La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2018 and Highlights Recent Corporate Progress and Key Objectives
Recent Corporate Progress and Key Objectives
GIAPREZATM (angiotensin II)
- 2018 Net Sales: Fourth-quarter 2018 net sales were
$4.2 million, up 20% from the third quarter of 2018. 2018 net sales were $10.1 million. GIAPREZA was launched in March 2018.
- 2019 Net Sales Guidance: La Jolla expects 2019 net sales of
$24 million to $28 million.
- Decision on GIAPREZA MAA by EMA Expected in June of 2019: La Jolla expects a decision on the GIAPREZA Marketing Authorisation Application (MAA) by the
European Medicines Agency(EMA) in June of 2019.
Investigational Products Update
- NDA Planned for New Investigational Product, LJPC-0118, for the Treatment of Severe Malaria, in Fourth Quarter of 2019: La Jolla plans to file a New Drug Application (NDA) with the
U.S. Food and Drug Administration( FDA) in the fourth quarter of 2019 for LJPC-0118. LJPC-0118 is La Jolla’s new investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.
- Topline Results of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis Expected in Second Half of 2019: La Jolla expects topline results in the second half of 2019 for LJ401-HH01, a multinational, multicenter, randomized, Phase 2 study that is designed to evaluate the safety and efficacy of LJPC-401, La Jolla’s proprietary formulation of synthetic human hepcidin, as a treatment for hereditary hemochromatosis (HH). The primary efficacy endpoint of the study is the change in transferrin saturation, a standard measurement of iron levels in the body and one of the two key measurements used to detect iron overload, from baseline to end of treatment.
- Topline Results of Pivotal Study of LJPC-401 in Patients with Beta Thalassemia Expected in Mid-2020: La Jolla expects topline results in mid-2020 for LJ401-BT01, a pivotal, multinational, multicenter, randomized, controlled study that is designed to evaluate the safety and efficacy of LJPC-401 as a treatment for beta thalassemia (BT) patients who, despite chelation therapy, have cardiac iron levels above normal. The primary efficacy endpoint of this study is the change in iron content in the heart after 6 months, as measured by cardiac magnetic resonance imaging (MRI). If this study is successful, La Jolla anticipates filing an MAA for LJPC-401 in the
“We are excited to have launched GIAPREZA, our first commercial product, in 2018, and we look forward to executing on a number of initiatives that we believe will support its continued, increased adoption in 2019,” said
For the three months ended
Conference Call Details
La Jolla will host a conference call and webcast today,
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.
LJPC-0118 is La Jolla’s investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies. La Jolla plans to file a New Drug Application (NDA) with the
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, 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, including, but not limited to, statements related to La Jolla’s expectations regarding net sales and net cash used in operating activities for the full-year 2019, the expectations regarding future clinical and regulatory milestones, such as NDA submission and expected timing for commencement and completion of clinical studies. 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 (
Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended
|Net product sales||$||4,184||$||—||$||10,056||$||—|
|Cost of product sales||1,200||—||1,643||—|
|Research and development||27,567||26,909||117,302||84,575|
|Selling, general and administrative||18,843||11,937||85,162||30,852|
|Total operating expenses||47,610||38,846||204,107||115,427|
|Loss from operations||(43,426||)||(38,846||)||(194,051||)||(115,427||)|
|Other (expense) income|
|Total other (expense) income, net||(1,992||)||300||(5,418||)||624|
|Net loss per share, basic and diluted||$||(1.73||)||$||(1.74||)||$||(7.85||)||$||(5.41||)|
|Weighted-average common shares outstanding, basic and diluted||26,242||22,151||25,422||21,215|
Consolidated Balance Sheets
(in thousands, except share and par value amounts)
|Cash and cash equivalents||$||172,604||$||90,915|
|Accounts receivable, net||1,381||—|
|Prepaid expenses and other current assets||5,111||3,147|
|Total current assets||181,116||94,062|
|Property and equipment, net||22,267||24,568|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Accrued payroll and related expenses||7,509||4,995|
|Deferred rent, current portion||1,370||1,370|
|Total current liabilities||30,439||18,552|
|Deferred rent, less current portion||13,609||12,785|
|Deferred royalty obligation, net||124,323||—|
|Commitments and contingencies|
|Common Stock, $0.0001 par value; 100,000,000 shares authorized,
26,259,254 and 22,167,529 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively
|Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized,
3,906 shares issued and outstanding at December 31, 2018 and December 31, 2017,
and a liquidation preference of $3,906 at December 31, 2018 and 2017
|Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized,
2,737 shares issued and outstanding at December 31, 2018 and December 31, 2017,
and a liquidation preference of $2,737 at December 31, 2018 and 2017
|Additional paid-in capital||950,258||803,071|
|Total shareholders’ equity||35,921||88,202|
|Total liabilities and shareholders’ equity||$||204,292||$||119,539|
Director, Investor Relations & Human Resources
Phone: (858) 207-4264 Ext: 1135
Chief Financial Officer
Phone: (858) 207-4264 Ext: 1040