Baudax Bio Reports 2019 Annual Financial Results
February 13 2020 - 04:08PM
Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on
therapeutics for acute care settings, today reported its financial
results for the year ended December 31, 2019.
“We have been working with the U.S. Food and
Drug Administration (FDA) during their review of the intravenous
(IV) meloxicam New Drug Application (NDA), and we are currently
awaiting the upcoming PDUFA goal date of February 20, 2020,” said
Gerri Henwood, President and Chief Executive Officer of Baudax Bio.
“In parallel, we are making the necessary commercial preparations
for our planned product launch.”
Recent Highlights
- Baudax Bio™ Launched as a
New Pharmaceutical Company Advancing Promising, Acute Care
Therapies. In November 2019, Baudax launched as an
independent, publicly traded pharmaceutical company focused on
advancing a non-opioid analgesic and other products for the
hospital and other acute care settings. Baudax launched with
$19 million in funding from Recro Pharma, Inc., its former parent
company, and holds the rights to a pipeline of pharmaceutical
assets, including IV meloxicam, two neuromuscular blocking agents
and a reversal agent, and dexmedetomidine dosage forms.
- FDA Assigns PDUFA Date for
IV Meloxicam. In January 2020, Baudax announced that
the FDA has set a PDUFA goal date of February 20, 2020 for its
decision on the refiled NDA for IV meloxicam.
- FDA Granted Appeal for IV
Meloxicam New Drug Application. In October 2019,
Recro announced that it had received a written decision from the
FDA granting its appeal seeking approval for IV meloxicam, and
proposing resubmission of the NDA with prescribing information to
be worked out with the reviewing Division. The Company
resubmitted the NDA to the FDA in late December 2019 that included
proposed labeling and other information as requested by the
FDA.
Financial Results for the Year Ended
December 31, 2019
As of December 31, 2019, Baudax had cash and
cash equivalents of $17.7 million.
For the year ended December 31, 2019, research
and development expenses were $20.1 million compared to $35.6
million for the year ended December 31, 2018. Excluding $2.8
million of costs associated with the strategic restructuring
initiative associated with the March 2019 CRL and recorded in the
year ended December 31, 2019, the decrease of $18.3 million was
primarily due to a decrease in pre-commercialization manufacturing
and clinical costs for IV meloxicam, a decrease in development
costs for other pipeline products, and a decrease in personnel
costs.
For the year ended December 31, 2019, general
and administrative expenses were $27.0 million compared to $29.5
million for the year ended December 31, 2018. Excluding $4.4
million of costs associated with the strategic restructuring
initiative associated with the March 2019 CRL and recorded in the
year ended December 31, 2019, the decrease of $6.9 million was due
to decreases in commercial team personnel and pre-commercial
consulting costs incurred for the anticipated launch of IV
meloxicam following the receipt of the second CRL in March of 2019.
These decreases in costs were partially offset by increases in
costs associated with the cost of the separation from Recro
Pharma.
For the year ended December 31, 2019, Baudax
reported a net loss of $32.6 million, or $3.48 per share, compared
to a net loss of $73.7 million, or $7.88 per share, for the
comparable period in 2018.
About Baudax Bio, Inc.
Baudax Bio is a pharmaceutical company focused
on therapeutics for acute care settings. The Company’s lead product
candidate is a proprietary intravenous (IV) form of meloxicam, a
non-opioid, once a day injectible product which is a preferential
COX-2 inhibitor. IV meloxicam has successfully completed two
pivotal Phase III clinical efficacy trials, a large double-blind
placebo-controlled Phase III safety trial, four Phase II clinical
efficacy trials, as well as other safety studies. As a non-opioid,
IV meloxicam has the potential to overcome many of the issues
associated with commonly prescribed opioid therapeutics, including
respiratory depression, constipation, excessive nausea and
vomiting, as well as having no addictive potential while
maintaining meaningful analgesic effects for relief of pain. For
more information please visit www.baudaxbio.com.
Cautionary Statement Regarding Forward
Looking Statements
This press release contains forward-looking
statements that involve risks and uncertainties. Such
forward-looking statements reflect Baudax Bio's expectations about
its future performance and opportunities that involve substantial
risks and uncertainties. When used herein, the words "anticipate,"
"believe," "estimate," "may," "upcoming," "plan," "target," “goal”,
"intend" and "expect" and similar expressions, as they relate to
Baudax Bio or its management, are intended to identify such
forward-looking statements. These forward-looking statements are
based on information available to Baudax Bio as of the date of this
press release and are subject to a number of risks, uncertainties,
and other factors that could cause Baudax Bio’s performance to
differ materially from those expressed in, or implied by, these
forward-looking statements. Baudax Bio assumes no obligation to
update any such forward-looking statements. Factors that could
cause Baudax Bio’s actual performance to materially differ from
those expressed in the forward-looking statements set forth in this
press release include, without limitation: the Company’s ability to
execute its strategy for further development and commercialization
of IV meloxicam, the Company’s ability to execute its strategic
initiatives, the Company’s ability to adequately resolve the
outstanding labeling issues with the FDA for IV meloxicam, and ,the
time frame associated with any such resolution as well as the
timeframe of any FDA action related to the IV meloxicam NDA; the
Company’s ability to raise future financing for continued product
development and IV meloxicam commercialization; with regard to the
Company’s clinical trial results, whether there may be changes in
the interpretation by the FDA of the data of the Company’s clinical
trials and the length, cost and uncertain results and timing of our
ongoing clinical trials; with regard to the potential commercial
opportunity of IV meloxicam, whether any FDA approval of IV
meloxicam will include labeling restrictions and the potential that
IV meloxicam does not receive regulatory approval or does not
receive reimbursement by third party payors, that IV meloxicam is
not accepted by the medical community, including physicians,
patients, health care providers and hospital formularies or that a
commercial market for IV meloxicam does not develop; the Company’s
ability to manage costs and execute on its operational and budget
plans; the Company’s ability to achieve its financial goals; the
Company’s ability to obtain, maintain and successfully enforce
adequate patent and other intellectual property protection; the
Company’s lack of operating history as a standalone business; risks
relating to the separation from Recro, including, among others,
failure to achieve the anticipated benefits from the separation,
reliance on Recro and other third parties to provide certain
services post-separation, and the Company’s ability to satisfy
liabilities and potential indemnification obligations in connection
with the separation. The forward-looking statements in this press
release should be considered together with the risks and
uncertainties that may affect Baudax Bio’s business and future
results included in Baudax Bio’s filings with the Securities and
Exchange Commission at www.sec.gov.
