La Jolla Pharmaceutical Company Announces Financial Results for the Three and Nine Months Ended September 30, 2019 and Highlights Recent Corporate Progress
SAN DIEGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate progress.
Recent Corporate Progress
- GIAPREZA™ (Angiotensin II) U.S. Net Sales: For the three months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million, up 64% from the same period in 2018. For the nine months ended September 30, 2019, GIAPREZA U.S. net sales were $15.8 million, up 169% from the same period in 2018. La Jolla expects that its full-year 2019 GIAPREZA U.S. net sales will be $22 million to $25 million.
- GIAPREZA European Commission Approval: In August 2019, the European Commission (EC) approved GIAPREZA 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) Orphan Drug Designation: In July 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for LJPC-0118 for the treatment of malaria.
- Positive Results from Pre-Specified Interim Analysis of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis: In June 2019, La Jolla announced positive results from the pre-specified interim analysis of its Phase 2 study of LJPC-401 (synthetic human hepcidin) in patients with hereditary hemochromatosis (HH). The pre-specified interim analysis of efficacy included 26 patients who had reached the end of the 16-week treatment period, and the interim analysis of safety included 60 randomized patients. Treatment with LJPC-401 resulted in a statistically significant reduction in transferrin saturation (TSAT) from baseline to the end of treatment (16 weeks), the primary efficacy endpoint of the study: LJPC‑401‑treated patients had a mean reduction in TSAT of 42% compared to placebo-treated patients who had a mean reduction of 6% (p<0.0001). The requirement for and frequency of phlebotomy procedures, a key secondary endpoint of the study, also was statistically significant: LJPC-401-treated patients had 0.06 phlebotomies per month compared to placebo-treated patients who had 0.41 phlebotomies per month (p=0.003). We expect to announce top-line results from this study in the fourth quarter of 2019.
“Our recent corporate progress has included the approval of GIAPREZA by the European Commission, the granting of Orphan Drug designation for LJPC-0118 for the treatment of malaria by the FDA and positive results from a pre-specified interim analysis of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “In the fourth quarter of 2019, we plan to report top-line results of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis and report the filing of our New Drug Application for LJPC-0118 for the treatment of severe malaria.”
Financial Results
For the three and nine months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million and $15.8 million, respectively, compared to $3.5 million and $5.9 million, respectively, for the same periods in 2018. La Jolla’s net loss for the three and nine months ended September 30, 2019 was $29.2 million and $91.3 million, or $1.08 per share and $3.37 per share, respectively, compared to $50.7 million and $154.1 million, or $1.93 per share and $6.15 per share, respectively, for the same periods in 2018.
As of September 30, 2019, La Jolla had $104.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and nine months ended September 30, 2019 was $18.6 million and $67.8 million, respectively, compared to $36.9 million and $120.3 million, respectively, for the same periods in 2018. La Jolla has no debt. La Jolla expects that its net cash used in operating activities in 2019 will be $88 million to $91 million.
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 regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase 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 (ARB) 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 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies. 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 plans to file a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the fourth quarter of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito, which feeds on humans. Symptoms include but are not limited to: fever, chills, sweating, hypoglycemia and shock. Severe malaria is often complicated by central nervous system infections that may lead to delirium, which may progress to coma. Infections usually occur a few weeks after being bitten. In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 200 million of these cases occurring in the World Health Organization (WHO) African Region, and, in 2013, the global annual incidence of severe malaria was estimated to be 2 million cases. In 2017, an estimated 435,000 people died from malaria worldwide.
About LJPC-401
LJPC‑401 (synthetic human hepcidin) is La Jolla’s investigational product for the potential treatment of conditions characterized by iron overload. 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. La Jolla is 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 (BT), sickle cell disease (SCD), myelodysplastic syndrome (MDS) and polycythemia vera. The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has designated LJPC‑401 as an orphan medicinal product for the treatment of beta thalassemia intermedia and major and SCD. LJPC-401 is being investigated in a pivotal study in BT patients with iron overload and in a Phase 2 study in patients with HH.
About La Jolla Pharmaceutical Company
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. 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. LJPC‑401 (synthetic human hepcidin) is La Jolla’s investigational product for the potential treatment of conditions characterized by iron overload. LJPC-401 is being investigated in a pivotal study in beta thalassemia patients with iron overload and in a Phase 2 study in patients with hereditary hemochromatosis. 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; cash used in operating activities; regulatory actions relating to La Jolla’s products by the U.S. Food and Drug Administration, European Medicines Agency and/or other regulatory authorities; the outcomes of clinical studies of La Jolla’s products; 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 Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | |||||||||||||||
| Net product sales | $ | 5,706 | $ | 3,470 | $ | 15,804 | $ | 5,872 | |||||||
| Total revenue | 5,706 | 3,470 | 15,804 | 5,872 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of product sales | 554 | 256 | 1,605 | 443 | |||||||||||
| Research and development | 21,182 | 30,439 | 64,469 | 89,735 | |||||||||||
| Selling, general and administrative | 10,782 | 21,139 | 34,425 | 66,319 | |||||||||||
| Total operating expenses | 32,518 | 51,834 | 100,499 | 156,497 | |||||||||||
| Loss from operations | (26,812 | ) | (48,364 | ) | (84,695 | ) | (150,625 | ) | |||||||
| Other (expense) income | |||||||||||||||
| Interest expense | (2,863 | ) | (2,926 | ) | (8,398 | ) | (4,581 | ) | |||||||
| Interest income | 501 | 545 | 1,818 | 1,155 | |||||||||||
| Total other expense, net | (2,362 | ) | (2,381 | ) | (6,580 | ) | (3,426 | ) | |||||||
| Net loss | $ | (29,174 | ) | $ | (50,745 | ) | $ | (91,275 | ) | $ | (154,051 | ) | |||
| Net loss per share, basic and diluted | $ | (1.08 | ) | $ | (1.93 | ) | $ | (3.37 | ) | $ | (6.15 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 27,135 | 26,226 | 27,093 | 25,055 | |||||||||||
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
| September 30, 2019 |
December 31, 2018 |
||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash | $ | 104,768 | $ | 172,604 | |||
| Accounts receivable, net | 1,417 | 1,381 | |||||
| Inventory, net | 1,910 | 2,020 | |||||
| Prepaid expenses and other current assets | 4,783 | 5,111 | |||||
| Total current assets | 112,878 | 181,116 | |||||
| Property and equipment, net | 19,523 | 22,267 | |||||
| Right-of-use lease asset | 15,829 | — | |||||
| Restricted cash | 909 | 909 | |||||
| Total assets | $ | 149,139 | $ | 204,292 | |||
| LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 5,338 | $ | 8,572 | |||
| Accrued expenses | 9,351 | 8,485 | |||||
| Accrued payroll and related expenses | 5,118 | 7,509 | |||||
| Lease liability, current portion | 2,705 | — | |||||
| Deferred rent, current portion | — | 1,370 | |||||
| Total current liabilities | 22,512 | 25,936 | |||||
| Lease liability, less current portion | 27,199 | — | |||||
| Deferred rent, less current portion | — | 13,609 | |||||
| Deferred royalty obligation, net | 124,366 | 124,323 | |||||
| Other noncurrent liabilities | 10,233 | 4,503 | |||||
| Total liabilities | 184,310 | 168,371 | |||||
| Shareholders’ (deficit) equity: | |||||||
| Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,147,387 and 26,259,254 shares issued and outstanding at September 30, 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 September 30, 2019 and December 31, 2018; and liquidation preference of $3,906 at September 30, 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 September 30, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at September 30, 2019 and December 31, 2018, respectively | — | 2,737 | |||||
| Additional paid-in capital | 973,018 | 950,258 | |||||
| Accumulated deficit | (1,012,098 | ) | (920,983 | ) | |||
| Total shareholders’ (deficit) equity | (35,171 | ) | 35,921 | ||||
| Total liabilities and shareholders’ (deficit) equity | $ | 149,139 | $ | 204,292 | |||
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
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
