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
September 30, 2020 and provided a corporate update.
“Nabriva started the third quarter by completing an important
business development transaction with Merck & Co., Inc. to
promote and distribute SIVEXTRO in the U.S. It was one of several
key components in our plan towards re-establishing our
community-focused sales effort, along with continuing to expand our
strong managed care coverage and deploying the Amplity sales
force,” said Ted Schroeder, Chief Executive Officer of Nabriva
Therapeutics. “Since late September, there have been 15 Amplity
representatives in the field promoting both SIVEXTRO and
XENLETA. Initial indications are promising with better than
expected access to physicians due to SIVEXTRO’s brand recognition.
We are leveraging Amplity’s experience by targeting the most
accessible health care providers (HCPs) during the pandemic which
is also enabling increased promotion of XENLETA. Given the
favorable experience to date, an additional 45 professional
representatives are expected to be placed in select territories in
November. We estimate that the expanded team will be able to call
on almost 8,000 HCPs in total and reach approximately 60% of
historical SIVEXTRO prescribers and about 57% of estimated XENLETA
prescribers. With an estimated 50% of these physicians being
potential prescribers of both brands, we believe Nabriva will be in
a position to efficiently establish a right-sized organization to
drive demand for both products.”
CORPORATE AND DEVELOPMENT
UPDATES
- On October 30th, Nabriva participated in a Type A meeting with
the U.S. Food and Drug Administration (FDA) to obtain any new
information related to the FDA’s pending conduct of inspections of
foreign manufacturers during the COVID-19 pandemic that has
negatively impacted a number of FDA product reviews, including the
CONTEPO (fosfomycin for injection) New Drug Application (NDA). The
FDA informed us that it has not yet determined how it will conduct
international inspections during the COVID-19 pandemic. As a
result, next steps and specific timing of the CONTEPO NDA
resubmission cannot be finalized until the agency issues industry
guidance. We and the industry await future communication from the
FDA as it continues to assess the options available under existing
regulations and laws to conduct these foreign facility inspections.
It is noteworthy that the FDA has not requested any new
non-clinical or clinical data and did not raise any other concerns
with regard to the safety or efficacy of CONTEPO.
- In September 2020, the Centers for Medicare & Medicaid
Services (CMS) granted a new technology add-on payment (NTAP)
for XENLETA (lefamulin) for injection when administered in the
hospital inpatient setting. Both the intravenous (IV) and oral
formulations of XENLETA were granted Qualified Infectious Disease
Product (QIDP) and Fast Track designation by the FDA. CONTEPO was
granted an NTAP making it the first QIDP antibiotic to be granted
conditional NTAP approval prior to receiving FDA approval. CONTEPO
was granted QIDP and Fast Track Designation by the FDA for the
treatment of complicated urinary tract infections (cUTIs),
including acute pyelonephritis.
- On July 28, 2020, Nabriva announced that the European
Commission (EC) approved the Marketing Authorization Application
(MAA) for XENLETA for the treatment of community-acquired pneumonia
(CAP) in adults in the European Union following a review by the
European Medicines Agency (EMA).
- On July 16, 2020, Nabriva announced that Sunovion
Pharmaceuticals Canada Inc. received approval from Health Canada to
market oral and IV formulations of XENLETA for the treatment of
community-acquired pneumonia in adults in Canada. Nabriva entered
into a license and commercialization agreement with Sunovion
Pharmaceuticals Canada Inc. in March 2019 for XENLETA in
Canada. In the third quarter of 2020, Nabriva received a
milestone payment of $500,000 from Sunovion due to the approval of
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
indicated for acute bacterial skin and skin structure infections
(ABSSSI). 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.
FINANCIAL RESULTS
Three Months Ended September 30, 2019 and
2020
- Revenues decreased by $5.6 million from $6.9 million for the
three months ended September 30, 2019 to $1.3 million for the three
months ended September 30, 2020, primarily due to a $4.4 million
decrease in collaboration revenue and a $1.5 million decrease in
product revenues, net. Collaboration revenues in 2019 included a
$5.0 million milestone payment from Sinovant. For the three months
ended September 30, 2020, we recorded $5 thousand of product
revenue, net of gross-to-net accruals. In addition, we recorded a
$0.1 million adjustments for returns from mail order specialty
pharmacies, resulting in $47 thousand of negative product revenue,
net for the three months ended September 30, 2020. For the three
months ended September 30, 2019, we recorded $1.4 million of
product revenue, net upon the initial launch of XENLETA.
