Full Press Release Details
MESOBLAST REPORTS STRONG FINANCIAL POSITION AND SUBSTANTIAL OPERATIONAL PROGRESS FOR THE PERIOD ENDED MARCH 31, 2020
Melbourne, Australia, May 28, 2020 and New York, USA, May 27, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial, corporate and operational highlights for the nine months ended March 31, 2020. Cash on hand at March 31, 2020 was US$60.1 million (A$97.3 million) and in May 2020, pro forma cash on hand was approximately US$150 million (A$235 million) after adjusting for a US$90 million (A$138 million) capital raise.
Mesoblast Chief Executive Dr Silviu Itescu stated: "This past quarter has underscored the value of our lead product candidate remestemcel-L and the experience we have gained in its use over recent years in patients with severe cytokine release syndromes.
"Our Biologics License Application for marketing approval of RYONCILTM (remestemcel-L) in children with steroid-refractory acute graft versus host disease is currently under priority review by the United States Food and Drug Administration (FDA), and we hope to be able to make the product available to patients suffering with this life-threatening inflammatory condition during 2020. We are also proud to be developing remestemcel-L as a potential very important therapy in the battle against COVID-19. A Phase 3 randomized controlled trial in the United States is underway to confirm the remarkable pilot data from compassionate use of remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS), and to definitively determine whether this product candidate can contribute meaningfully to this urgent, unmet medical need."
Financial Highlights for the Nine Months of FY2020 Compared with the Nine Months of FY2019:
Operational and Corporate Highlights for the Nine Months of FY2020:
Major Operational Milestones for the Next 12 Months
Remestemcel-L for SR-aGVHD and Other Inflammatory Diseases
Remestemcel-L for Acute Respiratory Distress Syndrome (ARDS) in COVID-19
REVASCOR for Advanced and End-Stage Heart Failure
MPC-06-ID for Chronic Low Back Pain
Lead Program Updates
RYONCIL (remestemcel-L) for Steroid-refractory Acute GVHD in Children
Remestemcel-L for COVID-19 ARDS
REVASCOR for Advanced and End-stage Heart Failure
MPC-06-ID for Chronic Low Back Pain
Financial Results for the Nine Months Ended March 31, 2020 (nine months of FY2020):
Loss after tax reduced by US$23.7 million to US$45.3 million for the nine months of FY2020 compared to US$69.1 million for the nine months of FY2019 as detailed below:
Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, including fair value remeasurement of contingent consideration for which we recognized a gain on remeasurement of US$1.3 million in the nine months of FY2020 compared to a loss of US$3.4 million in the nine months of FY2019 due to the revaluation of contingent consideration in each relevant period.
The net loss attributable to ordinary shareholders was 8.66 US cents per share for the nine months of FY2020, compared with 14.02 US cents per share for the nine months of FY2019.
Financial Results for the Three Months Ended March 31, 2020 (third quarter FY2020):
Loss after tax reduced by US$9.7 million to US$15.3 million for the third quarter FY2020 compared to US$25.0 million for the third quarter FY2019 as detailed below:
Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, including fair value remeasurement of contingent consideration for which we recognized a gain on remeasurement of US$2.2 million in the third quarter FY2020 compared to a loss of US$2.7 million in the third quarter FY2019 due to the revaluation of contingent consideration in each relevant period.
The net loss attributable to ordinary shareholders was 2.84 US cents per share for the third quarter FY2020, compared with 5.00 US cents per share for the third quarter FY2019.
There will be a webcast today on the financial results beginning at 8am, Thursday May 28 AEST and 6pm, Wednesday, May 27, 2020 EDT.
The live webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200526/NaNmesoblast-q3-financial-results
To access the call only, dial 1 855 881 1339 (US), 1800 870 643 or 1800 809 971 (Australia) or +61 2 9007 3187 (outside of the US and Australia). The conference identification code is 10007263.
