La Jolla Pharmaceutical Company Announces Financial Results for the Three and Six Months Ended June 30, 2019 and Highlights Recent Corporate Progress
Recent Corporate Progress
GIAPREZATM (angiotensin II)
- Net Sales: For the three months ended
June 30, 2019, GIAPREZA net sales were $5.7 million, up 258% from the same period in 2018, and up 30% from the three months ended March 31, 2019. For the six months ended June 30, 2019, GIAPREZA net sales were $10.1 million, up 320% from the same period in 2018.
- Positive CHMP Opinion: In
June 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use(CHMP) adopted a positive opinion for La Jolla’s Marketing Authorisation Application (MAA) for GIAPREZA for the treatment of refractory hypotension in adults with septic or other distributive shock. The CHMP’s positive opinion was sent to the European Commission(EC), which has the authority to approve medicines for the 28 European Unionmember countries. Approval would also be recognized in Iceland, Norwayand Liechtenstein. We expect a final approval decision on the GIAPREZA MAA by the EC in the third quarter of 2019.
- Breakthrough Therapy Designation and Orphan Drug Designation Received from the
FDAfor LJPC-0118 (artesunate): 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 2019and July 2019, respectively. 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. We plan to file a New Drug Application (NDA) for LJPC-0118 with the FDAin the fourth quarter of 2019.
- Positive Results Announced from Pre-Specified Interim Analysis of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis: In
June 2019, we announced positive results from the pre-specified interim analysis of our Phase 2 study of LJPC-401 (synthetic human hepcidin) in patients with hereditary hemochromatosis (HH). The 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). There were 3 phlebotomies in 2 LJPC-401-treated patients and 24 phlebotomies in 9 placebo-treated patients. LJPC-401 was well tolerated. The most frequent treatment-emergent adverse events (TEAEs) were injection site reactions (ISRs). The ISRs were all mild or moderate in severity, and no ISRs resulted in treatment discontinuation. As of the interim analysis, there were no serious TEAEs reported. We expect to announce top-line results of LJ401-HH01 in the fourth quarter of 2019.
“We are pleased with the progress made in the first half of 2019, which included the achievement of significant milestones for each of GIAPREZA, LJPC-0118 and LJPC-401,” said
For the three and six 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 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, a clinical-stage investigational product, is La Jolla’s 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. 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. These statements relate to expectations regarding future events or La Jolla’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. La Jolla cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties and other factors are described in greater detail in La Jolla’s filings with the U.S. Securities and Exchange Commission (
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended
|Six Months Ended
|Net product sales||$||5,703||$||1,593||$||10,098||$||2,402|
|Cost of product sales||551||129||1,051||187|
|Research and development||22,043||30,867||43,287||59,296|
|Selling, general and administrative||11,323||22,164||23,643||45,180|
|Total operating expenses||33,917||53,160||67,981||104,663|
|Loss from operations||(28,214||)||(51,567||)||(57,883||)||(102,261||)|
|Other (expense) income|
|Total other expense, net||(2,202||)||(1,211||)||(4,218||)||(1,045||)|
|Net loss per share, basic and diluted||$||(1.12||)||$||(2.02||)||$||(2.29||)||$||(4.22||)|
|Weighted-average common shares outstanding, basic and diluted||27,108||26,182||27,071||24,462|
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
|Accounts receivable, net||1,893||1,381|
|Prepaid expenses and other current assets||5,089||5,111|
|Total current assets||132,396||181,116|
|Property and equipment, net||20,430||22,267|
|Right-of-use lease asset||16,159||—|
|LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY|
|Accrued payroll and related expenses||4,080||7,509|
|Lease liability, current portion||2,646||—|
|Deferred rent, current portion||—||1,370|
|Total current liabilities||21,981||25,936|
|Lease liability, less current portion||27,890||—|
|Deferred rent, less current portion||—||13,609|
|Deferred royalty obligation, net||124,351||124,323|
|Other noncurrent liabilities||8,265||4,503|
|Shareholders’ (deficit) equity:|
|Common Stock, $0.0001 par value; 100,000,000 shares authorized,
27,125,215 and 26,259,254 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized,
3,906 shares issued and outstanding at June 30, 2019 and December 31, 2018; and liquidation preference of $3,906 at June 30, 2019 and December 31, 2018
|Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized,
0 and 2,737 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at June 30, 2019 and December 31, 2018, respectively
|Additional paid-in capital||966,422||950,258|
|Total shareholders’ (deficit) equity||(12,593||)||35,921|
|Total liabilities and shareholders’ (deficit) equity||$||169,894||$||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