UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

FORM 10-Q

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

For the quarterly period ended June 30, 2020

March 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: 1-36282

LA JOLLA PHARMACEUTICAL COMPANY

(Exact name of registrant as specified in its charter)

California

33-0361285

California33-0361285

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

4550 Towne Centre Court,

201 Jones Road,

Suite 400, Waltham, MA

San Diego,

CA92121

02451

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (858207-4264

(617) 715-3600

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

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

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

LJPC

The

NasdaqCapital 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. YesNo

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). YesNo

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer


Accelerated filer


Non-accelerated filer


Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No


As of July 27, 2020,April 3, 2021, there were 27,362,10027,448,571 shares of common stock outstanding.







TABLE OF CONTENTS


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PART I. FINANCIAL INFORMATION


Item 1. Financial Statements


LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Balance Sheets

(in thousands, except par value and share amounts)

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

38,634

 

 

$

21,221

 

Accounts receivable, net

 

 

4,153

 

 

 

5,834

 

Inventory, net

 

 

5,374

 

 

 

6,013

 

Prepaid expenses and other current assets

 

 

6,104

 

 

 

3,388

 

Total current assets

 

 

54,265

 

 

 

36,456

 

Goodwill

 

 

20,123

 

 

 

20,123

 

Intangible assets, net

 

 

14,485

 

 

 

14,873

 

Right-of-use lease assets

 

 

490

 

 

 

536

 

Property and equipment, net

 

 

186

 

 

 

215

 

Restricted cash

 

 

40

 

 

 

40

 

Total assets

 

$

89,589

 

 

$

72,243

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,098

 

 

$

2,762

 

Accrued expenses

 

 

8,721

 

 

 

6,494

 

Accrued payroll and related expenses

 

 

1,693

 

 

 

2,878

 

Lease liabilities, current portion

 

 

196

 

 

 

204

 

Total current liabilities

 

 

11,708

 

 

 

12,338

 

Deferred royalty obligation, net

 

 

124,453

 

 

 

124,437

 

Accrued interest expense on deferred royalty obligation, less current portion

 

 

20,884

 

 

 

19,111

 

Lease liabilities, less current portion

 

 

294

 

 

 

332

 

Other noncurrent liabilities

 

 

4,568

 

 

 

4,112

 

Total liabilities

 

 

161,907

 

 

 

160,330

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Shareholders’ deficit:

 

 

 

 

 

 

 

 

Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,448,571 and 27,402,648 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

 

 

3

 

 

 

3

 

Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at March 31, 2021 and December 31, 2020; and liquidation preference of $3,906 at March 31, 2021 and December 31, 2020

 

 

3,906

 

 

 

3,906

 

Additional paid-in capital

 

 

986,107

 

 

 

984,756

 

Accumulated deficit

 

 

(1,062,334

)

 

 

(1,076,752

)

Total shareholders’ deficit

 

 

(72,318

)

 

 

(88,087

)

Total liabilities and shareholders’ deficit

 

$

89,589

 

 

$

72,243

 

 June 30,
2020
 December 31,
2019
 (Unaudited)  
ASSETS   
Current assets:   
Cash$68,353
 $87,820
Short-term investments3,062
 
Accounts receivable, net1,843
 2,960
Inventory, net3,120
 2,211
Prepaid expenses and other current assets2,792
 4,467
Total current assets79,170
 97,458
Property and equipment, net12,827
 18,389
Right-of-use lease asset14,792
 15,491
Restricted cash606
 909
Total assets$107,395
 $132,247
    
LIABILITIES AND SHAREHOLDERS’ DEFICIT   
Current liabilities:   
Accounts payable$2,481
 $4,177
Accrued expenses6,772
 9,312
Accrued payroll and related expenses5,741
 8,332
Lease liability, current portion2,890
 2,766
Total current liabilities17,884
 24,587
Lease liability, less current portion25,000
 26,481
Deferred royalty obligation, net124,406
 124,379
Other noncurrent liabilities15,317
 12,790
Total liabilities182,607
 188,237
Commitments and contingencies (Note 6)   
Shareholders’ deficit:   
Common Stock, $0.0001 par value; 100,000,000 shares authorized,
27,358,611 and 27,195,469 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively
3
 3
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2020 and December 31, 2019; and liquidation preference of $3,906 at June 30, 2020 and December 31, 2019
3,906
 3,906
Additional paid-in capital982,393
 977,432
Accumulated deficit(1,061,514) (1,037,331)
Total shareholders’ deficit(75,212) (55,990)
Total liabilities and shareholders’ deficit$107,395
 $132,247

See accompanying notes to the condensed consolidated financial statements.





LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share amounts)

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

Revenue

 

 

 

 

 

 

 

 

Net product sales

 

$

8,637

 

 

$

7,591

 

License revenue

 

 

25,500

 

 

 

-

 

Total revenue

 

 

34,137

 

 

 

7,591

 

Operating expenses

 

 

 

 

 

 

 

 

Cost of product sales

 

 

2,731

 

 

 

716

 

Cost of license revenue

 

 

3,600

 

 

 

-

 

Selling, general and administrative

 

 

8,755

 

 

 

8,152

 

Research and development

 

 

1,558

 

 

 

9,183

 

Total operating expenses

 

 

16,644

 

 

 

18,051

 

Income (loss) from operations

 

 

17,493

 

 

 

(10,460

)

Other (expense) income

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,609

)

 

 

(2,406

)

Interest income

 

 

2

 

 

 

190

 

Other income—related party

 

 

-

 

 

 

4,085

 

Other expense

 

 

(450

)

 

 

-

 

Total other (expense) income, net

 

 

(3,057

)

 

 

1,869

 

Income (loss) before income taxes

 

 

14,436

 

 

 

(8,591

)

Provision for income taxes

 

 

18

 

 

 

-

 

Net income (loss)

 

$

14,418

 

 

$

(8,591

)

Earnings (loss) per share

 

 

 

 

 

 

 

 

Basic

 

$

0.53

 

 

$

(0.32

)

Diluted

 

$

0.42

 

 

$

(0.32

)

Shares used in computing earnings (loss) per share

 

 

 

 

 

 

 

 

Basic

 

 

27,427

 

 

 

27,238

 

Diluted

 

 

34,183

 

 

 

27,238

 


 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 2020 2019
Revenue       
Net product sales$5,805
 $5,703
 $13,396
 $10,098
Total revenue5,805
 5,703
 13,396
 10,098
Operating expenses       
Cost of product sales808
 551
 1,524
 1,051
Research and development8,781
 22,043
 17,964
 43,287
Selling, general and administrative8,677
 11,323
 16,829
 23,643
Total operating expenses18,266
 33,917
 36,317
 67,981
Loss from operations(12,461) (28,214) (22,921) (57,883)
Other income (expense)       
Interest expense(2,470) (2,806) (4,876) (5,535)
Interest income32
 604
 222
 1,317
Other income—related party
 
 4,085
 
Other expense(693) 
 (693) 
Total other income (expense), net(3,131) (2,202) (1,262) (4,218)
Net loss$(15,592) $(30,416) $(24,183) $(62,101)
Net loss per share, basic and diluted$(0.57) $(1.12) $(0.89) $(2.29)
Weighted-average common shares outstanding, basic and diluted27,326
 27,108
 27,282
 27,071

See accompanying notes to the condensed consolidated financial statements.




LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Shareholders (Deficit) Equity

Deficit

(Unaudited)

(in thousands)

 

 

Series C-12

Convertible

Preferred Stock

 

 

Common

Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Total

Shareholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2020

 

 

4

 

 

$

3,906

 

 

 

27,403

 

 

$

3

 

 

$

984,756

 

 

$

(1,076,752

)

 

$

(88,087

)

Share-based compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,116

 

 

 

-

 

 

 

1,116

 

Issuance of common stock under 2013 Equity Plan

 

 

-

 

 

 

-

 

 

 

29

 

 

 

-

 

 

 

154

 

 

 

-

 

 

 

154

 

Issuance of common stock under ESPP

 

 

-

 

 

 

-

 

 

 

17

 

 

 

-

 

 

 

81

 

 

 

-

 

 

 

81

 

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

14,418

 

 

 

14,418

 

Balance at March 31, 2021

 

 

4

 

 

$

3,906

 

 

 

27,449

 

 

$

3

 

 

$

986,107

 

 

$

(1,062,334

)

 

$

(72,318

)

 

 

Series C-12

Convertible

Preferred Stock

 

 

Common

Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Total

Shareholders'

(Deficit)

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2019

 

 

4

 

 

$

3,906

 

 

 

27,195

 

 

$

3

 

 

$

977,432

 

 

$

(1,037,331

)

 

$

(55,990

)

Share-based compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,407

 

 

 

-

 

 

 

2,407

 

Issuance of common stock under 2013 Equity Plan

 

 

-

 

 

 

-

 

 

 

44

 

 

 

-

 

 

 

305

 

 

 

-

 

 

 

305

 

Issuance of common stock under ESPP

 

 

-

 

 

 

-

 

 

 

38

 

 

 

-

 

 

 

200

 

 

 

-

 

 

 

200

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,591

)

 

 

(8,591

)

Balance at March 31, 2020

 

 

4

 

 

$

3,906

 

 

 

27,277

 

 

$

3

 

 

$

980,344

 

 

$

(1,045,922

)

 

$

(61,669

)

  
Series C-12
Convertible
Preferred Stock
 
Series F
Convertible
Preferred Stock
 
Common
Stock
 
Additional
Paid-in
Capital
 
Accumulated
Deficit
 
Total
Shareholders’
(Deficit)
Equity
  Shares Amount Shares Amount Shares Amount   
Balance at December 31, 2019 4
 $3,906
 
 $
 27,195
 $3
 $977,432
 $(1,037,331) $(55,990)
Share-based compensation expense 
 
 
 
 
 
 2,407
 
 2,407
Issuance of common stock under 2013 Equity Plan 
 
 
 
 44
 
 305
 
 305
Issuance of common stock under ESPP 
 
 
 
 38
 
 200
 
 200
Net loss 
 
 
 
 
 
 
 (8,591) (8,591)
Balance at March 31, 2020 4
 3,906
 
 
 27,277
 3
 980,344
 (1,045,922) (61,669)
Share-based compensation expense 
 
 
 
 
 
 1,590
 
 1,590
Issuance of common stock under 2013 Equity Plan 
 
 
 
 50
 
 300
 
 300
Issuance of common stock under ESPP 
 
 
 
 32
 
 159
 
 159
Net loss 
 
 
 
 
 
 
 (15,592) (15,592)
Balance at June 30, 2020 4
 $3,906



$

27,359

$3

$982,393

$(1,061,514)
$(75,212)

  
Series C-12
Convertible
Preferred Stock
 
Series F
Convertible
Preferred Stock
 
Common
Stock
 
Additional
Paid-in
Capital
 
Accumulated
Deficit
 
Total
Shareholders’
(Deficit)
Equity
  Shares Amount Shares Amount Shares Amount   
Balance at December 31, 2018 4
 $3,906
 3
 $2,737
 26,259
 $3
 $950,258
 $(920,983) $35,921
Share-based compensation expense 
 
 
 
 
 
 6,782
 
 6,782
Issuance of common stock under ESPP 
 
 
 
 52
 
 283
 
 283
Issuance of common stock for conversion of Series F Preferred Stock 
 
 (3) (2,737) 782
 
 2,737
 
 
Cumulative-effect adjustment from adoption of ASU 2018-07 
 
 
 
 
 
 (160) 160
 
Net loss 













(31,685)
(31,685)
Balance at March 31, 2019 4
 3,906
 
 
 27,093
 3
 959,900
 (952,508) 11,301
Share-based compensation expense 
 
 
 
 
 
 6,321
 
 6,321
Issuance of common stock under ESPP 
 
 
 
 32
 
 201
 
 201
Net loss 













(30,416)
(30,416)
Balance at June 30, 2019 4
 $3,906
 
 $
 27,125
 $3
 $966,422
 $(982,924) $(12,593)



See accompanying notes to the condensed consolidated financial statements.




LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

Operating activities

 

 

 

 

 

 

 

 

Net income (loss)

 

$

14,418

 

 

$

(8,591

)

Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

1,116

 

 

 

2,407

 

Depreciation expense

 

 

29

 

 

 

1,060

 

Non-cash interest expense

 

 

1,736

 

 

 

1,682

 

Inventory fair value step-up adjustment included in cost of product sales

 

 

850

 

 

 

-

 

Amortization of intangible assets

 

 

388

 

 

 

-

 

Loss on change in fair value of contingent value rights

 

 

450

 

 

 

-

 

Amortization of right-of-use lease assets

 

 

46

 

 

 

345

 

Loss on disposal of property and equipment

 

 

-

 

 

 

148

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

1,681

 

 

 

(592

)

Inventory, net

 

 

(211

)

 

 

251

 

Prepaid expenses and other current assets

 

 

(2,716

)

 

 

1,084

 

Accounts payable

 

 

(1,664

)

 

 

(2,282

)

Accrued expenses

 

 

2,286

 

 

 

(2,404

)

Accrued payroll and related expenses

 

 

(1,185

)

 

 

(4,683

)

Lease liabilities

 

 

(46

)

 

 

(674

)

Net cash provided by (used for) operating activities

 

 

17,178

 

 

 

(12,249

)

Investing activities

 

 

 

 

 

 

 

 

Proceeds from the sale of property and equipment

 

 

-

 

 

 

1,143

 

Net cash provided by investing activities

 

 

-

 

 

 

1,143

 

Financing activities

 

 

 

 

 

 

 

 

Net proceeds from issuance of common stock under 2013 Equity Plan

 

 

154

 

 

 

305

 

Net proceeds from issuance of common stock under ESPP

 

 

81

 

 

 

200

 

Net cash provided by financing activities

 

 

235

 

 

 

505

 

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

 

 

17,413

 

 

 

(10,601

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

21,261

 

 

 

88,729

 

Cash, cash equivalents and restricted cash, end of period

 

$

38,674

 

 

$

78,128

 

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

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

38,634

 

 

$

77,219

 

Restricted cash

 

 

40

 

 

 

909

 

Total cash, cash equivalents and restricted cash

 

$

38,674

 

 

$

78,128

 

 Six Months Ended June 30,
 2020 2019
Operating activities   
Net loss$(24,183) $(62,101)
Adjustments to reconcile net loss to net cash used for operating activities:   
Share-based compensation expense3,997
 13,103
Depreciation and amortization expense1,798
 2,263
Loss on disposal of equipment904
 15
Unrealized gains on short-term investments(63) 
Non-cash interest expense3,392
 4,678
Non-cash rent expense699
 639
Changes in operating assets and liabilities:   
Accounts receivable, net1,117
 (512)
Inventory, net(909) 52
Prepaid expenses and other current assets1,675
 22
Accounts payable(1,696) (3,664)
Accrued expenses(3,378) 974
Accrued payroll and related expenses(2,591) (3,429)
Lease liability(1,357) (1,241)
Net cash used for operating activities(20,595) (49,201)
Investing activities   
Proceeds from the sale of property and equipment2,860
 
Purchases of property and equipment
 (441)
Purchases of short-term investments(2,999) 
Net cash used for investing activities(139) (441)
Financing activities   
Net proceeds from issuance of common stock under 2013 Equity Plan605
 
Net proceeds from issuance of common stock under ESPP359
 484
Net cash provided by financing activities964
 484
Net decrease in cash and restricted cash(19,770) (49,158)
Cash and restricted cash at beginning of period88,729
 173,513
Cash and restricted cash at end of period$68,959
 $124,355
Supplemental disclosure of non-cash investing and financing activities:   
Conversion of Series F Convertible Preferred Stock into common stock$
 $2,737
Cumulative-effect adjustment from adoption of ASU 2018-07$
 $(160)
Initial recognition of right-of-use lease asset$
 $16,798
Reconciliation of cash and restricted cash to the condensed consolidated balance sheets
Cash$68,353
 $123,446
Restricted cash606
 909
Total cash and restricted cash$68,959
 $124,355

See accompanying notes to the condensed consolidated financial statements.





LA JOLLA PHARMACEUTICAL COMPANY


Notes to the Condensed Consolidated Financial Statements

(Unaudited)

1.  Business


La Jolla Pharmaceutical Company (collectively with its wholly owned subsidiaries, “La Jolla” or the “Company”) is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZATM (angiotensin II) for injection is approved by the U.S. Food and Drug Administration (“FDA”) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock.


XERAVA (eravacycline) for injection is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (“cIAI”) in patients 18 years of age and older.

On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc. and its subsidiaries (“Tetraphase”), a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVA,TM (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. The Company’s consolidated financial results exclude Tetraphase’s financial results prior to the acquisition closing date of July 28, 2020 (see Note 11).

In January 2021, La Jolla and certain of its wholly owned subsidiaries, including La Jolla Pharma, LLC, entered into a license agreement with PAION AG to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland. Pursuant to the agreement: (i) the Company has received an upfront cash payment of $22.5 million, less a 15% refundable withholding tax; and (ii) the Company is entitled to receive potential commercial milestone payments of up to $109.5 million and royalties on net sales of GIAPREZA and XERAVA.

In March 2021, under its license agreement with Everest Medicines Limited (“Everest”), the Company received a $3.0 million milestone payment associated with the submission of a New Drug Application (“NDA”) with the China National Medical Products Administration (“NMPA”) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the FDAXERAVA for the treatment of complicated intra-abdominal infections (“cIAI”)cIAI in patients 18 yearsin China. The Company previously granted Everest an exclusive license to develop and commercialize XERAVA for the treatment of agecIAI and older. See Note 12.


other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines. The Company is eligible to receive an additional $8.0 million regulatory milestone payment and up to an aggregate of $20.0 million in sales milestone payments. The Company is also entitled to receive royalties from Everest on sales, if any, by Everest of products containing eravacycline.

As of June 30, 2020March 31, 2021 and December 31, 2019,2020, the Company had cash and short-term investmentscash equivalents of $71.4$38.6 million and $87.8$21.2 million, respectively. Based on the Company’s current operating plans and projections, the Company expects that its existing cash and short-term investmentscash equivalents will be sufficient to fund operations for at least one year from the date this Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (the “SEC”).


2.  Basis of Presentation and Summary of Significant Accounting Policies


Basis of Presentation and Use of Estimates


The accompanyingCompany’s condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 108 of SEC Regulation S-X. Accordingly, certain information and disclosures required by GAAP for annual financial statements have been omitted. In the opinion of management, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 20192020 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019,2020, filed with the SEC on March 2, 20208, 2021 (the “Form 10-K”). The accompanying condensed consolidated financial statements include the accounts of La Jolla Pharmaceutical Company and its wholly owned subsidiaries. All inter-company transactions and balances have been eliminated in consolidation.


The preparation of the Company’s condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and the accompanying notes. Actual results may differ materially from these estimates. Certain amounts previously


reported in the financial statements have been reclassified to conform to the current year presentation. Such reclassifications did not affect net loss, shareholders’ (deficit) equitydeficit or cash flows. The results of operations for the three and six months ended June 30, 2020March 31, 2021 are not necessarily indicative of the results to be expected for the full year or any future interim periods. The accompanying condensed consolidated balance sheet as of December 31, 20192020 has been derived from the audited consolidated balance sheet as of December 31, 20192020 contained in the Form 10-K.


Summary of Significant Accounting Policies


During the sixthree months ended June 30, 2020,March 31, 2021, other than the short-term investmentslicense revenue recognition policy described below, there have been no changes to the Company’s significant accounting policies as described in Note 2 of the Form 10-K.


Short-term investments



Short-term investments are comprised of marketable equity securities that are “available-for-sale,” as such term is defined by the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 320. Marketable equity securities are classified as current assets. Short-term investments are measured at fair value, and unrealized gains and losses are recorded in other income (expense), net in the consolidated statements of operations.

Concentration of Credit Risk


Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and accounts receivable.cash. The Company maintains its cash in checking and savings accounts at federally insured financial institutions in excess of federally insured limits.


During the sixthree months ended June 30, 2020, 409March 31, 2021, 291 hospitals in the U.S. purchased GIAPREZA. During the three months ended March 31, 2021, 390 hospitals and other healthcare organizations in the U.S. purchased XERAVA. Hospitals and other healthcare organizations purchase our products through a network of specialty and wholesale distributors. These specialty and wholesale distributors (“Customers”).are considered our customers for accounting purposes. The Company does not believe that the loss of one of these distributors would significantly impact the ability to distribute GIAPREZA,our products, as the Company expects that sales volume would be absorbed by the remaining distributors. The following table includes the percentage of U.S. net product sales and accounts receivable balances for the Company’s three3 major Customers,customers, each of which comprised 10% or more of its U.S. net product sales:

 

 

U.S. Net Product

Sales

 

 

 

Accounts

Receivable

 

 

 

Three Months Ended

March 31, 2021

 

 

 

As of March 31, 2021

 

Customer A

 

 

38

%

 

 

 

30

%

Customer B

 

 

33

%

 

 

 

39

%

Customer C

 

 

25

%

 

 

 

29

%

Total

 

 

96

%

 

 

 

98

%

Business Combinations

The Company accounts for business combinations using the acquisition method pursuant to the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 805. This method requires, among other things, that results of operations of acquired companies are included in La Jolla's financial results beginning on the respective acquisition dates, and that assets acquired and liabilities assumed are recognized at fair value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of capital and terminal values from the perspective of a market participant. Any excess of the fair value of consideration transferred (the “Purchase Price”) over the fair values of the net assets acquired is recognized as goodwill. Contingent consideration liabilities are recognized as part of the Purchase Price at the estimated fair value on the acquisition date. Subsequent changes to the fair value of contingent consideration liabilities will be included in other (expense) income, net in the consolidated statements of operations. The fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred.

Intangible Assets

Intangible assets acquired in a business combination are initially recorded at fair value. Intangible assets with a definite useful life are amortized on a straight-line basis over the estimated useful life of the related assets. Intangible assets with an indefinite useful life are not amortized.

 U.S. Net Product Sales Accounts Receivable
 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 As of June 30, 2020
Customer A38% 38% 22%
Customer B33% 31% 41%
Customer C25% 29% 33%
Total96% 98% 96%



Revenue Recognition

The Company reviews its intangible assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Fair value is estimated through discounted cash flow models to project cash flows from the asset.

The Company recognized 0 impairment charge for the three months ended March 31, 2021.

Goodwill

Goodwill represents the excess of the Purchase Price over the fair value of the net assets acquired as of the acquisition date. Goodwill has adoptedan indefinite useful life and is not amortized.

The Company reviews its goodwill for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of the Company may exceed its fair value. The Company first assesses qualitative factors to determine whether it is more likely than not that the fair value of the Company is less than its carrying amount, including goodwill. If that is the case, the Company performs a quantitative impairment test, and, if the carrying amount of the Company exceeds its fair value, then the Company will recognize an impairment charge for the amount by which its carrying amount exceeds its fair value, not to exceed the carrying amount of the goodwill.

