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, 2020.
“As we continue to navigate the ongoing global
pandemic, we continue to see a slower rate of commercialization of
ANJESO than we would have expected without COVID-19, but feedback
from users of ANJESO and our third-party market research is
encouraging,” said Gerri Henwood, President and CEO of Baudax Bio.
“Interest in the product continues to grow as we raise awareness
and educate health care providers on the benefits of ANJESO for the
management of moderate to severe pain in the acute care setting. We
are happy to have added our fifth additional Orange Book listed
patent in November, which has an expiry date of May 2030 and we
have seen continued support for the safety and efficacy of ANJESO
from peer-reviewed publications.”
“The fourth quarter and full year 2020 was
marked by several significant milestones for Baudax Bio. We secured
approximately $24 million of gross proceeds in the fourth quarter
of 2020 and $31 million in the first quarter of 2021 from
registered direct offerings and warrant exercises,” concluded Ms.
Henwood.
Recent Highlights
ANJESO
- Update
on Vials Sold to End-Customer. In 2020, over 65
institutions added ANJESO to their formulary. The number of vials
sold to end-customers has increased 58% in the fourth quarter of
2020 versus the third quarter of 2020. The number of vials sold to
hospitals and ambulatory surgical centers increased over 80% during
the same time period. The average quarterly orders per account
increased over 60% in the fourth quarter of 2020 versus the third
quarter of 2020 and the re-order rate is approximately 55% with a
deepening usage pattern.
-
Commercialization Update. While the Company
reduced its commercial headcount in November, it launched a virtual
tele-sales team to help increase awareness and broaden usage in a
cost-efficient manner. This team, deployed in December, has had
early success increasing awareness of ANJESO in hospitals not
currently targeted by our sales team and has expanded modestly in
late January 2021. Another approach deployed in late January 2021
enlists individuals with medical device background and previous
relationships with orthopedic surgeons to further expand our access
and reach in orthopedics.
- Publication of ANJESO
Network Meta-Analysis in Peer-Reviewed Journal BMC
Anesthesiology. In November 2020, the company announced
the online publication of a Network Meta-Analysis for ANJESO
injection in the peer-reviewed medical journal BMC Anesthesiology.
ANJESO was found to be superior in pain reduction for
abdominoplasty, bunionectomy and hysterectomy with similar or
better safety compared to other approved IV non-opioid
analgesics.
- Receipt of Additional
Orange Book Listed Patent for ANJESO. In November 2020,
the company announced the issuance of an additional United States
patent on July 14, 2020. The patent covers the use of ANJESO to
treat moderate to severe pain and has been listed in the U.S. Food
and Drug Administration’s (FDA) Orange Book: Approved Drug Products
with Therapeutic Equivalence Evaluations as it relates to ANJESO.
This patent is an additional ANJESO patent to be listed in the
Orange Book with an expiry date of May 2030 and joins four other
patents listed in the Orange Book, amongst others owned or licensed
by Baudax that currently provide exclusivity to the ANJESO
franchise.
Corporate and Financial
- Announced a $17.6
Million Registered Direct Offering. In
February 2021, the company entered into a definitive agreement with
institutional and accredited investors for the purchase and sale of
an aggregate of 11,000,000 shares of common stock at a purchase
price of $1.60 per share in a registered direct offering priced
at-the-market under Nasdaq rules. The gross proceeds from the
offering were approximately $17.6 million, prior to deducting fees
and expenses.
- Announced Exercise of
Warrants for Gross Proceeds of $13.4 Million. In January
2021, the company entered into an agreement with an accredited
healthcare-focused institutional investor to cash exercise its
warrants to purchase 10,300,430 shares of common stock having an
exercise price of $1.18. In connection therewith, the company sold
the exercising holder new warrants, which are cash exercisable for
an aggregate of 10,300,430 shares of common stock at an exercise
price of $1.60 per share. The purchase price of the additional
warrants was $1,287,554, or $0.125 per warrant. The gross proceeds
to the company from the exercise of the warrants and the sale of
the additional warrants were $13.4 million, prior to deducting fees
and expenses. The offering was conducted as a registered direct
offering priced at-the-market under Nasdaq rules.
