BXRX Baudax Bio Inc.

4
-0.08  -2%
Previous Close 4.08
Open 4.19
52 Week Low 2.16
52 Week High 10.14
Market Cap $70,279,952
Shares 17,569,988
Float 16,013,234
Enterprise Value $34,070,551
Volume 391,826
Av. Daily Volume 1,035,569
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Drug Pipeline

Drug Stage Notes
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
Approved
Approved
FDA Approval announced February 20, 2020.
RP-1000
Phase 1
Phase 1
Phase 1 trial to be initiated 1H 2020.

Latest News

  1. MALVERN, Pa., July 03, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 450,816 shares of Baudax Bio's common stock and restricted stock units covering 119,923 shares of Baudax Bio's common stock to 57 newly-hired employees, with a grant date of June 30, 2020.  The equity awards were granted pursuant to the NASDAQ Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax…

    MALVERN, Pa., July 03, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the Compensation Committee of Baudax Bio's Board of Directors approved inducement grants of stock options to purchase an aggregate of 450,816 shares of Baudax Bio's common stock and restricted stock units covering 119,923 shares of Baudax Bio's common stock to 57 newly-hired employees, with a grant date of June 30, 2020.  The equity awards were granted pursuant to the NASDAQ Rule 5635(c)(4) inducement grant exception as a component of each individual's employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax Bio.

    The options have an exercise price equal to $4.15 per share, the closing price of Baudax Bio's common stock as reported by NASDAQ on June 30, 2020. The options have a ten-year term and vest over four years, with 25% of the number of shares underlying the stock option vesting on the one-year anniversary of the grant date and the remaining shares vesting monthly over 36 months thereafter. The restricted stock units vest annually over four years. The equity awards are subject to each individual's continued service with Baudax Bio through the applicable vesting dates.

    About Baudax Bio, Inc.

    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. 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





    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  2. MALVERN, Pa., June 15, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the commercial launch of ANJESO™ (meloxicam) injection. ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020. Baudax has hired, trained, and now deployed 50 acute care sales representatives across the country. Baudax also announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new reimbursement code for ANJESO. The code, C9059, is scheduled to become effective July 1, 2020.

    "We have assembled an acute care sales team with deep experience in the hospital market…

    MALVERN, Pa., June 15, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the commercial launch of ANJESO™ (meloxicam) injection. ANJESO was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020. Baudax has hired, trained, and now deployed 50 acute care sales representatives across the country. Baudax also announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new reimbursement code for ANJESO. The code, C9059, is scheduled to become effective July 1, 2020.

    "We have assembled an acute care sales team with deep experience in the hospital market, and they completed their comprehensive virtual training by the end of May. As of June 1, the field has been meeting with key customers live and virtually across hospitals, ambulatory surgery centers and other strategic accounts to introduce ANJESO," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "At Baudax, we believe ANJESO is a major advancement for physicians managing moderate to severe pain following a wide variety of surgical procedures. The receipt of pass-through status and the assignment of a unique C-code from CMS also marks another important milestone in our commercialization efforts for ANJESO. Hospitals and ambulatory surgical centers can use this new code in July to obtain reimbursement for the product."

    A C-code is a unique product code established by CMS to report claims for hospital outpatient department and ambulatory surgical center services and procedures. The formal receipt of the C-code facilitates the reimbursement of ANJESO until such later time as CMS may potentially approve a J-code and such approval becomes effective. Drugs that are administered in these settings can be reimbursed under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is temporary for three years and products are reimbursed under a C-code.

    ANJESO is the first and only once-daily IV analgesic. It provides up to 24 hours of efficacy for the management of moderate to severe pain, has demonstrated safety and tolerability, is a COX-2 preferential IV NSAID and is available as a once-daily IV push.

    For more information about ANJESO, visit www.ANJESO.com or call 1-855-405-9983.

    INDICATION AND USAGE

    ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

    Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Risk

    • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.  This risk may occur early in treatment and may increase with duration of use.
    • ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Risk

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    CONTRAINDICATIONS

    ANJESO is contraindicated in patients with:

    • Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
    • In the setting of coronary artery bypass graft (CABG) surgery.
    • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion.

    WARNINGS AND PRECAUTIONS

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

    Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

    Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

    Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    DRUG INTERACTIONS

    Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

    Angiotensin Converting Enzymes (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

    ADVERSE REACTIONS

    The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include:  constipation, gamma-glutamyl transferase increased, and anemia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

    Please see full Prescribing Information, including Boxed Warning at www.ANJESO.com.

    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. 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



    Baudax Bio, Inc.

