Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections, today
announced its financial results for the three months ended June 30,
2020 and provided a corporate update.
“We have been actively building the foundation for relaunching
our commercial efforts in the community. Nabriva now has an
experienced contract sales partner and the opportunity to promote
and distribute an important new revenue-generating product in
SIVEXTRO. Adding SIVEXTRO to our portfolio is an important
component of our strategy to actively pursue business development
and licensing opportunities that have a highly complementary
customer base and leverage Nabriva’s capabilities,” said Ted
Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We
recently secured an agreement with Amplity Health, a leading
pharmaceutical contract commercial organization, to provide Nabriva
the ability to build a flexible and efficient sales infrastructure
to leverage brand awareness for both XENLETA and SIVEXTRO. We
believe Nabriva now has a solid foundation in place to educate
health care providers about the benefits of these two important
anti-infective treatment options for their patients. Our managed
care presence continues to strengthen in the U.S. and XENLETA is
now accessible to more than 225 million covered lives. This,
coupled with our partnership with WEP Clinical and recent approvals
for XENLETA in the European Union and Canada, have enhanced our
ability to provide access for patients despite the challenges
presented by the ongoing global pandemic.”
CORPORATE AND DEVELOPMENT
UPDATES
- On July 28, 2020, Nabriva announced that the European
Commission (EC) approved the marketing authorization application
for XENLETA (lefamulin) for the treatment of community-acquired
pneumonia (CAP) in adults in the European Union following a review
by the European Medicines Agency.
- On July 16, 2020, Nabriva announced that Sunovion
Pharmaceuticals Canada Inc., received approval from Health Canada
to market oral and intravenous (IV) formulations of XENLETA for the
treatment of community-acquired pneumonia in adults in Canada.
Nabriva entered into a license and commercialization agreement in
March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in
Canada.
- On July 15, 2020, Nabriva announced that it 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. SIVEXTRO is an oxazolidinone-class antibacterial. In
addition, Nabriva engaged Amplity Health, a leading pharmaceutical
contract commercial organization, to provide community-based
commercial and sales services for SIVEXTRO and XENLETA in the
United States.
- On June 30, 2020, Nabriva announced that it had signed an
exclusive agreement with WEP Clinical (WEP), a specialist
pharmaceutical services company, to supply XENLETA on a named
patient or expanded access basis in certain countries outside of
the U.S., China and Canada. The Named Patient Program (NPP) is
designed to ensure that physicians, contingent on meeting the
necessary eligibility criteria and receiving approval, can request
IV or oral XENLETA on behalf of patients who live in certain
countries where it is not yet available and have an unmet medical
need.
- On June 19, 2020, Nabriva received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration for the New Drug
Application (NDA) resubmission seeking marketing approval of
CONTEPO™ (fosfomycin) for injection for the treatment of
complicated urinary tract infections (cUTIs), including acute
pyelonephritis. Although Nabriva’s European contract manufacturing
partners were prepared for regulatory authority inspections, the
CRL cites observations at its manufacturing partners that could not
be resolved due to FDA’s inability to conduct onsite inspections
because of travel restrictions caused by the COVID-19 pandemic. In
general, previously identified product quality and facility
inspection related observations at its contract manufacturing
partners are required to be satisfactorily resolved before the NDA
may be approved. The FDA did not request any new clinical data and
did not raise any other concerns with regard to the safety or
efficacy of CONTEPO in the CRL. Nabriva plans to request a Type A
meeting with the FDA to discuss its plans for completing foreign
facility inspections and the appropriate next steps to refile the
NDA. CONTEPO has been granted Qualified Infectious Disease Product
(QIDP) and Fast Track designations by the FDA for the treatment of
serious infections, including cUTIs.
