BXRX Baudax Bio Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
|
Approved
Approved
|
FDA Approval announced February 20, 2020.
|
Latest News
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MALVERN, Pa., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced Gerri Henwood, the Company's President and Chief Executive Officer, will present at the Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on Tuesday, September 22, 2020 at 3:20 p.m. ET.
A live webcast of the presentation will be available on the "Presentations" page within the Investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. A replay will be available on the Baudax Bio website for a period of 30 days following the event.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of the Company's first commercial product, ANJESO®, began in June of 2020. Baudax's New Drug Application for ANJESO was approved by FDA on February 20, 2020 for the management the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 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. 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.
CONTACT:
Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected]
-
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MALVERN, Pa., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has been awarded a Group Purchasing Agreement with Premier Inc. Effective August 2020, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for ANJESO (meloxicam) injection, for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
"Securing this agreement with Premier provides Baudax with access to industry-leading resources and customers that we believe will lead to increased usage of ANJESO," said Gerri Henwood, President and CEO of Baudax Bio. "We look forward to expanding our commercial reach to now include Premier members who will benefit from meaningful contract savings."
Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,000 U.S. hospitals and 175,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost.
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 approved by the U.S. Food and Drug Administration in February 2020 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. The ANJESO product approval was 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 Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 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. 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 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. Baudax Bio assumes no obligation to update any such 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 our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. 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.
CONTACT:
Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] -
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MALVERN, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that Arnold Baskies, M.D. and Andrew Drechsler, have been appointed to the Company's Board of Directors.
Dr. Baskies is a past Chief Science Officer and Chairman of the National Board of Directors of the American Cancer Society. He is a fellowship trained surgical oncologist recognized with numerous major awards in the field. Mr. Drechsler serves as the Chief Financial Officer of Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, and previously as Chief Financial Officer of Insmed Incorporated.
"We are pleased to welcome both Arnold Baskies, M.D. and Andy Drechsler to Baudax's Board," said Alfred Altomari, Chairman of the Board at Baudax Bio. "Arnold's breadth of experience in all facets of general surgical problems as well as validation through receipt of many national awards in the field of surgery, will prove to be beneficial as we advance our pipeline. Similarly, Andy's experience, and background in finance, most recently as Chief Financial Officer for Provention Bio and previously of Insmed Incorporated, comes at a perfect time in our commercialization efforts of ANJESO®. We look forward to the expertise they bring to our board, and feel we are well positioned to strengthen our efforts to communicate the benefits of ANJESO as an option for the management of moderate to severe pain in surgical settings."
Dr. Baskies has served as the Chief Medical Officer for the American Cancer Society of New York and New Jersey, and has served on the Executive Committee and the Board of Directors, and was elected as President, of the American Cancer Society for New York and New Jersey in September 2010. He is the recipient of major awards in cancer research from the Society of Surgical Oncology, the American Radium Society, the Society of Head and Neck Surgeons and the American Cancer Society. In addition, he has received the EPIC Award from the NJ Institute of Nursing and the Silver Chalice Award from the American Cancer Society, for his role in providing leadership in cancer prevention and treatment for the citizens of New Jersey. He has maintained a medical practice in southern New Jersey for 37 years and has personally treated over 3,000 patients with various types of cancer and has performed over 10,000 surgical procedures. Dr. Baskies received his Bachelor of Arts degree summa cum laude at Boston University, graduated from the Boston University School of Medicine, and completed his surgical residency at Boston Medical Center. He received his fellowship in surgical oncology at the National Cancer Institute.
"I am eager to join Baudax's Board of Directors and support them in clinical areas including the development of the neuromuscular blocker product group," said Dr. Baskies M.D. "I believe my well-versed experience in the surgical setting will prove advantageous as the Company advances these product candidates through the clinic, with aims of improving the patient experience."
Mr. Drechsler brings over 20 years of financial and life science industry experience to Baudax Bio. Prior to his Chief Financial Officer roles at Provention Bio and Insmed, Mr. Drechsler served as Chief Financial Officer for VaxInnate Corporation, a privately-held company that developed vaccines for infectious diseases, including seasonal and pandemic flu, where he played a critical role in securing approximately $200 million in U.S. government funding for the company's vaccine programs. Before joining VaxInnate, Mr. Drechsler served as Chief Financial Officer for Valera Pharmaceuticals, Inc. where he helped Valera raise funding through an initial public offering. Mr. Drechsler received a B.S. in Accountancy from Villanova University, graduating Magna Cum Laude. He obtained his Certified Public Accountant license in the State of New Jersey and actively raises funds for and awareness of juvenile diabetes via the Juvenile Diabetes Research Foundation.
