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Oryzon Genomics — New data further back MS indication

Oryzon Genomics (BME: ORY)

Last close As at 05/08/2026

EUR2.93

▲ −0.02 (−0.81%)

Market capitalisation

EUR248m

More on this equity

Research: Healthcare

Oryzon Genomics — New data further back MS indication

Oryzon has two assets, ORY-1001 and ORY-2001, in the clinical stage of development, with ORY-3001 being investigated for oncology indications in the preclinical stage. While the most advanced, ORY-1001, is now in Roche’s hands, Oryzon has been making progress with the newer programmes. Data from the Phase I trial with ORY-2001 for Alzheimer’s disease (AD) will be announced by end March 2017 and fresh preclinical data from ORY-2001 studies support its potential in a second indication, multiple sclerosis (MS). We make minor adjustments to our valuation, increasing it slightly to €266m.

Analyst avatar placeholder

Written by

Healthcare

Oryzon Genomics

New data further back MS indication

Q416 results and R&D update

Pharma & biotech

13 March 2017

Price

€4.18

Market cap

€119m

Net cash (€m) at end Q416 (including term deposits)

4.3

Shares in issue

28.5m

Free float

30%

Code

ORY

Primary exchange

Madrid Stock Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.5)

(10.5)

27.0

Rel (local)

(10.5)

(18.0)

11.3

52-week high/low

€5.1

€2.6

Business description

Oryzon Genomics is a Spanish biotechnology company focused on developing novel epigenetic compounds. Lead compound ORY-1001 is partnered with Roche, which is responsible for further development in acute leukaemia and SCLC. ORY-2001 has potential for Alzheimer’s disease and has entered Phase I. ORY-3001 is a new preclinical asset.

Next events

ORY-2001 Phase I results

H117

News from Roche on ORY-1001 in AML

2017

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Juan Pedro Serrate

+44 (0)20 3681 2534

Oryzon Genomics is a research client of Edison Investment Research Limited

Oryzon has two assets, ORY-1001 and ORY-2001, in the clinical stage of development, with ORY-3001 being investigated for oncology indications in the preclinical stage. While the most advanced, ORY-1001, is now in Roche’s hands, Oryzon has been making progress with the newer programmes. Data from the Phase I trial with ORY-2001 for Alzheimer’s disease (AD) will be announced by end March 2017 and fresh preclinical data from ORY-2001 studies support its potential in a second indication, multiple sclerosis (MS). We make minor adjustments to our valuation, increasing it slightly to €266m.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/15

7.2

(0.1)

(0.01)

0.0

N/A

N/A

12/16

5.0

(4.7)

(0.17)

0.0

N/A

N/A

12/17e

4.2

(6.1)

(0.21)

0.0

N/A

N/A

12/18e

4.5

(6.8)

(0.24)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Financials: FY16 EBIT matches our estimate

Oryzon’s FY16 results released on 24 February 2016 showed full year revenues at €735k (our estimate was €915k), consisting of a reimbursement payment from Roche and the recognition of deferred income. In addition, the company recorded €4.3m in income to account for the capitalisation of development costs, higher than our expected €3.9m. FY16 R&D costs of €5.2m were slightly ahead of our estimate of €4.8m, while personnel expenses of €2.5m were spot on. Adding other operating costs, Oryzon’s operating loss was €4.6m, close to our expectation of €4.7m.

R&D pipeline progress

Roche, Oryzon’s partner for ORY-1001, has initiated its first clinical Phase I trial in small cell lung cancer with the first patient dosed in January 2017. Roche took over the development of the asset after Oryzon presented positive Phase I/IIa data in December 2016. The next catalyst for Oryzon is a data readout from Phase I with its second lead candidate, ORY-2001. Oryzon announced that it will present the findings during the presentation on 31 March 2017 at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria. ORY-2001 is selective dual LSD1-MAOB inhibitor and the first-in-man clinical trial with 88 healthy volunteers sought to assess safety, the PK/PD profile and a potential biomarker for the drug. Subject to favourable data, ORY-2001 could move to Phase II in H217 to be investigated in AD patients for the first time, while other neurodegenerative diseases may also be added with fresh preclinical data supporting MS.

Valuation: Slightly upped to €266m or €9.3/share

We value Oryzon at €266m or €9.3/share, slightly up from €250m or €8.8/share previously. The main changes include the revision of our forecasts following FY16 results and rolling our model forward, while we keep our valuation assumptions unchanged. The next catalyst is Phase I data; however, we also look forward to any new details about ORY-3001, which is approaching clinical testing.

Fresh preclinical ORY-2001 data for MS

Initially, ORY-2001 demonstrated efficacy in preclinical dementia models and AD was therefore selected as a primary indication. However, following the insights from biomarker analysis showing ORY-2001’s down-regulating effect on neuroinflammatory genes, including S100A9, Oryzon investigated ORY-2001 in an experimental autoimmune encephalomyelitis (EAE) mice model, a widely used proxy for MS, which has been shown to up-regulated S100A9. First preclinical data from this study supporting ORY-2001 for MS were announced in September 2016 and discussed in our previous report. We subsequently included the indication in our valuation.

The new set of data was presented at the second annual conference of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in Orlando, Florida, in February 2017 and expands on the insights presented in September 2016. During the study mice were injected with a specific peptide, which triggered an autoimmune reaction and the production of antibodies against the myelin sheet protecting the motor neurons. A gradual demyelination (destruction of the neurons’ protective sheet) leads to the development of different degrees of paralysis, mimicking the natural course of MS. The study included a vehicle (sham) and two controlled arms: EAE mice treated with ORY-2001 (dual LSD1-MAO-B inhibitor) and ORY-LSD1 (proprietary selective LSD1 inhibitor). Key findings include:

■

When administered from the onset of the first symptoms, ORY-2001 provided an effective and long-lasting protection in terms of survival and mobility, therefore decreasing the development of EAE (Exhibit 1A). This was observed even at very low doses of ORY-2001 (0.05mg/kg; up to 3mg/kg safely tested).

■

The histopathological analysis two weeks after the first symptoms showed a substantially lower number of demyelination plaques in the lumbar and cervical regions of ORY-2001-treated animals (Exhibit 1B).

■

Treatment with ORY-2001 and ORY-LSD1 resulted in a significant increase in the number of immune cells retained in the spleen and lymph nodes of treated animals, suggesting a reduced egress of lymphocytes from immune tissues (egress is usually associated with an inflammatory response) (Exhibit 1C).

■

Treatment with ORY-2001 also caused a reduction of various pro-inflammatory cytokines such as IL-6 and IL-1beta and chemokines such as IP-10 and MCP-1, which are involved in inflammation leading to the destruction of motor neurons in MS.

Cumulatively, these findings indicate that ORY-2001 shows an ability to counteract a number of pathophysiological processes associated with MS and that the dual inhibition of LSD1-MAOB (ORY-2001’s mechanism of action) appears to be more efficacious in this context than LSD1 inhibition alone.

MS is an autoimmune disease that attacks and destroys neurons in the central nervous system to variable degrees and causes significant physical disability. The hallmark of MS is episodic relapses that occur months or years apart and affect various anatomic locations. Around 400,000 people are diagnosed with MS in the US each year and around 85% of those have a relapsing-remitting course of the disease, which is in contrast to the progressive type when symptoms gradually get worse over time rather than appearing as relapses (source: Multiple Sclerosis, Medscape). We discussed the MS market potential including the competitive landscape in more detail in our previous report.

Exhibit 1: Effects of the treatment with ORY-2001 in EAE mice model

Source: T. Maes et al. ORY-2001 Reduces Lymphocyte Egress and Demyelination in Experimental Autoimmune Encephalomyelitis and Highlights the Epigenetic Axis in Multiple Sclerosis. Presented at the second annual conference of ACTRIMS, February 2017. Note: Clinical score reflects the extent of the paralysis – 0 = no signs; 5.0 = hind and foreleg paralysis.

Valuation

We value Oryzon at €266m or €9.3/share, slightly up from €250m or €8.8/share previously. The main changes include the revision of our estimates to reflect higher R&D costs and rolling our model forward. We have not made any significant changes to our valuation assumptions, which are included in more detail for all projects in our previous reports. We are still not including ORY-3001 in our rNPV calculations, although Oryzon is clearly making progress, with the latest update being the indication that this asset may be ready for Phase I in H217. We will revisit ORY-3001 when more details are announced, eg the exact indications that the project will include and potential timelines.

Exhibit 2: Oryzon rNPV valuation

Product

Indication

Launch

Peak sales*
(US$m)

Value
(€m)

Probability
(%)

rNPV
(€m)

NPV/share
(€/share)

ORY-1001

AML

2022

900

259.0

20%

60.0

2.1

ORY-1001

SCLC

2025

635

121.8

12%

21.8

0.8

ORY-2001

AD

2026

4,510

813.0

12%

99.7

3.5

ORY-2001

MS

2026

1,940

359.5

20%

80.1

2.8

Net cash (end-2016)

4.3

100%

4.3

0.2

Valuation

 

 

1,557.6

 

265.8

9.3

Source: Edison Investment Research. Note: *Peak sales are rounded to the nearest US$10m, shown in US$. SCLC = small cell lung cancer; AML = acute myeloid leukaemia; AD = Alzheimer’s disease; MS = multiple sclerosis. Net cash includes term deposits.

Financials

In FY16 Oryzon reported revenues of €735k (our estimate was €915k), which consisted of a reimbursement payment from Roche according to the R&D collaboration agreement (separate to the ORY-1001 licensing deal) and the recognition of deferred in income after a milestone payment of $4m from Roche in July 2015. In addition, the company recorded €4.3m income to account for the capitalisation of the development costs. Oryzon follows Spanish GAAP and research costs are expensed, while development costs can be capitalised by recognising income in the P&L statement. As this capitalisation level was above our expectations of €3.9m, we have therefore increased our forecasts.

Oryzon reported FY16 R&D costs of €5.2m, slightly ahead of our estimate of €4.8m, while personnel expenses of €2.5m were spot on. Adding other operating costs, Oryzon’s operating loss was €4.6m, close to our expectation of €4.7m. We initially expected 2017 R&D costs to come in lower than 2016 after Roche took over the development of ORY-1001. However, in recent months Oryzon disclosed the third asset, ORY-3001, which is undergoing preclinical testing, and is ramping up the development of ORY-2001 in at least two indications currently, with potential to expand. We have therefore revised our 2017 R&D costs estimates upwards, which is the main change in our forecasts. This was offset by higher than expected capitalisation level, leading to a negligible effect on EPS in 2017 and a slight positive effect in 2018.

The 2016 year-end cash position was €27.3m (cash and term deposits classed as other current assets) and net cash of €4.3m (including term deposits); we expect cash to be at €14.4m by the end-2017. In total, during 2016 Oryzon managed to attract around €16m in new funding, assuming debt at attractive commercial terms. In addition, the company has a history of efficient use of available public grants, which could provide further non-dilutive financing (most recently it received a small public grant of $0.8m in December 2016).

Exhibit 3: Key changes to our financial forecasts

€m

2016

2017e

2018e

Estimate

Actual

Change (%)

Old

New

Change (%)

New

Revenue

4.835

5.009

+4%

2.797

4.156

+49%

4.515

Gross profit

4.835

5.009

+4%

2.797

4.156

+49%

4.515

R&D costs

(4.783)

(5.210)

N/M

(3.774)

(5.274)

N/M

(6.041)

Operating profit (reported)

(4.715)

(4.578)

N/M

(6.281)

(5.783)

N/M

(6.682)

Profit before tax (reported)

(5.708)

(5.480)

N/M

(7.124)

(7.052)

N/M

(7.896)

Profit after tax (reported)

(5.312)

(5.448)

N/M

(7.124)

(7.052)

N/M

(7.896)

EPS reported (€)

(0.19)

(0.20)

N/M

(0.25)

(0.25)

N/M

(0.28)

Source: Oryzon accounts, Edison Investment Research

Exhibit 4: Financial summary

EUR'000s

2013

2014

2015

2016

2017e

2018e

December

Local GAAP

Local GAAP

Local GAAP

Local GAAP

Local GAAP

Local GAAP

PROFIT & LOSS

Revenue

 

 

2,360

15,536

7,185

5,009

4,156

4,515

Cost of Sales

0

0

0

0

0

0

Gross Profit

2,360

15,536

7,185

5,009

4,156

4,515

Research and development

(873)

(1,108)

(3,191)

(5,210)

(5,274)

(6,041)

EBITDA

 

 

(94)

11,659

688

(3,721)

(4,749)

(5,537)

Operating Profit (before amort. and except.)

