Nabriva Therapeutics Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights
November 06 2018 - 7:00AM
- New Drug Application for CONTEPO™ submitted to
FDA in October 2018 -- Company preparing for potential
commercialization of two, first-in-class antibiotics,Lefamulin (IV
and Oral) and CONTEPO (IV) in the United States in 2019 -
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical stage
biopharmaceutical company engaged in the research and development
of innovative anti-infective agents to treat serious infections,
today provided a business and clinical development update and
reported its financial results for the quarter ended September 30,
2018.
“Nabriva has continued to make significant
progress in potentially bringing two first-in-class antibiotics to
patients in need of better treatment options here in the United
States,” said Ted Schroeder, Chief Executive Officer of Nabriva
Therapeutics. “We have completed our NDA submission for CONTEPO to
treat complicated-urinary tract infections (cUTI), including acute
pyelonephritis, and remain on track for our NDA submission for
lefamulin for the treatment of community-acquired bacterial
pneumonia (CABP) by both intravenous and oral routes in the fourth
quarter of 2018. We remain focused on commercializing both
lefamulin and CONTEPO in the United States with our own targeted
sales, marketing and medical affairs organizations and continue to
identify and potentially secure external collaborators to help
advance our efforts to develop and commercialize lefamulin outside
the United States.”
RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
- Submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for Intravenous CONTEPO in the fourth
quarter of 2018 to treat cUTIs, including acute pyelonephritis.
CONTEPO has been granted Qualified Infectious Disease Product
(QIDP) and Fast Track designations by the FDA for the treatment of
several serious infections, including cUTI, which enables Priority
Review of the NDA, following acceptance.
- Completed the acquisition of Zavante Therapeutics (“Zavante”)
in July 2018, a biopharmaceutical company focused on developing
novel therapies to improve the outcomes of hospitalized patients,
for upfront consideration of approximately 8.2 million of Nabriva
Therapeutics’ ordinary shares (which includes an indemnity
holdback) to Zavante’s former stockholders upon completion of
the acquisition. In addition, Zavante’s former stockholders are
eligible to receive up to $97.5 million upon the achievement of
specified regulatory and commercial milestones, which subject to
specified limitations, may be settled in Nabriva Therapeutics’
ordinary shares.
- Bolstered the senior leadership team with the appointment of
Ted Schroeder, former Chief Executive Officer of Zavante, as Chief
Executive Officer of Nabriva Therapeutics to succeed Dr. Colin
Broom, who remains on the Board of Directors of Nabriva
Therapeutics. In addition, Dr. Steven Gelone was named
President and Chief Operating Officer of Nabriva Therapeutics.
- Strengthened the Company’s cash resources with the completion
of its public offering of ordinary shares in July 2018. The gross
proceeds from the offering were $50.0 million and net proceeds to
the Company were $46.1 million, after deducting underwriting
discounts and commissions and offering expenses. The Company ended
the third quarter of 2018 with $100.7 million of cash, cash
equivalents and short-term investments which the Company expects to
fund operations into the first quarter of 2020.
- At the Infectious Diseases Society of America (IDSA)
IDWeek™ 2018, the Company made three poster presentations and
an oral platform presentation for LEAP 2, the pivotal, Phase 3
clinical trial of lefamulin, which demonstrated non-inferiority of
5 days of oral lefamulin to 7 days of oral moxifloxacin which
featured both clinical and in vitro microbiological data that
supports lefamulin as a potential IV and oral treatment for
CABP.
- At the same conference, one poster presentation featuring
CONTEPO focused on clinical and microbiological response at test of
cure in secondary efficacy populations from the pivotal Phase 2/3
clinical trial.
FINANCIAL RESULTS
Three Months Ended September 30, 2018 and
2017
- For the three months ended September 30, 2018, Nabriva
Therapeutics reported a net loss of $52.8 million, or $0.90 per
share, compared to a net loss of $22.3 million, or $0.79 per share,
for the three months ended September 30, 2017.
- Research and development expenses increased by
$28.1 million from $12.7 million for the three months
ended September 30, 2017 to $40.8 million for the three months
ended September 30, 2018. The increase was primarily due to a $31.9
million in-process research and development charge associated with
the acquisition of Zavante, a $3.3 million increase in research
consulting fees, partly offset by a $5.4 million decrease in
research materials and purchased services related to the
development of lefamulin and a $1.4 million decrease in stock-based
compensation expense.
