La Jolla Pharmaceutical Company (LJPC)
Chart Events
Performance Outlook
| Previous Close | 3.7900 |
| Open | 3.8000 |
| Bid | 3.5500 x 800 |
| Ask | 3.7100 x 1800 |
| Day's Range | 3.5600 - 3.8000 |
| 52 Week Range | 2.3000 - 11.4100 |
| Volume | 743,842 |
| Avg. Volume | 668,082 |
| Market Cap | 97.73M |
| Beta (5Y Monthly) | N/A |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.8910 |
| Earnings Date | Aug 06, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 10.67 |
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- GlobeNewswire
La Jolla Pharmaceutical Company Announces Financial Results for the Three and Six Months Ended June 30, 2020 and Highlights Recent Corporate Progress
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 ResultsFor 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 GIAPREZAGIAPREZA™ (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 InformationContraindicationsNone.Warnings and PrecautionsThere is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.Adverse ReactionsThe most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.Drug InteractionsAngiotensin 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 XERAVAXERAVA™ (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 InformationXERAVA 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 CompanyLa 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 StatementsThis 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 COMPANYCondensed 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 investments3,062 — Accounts receivable, net1,843 2,960 Inventory, net3,120 2,211 Prepaid expenses and other current assets2,792 4,467 Total current assets79,170 97,458 Property and equipment, net12,827 18,389 Right-of-use lease asset14,792 15,491 Restricted cash606 909 Total assets$107,395 $132,247 LIABILITIES AND SHAREHOLDERS’ DEFICIT Current liabilities: Accounts payable$2,481 $4,177 Accrued expenses6,772 9,312 Accrued payroll and related expenses5,741 8,332 Lease liability, current portion2,890 2,766 Total current liabilities17,884 24,587 Lease liability, less current portion25,000 26,481 Deferred royalty obligation, net124,406 124,379 Other noncurrent liabilities15,317 12,790 Total liabilities182,607 188,237 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, respectively3 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, 20193,906 3,906 Additional paid-in capital982,393 977,432 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 COMPANYCondensed 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 $10,098 Total revenue5,805 5,703 13,396 10,098 Operating expenses Cost of product sales808 551 1,524 1,051 Research and development8,781 22,043 17,964 43,287 Selling, general and administrative8,677 11,323 16,829 23,643 Total operating expenses18,266 33,917 36,317 67,981 Loss from operations(12,461) (28,214) (22,921) (57,883) Other income (expense) Interest expense(2,470) (2,806) (4,876) (5,535) Interest income32 604 222 1,317 Other income—related party— — 4,085 — Other expense(693) — (693) — Total other income (expense), net(3,131) (2,202) (1,262) (4,218) Net loss$(15,592) $(30,416) $(24,183) $(62,101) Net loss per share, basic and diluted$(0.57) $(1.12) $(0.89) $(2.29) Weighted-average common shares outstanding, basic and diluted27,326 27,108 27,282 27,071 LA JOLLA PHARMACEUTICAL COMPANYCondensed Consolidated Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2020 2019 Operating activities Net loss$(24,183) $(62,101) Adjustments to reconcile net loss to net cash used for operating activities: Share-based compensation expense3,997 13,103 Depreciation and amortization expense1,798 2,263 Loss on disposal of equipment904 15 Unrealized gains on short-term investments(63) — Non-cash interest expense3,392 4,678 Non-cash rent expense699 639 Changes in operating assets and liabilities: Accounts receivable, net1,117 (512) Inventory, net(909) 52 Prepaid expenses and other current assets1,675 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 equipment2,860 — 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 Plan605 — Net proceeds from issuance of common stock under ESPP359 484 Net cash provided by financing activities964 484 Net decrease in cash and restricted cash(19,770) (49,158) Cash and restricted cash at beginning of period88,729 173,513 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 cash606 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
- GlobeNewswire
Larry Edwards Appointed President and Chief Executive Officer of La Jolla Pharmaceutical Company
SAN DIEGO, July 28, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced today that its Board of Directors has appointed Larry Edwards as President and Chief Executive Officer. “Larry has an impressive track record bringing innovative treatments that address unmet medical needs to patients in the acute-care setting," said Kevin Tang, Chairman of La Jolla. “We are delighted to have Larry join the Company.”“I look forward to working with the La Jolla team to continue to expand patient access to GIAPREZA and XERAVA,” said Larry Edwards, President and Chief Executive Officer of La Jolla. “I am grateful to have the opportunity to join a company that focuses on improving outcomes in patients suffering from life-threatening diseases.” From 2015 to 2020, Mr. Edwards served in various positions at Tetraphase Pharmaceuticals, Inc., most recently serving as Chief Executive Officer. From 2014 to 2015, he served as Senior Director of Marketing of the Gram-negative Franchise of Cubist Pharmaceuticals, Inc. (acquired by Merck & Co., Inc.). From 1999 to 2014, Mr. Edwards served in various positions at Merck and Co., Inc., most recently serving as Global Marketing Director of Clostridium Difficile and New Infectious Disease Products. Mr. Edwards received a B.S. degree in business and healthcare administration from Ohio University.About GIAPREZAGIAPREZA™ (angiotensin II) for injection 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. GIAPREZA was 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 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 InformationContraindicationsNone.Warnings and PrecautionsThere is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.Adverse ReactionsThe most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.Drug InteractionsAngiotensin 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 XERAVAXERAVA™ (eravacycline) for injection was approved by the U.S. Food and Drug Administration (FDA) as a novel fluorocycline of the tetracycline class antibacterials indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of Tetraphase's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. 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 InformationXERAVA 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 CompanyLa 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 StatementsThis 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 XERAVATM (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 Contact:Michael Hearne Chief Financial Officer La Jolla Pharmaceutical Company (858) 333-5769 mhearne@ljpc.com
- GlobeNewswire
La Jolla Pharmaceutical Company Announces the Closing of Acquisition of Tetraphase Pharmaceuticals, Inc.
-Combined Company Offers Two Innovative Therapies to Treat Patients Suffering from Life-threatening Diseases-SAN DIEGO, California and WATERTOWN, Massachusetts, July 28, 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, and Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA™ (eravacycline) to treat serious and life-threatening infections, today announced the closing of La Jolla's acquisition of Tetraphase. La Jolla acquired Tetraphase for $43.0 million in upfront cash plus potential future cash payments of up to $16.0 million pursuant to contingent value rights (CVRs). The holders of the CVRs are entitled to receive payments of up to an additional $16.0 million in the aggregate upon the achievement of certain net sales of XERAVA in the United States. “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.”About GIAPREZAGIAPREZA™ (angiotensin II) for injection 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. GIAPREZA was 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 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 InformationContraindicationsNone.Warnings and PrecautionsThere is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.Adverse ReactionsThe most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.Drug InteractionsAngiotensin 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 XERAVAXERAVA™ (eravacycline) for injection was approved by the U.S. Food and Drug Administration (FDA) as a novel fluorocycline of the tetracycline class antibacterials indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of Tetraphase's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. 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 InformationXERAVA 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 CompanyLa 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 StatementsThis 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 Contact: Michael Hearne Chief Financial Officer La Jolla Pharmaceutical Company (858) 333-5769 mhearne@ljpc.com
