flxn-10q_20180930.htm

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2018

or

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

FOR THE TRANSITION PERIOD FROM                 TO                

Commission file number: 001-36287

 

Flexion Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

26-1388364

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

10 Mall Road, Suite 301

Burlington, Massachusetts

 

01803

(Address of Principal Executive Offices)

 

(Zip Code)

(781) 305-7777

(Registrant’s Telephone Number, Including Area Code)

 

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 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.

 

Large accelerated filer

 

Accelerated filer

 

 

 

 

 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

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

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

As of November 1, 2018, the registrant had 37,856,737 shares of Common Stock ($0.001 par value) outstanding.

 

 

 


FLEXION THERAPEUTICS, INC.

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

 

Item 1. Financial Statements

3

 

Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017 (Unaudited)

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2018 and 2017 (Unaudited)

4

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited)

5

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (Unaudited)

6

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

7

 

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

22

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

29

 

Item 4. Controls and Procedures

30

PART II. OTHER INFORMATION

 

 

Item 1. Legal Proceedings

31

 

Item 1A. Risk Factors

31

 

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

58

 

Item 3. Defaults Upon Senior Securities

58

 

Item 4. Mine Safety Disclosures

58

 

Item 5. Other Information

58

 

Item 6. Exhibits

59

 

Signatures

60

 

 

2


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Flexion Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited in thousands, except share amounts)

 

 

 

September 30,

2018

 

 

December 31,

2017

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

117,766

 

 

$

127,789

 

Marketable securities

 

 

185,094

 

 

 

264,589

 

Accounts receivable, net

 

 

8,798

 

 

 

410

 

Inventories

 

 

5,076

 

 

 

1,799

 

Prepaid expenses and other current assets

 

 

4,676

 

 

 

3,403

 

Total current assets

 

$

321,410

 

 

$

397,990

 

Property and equipment, net

 

 

10,285

 

 

 

11,189

 

Long-term investments

 

 

 

 

 

31,538

 

Restricted cash

 

 

 

 

 

600

 

Total assets

 

$

331,695

 

 

$

441,317

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

8,657

 

 

$

6,222

 

Accrued expenses and other current liabilities

 

 

17,588

 

 

 

14,383

 

Current portion of long-term debt

 

 

9,967

 

 

 

9,967

 

Total current liabilities

 

$

36,212

 

 

$

30,572

 

Long-term debt, net

 

 

5,964

 

 

 

12,936

 

2024 convertible notes, net

 

 

142,868

 

 

 

137,107

 

Other long-term liabilities

 

 

546

 

 

 

428

 

Total liabilities

 

$

185,590

 

 

$

181,043

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2018

   and December 31, 2017 and 0 shares issued and outstanding at September 30, 2018

   and December 31, 2017

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 37,825,275 and

   37,610,897 shares issued and outstanding, at September 30, 2018 and

   December 31, 2017, respectively

 

 

38

 

 

 

38

 

Additional paid-in capital

 

 

624,475

 

 

 

609,810

 

Accumulated other comprehensive loss

 

 

(157

)

 

 

(407

)

Accumulated deficit

 

 

(478,251

)

 

 

(349,167

)

Total stockholders' equity

 

 

146,105

 

 

 

260,274

 

Total liabilities and stockholders' equity

 

$

331,695

 

 

$

441,317

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

3


Flexion Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited in thousands, except per share amounts)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

6,990

 

 

$

 

 

$

12,981

 

 

$

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

1,619

 

 

 

 

 

 

5,264

 

 

 

 

Research and development

 

 

13,578

 

 

 

12,846

 

 

 

38,223

 

 

 

35,371

 

Selling, general and administrative

 

 

32,804

 

 

 

18,375

 

 

 

90,739

 

 

 

46,533

 

Total operating expenses

 

 

48,001

 

 

 

31,221

 

 

 

134,226

 

 

 

81,904

 

Loss from operations

 

 

(41,011

)

 

 

(31,221

)

 

 

(121,245

)

 

 

(81,904

)

Other (expense) income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,157

 

 

 

1,095

 

 

 

3,572

 

 

 

2,450

 

Interest expense

 

 

(3,930

)

 

 

(3,843

)

 

 

(11,775

)

 

 

(7,363

)

Other income (expense)

 

 

144

 

 

 

(219

)

 

 

364

 

 

 

(136

)

Total other (expense) income

 

 

(2,629

)

 

 

(2,967

)

 

 

(7,839

)

 

 

(5,049

)

Net loss

 

$

(43,640

)

 

$

(34,188

)

 

$

(129,084

)

 

$

(86,953

)

Net loss per common share, basic and diluted

 

$

(1.15

)

 

$

(1.07

)

 

$

(3.42

)

 

$

(2.73

)

Weighted average common shares outstanding, basic and diluted

 

 

37,818

 

 

 

31,931

 

 

 

37,712

 

 

 

31,821

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains from available-for-sale securities, net

   of tax of $0

 

 

153

 

 

 

18

 

 

 

250

 

 

 

9

 

Total other comprehensive income (loss)

 

 

153

 

 

 

18

 

 

 

250

 

 

 

9

 

Comprehensive loss

 

$

(43,487

)

 

$

(34,170

)

 

$

(128,834

)

 

$

(86,944

)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


Flexion Therapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited in thousands)

 

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated

Other

 

 

 

 

 

 

Total

 

 

 

 

Shares

 

 

Par Value

 

 

Paid-in-

Capital

 

 

Comprehensive

Income (Loss)

 

 

Accumulated

Deficit

 

 

Stockholders'

Equity

 

Balance at December 31, 2015

 

 

 

21,570

 

 

$

22

 

 

$

243,853

 

 

$

(97

)

 

$

(139,792

)

 

$

103,986

 

Issuance of common stock net of issuance

   costs

 

 

 

10,040

 

 

 

10

 

 

 

147,491

 

 

 

 

 

 

 

 

 

 

 

147,501

 

Issuance of common stock for equity

   awards

 

 

 

30

 

 

 

 

 

 

 

167

 

 

 

 

 

 

 

 

 

 

 

167

 

Employee stock purchase plan

 

 

 

27

 

 

 

 

 

 

 

476

 

 

 

 

 

 

 

 

 

 

 

476

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

6,770

 

 

 

 

 

 

 

 

 

 

 

6,770

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(71,894

)

 

 

(71,894

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26

 

 

 

 

 

 

 

26

 

Balance at December 31, 2016

 

 

 

31,667

 

 

$

32

 

 

$

398,757

 

 

$

(71

)

 

$

(211,686

)

 

$

187,032

 

Issuance of common stock net of issuance

   costs

 

 

 

5,520

 

 

 

6

 

 

 

132,171

 

 

 

 

 

 

 

 

 

 

 

132,177

 

Issuance of common stock for equity

   awards

 

 

 

334

 

 

 

 

 

 

 

3,858

 

 

 

 

 

 

 

 

 

 

 

3,858

 

Employee stock purchase plan

 

 

 

90

 

 

 

 

 

 

 

1,016

 

 

 

 

 

 

 

 

 

 

 

1,016

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

11,542

 

 

 

 

 

 

 

 

 

 

 

11,542

 

Portion of convertible debt proceeds

   allocated to equity component

 

 

 

 

 

 

 

 

 

 

 

62,466

 

 

 

 

 

 

 

 

 

 

 

62,466

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(137,481

)

 

 

(137,481

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(336

)

 

 

 

 

 

 

(336

)

Balance at December 31, 2017

 

 

 

37,611

 

 

$

38

 

 

$

609,810

 

 

$

(407

)

 

$

(349,167

)

 

$

260,274

 

Issuance of common stock for equity

   awards

 

 

 

161

 

 

 

 

 

 

 

1,896

 

 

 

 

 

 

 

 

 

 

$

1,896

 

Employee stock purchase plan

 

 

 

53

 

 

 

 

 

 

 

1,129

 

 

 

 

 

 

 

 

 

 

 

1,129

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

11,640

 

 

 

 

 

 

 

 

 

 

 

11,640

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(129,084

)

 

 

(129,084

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

250

 

 

 

 

 

 

 

250

 

Balance at September 30, 2018

 

 

 

37,825

 

 

$

38

 

 

$

624,475

 

 

$

(157

)

 

$

(478,251

)

 

$

146,105

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5


Flexion Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2018

 

 

2017

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(129,084

)

 

$

(86,953

)

Adjustments to reconcile net loss to cash used in operating activities

 

 

 

 

 

 

 

 

Depreciation

 

 

1,494

 

 

 

1,456

 

Stock-based compensation expense

 

 

11,640

 

 

 

7,570

 

(Accretion) Amortization of (discount) premium on marketable securities

 

 

(803

)

 

 

355

 

Amortization of debt discount and debt issuance costs

 

 

5,786

 

 

 

2,985

 

Premium paid on securities purchased

 

 

(215

)

 

 

(676

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(8,388

)

 

 

 

Inventory

 

 

(3,044

)

 

 

 

Prepaid expenses, other current and long-term assets

 

 

(1,273

)

 

 

181

 

Accounts payable

 

 

2,300

 

 

 

2,020

 

Accrued expenses and other current and long-term liabilities

 

 

3,826

 

 

 

7,124

 

Net cash used in operating activities

 

 

(117,761

)

 

 

(65,938

)

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(688

)

 

 

(1,882

)

Purchases of marketable securities

 

 

(157,116

)

 

 

(199,756

)

Sale and redemption of marketable securities

 

 

269,417

 

 

 

203,578

 

Net cash provided by investing activities

 

 

111,613

 

 

 

1,940

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from the issuance of 2024 convertible notes

 

 

 

 

 

201,250

 

Payment of debt issuance costs

 

 

 

 

 

(6,470

)

Payments on notes payable

 

 

(7,500

)

 

 

(5,833

)

Payments of public offering costs

 

 

 

 

 

(95

)

Proceeds from the exercise of stock options

 

 

1,896

 

 

 

3,077

 

Proceeds from employee stock purchase plan

 

 

1,129

 

 

 

453

 

Net cash (used in) provided by financing activities

 

 

(4,475

)

 

 

192,382

 

Net (decrease) increase in cash, cash equivalents, and restricted cash

 

 

(10,623

)

 

 

128,384

 

Cash, cash equivalents, and restricted cash at beginning of period

 

 

128,389

 

 

 

31,395

 

Cash, cash equivalents, and restricted cash at end of period

 

$

117,766

 

 

$

159,779

 

Supplemental disclosures of cash flow information

 

 

 

 

 

 

 

 

Cash paid for interest

 

 

4,268

 

 

 

1,334

 

Supplemental disclosures of non-cash financing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment in accounts payable and accrued expenses

 

 

143

 

 

 

14

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6


Flexion Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

1. Overview and Nature of the Business

Flexion Therapeutics, Inc. (“Flexion” or the “Company”) was incorporated under the laws of the state of Delaware on November 5, 2007. Flexion is a biopharmaceutical company focused on the discovery, development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, or OA, a type of degenerative arthritis. The Company has an approved product, ZILRETTA®, which it markets in the United States.  ZILRETTA is the first and only extended-release, intra-articular, or IA (meaning in the joint), injection indicated for the management of OA related knee pain. ZILRETTA is a non-opioid therapy that employs Flexion’s proprietary microsphere technology to provide pain relief for over 12 weeks.  ZILRETTA is not intended for repeat administration, as the efficacy and safety of repeat administration of ZILRETTA have not been evaluated. The Company also has an additional product candidate (FX201) in development for OA.

The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations. Successfully commercializing ZILRETTA requires significant sales and marketing efforts and the Company’s pipeline programs may require significant additional research and development efforts, including extensive preclinical and clinical testing. These activities will in turn require significant amounts of capital, sufficient and qualified personnel and adequate supporting infrastructure. There can be no assurance when, if ever, the Company will realize significant revenue from the sales of ZILRETTA or if the development efforts supporting the Company’s pipeline, including future clinical trials, will be successful.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements as of September 30, 2018, and for the three and nine months ended September 30, 2018 and 2017, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and Generally Accepted Accounting Principles (“GAAP”) for consolidated financial information including the accounts of the Company and its wholly-owned subsidiary after elimination of all significant intercompany accounts and transactions. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, these condensed consolidated financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2018.

The information presented in the condensed consolidated financial statements and related notes as of September 30, 2018, and for the three and nine months ended September 30, 2018 and 2017, is unaudited.  The December 31, 2017 condensed consolidated balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements.

Interim results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2018, or any future period.

The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. As of September 30, 2018, the Company had cash, cash equivalents, and marketable securities of approximately $302.9 million. Management believes that current cash, cash equivalents and marketable securities on hand at September 30, 2018 should be sufficient to fund operations for at least the next twelve months from the issuance date of these financial statements. The future viability of the Company may be dependent on its ability to raise additional capital to finance its operations, including to support the commercialization of ZILRETTA and fund increased research and development costs in order to seek approval and commercialize its product candidates. The Company may not be able to obtain financing on acceptable terms, or at all. If the Company is unable to obtain funding on a timely basis, the Company may need to curtail its operations, including the commercialization of ZILRETTA and research and development activities, which could adversely affect its prospects.

7


Recent Accounting Pronouncements

Accounting Standards Recently Adopted

In January 2016, the Financial Accounting Standards Board, or FASB, issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). This new standard amends certain aspects of accounting and disclosure requirements of financial instruments, including the requirement that equity investments with readily determinable fair values be measured at fair value with changes in fair value recognized in the statement of operations. This new standard does not apply to investments accounted for under the equity method of accounting or those that result in consolidation of the investee. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minus impairment adjusted for changes in observable prices. A financial liability that is measured at fair value in accordance with the fair value option is required to be presented separately in other comprehensive income for the portion of the total change in the fair value resulting from change in the instrument-specific credit risk. In addition, a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination with other deferred tax assets. The Company adopted ASU 2016-01 on January 1, 2018. The adoption of ASU 2016-01 did not have a material impact on the Company’s financial position or results of operations.  

In August 2016, the FASB issued ASU 2016-15, Statement of cash flows (Topic 230) (“ASU 2016-15”), to increase the consistency of presentation in how certain cash receipts and cash payments are presented and classified in the statement of cash flows.  The Company adopted ASU 2016-15 on January 1, 2018. The adoption of ASU 2016-15 did not have a material impact on the Company’s financial position or results of operations.  

In November 2016, the FASB issued ASU 2016-18, Statement of cash flows (Topic 230): Restricted Cash (“ASU 2016-18”), to provide specific guidance on the cash flow classification and presentation of changes in restricted cash and restricted cash equivalents. The amendments in ASU 2016-18 require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The Company adopted ASU 2016-18 on January 1, 2018. As a result of the adoption of ASU 2016-18, $0.6 million and $0.5 million of restricted cash was included in the beginning-of-period cash, cash equivalents, and restricted cash amount shown on the statement of cash flows for the nine months ended September 30, 2018 and 2017, respectively, and no restricted cash and $0.6 million of restricted cash was included in the end-of-period cash, cash equivalents, and restricted cash amount shown on the statement of cash flows for the nine months ended September 30, 2018 and 2017, respectively.

In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) (“ASU 2017-09”) Scope of Modification Accounting. ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company adopted ASU 2016-18 on January 1, 2018 and it will be applied prospectively to an award modified on or after the adoption date.

Accounting Standards Recently Issued

In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”), to increase transparency and comparability among organizations by recognizing lease assets and liabilities, including operating leases, on the balance sheet and disclosing key information about leasing arrangements. ASU 2016-02 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company currently expects that its operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon the adoption of ASU 2016-02. The Company is evaluating these leases and the amount of the impact, which may be material, and whether there are other existing contracts that may become leases under the new lease standard. The Company’s analysis includes, but is not limited to, reviewing existing leases, reviewing other agreements for potential embedded leases, establishing policies and procedures for identifying and accounting for new leases, assessing potential disclosures and evaluating the impact of adoption on the Company’s condensed consolidated financial statements. The Company plans to adopt ASU 2016-02 using the transition approach approved by the FASB in July 2018 as part of ASU 2018-11. Under this method, the Company will initially apply the new lease requirements at the effective date (i.e., January 1, 2019), report comparative periods presented in the financial statements in the period of adoption under current GAAP (i.e., ASC 840, Leases), and provide the required disclosures under ASC 842 for the current year and ASC 840 for all periods presented under ASC 840.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The new standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 is effective for fiscal years, and the interim periods within those years, beginning after December 15, 2019 and early adoption is permitted. The Company is currently evaluating the impact of ASU 2016-13 on the Company’s consolidated financial statements.