"I am very much looking forward to supporting Baudax on their mission to develop and commercialize innovative products for patients in the acute care setting," said Mr. Drechsler. "Having worked in the life science industry for over 20 years, and serving as Chief Financial Officer for several corporations, I feel strongly that my experience will be beneficial in supporting the launch of ANJESO."
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 approved by the U.S. Food and Drug Administration in February 2020 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. The ANJESO product approval was 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 specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 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. 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 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 and any future product candidates; 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 its 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 its 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 Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] -
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Commenced Commercial Launch of ANJESO® in the U.S.
Awarded J-Code from CMS
Executed Contract with a top National GPO for hospital purchases, Vizient, and one of the top 3 IDNs Nationally
Secured $50 Million Credit Facility
MALVERN, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today reported financial results for the three and six months ended June 30, 2020.
"The second quarter of 2020 was most important because of the full commercial launch of ANJESO," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We believe that with our experienced acute care sales force, receipt of our J-code from the Centers for Medicare and Medicaid Services (CMS) (effective in October 2020), entry into an agreement with the Group Purchasing Organization (GPO) Vizient Inc., and other strategic initiatives underway, we are well positioned to continue to target the acute care space. We look forward to continuing to raise awareness and educate acute care providers about ANJESO as an advantageous option for the management of moderate to severe pain."
Second Quarter 2020 and Recent Business Highlights
- Commenced Full Commercial Launch of ANJESO. In June 2020, the Company commenced the commercial launch of ANJESO, following its approval by the U.S. Food and Drug Administration (FDA) in February 2020. ANJESO is the only approved 24-hour, intravenous COX-2 preferential NSAID that offers once-daily dosing. Baudax has hired, trained, and now deployed 50 acute care sales representatives to match key territories identified in the U.S.
- Receipt of J-Code from CMS. In early August 2020, CMS established a new permanent J-code for ANJESO, facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), will take effect on October 1, 2020 and it is expected to replace the previously issued C-code (C9059).
- Company Secures Pharmacy Supplier Agreement with Vizient Inc. In July 2020, Baudax entered into an agreement with the GPO Vizient Inc., the largest member-driven healthcare performance improvement company in the U.S., to offer ANJESO with enhanced savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care providers, 95% of the nation's academic medical centers, and more than 20% of ambulatory care providers. Vizient represents more than $100 billion in annual purchasing volume.
- Company signed agreement with top IDN. In July 2020, the Company signed an agreement with one of the top 3 Integrated Delivery Networks (IDNs) for terms for availability of ANJESO to their member institutions and the company has begun the regional formulary processes associated with this central review and approval.
- Presented New Phase IIIb ANJESO Data at American Society of Colon and Rectal Surgeons (ASCRS) Meeting. In July 2020, Baudax presented a virtual poster highlighting new Phase IIIb ANJESO (meloxicam) injection clinical data as part of the ASCRS 2020 Annual Scientific Meeting. The published data supports the use of ANJESO administered preoperatively to patients prior to undergoing colorectal surgery. The key findings from this study include statistically significant reductions in opioid use, as well as time to bowel function recovery and hospital discharge, resulting in cost savings for ANJESO-treated patients.
- Secured $50 Million Credit Facility. In June 2020, the company announced the close of a credit facility of up to $50 million from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESO (meloxicam) injection, and for working capital purposes. JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.
COVID-19 Impact
The Company's efforts to commercialize ANJESO have been, and may continue to be, impacted by the COVID-19 pandemic. Hospitals have reduced and diverted staffing, diverted resources to patients suffering from COVID-19 and limited hospital access for nonpatients, including our sales professionals, which the Company believes may impact their marketing and commercialization efforts. The Company believes that the reduction in elective surgeries during the COVID-19 pandemic has and may continue to result in decreased demand for ANJESO. The Company anticipates that many hospitals and health care providers will continue to suffer negative financial consequences due to an increase in unexpected costs, including for additional staff, personal protective equipment and ventilators, along with a reduction in revenue due to fewer elective procedures being performed, which may result in a decreased demand for ANJESO. While access restrictions have eased in some locations, spikes of COVID-19 cases in certain states or regions may further impact the Company's sales force as access to hospitals may be restricted and elective surgeries may be limited in those areas. Due to the rapidly evolving environment, continued uncertainties from the impact of the COVID-19 global pandemic, and recent regional outbreaks that are impacting the recovery, the Company cannot estimate the full extent to which the Company's commercialization of ANJESO and financial results may be adversely impacted.
