Celyad has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at €1,040m, €84 per share.
Written by
Celyad |
Developing a sophisticated clinical strategy |
Clinical update |
Pharma & biotech |
21 June 2018 |
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Celyad has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at €1,040m, €84 per share.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/16 |
8.52 |
(20.00) |
(2.09) |
0.0 |
N/A |
N/A |
12/17 |
3.54 |
(26.80) |
(2.79) |
0.0 |
N/A |
N/A |
12/18e |
0.00 |
(27.25) |
(2.43) |
0.0 |
N/A |
N/A |
12/19e |
0.00 |
(28.50) |
(2.38) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
A sophisticated clinical programme in AML
In 2017, an AML patient given three doses of 3x108 NKR CAR T-cells (CYAD-01) over 28 days had a near complete response; the case report has been published. This encouraging response with strong blood cell recovery levels and reduction in cancer cells (blasts) is being developed in three ways. First, the planned 3x109 CYAD-01 dose is now being tested in the THINK study and this may enable a trial expansion to assess efficacy. Second, multiple CYAD-01 28-day courses are being tested, initially at the 1x109 dose when a patient shows an initial response; this indicates that responses are being seen. A second course may enhance overall responses as no preconditioning is used in THINK so no cell expansion is seen. Third, the DEPLETHINK study will test a non-myeloablative preconditioning regimen plus CYAD-01 in AML /MDS patients to test for CYAD-01 expansion.
Leading position in solid cancers and allogeneic cells
The generalised targeting of its NKR CAR approach gives Celyad a potentially dominant position in solid cancers, an area other CAR approaches find hard to access (see detailed report). Dose escalation of CYAD-01 in solid cancers in THINK is ongoing. Importantly, Celyad is evaluating CYAD-01 in combination with FOLFOX in the SHRINK trial; the first patient was enrolled in May in Belgium. The Belgium LINK study tests direct hepatic injection of CYAD-01 to treat metastatic CRC. An allogeneic NKR CAR trial could start; Celyad holds key patents.
Valuation: €84 per share pending fresh data
The valuation is focused on AML at 25% probability and colorectal cancer at 20%. The unchanged indicative value is €1,040m, €84 per share. Management states that the May 2018 placing proceeds, €46.1m gross, could fund Celyad through H220. Value progression depends on THINK data especially in AML.
Exhibit 1: Financial summary
€000s |
2016 |
2017 |
2018e |
2019e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
8,523 |
3,540 |
0 |
0 |
Cost of Sales |
(53) |
(515) |
(500) |
(500) |
||
Gross Profit |
8,470 |
3,025 |
(500) |
(500) |
||
EBITDA |
|
|
(21,246) |
(22,317) |
(26,500) |
(27,750) |
Operating Profit (before amort. and except). |
|
|
(22,006) |
(23,283) |
(27,500) |
(28,750) |
Intangible Amortisation |
(756) |
(748) |
(750) |
(750) |
||
Other income and charges |
0 |
(26,273) |
0 |
0 |
||
Share-based payments |
(2,847) |
(2,569) |
(2,600) |
(2,600) |
||
Operating Profit |
(25,609) |
(52,873) |
(30,850) |
(32,100) |
||
Net Interest |
1,997 |
(3,521) |
250 |
250 |
||
Profit Before Tax (norm) |
|
|
(20,009) |
(26,804) |
(27,250) |
(28,500) |
Profit Before Tax (FRS 3) |
|
|
(23,612) |
(56,394) |
(30,600) |
(31,850) |
Tax |
6 |
1 |
0 |
0 |
||
Profit After Tax (norm) |
(20,003) |
(26,803) |
(27,250) |
(28,500) |
||
Profit After Tax (FRS 3) |
(23,606) |
(56,393) |
(30,600) |
(31,850) |
||
Average Number of Shares Outstanding (m) |
9.3 |
9.6 |
11.2 |
12.0 |
||
EPS - normalised (c) |
|
|
(209) |
(279) |
(243) |
(238) |
EPS - (IFRS) (c) |
|
|
(253) |
(586) |
(273) |
(267) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
N/A |
N/A |
N/A |
N/A |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except) (%) |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
53,440 |
41,232 |
40,492 |
39,752 |
Intangible Assets |
49,566 |
36,508 |
35,768 |
35,028 |
||
Tangible Assets |
3,563 |
3,290 |
3,290 |
3,290 |
||
Investments |
311 |
1,434 |
1,434 |
1,434 |
||
Current Assets |
|
|
85,366 |
36,393 |
50,659 |
22,149 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
1,359 |
233 |
233 |
233 |
||
Cash (cash plus deposits) |
82,587 |
33,905 |
48,171 |
19,661 |
||
Other |
1,420 |
2,255 |
2,255 |
2,255 |
||
Current Liabilities |
|
|
(11,275) |
(7,944) |
(7,944) |
(7,944) |
Creditors |
(9,960) |
(7,509) |
(7,509) |
(7,509) |
||
Deferred revenue |
0 |
0 |
0 |
0 |
||
Walloon loans and bank loan |
(1,315) |
(435) |
(435) |
(435) |
||
Long Term Liabilities |
|
|
(36,646) |
(22,146) |
(22,146) |
(22,146) |
Loans (non-current) Bank and Walloon |
(7,866) |
(1,870) |
(1,870) |
(1,870) |
||
Other long term liabilities |
(28,780) |
(20,276) |
(20,276) |
(20,276) |
||
Net Assets |
|
|
90,885 |
47,535 |
61,061 |
31,811 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(26,695) |
(46,027) |
(26,514) |
(27,471) |
Net Interest |
1,997 |
(3,521) |
264 |
(29) |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(1,782) |
(858) |
(1,010) |
(1,010) |
||
Acquisitions/disposals |
(1,561) |
0 |
0 |
0 |
||
Financing |
0 |
625 |
46,140 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
3,109 |
1,099 |
(4,614) |
0 |
||
Net Cash Flow |
(24,932) |
(48,682) |
14,266 |
(28,510) |
||
Opening net debt/(cash) |
|
|
(96,131) |
(73,406) |
(31,600) |
(45,866) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Loan and finance movements |
2,207 |
6,876 |
(0) |
0 |
||
Closing net debt/(cash) |
|
|
(73,406) |
(31,600) |
(45,866) |
(17,356) |
Source: Edison Investment Research estimates, Celyad reports and announcements
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