- Closed Two $12 Million
Registered Direct Offerings. In November and December
2020, the company entered into two definitive agreements with a
healthcare-focused institutional investor for the purchase and sale
of an aggregate of 10,126,583 and 10,300,430 shares of common stock
(or pre-funded warrants in lieu of shares of common stock) and
warrants to purchase up to an aggregate of 10,126,583 and
10,300,430 shares of common stock, respectively. Both offerings
were registered direct offerings priced at-the-market under Nasdaq
rules. The gross proceeds to Baudax Bio from the offerings were
approximately $24 million, prior to deducting fees and
expenses.
Financial Results for the Year Ended
December 31, 2020
As of December 31, 2020, Baudax had cash and
cash equivalents of $30.3 million.
Net product revenue for the year ended December
31, 2020 was $0.5 million related to sales of ANJESO in the U.S.
since its launch in June 2020. There was no product revenue
recognized for the year ended December 31, 2019.
Cost of sales for the year ended December 31,
2020 was $1.7 million and consisted of product costs, royalty
expense and certain fixed costs associated with the manufacturing
of ANJESO, including supply chain and quality costs. Certain
product costs of ANJESO units recognized as revenue for the year
ended December 31, 2020 were incurred prior to the FDA approval of
ANJESO in February 2020, and therefore are not included in cost of
sales during the period. Baudax Bio expects that over time, its
cost of sales will increase as sales increase and as inventory
values change to include all direct and indirect costs and expenses
post FDA approval. No cost of sales was recorded for the year ended
December 31, 2019.
Research and development expenses for the year
ended December 31, 2020 were $9.1 million compared to $20.1 million
for the year ended December 31, 2019. Excluding $0.9 million and
$2.8 million of costs associated with restructuring initiatives
recorded for the years ended December 31, 2020 and 2019,
respectively, research and development expenses decreased $9.1
million. The decrease was primarily due to a decrease in
pre-commercial manufacturing and clinical costs of $5.9 million, a
decrease of $1.3 million as a result of re-allocating costs related
to supply chain, regulatory, quality, and medical affairs
associated with support of the commercial launch of ANJESO, a
decrease of $1.2 million in preclinical costs and a decrease of
$0.7 million in other general expenses.
Selling, general and administrative expenses for
the year ended December 31, 2020 were $43.3 million, compared to
$27.0 million for the same prior year period, an increase of $16.3
million. Excluding $0.8 million and $4.4 million of costs
associated with restructuring initiatives recorded for the years
ended December 31, 2020 and 2019, respectively, selling, general
and administrative expenses increased $19.9 million. This increase
was primarily due to the commercial launch of ANJESO, specifically,
an increase in personnel related costs of $11.6 million, an
increase in marketing and consulting costs of $6.4 million, and an
increase of $3.9 million attributable to medical affairs and
regulatory support. Other general costs increased $0.9 million.
These increases were partially offset by the decrease in costs
associated with the separation from Recro of $2.9 million in
2019.
For the year ended December 31, 2020, Baudax
reported a net loss, including non-cash charges of $31.4 million,
of $76.1 million, or $3.93 per share, compared to a net loss of
$32.6 million, including non-cash income of $8.6 million, or $3.48
per share, for the comparable period in 2019. The non-cash charges
of $31.4 million in 2020 were associated with stock-based
compensation, non-cash interest expense, depreciation,
amortization, changes in warrant valuations, and changes in fair
value of contingent consideration. The non-cash income of $8.6
million in 2019 was associated with changes in fair value of
contingent consideration, stock-based compensation, and
depreciation.
Conference Call Information
Baudax will host a conference call today,
Tuesday, February 16, 2021, at 8:00 a.m. Eastern Time, to discuss
the full year 2020 financial results and recent corporate
achievements. To access the conference call, please dial (866)
220-5595 (local) or (615) 622-8062 (international) at least 10
minutes prior to the start time and refer to conference ID 4354098.
