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Hybrigenics — Leukaemia pipeline advances with new data

Hybrigenics — Leukaemia pipeline advances with new data

Hybrigenics has published data from a Phase II study in chronic myeloid leukaemia (CML). After one year of treatment, 40% of patients showed improvements beyond a major molecular response (MMR) and 20% achieved a deep molecular response (DMR), consistent with a functional cure. The ongoing Phase II trial in acute myeloid leukaemia (AML) will complete enrolment before end 2018, with data readout in 2019. Hybrigenics has completed its refocusing on R&D with the sale of the genomics division, Helixio. The internal R&D programme on ubiquitin-specific proteases (USP) inhibition continues. Hybrigenics also has an R&D partnership with Servier focused on oncology worth up to €12m. Cash at end 2017 was €7m. Our valuation is €129.5m or €2.77/share.

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Written by

Hybrigenics

Leukaemia pipeline advances with new data

FY17 update

Pharma & biotech

24 May 2018

Price

€0.44

Market cap

€20m

Net cash (€m) at 31 December 2017

6.9

Shares in issue

46.8m

Free float

90%

Code

ALHYG

Primary exchange

Euronext Growth

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(19.4)

(22.0)

(43.1)

Rel (local)

(21.2)

(25.3)

(45.5)

52-week high/low

€0.8

€0.4

Business description

Hybrigenics is a French biotech company. It is developing its lead drug, inecalcitol, against orphan adult leukaemias and is currently conducting an international Phase II study in acute myeloid leukaemia. The company has a research programme on USP inhibitors and an R&D collaboration with Servier focused on USP inhibitors in oncology.

Next events

Orphan designation in CML in EU and the US

2018

AML Phase II data

2019

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Jonas Peciulis

+44 (0)20 3077 5728

Hybrigenics is a research client of Edison Investment Research Limited

Hybrigenics has published data from a Phase II study in chronic myeloid leukaemia (CML). After one year of treatment, 40% of patients showed improvements beyond a major molecular response (MMR) and 20% achieved a deep molecular response (DMR), consistent with a functional cure. The ongoing Phase II trial in acute myeloid leukaemia (AML) will complete enrolment before end 2018, with data readout in 2019. Hybrigenics has completed its refocusing on R&D with the sale of the genomics division, Helixio. The internal R&D programme on ubiquitin-specific proteases (USP) inhibition continues. Hybrigenics also has an R&D partnership with Servier focused on oncology worth up to €12m. Cash at end 2017 was €7m. Our valuation is €129.5m or €2.77/share.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/16*

2.6

(4.0)

(11.2)

0.0

N/A

N/A

12/17

1.9

(7.3)

(17.7)

0.0

N/A

N/A

12/18e

3.6

(4.1)

(8.7)

0.0

N/A

N/A

12/19e

2.2

(4.0)

(7.6)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation and exceptionals. *12/16 corresponds to retained activities.

CML trial reads out; AML data on track for 2019

In CML a DMR may be considered a functional cure and stopping treatment (even temporarily) can be an option. The Phase II study in CML showed that 40% (8/20) of patients had a decrease of BCL-ABL beyond 3 log, which is an MMR. A decrease of more than 4.5 log was achieved by 20% (4/20) of patients. These data are lower than previous interim data released in February 2017 where MMR was 43% and DMR was 33%. Separately, the Phase II study in AML in combination with decitabine has enrolled 87 of the planned 110 patients. The company expects to complete enrolment by this year’s end and report results in 2019. To maximise the cash runway, Hybrigenics will assess the next studies in CML, chronic lymphocytic leukaemia (CLL) and prostate cancer once the AML data are announced.

R&D refocus completed; USP research continues

Hybrigenics has sold its genomics division, Helixio (financial terms not disclosed), which completes the company’s refocusing on R&D initiated last year with the sale of its controlling stake in Hybrigenics Services, its subsidiary dedicated to proteomics. Hybrigenics is now a pure R&D company focused on inecalcitol and drug discovery of inhibitors of USPs. The company’s broad spectrum USP inhibitor, HBX 47,939, has been shown to inhibit viral replication and decrease the production of new virions in in vitro experiments. Hybrigenics continues its internal R&D programme focused on USP inhibitors, particularly of USP7, USP8 and USP10, for oncology. Hybrigenics also has an R&D collaboration with Servier on USP inhibitors in oncology worth up to €12m in potential payments until registration.

Valuation: rNPV of €129.5m or €2.77/share

Our valuation is now €129.5m or €2.77/share (from €121m or €2.6/share). We have pushed back the launch of inecalcitol in CML by one year. We have rolled the model forward in time and updated the FY17 net cash position of €6.9m.

