Full Press Release Details
MESOBLAST REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
Melbourne, Australia; August 30, 2018; and New York, USA, August 29, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today reported strong financial results and provided operational highlights for the fourth quarter and full-year ended June 30, 2018 (FY2018).
Key financial results for the 12 months ended June 30, 2018
Corporate highlights
Mesoblast entered into a strategic alliance with Tasly Pharmaceutical Group for the development, manufacture and commercialization of MPC-150-IM and MPC-25-IC in the treatment and prevention of chronic heart failure and heart attacks in China.
Mesoblast granted TiGenix NV (now fully owned by Takeda Pharmaceutical Co. Ltd) exclusive access to certain of its patents to support global commercialization of Alofisel in the local treatment of fistulae. This product is the first allogeneic mesenchymal stem cell therapy to receive approval from the European Commission. As consideration, Mesoblast will receive up to 20 million in payments, as well as single digit royalties on net sales.
Mesoblast accessed non-dilutive capital for commercialization of MSC-100-IV (remestemcel-L) through credit facilities with Hercules Capital and NovaQuest.
New non-executive Directors Joseph R. Swedish and Shawn Cline Tomasello joined the Board of Directors, bringing substantial commercial and transactional healthcare expertise.
Operational highlights and anticipated upcoming milestones
MSC-100-IV (remestemcel-L) for pediatric steroid-refractory acute Graft Versus Host Disease (SR-aGVHD):
MPC-150-IM for Advanced and End-Stage Heart Failure:
MPC-06-ID for Chronic Low Back Pain:
Financial Results for the Three Months Ended June 30, 2018 (fourth quarter) (in U.S. Dollars)
Loss after tax was significantly reduced by US$6.3 million (23%) for the fourth quarter of FY2018, compared with the fourth quarter of FY2017 due to the items below:
The overall increase in loss after income tax also includes 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$1.0 million was recognized in the fourth quarter of FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, compared to US$4.1 million in the fourth quarter of FY2017.
The net loss attributable to ordinary shareholders was US$20.8 million, or 4.39 cents loss per share, for the fourth quarter of FY2018, compared with US$27.2 million, or 6.34 cents loss per share, for the fourth quarter of FY2017.
At June 30, 2018, the Company had cash reserves of US$37.8 million. As of June 30, 2018, the Company recognized funds receivable from debt financing and unissued capital of US$39.0 million pursuant to a financing facility with NovaQuest. On July 10, 2018 the net proceeds from the financing facility of US$39.0 million were received and recognized in cash reserves. The Company will also receive US$40.0 million from Tasly on closing of the strategic alliance that the two companies announced in July 2018 for cardiovascular therapies in China. This transaction has been approved by the Tianjin Bureau of Ministry of Commerce and the Tianjin Bureau of National Development Reform Commission, and is subject to filing with the State Administration of Foreign Exchange.
Mesoblast retains an equity facility for up to A$120 million/US$90 million, to be used at its discretion over the next 12 months to provide additional funds as required.
Financial Results for the Year Ended June 30, 2018 (in U.S. Dollars)
Loss after tax was significantly reduced by US$41.5 million (54%) for FY2018, compared with FY2017.
The main items which reduced loss after income tax were:
The overall decrease in loss after income tax also includes 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$30.7 million was recognized in FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, primarily due to a revaluation of our deferred tax assets and liabilities recognized as a result of changes in tax rates. 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%.
A non-cash income tax benefit of US$13.4 million was recognized in FY2017 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$35.3 million, or 7.58 cents loss per share, for FY2018, compared with US$76.8 million, or 19.25 cents loss per share, for FY2017.
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 6:00 pm EDT on Wednesday, August 29, 2018; 8:00 am Thursday, August 30, 2018 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 471961.
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 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
| (unaudited) | (audited) | |||||||||||||||
| Three Months Ended June 30, | Year Ended June 30, | |||||||||||||||
| (in U.S. dollars, in thousands, except per share amount) | 2018 | 2017 | 2018 | 2017 | ||||||||||||
| Revenue | 1,700 | 566 | 17,341 | 2,412 | ||||||||||||
| Research & development | (17,539 | ) | (15,939 | ) | (65,927 | ) | (58,914 | ) | ||||||||
| Manufacturing commercialization | (2,121 | ) | (1,150 | ) | (5,508 | ) | (12,065 | ) | ||||||||
| Management and administration | (5,219 | ) | (7,148 | ) | (21,907 | ) | (23,007 | ) | ||||||||
| Fair value remeasurement of contingent consideration | 2,661 | (7,908 | ) | 10,541 | (130 | ) | ||||||||||
| Other operating income and expenses | 69 | 321 | 1,312 | 1,489 | ||||||||||||
| Finance costs | (1,406 | ) | - | (1,829 | ) | - | ||||||||||
| Impairment of intangible assets | - | - | - | - | ||||||||||||
| Loss before income tax | (21,855 | ) | (31,258 | ) | (65,977 | ) | (90,215 | ) | ||||||||
| Income tax benefit/(expense) | 1,021 | 4,076 | 30,687 | 13,400 | ||||||||||||
| Loss attributable to the owners of Mesoblast Limited | (20,834 | ) | (27,182 | ) | (35,290 | ) | (76,815 | ) | ||||||||
| Losses per share from continuing operations attributable to the ordinary equity holders of the Group: | Cents | Cents | Cents | Cents | ||||||||||||
| Basic - losses per share | (4.39 | ) | (6.34 | ) | (7.58 | ) | (19.25 | ) | ||||||||
| Diluted - losses per share | (4.39 | ) | (6.34 | ) | (7.58 | ) | (19.25 | ) |
Consolidated Statement of Comprehensive Income
| (unaudited) | (audited) | |||||||||||||||
| Three Months Ended June 30, | Year Ended June 30, | |||||||||||||||
| (in U.S. dollars, in thousands) | 2018 | 2017 | 2018 | 2017 | ||||||||||||
| Loss for the year | (20,834 | ) | (27,182 | ) | (35,290 | ) | (76,815 | ) | ||||||||
| Other comprehensive (loss)/income | ||||||||||||||||
| Items that may be reclassified to profit and loss | ||||||||||||||||
| Changes in the fair value of available-for-sale financial assets | 183 | 86 | 324 | 31 | ||||||||||||
| Exchange differences on translation of foreign operations | (334 | ) | (52 | ) | (903 | ) | 316 | |||||||||
| Other comprehensive (loss)/income for the period, net of tax | (151 | ) | 34 | (579 | ) | 347 | ||||||||||
| Total comprehensive losses attributable to the owners of Mesoblast Limited | (20,985 | ) | (27,148 | ) | (35,869 | ) | (76,468 | ) |
Consolidated Statement of Balance Sheet
| As of June 30, | ||||||||
| (in U.S. dollars, in thousands) | 2018 | 2017 | ||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash & cash equivalents | 37,763 | 45,761 | ||||||
| Trade & other receivables | 50,366 | 3,743 | ||||||
| Prepayments | 12,942 | 14,105 | ||||||
| Total Current Assets | 101,071 | 63,609 | ||||||
| Non-Current Assets | ||||||||
| Property, plant and equipment | 1,084 | 1,814 | ||||||
| Available-for-sale financial assets | 2,321 | 1,997 | ||||||
| Other non-current assets | 3,361 | 1,916 | ||||||
| Intangible assets | 584,606 | 586,350 | ||||||
| Total Non-Current Assets | 591,372 | 592,077 | ||||||
| Total Assets | 692,443 | 655,686 | ||||||
| Liabilities | ||||||||
| Current Liabilities | ||||||||
| Trade and other payables | 18,921 | 21,805 | ||||||
| Provisions | 5,082 | 14,865 | ||||||
| Total Current Liabilities | 24,003 | 36,670 | ||||||
| Non-Current Liabilities | ||||||||
| Deferred tax liability | 20,079 | 49,293 | ||||||
| Provisions | 42,956 | 52,957 | ||||||
| Borrowings | 59,397 | - | ||||||
| Total Non-Current Liabilities | 122,432 | 102,250 | ||||||
| Total Liabilities | 146,435 | 138,920 | ||||||
| Net Assets | 546,008 | 516,766 | ||||||
| Equity | ||||||||
| Issued Capital | 889,481 | 830,425 | ||||||
| Reserves | 36,719 | 31,243 | ||||||
| (Accumulated losses)/retained earnings | (380,192 | ) | (344,902 | ) | ||||
| Total Equity | 546,008 | 516,766 |
Consolidated Statement of Cash Flows
| Year ended June 30, | ||||||||
| (in U.S. dollars, in thousands) | 2018 | 2017 | ||||||
| Cash flows from operating activities | ||||||||
| Commercialization revenue received | 3,019 | 1,332 | ||||||
| Milestone payment received | 7,125 | 500 | ||||||
| Research and development tax incentive received | - | 2,813 | ||||||
| Payments to suppliers and employees (inclusive of goods and services tax) | (84,682 | ) | (100,598 | ) | ||||
| Interest received | 367 | 483 | ||||||
| Interest paid | (816 | ) | - | |||||
| Income taxes (paid)/refunded | (25 | ) | (1 | ) | ||||
| Net cash (outflows) in operating activities | (75,012 | ) | (95,471 | ) | ||||
| Cash flows from investing activities | ||||||||
| Payments for contingent consideration | (952 | ) | - | |||||
| Investment in fixed assets | (201 | ) | (311 | ) | ||||
| Rental deposits received | - | 453 | ||||||
| Payments for investments | - | - | ||||||
| Payments for licenses | - | - | ||||||
| Net cash (outflows)/inflows in investing activities | (1,153 | ) | 142 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from borrowings | 31,704 | - | ||||||
| Payments of transaction costs from borrowings | (392 | ) | - | |||||
| Proceeds from issue of shares | 40,566 | 61,932 | ||||||
| Payments for share issue costs | (3,265 | ) | (1,927 | ) | ||||
| Net cash inflows by financing activities | 68,613 | 60,005 | ||||||
| Net decrease in cash and cash equivalents | (7,552 | ) | (35,324 | ) | ||||
| Cash and cash equivalents at beginning of period | 45,761 | 80,937 | ||||||
| FX (losses)/gains on the translation of foreign bank accounts | (446 | ) | 148 | |||||
| Cash and cash equivalents at end of period | 37,763 | 45,761 |