Form 8-K
8-K — COLLEGIUM PHARMACEUTICAL, INC
Accession: 0001104659-26-059018
Filed: 2026-05-12
Period: 2026-05-12
CIK: 0001267565
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Completion of Acquisition or Disposition of Assets
Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — tm2614189d1_8k.htm (Primary)
EX-10.1 — EXHIBIT 10.1 (tm2614189d1_ex10-1.htm)
EX-99.1 — EXHIBIT 99.1 (tm2614189d1_ex99-1.htm)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): May 12, 2026
COLLEGIUM PHARMACEUTICAL, INC.
(Exact Name of Registrant as Specified in its Charter)
Virginia
001-37372
03-0416362
(State
or Other Jurisdiction
of Incorporation or Organization)
(Commission
File Number)
(IRS Employer Identification
No.)
100 Technology Center Drive
Suite 300
Stoughton, MA 02072
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (781) 713-3699
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
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨
Item 2.01
Completion of Acquisition or Disposition of Assets.
As previously disclosed, on March 19, 2026, Collegium Pharmaceutical, Inc.
(the “Company”), entered into an Equity Purchase Agreement (the “Purchase
Agreement”) with Corium Therapeutics Holdings, LLC, a Delaware limited liability company (“Commave
Seller”), and Corium, LLC, a Delaware limited liability company (“Corium Seller”
and together with Commave Seller, the “Seller Parties”). On May 12, 2026,
pursuant to the Purchase Agreement, the Company completed the acquisition (the “Closing”)
of (i) all of the issued and outstanding limited liability interests of GPC Commave Holding, LLC, a Delaware limited liability company
(“GPC”) from Commave Seller, and (ii) all of the issued and outstanding
limited liability interests of Commave Sub, LLC, a Delaware limited liability company from Corium Seller. Upon the Closing, the Company
acquired AZSTARYS®, a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit/Hyperactivity
Disorder, in people 6 years of age and older.
The aggregate consideration paid by the Company at the Closing pursuant
to the Purchase Agreement was approximately $650 million in cash (subject to customary adjustments for net working capital, indebtedness,
cash, and transaction expenses), which was funded by approximately $350 million of the Company’s existing cash on hand and $300
million from a delayed draw term loan which is part of the syndicated credit facility announced by the Company in December 2025.
The Company may also pay Commave Seller up to $135 million in additional consideration if AZSTARYS achieves certain future commercial
and manufacturing milestones.
The foregoing description of the Purchase Agreement does not purport
to be complete and is qualified in its entirety by the full text of the Purchase Agreement, a copy of which was filed by the Company as
Exhibit 2.1 to its Current Report on Form 8-K, filed on March 19, 2026, and incorporated herein by reference.
Item 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
2026 Inducement Plan
On May 11, 2026, the Company’s board of
directors adopted the Company’s 2026 Inducement Plan (the “Inducement Plan”), pursuant to which the Company may
grant non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards,
and dividend equivalent rights with respect to an aggregate of 325,000 shares of the Company’s common stock, par value $0.001 per
share. Awards under the Inducement Plan may only be granted to new employees who were not previously an employee or director of the Company
or are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material
to the individual’s entering into employment with the Company. In accordance with Nasdaq Listing Rule 5635(c)(4), the Company did
not seek approval of the Inducement Plan by its stockholders.
The foregoing description of the Inducement Plan
does not purport to be complete and is qualified in its entirety by reference to the Inducement Plan, a copy of which is filed as Exhibit
10.1 hereto and is incorporated by reference herein.
Leadership Changes
On May 11, 2026, the Company announced that Scott
Dreyer, Executive Vice President and Chief Commercial Officer of the Company will depart from his positions at the Company effective August
30, 2026. Mr. Dreyer’s departure will be treated as a termination without cause pursuant to the terms of his existing employment
agreement with the Company.
On May 11, 2026, the Company also announced that
Thomas Smith, M.D., Executive Vice President and Chief Medical Officer of the Company will depart from his positions at the Company following
a transition period during which the Company will conduct a search for his successor. Dr. Smith’s departure will be treated as a
termination without cause pursuant to the terms of his existing employment agreement with the Company.
Item 7.01
Regulation FD Disclosure.
On May 12, 2026, the Company issued a press
release announcing the Closing, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included in this item and Exhibit 99.1
is not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), nor shall this item or Exhibit 99.1 be incorporated by reference into the Company’s filings under the Securities
Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference
in such future filing.
Item 9.01
Financial Statements and Exhibits.
(a) Financial Statements of the Business Acquired.
Financial statements, to the extent required by this Item 9.01, will
be filed by amendment to this Current Report on Form 8-K within seventy-one (71) calendar days from the date that this Current Report
on Form 8-K is required to be filed.
(b) Pro Forma Financial Information.
Pro forma financial information, to the extent required by this Item
9.01, will be filed by amendment to this Current Report on Form 8-K within seventy-one (71) calendar days from the date that this
Current Report on Form 8-K is required to be filed.
(d) Exhibits.
2.1*^
Equity Purchase Agreement, dated
as of March 19, 2026, by and among the Company, Corium Therapeutics Holdings, LLC, and Corium, LLC.
10.1
Collegium Pharmaceutical, Inc. 2026 Inducement Plan
99.1
Press Release, dated May 12, 2026
104
Cover Page Interactive Data File (embedded within
the Inline XBRL document)
* Schedules omitted pursuant to Item 601(b)(2) of Regulation
S-K. The Company agrees to furnish supplementally a copy of any omitted schedule to the SEC upon request.
^ Certain portions of this Exhibit have been redacted pursuant
to Item 601(b)(10)(iv) of Regulation S-K. The Company hereby agrees to furnish supplementally an unredacted copy of the exhibit to
the SEC upon its request.
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 hereunto duly authorized.
Dated: May 12, 2026
Collegium Pharmaceutical, Inc.
By:
/s/ Colleen Tupper
Name:
Colleen Tupper
Title:
Executive Vice President and Chief Financial Officer
EX-10.1 — EXHIBIT 10.1
EX-10.1
Filename: tm2614189d1_ex10-1.htm · Sequence: 2
Exhibit 10.1
COLLEGIUM PHARMACEUTICAL, INC.
2026 INDUCEMENT
PLAN
SECTION 1.
