UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DCD.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 June 30, 2020March 31, 2021

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: 001-38112

 

ATHENEX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

43-1985966

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

 

1001 Main Street, Suite 600

Buffalo, NY

14203

(Address of principal executive offices)

(Zip Code)

 

(716) 427-2950

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

ATNX

 

The 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, 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

 

 

  

Small 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 31, 2020,April 30, 2021, the registrant had 81,725,53493,512,700  shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

 

 

Page

PART I.

 

FINANCIAL INFORMATION

 

1

Item 1.

 

Financial Statements

 

1

 

 

Condensed Consolidated Balance Sheets (Unaudited)

 

1

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

 

2

 

 

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

 

3

 

 

Condensed Consolidated Statements of Cash Flows (Unaudited)

 

4

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

5

Item 2.

 

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

 

2624

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

4034

Item 4.

 

Controls and Procedures

 

4135

PART II.

 

OTHER INFORMATION

 

4236

Item 1.

 

Legal Proceedings

 

4236

Item 1A.

 

Risk Factors

 

4236

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

4736

Item 3.

 

Defaults Upon Senior Securities

 

4736

Item 4.

 

Mine Safety Disclosures

 

4736

Item 5.

 

Other Information

 

4737

Item 6.

 

Exhibits

 

4838

Signatures

 

4940

 

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.

ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share data)

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

105,901

 

 

$

127,674

 

 

$

47,980

 

 

$

69,587

 

Restricted cash

 

 

11,000

 

 

 

 

 

 

16,500

 

 

 

16,500

 

Short-term investments

 

 

10,414

 

 

 

33,139

 

 

 

123,186

 

 

 

138,636

 

Accounts receivable, net of chargebacks and other deductions of $12,769

and $14,394, respectively, and provision for credit losses

of $163 and $124, respectively

 

 

38,620

 

 

 

16,689

 

Accounts receivable, net of chargebacks and other deductions of $17,264

and $12,552, respectively, and provision for credit losses

of $9,482 and $9,637, respectively

 

 

20,189

 

 

 

23,603

 

Inventories

 

 

31,143

 

 

 

32,630

 

 

 

26,324

 

 

 

28,846

 

Prepaid expenses and other current assets

 

 

19,528

 

 

 

20,794

 

 

 

16,968

 

 

 

14,789

 

Total current assets

 

 

216,606

 

 

 

230,926

 

 

 

251,147

 

 

 

291,961

 

Property and equipment, net

 

 

26,867

 

 

 

23,153

 

 

 

41,778

 

 

 

34,388

 

Goodwill

 

 

38,496

 

 

 

38,513

 

 

 

38,840

 

 

 

38,891

 

Intangible assets, net

 

 

8,015

 

 

 

8,522

 

 

 

9,482

 

 

 

10,218

 

Operating lease right-of-use assets, net

 

 

7,846

 

 

 

8,818

 

 

 

7,462

 

 

 

7,921

 

Other assets

 

 

222

 

 

 

 

 

 

947

 

 

 

950

 

Total assets

 

$

298,052

 

 

$

309,932

 

 

$

349,656

 

 

$

384,329

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,945

 

 

$

23,331

 

 

$

15,858

 

 

$

18,673

 

Accrued expenses

 

 

47,144

 

 

 

44,307

 

 

 

28,714

 

 

 

38,273

 

Current portion of operating lease liabilities

 

 

2,713

 

 

 

3,010

 

 

 

3,161

 

 

 

3,185

 

Current portion of long-term debt

 

 

1,107

 

 

 

880

 

Current portion of long-term debt and finance lease obligations

 

 

1,970

 

 

 

2,010

 

Total current liabilities

 

 

66,909

 

 

 

71,528

 

 

 

49,703

 

 

 

62,141

 

Long-term liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term operating lease liabilities

 

 

6,850

 

 

 

7,620

 

 

 

5,832

 

 

 

6,355

 

Long-term debt and finance lease obligations

 

 

95,389

 

 

 

52,366

 

 

 

147,265

 

 

 

146,577

 

Deferred tax liabilities

 

 

51

 

 

 

 

 

 

58

 

 

 

56

 

Other long-term liabilities

 

 

2,607

 

 

 

2,563

 

 

 

3,674

 

 

 

3,852

 

Total liabilities

 

 

171,806

 

 

 

134,077

 

 

 

206,532

 

 

 

218,981

 

Commitments and contingencies (See Note 16)

 

 

 

 

 

 

 

 

Commitments and contingencies (See Note 15)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock, par value $0.001 per share, 250,000,000 shares authorized at

June 30, 2020 and December 31, 2019; 83,362,454 and 83,231,063 shares

issued at June 30, 2020 and December 31, 2019, respectively; 81,689,534

and 81,558,143 shares outstanding at June 30, 2020 and

December 31, 2019, respectively

 

 

83

 

 

 

83

 

Common stock, par value $0.001 per share, 250,000,000 shares authorized at

March 31, 2021 and December 31, 2020; 95,185,620 and 95,066,195 shares

issued at March 31, 2021 and December 31, 2020, respectively; 93,512,700

and 93,393,275 shares outstanding at March 31, 2021 and

December 31, 2020, respectively

 

 

95

 

 

 

95

 

Additional paid-in capital

 

 

775,042

 

 

 

763,648

 

 

 

904,950

 

 

 

901,864

 

Accumulated other comprehensive loss

 

 

(1,067

)

 

 

(635

)

 

 

(841

)

 

 

(1,134

)

Accumulated deficit

 

 

(627,345

)

 

 

(567,465

)

 

 

(738,694

)

 

 

(713,644

)

Less: treasury stock, at cost; 1,672,920 shares at June 30, 2020 and

December 31, 2019

 

 

(7,406

)

 

 

(7,406

)

Less: treasury stock, at cost; 1,672,920 shares at March 31, 2021 and

December 31, 2020

 

 

(7,406

)

 

 

(7,406

)

Total Athenex, Inc. stockholders' equity

 

 

139,307

 

 

 

188,225

 

 

 

158,104

 

 

 

179,775

 

Non-controlling interests

 

 

(13,061

)

 

 

(12,370

)

 

 

(14,980

)

 

 

(14,427

)

Total stockholders' equity

 

 

126,246

 

 

 

175,855

 

 

 

143,124

 

 

 

165,348

 

Total liabilities and stockholders' equity

 

$

298,052

 

 

$

309,932

 

 

$

349,656

 

 

$

384,329

 

 

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


ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(In thousands, except share and per share data)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

40,167

 

 

$

22,033

 

 

$

58,714

 

 

$

47,196

 

 

$

20,360

 

 

$

18,547

 

License and other revenue

 

 

5

 

 

 

164

 

 

 

28,393

 

 

 

308

 

 

 

20,665

 

 

 

28,388

 

Total revenue

 

 

40,172

 

 

 

22,197

 

 

 

87,107

 

 

 

47,504

 

 

 

41,025

 

 

 

46,935

 

Cost of sales

 

 

33,006

 

 

 

16,942

 

 

 

52,578

 

 

 

36,844

 

 

 

16,405

 

 

 

19,572

 

Gross Profit

 

 

7,166

 

 

 

5,255

 

 

 

34,529

 

 

 

10,660

 

 

 

24,620

 

 

 

27,363

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

22,015

 

 

 

18,507

 

 

 

39,207

 

 

 

42,982

 

 

 

23,070

 

 

 

17,192

 

Selling, general, and administrative expenses

 

 

17,486

 

 

 

17,169

 

 

 

43,234

 

 

 

32,357

 

 

 

22,120

 

 

 

25,748

 

Total operating expenses

 

 

39,501

 

 

 

35,676

 

 

 

82,441

 

 

 

75,339

 

 

 

45,190

 

 

 

42,940

 

Operating loss

 

 

(32,335

)

 

 

(30,421

)

 

 

(47,912

)

 

 

(64,679

)

 

 

(20,570

)

 

 

(15,577

)

Interest income

 

 

185

 

 

 

475

 

 

 

598

 

 

 

758

 

 

 

29

 

 

 

413

 

Interest expense

 

 

1,565

 

 

 

1,754

 

 

 

3,238

 

 

 

3,509

 

 

 

4,908

 

 

 

1,673

 

Loss on extinguishment of debt

 

 

7,230

 

 

 

 

 

 

7,230

 

 

 

 

Loss before income tax expense

 

 

(40,945

)

 

 

(31,700

)

 

 

(57,782

)

 

 

(67,430

)

 

 

(25,449

)

 

 

(16,837

)

Income tax expense

 

 

106

 

 

 

405

 

 

 

2,987

 

 

 

905

 

 

 

154

 

 

 

2,881

 

Net loss

 

 

(41,051

)

 

 

(32,105

)

 

 

(60,769

)

 

 

(68,335

)

 

 

(25,603

)

 

 

(19,718

)

Less: net loss attributable to non-controlling interests

 

 

(600

)

 

 

(74

)

 

 

(889

)

 

 

(1,071

)

 

 

(553

)

 

 

(289

)

Net loss attributable to Athenex, Inc.

 

$

(40,451

)

 

$

(32,031

)

 

$

(59,880

)

 

$

(67,264

)

 

$

(25,050

)

 

$

(19,429

)

Unrealized gain (loss) on investment, net of income taxes

 

 

117

 

 

 

(83

)

 

 

49

 

 

 

(80

)

 

 

16

 

 

 

(68

)

Foreign currency translation adjustment, net of income taxes

 

 

(43

)

 

 

(446

)

 

 

(481

)

 

 

622

 

 

 

277

 

 

 

(438

)

Comprehensive loss

 

$

(40,377

)

 

$

(32,560

)

 

$

(60,312

)

 

$

(66,722

)

 

$

(24,757

)

 

$

(19,935

)

Net loss per share attributable to Athenex, Inc. common

stockholders, basic and diluted (See Note 13)

 

$

(0.50

)

 

$

(0.44

)

 

$

(0.73

)

 

$

(0.96

)

Weighted-average shares used in computing net loss per share

attributable to Athenex, Inc. common stockholders, basic and

diluted (See Note 13)

 

 

81,564,441

 

 

 

73,114,392

 

 

 

81,551,995

 

 

 

70,079,771

 

Net loss per share attributable to Athenex, Inc. common

stockholders, basic and diluted (See Note 12)

 

$

(0.27

)

 

$

(0.24

)

Weighted-average shares used in computing net loss per share

attributable to Athenex, Inc. common stockholders, basic and

diluted (See Note 12)

 

 

93,429,935

 

 

 

81,539,548

 

 

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

 


ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity

(unaudited)

(In thousands, except share data)

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

income (loss)

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

loss

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

Balance at January 1, 2019

 

 

68,668,986

 

 

$

69

 

 

$

591,064

 

 

$

(443,716

)

 

$

(656

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

139,355

 

 

$

(10,586

)

 

$

128,769

 

Balance at January 1, 2020

 

 

83,231,063

 

 

$

83

 

 

$

763,648

 

 

$

(567,465

)

 

$

(635

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

188,225

 

 

$

(12,370

)

 

$

175,855

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

1,693

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,693

 

 

 

 

 

 

1,693

 

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

1,864

 

Stock options and warrants exercised

 

 

49,632

 

 

 

 

 

 

278

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

278

 

 

 

 

 

 

278

 

Restricted stock expense

 

 

(3,000

)

 

 

 

 

 

397

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

397

 

 

 

 

 

 

397

 

Stock options exercised

 

 

70,200

 

 

 

 

 

 

344

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

344

 

 

 

 

 

 

344

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(35,233

)

 

 

 

 

 

 

 

 

 

 

 

(35,233

)

 

 

(997

)

 

 

(36,230

)

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

(289

)

 

 

(19,718

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,071

 

 

 

 

 

 

 

 

 

1,071

 

 

 

 

 

 

1,071

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

(506

)

Balance at March 31, 2019 (unaudited)

 

 

68,718,618

 

 

 

69

 

 

 

593,035

 

 

 

(478,949

)

 

 

415

 

 

 

(1,672,920

)

 

 

(7,406

)

 

 

107,164

 

 

 

(11,583

)

 

 

95,581

 

Sale of common stock, net of costs of $54

 

 

10,033,362

 

 

 

10

 

 

 

100,309

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

100,319

 

 

 

 

 

 

100,319

 

Stock-based compensation cost

 

 

92,723

 

 

 

 

 

 

3,382

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,382

 

 

 

 

 

 

3,382

 

Stock options exercised

 

 

92,442

 

 

 

 

 

 

559

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

559

 

 

 

 

 

 

559

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(32,031

)

 

 

 

 

 

 

 

 

 

 

 

(32,031

)

 

 

(74

)

 

 

(32,105

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(529

)

 

 

 

 

 

 

 

 

(529

)

 

 

 

 

 

(529

)

Balance at June 30, 2019 (unaudited)

 

 

78,937,145

 

 

$

79

 

 

$

697,285

 

 

$

(510,980

)

 

$

(114

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

178,864

 

 

$

(11,657

)

 

$

167,207

 

Balance at March 31, 2020 (unaudited)

 

 

83,298,263

 

 

$

83

 

 

$

766,253

 

 

$

(586,894

)

 

$

(1,141

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

170,895

 

 

$

(12,659

)

 

$

158,236

 

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

income (loss)

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

loss

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

Balance at January 1, 2020

 

 

83,231,063

 

 

$

83

 

 

$

763,648

 

 

$

(567,465

)

 

$

(635

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

188,225

 

 

$

(12,370

)

 

$

175,855

 

Balance at January 1, 2021

 

 

95,066,195

 

 

$

95

 

 

$

901,864

 

 

$

(713,644

)

 

$

(1,134

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

179,775

 

 

$

(14,427

)

 

$

165,348

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

1,864

 

 

 

 

 

 

 

 

 

2,205

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,205

 

 

 

 

 

 

2,205

 

Restricted stock expense

 

 

(3,000

)

 

 

 

 

 

397

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

397

 

 

 

 

 

 

397

 

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

29

 

Stock options exercised

 

 

70,200

 

 

 

 

 

 

344

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

344

 

 

 

 

 

 

344

 

 

 

119,425

 

 

 

 

 

 

852

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

852

 

 

 

 

 

 

852

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

(289

)

 

 

(19,718

)

 

 

 

 

 

 

 

 

 

 

 

(25,050

)

 

 

 

 

 

 

 

 

 

 

 

(25,050

)

 

 

(553

)

 

 

(25,603

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

(506

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

293

 

 

 

 

 

 

 

 

 

293

 

 

 

 

 

 

293

 

Balance at March 31, 2020 (unaudited)

 

 

83,298,263

 

 

 

83

 

 

 

766,253

 

 

 

(586,894

)

 

 

(1,141

)

 

 

(1,672,920

)

 

 

(7,406

)

 

 

170,895

 

 

 

(12,659

)

 

 

158,236

 

Sale of common stock and issuance of stock in connection with acquisition

 

 

51,691

 

 

 

 

 

 

269

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

269

 

 

 

 

 

 

269

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

2,640

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,640

 

 

 

 

 

 

2,640

 

Restricted stock expense

 

 

 

 

 

 

 

 

413

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

413

 

 

 

 

 

 

413

 

Stock options exercised

 

 

12,500

 

 

 

 

 

 

125

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

125

 

 

 

 

 

 

125

 

Issuance of warrants, net

 

 

 

 

 

 

 

 

5,342

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,342

 

 

 

 

 

 

5,342

 

Non-controlling interests

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

198

 

 

 

198

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(40,451

)

 

 

 

 

 

 

 

 

 

 

 

(40,451

)

 

 

(600

)

 

 

(41,051

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74

 

 

 

 

 

 

 

 

 

74

 

 

 

 

 

 

74

 

Balance at June 30, 2020 (unaudited)

 

 

83,362,454

 

 

$

83

 

 

$

775,042

 

 

$

(627,345

)

 

$

(1,067

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

139,307

 

 

$

(13,061

)

 

$

126,246

 

Balance at March 31, 2021 (unaudited)

 

 

95,185,620

 

 

$

95

 

 

$

904,950

 

 

$

(738,694

)

 

$

(841

)

 

$

(1,672,920

)

 

$

(7,406

)

 

$

158,104

 

 

$

(14,980

)

 

$

143,124

 

 

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

 

 


ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(unaudited)

(In thousands)

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(60,769

)

 

$

(68,335

)

 

$

(25,603

)

 

$

(19,718

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

2,121

 

 

 

1,807

 

 

 

1,274

 

 

 

1,086

 

Stock-based compensation expense

 

 

5,314

 

 

 

5,075

 

 

 

2,234

 

 

 

2,261

 

Amortization of debt discount

 

 

553

 

 

 

513

 

 

 

779

 

 

 

256

 

Loss on disposal of assets and impairment charges

 

 

173

 

 

 

 

 

 

 

 

 

173

 

Loss on extinguishment of debt

 

 

7,230

 

 

 

 

Deferred income taxes

 

 

51

 

 

 

486

 

 

 

2

 

 

 

48

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Receivables, net

 

 

(21,931

)

 

 

3,387

 

 

 

3,414

 

 

 

(34,728

)

Prepaid expenses and other assets

 

 

1,044

 

 

 

(25,310

)

 

 

(2,176

)

 

 

3,748

 

Inventories

 

 

1,487

 

 

 

1,548

 

 

 

2,523

 

 

 

(3,101

)

Accounts payable and accrued expenses

 

 

(5,341

)

 

 

43,056

 

 

 

(12,323

)

 

 

4,430

 

Net cash used in operating activities

 

 

(70,068

)

 

 

(37,773

)

 

 

(29,876

)

 

 

(45,545

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(4,566

)

 

 

(4,891

)

 

 

(7,341

)

 

 

(1,736

)

Payments for licenses

 

 

(83

)

 

 

(4,175

)

 

 

(1,088

)

 

 

(64

)

Purchases of short-term investments

 

 

(23,571

)

 

 

(43,461

)

 

 

(55,784

)

 

 

(23,571

)

Sales and maturities of short-term investments

 

 

46,345

 

 

 

57,291

 

 

 

71,250

 

 

 

14,920

 

Net cash provided by investing activities

 

 

18,125

 

 

 

4,764

 

Net cash provided by (used in) investing activities

 

 

7,037

 

 

 

(10,451

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from sale of stock

 

 

269

 

 

 

100,373

 

Proceeds from issuance of debt

 

 

95,164

 

 

 

3,649

 

 

 

 

 

 

435

 

Proceeds from issuance of warrants

 

 

5,836

 

 

 

 

Costs incurred related to the sale of stock

 

 

 

 

 

(54

)

Costs incurred related to the issuance of debt and warrants

 

 

(6,125

)

 

 

 

Proceeds from exercise of stock options

 

 

469

 

 

 

837

 

 

 

852

 

 

 

344

 

Investment from non-controlling interest

 

 

198

 

 

 

 

Repayment of finance lease obligations and long-term debt

 

 

(54,238

)

 

 

(107

)

 

 

(98

)

 

 

(47

)

Net cash provided by financing activities

 

 

41,573

 

 

 

104,698

 

 

 

754

 

 

 

732

 

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

 

 

(10,370

)

 

 

71,689

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(22,085

)

 

 

(55,264

)

Cash, cash equivalents, and restricted cash, beginning of period

 

 

127,674

 

 

 

49,794

 

 

 

86,087

 

 

 

127,674

 

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

 

 

(403

)

 

 

715

 

 

 

478

 

 

 

(427

)

Cash, cash equivalents, and restricted cash, end of period (See Note 3)

 

$

116,901

 

 

$

122,198

 

 

$

64,480

 

 

$

71,983

 

Supplemental cash flow disclosures

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest paid

 

$

3,081

 

 

$

2,471

 

 

$

7,708

 

 

$

1,390

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accrued purchases of property and equipment

 

$

436

 

 

$

1,174

 

 

$

1,215

 

 

$

1,009

 

Accrued purchases of licenses

 

$

500

 

 

$

 

 

$

1,800

 

 

$

500

 

Equipment purchased with capital lease obligation

 

$

564

 

 

$

 

Accrued cost of debt issuance

 

$

287

 

 

$

 

ROU assets derecognized from modification of operating lease obligations

 

$

(468

)

 

$

 

 

$

 

 

$

(468

)

ROU assets recognized in exchange for operating lease obligations

 

$

353

 

 

$

583

 

 

$

 

 

$

353

 

 

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


Athenex, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements (Unaudited)

1. Company and Nature of Business

Organization and Description of Business

Athenex, Inc. and subsidiaries (the “Company” or “Athenex”), originally under the name Kinex Pharmaceuticals LLC (“Kinex”), formed in November 2003, commenced operations on February 5, 2004, and operated as a limited liability company until it was incorporated in the State of Delaware under the name Kinex Pharmaceuticals, Inc. on December 31, 2012. The Company changed its name to Athenex, Inc. on August 26, 2015.

Athenex is a global biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. The Company’s mission is to improve the lives of cancer patients by creating more effective, safer and tolerable treatments. The Company’s current clinical pipeline is derived from Orascovery, Src Kinase Inhibition, T-cell receptor-engineered T-cells (“TCR-T”), and Arginine Deprivation Therapy technology platforms. The Company has assembled a strong and experienced leadership team and has established global operations across the pharmaceutical value chain to execute itsour goal of becoming a global leader in bringing innovative cancer treatments to the market and improveimproving health outcomes.

The Company is organized around three operating segments: (1) its Oncology Innovation Platform, dedicated to the research and development of our proprietary drugs; (2) its Commercial Platform, focused on the sales and marketing of our specialty drugs and the market development of our proprietary drugs; and (3) its Global Supply Chain Platform, dedicated to providing a stable and efficient supply of APIs for our clinical and commercial efforts. The Company’s current clinical pipeline in the Oncology Innovation Platform is derived from four different proprietary technologies: (1) Orascovery, based on a P-glycoprotein (“P-gp”) pump inhibitor, (2) Src Kinase Inhibition, (3) Cell Therapy, and (4) Arginine Deprivation Therapy.

The Company is primarily engaged in conducting research and development activities through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology, conducting preclinical and clinical testing, recruiting personnel, identifying and evaluating additional drug candidates for potential in-licensing or acquisition, and raising capital to support development and commercialization activities. The Company also conducts commercial sales of specialty products through its wholly owned subsidiary, Athenex Pharmaceutical Division (“APD”), and 503B products through its wholly owned subsidiary, Athenex Pharma Solutions (“APS”).                                

Significant Risks and Uncertainties

The Company has incurred operating losses since its inception and, as a result, as of June 30, 2020March 31, 2021 and December 31, 20192020 had an accumulated deficit of $627.3 $738.7million and $567.5$713.6 million, respectively.As of June 30, 2020,March 31, 2021, the Company had cash and cash equivalents of $105.9$48.0 million, restricted cash of $11.0 $16.5million, and short-term investments of $10.4$123.2 million.

The Company believes that the existing cash and cash equivalents, restricted cash, and short-term investments will enable us to meet our current operational liquidity needs and fund operations into the second quarterhalf of 2021 but will not be sufficient to fund current operating plans through one year after the date that these unaudited condensed consolidated financial statements are issued.  This conclusion does not contemplate the additional funding the Company may receive through the Senior Credit Agreement and Revenue Interest Financing Agreement, further discussed below.2022. The Company has based these estimates on assumptions that may prove to be wrong, and it could spend the available financial resources much faster than expected and need to raise additional funds sooner than anticipated. Operations have been funded primarily through the sale of common stock, senior secured loans, and to a lesser extent, from convertible bond financing, revenue, and grant funding. The Company will require significant additional funds to conduct clinical trials and to fund its commercialization and manufacturing operations. There can be no assurance that this funding will be available for our use when needed, or at all. In addition, disruptions in the capital markets and the operations of commercial partners due to the COVID-19 pandemic may make it difficult for us to raise additional funds. If adequate funds are not available, the Company may be required to delay, modify, or terminate its research and development programs or reduce its planned commercialization efforts. Further, if the Company is unable to obtain additional financing, the Company will need to reevaluate future operating plans.Although the Company plans to raise additional funds, or access additional funding via the Senior Credit Agreement and Revenue Interest Financing, these plans are subject to market conditions which are outside of its control and based on the satisfaction of future milestone funding conditions, and therefore cannot be deemed to be probable.  As

In February 2021, the Company received a result, these uncertainties, among others, raise substantial doubt aboutComplete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for oral paclitaxel and encequidar (“Oral Paclitaxel”) for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm in the Phase III study. The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (“BICR”). The FDA stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR. The FDA recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The FDA determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization as well as, or in addition to, exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA. We are working to consider the appropriate next steps in the development of Oral Paclitaxel. We have been preparing for and plan to request a meeting


with the FDA and plan to engage in a dialogue on the design and scope of a clinical trial to address the FDA’s requirements and align on the next steps required to obtain approval.The Company’s ability to continue as a going concern.  

Since therepotentially commercialize Oral Paclitaxel, and the timing of potential commercialization, is uncertainty arounddependent on the discussion with the agency, the Company’s ability to achieve various funding conditions that trigger the lenders’ obligations to make payments under the Senior Credit Agreementresubmission of its NDA, ultimate FDA approval, and the Revenue Interest Financing Agreement, there can be no assurance that this funding will be available for our use when needed, or at all. However, if the Company meets applicable funding conditions, anticipated future proceeds from the Senior Credit Agreement and the Revenue Interest Financing Agreement, together with the existing cash and cash equivalents, restricted cash, and short-term investments, are estimated to extend the Company’s cash runway into 2022, as they provide us the financial flexibility to draw another $125.0 million and $50.0 million of contingent milestone-based, non-dilutivepotentially additional capital. See below for a description of the Senior Credit Agreement and Note 17 of the Notes to Condensed Consolidated Financial Statements contained in Item 1 of this quarterly report on Form 10-Q for a description of the Revenue Interest Financing Agreement.


