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Oryzon Genomics — Update 8 August 2016

Oryzon Genomics (BME: ORY)

Last close As at 05/08/2026

EUR2.92

▲ −0.01 (−0.41%)

Market capitalisation

EUR248m

More on this equity

Research: Healthcare

Oryzon Genomics — Update 8 August 2016

Oryzon Genomics

Analyst avatar placeholder

Written by

Healthcare

Oryzon Genomics

Preliminary Phase I/IIa data read-out likely at ASH

Q216 results

Pharma & biotech

8 August 2016

Price

€2.85

Market cap

€81m

Net cash (€m) at end of Q216

7.1

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

2.3

(5.6)

N/A

Rel (local)

(3.4)

(4.0)

N/A

52-week high/low

€4.60

€2.60

Business description

Oryzon Genomics is a Spanish biotechnology company focused on developing novel epigenetic compounds. Lead compound ORY-1001 is partnered with Roche and is undergoing a Phase I/IIa study for acute leukaemia. ORY-2001 has potential for Alzheimer’s disease and has entered Phase I. ORY-3001 is a new preclinical asset.

Next events

ORY-1001 Phase I/IIa results

Dec 2016 (ASH)

ORY-2001 Phase I results

H117

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

With its Q216 results, Oryzon reported that the two ongoing clinical studies, involving clinical-stage products ORY-1001 and ORY-2001, are proceeding as planned. Preliminary data from the Phase I/IIa trial with ORY-1001 are due by end-2016, which is the main catalyst for the company in the near term. ORY-2001 demonstrated safety when administered in a single dose and is now being tested in multiple ascending doses in Phase I. Recently Oryzon expanded its R&D pipeline with a new preclinical asset leveraging its proprietary epigenetics platform. Our valuation is virtually unchanged at €158m or €5.5/share.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/14

15.5

11.3

0.48

0.0

N/A

N/A

12/15

7.2

(0.1)

(0.01)

0.0

N/A

N/A

12/16e

3.9

(4.7)

(0.15)

0.0

N/A

N/A

12/17e

2.5

(5.6)

(0.19)

0.0

N/A

N/A

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

Q216 results in line, solid cash position

Oryzon reported its Q216 results on 8 August. R&D expenses were €2.2m, slightly up year-on-year. G&A costs were €2.1m (Q215: €1.6m) due to new personnel hires and increased other expenses after the IPO in December 2015. Solid cash and term deposits of €30.1m (net cash of €7.1m) at the end of Q216 were significantly boosted with the new debt of €10.5m in May. Oryzon has a history of efficient use of available public grants, which could provide further non-dilutive financing.

Clinical trials progress, new preclinical candidate

Oryzon’s near-term focus is its lead product ORY-1001, lysine specific demethylase 1 (LSD1) inhibitor, which is currently in the second part of a Phase I/IIa trial with different subsets of acute leukaemia patients. ORY-2001 (dual LSD1 and monoamine oxidase B inhibitor), which is being developed for Alzheimer’s disease (AD), entered a Phase I trial in Q116 with healthy volunteers to establish safety/tolerability. The company announced in July that safety/tolerability of a single dose of ORY-2001 in 40 healthy volunteers was satisfactory and the trial is now progressing with multiple ascending doses and is expected to recruit 48 additional volunteers. As guided previously, Phase II with AD patients could start in H117. In separate news in July, Oryzon revealed its third preclinical candidate, ORY-3001, which is also an LSD1 inhibitor. The precise indication has not been named, but the company said it will target non-oncological conditions. ORY-3001 could enter the clinic in H217 subject to passing animal toxicology studies.

Valuation: Risk-adjusted NPV of €158m or €5.5/share

We value Oryzon at a virtually unchanged €158m (previously €160m) or €5.5/share (previously €5.6/share), based on a risk-adjusted NPV, which includes €7.1m net cash at end Q216. Changes to our valuation include the updated net cash position, fine-tuning our near-term forecasts and rolling our model forward by one quarter. The upcoming Phase I/IIa data will potentially provide a catalyst for value inflection.

ORY-1001 to deliver preliminary clinical data end-2016

ORY-1001 is a first-in-class inhibitor of LSD1, partnered with Roche, and represents a second-generation epigenetic therapeutic agent with increased specificity and a novel target compared to a handful of approved first-generation HDAC inhibitors. As a reminder, ORY-1001 was the first specific LSD1 inhibitor to enter a clinical trial in January 2014. Part one of the Phase I/IIa study included patients with relapsed or refractory acute leukaemia and demonstrated preliminary safety and tolerability. Part two started in November 2015, enrolling genetically selected patients with different subpopulations of acute myeloid leukaemia (AML) including mixed lineage leukaemia (MLL). This extension arm will also provide preliminary efficacy data and thus represents the next milestone event for the company. The results are expected to be presented at the American Society of Hematology (ASH) annual meeting on 3-6 December 2016.