GENERAL PURPOSE OF THE PLAN; DEFINITIONS
The
name of the plan is the Collegium Pharmaceutical, Inc. 2026 Inducement Plan (the “Plan”). The purpose of the Plan is
to enable Collegium Pharmaceutical, Inc. (the “Company”) and its Affiliates to grant equity awards to induce highly-qualified
prospective officers and employees who are Eligible Employees to accept employment and to provide them with a proprietary interest in
the Company. It is anticipated that providing such persons with a direct stake in the Company’s welfare will assure a closer identification
of their interests with those of the Company and its stockholders, thereby stimulating their efforts on the Company’s behalf and
strengthening their desire to remain with the Company. The Company intends that the Plan be reserved for persons to whom the Company
may issue securities without stockholder approval as an inducement pursuant to Rule 5635(c)(4) of the Marketplace Rules of
The Nasdaq Stock Market LLC.
The
following terms shall be defined as set forth below:
“Act”
means the Securities Act of 1933, as amended, and the rules and regulations thereunder.
“Administrator”
means either the Board or the compensation committee of the Board or a similar committee performing the functions of the compensation
committee and which is comprised of not less than two Non-Employee Directors who are independent.
“Affiliate”
means, at the time of determination, any “parent” or “subsidiary” of the Company as such terms are defined in
Rule 405 of the Act. The Board will have the authority to determine the time or times at which “parent” or “subsidiary”
status is determined within the foregoing definition.
“Award”
or “Awards,” except where referring to a particular category of grant under the Plan, shall include Stock Options,
Stock Appreciation Rights, Restricted Stock Units, Restricted Stock Awards, Unrestricted Stock Awards, and Dividend Equivalent Rights.
“Award
Agreement” means a written or electronic document setting forth the terms and provisions applicable to an Award granted under
the Plan. Each Award Agreement is subject to the terms and conditions of the Plan.
“Board”
means the Board of Directors of the Company.
“Code”
means the Internal Revenue Code of 1986, as amended, and any successor Code, and related rules, regulations and interpretations.
“Consultant”
means a consultant or adviser who provides bona fide services to the Company or an Affiliate as an independent contractor and
who qualifies as a consultant or advisor under Instruction A.1.(a)(1) of Form S-8 under the Act.
“Dividend
Equivalent Right” means an Award entitling the grantee to receive credits based on cash dividends that would have been paid
on the shares of Stock specified in the Dividend Equivalent Right (or other award to which it relates) if such shares had been issued
to and held by the grantee.
“Effective
Date” means the date on which the Plan becomes effective as set forth in Section 18.
“Eligible
Employee” means any individual who was not previously an employee or a Non-Employee Director of the Company or any of its Affiliates
(or who has had a bona fide period of non-employment with the Company and its Affiliates ), who is hired as a full or part-time employee
by the Company or one of its Affiliates, and for whom the Award is being made as an inducement material to the individual’s entering
into such employment.
“Exchange
Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.
“Fair
Market Value” of the Stock on any given date means the fair market value of the Stock determined in good faith by the Administrator;
provided, however, that if the Stock is listed on the National Association of Securities Dealers Automated Quotation System (“Nasdaq”),
Nasdaq Global Market, The New York Stock Exchange or another national securities exchange or traded on any established market, the determination
shall be made by reference to market quotations. If there are no market quotations for such date, the determination shall be made by
reference to the last date preceding such date for which there are market quotations.
“Non-Employee
Director” means a member of the Board who is not also an employee of the Company or any Subsidiary.
“Option”
or “Stock Option” means any option to purchase shares of Stock granted pursuant to Section 5.
“Restricted
Shares” means the shares of Stock underlying a Restricted Stock Award that remain subject to a risk of forfeiture or the Company’s
right of repurchase.
“Restricted
Stock Award” means an Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine
at the time of grant.
“Restricted
Stock Units” means an Award of stock units subject to such restrictions and conditions as the Administrator may determine at
the time of grant.
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“Sale
Event” means (i) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated
person or entity, (ii) a merger, reorganization or consolidation pursuant to which the holders of the Company’s outstanding
voting power and outstanding stock immediately prior to such transaction do not own a majority of the outstanding voting power and outstanding
stock or other equity interests of the resulting or successor entity (or its ultimate parent, if applicable) immediately upon completion
of such transaction, (iii) the sale of all of the Stock of the Company to an unrelated person, entity or group thereof acting in
concert or (iv) any other transaction in which the owners of the Company’s outstanding voting power immediately prior to such
transaction do not own at least a majority of the outstanding voting power of the Company or any successor entity immediately upon completion
of the transaction other than as a result of the acquisition of securities directly from the Company.
“Sale
Price” means the value as determined by the Administrator of the consideration payable, or otherwise to be received by stockholders,
per share of Stock pursuant to a Sale Event.
“Section 409A”
means Section 409A of the Code and the regulations and other guidance promulgated thereunder.
“Service
Relationship” means any relationship as an employee, director or Consultant of the Company or any Affiliate (e.g., a Service
Relationship shall be deemed to continue without interruption in the event an individual’s status changes from full-time employee
to part-time employee or Consultant).
“Stock”
means the Common Stock, par value $0.001 per share, of the Company, subject to adjustments pursuant to Section 3.
“Stock
Appreciation Right” means an Award entitling the recipient to receive shares of Stock (or cash, to the extent explicitly provided
for in the applicable Award Agreement) having a value equal to the excess of the Fair Market Value of the Stock on the date of exercise
over the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock Appreciation
Right shall have been exercised.
“Subsidiary”
means any corporation or other entity (other than the Company) in which the Company has at least a 50 percent interest, either directly
or indirectly.
“Unrestricted
Stock Award” means an Award of shares of Stock free of any restrictions.
SECTION 2.
ADMINISTRATION OF PLAN; ADMINISTRATOR AUTHORITY TO SELECT
GRANTEES AND DETERMINE AWARDS
(a) Administration
of Plan. The Plan shall be administered by the Administrator.
(b) Powers
of Administrator. The Administrator shall have the power and authority to grant Awards consistent with the terms of the Plan, including
the power and authority:
(i) to
select the individuals to whom Awards may from time to time be granted, provided that such individuals are Eligible Employees;
(ii) to
determine the time or times of grant, and the extent, if any, of Stock Options, Stock Appreciation Rights, Restricted Stock Awards, Restricted
Stock Units, Unrestricted Stock Awards, and Dividend Equivalent Rights, or any combination of the foregoing, granted to any one or more
grantees;
3
(iii) to
determine the number of shares of Stock to be covered by any Award;
(iv) to
determine and modify from time to time the terms and conditions, including restrictions, not inconsistent with the terms of the Plan,
of any Award, which terms and conditions may differ among individual Awards and grantees, and to approve the forms of Award Agreements;
(v) to
accelerate at any time the exercisability or vesting of all or any portion of any Award;
(vi) subject
to the provisions of Section 5(c), to extend at any time the period in which Stock Options may be exercised; and
(vii) at
any time to adopt, alter and repeal such rules, guidelines and practices for administration of the Plan and for its own acts and proceedings
as it shall deem advisable; to interpret the terms and provisions of the Plan and any Award (including related written instruments);
to make all determinations it deems advisable for the administration of the Plan; to decide all disputes arising in connection with the
Plan; and to otherwise supervise the administration of the Plan.