These condensed consolidated financial statements have been prepared on a going concern basis, which implies the Company will continue to realize its assets and discharge its liabilities in the normal course of the business. The Company’s recurring losses from operations and negative cash flows from operations have raised substantial doubt regarding its ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

The Company entered into a senior secured loan agreement and related security agreements (the “Senior Credit Agreement”) with Oaktree Fund Administration, LLC as administrative agent, and the lenders party thereto (collectively “Oaktree”) which contains various affirmative, negative, and financial covenants customary to agreements of this type. A breach of any of these covenants could result in a default. If a default under the Senior Credit Agreement is not cured or waived, the default could result in the acceleration of debt, which could require the Company to repay the outstanding debt in full prior to the date it is otherwise due together with exit fees and any applicable prepayment fees. If the Company defaults, the lenders may seek repayment through the Company’s subsidiary guarantors or by executing on the security interest granted pursuant to the Senior Credit Agreement. The Company was in compliance with all applicable covenants as of June 30, 2020.

The Company is subject to a number of risks similar to other biopharmaceutical companies, including, but not limited to, the lack of available capital,capital; possible failure of preclinical testing or clinical trials, inability to obtain marketingregulatory approval of product candidates,candidates; competitors developing new technological innovations,innovations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates,candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products,products; and protection of proprietary technology. If the Company doesor its partners do not successfully commercialize any of itsthe Company’s product candidates, it will be unable to generate sufficient product revenue and might not, if ever, achieve profitability and positive cash flow.

Senior Secured Loan Agreement and Detachable Warrants

On June 19, 2020, the Company entered into the Senior Credit Agreement to borrow up to $225.0 million in 5 tranches with a maturity date of June 19, 2026, bearing interest at a fixed annual rate of 11.0%. The first tranche of $100.0 million was drawn by the Company prior to June 30, 2020, with the proceeds used in part to repay in full the outstanding loan and fees under the credit agreement with Perceptive Advisors LLC and its affiliates (“Perceptive”). Additional debt tranches of $125 million in aggregate are available subject to the Company’s achievement of certain regulatory and commercial milestones. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity.

In connection with our entry into the Senior Credit Agreement, the Company granted warrants to Oaktree to purchase up to an aggregate of up to 908,393 shares of the Company’s common stock at a purchase price of $12.63 per share. This transaction was accounted for as a detachable warrant at its fair value, using the relative fair value method, which is based on a number of unobservable inputs, and is recorded as an increase to additional paid-in-capital on the consolidated statement of stockholders’ equity.

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. These condensed consolidated financial statements reflect the accounts and operations of Athenex, Inc. and those of its subsidiaries in which Athenex, Inc. has a controlling financial interest. Intercompany transactions and balances have been fully eliminated in consolidation.

Results of the Company’s operations for the three and six months ended June 30, 2020March 31, 2021 are not necessarily indicative of the results expected for the year ending December 31, 2020,2021, or for any other future annual or interim period. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019,2020, filed with the Securities and Exchange Commission (“SEC”) on March 2, 2020.1, 2021.


Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting period. Such management estimates include those relating to assumptions used in clinical research accruals, chargebacks, measurement of acquired assets and assumed liabilities in business combinations, provision for credit losses, inventory reserves, deferred income taxes, the estimated useful life and recoverability of long-lived assets, and the valuation of stock-based awards.awards and other items as appropriate. Actual results could differ from those estimates.

Credit Losses

The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables and contract assets recorded under Financial Accounting Standards Board (“FASB”) ASC 606, Revenue from Contracts with Customers (“Topic 606”). The Company considers historical collection rates, current financial status of its customers, macroeconomic factors, and other industry-specific factors when evaluating for current expected credit losses. Forward-looking information is also considered in the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable and contract assets, the Company believes that the carrying value, net of excepted losses, approximates fair value and therefore, relies more on historical and current analysis of such financial instruments.

To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer, as the Company determined that risk profile of its customers is consistent based on the type and industry in which they operate. These customer classes include pharmaceutical wholesalers for specialty product sales, drug manufacturers for active pharmaceutical ingredient (API) sales, and hospitals and end-users for 503B sales. Each class of customer is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceutical industry, including unemployment rates, industry indices, and other factors, to estimate if there are current expected credit losses within its trade receivables based on the trends and the Company’s expectation of the future status of such economic and industry-specific factors. The Company believes that its customers, the majority of which are in the pharmaceutical industries with sound financial condition, and therefore, the Company’s evaluation of macroeconomic and industry-specific factors did not have a significant impact on the provision for credit losses.     As of June 30, 2020, the Company recorded a provision for credit losses of $0.2 millionfor accounts receivable related to the customer classes of pharmaceutical wholesalers, drug manufacturers, and hospitals and end users.

Expected credit losses related to contract assets are evaluated on an individual basis. The Company’s contract assets relate to upfront fees or milestone payments due from licensees for which the underlying performance obligations have been satisfied. The Company evaluates the financial status of the licensee and any historical payment activity from them. Macroeconomic and industry-specific factors are considered when estimated current expected credit losses related to contract assets. Contract assets are generally classified as short-term, and the Company is in frequent communication with licensees to establish timely payment terms. If the Company expects that credit losses exist for license-related contract assets, it will record provision for such losses against the contract asset. As of June 30, 2020, the Company determined that credit losses related to its contract assets recognized in connection with its license arrangements are not expected to be significant.

Concentration of Credit Risk, Other Risks and Uncertainties

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, restricted cash, and short-term investments. The Company deposits its cash equivalents in interest-bearing money market accounts and certificates of deposit, invests in highly liquid U.S. treasury notes, commercial paper, and high-quality investment grade commercial paper.corporate bonds. The Company deposits its cash with multiple financial institutions. Cash balances exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer and establishing a minimum allowable credit


rating. The Company also has significant assets and liabilities held in its overseas including its manufacturing facility, and research and development facility in China, and therefore is subject to foreign currency fluctuation.

Recent Adopted Accounting Pronouncements fluctuation and regulatory uncertainties.

In June 2016, the FASB issued ASU No. 2016-13, “Measurement of Credit Losses on Financial Instruments”to improve reporting requirements specific to loans, receivables, and other financial instruments. The new standard requires that credit losses on financial assets, including trade receivables and held-to-maturity debt securities, measured at amortized cost be determined using an expected loss model, instead of the current incurred loss model. In addition, ASC 326 requires that credit losses related to available-for-sale debt securities be recorded through an allowance for credit losses if the Company does not intend to sell or believes that it is more likely than not they will be required to sell, and limited to the amount by which carrying value exceeds fair value. The new standard also requires enhanced disclosure of credit risk associated with financial assets.


The standard is effective for interim and annual periods beginning after December 15, 2019 with early adoption permitted. The standard is required to be applied using the modified retrospective approach with a cumulative-effect adjustment to retained earnings, if any, upon adoption.

This standard became effective for us on January 1, 2020, and based on the composition of our trade receivables, investment portfolio and other financial assets, current economic conditions and historical credit loss activity, the adoption of this standard did not have a material impact on our condensed consolidated financial statements and related disclosures. A significant portion of the Company’s accounts receivable is from large pharmaceutical wholesalers in the U.S., and a licensing fee receivable from a public company in the People’s Republic of China (“PRC”).The Company’s estimate of expected credit losses as of June 30, 2020, using its expected credit loss evaluation process described above, resulted in no adjustments to the provision for credit losses and 0 cumulative-effect adjustment to retained earnings on the adoption date of the standard.

Subsequent Events

The Company reviewed and evaluated subsequent events through the issuance date of the Company’s unaudited condensed consolidated financial statements.

3. Restricted Cash

The Company hashad a restricted cash balance of $11.0$16.5 million as of June 30,March 31, 2021 and December 31, 2020 held in a controlled bank account in connection with the Company’s senior secured loan agreement and related security agreements (the “Senior Credit Agreement”) with Oaktree Fund Administration, LLC, as administrative agent, and the lenders party thereto (collectively, “Oaktree”). The Senior Credit Agreement which requires the Company to maintain, in a debt service reserve account, a minimum cash balance equal to twelve months of interest on the outstanding loans under the Senior Credit Agreement.

4. Inventories

Inventories consist of the following (in thousands):

 

 

June 30,

2020

 

 

December 31,

2019

 

 

March 31,

2021

 

 

December 31,

2020

 

Raw materials and purchased parts

 

$

3,191

 

 

$

4,176

 

 

$

3,054

 

 

$

6,498

 

Work in progress

 

 

1,453

 

 

 

1,870

 

 

 

1,728

 

 

 

776

 

Finished goods

 

 

26,499

 

 

 

26,584

 

 

 

21,542

 

 

 

21,572

 

Total inventories

 

$

31,143

 

 

$

32,630

 

 

$

26,324

 

 

$

28,846

 

 

5. Intangible Assets, net

The Company’s identifiable intangible assets, net, consist of the following (in thousands):

 

 

June 30, 2020

 

 

March 31, 2021

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

Amortizable intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licenses

 

$

9,518

 

 

$

4,358

 

 

$

 

 

$

5,160

 

 

$

12,641

 

 

$

5,745

 

 

$

 

 

$

6,896

 

Polymed customer list

 

 

1,593

 

 

 

1,291

 

 

 

 

 

 

302

 

 

 

1,593

 

 

 

1,482

 

 

 

 

 

 

111

 

Polymed technology

 

 

3,712

 

 

 

1,417

 

 

 

 

 

 

2,295

 

 

 

3,712

 

 

 

1,754

 

 

 

 

 

 

1,958

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CDE in-process research and development (IPR&D)

 

 

723

 

 

 

 

 

 

 

 

 

723

 

 

 

728

 

 

 

 

 

 

 

 

 

728

 

Effect of currency translation adjustment

 

 

(465

)

 

 

 

 

 

 

 

 

(465

)

 

 

(211

)

 

 

 

 

 

 

 

 

(211

)

Total intangible assets, net

 

$

15,081

 

 

$

7,066

 

 

$

 

 

$

8,015

 

 

$

18,463

 

 

$

8,981

 

 

$

 

 

$

9,482

 

 

 

December 31, 2019

 

 

December 31, 2020

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

Amortizable intangible assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licenses

 

$

8,935

 

 

$

3,561

 

 

$

 

 

$

5,374

 

 

$

12,641

 

 

$

5,157

 

 

$

 

 

$

7,484

 

Polymed customer list

 

 

1,593

 

 

 

1,164

 

 

 

 

 

 

429

 

 

 

1,593

 

 

 

1,418

 

 

 

 

 

 

175

 

Polymed technology

 

 

3,712

 

 

 

1,297

 

 

 

 

 

 

2,415

 

 

 

3,712

 

 

 

1,685

 

 

 

 

 

 

2,027

 

Product rights

 

 

530

 

 

 

360

 

 

 

170

 

 

 

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CDE in-process research and development (IPR&D)

 

 

728

 

 

 

 

 

 

 

 

 

728

 

 

 

728

 

 

 

 

 

 

 

 

 

728

 

Effect of currency translation adjustment

 

 

(424

)

 

 

 

 

 

 

 

 

(424

)

 

 

(196

)

 

 

 

 

 

 

 

 

(196

)

Total intangibles, net

 

$

15,074

 

 

$

6,382

 

 

$

170

 

 

$

8,522

 

 

$

18,478

 

 

$

8,260

 

 

$

 

 

$

10,218

 


 

As of June 30, 2020,March 31, 2021, licenses at cost include an Orascovery license of $0.4 million, licenses purchased from Gland Pharma Limited (“Gland”) of $4.4 million, a license purchased from MAIA Pharmaceuticals, Inc. (“MAIA”) for $4.0 million, licenses purchased from Ingenus Pharmaceuticals, LLC (“Ingenus”) for $3.0 million, and licenses of other specialty products of $0.7$0.8 million. The Orascovery license with Hanmi Pharmaceuticals Co. Ltd. (“Hanmi”) was purchased directly from Hanmi and is being amortized on a straight-line basis over a period of 12.75 years, the remaining life of the license agreement at the time of purchase. The licenses purchased from Gland are being amortized on a straight-line basis over a period of 5 years, the remaining life of the license agreement at the time of purchase. The license purchased from MAIA is being amortized over a period of 7 years, the remaining life of the license agreement at the time of purchase. Of the $3.0 million licenses purchased from Ingenus, a $2.0 million license is being amortized over a period of 5 years, the estimated useful life of the license agreement and a $1.0 million license purchased from Ingenus is being amortized over a period of 3 years, the remaining life of the license agreement at the time of purchase.

The remaining intangible assets were acquired in connection with the acquisitions of Polymed Therapeutics, Inc. (“Polymed”) and Comprehensive Drug Enterprises (“CDE”). Intangible assets are amortized using an economic consumption model over their useful lives. The Polymed customer list and technology are amortized on a straight-line basis over 6 and 12 years, respectively. The CDE in-process research and development, (“IPR&D”), will not be amortized until the related projects are completed. IPR&D is tested annually for impairment, unless conditions exist causing an earlier impairment test (e.g., abandonment of project). The Company recorded 0 impairments of IPR&D during the sixthree months ended June 30, 2020.March 31, 2021. The weighted-average useful life for all intangible assets was 7.697.1 years as of June 30, 2020.March 31, 2021.

The Company recorded $0.50.6 million and $0.5 million of amortization expense for both the three-month periods ended June 30,March 31, 2021 and 2020, and 2019, and $0.9 million of amortization expense for both the six-month periods ended June 30, 2020 and 2019, respectively.    

The Company’s goodwill balance is the result of prior period acquisitions and is allocated to the Global Supply Chain Platform reporting unit and the Oncology Innovation Platform reporting unit. Changes in goodwill balances reported within the unaudited condensed consolidated balance sheet as of June 30, 2020March 31, 2021 are due to the effect of foreign currency on goodwill from acquisitions of subsidiaries that have a functional currency other than USD.

During the first quarter of 2021, due to the significant decrease in its market capitalization, the Company evaluated the impact on each of its reporting units to assess whether there was a triggering event requiring it to perform a goodwill impairment test (ASC350-20-35). The Company determined a triggering event occurred and, as such, performed an interim goodwill quantitative impairment test for its reporting units. It also considered certain qualitative factors, such as the Company’s performance, business forecasts, and expansion plans. It reviewed key assumptions, including revisions of projected cash flows and future revenue for reporting units against the results of the annual quantitative impairment test performed during the last quarter of 2020. Using both the income approach and the market approach for its Global Supply Chain Platform and Oncology Innovation Platform, with the discount rate selected considering and capturing the related risk associated with the forecast, the Company compared the fair value of the 2 reporting units to carrying value. Based on the results, the fair value of each of our reporting units exceeded their carrying value and the goodwill was not impaired. However, there can be no assurances that goodwill will not be impaired in future periods. Estimating the fair value of goodwill requires the use of estimates and significant judgments that are based on a number of factors. These estimates and judgments may not be within the control of the Company and accordingly it is reasonably possible that the judgments and estimates could change in future periods.  

6. Fair Value Measurements

Financial instruments consist of cash and cash equivalents, restricted cash, short-term investments, an available-for-sale equity investment, accounts receivable, accounts payable, accrued liabilities, detachable warrants issued in connection with the Senior Credit Agreement, and debt. Short-term investments and the equity investment are stated at fair value. Cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities, and debt, are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts.

ASC 820, Fair Value Measurements, establishes a framework for measuring fair value. That framework provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). The three levels of the fair value hierarchy under the ASC 820 are described as follows:

Level 1—Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access.

Level 2—Inputs to the valuation methodology include:

 

Quoted prices for similar assets or liabilities in active markets;

 

Quoted prices for identical or similar assets or liabilities in inactive markets;


 

Inputs other than quoted prices that are observable for the asset or liability;


 

Inputs that are derived principally from or corroborated by observable market data by correlation or other means; and

 

If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability.

Level 3—Inputs to the valuation methodology are unobservable, supported by little or no market activity, and are significant to the fair value measurement.

Transfers between levels, if any, are recorded as of the beginning of the reporting period in which the transfer occurs. There were 0 transfers between Levels 1, 2 or 3 for any of the periods presented.

The following tables represent the fair value hierarchy for those assets and liabilities that the Company measures at fair value on a recurring basis (in thousands):

 

 

Fair Value Measurements at June 30, 2020 Using:

 

 

Fair Value Measurements at March 31, 2021 Using:

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial assets included within cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

13,749

 

 

$

13,749

 

 

$

 

 

$

 

 

$

5,497

 

 

$

5,497

 

 

$

 

 

$

 

Short-term investments - certificates of deposit

 

 

15,188

 

 

 

 

 

 

15,188

 

 

 

 

 

 

1,000

 

 

 

 

 

 

1,000

 

 

 

 

Short-term investments - U.S. government bonds

 

 

19,998

 

 

 

 

 

 

19,998

 

 

 

 

Short-term investments - commercial paper

 

 

24,997

 

 

 

 

 

 

24,997

 

 

 

 

 

 

22,548

 

 

 

 

 

 

22,548

 

 

 

 

Financial assets included within short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term investments - certificates of deposit

 

 

10,144

 

 

 

 

 

 

10,144

 

 

 

 

 

 

22,769

 

 

 

 

 

 

22,769

 

 

 

 

Short-term investments - U.S. government bonds

 

 

15,000

 

 

 

 

 

 

15,000

 

 

 

 

Short-term investments - commercial paper

 

 

85,185

 

 

 

 

 

 

85,185

 

 

 

 

Available-for-sale investment

 

 

270

 

 

 

270

 

 

 

 

 

 

 

 

 

232

 

 

 

232

 

 

 

 

 

 

 

Total assets

 

$

84,346

 

 

$

14,019

 

 

$

70,327

 

 

$

 

 

$

152,231

 

 

$

5,729

 

 

$

146,502

 

 

$

 

 

 

Fair Value Measurements at December 31, 2019 Using:

 

 

Fair Value Measurements at December 31, 2020 Using:

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial assets included within cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

5,460

 

 

$

5,460

 

 

$

 

 

$

 

 

$

5,615

 

 

$

5,615

 

 

$

 

 

$

 

Short-term investments - certificates of deposit

 

 

15,110

 

 

 

 

 

 

15,110

 

 

 

 

 

 

4,070

 

 

 

 

 

 

4,070

 

 

 

 

Short-term investments - U.S. government bonds

 

 

5,000

 

 

 

 

 

 

5,000

 

 

 

 

Short-term investments - commercial paper

 

 

51,017

 

 

 

 

 

 

51,017

 

 

 

 

 

 

34,860

 

 

 

 

 

 

34,860

 

 

 

 

Financial assets included within short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term investments - certificates of deposit

 

 

10,054

 

 

 

 

 

 

10,054

 

 

 

 

 

 

20,696

 

 

 

 

 

 

20,696

 

 

 

 

Short-term investments - U.S. government bonds

 

 

14,998

 

 

 

 

 

 

14,998

 

 

 

 

Short-term investments - commercial paper

 

 

22,835

 

 

 

 

 

 

22,835

 

 

 

 

 

 

102,715

 

 

 

 

 

 

102,715

 

 

 

 

Available-for-sale investment

 

 

250

 

 

 

250

 

 

 

 

 

 

 

 

 

227

 

 

 

227

 

 

 

 

 

 

 

Total assets

 

$

104,726

 

 

$

5,710

 

 

$

99,016

 

 

$

 

 

$

188,181

 

 

$

5,842

 

 

$

182,339

 

 

$

 

 

The Company classifies its money market funds within Level 1 because it uses quoted market prices to determine their fair value. The Company classifies its commercial paper, corporate notes, certificates of deposit, and U.S. government bonds within Level 2 because it uses quoted prices for similar assets or liabilities in active markets and each has a specified term and all Level 2 inputs are observable for substantially the full term of each instrument.

The Company owns 68,000 shares of PharmaEssentia, a company publicly traded on the Taiwan OTC Exchange. As of June 30, 2020March 31, 2021 and December 31, 2019,2020, the Company’s investment in PharmaEssentia was valued at the reported closing price on such dates. This investment is classified as a Level 1 investment and is recorded as an available-for-sale investment within short-term investments on the Company’s condensed consolidated balance sheet.  


7. Acquisitions and Business Combinations

CIDAL

On June 27, 2019, the Company entered into a definitive asset purchase agreement (the “APA”) with CIDAL Limited, a British Virgin Islands company limited by shares, and several of its affiliates (“CIDAL”). CIDAL operates as a contract research organization with headquarters in Guatemala and operations in various countries in Central America. Pursuant to the terms of the APA, the Company acquired certain assets of CIDAL in exchange for agreeing to assume certain liabilities of CIDAL and issuing milestone payments of an aggregate of 67,796 shares of the Company’s common stock, contingent upon the achievement of certain developmental and regulatory events through the third quarter of 2021. The Company accounted for the asset purchase using the acquisition method of accounting and accordingly, the identifiable assets acquired, and liabilities assumed were recorded based upon management’s estimates of current fair values as of the acquisition date. The Company received net cash of $0.9 million, acquired property and equipment of less than $0.1 million, assumed liabilities of $1.1 million, and recorded goodwill of approximately $1.0 million, and has paid contingent equity consideration associated with the transaction of $0.8 million to date. 

The operating results of CIDAL have been included within the Company’s Oncology Innovation Platform operating segment from the closing date of the acquisition. CIDAL incurred a net loss of $1.1 million for the three months ended June 30, 2020 and added $0.1 million of revenue and incurred a net loss of $2.1 million for the six months ended June 30, 2020. During the six months ended June 30, 2020, CIDAL achieved 2 of its 6 clinical milestones associated with the contingent equity consideration from the acquisition. As a result, the Company issued 22,598 shares of its common stock to CIDAL during the six months ended June 30, 2020.         

8. Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Accrued wages and benefits

 

$

11,091

 

 

$

7,541

 

 

$

7,798

 

 

$

6,720

 

Accrued selling fees and rebates

 

 

10,101

 

 

 

1,577

 

Accrued selling fees, rebates, and royalties

 

 

4,388

 

 

 

9,046

 

Accrued operating expenses

 

 

3,804

 

 

 

3,222

 

Accrued construction costs

 

 

8,202

 

 

 

22,811

 

 

 

3,421

 

 

 

4,104

 

Accrued tax withholdings

 

 

5,228

 

 

 

187

 

Accrued inventory purchases

 

 

4,774

 

 

 

7,194

 

 

 

2,397

 

 

 

3,714

 

Accrued clinical expenses

 

 

3,600

 

 

 

2,510

 

 

 

2,073

 

 

 

2,949

 

Accrued operating expenses

 

 

2,065

 

 

 

1,885

 

Accrued tax withholdings

 

 

1,863

 

 

 

1,948

 

Accrued costs for product launch

 

 

1,602

 

 

 

 

 

 

1,415

 

 

 

1,474

 

Deferred revenue

 

 

1,289

 

 

 

1,147

 

Accrued R&D licensing fees

 

 

384

 

 

 

384

 

 

 

266

 

 

 

366

 

Deferred revenue

 

 

97

 

 

 

218

 

Accrued interest

 

 

 

 

 

3,583

 

Total accrued expenses

 

$

47,144

 

 

$

44,307

 

 

$

28,714

 

 

$

38,273

 

 

The accrued construction costs relate to the building of the manufacturing facility in Dunkirk, NY. This amount, plus an additional $0.3$0.4 million paid by the Company is expected to be funded by New York State. Therefore, $8.5$3.8 million is recorded within prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet as of June 30, 2020March 31, 2021

9.8. Income Taxes

The Company did 0t record a provision for U.S. federal income taxes for the sixthree months ended June 30, 2020March 31, 2021 because it expects to generate a loss for the year ending December 31, 20202021 and the Company’s net deferred tax assets continue to be fully offset by a valuation allowance. Tax expense to date is primarily the result of tax to be withheld in China,Taiwan, in the amount of $2.8 $0.1 million, on a milestone paymentpayments in connection with an out-license agreement and recording a deferred tax liability, in the amount of $0.1 million, against indefinite lived intangible assets.    agreement.

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) into law. The CARES Act includes several significant business tax provisions that, among other things, would eliminate the taxable income limit for certain net operating losses (“NOLs”) and allow businesses to carry back NOLs arising in 2018, 2019, and 2020 to the five prior tax years, accelerate refunds of previously generated corporate alternative minimum tax credits, change the business interest limitation under IRC section 163(j) of the Internal Revenue Code from 30 percent to 50 percent, and fix qualified improvement property from the Tax Cuts and Jobs Act of 2017.  This new legislation did not materially affect the Company’s income tax position.


10.9. Debt and Lease Obligations

Debt

The Company’s debt as of June 30, 2020March 31, 2021 and December 31, 2019,2020, consists of the following (in thousands):

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Current portion of mortgage

 

$

676

 

 

$

686

 

 

$

729

 

 

$

731

 

Current portion of finance and capital lease obligations

 

 

361

 

 

 

194

 

Current portion of bank loan

 

 

761

 

 

 

764

 

Current portion of senior secured loan

 

 

70

 

 

 

70

 

Current portion of finance lease obligations

 

 

410

 

 

 

445

 

Current portion of operating lease obligations

 

 

2,713

 

 

 

3,010

 

 

 

3,161

 

 

 

3,185

 

Long-term portion of finance and capital lease obligations

 

 

506

 

 

 

227

 

Long-term portion of finance lease obligations

 

 

474

 

 

 

537

 

Long-term portion of operating lease obligations

 

 

6,850

 

 

 

7,620

 

 

 

5,832

 

 

 

6,355

 

Chongqing Maliu Credit Agreement

 

 

6,636

 

 

 

5,731

 

Senior secured loan, net of debt discount and financing fees

of $11,753 and $3,592, respectively

 

 

88,247

 

 

 

46,408

 

Chongqing Maliu credit agreement

 

 

7,614

 

 

 

7,641

 

Senior secured loan, net of debt discount and financing fees

of $10,822 and $11,601 respectively

 

 

139,178

 

 

 

138,399

 

Total

 

$

105,989

 

 

$

63,876

 

 

$

158,229

 

 

$

158,127

 


 

The mortgage payments, assumed in connection with the acquisition of CDE, extend through December 31, 2020.         

During the first quarter of 2019, the Company was issued an unsecured, subordinated bank loan from China Merchants Bank to fund operations in China. This loan had a principal value of $0.7 million, a maturity date of December 11, 2019, and bore interest at a fixed rate of 5.7% annually. The loan was paid in full as of December 31, 2019.

During the second quarter of 2019, the Company entered into a credit agreement which amended the existing partnership agreement with Chongqing Maliu Riverside Development and Investment Co., LTD (“CQ”), for a Renminbi ¥50.0 million (USD $7.2 million at June 30, 2020) line of credit to be used for the construction of the new API plant in China. The Company is required to repay the principal amount with accrued interest within three years after the plant receives the U.S. Current Good Manufacturing Practices (“cGMP”) certification, with 20% of the total loan with accrued interest is due within the first twelve months following receiving the certification, 30% of the total loan with accrued interest due within twenty-four months, and the remaining balance with accrued interest due within thirty-six months. Interest accrues at the three-year loan interest rate by the People’s Bank of China for the same period on the date of the deposit of the full loan amount. If the Company fails to obtain the cGMP certification within three years upon the acceptance of the plant, it shall return all renovation costs with the accrued interest to CQ in a single transaction within the first ten business days. The Company draws on this debt as needed and received $1.0 million during the six months ended June 30, 2020. As of June 30, 2020, the balance due to CQ was $6.6 million. 

On June 19, 2020, the Company paid off all obligations owing under, and terminated, the senior secured loan agreement with Perceptive. The secured interests were terminated in connection with the Company’s payoff of all obligations. In connection with the repayment of the Perceptive loan, the Company incurred a $3.8 million prepayment fee, the unamortized debt discount of $3.1 million, and $0.3 million in other charges. The Perceptive debt extinguishment resulted in a $7.2 million loss that was included in debt extinguishment expenses, in the unaudited condensed consolidated statements of operations.Senior Credit Agreement

On June 19, 2020 (“Closing Date”), the Company entered into the Senior Credit Agreement with Oaktree to borrow up to $225.0 million in 5 tranches, with a maturity date of June 19, 2026. The first trancheThree tranches (“Tranche A”, “Tranche B”, and “Tranche D”) of the term loans with an aggregate principal amount of $100.0$150.0 million waswere drawn by the Company as of June 30,in 2020. A portion of the proceeds of the firstOne tranche was used to repay in full the existing senior secured loan with Perceptive, including related prepayment fees, unpaid interest, and legal fees. The second advance(“Tranche C”) of $25.0 million (“Tranche B”), the third advance of $25.0 million (“Tranche C”), and the fourth advance of $25.0 million (“Tranche D”) will be available to the Company from 90 days after the Closing Date through June 20, 2022, subject to the Company’s satisfaction of a certain regulatory and commercial milestones;milestone; and the fifth advancelast tranche of $50.0 million (“Tranche E”) will be available to the Company from 90 days after the Closing Date through June 19, 2023, also subject to the Company’s satisfaction of a certain regulatory and commercial milestones.milestone. The loan bears interest at a fixed annual rate of 11.0%. The Company allocated the proceeds of the drawn tranches between liability and equity components and the fair value of such equity components, along with the direct costs related to the issuance of the debt were recorded as an offset to long-term debt on the consolidated balance sheets. The debt discount and financing fees are amortized on a straight-line basis, which approximates the effective interest method, over the remaining maturity of the Senior Credit Agreement. The effective interest rate of Tranches A, B and D, including the amortization of debt discount and financing fees amounts to 13.3% annually. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Beginning on September 17, 2020, the Company will bewas required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date or the commitment termination date. Prepayments of the loan, in whole or in part, will be subject to early prepayment fee which declines each year until the fourth anniversary date of the Closing Date, after which no prepayment fee is required. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company, and as of June 30,March 31, 2021 and December 31, 2020, the Company has reflected a long-term exit fee liability of $2.0$3.0 million within long-term debt and finance lease obligations on the unaudited condensed consolidated balance sheet.


The Senior Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that were customarily required for similar financings. The Company is subject to certain financial covenants under the Senior Credit Agreement, including (1) a minimum liquidity amount in cash or permitted cash equivalent investments of $20.0 million from the closing date until the date on which the aggregate principal amount of loans outstanding is greater than or equal to $150.0 million (the “First Step-Up Date”), $25.0 million from the First Step-Up Date until the date on which the aggregate principal amount of loans outstanding balance is equal to $225.0 million (the “Second Step-Up Date)Date”), and $30.0 million from the Second Step-up Date until the maturity date ;date; (2) minimum revenue no less than 50% of target revenue beginning with the fiscal quarter ended on December 31, 2020 and with respect to each such subsequent fiscal quarter prior to the revenue covenant termination date; (3) leverage ratio covenant not to exceed 4.50 to 1.00 as of the last day of any fiscal quarter beginning with the first fiscal quarter following the revenue covenant termination date. At June 30, 2020,March 31, 2021, the Company was in compliance with all applicable debt covenants.

Revenue Interest Financing Agreement

On August 4, 2020, the Company entered into a Revenue Interest Financing Agreement with Sagard, pursuant to which Sagard agreed to pay the Company $50.0 million to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the U.S. FDA for the treatment of metastatic breast cancer. In the event the Company is unable to do so before December 31, 2021, Sagard will have a termination right. In exchange for the Product Payment, the Company agreed to make payments to Sagard equal to 5.0% of its world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price as discussed below and further set forth in the Revenue Interest Financing Agreement. The Company is required to make certain additional payments to Sagard to the extent Sagard has not received Payments equaling at least $20.0 million by September 30, 2024 and at least $50.0 million by August 4, 2026, in the amount of the applicable shortfall, and, subject to the Hard Cap, if Sagard has not received Payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded, in an amount such that Sagard will have obtained a 6.0% internal rate of return on the Product Payment.

The Company’s obligations under the Revenue Interest Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree as administrative agent for the lenders under our Senior Credit Agreement, by a perfected security interest in (i) accounts receivable arising from net sales of Oral Paclitaxel and (ii) intellectual property that is claiming or covering Oral Paclitaxel itself or any method of using, making or manufacturing Oral Paclitaxel.


Credit Agreements, Bank Loan and Mortgage

During the second quarter of 2019, the Company entered into a credit agreement which amended the existing partnership agreement with Chongqing Maliu Riverside Development and Investment Co., LTD (“CQ”), for a Renminbi ¥50.0 million (USD $7.7 million at December 31, 2020) line of credit to be used for the construction of the new API plant in China. The Company is required to repay the principal amount with accrued interest within three years after the plant receives the cGMP certification, with 20% of the total loan with accrued interest is due within the first twelve months following receiving the certification, 30% of the total loan with accrued interest due within twenty-four months, and the remaining balance with accrued interest due within thirty-six months. Interest accrues at the three-year loan interest rate by the People’s Bank of China for the same period on the date of the deposit of the full loan amount, which is expected to approximate 4.75% annually. If the Company fails to obtain the cGMP certification within three years upon the acceptance of the plant, it shall return all renovation costs with the accrued interest to CQ in a single transaction within the first ten business days. As of March 31, 2021, the balance due to CQ was $7.6 million.

On May 15, 2020, the Company entered into a credit agreement with China Merchants Bank, enabling the Company to draw up to a Renminbi ¥5.0 million (USD $0.8 million at March 31, 2021) during the period through May 14, 2021. The Company drew the entire available credit in July 2020. This loan has a maturity date of May 14, 2021 and bears interest at a fixed rate of 4.35% annually. The Company is required to pay the outstanding principal and all accrued interest at maturity.

The mortgage payments, assumed in connection with the acquisition of CDE, extend through December 31, 2021.                

Lease Obligations

The Company has operating leases for office and manufacturing facilities in several locations in the U.S., Asia, and Latin America and has three finance leases for manufacturing equipment used in its facilities near Buffalo, NY. The components of lease expense are as follows (in thousands):

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Operating lease cost

 

 

768

 

 

$

793

 

 

 

1,523

 

 

$

1,571

 

 

 

746

 

 

$

755

 

Finance lease cost:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of assets

 

 

64

 

 

 

14

 

 

 

81

 

 

 

26

 

 

 

75

 

 

 

34

 

Interest on lease liabilities

 

 

20

 

 

 

8

 

 

 

26

 

 

 

17

 

 

 

24

 

 

 

6

 

Total net lease cost

 

$

852

 

 

$

815

 

 

$

1,630

 

 

$

1,614

 

 

$

845

 

 

$

795

 

 

The Company has elected to exclude short-term leases from its operating lease right-of-use (“ROU”) assets and lease liabilities. Lease costs for short-term leases were not material to the financial statements for the three months ended June 30,March 31, 2021 and 2020. Variable lease costs for the three months ended June 30, 2020March 31, 2021 were not material to the financial statements.

Supplemental balance sheet information related to leases is as follows (in thousands, except lease term and discount rate):

 

 

June 30, 2020

 

 

March 31, 2021

 

 

December 31, 2020

 

Finance leases:

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment, at cost

 

$

1,252

 

 

$

1,535

 

 

$

1,535

 

Accumulated amortization, net

 

 

(207

)

 

 

(422

)

 

 

(347

)

Property and equipment, net

 

$

1,045

 

 

$

1,113

 

 

$

1,188

 

 

 

 

 

 

 

 

 

 

 

 

 

Current obligations of finance leases

 

$

361

 

 

$

410

 

 

$

445

 

Long-term portion of finance leases

 

 

506

 

 

 

474

 

 

 

537

 

Total finance lease obligations

 

$

867

 

 

$

884

 

 

$

982

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average remaining lease term (in years):

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

 

4.89

 

 

 

3.96

 

 

 

4.23

 

Finance leases

 

 

3.24

 

 

 

3.06

 

 

 

3.40

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average discount rate:

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

 

12.9

%

 

 

12.8

%

 

 

12.8

%

Finance leases

 

 

9.5

%

 

 

10.8

%

 

 

10.4

%


 


Supplemental cash flow information related to leases is as follows (in thousands):

 

 

Six

Months Ended

June 30, 2020

 

 

Three

Months Ended

March 31, 2021

 

 

Three

Months Ended

March 31, 2020

 

Cash paid for amount included in the measurements of lease

liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

(1,617

)

 

$

(979

)

 

$

(820

)

Operating cash flows from finance leases

 

 

(26

)

 

 

(24

)

 

 

(6

)

Financing cash flows from finance leases

 

 

(118

)

 

 

(98

)

 

 

(47

)

 

 

 

 

 

 

 

 

 

 

 

 

ROU assets derecognized from modification of operating

lease obligations

 

 

(468

)

 

 

 

 

 

(468

)

ROU assets recognized in exchange for operating lease

obligations

 

$

353

 

 

$

 

 

$

353

 

 

Future minimum payments and maturities of leases is as follows (in thousands):

 

Year ending December 31:

 

Operating Leases

 

Finance Leases

 

 

Operating Leases

 

Finance Leases

 

2020 (remaining six months)

 

$

1,486

 

$

194

 

2021

 

 

2,840

 

389

 

2021 (remaining nine months)

 

$

2,577

 

$

351

 

2022

 

 

2,621

 

182

 

 

 

2,918

 

275

 

2023

 

 

2,096

 

147

 

 

 

2,096

 

248

 

2024

 

 

2,002

 

110

 

 

 

2,002

 

157

 

2025

 

 

1,472

 

 

Thereafter

 

 

1,950

 

 

 

 

 

478

 

 

 

Total lease payments

 

 

12,995

 

 

1,022

 

 

 

11,543

 

 

1,031

 

Less: Imputed interest

 

 

(3,432

)

 

(155

)

 

 

(2,550

)

 

(147

)

Total lease obligations

 

 

9,563

 

 

867

 

 

 

8,993

 

 

884

 

Less: Current obligations

 

 

(2,713

)

 

(361

)

 

 

(3,161

)

 

(410

)

Long-term lease obligations

 

$

6,850

 

$

506

 

 

$

5,832

 

$

474

 

 

Pursuant to the public-private partnership agreements with the State of New York, and CQ, the Company will rent the manufacturing facilities in Dunkirk, NY and Chongqing, China, respectively. In 2019, constructionNY. The facility is in the final stage of the API plant was completed.completion. However, neitherno lease term had commenced as of June 30, 2020,March 31, 2021, as neitherit was not yet operational and the Company could not direct the use of the facilities were operational, and nofacility. No lease costs were incurred related to the manufacturing facility during the six-monththree-month period ended June 30, 2020.March 31, 2021.

On January 5, 2021, Chongqing Sintaho Pharmaceuticals Co., Ltd. (“CQ Sintaho”), a subsidiary of the Company in China, entered into a lease agreement with Chongqing International Biological City Development & Investment Co., Ltd (“CQ D&I”). Under the lease agreement, the provisions of which are consistent with those agreed upon in the 2015 Agreement, CQ Sintaho leased the newly constructed API facility, or Sintaho API Facility, of 34,517 square meters rent-free, for the first 10-year term, with an option to extend the lease for an additional 10-year term, during which, if CQ Sintaho is profitable, it will pay a monthly rent of 5 RMB per square meter of space occupied. The Company determined the lease had commenced as of March 31, 2021, as it was operational and CQ Sintaho could direct the use of the facility. The Company also evaluated the probability of exercising the renewal and purchase options, and determined that it is not reasonably certain whether it will exercise those options. Therefore, the lease term is comprised only of the rent-free period and the recognition of the right-of-use asset and liability did not have a significant effect on the Company’s consolidated financial statements.

The Company exercises judgment in determining the discount rate used to measure the lease liabilities. When rates are not implicit within an operating lease, the Company uses its incremental borrowing rate as its discount rate, which is based on yield trends in the biotechnology and healthcare industry and debt instruments held by the Company with stated interest rates. The Company re-assesses its incremental borrowing rate when new leases arise, or existing leases are modified.


11.10. Related Party Transactions

During the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, the Company entered into transactions with individuals and companies that have financial interests in the Company. Related party transactions included the following:

a.

In June 2018, the Company entered into 2 in-licensing agreements with Avalon BioMedical (Management) Limited (“Avalon”) wherein the Company obtained certain intellectual property (“IP”)IP from Avalon to develop and commercialize the underlying products. Under these agreements the Company is required to pay upfront fees and future milestone payments and sales-based royalties. During the year ended December 31, 2019, the Company recorded a $1.0 million milestone fee paid to Avalon, as research and development expenses on its condensed consolidated statement of operations and comprehensive loss. During the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, 0 fees were paid to Avalon in connection with the license agreements. Certain members of the Company’s board and management collectively have a controlling interest in Avalon. The Company does not hold any interest in Avalon and does not have any obligations to absorb losses or any rights to receive benefits from Avalon. As of June 30, 2020,March 31, 2021, and December 31, 2019,2020, Avalon held 786,061 shares of the Company’s common stock, which represented approximately 1% of the Company’s total issued shares for both periods. Balances due from Avalon recorded on the condensed consolidated balance sheets were not significant.   


In June 2019, the Company entered into an agreement whereby Avalon would hold a 90% ownership interest and the Company would hold a 10% ownership interest of the newly formed entity under the name Nuwagen Limited (“Nuwagen”), incorporated under the laws of Hong Kong. Nuwagen is principally engaged in the development and commercialization of herbal medicine products for metabolic, endocrine, and other related indications. The Company contributed nonmonetary assets in exchange for the 10% ownership interest. In July 2020, the transaction was closed. The activities of Nuwagen were not material to the financial statements for the three months ended March 31, 2021.

b.

The Company earns licensing revenue from PharmaEssentia, an entity in which the Company has an investment classified as available-for-sale (see Note 6—Fair Value Measurements). During the three months ended March 31, 2021, the Company recorded $0.5 Fundsmillion milestone fee earned from PharmaEssentia under a license agreement. There were 0 funds paid to or received from PharmaEssentia under the license and cost-sharingagreements were not material for the three months ended March 31, 2021 and six-month periods ended June 30, 2020, and 2019.2020. 

In September 2020, Axis Therapeutics Limited (“Axis”), a majority-owned subsidiary of the Company, entered into a collaboration agreement with PharmaEssentia, pursuant to which Axis granted to PharmaEssensia an exclusive, non-transferrable and revocable sublicense of TCR-engineered T Cell therapy for the development of the technology in Taiwan. Axis received license fee of $1.0 million, net of $0.3 million withholding tax, in the fourth quarter of 2020. This amount was recorded as deferred revenue as of March 31, 2021.        

c.

The Company receives certain clinical development services from ZenRx Limited and its affiliate (“ZenRx”(collectively, “ZenRx”), a company for which 1 of the Company’s executive officers serves on the board of directors. In connection with such services, the Company made payments to ZenRx of $0.20.3 million and $0.3$0.5 million for the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and $0.3 million and $0.6 million for the six months ended June 30, 2020 and 2019, respectively.  In April 2013, the Company entered into a license agreement with ZenRx pursuant to which the Company granted an exclusive, sublicensable license to use certain of the Company’s IP to develop and commercialize oral irinotecan and encequidar (“Oral Irinotecan”), and oral paclitaxel and encequidar (“Oral Paclitaxel”)Paclitaxel in Australia and New Zealand, and a non-exclusive license to manufacture a certain compound, but only for use in Oral Irinotecan and Oral Paclitaxel. ZenRx is responsible for all development, manufacturing and commercialization, and the related costs and expenses, of any product candidates resulting from the agreement. NaN revenue was earned from this license agreement in the periods presented in these consolidated financial statements.         

d.

Certain family members of executives perform consulting services for the Company. Such services were not significant to the condensed consolidated financial statements.

12.11. Stock-Based Compensation

Common Stock Option Plans

The Company has four equity compensation plans, adopted in 2017, 2013, 2007 and 2004 (the “Plans”) which, taken together, authorize the grant of up to 16,000,000 shares of common stock to employees, directors, and consultants. On May 23, 2019, the board of directors approved the amendment and restatement of the 2017 Omnibus Incentive Plan (the “2017 Plan”, which increases the number of shares available for issuance under the 2017 planPlan by up to 3,500,000 shares, which was approved by the Company’s stockholders at the Company’s 2020 annual meeting of stockholders. On April 26, 2021, the board of directors approved an amendment to the 2017 Plan, which increases the number of shares available for issuance under the 2017 Plan by 5,000,000 shares, subject to the approval of the Company’s stockholders at the Company’s 2021 annual meeting of stockholders. The Company also has an employee stock purchase plan, the 2017 Employee Stock Purchase Plan (the “ESPP”), adopted on June 14, 2017, which authorizes the issuance of up to 1,000,000 shares of common stock for future issuances to eligible employees.  


Stock Options

The total fair value of stock options vested and recorded as compensation expense during the three months ended June 30,March 31, 2021 and 2020 and 2019, and six months ended June 30, 2020 and 2019 was $2.5million, $2.1 million, $4.4$2.2 million and $3.8$1.9 million, respectively. As of June 30, 2020, $17.5 March 31, 2021, $16.5million of unrecognized cost related to non-vested stock options was expected to be recognized over a weighted-average period of approximately 1.76 years.1.8 years. The total intrinsic value of options exercised was approximately $0.8$0.2 million and $1.0$0.8 million for the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, respectively.

The following table summarizes the status of the Company’s stock option activity granted under the Plans to employees, directors, and consultants (aggregate intrinsic value in thousands):

 

 

Stock

Options

 

 

Weighted-

Average

Exercise price

 

 

Weighted-

Average

Remaining

Contractual

Term

 

 

Aggregate

Intrinsic Value

 

 

Stock

Options

 

 

Weighted-

Average

Exercise price

 

 

Weighted-

Average

Remaining

Contractual

Term

 

 

Aggregate

Intrinsic Value

 

Outstanding at December 31, 2019

 

 

10,916,936

 

 

$

8.88

 

 

 

5.68

 

 

$

69,785

 

Outstanding at December 31, 2020

 

 

12,496,888

 

 

$

9.26

 

 

 

5.42

 

 

$

22,463

 

Granted

 

 

932,545

 

 

 

12.62

 

 

 

 

 

 

 

 

 

20,000

 

 

 

11.90

 

 

 

 

 

 

 

Exercised

 

 

(82,700

)

 

 

5.54

 

 

 

 

 

 

 

 

 

(119,425

)

 

 

7.10

 

 

 

 

 

 

 

Forfeited and expired

 

 

(64,328

)

 

 

14.29

 

 

 

 

 

 

 

 

 

(32,830

)

 

 

12.92

 

 

 

 

 

 

 

Outstanding at June 30, 2020

 

 

11,702,453

 

 

$

9.17

 

 

 

5.56

 

 

$

53,727

 

Vested and exercisable at June 30, 2020

 

 

9,117,601

 

 

$

7.81

 

 

 

4.73

 

 

$

54,226

 

Outstanding at March 31, 2021

 

 

12,364,633

 

 

$

9.28

 

 

 

5.20

 

 

$

 

Vested and exercisable at March 31, 2021

 

 

9,504,028

 

 

$

8.21

 

 

 

4.28

 

 

$

 

 


The Company determines the fair value of stock-based awards on the grant date using the Black-Scholes option pricing model, which is impacted by assumptions regarding several highly subjective variables. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes model during the periods indicated:

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Weighted average grant date fair value

 

$

7.60

 

 

$

8.03

 

 

$

7.40

 

 

$

7.32

 

Expected dividend yield

 

 

%

 

 

%

 

 

0

%

 

 

0

%

Expected stock price volatility

 

 

66

%

 

 

64

%

 

 

68

%

 

 

67

%

Risk-free interest rate

 

 

1.34

%

 

 

2.61

%

 

 

1.37

%

 

 

0.75

%

Expected life of options (in years)

 

 

6.2

 

 

 

6.3

 

 

 

6.3

 

 

 

5.0

 

 

Restricted Stock Awards

NaN restricted stock awards were granted during the three months ended March 31, 2021 and 2020. Stock-based compensation related to the restricted stock awards amounted to less than $0.1 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. As of March 31, 2021, $0.3 millionof unrecognized cost related to non-vested restricted stock awards were expected to be recognized over a weighted-average period of approximately 1.4 years.   

Employee Stock Purchase Plan

The ESPP is available to eligible employees (as defined in the plan document). Under the ESPP, shares of the Company’s common stock may be purchased at a discount (15%) of the lesser of the closing price of the Company’s common stock on the first trading or the last trading day of the offering period. The current offering period extends from JuneDecember 1, 2020 to November 30, 2020.May 31, 2021. The Company expects to offer six-month offering periods after the current period. The 2017 PlansESPP reserved 1,000,000 shares of common stock for issuance under the ESPP. Stock-based compensation related to the ESPP amounted to $0.1 million for each of the three months ended June 30, 2020March 31, 2021 and 2019, and $0.1 million and $0.2 million for the six months ended June 30, 2020 and 2019, respectively.2020.

Restricted Stock Awards 

The Company granted 131,000restricted stock awards to employees during 2019. NaN restricted stock awards were granted during the six months ended June 30, 2020. Stock-based compensation related to the restricted stock awards amounted to $0.4million for the three months ended June 30, 2020 and $0.8 million for the six months ended June 30, 2020. NaN stock-based compensation related to restricted stock was recorded during the three or six months ended June 30, 2019. As of June 30, 2020, $1.0millionof unrecognized cost related to non-vested restricted stock awards were expected to be recognized over a weighted-average period of approximately 0.1 years.  


Stock-Based Compensation Cost

The components of stock-based compensation and the amounts recorded within cost of sales, research and development expenses and selling, general, and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss consisted of the following for the three and six months ended June 30,March 31, 2021 and 2020 and 2019 (in thousands):

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Stock options

 

$

2,501

 

 

$

2,108

 

 

$

4,365

 

 

$

3,801

 

 

$

2,205

 

 

$

1,864

 

Restricted stock expense

 

 

413

 

 

 

 

 

 

810

 

 

 

 

 

 

29

 

 

 

397

 

Stock grants to officers and employees

 

 

 

 

 

1,106

 

 

 

 

 

 

1,106

 

Employee stock purchase plan

 

 

139

 

 

 

83

 

 

 

139

 

 

 

168

 

 

 

46

 

 

 

70

 

Total stock-based compensation expense

 

$

3,053

 

 

$

3,297

 

 

$

5,314

 

 

$

5,075

 

 

$

2,280

 

 

$

2,331

 

Cost of sales

 

$

55

 

 

$

64

 

 

$

109

 

 

$

128

 

 

$

56

 

 

$

54

 

Research and development expenses

 

 

1,012

 

 

 

914

 

 

 

1,958

 

 

 

1,505

 

 

 

601

 

 

 

946

 

Selling, general, and administrative expenses

 

 

1,986

 

 

 

2,319

 

 

 

3,247

 

 

 

3,442

 

 

 

1,623

 

 

 

1,331

 

Total stock-based compensation expense

 

$

3,053

 

 

$

3,297

 

 

$

5,314

 

 

$

5,075

 

 

$

2,280

 

 

$

2,331

 

 


13.12. Net Loss per Share Attributable to Athenex, Inc. Common Stockholders

Basic net loss per share is calculated by dividing net loss attributable to Athenex, Inc. common stockholders by the weighted-average number of common shares issued, outstanding, and vested during the period. Diluted net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common stock and common stock equivalents for the period using the treasury-stock method. For the purposes of this calculation, warrants to purchase common stock and stock options are considered common stock equivalents but are only included in the calculation of diluted net loss per share when their effect is dilutive.

