SAN DIEGO, California, Aug. 06, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and six months ended June 30, 2020 and highlighted recent corporate progress.
Recent Corporate Progress
- Acquisition of Tetraphase Pharmaceuticals, Inc.: On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVA™ (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. For the three and six months ended June 30, 2020, U.S. net sales of XERAVA, which was launched in October 2018, were $1.5 million and $3.2 million, up 88% and 191%, respectively, from the same periods in 2019. Complete financial results of Tetraphase for the six months ended June 30, 2020 will be included in an amended Form 8-K to be filed by La Jolla on or before October 13, 2020. Financial results for periods ending September 30, 2020 and beyond will include Tetraphase’s financial results subsequent to the acquisition closing date of July 28, 2020.
- Appointment of Larry Edwards as President and Chief Executive Officer: Effective July 28, 2020, La Jolla’s Board of Directors appointed Larry Edwards as President and Chief Executive Officer of La Jolla.
“With two, FDA-approved, innovative therapies for life-threatening diseases, La Jolla is well-positioned to help patients in need,” said Larry Edwards, President and Chief Executive Officer of La Jolla. “By leveraging the stronger platform that the combined company will provide, we look forward to increasing patient access to these important medicines.”
Financial Results
For the three and six months ended June 30, 2020, U.S. net sales of GIAPREZA were $5.8 million and $13.4 million, up 2% and 33%, respectively, from the same periods in 2019.
La Jolla’s net loss for the three and six months ended June 30, 2020 was $15.6 million and $24.2 million, or $0.57 and $0.89 per share, respectively, compared to $30.4 million and $62.1 million, or $1.12 per share and $2.29 per share, respectively, for the same periods in 2019.
As of June 30, 2020, La Jolla had $71.4 million of cash and short-term investments, compared to $87.8 million as of December 31, 2019. Net cash used in operating activities for the three and six months ended June 30, 2020 was $8.4 million and $20.6 million, respectively, down 49% and 58%, respectively, from the same periods in 2019.
About GIAPREZA
GIAPREZA™ (angiotensin II) for injection is 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. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at http://www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
GIAPREZA Important Safety Information
Contraindications
None.
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.
Adverse Reactions
The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) 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 for the United States and the Summary of Product Characteristics for the European Union.
About XERAVA
XERAVA™ (eravacycline) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated intra‑abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. Prescribing information for XERAVA is available at www.xerava.com. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla.
XERAVA Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.
XERAVA is not indicated for the treatment of complicated urinary tract infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea and vomiting.
XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri and anti-anabolic action, which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.
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 for the United States.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II) is approved by the U.S. FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA™ (eravacycline) is approved by the U.S. FDA for the treatment of complicated intra-abdominal infections. For more information, please visit www.ljpc.com.
Forward-looking Statements
This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA™ (angiotensin II) and XERAVA™ (eravacycline) sales; whether La Jolla will realize the benefits from the acquisition of Tetraphase Pharmaceuticals, Inc.; regulatory actions relating to La Jolla’s products by the U.S. FDA, European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
| June 30, 2020 | December 31, 2019 | ||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash | $ | 68,353 | $ | 87,820 | |||
| Short-term investments | 3,062 | — | |||||
| Accounts receivable, net | 1,843 | 2,960 | |||||
| Inventory, net | 3,120 | 2,211 | |||||
| Prepaid expenses and other current assets | 2,792 | 4,467 | |||||
| Total current assets | 79,170 | 97,458 | |||||
| Property and equipment, net | 12,827 | 18,389 | |||||
| Right-of-use lease asset | 14,792 | 15,491 | |||||
| Restricted cash | 606 | 909 | |||||
| Total assets | $ | 107,395 | $ | 132,247 | |||
| LIABILITIES AND SHAREHOLDERS’ DEFICIT | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,481 | $ | 4,177 | |||
| Accrued expenses | 6,772 | 9,312 | |||||
| Accrued payroll and related expenses | 5,741 | 8,332 | |||||
