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 March
31, 2022 and provided a corporate update.
“We continued to execute on our near-term strategy in the first
quarter of 2022. We extended our agreement with Merck to promote
and distribute SIVEXTRO, by three years, through at least December
2026. We are seeing consistent growth in SIVEXTRO sales from our
commercial efforts, highlighted by the 10% growth in SIVEXTRO
prescription demand in the first quarter of 2022 versus the first
quarter of 2021. With historically higher demand quarters still in
front of us this year, we are confident in our goal to return
SIVEXTRO to historical peak run rate sales by the third quarter of
2022. We anticipate SIVEXTRO to be a significant contributor
to the business and plan to leverage this momentum to continue to
grow Nabriva’s commercial business.”
Mr. Schroeder added, “We also continue to educate the medical
community, especially pulmonologists, about the differentiated
profile of XENLETA for the treatment of community-acquired
bacterial pneumonia in adults. We are encouraged by our targeted
life cycle management activities focused on significant unmet
medical needs that may be addressed by XENLETA. In particular, we
are pleased to report enrollment in our Phase 1 clinical trial in
patients with cystic fibrosis has commenced and we expect to report
results from the trial in the first half of 2023.”
CORPORATE AND DEVELOPMENT
UPDATES
- On May 5, 2022, we announced that we signed an agreement to
officially extend our SIVEXTRO Distribution and Promotion Agreement
with Merck through at least December 2026.
- On April 11, 2022, we announced that the first patient in our
Phase 1 clinical trial of XENLETA for the treatment of resistant
bacterial infections in patients with Cystic Fibrosis was
randomized and dosed. The Phase 1 trial is an open-label,
randomized, crossover study to assess the safety and
pharmacokinetics following single doses of oral and intravenous
XENLETA in adult patients with cystic fibrosis.
FINANCIAL RESULTS
Three Months Ended March 31, 2022 and 2021
- Revenues for the three months ended
March 31, 2022 were $8.0 million compared to $2.5 million for the
three months ended March 31, 2021. The $5.5 million increase was
primarily due to $7.2 million in SIVEXTRO product revenue, net for
the three months ended March 31, 2022, partially offset by a $1.4
million decrease in collaboration.
- Cost of revenues for the three
months ended March 31, 2022 was $3.4 million compared to $62
thousand for the three months ended March 31, 2021. The $3.3
million increase was primarily due to the launch of our own
SIVEXTRO National Drug Code on April 12, 2021.
- Research and development expenses
for the three months ended March 31, 2022 were $3.5 million
compared to $3.9 million for the three months ended March 31, 2021.
The $0.4 million decrease was primarily due to a $0.2 million
decrease in research consulting fees, and a $0.2 million decrease
in research materials and purchased services.
- Selling, general and administrative
expenses for the three months ended March 31, 2022 were $12.7
million compared to $12.0 million for the three months ended March
31, 2021. The $0.7 million increase was primarily due to a $0.4
million increase in staff costs, a $0.2 million increase in
stock-based compensation, and a $0.1 million increase in advisory
and external consultancy expenses primarily related to
commercialization activities.
- Net loss decreased by $2.2 million
from a $14.0 million net loss for the three months ended March 31,
2021, to a $11.8 million net loss for the three months ended March
31, 2022.
- As of March 31, 2022, Nabriva had
$33.8 million in cash and cash equivalents. Based on its current
operating plans, Nabriva expects that its existing cash resources
will be sufficient to enable it to fund its operating expenses,
debt service obligations and capital expenditure requirements well
into the fourth quarter of 2022.
Please refer to our Annual Report on
Forms 10-K for the fiscal year ended December 31,
2021 and our Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2022 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 (800)
579-2543 for domestic participants and (203) 518-9708 for
international participants, with Conference ID # NBRVQ122. 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 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. 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.
About SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and
Drug Administration in 2014. It is indicated in adults and
pediatric patients 12 years of age and older for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus group (including Streptococcus anginosus,
Streptococcus intermedius and Streptococcus constellatus), and
Enterococcus faecalis. To reduce the development of drug-resistant
bacteria and maintain the effectiveness of SIVEXTRO and other
antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
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.
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
commercialize XENLETA for the treatment of CABP, including the
managed care coverage for XENLETA, the distribution and promotion
of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO
for Complicated Urinary Tract Infections (cUTI), the clinical
utility of XENLETA for CABP and Cystic Fibrosis, SIVEXTRO for
ABSSSI and of CONTEPO for cUTI, the impact of macro events on sales
of SIVEXTRO and XENLETA, plans for and timing of the review of
regulatory filings for XENLETA and 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 prospects for future sales of SIVEXTRO, 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, plans to pursue business development
initiatives, 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 execute 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.