    Ryan D. Lake

    (484) 395-2436

    Media Contact:

    Argot Partners

    David Rosen

    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  3. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has closed on 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 ANJESOTM (meloxicam) injection, and for working capital purposes.  JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.

    "This strategic non-dilutive financing represents our strong belief in the future commercial prospects for ANJESO as a new, intravenous non-opioid option for the management…

    MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that it has closed on 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 ANJESOTM (meloxicam) injection, and for working capital purposes.  JMP Securities LLC acted as exclusive financial advisor and sole placement agent to Baudax on this transaction.

    "This strategic non-dilutive financing represents our strong belief in the future commercial prospects for ANJESO as a new, intravenous non-opioid option for the management of moderate to severe pain," said Gerri Henwood, CEO of Baudax Bio. "The availability of these new funds, as well as incremental amounts of up to an additional $50 million, at Marathon's discretion, to help support complementary and accretive acquisitions provides important financial flexibility for our commercial-stage organization and leaves us well positioned to execute on the launch of ANJESO and to grow our acute care franchise.  Our newly hired sales force is on track to commence the launch this month."

    This financing is in the form of a five-year term loan bearing interest at a fixed rate of 13.5%.  Baudax will pay interest only for the first 24 months of the loan.  The funds are structured in five tranches, to provide financial flexibility as needed, while balancing debt leverage and managing interest expense, with $10 million available immediately upon closing of the transaction.  The additional four tranches will be available upon achieving certain minimum net revenue thresholds within set periods of times from the closing date. If Baudax achieves $10 million trailing 12-month EBITDA within 24 months of closing, then the term of the loan can be extended to six years with an interest only period of 36 months.

    In connection with the credit facility, Baudax issued to Marathon warrants to purchase 527,100 shares of Baudax common stock at an exercise price of $4.59 per share.  Further information with respect to the credit facility and the warrants is set forth in the Form 8-K which will be filed by the Company with the Securities and Exchange Commission.

    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.

    About Marathon Asset Management

    Marathon Asset Management L.P. ("Marathon") is a global credit solutions partner. Marathon seeks attractive absolute returns through investments in the global credit markets and real estate related markets with a long-term goal of building a world-class asset management platform. Marathon's core competency is opportunistic investing in the global corporate, emerging market and structured credit markets based on fundamental, bottom-up research across distinct investment funds, managed vehicles, and separate accounts. Marathon's private credit business includes direct lending, asset-based lending, including healthcare and aircraft leasing along with real estate lending. The team has significant experience investing in credit dislocations through multiple cycles and is fully integrated to capitalize on credit opportunities globally. Marathon possesses a unique, broad-based skill set and proprietary platform to research, analyze and act upon complex capital structures and situations.

    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

      

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

    Primary Logo

    View Full Article Hide Full Article
  4.  ANJESO™ Approved by FDA for the Management of Moderate to Severe Pain; Product
    Now Available for Ordering and Delivery for Customers

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public
    Offering Resulting in Net Proceeds of $23.1 Million

    Company on Track to Commence Commercial ANJESO Launch by Early June 2020

    MALVERN, Pa., May 08, 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 months ended March 31, 2020.

    "During the first quarter of 2020, we received regulatory approval from the U.S. Food and Drug Administration (FDA) for ANJESO™ (meloxicam) injection," said Gerri Henwood, President…

     ANJESO™ Approved by FDA for the Management of Moderate to Severe Pain; Product
    Now Available for Ordering and Delivery for Customers

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public
    Offering Resulting in Net Proceeds of $23.1 Million

    Company on Track to Commence Commercial ANJESO Launch by Early June 2020

    MALVERN, Pa., May 08, 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 months ended March 31, 2020.

    "During the first quarter of 2020, we received regulatory approval from the U.S. Food and Drug Administration (FDA) for ANJESO™ (meloxicam) injection," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We are also making significant progress strengthening the balance sheet and securing capital to execute on the planned launch and commercialization of ANJESO. Despite the challenging macro-market conditions due to the COVID-19 pandemic, we are on track to advance into a commercial launch by early June 2020."

    First Quarter 2020 and Recent Business Highlights

    • FDA Approves ANJESO for Management of Moderate to Severe Pain. On February 20, 2020, Baudax received approval from the FDA for ANJESO, which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.  ANJESO will be administered as a once-a-day intravenous (IV) bolus.

    • ANJESO Now Available in the U.S. In April 2020, Baudax announced that ANJESO, the only 24-hour, IV COX-2 preferential NSAID to offer once-daily dosing for acute pain, is available for ordering and delivery to customers. In April, Baudax had its first product sale to an end user customer. Baudax is in the process of hiring and training its field sales force and expects to execute the ANJESO commercial launch by early June 2020.

