Full Press Release Details
MESOBLAST REPORTS FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
FOR THE PERIOD ENDED MARCH 31, 2019
Major corporate milestone achieved in initiating BLA filing with FDA for Mesoblast's cell therapy in the treatment of acute graft versus host disease
Melbourne, Australia, May 31, 2019 and New York, USA, May 30, 2019: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today reported its financial results and operational highlights for the nine months ended March 31, 2019. Financial results for the period are in line with expectations including the Company's cash position at March 31, 2019 of US$70.4 million (A$99.3 million).
Mesoblast Chief Executive Dr Silviu Itescu stated: "We achieved a significant corporate milestone by initiating our first BLA submission to the FDA. We will focus our efforts on launch activities in preparation for our first product roll-out in the United States, and on our supply chain to meet the projected market demand for this and our follow-on products."
Recent Corporate Highlights
Key Financial Highlights for the Nine Months of FY2019:
Key milestones anticipated for CY2019 include:
Detailed Financial Results for the Nine Months Ended March 31, 2019 (nine months of FY2019):
Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, such as income tax benefits, fair value remeasurement of contingent consideration, remeasurement of borrowing arrangements and foreign exchange movements within other operating income and expenses.
In the nine months of FY2019, the net loss attributable to ordinary shareholders was 14.02 cents per share for the nine months of FY2019, compared with a loss per share of 3.12 cents for the nine months of FY2018. There was
an after tax loss of US$69.1 million compared to $14.5 million for the nine months of FY2018. The increase in the loss is primarily due to commercial manufacturing investment of US$9.5 million to support potential launch for aGVHD product, and an increase of US$7.5 million in finance costs. In the comparative period of FY2018, the Company recognized a one-off non-cash income tax benefit of US$23.0 million due to a revaluation of tax liabilities given changes in tax rates and a non-cash US$7.9 million gain on remeasurement of contingent consideration for reduction of future payments to third parties.
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 6.30pm on Thursday May 30, 2019 EDT; 8:30am on Friday May 31, 2019 AEST.
The live webcast can be accessed via
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 10000574.
The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com
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 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 March 31, | Nine Months Ended March 31, | ||||||||||||||||
| (in U.S. dollars, in thousands, except per share amount) | Note | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | 3 | 1,249 | 1,070 | 14,755 | 15,641 | ||||||||||||
| Research & development | (14,407 | ) | (16,798 | ) | (48,380 | ) | (48,388 | ) | |||||||||
| Manufacturing commercialization | (3,193 | ) | (1,709 | ) | (12,910 | ) | (3,387 | ) | |||||||||
| Management and administration | (5,256 | ) | (6,033 | ) | (15,998 | ) | (16,688 | ) | |||||||||
| Fair value remeasurement of contingent consideration | 3 | (2,718 | ) | (822 | ) | (3,352 | ) | 7,880 | |||||||||
| Other operating income and expenses | 3 | (82 | ) | 152 | (1,060 | ) | 1,243 | ||||||||||
| Finance costs | 3 | (2,768 | ) | (423 | ) | (7,906 | ) | (423 | ) | ||||||||
| Loss before income tax | 3 | (27,175 | ) | (24,563 | ) | (74,851 | ) | (44,122 | ) | ||||||||
| Income tax benefit | 4 | 2,205 | 3,426 | 5,778 | 29,666 | ||||||||||||
| Loss attributable to the owners of Mesoblast Limited | (24,970 | ) | (21,137 | ) | (69,073 | ) | (14,456 | ) | |||||||||
| Losses per share from continuing operations attributable to the ordinary equity holders of the Group: | Cents | Cents | Cents | Cents | |||||||||||||
| Basic - losses per share | 10 | (5.00 | ) | (4.47 | ) | (14.02 | ) | (3.12 | ) | ||||||||
| Diluted - losses per share | 10 | (5.00 | ) | (4.47 | ) | (14.02 | ) | (3.12 | ) |
Consolidated Statement of Comprehensive Income
| Three Months Ended March 31, | Nine Months Ended March 31, | ||||||||||||||||
| (in U.S. dollars, in thousands) | Note | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Loss for the period | (24,970 | ) | (21,137 | ) | (69,073 | ) | (14,456 | ) | |||||||||
| Other comprehensive (loss)/income | |||||||||||||||||
| Items that may be reclassified to profit and loss | |||||||||||||||||
| Changes in the fair value of financial assets | 85 | 74 | 280 | 141 | |||||||||||||
| Exchange differences on translation of foreign operations | 79 | (69 | ) | (104 | ) | (569 | ) | ||||||||||
| Other comprehensive (loss)/income for the period, net of tax | 164 | 5 | 176 | (428 | ) | ||||||||||||
| Total comprehensive losses attributable to the owners of Mesoblast Limited | (24,806 | ) | (21,132 | ) | (68,897 | ) | (14,884 | ) |
Consolidated Statement of Balance Sheet
| (in U.S. dollars, in thousands) | Note | As of March 31, 2019 | As of June 30, 2018 | |||||||
| Assets | ||||||||||
| Current Assets | ||||||||||
| Cash & cash equivalents | 5(a) | 70,385 | 37,763 | |||||||
| Trade & other receivables | 5(b) | 3,508 | 50,366 | |||||||
| Prepayments | 5(b) | 11,634 | 12,942 | |||||||
| Total Current Assets | 85,527 | 101,071 | ||||||||
| Non-Current Assets | ||||||||||
| Property, plant and equipment | 825 | 1,084 | ||||||||
| Financial assets at fair value through other comprehensive income | 2,601 | 2,321 | ||||||||
| Other non-current assets | 3,331 | 3,361 | ||||||||
| Intangible assets | 6(a) | 583,421 | 584,606 | |||||||
| Total Non-Current Assets | 590,178 | 591,372 | ||||||||
| Total Assets | 675,705 | 692,443 | ||||||||
| Liabilities | ||||||||||
| Current Liabilities | ||||||||||
| Trade and other payables | 5(c) | 18,551 | 18,921 | |||||||
| Provisions | 6,592 | 5,082 | ||||||||
| Borrowings | 5(d) | 9,359 | - | |||||||
| Deferred consideration | 6(c) | 10,000 | - | |||||||
| Total Current Liabilities | 44,502 | 24,003 | ||||||||
| Non-Current Liabilities | ||||||||||
| Deferred tax liability | 6(b) | 14,301 | 20,079 | |||||||
| Provisions | 45,742 | 42,956 | ||||||||
| Borrowings | 5(d) | 70,218 | 59,397 | |||||||
| Total Non-Current Liabilities | 130,261 | 122,432 | ||||||||
| Total Liabilities | 174,763 | 146,435 | ||||||||
| Net Assets | 500,942 | 546,008 | ||||||||
| Equity | ||||||||||
| Issued Capital | 8 | 910,405 | 889,481 | |||||||
| Reserves | 39,802 | 36,719 | ||||||||
| (Accumulated losses)/retained earnings | (449,265 | ) | (380,192 | ) | ||||||
| Total Equity | 500,942 | 546,008 |
Consolidated Statement of Cash Flows
| Nine months ended March 31, | ||||||||||
| (in U.S. dollars, in thousands) | Note | 2019 | 2018 | |||||||
| Cash flows from operating activities | ||||||||||
| Commercialization revenue received | 3,321 | 2,529 | ||||||||
| Milestone payment received | 26,409 | 6,125 | ||||||||
| Research and development tax incentive received | 1,654 | - | ||||||||
| Payments to suppliers and employees (inclusive of goods and services tax) | (67,672 | ) | (63,719 | ) | ||||||
| Interest received | 493 | 266 | ||||||||
| Interest paid | (2,906 | ) | - | |||||||
| Income taxes (paid) | (3 | ) | (25 | ) | ||||||
| Net cash (outflows) in operating activities | 7(b) | (38,704 | ) | (54,824 | ) | |||||
| Cash flows from investing activities | ||||||||||
| Investment in fixed assets | (202 | ) | (174 | ) | ||||||
| Payments for contingent consideration | - | (543 | ) | |||||||
| Net cash (outflows) in investing activities | (202 | ) | (717 | ) | ||||||
| Cash flows from financing activities | ||||||||||
| Proceeds from borrowings | 43,572 | 31,704 | ||||||||
| Payments of transaction costs from borrowings | (1,582 | ) | (40 | ) | ||||||
| Proceeds from issue of shares | 30,258 | 40,566 | ||||||||
| Payments for share issue costs | (607 | ) | (2,604 | ) | ||||||
| Net cash inflows by financing activities | 71,641 | 69,626 | ||||||||
| Net increase in cash and cash equivalents | 32,735 | 14,085 | ||||||||
| Cash and cash equivalents at beginning of period | 37,763 | 45,761 | ||||||||
| FX (losses) on the translation of foreign bank accounts | (113 | ) | (307 | ) | ||||||
| Cash and cash equivalents at end of period | 7(a) | 70,385 | 59,539 |