- Research and development expenses decreased by $2.1 million
from $5.6 million for the three months ended September 30, 2019 to
$3.5 million for the three months ended September 30, 2020. The
decrease was primarily due to a $0.8 million decrease in
stock-based compensation expense, a $0.3 million decrease in staff
costs, a $0.5 million decrease in research materials and purchased
services, a $0.2 million decrease in consulting fees, and a $0.2
million decrease in travel costs.
- Selling, general and administrative expense decreased by $7.5
million from $18.5 million for the three months ended September 30,
2019 to $11.0 million for the three months ended September 30,
2020. The decrease was primarily due to a $3.5 million decrease in
advisory and external consultancy expenses primarily related to
pre-commercialization activities and professional service fees in
2019, a $2.3 million decrease in staff costs due to the reduction
of headcount, and a $2.2 million decrease in stock-based
compensation expense, partly offset by a $0.3 million increase in
legal fees, and a $0.1 million increase in tax and audit related
fees.
Nine Months Ended September 30, 2019 and
2020
- Revenues decreased by $6.6 million from $9.1 million for the
nine months ended September 30, 2019 to $2.5 million for the nine
months ended September 30, 2020, primarily due a $5.3 million
decrease in collaboration revenue and a $1.4 million decrease in
product revenue, net associated with the launch of XENLETA in 2019,
offset by a $0.1 million increase in research premium and grant
revenue. Collaboration revenues in 2019 included $6.5 million for
two milestone payments from Sinovant. For the nine months ended
September 30, 2020 we recorded $0.3 million of product revenue, net
of gross-to-net accruals. In addition, we recorded a $0.4 million
returns reserve adjustment for slow moving inventory, representing
50% of XENLETA IV inventory held at our Specialty Distributors and
adjustments for returns from mail order specialty pharmacies,
partly offset by a favorable $0.2 million gross-to-net adjustment,
resulting in $61 thousand product revenue, net for the nine months
ended September 30, 2020.
- Research and development expenses decreased by $6.3 million
from $21.2 million for the nine months ended September 30, 2019 to
$14.9 million for the nine months ended September 30, 2020. The
decrease was primarily due to a $3.5 million decrease in research
materials and purchased services, a $1.9 million decrease in
research consulting fees, a $2.2 million decrease in staff costs, a
$0.7 million decrease in stock-based compensation expense, and a
$0.3 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 $10.2
million from $45.3 million for the nine months ended September 30,
2019 to $35.1 million for the nine months ended September 30, 2020.
The decrease was primarily due to a $6.0 million decrease in
advisory and external consultancy expenses primarily related to
pre-commercialization activities and professional service fees in
2019, a $2.9 million decrease in stock-based compensation expense,
a $0.8 million decrease in travel, a $0.1 million decrease
infrastructure costs, and a $0.1 million decrease in other
corporate costs.
- 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 third quarter
of 2020. In light of the COVID-19 pandemic and the associated
disruption to the healthcare industry, future sales amounts in 2020
are uncertain.
- As of September 30, 2020, Nabriva Therapeutics had $41.1
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 substantially through 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 September 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 #5564729. 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.
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
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 expansion of its commercial
sales force, the clinical utility of XENLETA for CABP, SIVEXTRO for
ABSSSI 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 InvestorsKim AndersonNabriva 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 |
|
September 30, 2020 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,019 |
|
|
$ |
41,122 |
|
Restricted cash |
|
|
392 |
|
|
|
230 |
|
Short-term investments |
|
|
175 |
|
|
|
16 |
|
Accounts receivable, net and other receivables |
|
|
2,744 |
|
|
|
3,385 |
|
Inventory |
|
|
682 |
|
|
|
5,803 |
|
Prepaid expenses |
|
|
1,158 |
|
|
|
3,754 |
|
Total current assets |
|
|
91,170 |
|
|
|
54,310 |
|
Property, plant and equipment,
net |
|
|
2,474 |
|
|
|
2,007 |
|
Intangible assets, net |
|
|
91 |
|
|
|
84 |
|
Long-term receivables |
|
|
378 |
|
|
|
369 |
|
Total assets |
|
$ |
94,113 |
|
|
$ |
56,770 |
|
Liabilities and
equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,673 |
|
|
$ |
2,041 |
|
Accrued expense and other current liabilities |
|
|
11,966 |
|
|
|
8,934 |
|
Total current liabilities |
|
|
16,639 |
|
|
|
10,975 |
|
Non-current liabilities |
|
|
|
|
|
|
Long-term debt |
|
|
34,502 |
|
|
|
7,610 |
|
Other non-current liabilities |
|
|
1,698 |
|
|
|
1,956 |
|
Total non-current liabilities |
|
|
36,200 |
|
|
|
9,566 |
|
Total liabilities |
|
|
52,839 |
|
|
|
20,541 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares
authorized at September 30, 2020; 94,545,116 and 150,006,432 issued
and outstanding at December 31, 2019 and September 30, 2020,
respectively |
|
|
945 |
|
|
|
1,500 |
|
Preferred shares, par value $0.01, 100,000,000 shares authorized at
September 30, 2020; None issued and outstanding |
|
|
— |
|
|
|
— |
|
Additional paid in capital |
|
|
517,044 |
|
|
|
563,095 |
|
Accumulated other comprehensive income |
|
|
27 |
|
|
|
27 |
|
Accumulated deficit |
|
|
(476,742 |
) |
|
|
(528,393 |
) |
Total stockholders’ equity |
|
|
41,274 |
|
|
|
36,229 |
|
Total liabilities and stockholders’ equity |
|
$ |
94,113 |
|
|
$ |
56,770 |
|
Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
(in thousands, except share and per share
data) |
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
1,445 |
|
|
|
(47 |
) |
|
$ |
1,445 |
|
|
$ |
61 |
|
Collaboration revenue |
|
|
5,051 |
|
|
|
616 |
|
|
|
6,051 |
|
|
|
768 |
|
Research premium and grant revenue |
|
|
424 |
|
|
|
722 |
|
|
|
1,652 |
|
|
|
1,738 |
|
Total revenue |
|
|
6,920 |
|
|
|
1,291 |
|
|
|
9,148 |
|
|
|
2,567 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
(15 |
) |
|
|
(25 |
) |
|
|
(15 |
) |
|
|
(401 |
) |
Research and development expenses |
|
|
(5,601 |
) |
|
|
(3,486 |
) |
|
|
(21,213 |
) |
|
|
(14,930 |
) |
Selling, general and administrative expenses |
|
|
(18,503 |
) |
|
|
(10,997 |
) |
|
|
(45,339 |
) |
|
|
(35,094 |
) |
Total operating expenses |
|
|
(24,119 |
) |
|
|
(14,508 |
) |
|
|
(66,567 |
) |
|
|
(50,425 |
) |
Loss from
operations |
|
|
(17,199 |
) |
|
|
(13,217 |
) |
|
|
(57,419 |
) |
|
|
(47,858 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(10 |
) |
|
|
450 |
|
|
|
116 |
|
|
|
614 |
|
Interest income |
|
|
94 |
|
|
|
5 |
|
|
|
176 |
|
|
|
85 |
|
Interest expense |
|
|
(709 |
) |
|
|
(261 |
) |
|
|
(2,512 |
) |
|
|
(1,536 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,757 |
) |
Loss before income taxes |
|
|
(17,824 |
) |
|
|
(13,023 |
) |
|
|
(59,639 |
) |
|
|
(51,452 |
) |
Income tax benefit
(expense) |
|
|
29 |
|
|
|
72 |
|
|
|
(80 |
) |
|
|
(199 |
) |
Net loss |
|
$ |
(17,795 |
) |
|
|
(12,951 |
) |
|
$ |
(59,719 |
) |
|
$ |
(51,651 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted ($ per
share) |
|
$ |
(0.24 |
) |
|
|
(0.09 |
) |
|
$ |
(0.83 |
) |
|
$ |
(0.44 |
) |
Weighted average
number of shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
75,161,192 |
|
|
|
144,690,904 |
|
|
|
72,153,405 |
|
|
|
117,454,536 |
|
Condensed Consolidated Statements of Cash
Flows(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
EndedSeptember 30, |
|
(in thousands) |
|
|
|
2019 |
|
|
2020 |
|
|
Net cash provided by
(used in): |
|
|
|
|
|
|
|
Operating activities |
|
|
|
$ |
(56,405 |
) |
|
$ |
(57,967 |
) |
|
Investing activities |
|
|
|
131 |
|
|
(257 |
) |
|
Financing activities |
|
|
|
32,680 |
|
|
12,903 |
|
|
Effects of foreign currency
translation on cash and cash equivalents |
|
|
|
(80 |
) |
|
262 |
|
|
Net decrease in cash and cash
equivalents |
|
|
|
(23,674 |
) |
|
(45,059 |
) |
|
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 |
|
|
|
$ |
78,329 |
|
|
$ |
41,352 |
|
|
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