption

~~August 9, 2023~~February 26, 2024

~~August 8,~~December 31, 2024

~~33,560~~157,285

Colleen Tupper

Executive Vice President and Chief Finance Officer

Adoption

February 26, 2024

October 31, 2024

19,710

Shirley Kuhlmann

Executive Vice President, Chief Administrative Officer, General Counsel & Secretary

Adoption

February 26, 2024

June 7, 2024

37,500

(1)

A trading arrangement may expire on an earlier date if all contemplated transactions are completed before such trading arrangement’s expiration date, upon termination by broker or the holder of the trading arrangement, or as otherwise provided in the trading arrangement.

Item 6. Exhibits.

Exhibit Number		Exhibit Description
31.1		Certification of Chief Executive Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
31.2		Certification of Chief Financial Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


			COLLEGIUM PHARMACEUTICAL, INC.

Date:	~~November 7, 2023~~May 9, 2024	By:	/s/ JOSEPH CIAFFONI
			Joseph Ciaffoni
			Chief Executive Officer
			(Principal executive officer)

Date:	~~November 7, 2023~~May 9, 2024	By:	/s/ COLLEEN TUPPER
			Colleen Tupper
			Chief Financial Officer
			(Principal financial and accounting officer)

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	PART I—FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	3632
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	4539
Item 4.	Controls and Procedures	4639

	PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	4741
Item 1A.	Risk Factors	4741
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	6660
Item 3.	Defaults Upon Senior Securities	6660
Item 4.	Mine Safety Disclosures	6660
Item 5.	Other Information	6660
Item 6.	Exhibits	6761
~~Signature~~Signatures		6862


					Trade						Trade
	Rebates and		Product		Allowances and		Rebates and		Product		Allowances and
	Incentives (1)		Returns (2)		Chargebacks (3)		Incentives ⁽¹⁾		Returns ⁽²⁾		Chargebacks ⁽³⁾
Balance as of December 31, 2022	$	156,937	$	73,554	$	22,058
Balance as of December 31, 2023							$	149,826	$	77,505	$	20,917
Provision related to current period sales		325,725		31,904		112,550		92,569		9,697		39,013
Changes in estimate related to prior period sales		2		3,722		589		1,061		1,519		(53)
Credits/payments made		(315,170)		(31,662)		(113,263)		(105,228)		(9,069)		(39,245)
Balance as of September 30, 2023	$	167,494	$	77,518	$	21,934
Balance as of March 31, 2024							$	138,228	$	79,652	$	20,632


Fair Value of Purchase Price Consideration	Amount
Fair value of purchase price consideration paid at closing:
Cash consideration for all outstanding shares of BDSI's common and preferred stock (103,235,298 shares acquired at $5.60 per share)	$	578,118
Cash consideration paid to settle RSUs and in-the-money options		28,309
Cash paid to settle BDSI debt		63,004
Total purchase consideration	$	669,431


	Amounts Recognized at the Acquisition Date
Assets Acquired
Cash and cash equivalents	$	97,362
Accounts receivable		55,495
Inventory		77,382
Prepaid expenses and other current assets		6,125
Property and equipment		1,242
Operating lease assets		481
Intangible assets		435,000
Total assets	$	673,087
Liabilities Assumed
Accounts payable	$	12
Accrued expenses		18,249
Accrued rebates, returns and discounts		56,261
Operating lease liabilities		481
Deferred tax liabilities		62,510
Total liabilities	$	137,513
Total identifiable net assets acquired		535,574
Goodwill		133,857
Total consideration transferred	$	669,431


Level 1 inputs:	Quoted prices (unadjusted) in active markets for identical assets or ~~liabilities~~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~~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~~liability.


						Significant								Significant
				Quoted Prices		other		Significant				Quoted Prices		other		Significant
				in active		observable		unobservable				in active		observable		unobservable
				markets		inputs		inputs				markets		inputs		inputs
		Total		(Level 1)		(Level 2)		(Level 3)		Total		(Level 1)		(Level 2)		(Level 3)
September 30, 2023
March 31, 2024
Cash equivalents:
Money market funds	$	104,250	$	104,250	$	—	$	—	$	69,772	$	69,772	$	—	$	—
Marketable securities:
Corporate debt securities		17,813		—		17,813		—		62,501		—		62,501		—
U.S. Treasury securities		23,740		—		23,740		—		24,442		—		24,442		—
Government-sponsored securities		4,480		—		4,480		—		2,495		—		2,495		—
Total assets measured at fair value	$	150,283	$	104,250	$	46,033	$	—	$	159,210	$	69,772	$	89,438	$	—

