SAN DIEGO, May 04, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three months ended March 31, 2020.
For the three months ended March 31, 2020, GIAPREZA U.S. net sales were $7.6 million, up 73% from the three months ended March 31, 2019 and up 5% from the three months ended December 31, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 58% for the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 and decreased 1% as compared to the three months ended December 31, 2019.
La Jolla’s net loss for the three months ended March 31, 2020 was $8.6 million, or $0.32 per share, compared to $31.7 million, or $1.17 per share, for the same period in 2019.
As of March 31, 2020, La Jolla had $77.2 million in cash, compared to $87.8 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $12.2 million, compared to $32.7 million for the same period in 2019. La Jolla has no debt.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
IMPORTANT SAFETY INFORMATION
Contraindications
None.
Warnings and Precautions
There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.
Adverse Reactions
The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
LJPC-0118 (I.V. artesunate) is La Jolla’s investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was compared to quinine in patients with severe falciparum malaria infection in two randomized, active-controlled, clinical studies. In both studies, in-hospital mortality in the artesunate group was statistically significantly lower than in-hospital mortality in the quinine group. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla filed a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the second half of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito. Symptoms include: fever, chills, sweating, hypoglycemia and shock. In 2013, an estimated 2 million cases of severe malaria occurred worldwide. In 2018, an estimated 405,000 people died from malaria worldwide.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. For more information, please visit www.ljpc.com.
Forward-looking Statements
This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA™ (angiotensin II) sales; regulatory actions relating to La Jolla’s products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts)
March 31, 2020
December 31, 2019
(Unaudited)
ASSETS
Current assets:
Cash
$
77,219
$
87,820
Accounts receivable, net
3,552
2,960
Inventory, net
1,960
2,211
Prepaid expenses and other current assets
3,383
4,467
Total current assets
86,114
97,458
Property and equipment, net
16,038
18,389
Right-of-use lease asset
15,146
15,491
Restricted cash
909
909
Total assets
$
118,207
$
132,247
LIABILITIES AND SHAREHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$
1,895
$
4,177
Accrued expenses
7,675
9,312
Accrued payroll and related expenses
3,649
8,332
Lease liability, current portion
2,828
2,766
Total current liabilities
16,047
24,587
Lease liability, less current portion
25,745
26,481
Deferred royalty obligation, net
124,392
124,379
Other noncurrent liabilities
13,692
12,790
Total liabilities
179,876
188,237
Shareholders’ deficit:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,276,734 and 27,195,469 shares issued and outstanding at March 31, 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 March 31, 2020 and December 31, 2019; and liquidation preference of $3,906 at March 31, 2020 and December 31, 2019
3,906
3,906
Additional paid-in capital
980,344
977,432
Accumulated deficit
(1,045,922
)
(1,037,331
)
Total shareholders’ deficit
(61,669
)
(55,990
)
Total liabilities and shareholders’ deficit
$
118,207
$
132,247
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except per share amounts)
Three Months Ended March 31,
2020
2019
Revenue
Net product sales
$
7,591
$
4,395
Total revenue
7,591
4,395
Operating expenses
Cost of product sales
716
500
Research and development
9,183
21,244
Selling, general and administrative
8,152
12,320
Total operating expenses
18,051
34,064
Loss from operations
(10,460
)
(29,669
)
Other income (expense)
Interest expense
(2,406
)
(2,729
)
Interest income
190
713
Other income—related party
4,085
—
Total other expense, net
1,869
(2,016
)
Net loss
$
(8,591
)
$
(31,685
)
Net loss per share, basic and diluted
$
(0.32
)
$
(1.17
)
Weighted-average common shares outstanding, basic and diluted
27,238
27,035
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands)
Three Months Ended March 31,
2020
2019
Operating activities
Net loss
$
(8,591
)
$
(31,685
)
Adjustments to reconcile net loss to net cash used for operating activities:
Share-based compensation expense
2,407
6,711
Depreciation and amortization expense
1,060
1,130
Loss on disposal of equipment
148
15
Non-cash interest expense
1,682
2,310
Non-cash rent expense
345
316
Changes in operating assets and liabilities:
Accounts receivable, net
(592
)
(618
)
Inventory, net
251
43
Prepaid expenses and other current assets
1,084
(28
)
Accounts payable
(2,282
)
(5,531
)
Accrued expenses
(2,404
)
742
Accrued payroll and related expenses
(4,683
)
(5,473
)
Lease liability
(674
)
(618
)
Net cash used for operating activities
(12,249
)
(32,686
)
Investing activities
Proceeds from the sale of property and equipment
1,143
—
Purchase of property and equipment
—
(184
)
Net cash provided by (used for) investing activities
1,143
(184
)
Financing activities
Net proceeds from issuance of common stock under 2013 Equity Plan
305
—
Net proceeds from issuance of common stock under ESPP
200
283
Net cash provided by financing activities
505
283
Net decrease in cash and restricted cash
(10,601
)
(32,587
)
Cash and restricted cash at beginning of period
88,729
173,513
Cash and restricted cash at end of period
$
78,128
$
140,926
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
$
77,219
$
140,017
Restricted cash
909
909
Total cash and restricted cash
$
78,128
$
140,926
Company Contacts
Sandra Vedrick Senior Director, Investor Relations La Jolla Pharmaceutical Company Phone: (858) 207-4264 Ext: 1135 Email: svedrick@ljpc.com
and
Dennis Mulroy Chief Financial Officer La Jolla Pharmaceutical Company Phone: (858) 207-4264 Ext: 1040 Email: dmulroy@ljpc.com
