UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
   
FORM 10-Q
   
xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2017March 31, 2018
OR
oTRANSITION 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
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
   
10182 Telesis4550 Towne Centre Court, 6th Floor, San Diego, CA 92121
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (858) 207-4264
   
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one)
Large accelerated fileroAccelerated filerx
Non-accelerated fileroSmaller reporting companyo
  Emerging growth companyo
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 7(a)(2)(B) of the Securities Act.o


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

As of October 20, 2017,April 23, 2018, La Jolla Pharmaceutical Company had 22,145,24326,154,439 shares of common stock $0.0001 par value per share, outstanding.
 



LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT

TABLE OF CONTENTS

 
  
 
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  





PART I. FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except share and par value amounts)

September 30,
2017
 December 31,
2016
March 31,
2018
 December 31,
2017
(Unaudited)  (Unaudited)  
ASSETS      
Current assets:      
Cash and cash equivalents$120,840
 $65,726
$154,408
 $90,915
Restricted cash911
 200
Inventory820
 
Prepaid expenses and other current assets1,772
 1,505
6,326
 3,147
Total current assets123,523
 67,431
161,554
 94,062
Property and equipment, net6,534
 3,145
24,438
 24,568
Other assets
 219
Restricted cash909
 909
Total assets$130,057
 $70,795
$186,901
 $119,539
      
LIABILITIES AND SHAREHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable$6,239
 $6,652
$7,321
 $11,484
Accrued clinical and other expenses795
 1,029
4,280
 703
Accrued payroll and related expenses3,228
 2,077
3,044
 4,995
Deferred rent, current portion1,370
 1,370
Total current liabilities10,262
 9,758
16,015
 18,552
Deferred rent, less current portion13,473
 12,785
Total liabilities29,488
 31,337
Shareholders’ equity:      
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,145,243 and 18,261,557 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively2
 2
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at September 30, 2017 and December 31, 2016, and liquidation preference of $3,906 at September 30, 2017 and December 31, 2016
3,906
 3,906
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737 shares issued and outstanding at September 30, 2017 and December 31, 2016, and liquidation preference of $2,737 at September 30, 2017 and December 31, 20162,737
 2,737
Common Stock, $0.0001 par value; 100,000,000 shares authorized,
26,154,439 and 22,167,529 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively
3
 2
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized,
3,906 shares issued and outstanding at March 31, 2018 and December 31, 2017, and liquidation preference of $3,906 at March 31, 2018 and December 31, 2017
3,906
 3,906
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized,
2,737 shares issued and outstanding at March 31, 2018 and December 31, 2017, and liquidation preference of $2,737 at March 31, 2018 and December 31, 2017
2,737
 2,737
Additional paid-in capital796,118
 661,103
922,809
 803,071
Accumulated deficit(682,968) (606,711)(772,042) (721,514)
Total shareholders’ equity119,795
 61,037
157,413
 88,202
Total liabilities and shareholders’ equity$130,057
 $70,795
$186,901
 $119,539

See accompanying notes to the condensed consolidated financial statements.



LA JOLLA PHARMACEUTICAL COMPANY
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)

Three Months Ended 
 September 30,
 
Nine Months Ended
September 30,
Three Months Ended 
 March 31,
2017 2016 2017 20162018 2017
Revenue          
Contract revenue - related party$
 $44
 $
 $531
Net product sales$809
 $
Total revenue
 44
 
 531
809
 
Expenses       
Operating expenses   
Cost of product sales58
 
Research and development19,093
 16,992
 57,666
 42,111
28,429
 17,765
General and administrative7,390
 4,349
 18,915
 11,868
Total expenses26,483
 21,341
 76,581
 53,979
Selling, general and administrative23,016
 5,503
Total operating expenses51,503
 23,268
Loss from operations(26,483) (21,297) (76,581) (53,448)(50,694) (23,268)
Other income, net195
 46
 324
 150
166
 28
Net loss$(26,288) $(21,251) $(76,257) $(53,298)$(50,528) $(23,240)
Basic and diluted net loss per share$(1.19) $(1.23) $(3.65) $(3.10)
Weighted-average common shares outstanding - basic and diluted22,125
 17,211
 20,900
 17,211
Net loss per share, basic and diluted$(2.22) $(1.26)
Weighted-average common shares outstanding, basic and diluted22,742
 18,410

See accompanying notes to the condensed consolidated financial statements.



LA JOLLA PHARMACEUTICAL COMPANY
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)

Nine Months Ended
September 30,
Three Months Ended
March 31,
2017 20162018 2017
Operating activities      
Net loss$(76,257) $(53,298)$(50,528) $(23,240)
Adjustments to reconcile net loss to net cash used for operating activities:      
Share-based compensation expense14,429
 10,804
9,402
 4,983
Third party share-based compensation expense747
 167
Depreciation expense899
 510
992
 281
Loss on disposal of equipment
 75
132
 
Changes in operating assets and liabilities:      
Restricted cash(711) 37
Inventory(820) 
Prepaid expenses and other current assets(267) (660)(3,179) (182)
Other assets219
 (149)
 199
Accounts payable(413) (508)(4,163) (2,479)
Accrued clinical and other expenses(234) 2,693
3,577
 (439)
Accrued payroll and related expenses1,151
 231
(1,951) (1,167)
Deferred rent688
 
Net cash used for operating activities(60,437) (40,098)(45,850) (22,044)
      
Investing activities      
Purchase of property and equipment(4,288) (1,419)(994) (750)
Net cash used for investing activities(4,288) (1,419)(994) (750)
      
Financing activities      
Net proceeds from the issuance of common stock117,480
 
109,809
 117,480
Proceeds from the exercise of stock options for common stock2,359
 85
528
 2,074
Net cash provided by financing activities119,839
 85
110,337
 119,554
      
Net increase (decrease) in cash and cash equivalents55,114
 (41,432)
Cash and cash equivalents at beginning of period65,726
 126,467
Cash and cash equivalents at end of period$120,840
 $85,035
Net increase in cash, cash equivalents and restricted cash63,493
 96,760
Cash, cash equivalents and restricted cash at beginning of period91,824
 65,926
Cash, cash equivalents and restricted cash at end of period$155,317
 $162,686
   
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheetsReconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets
Cash and cash equivalent$154,408
 $162,382
Restricted cash, current portion
 304
Restricted cash, less current portion909
 
Total cash, cash equivalent and restricted cash$155,317
 $162,686

See accompanying notes to the condensed consolidated financial statements.



