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Hybrigenics — Update 6 December 2016

Hybrigenics — Update 6 December 2016

Hybrigenics

Analyst avatar placeholder

Written by

Hybrigenics

First patients enrolled in AML Phase II trial

H116 results and business update

Pharma & biotech

6 December 2016

Price

€0.78

Market cap

€30m

Net cash (€m) at June 2016

8.0

Shares in issue

35.8m

Free float

100%

Code

ALHYG

Primary exchange

Alternext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

11.8

(5.6)

(26.7)

Rel (local)

7.5

(5.6)

(24.4)

52-week high/low

€1.20

€0.71

Business description

Hybrigenics is a French biotech company. It provides protein-protein, genetic and small molecule analysis services and is conducting Phase II studies on lead drug inecalcitol in orphan adult leukaemias: chronic lymphocytic leukaemia, chronic myeloid leukaemia and acute myeloid leukaemia.

Next events

Phase II data in CML

YE16/Q117

Orphan designation in CML in the EU and US

2017

Phase II data in AML

YE18/H119

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Lala Gregorek

+44 (0)20 3681 2527

Hybrigenics is a research client of Edison Investment Research Limited

Hybrigenics has started dosing the first patients in France and the US in a double-blind, placebo-controlled Phase II study in elderly or frail acute myeloid leukaemia (AML) patients. Data are expected in Q418 or H119. Additionally, an open-label Phase II study in patients with chronic myeloid leukaemia (CML) in combination with imatinib continues; an update will be provided by Q117. Hybrigenics has an R&D collaboration with Servier focused on oncology, from which it received a €1.5m milestone payment in H216. Our updated valuation is €146.1m or €4.1/share.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/14

6.8

(2.2)

(8.5)

0.0

N/A

N/A

12/15

6.5

(3.9)

(11.4)

0.0

N/A

N/A

12/16e

7.5

(4.2)

(11.8)

0.0

N/A

N/A

12/17e

8.0

(4.4)

(12.4)

0.0

N/A

N/A

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

Phase II trial in AML starts, CML study continues

During H216 Hybrigenics commenced dosing of the first patients in France and the US in its Phase II trial in AML patients unfit for chemotherapy. The company will test inecalcitol vs placebo in 110 patients and present overall survival data in Q418 or H119. Furthermore, a Phase II study in patients with CML in combination with imatinib continues; an update is expected by Q117. The collaboration with Servier has been renegotiated and is now focused on oncology. Hybrigenics received a €1.5m milestone payment from Servier. An additional €12m is due on completion of undisclosed development and regulatory targets. In vitro data showing the increase of CD38 expression were presented at the annual meeting of the American Society of Hematology (ASH).

Company reports H116 results

For the first half of 2016 services revenues increased by 5% to €1.7m vs €1.5m in H115. Research subsidies, subleases, services to subleasers and current year research tax credits amounted to €1m vs €0.9m in H115, which drove total revenues to €2.7m (vs €2.8m in H115). No research payments from Servier were received in H116; the €1.5m milestone payment will be recognised in H216. Operating expenses are €4m vs €3.8m in H115. Cash burn was c €3m for H116 vs €2.8 in H115, and cash and equivalents stood at €8.4m, which provides funding into 2017.

Valuation: Updated valuation of €146.1m or €4.1/share

We are updating our valuation to €146.1m or €4.1/share vs €137m and €3.8 per share previously. We are now including the €12m risk-adjusted milestone payments from the collaboration with Servier, updating for end-2016 cash, rolling the valuation forward in time and making other minor adjustments.

Phase II study in AML starts, H116 results published

Hybrigenics has enrolled the first patients in a Phase II study of inecalcitol in patients with acute myeloid leukaemia. The study is a double-blind, placebo-controlled trial that will recruit 110 patients (55 in the US and 55 in France) unfit for chemotherapy. Daily oral inecalcitol (4mg) or placebo will be administered to patients that can only receive monthly cycles of decitabine infusions. The trial’s protocol is the same for France and the US, with the primary endpoint of overall survival and secondary endpoints of response rate and tolerance. The first patient was enrolled in September 2016 in France and in November 2016 in the US. Data will read out in late 2018 or H119. This clinical study builds on preclinical data presented at the 12th International Congress on Targeted Anticancer Therapies in 2014, in which inecalcitol prolonged survival and reduced splenomegaly (increase in spleen size and weight) in animal models of AML.