Second Quarter 2020 Financial Results
As of June 30, 2020, Baudax had cash and cash equivalents of $39.4 million.
For the three months ended June 30, 2020, net product revenue was $350,000, related to sales of ANJESO in the U.S. There was no product revenue recognized during the three months ended June 30, 2019.
For the three months ended June 30, 2020, cost of sales was $0.7 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 during the three months ended June 30, 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. We expect cost of sales to increase as we build new inventory not expensed during the pre-approval period, validate a larger manufacturing suite and deplete our initial inventory levels. No cost of sales were recorded for the three months ended June 30, 2019.
For the three months ended June 30, 2020, research and development expenses were $1.4 million, compared to $7.2 million for the three months ended June 30, 2019, a decrease of $5.8 million. Excluding $2.6 million of costs associated with the strategic restructuring initiative recorded in the three months ended June 30, 2019, our research and development expenses decreased $3.2 million primarily resulting from a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $2.3 million and a decrease in personnel costs and overhead expenses of $0.9 million as we allocated or recategorized certain expenses related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO.
For the three months ended June 30, 2020, selling, general and administrative expenses were $11.2 million, compared to $7.4 million for the same prior year period, an increase of $3.8 million. Excluding $3.4 million of costs associated with the strategic restructuring initiative recorded in the three months ended June 30, 2019, our selling, general and administrative expenses increased $7.2 million primarily due to selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $5.6 million for the three months ended June 30, 2020 increased $5.0 million due to increased personnel costs of $3.1 million and increased commercial costs of $1.9 million. General and administrative expenses of $5.6 million for the three months ended June 30, 2020 increased $2.2 million primarily due to increased personnel costs, including over half of which was attributed to medical affairs and regulatory support functions which had previously been recorded within research and development expense in the prior year period.
For the three months ended June 30, 2020, Baudax reported a net loss (including non-cash charges of $19.8 million) of $30.4 million, or $1.72 per share. The non-cash charges of $19.8 million were associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss of $10.6 million, or $1.13 per share, for the comparable period in 2019. For the three months ended June 30, 2020, there was $10.6 million in cash based expenses and an additional $0.7 million use of cash associated with working capital adjustments primarily related to the build of inventory for ANJESO.
Six months ended June 30, 2020 Financial Results
For the six months ended June 30, 2020, net product revenue was $350,000, related to sales of ANJESO in the U.S. There was no product revenue recognized during the six months ended June 30, 2019.
For the six months ended June 30, 2020, cost of sales was $0.7 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 during the six months ended June 30, 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. We expect cost of sales to increase as we build new inventory not expensed during the pre-approval period, validate a larger manufacturing suite and deplete our initial inventory levels. No cost of sales were recorded for the six months ended June 30, 2019.
For the six months ended June 30, 2020, research and development expenses were $4.4 million, compared to $16.7 million for the six months ended June 30, 2019, a decrease of $12.3 million. Excluding $2.8 million of costs associated with the strategic restructuring initiative recorded in the six months ended June 30, 2019, our research and development expenses decreased $9.5 million primarily resulting from a decrease in pre-commercialization manufacturing and clinical costs for ANJESO of $6.2 million, a decrease in development costs for other pipeline products of $2.1 million and a decrease in personnel and overhead expenses of $1.2 million as we re-allocated costs related to supply chain, regulatory, quality and medical affairs associated with support of the commercial launch of ANJESO.
For the six months ended June 30, 2020, selling, general and administrative expenses were $19.3 million, compared to $17.3 million for the same prior year period, an increase of $2.0 million. Excluding $4.4 million of costs associated with the strategic restructuring initiative recorded in the six months ended June 30, 2019, our selling, general and administrative expenses increased $6.4 million primarily due to increased selling and marketing expenses in connection with the commercial launch of ANJESO. Selling and marketing expenses of $8.9 million for the six months ended June 30, 2020 increased $3.5 million primarily due to increased personnel costs of $1.9 million and increased commercial costs of $1.6 million. General and administrative expenses of $10.4 million for the six months ended June 30, 2020 increased $2.9 million primarily due to increased personnel costs of $2.4 million, including over half of which was attributed to medical affairs and regulatory support functions which had previously been recorded within research and development expense in the prior year period and increased public company costs of approximately $0.5 million as the prior year costs represent an allocated portion of the costs in the historical combined financial statements prior to our separation from Recro Pharma, Inc.