- General and administrative expense increased by $3.1 million
from $9.5 million for the three months ended September 30,
2017 to $12.6 million for the three months ended September 30,
2018. The increase was primarily due to a $3.4 million increase in
staff costs due to the addition of employees and a $1.2 million
increase in stock-based compensation expense, partly offset by a
$1.2 million decrease in legal fees.
Nine Months Ended September 30, 2018 and
2017
- For the nine months ended September 30, 2018, Nabriva
Therapeutics reported a net loss of $84.0 million, or $1.85 per
share, compared to a net loss of $52.1 million, or $1.89 per share,
for the nine months ended September 30, 2017.
- Research and development expenses increased by
$24.4 million from $36.4 million for the nine months
ended September 30, 2017 to $60.8 million for the nine months
ended September 30, 2018. The increase was primarily due to a $31.9
million in-process research and development charge associated with
the acquisition of Zavante, a $4.1 million increase in research
consulting fees, a $0.5 million increase in staff costs due to the
addition of employees, partly offset by a $10.7 million decrease in
research materials and purchased services related to the
development of lefamulin and a $1.7 million decrease in stock-based
compensation expense.
- General and administrative expense increased by $12.3 million
from $19.3 million for the nine months ended September 30, 2017 to
$31.6 million for the nine months ended September 30, 2018.
The increase was primarily due to a $8.1 million increase in staff
costs due to the addition of employees, a $4.7 million increase of
advisory and external consultancy expenses primarily related to
pre-commercialization activities and professional service fees and
a $0.6 million increase in stock-based compensation expense,
partly offset by a $1.8 million decrease in legal fees.
- As of September 30, 2018, Nabriva Therapeutics had $100.7
million in cash, cash equivalents and short-term investments
compared to $86.9 million as of December 31, 2017.
Please refer to the Annual Report on
Form 10-K of Nabriva Therapeutics for the fiscal year ended
December 31, 2017 and Nabriva Therapeutics’ Quarterly Report on
Form 10-Q for the three months ended September 30, 2018, filed with
the U.S. Securities and Exchange Commission, for additional
information regarding the Company’s business and financial
results.
About Nabriva Therapeutics
plcNabriva Therapeutics is a clinical-stage
biopharmaceutical company engaged in the research and development
of innovative anti-infective agents to treat serious infections.
Nabriva Therapeutics has two product candidates that are in late
stage development: lefamulin, under development to potentially be
the first pleuromutilin antibiotic available for I.V. and oral
administration in humans, and CONTEPO, a potential first-in-class
in the United States I.V. antibiotic for cUTI. Nabriva Therapeutics
is developing both I.V. and oral formulations of lefamulin for the
treatment of community-acquired bacterial pneumonia (CABP) and
CONTEPO I.V. for cUTIs, including acute pyelonephritis. Nabriva
Therapeutics may potentially develop lefamulin and CONTEPO for
additional indications. 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 the development of Nabriva Therapeutics’
product candidates, such as the future development or
commercialization of lefamulin and CONTEPO, conduct and timelines
of clinical trials, 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, the market opportunity for and the potential market
acceptance of lefamulin for CABP and CONTEPO for cUTI, 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, 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: 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 moderate to severe 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.com610-816-6657
FOR MEDIABenjamin Navon W2O Group
bnavon@w2ogroup.com617-337-4166
Consolidated Balance
Sheets(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except share
data) |
|
As ofDecember