The Company recognized 0 impairment charge for the three months ended March 31, 2021.

Revenue Recognition

Pursuant to FASB ASC Topic 606—606Revenue from Contracts with Customers (“ASC 606”). Under ASC 606,, the Company recognizes revenue when its customers obtain control of the Company’s product, which typically occurs on delivery. Revenue is recognized in an amount that reflects the consideration that the Company expects to receive in exchange for those goods. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following 5 steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies the relevant performance obligations. There have been no contract assets or liabilities recorded to date relating to product sales.

Product Sales


Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns, Medicaid rebates and administrative fees. Variable consideration is estimated using the expected-value amount method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items include:

Chargebacks—Chargebacks are discounts the Company provides to distributors in the event that the sales prices to end users are below the distributors’ acquisition price. This may occur due to a direct contract with a health system, a group purchasing organization (“GPO”) agreement or a sale to a government facility. Chargebacks are estimated based on known chargeback rates and recorded as a reduction of revenue on delivery to the Company’s customers.


Chargebacks—Chargebacks are discounts the Company provides to distributors in the event that the sales prices to end users are below the distributors’ acquisition price. This may occur due to a direct contract with a health system, a group purchasing organization (“GPO”) agreement or a sale to a government facility. Chargebacks are estimated based on known chargeback rates and recorded as a reduction of revenue on delivery to the Company’s customers.

Discounts—The Company offers customers various forms of incentives and consideration, including prompt-pay and other discounts. The Company estimates discounts primarily based on contractual terms. These discounts are recorded as a reduction of revenue on delivery to the Company’s customers.

Returns—The Company offers customers a limited right of return, generally for damaged or expired product. The Company estimates returns based on an internal analysis, which includes actual experience. The estimates for returns are recorded as a reduction of revenue on delivery to the Company’s customers.

Medicaid Rebates—We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within three months after the



quarter in which product was sold. The estimates for rebates are recorded as a reduction of revenue on delivery to the Company’s customers.

Returns—The Company offers customers a limited right of return, generally for damaged or expired product. The Company estimates returns based on an internal analysis, which includes actual experience. The estimates for returns

Administrative Fees—The Company pays administrative fees to GPOs for services and access to data. Additionally, the Company pays an Industrial Funding Fee as part of the U.S. General Services Administration’s Federal Supply Schedules program. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the applicable GPO or government agency. Administrative fees are recorded as a reduction of revenue on delivery to the Company’s customers.

Administrative Fees—The Company pays administrative fees to GPOs for services and access to data. Additionally, the Company pays an Industrial Funding Fee as part of the U.S. General Services Administration’s Federal Supply Schedules program. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the applicable GPO or government agency.

The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly.


License Revenue

We enter into out-license agreements with counterparties to develop and/or commercialize our products in territories outside of the U.S. in exchange for: (i) nonrefundable, upfront license fees; (ii) development and regulatory milestone payments; and/or (iii) sales-based royalties and milestones.

If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from nonrefundable, upfront fees allocated to the license when the license is transferred to the customer and the customer can benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of progress and related revenue recognition.

At the inception of each arrangement that include milestone and other payments, other than sales-based milestone payments and nonrefundable, upfront license fees, we evaluate whether achieving each milestone payment or other payment is considered probable and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs.

For arrangements that include sales-based royalties and milestone payments, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of: (i) when the related sales occur; or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.

Recent Accounting Pronouncements


Management

The Company has consideredimplemented all recentnew accounting pronouncements that are in effect and has concludedthat may impact its financial statements and does not believe that there are no recently issuedany other new accounting pronouncements that mayhave been issued that might have a material effectimpact on the Company’sits financial position and results of operations, financial condition or cash flows based on current information.


operations.

3.  Net LossEarnings (Loss) per Share


Basic net lossearnings (loss) per share is calculated by dividing net lossincome (loss) by the weighted-average number of common shares outstanding during the period, without consideration of potential common shares. Diluted net lossearnings (loss) per share is calculated by dividing net lossincome (loss) by the weighted-average number of common shares outstanding plus potential common shares. Convertible preferred stock and stock options and warrants are considered potential common shares and are included in the calculation of diluted net lossearnings (loss) per share using the treasury stock method when their effect is dilutive. Potential common shares are excluded from the calculation of diluted net lossearnings (loss) per share when their effect is anti-dilutive. As of June 30, 2020 and 2019,For the three months ended March 31, 2021, there were 10.2 million and 14.06.8 million potential common shares that were included in the calculation of diluted earnings per share, which consists of: (i) 6.7 million shares of common stock issuable upon conversion of existing convertible preferred stock; and (ii) 21,000 stock options. For the three months ended March 31, 2021 and 2020, there were 4.1 million and 11.6 million, respectively, of potential common shares that were excluded from the calculation of diluted net loss per share because their effect was anti-dilutive.



4.  Balance Sheet Details


Restricted Cash


Restricted cash as of June 30, 2020March 31, 2021 and December 31, 2019 represents2020 consisted of a standby letter of credit$40,000 security deposit for the Company’s building lease in lieu of a security deposit during the term of such lease (see Note 6). There is a requirement to maintain $0.6 million of cash collateral in an account pledged as security for such letter of credit.


corporate purchasing credit card.

Inventory, Net


Inventory, net consisted of the following (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Raw materials

 

$

802

 

 

$

802

 

Work-in-process

 

 

3,235

 

 

 

3,213

 

Finished goods

 

 

1,337

 

 

 

1,998

 

Total inventory, net

 

$

5,374

 

 

$

6,013

 

  June 30,
2020
 December 31,
2019
Work-in-process $1,801
 $1,505
Finished goods 1,319
 706
Total inventory, net $3,120
 $2,211


As of June 30, 2020March 31, 2021 and December 31, 2019,2020, inventory, net included 0 and $0.9 million, respectively, of the fair value step-up adjustment to Tetraphase’s inventory recorded in connection with the acquisition of Tetraphase (see Note 11). As of March 31, 2021 and December 31, 2020, total inventory is recorded net of inventory reserves of $0.2$1.1 million and $0.1$0.9 million, respectively.

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assetsconsisted of the following (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Refundable withholding tax

 

$

3,375

 

 

$

-

 

Prepaid manufacturing costs

 

 

529

 

 

 

930

 

Prepaid clinical costs

 

 

294

 

 

 

820

 

Prepaid insurance

 

 

319

 

 

 

505

 

Other prepaid expenses and current assets

 

 

1,587

 

 

 

1,133

 

Total prepaid expenses and other current assets

 

$

6,104

 

 

$

3,388

 


Property and Equipment, Net




Property and equipment, net consisted of the following (in thousands):

  June 30,
2020
 December 31,
2019
Leasehold improvements $14,504
 $14,504
Furniture and fixtures 2,549
 2,598
Computer hardware 1,296
 1,296
Software 733
 733
Lab equipment 
 9,665
Total property and equipment, gross 19,082
 28,796
Accumulated depreciation and amortization (6,255) (10,407)
Total property and equipment, net $12,827
 $18,389

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Computer hardware

 

$

310

 

 

$

310

 

Furniture and fixtures

 

 

309

 

 

 

309

 

Software

 

 

203

 

 

 

733

 

Total property and equipment, gross

 

 

822

 

 

 

1,352

 

Accumulated depreciation and amortization

 

 

(636

)

 

 

(1,137

)

Total property and equipment, net

 

$

186

 

 

$

215

 



Intangible Assets, Net

Intangible assets, net consisted of the following (in thousands):

 

 

Weighted-average

 

March 31,

 

 

December 31,

 

 

 

Years

 

2021

 

 

2020

 

Technology

 

10

 

$

14,000

 

 

$

14,000

 

Trade name

 

10

 

 

1,520

 

 

 

1,520

 

Total intangible assets, gross

 

 

 

 

15,520

 

 

 

15,520

 

Accumulated amortization

 

 

 

 

(1,035

)

 

 

(647

)

Total intangible assets, net

 

 

 

$

14,485

 

 

$

14,873

 

The intangible assets were recorded in connection with the acquisition of Tetraphase (see Note 11).The Company recorded amortization expense of $0.4 million and 0 for the three months ended March 31, 2021 and 2020, respectively.

Accrued Expenses


Accrued expenses consisted of the following (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Accrued interest expense on deferred royalty obligation, current portion

 

$

3,514

 

 

$

3,567

 

Accrued royalties and in-license fees

 

 

2,445

 

 

 

685

 

Accrued manufacturing costs

 

 

1,306

 

 

 

627

 

Accrued professional fees

 

 

581

 

 

 

660

 

Accrued clinical costs

 

 

22

 

 

 

20

 

Accrued other

 

 

853

 

 

 

935

 

Total accrued expenses

 

$

8,721

 

 

$

6,494

 

Other Noncurrent Liabilities

Other noncurrent liabilities consisted of the following (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Paycheck Protection Program loan

 

$

2,308

 

 

$

2,302

 

Fair value of contingent value rights (see Note 11)

 

 

2,260

 

 

 

1,810

 

Total other noncurrent liabilities

 

$

4,568

 

 

$

4,112

 

On April 22, 2020, Tetraphase entered into a promissory note for $2.3 million under the Paycheck Protection Program (the “PPP Loan”). The interest rate on the PPP Loan is 1.0% per annum. The PPP Loan is unsecured and guaranteed by the U.S. Small Business Administration (the “SBA”). The principal amount of the PPP Loan may be forgiven under the Paycheck Protection Program, subject to certain requirements and to the extent that the PPP Loan proceeds are used to pay permitted expenses, including certain payroll, rent and utility payments. The Company intends to apply for forgiveness of the PPP Loan. The Company will be obligated to make monthly payments of principal and interest with respect to any unforgiven portion of the PPP Loan. The obligation to repay the PPP Loan may be accelerated upon the occurrence of an event of default.


  June 30,
2020
 December 31,
2019
Accrued interest expense $3,530
 $2,692
Accrued manufacturing costs 1,369
 1,339
Accrued clinical study costs 815
 3,496
Accrued other 1,058
 1,785
Total accrued expenses $6,772
 $9,312



5.  Deferred Royalty Obligation


In May 2018, the Company closed a $125.0 million royalty financing agreement (the “Royalty Agreement”) with HealthCare Royalty Partners (“HCR”). Under the terms of the Royalty Agreement, the Company received $125.0 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. HCR is entitled to receive quarterly royalties on worldwide net sales of GIAPREZA beginning April 1, 2018. Quarterly payments to HCR under the Royalty Agreement start at a maximum royalty rate, with step-downs based on the achievement of annual net product sales thresholds. Through December 31, 2021, the royalty rate will be a maximum of 10%. Starting January 1, 2022, the maximum royalty rate may increase by 4% if an agreed-upon, cumulative net product sales threshold has not been met, and, starting January 1, 2024, the maximum royalty rate may increase by an additional 4% if a different agreed-upon, cumulative net product sales threshold has not been met. The Royalty Agreement is subject to maximum aggregate royalty payments to HCR of $225.0 million. The Royalty Agreement expires upon the first to occur of January 1, 2031 or when the maximum aggregate royalty payments have been made. The Royalty Agreement was entered into by the Company’s wholly owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the Royalty Agreement against La Jolla Pharmaceutical Company or any assets other than GIAPREZA.