All
decisions and interpretations of the Administrator shall be binding on all persons, including the Company and Plan grantees.
(c) Award
Agreement. Awards under the Plan shall be evidenced by Award Agreements that set forth the terms, conditions and limitations for
each Award which may include, without limitation, the term of an Award and the provisions applicable in the event employment or service
terminates.
(d) Indemnification.
Neither the Board nor the Administrator, nor any member of either or any delegate thereof, shall be liable for any act, omission, interpretation,
construction or determination made in good faith in connection with the Plan, and the members of the Board and the Administrator (and
any delegate thereof) shall be entitled in all cases to indemnification and reimbursement by the Company in respect of any claim, loss,
damage or expense (including, without limitation, reasonable attorneys’ fees) arising or resulting therefrom to the fullest extent
permitted by law and/or under the Company’s articles or bylaws or any directors’ and officers’ liability insurance
coverage which may be in effect from time to time and/or any indemnification agreement between such individual and the Company.
(e) Non-U.S.
Award Recipients. Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws in other countries
in which the Company and its Affiliates operate or have employees eligible for Awards, the Administrator, in its sole discretion, shall
have the power and authority to: (i) determine which Affiliates shall be covered by the Plan; (ii) determine which Eligible
Employees outside the United States are eligible to participate in the Plan; (iii) modify the terms and conditions of any Award
granted to individuals outside the United States to comply with applicable laws and subject to Nasdaq listing Rule 5635(c)(4) and
related guidelines and interpretations; (iv) establish subplans and modify exercise procedures and other terms and procedures, to
the extent the Administrator determines such actions to be necessary or advisable (and such subplans and/or modifications shall be incorporated
into and made part of this Plan); provided, however, that no such subplans and/or modifications shall increase the share limitations
contained in Section 3(a) hereof; and (v) take any action, before or after an Award is made, that the Administrator determines
to be necessary or advisable to obtain approval or comply with any local governmental regulatory exemptions or approvals. Notwithstanding
the foregoing, the Administrator may not take any actions hereunder, and no Awards shall be granted, that would violate Nasdaq Listing
Rule 5636(c), the Exchange Act or any other applicable United States securities law, the Code, or any other applicable United States
governing statute or law.
4
SECTION 3.
STOCK ISSUABLE UNDER THE PLAN; MERGERS; SUBSTITUTION
(a) Stock
Issuable. The maximum number of shares of Stock reserved and available for issuance under the Plan shall be equal to 325,000 shares,
subject to adjustment as provided in this Section 3. For purposes of this limitation, the shares of Stock underlying any awards
under the Plan that are forfeited, canceled or otherwise terminated (other than by exercise) shall be added back to the shares of Stock
available for issuance under the Plan. Notwithstanding the foregoing, the following shares shall not be added to the shares authorized
for grant under the Plan: (i) shares tendered or held back upon exercise of an Option or settlement of an Award to cover the exercise
price or tax withholding and (ii) shares subject to a Stock Appreciation Right that are not issued in connection with the stock
settlement of the Stock Appreciation Right upon exercise thereof. In the event the Company repurchases shares of Stock on the open market,
such shares shall not be added to the shares of Stock available for issuance under the Plan. The shares available for issuance under
the Plan may be authorized but unissued shares of Stock or shares of Stock reacquired by the Company.
(b) Changes
in Stock. Subject to Section 3(c) hereof, if, as a result of any reorganization, recapitalization, reclassification, stock
dividend, stock split, reverse stock split or other similar change in the Company’s capital stock, the outstanding shares of Stock
are increased or decreased or are exchanged for a different number or kind of shares or other securities of the Company, or additional
shares or new or different shares or other securities of the Company or other non-cash assets are distributed with respect to such shares
of Stock or other securities, or, if, as a result of any merger or consolidation, sale of all or substantially all of the assets of the
Company, the outstanding shares of Stock are converted into or exchanged for securities of the Company or any successor entity (or a
parent or subsidiary thereof), the Administrator shall make an appropriate or proportionate adjustment in (i) the maximum number
of shares reserved for issuance under the Plan, (ii) the number and kind of shares or other securities subject to any then outstanding
Awards under the Plan, (iii) the repurchase price, if any, per share subject to each outstanding Restricted Stock Award and (iv) the
exercise price for each share subject to any then outstanding Stock Options and Stock Appreciation Rights under the Plan, without changing
the aggregate exercise price (i.e., the exercise price multiplied by the number of shares subject to Stock Options and Stock Appreciation
Rights) as to which such Stock Options and Stock Appreciation Rights remain exercisable. The Administrator shall also make equitable
or proportionate adjustments in the number of shares subject to outstanding Awards and the exercise price and the terms of outstanding
Awards to take into consideration cash dividends paid other than in the ordinary course or any other extraordinary corporate event. The
adjustment by the Administrator shall be final, binding and conclusive. No fractional shares of Stock shall be issued under the Plan
resulting from any such adjustment, but the Administrator in its discretion, may make a cash payment in lieu of fractional shares.
5
(c) Mergers
and Other Transactions. In the case of and subject to the consummation of a Sale Event, the parties thereto may cause the assumption
or continuation of Awards theretofore granted by the successor entity, or the substitution of such Awards with new Awards of the successor
entity or parent thereof, with appropriate adjustment as to the number and kind of shares and, if appropriate, the per share exercise
prices, as such parties shall agree. To the extent the parties to such Sale Event do not provide for the assumption, continuation or
substitution of Awards, upon the effective time of the Sale Event, the Plan and all outstanding Awards granted hereunder shall terminate.