The following outstanding shares of common stock equivalents were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Stock options and other common stock equivalents

 

 

11,700,399

 

 

 

11,447,877

 

 

 

11,709,928

 

 

 

11,184,541

 

 

 

13,899,191

 

 

 

11,347,475

 

Unvested restricted shares

 

 

79,000

 

 

 

 

 

 

105,000

 

 

 

 

 

 

22,500

 

 

 

105,000

 

Total potential dilutive shares

 

 

11,779,399

 

 

 

11,447,877

 

 

 

11,814,928

 

 

 

11,184,541

 

 

 

13,921,691

 

 

 

11,452,475

 

 

14.13. Business Segment, Geographic, and Concentration Risk Information

The Company has 3 operating segments, which are organized based mainly on the nature of the business activities performed and regulatory environments in which they operate. The Company also considers the types of products from which the reportable segments derive their revenue (only applicable to 2 reportable segments). Each operating segment has a segment manager who is held accountable for operations and has discrete financial information that is regularly reviewed by the Company’s chief operating decision-maker. Consequently, the Company has concluded each operating segment to be a reportable segment. The Company’s operating segments are as follows:   

Oncology Innovation PlatformPlatform—This operating segment performs research and development on certain of the Company’s proprietary drugs, from the preclinical development of its chemical compounds, to the execution and analysis of its several clinical trials. It focuses specifically on Orascovery and Src Kinase Inhibition research platforms, cell therapy programs and TCR-T Immunotherapy and Arginine Deprivation Therapy. This segment operates in the United States, Taiwan, Hong Kong, mainland China, the United Kingdom, and Latin America.arginine deprivation therapy.

Global Supply Chain Platform— This operating segment includes APS and Polymed and the construction of the manufacturing facilities in Chongqing, China, and Dunkirk, New York.NY. APS is a contract manufacturing company that provides smallsupplies sterile injectable drugs to mid-scale cGMP manufacturing of clinical and commercial products for pharmaceutical and biotech companies and for use as internal supplies tohospital pharmacies across the clinical studies and commercial development of the Company’s proprietary drugs.U.S. APS also performs microbiological and analytical testing for raw material and formulated products and has expanded to manufacture and sell pharmaceuticalmanufactures products under Section 503B of the Compounding Quality Act within the Federal Food, Drug & Cosmetic Act (“FDCA”). Additionally, APS provides products for the development and manufacturing of the Company’s proprietary drug candidates as well as providing the Company with a cGMP analytical services function. Polymed is primarily in the business of marketing and selling API in North America, Europe, and Asia from its locations in Texas and China. Polymed also develops new compounds and processing techniques and recently completed constructionis in the final phase of acompletion of the new API manufacturing facility in Chongqing, China. The 440,000-square-foot facility is expected to commence operations in the second half of 2020. The Company has an existing API manufacturing facility in Chongqing, China, where operations were suspended as a result of the COVID-19 outbreak in China but resumed producing API primarily for internal use in March in accordance with local regulatory guidance.


Commercial Platform— This operating segment includes APD and Athenex Oncology, which focus on the manufacturing, distribution, and sales of specialty pharmaceuticals and the pre-launch commercial activities for the Company’s proprietary drugs, respectively. This segment provides services and products to external customers based mainly in the United States.U.S.

The Company’s Oncology Innovation Platform segment operates and holds long-lived assets located in the United States,U.S., Taiwan, Hong Kong, mainland China, the United Kingdom, and Latin America. The Global Supply Chain Platform segment operates and holds long-lived assets located in the United StatesU.S. and China. The Commercial Platform segment operates and holds long-lived assets located in the United States.U.S. For geographic segment reporting, product sales have been attributed to countries based on the location of the customer.


Segment information is as follows (in thousands):

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Total revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

5

 

 

$

164

 

 

$

28,393

 

 

$

308

 

 

$

20,665

 

 

$

28,387

 

Global Supply Chain Platform

 

 

4,982

 

 

 

11,407

 

 

 

8,696

 

 

 

22,745

 

 

 

8,207

 

 

 

3,714

 

Commercial Platform

 

 

36,214

 

 

 

11,597

 

 

 

51,755

 

 

 

26,273

 

 

 

13,259

 

 

 

15,542

 

Total revenue for reportable segments

 

 

41,201

 

 

 

23,168

 

 

 

88,844

 

 

 

49,326

 

 

 

42,131

 

 

 

47,643

 

Intersegment revenue

 

 

(1,029

)

 

 

(971

)

 

 

(1,737

)

 

 

(1,822

)

 

 

(1,106

)

 

 

(708

)

Total consolidated revenue

 

$

40,172

 

 

$

22,197

 

 

$

87,107

 

 

$

47,504

 

 

$

41,025

 

 

$

46,935

 

 

Intersegment revenue eliminated in the above table reflects $0.6 million in sales from the Global Supply Chain Platform to the Commercial Platform and $0.5 million in sales from the Global Supply Chain Platform to the Oncology Innovation Platform (in thousands).

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Total revenue by product group:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License fees

 

$

 

 

$

 

 

$

28,381

 

 

$

 

 

$

20,500

 

 

$

28,381

 

Commercial product sales

 

 

38,881

 

 

 

18,165

 

 

 

56,383

 

 

 

38,246

 

 

 

18,061

 

 

 

17,502

 

API sales

 

 

1,229

 

 

 

3,830

 

 

 

2,251

 

 

 

8,661

 

 

 

1,868

 

 

 

1,022

 

Contract manufacturing revenue

 

 

57

 

 

 

38

 

 

 

80

 

 

 

289

 

 

 

430

 

 

 

23

 

Other revenue

 

 

5

 

 

 

164

 

 

 

12

 

 

 

308

 

 

 

166

 

 

 

7

 

Total consolidated revenue

 

$

40,172

 

 

$

22,197

 

 

$

87,107

 

 

$

47,504

 

 

$

41,025

 

 

$

46,935

 

 

Intersegment revenue is recognized by the selling segment when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. Upon consolidation, all intersegment revenue and related cost of sales are eliminated from the selling segment’s ledger (in thousands).

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Net loss attributable to Athenex, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

(35,024

)

 

$

(29,792

)

 

$

(35,982

)

 

$

(57,395

)

 

$

(5,441

)

 

$

(958

)

Global Supply Chain Platform

 

 

(5,745

)

 

 

313

 

 

 

(11,731

)

 

 

(454

)

 

 

(3,682

)

 

 

(5,986

)

Commercial Platform

 

 

318

 

 

 

(2,552

)

 

 

(12,167

)

 

 

(9,415

)

 

 

(15,927

)

 

 

(12,485

)

Total consolidated net loss attributable to

Athenex, Inc.

 

$

(40,451

)

 

$

(32,031

)

 

$

(59,880

)

 

$

(67,264

)

 

$

(25,050

)

 

$

(19,429

)


 

 

Three Months

Ended March 31,

 

 

 

2021

 

 

2020

 

Total depreciation and amortization:

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

207

 

 

$

175

 

Global Supply Chain Platform

 

 

523

 

 

 

496

 

Commercial Platform

 

 

544

 

 

 

415

 

Total consolidated depreciation and

   amortization

 

$

1,274

 

 

$

1,086

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Total depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets:

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

188

 

 

$

210

 

 

$

363

 

 

$

399

 

 

$

199,741

 

 

$

234,153

 

Global Supply Chain Platform

 

 

426

 

 

 

325

 

 

 

922

 

 

 

636

 

 

 

101,621

 

 

 

99,087

 

Commercial Platform

 

 

421

 

 

 

393

 

 

 

836

 

 

 

772

 

 

 

48,294

 

 

 

51,089

 

Total consolidated depreciation and

amortization

 

$

1,035

 

 

$

928

 

 

$

2,121

 

 

$

1,807

 

Total consolidated assets

 

$

349,656

 

 

$

384,329

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Total assets:

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

139,152

 

 

$

194,183

 

Global Supply Chain Platform

 

 

97,772

 

 

 

63,598

 

Commercial Platform

 

 

61,128

 

 

 

52,151

 

Total consolidated assets

 

$

298,052

 

 

$

309,932

 

 

 

Three Months

Ended March 31,

 

 

 

2021

 

 

2020

 

Total revenue:

 

 

 

 

 

 

 

 

United States

 

$

38,645

 

 

$

17,522

 

China

 

 

205

 

 

 

28,513

 

Other foreign countries

 

 

2,175

 

 

 

900

 

Total consolidated revenue

 

$

41,025

 

 

$

46,935

 

 


 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Total revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

26,001

 

 

$

18,160

 

 

$

43,522

 

 

$

38,495

 

United Kingdom

 

 

12,933

 

 

 

 

 

 

12,933

 

 

 

1,023

 

South Korea

 

 

1,060

 

 

 

 

 

 

1,693

 

 

 

 

 

China

 

 

125

 

 

 

889

 

 

 

28,638

 

 

 

1,275

 

Austria

 

 

33

 

 

 

1,773

 

 

 

33

 

 

 

3,947

 

India

 

 

 

 

 

605

 

 

 

 

 

 

1,382

 

Other foreign countries

 

 

20

 

 

 

770

 

 

 

288

 

 

 

1,382

 

Total consolidated revenue

 

$

40,172

 

 

$

22,197

 

 

$

87,107

 

 

$

47,504

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Total property and equipment, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

12,503

 

 

$

11,486

 

 

$

20,902

 

 

$

15,511

 

China

 

 

14,364

 

 

 

11,667

 

 

 

20,876

 

 

 

18,877

 

Total consolidated property and equipment, net

 

$

26,867

 

 

$

23,153

 

 

$

41,778

 

 

$

34,388

 

 

Customer revenue and accounts receivable concentration amounted to the following for the identified periods. These customers relate to the Commercial Platform segment and the Global Supply Chain Platform segment.

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

Three Months

Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Percentage of total revenue by customer:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer A

 

 

32

%

 

 

0

%

 

 

15

%

 

 

0

%

 

 

49

%

 

 

0

%

Customer B

 

 

15

%

 

 

19

%

 

 

7

%

 

 

21

%

 

 

11

%

 

 

9

%

Customer C

 

 

14

%

 

 

7

%

 

 

6

%

 

 

14

%

 

 

9

%

 

 

11

%

Customer D

 

 

9

%

 

 

18

%

 

 

4

%

 

 

15

%

 

 

9

%

 

 

7

%

Customer E

 

 

0

%

 

 

0

%

 

 

32

%

 

 

0

%

 

 

0

%

 

 

60

%

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Percentage of total accounts receivable by customer:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer A

 

 

28

%

 

 

0

%

 

 

36

%

 

 

33

%

Customer B

 

 

24

%

 

 

0

%

 

 

30

%

 

 

24

%

Customer C

 

 

15

%

 

 

45

%

 

 

10

%

 

 

16

%

Customer D

 

 

13

%

 

 

31

%

 

 

0

%

 

 

6

%

Customer E

 

 

6

%

 

 

10

%

 


15.

14. Revenue Recognition

The Company records revenue in accordance with ASC, Topic 606 “Revenue from Contracts with Customers.” Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Below is a description of principal activities – separated by reportable segments – from which the Company generates its revenue.

 

1.

Oncology Innovation Platform

The Company out-licenses certain of its IP to other pharmaceutical companies in specific territories that allow the customer to use, develop, commercialize, or otherwise exploit the licensed IP. In accordance with Topic 606, the Company analyzes the contracts to identify its performance obligations within the contract. Most of the Company’s out-license arrangements contain multiple performance obligations and variable pricing. After the performance obligations are identified, the Company determines the transaction price, which generally includes upfront fees, milestone payments related to the achievement of developmental, regulatory, or commercial goals, and royalty payments on net sales of licensed products. The Company considers whether the transaction price is fixed or variable, and whether such consideration is subject to return. Variable consideration is only included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. If any portion of the transaction price is constrained, it is excluded from the transaction price until the constraint no longer exists. The Company then allocates the transaction price to the performance obligation to which the consideration is related. Where a portion of the transaction price is received and allocated to continuing performance obligations under the terms of the arrangement, it is recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied.

The Company’s contracts may contain one or multiple promises, including the license of IP and development services. The licensed IP is capable of being distinct from the other performance obligations identified in the contract and is distinct within the context of the contract, as upon transfer of the IP, the customer is able to use and benefit from it, and the customer could obtain the development services from other parties. The Company also considers the economic and regulatory characteristics of the licensed IP and other promises in the contract to determine if it is a distinct performance obligation. The Company considers if the IP is modified or enhanced by other performance obligations through the life of the agreement and whether the customer is contractually or practically required to use updated IP. The IP licensed by the Company has been determined to be functional IP. The IP is not modified during the license period and therefore, the Company recognizes revenues from any portion of the transaction price allocated to the licensed IP when the license is transferred to the customer and they can benefit from the right to use the IP. For the six-monththree-month period ended June 30, 2020,March 31, 2021, the Company recognized license revenue of $28.3$20.5 million,net of $1.7which $20.0 million value added tax (“VAT”) collected on behalfwas recognized upon the achievement of the counterparty,first commercial milestone pursuant to the 2017 Almirall out-license arrangement upon the launch of Klisyri in the U.S., and $0.5 million was recognized for an upfront fee upon transferring certain IP to the customer.NaNcustomer upon execution of the second amendment to the 2011 PharmaEssentia license revenue was recognizedagreement. Under the collaboration agreement between Axis Therapeutics and PharmaEssentia, the Company received $1.0 million, net of $0.3 million withholding tax, of upfront fees allocated to its performance obligation to deliver functional IP to the Customer. As of March 31, 2021, the Company had not satisfied this performance obligation by delivering the license with the data necessary for the three-month period ended June 30, 2020customer to benefit from the right to use the IP and, 0 license revenuetherefore, the amount was recognized for the same three and six-month periods ended June 30, 2019.recorded as deferred revenue.       

Other performance obligations included in most of the Company’s out-licensing agreements include performing development services to reach clinical and regulatory milestone events. The Company satisfies these performance obligations at a point-in-time, because the customer does not simultaneously receive and consume the benefits as the development occurs, the development does not create or enhance an asset controlled by the customer, and the development does not create an asset with no alternative use. The Company considers milestone payments to be variable consideration measured using the most likely amount method, as the entitlement to the consideration is contingent on the occurrence or nonoccurrence of future events. The Company allocates each variable milestone payment to the associated milestone performance obligation, as the variable payment relates directly to the Company’s efforts to satisfy the performance obligation and such allocation depicts the amount of consideration to which the Company expects to be entitled for satisfying the corresponding performance obligation. The Company re-evaluates the probability of achievement of such performance obligations and any related constraint and adjusts its estimate of the transaction price as appropriate.  To date, no amounts have been constrained in the initial or subsequent assessments of the transaction price. The Company did 0t recognize revenue from other performance obligations included in the Company’s out-licensing agreements during the three month periods ended March 31, 2021 and 2020.


Certain out-license agreements include performance obligations to manufacture and provide drug product in the future for commercial sale when the licensed product is approved. For the commercial, sales-based royalties, the consideration is predominantly related to the licensed IP and is contingent on the customer’s subsequent sales to another commercial customer. Consequently, the sales- or usage-based royalty exception would apply. Revenue will be recognized for the commercial, sales-based milestones as the underlying sales occur.

The Company exercises significant judgment when identifying distinct performance obligations within its out-license arrangements, determining the transaction price, which often includes both fixed and variable considerations, and allocating the transaction price to the proper performance obligation.  The Company did not use any other significant judgments related to out-licensing revenue during the three and six-monththree-month periods ended June 30,March 31, 2021 and 2020 and 2019.

 

2.

Global Supply Chain Platform

The Company’s Global Supply Chain Platform manufactures API for use internally in its research and development activities as well as its clinical studies, and for sale to pharmaceutical customers globally. The Company generates additional revenue on this platform, by providing small to mid-scale cGMP manufacturing of clinical and commercial products for pharmaceutical and biotech companies and selling pharmaceutical products under 503B regulations set forth by the U.S. Food and Drug Administration (“FDA”).FDA.

Revenue earned by the Global Supply Platform is recognized when the Company has satisfied its performance obligation, which is the shipment or the delivery of drug products. The underlying contracts for these sales are generally purchase orders and the Company recognizes revenue at a point-in-time. Any remaining performance obligations related to product sales are the result of customer deposits and are reflected in the deferred revenue contract liability balance.

 

3.

Commercial Platform

The Company’s Commercial Platform generates revenue by distributing specialty products through independent pharmaceutical wholesalers. The wholesalers then sell to an end-user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously established by the end-user and the Company. Upon the sale by the wholesaler to the end-user, the wholesaler will chargeback the difference, if any, between the original list price and price at which the product was sold to the end-user. The Company also offers cash discounts, which approximate 2.3% of the gross sales price, as an incentive for prompt customer payment, and, consistent with industry practice, the Company’s return policy permits customers to return products within a window of time before and after the expiration of product dating. Further, the Company offers contractual allowances, generally in the form of rebates or administrative fees, to certain wholesale customers, group purchasing organizations (“GPOs”), and end-user customers, consistent with pharmaceutical industry practices. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, GPO allowances, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). As of June 30, 2020,March 31, 2021, and December 31, 2019,2020, the Company’s total provision for chargebacks and other deductions included as a reduction of accounts receivable totaled $12.8$17.3 million and $14.4$12.6 million, respectively. The Company’s total provision for chargebacks and other revenue deductions was $20.2$25.6 million, and $20.1$24.9 million for the three months ended June 30,March 31, 2021, and 2020, and 2019, respectively, and $45.1 million, and $39.5 million for the six months ended June 30, 2020.respectively.  

The Company exercises significant judgment in its estimates of the variable transaction price at the time of the sale and recognizes revenue when the performance obligation is satisfied. Factors that determine the final net transaction price include chargebacks, fees for service, cash discounts, rebates, returns, warranties, and other factors. The Company estimates all of these variables based on historical data obtained from previous sales finalized with the end-user customer on a product-by-product basis. At the time of sale, revenue is recorded net of each of these deductions. Through the normal course of business, the wholesaler will sell the product to the end-user, determining the actual chargeback, return products, and take advantage of cash discounts, charge fees for services, and claim warranties on products. The final transaction price per product is compared to the initial estimated net sale price and reviewed for accuracy. The final prices and other factors are immediately included in the Company’s historical data from which it will estimate the transaction price for future sales. The underlying contracts for these sales are generally purchase orders including a single performance obligation, generally the shipment or delivery of products and the Company recognizes this revenue at a point-in-time.


Disaggregation of revenue

The following represents the Company’s revenue for its reportable segment by country, based on the locations of the customer.

 

 

For the Three Months Ended June 30, 2020

 

 

For the Three Months Ended March 31, 2021

 

 

(In Thousands)

 

 

(In Thousands)

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

 

 

$

2,720

 

 

$

23,281

 

 

$

26,001

 

 

$

20,157

 

 

$

5,229

 

 

$

13,259

 

 

$

38,645

 

United Kingdom

 

 

 

 

 

 

 

 

12,933

 

 

 

12,933

 

South Korea

 

 

 

 

 

1,060

 

 

 

 

 

 

1,060

 

China

 

 

5

 

 

 

120

 

 

 

 

 

 

125

 

 

 

8

 

 

 

197

 

 

 

 

 

 

205

 

Other foreign countries

 

 

 

 

 

53

 

 

 

 

 

 

53

 

 

 

500

 

 

 

1,675

 

 

 

 

 

 

2,175

 

Total revenue

 

$

5

 

 

$

3,953

 

 

$

36,214

 

 

$

40,172

 

 

$

20,665

 

 

$

7,101

 

 

$

13,259

 

 

$

41,025

 

 

 

For the Three Months Ended June 30, 2019

 

 

For the Three Months Ended March 31, 2020

 

 

(In Thousands)

 

 

(In Thousands)

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

China

 

$

28,308

 

 

$

205

 

 

$

 

 

$

28,513

 

United States

 

$

 

 

$

6,563

 

 

$

11,597

 

 

$

18,160

 

 

 

 

 

 

1,980

 

 

 

15,542

 

 

 

17,522

 

India

 

 

 

 

 

605

 

 

 

 

 

 

605

 

Austria

 

 

 

 

 

1,773

 

 

 

 

 

 

1,773

 

China

 

 

164

 

 

 

725

 

 

 

 

 

 

889

 

Other foreign countries

 

 

 

 

 

770

 

 

 

 

 

 

770

 

 

 

79

 

 

 

821

 

 

 

 

 

 

900

 

Total revenue

 

$

164

 

 

$

10,436

 

 

$

11,597

 

 

$

22,197

 

 

$

28,387

 

 

$

3,006

 

 

$

15,542

 

 

$

46,935

 

 

 

 

For the Six Months Ended June 30, 2020

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

 

 

$

4,700

 

 

$

38,822

 

 

$

43,522

 

China

 

 

28,314

 

 

 

324

 

 

 

 

 

 

28,638

 

United Kingdom

 

 

 

 

 

 

 

 

12,933

 

 

 

12,933

 

South Korea

 

 

 

 

 

1,693

 

 

 

 

 

 

1,693

 

Other foreign countries

 

 

79

 

 

 

242

 

 

 

 

 

 

321

 

Total revenue

 

$

28,393

 

 

$

6,959

 

 

$

51,755

 

 

$

87,107

 

 

 

 

For the Six Months Ended June 30, 2019

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

 

 

$

12,222

 

 

$

26,273

 

 

$

38,495

 

India

 

 

 

 

 

1,382

 

 

 

 

 

 

1,382

 

Austria

 

 

 

 

 

3,947

 

 

 

 

 

 

3,947

 

China

 

 

308

 

 

 

967

 

 

 

 

 

 

1,275

 

United Kingdom

 

 

 

 

 

1,023

 

 

 

 

 

 

1,023

 

Other foreign countries

 

 

 

 

 

1,382

 

 

 

 

 

 

1,382

 

Total revenue

 

$

308

 

 

$

20,923

 

 

$

26,273

 

 

$

47,504

 

 


The Company also disaggregates its revenue by product group which can be found in Note 1413Business Segment, Geographic, and Concentration Risk Information.

Contract balances

The following table provides information about receivables and contract liabilities from contracts with customers. The Company has not recorded any contract assets from contracts with customers.

 

 

June 30,

2020

 

 

December 31,

2019

 

 

March 31,

2021

 

 

December 31,

2020

 

 

(In Thousands)

 

 

(In Thousands)

 

Accounts receivable, gross

 

$

51,552

 

 

$

31,207

 

 

$

46,935

 

 

$

45,792

 

Chargebacks and other deductions

 

 

(12,769

)

 

 

(14,394

)

 

 

(17,264

)

 

 

(12,552

)

Provision for credit losses

 

 

(163

)

 

 

(124

)

 

 

(9,482

)

 

 

(9,637

)

Accounts receivable, net

 

$

38,620

 

 

$

16,689

 

 

$

20,189

 

 

$

23,603

 

Deferred revenue

 

 

97

 

 

 

218

 

 

 

1,289

 

 

 

1,147

 

Total contract liabilities

 

$

97

 

 

$

218

 

 

$

1,289

 

 

$

1,147

 

 

The following tables illustrate accounts receivable and contract asset balances by reportable segments.

 

 

June 30, 2020

 

 

March 31, 2021

 

 

(In Thousands)

 

 

(In Thousands)

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

Accounts receivable, gross

 

$

11,056

 

 

$

1,565

 

 

$

38,931

 

 

$

51,552

 

 

$

9,167

 

 

$

3,589

 

 

$

34,179

 

 

$

46,935

 

Chargebacks and other deductions

 

 

 

 

 

(1

)

 

 

(12,768

)

 

 

(12,769

)

 

 

 

 

 

 

 

 

(17,264

)

 

 

(17,264

)

Provision for credit losses

 

 

 

 

 

(118

)

 

 

(45

)

 

 

(163

)

 

 

(8,919

)

 

 

(138

)

 

 

(425

)

 

 

(9,482

)

Accounts receivable, net

 

 

11,056

 

 

 

1,446

 

 

 

26,118

 

 

 

38,620

 

 

 

248

 

 

 

3,451

 

 

 

16,490

 

 

 

20,189

 


 

 

December 31, 2019

 

 

December 31, 2020

 

 

(In Thousands)

 

 

(In Thousands)

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

Accounts receivable, gross

 

$

49

 

 

$

1,522

 

 

$

29,636

 

 

$

31,207

 

 

$

10,783

 

 

$

4,074

 

 

$

30,935

 

 

$

45,792

 

Chargebacks and other deductions

 

 

 

 

 

(1

)

 

 

(14,393

)

 

 

(14,394

)

 

 

 

 

 

(1

)

 

 

(12,551

)

 

 

(12,552

)

Provision for credit losses

 

 

 

 

 

(114

)

 

 

(10

)

 

 

(124

)

 

 

(8,919

)

 

 

(164

)

 

 

(554

)

 

 

(9,637

)

Accounts receivable, net

 

$

49

 

 

$

1,407

 

 

$

15,233

 

 

$

16,689

 

 

$

1,864

 

 

$

3,909

 

 

$

17,830

 

 

$

23,603

 

 

As of June 30, 2020, $10.9 million of accounts receivable, net, related to an upfront fee receivable in connection with the license agreement entered into with Guangzhou Xiangxue Pharmaceutical Co., Ltd in December 2019.

