Nabriva Therapeutics Reports First Quarter 2019 Financial Results and Recent Corporate Highlights
“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
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).
April 2019, received a Complete Response Letter from the U.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. The FDAdid not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.
February 2019, announced the FDAaccepted 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 of August 19, 2019.
- At the 29th
European Congress of Clinical Microbiology and Infectious Diseases(ECCMID) that took place in Amsterdam, the Netherlandsfrom April 13-16, 2019, Nabriva Therapeuticspresented new data that continue to support lefamulin and CONTEPO as potential first-in-class antibiotics in the United Statesthat target the most common causative pathogens of CABP and cUTI, including multi-drug resistant (MDR) strains.
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.
March 2019, announced entry into a license and commercialization agreement with Sunovion Pharmaceutics Canada, Inc.(Sunovion), pursuant to which Sunovion will be responsible for developing, obtaining regulatory approval of and commercializing lefamulin in Canada, and Nabriva Therapeuticsreceived 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, in Canada.
FIRST QUARTER 2019 FINANCIAL RESULTS
- For the three months ended
March 31, 2019, Nabriva Therapeuticsreported a net loss of $20.2 million, or $0.29per share, compared to a net loss of $13.3 million, or $0.36per share, for the three months ended March 31, 2018. Revenues decreased by $5.8 million from $7.6 million for the three months ended March 31, 2018to $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 ended March 31, 2018to $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 the FDAfor 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 ended March 31, 2018to $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 Therapeuticshad $91.3 millionin cash, cash equivalents and short-term investments compared to $102.2 millionas of December 31, 2018. Existing cash resources are expected to fund operations into the second quarter of 2020.
Please refer to our Annual Report on Forms 10-K for the fiscal year ended
Any statements in this press release about future expectations, plans and prospects for
Sam Brown Inc.
Consolidated Balance Sheets
|(in thousands, except share data)||As of
|Cash and cash equivalents||$||102,003||$||91,042|
|Total current assets||108,753||100,478|
|Property, plant and equipment, net||1,139||2,972|
|Intangible assets, net||98||99|
|Liabilities and Stockholders’ equity|
|Accrued expense and other current liabilities||14,502||10,533|
|Total current liabilities||17,806||18,095|
|Other non-current liabilities||264||1,840|
|Total non-current liabilities||23,982||25,785|
|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 $0.01, 100,000,000 shares authorized at March 31, 2019; None issued and outstanding||—||—|
|Additional paid in capital||461,911||473,562|
|Accumulated other comprehensive income||27||27|
|Total stockholders’ equity||68,630||60,107|
|Total liabilities and stockholders’ equity||$||110,418||$||103,987|
Consolidated Statements of Operations
|Three Months Ended
|(in thousands, except share and per share data)||2018||2019|
|Research premium and grant revenue||1,051||703|
|Research and development||(10,279||)||(7,538||)|
|General and administrative||(10,136||)||(13,409||)|
|Total operating expenses||(20,415||)||(20,947||)|
|Loss from operations||(12,864||)||(19,244||)|
|Other income (expense):|
|Other income (expense), net||23||70|
|Loss before income taxes||(12,836||)||(20,063||)|
|Income tax expense||(506||)||(154||)|
|Loss per share|
|Basic and diluted||$||(0.36||)||$||(0.29||)|
|Weighted average number of shares:|
|Basic and diluted||36,911,604||68,701,599|
|Condensed Consolidated Statements of Cash Flows
|Three Months Ended
|Net cash provided by (used in):|
|Effects of foreign currency translation on cash and cash equivalents||112||27|
|Net increase (decrease) in cash and cash equivalents||2,672||(10,961||)|
|Cash and cash equivalents at beginning of year||86,769||102,003|
|Cash and cash equivalents at end of year||$||89,441||$||91,042|
Source: Nabriva Therapeutics US, Inc