SAN DIEGO, March 02, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq: 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 and twelve months ended December 31, 2019.
For the three months ended December 31, 2019, GIAPREZA U.S. net sales were $7.3 million, up 74% from the three months ended December 31, 2018 and up 28% from the three months ended September 30, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 74% for the three months ended December 31, 2019 as compared to the three months ended December 31, 2018 and 18% as compared to the three months ended September 30, 2019. GIAPREZA U.S. net sales were $23.1 million in 2019 compared to $10.1 million in 2018, an increase of 129%. La Jolla announced the commercial availability of GIAPREZA in the U.S. in March 2018.
La Jolla’s net loss for the three and twelve months ended December 31, 2019 was $25.2 million and $116.5 million, or $0.93 per share and $4.30 per share, respectively, compared to $45.4 million and $199.5 million, or $1.73 per share and $7.85 per share, respectively, for the same periods in 2018.
As of December 31, 2019, La Jolla had $87.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and twelve months ended December 31, 2019 was $17.1 million and $85.0 million, respectively, compared to $32.0 million and $152.4 million, respectively, for the same periods in 2018. 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. GIAPREZA is marketed 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.
For additional information, please see Full Prescribing Information for the United States.
About LJPC-0118
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
Consolidated Balance Sheets
(in thousands, except par value and share amounts)
| December 31, 2019 | December 31, 2018 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash | $ | 87,820 | $ | 172,604 | |||
| Accounts receivable, net | 2,960 | 1,381 | |||||
| Inventory, net | 2,211 | 2,020 | |||||
| Prepaid expenses and other current assets | 4,467 | 5,111 | |||||
| Total current assets | 97,458 | 181,116 | |||||
| Property and equipment, net | 18,389 | 22,267 | |||||
| Right-of-use lease asset | 15,491 | — | |||||
| Restricted cash | 909 | 909 | |||||
| Total assets | $ | 132,247 | $ | 204,292 | |||
| LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 4,177 | $ | 8,572 | |||
| Accrued expenses | 9,312 | 8,485 | |||||
| Accrued payroll and related expenses | 8,332 | 7,509 | |||||
| Lease liability, current portion | 2,766 | — | |||||
| Deferred rent, current portion | — | 1,370 | |||||
| Total current liabilities | 24,587 | 25,936 | |||||
| Lease liability, less current portion | 26,481 | — | |||||
| Deferred rent, less current portion | — | 13,609 | |||||
| Deferred royalty obligation, net | 124,379 | 124,323 | |||||
| Other noncurrent liabilities | 12,790 | 4,503 | |||||
| Total liabilities | 188,237 | 168,371 | |||||
| Shareholders’ (deficit) equity: | |||||||
| Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,195,469 and 26,259,254 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 3 | 3 | |||||
| Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at December 31, 2019 and December 31, 2018; and liquidation preference of $3,906 at December 31, 2019 and December 31, 2018 | 3,906 | 3,906 | |||||
| Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 0 and 2,737 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at December 31, 2019 and December 31, 2018, respectively | — | 2,737 | |||||
| Additional paid-in capital | 977,432 | 950,258 | |||||
| Accumulated deficit | (1,037,331 | ) | (920,983 | ) | |||
| Total shareholders’ (deficit) equity | (55,990 | ) | 35,921 | ||||
| Total liabilities and shareholders’ (deficit) equity | $ | 132,247 | $ | 204,292 | |||
LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | |||||||||||||||
| Net product sales | $ | 7,250 | $ | 4,184 | $ | 23,054 | $ | 10,056 | |||||||
| Total revenue | 7,250 | 4,184 | 23,054 | 10,056 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of product sales | 787 | 1,200 | 2,392 | 1,643 | |||||||||||
| Research and development | 20,860 | 27,567 | 85,329 | 117,302 | |||||||||||
| Selling, general and administrative | 10,709 | 18,843 | 45,134 | 85,162 | |||||||||||
| Total operating expenses | 32,356 | 47,610 | 132,855 | 204,107 | |||||||||||
| Loss from operations | (25,106 | ) | (43,426 | ) | (109,801 | ) | (194,051 | ) | |||||||
| Other (expense) income | |||||||||||||||
| Interest expense | (2,376 | ) | (2,722 | ) | (10,774 | ) | (7,303 | ) | |||||||
| Interest income | 310 | 730 | 2,128 | 1,885 | |||||||||||
| Other income—related party | 1,939 | — | 1,939 | — | |||||||||||
| Total other expense, net | (127 | ) | (1,992 | ) | (6,707 | ) | (5,418 | ) | |||||||
| Net loss | $ | (25,233 | ) | $ | (45,418 | ) | $ | (116,508 | ) | $ | (199,469 | ) | |||
| Net loss per share, basic and diluted | $ | (0.93 | ) | $ | (1.73 | ) | $ | (4.30 | ) | $ | (7.85 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 27,169 | 26,242 | 27,112 | 25,422 | |||||||||||
LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Statements of Cash Flows
(in thousands)
| Year Ended December 31, | |||||||
| 2019 | 2018 | ||||||
| Operating activities | |||||||
| Net loss | $ | (116,508 | ) | $ | (199,469 | ) | |
| Adjustments to reconcile net loss to net cash used for operating activities: | |||||||
| Share-based compensation expense | 23,733 | 35,151 | |||||
| Depreciation and amortization expense | 4,552 | 4,405 | |||||
| Loss on disposal of equipment | 24 | 236 | |||||
| Non-cash interest expense | 8,775 | 6,797 | |||||
| Non-cash rent expense | 1,307 | — | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable, net | (1,579 | ) | (1,381 | ) | |||
| Inventory, net | (191 | ) | (2,020 | ) | |||
| Prepaid expenses and other current assets | 644 | (1,964 | ) | ||||
| Accounts payable | (4,395 | ) | (2,912 | ) | |||
| Accrued expenses | 395 | 5,451 | |||||
| Accrued payroll and related expenses | 823 | 2,514 | |||||
| Lease liability | (2,530 | ) | — | ||||
| Deferred rent | — | 824 | |||||
| Net cash used for operating activities | (84,950 | ) | (152,368 | ) | |||
| Investing activities | |||||||
| Purchase of property and equipment | (698 | ) | (2,340 | ) | |||
| Net cash used for investing activities | (698 | ) | (2,340 | ) | |||
| Financing activities | |||||||
| Net proceeds from issuance of common stock under ESPP | 833 | 391 | |||||
| Net proceeds from issuance of common stock under 2013 Equity Plan | 31 | 1,908 | |||||
| Net proceeds from royalty financing | — | 124,289 | |||||
| Net proceeds from the issuance of common stock | — | 109,809 | |||||
| Net cash provided by financing activities | 864 | 236,397 | |||||
| Net (decrease) increase in cash and restricted cash | (84,784 | ) | 81,689 | ||||
| Cash and restricted cash at beginning of period | 173,513 | 91,824 | |||||
| Cash and restricted cash at end of period | $ | 88,729 | $ | 173,513 | |||
| 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 | $ | — | |||
| Interest paid | $ | 1,999 | $ | 506 | |||
| Reconciliation of cash and restricted cash to the consolidated balance sheets | |||||||
| Cash | $ | 87,820 | $ | 172,604 | |||
| Restricted cash | 909 | 909 | |||||
| Total cash and restricted cash | $ | 88,729 | $ | 173,513 | |||
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