Full Press Release Details
MESOBLAST FINANICAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2019
Continued Increase in Revenues and Strong Balance Sheet
Melbourne, Australia, November 26, 2019 and New York, USA, November 25, 2019: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today reported operational highlights and financial results for the first quarter ended September 30, 2019.
Mesoblast Chief Executive Dr Silviu Itescu stated: "The Company's financial results for the quarter reflect continued growth in revenues from product sales in Japan and ongoing strategic partnering activities, and a reduction in R&D expenditures. Our balance sheet positions us well as we prepare for first product approval and launch in the United States market."
Financial Highlights for the First Quarter FY2020
Operational Highlights for the First Quarter FY2020
Remestemcel-L for aGVHD
Revascor for advanced and end-stage heart failure
MPC-06-ID for chronic low back pain
Strategic partnerships
Financial Results for the Three Months Ended September 30, 2019 (first quarter FY2020)
Loss after tax reduced by US$14.0 million to US$5.5 million for the first quarter FY2020 compared to US$19.5 million for the first quarter FY2019 as detailed below:
The net loss attributable to ordinary shareholders was 1.10 cents per share for the first quarter FY2020, compared with 4.07 cents for the first quarter FY2019.
Cash on hand was US$34.5 million at September 30, 2019, pro forma cash on hand was US$100.0 million after adjusting for US$15.0 million upfront received on October 1, 2019 from Gr nenthal GmbH and US$50.5 million of gross cash proceeds from the capital raise on October 3, 2019.
There will be a webcast today on the financial results beginning at 8.30am on Tuesday November 26, 2019 AEDT; 4.30pm Monday November 25, 2019 EST.
The live webcast can be accessed via https://webcasting.boardroom.media/broadcast/5dcdf529dbec873524b6116b
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. Mesoblast does not make any representation or give any assurance that such partnering transactions will be concluded
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) 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
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.
For further information, please contact:
| Julie Meldrum | Schond Greenway |
| Corporate Communications | Investor Relations |
| Mesoblast | Mesoblast |
| T: +61 3 9639 6036 | T: +1 212 880 2060 |
| E: julie.meldrum@mesoblast.com | E: schond.greenway@mesoblast.com |
Consolidated Income Statement
| Three Months Ended September 30, | |||||||||
| (in U.S. dollars, in thousands, except per share amount) | 2019 | 2018 | |||||||
| Revenue | 17,048 | 11,637 | |||||||
| Research & development | (12,389 | ) | (18,489 | ) | |||||
| Manufacturing commercialization | (2,698 | ) | (4,317 | ) | |||||
| Management and administration | (5,463 | ) | (5,614 | ) | |||||
| Fair value remeasurement of contingent consideration | (288 | ) | (622 | ) | |||||
| Other operating income and expenses | (169 | ) | (151 | ) | |||||
| Finance costs | (3,457 | ) | (2,653 | ) | |||||
| Loss before income tax | (7,416 | ) | (20,209 | ) | |||||
| Income tax benefit | 1,932 | 711 | |||||||
| Loss attributable to the owners of Mesoblast Limited | (5,484 | ) | (19,498 | ) | |||||
| Losses per share from continuing operations attributable to the ordinary equity holders of the Group: | Cents | Cents | |||||||
| Basic - losses per share | (1.10 | ) | (4.07 | ) | |||||
| Diluted - losses per share | (1.10 | ) | (4.07 | ) |
Consolidated Statement of Comprehensive Income
| Three Months Ended September 30, | |||||||||
| (in U.S. dollars, in thousands) | 2019 | 2018 | |||||||
| Loss for the period | (5,484 | ) | (19,498 | ) | |||||
| Other comprehensive (loss)/income | |||||||||
| Items that may be reclassified to profit and loss | |||||||||
