Supernus Pharmaceuticals : 2023 Annual Report

Dear Supernus Stockholder,

We are very pleased with our performance in 2023 as we continued to successfully transition from our mature brands and set the stage to deliver growth in 2025 and beyond. Supernus finished the year in a position of strength with both Qelbree® and GOCOVRI®-our two growth products-achieving record sales with strong prescription growth. Our performance underscored our strong execution and emphasis on growing our revenue base despite the loss of exclusivity on Trokendi XR®. I am very proud of what the Supernus team continues to accomplish scientifically, commercially, and operationally putting Supernus in the best possible position to execute on a successful transition.

Excluding Trokendi XR, Supernus delivered strong growth of 26% in total revenues in 2023 compared to 2022. Specifically, our growth products, Qelbree and GOCOVRI, delivered robust 57% growth in combined net sales compared to 2022. In addition, combined full year 2023 net sales for Qelbree and GOCOVRI reached approximately $260 million, which significantly exceeded the $167 million decline in net sales of Trokendi XR. As a result of our emphasis on growing the rest of our portfolio throughout 2023, we were able to significantly mitigate the impact of reduced net product sales of Trokendi XR, with its net product sales representing less than 13% of total revenues during the last quarter of 2023.

In 2023, the Company held an R&D Day sharing an overview of its emerging CNS pipeline of novel product candidates and highlighting an exciting pipeline of new chemical entities, some of which are first-in- class mechanisms of action to treat multiple therapeutic areas in CNS. These product candidates include SPN-820 that is currently in Phase IIb for the treatment of depression, and SPN-817 that is in Phase IIa for the treatment of epilepsy.

Qelbree®-A Novel Non-Stimulant ADHD Product

2023 represented the first full year with both the pediatric and adult indications for Qelbree. We launched Qelbree in 2021 with the pediatric indication and expanded the market opportunity by launching in 2022 with the adult indication. As a well-differentiated product that is a non-controlled medication, Qelbree provides a novel and unique treatment option for the millions of patients who suffer from ADHD. Qelbree addresses a multi-billion-dollar market opportunity between pediatrics and adults and continues to show great potential to grow in both segments.

For full year 2023, Qelbree's prescriptions as reported by IQVIA increased 91% compared to 2022, while net sales recorded an even stronger growth rate of 129% benefiting from the prescription growth and the steady improvement in gross to net throughout the year. In 2024, we will be placing more emphasis on the adult segment that represents approximately 67% of the total ADHD market. We expect the ADHD market to have a prescription growth rate in line with the 3% growth rate it had in 2023 when it reached an all- time high of 93.4 million annual prescriptions.

Additional Highlights and Achievements in 2023

We continue to be pleased with the performance of GOCOVRI based on its unique position in the marketplace treating both off episodes and dyskinesia. In 2023, prescriptions increased by 10% compared to 2022 and net sales increased by 15% reaching a record of $120 million. Oxtellar XR® and APOKYN® net sales were $113 million and $75 million, respectively for full year 2023, essentially stable compared to 2022. In addition, we look forward to working with the U.S. Food and Drug Administration in 2024 to address the Complete Response Letter we received in April 2024 and to successfully resubmit the New Drug Application (NDA) for SPN-830, our investigational apomorphine infusion device for the continuous treatment of motor fluctuations ("off " episodes) in Parkinson's disease (PD). SPN-830 represents a third potential future growth driver for the Company.

2024 Key Milestones

We finished 2023 in a position of strength with both Qelbree and GOCOVRI achieving record sales with strong prescription growth. We believe we are well positioned for continued growth beyond the current transition and are focused on three key strategic areas:

• Driving significant growth with Qelbree and GOCOVRI, and together with the rest of the portfolio, generating strong cash flow allowing us to continue our investments in our pipeline.
• Working towards resubmission of the NDA for SPN-830.
• Advancing our innovative R&D portfolio of differentiated, first-in-class molecules that has several exciting and upcoming clinical milestones.

We will also continue to be active in looking for strategic opportunities in corporate development with the goal of further strengthening our future growth and leadership position in CNS. This includes in-licensing products, co-development partnerships for novel pipeline products and growth opportunities through value- creating and transformative merger and acquisition transactions.

2023 was an important year for Supernus, with significant corporate achievements that will prepare us for the next step as a growth company. We look forward to driving growth behind Qelbree, GOCOVRI and our pipeline products, and successfully managing our transition away from our legacy products.

