StockSelector.com
  Research, Select, & Monitor Tuesday, October 16, 2018 3:38:14 PM ET  
Trade Ideas The Market Industries Stocks Portfolio

 
Ticker Lookup
La Jolla Pharmaceutical Company$17.32$1.076.58%

  Quote | Ranking | Chart | Valuations | Sentiment | Industry | News | Earnings | Analysts | More...

Your Target?

 La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2017 and Recent Corporate Progress
   Thursday, February 22, 2018 5:16:55 PM ET

La Jolla Pharmaceutical Company (LJPC ), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and twelve months ended December 31, 2017 and highlighted recent corporate progress.

Recent Corporate Progress

-- In December 2017, GIAPREZA(TM) (angiotensin II), injection for intravenous infusion, formerly known as LJPC-501, 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 December 2017, La Jolla announced the initiation of LJ401-HH01, a multinational, multicenter, randomized, placebo-controlled, double-blind, Phase 2 study that is designed to evaluate the safety and efficacy of LJPC-401 (synthetic human hepcidin) as a treatment for hereditary hemochromatosis (HH). Approximately 60 patients in 5 countries will be randomized to receive weekly subcutaneous injections of either LJPC-401 or placebo for 12 weeks. 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. Secondary efficacy endpoints include: (i) the change in serum ferritin, the other key measurement used to detect iron overload, from baseline to end of treatment; and (ii) the requirement for and frequency of phlebotomy procedures used during the study.

-- In December 2017, La Jolla announced the initiation of LJ401-BT01, a pivotal, multinational, multicenter, randomized, controlled study of LJPC-401 in patients with transfusion-dependent beta thalassemia who, despite chelation therapy, have cardiac iron levels above normal. Approximately 100 patients in 9 countries, including the U.S., will be randomized 1:1 to receive either: (i) weekly subcutaneous injections of LJPC-401, while continuing standard-of-care chelation therapy (LJPC-401 treatment arm); or (ii) a continuation of standard-of-care chelation therapy only (observation arm). After 6 months of treatment, patients randomized to the observation arm will cross over to receive LJPC-401 (plus standard-of-care chelation therapy) for 6 months, while patients randomized to the LJPC-401 treatment arm will continue with LJPC-401 (plus standard-of-care chelation therapy) for an additional 6 months (for a total of one year). 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, we would anticipate filing a market authorization application (MAA) for LJPC-401 in Europe.

"2017 was an exciting year for La Jolla, highlighted by the FDA’s approval of GIAPREZA," said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. "We are excited to bring this new treatment option to the many critically ill patients suffering from septic or other distributive shock."

Results of Operations

As of December 31, 2017, La Jolla had $90.9 million in cash and cash equivalents, compared to $65.7 as of December 31, 2016. La Jolla’s net cash used for operating activities for the twelve months ended December 31, 2017 was $84.9 million compared to net cash used for operating activities of $58.7 million for the same period in 2016. La Jolla’s net loss for the three and twelve months ended December 31, 2017 was $38.5 million and $114.8 million, or $1.74 per share and $5.41 per share, respectively, compared to a net loss of $24.9 million and $78.2 million, or $1.44 per share and $4.54 per share, respectively, for the same periods in 2016.

About GIAPREZA

In December 2017, GIAPREZA(TM) (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. In the ATHOS-3 Phase 3 study, the primary endpoint of: (i) a mean arterial pressure (MAP) increase of greater-than or equal to 10 mmHg; or (ii) a MAP of greater-than or equal to 75 mmHg, was achieved by 70% of patients randomized to GIAPREZA, compared to 23% of patients randomized to placebo (p < 0.0001); both arms were treated with standard-of-care vasopressors. The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg/min via continuous intravenous infusion. Close monitoring during the first 5 minutes of GIAPREZA initiation is recommended. GIAPREZA is available in 1 mL single dose vials, each containing 2.5 mg of angiotensin II (as a sterile liquid). Prescribing information for GIAPREZA is available at www.giapreza.com.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled Phase 3 study, ATHOS-3. There was a higher incidence of venous and arterial thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.

Adverse Reactions

Adverse reactions that occurred in greater-than or equal to4% of patients treated with GIAPREZA and greater-than or equal to1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia and peripheral ischemia.

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.

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. GIAPREZA(TM) (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. LJPC??’401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. For more information, please visit www.ljpc.com.

Forward-looking Statements

This press release contains forward-looking statements, as that term is defined in 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 (SEC), all of which are available free of charge on the SEC’s website www.sec.gov. These risks include, but are not limited to, risks relating to: our ability to successfully commercialize, market and achieve market acceptance of GIAPREZA and other product candidates; potential market sizes, including for septic or other distributive shock; the success of development activities for LJPC-401 and other product candidates; and other risks and uncertainties identified in our filings with the SEC. Forward-looking statements are presented as of the date of this press release, and La Jolla expressly disclaims any intent to update any forward??’looking statements to reflect the outcome of subsequent events.

LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Statements of Operations
(in thousands, except per share amounts)
                                                               Three Months Ended              Year Ended
                                                               December 31,                    December 31,
                                                               2017            2016            2017              2016
                                                               (Unaudited)
Revenue
Contract revenue - related party                               $   --          $   85          $    --           $   616
Total revenue                                                  --              85              --                616
Operating expenses
Research and development                                       26,909          20,177          84,575            62,288
General and administrative                                     11,937          4,832           30,852            16,700
Total operating expenses                                       38,846          25,009          115,427           78,988
Loss from operations                                           (38,846     )   (24,924     )   (115,427      )   (78,372     )
Other income, net                                              300             37              624               187
Net loss                                                       $   (38,546 )   $   (24,887 )   $    (114,803 )   $   (78,185 )
Basic and diluted net loss per share                           $   (1.74   )   $   (1.44   )   $    (5.41    )   $   (4.54   )
Weighted-average common shares outstanding - basic and diluted 22,151          17,280          21,215            17,228
LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Balance Sheets
(in thousands, except share and par value amounts)
                                                                                           December 31,      December 31,
                                                                                           2017              2016
ASSETS
Current assets:
Cash and cash equivalents                                                                  $      90,915     $      65,726
Restricted cash, current portion                                                           --                200
Prepaid expenses and other current assets                                                  3,147             1,505
Total current assets                                                                       94,062            67,431
Property and equipment, net                                                                24,568            3,145
Restricted cash, less current portion                                                      909               --
Other assets                                                                               --                219
Total assets                                                                               $      119,539    $      70,795
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable                                                                           $      11,484     $      6,652
Accrued clinical and other expenses                                                        703               905
Accrued payroll and related expenses                                                       4,995             2,077
Deferred rent, current portion                                                             1,370             124
Total current liabilities                                                                  18,552            9,758
Deferred rent, less current portion                                                        12,785            --
Total liabilities                                                                          31,337            9,758
Commitments and contingencies
Shareholders’ equity:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,167,529 and             2                 2
18,261,557 shares issued and outstanding at December 31, 2017 and December 31, 2016,
respectively
Series C-1 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 3,906             3,906
shares issued and outstanding at December 31, 2017 and December 31, 2016, and a
liquidation preference of $3,906 at December 31, 2017 and 2016
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737   2,737             2,737
shares issued and outstanding at December 31, 2017 and December 31, 2016, and a
liquidation preference of $2,737 at December 31, 2017 and 2016
Additional paid-in capital                                                                 803,071           661,103
Accumulated deficit                                                                        (721,514       )  (606,711      )
Total shareholders’ equity                                                                 88,202            61,037
Total liabilities and shareholders’ equity                                                 $      119,539    $      70,795

Company Contacts

Sandra Vedrick

Director, Investor Relations & Human Resources

La Jolla Pharmaceutical Company

Phone: (858) 207-4264 Ext: 1135

Email: svedrick@ljpc.com

and

Dennis M. Mulroy

Chief Financial Officer

La Jolla Pharmaceutical Company

Phone: (858) 207-4264 Ext: 1040

Email: dmulroy@ljpc.com

https://resource.globenewswire.com/Resource/Download/9b144999-cc1c-484a-a3cd-31dce41ddfaa?size=1

<img src="http://www.globenewswire.com/newsroom/ti?ndecode=MTUwIzcxNDk3MzA=" alt="" width="1" height="1"/>



Register |  Password |  Feedback |  Copyright |  Usage Agreement |  Privacy Policy |  Advertising |  About Us |  Contact Us |  FAQ 

Past performance is not indicative of future results

StockSelector.com, the StockSelector.com logo, and News Selects are trademarks of StockSelector.com.
Copyright © 1998 - 2018 StockSelector.com. All rights reserved.