10-Q 1 kpti-20230930.htm 10-Q 10-Q
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Table of Contents

 

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 September 30, 2023

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: 001-36167

Karyopharm Therapeutics Inc.

(Exact name of registrant as specified in its charter)

Delaware

 

26-3931704

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

85 Wells Avenue, 2nd Floor

Newton, MA

 

02459

(Address of principal executive offices)

 

(Zip Code)

 

(617) 658-0600

(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

 

KPTI

 

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 27, 2023, there were 114,533,991 shares of Common Stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

TABLE OF CONTENTS

 

 

 

PART I - FINANCIAL INFORMATION

 

3

 

 

 

 

 

Item 1.

 

Condensed Consolidated Financial Statements (Unaudited)

 

3

 

 

Condensed Consolidated Balance Sheets

 

3

 

 

Condensed Consolidated Statements of Operations

 

4

 

 

Condensed Consolidated Statements of Comprehensive Loss

 

5

 

 

Condensed Consolidated Statements of Cash Flows

 

6

 

 

Condensed Consolidated Statements of Stockholders’ Deficit

 

7

 

 

Notes to Condensed Consolidated Financial Statements

 

8

Item 2.

 

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

 

18

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

25

Item 4.

 

Controls and Procedures

 

25

 

 

 

 

 

 

 

PART II - OTHER INFORMATION

 

26

 

 

 

 

Item 1A.

 

Risk Factors

 

26

Item 5.

 

Other Information

 

71

Item 6.

 

Exhibits

 

72

 

 

Signatures

 

73

 

2


Table of Contents

PART I - FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited).

KARYOPHARM THERAPEUTICS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except per share amounts)

 

 

 

September 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

43,655

 

 

$

135,188

 

Investments

 

 

164,660

 

 

 

142,779

 

Accounts receivable, net

 

 

37,923

 

 

 

47,086

 

Inventory

 

 

3,105

 

 

 

4,224

 

Prepaid expenses and other current assets

 

 

13,334

 

 

 

19,821

 

Restricted cash

 

 

545

 

 

 

1,064

 

Total current assets

 

 

263,222

 

 

 

350,162

 

Property and equipment, net

 

 

686

 

 

 

1,139

 

Operating lease right-of-use assets

 

 

4,796

 

 

 

6,238

 

Restricted cash

 

 

381

 

 

 

633

 

Other assets

 

 

875

 

 

 

 

Total assets

 

$

269,960

 

 

$

358,172

 

Liabilities and stockholders’ deficit

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

943

 

 

$

2,773

 

Accrued expenses

 

 

55,713

 

 

 

58,415

 

Operating lease liabilities

 

 

3,195

 

 

 

2,872

 

Other current liabilities

 

 

2,228

 

 

 

1,848

 

Total current liabilities

 

 

62,079

 

 

 

65,908

 

Convertible senior notes

 

 

170,702

 

 

 

170,105

 

Deferred royalty obligation

 

 

132,479

 

 

 

132,718

 

Operating lease liabilities, net of current portion

 

 

3,668

 

 

 

6,097

 

Other liabilities

 

 

1,428

 

 

 

 

Total liabilities

 

 

370,356

 

 

 

374,828

 

Stockholders’ deficit:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 5,000 shares authorized; none issued and
   outstanding

 

 

 

 

 

 

Common stock, $0.0001 par value;

 

 

 

 

 

 

400,000 shares authorized, 114,523 shares issued and outstanding at September 30, 2023;

 

 

 

 

 

 

200,000 shares authorized; 113,213 shares issued and outstanding at December 31, 2022

 

 

12

 

 

 

12

 

Additional paid-in capital

 

 

1,345,535

 

 

 

1,327,909

 

Accumulated other comprehensive loss

 

 

(742

)

 

 

(638

)

Accumulated deficit

 

 

(1,445,201

)

 

 

(1,343,939

)

Total stockholders’ deficit

 

 

(100,396

)

 

 

(16,656

)

Total liabilities and stockholders’ deficit

 

$

269,960

 

 

$

358,172

 

 

See accompanying notes to condensed consolidated financial statements.

3


Table of Contents

KARYOPHARM THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

30,207

 

 

$

32,009

 

 

$

86,955

 

 

$

89,319

 

 

License and other revenue

 

 

5,802

 

 

 

4,136

 

 

 

25,331

 

 

 

34,175

 

 

Total revenue

 

 

36,009

 

 

 

36,145

 

 

 

112,286

 

 

 

123,494

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

911

 

 

 

980

 

 

 

3,456

 

 

 

3,345

 

 

Research and development

 

 

35,553

 

 

 

31,359

 

 

 

99,369

 

 

 

117,730

 

 

Selling, general and administrative

 

 

30,805

 

 

 

34,645

 

 

 

101,193

 

 

 

110,752

 

 

Total operating expenses

 

 

67,269

 

 

 

66,984

 

 

 

204,018

 

 

 

231,827

 

 

Loss from operations

 

 

(31,260

)

 

 

(30,839

)

 

 

(91,732

)

 

 

(108,333

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,750

 

 

 

658

 

 

 

8,423

 

 

 

1,025

 

 

Interest expense

 

 

(6,073

)

 

 

(6,114

)

 

 

(17,615

)

 

 

(19,111

)

 

Other income (expense), net

 

 

89

 

 

 

16

 

 

 

(145

)

 

 

(70

)

 

Total other expense, net

 

 

(3,234

)

 

 

(5,440

)

 

 

(9,337

)

 

 

(18,156

)

 

Loss before income taxes

 

 

(34,494

)

 

 

(36,279

)

 

 

(101,069

)

 

 

(126,489

)

 

Income tax provision

 

 

(12

)

 

 

(45

)

 

 

(193

)

 

 

(296

)

 

Net loss

 

$

(34,506

)

 

$

(36,324

)

 

$

(101,262

)

 

$

(126,785

)

 

Net loss per share—basic and diluted

 

$

(0.30

)

 

$

(0.45

)

 

$

(0.89

)

 

$

(1.60

)

 

Weighted-average number of common shares outstanding used to
    compute net loss per share—basic and diluted

 

 

114,401

 

 

 

80,210

 

 

 

114,033

 

 

 

79,153

 

 

 

See accompanying notes to condensed consolidated financial statements.

4


Table of Contents

KARYOPHARM THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(unaudited)

(in thousands)

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net loss

 

$

(34,506

)

 

$

(36,324

)

 

$

(101,262

)

 

$

(126,785

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

 

169

 

 

 

(145

)

 

 

(95

)

 

 

(329

)

Foreign currency translation adjustment

 

 

(128

)

 

 

(69

)

 

 

(9

)

 

 

(614

)

Comprehensive loss

 

$

(34,465

)

 

$

(36,538

)

 

$

(101,366

)

 

$

(127,728

)

 

See accompanying notes to condensed consolidated financial statements.

5


Table of Contents

KARYOPHARM THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

 

For the Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(101,262

)

 

$

(126,785

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

16,527

 

 

 

29,226

 

Depreciation and amortization

 

 

453

 

 

 

508

 

Amortization of debt issuance costs

 

 

597

 

 

 

602

 

Net amortization of premiums and discounts on investments

 

 

(3,077

)

 

 

(361

)

Other

 

 

3

 

 

 

(3

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

9,163

 

 

 

(4,949

)

Inventory

 

 

1,119

 

 

 

(143

)

Prepaid expenses and other assets

 

 

5,612

 

 

 

(7,977

)

Operating lease right-of-use assets

 

 

1,442

 

 

 

1,234

 

Accounts payable

 

 

(1,830

)

 

 

(790

)

Accrued expenses and other liabilities

 

 

(779

)

 

 

(11,621

)

Operating lease liabilities

 

 

(2,106

)

 

 

(1,652

)

Net cash used in operating activities

 

 

(74,138

)

 

 

(122,711

)

Investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

 

 

 

(118

)

Proceeds from sales and maturities of investments

 

 

123,688

 

 

 

90,078

 

Purchases of investments

 

 

(142,591

)

 

 

(128,918

)

Net cash used in investing activities

 

 

(18,903

)

 

 

(38,958

)

Financing activities

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

 

 

 

35,082

 

Proceeds from the exercise of stock options and shares issued under employee
   stock purchase plan

 

 

860

 

 

 

2,813

 

Net cash provided by financing activities

 

 

860

 

 

 

37,895

 

Effect of exchange rate on cash, cash equivalents and restricted cash

 

 

(123

)

 

 

(614

)

Net decrease in cash, cash equivalents and restricted cash

 

 

(92,304

)

 

 

(124,388

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

136,885

 

 

 

197,445

 

Cash, cash equivalents and restricted cash at end of period

 

$

44,581

 

 

$

73,057

 

Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets

 

 

 

 

 

 

Cash and cash equivalents

 

$

43,655

 

 

$

71,351

 

Short-term restricted cash

 

 

545

 

 

 

1,080

 

Long-term restricted cash

 

 

381

 

 

 

626

 

Total cash, cash equivalents and restricted cash

 

$

44,581

 

 

$

73,057

 

Supplemental disclosures:

 

 

 

 

 

 

Cash paid for interest on convertible debt

 

$

2,588

 

 

$

2,588

 

Cash paid for amounts included in the measurement of operating lease liabilities

 

$

2,770

 

 

$

2,523

 

Cash paid for interest on deferred royalty obligation

 

$

12,225

 

 

$

24,960

 

 

See accompanying notes to condensed consolidated financial statements.

6


Table of Contents

KARYOPHARM THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(unaudited)

(in thousands)

 

 

 

Common Shares

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Other
Comprehensive (Loss)
Income

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
(Deficit) Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2023

 

 

114,340

 

 

$

12

 

 

$

1,340,218

 

 

$

(783

)

 

$

(1,410,695

)

 

 

(71,248

)

Vesting of restricted stock

 

 

183

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

5,078

 

 

 

 

 

 

 

 

 

5,078

 

Issuance of common stock warrants

 

 

 

 

 

 

 

 

239

 

 

 

 

 

 

 

 

 

239

 

Unrealized gain on investments

 

 

 

 

 

 

 

 

 

 

 

169

 

 

 

 

 

 

169

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(128

)

 

 

 

 

 

(128

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,506

)

 

 

(34,506

)

Balance at September 30, 2023

 

 

114,523

 

 

$

12

 

 

$

1,345,535

 

 

$

(742

)

 

$

(1,445,201

)

 

 

(100,396

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2022

 

 

79,798

 

 

$

8

 

 

$

1,153,301

 

 

$

(538

)

 

$

(1,269,109

)

 

$

(116,338

)

Vesting of restricted stock

 

 

171

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and shares issued under the employee stock purchase plan

 

 

7

 

 

 

 

 

 

11

 

 

 

 

 

 

 

 

 

11

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

6,797

 

 

 

 

 

 

 

 

 

6,797

 

Issuance of common stock, net of issuance costs

 

 

1,051

 

 

 

 

 

 

5,788

 

 

 

 

 

 

 

 

 

5,788

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

(145

)

 

 

 

 

 

(145

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(69

)

 

 

 

 

 

(69

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(36,324

)

 

 

(36,324

)

Balance at September 30, 2022

 

 

81,027

 

 

$

8

 

 

$

1,165,897

 

 

$

(752

)

 

$

(1,305,433

)

 

$

(140,280

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

113,213

 

 

$

12

 

 

$

1,327,909

 

 

$

(638

)

 

$

(1,343,939

)

 

$

(16,656

)

Vesting of restricted stock

 

 

1,019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and shares issued under the employee stock purchase plan

 

 

291

 

 

 

 

 

 

860

 

 

 

 

 

 

 

 

 

860

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

16,527

 

 

 

 

 

 

 

 

 

16,527

 

Issuance of common stock warrants

 

 

 

 

 

 

 

 

239

 

 

 

 

 

 

 

 

 

239

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

(95

)

 

 

 

 

 

(95

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(9

)

 

 

 

 

 

(9

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(101,262

)

 

 

(101,262

)

Balance at September 30, 2023

 

 

114,523

 

 

$

12

 

 

$

1,345,535

 

 

$

(742

)

 

$

(1,445,201

)

 

$

(100,396

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

75,746

 

 

$

8

 

 

$

1,098,776

 

 

$

191

 

 

$

(1,178,648

)

 

$

(79,673

)

Vesting of restricted stock

 

 

844

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and shares issued under the employee stock purchase plan

 

 

445

 

 

 

 

 

 

2,813

 

 

 

 

 

 

 

 

 

2,813

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

29,226