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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 March 31, 2023

OR

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

Commission File Number 001-35839

 

ENANTA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

DELAWARE

 

04-3205099

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

500 Arsenal Street

Watertown, Massachusetts

 

02472

(Address of principal executive offices)

 

(Zip Code)

 

(Registrants telephone number, including area code:) (617) 607-0800

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

ENTA

NASDAQ

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 an 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 April 28, 2023, the registrant had 21,055,392 shares of common stock, $0.01 par value per share, outstanding.

 

 

 


Table of Contents

 

Page

PART I.

UNAUDITED FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements

3

Consolidated Balance Sheets

3

Consolidated Statements of Operations

4

Consolidated Statements of Comprehensive Loss

5

 

Consolidated Statements of Stockholders' Equity

6

Consolidated Statements of Cash Flows

7

Notes to Consolidated Financial Statements (unaudited)

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

 

Item 1A.

Risk Factors

25

Item 6.

Exhibits

26

Signatures

27

 

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q ("Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “will” or the negative of these terms or other similar expressions. We caution you that the foregoing list may not encompass all of the forward-looking statements made in this Quarterly Report.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2022.

2


PART I—UNAUDITED FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

ENANTA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except per share amounts)

 

 

 

March 31,

 

 

September 30,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

73,178

 

 

$

43,994

 

Short-term marketable securities

 

 

136,906

 

 

 

205,238

 

Accounts receivable

 

 

17,795

 

 

 

20,318

 

Prepaid expenses and other current assets

 

 

14,484

 

 

 

13,445

 

Income tax receivable

 

 

28,774

 

 

 

28,718

 

Total current assets

 

 

271,137

 

 

 

311,713

 

Long-term marketable securities

 

 

15,040

 

 

 

29,285

 

Property and equipment, net

 

 

11,050

 

 

 

6,173

 

Operating lease, right-of-use assets

 

 

24,554

 

 

 

23,575

 

Restricted cash

 

 

3,968

 

 

 

3,968

 

Other long-term assets

 

 

696

 

 

 

696

 

Total assets

 

$

326,445

 

 

$

375,410

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

11,761

 

 

$

6,000

 

Accrued expenses and other current liabilities

 

 

15,482

 

 

 

20,936

 

Operating lease liabilities

 

 

4,923

 

 

 

2,891

 

Total current liabilities

 

 

32,166

 

 

 

29,827

 

Operating lease liabilities, net of current portion

 

 

23,073

 

 

 

22,372

 

Series 1 nonconvertible preferred stock

 

 

1,423

 

 

 

1,423

 

Other long-term liabilities

 

 

408

 

 

 

454

 

Total liabilities

 

 

57,070

 

 

 

54,076

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common stock; $0.01 par value per share, 100,000 shares authorized;
   
21,049 and 20,791 shares issued and outstanding at March 31, 2023
   and September 30, 2022, respectively

 

 

210

 

 

 

208

 

Additional paid-in capital

 

 

410,803

 

 

 

398,029

 

Accumulated other comprehensive loss

 

 

(1,815

)

 

 

(3,724

)

Accumulated deficit

 

 

(139,823

)

 

 

(73,179

)

Total stockholders' equity

 

 

269,375

 

 

 

321,334

 

Total liabilities and stockholders' equity

 

$

326,445

 

 

$

375,410

 

 

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

3


ENANTA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

Six Months Ended March 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

17,795

 

 

$

18,716

 

 

$

40,380

 

 

$

46,364

 

License revenue

 

 

 

 

 

 

 

 

1,000

 

 

 

 

Total revenue

 

 

17,795

 

 

 

18,716

 

 

 

41,380

 

 

 

46,364

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

43,468

 

 

 

42,087

 

 

 

84,370

 

 

 

90,636

 

General and administrative

 

 

13,778

 

 

 

10,476

 

 

 

26,474

 

 

 

19,984

 

Total operating expenses

 

 

57,246

 

 

 

52,563

 

 

 

110,844

 

 

 

110,620

 

Loss from operations

 

 

(39,451

)

 

 

(33,847

)

 

 

(69,464

)

 

 

(64,256

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest and investment income, net

 

 

1,837

 

 

 

255

 

 

 

2,830

 

 

 

549

 

Total other income, net

 

 

1,837

 

 

 

255

 

 

 

2,830

 

 

 

549

 

Loss before income taxes

 

 

(37,614

)

 

 

(33,592

)

 

 

(66,634

)

 

 

(63,707

)

Income tax expense

 

 

(44

)

 

 

 

 

 

(10

)

 

 

 

Net loss

 

$

(37,658

)

 

$

(33,592

)

 

$

(66,644

)

 

$

(63,707

)

Net loss per share, basic and diluted

 

$

(1.79

)

 

$

(1.63

)

 

$

(3.19

)

 

$

(3.11

)

Weighted average common shares outstanding, basic and
   diluted

 

 

21,035

 

 

 

20,551

 

 

 

20,882

 

 

 

20,473

 

 

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

4


ENANTA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

Six Months Ended March 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net loss

 

$

(37,658

)

 

$

(33,592

)

 

$

(66,644

)

 

$

(63,707

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized gains (losses) on marketable securities

 

 

860

 

 

 

(2,031

)

 

 

