Nabriva Therapeutics Reports First Quarter 2019 Financial Results and Recent Corporate Highlights
May 10 2019 - 7:00AM
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the development of innovative anti-infective
agents to treat serious infections, today announced its financial
results for the three months ended March 31, 2019 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 Ted Schroeder,
Chief Executive Officer of Nabriva Therapeutics. “Additionally, we
will be working with the FDA in the coming weeks to gain a full
understanding of the FDA’s comments related to the CONTEPO Complete
Response Letter (CRL), with the goal of bringing this important
treatment to patients as quickly as possible.”
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 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 FDA did not request
any new clinical data and did not raise any concerns with regard to
the safety of CONTEPO.
- In February 2019, announced the FDA 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 of August 19, 2019.
- At the 29th European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) that took place in Amsterdam, the
Netherlands from April 13-16, 2019, Nabriva Therapeutics presented
new data that continue to support lefamulin and CONTEPO as
potential first-in-class antibiotics in the 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 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
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,
in Canada.
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 ended March 31, 2018. Revenues decreased by
$5.8 million from $7.6 million for the three months ended
March 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
ended March 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 the FDA 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
ended March 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 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 December 31, 2018 and our
Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2019, which are filed with the U.S. Securities and Exchange
Commission, for additional information regarding our business and
financial results.
About Nabriva Therapeutics
plcNabriva Therapeutics is a biopharmaceutical company
engaged in the development of innovative anti-infective agents to
treat serious infections. Nabriva Therapeutics has two product
candidates that are in late stage development: lefamulin,
potentially the first systemic pleuromutilin antibiotic for CABP
and CONTEPO (fosfomycin) for injection, a potential first-in-class
epoxide antibiotic in the United States for complicated urinary
tract infections (cUTIs) including acute pyelonephritis (AP). For
more information, please visit https://www.nabriva.com.
Forward-Looking StatementsAny
statements in this press release about future expectations, plans
and prospects for Nabriva Therapeutics, including but not limited
to statements about Nabriva Therapeutics’ plans for further
interactions with the FDA and EMA; the development of Nabriva
Therapeutics’ product candidates, such as the future development or
commercialization of lefamulin and CONTEPO, the clinical utility of
lefamulin for CABP and of CONTEPO for cUTI, plans for and timing of
the review of regulatory filings, efforts to bring lefamulin and
CONTEPO to market, plans to enter into arrangements with third
parties to commercialize lefamulin in Europe, if approved; the
market opportunity for and the potential market acceptance of
lefamulin for CABP and CONTEPO for cUTI, the potential benefits
under its license agreements with Sinovant Sciences, Ltd. and
Sunovion Pharmaceutics Canada, Inc., the development of lefamulin
and CONTEPO for additional indications, the development of
additional formulations of lefamulin and CONTEPO, plans to pursue
research and development of other product candidates, its ability
to achieve any of the specified regulatory or performance
milestones under its loan agreement with Hercules Capital, the
sufficiency of Nabriva Therapeutics’ existing cash resources 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 resolve the matters set forth in the
Complete Response Letter it received from the FDA in connection
with its NDA for CONTEPO (fosfomycin) for injection; Nabriva
Therapeutics’ reliance on third-party manufacturers to manufacture
the clinical and commercial supply of its product candidates and
the ability of such third parties to comply with applicable
regulatory requirements; the content and timing of decisions made
by the U.S. Food and Drug Administration and other regulatory
authorities, Nabriva Therapeutics’ ability to realize the
anticipated benefits, synergies and growth prospects of its
acquisition of Zavante Therapeutics, 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, whether
results of ZEUS will be indicative of results for any ongoing or
future clinical trials and studies of CONTEPO, uncertainties
associated with regulatory review of clinical trials and
applications for marketing approvals, the availability or
commercial potential of product candidates including lefamulin for
use as a first-line empiric monotherapy for the treatment of CABP
and CONTEPO for the treatment of cUTI, the ability to retain and
hire key personnel, the sufficiency of cash resources and need for
additional financing 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 InvestorsDave GarrettNabriva Therapeutics
plcdavid.garrett@nabriva.com 610-816-6657
For MediaMike BeyerSam Brown Inc.
mikebeyer@sambrown.com312-961-2502
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 |
|
|
|
|
|
|
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