Next steps with ORY-1001

Based on findings in the Phase I/IIa Part two, Roche will decide the way forward to Phase II, which is when there will be more clarity as to exactly which acute leukaemia patient subpopulations will be targeted with ORY-1001.

Valuation

We value Oryzon at €158m or €5.5/share, based on a risk-adjusted NPV analysis, which includes €7.1m net cash at end Q216. Fine-tuning our near-term forecasts did not significantly affect our long-term product forecasts or valuation. Rolling out model forward by one quarter mostly offset the decrease in the net cash position (with the new debt). We use a 12.5% discount rate, with probabilities of reaching the market of 15% and 12% for ORY-1001 and ORY-2001, respectively.

Exhibit 1: Oryzon rNPV valuation

Product

Indication

Launch

Peak sales
(US$m)

Value
(€m)

Probability

(%)

rNPV
(€m)

NPV/share (€/share)

ORY-1001

AML

2022

900

240.1

15%

42.8

1.5

ORY-1001

SCLC

2025

630*

113.7

8%

16.1

0.6

ORY-2001

AD

2026

4,510*

757.1

12%

91.8

3.2

Net cash (Q216)

7.1

100%

7.1

0.2

Valuation

 

 

1,118.0

157.7

5.5

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.

We do not include the new preclinical candidate in our valuation yet, which we will revisit once more details have emerged. Currently our valuation is based on clinical-stage compounds and one preclinical indication (Exhibit 1). ORY-1001 has been partnered with Roche since April 2014 (for deal details see our previous report). After completion of the ongoing Phase I/IIa, Roche will be solely responsible for further clinical development and commercialisation of ORY-1001 and could expand beyond acute leukaemia. Specifically, we include ORY-1001 to be developed for small cell lung cancer (SCLC), because, in our view, this indication appears to be the most likely indication for Roche to expand. GlaxoSmithKline (GSK) has an LSD1 inhibitor, GSK2879552, in Phase I for SCLC and showed the compound’s activity in SCLC cell lines and in SCLC xenograft models, providing support for the use of LSD1 inhibitors in non-haematological cancers.1 As GSK’s interest in GSK2879552 validates LSD1 inhibition potential in SCLC and the SCLC market is larger than AML’s, Roche may be interested in expanding to this indication.

  T. Maes et al. KDM1 histone lysine demethylases as targets for treatments of oncological and neurodegenerative disease. Epigenomics (2015) 7(4), 609–626.

ORY-2001 is still unpartnered, but Oryzon’s strategy is to develop the asset until clinical proof-of-concept stage and then seek to out-license it. We have assumed a licensing deal for this asset in our model (see our initiation report for more details).

Financials

In H116 Oryzon reported revenues of €477k, 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 income after a milestone payment of $4m from Roche in July 2015. In addition, the company recorded €1.8m 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.

We have revised our near-term financial forecasts, while our projections for Oryzon’s products remain unchanged; therefore estimate revisions did not have a significant effect on our valuation. The increase in 2016 and 2017 revenue estimates come from higher R&D costs projections, which allow for more spending to be capitalised, as explained above. The increase in our R&D cost estimates mostly reflects higher overall activity, including the preclinical development with a new candidate ready for toxicological studies. G&A costs were higher year-on-year, reflecting headcount and compliance costs; we therefore increased our projections for FY16 and FY17 as well. This led to our loss per share estimates falling from €0.14 to €0.18 in FY16 and from €0.20 to €0.23 in FY17.

We forecast a comfortable 2016 year-end cash position of €25.0m (cash and term deposits classed as other current assets). In total, during the past 12-18 months Oryzon has managed to attract €27m in new funding from various sources. In addition, Oryzon has a history of efficient use of available public grants, which could provide further non-dilutive financing.

Exhibit 2: Key changes to our financial forecasts

€m

2015

2016e

2017e

Actual

Old

New

Change (%)

Old

New

Change (%)

Revenue

7.185

3.047

3.886

+28%

2.170

2.467

+14%

Gross profit

7.185

3.047

3.886

+28%

2.170

2.467

+14%

Operating profit (reported)

(0.233)

(4.022)

(4.612)

N/A

(5.052)

(5.590)

N/A

Profit before tax (reported)

(0.955)

(4.391)

(5.474)

N/A

(5.574)

(6.433)

N/A

Profit after tax (reported)

(0.992)

(4.053)

(5.107)

N/A

(5.574)

(6.433)

N/A

EPS reported (€)

(0.04)

(0.14)

(0.18)

N/A

(0.20)

(0.23)

N/A

Source: Oryzon accounts, Edison Investment Research

Exhibit 3: Financial summary

EUR'000s

2012

2013

2014

2015

2016e

2017e

December

Local GAAP

Local GAAP

Local GAAP

Local GAAP

Local GAAP

Local GAAP

PROFIT & LOSS

Revenue

 

 

4,353

2,360

15,536

7,185

3,886

2,467

Cost of Sales

0

0

0

0

0

0

Gross Profit

4,353

2,360

15,536

7,185

3,886

2,467

Research and development

(876)

(873)

(1,108)

(3,191)

(4,574)

(3,774)

EBITDA

 

 

856

(94)

11,659

688

(3,686)

(4,590)

Operating Profit (before amort. and except.)

559

(370)

11,398

448

(3,804)

(4,708)

Intangible Amortisation

(455)

(657)

(657)

(657)

(808)

(882)

Exceptionals

0

(186)

(4,617)

(24)

0

0

Other

0

0

0

0

0

0

Operating Profit

104

(1,213)

6,124

(233)

(4,612)

(5,590)

Exceptionals

(220)

0

667

(169)

0

0

Net Interest

(582)

(672)

(52)

(553)

(861)

(843)

Profit Before Tax (norm)

 

 

(23)

(1,042)

11,346

(105)

(4,665)

(5,551)

Profit Before Tax (reported)

 

 

(698)

(1,885)

6,739

(955)

(5,474)

(6,433)

Tax

90

89

(88)

(37)

367

0

Profit After Tax (norm)

67

(953)

11,258

(142)

(4,298)

(5,551)

Profit After Tax (reported)

(608)

(1,796)

6,651

(992)

(5,107)

(6,433)

Average Number of Shares Outstanding (m)

23.0

23.0

23.3

24.5

28.5

28.5

EPS - normalised (EUR)

 

 

0.00

(0.04)

0.48

(0.01)

(0.15)

(0.19)

EPS - (reported) (EUR)

 

 

(0.03)

(0.08)

0.29

(0.04)

(0.18)

(0.23)

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 (%)

19.7

N/A

75.0

9.6

N/A

N/A

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

12.8

N/A

73.4

6.2

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

18,765

20,128

16,059

18,050

20,852

22,319

Intangible Assets

15,062

15,825

12,928

15,188

17,770

19,355

Tangible Assets

1,485

1,159

981

854

736

618

Investments

2,217

3,145

2,150

2,008

2,346

2,346

Current Assets

 

 

3,808

2,851

9,999

22,681

26,511

16,473

Stocks

19

2

9

4

10

7

Debtors

977

663

704

940

1,538

1,239

Cash

2,302

2,033

3,633

19,467

19,342

9,605

Other

510

153

5,654

2,270

5,621**

5,621**

Current Liabilities

 

 

(2,283)

(2,724)

(3,969)

(5,296)

(4,327)

(4,102)

Creditors

(765)

(1,005)

(1,299)

(2,401)

(1,432)

(1,737)

Short term borrowings

(1,519)

(1,719)

(2,670)

(2,895)

(2,895)

(2,365)

Long Term Liabilities

 

 

(9,949)

(11,251)

(8,196)

(7,841)

(20,549)

(18,636)

Long term borrowings

(7,963)

(9,117)

(6,420)

(6,177)

(19,077)

(18,007)

Other long term liabilities

(1,986)

(2,134)

(1,776)

(1,664)

(1,472)

(629)

Net Assets

 

 

10,341

9,004

13,893

27,594

22,487

16,054

CASH FLOW

Operating Cash Flow

 

 

1,420

(113)

12,178

1,076

(9,245)

(4,827)

Net Interest

(582)

(672)

(52)

(553)

(861)

(843)

Tax

0

0

0

0

367

0

Capex

0

0

0

0

0

0

Acquisitions/disposals

107

(677)

798

0

0

0

Financing

0

0

0

14,725

0

0

Other

(8,125)

(161)

(9,579)

605

(3,286)*

(2,467)*

Dividends

0

0

0

0

0

0

Net Cash Flow

(7,180)

(1,623)

3,345

15,853

(13,025)

(8,136)

Opening net debt/(cash)

 

 

0

7,180

8,803

5,458

(10,395)

2,630

HP finance leases initiated

0

0

0

0

0

0

Other

0

0

0

0

0

0

Closing net debt/(cash)

 

 

7,180

8,803

5,458

(10,395)

2,630

10,767

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

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 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). 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Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 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. 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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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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