California | 1-36282 | 33-0361285 |
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). |
Emerging growth company o |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o |
Item 2.02 | Results of Operations and Financial Condition. |
Exhibit No. | Description | |
La Jolla Pharmaceutical Company | |||
Date: | August 8, 2018 | By: | /s/ Dennis M. Mulroy |
Name: | Dennis M. Mulroy | ||
Title | Chief Financial Officer |
• | In August 2018, La Jolla announced that the Centers for Medicare & Medicaid Services (CMS) had granted a New Technology Add-on Payment (NTAP) for GIAPREZATM (angiotensin II) Injection for Intravenous Infusion. The NTAP program provides additional reimbursement to hospitals beyond the Medicare Severity Diagnosis-Related Group (MS-DRG) reimbursement for specific products that meet strict criteria for the treatment of Medicare patients. The amount of the NTAP is equal to 50% of the amount by which the covered costs exceed the MS-DRG reimbursement, or 50% of the cost of the drug, whichever is less. The NTAP for GIAPREZA is effective for the CMS 2019 fiscal year, which begins on October 1, 2018, and is expected to continue for a period of up to two or three years, after which the MS-DRG payments will be adjusted based on hospital-reported costs and utilization. The NTAP program is only available to new drugs that represent an advance in medical technology that substantially improves, relative to technologies previously available, the treatment of Medicare patients. |
• | In June 2018, La Jolla announced that the Marketing Authorization Application (MAA) for GIAPREZA was validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission is complete and starts the EMA’s centralized review process. La Jolla submitted the GIAPREZA MAA for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The MAA is based on data from the ATHOS-3 Phase 3 study, which establishes the safety and efficacy of GIAPREZA in the proposed indication. If approved, GIAPREZA could be available for marketing in the European Union in the second half of 2019. |
• | In June 2018, two presentations on LJPC-401 (synthetic human hepcidin) were given at the 23rd Congress of the European Hematology Association (EHA). The first was an oral presentation, entitled “A Phase 1, Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of LJPC-401 (Synthetic Human Hepcidin) in Patients with Iron Overload.” The second was a poster presentation, entitled “A Phase 1, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Escalating Subcutaneous Doses of LJPC-401 (Synthetic Human Hepcidin) in Healthy Adults.” |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenue | |||||||||||||||
Net product sales | $ | 1,593 | $ | — | $ | 2,402 | $ | — | |||||||
Total revenue | 1,593 | — | 2,402 | — | |||||||||||
Operating expenses | |||||||||||||||
Cost of product sales | 129 | — | 187 | — | |||||||||||
Research and development | 30,867 | 20,808 | 59,296 | 38,573 | |||||||||||
Selling, general and administrative | 22,164 | 6,022 | 45,180 | 11,525 | |||||||||||
Total operating expenses | 53,160 | 26,830 | 104,663 | 50,098 | |||||||||||
Loss from operations | (51,567 | ) | (26,830 | ) | (102,261 | ) | (50,098 | ) | |||||||
Interest (expense) income, net | (1,211 | ) | 101 | (1,045 | ) | 129 | |||||||||
Net loss | $ | (52,778 | ) | $ | (26,729 | ) | $ | (103,306 | ) | $ | (49,969 | ) | |||
Net loss per share, basic and diluted | $ | (2.02 | ) | $ | (1.21 | ) | $ | (4.22 | ) | $ | (2.46 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 26,182 | 22,123 | 24,462 | 20,277 |
June 30, 2018 | December 31, 2017 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 241,427 | $ | 90,915 | |||
Accounts receivable, net | 372 | — | |||||
Inventory | 939 | — | |||||
Prepaid expenses and other current assets | 5,282 | 3,147 | |||||
Total current assets | 248,020 | 94,062 | |||||
Property and equipment, net | 24,211 | 24,568 | |||||
Restricted cash | 909 | 909 | |||||
Total assets | $ | 273,140 | $ | 119,539 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,069 | $ | 11,484 | |||
Accrued expenses | 6,952 | 703 | |||||
Accrued payroll and related expenses | 4,618 | 4,995 | |||||
Deferred rent, current portion | 1,370 | 1,370 | |||||
Total current liabilities | 19,009 | 18,552 | |||||
Deferred rent, less current portion | 14,161 | 12,785 | |||||
Deferred royalty obligation, net | 124,303 | — | |||||
Total liabilities | 157,473 | 31,337 | |||||
Shareholders’ equity: | |||||||
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 26,218,522 and 22,167,529 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 3 | 2 | |||||
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2018 and December 31, 2017; and liquidation preference of $3,906 at June 30, 2018 and December 31, 2017 | 3,906 | 3,906 | |||||
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737 shares issued and outstanding at June 30, 2018 and December 31, 2017; and liquidation preference of $2,737 at June 30, 2018 and December 31, 2017 | 2,737 | 2,737 | |||||
Additional paid-in capital | 933,841 | 803,071 | |||||
Accumulated deficit | (824,820 | ) | (721,514 | ) | |||
Total shareholders’ equity | 115,667 | 88,202 | |||||
Total liabilities and shareholders’ equity | $ | 273,140 | $ | 119,539 |