(370)

11,398

448

(3,879)

(4,845)

(5,633)

Intangible Amortisation

(657)

(657)

(657)

(695)

(938)

(1,049)

Exceptionals

(186)

(4,617)

(24)

(4)

0

0

Other

0

0

0

0

0

0

Operating Profit

(1,213)

6,124

(233)

(4,578)

(5,783)

(6,682)

Exceptionals

0

667

(169)

(58)

0

0

Net Interest

(672)

(52)

(553)

(844)

(1,269)

(1,214)

Profit Before Tax (norm)

 

 

(1,042)

11,346

(105)

(4,724)

(6,115)

(6,847)

Profit Before Tax (reported)

 

 

(1,885)

6,739

(955)

(5,480)

(7,052)

(7,896)

Tax

89

(88)

(37)

32

0

0

Profit After Tax (norm)

(953)

11,258

(142)

(4,692)

(6,115)

(6,847)

Profit After Tax (reported)

(1,796)

6,651

(992)

(5,448)

(7,052)

(7,896)

Average Number of Shares Outstanding (m)

23.0

23.3

24.7

27.6

28.5

28.5

EPS - normalised (EUR)

 

 

(0.04)

0.48

(0.01)

(0.17)

(0.21)

(0.24)

EPS - (reported) (EUR)

 

 

(0.08)

0.29

(0.04)

(0.20)

(0.25)

(0.28)

Dividend per share (EUR)

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 (%)

N/A

75.0

9.6

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

73.4

6.2

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

20,128

16,059

18,050

21,269

24,390

27,760

Intangible Assets

15,825

12,928

15,188

18,810

22,028

25,494

Tangible Assets

1,159

981

854

696

600

503

Investments

3,145

2,150

2,008

1,763

1,763

1,763

Current Assets

 

 

2,851

9,999

22,681

28,475

16,993

4,532

Stocks

2

9

4

8

6

7

Debtors

663

704

940

978

959

969

Cash

2,033

3,633

19,467

22,028

10,566

3,556

Other

153

5,654

2,270

5,461*

5,461*

0

Current Liabilities

 

 

(2,724)

(3,969)

(5,296)

(7,597)

(7,557)

(8,277)

Creditors

(1,005)

(1,299)

(2,401)

(2,119)

(2,080)

(2,100)

Short term borrowings

(1,719)

(2,670)

(2,895)

(5,477)

(5,477)

(6,177)

Long Term Liabilities

 

 

(11,251)

(8,196)

(7,841)

(19,419)

(19,419)

(18,719)

Long term borrowings

(9,117)

(6,420)

(6,177)

(17,723)

(17,723)

(17,023)

Other long term liabilities

(2,134)

(1,776)

(1,664)

(1,696)

(1,696)

(1,696)

Net Assets

 

 

9,004

13,893

27,594

22,729

14,406

5,296

CASH FLOW

Operating Cash Flow

 

 

(113)

12,178

1,076

(4,536)

(6,036)

(6,742)

Net Interest

(672)

(52)

(553)

(471)

(1,269)

(1,214)

Tax

0

0

0

0

0

0

Capex

0

0

0

(28)

0

0

Acquisitions/disposals

(677)

798

0

0

0

0

Financing

0

0

14,725

287

0

0

Other

(161)

(9,579)

605

(6,819)**

(4,156)**

946

Dividends

0

0

0

0

0

0

Net Cash Flow

(1,623)

3,345

15,853

(11,567)

(11,462)

(7,010)

Opening net debt/(cash)

 

 

7,180

8,803

5,458

(10,395)

1,172

12,634

HP finance leases initiated

0

0

0

0

0

0

Other

0

0

0

0

0

(0)

Closing net debt/(cash)

 

 

8,803

5,458

(10,395)

1,172

12,634

19,644

Source: Source: Edison Investment Research, Oryzon Genomics accounts. Note: Oryzon reports in Spanish GAAP. *Term deposits classed as other current assets. **Includes cash outflows related to development costs that were capitalised.

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Oryzon Genomics and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

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London +44 (0)20 3077 5700

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United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney NSW 2000

Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney NSW 2000

Australia

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

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Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Oryzon Genomics and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. 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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney NSW 2000

Australia

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