On receipt of the $125.0 million payment from HCR, the Company recorded a deferred royalty obligation of $125.0 million, net of issuance costs of $0.7 million. For the three months ended June 30,March 31, 2021 and 2020, and 2019, the Company recognized interest expense, including amortization of the obligation discount, of $2.5$2.6 million and $2.8 million, respectively. For the six months ended June 30, 2020 and 2019, the Company recognized interest expense, including amortization of the obligation discount, of$4.9 million and $5.5$2.4 million, respectively. The carrying value of the deferred royalty obligation as of June 30, 2020March 31, 2021 was $124.4$124.5 million, net of unamortized obligation discount of $0.6$0.5 million, and was classified as noncurrent. The related accrued interest expense was $18.8$24.4 million and $15.5$22.7 million as of June 30, 2020March 31, 2021 and December 31, 2019,2020, respectively, of which $15.3$20.9 million and $12.8$19.1 million was classified as other noncurrent liabilities, respectively. During the three and six months ended June 30,March 31, 2021 and March 31, 2020, the Company made royalty payments to HCR of $0.8$0.9 million and $1.5$0.7 million, respectively, and, as of June 30, 2020,March 31, 2021, the Company recorded royalty obligations payable of $0.6$0.7 million in accrued expenses. The deferred royalty obligation is classified as Level 3 in the FASB ASC Topic 820-10, three-tier fair value hierarchy, and its carrying value approximates fair value.



Under the terms of the Royalty Agreement, La Jolla Pharma, LLC has certain obligations, including the obligation to use commercially reasonable and diligent efforts to commercialize GIAPREZA. If La Jolla Pharma, LLC is held to not have met these obligations, HCR would have the right to terminate the Royalty Agreement and demand payment from La Jolla Pharma, LLC of either $125.0 million or $225.0 million (depending on which obligation La Jolla Pharma, LLC is held to not have met), minus aggregate royalties already paid to HCR. In the event that La Jolla Pharma, LLC fails to timely pay such amount if and when due, HCR would have the right to foreclose on the GIAPREZA-related assets. The Company concluded that certain of these contract provisions that could result in an acceleration of amounts due under the Royalty Agreement are embedded derivatives that require bifurcation from the deferred royalty obligation and fair value recognition. The Company determined the fair value of each derivative by assessing the probability of each event occurring, as well as the potential repayment amounts and timing of such repayments that would result under various scenarios. As a result of this assessment, the Company determined that the fair value of the embedded derivatives is immaterial as of June 30, 2020March 31, 2021 and December 31, 2019.2020. Each reporting period, the Company estimates the fair value of the embedded derivatives until the features lapse and/or the termination of the Royalty Agreement. Any material change in the fair value of the embedded derivatives will be recorded as either a gain or loss on the consolidated statements of operations.




6.  Commitments and Contingencies


Lease Commitments

Future minimum lease payments, excluding Lease Operating Costs, as of March 31, 2021 are as follows (in thousands):

2021

 

$

175

 

2022

 

 

181

 

2023

 

 

166

 

Thereafter

 

 

-

 

Total future minimum lease payments

 

 

522

 

Less: discount

 

 

(32

)

Total lease liabilities

 

$

490

 


On

Lease expense under current and former leases was approximately $0.1 million and $0.7 million for the three months ended March 31, 2021 and 2020, respectively. Cash paid for amounts included in the measurement of lease liabilities was $50,000 and $1.6 million for the three months ended March 31, 2021 and 2020, respectively. As of March 31, 2021, the weighted-average remaining lease term and the weighted-average discount rate for the Company’s only operating lease, the Waltham Sublease, was 2.6 years and 4.0%, respectively.

Waltham Sublease

In December 29, 2016,2020, the Company entered into ana sublease agreement with BMR-Axiom LPfor office space in Waltham, Massachusetts (the “Landlord”) to lease office and laboratory space as its corporate headquarters located at 4550 Towne Centre Court, San Diego, California (the “Lease”) for a period of 10 years commencing on October 30, 2017 (the “Initial Lease Term”“Waltham Sublease”). The Company has an option to extend the Lease for an additional 5 years at the end of the Initial Lease Term.


The Company provided a standby letter of credit for $0.9 million in lieu of a security deposit. This amount decreased to $0.6 million after year two of the Initial Lease TermWaltham Sublease commenced on December 21, 2020 and will decrease to $0.3 million after year 5 of the Initial Lease Term. As of Juneexpires on November 30, 2020, $0.6 million of cash was pledged as collateral for such letter of credit and recorded as restricted cash. The annual rent under the Lease is subject to escalation during the term.2023. In addition to rent of approximately $15,000 per month, the LeaseWaltham Sublease requires the Company to pay certain taxes, insurance and operating costs relating to the leased premises.premises (collectively, “Lease Operating Costs”). The LeaseWaltham Sublease contains customary default provisions, representations, warranties and covenants. The LeaseWaltham Sublease is classified as an operating lease.

Future minimum lease payments under the Lease as of June 30, 2020 are as follows (in thousands):
2020$2,039
20214,174
20224,294
20234,417
20244,544
Thereafter13,590
Total future minimum lease payments33,058
Less: discount(5,168)
Total lease liability$27,890


The Company recordedrecognizes the Waltham Sublease expense in the consolidated statements of operations and records a lease liability and right-of-use asset for this lease.

San Diego Sublease

In September 2020, the Lease based onCompany entered into a sublease agreement for office space in San Diego, California with an entity of which the present valueChairman of the Lease payments overCompany’s board of directors is also the Initial Lease Term, discounted usingchairman and chief executive officer (the “San Diego Sublease”). The San Diego Sublease term is approximately 7 years, and the Company’s incremental borrowing rate.rent is approximately $12,000 per month. The San Diego Sublease is cancellable without penalty by either party with 30-days’ written notice. The San Diego Sublease is a short-term lease for accounting purposes. The Company recordedmade payments of approximately $36,000 under the San Diego Sublease during the three months ended March 31, 2021. The Company recognizes the San Diego Sublease payments in the consolidated statements of operations and does not record a corresponding right-of-use lease asset based on the lease liability, adjusted for incentives received prior to the Lease commencement date. The option to extend the Initial Lease Term was not recognized as a part of either the Company’s lease liability or right-of-use lease asset. Lease expense was $0.7 million and $1.4 millionasset for the three and six months ended June 30, 2020, respectively, and for the same periods in 2019. Amortization for the right-of-use lease asset was $0.4 million and $0.7 million for the three and six months ended June 30, 2020,respectively, and was $0.3 million and $0.6 million for the three and six months ended June 30, 2019, respectively.


this lease.

Contingencies



From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. The Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation.




7.  Shareholders’ Equity


Preferred Stock


As of June 30, 2020March 31, 2021 and December 31, 2019,2020, 3,906 shares of Series C-12 Convertible Preferred Stock (“Series C-12Preferred”) were issued, outstanding and convertible into 6,735,378 shares of common stock. In January 2019, the Company issued 782,031 shares of common stock upon the conversion of 2,737 shares of Series F Convertible Preferred Stock. As of June 30, 2020March 31, 2021 and December 31, 2019, there were no shares2020, the Series C-12 Preferred liquidation preference was approximately $3.9 million. The Series C-12 Preferred does not pay a dividend. The holders of the Series F ConvertibleC-12 Preferred Stock issued and outstanding.


Warrants

As of June 30, 2020 and December 31, 2019,do not have voting rights, other than for general protective rights required by the Company had outstanding warrants to purchase 10,000 shares of common stock. The Company did not recognize share-based compensation expense for these outstanding warrants for the three and six months ended June 30, 2020 and 2019.

California General Corporation Law.

8.  Equity Incentive Plans


2013 Equity Incentive Plan


A total of 9,600,000 shares of common stock have been reserved for issuance under the La Jolla Pharmaceutical Company 2013 Equity Incentive Plan (the “2013 Equity Plan”). As of June 30, 2020, 5,940,653March 31, 2021, 5,488,481 shares of common stock remained available for future grants under the 2013 Equity Plan.


2018 Employee Stock Purchase Plan


A total of 750,000 shares of common stock have been reserved for issuance under the La Jolla Pharmaceutical Company 2018 Employee Stock Purchase Plan (the “ESPP”). As of June 30, 2020, 499,805March 31, 2021, 438,845 shares of common stock remained available for future grants under the ESPP.


Equity Awards


The activity related to equity awards, which are comprised of stock options, and inducement grants, during the sixthree months ended June 30, 2020March 31, 2021 is summarized as follows:

 

Equity

Awards

 

 

Weighted-

average

Exercise Price

per Share

 

 

Weighted-

average

Remaining

Contractual

Term(1)

(years)

 

 

Aggregate

Intrinsic

Value(2)

 

Equity Awards 
Weighted-
average
Exercise Price
per Share
 
Weighted-
average
Remaining
Contractual
Term
 Aggregate
Intrinsic
Value
Outstanding at December 31, 20195,616,840
 $19.50
  

Outstanding at December 31, 2020

 

 

4,121,666

 

 

$

8.67

 

 

 

 

 

 

 

 

 

Granted806,923
 $5.27
  

 

 

335,548

 

 

$

5.48

 

 

 

 

 

 

 

 

 

Exercised(94,219) $6.42
  

 

 

(29,000

)

 

$

5.25

 

 

 

 

 

 

 

 

 

Cancelled/forfeited(2,883,533) $19.43
  

 

 

(316,695

)

 

$

8.00

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 20203,446,011
 $16.59
 5.87 years $35,037
Exercisable at June 30, 20202,144,609
 $20.84
 4.27 years $

Outstanding at March 31, 2021

 

 

4,111,519

 

 

$

8.48

 

 

 

8.39

 

 

$

175,807

 

Exercisable at March 31, 2021

 

 

1,146,185

 

 

$

17.18

 

 

 

5.68

 

 

$

21,693

 



(1) Represents the weighted-average remaining contractual term of stock options.

(2) Aggregate intrinsic value represents the product of the number of equity awards outstanding or equity awards exercisable multiplied by the difference between the Company’s closing stock price per share on the last trading day of the period, which was $4.24 as of March 31, 2021, and the exercise price.

Share-based Compensation Expense


The classification of share-based compensation expense is summarized as follows (in thousands):

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

Selling, general and administrative

 

$

840

 

 

$

844

 

Research and development

 

 

276

 

 

 

1,563

 

Total share-based compensation expense

 

$

1,116

 

 

$

2,407

 

 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 2020 2019
Research and development$964
 $3,960
 $2,527
 $7,893
Selling, general and administrative626
 2,361
 1,470
 5,210
Total share-based compensation expense$1,590
 $6,321
 $3,997
 $13,103


As of June 30, 2020,March 31, 2021, total unrecognized share-based compensation expense related to unvested equity awards was $8.6$9.8 million, which is expected to be recognized over a weighted-average period of 2.23.1 years. As of June 30, 2020,March 31, 2021, there was no0 unrecognized share-based compensation expense related to shares of common stock issued under the ESPP.



9.  Other Income—Related Party


The Company has a non-voting profits interest in a related party, which provides the Company with the potential to receive a portion of the future distributions of profits, if any. Investment funds affiliated with the Chairman of the Company’s board of directors have a controlling interest in the related party. During the sixthree months ended June 30,March 31, 2021, the Company did 0t receive any distributions in connection with this profits interest. During the three months ended March 31, 2020, the Company received distributions of $4.1 million in connection with this profits interest.


