10-Q
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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 June 30, 2021

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)

 

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, $0.001 par value per share

FLXN

Nasdaq Global Market

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 August 1, 2021, the registrant had 50,292,110 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 June 30, 2021, and December 31, 2020 (Unaudited)

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2021 and 2020 (Unaudited)

4

 

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

5

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021, and 2020 (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

31

 

Item 4. Controls and Procedures

32

PART II. OTHER INFORMATION

 

 

Item 1. Legal Proceedings

33

 

Item 1A. Risk Factors

33

 

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

36

 

Item 3. Defaults Upon Senior Securities

37

 

Item 4. Mine Safety Disclosures

37

 

Item 5. Other Information

37

 

Item 6. Exhibits

38

 

Signatures

39

 

 


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Flexion Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited in thousands, except share and per share amounts)

 

 

June 30,
2021

 

December 31,
2020

 

Assets

 

 

 

 

Current assets

 

 

 

 

Cash and cash equivalents

$

107,629

 

$

107,704

 

Marketable securities

 

23,620

 

 

67,576

 

Accounts receivable, net

 

35,097

 

 

30,025

 

Inventories

 

12,301

 

 

15,394

 

Prepaid expenses and other current assets

 

5,474

 

 

5,112

 

Total current assets

 

184,121

 

 

225,811

 

Property and equipment, net

 

19,783

 

 

19,538

 

Right-of-use assets

 

6,143

 

 

6,577

 

Total assets

$

210,047

 

$

251,926

 

Liabilities and Stockholders’ Deficit

 

 

 

 

Current liabilities

 

 

 

 

Accounts payable

$

5,474

 

$

6,928

 

Accrued expenses and other current liabilities

 

21,352

 

 

20,008

 

Deferred revenue

 

10,000

 

 

10,000

 

Operating lease liabilities

 

1,577

 

 

1,526

 

Current portion of long-term debt

 

1,528

 

 

16,806

 

Total current liabilities

 

39,931

 

 

55,268

 

Long-term operating lease liability, net

 

5,777

 

 

6,123

 

Long-term debt, net

 

52,207

 

 

44,114

 

2024 convertible notes, net

 

167,814

 

 

162,786

 

Other long-term liabilities

 

489

 

 

295

 

Total liabilities

 

266,218

 

 

268,586

 

Commitments and contingencies

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2021
   and December 31, 2020 and
0 shares issued and outstanding at June 30, 2021
   and December 31, 2020

 

 

 

 

Stockholders' deficit

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 50,105,620 and
   
49,403,034 shares issued and outstanding, at June 30, 2021 and
   December 31, 2020, respectively

 

50

 

 

49

 

Additional paid-in capital

 

776,850

 

 

765,607

 

Accumulated other comprehensive loss

 

(2

)

 

(11

)

Accumulated deficit

 

(833,069

)

 

(782,305

)

Total stockholders' deficit

 

(56,171

)

 

(16,660

)

Total liabilities and stockholders' deficit

$

210,047

 

$

251,926

 

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

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2021

 

2020

 

2021

 

2020

 

Revenues

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

28,175

 

$

15,451

 

$

52,764

 

$

35,578

 

Operating expenses

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

4,979

 

 

5,481

 

 

11,064

 

 

7,757

 

Research and development

 

 

12,669

 

 

12,507

 

 

26,716

 

 

33,641

 

Selling, general and administrative

 

 

27,409

 

 

24,730

 

 

55,007

 

 

54,029

 

Total operating expenses

 

 

45,057

 

 

42,718

 

 

92,787

 

 

95,427

 

Loss from operations

 

 

(16,882

)

 

(27,267

)

 

(40,023

)

 

(59,849

)

Other (expense) income

 

 

 

 

 

 

 

 

 

Interest income

 

 

177

 

 

95

 

 

477

 

 

522

 

Interest expense

 

 

(5,180

)

 

(5,002

)

 

(10,369

)

 

(9,723

)

Other expense

 

 

(323

)

 

(197

)

 

(849

)

 

(123

)

Total other (expense) income

 

 

(5,326

)

 

(5,104

)

 

(10,741

)

 

(9,324

)

Loss before income taxes

 

 

(22,208

)

 

(32,371

)

 

(50,764

)

 

(69,173

)

Income tax expense

 

 

 

 

248

 

 

 

 

248

 

Net loss

 

$

(22,208

)

$

(32,619

)

 

(50,764

)

 

(69,421

)

Net loss per common share, basic and diluted

 

$

(0.44

)

$

(0.76

)

$

(1.02

)

$

(1.71

)

Weighted average common shares outstanding, basic and diluted

 

 

49,968

 

 

42,776

 

 

49,905

 

 

40,664

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) from available-for-sale securities, net of tax of $0

 

 

8

 

 

(3

)

 

9

 

 

(59

)

Total other comprehensive income (loss)

 

 

8

 

 

(3

)

 

9

 

 

(59

)

Comprehensive loss

 

$

(22,200

)

$

(32,622

)

$

(50,755

)

$

(69,480

)

 

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

4


 

Flexion Therapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Deficit

(Unaudited in thousands)

 

 

Common Stock

 

Additional

 

Accumulated
Other

 

 

 

Total

 

 

Shares

 

Par Value

 

Paid-in-
Capital

 

Comprehensive
(Loss) Income

 

Accumulated
Deficit

 

Stockholders'
Deficit

 

Balance at December 31, 2020

 

49,403

 

$

49

 

$

765,607

 

$

(11

)

$

(782,305

)

$

(16,660

)

Issuance of common stock, net of issuance costs

 

134

 

 

 

 

1,700

 

 

 

 

 

 

1,700

 

Issuance of common stock for equity
   awards, net of shares withheld for taxes

 

405

 

 

1

 

 

7

 

 

 

 

 

 

8

 

Stock-based compensation expense

 

 

 

 

 

4,640

 

 

 

 

 

 

4,640

 

Net loss

 

 

 

 

 

 

 

 

 

(28,556

)

 

(28,556

)

Other comprehensive income

 

 

 

 

 

 

 

1

 

 

 

 

1

 

Balance at March 31, 2021

 

49,942

 

$

50

 

$

771,954

 

$

(10

)

$

(810,861

)

$

(38,867

)

Issuance of common stock for equity
   awards, net of shares withheld for taxes

 

46

 

 

 

 

 

 

 

 

 

 

 

Employee stock purchase plan

 

118

 

 

 

 

921

 

 

 

 

 

 

921

 

Stock-based compensation expense

 

 

 

 

 

3,975

 

 

 

 

 

 

3,975

 

Net loss

 

 

 

 

 

 

 

 

 

(22,208

)

 

(22,208

)

Other comprehensive income

 

 

 

 

 

 

 

8

 

 

 

 

8

 

Balance at June 30, 2021

 

50,106

 

$

50

 

$

776,850

 

$

(2

)

$

(833,069

)

$

(56,171

)

 

 

Common Stock

 

Additional

 

Accumulated
Other

 

 

 

Total

 

 

Shares

 

Par Value

 

Paid-in-
Capital

 

Comprehensive
Income (Loss)

 

Accumulated
Deficit

 

Stockholders'
(Deficit) Equity

 

Balance at December 31, 2019

 

38,361

 

$

38

 

$

648,391

 

$

62

 

$

(668,599

)

$

(20,108

)

Issuance of common stock for equity
   awards, net of shares withheld for taxes

 

201

 

 

1

 

 

8

 

 

 

 

 

 

9

 

Stock-based compensation expense

 

 

 

 

 

4,651

 

 

 

 

 

 

4,651

 

Net loss

 

 

 

 

 

 

 

 

 

(36,802

)

 

(36,802

)

Other comprehensive loss

 

 

 

 

 

 

 

(56

)

 

 

 

(56

)

Balance at March 31, 2020

 

38,562

 

$

39

 

$

653,050

 

$

6

 

$

(705,401

)

$

(52,306

)

Issuance of common stock, net of issuance costs

 

10,615

 

$

10

 

$

96,754

 

 

 

 

 

 

96,764

 

Issuance of common stock for equity
   awards

 

11

 

 

 

 

1

 

 

 

 

 

 

1

 

Employee stock purchase plan

 

82

 

