false 0001419600 0001419600 2020-07-14 2020-07-14










Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 14, 2020


Flexion Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)






(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)




10 Mall Road, Suite 301

Burlington, Massachusetts



(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





Name of each exchange on which registered

Common Stock, par value $0.001 per share




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 July 14, 2020, Flexion Therapeutics, Inc. issued a press release announcing its preliminary financial results for the second quarter ended June 30, 2020 and made available on its corporate website a presentation of certain additional operating results. A copy of the press release and the 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, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.








Press Release of Flexion Therapeutics, Inc. dated July 14, 2020



Presentation of Flexion Therapeutics, Inc. dated July 14, 2020



Cover Page Interactive Data File (embedded within the Inline XBRL document)







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: July 14, 2020



/s/ Mark S. Levine




Mark S. Levine




General Counsel and Corporate Secretary




Exhibit 99.1




Flexion Therapeutics Announces Preliminary Second-Quarter 2020 ZILRETTA® Net Sales


Company reported ZILRETTA (triamcinolone acetonide extended-release injectable suspension) preliminary net sales of $15.4 million in the second quarter

Demand for ZILRETTA from healthcare providers increased month-over-month throughout the second quarter with total demand in line with the first quarter

Company plans to recommence ZILRETTA manufacturing in the fourth quarter following voluntary pause due to impacts from COVID-19

Conference call scheduled for today at 8:30 a.m. ET


BURLINGTON, Mass., July 14, 2020 – Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced preliminary ZILRETTA net sales of $15.4 million for the quarter ended June 30, 2020. Demand for ZILRETTA increased month-over-month throughout the second quarter with purchases by healthcare providers reaching 4,863 units, 13,547 units and 18,287 units in April, May and June, respectively. The total ZILRETTA purchases by healthcare providers in the second quarter (approximately 36,700 units) was in line with the first quarter (36,540 units). In addition, the Company also announced plans to recommence ZILRETTA manufacturing in the fourth quarter to help ensure adequate and uninterrupted supply to meet future demand.

“Considering the unprecedented impacts of the COVID-19 pandemic, we are very pleased with our sales performance in the second quarter,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion Therapeutics. “While the future impacts of the pandemic remain impossible to predict, our confidence in both the near and long-term prospects for ZILRETTA remains undiminished.”

Dr. Clayman added, “ZILRETTA is an important treatment option for millions of people seeking durable pain relief from OA knee pain, including those whose who have had knee replacement surgeries deferred due to COVID-19. We believe this creates a new entry point for prescribers to gain product experience in different patient types and supports the broader incorporation of ZILRETTA into their practices moving forward.”


ZILRETTA Cumulative Commercial Metrics
Since the launch of ZILRETTA in November 2017 through June 30, 2020:

3,858 of our approximately 5,000 target accounts had purchased ZILRETTA. This reflects growth of 186 accounts since March 31, 2020 when 3,672 accounts had purchased product.

77% of purchasing accounts (2,983) placed at least one reorder up from 2,832 accounts that had reordered ZILRETTA as of March 31, 2020.

1,023 accounts had made ZILRETTA purchases of more than 50 units; 1,102 accounts had purchased 11 to 50 units; and 1,733 accounts had purchased between 1 and 10 units.


Exhibit 99.1



Accounts that had purchased more than 50 ZILRETTA units accounted for 213,721 of the total 249,024 ZILRETTA units purchased.


This financial information is preliminary and subject to adjustment. Flexion expects to report its complete second-quarter financial results in August. 


Conference Call
Flexion’s management will host a conference call today at 8:30 a.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 #2618419. 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.


Exhibit 99.1




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.

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 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, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 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, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.

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 people with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Visit flexiontherapeutics.com.

Forward-Looking Statements
This 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; expected impacts from COVID-19 and the timing and duration of such impacts; expected timing of manufacturing activities and Flexion’s ability to maintain commercial supply of ZILRETTA; the long-term potential of ZILRETTA, including following the COVID-19 pandemic; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of


Exhibit 99.1



ZILRETTA, 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, the fact that the impacts and expected duration of the COVID-19 pandemic are uncertain and rapidly changing; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; 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 clinical trials, including potential delays, safety issues or negative results; 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 Quarterly Report on Form 10-Q for the year ended March 31, 2020 filed with the SEC on May 7, 2020 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.

# # #







Scott Young


Vice President, Corporate Communications & Investor Relations


T: 781-305-7194






Julie Downs


Associate Director, Corporate Communications & Investor Relations


T: 781-305-7137







Commercial Metrics Overview July 14,2020 Exhibit 99.2

Commercial Metrics Overview ZILRETTA® net sales of ~$15.4 million in Q2 2020 3,858 accounts (of 5,000 targets) have purchased ZILRETTA, as of June 30, 2020; up from 3,672, as of March 31, 2020 2,983 accounts have re-ordered ZILRETTA (77% of accounts that had purchased), as of June 30, 2020; up from 2,832 accounts that had re-ordered ZILRETTA (77% of accounts that had purchased) as of March 31, 2020

ZILRETTA Net Sales Quarterly Since Launch Note: Flexion recognizes Zilretta sales upon receipt of product by specialty distributors and pharmacies.

Distribution of Accounts by ZILRETTA Purchases Cumulative Note: Flexion primarily sells ZILRETTA to specialty distributors and a specialty pharmacy; accounts (physicians, clinics and certain medical centers or hospitals) then subsequently purchase ZILRETTA directly from these specialty distributors and specialty pharmacy

Distribution of ZILRETTA Purchases by Accounts Cumulative Note: Flexion primarily sells ZILRETTA to specialty distributors and a specialty pharmacy; accounts (physicians, clinics and certain medical centers or hospitals) then subsequently purchase ZILRETTA directly from these specialty distributors and specialty pharmacy

Distribution of ZILRETTA Purchases by New and Existing Accounts Cumulative Note: Flexion primarily sells ZILRETTA to specialty distributors and a specialty pharmacy; accounts (physicians, clinics and certain medical centers or hospitals) then subsequently purchase ZILRETTA directly from these specialty distributors and specialty pharmacy

Document and Entity Information
Jul. 14, 2020
Cover [Abstract]  
Entity Registrant Name Flexion Therapeutics, Inc
Document Type 8-K
Amendment Flag false
Entity Central Index Key 0001419600
Document Period End Date Jul. 14, 2020
Entity Emerging Growth Company false
Entity File Number 001-36287
Entity Incorporation State Country Code DE
Entity Tax Identification Number 26-1388364
Entity Address, Address Line One 10 Mall Road
Entity Address, Address Line Two Suite 301
Entity Address, City or Town Burlington
Entity Address, State or Province MA
Entity Address, Postal Zip Code 01803
City Area Code (781)
Local Phone Number 305-7777
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.001 per share
Trading Symbol FLXN
Security Exchange Name NASDAQ