In such case, except as may be otherwise provided in the relevant Award Agreement, all Options and Stock Appreciation Rights with time-based
vesting conditions or restrictions that are not vested and/or exercisable immediately prior to the effective time of the Sale Event shall
become fully vested and exercisable as of the effective time of the Sale Event, all other Awards with time-based vesting, conditions
or restrictions shall become fully vested and nonforfeitable as of the effective time of the Sale Event, and all Awards with conditions
and restrictions relating to the attainment of performance goals may become vested and nonforfeitable in connection with a Sale Event
in the Administrator’s discretion or to the extent specified in the relevant Award Agreement. In the event of such termination,
(i) the Company shall have the option (in its sole discretion) to make or provide for a payment, in cash or in kind, to the grantees
holding Options and Stock Appreciation Rights, in exchange for the cancellation thereof, in an amount equal to the difference between
(A) the Sale Price multiplied by the number of shares of Stock subject to outstanding Options and Stock Appreciation Rights (to
the extent then exercisable at prices not in excess of the Sale Price) and (B) the aggregate exercise price of all such outstanding
Options and Stock Appreciation Rights (provided that, in the case of an Option or Stock Appreciation Right with an exercise price equal
to or greater than the Sale Price, such Option or Stock Appreciation Right shall be cancelled for no consideration); or (ii) each
grantee shall be permitted, within a specified period of time prior to the consummation of the Sale Event as determined by the Administrator,
to exercise all outstanding Options and Stock Appreciation Rights (to the extent then exercisable) held by such grantee. The Company
shall also have the option (in its sole discretion) to make or provide for a payment, in cash or in kind, to the grantees holding other
Awards in an amount equal to the Sale Price multiplied by the number of vested shares of Stock under such Awards.
SECTION 4.
ELIGIBILITY
Grantees
under the Plan will be Eligible Employees to whom the Company may issue securities without stockholder approval in accordance with Rules 5635(c)(4) of
the Marketplace Rules of The Nasdaq Stock Market LLC as are selected from time to time by the Administrator in its sole discretion.
SECTION 5.
STOCK OPTIONS
(a) Award
of Stock Options. The Administrator may grant Stock Options under the Plan. Any Stock Option granted under the Plan shall be non-qualified
stock options.
Stock
Options granted pursuant to this Section 5 shall be subject to the following terms and conditions and shall contain such additional
terms and conditions, not inconsistent with the terms of the Plan, as the Administrator shall deem desirable.
6
(b) Exercise
Price. The exercise price per share for the Stock covered by a Stock Option granted pursuant to this Section 5 shall be determined
by the Administrator at the time of grant but shall not be less than 100 percent of the Fair Market Value on the date of grant. Notwithstanding
the foregoing, Stock Options may be granted with an exercise price per share that is less than 100 percent of the Fair Market Value on
the date of grant (i) pursuant to a transaction described in, and in a manner consistent with, Section 424(a) of the Code,
(ii) to individuals who are not subject to U.S. income tax on the date of grant or (iii) the Stock Option is otherwise compliant
with Section 409A.
(c) Option
Term. The term of each Stock Option shall be fixed by the Administrator, but no Stock Option shall be exercisable more than ten years
after the date the Stock Option is granted.
(d) Exercisability;
Rights of a Stockholder. Stock Options shall become exercisable at such time or times, whether or not in installments, as shall be
determined by the Administrator at or after the grant date. The Administrator may at any time accelerate the exercisability of all or
any portion of any Stock Option. An optionee shall have the rights of a stockholder only as to shares acquired upon the exercise of a
Stock Option and not as to unexercised Stock Options.
(e) Method
of Exercise. Stock Options may be exercised in whole or in part, by giving written or electronic notice of exercise to the Company,
specifying the number of shares to be purchased. Payment of the purchase price may be made by one or more of the following methods except
to the extent otherwise provided in the Award Agreement:
(i) In
cash, by certified or bank check or other instrument acceptable to the Administrator;
(ii) Through
the delivery (or attestation to the ownership following such procedures as the Company may prescribe) of shares of Stock that are not
then subject to restrictions under any Company plan. Such surrendered shares shall be valued at Fair Market Value on the exercise date;
(iii) By
the optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly
deliver to the Company cash or a check payable and acceptable to the Company for the purchase price; provided that in the event the optionee
chooses to pay the purchase price as so provided, the optionee and the broker shall comply with such procedures and enter into such agreements
of indemnity and other agreements as the Company shall prescribe as a condition of such payment procedure; or
(iv) By
a “net exercise” arrangement pursuant to which the Company will reduce the number of shares of Stock issuable upon exercise
by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price.
7
Payment instruments
will be received subject to collection. The transfer to the optionee on the records of the Company or of the transfer agent of the shares
of Stock to be purchased pursuant to the exercise of a Stock Option will be contingent upon receipt from the optionee (or a purchaser
acting in his stead in accordance with the provisions of the Stock Option) by the Company of the full purchase price for such shares
and the fulfillment of any other requirements contained in the Award Agreement or applicable provisions of laws (including the satisfaction
of any withholding taxes that the Company is obligated to withhold with respect to the optionee). In the event an optionee chooses to
pay the purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred
to the optionee upon the exercise of the Stock Option shall be net of the number of attested shares. In the event that the Company establishes,
for itself or using the services of a third party, an automated system for the exercise of Stock Options, such as a system using an internet
website or interactive voice response, then the paperless exercise of Stock Options may be permitted through the use of such an automated
system.
SECTION 6.
STOCK APPRECIATION RIGHTS
(a) Award
of Stock Appreciation Rights. The Administrator may grant Stock Appreciation Rights under the Plan. A Stock Appreciation Right is
an Award entitling the recipient to receive shares of Stock (or cash, to the extent explicitly provided for in the applicable Award Agreement)
having a value equal to the excess of the Fair Market Value of a share of Stock on the date of exercise over the exercise price of the
Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock Appreciation Right shall have been
exercised.
(b) Exercise
Price of Stock Appreciation Rights. The exercise price of a Stock Appreciation Right shall not be less than 100 percent of the Fair
Market Value of the Stock on the date of grant.
(c) Grant
and Exercise of Stock Appreciation Rights. Stock Appreciation Rights may be granted by the Administrator independently of any Stock
Option granted pursuant to Section 5 of the Plan.
(d) Terms
and Conditions of Stock Appreciation Rights. Stock Appreciation Rights shall be subject to such terms and conditions as shall be
determined on the date of grant by the Administrator. The term of a Stock Appreciation Right may not exceed ten years. The terms and
conditions of each such Award shall be determined by the Administrator, and such terms and conditions may differ among individual Awards
and grantees.
SECTION 7.
RESTRICTED STOCK AWARDS
(a) Nature
of Restricted Stock Awards. The Administrator may grant Restricted Stock Awards under the Plan. A Restricted Stock Award is any Award
of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time of grant. Conditions
may be based on continuing employment (or other Service Relationship) and/or achievement of pre-established performance goals and objectives.
