“This will be a transformational year for Nabriva as we look forward to the upcoming PDUFA dates for both the intravenous and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP),” said
RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
RESEARCH AND DEVELOPMENT
- In
May 2019 , submitted a marketing authorization application for both the intravenous and oral formulations of lefamulin for the treatment of community-acquired pneumonia in adults 18 years of age and older to the European Medicines Agency (EMA). - In
April 2019 , received a Complete Response Letter from theU.S. Food and Drug Administration (FDA ) for the New Drug Application (NDA) seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, due to issues related to facility inspections and manufacturing deficiencies at one contract manufacturer. TheFDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO. - In
February 2019 , announced theFDA accepted the NDAs and granted Priority Review for both formulations of lefamulin with a Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA’s review ofAugust 19, 2019 . - At the 29th
European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) that took place inAmsterdam, the Netherlands fromApril 13-16, 2019 ,Nabriva Therapeutics presented new data that continue to support lefamulin and CONTEPO as potential first-in-class antibiotics inthe United States that target the most common causative pathogens of CABP and cUTI, including multi-drug resistant (MDR) strains.
CORPORATE
- In
January 2019 , hosted an Investor/Analyst Event featuring discussions with leading clinicians and researchers who addressed current and potential new treatments for CABP and cUTIs. Nabriva management also discussed the commercial strategy for the Company’s investigational antibiotics, lefamulin and CONTEPO. - Partnering
- In
March 2019 , announced entry into a license and commercialization agreement withSunovion Pharmaceutics Canada, Inc. (Sunovion), pursuant to which Sunovion will be responsible for developing, obtaining regulatory approval of and commercializing lefamulin inCanada , andNabriva Therapeutics received an upfront payment, potential milestone payments upon the achievement of certain regulatory and sales milestone events and royalties on net sales of lefamulin, if any, inCanada .
- In
FIRST QUARTER 2019 FINANCIAL RESULTS
- For the three months ended
March 31, 2019 ,Nabriva Therapeutics reported a net loss of$20.2 million , or$0.29 per share, compared to a net loss of$13.3 million , or$0.36 per share, for the three months endedMarch 31, 2018 . Revenues decreased by$5 .8 million from$7 .6 million for the three months endedMarch 31, 2018 to$1 .7 million for the three months ended March 31, 2019, primarily due to a decrease in collaboration revenue of$5 .5 million. - Research and development expenses decreased by
$2 .7 million from$10 .3 million for the three months endedMarch 31, 2018 to$7 .5 million for the three month ended March 31, 2019. The decrease was primarily due to a$2 .6 million refund of payment of the NDA fees to theFDA for CONTEPO, and a$1 .5 million decrease in research materials and purchased services related to the development of lefamulin, partly offset by a $0.7 million increase in research consulting fees and a $0.6 million increase in staff costs due to the addition of employees. - General and administrative expense increased by
$3 .3 million from$10 .1 million for the three months endedMarch 31, 2018 to$13 .4 million for the three month ended March 31, 2019. The increase was primarily due to a$1 .8 million increase in staff costs due to the addition of employees, a $0.8 million increase in stock‑based compensation expense and a $0.6 million increase in external consultancy expenses. - As of
March 31, 2019 ,Nabriva Therapeutics had$91.3 million in cash, cash equivalents and short-term investments compared to$102.2 million as ofDecember 31, 2018 . Existing cash resources are expected to fund operations into the second quarter of 2020.
Please refer to our Annual Report on Forms 10-K for the fiscal year ended
About
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
CONTACTS:
For Investors
david.garrett@nabriva.com
610-816-6657
For Media
mikebeyer@sambrown.com
312-961-2502
Consolidated Balance Sheets
(unaudited)
(in thousands, except share data) | As of December 31, 2018 |
As of March 31, 2019 |
|||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 102,003 | $ | 91,042 | |||
Short-term investments | 225 | 225 | |||||
Other receivables | 3,871 | 7,238 | |||||
Contract asset | 1,500 | 1,000 | |||||
Prepaid expenses | 1,154 | 973 | |||||
Total current assets | 108,753 | 100,478 | |||||
Property, plant and equipment, net | 1,139 | 2,972 | |||||
Intangible assets, net | 98 | 99 | |||||
Long-term receivables | 428 | 438 | |||||
Total assets | $ | 110,418 | $ | 103,987 | |||
Liabilities and Stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,304 | $ | 7,562 | |||
Accrued expense and other current liabilities | 14,502 | 10,533 | |||||
Total current liabilities | 17,806 | 18,095 | |||||
Non-current liabilities | |||||||
Long-term debt | 23,718 | 23,945 | |||||
Other non-current liabilities | 264 | 1,840 | |||||
Total non-current liabilities | 23,982 | 25,785 | |||||
Total liabilities | 41,788 | 43,880 | |||||
Stockholders’ Equity: | |||||||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at March 31, 2019; 67,019,094 and 71,335,980 issued and outstanding at December 31, 2018 and March 31, 2019, respectively | 670 | 713 | |||||
Preferred shares, par value $0.01, 100,000,000 shares authorized at March 31, 2019; None issued and outstanding | — | — | |||||
Additional paid in capital | 461,911 | 473,562 | |||||
Accumulated other comprehensive income | 27 | 27 | |||||
Accumulated deficit | (393,978 | ) | (414,195 | ) | |||
Total stockholders’ equity | 68,630 | 60,107 | |||||
Total liabilities and stockholders’ equity | $ | 110,418 | $ | 103,987 | |||
Consolidated Statements of Operations
(unaudited)
Three Months Ended March 31, |
||||||||
(in thousands, except share and per share data) | 2018 | 2019 | ||||||
Revenues: | ||||||||
Collaboration revenue | $ | 6,500 | $ | 1,000 | ||||
Research premium and grant revenue | 1,051 | 703 | ||||||
Total revenues | 7,551 | 1,703 | ||||||
Operating expenses: | ||||||||
Research and development | (10,279 | ) | (7,538 | ) | ||||
General and administrative | (10,136 | ) | (13,409 | ) | ||||
Total operating expenses | (20,415 | ) | (20,947 | ) | ||||
Loss from operations | (12,864 | ) | (19,244 | ) | ||||
Other income (expense): | ||||||||
Other income (expense), net | 23 | 70 | ||||||
Interest income | 9 | 10 | ||||||
Interest expense | (4 | ) | (899 | ) | ||||
Loss before income taxes | (12,836 | ) | (20,063 | ) | ||||
Income tax expense | (506 | ) | (154 | ) | ||||
Net loss | $ | (13,342 | ) | $ | (20,217 | ) | ||
Loss per share | ||||||||
Basic and diluted | $ | (0.36 | ) | $ | (0.29 | ) | ||
Weighted average number of shares: | ||||||||
Basic and diluted | 36,911,604 | 68,701,599 | ||||||
Condensed Consolidated Statements of Cash Flows (unaudited) |
||||||||
Three Months Ended March 31, |
||||||||
(in thousands) | 2018 | 2019 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (16,339 | ) | $ | (20,625 | ) | ||
Investing activities | (160 | ) | (42 | ) | ||||
Financing activities | 19,059 | 9,679 | ||||||
Effects of foreign currency translation on cash and cash equivalents | 112 | 27 | ||||||
Net increase (decrease) in cash and cash equivalents | 2,672 | (10,961 | ) | |||||
Cash and cash equivalents at beginning of year | 86,769 | 102,003 | ||||||
Cash and cash equivalents at end of year | $ | 89,441 | $ | 91,042 | ||||
Source: Nabriva Therapeutics US, Inc