Advancing leukaemia programmes; AML data in 2019

Data from the CML study showed that after one year, eight out of 20 patients (40%) achieved a reduction of more than 3 log, which is considered a MMR, and four out of 20 patients (20%) achieved a DMR, which is a reduction of 4.5 log or more, meeting the primary endpoint of the trial. In this open-label Phase II study, inecalcitol was administered in combination with oral imatinib in CML patients with incomplete molecular response after at least two years on imatinib. Molecular response is a measure of efficacy used in CML that determines the expression of BCL-ACR by polymerase chain reaction in circulating blood cells. The trial was conducted in France and enrolled 22 patients (from the previous target of 42) of which 20 completed one year of treatment.

Achieving lasting DMRs could reduce treatment costs by taking the patient off treatment earlier. This would represent an innovative approach to improve patients’ quality of life and reduce costs from current expensive treatments. For instance, Gleevec’s list price is $120k per year, per patient in the US; Sprycel and Tasigna cost approximately the same, while in Europe most tyrosine-kinase inhibitors cost around $30k per year per patient. Inecalcitol could fit in this strategy and become an adjunct to other therapies, rather than directly competing with them. We believe the Phase II initial data show the potential impact of inecalcitol on the CML treatment paradigm, due to its benign safety profile and potential to further improve molecular responses leading to discontinuation of treatment and functional cures. This potential, however, will have to be confirmed in randomised, controlled late-stage clinical trials to fully assess the benefit of adding inecalcitol to current treatments in patients with CML.

We note this was a small trial with the inherent biases associated with open-label studies. The lack of a comparator arm further complicates the interpretation of the data. Historic data show 1% DMR at one year in the imatinib arm in the ENESTnd study and 3% in the DASISION study.

We estimate c 14,250 new CML patients per year in the EU and the US (sources: US National Cancer Institute’s Surveillance, Epidemiology and End Results programme and the European Treatment and Outcomes Study for CML). We maintain our forecast of EU/US peak sales for inecalcitol of $257m in CML. Hybrigenics plans to apply for orphan drug status in the EU and US based on these data.

Due to the need to focus resources, Hybrigenics will wait for the outcome of the AML study to decide on the next steps for the CML programme, as well as CLL and prostate cancer. Hybrigenics expects to publish results from the Phase II study with inecalcitol in patients with AML in 2019. Recruitment is well on track to complete its target of 110 patients by this year’s end; 87 patients have been enrolled so far, mostly in the US and France. Other European countries such as Spain and Belgium are recruiting patients. This is a double-blind, placebo-controlled trial in patients over 65 years old and unfit for chemotherapy. Daily doses of oral inecalcitol (4mg) or placebo will be administered to patients who can only receive monthly cycles of decitabine infusions. The primary endpoint is overall survival. Inecalcitol has orphan drug status for AML in Europe and the US.

We estimate c 40,000 new AML patients in the EU and US and forecast inecalcitol peak sales of $119m in this indication.

Financials: FY17 results

Hybrigenics’s full-year 2017 results reflect the R&D reorganisation of the company, which involved the sale of its stakes in Hybrigenics Services, its proteomics subsidiary; and of Helixio, its genomics division. Hybrigenics reports the results of its retained activities, which comprise the development of inecalcitol and research on ubiquitin-specific proteases.

FY17 revenues were c €1.9m, which comprises subleases, services to sub-leasers and 2017 research tax credit. This is a 73% increase compared to other operating revenues of €1.1m in 2016. Total revenues were down 27% from €2.6m in 2016 to €1.9m in 2017 as there were no milestone payments from the ongoing collaboration with Servier. We forecast lower revenues of €3.6m in 2018 vs €5.5m previously due to discontinued revenues from services and less tax credit. We project a potential milestone payment from Servier of €1.5m in 2018.

FY17 operating costs were €9.3m vs €6.6m in FY16. We forecast that there will be a decrease in FY18 operating expenses to €7.7m, down from our previous forecast of €10m due to decreased R&D expenditure as the CML trial was completed before we expected (estimated H218).

Hybrigenics’s net cash position was €6.9m as at end-2017. We estimate this should be sufficient to fund operations into the second half of 2019. However, we expect the group to move into a cash shortfall during 2019, which we have assumed will require new funds of €5m in the form of long-term debt, for modelling purposes.

Valuation: rNPV of €129.5m

Our updated valuation is €129.5m or €2.77/share (previously €121m or €2.6/share). As development in CML is paused until the release of the AML data next year, we have pushed back the launch date by one year, from 2020 to 2021 in the EU and US. This is offset by rolling the model forward in time.

We maintain the probability of success in CML at 40% and 30% in AML. We include inecalcitol in CLL in our valuation with a probability of success of 20%; we will update this next year when the company announces its plans after the release of data from the AML trial.

We include our forecast of the milestone payments from the collaboration with Servier and our forecast of revenues associated with subleases, tax credits and services. We exclude preclinical projects and prostate cancer from our valuation.

Exhibit 1: Financial summary

€'000s

2016*

2017

2018e

2019e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

2,581

1,880

3,568

2,171

Cost of sales

22

0

0

0

Gross profit

2,603

1,880

3,568

2,171

EBITDA

 

 

(3,493)

(6,781)

(3,528)

(3,318)

Intangible amortisation

(119)

(280)

(280)

(280)

Share-based payments

(166)

(68)

(125)

(150)

Operating profit (before amort. and except.)

 

(4,023)

(7,377)

(4,181)

(3,996)

Exceptionals

0

0

0

0

Operating profit

(4,023)

(7,377)

(4,181)

(3,996)

Net interest and other financial items

31

83

121

12

Profit before tax (norm)

 

 

(3,992)

(7,294)

(4,060)

(3,983)

Profit before tax (reported)

 

 

(3,993)

(7,293)

(4,060)

(3,983)

Tax

0

0

0

0

Profit after tax (norm)

(3,992)

(7,293)

(4,059)

(3,981)

Profit after tax (reported)

(3,992)

(7,293)

(4,059)

(3,981)

Discontinued operations

(1,259)

(664)

0

0

Net income (norm)

(3,992)

(7,293)

(4,059)

(3,980)

Net income (reported)

(5,252)

(7,957)

(4,060)

(3,983)

Average number of shares outstanding (m)

35.8

41.3

46.8

52.2

EPS - normalised (c)

 

 

(11.2)

(17.7)

(8.7)

(7.6)

EPS - FRS 3 (c)

 

 

(14.7)

(19.3)

(8.7)

(7.6)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross margin (%)

101%

100%

100%

100%

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

 

 

1,133

1,303

975

646

Intangible assets

524

518

238

-42

Tangible assets

326

238

190

141

Investments

283

547

547

547

Current assets

 

 

15,048

12,570

8,280

9,775

Stocks

55

0

0

0

Debtors

546

1,276

2,422

1,475

Cash

8,489

7,015

1,579

4,020

Other

3,833

4,279

4,279

4,279

Assets held for sale

2,125

0

0

0

Current liabilities

 

 

(4,955)

(4,367)

(3,686)

(3,686)

Creditors

(1,565)

(2,409)

(1,726)

(1,725)

Short-term borrowings

(91)

(97)

(97)

(97)

Other

(1,145)

(1,861)

(1,863)

(1,864)

Liabilities associated with assets held for sale

(2,154)

0

0

0

Non-current liabilities

 

 

(346)

(306)

(306)

(306)

Long-term borrowings

0

0

0

0

Other

(346)

(306)

(306)

(306)

Net assets

 

 

10,881

9,200

5,263

6,428

CASH FLOW

Operating cash flow

 

 

(2,494)

(7,573)

(5,357)

(2,372)

Net interest

6

(24)

121

12

Tax

0

0

0

0

Capex

(199)

(136)

(200)

(199)

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

0

0

0

Financing

(228)

6,257

0

5,000

Dividends

0

0

0

0

Net cash flow

(2,915)

(1,476)

(5,436)

2,441

Opening net debt/(cash)

 

 

(11,314)

(8,398)

(6,918)

(1,482)

HP finance leases initiated

0

0

0

0

Other

(1)

(4)

0

0

Closing net debt/(cash)

 

 

(8,398)

(6,918)

(1,482)

(3,923)

Source: Edison Investment Research, company accounts. Reinstated to reflect discontinuation of Helixio activities.

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. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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 2018. “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

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Germany

London +44 (0)20 3077 5700

280 High Holborn

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United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

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US

Sydney +61 (0)2 8249 8342

Level 4, 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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, 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. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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 2018. “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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, 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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Research: Healthcare

RedHill BioPharma — Continued GI product growth, CD PhIII data in 3M

With its Q118 results, RedHill reported GI product revenues growing by 22% q-o-q to $2.4m in Q118. It also provided updates on its Phase III programmes. The last patient has been assessed against the primary endpoint in the RHB-104 first Phase III trial in Crohn’s disease (CD), and top-line data are expected by August (including) this year. Additionally, more than 70% of patients have been enrolled for the TALICIA confirmatory Phase III trial in H. pylori infection. Management now expects top-line data from this trial in Q418. We value the company at $404.5m (NIS1.5bn) or $19.0/ADS (NIS6.8/share).

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