- On May 29, 2020, Nabriva announced that it entered into a
definitive agreement with several healthcare-focused institutional
investors, including Fidelity Management & Research Company,
LLC, to issue and sell ordinary shares and warrants in a registered
direct offering priced at-the-market under Nasdaq rules for
aggregate gross proceeds of $38.0 million before deducting
placement agent fees and other offering expenses payable by
Nabriva.
- On April 7, 2020, Nabriva announced it was restructuring its
hospital-based commercial sales force and transitioning to a
community-based sales force. The restructuring aligns the
capabilities of the Company’s sales force with its strategic
refocus for promoting XENLETA to community health care
professionals, the excellent managed care coverage it has secured
and its business development strategy to in-license additional
community products, resulting in a substantial reduction in
expenditures. In the second quarter, Nabriva also reduced
commercial, medical affairs and administrative expenses.
- On April 9, 2020, Nabriva received confirmation from the
Centers for Medicare and Medicaid Services (CMS) of a preliminary
decision to assign permanent product-specific Healthcare Common
Procedure Coding System (HCPCS) J-code for XENLETA 150 mg
injection. The new billing code, J0691 Injection, became effective
July 1, 2020, replaced the C Code, C9054 and enables healthcare
providers to list physician-administered drugs on claim forms
submitted to CMS to receive proper reimbursement for
Medicare-eligible patients.
- On April 29, 2020, Nabriva received written notice from Nasdaq
indicating that, based on the closing bid for the last 30
consecutive business days, the Company was not in compliance with
the $1.00 minimum bid price (Bid Price Rule) requirement for
continued listing on The Nasdaq Global Select Market. The Notice
does not result in the immediate delisting of the Company’s
ordinary shares from The Nasdaq Global Select Market. Nabriva will
have until December 28, 2020 to regain compliance with the Bid
Price Rule. To regain compliance, the closing bid price of
Nabriva’s ordinary shares must be at least $1.00 per share for a
minimum of ten consecutive business days on or before December 28,
2020. At its July 29, 2020 Annual General Meeting, Nabriva’s
shareholders approved a reverse stock split (i.e., a consolidation
of share capital under Irish law), subject to and conditional upon
the board of directors determining, in its sole discretion, that a
reverse stock split is necessary for the Company to comply with the
Bid Price Rule, whereby every 10 ordinary shares of $0.01 (nominal
value) each in the authorized and unissued and authorized and
issued share capital of the Company be consolidated into 1 ordinary
share of $0.10 (nominal value) each, and the subsequent reduction
in the nominal value of the ordinary shares in the authorized and
unissued and authorized and issued share capital of the Company
from $0.10 each to $0.01 each. Nabriva’s board of directors is
evaluating whether a reverse stock split is necessary.
FINANCIAL RESULTS
Three Months Ended June 30, 2019 and 2020
- Revenues were $0.5 million for the three months ended June 30,
2019 and $0.5 million for the three months ended June 30, 2020,
primarily due to grant revenues. For the three months ended
June 30, 2020 we recorded $0.1 million of product revenue, net of
gross-to-net accruals. In addition, we recorded a $0.3 million
returns reserve adjustment for slow moving inventory, representing
50% of XENLETA IV inventory held at our Specialty Distributors,
partly offset by a favorable $0.2 million gross-to-net adjustment,
resulting in $48 thousand of negative product revenue, net for the
three months ended June 30, 2020.
- Research and development expenses decreased by $1.6 million
from $8.1 million for the three months ended June 30, 2019 to $6.5
million for the three months ended June 30, 2020. The decrease was
primarily due to a $0.9 million decrease in staff costs, a $0.5
million decrease in research consulting fees, and a $0.1 million
decrease in travel costs.
- Selling, general and administrative expense decreased by $5.3
million from $13.4 million for the three months ended June 30, 2019
to $8.1 million for the three months ended June 30, 2020. The
decrease was primarily due to a $4.5 million decrease in advisory
and external consultancy expenses primarily related to
pre-commercialization activities and professional service fees in
2019, a $0.5 million decrease in staff costs due to the termination
of employees, a $0.4 million decrease in travel expenses and a $0.4
million decrease in infrastructure costs, partly offset by a $0.4
million increase in legal fees.
Six Months Ended June 30, 2019 and 2020
- Revenues decreased by $1.0 million from $2.2 million for the
six months ended June 30, 2019 to $1.3 million for the six months
ended June 30, 2020, primarily due a $0.8 million decrease in
collaboration revenue and a $0.2 million decrease in grant revenue,
offset by a $0.1 million increase in product revenue, net
associated with the launch of XENLETA. For the six months ended
June 30, 2020, we recorded $0.2 million of product revenue, net of
gross-to-net accruals. In addition, we recorded a $0.3 million
returns reserve adjustment for slow moving inventory, representing
50% of XENLETA IV inventory held at our Specialty Distributors,
partly offset by a favorable $0.2 million gross-to-net adjustment,
resulting in $0.1 million product revenue, net for the six months
ended June 30, 2020.
- Research and development expenses decreased by $4.2 million
from $15.6 million for the six months ended June 30, 2019 to $11.4
million for the six months ended June 30, 2020. The decrease was
primarily due to a $3.0 million decrease in research materials and
purchased services related to the development of XENLETA, a $1.7
million decrease in research consulting fees, a $1.8 million
decrease in staff costs and a $0.2 million decrease in travel and
infrastructure costs, partly offset by a $2.6 million refund of NDA
filing fees for our product candidate, CONTEPO, in 2019.
- Selling, general and administrative expense decreased by $2.7
million from $26.8 million for the six months ended June 30, 2019
to $24.1 million for the six months ended June 30, 2020. The
decrease was primarily due to a $5.2 million decrease in advisory
and external consultancy expenses primarily related to
pre-commercialization activities and professional service fees in
2019, a $0.7 million decrease in stock-based compensation expense
and a $0.1 million decrease in other corporate costs, partly offset
by a $0.3 million increase in legal fees and a $3.0 million
increase in staff costs due to the addition of employees, prior to
our reduction in sales force in April 2020.
- As previously disclosed, Nabriva’s distribution partners
continue to primarily utilize their existing inventory to satisfy
product demand, which in turn impacted sales in the second quarter
of 2020. In light of the COVID-19 pandemic, the associated
disruption to the healthcare delivery and the uncertainty of
resuming full direct physician medical education and promotion,
future sales amounts in 2020 are uncertain.
- As of June 30, 2020, Nabriva Therapeutics had $49.7 million in
cash and cash equivalents, compared to $86.0 million as of December
31, 2019.
- Based on its current operating plans, the Company expects that
its existing cash resources will be sufficient to enable Nabriva to
fund its operating expenses, debt service obligations and capital
expenditure requirements into the first quarter of 2021. This
estimate assumes, among other things, that Nabriva remains in
compliance with the covenants under its Loan Agreement.
Please refer to our Annual Report on
Forms 10-K for the fiscal year ended December 31,
2019 and our Quarterly Report on Form 10-Q for the quarterly period
ended June 30, 2020, which are 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 #4007639. 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.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the
treatment of adults with community-acquired bacterial pneumonia
(CABP) caused by the following susceptible microorganisms:
Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XENLETA and other antibacterial
drugs, XENLETA should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known
hypersensitivity to XENLETA or pleuromutilins.XENLETA tablets are
contraindicated for use with CYP3A4 substrates that prolong the QT
interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid
XENLETA in patients with known QT prolongation, ventricular
arrhythmias, and patients receiving drugs that may prolong the QT
interval.Based on animal studies, XENLETA may cause fetal harm.
Advise females of reproductive potential of the potential risk to
the fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with nearly all systemic antibacterial agents, including
XENLETA, with severity ranging from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA
Injection are administration site reactions, hepatic enzyme
elevation, nausea, hypokalemia, insomnia, and headache and (b)
XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme
elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of
XENLETA Injection to 150 mg infused over 60 minutes every 24 hours.