December 31, 2022
December 31, 2023
Cash equivalents:
Money market funds	$	172,590	$	172,590	$	—	$	—	$	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	$	172,590	$	172,590	$	—	$	—	$	153,629	$	77,299	$	76,330	$	—


	Amortized Cost		Gross Unrealized (Losses) Gains		Fair Value
March 31, 2024							Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
Corporate debt securities	$	17,858	$	(45)	$	17,813	$	62,618	$	10	$	(127)	$	62,501
U.S. Treasury securities		23,741		(1)		23,740		24,448		—		(6)		24,442
Government-sponsored securities		4,486		(6)		4,480		2,496		—		(1)		2,495
Total	$	46,085	$	(52)	$	46,033	$	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


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


Years ended December 31,	Belbuca		Nucynta Products ⁽¹⁾		Symproic		Total
2023	$	18,848	$	13,845	$	1,821	$	34,514
2024		75,393		55,384		7,285		138,062
2025		75,393		55,384		7,285		138,062
2026		75,393		27,692		7,285		110,370
2027		—		—		7,285		7,285
Thereafter		—		—		27,929		27,929
Remaining amortization expense	$	245,027	$	152,305	$	58,890	$	456,222


Years ended December 31,	Principal Payments		Principal Payments
2023	$	45,834
2024		183,333	$	137,500
2025		183,333		183,333
2026		45,834		45,834
Total before unamortized discount and issuance costs	$	458,334	$	366,667
Less: unamortized discount and issuance costs		(9,115)		(5,974)
Term notes carrying value	$	449,219	$	360,693


	2026 Convertible Notes		2029 Convertible Notes		Total Convertible Notes		2026 Convertible Notes		2029 Convertible Notes		Total Convertible Notes
Principal	$	26,350	$	241,500	$	267,850	$	26,350	$	241,500	$	267,850
Less: unamortized issuance costs		(401)		(5,626)		(6,027)		(317)		(5,108)		(5,425)
Net carrying amount	$	25,949	$	235,874	$	261,823	$	26,033	$	236,392	$	262,425


				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, 2023	38,192,441	$	38	$	565,949	(6,323,892)	$	(137,381)	$	(233,189)	$	14	$	195,431
Exercise of common stock options	200,200		—		4,205	—		—		—		—		4,205
Issuance for employee stock purchase plan	18,538		—		356	—		—		—		—		356
Vesting of RSUs and PSUs	1,000,357		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, 2024	39,029,639	$	39	$	565,111	(6,323,892)	$	(137,381)	$	(205,476)	$	(124)	$	222,169


		Weighted-Average			Weighted-Average
	Shares	Grant Date Fair Value		Shares	Grant Date Fair Value
Outstanding as of December 31, 2022	447,770	$	28.71
Outstanding as of December 31, 2023				503,880	$	33.13
Granted	216,500		38.71	203,000		45.06
Vested	(223,170)		27.99	(314,921)		33.90
Forfeited	—		—	—		—
Performance adjustment	62,780		27.14	119,721		34.26
Outstanding as of September 30, 2023	503,880	$	33.13
Outstanding as of March 31, 2024				511,680	$	37.66


				Weighted-						Weighted-
			Weighted-	Average					Weighted-	Average
			Average	Remaining		Aggregate			Average	Remaining		Aggregate
			Exercise Price	Contractual		Intrinsic			Exercise Price	Contractual		Intrinsic
	Shares		per Share	Term (in years)		Value	Shares		per Share	Term (in years)		Value
Outstanding as of December 31, 2022	1,683,805	$	18.84	5.5	$	7,953
Outstanding as of December 31, 2023							1,176,750	$	19.48	4.3	$	13,297
Exercised	(327,722)		16.43				(200,200)		20.96
Cancelled	(8,923)		18.87				(1,000)		27.73
Outstanding as of September 30, 2023	1,347,160	$	19.43	4.7	$	4,952
Exercisable as of September 30, 2023	1,310,344	$	19.38	4.6	$	4,910
Outstanding as of March 31, 2024							975,550	$	19.17	4.0	$	19,172
Exercisable as of March 31, 2024							974,941	$	19.17	4.0	$	19,160