(b) Rights
as a Stockholder. Upon the grant of the Restricted Stock Award and payment of any applicable purchase price, a grantee shall have
the rights of a stockholder with respect to the voting of the Restricted Shares and receipt of dividends; provided that any dividends
paid by the Company with respect to any unvested Restricted Shares shall accrue and shall not be paid to the grantee unless and until
such Restricted Shares have vested. Unless the Administrator shall otherwise determine, (i) uncertificated Restricted Shares shall
be accompanied by a notation on the records of the Company or the transfer agent to the effect that they are subject to forfeiture until
such Restricted Shares are vested as provided in Section 7(d) below, and (ii) certificated Restricted Shares shall remain
in the possession of the Company until such Restricted Shares are vested as provided in Section 7(d) below, and the grantee
shall be required, as a condition of the grant, to deliver to the Company such instruments of transfer as the Administrator may prescribe.
8
(c) Restrictions.
Restricted Shares may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of except as specifically provided
herein or in the Restricted Stock Award Agreement. Except as may otherwise be provided by the Administrator either in the Award Agreement
or, subject to Section 15 below, in writing after the Award is issued, if a grantee’s employment (or other Service Relationship)
with the Company and its Subsidiaries terminates for any reason, any Restricted Shares that have not vested at the time of termination
shall automatically and without any requirement of notice to such grantee from or other action by or on behalf of, the Company be deemed
to have been reacquired by the Company at its original purchase price (if any) from such grantee or such grantee’s legal representative
simultaneously with such termination of employment (or other Service Relationship), and thereafter shall cease to represent any ownership
of the Company by the grantee or rights of the grantee as a stockholder. Following such deemed reacquisition of Restricted Shares that
are represented by physical certificates, a grantee shall surrender such certificates to the Company upon request without consideration.
(d) Vesting
of Restricted Shares. The Administrator at the time of grant shall specify the date or dates and/or the attainment of pre-established
performance goals, objectives and other conditions on which the non-transferability of the Restricted Shares and the Company’s
right of repurchase or forfeiture shall lapse. Subsequent to such date or dates and/or the attainment of such pre-established performance
goals, objectives and other conditions, the shares on which all restrictions have lapsed shall no longer be Restricted Shares and shall
be deemed “vested.”
SECTION 8.
RESTRICTED STOCK UNITS
(a) Nature
of Restricted Stock Units. The Administrator may grant Restricted Stock Units under the Plan. A Restricted Stock Unit is an Award
of stock units that may be settled in shares of Stock (or cash, to the extent explicitly provided for in the Award Agreement) upon the
satisfaction of such restrictions and conditions at the time of grant. Conditions may be based on continuing employment (or other Service
Relationship) and/or achievement of pre-established performance goals and objectives. The terms and conditions of each such Award shall
be determined by the Administrator, and such terms and conditions may differ among individual Awards and grantees. Except in the case
of Restricted Stock Units with a deferred settlement date that complies with Section 409A, at the end of the vesting period, the
Restricted Stock Units, to the extent vested, shall be settled in the form of shares of Stock. Restricted Stock Units with deferred settlement
dates are subject to Section 409A and shall contain such additional terms and conditions as the Administrator shall determine in
its sole discretion in order to comply with the requirements of Section 409A.
(b) Rights
as a Stockholder. A grantee shall have the rights as a stockholder only as to shares of Stock acquired by the grantee upon settlement
of Restricted Stock Units; provided, however, that the grantee may be credited with Dividend Equivalent Rights with respect to the stock
units underlying his Restricted Stock Units, subject to the provisions of Section 11 and such terms and conditions as the Administrator
may determine.
9
(c) Termination.
Except as may otherwise be provided by the Administrator either in the Award Agreement or, subject to Section 15 below, in writing
after the Award is issued, a grantee’s right in all Restricted Stock Units that have not vested shall automatically terminate upon
the grantee’s termination of employment (or cessation of Service Relationship) with the Company and its Subsidiaries for any reason.
SECTION 9.
UNRESTRICTED STOCK AWARDS
Grant
or Sale of Unrestricted Stock. The Administrator may grant (or sell at par value or such higher purchase price determined by the
Administrator) an Unrestricted Stock Award under the Plan. An Unrestricted Stock Award is an Award pursuant to which the grantee may
receive shares of Stock free of any restrictions under the Plan.
SECTION 10.
DIVIDEND EQUIVALENT RIGHTS
(a) Dividend
Equivalent Rights. The Administrator may grant Dividend Equivalent Rights under the Plan. A Dividend Equivalent Right is an Award
entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock specified in the Dividend
Equivalent Right (or other Award to which it relates) if such shares had been issued to the grantee. A Dividend Equivalent Right may
be granted hereunder to any grantee as a component of an award of Restricted Stock Units or as a freestanding award. The terms and conditions
of Dividend Equivalent Rights shall be specified in the Award Agreement. Dividend equivalents credited to the holder of a Dividend Equivalent
Right may be paid currently or may be deemed to be reinvested in additional shares of Stock, which may thereafter accrue additional equivalents.
Any such reinvestment shall be at Fair Market Value on the date of reinvestment or such other price as may then apply under a dividend
reinvestment plan sponsored by the Company, if any. Dividend Equivalent Rights may be settled in cash or shares of Stock or a combination
thereof, in a single installment or installments. A Dividend Equivalent Right granted as a component of an Award of Restricted Stock
Units shall provide that such Dividend Equivalent Right shall be settled only upon settlement or payment of, or lapse of restrictions
on, such other Award, and that such Dividend Equivalent Right shall expire or be forfeited or annulled under the same conditions as such
other Award. For the avoidance of doubt, in no event shall any Dividend Equivalent Rights be paid unless or until such Award has vested.
In no event shall any Dividend Equivalent Rights be granted as a component of a Stock Option or Stock Appreciation Right.
(b) Termination.
Except as may otherwise be provided by the Administrator either in the Award Agreement or, subject to Section 15 below, in writing
after the Award is issued, a grantee’s rights in all Dividend Equivalent Rights shall automatically terminate upon the grantee’s
termination of employment (or cessation of Service Relationship) with the Company and its Subsidiaries for any reason.
10
SECTION 11. Transferability
of Awards
(a) Transferability.
Except as provided in Section 11(b) below, during a grantee’s lifetime, his or her Awards shall be exercisable only by
the grantee, or by the grantee’s legal representative or guardian in the event of the grantee’s incapacity. No Awards shall
be sold, assigned, transferred or otherwise encumbered or disposed of by a grantee other than by will or by the laws of descent and distribution
or pursuant to a domestic relations order. No Awards shall be subject, in whole or in part, to attachment, execution, or levy of any
kind, and any purported transfer in violation hereof shall be null and void.
(b) Administrator
Action. Notwithstanding Section 11(a), the Administrator, in its discretion, may provide either in the Award Agreement regarding
a given Award or by subsequent written approval that the grantee may transfer his or her Stock Options to his or her immediate family
members, to trusts for the benefit of such family members, or to partnerships in which such family members are the only partners, provided
that the transferee agrees in writing with the Company to be bound by all of the terms and conditions of this Plan and the applicable
Award. In no event may an Award be transferred by a grantee for value.
(c) Family
Member. For purposes of Section 11(b), “family member” shall mean a grantee’s child, stepchild, grandchild,
parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law,
brother-in-law, or sister-in-law, including adoptive relationships, any person sharing the grantee’s household (other than a tenant
of the grantee), a trust in which these persons (or the grantee) have more than 50 percent of the beneficial interest, a foundation in
which these persons (or the grantee) control the management of assets, and any other entity in which these persons (or the grantee) own
more than 50 percent of the voting interests.
(d) Designation
of Beneficiary. To the extent permitted by the Company, each grantee to whom an Award has been made under the Plan may designate
a beneficiary or beneficiaries to exercise any Award or receive any payment under any Award payable on or after the grantee’s death.
Any such designation shall be on a form provided for that purpose by the Administrator and shall not be effective until received by the
Administrator. If no beneficiary has been designated by a deceased grantee, or if the designated beneficiaries have predeceased the grantee,
the beneficiary shall be the grantee’s estate.
SECTION 12.
TAX WITHHOLDING
(a) Payment
by Grantee. Each grantee shall, no later than the date as of which the value of an Award or of any Stock or other amounts received
thereunder first becomes includable in the gross income of the grantee for Federal income tax purposes, pay to the Company, or make arrangements
satisfactory to the Administrator regarding payment of, any Federal, state, or local taxes of any kind required by law to be withheld
by the Company with respect to such income. The Company and its Subsidiaries shall, to the extent permitted by law, have the right to
deduct any such taxes from any payment of any kind otherwise due to the grantee. The Company’s obligation to deliver evidence of
book entry (or stock certificates) to any grantee is subject to and conditioned on tax withholding obligations being satisfied by the
grantee.
11
(b) Payment
in Stock. The Administrator may require the Company’s tax withholding obligation to be satisfied, in whole or in part, by the
Company withholding from shares of Stock to be issued pursuant to any Award a number of shares with an aggregate Fair Market Value (as
of the date the withholding is effected) that would satisfy the withholding amount due; provided, however, that the amount withheld does
not exceed the maximum statutory tax rate or such lesser amount as is necessary to avoid liability accounting treatment. For purposes
of share withholding, the Fair Market Value of withheld shares shall be determined in the same manner as the value of Stock includible
in income of the grantees. The Administrator may also require the Company’s tax withholding obligation to be satisfied, in whole
or in part, by an arrangement whereby a certain number of shares of Stock issued pursuant to any Award are immediately sold and proceeds
from such sale are remitted to the Company in an amount that would satisfy the withholding amount due.
SECTION 13.
Section 409A awards
Awards
are intended to be exempt from Section 409A to the greatest extent possible and to otherwise comply with Section 409A. The
Plan and all Awards shall be interpreted in accordance with such intent. To the extent that any Award is determined to constitute “nonqualified
deferred compensation” within the meaning of Section 409A (a “409A Award”), the Award shall be subject to such
additional rules and requirements as specified by the Administrator from time to time in order to comply with Section 409A.
In this regard, if any amount under a 409A Award is payable upon a “separation from service” (within the meaning of Section 409A)
to a grantee who is then considered a “specified employee” (within the meaning of Section 409A), then no such payment
shall be made prior to the date that is the earlier of (i) six months and one day after the grantee’s separation from service,
or (ii) the grantee’s death, but only to the extent such delay is necessary to prevent such payment from being subject to
interest, penalties and/or additional tax imposed pursuant to Section 409A. Further, the settlement of any 409A Award may not be
accelerated except to the extent permitted by Section 409A.
SECTION 14.
TERMINATION OF SERVICE RELATIONSHIP, TRANSFER, LEAVE OF
ABSENCE, ETC.
(a) Termination
of Service Relationship. If the grantee’s Service Relationship is with an Affiliate and such Affiliate ceases to be an Affiliate,
the grantee shall be deemed to have terminated his or her Service Relationship for purposes of the Plan.
(b) For
purposes of the Plan, the following events shall not be deemed a termination of a Service Relationship:
(i) a
transfer to the employment of the Company from an Affiliate or from the Company to an Affiliate, or from one Affiliate to another; or
(ii) an
approved leave of absence for military service or sickness, or for any other purpose approved by the Company, if the employee’s
right to re-employment is guaranteed either by a statute or by contract or under the policy pursuant to which the leave of absence was
granted or if the Administrator otherwise so provides in writing.
SECTION 15.
AMENDMENTS AND TERMINATION
The
Board may, at any time, amend or discontinue the Plan and the Administrator may, at any time, amend or cancel any outstanding Award for
the purpose of satisfying changes in law or for any other lawful purpose, but no such action shall materially and adversely affect rights
under any outstanding Award without the holder’s consent. Except as provided in Section 3(b) or 3(c), without prior stockholder
approval, in no event may the Administrator exercise its discretion to reduce the exercise price of outstanding Stock Options or Stock
Appreciation Rights or effect repricing through cancellation and re-grants or cancellation of Stock Options or Stock Appreciation Rights
in exchange for cash or other Awards. Nothing in this Section 15 shall limit the Administrator’s authority to take any action
permitted pursuant to Section 3(b) or 3(c).
12
SECTION 16.
STATUS OF PLAN
With
respect to the portion of any Award that has not been exercised and any payments in cash, Stock or other consideration not received by
a grantee, a grantee shall have no rights greater than those of a general creditor of the Company unless the Administrator shall otherwise
expressly determine in connection with any Award or Awards. In its sole discretion, the Administrator may authorize the creation of trusts
or other arrangements to meet the Company’s obligations to deliver Stock or make payments with respect to Awards hereunder, provided
that the existence of such trusts or other arrangements is consistent with the foregoing sentence.
SECTION 17.
GENERAL PROVISIONS
(a) No
Distribution. The Administrator may require each person acquiring Stock pursuant to an Award to represent to and agree with the Company
in writing that such person is acquiring the shares without a view to distribution thereof.
(b) Issuance
of Stock. To the extent certificated, stock certificates to grantees under this Plan shall be deemed delivered for all purposes when
the Company or a stock transfer agent of the Company shall have mailed such certificates in the United States mail, addressed to the
grantee, at the grantee’s last known address on file with the Company. Uncertificated Stock shall be deemed delivered for all purposes
when the Company or a Stock transfer agent of the Company shall have given to the grantee by electronic mail (with proof of receipt)
or by United States mail, addressed to the grantee, at the grantee’s last known address on file with the Company, notice of issuance
and recorded the issuance in its records (which may include electronic “book entry” records). Notwithstanding anything herein
to the contrary, the Company shall not be required to issue or deliver any evidence of book entry or certificates evidencing shares of
Stock pursuant to the exercise or settlement of any Award, unless and until the Administrator has determined, with advice of counsel
(to the extent the Administrator deems such advice necessary or advisable), that the issuance and delivery is in compliance with all
applicable laws, regulations of governmental authorities and, if applicable, the requirements of any exchange on which the shares of
Stock are listed, quoted or traded. Any Stock issued pursuant to the Plan shall be subject to any stop-transfer orders and other restrictions
as the Administrator deems necessary or advisable to comply with federal, state or foreign jurisdiction, securities or other laws, rules and
quotation system on which the Stock is listed, quoted or traded. The Administrator may place legends on any Stock certificate or notations
on any book entry to reference restrictions applicable to the Stock. In addition to the terms and conditions provided herein, the Administrator
may require that an individual make such reasonable covenants, agreements, and representations as the Administrator, in its discretion,
deems necessary or advisable in order to comply with any such laws, regulations, or requirements. The Administrator shall have the right
to require any individual to comply with any timing or other restrictions with respect to the settlement or exercise of any Award, including
a window-period limitation, as may be imposed in the discretion of the Administrator.
13
(c) Stockholder
Rights. Until Stock is deemed delivered in accordance with Section 17(b), no right to vote or receive dividends or any other
rights of a stockholder will exist with respect to shares of Stock to be issued in connection with an Award, notwithstanding the exercise
of a Stock Option or any other action by the grantee with respect to an Award.
(d) Other
Compensation Arrangements; No Employment Rights. Nothing contained in this Plan shall prevent the Board from adopting other or additional
compensation arrangements, including trusts, and such arrangements may be either generally applicable or applicable only in specific
cases. The adoption of this Plan and the grant of Awards do not confer upon any employee any right to continued employment with the Company
or any Subsidiary.
(e) Trading
Policy Restrictions. Option exercises and other Awards under the Plan shall be subject to the Company’s insider trading policies
and procedures, as in effect from time to time.
(f) Clawback
Policy. Awards under the Plan shall be subject to the Company’s clawback policy, as in effect from time to time.
SECTION 18.
EFFECTIVE DATE OF PLAN
This
Plan shall become effective upon approval by the Board.
SECTION 19.
GOVERNING LAW
This
Plan and all Awards and actions taken thereunder shall be governed by, and construed in accordance with, the Commonwealth of Virginia,
applied without regard to conflict of law principles.
14
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2614189d1_ex99-1.htm · Sequence: 3
Exhibit 99.1
Collegium Completes Acquisition of AZSTARYS®
from Corium Therapeutics
– Adds Highly Complementary and Differentiated
Medicine with Significant Growth Potential to Collegium’s Existing ADHD Portfolio –
– Extends Collegium’s Long-Term
Revenue Outlook; AZSTARYS has Expected Patent Protection Through 2037 –
– Collegium Raises 2026 Financial Guidance
to Reflect Expected Immediate Accretion from Acquisition –
– 2026 Total Product Revenues, Net Expected
in the Range of $865 to $895 Million and Adjusted EBITDA in the Range of $475 to $500 Million –
STOUGHTON, Mass., May 12, 2026 -- Collegium Pharmaceutical, Inc.
(Nasdaq: COLL), today announced that it has completed the acquisition of AZSTARYS (serdexmethylphenidate and dexmethylphenidate), a central
nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people
6 years of age and older. Collegium also raised its 2026 financial guidance to include the anticipated impact of the AZSTARYS acquisition.
“We are pleased to complete the acquisition
of AZSTARYS, a highly strategic addition to our portfolio that strengthens our position in ADHD and further reinforces our long-standing
commitment to improving patient care and delivering shareholder value,” said Vikram Karnani, President and Chief Executive Officer.
“AZSTARYS is a complementary and differentiated therapy that expands the treatment options we can offer patients and prescribers,
and we look forward to rapidly integrating it into our existing commercial infrastructure. This transaction aligns with our disciplined
capital deployment approach, and we expect it to be immediately accretive, enabling us to raise our 2026 financial guidance.”
Strategic Rationale
· Strategically aligns with Collegium’s mission
of building a leading, diversified biopharmaceutical company committed to improving the lives of
people living with serious medical conditions by expanding its position in ADHD and further diversifying its commercial portfolio
beyond responsible pain management.
· Leverages Collegium’s established ADHD
commercial infrastructure and expertise to accelerate AZSTARYS’ growth trajectory and drive operational efficiencies, further strengthening
Collegium’s financial position. Annual run rate synergies expected to be in excess of $50 million within twelve months.
· Strengthens Collegium’s position in ADHD. AZSTARYS generated more than
760,000 prescriptions in 2025 and adds a complementary medicine to Collegium’s ADHD portfolio. AZSTARYS is expected to generate
$60 to $70 million of net revenue during the remainder of 2026.
· Expected to extend the longevity of Collegium’s
revenue base as AZSTARYS is supported by six Orange Book-listed patents, most of which do not expire until December 2037.
· Further strengthens Collegium’s financial
position by increasing revenues, supporting margin expansion, and enhancing future cash flow generation.
For additional background on the acquisition, please read the announcement
press release here and view Collegium’s investor presentation here.
Additional Transaction Details
Under the terms of the agreement, Collegium acquired the AZSTARYS business
from Corium Therapeutics for approximately $650 million in cash (subject to customary adjustments for net working capital, indebtedness,
cash, and transaction expenses), which was funded by approximately $350 million of Collegium’s existing cash on hand and $300 million
from a delayed draw term loan which is part of the syndicated credit facility announced by Collegium in December 2025. Collegium
may also pay Corium Therapeutics up to $135 million in additional consideration if AZSTARYS achieves certain future commercial and manufacturing
milestones.
Financial Guidance for 2026
Collegium raises its full-year 2026 financial guidance for Product Revenues,
Net, and Adjusted EBITDA, which now includes the anticipated impact of the acquisition of AZSTARYS.
Prior
Updated
Product Revenues, Net
$805 to $825 million
$865 to $895 million
JORNAY PM Revenue, Net
$190 to $200 million
Unchanged
AZSTARYS Revenue, Net
N/A
$60 to $70 million
Adjusted EBITDA
$455 to $475 million
$475 to $500 million
Leadership Updates
The Company also announced two leadership updates.
Scott Dreyer will depart from his role as Chief
Commercial Officer effective at the end of August 2026 and will remain with the Company through that time to support a smooth
transition.
In addition, Thomas Smith, M.D., will depart from his role as Chief
Medical Officer following a transition period during which the Company will conduct a search for his successor.
“I want to thank Scott and Tom for their
leadership and meaningful contributions to Collegium,” said Vikram Karnani. “Scott has played an important role in building
and scaling our commercial organization, and Tom has helped shape our medical and scientific foundation. We are grateful for their commitment
and impact.”
About Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical is a dynamic, biopharmaceutical
company delivering medicines with formulation and delivery innovation for people living with complex central nervous system and pain conditions.
Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine
what treatment looks like in categories too often shaped by complexity and misconceptions.
With a portfolio of differentiated ADHD medications,
anchored by JORNAY PM® (methylphenidate HCl) and AZSTARYS® (serdexmethylphenidate and dexmethylphenidate), and an established
leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver
treatment options around how people live their lives. For more information, please visit collegiumpharma.com or find
us on LinkedIn.
Non-GAAP Financial Measures
To supplement our financial results presented
on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP
financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide analysts, investors, lenders,
and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from
operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In addition, certain non-GAAP financial measures,
primarily adjusted EBITDA, are used to measure performance when determining components of annual compensation for substantially all non-sales
force employees, including senior management.
In this press release we discuss the following financial measures that
are not calculated in accordance with GAAP.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure
that represents GAAP net income 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.
There are several limitations related to the use
of adjusted EBITDA rather than net income 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;
· adjusted EBITDA does not reflect changes in, or cash requirements for, working
capital needs;
· 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 stock-based compensation expense from adjusted EBITDA 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; and (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;
· we exclude impairment expenses from adjusted EBITDA and, although these are
non-cash expenses, the 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 and contingencies that are subject to recovery
from adjusted EBITDA, as well as any applicable income items, credit adjustments, or recoveries 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, legal defense expenses for specific acquired claims
that relate to acts that occurred prior to our 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;
· we exclude changes in the fair value of contingent consideration, which are
non-cash, acquisition-related items that are not part of our underlying business;
· 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;
· we exclude executive transition expenses from adjusted EBITDA as the amount
and/or frequency of these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing
basis; and
· we exclude other expenses, from time to time, that are episodic in nature
and do not directly correlate to the cost of operating our business on an ongoing basis.
The Company has not provided a reconciliation
of its full-year 2026 guidance for adjusted EBITDA to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable
efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable
efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation
expense, acquisition related expenses, amortization of acquired intangible assets, and changes in fair value of contingent consideration.
These items are uncertain and depend on various factors that are outside of the Company’s control or cannot be reasonably predicted.
While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income
and operating expenses for the guidance period. A reconciliation of adjusted EBITDA would imply a degree of precision and certainty as
to these future items that does not exist and could be confusing to investors.
Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may,
in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, projected
financial performance, including expected revenue and adjusted EBITDA; statements related to the anticipated benefits of the acquisition
of AZSTARYS, including its impact on Collegium’s ADHD portfolio and commercial strategy;
statements related to current and future market opportunities for our products and our assumptions related thereto and other statements
that are not historic facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual
events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating
to, among others: our ability to realize the anticipated benefits of the AZSTARYS acquisition, including the possibility that the expected
benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses
will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships;
negative effects of this announcement or the consummation of the acquisition on the market price of our common stock and/or operating
results; significant transaction costs or the acquisition of unknown liabilities; potential litigation related to the acquisition; future
opportunities and plans for AZSTARYS, including uncertainty of the expected financial performance
of AZSTARYS; future opportunities and plans for our products, including uncertainty of the
expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our
relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval
of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for
our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products;
the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution;
changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against
us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical
ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding
for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain
and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign
government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer
concentration; and the accuracy of our estimates regarding expenses, revenues, capital requirements and need for additional financing.
These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly
Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this press release.
About AZSTARYS®
AZSTARYS is a central nervous
system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a
higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: ABUSE, MISUSE, AND ADDICTION
See full prescribing information for complete
boxed warning.
AZSTARYS has a high potential for abuse, misuse, which can lead
to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result
in overdose and death.
– Before prescribing, assess
each patient’s risk for abuse, misuse, and addiction.
– Educate patients and
families about risks, proper storage, and proper disposal of any unused drug.
– Frequently monitor for
signs and symptoms of abuse, misuse, and addiction throughout treatment.
CONTRAINDICATIONS
· Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product
components.
· Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of
an MAOI within the preceding 14 days.
WARNINGS AND PRECAUTIONS
· Risks to patients with serious cardiac disease: Avoid use in patients with
known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac
disease.
· Increased blood pressure and heart rate: Monitor blood pressure and pulse.
· Psychiatric adverse reactions: Prior to initiating AZSTARYS, screen patients
for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing AZSTARYS
· Priapism: If abnormally sustained or frequent and painful erections occur,
patients should seek immediate medical attention.
· Peripheral vasculopathy, including Raynaud's Phenomenon: Careful observation
for digital changes is necessary during AZSTARYS treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral)
may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6)
· Long-term suppression of growth in pediatric patients: Monitor height and
weight at appropriate intervals in pediatric patients.
· Acute angle closure glaucoma: AZSTARYS-treated patients considered at risk
for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
· Increased intraocular pressure (IOP) and glaucoma: Prescribe AZSTARYS to
patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely
monitor patients with a history of increased IOP or open angle glaucoma.
· Motor and verbal tics, and worsening of Tourette’s syndrome: Before
initiating AZSTARYS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor
patients for the emergence or worsening of tics or Tourette’s syndrome.
· Discontinue treatment if clinically appropriate.
ADVERSE REACTIONS
· The most common adverse reactions (≥5% and twice the rate of placebo)
include decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability,
dizziness, increased blood pressure, and tachycardia.
DRUG INTERACTIONS
· Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive
drug as needed
Please visit https://www.corium.com/products/AZSTARYS/AZSTARYS_PI_ENGLISH_US.pdf for
additional important safety information and the Full Prescribing Information, including Boxed Warning, for AZSTARYS.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Investor Contacts:
Ian Karp
Head of Investor Relations
ir@collegiumpharma.com
Danielle Jesse
Director, Investor Relations
ir@collegiumpharma.com
Media Contact:
Jessica Cotrone
Senior Vice President, Communications & Corporate Affairs
communications@collegiumpharma.com
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