    • Strengthened the Balance Sheet Through the Completion of a $25 Million Public Offering of Securities. In March 2020, Baudax announced completion of an underwritten public offering reflective of 7,692,308 shares of its common stock, Series A Warrants to purchase 7,692,308 shares of common stock and Series B Warrants to purchase 7,692,308 shares of common stock, at an exercise price of $4.59 per share for Series A Warrants and at an exercise price of $3.25 per share for Series B Warrants. Each share of common stock was sold together with one Series A warrant and one Series B warrant for a combined price of $3.25 per share. Net proceeds to Baudax from this offering were approximately $23.1 million.

    • Company Signs Non-Binding Term Sheet for Debt Facility. In March 2020, Baudax signed a non-binding term sheet with an undisclosed party for a secured term loan for up to $20 million in non-dilutive funding over the next 12 to 18 months. It did so as part of its overall capital financing strategy to fund the Company and support the upcoming commercial launch of ANJESO. The Company continues to pursue this debt facility.

    First Quarter 2020 Financial Results

    As of March 31, 2020, Baudax had cash and cash equivalents of $38.3 million.

    For the three months ended March 31, 2020, research and development expenses were $3.1 million, compared to $9.6 million for the three months ended March 31, 2019. The decrease of $6.5 million was primarily due to a decrease in pre-commercialization manufacturing and clinical costs for ANJESO, a decrease in development costs for other pipeline products, and a decrease in personnel costs.

    For the three months ended March 31, 2020, selling, general and administrative expenses were $8.0 million, compared to $9.8 million for the three months ended March 31, 2019. The decrease of $1.8 million was due to decreases in personnel and pre-commercial consulting costs. These decreases in costs were partially offset by increases in public company costs as the prior year costs represent an allocated portion of the costs in the historical combined financial statements prior to the separation of Baudax from Recro Pharma, Inc. in November 2019.

    For the three months ended March 31, 2020, Baudax reported a net loss of $40.3 million, or $4.03 per share, which includes non-cash charges of approximately $32 million associated with a change in contingent consideration and in-process research and development intangible amortization because of FDA approval of ANJESO, depreciation, marked to market expense on the warrants, and stock-based compensation. This compares to a net loss of $4.3 million, or $0.46 per share, for the comparable period in 2019. Cash used in operating activities was $6.3 million for the three months ended March 31, 2020 which reflects the net loss excluding non-cash items offset by changes in working capital.

    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 Company expects commercial launch of ANJESO by early June 2020. 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. 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 and ANJESO commercialization, 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

      

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

       
    BAUDAX BIO, INC.  
    Consolidated Balance Sheets  
       
         
    (amounts in thousands, except share and per share data)  
         
    Assets   March 31, 2020   December 31, 2019  
    Current assets:          
      Cash and cash equivalents $ 38,284   $ 17,740    
      Prepaid expenses and other current assets   2,211     2,395    
          Total current assets   40,495     20,135    
                 
      Property, plant and equipment, net   4,716     4,821    
      Right of use asset   631     730    
      Intangible assets   26,185     26,400    
      Goodwill   2,127     2,127    
           Total assets $ 74,154   $ 54,213    
    Liabilities and Shareholders' Equity          
    Current liabilities:          
      Accounts payable $ 2,062   $ 271    
      Accrued expenses and other current liabilities   3,842     3,532    
      Current operating lease liability   278     318    
      Current portion of contingent consideration   12,523     3,592    
            Total current liabilities   18,705     7,713    
      Long-term operating lease liability   391     455    
      Warrant liability   9,489     —     
      Long-term portion of contingent consideration   81,461     62,766    
             Total liabilities   110,046     70,934    
    Shareholders' equity:          
      Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and
    outstanding, 17,569,988 shares at March 31, 2020 and 9,350,709 shares at
    December 31, 2019
      176     94    
      Additional paid in-capital   40,450     19,405    
      Accumulated deficit   (76,518 )   (36,220 )  
            Total shareholders' equity   (35,892 )   (16,721 )  
            Total liabilities and shareholders' equity $ 74,154   $ 54,213    
                 


    BAUDAX BIO, INC.  
    Consolidated and Combined Statements of Operations  
       
               
    (amounts in thousands, except share and per share data)          
               
        Three Months Ended  
        March 31,  
        2020     2019    
    Revenue $ —    $ —     
               
    Operating expenses:          
    Cost of sales   —      —     
    Research and development   3,070     9,554    
    Selling, general and administrative   8,046     9,835    
    Amortization of intangible assets   215     —     
    Change in warrant valuation   1,378     —     
    Change in contingent consideration valuation   27,626     (15,091 )  
           Total operating expenses   40,335     4,298    
           Operating loss   (40,335 )   (4,298 )  
    Other income (expense):          
    Other income (expense)   37     (37 )  
    Net loss $ (40,298 ) $ (4,335 )  
               
    Per share information:          
    Net loss per share of common stock, basic and diluted $ (4.03 ) $ (0.46 )  
               
    Weighted average common shares outstanding, basic and diluted   10,001,228     9,350,709    
               


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  5. MALVERN, Pa., May 05, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting ANJESO™ (meloxicam) injection data at Digestive Disease Week (DDW) 2020.

