Sunday, February 22, 2015 2:35:27 PM
Ladenburg Thalmann
Jeffrey Cohen
Creation of a Critical Care Focused Company with a U.S. Phase III Levosimendan (SIMDAX) Trial. Initiating Coverage with Buy Rating and Price Target of $10.50.
We are initiating coverage of Oxygen Biotherapeutics (OXBT) with a Buy rating and price target of $10.50.
On October 21, 2013 Oxygen Biotherapeutics, Inc. announced that they had signed a definitive agreement to acquire certain assets of privatelyheld Phyxius Pharma which is focused on the North American development and near-term commercialization of levosimendan (trade name Simdax) to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS). We believe this drug represents an estimated $600 million U.S. market.
Levosimendan is a calcium sensitizer which was developed for intravenous use (24 hour) in hospitalized patients with Acutely Decompensated Heart Failure (ADHF). The compound was first approved in Sweden during 2000 and is currently manufactured and marketed in 53 countries by Orion Pharmaceuticals (€20.63-ORNBV, NR) of Espoo, Finland and has produced revenues of €44 million Euros ($60
million USD) during CY-2012. The drug is also marketed within certain Latin American countries by Abbott Laboratories ($39.57-ABT, NR) who also had owned rights to certain other territories which were sold back to Orion in 2009.
The drug has a plethora of published clinical studies, clinical trials, health economic data and meta-analysis and has been administered to more than 600,000 patients to date. The drug’s administration regimen and more specific use (indications) has evolved significantly through clinical experience and includes the decrease (or virtual elimination) of loading (bolus) doses and dramatically increased use specific for cardiac surgeries (mitral valve replacement and Coronary Artery Bypass Grafting (CABG)).
We believe that the Company has taken into account the drug’s vast experience in designing what we believe to be a well thought out Phase III protocol which utilizes all of the European experience throughout the past decade, coupled with a focus on cardiac surgery patients classified with Low Cardiac Output Syndrome (LCOS).
Oxygen Biotherapeutics, Inc. is based in Morrisville, North Carolina. The Company has approximately 14 employees as of Q2-2014 (October, 2013) and is also conducting a Phase II trial in Europe studying perfluorocarbon (PFC) therapeutic oxygen carrier (Oxycyte) for Traumatic Brain Injury (TBI).
We anticipate that Levosimendan could become commercially available in the U.S. during CY-2017 (and in Canada during CY-2018) and we have modelled in peak revenues of $244.4 million during FY-2023 prior to anticipated generic competition. Our price target of $10.50 is based upon the net present value (NPV) of discounted cash flows (DCF) to the Company through FY-2027 with peak free cash flow of $42.3 million during FY-2023. We are using a 15% annual discount rate and 20 million outstanding shares for our calculation.
Recent TENX News
- Tenax Therapeutics Announces New U.S. Patent Covering the Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) • GlobeNewswire Inc. • 04/30/2024 11:30:00 AM
- Tenax Therapeutics to Host KOL Event: “LEVEL Setting: the Scientific Rationale for Levosimendan as a Potential First Treatment for PH-HFpEF, and the Ongoing Phase 3 LEVEL Study” • GlobeNewswire Inc. • 04/09/2024 12:30:00 PM
- Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 12:30:00 PM
- Tenax Therapeutics to Present at the 36th Annual Roth Conference • GlobeNewswire Inc. • 03/12/2024 12:30:00 PM
- Tenax Therapeutics Announces Oral Presentation of Levosimendan for the Treatment of PH-HFpEF at THT 2024 • GlobeNewswire Inc. • 02/29/2024 02:00:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/26/2024 09:31:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/23/2024 09:30:34 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/20/2024 09:01:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 01:33:49 PM
- Tenax Therapeutics Announces Global License Amendment that Significantly Expands Rights to Levosimendan • GlobeNewswire Inc. • 02/20/2024 01:30:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/16/2024 04:28:52 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/16/2024 12:36:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/12/2024 09:46:29 PM
- Tenax Therapeutics Announces Pricing of Approximately $9 Million Public Offering • GlobeNewswire Inc. • 02/08/2024 01:16:41 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/08/2024 05:15:17 AM
- Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) • GlobeNewswire Inc. • 02/08/2024 01:01:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/06/2024 01:56:32 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM