Mesoblast

Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target the cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Itescu Silviu on June 8, 2004 and is headquartered in Melbourne, Australia.

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Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Silviu Itescu on June 8, 2004 and is headquartered in Melbourne, Australia.

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MELBOURNE, Australia and NEW YORK, Jan.  02, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq: MESO), global leader in cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration (US FDA) has confirmed receipt of Mesoblast’s filing of clinical efficacy and safety data for remestemcel-L in its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed during January, and Mesoblast will request an expedited FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, remestemcel-L is planned to be launched in the US in 2020. The clinical submission included analyses of 309 children with SR-aGVHD who have received remestemcel-L across three separate studies. In addition, Mesoblast provided new data in control pediatric subjects from the contemporaneous database of the Mount Sinai Acute GVHD International Consortium (MAGIC) to provide an unbiased and independent estimate of response rates and outcomes in matched pediatric control patients treated with institutional standard of care.     The results of the comparative analysis between Mesoblast’s open-label Phase 3 study and contemporaneous controls receiving institutional standard of care demonstrate the effectiveness of remestemcel-L in this patient population, with particular efficacy and survival benefit in patients with the most severe forms of aGVHD. These conclusions are supported by prior results from an Expanded Access Program in 241 children where remestemcel-L was used as salvage therapy after failure of steroids and other agents. Acute GVHD is a potentially life-threatening condition which occurs in about 50% of patients who receive an allogeneic bone marrow transplant. Over 30,000 patients worldwide receive an allogeneic bone marrow transplant, primarily during treatment for blood cancers, and 20-25% are children1. Mortality at 12 months is as high as 90% in those with aGVHD and Grade C/D or III/IV disease severity2,3, and there are no approved treatments in the US for children under 12. In Mesoblast’s open-label Phase 3 trial of remestemcel-L in 55 children with SR-aGVHD, 89% of whom had Grade C/D disease, the primary endpoint of Day 28 Overall Response in those exposed to remestemcel-L was achieved in 70% and Day 100 survival was 75%. These outcomes were superior to those from a cohort of 30 pediatric patients with SR-aGVHD from the MAGIC consortium matched for inclusion criteria and disease severity (80% Grade C/D). In the MAGIC controls, Day 28 Overall Response was 43% and Day 100 survival was 57%. Mesoblast Chief Medical Officer Dr Fred Grossman said: “We are pleased to have submitted to the FDA clinical efficacy and safety data for remestemcel-L, as well as comparative clinical outcome data from contemporaneous controls. We are working closely with the FDA to make our cellular medicine available and improve outcomes in children with this devastating condition.”  Abo ut Remestemcel-L Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

Mesoblast Submits Clinical Efficacy And Safety Data To FDA In Rolling Biologics License Application For Remestemcel-L

NEW YORK, Dec.  18, 2019  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announced today that the independent Data Monitoring Committee (DMC) overseeing the Phase 3 trial of Revascor for advanced chronic heart failure has held its tenth and final scheduled meeting, and has recommended that the trial continue as planned. This cardiovascular outcomes trial has now initiated final study visits for all surviving patients with a target of last patient/last visit at the end of January 2020. The DMC reviewed available data from the 566 randomized patients, including components of the trial’s primary and secondary endpoints, and all safety data. The results from this pivotal trial are expected to be read out by mid-2020.  About Mesoblast Mesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Two products have been commercialized in Japan and Europe by its licensees, and it has established commercial partnerships in Europe and China for certain Phase 3 assets. In the United States, Mesoblast has initiated submission of a rolling Biologics License Application to the FDA to seek approval of its product candidate for acute graft versus host disease following a successful Phase 3 trial, and is completing Phase 3 trials for its advanced heart failure and chronic low back pain product candidates. Mesoblast’s proprietary manufacturing process yields industrial-scale, frozen, off-the-shelf, cellular medicines based on its mesenchymal lineage cell platform technology. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see  www.mesoblast.com , LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Data Monitoring Committee Completes Final Scheduled Review of Mesoblast’s Phase 3 Trial of Revascor in Advanced Chronic Heart Failure

NEW YORK, Dec.  17, 2019  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that its Phase 3 trial of Revascor for advanced chronic heart failure has surpassed the number of primary endpoint events required for trial completion. This cardiovascular outcomes trial has now initiated final study visits for all surviving patients with a target of last patient/last visit at the end of January 2020.

Mesoblast’s Phase 3 Trial of Revascor in Advanced Chronic Heart Failure Surpasses the Number of Primary Endpoint Events for Trial Completion

Mesoblast Limited (MESO) CEO Silviu Itescu on Q1 2020 Results - Earnings Call Transcript

MELBOURNE, Australia and NEW YORK and BASEL, Switzerland, Oct.  16, 2019  (GLOBE NEWSWIRE) -- Mesoblast (ASX:MSB; Nasdaq:MESO) and Lonza (SWX: LONN) announced today that they have entered into an agreement for commercial manufacture of Mesoblast’s lead allogeneic (off-the-shelf) cell therapy product candidate, remestemcel-L for pediatric steroid-refractory acute graft versus host disease (aGVHD). This agreement will facilitate inventory build ahead of the planned United States (US) market launch of remestemcel-L and commercial supply to meet Mesoblast’s long-term market projections. 

Mesoblast and Lonza Enter Into Agreement for Commercial Manufacture of Mesoblast’s Potential First United States Allogeneic Cell Therapy

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NEW YORK, Sept.  09, 2019  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, will provide a corporate update during an analyst call today. The webcast will begin at 8.30pm EDT Monday September 9, 2019; 10.30am AEST Tuesday September 10, 2019. The webcast can be accessed via https://webcasting.boardroom.media/broadcast/5d71f3b98ab2617d254fa91c  To access the call only, dial 1 855 881 1339 (U.S.), 1 800 558 698 (toll-free Australia) or +61 2 9007 3187 (outside of the U.S. and Australia). The conference identification code is 10002044.

Mesoblast Corporate Update: Analyst Call

Mesoblast's (MESO) CEO Silviu Itescu on Q4 2019 Results - Earnings Call Transcript

Strong Operational Progress and Continued Growth in Revenues from Royalties Strong Operational Progress and Continued Growth in Revenues from Royalties

Mesoblast Reports 2019 Full Year Results

NEW YORK and MELBOURNE, Australia, Aug.  27, 2019  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, will host a webcast to discuss the financial results for the period ending June 30, 2019.

Mesoblast to Host Analyst Call on 2019 Financial Results for Year and Fourth Quarter Ended June 30, 2019

Primary Endpoint of Confirmatory Trial to be Reduction in Major Mucosal Bleeding Events Primary Endpoint of Confirmatory Trial to be Reduction in Major Mucosal Bleeding Events

FDA Provides Guidance on Clinical Pathway to Marketing Application for Revascor in End-Stage Heart Failure Patients With an LVAD

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Mesoblast Limited product rexlemestrocel-L has received Orphan Drug Destination from the U.S. Food and Drug Administration for prevention of gastrointestinal bleeding in patients with left ventricular assist device.

Mesoblast Trades Higher After Heart Failure Cell Therapy Receives Orphan Drug Status

Mesoblast's (MESO) CEO Silviu Itescu on Q3 2019 Results - Earnings Call Transcript

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Mesoblast (MESO) begins the rolling submission of a BLA for its lead product, candidate remestemcel-L, to the FDA for treating children with steroid-refractory acute graft versus host disease.

Mesoblast Starts Rolling BLA Submission for Remestemcel-L

News for Mesoblast Stock (MESO)