CONTACT:
Investor Relations Contact: Argot Partners Sam Martin / Claudia
Styslinger (212) 600-1902 sam@argotpartners.com
claudia@argotpartners.com
Baudax Bio, Inc. Ryan D. Lake (484) 395-2436
rlake@rbaudaxbio.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
|
BAUDAX BIO, INC. AND SUBSIDIARIES |
Consolidated and Combined Balance Sheets |
|
|
|
|
(amounts in thousands, except share and per share data) |
|
|
|
|
Assets |
|
|
December 31, 2019 |
|
December 31, 2018 |
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
17,740 |
|
$ |
— |
|
|
Prepaid expenses and other current assets |
|
2,395 |
|
|
2,514 |
|
|
|
|
|
|
Total current assets |
|
20,135 |
|
|
2,514 |
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
4,821 |
|
|
3,982 |
|
|
Right of use asset |
|
730 |
|
|
— |
|
|
Intangible assets |
|
26,400 |
|
|
26,400 |
|
|
Goodwill |
|
|
2,127 |
|
|
2,127 |
|
|
|
|
|
|
Total assets |
$ |
54,213 |
|
$ |
35,023 |
|
Liabilities and Shareholders’ Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
271 |
|
$ |
2,653 |
|
|
Accrued expenses and other current liabilities |
|
3,532 |
|
|
9,773 |
|
|
Current operating lease liability |
|
318 |
|
|
— |
|
|
Current portion of contingent consideration |
|
3,592 |
|
|
10,354 |
|
|
|
|
|
|
Total current liabilities |
|
7,713 |
|
|
22,780 |
|
|
Long-term operating lease liability |
|
455 |
|
|
— |
|
|
Other long-term liabilities |
|
— |
|
|
32 |
|
|
Long-term portion of contingent consideration |
|
62,766 |
|
|
80,558 |
|
|
|
|
|
|
Total liabilities |
|
70,934 |
|
|
103,370 |
|
Shareholders’ equity: |
|
|
|
|
|
Preferred stock, $0.01 par value. Authorized, 10,000,000
shares; none issued and outstanding as of December 31,
2019 |
|
— |
|
|
— |
|
|
Parent company net investment |
|
— |
|
|
(68,347 |
) |
|
Common stock, $0.01 par value. Authorized, 100,000,000 shares;
issued and outstanding, 9,350,709 shares at December 31,
2019 |
|
94 |
|
|
— |
|
|
Additional paid in-capital |
|
19,405 |
|
|
— |
|
|
Accumulated deficit |
|
(36,220 |
) |
|
— |
|
|
|
|
|
|
Total shareholders’ equity |
|
(16,721 |
) |
|
(68,347 |
) |
|
|
|
|
|
Total liabilities and shareholders’ equity |
$ |
54,213 |
|
$ |
35,023 |
|
|
|
|
|
|
|
|
|
|
|
|
BAUDAX BIO,
INC. AND SUBSIDIARIES |
Consolidated and
Combined Statements of Operations |
|
|
|
|
|
|
(amounts in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve
Months Ended |
|
|
|
|
|
|
|
December
31, |
|
|
|
|
|
|
|
2019 |
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
20,061 |
|
$ |
35,583 |
|
|
General and administrative |
|
27,012 |
|
|
29,453 |
|
|
Change in contingent consideration valuation |
|
(14,554 |
) |
|
8,499 |
|
|
|
|
|
|
Total
operating expenses |
|
32,519 |
|
|
73,535 |
|
|
|
|
|
|
Operating
loss |
|
(32,519 |
) |
|
(73,535 |
) |
Other income (expense): |
|
|
|
|
|
Other income (expense) |
|
(38 |
) |
|
(132 |
) |
|
Net loss |
|
$ |
(32,557 |
) |
$ |
(73,667 |
) |
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(3.48 |
) |
$ |
(7.88 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted |
|
9,350,709 |
|
|
9,350,709 |
|
Baudax Bio (NASDAQ:BXRX)
Historical Stock Chart
From Feb 2024 to Mar 2024
Baudax Bio (NASDAQ:BXRX)
Historical Stock Chart
From Mar 2023 to Mar 2024