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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 ...
Mesoblast (MESO) - 2019 Q2 - Earnings Call Presentation
2019-02-21 03:44
Operational Highlights and Financial Results for the Half Year Ended December 31, 2018 February 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's (MESO) CEO Silviu Itescu on First Half Year and Second Quarter Ended December 31, 2018 - Earnings Call Transcript
2019-02-21 03:38
Company and Industry Highlights * **Company**: Mesoblast (NASDAQ: MESO) * **Industry**: Biotechnology, Cell Therapy * **Date**: February 20, 2019 Key Points: **1. Pipeline and Clinical Trials**: * **Remestemcel-L**: Phase 3 trial for steroid-refractory acute graft-versus-host disease (GVHD) completed, BLA submission expected in early 2019. * **Revascor**: Phase 3 trial for advanced heart failure completed enrollment, expected to complete within 12 months. * **MPC-06-ID**: Phase 3 trial for chronic low back pain due to disc degeneration completed enrollment, 12-month assessment for safety and efficacy expected in first half of 2019. **2. Financial Highlights**: * **Cash Position**: $92 million pro forma cash on hand as of December 31, 2018. * **Revenue**: $13.5 million for six months ended December 31, 2018. * **Milestone Payments**: Significant increase in milestone payments from licensees Takeda and Tasly. **3. Partnerships and Collaborations**: * **Tasly**: Cardiovascular partnership established, upfront payment of $40 million received. * **JCR Pharma**: Licensee for TEMCELL in Japan. * **Takeda**: Licensee for Alofisel in Europe. **4. Regulatory Updates**: * **Remestemcel-L**: Scheduled meeting with FDA in April 2019 for BLA filing. * **Revascor**: Partner Tasly plans to meet with National Medical Products Administration of China in first half of 2019. * **MPC-06-ID**: No specific regulatory updates mentioned. **5. Future Outlook**: * Company expects to achieve several key milestones in 2019, including BLA submission for Remestemcel-L and completion of Phase 3 trials for Revascor and MPC-06-ID. * Company aims to expand its commercial presence and explore additional licensing opportunities. Additional Important Points: * **Rheumatoid Arthritis Program**: Company plans to update on further data readout and explore partnership opportunities. * **Sales Force**: Company building a focused U.S. sales force for Remestemcel-L launch. * **Regenerative Medicine Advanced Therapy (RMAT) Designation**: Received RMAT designation from FDA for Revascor for reduction of gastrointestinal bleeding in patients with LVADs.