LA JOLLA PHARMACEUTICAL COMPANY

Notes to Condensed Consolidated Financial Statements
(Unaudited)

September 30, 2017March 31, 2018

1. Business

La Jolla Pharmaceutical Company (collectively with its subsidiaries, the Company) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has severalGIAPREZATM (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. LJPC-401 (synthetic human hepcidin), a clinical-stage investigational product, candidates in development. LJPC-501 is the Company’s proprietary formulation of synthetic human angiotensin II for the potential treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. LJPC-401 is the Company’s proprietary formulation of synthetic human hepcidinbeing developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. The Company was incorporated in 1989 as a Delaware corporation and reincorporated in California in 2012.

As of September 30, 2017,March 31, 2018, the Company had $120.8$154.4 million in cash and cash equivalents.equivalents, compared to $90.9 million in cash and cash equivalents as of December 31, 2017. On a pro-forma basis, adjusting for the net proceeds from the May 2018 royalty financing (see Note 5), the Company’s cash and cash equivalents as of March 31, 2018 were $279 million. Based on ourthe Company’s current operating plans and projections, management believes that available cash and cash equivalents are 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 (SEC). The Company was incorporated in 1989 as a Delaware corporation and reincorporated in California in 2012.

2. Summary of Significant Accounting Policies

During the three and nine months ended September 30, 2017,March 31, 2018, there have been no changes to the Company’s significant accounting policies as described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2016.2017, except as described below.

Basis of Presentation and Use of Estimates

The accompanying unaudited 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 10 of the SEC Regulation S-X. Accordingly, they should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 20162017 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 23, 2017.22, 2018. The accompanying unaudited condensed consolidated financial statements include the accounts of La Jolla Pharmaceutical Company and its wholly-owned subsidiaries. All significant inter-company transactions and balances have been eliminated in consolidation. The unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated balance sheet of the Company at September 30, 2017,March 31, 2018, the condensed consolidated statement of operations for the three and nine months ended September 30, 2017March 31, 2018 and the condensed consolidated statement of cash flows for the ninethree months ended September 30, 2017.March 31, 2018. Estimates were made relating to useful lives of inventory, fixed assets, return and valuation allowances, impairment of assets, share-based compensation expense and accruals for clinical studies and research and development expenses.expense. Actual results could differ materially from those estimates. Certain amounts previously reported in the financial statements have been reclassified to conform to the current presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows. The results of operations for the three and nine months ended September 30, 2017March 31, 2018 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 at December 31, 20162017 has been derived from the audited consolidated balance sheet at December 31, 20162017 contained in the above referenced Annual Report on Form 10-K.

Comprehensive LossInventory

Comprehensive loss forInventory is stated at the periods reported was comprised solelylower of cost or estimated net realizable value, on a first-in, first-out (FIFO) basis. The Company periodically analyzes its inventory levels and writes down inventory as cost of product sales when: inventory has become obsolete; inventory has a cost basis in excess of its estimated net realizable value; or inventory quantities are in excess of expected sales.



Revenue Recognition

The Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 606 - Revenue from Contracts with Customers (ASC 606) at the time of its first commercial shipment of GIAPREZA in the first quarter of 2018. The Company had no revenue from product sales prior to the first quarter of 2018.

Under ASC 606, the Company recognizes revenue when distributors (our customers) obtain control of the Company’s net loss. The comprehensive lossproduct, 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 threescope of ASC 606, the Company performs the following five 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 nine months ended September 30, 2017 was $26.3 million and $76.3 million, respectively, and for(v) recognize revenue when (or as) the three and nine months ended September 30, 2016 was $21.3 million and $53.3 million, respectively. There were no other changes in equity that were excluded from net loss for all periods presented.entity satisfies a performance obligation.

Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns and other allowances offered to our customers. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. 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.

Chargebacks. Chargebacks are discounts the Company provides to distributors in the event that the sales prices to end users are below the distributors’ price they acquire the product from the Company. The accrual for distributor chargebacks is estimated based on known chargeback rates. Estimates for chargebacks are recorded as a reduction of revenue and accounts receivable upon delivery to the Company’s customers.

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

Returns. The Company offers customers a limited right of return, generally for damaged or expired product. To date, there have been no product returns. The Company estimates returns based on an analysis of comparable companies. The estimates for returns are recorded as a reduction of revenue and accounts receivable upon delivery to the Company’s customers.

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

Net Loss per Share

Basic net loss per share is calculated based on the weighted-average number of common shares outstanding, excluding unvested restricted stock awards. Diluted net loss per share is calculated usingbased on the weighted-average number of common shares outstanding plus common stock equivalents. Convertible preferred stock, stock options, warrants and unvested restricted stock awards are considered common stock equivalents and are included in the calculation of diluted net loss per share using the treasury stock method when their effect is dilutive. Common stock equivalents are excluded from the calculation of diluted net loss per share when their effect is anti-dilutive. As of September 30,March 31, 2018 and 2017, and 2016, there were common stock equivalents of 11.914.1 million shares and 11.211.4 million shares, respectively, of common stock equivalents, which were excluded from the calculation of diluted net loss per share because they weretheir effect was anti-dilutive.

Recent Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In May 2017, the Financial Accounting Standards Board (FASB)FASB issued Accounting Standard Update (ASU) 2017-09, Compensation - Stock Compensation (Topic 718), Scope of Modification Accounting. The new standard clarifies when to account for a change toin the terms or conditions of a share-based payment award as a modification. ASU 2017-09 will beThe standard is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2017. The Company adopted the Companystandard in the first quarter of 2018. Early adoption is permitted, including adoption in an interim period for which financial statements have not yet been issued. The Company plans to adopt the ASU in the first quarterAdoption of 2018 and expects the standard todid not have noa material impact on the Company’s financial position or results of operations.