1,909

 

 

 

(2,655

)

Total other comprehensive income (loss)

 

 

860

 

 

 

(2,031

)

 

 

1,909

 

 

 

(2,655

)

Comprehensive loss

 

$

(36,798

)

 

$

(35,623

)

 

$

(64,735

)

 

$

(66,362

)

 

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

5


ENANTA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balances at September 30, 2022

 

 

20,791

 

 

$

208

 

 

$

398,029

 

 

$

(3,724

)

 

$

(73,179

)

 

$

321,334

 

Exercise of stock options

 

 

56

 

 

 

1

 

 

 

1,125

 

 

 

 

 

 

 

 

 

1,126

 

Vesting of restricted stock units, net of
   withholding

 

 

37

 

 

 

 

 

 

(825

)

 

 

 

 

 

 

 

 

(825

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,139

 

 

 

 

 

 

 

 

 

7,139

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

1,049

 

 

 

 

 

 

1,049

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28,986

)

 

 

(28,986

)

Balances at December 31, 2022

 

 

20,884

 

 

 

209

 

 

 

405,468

 

 

 

(2,675

)

 

 

(102,165

)

 

 

300,837

 

Exercise of stock options

 

 

61

 

 

 

1

 

 

 

881

 

 

 

 

 

 

 

 

 

882

 

Vesting of restricted stock units, net of
   withholding

 

 

104

 

 

 

 

 

 

(2,909

)

 

 

 

 

 

 

 

 

(2,909

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,363

 

 

 

 

 

 

 

 

 

7,363

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

860

 

 

 

 

 

 

860

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,658

)

 

 

(37,658

)

Balances at March 31, 2023

 

 

21,049

 

 

$

210

 

 

$

410,803

 

 

$

(1,815

)

 

$

(139,823

)

 

$

269,375

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

Retained

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

Earnings

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

(Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit)

 

 

Equity

 

Balances at September 30, 2021

 

 

20,238

 

 

$

202

 

 

$

351,033

 

 

$

(382

)

 

$

48,576

 

 

$

399,429

 

Exercise of stock options

 

 

248

 

 

 

2

 

 

 

10,407

 

 

 

 

 

 

 

 

 

10,409

 

Vesting of restricted stock units, net of
   withholding

 

 

20

 

 

 

1

 

 

 

(778

)

 

 

 

 

 

 

 

 

(777

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

6,062

 

 

 

 

 

 

 

 

 

6,062

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(624

)

 

 

 

 

 

(624

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,115

)

 

 

(30,115

)

Balances at December 31, 2021

 

 

20,506

 

 

 

205

 

 

 

366,724

 

 

 

(1,006

)

 

 

18,461

 

 

 

384,384

 

Exercise of stock options

 

 

97

 

 

 

1

 

 

 

3,801

 

 

 

 

 

 

 

 

 

3,802

 

Vesting of restricted stock units, net of
   withholding

 

 

15

 

 

 

 

 

 

(451

)

 

 

 

 

 

 

 

 

(451

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

6,471

 

 

 

 

 

 

 

 

 

6,471

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(2,031

)

 

 

 

 

 

(2,031

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(33,592

)

 

 

(33,592

)

Balances at March 31, 2022

 

 

20,618

 

 

$

206

 

 

$

376,545

 

 

$

(3,037

)

 

$

(15,131

)

 

$

358,583

 

 

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

6


ENANTA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

Six Months Ended March 31,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(66,644

)

 

$

(63,707

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

14,502

 

 

 

12,533

 

Depreciation and amortization expense

 

 

1,051

 

 

 

1,602

 

Premium paid on marketable securities

 

 

(42

)

 

 

(802

)

Amortization (accretion) of premiums (discounts) on marketable securities

 

 

(1,345

)

 

 

928

 

Loss on disposal of property and equipment

 

 

7

 

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

2,523

 

 

 

4,860

 

Prepaid expenses and other current assets

 

 

(1,039

)

 

 

110

 

Income tax receivable

 

 

(56

)

 

 

8,507

 

Operating lease, right-of-use assets

 

 

1,891

 

 

 

2,784

 

Accounts payable

 

 

5,963

 

 

 

(3,473

)

Accrued expenses

 

 

(6,052

)

 

 

(808

)

Operating lease liabilities

 

 

(137

)

 

 

(2,498

)

Other long-term liabilities

 

 

(46

)

 

 

318

 

Net cash used in operating activities

 

 

(49,424

)

 

 

(39,646

)

Cash flows from investing activities

 

 

 

 

 

 

Purchase of marketable securities

 

 

(90,627

)

 

 

(124,631

)

Proceeds from maturities and sales of marketable securities

 

 

176,500

 

 

 

135,514

 

Purchase of property and equipment

 

 

(5,539

)

 

 

(437

)

Net cash provided by investing activities

 

 

80,334

 

 

 

10,446

 

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

2,008

 

 

 

14,211

 

Payments for settlement of share-based awards

 

 

(3,734

)

 

 

(1,228

)

Net cash provided by (used in) financing activities

 

 

(1,726

)

 

 

12,983

 

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

 

 

29,184

 

 

 

(16,217

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

47,962

 

 

 

57,814

 

Cash, cash equivalents and restricted cash at end of period

 

$

77,146