A live audio webcast of the call will be available under "Events"
in the News & Investors section of the Company's website,
https://www.baudaxbio.com/news-and-investors/events. An archived
webcast will be available on the Company's website approximately
two hours after the event.
About
ANJESO®
ANJESO (meloxicam) injection is a proprietary,
long-acting, preferential COX-2 inhibitor that possesses analgesic,
anti-inflammatory and antipyretic activities, which are believed to
be related to the inhibition of cyclooxygenase type 2 pathway
(COX-2) and subsequent reduction in prostaglandin biosynthesis.
ANJESO was launched in the U.S. in June 2020 following its approval
by the Food and Drug Administration in February 2020. ANJESO is
indicated for the management of moderate to severe pain, alone or
in combination with other non-NSAID analgesics. Because of the
delayed onset of analgesia, ANJESO alone is not recommended for use
when rapid onset of analgesia is required. ANJESO is supported by
two pivotal Phase III clinical efficacy trials, a large
double-blind, placebo-controlled Phase III safety trial and four
Phase II clinical efficacy trials, as well as other safety studies.
As a non-opioid, Baudax Bio believes ANJESO 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. ANJESO was designed using the
NanoCrystal® platform, a technology that enables enhanced
bioavailability of poorly water-soluble drug compounds.
NanoCrystal® is a registered trademark of Alkermes Pharma
Ireland Limited (APIL).
About Baudax Bio
Baudax Bio is a pharmaceutical company focused
on therapeutics for acute care settings. The launch of Baudax Bio’s
first commercial product ANJESO® began in June 2020 following
its approval by the U.S. Food and Drug Administration in February
2020. ANJESO is a once daily IV NSAID with preferential Cox-2
activity, which has successfully completed three Phase III clinical
trials, including two pivotal efficacy trials, a large double-blind
Phase III safety trial and other studies for the management of
moderate to severe pain. In addition to ANJESO, Baudax Bio has a
pipeline of other pharmaceutical assets including two novel
neuromuscular blocking agents (NMBAs) and a proprietary chemical
reversal agent specific to these NMBAs which is currently in
preclinical studies, and intranasal dexmedetomidine which is being
developed for possible uses in pain or sedation. 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
publication on this internet site 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. These forward-looking
statements are subject to risks and uncertainties including, among
other things, the ongoing economic and social consequences of the
COVID-19 pandemic, including any adverse impact on the commercial
launch of ANJESO® or disruption in supply chain, Baudax Bio’s
ability to maintain regulatory approval for ANJESO, Baudax Bio’s
ability to successfully commercialize ANJESO; the acceptance of
ANJESO by the medical community, including physicians, patients,
health care providers and hospital formularies; Baudax Bio’s
ability and that of Baudax Bio’s third party manufacturers to
successfully scale-up our commercial manufacturing process for
ANJESO, Baudax Bio’s ability to produce commercial supply in
quantities and quality sufficient to satisfy market demand for
ANJESO, Baudax Bio’s ability to raise future financing for
continued product development, payment of milestones and ANJESO
commercialization, Baudax Bio’s ability to pay its debt and satisfy
conditions necessary to access future tranches of debt, Baudax
Bio’s ability to comply with the financial and other covenants
under its credit facility, Baudax Bio’s ability to manage costs and
execute on our operational and budget plans, the accuracy of Baudax
Bio’s estimates of the potential market for ANJESO, Baudax Bio’s
ability to achieve its financial goals; and Baudax Bio’s ability to
obtain, maintain and successfully enforce adequate patent and other
intellectual property protection. These forward-looking statements
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. These forward-looking statements are based on
information currently available to Baudax Bio, and Baudax Bio
assumes no obligation to update any forward-looking statements
except as required by applicable law.