10.  License Agreements

In-license Agreements

George Washington University License


In December 2014, the Company entered into a patent license agreement with George Washington University (“GW”), which was subsequently amended and restated on March 1, 2016 (the “GW License”) and subsequently assigned to La Jolla Pharma, LLC. Pursuant to the GW License, GW exclusively licensed to the Company certain intellectual property rights relating to GIAPREZA, including the exclusive rights to certain issued patents and patent applications covering GIAPREZA. Under the GW License, the CompanyLa Jolla Pharma, LLC is obligated to use commercially reasonable efforts to develop, commercialize, market and sell GIAPREZA. The Company has paid a one-time license initiation fee, annual maintenance fees, an amendment fee, additional payments following the achievement of certain development and regulatory milestones and royalties. As a result of the EC’sEuropean Commission’s approval of GIAPREZA in August 2019, the Company made a milestone payment to GW in the amount of $0.5 million in the first quarter of 2020. The Company is obligated to pay a 6% royalty on net sales of GIAPREZA.GIAPREZA and 15% on payments received from sublicensees. The patents and patent applications covered by the GW License are expected to expire between 2029 and 2034, and the obligation to pay royalties under this agreement extends through the last-to-expire patent covering GIAPREZA.


11. Company-wide Realignments

On December 2, 2019, the Board of Directors of the Company approved a restructuring plan (the “2019 Realignment”) that reduced the Company’s headcount. The 2019 Realignment did not result in any reductions in headcount in the Company’s commercial organization supporting GIAPREZA. For the year ended December 31, 2019, total expense was comprised of $5.8 million for one-time termination benefits to the affected employees, including severance and health care benefits, offset by a $0.9 million reversal of non-cash, share-based compensation expense related to forfeited, unvested equity awards. As of June 30, 2020, the Company had paid $4.8 million of the $5.8 million cash severance and health care benefits charges, and the remaining $1.0 million of the health care benefits charges were included in accrued payroll and related expenses.

On May 28, 2020, the Board of Directors of the Company approved a restructuring plan (the “2020 Realignment”) to align its organization with the Company’s sole focus on the commercialization of GIAPREZA. The 2020 Realignment reduced the Company’s headcount. For During the three months ended June 30, 2020, total expense was comprised of $4.1 million for one-time termination benefits to the affected employees, including severanceMarch 31, 2021 and health care benefits, offset by a $0.4 million reversal of non-cash, share-based compensation expense related to forfeited, unvested equity awards. As of June 30, 2020, the Company hadmade payments to GW of $2.8 million and $0.4 million, respectively.

Harvard University

In August 2006, the Company entered into a license agreement with Harvard University (“Harvard”), which was subsequently amended and restated (the “Harvard License”). Pursuant to the Harvard License, Harvard exclusively licensed to the Company certain intellectual property rights relating to tetracycline-based products, including XERAVA, including the exclusive rights to certain issued patents and patent applications covering such products. Under the Harvard License, the Company is obligated to use commercially reasonable efforts to develop, commercialize, market and sell tetracycline-based products, including XERAVA. For each product covered by the Harvard License, the Company is obligated to make certain payments for the following: (i) up to approximately $15.1 million upon the achievement of certain clinical development and regulatory milestones; (ii) a 5% royalty on direct U.S. net sales of XERAVA; (iii) a single-digit tiered royalty on direct ex-U.S. net sales of XERAVA, starting at a minimum royalty rate of 4.5%, with step-ups to a maximum royalty of 7.5% based on the achievement of annual net product sales thresholds; and (iv) 20% on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering tetracycline-based products, including XERAVA. During the three months ended March 31, 2021, the Company paid $0.7$0.1 million of royalties to Harvard, and did 0t make any payments to Harvard related to clinical development and regulatory milestones.

Paratek Pharmaceuticals, Inc.

In March 2019, the $4.1Company entered into a license agreement with Paratek Pharmaceuticals, Inc. (“Paratek”), which was subsequently amended and restated (the “Paratek License”). Pursuant to the Paratek License, Paratek non-exclusively licensed to the Company certain intellectual property rights relating to XERAVA, including non-exclusive rights to certain issued patents and patent applications covering XERAVA. The Company is obligated to pay Paratek a 2.25% royalty based on direct U.S. net sales of XERAVA. The Company’s obligation to pay royalties with respect to the licensed product is retroactive to the date of the first commercial sale of XERAVA and shall continue until there are no longer any valid claims of the Paratek patents, which will expire in October 2023. During the three months ended March 31, 2021, the Company paid $51,000 of royalties to Paratek.



Out-license Agreements

PAION AG

On January 12, 2021, La Jolla Pharmaceutical Company and certain of its wholly owned subsidiaries, including La Jolla Pharma, LLC, entered into an exclusive license agreement (the “PAION License”) with PAION AG and its wholly owned subsidiary (collectively, “PAION”). Pursuant to the PAION License, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland (collectively, the “PAION Territory”). La Jolla has received an upfront cash payment of $22.5 million, cash severanceless a 15% refundable withholding tax, and health care benefits charges,is entitled to receive potential commercial milestone payments of up to $109.5 million and double-digit tiered royalty payments. In addition, royalties payable under the PAION License will be subject to reduction on account of generic competition and after patent expiration in a jurisdiction. Pursuant to the PAION License, PAION will be solely responsible for the future development and commercialization of GIAPREZA and XERAVA in the PAION Territory. PAION is required to use commercially reasonable efforts to commercialize GIAPREZA and XERAVA in the PAION Territory. The Company agreed to use commercially reasonable efforts to negotiate and enter into a separate commercial supply agreement to manufacture drug product for commercial supply. The Company has not yet entered into a commercial supply agreement with PAION, which would set the quantity and timing of commercial supply. The Company has not received any payments from PAION related to either royalties or commercial milestones.

Everest Medicines Limited

In February 2018, the Company entered into a license agreement with Everest, which was subsequently amended and restated (the “Everest License”). Pursuant to the Everest License, the Company granted Everest an exclusive license to develop and commercialize XERAVA for the treatment of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the remaining $3.4 millionRepublic of the cash severancePhilippines (collectively, the “Everest Territory”). The Company is eligible to receive an additional $8.0 million regulatory milestone payment and health care



benefits chargesup to an aggregate of $20.0 million in sales milestone payments.The Company is also entitled to receive tiered royalties from Everest at percentages in the low double digits on sales, if any, in the Everest Territory of products containing eravacycline. Royalties are payable with respect to each jurisdiction in the Everest Territory until the latest to occur of: (1) the last-to-expire of specified patent rights in such jurisdiction in the Everest Territory; (2) expiration of marketing or regulatory exclusivity in such jurisdiction in the Everest Territory; or (3) 10 years after the first commercial sale of a product in such jurisdiction in the Everest Territory. The Company agreed to use commercially reasonable efforts to manufacture drug product for clinical development, which will be paid by Everest at the cost to manufacture, as well as manufacture drug product for commercial supply, which will be paid by Everest at cost plus a reasonable margin. During the three months ended March 31, 2021, the Company received a $3.0 million milestone payment associated with the submission of an NDA with the China NMPA for XERAVA for the treatment of cIAI in patients in China. Amounts due under the Harvard University license agreement were included in accrued payrollas research and related expenses. The Company expects to make substantially alldevelopment expense on the consolidated statements of the remaining payments resulting from the 2020 Realignment in the third quarter of 2020.operations.




12. Subsequent Events

11.  Acquisition of Tetraphase Pharmaceuticals, Inc.


On June 24, 2020, La Jolla entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Tetraphase, a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life‑threatening infections, and TTP Merger Sub, Inc., a wholly owned subsidiary of La Jolla. On July 28, 2020, La Jolla completed its acquisition of Tetraphase for $43 million in upfront cash plus potential future cash payments of up to $16 million pursuant to contingent value rights (“CVRs”). The holders of the CVRs are entitled to receive potential future cash payments of up to $16 million in the aggregate upon the achievement of certain net sales of XERAVA in the U.S. as follows: (i) $2.5 million if 2021 XERAVA U.S. net sales are at least $20 million; (ii) $4.5 million if XERAVA U.S. net sales are at least $35 million during any calendar year ending on or prior to December 31, 2024; and (iii) $9 million if XERAVA U.S. net sales are at least $55 million during any calendar year ending on or prior to December 31, 2024. Following the acquisition, Tetraphase became a wholly owned subsidiary of La Jolla.

The acquisition of Tetraphase will bewas accounted for as a business combination using the acquisition method pursuant to FASB ASC Topic 805. As the acquirer for accounting purposes, La Jolla has estimated the Purchase Price, assets acquired and liabilities assumed as of the acquisition date, with the excess of the Purchase Price over the fair value of net assets acquired recognized as goodwill. The estimated fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value.

The Purchase Price is comprised of the upfront cash of $43 million and the estimated fair value of potential future cash payments pursuant to the CVRs. The estimated fair value of assets acquired was $54.7 million, and the estimated fair value of liabilities assumed was $9.1 million.

The Purchase Price allocation as of the acquisition date is presented as follows (in thousands):

 

 

July 28,

 

 

 

2020

 

Cash

 

$

42,990

 

Fair Value of CVRs

 

 

2,610

 

Total Purchase Price

 

$

45,600

 

 

 

 

 

 

Cash and cash equivalents

 

$

8,778

 

Accounts receivable

 

 

1,187

 

Inventory

 

 

4,767

 

Prepaid expenses and other current assets

 

 

1,218

 

Property and equipment

 

 

58

 

Right-of-use lease assets

 

 

2,302

 

Restricted cash

 

 

699

 

Identifiable intangible assets

 

 

15,520

 

Goodwill

 

 

20,123

 

Accounts payable

 

 

(1,400

)

Accrued expenses

 

 

(2,979

)

Lease liabilities, current portion

 

 

(967

)

Lease liabilities, less current portion

 

 

(1,420

)

Other noncurrent liabilities

 

 

(2,286

)

Total Purchase Price

 

$

45,600

 

The estimated fair value of potential future cash payments pursuant to the CVRs was based on a Monte Carlo simulation and is classified as Level 3 in the ASC Topic 820-10, three-tier fair value hierarchy.

CVRs are measured at fair value on a recurring basis. During the three months ended March 31, 2021, the Company recorded a $0.5 million loss in other (expense) income in the consolidated statements of operations resulting from the change in fair value of CVRs.

The Company recorded a $3.3 million fair value step-up adjustment to Tetraphase’s inventory as of the acquisition date. Raw material components and active pharmaceutical ingredients were recorded based on estimated replacement cost. Finished drug product was valued at estimated selling cost, adjusted for costs of selling effort and a reasonable profit allowance for such selling effort from the viewpoint of a market participant. This



fair value step-up adjustment is recorded as cost of product sales when the inventory is sold to customers, $0.9 million of which was included in cost of product sales during the three months ended March 31, 2021.

Identifiable intangible assets consist of certain technology and trade names acquired from Tetraphase, and include the value of the Harvard, Paratek and Everest Licenses (see Note 10). The acquired intangible assets have definite useful lives and are being amortized on a straight-line basis over an estimated useful life of 10 years.

Goodwill represents the excess of the Purchase Price over the fair value of the net assets acquired as of the acquisition date. Goodwill represents the value of the stronger platform to increase patient access to the Company’s commercial products and the operational synergies of the combined Company. Goodwill has an indefinite useful life and is not amortized. The goodwill is only deductible for tax purposes if the Company makes a U.S. Internal Revenue Code Section 338 (“Section 338”) election. The Company did not make a Section 338 election.