8


In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). The new standard expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Equity-based payments to nonemployees were previously covered under ASC 505-50 and required companies to measure the awards based on the fair value of the consideration received or the fair value of the equity instruments issued and remeasure the fair value of such awards at each reporting date. ASU 2018-07 is effective for fiscal years, and the interim periods within those years, beginning after December 15, 2018 and early adoption is permitted. The Company does not expect the adoption of ASU 2018-07 to have a material impact on its consolidated financial statements.

In July 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). The new standard modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, as part of the FASB’s disclosure framework project. ASU 2018-13 is effective for fiscal years, and the interim periods within those years, beginning after December 15, 2019 and early adoption is permitted. Additionally, the new standard permits an entity to early adopt any removed or modified disclosures upon issuance of the ASU and delay adoption of the additional disclosures until their effective date. ASU 2018-13 removes the requirement to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy. The Company will early adopt this portion of the standard as of the quarter ended September 30, 2018. The Company does not expect the adoption of the remainder of ASU 2018-13 to have any impact on its consolidated financial statements, as the changes to the disclosures are primarily relevant for companies with Level 3 assets and liabilities, which the Company does not have.

 

Consolidation

The accompanying condensed consolidated financial statements include the Company and its wholly-owned subsidiary, Flexion Therapeutics Securities Corporation. The Company has eliminated all intercompany transactions for the three and nine months ended September 30, 2018 and the year ended December 31, 2017.

Revenue Recognition

On October 6, 2017, the U.S. Food and Drug Administration, or FDA, approved ZILRETTA. The Company entered into a limited number of arrangements with specialty distributors and a specialty pharmacy in the U.S. to distribute ZILRETTA. These arrangements are the Company’s initial contracts with customers and, as a result the Company adopted Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“Topic 606”) as of January 1, 2017. There was no impact for the transition to Topic 606 because the Company had no historical revenue prior to the launch of ZILRETTA. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.

To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract with a customer under Topic 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below).

Product Revenue, Net— The Company sells ZILRETTA to its customers who then subsequently resell ZILRETTA to physicians, clinics and certain medical centers or hospitals. In addition to distribution agreements with customers, the Company enters into arrangements with government payers that provide for government mandated rebates and chargebacks with respect to the purchase of ZILRETTA.  

The Company recognizes revenue on product sales when the customer obtains control of the Company's product, which occurs at a point in time (upon delivery to the customer). The Company has determined that the delivery of ZILRETTA to its customers constitutes a single performance obligation.  There are no other promises to deliver goods or services beyond what is specified in each accepted customer order.  The Company has assessed the existence of a significant financing component in the agreements with its customers.  The trade payment terms with customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component.  Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.

9


Transaction Price, including Variable Consideration— Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voluntary patient assistance, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2018 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2018. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.

Trade Discounts and Allowances— The Company compensates (through trade discounts and allowances) its customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss through September 30, 2018, as well as a reduction to trade receivables, net on the condensed consolidated balance sheets.

Product Returns— Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date.  The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as within accrued expenses and other current liabilities, net, on the condensed consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has not received any returns to date and believes that returns of ZILRETTA will be minimal.

The Company’s limited right of return allows for eligible returns of ZILRETTA in the following circumstances:

 

Shipment errors that were the result of an error by the Company;

 

Quantity delivered that is greater or less than the quantity ordered;

 

Product distributed by the Company that is damaged in transit prior to receipt by the customer;

 

Expired product, previously purchased directly from the Company, that is returned during the period beginning three months prior to the product’s expiration date and ending three months after the product’s expiration date;

 

Product subject to a recall; and

 

Product that the Company, at its sole discretion, has specified to be returned.

Government Chargebacks, Discounts and Rebates— Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified VA hospitals and 340b entities at prices lower than the list prices charged to customers who directly purchase the product from the Company. The 340b Drug Discount Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices.  Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and trade receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.

10


Government Rebates— The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company anticipates its exposure to utilization from the Medicare Part D coverage gap discount program to be immaterial.  For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs.  The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.

Other Incentives— Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.

To date, the Company’s only source of product revenue has been from the U.S. sales of ZILRETTA, which it began shipping to customers in October 2017.

The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2018:

 

(In thousands)

 

Trade Discounts,

Allowances and

Government

Chargebacks

 

 

Government

Rebates and

Other

Incentives

 

 

Returns

 

 

Total

 

Balance as of December 31, 2017

 

$

60

 

 

$

15

 

 

$

2

 

 

$

77

 

Provision related to sales in the current year

 

 

1,002

 

 

 

291

 

 

 

72

 

 

 

1,365

 

Credit and payments made

 

 

(606

)

 

 

(6

)

 

 

 

 

 

(612

)

Balance as of September 30, 2018

 

$

456

 

 

$

300

 

 

$

74

 

 

$

830

 

 

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that may affect the reported amounts of assets and liabilities, revenue and expenses and related disclosures. The Company bases estimates and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. The most significant estimates in these condensed consolidated financial statements include estimates related to revenue, useful lives with respect to long-lived assets, such as property and equipment and leasehold improvements, accounting for stock-based compensation, and accrued expenses, including clinical research costs. The Company’s actual results may differ from these estimates under different assumptions or conditions. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives:

 

 

 

Estimated

Useful Life

(Years)

Computers, office equipment, and minor computer software

 

3

Computer software

 

7

Manufacturing equipment

 

7-10

Furniture and fixtures

 

5

 

11


Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Costs of major additions and improvements are capitalized and depreciated on a straight-line basis over their useful lives. Repairs and maintenance costs are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to income. Property and equipment includes construction-in-progress that is not yet in service.

Foreign Currencies

The Company maintains a bank account denominated in British Pounds.  All foreign currency payables and cash balances are measured at the applicable exchange rate at the end of the reporting period.  All associated gains and losses from foreign currency transactions are reflected in the consolidated statements of operations.

3. Fair Value of Financial Assets and Liabilities

The following tables present information about the Company’s assets that are measured at fair value on a recurring basis as of September 30, 2018 and December 31, 2017 and indicate the level of the fair value hierarchy utilized to determine such fair value:

 

 

 

Fair Value Measurements as of September 30, 2018 Using:

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

 

 

$

105,085

 

 

$

 

 

$

105,085

 

Marketable securities

 

 

 

 

 

185,094

 

 

 

 

 

 

185,094

 

 

 

$

 

 

$

290,179

 

 

$

 

 

$

290,179

 

 

 

 

Fair Value Measurements as of December 31, 2017 Using:

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

 

 

$

109,196

 

 

$

 

 

$

109,196

 

Marketable securities

 

 

 

 

 

296,127

 

 

 

 

 

 

296,127

 

 

 

$

 

 

$

405,323

 

 

$

 

 

$

405,323

 

 

As of September 30, 2018 and December 31, 2017 the Company’s cash equivalents that are invested in money market funds and overnight repurchase contracts are valued based on Level 2 inputs. The Company measures the fair value of marketable securities using Level 2 inputs and primarily relies on quoted prices in active markets for similar marketable securities. Amortization and accretion of discounts and premiums are recorded in other income.

The Company has a term loan outstanding under its 2015 credit facility with MidCap Financial Funding XIII Trust and Silicon Valley Bank (the “2015 term loan”).  The amount outstanding on its 2015 term loan is reported at its carrying value in the accompanying balance sheet. The Company determined the fair value of the 2015 term loan using an income approach that utilizes a discounted cash flow analysis based on current market interest rates for debt issuances with similar remaining years to maturity, adjusted for credit risk. The 2015 term loan was valued using Level 2 inputs as of September 30, 2018 and December 31, 2017. The result of the calculation yielded a fair value that approximates its carrying value.

On May 2, 2017 the Company issued 3.375% convertible senior notes due 2024 (the “2024 Convertible Notes”) with embedded conversion features.  The Company estimated the fair value of the 2024 Convertible Notes using a discounted cash flow approach to derive the value of a debt instrument using the expected cash flows and the estimated yield related to the convertible notes. The significant assumptions used in estimating the expected cash flows were: the estimated market yield based on an implied yield and credit quality analysis of a term loan with similar attributes, and the average implied volatility of the Company’s traded and quoted options available as of May 2, 2017. The Company recorded approximately $136.7 million as the fair value of the liability on May 2, 2017, with a corresponding amount recorded as a discount on the initial issuance of the 2024 Convertible Notes of approximately $64.5 million. The debt discount was recorded to equity and is being amortized to the debt liability over the life of the 2024 Convertible Notes using the effective interest method.

The fair value of the 2024 Convertible Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices for the 2024 Convertible Notes observed in market trading.  The market for trading of the 2024 Convertible Notes is not considered to be an active market and therefore the estimate of fair value is based on Level 2 inputs.  The estimated fair value of the 2024 Convertible Notes, face value of $201.3 million, was $202.6 million at September 30, 2018.  

12


4. Marketable Securities

As of September 30, 2018 and December 31, 2017 the fair value of available-for-sale marketable securities by type of security was as follows:

 

 

 

September 30, 2018

 

(In thousands)

 

Amortized Cost

 

 

Gross Unrealized

Gains

 

 

Gross Unrealized

Losses

 

 

Fair Value

 

Commercial paper

 

 

23,358

 

 

 

 

 

 

 

 

 

23,358

 

U.S. government obligations

 

$

91,587

 

 

$

 

 

$

(52

)

 

$

91,535

 

Corporate bonds

 

 

70,306

 

 

 

 

 

 

(105

)

 

 

70,201

 

 

 

$

185,251

 

 

$

 

 

$

(157

)

 

$

185,094

 

 

 

 

December 31, 2017

 

(In thousands)

 

Amortized Cost

 

 

Gross Unrealized

Gains

 

 

Gross Unrealized

Losses

 

 

Fair Value

 

Commercial paper

 

$

22,436

 

 

$

 

 

$

 

 

$

22,436

 

U.S. government obligations

 

 

121,470

 

 

$

 

 

 

(136

)

 

 

121,334

 

Corporate bonds

 

 

152,630

 

 

$

 

 

 

(273

)

 

 

152,357

 

 

 

$

296,536

 

 

$

 

 

$

(409

)

 

$

296,127

 

 

As of September 30, 2018 and December 31, 2017, marketable securities consisted of approximately $185.1 and $264.6 million, respectively, of investments that mature within twelve months. As of December 31, 2017, long-term investments consisted of approximately $31.5 million of investments that mature after one year but within two years or less from the balance sheet date. There were no investments with maturities greater than twelve months as of September 30, 2018.

 

 

5.Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of September 30, 2018 and December 31, 2017:

 

(In thousands)

 

September 30,

2018

 

 

December 31,

2017

 

Prepaid expenses

 

$

4,243

 

 

$

2,359

 

Deposits

 

 

66

 

 

 

66

 

Interest receivable on marketable securities

 

 

367

 

 

 

978

 

Total prepaid expenses and other current assets

 

$

4,676

 

 

$

3,403

 

 

6. Inventory

Inventory consisted of the following as of September 30, 2018 and December 31, 2017:

 

(In thousands)

 

September 30,

2018

 

 

December 31,

2017

 

Raw materials

 

$

1,586

 

 

$

928

 

Work in process

 

 

2,726

 

 

 

746

 

Finished goods

 

 

764

 

 

 

125

 

Total inventories

 

$

5,076

 

 

$

1,799

 

 

Inventory acquired prior to receipt of the marketing approval for ZILRETTA, totaling approximately $3.7 million, was expensed as research and development expense as incurred. The Company began to capitalize the costs associated with the production of ZILRETTA upon receipt of FDA approval of ZILRETTA on October 6, 2017.  As of September 30, 2018, substantially all of the finished goods inventory that was previously expensed had been sold to customers.