Furthermore, Hybrigenics is running an open-label, exploratory Phase II study in patients with CML in combination with imatinib (Gleevec, Novartis). Inecalcitol in combination with imatinib has demonstrated synergistic effects in experiments in vitro by inhibiting the proliferation of CML stem cells, which are involved in relapse. The trial aims to replicate this effect and prolong remission or eliminate the disease altogether. It started in January 2015 and is expected to end in H117, with an interim update by Q117.

Inecalcitol has also been tested in a Phase II study in chronic lymphocytic leukaemia (CLL). Clinical data in early-stage untreated patients with CLL were published in July 2014 showing that inecalcitol was able to slow the progression of disease in half of patients. Of 21 evaluable CLL patients, 11 experienced stabilisation of disease as measured by their blood lymphocyte counts (BLC), including one patient who achieved a 95% decrease in BLC after 10 months of treatment. In CLL, inecalcitol is positioned as a treatment that can delay the start of chemotherapy. This programme is awaiting further funding before commencing Phase III trials.

Hybrigenics has to date met the oncology research targets of its agreement with Servier. Hybrigenics and Servier have a research agreement to explore new inhibitors of Ubiquitin-Specific Proteases (USPs). After completing this milestone, Hybrigenics received a payment of €1.5m. Up to €12m development and regulatory milestone payments are associated with this R&D programme in oncology.

The company presented additional in vitro data at the 58th annual meeting of ASH in San Diego, US. New data showed that inecalcitol stimulates the expression of CD38 in cell lines of multiple myeloma (MM), which indicates that inecalcitol could increase the response to anti-CD38 monoclonal antibodies in this indication.

Exhibit 1: Clinical pipeline (all inecalcitol)

Indication

Status

Setting

Notes

CLL

Phase II completed

Monotherapy/untreated/
high risk of progression

21 untreated pts dosed with 2mg oral inecalcitol for at least five months; disease progression was halted in 11 patients (52% of cases). Designated as orphan drug in the EU/US. Next stage is Phase III disease progression study.

CML

Phase II ongoing with potential interim results in 2016

+ first-line treatment/stable chronic phase

50 pts across six centres.

AML

Phase II start mid-2016

Newly diagnosed frail or elderly pts ineligible for standard chemo + decitabine or azacitidine

Trials in the US and France started. Primary completion date June 2018. Designated as orphan drug in the US and EU.

CRPC

Phase IIa completed

+ docetaxel/all

Dose-finding and safety study established daily 4mg oral dose – 40 out of 47 of patients exhibited an 85% reduction in PSA levels within three months, compared to a 65% reduction in PSA levels on docetaxel alone (in external registration study).

Phase IIb proof-of-concept next development stage.

Source: Hybrigenics, Edison Investment Research

Inecalcitol’s IP is secured until 2030 in the EU and until 2031 in the US and other key countries. Moreover, inecalcitol has orphan drug designation in the EU and US for AML and CLL. Hybrigenics is in the process of applying for orphan status in CML in the EU and US.

H116 financial results released

For the first half of 2016 services revenues increased by 5% to €1.7m vs €1.5m in H115. Total revenues including subsidies and research tax credits amounted to €2.7m (vs €2.8m in H115). We forecast H216 services revenues of €2.5m, reflecting the seasonality of the business in which approximately one-third of services revenues occur in the first half of the year and two-thirds in the second half. We project FY16 revenues of €7.6m (vs c €6.5m in FY15), which include the €1.5m milestone payment from Servier.

Operating expenses were c €4m in H116, similar to H115 (€3.8m). We model a 10% uptick in the second half of 2016 due to R&D expenses, mostly from the AML study. This would result in total expenses of €8.2m vs €7m in 2015, and an operating profit of almost €5m for FY16, vs €4.4m in 2015.

During H116 cash burn was c €3m, similar to €2.8 in H115. At the end of H116, cash and equivalents were €8.4m, which we expect to provide funding well into 2017. We project a cash shortfall at the end of 2017; thus, we include €1m as long-term debt. There will be another shortfall in 2018, which can be covered by other forms of funding such as a capital raise or a partnership. The undrawn €5m equity line with Yorkville will expire at end of 2016 and the company does not plan to use it.

Updating our DCF-based valuation to €146.1m

We are updating our valuation to €146.1m or €4.1/share vs €137m and €3.8 per share previously. The main changes are the inclusion of risk-adjusted milestone payments from the collaboration with Servier. We also update for end-2016 cash, roll the model forward in time and include a slower uptake in CLL. The main value driver is inecalcitol, while we value the Services Division at 2x FY16e revenue at €8.4m.

