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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 June 30, 2020

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: 001-37519

 

AIMMUNE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

45-2748244

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

8000 Marina Blvd., Suite 300

Brisbane, California 94005

(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (650614-5220

 

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 $0.0001 per share

 

AIMT

 

NASDAQ Global Select 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 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 July 24, 2020, the registrant had 65,450,142 shares of common stock, $0.0001 par value per share, outstanding.

 

 


AIMMUNE THERAPEUTICS, INC.

TABLE OF CONTENTS

 

 

 

Page

 

 

 

 

 

 

PART I. – FINANCIAL INFORMATION

 

3

Item 1.

 

Condensed Consolidated Financial Statements (Unaudited)

 

3

 

 

Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019

 

3

 

 

Condensed Consolidated Statements of Comprehensive Loss for the Quarters and Six Months Ended June 30, 2020 and 2019

 

4

 

  

Condensed Consolidated Statements of Stockholders’ Equity as of June 30, 2020 and 2019

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2020 and 2019

 

7

 

 

Notes to Condensed Consolidated Financial Statements

 

8

Item 2.

 

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

 

21

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

31

Item 4.

 

Controls and Procedures

 

31

 

 

 

 

 

PART II. – OTHER INFORMATION

 

33

Item 1.

 

Legal Proceedings

 

33

Item 1A.

 

Risk Factors

 

33

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

76

Item 3.

 

Defaults Upon Senior Securities

 

76

Item 4.

 

Mine Safety Disclosures

 

76

Item 5.

 

Other Information

 

76

Item 6.

 

Exhibits

 

77

SIGNATURES

 

79

 

 

 


PART I. – FINANCIAL INFORMATION

Item 1. Financial Statements

AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

266,559

 

 

$

79,880

 

Short-term investments

 

 

47,394

 

 

 

63,633

 

Trade receivables, net

 

 

25

 

 

 

 

Inventories

 

 

5,646

 

 

 

 

Prepaid expenses and other current assets

 

 

4,017

 

 

 

5,564

 

Total current assets

 

 

323,641

 

 

 

149,077

 

Long-term investments

 

 

4,127

 

 

 

14,661

 

Property and equipment, net

 

 

26,540

 

 

 

28,604

 

Operating lease right-of-use assets

 

 

10,397

 

 

 

11,512

 

Prepaid expenses and other assets

 

 

581

 

 

 

515

 

Total assets

 

$

365,286

 

 

$

204,369

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,107

 

 

$

13,882

 

Accrued liabilities

 

 

25,468

 

 

 

31,286

 

Operating lease liabilities, current

 

 

2,399

 

 

 

2,257

 

Other current liabilities

 

 

27

 

 

 

23

 

Total current liabilities

 

 

43,001

 

 

 

47,448

 

Long term debt, net of discount

 

 

131,462

 

 

 

41,028

 

Operating lease liabilities

 

 

9,323

 

 

 

10,524

 

Other liabilities

 

 

1,642

 

 

 

1,345

 

Total liabilities

 

 

185,428

 

 

 

100,345

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

   Preferred stock, par value $0.0001 per share— 10,000 shares authorized at

     June 30, 2020 and December 31, 2019; 526 and 0 shares issued and

     outstanding at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

 

Common stock, par value $0.0001 per share—290,000 shares authorized as of

  June 30, 2020 and December 31, 2019; 65,440 and 63,779 shares issued and

  outstanding as of June 30, 2020 and December 31, 2019, respectively

 

 

7

 

 

 

6

 

Additional paid-in capital

 

 

1,059,968

 

 

 

828,618

 

Accumulated other comprehensive income

 

 

239

 

 

 

80

 

Accumulated deficit

 

 

(880,356

)

 

 

(724,680

)

Total stockholders’ equity

 

 

179,858

 

 

 

104,024

 

Total liabilities and stockholders’ equity

 

$

365,286

 

 

$

204,369

 

 

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

3


AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands, except per share amounts)

(Unaudited)

 

 

Quarter Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Product revenue, net

 

$

 

 

$

 

 

$

575

 

 

$

 

Costs and operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

4,850

 

 

 

 

 

$

5,107

 

 

 

 

Research and development

 

 

23,047

 

 

 

31,988

 

 

 

59,510

 

 

 

63,304

 

Selling, general and administrative

 

 

38,094

 

 

 

31,200

 

 

 

87,232

 

 

 

54,912

 

Total costs and operating expenses

 

 

65,991

 

 

 

63,188

 

 

 

151,849

 

 

 

118,216

 

Loss from operations

 

 

(65,991

)

 

 

(63,188

)

 

 

(151,274

)

 

 

(118,216

)

Interest income

 

 

428

 

 

 

1,710

 

 

 

1,406

 

 

 

3,611

 

Interest expense

 

 

(3,212

)

 

 

(1,262

)

 

 

(5,441

)

 

 

(2,406

)

Other income, net

 

 

(148

)

 

 

(90

)

 

 

73

 

 

 

(56

)

Loss before provision for income taxes

 

 

(68,923

)

 

 

(62,830

)

 

 

(155,236

)

 

 

(117,067

)

Provision for income taxes

 

 

321

 

 

 

48

 

 

 

440

 

 

 

77

 

Net loss

 

$

(69,244

)

 

$

(62,878

)

 

$

(155,676

)

 

$

(117,144

)

Other comprehensive loss, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

$

8

 

 

$

 

 

$

18

 

 

$

 

Unrealized gain on available-for-sale investments

 

 

68

 

 

 

174

 

 

 

141

 

 

 

345

 

Comprehensive loss

 

$

(69,168

)

 

$

(62,704

)

 

$

(155,517

)

 

$

(116,799

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.06

)

 

$

(1.01

)

 

$

(2.40

)

 

$

(1.88

)

Weighted average shares used in computing net loss per common

   share, basic and diluted

 

 

65,182

 

 

 

62,332

 

 

 

64,848

 

 

 

62,178

 

 

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

 


4


AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2019

 

 

 

 

$

 

 

 

63,779

 

 

$

6

 

 

$

828,618

 

 

$

80

 

 

$

(724,680

)

 

$

104,024

 

Issuance of common stock

   pursuant to development

   arrangement

 

 

 

 

 

 

 

 

156

 

 

 

 

 

 

5,000

 

 

 

 

 

 

 

 

 

5,000

 

Issuance of preferred and

   common stock pursuant

   to financing arrangement

 

 

526

 

 

 

 

 

 

1,000

 

 

 

1

 

 

 

199,906

 

 

 

 

 

 

 

 

 

199,907

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

 

 

 

 

 

 

288

 

 

 

 

 

 

2,098

 

 

 

 

 

 

 

 

 

2,098

 

Stock-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,367

 

 

 

 

 

 

 

 

 

10,367

 

Foreign currency translation

   adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

10

 

Unrealized gain on available-

   for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

73

 

 

 

 

 

 

73

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(86,432

)

 

 

(86,432

)

Balance as of March 31, 2020

 

 

526

 

 

 

-

 

 

 

65,223

 

 

 

7

 

 

 

1,045,989

 

 

 

163

 

 

 

(811,112

)

 

 

235,047

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

 

 

 

 

 

 

217

 

 

 

 

 

 

2,131

 

 

 

 

 

 

 

 

 

2,131

 

Stock-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,848

 

 

 

 

 

 

 

 

 

11,848

 

Foreign currency translation

   adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

8

 

Unrealized gain on available-

   for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

68

 

 

 

 

 

 

68

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(69,244

)

 

 

(69,244

)

Balance as of June 30, 2020

 

 

526

 

 

$

 

 

 

65,440

 

 

$

7

 

 

$

1,059,968

 

 

$

239

 

 

$

(880,356

)

 

$

179,858

 

 

 

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

5


AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2018

 

 

62,142

 

 

$

6

 

 

$

775,283

 

 

$

(108

)

 

$

(476,234

)

 

$

298,947

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

328

 

 

 

 

 

 

3,633

 

 

 

 

 

 

 

 

 

3,633

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,765

 

 

 

 

 

 

 

 

 

7,765

 

Unrealized gain on available-

   for-sale investments

 

 

 

 

 

 

 

 

 

 

 

171

 

 

 

 

 

 

171

 

Accumulated depreciation upon

   adoption of ASU Topic 842

 

 

 

 

 

 

 

 

 

 

 

 

 

 

51

 

 

 

51

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(54,266

)

 

 

(54,266

)

Balance as of March 31, 2019

 

 

62,470

 

 

$

6

 

 

$

786,681

 

 

$

63

 

 

$

(530,449

)

 

$

256,301

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

189

 

 

 

 

 

 

2,637

 

 

 

 

 

 

 

 

 

2,637

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

8,740

 

 

 

 

 

 

 

 

 

8,740

 

Unrealized gain on available-

   for-sale investments

 

 

 

 

 

 

 

 

 

 

 

173

 

 

 

1

 

 

 

174

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(62,878

)

 

 

(62,878

)

Balance as of June 30, 2019

 

 

62,659

 

 

$

6

 

 

$

798,058

 

 

$

236

 

 

$

(593,326

)

 

$

204,974

 

 

 

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

6


AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(155,676

)

 

$

(117,144

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

 

2,738

 

 

 

1,751

 

Stock-based compensation expense

 

 

22,117

 

 

 

16,505

 

Non-cash interest expense

 

 

5,434

 

 

 

2,259

 

Amortization of premium on investment securities

 

 

1

 

 

 

(1,094

)

Research and development expenses recognized from issuance of common stock

 

 

5,000

 

 

 

 

Non-cash inventory write-offs

 

 

3,458

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Trade receivables, net

 

 

(25

)

 

 

 

Inventories

 

 

(9,007

)

 

 

 

Prepaid expenses and other assets

 

 

3,141

 

 

 

2,596

 

Accounts payable

 

 

1,359

 

 

 

5,466

 

Accrued liabilities

 

 

(5,818

)

 

 

(2,887

)

Other liabilities

 

 

358

 

 

 

553

 

Net cash used in operating activities

 

 

(126,920

)

 

 

(91,995

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(807

)

 

 

(4,860

)

Purchase of investments

 

 

(32,457

)

 

 

(106,980

)

Maturities of investments

 

 

59,369

 

 

 

127,146

 

Net cash provided by investing activities

 

 

26,105

 

 

 

15,306

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Borrowings under debt agreement

 

 

85,000

 

 

 

40,000

 

Debt issuance costs