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Research: Healthcare
Mesoblast has raised US$40m (gross) through a placement of 26.25m shares at A$2.00/share. The cash enables continued funding of the key MPC-150-IM Phase III heart failure (HF) study where an interim futility analysis is underway. We expect Q4 data from the Phase III in paediatric graft vs host disease (GvHD); Mallinckrodt has an option on partnering GvHD. Other projects can also be funded. Also in H2, top-line data from the NIH-funded Phase IIb study in end-stage HF with an LVAD may be reported. The indicative value has been increased to A$1.72bn from A$1.67bn to reflect reduced potential FY18 cash needs. The indicative value per share drops to A$4.02 from A$4.16 due to the increased dilution.
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Mesoblast |
Funding to deliver key data in 2017 |
Cash raised |
Pharma & biotech |
5 April 2017 |
Share price performance
Business description
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Analysts
Mesoblast is a research client of Edison Investment Research Limited |
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Mesoblast has raised US$40m (gross) through a placement of 26.25m shares at A$2.00/share. The cash enables continued funding of the key MPC-150-IM Phase III heart failure (HF) study where an interim futility analysis is underway. We expect Q4 data from the Phase III in paediatric graft vs host disease (GvHD); Mallinckrodt has an option on partnering GvHD. Other projects can also be funded. Also in H2, top-line data from the NIH-funded Phase IIb study in end-stage HF with an LVAD may be reported. The indicative value has been increased to A$1.72bn from A$1.67bn to reflect reduced potential FY18 cash needs. The indicative value per share drops to A$4.02 from A$4.16 due to the increased dilution.
Year |
Revenue (US$m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/15 |
32.4 |
(96.2) |
(30.0) |
0.0 |
N/A |
N/A |
06/16 |
44.2 |
(87.4) |
(0.2) |
0.0 |
N/A |
N/A |
06/17e |
5.8 |
(82.0) |
(20.6) |
0.0 |
N/A |
N/A |
06/18e |
9.0 |
(81.0) |
(18.9) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS (fully diluted) are normalised, excluding exceptional items and share-based payments.
GvHD and back pain covered by Mallinckrodt option
Mallinckrodt Pharmaceuticals has an exclusive negotiation period, which runs until September, covering Mesoblast’s Phase III chronic low back pain (CLBP) and GvHD programmes. A paediatric GvHD Phase III is expected to complete enrolment in mid-2017 and read out top-line data in Q417. The CLBP Phase III is on track to complete recruitment in H217. Mesoblast recently reported that improvements in pain and function after a single intra-disc injection of 6m MPCs in Phase II were maintained for at least 36 months in 84% of responders.
HF interim analysis underway, end-stage HF data Q4
The MPC-150-IM Phase III in HF patients is running well, with the funds raised being used to support the programme. An interim futility analysis on the first 270 patients (of 600 needed) is currently underway. A 150-patient Phase IIb (using Mesoblast MPC, but run and funded by NIH) in end-stage HF patients (with an LVAD pump) is expected to complete enrolment in H117. The NIH may report top-line data in H217. Positive results could potentially lead to an application for accelerated approval under the 21st Century Cures Act. This would have positive implications for Mesoblast’s ongoing MPC-150-IM Phase III in moderate HF.
Financials: Cash runway to end of calendar year
The indicative value has been adjusted to A$1.72bn (A$4.02/share) from A$1.67bn to reflect reduced potential FY18 cash needs. The US$60m in cash raised so far in 2017 comprises US$21.7m from Mallinckrodt received in January and US$40m gross in the placement; we estimate US$59.6m net in total. This adds to the balance of c US$34m as at 31 December 2016. We now estimate a 30 June 2017 cash balance of US$59m with an unchanged cash flow/earnings forecast, formerly US$21m. We forecast a reduced extra cash need of US$25m (formerly US$65m) to fund operations until end FY18; this cash could potentially come from partnering agreements or the US$90m discretionary equity facility with Kentgrove Capital.
Exhibit 1: Financial summary
US$'000s |
2015 |
2016 |
2017e |
2018e |
2019e |
||
30-June |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
|||||||
Revenue |
|
|
32,403 |
44,183 |
5,825 |
9,048 |
11,288 |
Cost of Sales |
0 |
0 |
0 |
(1,207) |
(2,382) |
||
Gross Profit |
32,403 |
44,183 |
5,825 |
7,841 |
8,906 |
||
R&D Expenses |
(62,649) |
(50,013) |
(50,013) |
(51,013) |
(53,054) |
||
Manufacturing & Commercialisation Expenses |
(23,783) |
(29,763) |
(22,025) |
(22,245) |
(22,912) |
||
SG&A Expenses |
(29,636) |
(22,500) |
(17,881) |
(17,820) |
(18,355) |
||
EBITDA |
|
|
(97,977) |
(86,319) |
(81,292) |
(80,320) |
(82,377) |
Operating Profit (before amort and except) |
|
(99,001) |
(88,511) |
(83,594) |
(82,737) |
(84,914) |
|
Intangible Amortisation |
0 |
0 |
0 |
0 |
0 |
||
Exceptionals |
0 |
0 |
0 |
0 |
0 |
||
Share-based payments |
0 |
(3,389) |
(2,500) |
(2,500) |
(2,500) |
||
Operating Profit |
(99,001) |
(91,900) |
(86,094) |
(85,237) |
(87,414) |
||
Net Interest |
2,757 |
1,079 |
1,619 |
1,767 |
101 |
||
Profit Before Tax (norm) |
|
|
(96,244) |
(87,432) |
(81,975) |
(80,970) |
(84,814) |
Profit Before Tax (FRS 3) |
|
|
(96,244) |
(90,821) |
(84,475) |
(83,470) |
(87,314) |
Tax |
0 |
86,694 |
0 |
0 |
0 |
||
Profit After Tax (norm) |
(96,244) |
(738) |
(81,975) |
(80,970) |
(84,814) |
||
Profit After Tax (FRS 3) |
(96,244) |
(4,127) |
(84,475) |
(83,470) |
(87,314) |
||
Average Number of Shares Outstanding (m) |
320.9 |
360.8 |
398.2 |
428.0 |
428.0 |
||
EPS - normalised fully diluted (c) |
|
|
(29.99) |
(0.20) |
(20.59) |
(18.92) |
(19.82) |
EPS - normalised (c) |
|
|
(29.99) |
(0.20) |
(20.59) |
(18.92) |
(19.82) |
EPS - (IFRS) (c) |
|
|
(29.99) |
(1.14) |
(21.22) |
(19.50) |
(20.40) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
100.0 |
100.0 |
100.0 |
86.7 |
78.9 |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except) (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
659,306 |
595,195 |
594,893 |
594,477 |
593,939 |
Intangible Assets |
650,241 |
587,823 |
587,823 |
587,823 |
587,823 |
||
Tangible Assets |
4,398 |
3,063 |
2,761 |
2,345 |
1,807 |
||
Investments |
4,667 |
4,309 |
4,309 |
4,309 |
4,309 |
||
Current Assets |
|
|
122,460 |
88,823 |
66,789 |
11,236 |
51,960 |
Stocks |
0 |
0 |
0 |
0 |
0 |
||
Debtors |
3,972 |
4,054 |
4,054 |
4,054 |
4,054 |
||
Cash |
110,701 |
80,937 |
58,903 |
3,350 |
44,074 |
||
Other |
7,787 |
3,832 |
3,832 |
3,832 |
3,832 |
||
Current Liabilities |
|
|
(48,407) |
(29,415) |
(29,415) |
(29,415) |
(29,415) |
Creditors |
(43,246) |
(27,155) |
(27,155) |
(27,155) |
(27,155) |
||
Deferred revenue |
(5,161) |
(2,260) |
(2,260) |
(2,260) |
(2,260) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(265,372) |
(126,442) |
(126,442) |
(151,442) |
(276,442) |
Long term borrowings |
0 |
0 |
0 |
(25,000) |
(150,000) |
||
Deferred revenue |
(22,505) |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(242,867) |
(126,442) |
(126,442) |
(126,442) |
(126,442) |
||
Net Assets |
|
|
467,987 |
528,161 |
505,826 |
424,856 |
340,042 |
CASH FLOW |
|||||||
Operating Cash Flow |
|
|
(104,079) |
(89,125) |
(81,292) |
(80,320) |
(82,377) |
Net Interest |
3,043 |
1,129 |
1,619 |
1,767 |
101 |
||
Tax |
0 |
0 |
0 |
0 |
0 |
||
Capex |
(2,204) |
(922) |
(2,000) |
(2,000) |
(2,000) |
||
Acquisitions/disposals |
0 |
(805) |
0 |
0 |
0 |
||
Financing |
45,852 |
62,066 |
59,640 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
||
Other |
(2,860) |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
(60,248) |
(27,657) |
(22,034) |
(80,553) |
(84,276) |
||
Opening net debt/(cash) |
|
|
(185,003) |
(110,701) |
(80,937) |
(58,903) |
21,650 |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
||
Other |
(14,054) |
(2,107) |
0 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(110,701) |
(80,937) |
(58,903) |
21,650 |
105,926 |
Source: Mesoblast accounts, Edison Investment Research. Note: Mesoblast reports in US dollars.
|
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Research: Healthcare
Quantum Genomics reported its yearly results, which highlighted the significant progress the company has made towards the commercialisation of its product, QGC001, for treatment of hypertension (HT) and heart failure (HF). In 2016, the company both completed a 34-person Phase II HT trial (results expected June 2017) and initiated a 75-person European Phase II trial examining the drug for HF (results early 2018). The company is also set up to initiate a US Phase II for HT in H217.