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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

 

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

 

For the quarterly period ended September 30, 2021

OR

f

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: 001-35945

 

EPIZYME, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

26-1349956

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

400 Technology Square, 4th Floor

Cambridge, Massachusetts

02139

(Address of principal executive offices)

(Zip code)

617-229-5872

(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, $0.0001 par value

EPZM

Nasdaq Global Select Market

The number of shares outstanding of the registrant’s common stock as of November 4, 2021: 103,895,022 shares.

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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See 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 ☒

 

 


 

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

Item 1. Financial Statements. — Unaudited

5

 

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020

5

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020

6

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020

7

 

 

Condensed Consolidated Statements of Stockholders Equity

8

 

 

Notes to Condensed Consolidated Financial Statements

9

 

 

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

33

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

48

 

 

Item 4. Controls and Procedures

48

 

 

PART II — OTHER INFORMATION

 

 

 

Item 1A. Risk Factors

49

 

 

Item 6. Exhibits

53

 

 

Signatures

54

 

Epizyme® and TAZVERIK® are registered trademarks of Epizyme, Inc. in the United States and other countries. Epizyme, Inc. has also submitted trademark applications for Epizyme™ and TAZVERIK™ in other countries. All other trademarks, service marks or other tradenames appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.

 

 

 


 

Forward-looking Information

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. These statements may be identified by such forward-looking terminology as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar statements or variations of such terms. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

our plans to develop and commercialize novel epigenetic medicines for patients with cancer;
the ongoing commercialization of TAZVERIK;
our sales, marketing and distribution capabilities and strategies, including for the commercialization and manufacturing of TAZVERIK and any future products;
the rate and degree of market acceptance and clinical utility of TAZVERIK and any future products;
our ongoing and planned clinical trials, including the timing of initiation and enrollment in the trials, the timing of availability of data from the trials and the anticipated results of the trials;
the timing of and our ability to apply for, obtain and maintain regulatory approvals for tazemetostat in epithelioid sarcoma, follicular lymphoma and other indications and for any future product candidates;
our ability to achieve anticipated milestones under our collaborations or to enter into additional collaborations;
the impact of the COVID-19 pandemic on our business, results of operations, and financial condition;
our intellectual property position;
our ability to successfully implement and execute on our changes to our commercial strategy and organization, adjustments to our operating plans, including operating expense reductions, and leadership transitions; and
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

All of our forward-looking statements are made as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information as a result of various important factors. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, or our Annual Report, or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission, or the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q which modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

Our management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared by us in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim periods and with Regulation S-X promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our management’s discussion and analysis should be read in conjunction with these unaudited condensed consolidated financial statements and the notes thereto as well as in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report. The three months ended September 30, 2021 and 2020 are referred to as the third quarter of 2021 and 2020, respectively.

 

3


 

Note regarding certain references in this Quarterly Report on Form 10-Q

Unless otherwise stated or the context indicates otherwise, all references herein to “Epizyme,” “Epizyme, Inc.,” “we,” “us,” “our,” “our company,” “the Company” and similar references refer to Epizyme, Inc. and its wholly owned subsidiary, Epizyme Securities Corporation.

In addition, unless otherwise stated or the context indicates otherwise, all references in this Quarterly Report on Form 10-Q to “TAZVERIK (tazemetostat)” and “TAZVERIK” refer to tazemetostat in the context of the commercially-available product for which we received accelerated approval from the United States Food and Drug Administration in January 2020 for epithelioid sarcoma and in June 2020 for follicular lymphoma, as more fully described herein; whereas, unless otherwise stated or the context indicates otherwise, all references herein to “tazemetostat” refer to tazemetostat in the context of the product candidate for which we are exploring further applications and indications, as more fully described herein.

4


 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

EPIZYME, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(Amounts in thousands, except per share data)

 

 

 

September 30,
2021

 

 

December 31,
2020

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

124,517

 

 

$

168,215

 

Marketable securities

 

 

96,776

 

 

 

205,391

 

Accounts receivable, net

 

 

3,332

 

 

 

3,105

 

Inventory

 

 

1,521

 

 

 

10,461

 

Prepaid expenses and other current assets

 

 

21,455

 

 

 

17,921

 

Total current assets

 

 

247,601

 

 

 

405,093

 

Property and equipment, net

 

 

1,739

 

 

 

2,152

 

Operating lease assets

 

 

21,141

 

 

 

17,305

 

Intangible assets, net

 

 

43,887

 

 

 

47,002

 

Restricted cash and other assets

 

 

17,903

 

 

 

2,021

 

Total assets

 

$

332,271

 

 

$

473,573

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

9,862

 

 

$

10,163

 

Accrued expenses

 

 

30,922

 

 

 

28,572

 

Current portion of operating lease obligation

 

 

3,951

 

 

 

4,665

 

Total current liabilities

 

 

44,735

 

 

 

43,400

 

Operating lease obligation, net of current portion

 

 

19,741

 

 

 

15,409

 

Related party long-term debt, net of debt discount

 

 

216,254

 

 

 

215,670

 

Other long-term liabilities

 

 

 

 

 

21

 

Deferred revenue

 

 

11,950

 

 

 

 

Related party liability related to sale of future royalties

 

 

15,581

 

 

 

14,176

 

Warrants to purchase common stock

 

 

8,630

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 5,000 shares authorized; 338 shares issued and outstanding (equivalent to 3,378 shares of common stock upon conversion at a 10:1 ratio)

 

 

36,127

 

 

 

36,127

 

Common stock, $0.0001 par value; 225,000 shares and 150,000 shares authorized, respectively; 103,662 shares and 101,627 shares issued and outstanding, respectively

 

 

10

 

 

 

10

 

Additional paid-in capital

 

 

1,168,430

 

 

 

1,137,470

 

Accumulated other comprehensive income (loss)

 

 

(3

)

 

 

3

 

Accumulated deficit

 

 

(1,189,184

)

 

 

(988,713

)

Total stockholders’ equity

 

 

15,380

 

 

 

184,897

 

Total liabilities and stockholders’ equity

 

$

332,271

 

 

$

473,573

 

 

See notes to condensed consolidated financial statements.

5


 

EPIZYME, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(Amounts in thousands, except per share data)

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

$

5,186

 

 

$

3,445

 

 

$

19,364

 

 

$

6,963

 

Collaboration and other revenue

 

15

 

 

 

121

 

 

 

6,480

 

 

 

424

 

Total revenue

 

5,201

 

 

 

3,566

 

 

 

25,844

 

 

 

7,387

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

1,999

 

 

 

1,608

 

 

 

7,345

 

 

 

3,244

 

Research and development

 

34,549

 

 

 

25,738

 

 

 

102,110

 

 

 

77,253

 

Selling, general and administrative

 

32,793

 

 

 

30,575

 

 

 

103,095

 

 

 

90,161

 

 Total operating expenses

 

69,341

 

 

 

57,921

 

 

 

212,550

 

 

 

170,658

 

Operating loss

 

(64,140

)

 

 

(54,355

)

 

 

(186,706

)

 

 

(163,271

)

Other (expense) income, net:

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

(5,645

)

 

 

(1,364

)

 

 

(16,703

)

 

 

(1,177

)

Other expense, net

 

(24

)

 

 

(42

)

 

 

(70

)

 

 

(105

)

Change in fair value of warrants to purchase common stock

 

4,420

 

 

 

-

 

 

 

4,420

 

 

 

-

 

Related party non-cash interest expense related to sale of future royalties

 

(445

)

 

 

(312

)

 

 

(1,412

)

 

 

(908

)

Other expense, net

 

(1,694

)

 

 

(1,718

)

 

 

(13,765

)

 

 

(2,190

)

Net loss

$

(65,834

)

 

$

(56,073

)

 

$

(200,471

)

 

$

(165,461

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

Unrealized (loss) gain on available-for-sale securities

 

(1

)

 

 

(340

)

 

 

(6

)

 

 

101

 

Comprehensive loss

$

(65,835

)

 

$

(56,413

)

 

$

(200,477

)

 

$

(165,360

)

Net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.64

)

 

$

(0.55

)

 

$

(1.96

)

 

$

(1.64

)

Diluted

$

(0.64

)

 

$

(0.55

)

 

$

(1.96

)

 

$

(1.64

)

Weighted-average common shares outstanding used in net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

102,513

 

 

 

101,512

 

 

 

102,123

 

 

 

100,747

 

Diluted

 

102,513

 

 

 

101,512

 

 

 

102,123

 

 

 

100,747

 

 

See notes to condensed consolidated financial statements.