As of June 30, 2020March 31, 2021 and December 31, 2019,2020, the deferred revenue balances relate to customer deposits made by customers of the Oncology Innovation Platform and Global Supply Chain Platform and are included within accrued expenses on the condensed consolidated balance sheet.sheets.   

There were no other material changes to contract balances during the three and six months ended June 30, 2020.March 31, 2021.


16.15. Commitments and Contingencies

Future minimum payments under the non-cancelable operating leases consists of the following as of June 30, 2020March 31, 2021 (in thousands):

 

Year ending December 31:

 

Minimum

payments

 

 

Minimum

payments

 

2020 (remaining six months)

 

$

1,486

 

2021

 

 

2,840

 

2021 (remaining nine months)

 

$

2,577

 

2022

 

 

2,621

 

 

 

2,918

 

2023

 

 

2,096

 

 

 

2,096

 

2024

 

 

2,002

 

 

 

2,002

 

2025

 

 

1,472

 

Thereafter

 

 

1,950

 

 

 

478

 

 

$

12,995

 

 

$

11,543

 

 

Legal Proceedings

From time to time,Following our receipt of the CRL in February 2021 and the subsequent decline of the market price of the Company’s common stock, 2 purported securities class action lawsuits were filed in the U.S. District Court for the Western District of New York on March 3, 2021 and March 22, 2021, respectively, against the Company may become subjectand certain members of its management team seeking to other legal proceedings, claimsrecover damages for alleged violations of Sections 10(b) and litigation arising in20(a) of the ordinary courseSecurities Exchange Act of business. In addition,1934.

The complaints generally allege that between August 7, 2019 and February 26, 2021 (the purported class period), the Company may receive letters alleging infringement of patent or other intellectual property rights. The Company is not currently a party to any other material legal proceedings, nor is it aware of any pending or threatened litigation that,and the individual defendants made materially false and misleading statements regarding the Company's business in the Company’s opinion, would have a material adverse effect on the business, operating results, cash flows or financial condition should such litigation be resolved unfavorably.

17. Subsequent Events

On August 4, 2020, we entered into a Revenue Interest Financing Agreementconnection with Sagard Healthcare Royalty Partners, LP (“Sagard”), pursuant to which Sagard has agreed to pay the Company $50.0 million (the “Product Payment”) to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the FDA for the treatment of metastatic breast cancer. In exchange for the Product Payment, we have agreed to make payments to Sagard (the “Payments”) equal to 5.0% of our world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price set forth below (the “Hard Cap”). We are required to make certain additional payments to Sagard to the extent Sagard has not received Payments equaling at least $20.0 million by September 30, 2024 and at least $50.0 million by August 4, 2026. In addition, if Sagard has not received Payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded (the “Funding Date”), then subject to the Hard Cap, we will be required to pay Sagard an amount such that Sagard will have obtained a 6.0% internal rate of return, calculated on a quarterly basis and calculated from the Funding Date to the tenth anniversary of the Funding Date, on the amount of the Product Payment, taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement.

Our obligations under the Revenue Interest Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree Fund Administration, LLC as administrative agent for the lenders under our Senior Credit Agreement, by a perfected security interest in (i) accounts receivable arising from net sales of Oral Paclitaxel and (ii) intellectual property that is claiming or covering Oral Paclitaxel itself or any method of using, making or manufacturing Oral Paclitaxel.

At any time after August 4, 2022, we will have the right, but not the obligation (the “Call Option”), to buy out Sagard’s interest in the Payments at a repurchase price (the “Put/Call Price”) equal to (a) on or before August 4, 2023, a payment sufficient to generate an internal rate of return of 18.0% of the Product Payment, (b) after August 4, 2023 and on or before August 4, 2024, a payment sufficient to generate an internal rate of return of 16.0% of the Product Payment, (c) after August 4, 2024 and on or before August 4, 2025, a payment sufficient to generate an internal rate of return of 15.0% of the Product Payment, and (d) thereafter, the greater of (i) an amount that, when paid to Sagard, would generate an internal rate of return of 13.0% of the Product Payment, and (ii) an amount equal to the product of the Product Payment and 165%, in the case of each foregoing clause (a) through (d), taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement.  


The Revenue Interest Financing Agreement contains customary representations and warranties and certain restrictions on our ability to incur indebtedness and grant liens on intellectual property related to Oral Paclitaxel. In addition, the Revenue Interest Financing Agreement provides that if certain events (“Put Option Events”) occur, including certain bankruptcy events, non-payment of Payments, a change of control, an out-license or sale of all of the rights in and to Oral Paclitaxel in the U.S. (other than any out-licensing transaction that includes all or substantially all of the U.S. and European development and commercialization rights to Oral Paclitaxel with a pharmaceutical company with global annual revenues for its most recently completed fiscal year that is greater than or equal to $500.0 million attributable to its oncology business) and (subject to applicable cure periods) non-compliance with the covenants in the Revenue Interest Financing Agreement, Sagard may require us to repurchase its interests in the Payments at the Put/Call Price.  Sagard may also terminate the Revenue Interest Financing Agreement if we have not received marketing authorization for Oral Paclitaxel by the FDA for the treatment of metastatic breast cancer by December 31, 2021.and the likelihood of FDA approval, and that the plaintiffs suffered losses when the Company’s stock price dropped after its announcement on February 26, 2021 regarding receipt of the CRL. The complaints seek class certification, damages, fees, costs, and expenses. The defendants expect that these two lawsuits will be consolidated and a lead plaintiff appointed in the coming months. Additional similar lawsuits might be filed. The Company and the individual defendants believe that the claims in these lawsuits are without merit, and the Company has 0t recorded a liability related to this shareholder class action lawsuit as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can be no assurances as to the outcome.


16. Subsequent Event

SagardOn May 4, 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Kuur Therapeutics, Inc., a Delaware corporation (“Kuur”). Kuur is a leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies. Pursuant to the terms of the Merger Agreement, the Company will pay $70.0 million upfront to Kuur shareholders and its co-investors OPB SHRP Co-Invest Credit Limitedformer employees and SIMCOE SHRP Co-Invest Credit Ltd. (the “IMCO Investors”) also acquired by assignment (the “Assignment”) term loansdirectors, comprised primarily of equity in the Company’s common stock. Additionally, Kuur shareholders and commitments equalits former employees and directors are eligible to $50.0receive up to $115.0 million underof milestone payments, which may be paid, at the Senior Credit Agreement. In connectionCompany’s sole discretion, in either cash or additional common stock of the Company (or a combination of both). The Company believes the acquisition strategically combines its TCR program with the Assignment, we granted warrantsgroundbreaking NKT cell platform to Sagardprovide a solution that may address some of the known limitations associated with the first generation of cell therapy treatments focused on autologous CAR-T. Due to the recency of the Merger Agreement, the Company has not yet completed its assessment of the fair value of the assets acquired, the liabilities assumed and the IMCO Investors to purchase up to 201,865 sharescontingent considerations. The Company will account for this in accordance with ASC 805, Business Combinations, and its evaluation the effect on its consolidated financial statements during the second quarter of our common stock at a purchase price of $12.63 per share (the “Sagard Warrants”).  The Sagard Warrants will expire on June 19, 2027 and may be net exercised at the holder’s election.  

2021.


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

The following discussion contains management’s discussion and analysis of our financial condition and results of operations and should be read together with the unaudited condensed consolidated financial statements and the notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes thereto for the year ended December 31, 20192020 included in our Annual Report on Form 10-K for the year ended December 31, 2019.2020. Unless the context indicates otherwise, as used in this Quarterly Report, the terms “Athenex,” the “Company,” “we,” “us,” and “our” refer to Athenex, Inc., a Delaware corporation, and its subsidiaries taken as a whole, unless otherwise noted. This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

NOTE ABOUT FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and section 27A of the Securities Act of 1933, as amended (the “Securities Act”). All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report. These forward-looking statements may include, but are not limited to, statements regarding our future results of operations and financial position, business strategy, potential market size, potential growth opportunities, the timing and results of clinical trials, the impact of COVID-19 on our business, and potential regulatory approval and commercialization of product candidates. In some cases, forward-looking statements may be identified by terminology such as “believe,” “may,” “will,” “should,” “predict,” “goal,” “strategy,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” “seek” and similar expressions and variations thereof. These words are intended to identify forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section included in our Annual Report on Form 10-K for the year ended December 31, 20192020 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.additional risk factors described herein. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business. In light of these risks, uncertainties and assumptions, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date hereof to conform these statements to actual results or to changes in our expectations, except as required by law.

Overview and Recent Developments

We are a global biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Our mission is to improve the lives of cancer patients by creating more effective, safer and tolerable treatments. We have assembled a strong and experienced leadership team and have established global operations across the pharmaceutical value chain to execute our goal of becoming a global leader in bringing innovative cancer treatments to the market and improving health outcomes.

We are organized around three operating segments: (1) our Oncology Innovation Platform, dedicated to the research and development of our proprietary drugs; (2) our Commercial Platform, focused on the sales and marketing of our specialty drugs and the market development of our proprietary drugs; and (3) our Global Supply Chain Platform, dedicated to providing a stable and efficient supply of APIs for our clinical and commercial efforts. Our current clinical pipeline in the Oncology Innovation Platform is derived from four different proprietary technologies: (1) Orascovery, based on a P-glycoprotein or P-gp,(“P-gp”) pump inhibitor, (2) Src Kinase inhibition,Inhibition, (3) TCR-T immunotherapy,Cell Therapy, and (4) arginine deprivation therapy.Arginine Deprivation Therapy.


Significant developments in our Orascovery platform include the following:

On May 29, 2020,4, 2021, we presented interim data fromentered into an ongoing Phase II clinical trial in which oral paclitaxelAgreement and encequidar (Oral Paclitaxel, formerly known as Oraxol) monotherapy showed encouraging efficacy and tolerability in elderly patientsPlan of Merger (the “Merger Agreement”) with unresectable cutaneous angiosarcoma, an aggressive malignancy with poor prognosis. The interim results were presented at the American SocietyKuur Therapeutics, Inc., a Delaware corporation (“Kuur”). Kuur is a leading developer of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program, held from May 29 to 31, 2020, and reflected data from 22 evaluable patients out of 26 enrolled patients (16 males and 10 females, median age 75 years (range: 49-93 years)).The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment, who reached their first post treatment efficacy evaluation. All 22 patients experienced a reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22). Oral Paclitaxel has been generally well tolerated in this predominantly elderly population. In April 2018, FDA granted an Orphan Drug Designation for Oral Paclitaxeloff-the-shelf CAR-NKT cell immunotherapies for the treatment of angiosarcoma,solid andOral Paclitaxel also received Orphan Designations from hematological malignancies. Pursuant to the European Commission forterms of the treatmentMerger Agreement, we will pay $70.0 million upfront to Kuur shareholders and its former employees and directors, comprised primarily of soft tissue sarcomaequity in October 2019.the Company’s common stock. Additionally, Kuur shareholders and its former employees and directors are eligible to receive up to $115.0 million of milestone payments, which may be paid, at the Company’s sole discretion, in either cash or additional common stock of the Company (or a combination of both). We believe the acquisition strategically combines our TCR program with the groundbreaking NKT cell platform to provide a solution that may address some of the known limitations associated with the first generation of cell therapy treatments focused on autologous CAR-T.

On April 9,December 15, 2020, we announced that we participatedthe FDA has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. Klisyri® is our first FDA approved branded proprietary product, manufactured by us, highlighting the vertically integrated capabilities of the Company ranging from a preclinical lead to a developed product for market launch. The Phase III trials evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp and included 702 patients across 62 sites in the United States. Enrollment of patients was controlled to achieve a 2:1 ratio of facial: scalp treatment areas. Patients were randomly assigned in a constructive meeting1:1 ratio to receive tirbanibulin ointment or vehicle ointment, which was self-administered to a contiguous treatment area of 25cm2 on the face or scalp containing 4-8 typical AK lesions once daily for five consecutive days. Both Phase III trials, KX01-AK-003 and KX01-AK-004, met the primary endpoint, which was defined as 100% clearance of AK lesions at Day 57 within the face or scalp treatment areas, each trial achieving a highly statistically significant result (p<0.0001). In KX01-AK-003, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for those treated with vehicle, and in KX01-AK-004, complete clearance was observed in 54% of the patients treated with tirbanibulin versus 13% for vehicle. Furthermore, tirbanibulin also achieved the secondary endpoint of partial (≥75%) clearance of lesions in each trial (68% of patients receiving tirbanibulin versus 16% receiving vehicle in KX01-AK-003, and 76% versus 20% respectively in KX01-AK-004). Both results were again highly statistically significant (p<0.0001). In both trials, patient-reported adverse events were mostly transient mild application-site pruritus and application-site pain. No patients experienced a serious adverse event or discontinuation due to tirbanibulin or vehicle in either clinical trial. Signs of local skin reactions assessed by investigators were mostly mild to moderate erythema, flaking or scaling that peaked at day 8 (maximum mean composite local skin reaction score ≤4.3 out of 18 across both trials) and resolved spontaneously in about 2 weeks.

Klisyri® was launched in the U.S., led by our partner Almirall S.A. (“Almirall”) on February 18, 2021, which resulted in a milestone payment of $20.0 million pursuant to the license agreement. Almirall will employ its expertise to support the development of tirbanibulin in Europe and Almirall will also commercialize the product in European countries, including Russia, if approved in those jurisdictions.

In September 2020, we announced that the U.S. FDA as scheduled, to discuss the clinical section ofaccepted for filing our New Drug Application (NDA)NDA for Oral Paclitaxel for the treatment of metastatic breast cancer (“MBC”). We will provide a further update on and has granted the NDA after an official response byapplication Priority Review. Under the Prescription Drug User Fee Act (PDUFA), the FDA on ourset a target action date of February 28, 2021. In February 2021, we received a Complete Response  Letter (“CRL”) from the FDA regarding its NDA filing becomes available.

We announced topline results in August 2019 for our Phase 3 study of Oral Paclitaxel for the treatment of MBCmetastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and presented further datathat the application is not ready for approval in its present form. In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm in the Phase III study. The FDA also expressed concerns regarding the uncertainty over the results of the Phase 3 study in an oral presentationprimary endpoint of objective response rate (ORR) at the 2019 San Antonio Breast Cancer Symposium, or SABCS, in December 2019. Results demonstratedweek 19 conducted by blinded independent central review (BICR). The agency stated that the study met its primary endpoint showing statistically significant improvementBICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR. The agency recommended that we conduct a new adequate and well-conducted clinical trial in overalla patient population with metastatic breast cancer representative of the population in the U.S. The agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA. We plan to request a meeting with the FDA to discuss the FDA’s response, rate forengage in a dialogue on the design and scope of a clinical trial to address the agency’s requirements, and align on the next steps required to obtain approval. Our ability to potentially commercialize Oral Paclitaxel, compared to intravenous (“IV”) paclitaxel and neuropathy was less frequentthe timing of potential commercialization, is dependent on the discussion with Oral Paclitaxel compared to IV paclitaxel. In addition, ongoing analysisthe agency, our resubmission of secondary endpoints of survival showed a strong trend favoring Oral Paclitaxel. In particular, Oral Paclitaxel showed a statistically significant improvement in overall survival compared to IV paclitaxel in the prespecified modified intention-to-treat population.its NDA, ultimate FDA approval, and potentially additional capital.

We are also evaluating Oral Paclitaxel in combination with other therapies, including anti-VEGF and anti-PD-1 therapies. We are studying Oral Paclitaxel with ramucirumab in a Phase 1b study in patients with advanced gastric cancer who failed previous chemotherapy. We presented results from the study at the 2019 European Society for Medical Oncology (ESMO) Congress on the first three patient cohorts and are continuing to advance in the expansion phase of the study. Our Phase 1/2 study of Oral Paclitaxel in combination with pembrolizumab, or Keytruda, in patients with advanced solid malignancies is ongoing.

In addition to our lead product candidate, development of our other Orascovery product candidates is ongoing. We presented preliminary results with respect to our Phase 1 study of oral irinotecan and encequidar (“Oral Irinotecan”) at the American Society of Clinical Oncology annual meeting in May 2019 (“2019 ASCO Annual Meeting”). We are planning Phase 2 studies for both oral irinotecan and encequidar (“Oral Irinotecan”) and oral docetaxel and encequidar (“Oral Docetaxel”). A Phase 1 study of oral eribulin and encequidar (“Oral Eribulin”) in patients with solid tumors is ongoing.

If approved, we intend to establish Oral Paclitaxel as the chemotherapy of choice for patients receiving chemotherapy for MBC, although we can provide no assurance that we will be successful in obtaining the FDA’s approval to commercialize Oral Paclitaxel. We intend to explore establishing Oral Paclitaxel in other oncology indications where we believe taxanes will continue to be a foundational treatment and continue to explore combination therapies. Our strategy is to develop and, if we receive approval from the FDA, commercialize Oral Paclitaxel in the U.S. through our Commercial Platform. We also plan to evaluate marketing options outside of the U.S., including using our internal resources, partnering with others, or out-licensing the product. In the second half of 2020, we plan to focus on:

quantitative and qualitative market research, including on health outcomes and qualitative pricing, to understand our customers, patients, and the market;

examining our competitive landscape;

developing brand strategy;

developing key opinion leader relationships;

attending priority medical conferences to increase awareness of the Company and Oral Paclitaxel;

creating a market access strategy;

developing and executing a scientific publication plan;

developing our patient and patient advocacy strategy;

completing account, physician and patient segmentation in order to prioritize and target commercial efforts effectively;

developing our distribution and patient support plans;


developing our patient adherence to therapy strategy;

completing our organizational design to determine the overall size of our go-to-market commercial team based on our market opportunity;

continuing to hire key commercial and medical affairs leadership roles;

completing a life cycle plan for Oral Paclitaxel; and

preliminary marketing and launching forecasts.

We can provide no assurance that we will be successful in obtaining the FDA’s approval to commercialize Oral Paclitaxel.

On June 13, 2020, Athenex Oncology, one of our U.S. based divisions, launched Facing MBC Together – a public education and patient support campaign that addresses isolation for people living with metastatic breast cancer (MBC). In addition to providing a unique digital resource that enables the provision of practical and emotional support to individuals with MBC, the campaign, which Athenex Oncology unveiled at the Living Beyond Breast Cancer (LBBC) 2020 Virtual Conference on Metastatic Breast Cancer, highlights the stories of nine people of diverse ages and backgrounds who share their insights about the challenges they face, their sources of support, and words of encouragement for others living with this advanced form of breast cancer.

Significant developments in our Src Kinase inhibition platform include the following:

In March 2020, we announced that the FDA had completed its filing review and determined that our NDA for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment) for the treatment of actinic keratosis (AK) is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 30, 2020.  Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application.In March 2020, our partner Almirall S.A. (“Almirall”) also announced that the European Medicines Agency (EMA) accepted the filing of a European marketing authorization for tirbanibulin ointment for the treatment of AK.

We completed two Phase 3 studies for tirbanibulin ointment in the treatment of AK and presented topline results from the two Phase 3 studies in a late breaker session at the 2019 annual meeting of the American Academy of Dermatology (AAD). The results showed that both studies achieved their primary endpoint with 44% and 54% of patients in studies KX01-AK-003 and KX01-AK-004, respectively, achieving 100% AK lesion clearance at Day 57 within the face or scalp treatment areas. There was a statistically significant greater clearance rate in favor of tirbanibulin ointment 1% versus vehicle in each study and in each of the pre-defined patient subgroups. Safety results showed that tirbanibulin ointment was well tolerated. In October 2019, we announced a progress update for tirbanibulin ointment in the treatment of AK from our partner Almirall, with whom we are collaborating for the development and commercialization of tirbanibulin in the U.S. and Europe.

The development of our other Src kinase programs/product candidates is ongoing.

Other Platforms

The other technologies in our Oncology Innovation Platform are our TCR-T immunotherapy technology under which we are advancing TCR affinity-enhancing specific T-cell (TAEST) therapy with our first drug candidate, TAEST16001,T cell therapy product, TCRT-ESO-A2, and our arginineArginine deprivation therapy technology under which we are advancing PT01, also known as Pegtomarginase.PT01.

In March 2019,September 2020, we announced that the FDA allowed our partner,Investigational New Drug (IND) application for TCRT-ESO-A2, an autologous T cell receptor (TCR)-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. TCRT-ESO-A2 is being developed by Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited (“XLifeSc”XLifeSc"), a subsidiary of Guangzhou Pharmaceutical Co., Ltd (“Xiangxue”), received notice of allowance from the China National Medical Product Administration (“NMPA”) of its Investigational New Drug (“IND”) application. We plan to initiate registration related clinical studiesa Phase 1 trial in China of TAEST therapy in patients with solid tumors that are HLA-A*02:01 positive and NY-ESO-1 positive. The cancer immunotherapy product, named TAEST 16001,1H 2021. TCRT-ESO-A2 is similar to TAEST16001, an autologous cell-based therapy utilizingbeing developed simultaneously by XLifeSc for clinical application in China in that both therapies express the TAEST technology to enhance affinity against the HLA-A*02:01 restricted antigen NY-ESO-1. We are currently preparing the US IND for TAEST 16001.same affinity-enhanced TCR.

In June 2019, the FDA allowed our IND application for the clinical investigation of PT01 for the treatment of patients with advanced malignancies. The compound targets cancer growth and survival by removing the supply of arginine to cancers that have a disrupted urea cycle. Also in June 2019 we presented preclinical study resultsThe FDA allowed our IND application for the clinical investigation of PT01 for the treatment of patients with advanced malignancies in a poster session at the 2019 ASCO Annual Meeting. The biologic agent demonstrated high enzymatic activity, predictable pharmacokinetic-pharmacodynamic profiles, and cytotoxicity2019. We plan to initiate first human exposure in vitro. Mouse xenograft models showed good tumor growth inhibition activity at tolerable doses with only transient weight loss during therapy. We are currently planning a Phase 1 clinical study for PT01.2021.


Recent business updates and COVID-19 related measures and recent business updates

In the first quarter ofSince early 2020, after monitoring developments related to the spread of COVID-19, we undertookhave undertaken a number of measures in response to the COVID-19 pandemic, with a goal to prioritize the health and safety of our employees and ensure continuity in our business. These measures included implementing a work-from-home policy at various times and other efforts in accordance with recommendations by local authorities for certain of our personnel across the globe as well as imposing restrictions on travel and in-person meetings to protect the health and safety of our workforce while we continue to advance our clinical programs and operations. WhileWe have continued to add additional safety procedures and tools in all our operationslocations. We adhere to all state and federal requirements as the same may be in China were disruptedforce from late Januarytime to early March due to the COVID-19 pandemic, during March our Chinese operations returned to normal operation.  time.

We have been deemed an “essential business” by New York State and, as a result, we have experienced minimal disruptions at our New York-based operations in Clarence and Buffalo inBuffalo. Despite these efforts, we may from time to time experience additional disruptions related to the first and second quarters.COVID-19 pandemic resulting from employees falling ill with COVID-19. We have supplied our employees with face coverings and other necessary personal protective equipment and have taken other measures to reduce the risk of the spread of COVID-19 at our work sites. Currently, construction at our Dunkirk facility is proceeding according to schedule and our recently constructed API plant in Chongqing also remains on schedule to commence operations during the second half of 2020. We are actively monitoring our operations and supply chain across the globe and are making adjustments to respond to logistical challenges that arise due to the COVID-19 pandemic where appropriate. Further, weWe have opened up our production facilitiescontinued to produce medicines that are used to treat COVID-19 as part of our commitment to contribute to the COVID-19 relief effort.

With respect to our clinical development program, our anticipated timelines for our later-stage product candidates remain largely unaffected by COVID-19. However, for our earlier stage product candidates, in line with the industry overall, we have experienced and expect to continue to experience slowed enrollment for our clinical trials as well as suspensions in our clinical trials as healthcare resources are diverted to address the COVID-19 pandemic. We remain committed to advancing our pipeline while ensuring the safety of all participants as well as the integrity of the data anddata. We will continue to monitor developments with respect to the COVID-19 pandemic as well as industry and regulatory best practices for continuing clinical development programs during the pandemic, including, if and where appropriate, the use of virtual communications, interviews and visits as well as self-administration and remote monitoring techniques to address health and safety concerns while minimizing disruptions and delays to our clinical development timelines.

In the first quarter, weWe also put in place a number of measures intended to adjust/adjust or allocate resources towards prioritizing key business operations such as clinical and regulatory activities for later-stage product candidates and pre-launch commercial activities, and to delay or defray compensation costs in order to preserve our cash on hand and liquidity during a volatile period in the U.S. and global capital markets. In addition

However, a lack of sustained recovery or further deterioration in market conditions related to deferring the paymentgeneral economy and the industries in which we operate, a sustained trend of 2019 bonusesweaker than anticipated financial performance, further decline in our share price for a sustained period of time, or an increase in the market-based weighted average cost of capital, among other factors, could significantly impact the impairment analysis and freezing base pay acrossmay result in future impairment charges that, if incurred, could have a material adverse effect on our financial condition and results of operations.


