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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Nabriva Therapeutics PLC | NASDAQ:NBRV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.42 | 1.41 | 1.47 | 0 | 01:00:00 |
“Aligned with the excellent managed care coverage we have secured since launch, earlier this year Nabriva made the strategic decision to refocus the XENLETA™ (lefamulin) commercial strategy to the community setting. We are extremely pleased to report that commercial and Medicare coverage from plans including Express Scripts, United Health and CIGNA, representing in excess of 200 million patients or almost 70% of covered lives in the United States, now have access to XENLETA,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
“While the global pandemic has limited our ability to interact in-person with health care providers, Nabriva initiated non-personal promotional activities, leveraging digital platforms as the primary means of providing clinicians product information and education. Although it remains unclear when it will be deemed safe to resume in-person promotional activities, we are actively laying the foundation to be poised to launch our community-focused sales effort as soon as it is practicable. In addition, we have proactively taken steps to conserve our cash resources so that we will be able to realize the full benefit from a strategic investment in a community-focused sales effort at the appropriate time. Through the judicious management of resources, we have been able to extend our cash runway into the fourth quarter of 2020.”
Additional priorities for 2020 include:
CORPORATE AND DEVELOPMENT UPDATES
FINANCIAL RESULTS
Three Months Ended March 31, 2020 and 2019
Please refer to our Annual Report on Forms 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, which are filed with the U.S. Securities and Exchange Commission, for additional information regarding the Company’s business and financial results.
Company to Host Conference Call
Nabriva’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. The dial-in number for the conference call is (866) 811-8671 for domestic participants and (409) 981-0874 for international participants, with Conference ID #1693918. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com. A replay will be available on this website shortly after conclusion of the event for 90 days.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. For more information, please visit www.nabriva.com.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for XENLETA.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, plans to pursue research and development of other product candidates, ability to regain compliance with the Nasdaq listing standards, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.
CONTACTS:
For InvestorsGary SenderNabriva Therapeutics plcir@nabriva.com
For MediaMike BeyerSam Brown Inc. mikebeyer@sambrown.com312-961-2502
Consolidated Balance Sheets(unaudited) | ||||||||
(in thousands, except share data) | As of December 31, 2019 | As of March 31, 2020 | ||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 86,019 | $ | 26,938 | ||||
Restricted cash | 392 | 444 | ||||||
Short-term investments | 175 | 175 | ||||||
Accounts receivable, net and other receivables | 2,744 | 3,467 | ||||||
Inventory | 682 | 4,224 | ||||||
Prepaid expenses | 1,158 | 2,925 | ||||||
Total current assets | 91,170 | 38,173 | ||||||
Property, plant and equipment, net | 2,474 | 2,340 | ||||||
Intangible assets, net | 91 | 111 | ||||||
Long-term receivables | 378 | 378 | ||||||
Total assets | $ | 94,113 | $ | 41,002 | ||||
Liabilities and equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 4,673 | $ | 2,033 | ||||
Accrued expense and other current liabilities | 11,966 | 9,929 | ||||||
Total current liabilities | 16,639 | 11,962 | ||||||
Non-current liabilities | ||||||||
Long-term debt | 34,502 | 7,374 | ||||||
Other non-current liabilities | 1,698 | 1,752 | ||||||
Total non-current liabilities | 36,200 | 9,126 | ||||||
Total liabilities | 52,839 | 21,088 | ||||||
Stockholders’ Equity: | ||||||||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at March 31, 2020; 94,545,116 and 95,109,047 issued and outstanding at December 31, 2019 and March 31, 2020, respectively | 945 | 951 | ||||||
Preferred shares, par value $0.01, 100,000,000 shares authorized at March 31, 2020; None issued and outstanding | — | — | ||||||
Additional paid in capital | 517,044 | 518,937 | ||||||
Accumulated other comprehensive income | 27 | 27 | ||||||
Accumulated deficit | (476,742 | ) | (500,001 | ) | ||||
Total stockholders’ equity | 41,274 | 19,914 | ||||||
Total liabilities and stockholders’ equity | $ | 94,113 | $ | 41,002 |
Consolidated Statements of Operations(unaudited) | ||||||||
Three Months Ended March 31, | ||||||||
(in thousands, except share and per share data) | 2019 | 2020 | ||||||
Revenues: | ||||||||
Product revenue, net | $ | — | $ | 156 | ||||
Collaboration revenue | 1,000 | 145 | ||||||
Research premium and grant revenue | 703 | 488 | ||||||
Total revenue | 1,703 | 789 | ||||||
Operating expenses: | ||||||||
Cost of product sales | — | (8 | ) | |||||
Research and development expenses | (7,538 | ) | (4,944 | ) | ||||
Selling, general and administrative expenses | (13,409 | ) | (16,025 | ) | ||||
Total operating expenses | (20,947 | ) | (20,977 | ) | ||||
Loss from operations | (19,244 | ) | (20,188 | ) | ||||
Other income (expense): | ||||||||
Other income (expense), net | 70 | 798 | ||||||
Interest income | 10 | 64 | ||||||
Interest expense | (899 | ) | (1,024 | ) | ||||
Loss on extinguishment of debt | — | (2,757 | ) | |||||
Loss before income taxes | (20,063 | ) | (23,107 | ) | ||||
Income tax expense | (154 | ) | (152 | ) | ||||
Net loss | $ | (20,217 | ) | $ | (23,259 | ) | ||
Loss per share | ||||||||
Basic and Diluted ($ per share) | $ | (0.29 | ) | $ | (0.25 | ) | ||
Weighted average number of shares: | ||||||||
Basic and Diluted | 68,701,599 | 94,595,152 |
Condensed Consolidated Statements of Cash Flows(unaudited) | ||||||||
Three Months Ended March 31, | ||||||||
(in thousands) | 2019 | 2020 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (20,625 | ) | $ | (28,108 | ) | ||
Investing activities | (42 | ) | (20 | ) | ||||
Financing activities | 9,679 | (30,219 | ) | |||||
Effects of foreign currency translation on cash and cash equivalents | 27 | (682 | ) | |||||
Net decrease in cash, cash equivalents and restricted cash | (10,961 | ) | (59,029 | ) | ||||
Cash, cash equivalents and restricted cash at beginning of quarter | 102,003 | 86,411 | ||||||
Cash, cash equivalents and restricted cash at end of quarter | $ | 91,042 | $ | 27,382 | ||||
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