6


 

EPIZYME, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(Amounts in thousands)

 

 

Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(200,471

)

 

$

(165,461

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

3,915

 

 

 

2,674

 

Stock-based compensation

 

 

19,903

 

 

 

21,188

 

Amortization of discount (premium) on investments

 

 

923

 

 

 

(262

)

Amortization of debt discount

 

 

584

 

 

 

260

 

Change in fair value of warrant liability

 

 

(4,420

)

 

 

 

Loss on disposal of property and equipment

 

 

 

 

 

19

 

Non-cash interest expense associated with the sale of future royalties

 

 

1,412

 

 

 

908

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(227

)

 

 

(2,044

)

Inventory, current and noncurrent

 

 

(6,483

)

 

 

(8,157

)

Prepaid expenses and other current assets

 

 

(3,267

)

 

 

(2,987

)

Accounts payable

 

 

(308

)

 

 

(1,296

)

Accrued expenses

 

 

2,300

 

 

 

263

 

Deferred revenue

 

 

11,950

 

 

 

7

 

Operating lease assets

 

 

(3,836

)

 

 

2,791

 

Operating lease liabilities

 

 

3,618

 

 

 

(1,099

)

Other assets and liabilities

 

 

(480

)

 

 

(25

)

Net cash used in operating activities

 

 

(174,887

)

 

 

(153,221

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Purchases of available-for-sale securities

 

 

(203,895

)

 

 

(156,938

)

Maturities of available-for-sale securities

 

 

311,581

 

 

 

212,421

 

Purchase of intangible asset

 

 

 

 

 

(50,000

)

Purchases of property and equipment

 

 

(387

)

 

 

(594

)

Net cash provided by investing activities

 

 

107,299

 

 

 

4,889

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of commissions

 

 

8,261

 

 

 

 

Payment of offering costs

 

 

(217

)

 

 

(79

)

Proceeds from the issuance of debt

 

 

 

 

 

45,000

 

Proceeds from the issuance of warrants

 

 

13,050

 

 

 

 

Payment of debt issuance costs

 

 

 

 

 

(93

)

Proceeds from the issuance of common stock in connection with the exercise of the Put Option, net of financing costs

 

 

 

 

 

49,915

 

Proceeds from stock options exercised

 

 

916

 

 

 

6,275

 

Proceeds from the issuance of shares under employee stock purchase plan

 

 

1,880

 

 

 

1,254

 

Net cash provided by financing activities

 

 

23,890

 

 

 

102,272

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(43,698

)

 

 

(46,060

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

169,724

 

 

 

140,991

 

Cash, cash equivalents and restricted cash, end of period

 

$

126,026

 

 

$

94,931

 

SUPPLEMENTAL CASH FLOW INFORMATION:

 

 

 

 

 

 

Interest paid

 

$

16,266

 

 

$

3,635

 

Unpaid offering costs

 

$

50

 

 

$

 

Property and equipment included in accounts payable or accruals

 

$

 

 

$

42

 

 

See notes to condensed consolidated financial statements

7


 

EPIZYME, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDER’S EQUITY

(Amounts in thousands, except share amounts)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2019

 

 

97,783,476

 

 

$

10

 

 

 

350,000

 

 

$

37,432

 

 

$

1,050,695

 

 

$

(757,019

)

 

$

19

 

 

$

331,137

 

Issuance of common stock in connection with the exercise of the Put Option (net of financing costs of $85)

 

 

2,500,000

 

 

 

 

 

 

 

 

 

 

 

 

49,915

 

 

 

 

 

 

 

 

 

49,915

 

Issuance of common stock in connection with the conversion of series A convertible preferred stock

 

 

122,000

 

 

 

 

 

 

(12,200

)

 

 

(1,305

)

 

 

1,305

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and vesting of restricted stock units

 

 

579,919

 

 

 

 

 

 

 

 

 

 

 

 

3,140

 

 

 

 

 

 

 

 

 

3,140

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,475

 

 

 

 

 

 

 

 

 

6,475

 

Issuance of shares under employee stock purchase plan

 

 

60,576

 

 

 

 

 

 

 

 

 

 

 

646

 

 

 

 

 

 

 

 

 

646

 

Issuance of shares of common stock in lieu of board fees

 

 

1,404

 

 

 

 

 

 

 

 

 

 

 

 

35

 

 

 

 

 

 

 

 

 

35

 

Unrealized loss on available for sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(94

)

 

 

(94

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,937

)

 

 

 

 

 

(50,937

)

Balance at March 31, 2020

 

 

101,047,375

 

 

$

10

 

 

 

337,800

 

 

$

36,127

 

 

$

1,112,211

 

 

$

(807,956

)

 

$

(75

)

 

$

340,317

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and vesting of restricted stock units

 

 

414,150

 

 

 

 

 

 

 

 

 

 

 

$

2,670

 

 

 

 

 

 

 

 

 

2,670

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,257

 

 

 

 

 

 

 

 

 

8,257

 

Issuance of shares of common stock in lieu of board fees

 

 

2,229

 

 

 

 

 

 

 

 

 

 

 

 

35

 

 

 

 

 

 

 

 

 

35

 

Unrealized gain on available for sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

535

 

 

 

535

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(58,451

)