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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 September 30, 2019

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 October 31, 2019, the registrant had 63,299,682 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 September 30, 2019 and December 31, 2018

 

3

 

 

Condensed Consolidated Statements of Comprehensive Loss for the Quarters and Nine Months Ended September 30, 2019 and 2018

 

4

 

  

Condensed Consolidated Statements of Stockholders’ Equity as of September 30, 2019 and 2018

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2019 and 2018

 

7

 

 

Notes to Condensed Consolidated Financial Statements

 

8

Item 2.

 

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

 

19

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

27

Item 4.

 

Controls and Procedures

 

27

 

 

 

 

 

PART II. – OTHER INFORMATION

 

28

Item 1.

 

Legal Proceedings

 

28

Item 1A.

 

Risk Factors

 

28

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

66

Item 3.

 

Defaults Upon Senior Securities

 

66

Item 4.

 

Mine Safety Disclosures

 

66

Item 5.

 

Other Information

 

66

Item 6.

 

Exhibits

 

67

SIGNATURES

 

69

 

 

 


PART I. – FINANCIAL INFORMATION

Item 1. Financial Statements

AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

76,844

 

 

$

107,511

 

Short-term investments

 

 

118,626

 

 

 

196,421

 

Prepaid expenses and other current assets

 

 

6,766

 

 

 

8,687

 

Total current assets

 

 

202,236

 

 

 

312,619

 

Long-term investments

 

 

5,038

 

 

 

 

Property and equipment, net

 

 

28,713

 

 

 

26,328

 

Operating lease right-of-use assets

 

 

11,904

 

 

 

 

Prepaid expenses and other assets

 

 

507

 

 

 

608

 

Total assets

 

$

248,398

 

 

$

339,555

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

11,941

 

 

$

8,833

 

Accrued liabilities

 

 

29,480

 

 

 

29,144

 

Operating lease liabilities, current

 

 

2,163

 

 

 

 

Other current liabilities

 

 

21

 

 

 

35

 

Total current liabilities

 

 

43,605

 

 

 

38,012

 

Long term debt, net of discount

 

 

39,782

 

 

 

 

Operating lease liabilities

 

 

11,153

 

 

 

 

Other liabilities

 

 

1,166

 

 

 

2,596

 

Total liabilities

 

 

95,706

 

 

 

40,608

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

     September 30, 2019 and December 31, 2018; 0 shares issued and outstanding at

     September 30, 2019 and December 31, 2018

 

 

 

 

 

 

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

  September 30, 2019, and December 31, 2018; 63,090 and 62,142 shares issued and

  outstanding as of September 30, 2019, and December 31, 2018, respectively

 

 

6

 

 

 

6

 

Additional paid-in capital

 

 

810,328

 

 

 

775,283

 

Accumulated other comprehensive gain (loss)

 

 

140

 

 

 

(108

)

Accumulated deficit

 

 

(657,782

)

 

 

(476,234

)

Total stockholders’ equity

 

 

152,692

 

 

 

298,947

 

Total liabilities and stockholders’ equity

 

$

248,398

 

 

$

339,555

 

 

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 September 30,

 

 

Nine Months Ended September 30,

 

2019

 

2018

 

 

2019

 

2018

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

30,558

 

$

31,691

 

 

$

93,862

 

$

100,391

 

General and administrative

 

34,044

 

$

21,285

 

 

 

88,956

 

 

56,517

 

Total operating expenses

 

64,602

 

 

52,976

 

 

 

182,818

 

 

156,908

 

Loss from operations

 

(64,602

)

 

(52,976

)

 

 

(182,818

)

 

(156,908

)

Interest income, net

 

43

 

 

1,303

 

 

 

1,192

 

 

3,233

 

Loss before (benefit) provision for income taxes

 

(64,559

)

 

(51,673

)

 

 

(181,626

)

 

(153,675

)

(Benefit) provision for income taxes

 

(104

)

 

29

 

 

 

(27

)

 

79

 

Net loss

$

(64,455

)

$

(51,702

)

 

$

(181,599

)

$

(153,754

)

Other comprehensive loss, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on investments

 

(97

)

 

(15

)

 

 

248

 

 

(30

)

Comprehensive loss

$

(64,552

)

$

(51,717

)

 

$

(181,351

)

$

(153,784

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

$

(1.03

)

$

(0.89

)

 

$

(2.91

)

$

(2.72

)

Weighted average shares used in computing net loss per common

   share, basic and diluted

 

62,615

 

 

58,274

 

 

 

62,325

 

 

56,602

 

 

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

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss)/Gain

 

 

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

 

 

328

 

 

 

 

 

 

3,633

 

 

 

 

 

 

 

 

 

3,633

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,765

 

 

 

 

 

 

 

 

 

7,765

 

Other comprehensive gain

 

 

 

 

 

 

 

 

 

 

 

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

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

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

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

431

 

 

 

 

 

 

4,189

 

 

 

 

 

 

 

 

 

4,189

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,081

 

 

 

 

 

 

 

 

 

8,081

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(96

)

 

 

(1

)

 

 

(97

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(64,455

)

 

 

(64,455

)

Balance as of September 30, 2019

 

 

63,090

 

 

$

6

 

 

$

810,328

 

 

$

140

 

 

$

(657,782

)

 

$

152,692

 

 

 

 

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

 

 

Loss

 

 

deficit

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2017

 

 

51,091

 

 

$

5

 

 

$

443,390

 

 

$

(108

)

 

$

(265,482

)

 

$

177,805

 

Issuance of common stock

   upon exercise of vested

   options

 

 

308

 

 

 

 

 

 

2,743

 

 

 

 

 

 

 

 

 

2,743

 

Issuance of common stock

   upon securities agreement

 

 

300

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock

   upon public offering

 

 

6,325

 

 

 

1

 

 

 

190,453

 

 

 

 

 

 

 

 

 

190,454

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,607

 

 

 

 

 

 

 

 

 

7,607

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(17

)

 

 

 

 

 

(17

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(49,500

)

 

 

(49,500

)

Balance as of March 31, 2018

 

 

58,024

 

 

$

6

 

 

$

644,193

 

 

$

(125

)

 

$

(314,982

)

 

$

329,092

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

437

 

 

 

 

 

 

2,641

 

 

 

 

 

 

 

 

 

2,641

 

Issuance of common stock

   upon public offering

 

 

 

 

 

 

 

 

(18

)

 

 

 

 

 

(1

)

 

 

(19

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

8,674

 

 

 

 

 

 

 

 

 

8,674

 

Other comprehensive gain

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

2

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(52,552

)

 

 

(52,552

)

Balance as of June 30, 2018

 

 

58,461

 

 

$

6

 

 

$

655,490

 

 

$

(123

)

 

$

(367,535

)

 

$

287,838

 

Issuance of common stock

   upon exercise of vested

   options and vesting of

   restricted stock units

 

 

190

 

 

 

 

 

 

2,660

 

 

 

 

 

 

1

 

 

 

2,661

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,382

 

 

 

 

 

 

 

 

 

8,382

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(15

)

 

 

 

 

 

(15

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(51,702

)

 

 

(51,702

)

Balance as of September 30, 2018

 

$

58,651

 

 

$

6

 

 

$

666,532

 

 

$

(138

)

 

$

(419,236

)

 

$

247,164

 

 

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)

 

 

 

Nine Months Ended September 30,

 

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(181,599

)

 

$

(153,754

)

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

 

 

 

 

 

 

 

 

Depreciation expense

 

 

2,908

 

 

 

1,121

 

Stock-based compensation expense

 

 

24,586

 

 

 

24,663

 

Non-cash interest expense

 

 

3,449

 

 

 

 

Amortization of premium on investment securities

 

 

(1,499

)

 

 

(529

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

3,854

 

 

 

412

 

Accounts payable

 

 

4,321

 

 

 

8,133

 

Accrued liabilities

 

 

290

 

 

 

2,067

 

Other liabilities

 

 

845

 

 

 

309

 

Net cash used in operating activities

 

 

(142,845

)

 

 

(117,578

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(7,094

)

 

 

(8,300

)

Purchase of investments

 

 

(139,398

)

 

 

(192,285

)

Maturities of investments

 

 

213,900

 

 

 

124,898

 

Net cash provided by (used in) investing activities

 

 

67,408

 

 

 

(75,687

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Borrowings under debt agreement

 

 

40,000

 

 

 

 

Debt issuance costs

 

 

(3,856

)

 

 

 

Proceeds from underwritten public offering, net of offering costs

 

 

 

 

 

190,435

 

Net cash proceeds from exercise of stock options, including early exercise

 

 

9,298

 

 

 

7,763

 

Tax withholdings related to net share settlements of restricted stock units

 

 

(672

)

 

 

 

Net cash provided by financing activities

 

 

44,770

 

 

 

198,198

 

Net increase (decrease) in cash and cash equivalents

 

 

(30,667

)

 

 

4,933

 

Cash and cash equivalents at the beginning of the period

 

 

107,511

 

 

 

73,487

 

Cash and cash equivalents at the end of the period

 

$

76,844

 

 

$

78,420

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Property and equipment purchases included in accounts payable and accrued liabilities

 

$

1,165

 

 

$

660

 

Receivable for stock option exercises

 

$

(1,161

)

 

$

(281

)

 

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

 

 

7


AIMMUNE THERAPEUTICS, INC.

NOTES TO UNAUDIT