While the Company,disruptions to our business caused by the pandemic are currently expected to be temporary, there is still uncertainty regarding the pandemic's overall duration and the severity of any future outbreaks. The recent surge of COVID-19 cases in India, a country where we entered into an arrangement withsource supplies and maintain partnerships that are key to our chairmanspecialty drug business, including API, presents business and chief executive officer, Dr. Lausupply chain disruption risks for us to the extent the virus is not able to be contained, there is widespread sickness and disruptions on March 24, 2020 whereby Dr. Lau agreedoperations and also in the event state governments in India impose additional lockdowns, restrictions on the operations of businesses and other containment measures to receive options to purchase shares of our common stock in lieu of his remaining base salary for fiscal 2020. Undercombat the termsspread of the arrangement, Dr. Lau reduced his remaining basevirus. The scope and impact of any such measures is not yet known and will depend on a number of factors, including the ultimate spread and severity of the outbreaks in India and the scope, duration and impact of containment measures on individuals and businesses. If our partners in India experience significant or extended disruptions to their business due to COVID-19, it could result in substantial supply shortages and harm our special drug business, as well as our overall financial condition and results of operations.

As a result of the significant decrease in our market capitalization since we last performed a goodwill impairment test in the fourth quarter of 2020, we evaluated the impact on each of its reporting units to assess whether there was a triggering event during the first quarter of 2021, requiring it to perform a goodwill impairment test (ASC350-20-35). We determined a triggering event occurred and, as such, performed an interim goodwill quantitative impairment test for fiscal 2020 to $40,000 in cash and, in exchange for his remaining base salary, agreed to receive a stock option to purchase 55,045 shares of common stock pursuant to our 2017 Omnibus Incentive Plan. The stock option vests in one lump sum on December 31, 2020. The grant datereporting units. We compared the fair value of our Global Supply Chain Platform and Oncology Innovation Platform reporting units to carrying value. Based on the stock option was equivalent toresults, the fair value of Dr. Lau’s foregone base salary.

On March 31, 2020, we entered into a letter agreement with Xiangxue to amend certain provisionseach of the license agreement entered into with Xiangxue in December 2019 (the “2019 Xiangxue License Agreement”). Pursuant to the letter agreement, Xiangxue acknowledges and agrees that Athenex is entitled to payment of the US $30 million upfront payment (the “Upfront Payment”) under the 2019 Xiangxue License Agreement. The parties further acknowledge certain difficulties Xiangxue has experienced due to the COVID-19 pandemic in making the Upfront Payment. Therefore, in order to facilitate Xiangxue’s payment of the Upfront Payment to Athenex, the parties have agreed to make certain allowances to the payment timeline as well as the payment mechanics. In particular, the parties have agreed that, notwithstanding the provisions of the 2019 Xiangxue License Agreement to the contrary,  Xiangxue shall be entitled to make the Upfront Payment in Chinese Renminbi to Chongqing Taihao Pharmaceutical Co. Ltd. (“Taihao”), Athenex’s wholly owned subsidiary in China, and that Xiangxue shall remit the gross amount of the Upfront Payment to Taihao with Athenex bearing the responsibility forour reporting units exceeded their carrying value, added taxes with respect to the same. On June 30, 2020, Athenex entered into a second supplemental agreement to amend certain provisions of the 2019 Xiangxue License Agreement to further facilitate the Company’s receipt of the remainder of the Upfront Payment, providing, among other things, that notwithstanding the provisions of the 2019 Xiangxue License Agreement to the contrary, Athenex would bear the responsibility for indirect taxes in connection with license payments made under the 2019 Xiangxue License Agreement rather than Xiangxue. We subsequently received the full amount of the Upfront Payment from Xiangxue during the 3rd quarter of 2020.

On June 19, 2020, we entered into a senior secured loan agreement and related security agreements (the “Senior Credit Agreement) with Oaktree Fund Administration, LLC as administrative agent, and the lenders party thereto (collectively “Oaktree”) to borrow up to $225.0 million in five tranches with a maturity date of June 19, 2026, bearing interest at a fixed annual rate of 11.0%. The first tranche of $100.0 milliongoodwill was funded up front, with a portion of the upfront loan proceeds being used to repay in full our existing credit facility with Perceptive Advisors LLC and its affiliates (“Perceptive”). Additional debt tranches of $125.0 million in aggregate are available, subject to our achievement of certain regulatory and commercial milestones (see not impaired (Liquidity and Capital Resources -Recent Debt Financings - Oaktree Facilitysee Note 5 Intangible Assets, Net). In connection withHowever, there can be no assurances that goodwill will not be impaired in future periods. Estimating the fair value of goodwill requires the use of estimates and significant judgments that are based on a number of factors. These estimates and judgments may not be within our entry intocontrol and accordingly it is reasonably possible that the Senior Credit Agreement, we granted


warrants to Oaktree to purchase up to an aggregate of 908,393 shares of our common stock at a purchase price of $12.63 per sharejudgments and entered into a registration rights agreement with Oaktree on June 19, 2020, pursuant to which, among other things, the Company agreed to register for resale the shares of common stock issuable upon exercise of the warrantsestimates could change in the third quarter of 2020.

Financial Summary and Outlookfuture periods.

We have three operating segments: our Oncology Innovation Platform, Global Supply Chain Platform and Commercial Platform. Since inception, we have devoted a substantial amount of our resources to research and development of our lead product candidates under our Orascovery, Src Kinase Inhibition research platforms, and TCR-T Immunotherapy and Arginine Deprivation Therapy.Therapy, and to buildup of our commercial infrastructure. We have incurred significant net losses since inception.

For the sixthree months ended June 30, 2020,March 31, 2021, our net loss was $60.8$25.6 million, compared to $68.3$19.7 million for the same period in 2019.2020. As of June 30, 2020March 31, 2021 and December 31, 2019,2020, we had an accumulated deficit of $627.3$738.7 million and $567.5$713.6 million, respectively. We expect to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantiallycover the following activities as we:

 

Continue to advance our lead programs, Orascovery and Src Kinase Inhibition technology platforms, through clinical and regulatory development;

 

ContinueThough we have reduced our planned expenditures in 2021 while there is uncertainty around the best path forward for Oral Paclitaxel, we may need to continue to invest in further developing our Commercial Platform ahead of ourany intended proprietary drug launch;  launch and other drug candidates upon approval;

 

Continue certain of our current preclinical and clinical research program and development activities;

 

Continue to invest in our manufacturing facilities;facilities in Dunkirk and Chongqing;  

 

Advance the preclinical and clinical research program and development activities of our in-licensed technology platforms, TCR-T Immunotherapy and Arginine Deprivation Therapy;cell therapy programs;

 

Seek to identify additional research programs and product candidates within existing platform technologies;

 

Attain new drugs and technologies through acquisitions or in-licensing opportunities;opportunities if complementary to our core business;

 

Hire additional research, development and business personnel;

 

Maintain, expand and protect our intellectual property (“IP”) portfolio; and

 

Incur additional costs associated with operating as a public company.


We have borrowed and, in the future, may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to our Senior Credit Agreement and Revenue Interest Financing Agreement, or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders.

We have funded our operations to date primarily from the issuance and sale of our common stock through public offerings, senior secured loans, private placements, and to a lesser extent, from convertible bond financing, revenue, and grant funding. Due to the COVID-19 pandemic, access to public and private debt and equity markets may be limited during 2020. As of June 30, 2020,March 31, 2021, we had cash and cash equivalents of $105.9$48.0 million, restricted cash of $11.0$16.5 million, and short-term investments of $10.4$123.2 million.

Key Components of Results of Operations

Revenue

We derive our consolidated revenue primarily from (i) the sales of generic injectable products by our Commercial Platform; (ii) the sales of 503B and API products by our Global Supply Chain Platform; (iii) licensing and collaboration projects conducted by our Oncology Innovation Platform, which generates revenue in the form of upfront payments, milestone payments, and payments received for providing research and development services for our collaboration projects and for other third parties; (iii) the sales of 503B and API products by our Global Supply Chain Platform; and (iv) grant awards from government agencies and universities for our continuing research and development efforts.


We do not anticipate revenue being generated from sales of our product candidates under development in our Oncology Innovation Platform until we have obtained regulatory approval. We cannot assure you that we will succeed in achieving regulatory approval for our drug candidates as planned, or at all.

Cost of Sales

Along with sourcing from third-party manufacturers, we manufacture clinical products in our cGMP facility in New York. Cost of sales primarily includes the cost of finished products, raw materials, labor costs, manufacturing overhead expenses and reserves for expected scrap, as well as transportation costs. Cost of sales also includes depreciation expense for production equipment, changes to our excess and obsolete inventory reserves, certain direct costs such as shipping costs, net of costs charged to customers, and royalty costs related to in-license agreements.

Research and Development Expenses

Research and development (“R&D”) expenses consist of the costs associated with in-licensing of product candidates, milestone payments, conducting preclinical studies and clinical trials, activities related to regulatory filings and correspondences, and other R&D activities. Our current R&D activities mainly relate to the clinical development of our Oncology Innovation Platform.

We expense R&D costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment or clinical site activations. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific R&D programs because these costs are deployed across multiple product programs under R&D.

We cannot determine with certainty the duration, costs and timing of the current or future preclinical or clinical studies of our drug candidates. The duration, costs, and timing of clinical studies and development of our drug candidates will depend on a variety of factors, including:

 

The scope, rate of progress, and costs of our ongoing, as well as any additional, clinical studies, regulatory activities, and other R&D activities;

 

Future clinical study results;

 

Uncertainties in clinical study enrollment rates;

 

Significant and changing government regulation; and

 

The timing and receipt of any regulatory approvals.


A change in the outcome of any of these variables with respect to the development of a drug candidate, including without limitation delays caused by the ongoing COVID-19 pandemic, could mean a significant change in the costs and timing associated with the development of that drug candidate.

R&D activities are central to our business model. We expect our R&D expenses to continue to increase for the foreseeable future as we continue to support the clinical trials of Oral Paclitaxel, Oral Irinotecan, Oral Docetaxel, Oral Topotecan, Oral Eribulin, tirbanibulin ointment, tirbanibulin oralour Orascovery platform product candidates, and KX2-361,our Src kinase inhibition platform product candidates, as well as initiate and prepare for additional clinical and preclinical studies, including TCR-T and Arginine Deprivation program activities.for the cell therapy programs. We also expect spending to increase in the R&D for API, 503B and specialty products. There are numerous factors associated with the successful commercialization of any of our drug candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial, regulatory and regulatorypublic health, including the ongoing COVID-19 pandemic, factors beyond our control will likely impact our clinical development programs and plans.

Selling, General and Administrative Expenses

Selling, general and administrative, (“SG&A”), expenses primarily consist of compensation, including salary, employee benefits and stock-based compensation expenses for sales and marketing personnel, and for administrative personnel that support our general operations such as executive management, legal counsel, financial accounting, information technology, and human resources personnel. SG&A expenses also include professional fees for legal, patent, consulting, auditing and tax services, as well as other direct and allocated expenses for rent and maintenance of facilities, development of the facility in Dunkirk, NY, insurance and other supplies used in the selling, marketing, general and administrative activities. SG&A expenses also include costs associated with our commercialization efforts for our proprietary drugs, such as market research, brand strategy and development work on market access, scientific publication, product distribution, and patient support.


We anticipate that our SG&A expenses will increase in future periods to support increases in our research and development. We expect these increases will likely result in increased headcount, increased share compensation charges, expanded infrastructure and increased costs for insurance. We also anticipate increases to legal expenses due to the on-going class action lawsuit (see Note 15 Commitments and Contingencies), insurance premium, compliance, accounting and investor and public relations expenses associated with being a public company.

Results of Operations

Three Months Ended June 30, 2020March 31, 2021 Compared to Three Months Ended June 30, 2019March 31, 2020

The following table sets forth a summary of our condensed consolidated results of operations for the three months ended June 30,March 31, 2021 and 2020, and 2019, together with the changes in those items in dollars and as a percentage. This information should be read together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Our operating results in any period are not necessarily indicative of the results that may be expected for any future period.

 

 

Three Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

(in thousands)

 

 

(in thousands)

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

(in thousands)

 

 

(in thousands)

 

 

%

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

40,167

 

 

$

22,033

 

 

$

18,134

 

 

 

82

%

 

$

20,360

 

 

$

18,547

 

 

$

1,813

 

 

 

10

%

License fees and other revenue

 

 

5

 

 

 

164

 

 

 

(159

)

 

NM

 

 

 

20,665

 

 

 

28,388

 

 

 

(7,723

)

 

 

-27

%

Total revenue

 

 

40,172

 

 

 

22,197

 

 

 

17,975

 

 

 

 

 

 

 

41,025

 

 

 

46,935

 

 

 

(5,910

)

 

 

 

 

Cost of sales

 

 

(33,006

)

 

 

(16,942

)

 

 

(16,064

)

 

 

95

%

 

 

(16,405

)

 

 

(19,572

)

 

 

3,167

 

 

 

-16

%

Gross profit

 

 

7,166

 

 

 

5,255

 

 

 

1,911

 

 

 

 

 

 

 

24,620

 

 

 

27,363

 

 

 

(2,743

)

 

 

 

 

Research and development expenses

 

 

(22,015

)

 

 

(18,507

)

 

 

(3,508

)

 

 

19

%

 

 

(23,070

)

 

 

(17,192

)

 

 

(5,878

)

 

 

34

%

Selling, general, and administrative expenses

 

 

(17,486

)

 

 

(17,169

)

 

 

(317

)

 

 

2

%

 

 

(22,120

)

 

 

(25,748

)

 

 

3,628

 

 

 

-14

%

Interest income

 

 

185

 

 

 

475

 

 

 

(290

)

 

 

-61

%

 

 

29

 

 

 

413

 

 

 

(384

)

 

 

-93

%

Interest expense

 

 

(1,565

)

 

 

(1,754

)

 

 

189

 

 

 

-11

%

 

 

(4,908

)

 

 

(1,673

)

 

 

(3,235

)

 

 

193

%

Loss on extinguishment of debt

 

 

(7,230

)

 

 

 

 

 

(7,230

)

 

NM

 

Income tax expense

 

 

(106

)

 

 

(405

)

 

 

299

 

 

 

-74

%

 

 

(154

)

 

 

(2,881

)

 

 

2,727

 

 

 

-95

%

Net loss

 

 

(41,051

)

 

 

(32,105

)

 

 

(8,946

)

 

 

 

 

 

 

(25,603

)

 

 

(19,718

)

 

 

(5,885

)

 

 

 

 

Less: net loss attributable to non-controlling interests

 

 

(600

)

 

 

(74

)

 

 

(526

)

 

 

711

%

 

 

(553

)

 

 

(289

)

 

 

(264

)

 

 

91

%

Net loss attributable to Athenex, Inc.

 

$

(40,451

)

 

$

(32,031

)

 

$

(8,420

)

 

 

 

 

 

$

(25,050

)

 

$

(19,429

)

 

$

(5,621

)

 

 

 

 


 

Revenue

Revenue from product sales increased to $40.2$20.4 million for the three months ended June 30, 2020,March 31, 2021, from $22.0$18.5 million for the three months ended June 30, 2019,March 31, 2020, an increase of $18.1$1.8 million or 82%10%. This increase was primarily attributable to a significantan increase of $2.8 million in specialty product sales of $24.6 million, driven by the impact of the global health pandemic which led to the increased demand for COVID-19 related drugs. We experienced an increase in purchases from our existing customers as well as obtaining large, non-recurring orders of specialty products from new customers.503B products. Fluctuations in the infection rate and the spread of the global health pandemic and market demand can significantly affect our product sales in the future. IfAPI product sales increased by $0.8 million and whencontract manufacturing revenue from supply of Klisyri to our partner Almirall increased by $0.4 million due to the COVID-19 pandemic recedes temporarily or is quelled, we expect to see a significant softeninglaunch of the drug in demand for these products. This increase was partiallyFebruary 2021. These increases were offset by a decrease of $2.3 million in APIAPD sales.

License fees and 503B products salesother revenue decreased by $7.7 million, or 27%. For the three months ended March 31, 2021, we recorded $20.0 million of $2.6 million, and $3.8 million, respectively, duelicense revenue pursuant to the suspension2017 Almirall License Agreement upon the launch of productionKlisyri in the U.S., and $0.5 million related to the upfront fee pursuant to the Second Amendment to the 2011 PharmaEssentia License Agreement. For the three months ended March 31, 2020 we recognized $28.3 million in license revenue, net of commercial batches at our API facilities and$1.7 million value added tax (“VAT”), pursuant to the discontinued vasopressin sales.2019 Xiangxue License Agreement.

Cost of Sales

Cost of sales for the three months ended June 30, 2020March 31, 2021 totaled $33.0$16.4 million, an increasea decrease of $16.1$3.2 million, or 95%16%, as compared to $16.9$19.6 million for the three months ended June 30, 2019. IncreaseMarch 31, 2020. The decrease was primarily due to the $2.0 million royalty payment incurred in 2020 on the license revenue from Xiangxue. The decrease in cost of specialty product sales was in-line with the increasedecrease in revenuerevenue. Cost of 503B and we continued to incur fixed costs despite decreasedAPI product sales increased slightly as production at our API and APS facilities.levels increased. Changes in the availability of products and market demand could increase or decrease our revenue and gross profit related to these products in the future.

Research and Development Expenses

R&D expenses for the three months ended June 30, 2020March 31, 2021 totaled $22.0$23.1 million, an increase of $3.5$5.9 million, or 19%34%, as compared to $18.5$17.2 million for the three months ended June 30, 2019.March 31, 2020. This was primarily due to an increase in regulatorypre-launch product development costs, R&D related compensation, preclinical operations, and drug licensing costs and included the following:

 

$3.46.3 million increase in regulatory costOral Paclitaxel and Encequidar product development and API costs and medical affairs costs prior to receipt of the Complete Response Letter in connection with our NDA preparation and filing for our late-stage drug candidates;2021;

 

$1.42.2 million increase in R&Dpreclinical operations, related compensation due to an increase in workforce;the development of TCR-T technology and Oral Eribulin;

 

$1.10.5 million increase in preclinical operationsdrug licensing costs related to API R&D and TCR-T development;specialty drug product in-licenses; and

 

$0.60.4 million increase in drug licensing costsR&D related to specialty product in-licenses.compensation expenses.


The increase in these R&D expenses was partially offset by a $2.6$2.9 million decrease in clinical studystudies and patient costs as both tirbanibulinon Oral Paclitaxel after completion of the Phase 3 studies wound down and a $0.4$0.6 million decrease in regulatory, API development, and 503B development costs.

Selling, General, and Administrative Expenses

SG&A expenses for the three months ended June 30, 2020March 31, 2021 totaled $17.5$22.1 million, an increasea decrease of $0.3$3.6 million, or 2%14%, as compared to $17.2$25.7 million for the three months ended June 30, 2019.March 31, 2020. This was primarily due to a decrease of $4.4 million related to the costs of preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021. This was partially offset by an increase of $1.3$0.7 million of general and administrative costs related to increased hiring, professional fees, and IT costs, partially offset by a $1.0 million decrease in certain operational costs as a result of travel and other office expenditures due to the COVID-19 pandemic.operational costs.

Interest Income and Interest Expense

Interest income consisted of interest earned on our short-term investments totaled less than $0.1 million and decreased from $0.5 million to $0.2$0.4 million for the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively. Interest expense totaled $1.6$4.9 million and $1.8$1.7 million for the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively. The majority of the interestInterest expense in the both periodscurrent period was incurred from our variable-rate, long-term debt with Perceptive entered into during the third quarter of 2018. The interest expense incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was $0.3 million for the three months ended June 30, 2020.

Loss on extinguishment ofincurred from debt

We recognized $7.2 million loss on the extinguishment of debt related to the termination of the senior secured loan under a former credit agreement with Perceptive for the three months ended June 30, 2020.Advisors LLC and its affiliates.

Income Tax Expense

For the three months ended June 30, 2020,March 31, 2021, we incurred income tax expense of $0.1$0.2 million, compared to $0.4$2.9 million for the same period in 2019.2020. The decrease in income tax expenses was primarily attributable to the recording a foreign valuation allowanceincome tax withholdings on our deferred tax asset duringrevenue earned under our out-license arrangements in the prior year.

Six Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019

The following table sets forth a summary of our condensed consolidated results of operations for the six months ended June 30, 2020 and 2019, together with the changes in those items in dollars and as a percentage. This information should be read together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Our operating results in any period are not necessarily indicative of the results that may be expected for any future period.

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

Change

 

 

 

(in thousands)

 

 

(in thousands)

 

 

(in thousands)

 

 

%

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

58,714

 

 

$

47,196

 

 

$

11,518

 

 

 

24

%

License fees and other revenue

 

 

28,393

 

 

 

308

 

 

 

28,085

 

 

NM

 

Total revenue

 

 

87,107

 

 

 

47,504

 

 

 

39,603

 

 

 

 

 

Cost of sales

 

 

(52,578

)

 

 

(36,844

)

 

 

(15,734

)

 

 

43

%

Gross profit

 

 

34,529

 

 

 

10,660

 

 

 

23,869

 

 

 

 

 

Research and development expenses

 

 

(39,207

)

 

 

(42,982

)

 

 

3,775

 

 

 

-9

%

Selling, general, and administrative expenses

 

 

(43,234

)

 

 

(32,357

)

 

 

(10,877

)

 

 

34

%

Interest income

 

 

598

 

 

 

758

 

 

 

(160

)

 

 

-21

%

Interest expense

 

 

(3,238

)

 

 

(3,509

)

 

 

271

 

 

 

-8

%

Loss on extinguishment of debt

 

 

(7,230

)

 

 

 

 

 

(7,230

)

 

NM

 

Income tax expense

 

 

(2,987

)

 

 

(905

)

 

 

(2,082

)

 

 

230

%

Net loss

 

 

(60,769

)

 

 

(68,335

)

 

 

7,566

 

 

 

 

 

Less: net loss attributable to non-controlling interests

 

 

(889

)

 

 

(1,071

)

 

 

182

 

 

 

-17

%

Net loss attributable to Athenex, Inc.

 

$

(59,880

)

 

$

(67,264

)

 

$

7,384

 

 

 

 

 


Revenue

Revenue from product sales increased to $58.7 million for the six months ended June 30, 2020, from $47.2 million for the six months ended June 30, 2019, an increase of $11.5 million or 24%. This increase was primarily attributable to a significant increase in specialty product sales of $25.5 million as the result of increased demand for COVID-19 related drugs due to the global health pandemic and the launch of additional products. We experienced an increase in purchases from our existing customers as well as obtaining large, non-recurring orders of specialty products from new customers.

Fluctuations in the infection rate and the spread of the global health pandemic and market demand can significantly affect our product sales in the future. If and when the COVID-19 pandemic recedes temporarily or is quelled, we expect to see a significant softening in demand for these products. This increase was partially offset by a decrease in API and 503B products sales of $6.5 million, and $7.3 million, respectively, due to the suspension of production of commercial batches at our API facilities and the discontinued vasopressin sales. We recognized $28.3 million in license revenue, net of $1.7 million VAT, for the six months ended June 30, 2020, pursuant to the 2019 Xiangxue License Agreement.

Cost of Sales

Cost of sales for the six months ended June 30, 2020 totaled $52.6 million, an increase of $15.8 million, or 43%, as compared to $36.8 million for the six months ended June 30, 2019. Increase in cost of specialty product sales was in-line with the increase in revenue and we continued to incur fixed costs despite decreased production at our API and APS facilities. Changes in the availability of products and market demand could increase or decrease our revenue and gross profit related to these products in the future.

Research and Development Expenses

R&D expenses for the six months ended June 30, 2020 totaled $39.2 million, a decrease of $3.8 million, or 9%, as compared to $43.0 million for the six months ended June 30, 2019. This was primarily due to a decrease in licensing fees, clinical operations, and preclinical operations and included the following:

$5.2 million decrease in drug licensing costs related to specialty product in-license expenses and an upfront license payment due to XLifeSc related to TCR-T technology incurred during the prior year;

$4.7 million decrease of clinical studies costs related to the supply of encequidar and tirbanibulin ointment for clinical studies. In addition, patient costs on the two Phase 3 tirbanibulin studies continued to decrease as both Phase 3 studies wound down; and

$0.3 million decrease of preclinical operations related to fewer up-front expenses for Arginine Deprivation Therapy, and a decrease in API R&D costs.

The decrease in these R&D expenses was partially offset by an increase of $6.4 million in regulatory costs in connection with our NDA preparations and compensation expense.

Selling, General, and Administrative Expenses

SG&A expenses for the six months ended June 30, 2020 totaled $43.2 million, an increase of $10.8 million, or 34%, as compared to $32.4 million for the six months ended June 30, 2019. This was primarily due to an increase of $7.4 million related to the costs of preparing to commercialize our proprietary drugs, if approved, and an increase of $3.4 million of general administrative expense, including professional service fees and other operating expenses.

Interest Income and Interest Expense

Interest income consisted of interest earned on our short-term investments and decreased to $0.6 million from $0.8 million for the six months ended June 30, 2020 and 2019, respectively. Interest expense totaled $3.2 million and $3.5 million for the six months ended June 30, 2020 and 2019, respectively. The majority of the interest expense in the both periods was incurred from our variable-rate, long-term debt with Perceptive entered into during the third quarter of 2018. The interest expense incurred from the Oaktree Senior Credit Agreement was $0.3 million for the six-months ended June 30, 2020.      

Loss on extinguishment of debt

We recognized $7.2 million loss on the extinguishment of debt related to the termination of the senior secured loan agreement with Perceptive for the six-months ended June 30, 2020.

Income Tax Expense

For the six months ended June 30, 2020, we incurred income tax expense of $3.0 million, compared to $0.9 million for the same period in 2019. The increase in income tax expenses was primarily attributable to $2.8 million foreign tax withholding in relation to license revenue recognized in the six months ended June 30, 2020.


