UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 20, 2020
Baudax Bio, Inc.
(Exact name of registrant as specified in its charter)
Pennsylvania | 001-39101 | 47-4639500 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
490 Lapp Road, Malvern, Pennsylvania | 19355 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (484) 395-2470
Not Applicable
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
Trading Symbol |
Name of Exchange on Which Registered |
||
Common Stock, par value $0.01 | BXRX | Nasdaq Capital Market |
Securities registered pursuant to Section 12(g) of the Act:
None
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 |
Regulation FD Disclosure. |
On February 20, 2020, Baudax Bio, Inc. (the Company) updated information reflected in a slide presentation, which representatives of the Company will use in various meetings with investors from time to time. A copy of the presentation is attached hereto as Exhibit 99.1, and incorporated herein by reference.
The information disclosed under Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 |
Other Events. |
On February 20, 2020, the Company issued a press release announcing that the U.S. Food and Drug Administration has approved the New Drug Application for ANJESO (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. A copy of the press release is attached hereto as Exhibit 99.2, and incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are being filed herewith:
Exhibit
|
Document |
|
99.1 | Investor Presentation of Baudax Bio, Inc., dated February 20, 2020. | |
99.2 | Press Release of Baudax Bio, Inc., dated February 20, 2020. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Baudax Bio, Inc. | ||
By: |
/s/ Gerri A. Henwood |
|
Name: | Gerri A. Henwood | |
Title: | Chief Executive Officer |
Date: February 20, 2020
Investor Conference Call to Discuss FDA Approval of ANJESO™ (meloxicam) Injection February 20, 2020 NASDAQ: BXRX Exhibit 99.1
This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "predict", "project", "will" and similar terms and phrases may be used to identify forward-looking statements in this presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. These forward-looking statements are subject to risks and uncertainties including, among other things, our ability to maintain regulatory approval for ANJESO™, our ability to successfully commercialize ANJESO™; the acceptance of ANJESO™ by the medical community, including physicians, patients, health care providers and hospital formularies; our ability and that of our third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO™, our ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO™, our ability to raise future financing for continued product development and ANJESO™ commercialization, our ability to manage costs and execute on our operational and budget plans, the accuracy of our estimates of the potential market for ANJESO™, our ability to achieve our financial goals; and our 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. Forward-Looking Statements
Introduction Gerri Henwood President and Chief Executive Officer
The first and only once-daily IV analgesic 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 the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com
Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com Indication & Usage Dosing & Administration 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 the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. CONTRAINDICATIONS: Known hypersensitivity 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: 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: Patients taking some antihypertensive medications may have impaired response to these therapies when taking ANJESO. Monitor blood pressure. Heart Failure and Edema: Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. Renal Toxicity: 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. Anaphylactic Reactions: 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: Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity. Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. 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. 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. 30 mg once daily, administered by intravenous bolus injection over 15 seconds Monitor patient analgesic response and administer a short-acting, non-NSAID, immediate-release analgesic if response is inadequate Source: ANJESO USPI, 2020 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. Selected Important Safety Information 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 included: constipation, gamma-glutamyl transferase increased and anemia.
1. Data on file. Baudax Bio, Inc. *The mechanism of action of IV meloxicam, like other NSAIDs, is not completely understood, but involves inhibition of both COX-1 and COX-2 pathways. COX-1 = cyclooxygenase 1; COX-2 = cyclooxygenase 2; IV = intravenous; NSAID = nonsteroidal anti-inflammatory drug; MMA = multimodal analgesia ANJESO (meloxicam) Injection: The First and Only Once-Daily IV Analgesic Up to 24-hour pain relief Demonstrated Safety & Tolerability COX-2 Preferential IV NSAID* Once-daily IV push Efficacy in orthopedic & soft tissue procedures Evaluated in more than 1400 patients1 That can be incorporated into MMA protocols Ready-to-use, no reconstitution or refrigeration
Source: ANJESO (meloxicam) injection Prescribing Information. 2020; Baudax Bio, Inc. Malvern, PA. Labelling Highlights: Onset of Action & Duration of Effect Onset of Action Label Section Language INDICATIONS 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. DOSAGE AND ADMINISTRATION When initiating ANJESO, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after ANJESO administration in two clinical studies, a non-NSAID analgesic with a rapid onset of effect may be needed, for example, upon anesthetic emergence or resolution of local or regional anesthetic blocks Duration of Effect Label Section Language DOSAGE AND ADMINISTRATION Some patients may not experience adequate analgesia for the entire 24-hour dosing interval and may require administration of a short-acting, non-NSAID, immediate-release analgesic. CLINICAL STUDIES A generally consistent separation in pain scores between the ANJESO and placebo groups was observed from time of onset through most of the dosing interval with a narrowing at the end of the first 24-hour dosing interval. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com
ANJESO™ Clinical Overview Stewart McCallum, MD Chief Medical Officer Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com
Source: 1. MOBIC® (meloxicam) tablets Prescribing Information. 2016; Boehringer Ingelheim Pharmaceuticals, Inc; Ridgefield, CT. 2. Data on file. Baudax Bio, Inc. 3. Pollak R et al. Clin J Pain. 2018;34(10):918-926. 4. Singla N et al. Plast Reconstr Surg Glob Open. 2018;6:e1846. 5. Bergese SD et al. Clin Pharmacol Drug Develop. 2019;8(8) 1062-1072. 6. ANJESO (meloxicam) injection Prescribing Information. 2020; Baudax Bio, Inc. Malvern, PA. Meloxicam Clinical Development From Oral to Intravenous Administration Oral Meloxicam Approval1 2000 2016 Today ANJESO Approval6 Phase 3 ANJESO Clinical Program3-5 Meloxicam (as a molecule) possesses analgesic, anti-inflammatory, and antipyretic activity Oral meloxicam is indicated to treat osteoarthrosis & rheumatoid arthritis in adults Tmax is not achieved until 5-6 hours after oral dosing The mean elimination half-life (t1/2) for ANJESO 30 mg is approximately 24 hours6 2009 Elan/Alkermes2 Begins Development Of ANJESO 2019 Phase 3b ANJESO Clinical Studies2 2017 2018
“Whenever possible, anesthesiologists should use multimodal pain management therapy…unless contraindicated, patients should receive an around-the-clock regimen of NSAIDs, COXIBs, or APAP.” Practice Guidelines for Acute Pain Management in the Perioperative Setting (2012)1 *The American Academy of Orthopaedic Surgeons and The Joint Commission recommend MMA, but do not specifically recommend NSAIDs. 1. American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273 MMA is Recommended to Provide Better Pain Control American Academy of Orthopaedic Surgeons* American College of Surgeons American Pain Society The Joint Commission* American Society of Anesthesiologists American Society of Regional Anesthesia and Pain Medicine Numerous clinical practice guidelines recommend multimodal approaches to pain management—including NSAIDs—to provide better pain control while reducing opioids and related adverse events
1. Pollak R et al. Clin J Pain. 2018;34(10):918-926.; 2. Bergese SD et al. Clin Pharmacol Drug Develop. 2019;8(8) 1062-1072.; 3. Christensen SE et al. J Clin Pharmacol. 2018;58(5):593-605.; 4. Singla N et al. Plast Reconstr Surg Glob Open. 2018;6:e1846.; 5. Rechberger T et al. Anesth Analg. 2018.; 6. Gottlieb IJ et al. J Pain Res.2018; 11:383–393.; 7. Data on file. Baudax Bio, Inc. ANJESO Studied in More Than 1400 Surgical Patients Phase 2 efficacy and safety studies: bunionectomy, gynecologic, and molar extraction Phase 3 efficacy and safety studies: bunionectomy and abdominoplasty Phase 3 safety study: abdominoplasty, bunionectomy, complex foot, gastrointestinal, gynecologic, other soft tissue surgeries, and total hip and knee replacements Phase 3b studies: ANJESO was also studied in 120 patients in total knee arthroplasty (n=93) and bowel resection surgery (n=27) Orthopedic Procedures Bunionectomy1,6 Complex foot2 Molar extraction3 Total hip replacement2 Total knee replacement2,7 Soft Tissue Procedures Abdominoplasty4 Gastrointestinal2,7 Gynecologic5 Other soft tissue2
1. Data on file. Baudax Bio, Inc.; 2. Christensen SE et al. J Clin Pharmacol. 2018;58(5):593-605.; 3. Rechberger T et al. Anesth Analg. 2018.; 4. . Gottlieb IJ et al. J Pain Res.2018; 11:383–393. ANJESO Evaluated in Wide Range of Phase 1 & 2 Studies with 676 Subjects Exposed Phase 2 Studies ANJESO Comparison Agents Key Findings Third Molar Extraction2 15 mg-60 mg Placebo Oral Ibuprofen 400 mg Dose dependent pain reduction for ANJESO 30mg and 60mg statistically superior to Motrin Open Abdominal Hysterectomy3 5 mg-60 mg Placebo IV Morphine Statistically significant pain reductions for all ANJESO groups compared to placebo and 15mg, 30mg and 60mg compared to morphine Bunionectomy4 30 mg-60 mg Placebo 15-30 sec bolus safe; 30 and 60mg demonstrate comparable efficacy Phase 1 Studies1 ANJESO Comparison Agents Key Findings Renal Impairment Study GFR (60-89 mL/min/1.73m2) Renal Impaired (65-80 yrs) Normal Renal Function (18-55 yrs) No dose adjustments required for older renal impaired subjects with ANJESO Single Ascending Dose QTc Study 30mg-180mg Placebo No Clinically Significant Effect on QTc with Clinical or Supratherapeutic Doses of ANJESO
*SPID (Sum of Pain Intensity Differences) is calculated by the sum of the difference between current pain and baseline pain at each post-dose time point. SPID48 = summed pain intensity difference from 0-48 hours, SPID24 = summed pain intensity difference from 0-24 hours. aAll studies completed with efficacy, safety and opioid reduction data. 1. Pollak RA et al. Clin J Pain. 2018;34(10):918-926. 2. Singla N et al. Plast Reconstr Surg Glob Open. 2018;6:e1846. 3. Bergese SD et al. Clin Pharmacol Drug Dev. 2019;8(8) 1062-1072. ANJESO Evaluated in Three Phase 3 Studies Study Populationa ANJESO 30 mg Placebo Primary Endpoint Outcome Bunionectomy1 n=100 n=101 SPID48* 31% greater pain reduction vs placebo (p=0.0034) Abdominoplasty2 n=110 n=109 SPID24* 17% greater pain reduction vs placebo (p=0.0145) Safety study; multiple hard & soft tissue procedures3 n=538 n=183 Safety, including number of patients with adverse events up to 28 days after dosing Adverse Events comparable to placebo
Source: ANJESO Prescribing Information ANJESO Adverse Events Across All Phase 3 Studies Adverse Reactions in Placebo-Controlled Phase 3 Clinical Trials occurring in ≥2% of Patients Treated with ANJESO and at a greater frequency than Placebo ANJESO 30 mg (n=748) Placebo (n=393) % (n) % (n) Constipation 57 (7.6%) 24 (6.1%) Gamma-Glutamyl Transferase Increased 21 (2.8%) 6 (1.5%) Anemia 18 (2.4%) 4 (1.0%) ANJESO (n=748)
Primary Objective: Safety and tolerability as evaluated by adverse events, clinical laboratory tests, opioid consumption, vital sign measurements, wound evaluation, and ECGs Study Design: Double-blind, randomized, placebo-controlled study in patients undergoing major elective surgery. Site-specific standard of care analgesia were used for pain management *As of February 2020. Study date: May 2017. CABG=coronary artery bypass graft. Source: Bergese SD et al. Clin Pharmacol Drug Dev. 2019;8(8) 1062-1072. ANJESO Evaluated in the Largest, Double-blind, Placebo-Controlled Safety Trial* of an IV NSAID to Date (N=721)
* Preoperative dosing = ANJESO 30mg was administered prior to surgical incision (TKA) or 30 minutes prior to the start of surgery (bowel resection), then once-daily while in hospital until discharge or IV analgesic was no longer appropriate. 1. Studies completed with efficacy, safety, opioid reduction and healthcare resource utilization measures. 2. Data on file. Baudax Bio, Inc. Abstracts and publications pending. MMA = multimodal analgesia; LOS = length of stay Two Phase 3b Health Economic Studies Completed with Preoperative Administration of ANJESO Study Population1 ANJESO 30 mg Placebo Primary Endpoint Selection of Secondary Endpoints Selection of Results2 Total Knee Arthroplasty (TKA) n=93 n=88 Evaluate efficacy of preoperative* administration measured by total opioid consumption Evaluate impact on pain control and healthcare resource utilization Preoperative administration of ANJESO as part of a MMA regimen was associated with lower total costs >$2,000 during the hospital stay than patients in the placebo group Bowel Resection Surgery n=27 n=28 Evaluate safety and tolerability of preoperative* administration Evaluate impact on hospital LOS, opioid consumption and healthcare resource utilization Preoperative administration of ANJESO as part of a MMA regimen was well tolerated and decreased mean LOS by 1.2 days (3.2 vs 4.4 days)
Source: ANJESO Prescribing Information. *Vial size approximately 16 X 34.5 mm ANJESO (meloxicam) Injection: The First and Only Once-Daily IV Analgesic Dosing and Administration Highlights Once-daily, IV bolus injection push over 15 seconds Administered as a 30-mg (1 mL) Available as a small* (2 mL) single-use vial Ready-to-use No reconstitution required Room temperature storage – no need to refrigerate When initiating ANJESO, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after ANJESO administration in two clinical studies, a non-NSAID analgesic with a rapid onset of effect may be needed, for example, upon anesthetic emergence or resolution of local or regional anesthetic blocks. Some patients may not experience adequate analgesia for the entire 24-hour dosing interval and may require administration of a short-acting, non-NSAID, immediate-release analgesic.
Market Opportunity & Launch Plans John Harlow Chief Commercial Officer Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com
50 Million procedures $6 Billion 50 Million procedures Few alternatives Complex Market IV Pain Management Opportunity
Source: Blinded market research feedback on market dynamics. Market Research Indicators of Success: Need To Demonstrate Clinical & Economic Value CLINICAL VALUE May avoid risks of analgesic-related AEs that lead to complications or prolong hospital stay Has potential for early patient mobilization so rehab begins within 24 hours May prevent avoidable readmissions due to surgical complications, adverse drug events or pain at the surgical site ECONOMIC VALUE Ambulatory surgical centers are looking to perform more complex procedures with higher reimbursements and discharge patients on the same day Hospitals are looking to speed up patient discharge, reduce inpatient admission, and/or length of stay ECONOMIC CLINICAL Influence Clinical Value Cost Economic Value
HOSPITAL INPATIENT HOPD ASC TOTAL ADDRESSABLE PROCEDURES* 11m 9m 2.2m ~22m Procedures CORE TARGET PROCEDURES TARGETED PROCEDURES 3.4m 6.9m 1.0m ~11.3m Procedures TARGETED ACCOUNTS ~1,450 HOSPITALS ~550 ASCs ~2,000 Accounts Source: Definitive, LexisNexis and Company Estimates. *Includes addressable procedures where ANJESO use is anticipated. Large Opportunity Waiting For Non-Opioid Solutions: Market Can Be Targeted Efficiently & Effectively Orthopedic (Hip/Knee, Spine, other) General Surgery Colorectal
*Product profile in surveys was fair balanced, based on clinical data and similar to final label. Stated shares do not account for possible access restrictions (i.e. special order, quantity limits, specific procedural prescribing, limitations by site of care, etc.) 1. December 2017 – Blinded, Third Party Market Research, n=462. 2. January 2020 – Blinded, Third Party Market Research, n=400. PACU = Post-Anesthesia Care Unit ANJESO Stated Shares in Market Surveys Remain Consistently Positive Approximately 65% of MDs surveyed believe they would likely use ANJESO with stated procedure shares ranging from 39-52% Anticipated Change in Share in PACU Setting % of Surgeries1 Oral Opioids Fentanyl IV Opioids IV Ketorolac IV Ibuprofen IV Acetaminophen Local Injections ANJESO ANJESO Stated Share by Procedure Type – % of Patients2 Knee & Shoulder Arthroscopy Total Hip Replacement Total Knee Replacement Other Orthopedic Procedures Hernia Repair Laproscopic Cholesysectomy Soft Tissue Procedures Bowel Resection and Other Colorectal Procedures
Commercial Launch Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.baudaxbio.com
Abbreviations: EMR = Electronic Medical Records, IPAT = Inpatient, HOPD = Hospital Outpatient Department, ASCs = Ambulatory Surgical Centers, HCP = Healthcare Practitioner Launching in the Acute Care Space: ASCs Provide a Strategic Entry Point for Early Experience Traditional Hospital Launches Focus on the Institutions Our Approach – Focus on the Physician and Their Settings of Care HCP Hospital IPAT HOPD ASC Deciding to Evaluate P+T Review Physician Usage Implementation (EMR & Order Sets) ASCs typically have lower barriers to adoption and early usage can drive formulary reviews
Prepared for an Efficient Launch Source: Definitive, LexisNexis and Company Estimates. *Includes addressable procedures where ANJESO use is anticipated. “Fast Start” Targets: ~200 Hospitals & ~100 ASCs Surgical claims data identified ~2,000 accounts that cover 80% of the market Launching with ~50 Reps enables coverage of 800-1,000 accounts (~50% of market) Prior field team activity qualified and prioritized ~300 “Fast Start” accounts Solid Foundation Efficient Launch Total Accounts: 1500 Hospitals & 500 ASCs Launch Targets: 800 – 1000 Accounts
Source: Wholesale Acquisition Cost Prices from Red Book accessed January 2020, which may not represent a customer’s cost. Price per day equals dosing schedule times price per dose. Dosing schedule according to product prescribing information for 24-hour coverage. Generic ketorolac has multiple manufacturers, price reflects the lowest manufacturer WAC. Wholesale Acquisition Cost: ANJESO and Other Non-Opioids Note: For illustration only. Not drawn to scale Strong Economic Evidence Available at Launch Economic Analysis of two Phase 3b studies completed with positive data available at launch Budget Impact & Cost Effectiveness Models to address ANJESO cost effectiveness vs. other IV analgesics Retrospective Analyses of claims database that models real-world AE rates and costs $47.37 $173.84 $$334.18 Ofirmev (4X dose) Ofirmev (per dose) Exparel (per dose) $9.84 IV Ketorolac (per day) Caldolor (4X dose) $69.40 $94.74 $142.11 Ofirmev (2X dose) Ofirmev (3X dose) $94.00
AWP=average wholesale price; DRG=diagnosis related group. Surgical Setting Coding and Reimbursement at Launch Medicare Use C9399 Reimbursed at 80% of 95% of AWP Medicare Use J3490 Reimbursement bundled into DRG payment Commercial Use J3490 May be bundled with procedure or separately reimbursed based on the facility contract Commercial Use J3490 May be bundled with procedure or separately reimbursed based on the facility contract Commercial Use J3490 Bundled and part of a case rate Medicare Use C9399 Reimbursed at 80% of 95% of AWP Miscellaneous reimbursement codes available day 1 of launch Ambulatory Surgery Centers Hospital Outpatient Hospital Inpatient
Source: Centers for Medicare & Medicaid Services (CMS) updated its Healthcare Common Procedural Coding System (HCPCS) Level II coding procedures in November 2019 to enable shorter and more frequent HCPCS code application cycles. More information can be found at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo 2020 C-Code & J-Code Application Timelines July 2020 CMS posts final decision March 1, 2020 Apply for unique C-code after FDA approval July 1, 2020 Earliest possible date C-code would be effective C-Code Application Timeline - Quarterly J-Code Application Timeline - Quarterly Miscellaneous C-code (C9399) can be used until unique C-code assigned Miscellaneous J-code (J3490) can be used until unique J-code assigned If granted, 3 years of pass-through coverage until June 30, 2023 July 2020 March 2020 April 2020 Oct 2020 April 6, 2020 Apply for unique J-code after FDA approval October 2020 J-code effective if granted and replaces unique C-code: Pass-through continues until June 30, 2023 Pass-through continues until June 30, 2023 July 2020 April 2020
1. Data on file. Baudax Bio, Inc. *The mechanism of action of IV meloxicam, like other NSAIDs, is not completely understood, but involves inhibition of both COX-1 and COX-2 pathways. COX-2 = cyclooxygenase 2; IV = intravenous; NSAID = nonsteroidal anti-inflammatory drug; MMA = multimodal analgesia ANJESO (meloxicam) Injection: The First and Only Once-Daily IV Analgesic Up to 24-hour pain relief Demonstrated Safety & Tolerability COX-2 Preferential IV NSAID* Once-daily IV push Efficacy in orthopedic & soft tissue procedures Evaluated in more than 1400 patients1 That can be incorporated into MMA protocols Ready-to-use, no reconstitution or refrigeration
NASDAQ: BXRX Question and Answer Session
Important Safety Information Please see Important Safety Information on slides 30-33 and full Prescribing Information at this presentation.
Indication and Boxed Warning INDICATION 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.
Important Safety Information (cont) 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.
Important Safety Information (cont) 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.
Important Safety Information (cont) DRUG INTERACTIONS Drugs That Interfere With Hemostasis (eg, 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 Enzyme (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 included: 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.baudaxbio.com.
Exhibit 99.2
Baudax Bio Announces FDA Approval of ANJESO for the Management of Moderate to Severe Pain
ANJESO Is The Only Approved 24-Hour, Intravenous COX-2 Preferential NSAID that
Offers Once-Daily Dosing
U.S. Commercial Launch Planned to Commence in Late April or Early May 2020
Management to Host Conference Call and Webcast Today at 4:30 p.m. ET
MALVERN, PA, February 20, 2020 Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ANJESO (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain, said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm. We expect to make ANJESO available to physicians and patients in late April or early May 2020.
ANJESO is approved for the management of moderate to severe pain and will be administered as a once-a-day intravenous (IV) bolus push. ANJESO is the only available 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) and offers once-daily dosing. The active ingredient meloxicam is a 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.
The safety and efficacy of ANJESO have been well-established through several mid- and late-stage clinical studies, said Stewart McCallum, M.D., Chief Medical Officer of Baudax Bio. Moreover, data from our Phase III safety trial demonstrated that ANJESO is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems.
The approval of ANJESO marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape, said Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami. While traditional opioid medications have proven effective at providing pain relief, the associated adverse side effects, including sedation and respiratory depression, have driven physicians to employ a multi-modal approach to treating post-operative pain. With 24-hour, durable pain relief and a safety profile comparable to placebo, ANJESO has the potential to serve as a meaningfully differentiated analgesic alternative.
1
The ANJESO approval is supported by two Phase III efficacy studies and one double-blind, placebo-controlled Phase III safety study. The results from these studies, as well as results from four Phase II clinical studies and other safety studies, comprised the NDA package.
The most common ADVERSE REACTIONS reported in ³2% of patients treated with ANJESO and at a greater frequency than placebo included: constipation, gamma-glutamyl transferase increased and anemia.
Please see News & Investors section of the Companys website at www.baudaxbio.com for full Prescribing Information in addition to the full Important Safety Information provided below.
Baudax expects ANJESO will be available in the U.S. in late April or early May 2020. For more information, visit www.baudaxbio.com.
