MELBOURNE, Australia and NEW YORK, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today reported strong financial results and provided operational highlights for the first quarter ended September 30, 2018.
Key financial results for the three months ended September 30, 2018 (first quarter FY2019)
Corporate Highlights
Operational Highlights and Anticipated Upcoming Milestones
MPC-150-IM for Moderate to Advanced Heart Failure:
MSC-100-IV (remestemcel-L) for pediatric steroid-refractory acute Graft Versus Host Disease (aGVHD):
MPC-06-ID for Chronic Low Back Pain:
Financial Results for the Three Months Ended September 30, 2018 (first quarter FY2019) (in U.S. Dollars)
Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, such as: fair value remeasurement of contingent consideration, and foreign exchange movements within other operating income and expenses.
A non-cash income tax benefit of US$0.7 million was recognized in the first quarter FY2019 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period. On December 22, 2017, the United States signed into law the Tax Cuts and Jobs Act (the Tax Act), which changed many aspects of United States corporate income taxation, including a reduction in the corporate income tax rate from 35% to 21%. In the first quarter FY2018 deferred tax assets in the United States were recognized at 35% compared with 21% in the first quarter FY2019.
A non-cash income tax benefit of US$2.9 million was recognized in first quarter FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period.
The net loss attributable to ordinary shareholders was US$19.5 million, or 4.07 cents loss per share, for the first quarter FY2019, compared with US$7.0 million, or 1.58 cents loss per share, for the first quarter FY2018.
1TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.
Conference Call Details
There will be a webcast today on the financial results beginning at 4.30pm on Thursday, November 15, 2018 EST; 8:30 am on Friday, November 16, 2018 AEDT.
The live webcast can be accessed via
http://webcasting.boardroom.media/broadcast/5bcfb51cf6a4f554d0fe76af
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 667811.
The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com
About Mesoblast
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates with three product candidates in Phase 3 trials – acute graft versus host disease, chronic heart failure and chronic low back pain due to degenerative disc disease. Through a proprietary process, Mesoblast selects rare mesenchymal lineage precursor and stem cells from the bone marrow of healthy adults and creates master cell banks, which can be industrially expanded to produce thousands of doses from each donor that meet stringent release criteria, have lot to lot consistency, and can be used off-the-shelf without the need for tissue matching. Mesoblast has facilities in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). www.mesoblast.com
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 timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; 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) | 2018 | 2017 | |||||||
Revenue | 11,637 | 1,174 | |||||||
Research & development | (18,489 | ) | (15,368 | ) | |||||
Manufacturing commercialization | (4,317 | ) | (877 | ) | |||||
Management and administration | (5,614 | ) | (5,012 | ) | |||||
Fair value remeasurement of contingent consideration | (622 | ) | 9,495 | ||||||
Other operating income and expenses | (151 | ) | 668 | ||||||
Finance costs | (2,653 | ) | — | ||||||
Loss before income tax | (20,209 | ) | (9,920 | ) | |||||
Income tax benefit/(expense) | 711 | 2,898 | |||||||
Loss attributable to the owners of Mesoblast Limited | (19,498 | ) | (7,022 | ) | |||||
Losses per share from continuing operations attributable to the ordinary equity holders of the Group: | Cents | Cents | |||||||
Basic - losses per share | (4.07 | ) | (1.58 | ) | |||||
Diluted - losses per share | (4.07 | ) | (1.58 | ) | |||||
Consolidated Statement of Comprehensive Income | |||||||||
Three Months Ended September 30, | |||||||||
(in U.S. dollars, in thousands) | 2018 | 2017 | |||||||
Loss for the period | (19,498 | ) | (7,022 | ) | |||||
Other comprehensive (loss)/income | |||||||||
Items that may be reclassified to profit and loss | |||||||||
Changes in the fair value of available-for-sale financial assets | 87 | 20 | |||||||
Exchange differences on translation of foreign operations | (23 | ) | (358 | ) | |||||
Other comprehensive income/(loss) for the period, net of tax | 64 | (338 | ) | ||||||
Total comprehensive losses attributable to the owners of Mesoblast Limited | (19,434 | ) | (7,360 | ) | |||||
Consolidated Statement of Balance Sheet | |||||||||
(in U.S. dollars, in thousands) | As of September 30, 2018 | As of June 30, 2018 | |||||||
Assets | |||||||||
Current Assets | |||||||||
Cash & cash equivalents | 55,143 | 37,763 | |||||||
Trade & other receivables | 29,539 | 50,366 | |||||||
Prepayments | 13,129 | 12,942 | |||||||
Total Current Assets | 97,811 | 101,071 | |||||||
Non-Current Assets | |||||||||
Property, plant and equipment | 1,016 | 1,084 | |||||||
Available-for-sale financial assets | 2,408 | 2,321 | |||||||
Other non-current assets | 3,344 | 3,361 | |||||||
Intangible assets | 584,210 | 584,606 | |||||||
Total Non-Current Assets | 590,978 | 591,372 | |||||||
Total Assets | 688,789 | 692,443 | |||||||
Liabilities | |||||||||
Current Liabilities | |||||||||
Trade and other payables | 19,292 | 18,921 | |||||||
Provisions | 8,101 | 5,082 | |||||||
Total Current Liabilities | 27,393 | 24,003 | |||||||
Non-Current Liabilities | |||||||||
Deferred tax liability | 19,368 | 20,079 | |||||||
Deferred consideration | 10,000 | — | |||||||
Provisions | 43,270 | 42,956 | |||||||
Borrowings | 61,159 | 59,397 | |||||||
Total Non-Current Liabilities | 133,797 | 122,432 | |||||||
Total Liabilities | 161,190 | 146,435 | |||||||
Net Assets | 527,599 | 546,008 | |||||||
Equity | |||||||||
Issued Capital | 889,980 | 889,481 | |||||||
Reserves | 37,309 | 36,719 | |||||||
(Accumulated losses)/retained earnings | (399,690 | ) | (380,192 | ) | |||||
Total Equity | 527,599 | 546,008 | |||||||
Consolidated Statement of Cash Flows | |||||||||
Three months ended September 30, | |||||||||
(in U.S. dollars, in thousands) | 2018 | 2017 | |||||||
Cash flows from operating activities | |||||||||
Commercialization revenue received | 1,095 | 474 | |||||||
Milestone payment received | 500 | — | |||||||
Research and development tax incentive received | 1,654 | — | |||||||
Payments to suppliers and employees (inclusive of goods and services tax) | (22,039 | ) | (20,892 | ) | |||||
Interest received | 136 | 63 | |||||||
Interest paid | (887 | ) | — | ||||||
Income taxes (paid)/refunded | (3 | ) | (1 | ) | |||||
Net cash (outflows) in operating activities | (19,544 | ) | (20,356 | ) | |||||
Cash flows from investing activities | |||||||||
Investment in fixed assets | (39 | ) | (83 | ) | |||||
Payments for contingent consideration | — | (543 | ) | ||||||
Net cash (outflows)/inflows in investing activities | (39 | ) | (626 | ) | |||||
Cash flows from financing activities | |||||||||
Proceeds from borrowings | 28,950 | — | |||||||
Payments of transaction costs from borrowings | (1,534 | ) | — | ||||||
Proceeds from issue of shares | 10,048 | 40,449 | |||||||
Payments for share issue costs | (358 | ) | (2,001 | ) | |||||
Net cash inflows by financing activities | 37,106 | 38,448 | |||||||
Net decrease in cash and cash equivalents | 17,523 | 17,466 | |||||||
Cash and cash equivalents at beginning of period | 37,763 | 45,761 | |||||||
FX (losses)/gains on the translation of foreign bank accounts | (143 | ) | (286 | ) | |||||
Cash and cash equivalents at end of period | 55,143 | 62,941 | |||||||