In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The new standard update clarifies the presentation of restricted cash and cash equivalents and requires companies to include restricted cash and cash equivalents in the beginning and ending balances of cash and cash equivalents on the statement of cash flows. AdditionalThe standard also requires additional disclosures will be required to describe the amount and detail of the restriction by balance sheet line item. ASU 2016-18 will beThe standard is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2017. The Company adopted the Companystandard in the first quarter of 2018. Early adoptionAccordingly, restricted cash is permitted, including adoption in an interim period usingincluded as a retrospective transition method to each period presented. The Company plans to adopt the ASUcomponent of cash, cash equivalents and restricted cash in the first quarterunaudited condensed consolidated statement of 2018.

In February 2016,cash flows for all periods presented, and we have disclosed the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right-of-use assetsamount and eliminates certain real estate-specific provisions. ASU 2016-02 will be effective for the Company in the first quarter of 2019 and will be adopted on a modified retrospective transition basis for leases existing at, or entered into after, the beginningdetail of the earliest comparative period presented in the financial statements. The Company currently plans to implement ASU 2016-02 in the first quarter of 2019. By 2019, all of the Company’s active existing leases will have ended. Those leases will not have an impact on the consolidated financial statements upon adoption in 2019, and there will be no requirement for modified retrospective application to the years prior to adoption. In December 2016, the Company entered into a 10-year lease agreement for its corporate headquarters. The expected lease commencement date is November 1, 2017. Upon adoption of ASU 2016-02, this lease will be recognized on therestriction by balance sheet as a lease liability with a corresponding right-of-use asset, which would require modified retrospective application upon adoption in 2019 back to the fourth quarter of 2017.line item.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, the FASB has issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations and principal versus agent considerations. Topic 606The Company adopted the standard in the first quarter of 2018. Refer to the revenue recognition disclosure above.

Not Yet Adopted Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The standard requires lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right-of-use assets and eliminates certain real estate-specific provisions. ASU 2016-02 will be effective for the Company in the first quarter of 20182019 and allows for full retrospective or awill be adopted with modified retrospective adoption approach. We currently do notapplication for the Company’s 10-year lease agreement for its corporate headquarters, which commenced October 30, 2017. This lease will be recognized on the balance sheet as a lease liability with a corresponding right-of-use asset, which will require modified retrospective application back to the fourth quarter of 2017 and for all of 2018. All of the Company’s other leases will have any products or revenues from customers. Accordingly,ended by the adoptionfirst quarter of this standard2019 and, therefore, will not have a material impact onrequire modified retrospective disclosures applied within the Company’sconsolidated financial position or results of operations. The Company plans to implement the requirements prospectivelystatements upon recognition of the first revenue from customers, and there will not be any retrospective impact to our financial statements. The Contract Revenue - Related Party reported in our results of operations for 2015 and 2016, which represents expense reimbursements from a related party, will not be impacted by the adoption of the new guidance.    standard.

3. Contract Revenue - Related PartyCash, Cash Equivalents and Restricted Cash

DuringRestricted cash as of March 31, 2018 represents a standby letter of credit for the year ended DecemberCompany’s building lease in lieu of a security deposit during the term of such lease. There is a requirement to maintain a $0.9 million collateral cash account pledged as security for such letter of credit. Restricted cash as of March 31, 2015,2017 represents collateral cash pledged for the Company entered intoCompany’s credit card arrangements of $0.2 million and a services agreement withstandby letter of credit for the Company’s prior lease in lieu of a related party. Pursuant tosecurity deposit during the services agreement, the Company provides certain services to this related party, including, but not limited to, research and development and clinical study design and management for projects undertaken. In exchange for providing such services, the Company receives payments at a negotiated, arms-length rate. As a result, the consideration received by the Company for its services is considered to be no less favorable to the Company than comparable terms that the Company could


obtain from an unaffiliated third party in an arms-length transaction. The services agreement may be canceled by either party upon 60-days’ written notice to the other party. In addition, the Company has a non-voting profit interest in the related party, which provides the Company with the potential to receive a portionterm of the future distributionslease of profits, if any.

No contract revenue was recognized for the three and nine months ended September 30, 2017. For the three and nine months ended September 30, 2016, the Company recognized approximately $44,000 and $531,000, respectively, in contract revenue for services provided and reimbursement of costs incurred under the services agreement.    $0.1 million.

4. Shareholders’ Equity
 
2017 Common Stock Offering

In March 2017, the Company offered and sold an aggregate of 3,731,344 shares of common stock in an underwritten public offering at a price of $33.50 per share withfor gross proceeds of approximately $125.0 million. The Company received proceeds of approximately $117.5 million, net of approximately $7.5 million in underwriting commissions, discounts and other issuance costs.

Share-Based Compensation Expense2018 Common Stock Offering

Total share-based compensation expense related to all share-based awardsIn March 2018, the Company offered and sold 3,910,000 shares of common stock in an underwritten public offering at a price of $29.50 per share for the three and nine months ended September 30, 2017 and 2016 was comprisedgross proceeds of the following (in thousands):
 Three Months Ended 
 September 30,
 
Nine Months Ended
September 30,
 2017 2016 2017 2016
Research and development:       
   Stock options$3,068
 $1,678
 $8,083
 $4,154
   Restricted stock
 
 
 30
   Warrants24
 10
 58
 25
Research and development share-based compensation expense3,092
 1,688
 8,141
 4,209
General and administrative:       
   Stock options2,203
 1,666
 6,151
 4,934
   Restricted stock
 516
 409
 1,645
   Warrants187
 56
 475
 183
General and administrative share-based compensation expense2,390
 2,238
 7,035
 6,762
Total share-based compensation expense included in expenses$5,482
 $3,926
 $15,176
 $10,971

Share-based compensation expense recognized for the three and nine months ended September 30, 2017 and 2016, was reduced by actual forfeitures in the period that the forfeiture occurred.

As of September 30, 2017, there was $55.3 million of total unrecognized share-based compensation expense related to non-vested stock options.approximately $115.3 million. The Company expects to recognize this expense over a weighted-average periodreceived proceeds of 3.0 years.approximately $109.8 million, net of approximately $5.5 million in underwriting commissions, discounts and other issuance costs.

Stock Option Valuation

The fair value of each stock option award is estimated on the grant date using a Black-Scholes option pricing model (Black-Scholes model), which uses the assumptions noted in the following table. Expected volatility is based on historical volatility of the Company’s common stock. In determining the expected life of employee stock options, the Company uses the “simplified” method. The expected life assumptions for non-employee options are based upon the contractual term of the stock options. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the stock options in effect at the time of the grants. The dividend yield assumption is based on the expectation of no future dividend payments by the Company.