Exhibit 2: Valuation assumptions for inecalcitol

Status

Launch date

Peak sales ($m)

Risk adjustment

Market penetration

Royalty

Inecalcitol CLL – US

Phase III ready

2023

180

30%

15%

25%

Inecalcitol CLL – EU

Phase III ready

2023

180

30%

15%

N/A

Inecalcitol CML

Phase II

2020

257

30%

15%

25%

Inecalcitol AML – US

Phase II

2020

62

30%

15%

25%

Inecalcitol AML – EU

Phase II

2020

45

30%

15%

N/A

Source: Edison Investment Research

Exhibit 3: rNPV valuation

Driver

Value per share (€)

Value (€m)

Inecalcitol CLL – US

0.8

29.0

Inecalcitol CLL – EU

2.1

76.0

Inecalcitol AML – US

0.3

12.2

Inecalcitol AML – EU

0.6

23.2

Inecalcitol CML

1.5

55.2

Milestones

0.3

11.5

Services Division

0.2

8.4

Servier collaboration

0.1

2.3

Risk-adjusted expenses including R&D

(0.6)

(22.3)

Tax

(1.6)

(56.6)

Net cash at end FY16

0.2

7.2

Total

4.1

146.1146.1

Number of shares

35.8

Source: Edison Investment Research

Exhibit 4: Financial summary

€'000s

2014

2015

2016e

2017e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

6,774

6,483

7,542

8,010

Cost of sales

(3,417)

(3,858)

(4,244)

(4,583)

Gross profit

3,357

2,625

3,298

3,426

EBITDA

 

 

(2,081)

(3,811)

(4,266)

(4,380)

Operating profit (before GW and except)

 

(2,170)

(3,961)

(4,416)

(4,530)

Intangible amortisation

(89)

(150)

(150)

(150)

Exceptionals

0

0

0

0

Share-based payments

(201)

(225)

(236)

(248)

Operating profit

(2,539)

(4,414)

(4,880)

(5,006)

Net interest

(26)

49

177

87

Profit before tax (norm)

 

 

(2,209)

(3,874)

(4,239)

(4,444)

Profit before tax (reported)

 

 

(2,499)

(4,327)

(4,703)

(4,920)

Tax

0

(14)

0

0

Profit after tax (norm)

(2,209)

(3,888)

(4,239)

(4,444)

Profit after tax (reported)

(2,578)

(4,341)

(4,703)

(4,920)

Average number of shares outstanding (m)

25.9

34.2

35.8

35.8

EPS - normalised (c)

 

 

(8.5)

(11.4)

(11.8)

(12.4)

EPS - FRS 3 (c)

 

 

(9.7)

(12.7)

(13.1)

(13.7)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross margin (%)

50%

40%

44%

43%

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

 

 

1,837

1,717

1,463

1,233

Intangible assets

1,023

820

670

520

Tangible assets

598

585

504

423

Investments

216

312

289

290

Current assets

 

 

15,708

19,584

15,348

11,907

Stocks

262

150

165

126

Debtors

1,701

1,513

1,760

1,869

Cash

9,644

11,716

7,218

3,707

Other

4,101

6,205

6,205

6,205

Current liabilities

 

 

(3,018)

(2,135)

(2,139)

(2,142)

Creditors

(2,116)

(1,787)

(1,789)

(1,791)

Short-term borrowings

(862)

(288)

(288)

(288)

Other

(40)

(60)

(62)

(64)

Non-current liabilities

 

 

0

(629)

(629)

(1,629)

Long-term borrowings

0

(114)

(114)

(1,114)

Other

0

(515)

(515)

(515)

Net assets

 

 

14,527

18,537

14,043

9,369

CASH FLOW

Operating cash flow

 

 

(3,042)

(5,262)

(4,528)

(4,450)

Net interest

49

28

177

87

Tax

0

(14)

0

0

Capex

(455)

(395)

(147)

(147)

Payment of deferred consideration

0

0

0

0

Capitalisation of development costs

0

0

0

0

Expenditure on intangibles

0

0

0

0

Acquisitions/disposals

0

(153)

0

0

Financing

11,619

8,331

0

0

Dividends

0

0

0

0

Net cash flow

8,171

2,535

(4,498)

(4,510)

Opening net debt/(cash)

 

 

(1,611)

(8,782)

(11,314)

(6,816)

HP finance leases initiated

0

0

0

0

Other

(1,000)

(3)

0

0

Closing net debt/(cash)

 

 

(8,782)

(11,314)

(6,816)

(2,305)

Source: Company accounts, Edison Investment Research

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 Hybrigenics 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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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 Hybrigenics 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

Acal — Update 6 December 2016

Acal

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