For the six months ended June 30, 2020, Baudax reported a net loss (including non-cash charges of $51.8 million) of $70.7 million, or $5.11 per share. The non-cash charges of $51.8 million were associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss of $14.9 million, or $1.60 per share, for the comparable period in 2019.
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 approved by the U.S. Food and Drug Administration in February 2020 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. The ANJESO product approval was 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 specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 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. 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 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 our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
CONTACT:
Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected]BAUDAX BIO, INC. Consolidated Balance Sheets (Unaudited) (amounts in thousands, except share and per share data) Assets June 30, 2020 December 31, 2019 Current assets: Cash and cash equivalents $ 39,410 $ 17,740 Accounts receivable 382 — Inventory 753 — Prepaid expenses and other current assets 2,122 2,395 Total current assets $ 42,667 $ 20,135 Property, plant and equipment, net 4,610 4,821 Right of Use asset 542 730 Intangible assets, net 25,541 26,400 Goodwill 2,127 2,127 Total assets $ 75,487 $ 54,213 Liabilities and Shareholders' Equity Current liabilities: Accounts payable 2,190 271 Accrued expenses & other current liabilities 3,972 3,532 Current portion of long-term debt, net 598 — Current portion of operating lease liability 258 318 Current portion of contingent consideration 13,135 3,592 Total current liabilities 20,153 7,713 Long-term debt, net 8,097 — Long-term operating lease liability 329 455 Warrant liability 21,410 — Long-term portion of contingent consideration 84,902 62,766 Total liabilities 134,891 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, 18,374,604 shares at June 30, 2020 and 9,350,709 shares at December 31, 2019 184 94 Additional paid in-capital 47,375 19,405 Accumulated deficit (106,963 ) (36,220 ) Total shareholders' equity (59,404 ) (16,721 ) Total liabilities and shareholders' equity $ 75,487 $ 54,213
BAUDAX BIO, INC. Consolidated and Combined Statements of Operations (Unaudited) (amounts in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Revenue, net $ 349 $ — $ 349 $ — Operating expenses: Cost of sales (excluding amortization of intangible assets) 650 — 650 — Research and development 1,350 7,180 4,420 16,734 Selling, general and administrative 11,217 7,449 19,263 17,284 Amortization of intangible assets 644 — 859 — Change in warrant valuation 12,667 — 14,045 — Change in contingent consideration valuation 4,053 (4,059 ) 31,679 (19,150 ) Total operating expenses 30,581 10,570 70,916 14,868 Operating income / (loss) (30,232 ) (10,570 ) (70,567 ) (14,868 ) Other income (expense): Interest income (expense) (213 ) (12 ) (176 ) (49 ) Net loss before income taxes $ (30,445 ) $ (10,582 ) $ (70,743 ) $ (14,917 ) Income tax benefit — — — — Net loss $ (30,445 ) $ (10,582 ) $ (70,743 ) $ (14,917 ) Per share information: Net loss per share of common stock, basic and diluted $ (1.72 ) $ (1.13 ) $ (5.11 ) $ (1.60 ) Weighted average common shares outstanding, basic and diluted 17,691,700 9,350,709 13,846,464 9,350,709 - Commenced Full Commercial Launch of ANJESO. In June 2020, the Company commenced the commercial launch of ANJESO, following its approval by the U.S. Food and Drug Administration (FDA) in February 2020. ANJESO is the only approved 24-hour, intravenous COX-2 preferential NSAID that offers once-daily dosing. Baudax has hired, trained, and now deployed 50 acute care sales representatives to match key territories identified in the U.S.
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MALVERN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it will report second quarter 2020 financial results on Monday, August 10, 2020. Baudax's management team will host a conference call and audio webcast at 9:00 a.m. ET on Monday, August 10, 2020 to discuss the financial results and recent operational highlights.
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 6734469. A live audio webcast of the call will be available under "Events" in the Investor 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 and will be available for 30 days.
About Baudax Bio
Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Company's first commercial product, ANJESO®, had its New Drug Application approved by FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. 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. As a non-opioid, 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. 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. Baudax Bio assumes no obligation to update any such 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 our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. 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.
CONTACT:
Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected]