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Mesoblast (MESO) - 2020 Q3 - Earnings Call Transcript
2020-05-29 17:15
Mesoblast Ltd (NASDAQ:MESO) Q4 2020 Earnings Conference Call May 27, 2020 6:00 PM ET Corporate Participants Silviu Itescu - CEO Josh Muntner - CFO Fred Grossman - CMO Conference Call Participants Louise Chen - Cantor Jeffrey Cohen - Ladenburg Thalmann Jason Folger - Dawson James Securities Tanushree Jain - Bell Potter Securities Operator Hello, and welcome to the financial results for the period ended March 31, 2020, and corporate update for Mesoblast. An announcement and presentation has been lodged with t ...
Mesoblast (MESO) - 2020 Q3 - Earnings Call Presentation
2020-05-28 17:52
Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial and Operational Highlights for the Third Quarter Ended March 31, 2020 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ ma ...
Mesoblast (MESO) - 2020 Q2 - Earnings Call Transcript
2020-03-01 03:05
Financial Data and Key Metrics Changes - Overall revenue grew 43% to $19.2 million from $13.5 million in the previous period [14] - Commercialization revenue from TEMCELL royalty increased 73% to $3.8 million from $2.2 million [14] - Milestone revenue from strategic partnerships rose 36% to $15 million from $11 million [14] - Loss after tax reduced by 32%, driven by increased revenue and a 22% decline in R&D expenses [15] Business Line Data and Key Metrics Changes - TEMCELL royalties contributed significantly to revenue growth, reflecting strong product adoption in Japan [9] - The company has two Phase 3 product candidates targeting heart failure and back pain, with trial readouts expected this year [5][8] Market Data and Key Metrics Changes - The U.S. addressable market for steroid-refractory acute graft versus host disease is anticipated to be approximately 8 times larger than in Japan [9] - The market opportunity for Ryoncil in acute graft versus host disease is substantial, with high mortality rates in severe cases [18] Company Strategy and Development Direction - The company completed the BLA filing for Ryoncil for treating steroid-refractory acute graft versus host disease in children, with plans for a U.S. launch in 2020 [6][20] - A lifecycle expansion strategy is in place for remestemcel-L, targeting additional indications including chronic graft versus host disease and biologic-refractory Crohn's disease [8][20] - Strategic partnerships are being established for product development and commercialization in various regions, including Europe and Latin America [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming U.S. launch of Ryoncil and the potential for sequential approval in Europe [34] - The company is optimistic about the Phase 3 trial outcomes for Revascor in heart failure, citing previous positive data from Phase 2 trials [35][36] - The management highlighted the importance of addressing the significant unmet needs in heart failure and chronic lower back pain markets [22][27] Other Important Information - The company has established manufacturing capabilities that meet international regulatory standards, ensuring product consistency and scalability [11] - The intellectual property estate includes over 1,000 patents, providing strong protection for the company's core commercial focus [10] Q&A Session Summary Question: What is the go-to-market strategy for Ryoncil in the U.S. and plans for Europe? - The company plans to target pediatric transplants in 15 centers in the U.S. with a small, efficient sales force and has established a relationship with Lonza for manufacturing [34] Question: What data supports a positive outcome for Revascor in the upcoming Phase 3 trial? - Previous Phase 2 trials showed a clear dose response and significant impact on reducing hospitalizations and mortality, providing confidence for the Phase 3 trial [35][36] Question: What is the expected timeline for the pivotal trial for chronic GVHD? - The company is still finalizing the number of patients and sites for the trial, with a focus on severe cases where existing therapies are least effective [39] Question: How many sales representatives will be on the ground for the U.S. launch? - The company is looking at a sales force of approximately 12 to 15 representatives [40] Question: What are the expectations for expenses over the next 12 to 24 months? - Overall cash burn is expected to decrease, with some resources shifting towards the commercial team and pre-launch inventory [59]
Mesoblast (MESO) - 2020 Q1 - Earnings Call Transcript
2019-11-26 10:54
Mesoblast Limited (NASDAQ:MESO) Q1 2020 Earnings Conference Call November 25, 2019 4:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Josh Muntner - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Jeffrey Cohen - Ladenburg Thalmann Tanushree Jain - Bell Potter Securities Operator Hello, and welcome to Mesoblast???s Financial Results Webcast for the Quarter Ended September 30, 2019. An announcement and slide presentation have bee ...
