La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported financial results for the three months ended March 31, 2017 and recent corporate progress.
Recent Corporate Progress
- In February 2017, La Jolla reported positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 in patients with catecholamine resistant hypotension (CRH). The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treated patients. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event. La Jolla plans to present and publish detailed results from ATHOS-3 later this year.
- In March 2017, La Jolla completed a common stock offering and received proceeds of approximately $117.5 million, net of issuance costs.
“The first quarter of 2017 was an exciting time at La Jolla, highlighted by the positive top-line results from ATHOS-3,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We look forward to continuing a productive 2017, with the expected LJPC-501 New Drug Application submission in the second half of 2017.”
Results of Operations
As of March 31, 2017, the Company had $162.4 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the three months ended March 31, 2017 was $22.1 million, compared to $13.0 million for the same period in 2016. Net loss for the three months ended March 31, 2017 was $23.2 million, or $1.26 per share, compared to $16.5 million, or $0.96 per share for the same period in 2016.
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. The Company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II for the potential treatment of catecholamine resistant hypotension. LJPC-401 is La Jolla’s proprietary formulation of synthetic human hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. LJPC-30S is La Jolla’s next-generation gentamicin derivative program that is focused on the potential treatment of serious bacterial infections as well as rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com.
Forward-Looking Statement Safe Harbor
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 future events or the Company’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. The Company 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 the Company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site www.sec.gov. These risks include, but are not limited to, risks relating to: the timing of the NDA submission for LJPC-501 and prospects for approval of the LJPC-501 NDA; risks that the full data set from ATHOS-3 will not be consistent with the top-line results of the study; risks relating to the scope of product labels (if approved) and potential market sizes, as well as the broader commercial opportunity; the anticipated timing for regulatory actions; the success of future development activities; potential indications for which the Company’s product candidates may be developed; and the expected duration over which the Company’s cash balances will fund its operations. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.
| LA JOLLA PHARMACEUTICAL COMPANY | ||||||||||||
| Unaudited Condensed Consolidated Statements of Operations | ||||||||||||
(in thousands, except per share amounts) | ||||||||||||
| Three Months Ended | ||||||||||||
| March 31, | ||||||||||||
| 2017 | 2016 | |||||||||||
| Revenue | ||||||||||||
| Contract revenue - related party | $ | — | $ | 234 | ||||||||
| Total revenue | — | 234 | ||||||||||
| Expenses | ||||||||||||
| Research and development | 17,765 | 12,715 | ||||||||||
| General and administrative | 5,503 | 4,053 | ||||||||||
| Total expenses | 23,268 | 16,768 | ||||||||||
| Loss from operations | (23,268 | ) | (16,534 | ) | ||||||||
| Other income, net | 28 | 53 | ||||||||||
| Net loss | $ | (23,240 | ) | $ | (16,481 | ) | ||||||
| Basic and diluted net loss per share | $ | (1.26 | ) | $ | (0.96 | ) | ||||||
| Weighted average common shares outstanding - basic and diluted | 18,410 | 17,210 | ||||||||||
| LA JOLLA PHARMACEUTICAL COMPANY | ||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||||
(in thousands, except share and par value amounts) | ||||||||||||
| March 31, | December 31, | |||||||||||
| 2017 | 2016 | |||||||||||
| (Unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 162,382 | $ | 65,726 | ||||||||
| Restricted cash | 304 | 200 | ||||||||||
| Prepaid expenses and other current assets | 1,687 | 1,505 | ||||||||||
| Total current assets | 164,373 | 67,431 | ||||||||||
| Property and equipment, net | 3,614 | 3,145 | ||||||||||
| Other assets | 20 | 219 | ||||||||||
| Total assets | $ | 168,007 | $ | 70,795 | ||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 4,173 | $ | 6,652 | ||||||||
| Accrued clinical and other expenses | 590 | 1,029 | ||||||||||
| Accrued payroll and related expenses | 910 | 2,077 | ||||||||||
| Total current liabilities | 5,673 | 9,758 | ||||||||||
| Shareholders’ equity: | ||||||||||||
| Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,123,456 and 18,261,557 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 2 | 2 | ||||||||||
| Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at March 31, 2017 and December 31, 2016, and liquidation preference of $3,906 at March 31, 2017 and December 31, 2016 | 3,906 | 3,906 | ||||||||||
| Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737 shares issued and outstanding at March 31, 2017 and December 31, 2016, and liquidation preference of $2,737 at March 31, 2017 and December 31, 2016 | 2,737 | 2,737 | ||||||||||
| Additional paid-in capital | 785,640 | 661,103 | ||||||||||
| Accumulated deficit | (629,951 | ) | (606,711 | ) | ||||||||
| Total shareholders’ equity | 162,334 | 61,037 | ||||||||||
| Total liabilities and shareholders’ equity | $ | 168,007 | $ | 70,795 | ||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170427006700/en/
Contacts:
Sandra Vedrick, (858) 256-7910
Associate
Director, Investor Relations & Human Resources
svedrick@ljpc.com
or
Dennis
M. Mulroy, (858) 433-6839
Chief Financial Officer
dmulroy@ljpc.com