12.  Company-wide Realignments

On May 28, 2020, the Board of Directors of the Company approved a restructuring plan (the “2020 Realignment”) to align its organization with the Company’s sole focus on the commercialization of its products. The 2020 Realignment reduced the Company’s headcount. For the year ended December 31, 2020, total expense was comprised of $4.1 million for one-time termination benefits to the affected employees, including severance and health care benefits, offset by a $0.4 million reversal of non-cash, share-based compensation expense related to forfeited, unvested equity awards. As of March 31, 2021, the Company had made substantially all of the payments related to the 2020 Realignment.

In connection with the acquisition of Tetraphase, the Company incurred one-time charges related to a reduction in the combined Company’s headcount. For the year ended December 31, 2020, total expense was comprised of $3.1 million for one-time termination benefits to the affected employees, including severance and health care benefits. As of March 31, 2021, the Company had paid $2.5 million of the $3.1 million cash severance and health care benefits charges, and the remaining $0.6 million of the cash severance and health care benefits charges were included in accrued payroll and related expenses. The Company expects to make substantially all of the payments related to this headcount reduction by the end of the second quarter of 2021.

13.  Income Taxes

For the three months ended March 31, 2021, the Company recorded an $18,000 provision for income taxes related to state income taxes. For the three months ended March 31, 2020, the Company did 0t record a provision for income taxes. As of March 31, 2021 and December 31, 2020, the Company established a full valuation allowance against its federal and state deferred tax assets due to the uncertainty surrounding the realization of such assets. There were 0 unrecognized tax benefits as of March 31, 2021 and December 31, 2020. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months.

14.  Subsequent Events

On April 21, 2021, La Jolla received a distribution of $2.5 million in connection with its non-voting profits interest (see Note 9). The distribution will be recorded as other income for the three months ended June 30, 2021.

On May 6, 2021, the Company entered into a commercial supply agreement with Everest whereby the Company will supply Everest a minimum quantity of XERAVA through December 31, 2023 and will transfer to Everest certain XERAVA-related manufacturing know-how. Pursuant to the supply agreement, the Company is entitled to receive $5.0 million of technology transfer payments in 2021 and will be reimbursed for manufacturing costs at 110% of costs through December 31, 2023.



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


You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 20192020 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 2, 20208, 2021 (the “Form 10-K”).


Forward-looking Statements


This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the federal securities laws, and such statements may involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this Quarterly Report on Form 10-Q, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, future expenses, financing needs, plans or intentions relating to acquisitions, business trends and other information referred to under this section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “anticipate,” “target,” “forecast” or the negative of these terms and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Forward-looking statements are also based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.


There are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors are described under “Risk Factors” in Item 1A of our Form 10-K for the year ended December 31, 2019 and under “Risk Factors” in Item 1A of this Quarterly Report on Form 10-Q.2020. We caution you that these risks, uncertainties and other factors may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. All forward-looking statements in this Quarterly Report on Form 10-Q apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.


Business Overview




La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZATM (angiotensin II) for injection is approved by the U.S. Food and Drug Administration (“FDA”) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. For the three and six months ended June 30, 2020, U.S. net sales of GIAPREZA were $5.8 million and $13.4 million, up 2% and 33%, respectively, from the same periods in 2019.


XERAVA (eravacycline) On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVATM (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. XERAVA for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (“cIAI”) in patients 18 years of age and older. For the threeolder.

On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc. and six months ended June 30, 2020, U.S. net salesits subsidiaries (“Tetraphase”), a biopharmaceutical company focused on commercializing XERAVA, for $43 million in upfront cash plus potential future cash payments of XERAVA, which was launched in October 2018, were $1.5 million and $3.2 million, up 88% and 191%, respectively, from the same periods in 2019. Completeto $16 million. La Jolla’s consolidated financial results of Tetraphase for the six months ended June 30, 2020 will be included in an amended Form 8-K to be filed by La Jolla on or before October 13, 2020. Financial results for periods ending September 30, 2020 and beyond will includeexclude Tetraphase’s financial results subsequentprior to the acquisition closing date of July 28, 2020.

In January 2021, La Jolla and certain of its wholly owned subsidiaries, including La Jolla Pharma, LLC, entered into a license agreement with PAION AG to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland. Pursuant to the agreement: (i) the Company has received an upfront cash payment of $22.5 million, less a 15% refundable withholding tax; and (ii) the Company is entitled to receive potential commercial milestone payments of up to $109.5 million and royalties on net sales of GIAPREZA and XERAVA.

In March 2021, under its license agreement with Everest Medicines Limited (“Everest”), the Company received a $3.0 million milestone payment associated with the submission of a New Drug Application (“NDA”) with the China National Medical Products Administration (“NMPA”) for XERAVA for the treatment of cIAI in patients in China. The Company previously granted Everest an exclusive license to develop and commercialize XERAVA for the treatment



of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines. The Company is eligible to receive an additional $8.0 million regulatory milestone payment and up to an aggregate of $20.0 million in sales milestone payments. The Company is also entitled to receive royalties from Everest on sales, if any, by Everest of products containing eravacycline.

Product Portfolio

ljpc10qimages0001.jpg

(1) For U.S. and European approval

(2) U.S.: GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock

European Union: GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies

(3) U.S.: XERAVA is a tetracycline class antibacterial indicated for the treatment of cIAIs in patients 18 years of age and older

European Union: XERAVA is indicated for the treatment of cIAI in adults

GIAPREZA

U.S.: GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
European Union: GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.
b
U.S.: XERAVA is a novel fluorocycline of the tetracycline class of antibacterials for the treatment of complicated intra-abdominal infections (“cIAI”) in patients 18 years of age and older.
European Union: XERAVA is indicated for the treatment of cIAI in adults.

GIAPREZATM (angiotensin II)

GIAPREZATM (angiotensin II) for injection is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (“EC”) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system (“RAAS”), which in turn regulates blood pressure. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.subsidiary, and will be marketed in Europe by PAION AG on behalf of La Jolla Pharma, LLC.


XERAVATM (eravacycline)


XERAVATM (eravacycline) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of cIAIcomplicated intra-abdominal infections (“cIAI”) in patients 18 years of age and older. XERAVA is approved by the EC for the treatment of cIAI in adults. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla.Jolla, and will be marketed in Europe by PAION AG on behalf of Tetraphase. Everest, the Company’s licensee for mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines, recently submitted an NDA in China.

Product Candidates

In connection with the acquisition of Tetraphase, we acquired the following product candidates that are in early stage clinical development: (1) TP-6076, an IV formulation of a fully synthetic fluorocycline derivative for the treatment of certain multidrug-resistant gram-negative bacteria; (2) TP-271, an IV and oral formulation of a fully synthetic fluorocycline for the treatment of respiratory disease caused by bacterial biothreat and antibiotic-resistant public health pathogens, as well as bacterial pathogens associated with community-acquired bacterial pneumonia; and (3) TP-2846, an IV formulation of a tetracycline for the treatment of acute myeloid leukemia. At this time, there are no active studies nor anticipated future studies for any of these product candidates. We intend to seek out-



license opportunities for these product candidates; however, at this time, we are unable to predict the likelihood of successfully out-licensing any of these product candidates.

Components of Our Results of Operations




The following table summarizes our results of operations for each of the periods below (in thousands):

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

 

Change

 

Net product sales

 

$

8,637

 

 

$

7,591

 

 

$

1,046

 

License revenue

 

 

25,500

 

 

 

-

 

 

 

25,500

 

Cost of product sales

 

 

2,731

 

 

 

716

 

 

 

2,015

 

Cost of license revenue

 

 

3,600

 

 

 

-

 

 

 

3,600

 

Selling, general and administrative expense

 

 

8,755

 

 

 

8,152

 

 

 

603

 

Research and development expense

 

 

1,558

 

 

 

9,183

 

 

 

(7,625

)

Other (expense) income, net

 

 

(3,057

)

 

 

1,869

 

 

 

(4,926

)

Provision for income taxes

 

 

18

 

 

 

-

 

 

 

18

 

Net income (loss)

 

$

14,418

 

 

$

(8,591

)

 

$

23,009

 

 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 Change 2020 2019 Change
Net product sales$5,805
 $5,703
 $102
 $13,396
 $10,098
 $3,298
Cost of product sales(808) (551) (257) (1,524) (1,051) (473)
Research and development expense(8,781) (22,043) 13,262
 (17,964) (43,287) 25,323
Selling, general and administrative expense(8,677) (11,323) 2,646
 (16,829) (23,643) 6,814
Other income (expense), net(3,131) (2,202) (929) (1,262) (4,218) 2,956
Net loss$(15,592) $(30,416) $14,824
 $(24,183) $(62,101) $37,918

Net Product Sales


Net product sales consist solely of revenue recognized from sales of GIAPREZA and XERAVA to hospitals and other healthcare organizations in the U.S. through a network of specialty and wholesalerwholesale distributors (“Customers”). These specialty and wholesale distributors are considered our customers for accounting purposes.For the three months ended March 31, 2021, La Jolla’s net product sales were $8.7 million, compared to $7.6 million for the same period in 2020. GIAPREZA U.S. net sales were $5.8 million and $13.4$6.9 million for the three and six months ended June 30, 2020, respectively,March 31, 2021, compared to $5.7$7.6 million and $10.1 million, respectively, for the same periodsperiod in 2019.


2020. XERAVA U.S. net sales were $1.8 million for the three months ended March 31, 2021, compared to zero for the same period in 2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on July 28, 2020.

License Revenue

License revenue consists of revenue from out-license agreements with counterparties to develop and/or commercialize our products in territories outside of the U.S. in exchange for: (i) nonrefundable, upfront license fees; (ii) development, regulatory or commercial milestone payments; and/or (iii) sales-based royalties. License revenue was $25.5 million for the three months ended March 31, 2021, which consists of: (i) a $22.5 million upfront cash payment in connection with the PAION License; and (ii) a $3.0 million regulatory milestone cash payment in connection with the Everest License.

Cost of Product Sales


Cost of product sales consists primarily consists of expense associated with: (i) royalties paid or payable to George Washington University, Harvard University and Paratek Pharmaceuticals, Inc.; (ii) the costs to produce, packageinventory fair value step-up adjustment recorded in connection with the acquisition of Tetraphase; (iii) manufacturing; (iv) regulatory fees; and deliver GIAPREZA to our Customers. These costs include raw materials, labor and manufacturing and quality control, as well as(v) shipping and distribution costs.distribution. Cost of product sales was $0.8 million and $1.5$2.7 million for the three and six months ended June 30, 2020, respectively,March 31, 2021, compared to $0.6$0.7 million and $1.1 million, respectively, for the same periodsperiod in 2019.2020. Cost of product sales excludes XERAVA for the three months ended March 31, 2020. For the three months ended March 31, 2021, cost of product sales includes $0.9 million of the inventory fair value step-up adjustment recorded in connection with the acquisition of Tetraphase.




Research

Cost of License Revenue

Cost of license revenue consists of amounts due under in-license agreements in connection with license revenuefrom commercially approved product. Cost of license revenue recognized in connection with product that is not commercially approved is recorded as research and Developmentdevelopment expense. Cost of license revenue was $3.6 million for the three months ended March 31, 2021, which consists of amounts due under the George Washington University and Harvard University license agreements in connection with the upfront cash payment received from the PAION License.

Selling, General and Administrative Expense


Research

Selling, general and developmentadministrative expense consists of non-personnel and personnel expenses. Non-personnel-related expense includes expense related to: (i) professional fees for legal, patent, consulting, accounting and audit services; (ii) sales and marketing costs such as speaker programs, advertising and promotion; (iii) facilities and information technology; and (iv) insurance. Personnel-related expense includes expense related to salaries, benefits and share-based compensation for personnel engaged in sales, finance and administrative functions. We expect our selling, general and administrative expense to decrease in the near term.

The following table summarizes these expenses for each of the periods below (in thousands):

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

 

Change

 

Non-personnel expense:

 

 

 

 

 

 

 

 

 

 

 

 

Professional fees

 

$

1,528

 

 

$

871

 

 

$

657

 

Sales and marketing

 

 

1,195

 

 

 

1,223

 

 

 

(28

)

Facility

 

 

14

 

 

 

493

 

 

 

(479

)

Other

 

 

792

 

 

 

586

 

 

 

206

 

Total non-personnel expense

 

 

3,529

 

 

 

3,173

 

 

 

356

 

Personnel expense:

 

 

 

 

 

 

 

 

 

 

 

 

Salaries, bonuses and benefits

 

 

4,386

 

 

 

4,135

 

 

 

251

 

Share-based compensation expense

 

 

840

 

 

 

844

 

 

 

(4

)

Total personnel expense

 

 

5,226

 

 

 

4,979

 

 

 

247

 

Total selling, general and administrative expense

 

$

8,755

 

 

$

8,152

 

 

$

603

 

 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 Change 2020 2019 Change
Non-personnel expenses:
          
GIAPREZA$1,762
 $1,623
 $139
 $2,843
 $3,021
 $(178)
LJPC-0118404
 113
 291
 917
 1,135
 (218)
LJPC-401
 4,880
 (4,880) 1,531
 8,795
 (7,264)
Other programs
 2,280
 (2,280) 
 3,843
 (3,843)
Facility1,124
 1,785
 (661) 2,560
 3,576
 (1,016)
Other
 992
 (992) 474
 1,918
 (1,444)
Total non-personnel expense$3,290
 $11,673
 $(8,383) $8,325
 $22,288
 $(13,963)
Personnel expenses:           
Salaries, bonuses and benefits4,527
 6,410
 (1,883) 7,112
 13,106
 (5,994)
Share-based compensation expense964
 3,960
 (2,996) 2,527
 7,893
 (5,366)
Total personnel expense$5,491
 $10,370
 $(4,879) $9,639
 $20,999
 $(11,360)
Total research and development expense$8,781
 $22,043
 $(13,262) $17,964
 $43,287
 $(25,323)

During the three and six months ended June 30, 2020,March 31, 2021, total researchselling, general and developmentadministrative non-personnel expense decreasedincreased compared to the same period in 2020 primarily as a result of: (i) increases in professional fee-related expenses due to one-time legal fees in connection with the execution of an out-license agreement and a commercial supply agreement, as well as increased surveillance programs, regulatory consulting and regulatory filing fees resulting from the acquisition of Tetraphase; and (ii) increases in other expenses due to intangible asset amortization resulting from the acquisition of Tetraphase; partially offset by decreases in facility-related expenses as a result of the termination of our San Diego Lease effective August 31, 2020 (see Note 6 to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q).

During the three months ended March 31, 2021, total selling, general and administrative personnel expense increased compared to the same period in 2020 primarily as a result of decreasesan increase in LJPC-401- and other programs-related expenses. During the three and six months ended June 30, 2020, total research and development personnel expense, including share-based compensation expense, decreased as a result of reduced headcount in 2020 from a Company-wide



realignment in November 2019, partially offset by $2.4 million of one-time charges in 2020 resulting from another Company-wide realignment in May 2020.

Selling, General and Administrative Expense

Selling,allocations to general and administrative activities.



Research and Development Expense

Research and development expense consists of non-personnel and personnel expenses. Non-personnel-related expense includes expense related to: (i) manufacturing development; (ii) amounts due under in-license agreements for drug product that is not commercially approved; (iii) facilities and information technology; and (iv) conducting clinical studies. Personnel-related expense includes expense related to salaries, benefits and share-based compensation for personnel engaged in research and development functions. We expect our research and development expense to decrease in the near term.

The following table summarizes these expenses for each of the periods below (in thousands):

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

 

Change

 

Non-personnel expense:

 

 

 

 

 

 

 

 

 

 

 

 

XERAVA

 

$

262

 

 

$

-

 

 

$

262

 

GIAPREZA

 

 

175

 

 

 

1,081

 

 

 

(906

)

LJPC-401

 

 

30

 

 

 

1,531

 

 

 

(1,501

)

LJPC-0118

 

 

5

 

 

 

513

 

 

 

(508

)

Facility

 

 

3

 

 

 

1,436

 

 

 

(1,433

)

Other

 

 

573

 

 

 

474

 

 

 

99

 

Total non-personnel expense

 

 

1,048

 

 

 

5,035

 

 

 

(3,987

)

Personnel expense:

 

 

 

 

 

 

 

 

 

 

 

 

Salaries, bonuses and benefits

 

 

234

 

 

 

2,585

 

 

 

(2,351

)

Share-based compensation expense

 

 

276

 

 

 

1,563

 

 

 

(1,287

)

Total personnel expense

 

 

510

 

 

 

4,148

 

 

 

(3,638

)

Total research and development expense

 

$

1,558

 

 

$

9,183

 

 

$

(7,625

)

 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 Change 2020 2019 Change
Non-personnel expenses:
 
   
   
Professional fees$1,356
 $1,139
 $217
 $2,227
 $2,095
 $132
Sales and marketing588
 1,471
 (883) 1,811
 3,492
 (1,681)
Facility554
 393
 161
 1,047
 773
 274
Other339
 595
 (256) 925
 1,187
 (262)
Total non-personnel expense$2,837
 $3,598
 $(761) $6,010
 $7,547
 $(1,537)
Personnel expenses:          
Salaries, bonuses and benefits5,214
 5,364
 (150) 9,349
 10,886
 (1,537)
Share-based compensation expense626
 2,361
 (1,735) 1,470
 5,210
 (3,740)
Total personnel expense$5,840
 $7,725
 $(1,885) $10,819
 $16,096
 $(5,277)
Total selling, general and administrative expense$8,677
 $11,323
 $(2,646) $16,829
 $23,643
 $(6,814)

During the three and six months ended June 30, 2020,March 31, 2021, total selling, generalresearch and administrativedevelopment non-personnel expense decreased compared to the same period in 2020 primarily as a result of the following: (i) decreases in salesprogram-related expenses as we de-prioritized our product candidates and marketing-related expenses. focused on the commercialization of GIAPREZA and XERAVA; and (ii) decreases in facility-related expenses primarily as a result of the termination of our San Diego Lease effective August 31, 2020 (see Note 6 to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q); partially offset by increases in manufacturing and clinical development costs related to the acquisition of XERAVA.

During the three months ended June 30, 2020, La Jolla incurred $0.6 million of professional fees related the acquisition of Tetraphase. During the threeMarch 31, 2021, total research and six months ended June 30, 2020, total selling, general and administrativedevelopment personnel expense, including share-based compensation expense, decreased compared to the same period in 2020 as a result of reduced headcount in 2020 from a Company-wide realignment in November 2019, partially offset by $1.7 million of one-time charges in 2020 resulting from another Company-wide realignment in May 2020.


headcount.

Other (Expense) Income, (Expense), Net


Other (expense) income, (expense), net primarily consists of the following: (i) interest expense accrued for our deferred royalty obligation; (ii) loss from changes in the fair value of contingent value rights (“CVRs”); (iii) income from distributions received in connection with our non-voting profits interest in a related party, interest accrued for our deferred royalty obligationparty; and (iv) interest income generated from cash held in savings accounts. accounts.

During the three months ended June 30, 2020,March 31, 2021, other expense,(expense) income, net increasedwas $(3.1) million, compared to $3.1$1.9 million from $2.2 million forin the same period in 2019, an increase2020. This $5.0 million decrease in other income was due to: (i) a $4.1 million decrease in the receipt of $0.9 million. This increase was primarily due todistributions in connection with the Company’s non-voting profits interest in a $0.9related party; (ii) a $0.5 million loss on disposalfrom changes in the fair value of equipmentCVRs; (iii) a $0.2 million increase in interest expense for our deferred royalty obligation; and (iv) $0.6$0.2 million decrease in interest income generated from cash held in savings accounts partially offset by a $0.3 million decrease in interest expense for our deferred royalty obligation. During the six months ended June 30, 2020, other expense, net decreased to $1.3 million from $4.2 million for the same period in 2019, a decrease of $2.9 million. This decrease was primarily due to the receipt of distributions of $4.1 million in connection with the Company’s non-voting profits interest in a related party and a $0.6 million decrease in interest expense for our deferred royalty obligation, partially offset by a $1.1 million decrease in interest income generated from cash held in savings accounts and a $0.9 million loss on disposal of equipment..




Liquidity and Capital Resources


Since January 2012, when the Company was effectively restarted, through June 30, 2020, our cash used in operating activities was $447 million.

As of June 30, 2020, we had an accumulated deficit of $1,062 million and have financed our operations through public and private offerings of securities, a royalty financing, revenues from net product sales, interest income on invested cash balances and other income.


As of June 30, 2020March 31, 2021 and December 31, 2019,2020, we had cash and short-term investmentscash equivalents of $71.4$38.6 million and $87.8$21.2 million, respectively. On July 28, 2020, La Jolla completed the acquisition of Tetraphase for $43.0 million in upfront cash. Based on our current operating plans and projections, we believe that our existing cash and short-


term investmentscash equivalents will be sufficient to fund operations for at least one year from the date this Quarterly Report on Form 10-Q is filed with the SEC.

Cash used for

La Jolla’s net cash provided by (used for) operating activities for the three months ended March 31, 2021 was $20.6$17.2 million, and $49.2compared to $(12.2) million for the sixsame period in 2020. La Jolla’s net cash provided by (used for) operating activities excluding net receipts in connection with license agreements and payments related to reductions in headcount for the three months ended June 30, 2020 and 2019, respectively. The decrease in cash used for operating activitiesMarch 31, 2021 was a result of decreases in our net loss and changes in working capital, partially offset by decreased non-cash expenses.


Cash used for investing activities was $0.1$(1.8) million, and $0.4 compared to $(9.2) million for the six months ended June 30, 2020 and 2019, respectively. The decreasesame period in cash used for investing activities resulted from the sale of property and equipment, partially offset by purchases of short-term investments.

Cash provided by financing activities was $1.0 million and $0.52020. Net receipts in connection with license agreements were $19.8 million for the sixthree months ended June 30, 2020March 31, 2021, compared to zero for the same period in 2020. Payments related to reductions in headcount were $0.8 million for the three months ended March 31, 2021, compared to $3.0 million for the same period in 2020.

The Company expects to fund future operations with existing cash or cash generated from operations, if any. The amount and 2019, respectively. The increase in cash provided bytiming of additional future funding needs, if any, will depend on many factors, including the success of our commercialization efforts for GIAPREZA and XERAVA and our ability to control expenses. If necessary, we will raise additional capital through equity or debt financings. We can provide no assurance that additional financing activities was primarily the result of net proceeds from issuance of common stock under employee stock plans.


will be available to us on favorable terms, or at all.

Contractual Obligations


HealthCare Royalty Partners Royalty Agreement

In May 2018, we closed a $125.0 million royalty financing agreement (the “Royalty Agreement”) with HealthCare Royalty Partners (“HCR”). Under the terms of the Royalty Agreement, we received $125.0 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. HCR is entitled to receive quarterly royalties on worldwide net sales of GIAPREZA beginning April 1, 2018. Quarterly payments to HCR under the Royalty Agreement start at a maximum royalty rate, with step-downs based on the achievement of annual net product sales thresholds. Through December 31, 2021, the royalty rate will be a maximum of 10%. Starting January 1, 2022, the maximum royalty rate may increase by 4% if an agreed-upon, cumulative net product sales threshold has not been met, and, starting January 1, 2024, the maximum royalty rate may increase by an additional 4% if a different agreed-upon, cumulative net product sales threshold has not been met. The Royalty Agreement is subject to maximum aggregate royalty payments to HCR of $225.0 million. The Royalty Agreement expires upon the first to occur of January 1, 2031 or when the maximum aggregate royalty payments have been made. The Royalty Agreement was entered into by our wholly owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the Royalty Agreement against La Jolla Pharmaceutical Company or any assets other than GIAPREZA.


GIAPREZA.

In-license Agreements

George Washington University

In December 2014, wethe Company entered into a patent license agreement with George Washington University (“GW”), which was subsequently amended and restated on March 1, 2016 (the “GW License”) and subsequently assigned to La Jolla Pharma, LLC. Pursuant to the GW License, GW exclusively licensed to usthe Company certain intellectual property rights relating to GIAPREZA, including the exclusive rights to certain issued patents and patent applications covering GIAPREZA. Under the GW License, we areLa Jolla Pharma, LLC is obligated to use commercially reasonable efforts to develop, commercialize, market and sell GIAPREZA. We haveThe Company has paid a one-time license initiation fee, annual maintenance fees, an amendment fee, additional payments following the achievement of certain development and regulatory milestones and royalties. As a result of the EC’sEuropean Commission’s approval of GIAPREZA in August 2019, wethe Company made a milestone payment to GW in the amount of $0.5 million in the first quarter of 2020. We areThe Company is obligated to pay a 6% royalty on net sales of GIAPREZA.GIAPREZA and 15% on payments received from sublicensees. The patents and patent applications covered by the GW License are expected to expire between 2029 and 2034, and the obligation to pay royalties under this agreement extends through the last-to-expire patent covering GIAPREZA.GIAPREZA.

Harvard University

In August 2006, the Company entered into a license agreement with Harvard University (“Harvard”), which was subsequently amended and restated (the “Harvard License”). Pursuant to the Harvard License, Harvard exclusively licensed to the Company certain intellectual property rights relating to tetracycline-based products, including


XERAVA, including the exclusive rights to certain issued patents and patent applications covering such products. Under the Harvard License, the Company is obligated to use commercially reasonable efforts to develop, commercialize, market and sell tetracycline-based products, including XERAVA. For each product covered by the Harvard License, the Company is obligated to make certain payments for the following: (i) up to approximately $15.1 million upon the achievement of certain clinical development and regulatory milestones; (ii) a 5% royalty on direct U.S. net sales of XERAVA; (iii) a single-digit tiered royalty on direct ex-U.S. net sales of XERAVA, starting at a minimum royalty rate of 4.5%, with step-ups to a maximum royalty of 7.5% based on the achievement of annual net product sales thresholds; and (iv) 20% on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering tetracycline-based products, including XERAVA.

Paratek Pharmaceuticals, Inc.

In March 2019, the Company entered into a license agreement with Paratek Pharmaceuticals, Inc. (“Paratek”), which was subsequently amended and restated (the “Paratek License”). Pursuant to the Paratek License, Paratek non-exclusively licensed to the Company certain intellectual property rights relating to XERAVA, including non-exclusive rights to certain issued patents and patent applications covering XERAVA. The Company is obligated to pay Paratek a 2.25% royalty based on direct U.S. net sales of XERAVA. The Company’s obligation to pay royalties with respect to the licensed product is retroactive to the date of the first commercial sale of XERAVA and shall continue until there are no longer any valid claims of the Paratek patents, which will expire in October 2023.

Out-license Agreements

PAION AG

On January 12, 2021, La Jolla Pharmaceutical Company and certain of its wholly owned subsidiaries, including La Jolla Pharma, LLC, entered into an exclusive license agreement with PAION AG and its wholly owned subsidiary (collectively, “PAION”) (the “PAION License”). Pursuant to the PAION License, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland (collectively, the “PAION Territory”). La Jolla has received an upfront cash payment of $22.5 million, less a 15% refundable withholding tax, and is entitled to receive potential commercial milestone payments of up to $109.5 million and double-digit tiered royalty payments. In addition, royalties payable under the PAION License will be subject to reduction on account of generic competition and after patent expiration in a jurisdiction. Pursuant to the PAION License, PAION will be solely responsible for the future development and commercialization of GIAPREZA and XERAVA in the PAION Territory. PAION is required to use commercially reasonable efforts to commercialize GIAPREZA and XERAVA in the PAION Territory. The Company agreed to use commercially reasonable efforts to negotiate and enter into a separate commercial supply agreement to manufacture drug product for commercial supply. The Company has not yet entered into a commercial supply agreement with PAION, which would set the quantity and timing of commercial supply. The Company has not received any payments from PAION related to either royalties or commercial milestones.

Everest Medicines Limited

In February 2018, the Company entered into a license agreement with Everest, which was subsequently amended and restated (the “Everest License”). Pursuant to the Everest License, the Company granted Everest an exclusive license to develop and commercialize XERAVA for the treatment of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines (collectively, the “Everest Territory”). The Company is eligible to receive an additional $8.0 million regulatory milestone payment and up to an aggregate of $20.0 million in sales milestone payments. The Company is also entitled to receive tiered royalties from Everest at percentages in the low double digits on sales, if any, in the Everest Territory of products containing eravacycline. Royalties are payable with respect to each jurisdiction in the Everest Territory until the latest to occur of: (1) the last-to-expire of specified patent rights in such jurisdiction in the Everest Territory; (2) expiration of marketing or regulatory exclusivity in such jurisdiction in the Everest Territory; or (3) 10 years after the first commercial sale of a product in such jurisdiction in the Everest Territory. The Company agreed to use commercially reasonable efforts to manufacture drug product for clinical development, which will be paid by Everest at the cost to manufacture, as well as manufacture drug product for commercial supply, which will be paid by Everest at cost plus a reasonable margin. During the three months ended March 31, 2021, the Company received a $3.0 million milestone payment associated with the submission of an NDA with the China NMPA for XERAVA for the treatment of cIAI in patients in China.



Off−Balance Sheet Arrangements


We have no off-balanceoff−balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in our financial condition, expenses, results of operations, liquidity, capital expenditures or capital resources.


resources.

Critical Accounting Estimates




We believe the estimates, assumptions and judgments involved in the accounting policies described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of our Form 10-K for the year ended December 31, 20192020 are most critical to understanding and evaluating our reported financial results. During the three and six months ended June 30, 2020,March 31, 2021, other than the license revenue recognition policy described in Note 2 to our condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q, there have been no material changes to the critical accounting policies and estimates as described in Item 7 of our Form 10-K for the year ended December 31, 2019.


2020.

Recent Accounting Pronouncements


See Note 2 to our condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.


Item 3. Quantitative and Qualitative DisclosureDisclosures about Market Risk


We are a smaller reporting company, as defined by Rule 12b-2 under the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.


Item 4. Controls and Procedures


Management’s Evaluation of our Disclosure Controls and Procedures


Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of June 30, 2020,March 31, 2021, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, 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 our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.


Changes in Internal Control over Financial Reporting


There was no change in our internal control over financial reporting that occurred during our most recent quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.



PART II. OTHER INFORMATION



From time to time, we may become subject to claims and litigation arising in the ordinary course of business. We are not a party to any material legal proceedings, nor are we aware of any material pending or threatened litigation.


Item 1A. Risk Factors


Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019.2020. There have been no material changes from the risk factors disclosed in Item 1A of our Annual Report on Form 10-K, except for the additional risk factor set forth below.




Our ability to realize the benefits from the acquisition of Tetraphase Pharmaceuticals, Inc. is substantially dependent on the commercial success of XERAVATM (eravacycline) and the cost savings resulting from the timely and effective integration of the operations of La Jolla and Tetraphase.

Our ability to realize the benefits from the acquisition of Tetraphase is substantially dependent on our ability to successfully commercialize XERAVATM (eravacycline). Combining with La Jolla may not accelerate XERAVA’s availability to patients in need, and our presence in the hospital may not increase with a second innovative therapy. If we are unsuccessful at convincing hospitals and health care providers to increase their rate of adoption of XERAVA, our sales could be adversely affected, and our business could suffer.

Further, our ability to realize the benefits from the acquisition of Tetraphase is substantially dependent on the cost savings resulting from the timely and effective integration of the operations La Jolla and Tetraphase. The process of integrating the operations of La Jolla and Tetraphase could encounter unexpected costs and delays, which include: the loss of key personnel; the loss of key customers; the loss of key suppliers; and unanticipated issues in integrating sales, marketing and administrative functions. If we are unable to timely and effectively integrate the operations of La Jolla and Tetraphase, our costs could be adversely affected, and our business could suffer. Further, even if the integration is timely and effective, we may never realize the cost savings expected from the integration of the operations of our two companies.

The ongoing COVID-19 pandemic may disrupt our operations and affect our ability to sell GIAPREZATM (angiotensin II) and XERAVA.

We are unable to accurately predict the full impact that the ongoing Coronavirus Disease 2019 (“COVID19”) pandemic will have on our results from operations, financial condition and our ability to sell GIAPREZATM (angiotensin II) and XERAVA due to numerous factors that are not within our control, including its duration and severity of the outbreak. Stay-at-home orders, business closures, travel restrictions, supply chain disruptions and employee illness or quarantines could result in disruptions to our operations, which could adversely impact our results from operations and financial condition. In addition, the COVID-19 pandemic has resulted in ongoing volatility in financial markets. If our access to capital is restricted or associated borrowing costs increase as a result of developments in financial markets relating to the COVID-19 pandemic, our operations and financial condition could be adversely impacted.

10-K.

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


None.


Item 3. Defaults upon Senior Securities


None.


Item 4. Mine Safety Disclosures


Not applicable.


Item 5. Other Information


None.



On May 6, 2021, Tetraphase Pharmaceuticals, Inc. (“Tetraphase”), a wholly owned subsidiary of La Jolla Pharmaceutical Company, entered into a commercial supply agreement with Everest Medicines Limited and Everest Medicines (Singapore) Pte. Ltd (collectively, “Everest”) whereby Tetraphase will supply Everest a minimum quantity of XERAVA through December 31, 2023 and will transfer to Everest certain XERAVA-related manufacturing know-how. Pursuant to the supply agreement, Tetraphase is entitled to receive $5.0 million of technology transfer payments in 2021 and will be reimbursed for manufacturing costs at 110% of costs through December 31, 2023.

Item 6. Exhibits

Exhibit

No.

Exhibit Description

31.1

Exhibit No.Exhibit Description

101.INS

Inline XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)



* Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on June 24, 2020, and incorporated herein by reference.



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.


La Jolla Pharmaceutical Company

Date:

August 6, 2020

May 7, 2021

By:

/s/    Larry Edwards

Larry Edwards

Director, President and Chief Executive Officer

(Principal Executive Officer)principal executive officer)

/s/    Michael Hearne

Michael Hearne

Chief Financial Officer

(Principal Financialprincipal financial and Accounting Officer)accounting officer)


22

27