CONTACT: Investor Relations Contact:Argot
PartnersSam Martin / Claudia Styslinger(212)
600-1902baudaxbio@argotpartners.com
Baudax Bio, Inc.Ryan D. Lake(484)
395-2436rlake@baudaxbio.com
Media Contact:Argot PartnersDavid Rosen(212)
600-1902david.rosen@argotpartners.com
BAUDAX BIO, INC. AND SUBSIDIARIES |
Consolidated Balance Sheets |
|
|
|
|
|
|
(amounts in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Assets |
|
December 31, 2020 |
|
December 31, 2019 |
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
30,342 |
|
$ |
17,740 |
|
Accounts receivable, net |
|
51 |
|
|
— |
|
Inventory |
|
2,978 |
|
|
— |
|
Prepaid expenses and other current assets |
|
3,346 |
|
|
2,395 |
|
Total current assets |
$ |
36,717 |
|
$ |
20,135 |
|
|
|
|
|
|
Property, plant and equipment, net |
|
5,052 |
|
|
4,821 |
|
Right-of-use asset |
|
583 |
|
|
730 |
|
Intangible assets, net |
|
24,254 |
|
|
26,400 |
|
Goodwill |
|
2,127 |
|
|
2,127 |
|
Total assets |
$ |
68,733 |
|
$ |
54,213 |
|
Liabilities and Shareholders’ Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
3,653 |
|
|
271 |
|
Accrued expenses & other current liabilities |
|
4,993 |
|
|
3,532 |
|
Current portion of long-term debt, net |
|
683 |
|
|
— |
|
Current portion of operating lease liability |
|
333 |
|
|
318 |
|
Current portion of contingent consideration |
|
8,467 |
|
|
3,592 |
|
Total current liabilities |
|
18,129 |
|
|
7,713 |
|
Long-term debt, net |
|
8,469 |
|
|
— |
|
Long-term operating lease liability |
|
293 |
|
|
455 |
|
Warrant liability |
|
65 |
|
|
— |
|
Long-term portion of contingent consideration |
|
56,576 |
|
|
62,766 |
|
Total liabilities |
|
83,532 |
|
|
70,934 |
|
Shareholders’
equity: |
|
|
|
|
Preferred stock, $0.01 par value. Authorized, 10,000,000
shares; |
|
|
|
|
none issued and outstanding. |
|
— |
|
|
— |
|
Common stock, $0.01 par value. Authorized, 100,000,000 shares;
issued and outstanding, 48,688,480 shares at December 31, 2020
and 9,350,709 shares at December 31, 2019 |
|
487 |
|
|
94 |
|
Additional paid in-capital |
|
97,034 |
|
|
19,405 |
|
Accumulated deficit |
|
(112,320 |
) |
|
(36,220 |
) |
Total shareholders’ equity |
|
(14,799 |
) |
|
(16,721 |
) |
Total liabilities and shareholders’ equity |
$ |
68,733 |
|
$ |
54,213 |
|
BAUDAX BIO, INC. AND SUBSIDIARIES |
Consolidated Statements of Operations and Comprehensive Loss |
|
|
|
|
|
|
(amounts in thousands, except
share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
$ |
493 |
|
$ |
— |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of sales |
|
1,732 |
|
|
— |
|
Research and development |
|
9,087 |
|
|
20,061 |
|
Selling, general and administrative |
|
43,335 |
|
|
27,012 |
|
Amortization of intangible assets |
|
2,146 |
|
|
— |
|
Change in warrant valuation |
|
16,734 |
|
|
— |
|
Change in contingent consideration valuation |
|
2,245 |
|
|
(14,554 |
) |
Total operating expenses |
|
75,279 |
|
|
32,519 |
|
Operating loss |
|
(74,786 |
) |
|
(32,519 |
) |
Other income (expense): |
|
|
|
|
Other income (expense) |
|
45 |
|
|
(38 |
) |
Interest expense |
|
(1,359 |
) |
|
— |
|
Net loss |
$ |
(76,100 |
) |
$ |
(32,557 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per share of common
stock, basic and diluted |
$ |
(3.93 |
) |
$ |
(3.48 |
) |
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
19,355,944 |
|
|
9,350,709 |
|
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