La Jolla Pharmaceutical Company Announces Financial Results for the Three and Nine Months Ended September 30, 2019 and Highlights 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
For the three and nine months ended
IMPORTANT SAFETY INFORMATION
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.
The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.
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
For additional information, please see Full Prescribing Information for
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.
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.
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
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended
|Nine Months Ended
|Net product sales||$||5,706||$||3,470||$||15,804||$||5,872|
|Cost of product sales||554||256||1,605||443|
|Research and development||21,182||30,439||64,469||89,735|
|Selling, general and administrative||10,782||21,139||34,425||66,319|
|Total operating expenses||32,518||51,834||100,499||156,497|
|Loss from operations||(26,812||)||(48,364||)||(84,695||)||(150,625||)|
|Other (expense) income|
|Total other expense, net||(2,362||)||(2,381||)||(6,580||)||(3,426||)|
|Net loss per share, basic and diluted||$||(1.08||)||$||(1.93||)||$||(3.37||)||$||(6.15||)|
|Weighted-average common shares outstanding, basic and diluted||27,135||26,226||27,093||25,055|
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
|Accounts receivable, net||1,417||1,381|
|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||—|
|LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY|
|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|
|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 $2,737 at September 30, 2019 and December 31, 2018, respectively||—||2,737|
|Additional paid-in capital||973,018||950,258|
|Total shareholders’ (deficit) equity||(35,171||)||35,921|
|Total liabilities and shareholders’ (deficit) equity||$||149,139||$||204,292|
Senior Director, Investor Relations & Human Resources
Phone: (858) 207-4264 Ext: 1135
Chief Financial Officer
Phone: (858) 207-4264 Ext: 1040
Source: La Jolla Pharmaceutical Company