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EUR248m
Research: Healthcare
According to the latest news from Oryzon, the first Alzheimer’s disease (AD) patients (3/90) were recruited into the Phase IIa ETHERAL clinical trial testing ORY-2001, a dual LSD1/MAOB inhibitor for CNS indications. The trial is expected to be finalised in Q419, but Oryzon plans to report preliminary data in early 2019, which is one of the main catalysts in the near term. The second Phase IIa trial with ORY-2001 SATEEN in multiple sclerosis (MS) continues to enrol patients, with the preliminary readout planned in early 2019, another key catalyst for the share price. Our valuation is marginally higher at €322m or €9.4/share (vs €315m or €9.2/share previously).
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Oryzon Genomics |
Phase IIa trial in Alzheimer’s disease initiated |
Q118 update |
Pharma & biotech |
22 May 2018 |
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According to the latest news from Oryzon, the first Alzheimer’s disease (AD) patients (3/90) were recruited into the Phase IIa ETHERAL clinical trial testing ORY-2001, a dual LSD1/MAOB inhibitor for CNS indications. The trial is expected to be finalised in Q419, but Oryzon plans to report preliminary data in early 2019, which is one of the main catalysts in the near term. The second Phase IIa trial with ORY-2001 SATEEN in multiple sclerosis (MS) continues to enrol patients, with the preliminary readout planned in early 2019, another key catalyst for the share price. Our valuation is marginally higher at €322m or €9.4/share (vs €315m or €9.2/share previously).
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/16 |
5.0 |
(4.7) |
(0.2) |
0.0 |
N/A |
N/A |
12/17 |
4.3 |
(4.6) |
(0.1) |
0.0 |
N/A |
N/A |
12/18e |
7.0 |
(5.6) |
(0.2) |
0.0 |
N/A |
N/A |
12/19e |
6.3 |
(7.3) |
(0.2) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
First patients enrolled into ORY-2001 AD trial
The first three patients out of 90 have been recruited at two sites in Barcelona into the randomised, double-blind, placebo-controlled, 26-week study (n=90) Phase IIa ETHERAL trial with ORY-2001 in AD after the trial was approved by the Spanish Medicines Agency (AEMPS) in April 2018. Oryzon has also recently received approval to start the trial in France and is awaiting approval for the UK, both of which should help with enrolment. In addition, it is planning to start a similar study in the US. The ETHERAL trial is expected to end in Q419, but a preliminary readout is planned in early 2019, which is one of the main catalysts in the near term.
Phase IIa SATEEN trial in MS ongoing
The second Phase IIa SATEEN trial with ORY-2001 in MS continues to enrol patients, with the first recruited in January this year. SATEEN is a randomised, double-blind, placebo-controlled, 36-week study (n=24) that will evaluate ORY-2001 in patients with relapsing-remitting MS and secondary progressive MS. The preliminary readout is planned in early 2019. Also, Oryzon reiterated its plans to submit clinical trial applications for a further two Phase IIa trials testing ORY-1001 in acute myeloid leukaemia and small cell lung cancer soon. ORY-3001 is still in preclinical stages, but has now completed regulatory toxicology studies and may move into Phase I.
Valuation: Marginally higher at €322m or €9.4/share
Our valuation is slightly up at €322m or €9.4/share from €315m or €9.2/share due to rolling our model forward, which is partially offset by lower net cash. The two near-term catalysts are the results from both Phase IIa trials with ORY-2001. We note that since the Oryzon’s shares were listed on Madrid Stock Exchange in December 2015, the trading volumes have been steadily increasing (Exhibit 2).
Financials and valuation
Oryzon’s Q118 financial results came in largely in line with our expectations. Q118 R&D expenses were €1.9m ($2.3m) compared with €1.3m ($1.6m) in Q117. The increase is related to more intensive clinical R&D activities, mainly the initiation of the two new trials. Q118 G&A costs were €0.7m ($0.9m) compared with €0.8 ($1.0m) a year ago. We leave our R&D cost estimates of €8.5m for FY18 and €9.5m for FY19 unchanged; these are the main cost drivers. €1.8m was booked as income and represents capitalised R&D costs (Oryzon follows local GAAP). The reported Q118 cash position was €30.9m (cash and short-term investments; net cash €9.2m). Our model suggests this should be sufficient to reach 2020.
As Oryzon is on track to develop its assets in all the indications we currently include in our valuation, we leave our assumptions unchanged. Our new valuation is €322m or €9.4/share, marginally up from €315m or €9.2/share due to rolling our model forward, which was partially offset by a lower net cash position.
Exhibit 1: Oryzon rNPV valuation
Product |
Indication |
Launch |
Peak sales* |
Value |
Probability |
rNPV |
rNPV/share |
ORY-1001 |
AML |
2023 |
927 |
257.1 |
15% |
47.0 |
1.4 |
ORY-1001 |
SCLC |
2026 |
571 |
125.7 |
8% |
21.8 |
0.6 |
ORY-2001 |
AD |
2026 |
4,510 |
938.1 |
15% |
145.2 |
4.3 |
ORY-2001 |
MS |
2027 |
1,940 |
415.1 |
20% |
98.4 |
2.9 |
Net cash (end-Q118) |
9.2 |
100% |
9.2 |
0.3 |
|||
Valuation |
|
|
1,745.1 |
321.7 |
9.4 |
Source: Edison Investment Research. Note: *Peak sales are rounded to the nearest US$10m, shown in US dollars. SCLC = small cell lung cancer; AML = acute myeloid leukaemia; AD = Alzheimer’s disease; MS = multiple sclerosis. Net cash includes term deposits.
|
Exhibit 2: Monthly trading volumes in Oryzon’s share |
|
|
Source: Edison Investment Research |
Exhibit 3: Financial summary
€000s |
2014 |
2015 |
2016 |
2017 |
2018e |
2019e |
||
December |
Local GAAP |
Local GAAP |
Local GAAP |
Local GAAP |
Local GAAP |
Local GAAP |
||
PROFIT & LOSS |
||||||||
Revenue |
|
|
15,536 |
7,185 |
5,009 |
4,317 |
7,034 |
6,301 |
Cost of Sales |
0 |
0 |
0 |
0 |
0 |
0 |
||
Gross Profit |
15,536 |
7,185 |
5,009 |
4,317 |
7,034 |
6,301 |
||
Research and development |
(1,108) |
(3,191) |
(5,210) |
(5,306) |
(8,502) |
(9,454) |
||
EBITDA |
|
|
11,659 |
688 |
(3,721) |
(3,498) |
(4,678) |
(6,350) |
Operating Profit (before amort. and except.) |
11,398 |
448 |
(3,879) |
(3,660) |
(4,789) |
(6,461) |
||
Intangible Amortisation |
(657) |
(657) |
(695) |
(664) |
(767) |
(887) |
||
Exceptionals |
(4,617) |
(24) |
(4) |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit |
6,124 |
(233) |
(4,578) |
(4,324) |
(5,556) |
(7,348) |
||
Exceptionals |
667 |
(169) |
(58) |
0 |
0 |
0 |
||
Net Interest |
(52) |
(553) |
(844) |
(928) |
(793) |
(802) |
||
Profit Before Tax (norm) |
|
|
11,346 |
(105) |
(4,724) |
(4,588) |
(5,582) |
(7,263) |
Profit Before Tax (reported) |
|
|
6,739 |
(955) |
(5,480) |
(5,252) |
(6,349) |
(8,150) |
Tax |
(88) |
(37) |
32 |
55 |
0 |
0 |
||
Profit After Tax (norm) |
11,258 |
(142) |
(4,692) |
(4,533) |
(5,582) |
(7,263) |
||
Profit After Tax (reported) |
6,651 |
(992) |
(5,448) |
(5,197) |
(6,349) |
(8,150) |
||
Average Number of Shares Outstanding (m) |
23.3 |
24.7 |
27.6 |
31.7 |
34.2 |
34.2 |
||
EPS - normalised (€) |
|
|
0.48 |
(0.01) |
(0.17) |
(0.14) |
(0.16) |
(0.21) |
EPS - reported (€) |
|
|
0.29 |
(0.04) |
(0.20) |
(0.16) |
(0.19) |
(0.24) |
Dividend per share (€) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
||
EBITDA Margin (%) |
75.0 |
9.6 |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except.) (%) |
73.4 |
6.2 |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
||||||||
Fixed Assets |
|
|
16,059 |
18,050 |
21,269 |
24,914 |
31,070 |
36,373 |
Intangible Assets |
12,928 |
15,188 |
18,810 |
22,458 |
28,725 |
34,139 |
||
Tangible Assets |
981 |
854 |
696 |
638 |
527 |
417 |
||
Investments |
2,150 |
2,008 |
1,763 |
1,818 |
1,818 |
1,818 |
||
Current Assets |
|
|
9,999 |
22,681 |
28,475 |
36,130 |
24,013 |
10,366 |
Stocks |
9 |
4 |
8 |
7 |
8 |
8 |
||
Debtors |
704 |
940 |
978 |
857 |
517 |
687 |
||
Cash |
3,633 |
19,467 |
22,028 |
34,950 |
23,488 |
9,671 |
||
Other* |
5,654 |
2,270 |
5,461 |
316 |
0 |
0 |
||
Current Liabilities |
|
|
(3,969) |
(5,296) |
(7,597) |
(8,696) |
(9,084) |
(8,890) |
Creditors |
(1,299) |
(2,401) |
(2,119) |
(1,343) |
(1,731) |
(1,537) |
||
Short term borrowings |
(2,670) |
(2,895) |
(5,477) |
(7,354) |
(7,354) |
(7,354) |
||
Long Term Liabilities |
|
|
(8,196) |
(7,841) |
(19,419) |
(17,915) |
(17,915) |
(17,915) |
Long term borrowings |
(6,420) |
(6,177) |
(17,723) |
(16,041) |
(16,041) |
(16,041) |
||
Other long term liabilities |
(1,776) |
(1,664) |
(1,696) |
(1,874) |
(1,874) |
(1,874) |
||
Net Assets |
|
|
13,893 |
27,594 |
22,729 |
34,432 |
28,083 |
19,933 |
CASH FLOW |
||||||||
Operating Cash Flow |
|
|
12,178 |
1,076 |
(4,536) |
(4,281) |
(4,621) |
(7,393) |
Net Interest |
(52) |
(553) |
(471) |
(426) |
(793) |
(802) |
||
Tax |
0 |
0 |
0 |
0 |
0 |
0 |
||
Capex |
0 |
0 |
(28) |
(105) |
0 |
0 |
||
Acquisitions/disposals |
798 |
0 |
0 |
0 |
0 |
0 |
||
Financing |
0 |
14,725 |
287 |
16,887 |
0 |
0 |
||
Other* |
(9,579) |
605 |
(6,819) |
653 |
(6,048) |
(5,622) |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
3,345 |
15,853 |
(11,567) |
12,728 |
(11,462) |
(13,817) |
||
Opening net debt/(cash) |
|
|
8,803 |
5,458 |
(10,395) |
1,172 |
(11,555) |
(93) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
5,458 |
(10,395) |
1,172 |
(11,555) |
(93) |
13,724 |
Source: Oryzon accounts, Edison Investment Research. Note: Oryzon reports in Spanish GAAP. *Includes cash outflows related to development costs that were capitalised.
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