31,2017 |
|
As ofSeptember
30,2018 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
86,769 |
|
|
$ |
100,331 |
|
|
Short-term investments |
|
110 |
|
|
326 |
|
|
Other receivables |
|
5,402 |
|
|
7,362 |
|
|
Contract asset |
|
— |
|
— |
1,500 |
|
|
Prepaid expenses |
|
1,558 |
|
|
1,163 |
|
|
Total current assets |
|
93,839 |
|
|
110,682 |
|
|
Property,
plant and equipment, net |
|
1,327 |
|
|
1,226 |
|
|
Intangible
assets, net |
|
172 |
|
|
109 |
|
|
Long-term
receivables |
|
425 |
|
|
428 |
|
|
Total assets |
|
$ |
95,763 |
|
|
$ |
112,445 |
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
5,136 |
|
|
$ |
4,765 |
|
|
Accrued expense and other current liabilities |
|
8,124 |
|
|
10,300 |
|
|
Total current liabilities |
|
13,260 |
|
|
15,065 |
|
|
Non-current
liabilities: |
|
|
|
|
|
Long-term debt |
|
232 |
|
|
710 |
|
|
Other non-current liabilities |
|
203 |
|
|
244 |
|
|
Total non-current liabilities |
|
435 |
|
|
954 |
|
|
Total liabilities |
|
|
13,695 |
|
|
|
16,019 |
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares
authorized at September 30, 2018; 36,707,685 and 66,484,159
issued and outstanding at December 31, 2017 and September 30,
2018, respectively |
|
|
367 |
|
|
|
665 |
|
|
Preferred shares, par value $0.01, 100,000,000 shares authorized at
September 30, 2018; None issued and outstanding |
|
|
— |
|
- |
|
— |
|
|
Additional paid in capital |
|
360,872 |
|
|
458,887 |
|
|
Accumulated other comprehensive income |
|
27 |
|
|
27 |
|
|
Accumulated deficit |
|
(279,198 |
) |
|
(363,153 |
) |
|
Total stockholders’ equity |
|
|
82,068 |
|
|
|
96,426 |
|
|
Total liabilities and stockholders’
equity |
|
$ |
95,763 |
|
|
$ |
112,445 |
|
|
Consolidated Statements
of Operations(unaudited) |
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
(in thousands, except share
and per share data) |
|
2017 |
|
2018 |
|
2017 |
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6,500 |
|
|
Research premium and grant revenue |
|
|
1,468 |
|
|
|
461 |
|
|
4,197 |
|
|
2,359 |
|
|
Total Revenue: |
|
|
1,468 |
|
|
|
461 |
|
|
4,197 |
|
|
8,859 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(12,668 |
) |
|
|
(40,804 |
) |
|
|
(36,371 |
) |
|
|
(60,800 |
) |
|
General and administrative |
|
|
(9,525 |
) |
|
|
(12,582 |
) |
|
(19,313 |
) |
|
(31,555 |
) |
|
Total operating expenses |
|
|
(22,193 |
) |
|
|
(53,386 |
) |
|
|
(55,684 |
) |
|
|
(92,355 |
) |
|
Loss from operations |
|
|
(20,725 |
) |
|
|
(52,925 |
) |
|
|
(51,487 |
) |
|
|
(83,496 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
301 |
|
|
|
(54 |
) |
|
391 |
|
|
(172 |
) |
|
Interest income |
|
|
69 |
|
|
|
11 |
|
|
302 |
|
|
39 |
|
|
Interest expense |
|
|
(42 |
) |
|
|
(8 |
) |
|
(46 |
) |
|
(19 |
) |
|
Loss before income taxes |
|
|
(20,397 |
) |
|
|
(52,976 |
) |
|
|
(50,840 |
) |
|
|
(83,648 |
) |
|
Income tax benefit (expense) |
|
|
(1,872 |
) |
|
|
151 |
|
|
(1,254 |
) |
|
(307 |
) |
|
Net loss |
|
$ |
(22,269 |
) |
|
$ |
(52,825 |
) |
|
$ |
(52,094 |
) |
|
$ |
(83,955 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.79 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.89 |
) |
|
$ |
(1.85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
28,147,226 |
|
|
|
58,442,987 |
|
|
|
27,517,267 |
|
|
|
45,369,040 |
|
|
Condensed Consolidated
Statements of Cash Flows(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
EndedSeptember 30, |
|
(in thousands) |
|
|
|
2017 |
|
2018 |
|
Net cash provided by (used in): |
|
|
|
|
|
|
|
Operating Activities |
|
|
|
|
$ |
(45,266 |
) |
|
$ |
(50,492 |
) |
|
Investing Activities |
|
|
|
49,361 |
|
|
(4,375 |
) |
|
Financing Activities |
|
|
|
73,929 |
|
|
68,596 |
|
|
Effects of foreign currency translation on cash and cash
equivalents |
|
|
|
1,356 |
|
|
(167 |
) |
|
Net
increase in cash and cash equivalents |
|
|
|
79,380 |
|
|
13,562 |
|
|
Cash
and cash equivalents at beginning of period |
|
|
|
32,778 |
|
|
86,769 |
|
|
Cash
and cash equivalents at end of period |
|
|
|
|
$ |
112,158 |
|
|
$ |
100,331 |
|
|
|
|
|
|
|
|
|
|
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