The archived webcast will be available on the Investor page of the Company's website www.mesoblast.com
1. TEMCELL HS. Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.
2. United States Adopted Name (USAN) assigned to Mesoblast's ex vivo cultured allogeneic human mesenchymal stem cells.
3. RYONCIL has been accepted by the FDA as the brand name for Mesoblast's remestemcel-L product.
4. Mesoblast does not make any representation or give any assurance that such partnering transactions will be concluded.
5. Petrilli CM et al. Factors associated with hospitalization and critical illness among 4,103 patients with Covid-19 disease in New York City. MedRxiv 2020 doi. https://www.medrxiv.org/content/10.1101/2020.04.08.20057794v1.full.pdf
6. Richardson S et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA 2020. doi:10.1001/jama.2020.6775.
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast's Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast's licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.
Mesoblast has locations in Australia, the United States and Singapore 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
Forward-Looking Statements
This announcement 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 expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive, as approved by the Board of Directors.
For further information, please contact:
| Media Julie Meldrum T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com | Kristen Bothwell T: +1 917 613 5434 E: kbothwell@rubenstein.com |
| Investors Schond Greenway T: +212 880 2060 E: schond.greenway@mesoblast.com | Paul Hughes T: +61 3 9639 6036 E: paul.hughes@mesoblast.com |
Consolidated Income Statement
| Three Months Ended March 31, | Nine Months Ended March 31, | ||||||||||||||||
| (in U.S. dollars, in thousands, except per share amount) | 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue | 12,201 | 1,249 | 31,455 | 14,755 | |||||||||||||
| Research & development | (14,379 | ) | (14,407 | ) | (40,922 | ) | (48,380 | ) | |||||||||
| Manufacturing commercialization | (7,612 | ) | (3,193 | ) | (15,456 | ) | (12,910 | ) | |||||||||
| Management and administration | (5,730 | ) | (5,256 | ) | (17,960 | ) | (15,998 | ) | |||||||||
| Fair value remeasurement of contingent consideration | 2,158 | (2,718 | ) | 1,276 | (3,352 | ) | |||||||||||
| Other operating income and expenses | (442 | ) | (82 | ) | (28 | ) | (1,060 | ) | |||||||||
| Finance costs | (3,414 | ) | (2,768 | ) | (9,853 | ) | (7,906 | ) | |||||||||
| Loss before income tax | (17,218 | ) | (27,175 | ) | (51,488 | ) | (74,851 | ) | |||||||||
| Income tax benefit | 1,955 | 2,205 | 6,158 | 5,778 | |||||||||||||
| Loss attributable to the owners of Mesoblast Limited | (15,263 | ) | (24,970 | ) | (45,330 | ) | (69,073 | ) | |||||||||
| Losses per share from continuing operations attributable to the ordinary equity holders of the Group: | Cents | Cents | Cents | Cents | |||||||||||||
| Basic - losses per share | (2.84 | ) | (5.00 | ) | (8.66 | ) | (14.02 | ) | |||||||||
| Diluted - losses per share | (2.84 | ) | (5.00 | ) | (8.66 | ) | (14.02 | ) |
Consolidated Statement of Comprehensive Income
| Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||||
| (in U.S. dollars, in thousands) | 2020 | 2019 | 2020 | 2019 | ||||||||||||||
| Loss for the period | (15,263 | ) | (24,970 | ) | (45,330 | ) | (69,073 | ) | ||||||||||
| Other comprehensive (loss)/income | ||||||||||||||||||
| Items that may be reclassified to profit and loss | ||||||||||||||||||
| Financial assets at fair value through other comprehensive income | 94 | 85 | (551 | ) | 280 | |||||||||||||
| Exchange differences on translation of foreign operations | (361 | ) | 79 | (405 | ) | (104 | ) | |||||||||||