| Financial assets at fair value through other comprehensive income | (365 | ) | 87 | ||||||
| Exchange differences on translation of foreign operations | (332 | ) | (23 | ) | |||||
| Other comprehensive income/(loss) for the period, net of tax | (697 | ) | 64 | ||||||
| Total comprehensive losses attributable to the owners of Mesoblast Limited | (6,181 | ) | (19,434 | ) |
Consolidated Balance Sheet
| (in U.S. dollars, in thousands) | As of September 30, 2019 | As of June 30, 2019 | |||||||
| Assets | |||||||||
| Current Assets | |||||||||
| Cash & cash equivalents | 34,536 | 50,426 | |||||||
| Trade & other receivables | 17,857 | 4,060 | |||||||
| Prepayments | 8,200 | 8,036 | |||||||
| Total Current Assets | 60,593 | 62,522 | |||||||
| Non-Current Assets | |||||||||
| Property, plant and equipment | 978 | 826 | |||||||
| Right-of-use assets | 4,233 | - | |||||||
| Financial assets at fair value through other comprehensive income | 1,952 | 2,317 | |||||||
| Other non-current assets | 3,299 | 3,324 | |||||||
| Intangible assets | 582,731 | 583,126 | |||||||
| Total Non-Current Assets | 593,193 | 589,593 | |||||||
| Total Assets | 653,786 | 652,115 | |||||||
| Liabilities | |||||||||
| Current Liabilities | |||||||||
| Trade and other payables | 12,740 | 13,060 | |||||||
| Provisions | 26,977 | 7,264 | |||||||
| Borrowings | 18,851 | 14,007 | |||||||
| Lease liabilities | 1,524 | - | |||||||
| Deferred consideration | 10,000 | 10,000 | |||||||
| Total Current Liabilities | 70,092 | 44,331 | |||||||
| Non-Current Liabilities | |||||||||
| Deferred tax liability | 9,195 | 11,124 | |||||||
| Provisions | 30,555 | 48,329 | |||||||
| Borrowings | 64,881 | 67,279 | |||||||
| Lease liabilities | 3,916 | - | |||||||
| Total Non-Current Liabilities | 108,547 | 126,732 | |||||||
| Total Liabilities | 178,639 | 171,063 | |||||||
| Net Assets | 475,147 | 481,052 | |||||||
| Equity | |||||||||
| Issued Capital | 910,942 | 910,405 | |||||||
| Reserves | 40,507 | 40,638 | |||||||
| (Accumulated losses)/retained earnings | (476,302 | ) | (469,991 | ) | |||||
| Total Equity | 475,147 | 481,052 |
Consolidated Statement of Cash Flows
| Three months ended September 30, | |||||||||
| (in U.S. dollars, in thousands) | 2019 | 2018 | |||||||
| Cash flows from operating activities | |||||||||
| Commercialization revenue received | 1,739 | 1,095 | |||||||
| Milestone payment received | - | 500 | |||||||
| Research and development tax incentive received | 1,499 | 1,654 | |||||||
| Payments to suppliers and employees (inclusive of goods and services tax) | (17,539 | ) | (22,039 | ) | |||||
| Interest received | 173 | 136 | |||||||
| Interest and other costs of finance paid | (1,427 | ) | (887 | ) | |||||
| Income taxes (paid)/refunded | (3 | ) | (3 | ) | |||||
| Net cash (outflows) in operating activities | (15,558 | ) | (19,544 | ) | |||||
| Cash flows from investing activities | |||||||||
| Investment in fixed assets | (153 | ) | (39 | ) | |||||
| Payments for licenses | (100 | ) | - | ||||||
| Net cash (outflows)/inflows in investing activities | (253 | ) | (39 | ) | |||||
| Cash flows from financing activities | |||||||||
| Proceeds from borrowings | - | 28,950 | |||||||
| Payments of transaction costs from borrowings | - | (1,534 | ) | ||||||
| Proceeds from issue of shares | 299 | 10,048 | |||||||
| Payments for share issue costs | - | (358 | ) | ||||||
| Payment of lease liabilities | (335 | ) | - | ||||||
| Net cash inflows by financing activities | (36 | ) | 37,106 | ||||||
| Net increase/(decrease) in cash and cash equivalents | (15,847 | ) | 17,523 | ||||||
| Cash and cash equivalents at beginning of period | 50,426 | 37,763 | |||||||
| FX (losses)/gains on the translation of foreign bank accounts | (43 | ) | (143 | ) | |||||
| Cash and cash equivalents at end of period | 34,536 | 55,143 |