 

Finished goods manufactured by the Company have a shelf life of approximately 24 months from the date of manufacture.

 

The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life.  During the three and nine months ended September 30, 2018, the Company expensed $1.4 million and $5.0 million to cost of sales for

13


unabsorbed manufacturing and overhead costs related to the operation of the United Kingdom facility at Patheon UK Limited. The Company determined that no write-downs to inventory for potentially excess, dated or obsolete inventory were required.

 

7. Property and Equipment, Net

Property and equipment, net, as of September 30, 2018 and December 31, 2017 consisted of the following:

 

(In thousands)

 

September 30,

2018

 

 

December 31,

2017

 

Computer and office equipment

 

$

1,133

 

 

$

1,124

 

Manufacturing equipment

 

 

11,953

 

 

 

11,780

 

Furniture and fixtures

 

 

604

 

 

 

456

 

Software

 

 

434

 

 

 

434

 

Leasehold improvements

 

 

815

 

 

 

474

 

Construction in progress

 

 

457

 

 

 

305

 

 

 

 

15,396

 

 

 

14,573

 

Less: Accumulated depreciation

 

 

(5,111

)

 

 

(3,384

)

Total property and equipment, net

 

$

10,285

 

 

$

11,189

 

 

Depreciation expense for the three and nine months ended September 30, 2018 was approximately $0.4 million and $1.5 million, respectively, compared to $0.5 million and $1.5 million for the same periods in the prior year.  No property and equipment was disposed of during the nine months ended September 30, 2018. Construction in progress consists of equipment purchased for the Company’s portfolio expansion efforts, as well as leasehold improvements related to the second floor space expansion of the Company’s Burlington, Massachusetts headquarters.

8. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following as of September 30, 2018 and December 31, 2017:

 

(In thousands)

 

September 30,

2018

 

 

December 31,

2017

 

Research and development

 

$

605

 

 

$

969

 

Payroll and other employee-related expenses

 

 

8,818

 

 

 

9,309

 

Professional services fees

 

 

3,953

 

 

 

2,591

 

Interest expense

 

 

2,904

 

 

 

1,249

 

Accrual for employee stock purchase plan

 

 

652

 

 

 

141

 

Other

 

 

656

 

 

 

124

 

Total accrued expenses and other current liabilities

 

$

17,588

 

 

$

14,383

 

 

 

9. Debt

 

Term Loan

On August 4, 2015, the Company entered into a credit and security agreement with MidCap Financial Trust, as agent, and MidCap Financial Funding XIII Trust and Silicon Valley Bank, as lenders, (the “Lenders”), to borrow up to $30.0 million in term loans. The Company concurrently borrowed an initial term loan of $15.0 million under the facility. The Company granted the Lenders a security interest in substantially all of its personal property, rights and assets, other than intellectual property, to secure the payment of all amounts owed under the credit facility. The Company agreed not to encumber any of its intellectual property without the Lenders’ prior written consent. The Company also agreed to maintain a balance in cash or cash equivalents at Silicon Valley Bank equal to the principal balance of the loan plus 5% for so long as the Company maintains any cash or cash equivalents in non-secured bank accounts.

On July 22, 2016, the Company borrowed the remaining $15.0 million under the credit and security agreement, in the form of a second term loan.  The second term loan is subject to the same credit terms as the initial term loan under the facility.

The credit and security agreement also contains certain representations, warranties, and covenants of the Company as well as a material adverse event clause. As of September 30, 2018, the Company was compliant with all covenants.

14


Borrowings under the credit facility accrue interest monthly at a fixed interest rate of 6.25% per annum. Following an interest-only period of 19 months, principal is due in 36 equal monthly installments commencing March 1, 2017 and ending February 1, 2020 (the “maturity date”). Upon the maturity date, the Company will be obligated to pay a final payment equal to 9% of the total principal amounts borrowed under the facility. The final payment amount is being accreted to the carrying value of the debt using the straight-line method, which approximates the effective interest method. As of September 30, 2018, the carrying value of the term loan was approximately $15.9 million, of which $10.0 million was due within 12 months and