8-K

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 7, 2021

Flexion Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-36287	26-1388364
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
10 Mall Road, Suite 301 Burlington, Massachusetts		01803
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (781) 305-7777

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:

☐	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))

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	FLXN	The Nasdaq Global Market

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 2.02 Results of Operations and Financial Condition.

On May 12, 2021, Flexion Therapeutics, Inc. (“Flexion”) issued a press release announcing its financial results for the quarter ended March 31, 2021, and made available on its corporate website a presentation of certain additional operating results. Copies of the press release and presentation are attached hereto as Exhibits 99.1 and 99.2, respectively.

The information in this Item 2.02 and Exhibits 99.1 and 99.2 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(b)On May 7, 2021, David Arkowitz informed us of his intention to resign his employment. Mr. Arkowitz’s last day of employment is expected to be May 31, 2021.

(c)On May 12, 2021, the Board of Directors of Flexion (the “Board”) appointed Frederick W. Driscoll as Chief Financial Officer, principal financial officer, and principal accounting officer, effective upon the termination of Mr. Arkowitz’s employment with Flexion.

Mr. Driscoll, age 70, served as Chief Financial Officer of Flexion from 2013 to 2017. Prior to joining Flexion in 2013, Mr. Driscoll served as Chief Financial Officer at Novavax, Inc., a publicly traded biopharmaceutical company, starting in 2009; Chief Executive Officer at Genelabs Technologies, Inc., a publicly traded biopharmaceutical and diagnostics company, from 2008 to 2009, and as its Chief Financial Officer from 2007 to 2008; Chief Financial Officer at Astraris, Inc., a private biotechnology company, from 2006 to 2007; and Chief Executive Officer at OXiGENE, Inc., a biopharmaceutical company, from 2002 to 2006. Mr. Driscoll earned a bachelor’s degree in accounting and finance from Bentley University.

There are no arrangements or understandings between Mr. Driscoll and any other person pursuant to which he was appointed as an officer of Flexion, and there is no family relationship between Mr. Driscoll and any of Flexion’s directors or executive officers.

Employment Terms for Mr. Driscoll

In connection with his appointment as Chief Financial Officer, Mr. Driscoll is expected to enter into an employment agreement with Flexion based on terms approved by the Board. Per these terms, Mr. Driscoll would be initially entitled to receive an annual base salary of $445,000 and an annual bonus of up to 45% of his annual base salary (pro-rated for 2021) based upon the Board’s assessment of Flexion’s attainment of targeted goals in the Board’s sole discretion. As approved by the Board, Mr. Driscoll would be awarded an option to purchase 168,000 shares of Flexion’s common stock and a restricted stock unit award covering 28,000 shares of common stock pursuant to Flexion’s 2013 Equity Incentive Plan. With respect to the option shares, 25% would vest on the first anniversary of Mr. Driscoll’s start date, with the remainder vesting in 36 equal monthly installments thereafter, subject to Mr. Driscoll’s continued service. With respect to the restricted stock unit award, 25% of the shares would vest on each one-year anniversary of Mr. Driscoll’s employment commencement date, such that all of the shares subject to the restricted stock unit award would be fully vested four years from that commencement date, subject to Mr. Driscoll’s continued service. It is expected that, pursuant to his employment agreement, Mr. Driscoll would be entitled to severance benefits and other payments upon the occurrence of certain events. Mr. Driscoll is also expected to enter into Flexion’s standard form of proprietary information, inventions, non-solicitation and non-competition agreement, as well as Flexion’s standard form of indemnity agreement for directors and officers.

The foregoing summary of Mr. Driscoll’s employment terms does not purport to be complete and is qualified in its entirety by reference to a complete employment agreement to be entered into by Mr. Driscoll and Flexion, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to Flexion’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are forward-looking statements, including, but not limited to, statements relating to Mr. Driscoll’s potential employment by, and entry into an employment agreement with, Flexion. These forward-looking statements are based on management’s expectations and assumptions as of the date of this report and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the risk that Mr. Driscoll and Flexion may not agree to additional terms relating to his employment, as well as other risks and uncertainties described in Flexion’s filings with the SEC, including under the heading “Risk Factors” in Flexion’s Annual Report on Form 10-K for the quarter and year

1

ended December 31, 2020, filed with the SEC on March 10, 2021, and subsequent filings with the SEC. There can be no assurance that Flexion will sell any Shares under the Distribution Agreement on the anticipated terms, or at all. The forward-looking statements in this Current Report on Form 8-K speak only as of the date hereof, and Flexion undertakes no obligation to update or revise any of the statements. Flexion cautions investors not to place considerable reliance on the forward-looking statements contained in this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit Number	Description
99.1	Press Release of Flexion Therapeutics, Inc. dated May 12, 2021
99.2	Presentation of Flexion Therapeutics, Inc. dated May 12, 2021
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

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

	Flexion Therapeutics, Inc.
Date: May 12, 2021	By:	/s/ Mark S. Levine
		Mark S. Levine
		General Counsel and Corporate Secretary

3

EX-99.1

Exhibit 99.1

Flexion Therapeutics Reports First-Quarter 2021 Financial Results and Recent Business Updates

• Flexion reported ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension) net sales of $24.6 million

• David Arkowitz, CFO, stepping down effective May 31,2021, and will be succeeded by Fred Driscoll

• New data presented at ASGCT indicate the low dose of FX201 provided durable pain improvement for two patients with knee OA out to Week 52

• Conference call scheduled for today at 4:30 p.m. ET

BURLINGTON, Mass., May 12, 2021 – Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended March 31, 2021.

“The first quarter of 2021 was marked by solid ZILRETTA sales and important progress with both FX201 and FX301, our exciting investigational drug candidates,” said Michael Clayman, M.D., President and Chief Executive Officer. “While COVID-19 continues to weigh on the nation, broad availability of vaccines and dropping infection rates, combined with our laser-like focus on commercial execution, reinforce our confidence in our ability to deliver full-year net sales in the range of $120 million to $130 million.”

Dr. Clayman added, “Today we announced that David Arkowitz, CFO, will be leaving the company at the end of the month to pursue other opportunities. While David’s leadership will be missed, I am particularly pleased to report that Fred Driscoll will be returning as CFO. Fred is uniquely qualified for this important role having served as Flexion’s CFO from IPO through the approval and launch of ZILRETTA. It is a pleasure to welcome him back to Flexion.”

First-Quarter Results & Financial Highlights

The Company reported a net loss of $28.6 million for the first quarter of 2021, compared to a net loss of $36.8 million for the same period of 2020. Net sales of ZILRETTA were $24.6 million and $20.1 million for the three months ended March 31, 2021 and 2020, respectively. Cost of sales was $6.1 million and $2.3 million for the three months ended March 31, 2021 and 2020, respectively.

Research and development expenses were $14.0 million and $21.1 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $7.1 million was primarily due to a decrease of $3.6 million in development expenses for ZILRETTA due to a reduction in ZILRETTA lifecycle management activities, a decrease of $2.2 million related to FX201 program costs, which is largely due to the $2.5 million milestone payment related to dosing the first human patient in the Phase 1 clinical trial, which occurred in the first quarter of 2020, as well as a decrease of $3.4 million in salary and other employee-related costs and stock-based compensation expense related to lower headcount. Decreases were partially offset by an increase of $2.4 million in expenses related to FX301, due to the achievement of certain development milestones, including the clearing of the IND by the U.S. Food and Drug Administration (FDA) and the initiation of the Phase 1b clinical trial, both of which occurred in the first quarter of 2021.

Selling, general and administrative expenses were $27.6million and $29.3million for the three months ended March31, 2021 and 2020, respectively. Selling expenses were $19.1million and $20.5million for the three months ended March31, 2021 and 2020, respectively. The year-over-year decrease in selling expenses of $1.4million was primarily due to the fact that the majority of industry conferences and physician speaker programs remained virtual due to COVID-19, and, although more physician offices are opening, business travel remains low compared to pre-pandemic levels. General and administrative expenses were $8.5million and $8.8million for the three months ended March31, 2021 and 2020, respectively, which represents a decrease of $0.3million.

Interest income was $0.3 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. Interest expense was $5.2 million and $4.7 million for the three months ended March 31, 2021 and 2020, respectively.

The Company anticipates 2021 full-year ZILRETTA net sales in the range of $120 million to $130 million. In addition, total operating expenses, including cost of sales, research and development expenses, and selling, general and administrative expenses, are anticipated in the range of $195 million to $205 million. As of March 31, 2021, the Company had $154.3million in cash, cash equivalents and marketable securities compared with $175.3 million as of December 31, 2020.

ZILRETTA Commercial Metrics

Today, Flexion introduced updated commercial metrics to provide increased visibility and insights into the commercial performance of ZILRETTA. In the first quarter of 2021:

• 2,044 accounts purchased ZILRETTA

• 90% of accounts that purchased ZILRETTA had purchased ZILRETTA in a prior quarter

• Total account purchases grew by 6% over the fourth quarter of 2020

• Approximately 38% of ZILRETTA purchases came from accounts purchasing more than 100 units

FX201 ASGCT Data and Clinical Trial Update

On May 11, Flexion presented preliminary FX201 data at the 2021 American Society of Gene & Cell Therapy (ASGCT) annual meeting (Abstract/Presentation #594). Key findings from the Phase 1 dose-escalation study evaluating the safety and tolerability of FX201 in patients with knee osteoarthritis (OA) pain include:

• FX201 was generally well-tolerated in the initial low-dose cohort (1.4E10 genome copies of FX201), and all five patients remain in the study at 38 to 56 weeks post-treatment.

o Two patients had self-limited Grade 2 index-knee adverse events (pain, swelling, effusion) possibly related to treatment; these were managed conservatively.

• No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or in swab samples from the injection site was observed in any patient.

• Improvement in WOMAC-A pain from baseline was observed in four of the five patients at Week 12 and 24 and in two of the three patients with Week 52 data.

• In a responder analysis based on IMMPACT criteria, two out of the five patients demonstrated substantial improvement in knee OA pain at Weeks 8, 12 and 24 following treatment with FX201.

o One of the three patients with data available at Week 52 continued to demonstrate substantial improvement in pain.

• Functional improvement from baseline assessed by the KOOS questionnaire was observed in four of the five patients at Week 24, and all three patients with Week 52 data reported an improved KOOS score compared to baseline at Week 52.

In May, one participant in the high-dose cohort experienced gastrointestinal bleeding and atrial fibrillation, which required hospitalization. An adverse event resulting in hospitalization is deemed serious; however, the investigator determined it to be unrelated to the study drug. As dictated by the protocol, any serious adverse event (SAE), regardless of relatedness, requires a pause in study enrollment, followed by a review of the event by the independent Data Monitoring Committee (DMC) for the study and FDA. Both the DMC and FDA agreed with the investigator’s assessment and endorsed the re-initiation of the trial, and enrollment has resumed.

Additional data readouts are expected by the end of 2021, including the interrogation of synovial fluid from patients to assess biological activity of FX201 locally in the joint and potential correlation with clinical endpoints over time.

Recent News & Business Updates

• Today the company announced that David Arkowitz, CFO, will step down on May 31, 2021, and will be succeeded by Fred Driscoll. Mr. Driscoll brings vast financial management experience in both the biotechnology and medical device industries. He previously served as Flexion’s CFO from 2013 to 2017.

• In March 2021, the Company announced the treatment of the first patient in a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Results from that trial could potentially be available in late 2021.

Conference Call

Flexion’s management will host a conference call today at 4:30 p.m. ET. A live webcast of the conference call can be accessed through the “Investors” tab on the Flexion Therapeutics website, and a replay will be available online after the call. For those planning to ask a question, the dial-in number for the conference call is 855-770-0022 for domestic participants and 908-982-4677 for international participants, with Conference ID # 9786283. Please dial in at least 15 minutes in advance to ensure a timely connection to the call.

Indication and Select Important Safety Information for ZILRETTA

Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.

Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

• Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.

• Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.

• Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.

• Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and, if confirmed, institute appropriate antimicrobial treatment.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see ZilrettaLabel.com for full Prescribing Information.

About ZILRETTA

On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.

About Osteoarthritis (OA) of the Knee

OA, also known as degenerative joint disease, is the most common form of arthritis, affecting more than 32.5 million adults living in the United States. In 2017, approximately 15 million Americans were diagnosed with OA of the knee, and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity, and sports injuries. Each year, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) or hyaluronic acid intra-articular injection to manage their knee pain.

About FX201

FX201 is an investigational gene therapy that utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.

About FX301

FX301 is an investigational locally administered NaV1.7 inhibitor known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral analgesic nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for at least three to five days while preserving motor function.

About Flexion Therapeutics

Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. Please visit flexiontherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; potential sales growth of ZILRETTA; expectations regarding full-year 2021 net sales and operating expenses; expected timing of clinical trials; expected increases in the rate of individuals with OA of the knee; the potential therapeutic and other benefits of ZILRETTA and Flexion’s product candidates; and expected changes in Flexion’s management, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risk that Flexion may not achieve net sales and operating expense expectations for 2021; the potential future impacts of the COVID-19 pandemic and actions taken in response to the pandemic; the risk that we may not achieve anticipated growth or advancements in our development programs; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; risks associated with clinical trials, including potential delays in enrollment or negative results; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized or adopted; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices, and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 10, 2021, and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

FLEXION THERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited in thousands, except for per share information)
	Three Months Ended March 31,
		2021	2020
Revenue		$24,589	$     20,127
Operating expenses:
Cost of sales		6,085	2,276
Research and development		14,047	21,134
Selling, general and administrative		27,598	29,299
Total operating expenses		47,730	52,709
Loss from operations		(23,141)	(32,582)
Interest income (expense), net		(4,889)	(4,294)
Other (expense) income		(526)	74
Net loss		$(28,556)	$(36,802)
Basic and diluted net loss per share		$     (0.57)	$     (0.95)
Basic and diluted weighted average number of common shares outstanding		49,841	38,553

FLEXION THERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEET DATA (Unaudited in thousands)
	March 31,	December 31,
	2021	2020
Cash and cash equivalents	$ 98,707	$107,704
Marketable securities	55,573	67,576
Total current assets	204,622	225,811
Working capital	146,640	170,543
Total assets	230,379	251,926
Total notes payable	58,091	60,920
Total convertible notes	165,271	162,786
Total stockholders' deficit	(38,867)	(16,660)

# # #

Contact:

Scott Young

Vice President, Corporate Communications & Investor Relations

T: 781-305-7194

syoung@flexiontherapeutics.com

Julie Downs

Associate Director, Corporate Communications & Investor Relations

T: 781-305-7137

jdowns@flexiontherapeutics.com

EX-99.2

Q1 2021 Commercial Metrics Overview May 12, 2021 Exhibit 99.2

ZILRETTA® net sales of $24.6 million in Q1 2021 In Q1 2,044 accounts purchased ZILRETTA Of the 2,044 accounts that purchased in Q1, 90% had purchased in a prior quarter Commercial Overview: Q1 Performance Metrics 2 Flexion primarily sells ZILRETTA to specialty distributors; Flexion recognizes ZILRETTA sales upon receipt of product by distributors; demand refers to end-user account purchases (physicians, clinics, and certain medical centers or hospitals) who purchase from these specialty distributors

ZILRETTA Net Sales by Quarter 3 Flexion recognizes ZILRETTA sales upon receipt of product by specialty distributors.

ZILRETTA Demand by Quarter 4 Flexion primarily sells ZILRETTA to specialty distributors; Flexion recognizes ZILRETTA sales upon receipt of product by distributors; demand refers to end-user account purchases (physicians, clinics, and certain medical centers or hospitals) who purchase from these specialty distributors.

In Q1, ~38% of Demand Came from Accounts Purchasing More than 100 Units 5 Flexion primarily sells ZILRETTA to specialty distributors; Flexion recognizes ZILRETTA sales upon receipt of product by distributors; demand refers to end-user account purchases (physicians, clinics, and certain medical centers or hospitals) who purchase from these specialty distributors. 5 8

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