CONTACT:
For Investors and MediaKim AndersonNabriva
Therapeutics plcir@nabriva.com
Consolidated Balance Sheets
(unaudited)
|
|
|
|
|
|
|
|
|
As of |
|
As of |
(in thousands, except share data) |
|
March 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,784 |
|
|
$ |
47,659 |
|
Restricted cash |
|
|
174 |
|
|
|
175 |
|
Short-term investments |
|
|
— |
|
|
|
16 |
|
Accounts receivable, net and other receivables |
|
|
11,007 |
|
|
|
12,751 |
|
Inventory |
|
|
15,632 |
|
|
|
14,509 |
|
Prepaid expenses |
|
|
4,602 |
|
|
|
5,155 |
|
Total current assets |
|
|
65,199 |
|
|
|
80,265 |
|
Property and equipment,
net |
|
|
181 |
|
|
|
233 |
|
Intangible assets, net |
|
|
21 |
|
|
|
31 |
|
Other non-current assets |
|
|
379 |
|
|
|
380 |
|
Total assets |
|
$ |
65,780 |
|
|
$ |
80,909 |
|
Liabilities and
stockholders´ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Current portion of long-term debt |
|
$ |
4,196 |
|
|
$ |
3,765 |
|
Accounts payable |
|
|
1,578 |
|
|
|
4,372 |
|
Accrued expense and other current liabilities |
|
|
10,496 |
|
|
|
13,829 |
|
Deferred revenue |
|
|
— |
|
|
|
374 |
|
Total current liabilities |
|
|
16,270 |
|
|
|
22,340 |
|
Non-current liabilities: |
|
|
|
|
|
|
Long-term debt |
|
|
3,917 |
|
|
|
4,265 |
|
Other non-current liabilities |
|
|
968 |
|
|
|
954 |
|
Total non-current liabilities |
|
|
4,885 |
|
|
|
5,219 |
|
Total liabilities |
|
|
21,155 |
|
|
|
27,559 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Ordinary shares, nominal value $0.01, 300,000,000 ordinary shares
authorized at March 31, 2022; 61,725,236 and 56,715,306 issued and
outstanding at March 31, 2022, and December 31, 2021,
respectively |
|
|
617 |
|
|
|
567 |
|
Preferred shares, par value $0.01, 100,000,000 shares authorized at
March 31, 2022; None issued and outstanding |
|
|
— |
|
|
|
— |
|
Additional paid in capital |
|
|
651,476 |
|
|
|
648,432 |
|
Accumulated other comprehensive income |
|
|
27 |
|
|
|
27 |
|
Accumulated deficit |
|
|
(607,495 |
) |
|
|
(595,676 |
) |
Total stockholders’ equity |
|
|
44,625 |
|
|
|
53,350 |
|
Total liabilities and stockholders’ equity |
|
$ |
65,780 |
|
|
$ |
80,909 |
|
Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
(in thousands, except share and per share
data) |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
Product revenue, net |
|
$ |
7,040 |
|
|
$ |
130 |
|
Collaboration revenue |
|
|
629 |
|
|
|
2,002 |
|
Research premium and grant revenue |
|
|
351 |
|
|
|
397 |
|
Total revenues |
|
|
8,020 |
|
|
|
2,529 |
|
Operating
expenses: |
|
|
|
|
|
|
Cost of revenues |
|
|
(3,361 |
) |
|
|
(62 |
) |
Research and development expenses |
|
|
(3,517 |
) |
|
|
(3,868 |
) |
Selling, general and administrative expenses |
|
|
(12,700 |
) |
|
|
(12,047 |
) |
Total operating expenses |
|
|
(19,578 |
) |
|
|
(15,977 |
) |
Loss from
operations |
|
|
(11,558 |
) |
|
|
(13,448 |
) |
Other income
(expense): |
|
|
|
|
|
|
Other income (expense), net |
|
|
308 |
|
|
|
(122 |
) |
Interest income (expense), net |
|
|
(215 |
) |
|
|
(221 |
) |
Loss before income taxes |
|
|
(11,465 |
) |
|
|
(13,791 |
) |
Income tax benefit
(expense) |
|
|
(354 |
) |
|
|
(190 |
) |
Net loss |
|
$ |
(11,819 |
) |
|
$ |
(13,981 |
) |
|
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
|
Basic and diluted ($ per
share) |
|
$ |
(0.20 |
) |
|
$ |
(0.53 |
) |
Weighted average
number of shares: |
|
|
|
|
|
|
Basic and diluted |
|
|
58,794,142 |
|
|
|
26,413,590 |
|
Condensed Consolidated Statements of Cash
Flows (unaudited)
|
|
|
|
|
Three Months
EndedMarch 31, |
(in thousands) |
|
2022 |
|
2021 |
Net cash provided by
(used in): |
|
|
|
|
Operating activities |
|
$ |
(15,870 |
) |
|
$ |
(21,626 |
) |
Investing activities |
|
(36 |
) |
|
(120 |
) |
Financing activities |
|
2,194 |
|
|
34,930 |
|
Effects of exchange rate
changes on the balance of cash held in foreign currencies |
|
(164 |
) |
|
244 |
|
Net increase (decrease) in
cash and cash equivalents and restricted cash |
|
(13,876 |
) |
|
13,428 |
|
Cash and cash equivalents and
restricted cash at beginning of quarter |
|
47,834 |
|
|
41,590 |
|
Cash and cash equivalents and
restricted cash at end of quarter |
|
$ |
33,958 |
|
|
$ |
55,018 |
|
Nabriva Therapeutics (NASDAQ:NBRV)
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