| Other comprehensive income/(loss) for the period, net of tax | (267 | ) | 164 | (956 | ) | 176 | ||||||||||||
| Total comprehensive losses attributable to the owners of Mesoblast Limited | (15,530 | ) | (24,806 | ) | (46,286 | ) | (68,897 | ) |
Consolidated Balance Sheet
| (in U.S. dollars, in thousands) | As of March 31, 2020 | As of June 30, 2019 | |||||||
| Assets | |||||||||
| Current Assets | |||||||||
| Cash & cash equivalents | 60,077 | 50,426 | |||||||
| Trade & other receivables | 3,001 | 4,060 | |||||||
| Prepayments | 6,315 | 8,036 | |||||||
| Total Current Assets | 69,393 | 62,522 | |||||||
| Non-Current Assets | |||||||||
| Property, plant and equipment | 1,965 | 826 | |||||||
| Right-of-use assets | 7,479 | - | |||||||
| Financial assets at fair value through other comprehensive income | 1,766 | 2,317 | |||||||
| Other non-current assets | 3,244 | 3,324 | |||||||
| Intangible assets | 581,943 | 583,126 | |||||||
| Total Non-Current Assets | 596,397 | 589,593 | |||||||
| Total Assets | 665,790 | 652,115 | |||||||
| Liabilities | |||||||||
| Current Liabilities | |||||||||
| Trade and other payables | 19,478 | 13,060 | |||||||
| Provisions | 27,152 | 7,264 | |||||||
| Borrowings | 27,000 | 14,007 | |||||||
| Lease liabilities | 3,059 | - | |||||||
| Deferred consideration | - | 10,000 | |||||||
| Total Current Liabilities | 76,689 | 44,331 | |||||||
| Non-Current Liabilities | |||||||||
| Deferred tax liability | 4,966 | 11,124 | |||||||
| Provisions | 28,109 | 48,329 | |||||||
| Borrowings | 59,951 | 67,279 | |||||||
| Lease liabilities | 5,762 | - | |||||||
| Deferred consideration | 2,500 | - | |||||||
| Total Non-Current Liabilities | 101,288 | 126,732 | |||||||
| Total Liabilities | 177,977 | 171,063 | |||||||
| Net Assets | 487,813 | 481,052 | |||||||
| Equity | |||||||||
| Issued Capital | 960,447 | 910,405 | |||||||
| Reserves | 43,514 | 40,638 | |||||||
| (Accumulated losses)/retained earnings | (516,148 | ) | (469,991 | ) | |||||
| Total Equity | 487,813 | 481,052 |
Consolidated Statement of Cash Flows
| Nine Months Ended March 31, | |||||||||
| (in U.S. dollars, in thousands) | 2020 | 2019 | |||||||
| Cash flows from operating activities | |||||||||
| Commercialization revenue received | 5,579 | 3,321 | |||||||
| Upfront and milestone payments received | 17,500 | 26,409 | |||||||
| Research and development tax incentive received | 1,499 | 1,654 | |||||||
| Payments to suppliers and employees (inclusive of goods and services tax) | (57,722 | ) | (67,672 | ) | |||||
| Interest received | 533 | 493 | |||||||
| Interest and other costs of finance paid | (4,165 | ) | (2,906 | ) | |||||
| Income taxes (paid)/refunded | (7 | ) | (3 | ) | |||||
| Net cash (outflows) in operating activities | (36,783 | ) | (38,704 | ) | |||||
| Cash flows from investing activities | |||||||||
| Investment in fixed assets | (1,305 | ) | (202 | ) | |||||
| Payments for licenses | (100 | ) | - | ||||||
| Net cash (outflows) in investing activities | (1,405 | ) | (202 | ) | |||||
| Cash flows from financing activities | |||||||||
| Proceeds from borrowings | - | 43,572 | |||||||
| Payments of transaction costs from borrowings | - | (1,582 | ) | ||||||
| Proceeds from issue of shares | 51,559 | 30,258 | |||||||
| Payments for share issue costs | (2,211 | ) | (607 | ) | |||||
| Payment of lease liabilities | (1,219 | ) | - | ||||||
| Net cash inflows by financing activities | 48,129 | 71,641 | |||||||
| Net increase in cash and cash equivalents | 9,941 | 32,735 | |||||||
| Cash and cash equivalents at beginning of period | 50,426 | 37,763 | |||||||
| FX gains/(losses) on the translation of foreign bank accounts | (290 | ) | (113 | ) | |||||
| Cash and cash equivalents at end of period | 60,077 | 70,385 |