I would like to thank our stockholders for their continued support and our employees for their hard work and dedication to improving the health of our patients.

Sincerely,

Jack A. Khattar,

President & Chief Executive Officer of

Supernus Pharmaceuticals, Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

• ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

FOR THE FISCAL YEAR ENDED December 31, 2023

or

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

	FOR THE TRANSITION PERIOD FROM			TO
		COMMISSION FILE NUMBER: 001-35518
	SUPERNUS PHARMACEUTICALS, INC.
		(Exact name of registrant as specified in its charter)
	Delaware								20-2590184
	(State or other jurisdiction of								(I.R.S. Employer
	incorporation or organization)								Identification Number)
9715 Key West Avenue Rockville MD	[phone]				20850
	(Address of Principal			(Registrant's telephone number,	(zip code)
	Executive Offices)			including area code)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
				Outstanding at	Trading	NAME OF EACH EXCHANGE ON
	TITLE OF EACH CLASS:			February 20, 2024			Symbol		WHICH REGISTERED:
	Common Stock, $0.001 Par Value	54,734,956			SUPN	NASDAQ Stock Market LLC

SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

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, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):

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. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☒ No ☐

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

As of June 30, 2023, the aggregate market value of the common stock held by non-affiliates of the registrant based on the closing price of the common stock on the NASDAQ Global Market was $1,639,709,489.

DOCUMENTS INCORPORATED BY REFERENCE

Certain portions of the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders, which will be filed with the Securities and Exchange Commission not later than 120 days after the end of the registrant's 2023 fiscal year end, are incorporated by reference into Part III of this Annual Report on Form 10-K.

	SUPERNUS PHARMACEUTICALS, INC.
	FORM 10-K
	For the Year Ended December 31, 2023
	TABLE OF CONTENTS
		Page
	PART I
Item 1.	Business	4
Item 1A.	Risk Factors	31
Item 1B.	Unresolved Staff Comments	74
Item 1C.	Cybersecurity	74
Item 2.	Properties	76
Item 3.	Legal Proceedings	76
Item 4.	Mine Safety Disclosures	85
	PART II
Item 5.	Market For Registrant's Common Equity, Related Stockholder Matters and Issuer
	Purchase of Equity Securities	86
Item 6.	Reserved	87
Item 7.	Management's Discussion and Analysis of Financial Condition and Results of
	Operations	88
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	101
Item 8.	Financial Statements and Supplementary Data	103
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial
	Disclosure	148
Item 9A.	Controls and Procedures	148
Item 9B.	Other Information	149
	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	150
Item 11.	Executive Compensation	150
Item 12.	Security Ownership of Certain Owners and Management and Related Stockholder
	Matters	150
Item 13.	Certain Relationships and Related Transactions, and Director Independence	150
Item 14.	Principal Accounting Fees and Services	150
	PART IV
Item 15.	Exhibits, Financial Statement Schedules	151
Item 16.	Form 10-K Summary	151
	SIGNATURES	157

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Unless the content requires otherwise, the words "Supernus," "we," "our" and "the Company" refer to Supernus Pharmaceuticals, Inc. and/or one or more of its subsidiaries, as the case may be. These terms are used solely for the convenience of the reader. Supernus Pharmaceuticals, Inc. and each of its subsidiaries are distinct legal entities. For example, MDD US Operations, LLC, a wholly-owned indirect subsidiary of Supernus Pharmaceuticals, Inc., is the exclusive licensee and distributor of APOKYN in the United States and its territories. Adamas Operations, LLC ("Adamas Operations"), a wholly-owned indirect subsidiary of Supernus Pharmaceuticals, Inc., wholly owns the patents and patent applications related to GOCOVRI and Osmolex ER and has a license agreement with Supernus Pharmaceuticals, Inc., granting Supernus Pharmaceuticals, Inc. rights to market and sell GOCOVRI and Osmolex ER.

We, including our subsidiaries, are the owner/licensee of various U.S. federal trademark registrations (®) and registration applications (™), including the following marks referred to in this Annual Report on Form 10-K, pursuant to applicable U.S. intellectual property laws: "Supernus®", "Microtrol®", "Solutrol®", "Trokendi XR®", "Oxtellar XR®", "Qelbree®", "XADAGO®", "MYOBLOC®", "APOKYN®", "GOCOVRI®", "Osmolex ER®", "Namzaric®", and the registered Supernus Pharmaceuticals logo.

All trademarks or trade names referred to in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report on Form 10-K are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

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PART I

This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Securities Exchange Act of 1934 and the Securities Act of 1933 that involve risks and uncertainties. Forward-looking statements convey our current expectations or forecasts of future events. All statements contained in this Annual Report other than statements of historical fact are forward-looking statements. Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans, and objectives of management for future operations. The words "may," "continue," "estimate," "intend," "plan," "will," "believe," "project," "expect," "seek," "anticipate," "should," "could," "would," "potential," or the negative of those terms and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking.

These forward-looking statements include expectations regarding the Company's recent and future interactions and communications with the U.S. Food and Drug Administration (FDA) concerning the New Drug Applications (NDA) for SPN-830, the outcome of any additional device testing associated with the SPN-830 NDA submission, the potential approval of SPN-830 following resubmission, and the potential benefits and commercialization of SPN-830. In addition to the factors mentioned in this annual report, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy, including the successful identification and implementation of business development opportunities; the Company's future financial performance and projected expenditures; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its products and product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the early entry into the market of generic equivalents to all the Company's approved products; the Company's ability to develop successful product formulations that are accepted by patients, physicians, and payors; availability of potential funding sources; the Company's ability to meet its staffing needs; the Company's ability to comply with the Corporate Integrity Agreement and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended.

You should not place undue reliance on these forward-looking statements, which speak only as of the date of this report. All of these forward-looking statements are based on information available to us at this time, and we assume no obligation to update any of these statements. Actual results could differ from those projected in these forward-looking statements as a result of many factors, including those identified in the "Business," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections, and elsewhere in this Annual Report on Form 10-K. We urge you to review and consider the various disclosures made by us in this report and those detailed from time to time in our filings with the Securities and Exchange Commission that attempt to advise you of the risks and factors that may affect our future results.

ITEM 1. BUSINESS.

Overview

Supernus Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. The Company is developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.

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The Company was incorporated in Delaware, commenced operations in 2005, became publicly traded in 2012, and is listed on the NASDAQ Stock Exchange under the ticker symbol SUPN. Our principal executive offices are located in Rockville, Maryland. Our extensive expertise in product development has been built over the past 30 years: initially as a stand-alone development organization; then, as a United States (U.S.) subsidiary of Shire Plc (Shire, a subsidiary of Takeda Pharmaceutical Company Ltd.); then upon our acquisition of substantially all of the assets of Shire Laboratories, Inc. in 2005, as Supernus Pharmaceuticals.

Our Strategy

Our mission is to improve the lives of patients suffering from CNS diseases. Our vision is to be a leader in the CNS industry by developing and commercializing new medicines for the treatment of CNS diseases. Key elements of our strategy to achieve this vision include:

• Drive growth and profitability. Using dedicated sales and marketing resources in the U.S., we will continue to drive the revenue growth of our marketed products.
• Advance product candidates toward commercialization. Several product candidates in our pipeline are in early-to-latestage clinical testing, and moving toward being commercially available to patients.
• Continue to grow our pipeline. We will continue to evaluate and develop additional CNS product candidates that we believe have significant commercial potential through our internal research and development efforts.
• Target strategic business development opportunities. We are actively exploring a broad range of strategic opportunities. This includes in-licensingproducts and entering into co-promotionand co- development partnerships for our commercial products and product candidates.

Commercial Products

Our commercial products, including those sold by or through our subsidiaries, include:

Qelbree®

Qelbree (viloxazine extended-release capsules) is a novel non-stimulant product indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. On April 2, 2021, the FDA approved Qelbree for the treatment of ADHD in pediatric patients 6 to 17 years of age. In May 2021, the Company launched Qelbree for pediatric patients in the U.S. On April 29, 2022, the FDA approved Qelbree for treatment of ADHD in adult patients. The Company launched Qelbree for adult patients in May 2022.

GOCOVRI®

GOCOVRI (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing "off " episodes.

GOCOVRI was approved by the FDA in August 2017 for treatment of dyskinesia and in February 2021 as an adjunctive treatment for "off" episodes. The February 2021 update to the label indication makes GOCOVRI the only medicine clinically proven and approved to reduce both "off " episodes and dyskinesia in PD patients taking a levodopa-based medication, resulting in a clinically meaningful increase in good "on" time without the need for a "trade-off' when managing these motor complications.

GOCOVRI has been granted orphan drug exclusivity until August 24, 2024 for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy with or without concomitant dopaminergic medications.

Oxtellar XR®

Oxtellar XR is indicated for treatment of partial-onset seizure in adults and children 6 years of age and older. Oxtellar XR is the first once-dailyextended-release oxcarbazepine product indicated for the treatment of epilepsy in the U.S. market. In 2013, we launched Oxtellar XR for adjunctive therapy in the treatment

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of partial-onset seizures in adults and children 6 to 17 years of age. In January 2019, we launched Oxtellar XR for monotherapy treatment of partial onset epilepsy seizures in adults and children 6 to 17 years of age.

The Company has entered into settlement and license agreements with third parties permitting the sale of a generic version of Oxtellar XR beginning in September 2024, or sooner under certain conditions, and entitling the Company to receive royalties on those sales. For more information, refer to Part I, Item I- Business-IntellectualProperty and Exclusivity in this annual Report on Form 10-K.

Trokendi XR®

Trokendi XR is indicated for (1) epilepsy: initial monotherapy for the treatment of partial-onset and primary generalized tonic-clonic (PGTC) seizure in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 6 years of age and older (1.2); and for (2) preventive treatment of migraine in patients 12 years of age and older. Trokendi XR is the first once-dailyextended-release topiramate product indicated for the treatment of epilepsy and the prophylaxis of migraine headaches in adults and adolescents in the U.S. market.

The Company entered into settlement agreements with third parties permitting the sale of a generic version of Trokendi XR beginning in January 2023 and entitling the Company to receive royalties on those sales. For more information, refer to Part I, Item I-Business-IntellectualProperty and Exclusivity in this annual Report on Form 10-K.

APOKYN®

APOKYN (apomorphine hydrochloride injection) is a product indicated for the acute, intermittent treatment of hypomobility or "off " episodes ("end-of-dose wearing off " and unpredictable "on-off " episodes) in patients with advanced PD. APOKYN's adjustable dose subcutaneous injection pen is designed to quickly and reliably reverse the effects of oral levodopa wearing off in patients with inadequately controlled PD.

XADAGO®

XADAGO (safinamide) is a once-daily product indicated as adjunctive treatment to levodopa/carbidopa in patients with PD who are experiencing "off " episodes. XADAGO is a monoamine oxidase B (MAO-B) inhibitor that works by blocking the catabolism of dopamine, which is believed to result in an increase in dopamine levels, and therefore a subsequent increase in dopaminergic activity in the brain. XADAGO was approved by the FDA in March 2017.

The Company has entered into settlement agreements with third parties permitting the sale of a generic version of XADAGO beginning in December 2027, or sooner under certain conditions. For more information, refer to Part I, Item I-Business-IntellectualProperty and Exclusivity in this annual Report on Form 10-K.

MYOBLOC®

MYOBLOC (rimabotulinumtoxinB) is a product indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults and treatment of chronic sialorrhea in adults. MYOBLOC is the only Type B toxin available on the market. MYOBLOC injections must be administered by a physician.

MYOBLOC was approved by the FDA in August 2019 for the treatment of chronic sialorrhea in adults and in December 2000 for the treatment of adults with cervical dystonia.

Osmolex ER®

Osmolex ER (amantadine) extended-release tablets is for the treatment of PD and drug-induced extrapyramidal reactions in adult patients. Osmolex ER was approved by the FDA in February 2018.

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In December 2023, the Company submitted to the FDA a notification of discontinuance to withdraw Osmolex ER from distribution, stating that manufacturing has been discontinued and distribution of the product will cease by April 1, 2024.

Research and Development

We are committed to the development of innovative product candidates in neurology and psychiatry, including the following:

We also engage in a variety of additional research and development efforts including development of a pipeline of novel CNS product candidates for the treatment of various CNS conditions. We have devoted and continue to devote significant resources to research and development activities. We expect to incur significant expenses as we continue developing each of our product candidates through FDA approval or until the program terminates; and expanding product indications for approved products and our intellectual property portfolio. Our expectations regarding our research and development programs are subject to the risks described under Item 1A-Risk Factors-RisksRelated to Our Industry and Business, which includes the risk that the Company's financial condition and results of operations for fiscal year 2023 and beyond may be materially and adversely affected by delays and failures in the completion of clinical development of our product candidates, which could increase our costs or delay or limit our ability to generate revenues.

SPN-830 (apomorphine infusion device)

SPN-830 is a late-stage drug/device combination product candidate for the continuous treatment of motor fluctuations ("off " episodes) in PD patients that are not adequately controlled with oral levodopa and one or more adjunct PD medications. If approved, it would be the only continuous infusion of apomorphine available in the U.S. and an important step for PD patients that would have otherwise been candidates for potentially invasive surgical procedures, such as deep brain stimulation. Continuous slow infusion may also limit some of the side effects of a bolus injection of apomorphine.

In December 2021, we resubmitted the NDA to the FDA. In February 2022, we received a notice from the FDA that the resubmission of the NDA for SPN-830 was considered as a Standard Review and was assigned a PDUFA target action date in early October 2022. In October 2022, the FDA issued a Complete Response Letter (CRL) regarding the NDA for SPN-830. In February 2023, the FDA granted the Company a

Type C meeting request to discuss the CRL with the meeting scheduled in April 2023. In October 2023, we resubmitted the NDA for SPN-830. In November 2023, the FDA accepted the resubmission of the NDA for SPN-830. The resubmission is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.

SPN-820(NV-5138)

SPN-820 is a first-in-class, orally active small molecule that activates the brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal. SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1.

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The mTORC1 activity governs the pace and ability of the cell to synthesize protein and other cellular components. This complex may be suppressed in people suffering from depression. In other disease states such as severe depression, inadequate mTORC1 activity contributes to disease pathology by limiting energy utilization and protein synthesis, leading to impaired function. Multiple preclinical studies have shown that mTORC1 activation is required for the efficacy of many rapid-acting antidepressant compounds, including but not limited to modulators of the N-methyl-D-aspartic-acid(NMDA)-mediated signaling pathway like ketamine.

A Phase I trial demonstrated early proof of concept in which a single dose of SPN-820 showed a rapid and sustained improvement in core symptoms, with favorable safety and tolerability in patients with treatment resistant depression. We believe the novel mechanism of action (MOA) in depression may improve symptoms of depression in patients who have failed other agents.

An Investigational New Drug (IND) application was submitted to the FDA in September 2021. We initiated a Phase II multi-center, randomized double-blindplacebo-controlled parallel design study of SPN-820 in adults with treatment resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale. Additionally, we initiated a Phase II multi-center open label study in 40 subjects with Major Depressive Disorder (MDD) in the fourth quarter of 2023. The study will evaluate the efficacy of SPN-820 in MDD, with the change from baseline in the Hamilton Depression Rating scale-6(HAM-D6) total score as the primary efficacy assessment.

SPN-817 (huperzine A)

SPN-817 represents a novel MOA for an anticonvulsant. SPN-817 is a novel synthetic form of

huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy. The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome. SPN-817 has received Orphan Drug designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA.

We are focused on completing and optimizing the synthesis process of the synthetic drug as well as developing a novel dosage form. Given the potency of SPN-817 (huperzine A), a novel extended-release oral dosage form is critical to the success of this program because initial studies with the immediate-release formulations of non-syntheticSPN-817 (huperzine A) have shown serious dose-limiting, side effects.

We have commenced an open-label Phase IIa clinical study of SPN-817 in patients with treatment-resistant seizures.

SPN-443-Novel stimulant for the treatment of ADHD/CNS

We plan to initiate a Phase 1 single dose study in healthy adults in 2024 following submission of an Investigational New Drug Application. The primary objective of the study is to assess the safety and tolerability. This molecule, along with its major metabolites, is an inhibitor of norepinephrine, dopamine and serotonin, also known as a triple reuptake inhibitor.

Sales and Marketing

We market our products through our own sales forces in the U.S. and seek strategic collaborations with other pharmaceutical companies to commercialize our products outside of the U.S. We have a commercial sales and marketing organization in the U.S. to support sales of our commercial products. We believe our current sales forces are effectively targeting healthcare providers to support and grow our current commercial products.

As a result of the acquisitions in 2021 and 2020, we established our commercial capabilities in the Parkinson's area with a focus on serving movement disorder specialists and other specialized health care providers in the U.S.

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