Conference Call and Webcast
Baudax Bio management will be hosting a conference call and webcast today beginning at 4:30 p.m. ET. 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 4373423.A live audio webcast of the call will be available under Events in the Investor section of the Companys website, https://www.baudaxbio.com/news-and-investors/events. An archived webcast will be available on the Companys website approximately two hours after the event and will be available for 30 days.
ANJESO COMPREHENSIVE CLINICAL TRIALS
Phase 3 Efficacy Study Evaluating ANJESO Following Bunionectomy Surgery
In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 201 patients were enrolled and randomly assigned to receive a postoperative regimen of ANJESO (30mg) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following bunionectomy surgery, a representative hard tissue surgery. The ANJESO treatment arm demonstrated a statistically significant reduction in SPID48 (p=0.0034) compared to the placebo arm. The study also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6 (p=0.0153), SPID12 (p=0.0053), SPID24 (p=0.0084), SPID24-48 (p=0.0050), time to first use of rescue medication (p=0.0076), and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo. The safety results demonstrated that ANJESO was well tolerated with no serious adverse events or bleeding events in the ANJESO-treated patients.
Phase 3 Efficacy Study Evaluating ANJESO Following Abdominoplasty Surgery
In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of ANJESO (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The ANJESO
2
treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm. The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12 (p=0.0434), time to perceptible pain relief (p=0.0050), subjects with ³30% improvement at 24 hours (p=0.0178), number of times patients required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009), and several other pain relief metrics, compared to placebo. The safety results demonstrated that ANJESO was well tolerated with no difference in serious adverse events (SAEs) related to bleeding for ANJESO treated patients versus placebo (1 each).
Phase 3 Safety Study Evaluating ANJESO Following Major Surgery
This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, included patients who had undergone major elective surgical procedures which were expected to result in hospitalization for at least 24-48 hours. Major surgical procedures included total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, as well as a range of other surgeries. Patient demographics were balanced across treatment groups and included 40% male patients and about 23% of patients who were over age 65. Unlike the pivotal efficacy trials, minimum pain scores were not required for treatment. Sites were permitted to use opioids and other pain management modes according to their standard of care and meloxicam or placebo was added to this regimen. Patients were randomized in a 3:1 ratio to receive either ANJESO or IV placebo daily for up to 7 doses. A total of 721 patients received at least one dose of study medication. In patients age 65 and over, the percentage of patients reporting at least one AE was approximately 7% less in the ANJESO treatment arm compared to the placebo arm. The total occurrence of patients with at least one serious adverse event (SAE) was observed to be lower in the ANJESO group, 2.6%, (14/538 meloxicam patients) than in the placebo group, 5.5%, (10/183 placebo patients). In this safety study only two SAE events were listed as possibly related to study treatment. Both of these SAEs occurred in one placebo treated patient. No deaths were reported in either treatment group. Approximately 3% of patients in each study group discontinued.
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
3
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.
4
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.
5
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 ³ 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.baudaxbio.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 Company expects to launch ANJESO in late April or early May 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).
6
About Baudax Bio, Inc.
Baudax Bio is a specialty pharmaceutical company focused on therapeutics for acute care settings. The Companys lead product candidate is a proprietary intravenous (IV) form of meloxicam, a non-opioid, once a day preferential COX-2 inhibitor. IV meloxicam has successfully completed two pivotal Phase III clinical efficacy trials, a large double-blind placebo-controlled Phase III safety trial, four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, IV meloxicam has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. For more information please visit www.baudaxbio.com.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bios expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words anticipate, believe, estimate, may, upcoming, plan, target, goal, intend and expect and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bios 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, our ability to maintain regulatory approval for ANJESO, our ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; our ability and that of our third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, our ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, our ability to raise future financing for continued product development and ANJESO commercialization, our ability to manage costs and execute on our operational and budget plans, the accuracy of our estimates of the potential market for ANJESO, our ability to achieve our financial goals; and our 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. The forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Baudax Bios business and future results included in Baudax Bios filings with the Securities and Exchange Commission at www.sec.gov.
7
CONTACT:
Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
sam@argotpartners.com
claudia@argotpartners.com
Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
rlake@baudaxbio.com
Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com
8