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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 |
“We saw our commercial business continue to gain momentum in the third quarter, with total revenues growing to $8.9 million. We experienced a significant step-up in SIVEXTRO performance during the quarter, with double-digit prescription growth building on the trend we saw in the second quarter of 2021,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “In addition, by driving continued operating efficiency, we were able to extend our cash runway by an additional quarter to substantially through the second quarter of 2022.”
Mr. Schroeder added, “Recent trends in the oral antibiotic market have been encouraging. We have started to see a rebound with current industry-wide volumes of antibiotic use approaching 2019 levels. Our focus remains on - establishing the benefits of XENLETA with healthcare providers (HCPs) for the community-acquired bacterial pneumonia (CABP) season over the coming quarters. We launched our in-house promotion initiative with additional remote representatives promoting to targeted incremental opportunities for both XENLETA and SIVEXTRO. We also entered into a partnership with Vizient Health that we believe will help expand access to XENLETA in the hospital setting through their pharmacy network and create increased opportunities for formulary inclusion and for HCPs to prescribe XENLETA in the inpatient and outpatient setting.”
CORPORATE AND DEVELOPMENT UPDATES
FINANCIAL RESULTS
Three Months Ended September 30, 2021 and 2020
Nine Months Ended September 30, 2021 and 2020
Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, to be 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 # 2675535. 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 (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.
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.
About SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and Drug Administration in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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 commercialize XENLETA for the treatment of CABP, including the managed care coverage for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the expansion of its commercial sales force, the clinical utility of XENLETA for CABP, SIVEXTRO for ABSSSI and of CONTEPO for cUTI, the impact on gross sales revenue from the recognition of SIVEXTRO sales in its results of operations, the impact of macro events on sales of SIVEXTRO and XENLETA, plans for and timing of the review of regulatory filings for XENLETA and CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI 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 the European Union, Canada and China, the timing for and receipt of milestone and royalty payments under its license agreement with Sumitomo Pharmaceuticals (Suzhou), plans to pursue research and development of other product candidates, plans to pursue business development initiatives, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, expectations regarding the impact of the interruptions resulting from COVID-19 on its business, 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 SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA and SIVEXTRO, 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 InvestorsKim AndersonNabriva Therapeutics plcir@nabriva.com
For MediaAndrea GreifOgilvyandrea.greif@ogilvy.com914-772-3027
Consolidated Balance Sheets (unaudited)
As of | As of | |||||||
(in thousands, except share data) | September 30, 2021 | December 31, 2020 | ||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 51,995 | $ | 41,359 | ||||
Restricted cash | 179 | 231 | ||||||
Short-term investments | 16 | 16 | ||||||
Accounts receivable, net and other receivables | 15,032 | 3,909 | ||||||
Inventory | 15,581 | 5,823 | ||||||
Prepaid expenses | 5,609 | 5,880 | ||||||
Total current assets | 88,412 | 57,218 | ||||||
Property, plant and equipment, net | 289 | 768 | ||||||
Intangible assets, net | 41 | 80 | ||||||
Other non-current assets | 380 | 370 | ||||||
Total assets | $ | 89,122 | $ | 58,436 | ||||
Liabilities and stockholders´ equity | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 2,780 | $ | 2,041 | ||||
Accounts payable | 1,476 | 2,889 | ||||||
Accrued expense and other current liabilities | 15,094 | 12,844 | ||||||
Deferred revenue | 375 | 750 | ||||||
Total current liabilities | 19,725 | 18,524 | ||||||
Non-current liabilities: | ||||||||
Long-term debt | 5,169 | 5,686 | ||||||
Other non-current liabilities | 938 | 1,091 | ||||||
Total non-current liabilities | 6,107 | 6,777 | ||||||
Total liabilities | 25,832 | 25,301 | ||||||
Stockholders’ Equity: | ||||||||
Ordinary shares, nominal value $0.01, 100,000,000 ordinary shares authorized at September 30, 2021; 54,315,492 and 21,078,781 issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 543 | 211 | ||||||
Preferred shares, par value $0.01, 100,000,000 shares authorized at September 30, 2021; None issued and outstanding | — | — | ||||||
Additional paid in capital | 645,333 | 579,123 | ||||||
Accumulated other comprehensive income | 27 | 27 | ||||||
Accumulated deficit | (582,613 | ) | (546,226 | ) | ||||
Total stockholders’ equity | 63,290 | 33,135 | ||||||
Total liabilities and stockholders’ equity | $ | 89,122 | $ | 58,436 |
Consolidated Statements of Operations (unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
(in thousands, except share and per share data) | 2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 7,858 | $ | (47 | ) | $ | 14,928 | $ | 61 | |||||||
Collaboration revenue | 562 | 616 | 3,377 | 768 | ||||||||||||
Research premium and grant revenue | 442 | 722 | 1,329 | 1,738 | ||||||||||||
Total revenue | 8,862 | 1,291 | 19,634 | 2,567 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of revenues | (4,199 | ) | (25 | ) | (7,882 | ) | (401 | ) | ||||||||
Research and development expenses | (3,221 | ) | (3,486 | ) | (10,239 | ) | (12,261 | ) | ||||||||
Selling, general and administrative expenses | (12,256 | ) | (10,997 | ) | (37,157 | ) | (37,763 | ) | ||||||||
Total operating expenses | (19,676 | ) | (14,508 | ) | (55,278 | ) | (50,425 | ) | ||||||||
Loss from operations | (10,814 | ) | (13,217 | ) | (35,644 | ) | (47,858 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Other income (expense), net | 131 | 450 | 479 | 614 | ||||||||||||
Interest income (expense), net | (221 | ) | (256 | ) | (678 | ) | (1,451 | ) | ||||||||
Loss on extinguishment of debt | — | — | — | (2,757 | ) | |||||||||||
Loss before income taxes | (10,904 | ) | (13,023 | ) | (35,843 | ) | (51,452 | ) | ||||||||
Income tax benefit (expense) | 252 | 72 | (544 | ) | (199 | ) | ||||||||||
Net loss | $ | (10,652 | ) | $ | (12,951 | ) | $ | (36,387 | ) | $ | (51,651 | ) | ||||
Loss per share | ||||||||||||||||
Basic and diluted ($ per share) | $ | (0.21 | ) | $ | (0.90 | ) | $ | (0.93 | ) | $ | (4.40 | ) | ||||
Weighted average number of shares: | ||||||||||||||||
Basic and diluted | 50,526,767 | 14,469,090 | 39,259,729 | 11,745,453 |
Condensed Consolidated Statements of Cash Flows (unaudited)
Nine Months EndedSeptember 30, | |||||||||||||
(in thousands) | 2021 | 2020 | |||||||||||
Net cash provided by (used in): | |||||||||||||
Operating activities | $ | (53,439 | ) | $ | (57,967 | ) | |||||||
Investing activities | (69 | ) | (257 | ) | |||||||||
Financing activities | 64,228 | 12,903 | |||||||||||
Effects of exchange rate changes on the balance of cash held in foreign currencies | (136 | ) | 262 | ||||||||||
Net increase (decrease) in cash and cash equivalents and restricted cash | 10,584 | (45,059 | ) | ||||||||||
Cash and cash equivalents and restricted cash at beginning of period | 41,590 | 86,411 | |||||||||||
Cash and cash equivalents and restricted cash at end of period | $ | 52,174 | $ | 41,352 |
1 Year Nabriva Therapeutics Chart |
1 Month Nabriva Therapeutics Chart |
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