Mesoblast (MESO) - 2019 Q4 - Annual Report
2019-09-09 10:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F | | | OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report For the transition period from to Commission file num ...
Mesoblast (MESO) - 2019 Q4 - Earnings Call Presentation
2019-08-30 01:49
blast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases FY Ended June 30, 2019 Nasdaq: MESO ASX: MSB CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity ...
Mesoblast (MESO) - 2019 Q4 - Earnings Call Transcript
2019-08-30 01:39
Financial Data and Key Metrics Changes - The company reported record royalty revenue from JCR Pharma on sales of TEMCELL, which increased to $5 million for FY2019, a 37% increase over the prior year [31] - Royalties for the most recent quarter saw a 54% increase to $1.7 million, indicating strong growth [32] - The company completed the year with just over $50 million in cash, using only $19 million in the prior quarter [39] Business Line Data and Key Metrics Changes - The lead product remestemcel-L for steroid refractory acute graft versus host disease is preparing for a U.S. launch, with a rolling BLA submission initiated [15][43] - Revascor for advanced heart failure has completed patient enrollment in its Phase 3 trial, with 566 patients randomized [18] - The MPC-06-ID for chronic lower back pain is in a Phase 3 program with 404 patients, with results expected in the first half of 2020 [24][50] Market Data and Key Metrics Changes - The U.S. addressable market for steroid-refractory acute graft versus host disease is estimated to be approximately $700 million [43] - The advanced heart failure market targets about 1.3 million patients in the U.S., representing 15% of the total heart failure pool [99] Company Strategy and Development Direction - The company is focused on expanding its commercialization efforts, particularly for remestemcel-L and Revascor, with plans for label extensions and partnerships [26][50] - The strategy includes building a targeted sales force and ramping up manufacturing capabilities to meet commercial demand [28][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of TEMCELL and its potential performance in the U.S. market [33] - The company anticipates significant upcoming milestones that will position it for strong returns in the coming fiscal year [111] Other Important Information - The company has over 995 patents and patent applications, providing a substantial competitive advantage [30] - Recent appointments to the board and senior executive team are aligned with commercialization plans [26] Q&A Session Summary Question: When could the confirmatory Phase 3 trial for end-stage heart failure start? - The trial is expected to commence over the next few months, with agreements being finalized [55] Question: Will there be any other information available before the MPC-06 results in mid-2020? - No additional information will be disclosed until the full dataset is available [57] Question: What is the expected timeline for royalty revenue from TEMCELL in 2020? - Continued growth is anticipated, with a ramp-up expected throughout the year [59][60] Question: Can you provide details on the clinical trial design for chronic GVHD? - The trial will be investigator-initiated, with established data supporting the efficacy of mesenchymal lineage cells [73] Question: What is the expected trial size for the confirmatory LVAD trial? - The trial size will be slightly larger than the previous 159-patient trial, with specifics to be finalized [108]
Mesoblast (MESO) - 2019 Q3 - Earnings Call Presentation
2019-05-31 18:45
Operational Highlights and Financial Results for the Nine Months and Quarter Ended March 31, 2019 May 2019 Nasdaq: MESO ASX: MSB CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of act ...
Mesoblast (MESO) - 2019 Q3 - Earnings Call Transcript
2019-05-31 01:58
Mesoblast (NASDAQ:MESO) Q3 2019 Earnings Conference Call May 30, 2019 4:30 PM ET Company Participants Silviu Itescu ??? Chief Executive Officer Josh Muntner ??? Chief Financial Officer Joanne Kurtzberg ??? Distinguished Professor of Pediatrics Conference Call Participants Mark Breidenbach ??? Oppenheimer Jason McCarthy ??? Maxim Group Jeffrey Cohen ??? Ladenburg Thalmann Operator Hello, and welcome to Mesoblast's Financial Update and Operational Highlights Webcast for the Third Quarter Ended March 31, 2019. ...
Mesoblast (MESO) Presents At Oppenheimer 29th Annual Healthcare Conference - Slideshow
2019-03-21 19:12
Global Leader in Cellular Medicines for Inflammatory Diseases March 2019 Nasdaq: MESO ASX: MSB CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements ...