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Genticel — Update 19 December 2016

Genticel — Update 19 December 2016

Genticel

Analyst avatar placeholder

Written by

Genticel

Final preclinical SIIL milestone achieved

Business update

Pharma & biotech

19 December 2016

Price

€2.57

Market cap

€40m

Net cash (€m) at end Q316

12.3

Shares in issue

15.6m

Free float

39%

Code

GTCL

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

76.0

29.1

(58.5)

Rel (local)

64.3

17.4

(60.3)

52-week high/low

€6.71

€1.30

Business description

Genticel is a development-stage biotechnology company focused on innovative immunotherapies. The company has Vaxiclase technology, which is part of a collaboration with the Serum Institute of India (SIIL). Genticel has offices in Toulouse and Paris.

Next events

In-licensing activities

2017

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Lala Gregorek

+44 (0)20 3681 2527

Genticel is a research client of Edison Investment Research Limited

Genticel has received a milestone payment of $1.2m from the Serum Institute of India (SIIL). This is the last milestone Genticel will receive associated with the preclinical development of GTL003 in new multivalent vaccines that contain pertussis (whooping cough). SIIL can now finish formal preclinical development before moving to clinical development, which could unlock further milestone payments. Under the collaboration with SIIL, Genticel is entitled to up to $57m development and sales milestone payments and single-digit royalties on net sales. Cash and equivalents at end Q316 were €12.3m. Our valuation is under review following the termination of the GTL001 and GTL002 programmes.

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/14

0.00

(10.81)

(78.1)

0.0

N/A

N/A

12/15

0.18

(11.19)

(72.1)

0.0

N/A

N/A

12/16e

N/A

N/A

N/A

N/A

N/A

N/A

12/17e

N/A

N/A

N/A

N/A

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments. 2014 restated due to IFRS adjustments.

Collaboration with SIIL continues as planned

The agreement with SIIL involves the evaluation of GTL003 in multivalent vaccines containing pertussis antigens. The most important is the DTaP vaccine which protects against diphtheria, tetanus and pertussis in a single shot; 86% of children aged 12-23 months receive this vaccine (source: World Bank), representing a significant opportunity. SIIL is using Genticel's engineered Bordetella pertussis's adenlylate cyclase GTL003, which induces strong IFN gamma and IL-17 responses. This represents the last milestone that Genticel will receive for the preclinical development of GTL003. The next milestones will be related to clinical development and sales performance.

Search for projects continues, IP reinforced

Genticel has engaged Eumedix, a consultancy specialised in advising healthcare and biotech companies in fundraising and corporate transactions, to help in the process to access external drug candidates. We have placed our valuation under review pending any future deal(s). Additionally, the patent covering Vaxiclase, when used as a product (as in its partnership with SIIL), has been granted by the US Patent and Trademark Office (USPTO) with number 9,499,809 and title “CyaA-based chimeric proteins comprising a heterologous polypeptide and their uses in the induction of immune responses”.

Valuation: Under review

We have placed our valuation and financial forecasts under review pending the in-licensing of new asset(s). Our previous valuation was €36m or €2.31/share before dilution based on the GTL001 programme. Genticel recently announced that it no longer intends to pursue the development of GTL001 and GTL002.

Deal with Serum Institute of India progresses

Genticel has received a milestone payment of $1.2m from the SIIL. This is the last milestone associated with preclinical research on GTL003 to which Genticel is entitled; hence, SIIL can now finish formal preclinical testing before starting clinical trials of GTL003 with multivalent vaccines that include Bordetella pertussis antigens, the causative agent of whooping cough.

The partnership with SIIL started in February 2015. As part of the agreement, Genticel licensed GTL003, its Vaxiclase technology, as an antigen to SIIL for use in the development of acellular multivalent combination vaccines that include pertussis antigens. The licence covers all countries of the world except the US, Europe, Canada, New Zealand, Australia, Japan, Israel and Turkey. Genticel is eligible for up to $57m in upfront, development and sales milestone payments, as well as single-digit royalties on net sales. To date, Genticel has received a $100k upfront payment and $350k in milestone-related revenues from SIIL, in addition to the recent $1.2m milestone payment.