XENLETA Tablets are not recommended in patients with moderate or
severe hepatic impairment due to insufficient information to
provide dosing recommendations.Avoid XENLETA Injection and Tablets
with concomitant strong or moderate CYP3A or P-gp inducers. Monitor
for reduced efficacy of XENLETA.Avoid XENLETA Tablets with strong
CYP3A or P-gp inhibitors.Monitor for adverse reactions of sensitive
CYP3A substrates administered with XENLETA Tablets.XENLETA has not
been studied in pregnant women. Verify pregnancy status in females
prior to initiating XENLETA and advise females to use contraception
during treatment and for 2 days after the final dose. Lactating
women should pump and discard milk for the duration of treatment
with XENLETA and for 2 days after the final dose.To report
SUSPECTED ADVERSE REACTIONS, or administration during pregnancy,
contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at
1-800-FDA-1088 or https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for
XENLETA.
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 launch and
commercialize XENLETA for the treatment of CABP, including the
availability of and ease of access to XENLETA through major U.S.
specialty distributors, marketing exclusivity and patent protection
for XENLETA, the distribution and promotion of SIVEXTRO for the
treatment of ABSSSI, the development of CONTEPO for Complicated
Urinary Tract Infections (cUTI), the ability to secure and deploy a
commercial sales force, the clinical utility of XENLETA for CABP
and of CONTEPO for cUTI, plans for and timing of the review of
regulatory filings for 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, plans to pursue research and development of other
product candidates, 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 InvestorsGary SenderNabriva Therapeutics
plcir@nabriva.com
For MediaMike BeyerSam Brown Inc.
mikebeyer@sambrown.com312-961-2502
|
Consolidated Balance Sheets (unaudited) |
|
|
|
|
|
|
|
|
|
As of |
|
As of |
(in thousands, except share data) |
|
December 31, 2019 |
|
June 30, 2020 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,019 |
|
|
$ |
49,660 |
|
Restricted cash |
|
|
392 |
|
|
|
229 |
|
Short-term investments |
|
|
175 |
|
|
|
175 |
|
Accounts receivable, net and other receivables |
|
|
2,744 |
|
|
|
3,228 |
|
Inventory |
|
|
682 |
|
|
|
5,196 |
|
Prepaid expenses |
|
|
1,158 |
|
|
|
3,921 |
|
Total current assets |
|
|
91,170 |
|
|
|
62,409 |
|
Property, plant and equipment,
net |
|
|
2,474 |
|
|
|
2,176 |
|
Intangible assets, net |
|
|
91 |
|
|
|
97 |
|
Long-term receivables |
|
|
378 |
|
|
|
368 |
|
Total assets |
|
$ |
94,113 |
|
|
$ |
65,050 |
|
Liabilities and
equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,673 |
|
|
$ |
2,620 |
|
Accrued expense and other current liabilities |
|
|
11,966 |
|
|
|
8,376 |
|
Total current liabilities |
|
|
16,639 |
|
|
|
10,996 |
|
Non-current liabilities |
|
|
|
|
|
|
Long-term debt |
|
|
34,502 |
|
|
|
7,477 |
|
Other non-current liabilities |
|
|
1,698 |
|
|
|
2,116 |
|
Total non-current liabilities |
|
|
36,200 |
|
|
|
9,593 |
|
Total liabilities |
|
|
52,839 |
|
|
|
20,589 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares
authorized at June 30, 2020; 94,545,116 and 142,965,483 issued and
outstanding at December 31, 2019 and June 30, 2020,
respectively |
|
|
945 |
|
|
|
1,430 |
|
Preferred shares, par value $0.01, 100,000,000 shares authorized at
June 30, 2020; None issued and outstanding |
|
|
— |
|
|
|
— |
|
Additional paid in capital |
|
|
517,044 |
|
|
|
558,446 |
|
Accumulated other comprehensive income |
|
|
27 |
|
|
|
27 |
|
Accumulated deficit |
|
|
(476,742 |
) |
|
|
(515,442 |
) |
Total stockholders’ equity |
|
|
41,274 |
|
|
|
44,461 |
|
Total liabilities and stockholders’ equity |
|
$ |
94,113 |
|
|
$ |
65,050 |
|
|
Consolidated Statements of Operations
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
(in thousands, except share and per share
data) |
|
2019 |
|
2020 |
|
2019 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
— |
|
|
|
(48 |
) |
|
$ |
— |
|
|
$ |
108 |
|
Collaboration revenue |
|
|
— |
|
|
|
7 |
|
|
|
1,000 |
|
|
|
152 |
|
Research premium and grant revenue |
|
|
525 |
|
|
|
528 |
|
|
|
1,228 |
|
|
|
1,016 |
|
Total revenue |
|
|
525 |
|
|
|
487 |
|
|
|
2,228 |
|
|
|
1,276 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
— |
|
|
|
(368 |
) |
|
|
— |
|
|
|
(376 |
) |
Research and development expenses |
|
|
(8,074 |
) |
|
|
(6,500 |
) |
|
|
(15,612 |
) |
|
|
(11,444 |
) |
Selling, general and administrative expenses |
|
|
(13,427 |
) |
|
|
(8,072 |
) |
|
|
(26,836 |
) |
|
|
(24,097 |
) |
Total operating expenses |
|
|
(21,501 |
) |
|
|
(14,940 |
) |
|
|
(42,448 |
) |
|
|
(35,917 |
) |
Loss from
operations |
|
|
(20,976 |
) |
|
|
(14,453 |
) |
|
|
(40,220 |
) |
|
|
(34,641 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
56 |
|
|
|
(634 |
) |
|
|
126 |
|
|
|
164 |
|
Interest income |
|
|
72 |
|
|
|
16 |
|
|
|
82 |
|
|
|
80 |
|
Interest expense |
|
|
(904 |
) |
|
|
(251 |
) |
|
|
(1,803 |
) |
|
|
(1,275 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,757 |
) |
Loss before income taxes |
|
|
(21,752 |
) |
|
|
(15,322 |
) |
|
|
(41,815 |
) |
|
|
(38,429 |
) |
Income tax benefit
(expense) |
|
|
45 |
|
|
|
(119 |
) |
|
|
(109 |
) |
|
|
(271 |
) |
Net loss |
|
$ |
(21,707 |
) |
|
|
(15,441 |
) |
|
$ |
(41,924 |
) |
|
$ |
(38,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted ($ per
share) |
|
$ |
(0.30 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.37 |
) |
Weighted average
number of shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
72,526,441 |
|
|
|
112,778,258 |
|
|
|
70,624,583 |
|
|
|
103,686,706 |
|
|
Condensed Consolidated Statements of Cash
Flows (unaudited) |
|
|
|
Six Months
Ended June 30, |
(in thousands) |
|
2019 |
|
2020 |
Net cash provided by
(used in): |
|
|
|
|
Operating activities |
|
$ |
(41,670 |
) |
|
$ |
(45,372 |
) |
Investing activities |
|
(57 |
) |
|
(248 |
) |
Financing activities |
|
13,428 |
|
|
9,168 |
|
Effects of foreign currency
translation on cash and cash equivalents |
|
40 |
|
|
(70 |
) |
Net decrease in cash and cash
equivalents |
|
(28,259 |
) |
|
(36,522 |
) |
Cash and cash equivalents and
restricted cash at beginning of period |
|
102,003 |
|
|
86,411 |
|
Cash and cash equivalents and
restricted cash at end of period |
|
$ |
73,744 |
|
|
$ |
49,889 |
|
|
|
|
|
|
Nabriva Therapeutics (NASDAQ:NBRV)
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