The Company estimated the fair value of each stock option grant on the grant date using the Black-Scholes model with the following weighted-average assumptions:
 
Nine Months Ended
September 30,
 2017 2016
Expected volatility143% 141%
Expected life6.19 years
 5.74 years
Risk-free interest rate2.0% 1.3%
Dividend yield
 

Stock Option Activity

The Company’s 2013 Equity Plan stock option activity under its option plans for the ninethree months ended September 30, 2017March 31, 2018 was comprised of the following:
Outstanding Stock Options and 2013 Equity Plan
Shares
Underlying
Stock Options
 
Weighted-
average
Exercise Price
per Share
Shares
Underlying
Stock Options
 
Weighted-
Average
Exercise Price
per Share
Outstanding at December 31, 20162,627,462
 $21.07
Outstanding at December 31, 20176,037,302
 $24.19
Granted1,879,925
 $22.97
701,900
 $30.02
Exercised(152,342) $15.48
(33,854) $15.62
Forfeited(93,608) $21.77
(84,178) $24.77
Outstanding at September 30, 20174,261,437
 $22.09
Outstanding at March 31, 20186,621,170
 $24.84

As of September 30, 2017,March 31, 2018, there were 3,673,8831,258,010 shares of common stock available for future grants under the 2013 Equity Plan,its option plans, and the Company has reserved an additional 4,201,4376,621,170 shares of common stock for future issuance upon exercise of all outstanding stock options granted under the 2013 Equity Plan.its option plans.

During the ninethree months ended September 30, 2017,March 31, 2018, stock options to purchase 152,34233,854 shares of common stock were exercised with an intrinsic value of $2.9$0.5 million.
Share-based Compensation Expense

Restricted Stock Award Activity

The Company’s restricted stock award activityTotal share-based compensation expense related to all share-based awards for the ninethree months ended September 30,March 31, 2018 and 2017 was comprised of the following:following (in thousands):
 
Number of
Shares
 
Weighted-
Average Grant
Date Fair
Market Value
Unvested at December 31, 2016542,680
 $13.22
Vested(542,680) $13.22
Unvested at September 30, 2017
 $
 Three Months Ended 
 March 31,
 2018 2017
Research and development:   
   Stock options$5,386
 $2,453
   Warrants10
 17
Research and development share-based compensation expense5,396
 2,470
Selling, general and administrative:   
   Stock options4,006
 1,955
   Restricted stock
 409
   Warrants
 149
Selling, general and administrative share-based compensation expense4,006
 2,513
Total share-based compensation expense$9,402
 $4,983

As of March 31, 2018, $103.7 million of total unrecognized share-based compensation expense related to unvested stock options remains and is expected to be recognized over a weighted-average period of 3.2 years.
    
Warrants

At September 30, 2017,As of March 31, 2018, the Company had outstanding warrants to purchase 93,01310,000 shares of common stock. In January 2017,During the three months ended March 31, 2018, the Company issued a warrant to purchase up to 25,01343,056 shares of common stock in a cashless exercise of 83,013 warrants to a third-party warrant holder.

5. Subsequent Events

On May 10, 2018, the Company closed a $125 million royalty financing agreement with HealthCare Royalty Partners (HCR). Under the terms of the agreement, the Company will receive $125 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. Payments under the agreement start annually at a maximum royalty rate, with step-downs based on the achievement of annual net 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 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 sales threshold has not been met. The agreement is subject to maximum aggregate royalty payments to HCR of 180% of the $125 million to be received by the Company, at which time the payment obligations under the agreement would expire. The agreement was entered into by the Company’s common stock to an outside third party at an exercise price equal towholly owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the fair market value ofagreement against the Company’s common stock on the grant date.Company or any assets other than GIAPREZA.





ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

In this report, all references to “we,” “our,” “us,” “La Jolla” and the “Company”“the Company” refer to La Jolla Pharmaceutical Company, a California corporation, and its subsidiaries.subsidiaries on a consolidated basis.

Forward-LookingForward-looking Statements

The forward-looking statements in this report involve significant risks, assumptions and uncertainties and a number of factors, both foreseen and unforeseen, which could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Accordingly, you should not rely uponon forward-looking statements as predictions of future events. Forward-looking statements include, but are not limited to, statements regarding risks relating to: our ability to successfully commercialize, market and achieve market acceptance of GIAPREZATM (angiotensin II) and other product candidates; our ability to meet the demand for GIAPREZA in a timely manner; potential market sizes for our products and product candidates, including the market for the treatment of septic or distributive shock; the cost of producing GIAPREZA; unforeseen safety issues from the administration of GIAPREZA and our other product candidates in patients; the timing and prospects for approval of LJPC-501GIAPREZA by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other regulatory authorities; risks relating to the scope of product label(s) (if approved) and potential market sizes, as well as the broader commercial opportunity for the Company'sGIAPREZA and our other product candidates; the impact of pharmaceutical industry regulation and health carehealthcare legislation in the United States; the success of future development activities; potential indications for which the Company’s product candidates may be developed; the timing, costs, conduct and outcome of clinical studies; the anticipated treatment of future clinical data by the FDA, EMA and other regulatory authorities, including whether such data will be sufficient for approval; and the expected duration over which the Company’s cash balances will fund our operations. The outcomes of the events described in these forward-looking statements are subject to the risks, uncertainties and other factors described in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the “Risk Factors” section contained in our Annual Report on Form 10-K for the year ended December 31, 2016,2017, filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2017,22, 2018, and in other reports and registration statements that we file with the SEC from time to time.SEC. We expressly disclaim any intent to update forward-looking statements.

Introduction

Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to the accompanying unaudited condensed consolidated financial statements and notes, which are included in Item 1 of this Quarterly Report on Form 10-Q, to help provide an understanding of our financial condition, the changes in our financial condition and our results of operations. Our discussion is organized as follows:
Business Overview. This section provides a general description of our business and significant events and transactions that we believe are important in understanding our financial condition and results of operations.
Program Overview. This section provides a current status overview for each of our product candidates in development.
Critical Accounting Policies and Estimates. This section provides a description of our significant accounting policies, including the critical accounting policies and estimates, which are summarized in Note 2 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.
Results of Operations. This section provides an analysis of our results of operations presented in the accompanying unaudited condensed consolidated statements of operations by comparing the results for the three and nine months ended September 30, 2017March 31, 2018 to the results for the three and nine months ended September 30, 2016.March 31, 2017.
Liquidity and Capital Resources. This section provides an analysis of our historical cash flows, as well as our future capital requirements.

Business Overview

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. We have severalGIAPREZATM (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. LJPC-401 (synthetic human hepcidin), a clinical-stage investigational product, candidates in development. LJPC-501 is our proprietary formulation of synthetic human angiotensin IIbeing developed for the potential treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. LJPC-401 is our proprietary formulation of synthetic human hepcidin for the


potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome.



Program Overview

LJPC-501GIAPREZATM (angiotensin II)

LJPC-501 is our proprietary formulationGIAPREZATM (angiotensin II), injection for intravenous infusion, was approved by the FDA on December 21, 2017 as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In March 2018, we announced the commercial availability of synthetic human angiotensin II.GIAPREZA. Angiotensin II is thea major bioactive component of the renin-angiotensin-aldosterone system (RAAS). The RAAS is one of three central regulators of blood pressure. LJPC-501 is a first

There are approximately 800,000 distributive shock cases in classthe U.S. each year. Of these cases, an estimated 90% are septic shock patients. Approximately 300,000 patients do not achieve adequate blood pressure response with initial vasopressor that leverages the RAAS. LJPC-501 is being developedtherapy and require additional therapy for the treatment of hypotension in adult patients with distributive or vasodilatory shock (dangerously low blood pressure with adequate cardiac function) who remain hypotensive despite fluid and vasopressor therapy (catecholamines and/or vasopressin).

Distributive or vasodilatory shock can become life-threatening when a patient is unablepressure. The Center for Disease Control estimates that approximately 250,000 people in the U.S. die each year from septic shock. The inability to achieve or maintain target mean arterialadequate blood pressure (MAP) despite treatmentresults in inadequate blood flow to the body’s organs and tissue and is associated with the currently available standard of care (fluids and vasopressors). This life-threatening syndrome has been described as clinically refractory hypotension, catecholamine resistant hypotension, high-dose vasopressor-dependent shock, catecholamine or vasopressor refractory shock or catecholamine-resistant vasodilatory shock. There are approximately 500,000 distributive or vasodilatory shock patients in the United States per year with an estimated 200,000 patients failing standard therapy. Approximately 50% of these patients die within 30 days.a mortality rate exceeding most acute conditions requiring hospitalization.

In March 2015, we initiated a Phase 3 study of LJPC-501GIAPREZA in adult patients with distributiveseptic or vasodilatoryother distributive shock who remain hypotensive despite fluid and vasopressor therapy, calledknown as the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study. Prior to commencing ATHOS-3, we reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this multicenter, randomized, double-blind, placebo-controlled, Phase 3 study. ATHOS-3 was conducted without any amendment to any part of the clinical protocol subject to the SPA agreement, including the primary endpoint and all other endpoints. In ATHOS-3, patients were randomized in a 1:1 fashion to receive either: (i) LJPC-501GIAPREZA plus standard-of-care vasopressors; or (ii) placebo plus standard-of-care vasopressors. Randomized patients received their assigned treatment via continuous IV infusion for up to seven7 days. The primary efficacy endpoint was the percentage of patients with a MAP ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3three hours following the initiation of study treatment without an increase in standard-of-care vasopressors. Secondary endpoints include comparison of changes in cardiovascular Sequential Organ Failure Assessment (SOFA) scores and the safety and tolerability of LJPC-501.

The ATHOS-3 Phase 3 study completed enrollment of 344 patients in the fourth quarter of 2016. In February 2017, we reported positive top-line results from ATHOS-3. In May 2017, the results of ATHOS-3 were published by The New England Journal of Medicine.Medicine.

The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treatedGIAPREZA-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treatedGIAPREZA-treated patients.

Throughout ATHOS-3, safety outcomes were followed by an independent Data Safety Monitoring Board (DSMB). The DSMB recommended that the study continue as originally planned. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treatedGIAPREZA-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treatedGIAPREZA-treated patients discontinued treatment due to an adverse event.

In August 2017, the FDA accepted for review our NDA for LJPC-501 for the treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The review classification for the NDA is Priority, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its letter to us, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application.

In August 2017, we initiated an expanded access program in the United States to provide LJPC-501 to adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. Expanded access, sometimes known as compassionate use, is an option facilitated by the FDA to make available prior to regulatory approval investigational medicine(s) for the treatment of serious or life-threatening diseases or conditions where there are no ongoing clinical trials and there is a lack of satisfactory therapeutic alternatives.     

In September 2017, an analysis from ATHOS-3, entitled “Baseline“Baseline angiotensin levels and ACE effects in patients with vasodilatory shock treated with angiotensin II,” was presented during the 30th30th European Society of Intensive Care Medicine


Annual Congress. The pre-specified analysis showed that a relatively low angiotensin II state (as measured by the ratio of angiotensin I to angiotensin II) predicted increased mortality in patients with vasodilatory shock, suggesting that a low angiotensin II state is a negative prognostic indicator of outcomes. Furthermore, the analysis showed a statistically significant treatment effect of LJPC-501GIAPREZA compared to placebo on mortality in these patients with a relatively low angiotensin II state (relative risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047).

In September 2017, we reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC-501.GIAPREZA. Based on this Advice, we intend to submit a Marketing Authorization Application (MAA) for LJPC-501GIAPREZA in the third quarter of 2018.

In December 2017, GIAPREZA™ (angiotensin II) was approved by the FDA to increase blood pressure in adults with septic or other distributive shock.