| Lease liability, current portion | 2,890 | 2,766 | |||||
| Total current liabilities | 17,884 | 24,587 | |||||
| Lease liability, less current portion | 25,000 | 26,481 | |||||
| Deferred royalty obligation, net | 124,406 | 124,379 | |||||
| Other noncurrent liabilities | 15,317 | 12,790 | |||||
| Total liabilities | 182,607 | 188,237 | |||||
| Commitments and contingencies (Note 6) | |||||||
| Shareholders’ deficit: | |||||||
| Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,358,611 and 27,195,469 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 3 | 3 | |||||
| Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2020 and December 31, 2019; and liquidation preference of $3,906 at June 30, 2020 and December 31, 2019 | 3,906 | 3,906 | |||||
| Additional paid-in capital | 982,393 | 977,432 | |||||
| Accumulated deficit | (1,061,514 | ) | (1,037,331 | ) | |||
| Total shareholders’ deficit | (75,212 | ) | (55,990 | ) | |||
| Total liabilities and shareholders’ deficit | $ | 107,395 | $ | 132,247 | |||
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenue | |||||||||||||||
| Net product sales | $ | 5,805 | $ | 5,703 | $ | 13,396 | $ | 10,098 | |||||||
| Total revenue | 5,805 | 5,703 | 13,396 | 10,098 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of product sales | 808 | 551 | 1,524 | 1,051 | |||||||||||
| Research and development | 8,781 | 22,043 | 17,964 | 43,287 | |||||||||||
| Selling, general and administrative | 8,677 | 11,323 | 16,829 | 23,643 | |||||||||||
| Total operating expenses | 18,266 | 33,917 | 36,317 | 67,981 | |||||||||||
| Loss from operations | (12,461 | ) | (28,214 | ) | (22,921 | ) | (57,883 | ) | |||||||
| Other income (expense) | |||||||||||||||
| Interest expense | (2,470 | ) | (2,806 | ) | (4,876 | ) | (5,535 | ) | |||||||
| Interest income | 32 | 604 | 222 | 1,317 | |||||||||||
| Other income—related party | — | — | 4,085 | — | |||||||||||
| Other expense | (693 | ) | — | (693 | ) | — | |||||||||
| Total other income (expense), net | (3,131 | ) | (2,202 | ) | (1,262 | ) | (4,218 | ) | |||||||
| Net loss | $ | (15,592 | ) | $ | (30,416 | ) | $ | (24,183 | ) | $ | (62,101 | ) | |||
| Net loss per share, basic and diluted | $ | (0.57 | ) | $ | (1.12 | ) | $ | (0.89 | ) | $ | (2.29 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 27,326 | 27,108 | 27,282 | 27,071 | |||||||||||
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Six Months Ended June 30, | |||||||
| 2020 | 2019 | ||||||
| Operating activities | |||||||
| Net loss | $ | (24,183 | ) | $ | (62,101 | ) | |
| Adjustments to reconcile net loss to net cash used for operating activities: | |||||||
| Share-based compensation expense | 3,997 | 13,103 | |||||
| Depreciation and amortization expense | 1,798 | 2,263 | |||||
| Loss on disposal of equipment | 904 | 15 | |||||
| Unrealized gains on short-term investments | (63 | ) | — | ||||
| Non-cash interest expense | 3,392 | 4,678 | |||||
| Non-cash rent expense | 699 | 639 | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable, net | 1,117 | (512 | ) | ||||
| Inventory, net | (909 | ) | 52 | ||||
| Prepaid expenses and other current assets | 1,675 | 22 | |||||
| Accounts payable | (1,696 | ) | (3,664 | ) | |||
| Accrued expenses | (3,378 | ) | 974 | ||||
| Accrued payroll and related expenses | (2,591 | ) | (3,429 | ) | |||
| Lease liability | (1,357 | ) | (1,241 | ) | |||
| Net cash used for operating activities | (20,595 | ) | (49,201 | ) | |||
| Investing activities | |||||||
| Proceeds from the sale of property and equipment | 2,860 | — | |||||
| Purchase of property and equipment | — | (441 | ) | ||||
| Purchase of short-term investments | (2,999 | ) | — | ||||
| Net cash used for investing activities | (139 | ) | (441 | ) | |||
| Financing activities | |||||||
| Net proceeds from issuance of common stock under 2013 Equity Plan | 605 | — | |||||
| Net proceeds from issuance of common stock under ESPP | 359 | 484 | |||||
| Net cash provided by financing activities | 964 | 484 | |||||
| Net decrease in cash and restricted cash | (19,770 | ) | (49,158 | ) | |||
| Cash and restricted cash at beginning of period | 88,729 | 173,513 | |||||
| Cash and restricted cash at end of period | $ | 68,959 | $ | 124,355 | |||
| Supplemental disclosure of non-cash investing and financing activities: | |||||||
| Conversion of Series F Convertible Preferred Stock into common stock | $ | — | $ | 2,737 | |||
| Cumulative-effect adjustment from adoption of ASU 2018-07 | $ | — | $ | (160 | ) | ||
| Initial recognition of right-of-use lease asset | $ | — | $ | 16,798 | |||
| Reconciliation of cash and restricted cash to the condensed consolidated balance sheets | |||||||
| Cash | $ | 68,353 | $ | 123,446 | |||
| Restricted cash | 606 | 909 | |||||
| Total cash and restricted cash | $ | 68,959 | $ | 124,355 | |||
La Jolla Pharmaceutical Company Contact
Michael Hearne
Chief Financial Officer
La Jolla Pharmaceutical Company
(858) 333-5769
mhearne@ljpc.com