SIIL is the world's largest producer of vaccines, with more than 1.3 billion doses sold annually. Among other vaccines, SIIL produces the measles and DTP (diphtheria, tetanus and pertussis) group of vaccines. Around 65% of children immunised globally are vaccinated with a product manufactured by SIIL. However, the commercial market in emerging countries is much smaller than developed countries, being 80% of the world’s population but only 20% of the market.

Pertussis as the backbone of current vaccination programmes

Most pertussis vaccines are administered in combination with diphtheria and tetanus, bacterial diseases that can be vaccinated against with a single shot (DTP). Approximately 86% of the world’s population is vaccinated with DTP, according to the WHO. The estimated global market for DTP vaccines that contain the acellular pertussis antigen exceeds $2bn per year according to Genticel. Additionally, Bordetella pertussis antigens are included in multiple complex vaccination schedules, often for hepatitis B (HB), polio (IPV) and influenza B (Hib). According to recent research, there is a resurgence of whooping cough in countries with high vaccination coverage due to short duration of efficacy from current acellular pertussis (aP) vaccines. Therefore, there is a need for an improved aP primary and boost vaccination for longer-lasting protection and greater effectiveness against colonisation.

Exhibit 1: Basics of whooping cough (pertussis).

Aspects

Comments

What is whooping cough?

Whooping cough (pertussis) is an infection of the respiratory system caused by the bacterium Bordetella pertussis. It takes about 7-10 days for symptoms to appear. Symptoms are usually mild at first and resemble those of a common cold (runny nose, nasal congestion, fever, mild cough). After one to two weeks symptoms worsen and can include vomiting, red or blue face, fatigue and a characteristic whooping sound during the next breath of air.

Complications

Complications arise in approximately 5-6% of cases, with bronchopneumonia and encephalitis the most common. In developed countries, there are around one in 1,000 deaths per year, which increases to 40 per 1,000 in infants in developing countries (source: WHO). According to the US CDC, there are an estimated 16 million cases of whooping cough worldwide and about 195,000 deaths per year. 90% of these are in developing countries.

Vaccination schedule

Whooping cough is prevented with the pertussis vaccine, which is included in multiple, complex vaccination schedules, eg DTP. All children should receive five doses of DTP vaccine at six weeks, 10 weeks and 14 weeks, with a first booster at 16-18 months and a second booster at five years.

Types of vaccines

There are two types of pertussis vaccines: whole-cell (wP) and acellular (aP). wP has all antigens of Bordetella pertussis, manufacturing methods vary among producers, it has heterogeneous efficacy (46-92% protection for DTwP) and is used less often nowadays. aP has highly purified selected antigens, although the number and type of antigens vary across manufacturers, with homogeneous efficacy at 85%. Most are combined with tetanus and diphtheria, named DTwP or DTaP.

Aspects

What is whooping cough?

Complications

Vaccination schedule

Types of vaccines

Comments

Whooping cough (pertussis) is an infection of the respiratory system caused by the bacterium Bordetella pertussis. It takes about 7-10 days for symptoms to appear. Symptoms are usually mild at first and resemble those of a common cold (runny nose, nasal congestion, fever, mild cough). After one to two weeks symptoms worsen and can include vomiting, red or blue face, fatigue and a characteristic whooping sound during the next breath of air.

Complications arise in approximately 5-6% of cases, with bronchopneumonia and encephalitis the most common. In developed countries, there are around one in 1,000 deaths per year, which increases to 40 per 1,000 in infants in developing countries (source: WHO). According to the US CDC, there are an estimated 16 million cases of whooping cough worldwide and about 195,000 deaths per year. 90% of these are in developing countries.

Whooping cough is prevented with the pertussis vaccine, which is included in multiple, complex vaccination schedules, eg DTP. All children should receive five doses of DTP vaccine at six weeks, 10 weeks and 14 weeks, with a first booster at 16-18 months and a second booster at five years.

There are two types of pertussis vaccines: whole-cell (wP) and acellular (aP). wP has all antigens of Bordetella pertussis, manufacturing methods vary among producers, it has heterogeneous efficacy (46-92% protection for DTwP) and is used less often nowadays. aP has highly purified selected antigens, although the number and type of antigens vary across manufacturers, with homogeneous efficacy at 85%. Most are combined with tetanus and diphtheria, named DTwP or DTaP.

Source: Edison Investment Research.

Genticel’s approach: Re-engineering Bordetella pertussis’s CyA

The enzyme adenylate cyclase (CyA) is used by Bordetella pertussis as a mechanism of protection from the immune system by rapidly entering white immune cells and breaking down the chemical energy source of the cell, adenosine triphosphate (ATP). Scientists at the Institut Pasteur developed an antigen delivery technology based on CyA from Bordetella pertussis and engineered CyA to remove the toxic enzyme activity so that immune cells are unharmed by the engineered protein. CyA is an excellent delivery vehicle as it enters the cell quickly without damaging it. Institut Pasteur demonstrated that it was possible to insert an antigen in the CyaA protein to activate the immune system against cells marked by that antigen (eg cells infected by the HPV virus). The resulting recombinant protein is suited to the development of immunotherapies.

Vaxiclase is Genticel’s proprietary technology that overcomes the limitation of current CyA that only one antigen per CyA protein can be delivered. More variants of CyA could be produced, but that is expensive. Thus, Vaxiclase uses a next-generation CyA protein to enable more antigens to be incorporated. Genticel has used Vaxiclase as a vector to carry other antigens to activate antigen-specific killer and helper T cells. In particular, Genticel's immunotherapeutic product, GTL002, contains antigens of six HPV types, compared to GTL001, which contains antigens of two HPV types.

In contrast, the deal with SIIL involves the use of Vaxiclase as an antigen (GTL003), with no exogenous antigens inserted. GTL003 aims to improve the duration of protection of aP vaccines, but with a good tolerability ie to achieve equivalent protection as the old generation of whole-cell pertussis vaccines but without their high reactogenicity.

Exhibit 2: Financial summary

€000s

2014

2015

Year end 31 December

IFRS

IFRS

PROFIT & LOSS

Revenue

 

0

178

Cost of Sales

0

0

Gross Profit

0

178

EBITDA

 

(10,885)

(11,361)

Operating Profit (before amort. and except.)

(10,912)

(11,412)

Intangible Amortisation

(8)

(4)

Exceptionals

0

0

Other

0

0

Operating Profit

(10,920)

(11,417)

Net Interest

105

223

Profit Before Tax (norm)

 

(10,808)

(11,189)

Profit Before Tax (FRS 3)

 

(10,815)

(11,193)

Tax

0

0

Profit After Tax (norm)

(10,780)

(11,137)

Profit After Tax (FRS 3)

(10,815)

(11,193)

Average Number of Shares Outstanding (m)

13.8

15.4

EPS - normalised (c)

 

(78.1)

(72.1)

EPS - (IFRS) (c)

 

(78.4)

(72.5)

Dividend per share (p)

0.0

0.0

Gross Margin (%)

NA

NA

EBITDA Margin (%)

NA

NA

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

NA

NA

BALANCE SHEET

Fixed Assets

 

228

346

Intangible Assets

19

54

Tangible Assets

95

156

Fixed term investments

10,076

5,154

Other

114

137

Current Assets

 

25,899

20,388

Stocks

31

53

Debtors

236

653

Cash

22,727

16,682

Other

2,904

3,000

Current Liabilities

 

(3,960)

(3,331)

Creditors

(3,448)

(2,710)

Short term borrowings

(512)

(621)

Long Term Liabilities

 

(2,026)

(2,223)

Long term borrowings

(1,646)

(1,901)

Other long term liabilities

(380)

(322)

Net Assets

 

20,141

15,180

CASH FLOW

Operating Cash Flow

 

(9,952)

(11,968)

Net Interest

105

223

Tax

0

0

Capex

(73)

(152)

Acquisitions/disposals

0

0

Equity Financing

41,353

318

Other items

(2,602)

568

Net Cash Flow

28,831

(11,010)

Opening net debt/(cash)

 

(2,125)

(30,645)

HP finance leases initiated

0

0

Other

(311)

(433)

Closing net debt/(cash)

 

(30,645)

(19,203)

Source: Edison Investment Research, Genticel accounts

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 Genticel 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 2016. “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.

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US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

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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

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 Genticel 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 2016. “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

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

Canadian Overseas Petroleum — Update 19 December 2016

Canadian Overseas Petroleum

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