In February 2018, an abstract, entitled “Effect of Disease Severity on Survival in Patients Receiving Angiotensin II for Vasodilatory Shock,” was presented at the Society of Critical Care Medicine’s (SCCM) 47th Critical Care Congress. The abstract, which was published in the January Supplement of Critical Care Medicine, includes results from a pre-specified


analysis from the ATHOS-3 Phase 3 study of GIAPREZA in patients with high severity of illness, defined as an APACHE II (Acute Physiology and Chronic Health Evaluation II) score > 30 or baseline MAP < 65 mmHg, despite treatment with high-dose vasopressors. The authors presented data showing a lower 28-day mortality rate in patients with baseline APACHE II scores > 30 in the GIAPREZA group versus the placebo group: 28-day mortality was 51.8% (n = 58) for the GIAPREZA group compared to 70.8% (n = 65) for the placebo group (hazard ratio=0.62 [95% CI: 0.39, 0.98; p=0.037]). In patients with a baseline MAP < 65 mmHg, a trend towards improved 28-day mortality was seen in the GIAPREZA group compared to the placebo group: 28-day mortality was 54.2% (n = 52) for the GIAPREZA group compared to 70.4% (n = 50) for the placebo group (hazard ratio=0.66 [95% CI: 0.40, 1.09; p=0.10]).

In March 2018, an analysis, entitled “Outcomes in Patients with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory Shock,” was presented at the 23rd International Conference on Advances in Critical Care Nephrology AKI & CRRT 2018. The manuscript of this analysis, entitled “Outcomes in patients with vasodilatory shock and renal replacement therapy treated with intravenous angiotensin II,” was published online in Critical Care Medicine. The presentation and manuscript detail the outcomes of patients with acute kidney injury (AKI) and vasodilatory shock enrolled in the ATHOS-3 study of GIAPREZA. In this post-hoc analysis, the data from 105 AKI patients (GIAPREZA n=45; placebo n=60) requiring renal replacement therapy (RRT) at study drug initiation were analyzed. Survival through day 28 was 53% (95% CI: 38%-67%) for the GIAPREZA group compared to 30% (95% CI: 19%-41%) for the placebo group (p = 0.012). By day 7, 38% (95% CI: 25%-54%) of patients treated with GIAPREZA discontinued RRT compared to 15% (95% CI: 8%-27%) of patients treated with placebo (p = 0.007). Mean arterial pressure (MAP) response at hour 3 was achieved in 53% (95% CI: 38%-68%) of patients treated with GIAPREZA compared to 22% (95% CI: 12%-34%) of patients treated with placebo (p = 0.001).

In March 2018, we announced the commercial availability of GIAPREZA. GIAPREZA is available in 1 mL single-dose vials, each containing 2.5 mg of angiotensin II (as a sterile liquid).

LJPC-401

LJPC-401, a clinical-stage investigational product, is our proprietary formulation of synthetic human hepcidin. Hepcidin, an endogenous peptide hormone, is the body’s naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death.

We are developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia, sickle cell disease (SCD) and myelodysplastic syndrome (MDS).

HH is a disease characterized by a genetic deficiency in hepcidin. HH is the most common genetic disease in Caucasians and causes liver cirrhosis, liver cancer, heart disease and/or failure, diabetes, arthritis and joint pain. There are no FDA approved therapies for HH and the current standard treatment for HH is a blood removal procedure known as phlebotomy. Each phlebotomy procedure, which is usually conducted at a hospital, medical office or blood center, typically involves the removal of approximately one pint of blood. The required frequency of procedures varies by patient but often ranges from one to two times per week for an initial period after diagnosis and once every one to three months for life. Since most of the body’s iron is stored in red blood cells, chronic removal of blood can effectively lower iron levels if a phlebotomy regimen is adhered to. However, phlebotomy procedures may cause and may be associated with pain, bruising and scarring at the venous puncture site, fatigue and dizziness during and following the procedure and disruption of daily activities. Furthermore, phlebotomy is not appropriate in patients with poor venous access, anemia or heart disease.

Beta thalassemia, SCD and MDS are genetic diseases of the blood that can cause life-threatening anemia and usually require frequent and life-long blood transfusions. These blood transfusions cause excessive iron accumulation in the body, which is toxic to vital organs, such as the liver and heart. In addition, the underlying anemia causes excessive iron accumulation independent of blood transfusions.

In 2015, the EMA Committee for Orphan Medicinal Products (COMP) designated LJPC-401 as an orphan medicinal product for the treatment of beta thalassemia intermedia and major. In 2016, the EMA COMP designated LJPC-401 as an orphan medicinal product for the treatment of SCD.

In September 2016, we reported positive results from a Phase 1 study of LJPC-401 in patients at risk of iron overload suffering from HH, thalassemia and SCD. Single,In this study, single, escalating doses of LJPC-401 were associated with a dose-dependent, statistically significant reduction in serum iron. LJPC-401 was well-tolerated with no dose-limiting toxicities. Injection-site reactions were the most commonly reported adverse event and were all mild or moderate in severity, self-limiting and fully resolved.

Also in

In September 2016, we announced that we reached agreement with the EMA on the design of a pivotal study of LJPC-401. The pivotal study will be a randomized, controlled, multicenter study inLJPC-401 for the treatment of beta thalassemia patients suffering from iron overload, a major unmet need in an orphan patient population. This study, which we refer to as LJ401-BT01, was initiated in December 2017. LJ401-BT01 is designed to enroll approximately 100 patients across 9 countries, including the U.S. Patients will be randomized 1:1 to receive either: (i) weekly subcutaneous injections of LJPC‑401, while continuing standard-of-care chelation therapy (LJPC‑401 treatment arm); or (ii) a continuation of standard-of-care chelation therapy only (observation arm). After 6 months of treatment, patients randomized to the observation arm will cross over to receive LJPC‑401 (plus standard-of-care chelation therapy) for 6 months, while patients randomized to the LJPC-401 treatment arm will continue with LJPC-401 (plus standard-of-care chelation therapy) for an additional 6 months (for a total of one year). The primary efficacy endpoint will be a clinically relevant measurement directly related to iron overload. We plan to initiateof this study is the change in iron content in the fourth quarter of 2017.heart after 6 months, as measured by cardiac magnetic resonance imaging (MRI). If this study is successful, we would anticipate filing an MAA for LJPC-401 in Europe.

LJPC-30S

LJPC-30SIn December 2017, we announced the initiation of LJ401-HH01, a Phase 2 clinical study of LJPC‑401 in patients with HH. LJ401-HH01 is our next-generation gentamicin derivative program. Despite kidney toxicity, gentamicin has becomea multinational, multicenter, randomized, placebo-controlled, double-blind, Phase 2 study that is designed to evaluate the safety and efficacy of LJPC-401 as a treatment for HH. Approximately 60 patients will be randomized to receive weekly subcutaneous injections of either LJPC‑401 or placebo for 12 weeks. The primary efficacy endpoint of the study is the change in transferrin saturation, a standard measurement of iron levels in the body and one of the most commonly prescribed hospital antibiotics duetwo key measurements used to its broad spectrumdetect iron overload, from baseline to end of antimicrobial efficacy. Gentamicin consists primarilytreatment. Secondary efficacy endpoints include: (i) the change in serum ferritin, the other key measurement used to detect iron overload, from baseline to end of a mixturetreatment; and (ii) the requirement for and frequency of four distinct but closely related chemical entities that may contribute differentially tophlebotomy procedures used during the product’s toxicity profile.

study.
Our LJPC-30S program has been focused on therapeutics derived from purified components of the currently marketed gentamicin product that retain the biologic activity of gentamicin, yet appear to lack the traditional kidney toxicity associated with its use. Based on a recent reprioritization of our research pipeline, which took into account competitive developments in the antibiotic field together with the status of our other programs, we have decided to no longer dedicate resources to this program.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and


liabilities. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

There have been no material changes to the critical accounting policies as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2016,2017, which was filed on February 23, 2017.22, 2018, except for the newly adopted inventory and revenue recognition policies disclosed in Note 2 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

Recent Accounting Pronouncements

Recent accounting pronouncements are disclosed in Note 2 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

Results of Operations

The following summarizes the results of our operations for the three and nine months ended September 30,March 31, 2018 and 2017 and 2016 (in thousands):
Three Months Ended 
 September 30,
 
Nine Months Ended
September 30,
Three Months Ended 
 March 31,
2017 2016 2017 20162018 2017
Contract revenue - related party$
 $44
 $
 $531
Net product sales$809
 $
Cost of product sales(58) 
Research and development expense(19,093) (16,992) (57,666) (42,111)(28,429) (17,765)
General and administrative expense(7,390) (4,349) (18,915) (11,868)
Selling, general and administrative(23,016) (5,503)
Other income, net195
 46
 324
 150
166
 28
Net loss$(26,288) $(21,251) $(76,257) $(53,298)$(50,528) $(23,240)

Contract Revenue - Related Party

DuringRevenue

In March 2018, we announced the yearcommercial availability of GIAPREZA.

Cost of Product Sales

For the three months ended DecemberMarch 31, 2015,2018, we entered into a services agreement with arecognized cost of product sales of $58,000 for sales of GIAPREZA, primarily related party. Pursuant to royalty, labeling, shipping and distribution costs. A portion of the services agreement, we provide certain servicescost to this related party, including, but not limitedmanufacture GIAPREZA was recorded to research and development and clinical study design and management for projects undertaken. Contract revenue is a function of the availability of potential projects identified by our customer and our ability and willingness to take on such projects. As such, this revenue may be significantly reduced in future periods, as has happened for the three and nine months ended September 30, 2017. In exchange for providing such services, we receive payments at a negotiated, arms-length rate. As a result, the consideration received by us for our services is considered to be no less favorable to us than comparable terms that we could obtain from an unaffiliated third party in an arms-length transaction. The services agreement may be canceled by either party upon 60-days’ written noticeexpense prior to the other party. In addition, we have a non-voting profit interest inapproval of GIAPREZA by the related party, which provides us with the potential to receive a portion of the future distributions of profits, if any.FDA.

No contract revenue was recognized for the three and nine months ended September 30, 2017. For the three and nine months ended September 30, 2016, we recognized approximately $44,000 and $531,000, respectively, in contract revenue for services provided and reimbursement of costs incurred under the agreement.



Research and Development Expense

The following summarizes our research and development expense for the three and nine months ended September 30,March 31, 2018 and 2017 and 2016 (in thousands):

Three Months Ended 
 September 30,
 
Nine Months Ended
September 30,
Three Months Ended 
 March 31,
2017 2016 2017 20162018 2017
Clinical development costs$6,744
 $9,438
 $24,895
 $22,740
$9,793
 $7,994
Personnel and related costs6,955
 3,690
 17,659
 9,067
9,164
 5,271
Share-based compensation expense3,092
 1,688
 8,141
 4,209
5,396
 2,470
Technology in-licensing costs181
 199
 451
 384
119
 253
Other research and development costs2,121
 1,977
 6,520
 5,711
3,957
 1,777
Total research and development expense$19,093
 $16,992
 $57,666
 $42,111
$28,429
 $17,765

ForDuring the three and nine months ended September 30, 2017,March 31, 2018, research and development expense increased to $19.1$28.4 million, and $57.7 million, respectively, from $17.0 million and $42.1compared to $17.8 million for the same periods in 2016, respectively.three months ended March 31, 2017. The increase was primarily driven bydue to increased personnel and related costs and share-based compensation expense as a result of increased headcount associated with the development of LJPC-501GIAPREZA and LJPC-401. We anticipate research and development expense to increase during the remainder of 2017throughout 2018 due to planned increases in personnel to support the continuation of our clinical development of GIAPREZA and LJPC-401, the initiation of additional clinical studies and ongoing development for ourof other product candidates and pre-commercialization activities for LJPC-501.candidates.

Selling, General and Administrative Expense

The following summarizes our selling, general and administrative expense for the three and nine months ended September 30,March 31, 2018 and 2017 and 2016 (in thousands):
Three Months Ended 
 September 30,
 
Nine Months Ended
September 30,
Three Months Ended 
 March 31,
2017 2016 2017 20162018 2017
Personnel and related costs$1,971
 $1,008
 $4,765
 $2,707
$9,586
 $1,354
Share-based compensation expense2,390
 2,238
 7,035
 6,762
4,006
 2,513
Other general and administrative expense3,029
 1,103
 7,115
 2,399
Total general and administrative expense$7,390
 $4,349
 $18,915
 $11,868
Other selling, general and administrative expense9,424
 1,636
Total selling, general and administrative expense$23,016
 $5,503

During the three and nine months ended September 30, 2017,March 31, 2018, selling, general and administrative expense increased to $7.4$23.0 million, and $18.9 million, respectively, from $4.3 million and $11.9compared to $5.5 million for the same periods in 2016, respectively.three months ended March 31, 2017. The increase was primarily due to increased personnel and related costs, share-based compensation and professionalcommercialization and outside services associated with our increasedpromotional activities to support the product launch of GIAPREZA and the development and pre-commercialization activities.of other product candidates. We anticipate selling, general and administrative expense to increase throughout 20172018 due to planned increases in personnelcommercial activities related to GIAPREZA and professional and outside services to support ongoing development for ourof other product candidates and pre-commercialization activities for LJPC-501.candidates.