    "The data virtually published by DDW demonstrate that ANJESO has positive impacts on many elements of healthcare resource utilization when administered preoperatively to patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "Key findings included statistically significant reductions in opioid use and in length of hospital stay by approximately 1 day…

    MALVERN, Pa., May 05, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting ANJESO™ (meloxicam) injection data at Digestive Disease Week (DDW) 2020.

    "The data virtually published by DDW demonstrate that ANJESO has positive impacts on many elements of healthcare resource utilization when administered preoperatively to patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen," said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. "Key findings included statistically significant reductions in opioid use and in length of hospital stay by approximately 1 day, as well as lower incidence of opioid-related adverse events, all while achieving similar or slightly reduced average cost of the hospital stay. We are thrilled ANJESO is now available for ordering and delivery to U.S. customers, and we are actively preparing for the full commercial launch by June 2020."

    The virtual presentation describes an economic sub-study of a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO as part of a MMA regimen compared to placebo in 55 patients who had undergone open or laparoscopic colorectal surgeries. The Phase IIIb study was designed to replicate conditions consistent with current clinical practice, including use of a standardized enhanced recovery after surgery protocol based on common best practices for colorectal surgeries. Patients were randomized 1:1 to receive ANJESO (30mg) or placebo. The first study dose was administered 30 minutes prior to the start of surgery.  Subsequent doses of ANJESO were administered every 24 hours.  The primary objective of the Phase IIIb study was to evaluate the safety and tolerability of preoperative dosing of ANJESO in subjects undergoing open or laparoscopic colorectal surgeries compared to placebo. The economic sub-study primary objective was to evaluate the impact of preoperative dosing of ANJESO on healthcare resource use (HRU) and healthcare costs.

    HRU Results Following Preoperative ANJESO Compared to Placebo

    This economic sub-study evaluated HRU and costs, including total hospital costs, hospital length of stay (LOS) and opioid use associated with preoperative administration of ANJESO compared to placebo. A subject-level database was developed to capture quantity of service, charges and date of service from UB-04 forms (from admission date to discharge), captured in the IIIB clinical trial. A national cost:charge ratio was applied to convert ‘charges' to ‘costs'.

    A total of 55 subjects (mean age: 60, female: 43%) were treated in the trial, with 54 subjects included in HRU analysis (n=27 per treatment; 1 excluded due to missing UB-04). The total mean costs of hospital stay were similar between the ANJESO group compared to the placebo group ($23,115 vs. $22,682; p=0.3370). After removing outliers (top 99th percentile), the total costs for the ANJESO group was numerically lower than the placebo group ($20,492 vs. $22,682; p=0.2196). Mean hospital LOS in days was numerically lower in the ANJESO group compared to the placebo group (86.2 vs. 111.7 hr; p=0.0162) and was statistically significant. 

    Mean total opioid use was significantly lower among the ANJESO group compared to placebo and from hour 0 through hospital discharge (29.22mg vs. 45.17mg; p<0.0339). The proportion of subjects with ≥1 opioid related adverse drug effects (ORADE) were higher for the placebo group than for the ANJESO group (63% vs. 41%). Presence of >1 ORADE was associated with a significant increase in LOS (exp (β)=1.303, p=0.0238) in hours (exp(β)=1.264, p =0.031) as compared to not having any ORADEs.

    Title: Healthcare Resource Utilization (HRU) Associated with Preoperative Meloxicam IV in Colorectal Surgery
    Lead Author: Libby Black
    Presentation #: 503-2020
    URL: https://ddw.apprisor.org/epsAbstractDDW.cfm?id=96

    For more information on this meeting, visit: www.ddw.org.

    About ANJESOTM

    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 Company expects full commercial launch of ANJESO by late Q2 2020. 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. 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 and ANJESO™ commercialization, 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

    Baudax Bio, Inc.
    Ryan D. Lake
    (484) 395-2436

    Media Contact:
    Argot Partners
    David Rosen
    (212) 600-1902

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