Liquidity and Capital Resources

Capital Resources

Since our inception, we have incurred net losses and negative cash flows from our operations. Substantially all of our losses have resulted from funding our R&D programs, SG&A costs associated with our operations, and the development of our specialty drug operations in our Commercial Platform and 503B operations and the investment we are making in our pre-launch activities in anticipation of commercializing our proprietary drugs. We incurred net losses of $60.8$25.6 million and $68.3$19.7 million for the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, respectively. As of June 30, 2020,March 31, 2021, we had an accumulated deficit of $627.3$738.7 million. Our operating activities used $70.1$29.9 million and $37.8$45.5 million of cash during the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, respectively. We intend to continue to advance our various clinical and pre-clinical programs which we expect will lead to increasedcontinuous cash outflow of R&D costs and though we have reduced our planned expenditures in 2021 while there is uncertainty around the best path forward for Oral Paclitaxel, we expect to increase our investments in commercialization activities for our proprietary drugs, if approved. In addition, we can provide no assurance that our funding requirements to diversify our product portfolio for specialty drug products in our Commercial Platform and 503B operations will decline in the future. AsOur principal sources of June 30, 2020 we hadliquidity as of March 31, 2021 were cash and cash equivalents of $105.9totaling $48.0 million, restricted cash of $11.0$16.5 million, and short-term investments of $10.4 million, which will fund operations into the second quarter of 2021 but will not be sufficient to fund current operating plans through one year after the date that these unaudited condensed consolidated financial statements are issued. This conclusion does not contemplate the additional funding the Company may receive throughheld in a controlled bank account in connection with the Senior Credit Agreement with Oaktree, and Revenue Interest Financing Agreement, further discussed below.

Recent Equity Financings

On May 7, 2019, we completed a private placement equity offering of 10short-term investments totaling $123.2 million, shares of our common stock. All shares were offered by us at a price of $10.00 per share to three institutional investors, namely Perceptive, Avoro Capital Advisors (formerly known as venBio Select Advisor), and OrbiMed. The aggregate net proceeds received by us from the offering were $99.9 million, net of offering expenses of approximately $0.1 million.

On December 9, 2019, we completed a private placement with a group of institutional investors, led by Kingdon Capital Management, LLC, pursuant to which we sold an aggregate of 3,945,750 shares of its common stock at a purchase price of $15.30 per share for aggregate net proceeds of $59.4 million, net of offering expenses of approximately $1.0 million.

Recent Debt Financingsare generally high-quality investment grade corporate debt securities.

Oaktree Facility

On June 19, 2020 (the “Closing Date”), we entered into the Senior Credit Agreement to borrow up to $225.0 million in five tranches with a maturity date of June 19, 2026, bearing interest at a fixed annual rate of 11.0%, payable quarterly. We are required to make quarterly interest-only payments until the second anniversary of the Closing Date, after which we are required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. After the date that is 90 days after the Closing Date, we will be required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date and the commitment termination date. We are also required to pay an exit fee at maturity equal to 2.0% of the aggregate principal amount of the loans funded under the Senior Credit Agreement.

The first tranche of $100.0 million was drawn prior to June 30, 2020, with $54.1 million of the proceeds used in part to repay in full the outstanding loan and fees under the credit agreement with Perceptive and an additional $11.0 million of the upfront loan proceeds held by us as restricted cash in a debt service reserve account, and $6.4 million in fees and expenses incurred in connection with the financing, leaving $28.5 million in available proceeds from the first tranche. An additional four debt tranches of $125 million in the aggregate are available for borrowing from time to time prior to the date that is either 24 or 36 months after the Closing Date, subject to our achievement of certain regulatory and commercial milestones, each as further set forth below:

Tranche

Funding Condition

Tranche Commitment Amount

Tranche B

Acceptance by the FDA of an NDA filing relating to Oral Paclitaxel.

$25.0 million

Tranche C

The receipt of approval from the FDA of an NDA in respect of the use of Oral Paclitaxel to treat metastatic breast cancer.

$25.0 million

Tranche D

The receipt of approval from the FDA of an NDA in respect of the use of Tirbanibulin to treat actinic keratosis.

$25.0 million

Tranche E

The achievement of (A) net sales for the twelve (12) consecutive month period ending on the last day of a fiscal quarter in excess of $200.0 million and (B) net sales attributable to Oral Paclitaxel for such quarter in excess of $40.0 million.

$50.0 million


We may voluntarily prepay the Senior Credit Agreement at any time subject to a prepayment premium which up until the second anniversary of the Closing Date is equal to the amount of interest that would have been paid up to, but not including, the second anniversary date (excluding interest amounts already paid), plus 3.0% of the principal amount of the senior secured loans being repaid. Thereafter, the prepayment premium equals 3.0% of the principal amount of the senior secured loans being repaid and is reduced over time until the fourth anniversary date, after which no prepayment premium is required.

We are required to make mandatory prepayments of the senior secured loans with net cash proceeds from certain asset sales or insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights.

Our obligations under the Senior Credit Agreement are guaranteed by us and certain of our existing domestic subsidiaries and subsequently acquired or organized subsidiaries subject to certain exceptions. Our obligations under the Senior Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of our direct subsidiaries, and (ii) a perfected security interest in all of our tangible and intangible assets.

The Senior Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. In addition, the Senior Credit Agreement contains certain financial covenants, including, among other things, maintenance of minimum liquidity and a minimum revenue test, measured quarterly until the last day of the second consecutive fiscal quarter where the consolidated leverage ratio does not exceed 4.5 to 1, provided that thereafter we cannot allow our consolidated leverage ratio to exceed 4.5 to 1, measured quarterly. Failure of the Company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company. At June 30, 2020,March 31, 2021, we were in compliance with all applicable covenants.

The Senior Credit Agreement contains events of default which are customary for financings of this type, in certain circumstances subject to customary cure periods. Following an event of default and any cure period, if applicable, Oaktree will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Senior Credit Agreement, in addition to other remedies available to it as a secured creditor of the Company.

In connection with our entry into the Senior Credit Agreement, we granted warrants to Oaktree to purchase up to an aggregate of 908,393 shares of our common stock at a purchase price of $12.63 per share and entered into a registration rights agreement with Oaktree on June 19, 2020, pursuant to which, among other things, the Company agreed to register for resale the shares of common stock issuable upon exercise of the warrants of no later than the 45th day following the issuance of the warrants.

Revenue Interest Financing Agreement

On August 4, 2020, we entered into a Revenue Interest Financing Agreement with Sagard Healthcare Royalty Partners, LP (“Sagard”), pursuant to which Sagard has agreed to pay the Company $50.0 million (the “Product Payment”) to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the FDA for the treatment of metastatic breast cancer. In exchange for the Product Payment, we have agreed to make payments to Sagard (the “Payments”) equal to 5.0% of our world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price set forth below (the “Hard Cap”). We are required to make certain additional payments to Sagard to the extent Sagard has not received Payments equaling at least $20.0 million by September 30, 2024 and at least $50.0 million by August 4, 2026. In addition, if Sagard has not received Payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded (the “Funding Date”), then subject to the Hard Cap, we will be required to pay Sagard an amount such that Sagard will have obtained a 6.0% internal rate of return, calculated on a quarterly basis and calculated from the Funding Date to the tenth anniversary of the Funding Date, on the amount of the Product Payment, taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement.

Our obligations under the Revenue Interest Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree Fund Administration, LLC as administrative agent for the lenders under our Senior Credit Agreement, by a perfected security interest in (i) accounts receivable arising from net sales of Oral Paclitaxel and (ii) intellectual property that is claiming or covering Oral Paclitaxel itself or any method of using, making or manufacturing Oral Paclitaxel.

At any time after August 4, 2022, we will have the right, but not the obligation (the “Call Option”), to buy out Sagard’s interest in the Payments at a repurchase price (the “Put/Call Price”) equal to (a) on or before August 4, 2023, a payment sufficient to generate an internal rate of return of 18.0% of the Product Payment, (b) after August 4, 2023 and on or before August 4, 2024, a payment sufficient to generate an internal rate of return of 16.0% of the Product Payment, (c) after August 4, 2024 and on or before August 4, 2025, a payment sufficient to generate an internal rate of return of 15.0% of the Product Payment, and (d) thereafter, the greater of (i) an amount that, when paid to Sagard, would generate an internal rate of return of 13.0% of the Product Payment, and (ii) an amount equal to the product of the Product Payment and 165%, in the case of each foregoing clause (a) through (d), taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement.  


The Revenue Interest Financing Agreement contains customary representations and warranties and certain restrictions on our ability to incur indebtedness and grant liens on intellectual property related to Oral Paclitaxel. In addition, the Revenue Interest Financing Agreement provides that if certain events (“Put Option Events”) occur, including certain bankruptcy events, non-payment of Payments, a change of control, an out-license or sale of all of the rights in and to Oral Paclitaxel in the U.S. (other than any out-licensing transaction that includes all or substantially all of the U.S. and European development and commercialization rights to Oral Paclitaxel with a pharmaceutical company with global annual revenues for its most recently completed fiscal year that is greater than or equal to $500.0 million attributable to its oncology business) and (subject to applicable cure periods) non-compliance with the covenants in the Revenue Interest Financing Agreement, Sagard may require us to repurchase its interests in the Payments at the Put/Call Price.  Sagard may also terminate the Revenue Interest Financing Agreement if we have not received marketing authorization for Oral Paclitaxel by the FDA for the treatment of metastatic breast cancer by December 31, 2021.

Sagard and its co-investors OPB SHRP Co-Invest Credit Limited and SIMCOE SHRP Co-Invest Credit Ltd. (the “IMCO Investors”) also acquired by assignment (the “Assignment”) term loans and commitments equal to $50.0 million under the Senior Credit Agreement. In connection with the Assignment, we granted warrants to Sagard and the IMCO Investors to purchase up to 201,865 shares of our common stock at a purchase price of $12.63 per share (the “Sagard Warrants”).  The Sagard Warrants will expire on June 19, 2027 and may be net exercised at the holder’s election.  

Outlook

We have borrowed and, in the future, may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to the Senior Credit Agreement, or potentially pursuant to new arrangements with different lenders. We may borrow additional funds on terms that may include restrictive covenants, including covenants that further restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders.

As of June 30, 2020, the CompanyMarch 31, 2021, we had cash and cash equivalents of $105.9$48.0 million, restricted cash of $11.0$16.5 million, and short-term investments of $10.4$123.2 million. The Company believesWe believe that the existing cash and cash equivalents, restricted cash, and short-term investments will enable us to meet our current operational liquidity needs and fund operations into the second quarterhalf of 2021 but will not be sufficient to fund current operating plans through one year after2022. The Company’s estimates are based on relevant conditions that are known and reasonably knowable at the date thatof these unaudited condensed consolidated financial statements being available for issuance and are issued.  This conclusion doessubject to change due to changes in business, industry or macroeconomic conditions. Further, we do not contemplate theexpect to have access to additional funding the Company may receive throughcapital under the Senior Credit Agreement and the Revenue Interest Financing Agreement, further discussed below.and will need to find alternative sources of financing until such time as Oral Paclitaxel is approved or will need to renegotiate these arrangements. We have based these estimates on assumptions that may prove to be wrong, and it could spend the available financial resources much faster than expected and need to raise additional funds sooner than anticipated. Since there is uncertainty around


We have made certain changes to our ability to achieve various funding conditions that triggerbudgeted expenses in light of the lenders’ obligations to make payments underCRL for Oral Paclitaxel we received in February 2021 pending further discussion with the Senior Credit AgreementFDA on the best pathway forward for Oral Paclitaxel, including curtailing commercialization expenses and the Revenue Interest Financing Agreement, there can be no assurance that this funding will be availableinvesting in additional products for our use when needed, or at all. In addition, disruptions in the capital markets and the operations of commercial partners due to the COVID-19 pandemic may make it difficult for us to raise additional funds. As a result, these uncertainties, among others, raise substantial doubt about the Company’s ability to continue as a going concern.  

Ifspecialty pharma business. However, we meet applicable funding conditions, anticipated future proceeds from the Senior Credit Agreement and the Revenue Interest Financing, together with the existing cash and cash equivalents, restricted cash, and short-term investments, are estimated to extend the Company’s cash runway into 2022, as they provide us the financial flexibility to draw another $125.0 million and $50.0 million of contingent milestone-based, non-dilutive capital.

We expect that our expenses will increase as we continue to fund clinical and preclinical development of our research programs pre-launch activities ofby advancing certain product candidates in our proprietary drugs, funding ofpipeline, including product candidates on our Commercial PlatformOrascovery and manufacturing facilities, andSrc Kinase Inhibition technology platforms, our cell therapy programs, our specialty drug products, working capital and other general corporate purposes. Capital expenditure at both Dunkirk and Sintaho facilities will continue to grow and be significant as we build out both plants to manufacture drugs including 503B, Tirbanibulin APIs and injectable products. We have based our estimates on assumptions that might prove to be wrong and our estimates are also subject to change depending on the outcome of our discussions with the FDA with respect to Oral Paclitaxel, and we might use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to accurately estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development and commercialization of our drug candidates.

Our future capital requirements will depend on many factors, some or all of which may be impacted by the COVID-19 pandemic, including:

 

Our ability to generate revenue and profits from our Commercial Platform or otherwise;

 

The costs, timing and outcome of regulatory reviews and approvals;

 

Progress of our drug candidates to progress through clinical development successfully;


 

The initiation, progress, timing, costs and results of nonclinical studies and clinical trials for our other programs and potential drug candidates;

 

The costs of preparing our Commercial Platform for the commercialization of our proprietary drugs;

 

The costs of construction and fit-out of planned drug at both Dunkirk and API manufacturing facilities;

 

The number and characteristics of the drug candidates we pursue;

 

The costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our IP rights and defending IP related claims;

 

The extent to which we acquire or in-license other products and technologies; and

 

Our ability to maintain and establish collaboration arrangements on favorable terms, if at all.

We believe that our existing cash, cash equivalents, restricted cash, and short-term investments will not be sufficient to enable us to complete all necessary development or commercially launch our proprietary drug candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, and government grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of holders of common stock. Additional debtDebt financing, if available, may involve agreements that include covenants further limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and might require the issuance of warrants, which could potentially dilute the ownership interest of holders of common stock. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we might have to relinquish valuable rights to our technologies, future revenue streams or research programs or to grant licenses on terms that might not be favorable to us. The COVID-19 pandemic has reduced the valuation of many publicly traded stocks, including our own, and has disrupted capital markets in the U.S. and globally.  Until global economies recover, we may not be able to raise additional funds through equity or debt financings. If we are unable to raise additional funds through equity or debt financings when needed, we might be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market products or drug candidates that we would otherwise prefer to develop and market ourselves.

Cash Flows

The following table provides information regarding our cash flows for the sixthree months ended June 30, 2020March 31, 2021 and 2019:2020:

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

 

(in thousands)

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(70,068

)

 

$

(37,773

)

 

$

(29,876

)

 

$

(45,545

)

Net cash provided by investing activities

 

 

18,125

 

 

 

4,764

 

Net cash provided by (used in) investing activities

 

 

7,037

 

 

 

(10,451

)

Net cash provided by financing activities

 

 

41,573

 

 

 

104,698

 

 

 

754

 

 

 

732

 

Net effect of foreign exchange rate changes

 

 

(403

)

 

 

715

 

 

 

478

 

 

 

(427

)

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

restricted cash

 

$

(10,773

)

 

$

72,404

 

Net decrease in cash, cash equivalents,

and restricted cash

 

$

(21,607

)

 

$

(55,691

)


 

Net Cash Used in Operating Activities

The use of cash in our operating activities resulted primarily from our net loss adjusted for non-cash charges and changes in components of working capital. The primary use of our cash in the periods presented was to fund our R&D, regulatory and other clinical trial costs, drug licensing costs, inventory purchases, pre-launch commercialization activities, and other expenditures related to sales, marketing and administration. Net cash used in operating activities increased $32.3decreased $15.7 million, or 85.5%34%, for the sixthree months ended June 30, 2020.March 31, 2021. The increasedecrease is primarily attributable to increasesthe increase in costproduct sales and collection of sales, SG&A costs, and losses related tolicense fees during the extinguishment of debt.three months ended March 31, 2021.

Net cash used in operating activities was $70.1$29.9 million for the sixthree months ended June 30, 2020.March 31, 2021. This resulted primarily from our net loss of $60.8$25.6 million, adjusted for non-cash charges of $15.4$4.3 million, and by cash used by our operating assets and liabilities of $24.7$8.6 million. Our operating assets increased $21.9$3.4 million for accounts receivable mainly related to the increased sales of 503B products, increased $2.5 million for inventory of all drug products, and offset by $2.2 million decrease in prepaid expenses and other assets. Our operating liabilities decreased by $12.3 million mainly due to a decrease in accrued selling fees and royalties on our specialty drugs, accrued purchases of specialty drug inventory, and accrued interest paid in the current period on our Senior Credit Agreement with Oaktree, partially offset by an increase in accrued wages and benefits. Our net non-cash charges during the three months ended March 31, 2021 primarily consisted of $2.2 million of stock-based compensation expense, $1.3 million depreciation and amortization expense, and $0.8 million amortization of debt discount.

Net cash used in operating activities was $45.5 million for the three months ended March 31, 2020. This resulted primarily from our net loss of $19.7 million, adjusted for non-cash charges of $3.8 million, and by cash used by our operating assets and liabilities of $29.7 million, the majority of which was due to the licensing fee receivable. Our operating assets increased $34.7 million for accounts receivable mainly related to the contract asset recognized from license revenue in the current period and the increasedthree months ended March 31, 2020 as well as increases sales of specialty products, during the six-months ended June 30, 2020, and decreased by $1.5$3.1 million for inventory of all drug products, and $1.0 forpartially offset by a $3.7 million decrease in prepaids and other assets. Our operating liabilities increased by $5.3$4.4 million mainly due to an increase in accrued selling costs and rebates, and an increase in accrued wages and benefits, and other operating liabilities.related the construction of our Dunkirk facility. Our net non-cash charges during the sixthree months ended June 30,March 31, 2020 primarily consisted of $7.2 million of loss on extinguishment of debt, $5.3$2.3 million of stock-based compensation expense and $2.1$1.1 million depreciation and amortization expense.


Net cash used in operating activities was $37.8 million for the six months ended June 30, 2019. This resulted primarily from our net loss of $68.3 million, adjusted for non-cash charges of $7.9 million, and by cash used by our operating assets and liabilities of $22.7 million. Our operating assets decreased $3.4 million for accounts receivable mainly related to the decreased sales of API products during the six months ended June 30, 2019, and $1.5 million for inventory of all drug products, while prepaid and accrued expenses increased by $25.3 million primarily related to construction at the Dunkirk facility. Our operating liabilities increased by $43.1 million mainly due to $24.3 million related to construction at our Dunkirk facility, and $20.0 million of deferred revenue related to a milestone payment received from Almirall. Our net non-cash charges during the six months ended June 30, 2019 primarily consisted of $5.1 million of stock-based compensation expense, and $1.8 million depreciation and amortization expense.

Net Cash Provided by (Used in) Investing Activities

Net cash provided by investing activities was $18.1$7.0 million for the sixthree months ended June 30, 2020,March 31, 2021, compared to $4.8$10.5 million used in investing activities in the sixthree months ended June 30, 2019.March 31, 2020. The difference was primarily due to more cash being obtainedprovided by the sales and maturities of short-term investments, partially offset by an increase in cash paid for property and a decrease inequipment at our API and Dunkirk facilities and cash paid for in-licenses fees related to our specialty drugs during the purchases of short-term investments and in-licenses.three months ended March 31, 2021.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $41.6$0.8 million for the sixthree months ended June 30, 2020,March 31, 2021, which primarily consisted of $94.2 million from the draw downs of debt from our credit facility with Oaktree and $1.0 million to fund our new API plant in China, $5.8 million from the issuance of warrants to Oaktree, and $0.8$0.9 million from the exercise of stock options, and sale of common stock, partially offset by $54.1$0.1 million repayment of Perceptive debt and $6.1 million issuance costs of the new Oaktree debt.finance lease obligations.

Net cash provided by financing activities was $104.7$0.7 million for the sixthree months ended June 30, 2019, March 31, 2020, which primarily consisted of net proceeds of $99.9 million from the issuance of common stock from the private placement and $3.6$0.4 million from the issuance of debt to fund our new API plant in China.China and $0.3 million from the exercise of stock options.

Contractual Obligations

A summary of our contractual obligations as of June 30, 2020March 31, 2021 is as follows:

 

 

Payments Due by Period

 

 

 

 

 

 

Payments Due by Period

 

 

 

 

 

 

Within

1 Year

 

 

1 to 3

years

 

 

3 to 5

years

 

 

More than

5 years

 

 

Total Amounts

Committed

 

 

Within

1 Year

 

 

1 to 3

years

 

 

3 to 5

years

 

 

More than

5 years

 

 

Total Amounts

Committed

 

 

(in thousands)

 

 

(in thousands)

 

Operating leases

 

$

2,903

 

 

$

5,095

 

 

$

4,050

 

 

$

947

 

 

$

12,995

 

 

$

3,389

 

 

$

4,702

 

 

$

3,085

 

 

$

367

 

 

$

11,543

 

Long-term debt

 

 

842

 

 

 

16,744

 

 

 

27,215

 

 

 

65,506

 

 

 

110,307

 

 

 

1,560

 

 

 

25,473

 

 

 

27,900

 

 

 

107,666

 

 

 

162,599

 

Finance lease obligations

 

 

389

 

 

 

450

 

 

 

183

 

 

 

 

 

 

1,022

 

 

 

430

 

 

 

502

 

 

 

99

 

 

 

 

 

 

1,031

 

Licensing fees

 

 

384

 

 

 

 

 

 

 

 

 

 

 

 

384

 

 

 

1,066

 

 

 

1,000

 

 

 

 

 

 

 

 

 

2,066

 

 

$

4,518

 

 

$

22,289

 

 

$

31,448

 

 

$

66,453

 

 

$

124,708

 

 

$

6,445

 

 

$

31,677

 

 

$

31,084

 

 

$

108,033

 

 

$

177,239

 


 

The above table includes the Company’s operating leases and the amounts committed under those leases by each location: (1) the rental of our global headquarters in the Conventus Center for Collaborative Medicine in Buffalo, NY; (2) the rental of our R&D facility in the IC Development Centre in Hong Kong; (3) the rental of the Commercial Platform headquarters in Chicago, IL; (4) the rental of our clinical research headquarters in Cranford, NJ; (5) the rental of our clinical data management center in Taipei, Taiwan; (6) the rental of eight facilities of our contract research organization throughout Latin America; (7) the rental of our Global Supply Chain distribution office in Houston, TX; (8) the rental of our Global Supply Chain API manufacturing facility in Chongqing, China; and (9) the rental of other facilities and equipment located mainly in Buffalo, NY.

The long-term debt is comprised of (1) the principal and fees related to the first and second tranche of our Senior Credit Agreement with Oaktree; (2) our credit arrangement with Chongqing Maliu Riverside Development and Investment Co., LTD; and (3) our mortgage assumed in connection with the acquisition of CDE.

The finance lease obligations represent the lease of various equipment for our facilities in and near Buffalo, NY.

The license fee obligations are due in connection with our in-licensing arrangements for certain of the Commercial Platform’s specialty products.

Off-Balance Sheet Arrangements

We do not maintain any off-balance sheet partnerships, arrangements, or other relationships with unconsolidated entities or others, often referred to as structured finance or special purpose entities, which are established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.


Critical Accounting Policies and Significant Judgments and Estimates

Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. These estimates form the basis for judgments we make about the carrying values of our assets and liabilities, which are not readily apparent from other sources. We base our estimates and judgments on historical experience and on various other assumptions that we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates and assumptions. Our actual results may differ from these estimates under different assumptions or conditions.

We believe that the assumptions and estimates associated with R&D expenses, chargebacks, stock-based compensation and inventory reserves have the most significant impact on our condensed consolidated financial statements. Therefore, we consider these to be our critical accounting policies and estimates.

There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in Management’s Discussion and Analysis of Financial Condition and Operations included in our Annual Report on Form 10-K for the year ended December 31, 2019.2020.

Recent Accounting Pronouncements

In the normal course of business, we evaluate all new accounting pronouncements issued by the Financial Accounting Standards Board,FASB, the Securities and Exchange Commission (the “SEC”),SEC, or other authoritative accounting bodies to determine the potential impact they may have on our condensed consolidated financial statements. See Note 2 of the Notes to Condensed Consolidated Financial Statements contained in Item 1 of this quarterly report on Form 10-Q for additional information about these recently issued accounting standards and their potential impact on our financial condition or results of operations.

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

Foreign Currency Exchange Risk

A significant portion of our business is located outside the United States and, as a result, we generate revenue and incur expenses denominated in currencies other than the U.S. dollar, a majority of which is denominated in Chinese Renminbi (“RMB”). In the sixthree months ended June 30,March 31, 2021 and 2020, and 2019, approximately 0% and 1%, respectively, of our sales, excluding intercompany sales, were denominated in foreign currencies. As a result, our revenue can be impacted by fluctuations in foreign currency exchange rates. We expect that foreign currencies will represent a lower percentage of our sales in the future due to the anticipated growth of our U.S. business. Our international selling, marketing, and administrative costs related to these sales are largely denominated in the same foreign currencies, which somewhat mitigates our foreign currency exchange risk rate exposure.


Currency Convertibility Risk

A portion of our revenues and expenses, and a portion of our assets and liabilities are denominated in RMB. The People’s Republic of China (“PRC”) government uses a single rate of exchange as quoted daily by the People’s Bank of China, (“PBOC”). The PRC imposes a number of procedural requirements that limit the ability to readily convert RMB into U.S. dollars or other foreign currencies. All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC. Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.

Additionally, the value of the RMB is subject to changes in PRC central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.

Interest Rate Sensitivity

We had cash, cash equivalents, restricted cash, and short-term investments of $127.3$187.7 million as of June 30, 2020.March 31, 2021. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in U.S. market interest rates is not expected to have a material impact on our condensed consolidated financial condition or results of operations. We do not believe that our cash or cash equivalents have significant risk of default or illiquidity.


Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Board Chairman (Principal Executive Officer) and our Chief Financial Officer (Principal Financial and Accounting Officer), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2020.March 31, 2021. The term “disclosure controls and procedures,” as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well-designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2020,March 31, 2021, our Chief Executive Officer and Board Chairman (Principal Executive Officer) and our Chief Financial Officer (Principal Financial and Accounting Officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended June 30, 2020March 31, 2021 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal controls over financial reporting despite the fact that most of our employees are working remotely due to the COVID-19 pandemic. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.


PART II—OTHER INFORMATION

From time to time we may become involvedFollowing our receipt of the CRL in legal proceedings or be subject to claims arisingFebruary 2021 and the subsequent decline of the market price of the Company’s common stock, two purported securities class action lawsuits were filed in the ordinary courseU.S. District Court for the Western District of our business. RegardlessNew York on March 3, 2021 and March 22, 2021, respectively, against the Company and certain members of its management team seeking to recover damages for alleged violations of Sections 10(b) and 20(a) of the outcome, litigationSecurities Exchange Act of 1934.

The complaints generally allege that between August 7, 2019 and February 26, 2021 (the purported class period), the Company and the individual defendants made materially false and misleading statements regarding the Company's business in connection with the Company’s development of Oral Paclitaxel for the treatment of metastatic breast cancer and the likelihood of FDA approval, and that the plaintiffs suffered losses when the Company’s stock price dropped after its announcement on February 26, 2021 regarding receipt of the CRL. The complaints seek class certification, damages, fees, costs, and expenses. The defendants expect that these two lawsuits will be consolidated and a lead plaintiff appointed in the coming months. Additional similar lawsuits might be filed. The Company and the individual defendants believe that the claims in these lawsuits are without merit, and the Company has not recorded a liability related to the lawsuits as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can have an adverse impact on us because of prosecution, defense and settlement costs, unfavorable awards, diversion of management resources and other factors.be no assurances as to the outcome.

Item 1A. Risk Factors.

For a discussion of the Company’s potential risks or uncertainties, please see “Part I—Item 1A—Risk Factors” and “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 20192020 filed with the SEC and “Part I—Item 2—Management’s Discussionthe additional risks described below.

We face litigation and Analysislegal proceedings and, while we cannot predict the outcomes of Financial Conditionsuch proceedings and Resultsother contingencies with certainty, some of Operations” herein.  Other than as described below these outcomes could adversely affect our business and financial condition. 

Following our Quarterly Report on Form 10-Q forreceipt of the quarter ended March 31, 2020, there have been no material changes toCRL in February 2021 and the risk factors disclosed in Part I—Item 1Asubsequent decline of the market price of the Company’s Annual Report on Form 10-Kcommon stock, two purported class action lawsuits were filed in the U.S. District Court for the year ended December 31, 2019.

Risks RelatedWestern District of New York on March 3, 2021 and March 22, 2021, respectively, against the Company and certain members of its management team. Defending against these and any future lawsuits and legal proceedings may involve significant expense, be disruptive to the COVID-19 Pandemic

The COVID-19 pandemic could continue toour business operations and divert our management's attention and resources. Negative publicity surrounding such legal proceedings may also harm our reputation, our stock price, and adversely impact our business and financial condition.

Further, we cannot predict with certainty the outcomes of these legal proceedings. The outcome of some of these legal proceeding could require us to take, or refrain from taking, actions which could negatively affect our operations or could require us to pay substantial amounts of money adversely affecting our financial condition and results of operations.

The resurgence of COVID-19 in India and other countries where we source supplies may create supply chain risk and disruption risks.

The recent surge of COVID-19 cases in India, a country where we source supplies and maintain partnerships that are key to our generics business, including our commercialAPI, presents business and supply chain disruption risks for the Company to the extent the virus is not able to be contained, there is widespread sickness and disruptions on operations clinical development activities and clinical trials.

As a resultalso in the event state governments in India impose additional lockdowns, restrictions on the operations of businesses and other containment measures to combat the spread of the COVID-19 pandemic, we experienced disruptions in production at our Chongqing API production facility in the first quarter of 2020, as well as difficulties in clinical trial recruitment suspensions of early stage trials, which continued through the second quarter of 2020.virus. The futurescope and impact of the COVID-19 pandemic on our businessany such measures is not yet known and operations is largely unknown and the situation is fluid. The extent to which our business and operations may be impacted by the pandemic will depend on a number of factors, including (i) the ultimate spread and severity of the outbreaks in the U.S.India and globally, (ii) the existence of additional waves of outbreak as containment measures are lifted, (iii) the scope, duration and impact of containment measures on individuals and businesses,businesses. If our partners in India experience significant or extended disruptions to their business due to COVID-19, it could result in substantial supply shortages and (iv) the timing to market and relative availability of testing and treatment options for COVID-19. If the pandemic worsens or we experience additional waves of outbreak on a local, national or global scale, we may experience a multitude of additional disruptions that could severely impactharm our generics business, operations, clinical development activities and planned clinical trials, including without limitation, the following:

a spread of COVID-19 among our workforce and/or management team, which would result in our reduced capacity to manage our business to the extent key personnel are impacted or our personnel are impacted in significant numbers;  

continued delays or difficulties in clinical trials, which could include extended periods of time in which early stage trials are suspended,  sustained difficulties enrolling patients in clinical trials and/or disruptions to ongoing trials based on the attrition of patients as a result of contracting or being exposed to COVID-19, facility closures or limitations on the use of hospitals as clinical trial sites and governmental restrictions on “non-essential” procedures and activities, any of which may further delay our clinical development plans and timelines and also may impact the integrity of our clinical trial data for ongoing trials;

temporary or long-term disruptions in our supply chains and resulting delays in the delivery of products, services or other materials necessary for our operations;

interruptions in FDA operations or the operations of comparable foreign regulatory agencies, which may in turn impact our timelines for receiving regulatory approvals and feedback;

complete or partial shutdowns of the construction efforts at our Dunkirk or PRC facilities or additional production slowdowns or stoppages at our Chongqing facility;

disruptions due to the increased cybersecurity vulnerabilities caused by remote work and a distributed workforce, including data breaches and data loss;

interruption or delays in our and our partners ability to meet expected clinical development deadlines or to comply with contractual commitments with respect to the same, including timelines around preclinical studies and planned clinical trials which could in turn delay overall developmental and commercialization timelines; and

limitations on our ability to engage in face-to-face essential business activities as well as marketing and public relations activities due to the health risks posed by such activities, the widespread cancellation of conferences and events targeting the biotech and medical fields, and restrictions on domestic and international travel, including travel bans and government imposed quarantines.


Each of these disruptions as well as others arising from the COVID-19 pandemic could adversely impact our ability to conduct clinical development activities, planned clinical trials and our business generally, and could have a material adverse impact on our operations and financial condition and results.

The economic disruption from the COVID-19 pandemic may result in material adverse consequences for general economic, financial and business conditions, and could result in increased credit and counterparty risks.

Through our normal business activities, we are subject to significant credit and counterparty risks that arise in the ordinary course of business. These risks have been heightened due to the COVID-19 pandemic and resulting economic turbulence, giving rise to substantial macroeconomic uncertainty. In the event of a sustained economic downturn, our customers, lenders, licensing partners, service providers, and other counterparties may be unable to fully fulfil their respective obligations to us in a timely manner, or at all. In addition, governments that we have partnered with and received grants from in connection with the construction of certain production facilities may be unable to timely fulfil their obligations under such agreements due to the impact of COVID-19 on their financial conditions.

In particular, we are a party to various strategic collaboration and license agreements that are important to our business and to our current and future product candidates. Unfavorable macroeconomic conditions caused by COVID-19 may lead our business partners to delay or curtail planned expenditures under our licensing arrangements, which could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects,overall financial condition and results of operations.

As a result of COVID-19, we have experienced difficulties in collecting certain license agreement receivables. For instance, we recently experienced a significant delay in the receipt of an upfront payment from a license partner – see Part 1, Item 2, “Management Discussion and Analysis,” under the heading “Recent business updates and COVID-19 related measures” for further information.  If any of these difficulties persist for one or more of our partnerships, we may need to declare a default and terminate a license arrangement, which could delay or impair our ability to develop and commercialize the product candidates in the territories covered by the license agreement. In addition, we may seek replacement partnerships to develop and commercialize these product candidates in the territories covered by the terminated arrangement, the negotiation and entry into which may impact our development timelines and otherwise be on terms less favorable compared to existing contractual terms. This could in turn have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

In addition, a prolonged downturn in macroeconomic conditions or negative trends in the global credit markets could further negatively impact our ability to collect on receivables, including milestone payments, due to us which may increase our concessions and discount rates as well as the length of time until these receivables are collected. An inability to timely collect may lead to an increase in our borrowing requirements, our accounts receivable and potentially lead to increased write-offs, with possible adverse effects on our business, financial condition, results of operations and cash flows.

Risks Related to Our Financial Position and Need for Additional Capital

Our ability to continue as a going concern will require us to obtain additional financing to fund our current operations, which may be unavailable on acceptable terms, or at all.

Our recurring losses from operations and our current operating plans raise substantial doubt about our ability to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended December 31, 2019 with respect to this uncertainty. Our ability to continue as a going concern will require us to obtain additional financing to fund our current operating plans. For additional information, please see “Note 1 - Company and Nature of Business - Significant Risks and Uncertainties”.

We will need to obtain additional financing to fund our operations, and if we are unable to obtain such financing, we may be unable to complete the development and commercialization of our drug candidates.

To date, we have financed our operations with the proceeds from debt financings, public and private securities offerings, public-private partnerships, the issuance of convertible notes and public grants. Our drug candidates will require the completion of clinical studies and regulatory review, significant sales and marketing efforts and substantial investment before they can provide us with any product sales revenue. Our operations have consumed substantial amounts of cash since inception. The net cash used for our operating activities was $97.5 million, $109.4 million and $81.5 million for the years ended December 31, 2019, 2018 and 2017 respectively. We expect to continue to spend substantial amounts on advancing the clinical and regulatory development of our proprietary drug candidates, launching and commercializing any proprietary drug candidates for which we receive regulatory approval, including building our own commercial infrastructure to address certain markets.


On June 19, 2020, we entered into a 6-year $225.0 million loan agreement with Oaktree Fund Administration, LLC as administrative agent, and the lenders party thereto (the “Senior Credit Agreement”), bearing interest at a fixed annual rate of 11%. We expect to use borrowings under our Senior Credit Agreement, proceeds from out-licensing arrangements and potential future financing transactions, if necessary, to fund expenditures that are in excess of our operating cash flow and cash on hand, including completing the development and commercialization of our proprietary drug candidates and to conduct additional clinical trials for the approval of our proprietary drug candidates if requested by regulatory bodies and to complete the development of any additional proprietary drug candidates we might discover. Moreover, our research and development expenses and other contractual commitments are substantial and are expected to increase in the future. In addition, we will require additional financial resources and personnel to begin operations at our public-private partnership facilities in Chongqing, China and Dunkirk, New York. To the extent the costs of constructing the Dunkirk facility exceed approximately $206 million, we will also be responsible for those costs.

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including, but not limited to:

the progress, timing, scope and costs of our clinical trials, including the ability to timely enroll patients in our planned and potential future clinical trials;

the outcome, timing and cost of regulatory approvals by the FDA, NMPA and regulatory authorities in jurisdictions where we seek such approvals, including the possibility that the FDA, NMPA or regulatory authorities may require that we perform more studies than those that we currently expect;

our ability to secure adequate coverage and reimbursement for our proprietary drug candidates from government (including U.S. federal health care programs) and private payors;

the number and characteristics of drug candidates that we may in-license and develop;

our ability to successfully and compliantly launch and commercialize our drug candidates;

the amount of sales and other revenues from drug candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate reimbursement by third-party payors;

the amount of rebates or other price concessions we may owe under U.S. federal health care programs that cover and reimburse our proprietary drug candidates;

the amount and timing of the milestone and royalty payments we receive from our collaborators under our licensing arrangements;

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

selling and marketing costs associated with our potential products, including the cost and timing of expanding our marketing and sales capabilities;

the terms and timing of any potential future collaborations, licensing or other arrangements that we may establish;

cash requirements of any future acquisitions and/or the development of other drug candidates;

the costs of operating as a public company;

the cost and timing of completion of commercial-scale outsourced manufacturing activities; and

the time and cost necessary to respond to technological and market developments.

We have also incurred debt service obligations under our Senior Credit Agreement and have minimum payment obligations under our Revenue Interest Financing Agreement, which could make it more difficult for us to fund our operations.  Under the Senior Credit Agreement, we are required to make quarterly interest-only payments until June 19, 2022, after which we are required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Beginning on September 17, 2020, we will also be required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date or the commitment termination date. Under the Revenue Interest Financing Agreement, to the extent we do not generate revenues from Oral Paclitaxel sufficient to satisfy minimum payment obligations of $20.0 million by September 30, 2024 and $50.0 million by August 4, 2026, we will in each instance be required to pay Sagard the amount of the shortfall. In addition, if Sagard has not received payments equaling at least $85.0 million by the tenth anniversary of the date the Product Payment is funded, then subject to the Hard Cap, we will be required to pay Sagard an amount such that Sagard will have obtained a 6.0% internal rate of return on the Product Payment (taking into account all other payments received by Sagard from us under the Revenue Interest Financing Agreement). For additional information, please see “Liquidity and Capital Resources —Recent Debt Financings”.


Until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, debt financings, collaborations and strategic alliances. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. General market conditions or the market price of our common stock may not support capital raising transactions such as an additional public or private offering of our common stock or other securities. In addition, our ability to raise additional capital may be dependent upon our common stock being quoted on The Nasdaq Global Select Market or upon obtaining stockholder approval to issue a sufficient number of shares of our common stock. There can be no assurance that we will be able to satisfy the criteria for continued listing on The Nasdaq Global Select Market or that we will be able to obtain stockholder approval of such stock issuances if it is necessary. If adequate funds are not available to us on acceptable terms, or at all, we may be required to delay or reduce the scope of, or eliminate, one or more of our research or development programs or our commercialization efforts. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. In addition, if we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or drug candidates or to grant licenses on terms that may not be favorable to us.

We believe that our existing cash and cash equivalents and short-term investments will not be sufficient to enable us to complete all necessary development or commercially launch our proprietary drug candidates. If we are unable to raise capital when needed or on attractive terms, we will be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. Our inability to obtain additional funding when needed could seriously harm our business.

Covenants in the agreements governing our existing debt agreement restrict the manner in which we conduct our business.

The Senior Credit Agreement contains various covenants that limit, subject to certain exemptions, our ability and/or our certain of our subsidiaries’ ability to, among other things, incur additional indebtedness or liens; make investments; consummate business combinations such as mergers and dispositions; prepay other indebtedness; and to declare dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. In addition, the Senior Credit Agreement contains certain financial covenants, including, among other things, maintenance of minimum liquidity and a minimum revenue test, measured quarterly until the last day of the second consecutive fiscal quarter where the consolidated leverage ratio does not exceed 4.5 to 1, provided that thereafter we cannot allow our consolidated leverage ratio to exceed 4.5 to 1, measured quarterly.

The Senior Credit Agreement requires that we maintain (i) a debt service reserve account with a minimum cash balance equal to the amount required to pay interest on the outstanding loan for a period of the next twelve months and (ii) a minimum liquidity amount in cash or permitted cash equivalent investments of $20.0 million until the date on which the aggregate principal amount of loans outstanding is greater than or equal to $150.0 million (the “First Step-Up Date”), $25.0 million from the First Step-Up Date until the date on which the aggregate principal amount of loans outstanding balance is equal to $225.0 million (the “Second Step-Up Date”), and $30.0 million from the Second Step-up Date until the maturity date. Our obligations under the Senior Credit Agreement are guaranteed by certain of our existing domestic subsidiaries and subsequently acquired or organized subsidiaries subject to certain exceptions. Our obligations under the Senior Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of our direct subsidiaries, and (ii) a perfected security interest in all of our tangible and intangible assets.

The restrictions contained in our Senior Credit Agreement governing our debt could adversely affect our ability to:

finance our operations;

make needed capital expenditures;

make strategic acquisitions or investments or enter into alliances;

withstand a future downturn in our business or the economy in general;

engage in business activities, including future opportunities, that may be in our interest; and

plan for or react to market conditions or otherwise execute our business strategies.

A breach of any of these covenants, subject to certain cure rights of the Company, could result in a default under the Senior Credit Agreement governing our debt. Further, additional indebtedness that we incur in the future may subject us to further covenants. If a default under any such loan agreement is not cured or waived, the default could result in the acceleration of debt, which could require us to repay debt prior to the date it is otherwise due and that could adversely affect our financial condition. If we default, the lenders under the Senior Credit Agreement may seek repayment through our subsidiary guarantors or by executing on the security interest granted pursuant to the Senior Credit Agreement and related security agreements.


Our ability to comply with the covenants, restrictions and specified financial ratios contained in our senior secured loan agreement may be affected by events beyond our control, including prevailing economic, financial, and industry conditions. Even if we are able to comply with all of the applicable covenants, the restrictions on our ability to manage our business in our sole discretion could adversely affect our business by, among other things, limiting our ability to take advantage of financings, mergers, acquisitions, and other corporate opportunities that we believe would be beneficial to us. In addition, our obligations under the loan agreement are secured, on a first-priority basis, and such security interests could be enforced in the event of default by the collateral agent for the loan agreement.

Our access to additional capital under the Oaktree facility and our out-licensing agreements is dependent on the achievement of certain milestones, which we may not achieve.

As of June 30, 2020, we had $100.0 million of indebtedness outstanding, $54.1 million of which was used to repay amounts outstanding under our previous facility with Perceptive and an additional $11.0 million of the upfront loan proceeds held by us as restricted cash in a debt service reserve account, and $6.4 million in fees and expenses incurred in connection with the financing, leaving $28.5 million in available proceeds from the first tranche after payment of fees and expenses incurred in connection with our entry into the Senior Credit Agreement. Under our Senior Credit Agreement and our out-licensing arrangements, our ability to access additional capital is dependent on our ability to achieve various regulatory and commercial milestones, which we may never achieve. Our Senior Credit Agreement provides that we must meet funding conditions to draw down the remaining $125 million of commitments under the Oaktree facility. For additional information, please see “Liquidity and Capital Resources —Recent Debt Financings —Oaktree Facility.”

In the event we are unable to meet the above funding conditions and/or achieve the various commercial and regulatory milestones in our out-licensing agreements, we will need to raise additional capital and can provide no assurances that we will be able to do so when needed or on acceptable terms. In the event we are unable to access additional capital we would be forced to delay, reduce or eliminate our research and drug development programs or commercialization efforts. In addition, the failure to meet these conditions and milestones would have broader implications on the value and prospects of our Company and could impair our ability to raise such additional necessary capital, grow our business, retain key employees and continue our operations.

Heightened tensions between the U.S. and China over Hong Kong and resulting retaliatory policies may materially and adversely affect our business, financial condition and results of operations and may result in our inability to sustain our growth and expansion strategies.

We have operations in Hong Kong and expect that a portion of our future revenue will be sourced from licensing partnerships and API sales in China. Accordingly, our operations, financial condition and results of operations are affected by economic, political and legal developments between the U.S. and China. The recent tensions between the U.S. and China over China’s June 30, 2020 enactment of a new national security law in Hong Kong has resulted in heightened diplomatic tensions and a number of escalating retaliatory measures by the U.S. and China, culminating in an executive order signed by President Trump on July 14, 2020, which ended the special economic status that was afforded to Hong Kong under the United States-Hong Kong Policy Act of 1992.

The increasing tensions between the U.S. and China create uncertainties for doing business in China, including the risk of additional protectionist trade policies and tariffs being imposed that could increase the cost of doing business, restrictions being placed on the sharing of intellectual property between the countries or measures enacted that further impede our ability to repatriate capital from our subsidiaries in China. The uncertainties caused by heightened tension, together with the risk of escalating retaliatory policies could increase our cost of doing business, adversely affect our business, financial condition and results of operations and may result in our inability to sustain our operations, and growth and expansion strategies with respect to China.  


Risks Related to Our Common Stock

Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of our common stock for return on your investment, if any.

We intend to retain most, if not all, of our available funds and earnings to fund the development and growth of our business. In addition, our Senior Credit Agreement with Oaktree restricts our and our restricted subsidiaries’ ability to pay dividends. As a result, we do not expect to pay any cash dividends in the foreseeable future. Therefore, you should not rely on an investment in our common stock as a source for any future dividend income.

Our board of directors has significant discretion as to whether to distribute dividends, subject to the restrictions contained in the Oaktree facility. Even if our board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on, among other things, restrictions on the form and amount of such dividends in our debt agreements, our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual restrictions and other factors deemed relevant by our board of directors. Accordingly, the return on an investment in our common stock will likely depend entirely upon any future price appreciation of our common stock. There is no guarantee that our common stock will appreciate in value or even maintain its current market price. You may not realize a return on your investment in our common stock and you may even lose your entire investment in our common stock.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

During the six months ended June 30, 2020, CIDAL achieved two of its six clinical milestones associated with the contingent equity consideration from our acquisition of CIDAL. As a result, the Company issued 22,598 shares of its common stock to CIDAL on June 30, 2020.  In issuing the shares to CIDAL, the Company relied on an exemption from registration under the Securities Act, as set forth in Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.     Not applicable

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable


Item 5. Other Information.

None.


Item 6. Exhibits.

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth below.

 

 

 

 

 

 

Incorporated by Reference

(Unless Otherwise Indicated)

Exhibit Number

 

Exhibit Title

 

Form

 

File

 

Exhibit

 

Filing Date

 

 

 

 

 

 

 

 

 

 

 

4.1

 

Form of Warrant to Purchase Common Stock

 

Form 8-K

 

001-38112

 

4.1

 

June 22, 2020

 

 

 

 

 

 

 

 

 

 

 

10.1

 

Credit Agreement and Guaranty dated as of June 19, 2020, by and among Athenex, Inc., the subsidiary guarantors from time to time party thereto, the lenders from time to time party thereto, and Oaktree Fund Administration, LLC, as administrative agent.

 

Form 8-K

 

001-38112

 

10.1

 

June 22, 2020

 

 

 

 

 

 

 

 

 

 

 

10.2

 

Security Agreement dated as of June 19, 2020, by and among Athenex, Inc., the subsidiary guarantors from time to time party thereto, the lenders from time to time party thereto, and Oaktree Fund Administration, LLC, as administrative agent.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

10.3

 

Registration Rights Agreement by and among Athenex, Inc. and the purchasers named therein, dated as of June 19, 2020.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

10.4

 

Amended and Restated 2017 Omnibus Incentive Plan

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

10.5

 

Second Supplemental Agreement to License Agreement dated December 12, 2019 by and among Athenex, Inc. and Chongqing Taihao Pharmaceutical Co. Ltd. and Guangzhou Xiangxue Pharmaceutical Co., Ltd., dated June 30, 2020.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

31.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

31.2

 

Certification of the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

32.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) and the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

Filed herewith

 

 

 

 

 

Incorporated by Reference

(Unless Otherwise Indicated)

Exhibit Number

 

Exhibit Title

 

Form

 

File

 

Exhibit

 

Filing Date

 

 

 

 

 

 

 

 

 

 

 

 10.1

 

Manufacture and Supply Agreement dated as of January 15, 2021 by and between Athenex Pharmaceutical Division, LLC and Ingenus Pharmaceuticals, LLC.

 

Form 10-K

 

001-38112

 

10.52

 

March 1, 2021

 

 

 

 

 

 

 

 

 

 

 

 10.2

 

Second Amendment to License Agreement dated as of February 15, 2021 by and between Athenex, Inc. and PharmaEssentia Corp.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

 10.3

 

Agreement and Plan of Merger, by and among Athenex, Inc., Athenex Pharmaceuticals LLC, Kuur Therapeutics, Inc., the holders of the shares of Series C Preferred Stock or Series C-1 Preferred Stock (the “Merger Stockholders”), Kevin S. Boyle, Sr., Kurt C. Gunter and Melinda K. Lackey (the “Key Employees”), the members of the Company Board (as defined therein) (the “Independent Company Directors”) and Shareholder Representative Services LLC, solely as representative, agent and attorney-in-fact of the Merger Stockholders, Key Employees and Individual Company Directors, dated May 4, 2021.

 

Form 8-K

 

001-38112

 

10.1

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

 10.4

 

Lock-Up Agreement between Athenex, Inc. and Touchstone Innovations Businesses LLP (IP Group), dated May 4, 2021.

 

Form 8-K

 

001-38112

 

10.2

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

 10.5

 

Lock-Up Agreement between Athenex, Inc. and each of the parties named therein, dated as of May 4, 2021.

 

Form 8-K

 

001-38112

 

10.3

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

 31.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

 31.2

 

Certification of the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

 32.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) and the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

Filed herewith


 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Athenex, Inc.

 

 

Date: AugustMay 6, 20202021

By:

 

/s/ Johnson Y.N. Lau

 

 

 

Chief Executive Officer and Board Chairman

(Principal Executive Officer)

 

 

 

 

Date: AugustMay 6, 20202021

By:

 

/s/ Randoll Sze

 

 

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

4940