Liquidity and Capital Resources

Since January 2012, when the Company was effectively restarted with new assets and a new management team, through September 30, 2017,March 31, 2018, our cash used in operating activities was $164.0$234.4 million. From inception through September 30, 2017,March 31, 2018, we


have incurred a cumulative net loss of $683.0$772.0 million and have financed our operations through public and private offerings of securities, revenues from collaborative agreements, equipment financings and interest income on invested cash balances. From inception through September 30, 2017,March 31, 2018, we have raised $706.0$816.1 million in net proceeds from the sales of equity securities.

In March 2017, we completed a common stock offering and received proceeds of approximately $117.5 million, net of issuance costs.



As of September 30, 2017,March 31, 2018, we had $120.8$154.4 million in cash and cash equivalents, compared to $65.7$90.9 million of cash and cash equivalents at December 31, 2016. Based on our cash and working capital as of September 30, 2017 and our current operating plans and projections, we believe that2017. On a pro-forma basis, adjusting for the availablenet proceeds from the May 2018 royalty financing, the Company’s cash and cash equivalents will beas of March 31, 2018 were $279 million. Cash used for operating activities for the three months ended March 31, 2018 was $45.9 million, compared to $22.0 million for the same period in 2017. The increase in cash used for operating activities was a result of the increase in our net loss, primarily offset by changes in working capital and increases in share-based compensation and depreciation expense. For the three months ended March 31, 2018, we used $1.0 million of cash for investing activities, compared to $0.8 million for the same period in 2017. The increase in cash used for investing activities was a result of purchases of property and equipment. Cash provided by financing activities for the three months ended March 31, 2018 was $110.3 million, compared to $119.6 million for the same period in 2017. The cash provided by financing activities for the three months ended March 31, 2018 was due to $109.8 million of proceeds from the March 2018 common stock offering and $0.5 million of proceeds from the exercise of stock options for common stock.

Based on the cash and cash equivalent resources available as of March 31, 2018, management believes that the Company has sufficient resources 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 in operating activities for the nine months ended September 30, 2017 was $60.4 million, compared to $40.1 million for the same period in 2016. The increase was primarily due to increased research and development activities. For the nine months ended September 30, 2017, we used $4.3 million of cash for investing activities related to purchases of property and equipment, compared to $1.4 million for the same period in 2016. Cash provided by financing activities for the nine months ended September 30, 2017 was $119.8 million, compared to $0.1 million for the same period in 2016. The increase was due to $117.5 million of proceeds from the March 2017 common stock offering and $2.4 million of proceeds from the exercise of stock options for common stock. As of September 30, 2017, we had positive working capital of $113.3 million, compared to positive working capital of $57.7 million at December 31, 2016. The increase in our cash and cash equivalents and working capital was primarily due to the cash provided by financing activities offset by cash used for operating and investing activities.

To fund future operations to the point where we are able to generate positive cash flow from the sales or out-licensing of our drug candidates, we will need to raise additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and prospects for approval of LJPC-501 by the FDA, the timing and results of our ongoing development efforts, the potential expansion of our current development programs, potential new development programs and related general and administrative support, as well as the overall condition of capital markets, including capital markets for development-stage and clinical-stage biopharmaceutical companies. We anticipate that we will seek to fund our operations through public and private equity and debt financings or other sources, such as potential collaboration agreements. Although we have previously been successful in obtaining financing through equity securities offerings, there can be no assurance that we will be able to do so in the future.

Off-Balance Sheet Arrangements

We have no off-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.


ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to financial market risks, including changes in interest rates. There were no material changes to our market risks in the ninethree months ended September 30, 2017,March 31, 2018, when compared to the disclosures in Item 7A of our Annual Report Form 10-K for the year ended December 31, 2016,2017, filed with the SEC on February 23, 2017.

22, 2018.

ITEM 4. CONTROLS AND PROCEDURES

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports, filed under the Securities Exchange Act of 1934, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As required by the SEC Rule 13a-15(b), we carried out an evaluation under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on the foregoing,


our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

ThereOther than controls implemented in connection with the newly adopted inventory and revenue recognition policies as disclosed in Note 2 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q, there has been no change in our internal control over financial reporting 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

ITEM 1. LEGAL PROCEEDINGS

In the ordinary course of business, we may face various claims brought by third parties. Any of these claims could subject us to costly litigation. As of the date of this report, we are not currently a party to any legal proceedings
that we believe could have a material adverse effect on our business, financial condition or results of operations. However, litigation is inherently uncertain, and any judgment or injunctive relief entered against us or any adverse settlement could negatively affect our business, financial condition and results of operations.

ITEM 1A. RISK FACTORS

No material changes to risk factors have occurred as previously disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2016,2017, filed with the SEC on February 23, 2017, as supplemented by those risk factors set forth under the caption “Risk Factors” in our Prospectus Supplement, dated March 22, 2017, filed with the SEC on March 24, 2017 pursuant to Rule 424(b), which are incorporated herein by reference.2018.

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.



ITEM 6. EXHIBITS

   Incorporated by Reference Herein
Exhibit Number DescriptionFormDate
 
Filed herewith 
 
Filed herewith 
 
Filed herewith 
101.INS XBRL Instance Document
Filed herewith 
101.SCH XBRL Taxonomy Extension Schema Document
Filed herewith 
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
Filed herewith 
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
Filed herewith 
101.LAB XBRL Taxonomy Extension Label Linkbase Document
Filed herewith 
101.PRE XBRL Taxonomy Extension Presentation Linkbase DocumentFiled herewith



SIGNATURES

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

  La Jolla Pharmaceutical Company
   
Date:October 26, 2017May 10, 2018/s/    George F. Tidmarsh
  George F. Tidmarsh, M.D., Ph.D.
  President, Chief Executive Officer and Secretary
  (Principal Executive Officer)
   
  /s/    Dennis M. Mulroy
  Dennis M. Mulroy
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

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