 

 

 

891

 

 

 

 

 

 

891

 

Stock-based compensation expense

 

 

 

 

 

3,787

 

 

 

 

 

 

3,787

 

Net loss

 

 

 

 

 

 

 

 

 

(32,619

)

 

(32,619

)

Other comprehensive loss

 

 

 

 

 

 

 

(3

)

 

 

 

(3

)

Balance at June 30, 2020

 

49,270

 

$

49

 

$

754,483

 

$

3

 

$

(738,020

)

$

16,515

 

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)

 

 

Six Months Ended

 

 

June 30,

 

 

2021

 

2020

 

Cash flows from operating activities

 

 

 

 

Net loss

$

(50,764

)

$

(69,421

)

Adjustments to reconcile net loss to cash used in operating activities

 

 

 

 

Depreciation

 

1,046

 

 

751

 

Amortization of right-of-use assets

 

867

 

 

809

 

Stock-based compensation expense

 

8,615

 

 

8,438

 

Provision for inventory

 

560

 

 

 

Non cash interest expense

 

454

 

 

292

 

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

 

401

 

 

(52

)

Loss on disposal of fixed assets

 

 

 

262

 

Amortization of debt discount and debt issuance costs

 

5,028

 

 

4,577

 

Premium paid on securities purchased

 

3

 

 

(17

)

Changes in operating assets and liabilities:

 

 

 

 

Accounts receivable

 

(5,072

)

 

15,591

 

Inventory

 

2,533

 

 

(2,502

)

Prepaid expenses and other current assets

 

(362

)

 

328

 

Accounts payable

 

(1,286

)

 

(7,540

)

Accrued expenses and other current liabilities

 

1,469

 

 

(4,375

)

Deferred revenue

 

 

 

5,000

 

Lease liabilities

 

(728

)

 

(748

)

Net cash used in operating activities

 

(37,236

)

 

(48,607

)

Cash flows from investing activities

 

 

 

 

Purchases of property and equipment

 

(1,265

)

 

(5,538

)

Purchases of marketable securities

 

(2,000

)

 

(12,490

)

Sale and redemption of marketable securities

 

45,561

 

 

49,398

 

Net cash provided by investing activities

 

42,296

 

 

31,370

 

Cash flows from financing activities

 

 

 

 

Proceeds from borrowings under term loan

 

 

 

15,000

 

Proceeds from revolving line of credit

 

 

 

20,000

 

Repayments of revolving line of credit

 

 

 

(15,000

)

Proceeds from the offering of common stock

 

 

 

97,289

 

Proceeds from issuance of common stock (net of issuance costs)

 

1,700

 

 

Payments of public offering costs

 

(125

)

 

(107

)

Payments on notes payable

 

(7,639

)

 

Proceeds from the exercise of stock options (net of shares withheld for taxes)

 

8

 

 

10

 

Proceeds from employee stock purchase plan

 

921

 

 

891

 

Net cash (used in) provided by financing activities

 

(5,135

)

 

118,083

 

Net (decrease) increase in cash and cash equivalents

 

(75

)

 

100,846

 

Cash and cash equivalents at beginning of period

 

107,704

 

 

82,253

 

Cash and cash equivalents at end of period

$

107,629

 

$

183,099

 

Non-cash operating, investing and financing activities

 

 

 

 

Right-of-use asset obtained in exchange for operating lease obligation

 

433

 

 

 

Purchases of property and equipment in accounts payable and accrued expenses

 

264

 

 

2,126

 

Public offering costs in accounts payable and accrued expenses

 

 

 

418

 

Supplemental disclosures of cash flow information

 

 

 

 

Cash paid for interest

 

5,259

 

 

5,048

 

 

 

 

 

 

 

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, the most common form of 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 knee pain. ZILRETTA is a non-opioid therapy that employs Flexion’s proprietary microsphere technology to provide pain relief. The pivotal Phase 3 trial, on which the approval of ZILRETTA was based, showed that ZILRETTA met the primary endpoint of pain reduction at Week 12, with statistically significant pain relief extending through Week 16. The Company also has two pipeline programs focused on the local treatment of musculoskeletal conditions: FX201, an investigational IA gene therapy product candidate in clinical development for the treatment of OA, and FX301, a locally administered peripheral nerve block product candidate in clinical development for the control of post-operative pain.

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 will require significant additional research and development efforts, including extensive preclinical and clinical testing. These activities will in turn require significant amounts of capital, qualified personnel, and adequate infrastructure. There can be no assurance as to when, if ever, the Company will generate sales of ZILRETTA that are significant enough to achieve profitability or if the development efforts supporting the Company’s pipeline, including future clinical trials, will be successful.

The accompanying condensed consolidated financial statements have been prepared on a basis that assumes that the Company will continue as a going concern and that 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 June 30, 2021, the Company had cash, cash equivalents, and marketable securities of approximately $131.2 million.

Management believes that current cash, cash equivalents, and marketable securities on hand at June 30, 2021 will be sufficient to fund operations and debt obligations for at least the next 12 months from the issuance date of these financial statements. The Company currently expects to be able to maintain the liquidity threshold in the amended and restated credit agreement described in Note 9 for at least 12 months following the issuance of these financial statements. As a result, the revenue covenant under the amended and restated credit and security agreement is not expected to be applicable through 12 months from the issuance of the financial statements. As of June 30, 2021, the Company was in compliance with all financial covenants under the amended and restated credit and security agreement.

The Company’s operations have been and continue to be affected by the ongoing global pandemic of a novel strain of coronavirus (“COVID-19”). In March 2020, the World Health Organization declared COVID-19 a pandemic and recommended containment and mitigation measures worldwide. The COVID-19 pandemic has caused significant volatility and uncertainty, which could result in a prolonged economic downturn that has disrupted and is expected to continue to disrupt the Company’s business. While there have been no material asset impairments recorded to date, any prolonged material future disruptions to the work of the Company’s employees, suppliers, contract manufacturers, or vendors, or to the operations of physicians that administer ZILRETTA could negatively impact the Company’s operations, availability of supplies, carrying value of assets, operating results, or cash flows.

The future viability of the Company is dependent on its ability to fund its operations through sales of ZILRETTA, and/or raising additional capital, such as through debt or equity offerings, as needed. If the Company is unable to grow sales of ZILRETTA in future periods, it is possible that the Company may not maintain compliance with the revenue covenant, in the event it applies, in future periods. As a result, the Company could be required to repay its outstanding borrowings under the term loan and revolving credit facility and would seek additional financing. The Company may not be able to obtain financing on acceptable terms, or at all. In particular, as a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility and disruptions, including declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any additional debt or equity financing more difficult, more costly, and more dilutive. 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/or reduce the scope of, or delay certain research and development activities, including the FX201 or FX301 programs, which could adversely affect its prospects.

7


 

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements as of June 30, 2021, and for the three and six months ended June 30, 2021 and 2020, 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 that 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 10, 2021.

The information presented in the condensed consolidated financial statements and related notes as of June 30, 2021, and December 31, 2020, and for the three and six months ended June 30, 2021 and 2020, is unaudited. The December 31, 2020, 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 six months ended June 30, 2021, are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021, or any future period.

Recent Accounting Pronouncements

Accounting Standards Recently Issued

In August 2020, the FASB issued ASU No. 2020-06, (“ASU 2020-06”). The new standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity. The new guidance reduced the number of accounting models for convertible debt and convertible preferred stock instruments and made certain disclosure amendments intended to improve the information provided to users. The guidance also amended the derivative guidance for the “own stock” scope exception, which exempts qualifying instruments from being accounted for as derivatives if certain criteria are met. Finally, the standard changed the way certain convertible instruments are treated when calculating earnings per share. The standard is effective for the Company for fiscal years, and the interim periods within those years, beginning after December 15, 2021, and early adoption is permitted. The Company is currently evaluating the impact of ASU 2020-06 on the Company’s condensed consolidated financial statements.

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 six months ended June 30, 2021, and the year ended December 31, 2020.

Revenue Recognition

On October 6, 2017, the U.S. Food and Drug Administration (“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. The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“Topic 606”). Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that 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.

Product Revenue, Net

The Company primarily sells ZILRETTA to specialty distributors and a specialty pharmacy, who then subsequently resell ZILRETTA to physicians, clinics, and certain medical centers or hospitals. The Company also contracts directly with healthcare providers and intermediaries such as Group Purchasing Organizations (“GPOs”). In addition, the Company enters into arrangements with government payers that provide for government mandated rebates and chargebacks with respect to the purchase of ZILRETTA.

8


 

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.

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 that 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 that 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. 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 variances become known.

Service Fees and Allowances

The Company compensates its customers and GPOs 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 June 30, 2021, 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 received an immaterial amount of returns to date and believes that future returns of ZILRETTA will be minimal.

Chargebacks

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 U.S. 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.

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 that 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

9


 

under the Medicare Part D program. The Company estimates 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 that remains in the distribution channel inventories at the end of each reporting period.

Purchaser/Provider Discounts and Rebates

The Company offers rebates to eligible purchasers and healthcare providers that are variable based on volume of product purchased. Rebates are based on actual purchase levels during the rebate purchase period. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets.

Other Incentives

Other incentives that 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 that 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 six months ended June 30, 2021 and 2020:

(In thousands)

Service Fees,
Allowances and
Chargebacks

 

Government
Rebates and
Other
Incentives

 

Product Returns

 

Purchaser/ Provider Discounts and Rebates

 

Total

 

Balance as of December 31, 2020

$

1,733

 

$

530

 

$

628

 

$

1,832

 

$

4,723

 

Provision related to sales in the current quarter

 

2,188

 

 

383

 

 

151

 

 

2,703

 

 

5,425

 

Credits and payments made

 

(1,969

)

 

(266

)

 

(9

)

 

(1,832

)

 

(4,076

)

Adjustments related to prior period sales

 

 

 

 

 

(111

)

 

 

 

(111

)

Balance as of March 31, 2021

 

1,952

 

 

647

 

 

659

 

 

2,703

 

 

5,961

 

Provision related to sales in the current quarter

 

2,682

 

 

424

 

 

179

 

 

3,100

 

 

6,385

 

Credits and payments made

 

(2,527

)

 

(311

)

 

(86

)

 

(2,711

)

 

(5,635

)

Adjustments related to prior period sales

 

(10

)

 

 

 

 

 

 

 

(10

)

Balance as of June 30, 2021

$

2,097

 

$

760

 

$

752

 

$

3,092

 

$

6,701

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2019

$

1,847

 

$

248

 

$

402

 

$

1,656

 

$

4,153

 

Provision related to sales in the current quarter

 

1,590

 

 

254

 

 

114

 

 

526

 

 

2,484

 

Credits and payments made

 

(1,852

)

 

(199

)

 

(10

)

 

(1,656

)

 

(3,717

)

Adjustments related to prior period sales

 —

 

 

95

 

 —

 

 —

 

 

95

 

Balance as of March 31, 2020

 

1,585

 

 

398

 

 

506

 

 

526

 

 

3,015

 

Provision related to sales in the current quarter

 

1,417

 

 

133

 

 

98

 

 

892

 

 

2,540

 

Credits and payments made

 

(1,172

)

 

(262

)

 

(1

)

 

(528

)

 

(1,963

)

Adjustments related to prior period sales

 —

 

 

90

 

 

 

 

2

 

 

92

 

Balance as of June 30, 2020

$

1,830

 

$

359

 

$

603

 

$

892

 

$

3,684

 

License Agreement – On March 30, 2020, the Company entered into an exclusive license agreement with Hong Kong Tainuo Pharma Ltd. (“HK Tainuo”) and Jiangsu Tainuo Pharmaceutical Co. Ltd. (“Jiangsu Tainuo”), a subsidiary of China Shijiazhuang Pharmaceutical Co, Ltd., for the development and commercialization (other than manufacturing) of ZILRETTA in Greater China (consisting of mainland China, Hong Kong and Macau, and Taiwan). Under the terms of the agreement, HK Tainuo paid the Company an upfront payment of $10.0 million, of which $5.0 million was received as of June 30, 2020, and the remaining $5.0 million was received as of September 30, 2020. The Company is also eligible to receive up to $32.5 million in aggregate development, regulatory, and commercial sales milestone payments. All payments received from HK Tainuo are subject to applicable Hong Kong withholding taxes. HK Tainuo is responsible for the clinical development, product registration, and commercialization of ZILRETTA in Greater China, and Jiangsu Tainuo serves as the guarantor of HK Tainuo’s obligations and responsibilities under the agreement. The Company is solely responsible for the manufacture and supply of ZILRETTA to HK Tainuo for all clinical and commercial activities. The terms related to product manufacturing and supply, including pricing and minimum purchase requirements agreed to in the license

10


 

agreement, will be covered by a separate supply agreement, which has not yet been finalized. All amounts owed to the Company are nonrefundable and non-creditable once paid. Unless terminated earlier in accordance with its terms, the license agreement continues in effect in perpetuity or as long as HK Tainuo or Jiangsu Tainuo continue to sell ZILRETTA in Greater China. Either party may terminate the agreement prior to expiration in the event of a material breach if not cured within 60 days from the date of notice of such breach (30 days in the case of payment obligations), or either party files for bankruptcy. The Company also has the right to terminate the agreement if HK Tainuo, Jiangsu Tainuo, or any affiliate of each commences any action or proceeding that challenges the validity, enforceability, or scope of any Company patent in Greater China. Upon any such termination, the license granted to HK Tainuo will terminate and all know-how and patents will revert back to the Company. The Company concluded that the license and supply obligations were not distinct performance obligations, and therefore the transaction price will be recognized as revenue as the Company’s supply obligation is fulfilled over the term of the supply agreement, which has not yet commenced. No revenue was recognized associated with this contract as of June 30, 2021. The proceeds associated with the upfront payment have been recorded in short-term deferred revenue on the Company’s condensed consolidated balance sheet as of June 30, 2021, as there is uncertainty around the timing of when the revenue will be recognized. The Company will re-evaluate the classification of deferred revenue when the supply agreement is finalized.

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 recognition and accrued expenses related to preclinical and clinical development 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.

The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations, and financial condition, including sales, expenses, reserves and allowances, clinical trials, research and development expenses, and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national, and international customers and markets. The Company has made estimates of the impact of COVID-19 within its financial statements, and there may be changes to those estimates in future periods.

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

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.

Leases

The Company determines if an arrangement is a lease at contract inception. Operating lease assets represent a right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. Operating lease liabilities with a term greater than one year and their corresponding right-of-use assets are recognized on the balance sheet at the commencement date of the lease based on the present value of lease payments over the expected lease term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The

11


 

Company made an accounting policy election to expense leases with a term of one year or less on a straight-line basis over the lease term. To date, the Company has not identified any material short-term leases, either individually or in the aggregate.

As the Company’s leases do not provide an implicit rate, the Company utilized the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company estimated the incremental borrowing rate based on a yield curve analysis of companies with a similar credit rating to its own, which was calculated using a number of financial ratios and qualitative considerations of the Company’s business. The yields on the Company’s currently outstanding debt (the convertible senior notes and term loan described below) were also used as inputs to the analysis to calculate a spread, adjusted for factors that reflect the profile of secured borrowing over the expected term of the lease.

The components of a lease should be split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, utilities, performance of manufacturing services, purchase of inventory, etc.), and non-components (e.g., property taxes, insurance, etc.). Then the fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain practical expedients are available to entities. Entities electing the practical expedient would not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company has elected to use this practical expedient for its real estate leases and account for each lease component and related non-lease component as one single component. In contrast, the Company has elected not to apply the practical expedient for its lease of manufacturing space at Patheon and has instead allocated consideration between the lease and non-lease components of the contract. The Company calculated the fair value of the lease component using publicly available information to identify comparable rentals in the same geographic area. The remainder of the consideration was allocated to the non-lease components. 

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 June 30, 2021 and December 31, 2020, and indicate the level of the fair value hierarchy utilized to determine such fair value:

 

 

Fair Value Measurements as of June 30, 2021 Using:

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

90,169

 

 

$

 

 

$

 

 

$

90,169

 

Marketable securities

 

 

 

 

 

23,620

 

 

 

 

 

 

23,620

 

 

 

$