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Celyad — Revision of clinical strategy after responses seen

Celyad — Revision of clinical strategy after responses seen

Celyad has reported a complete morphological leukaemia-free status (MFLS) response in acute myeloid leukaemia (AML) in the NKR CAR T-cell THINK study. Spontaneous remission in refractory/relapsed AML is extremely rare, so this is a significant result. Importantly, the response was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date. The clinical strategy has been updated to focus on AML and colorectal cancer. Additionally, with the approvals of Yescarta (Gilead) at a price of $373k and Kymirah (Novartis) at $475k, we have increased our expected price for NRK CAR T-cell therapy to $200k, formerly $150k. The revised strategy and price assumption change moves the indicative value to €103 per share, formerly €51.6 per share.

Analyst avatar placeholder

Written by

Celyad

Revision of clinical strategy after responses seen

Clinical trial data

Pharma & biotech

30 October 2017

Price

€50.05

Market cap

€494m

$1.18/€

Cash (€m) at 30 June 2017

68.8

Shares in issue (at 28 August 2017)

9.86m

Free float

61%

Code

CYAD

Primary exchange

Euronext Brussels

Secondary exchange

NASDAQ

Share price performance

%

1m

3m

12m

Abs

5.8

64.9

237.4

Rel (local)

3.1

60.6

195.8

52-week high/low

€54.0

€14.8

Business description

Celyad is developing an innovative CAR T-cell (NKR-2) immuno-oncology technology. The THINK Phase Ib study is underway in haematological and five sold tumour types. SHRINK is approved to enrol patients. Celyad is seeking a strategic partner for C-Cure for chronic heart disease.

Next events

Q317 update

Q417

Analysts

Dr John Savin MBA

+44 (0)20 3077 5735

Dr Daniel Wilkinson

+44 (0)20 3077 5734

Celyad is a research client of Edison Investment Research Limited

Celyad has reported a complete morphological leukaemia-free status (MFLS) response in acute myeloid leukaemia (AML) in the NKR CAR T-cell THINK study. Spontaneous remission in refractory/relapsed AML is extremely rare, so this is a significant result. Importantly, the response was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date. The clinical strategy has been updated to focus on AML and colorectal cancer. Additionally, with the approvals of Yescarta (Gilead) at a price of $373k and Kymirah (Novartis) at $475k, we have increased our expected price for NRK CAR T-cell therapy to $200k, formerly $150k. The revised strategy and price assumption change moves the indicative value to €103 per share, formerly €51.6 per share.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/15

0.00

(27.56)

(3.17)

0.0

N/A

N/A

12/16

8.52

(22.83)

(2.09)

0.0

N/A

N/A

12/17e

8.28

(27.23)

(2.86)

0.0

N/A

N/A

12/18e

9.00

(25.21)

(2.65)

0.0

N/A

N/A

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

First ‘clinical validity’ for NKR CAR T-cells

Celyad found one AML patient given 3x108 NKR CAR T-cells had a complete MLFS response. In effect, it was a near CRi; that is, a complete response with high but not normal blood cell levels. Treatment with NKR CAR T-cells has enabled him to move to stem cell transplant. Median survival of relapsed and refractory AML patients is typically less than four months (source Celyad, see AML treatment).

Revised clinical strategy

With a near complete response in AML and two stable disease cases at low dose in colorectal cancer, Celyad has decided to focus its development efforts on these two indications. The current THINK study in AML, MM and five solid cancers, including colorectal, will continue to find the optimal dose but with preferential recruitment of AML and colorectal patients. Celyad also intends to evaluate combination therapies. As the first such study, the SHRINK trial of CYAD-01 is ready to start recruitment in metastatic CRC in combination with FOLFOX chemotherapy.

Valuation: Revised to €1,047m from €524m

Our previous approach to valuing the Celyad NKR CAR T-cells portfolio was to treat AML and MM as defined indications with a probability of 20% and to take a weighted average of the five solid tumour indications. We have now focused the valuation on AML at 25% probability and colorectal at 20% (adjusted from 10% in August). The C-Cure a cardiac indication is still seeking a partner so is now given a nominal value of €10m, formerly €162m. Rebasing the valuation to January 2018 gives a new indicative value of €1,047m, formerly €524m (indicating €103 per share (formerly €51.60)). Management states that Celyad has cash to fund it through the first half of 2019. Additional cash might enable a broader and faster development of the clinical programme given its promising current outlook.

THINK

Celyad is in an interesting position with very promising initial results in AML and emerging responses in solid tumours – although both are at an early stage of clinical development. It was pointed out in the recent Edison report (27 September 2017) on T-cell cancer therapies that NKR CAR T-cells therapy by targeting ubiquitous ‘stress’ ligands could potentially target a number of solid and haematological tumours. The first indications from the clinic that this might be a reality have now been seen. It will be important to build on the successes so far with more consistent clinical responses at higher dose levels in the THINK study. The Therapeutic Immunotherapy with NKR-2 (THINK) study (NCT03018405) is an open-label, multiple-dose US and European study currently in a dose escalation phase (Exhibit 1).

Exhibit 1: THINK trial detail

Aspect

comment

Dose level

3x108, 1x109, 3x109 of the natural killer receptor CAR T-cell product, CYAD-01.

Dosing

Three doses of cells are given, each 14 days apart.

Preconditioning – lymphodepletion

Preconditioning is not used with CYAD-01 although potential combinations will eventually be explored.

Prior chemotherapy is essential for standard CAR-T therapies such as Kymriah (tisagenlecleucel, Novartis) and Yescarta (Axicabtagene Ciloleucel, Gilead (Kite)). Preconditioning enables rapid expansion of the transfused CAR T-cells and also reduces the tumour burden of the patient.

Dose ranging phase

This phase is at least 12 patients each in the haematological and solid cancer arms, respectively. If toxicity is seen, extra patient is recruited at that dose level. If the dose is safe, the next dose cohort is recruited. At the highest dose, an extra three patients are recruited.

Cohort expansion phase

Once a dose is established, the trial is planned to expand into separate cohorts, each with specific cancer indications. One of these cohorts will now definitely be colorectal cancer. The plan sizes 14 patients at the highest dose per cancer. However, with the revised clinical trial emphasis, it is possible that only some of these cancers will be pursued in the near term. In theory, this stage of the trial should have 98 patients in total made of 86 further patients plus the 12 at the highest dose cohort. However, under the revised strategy, not all these indications may be pursued initially.

Haematological indications

The haematological arm of the trial will recruit AML and multiple myeloma (MM) patients. Priority will now be given to AML patients.

Solid cancers

The trial is recruiting patients in the dose escalation phase with colorectal, ovarian, pancreatic, bladder and triple-negative breast cancers. So far, colorectal, pancreatic and ovarian cancer patients have been recruited. The dose escalation phase will now preferentially recruit colorectal cancer patients.

Toxicity seen to date

To date, Celyad has reported one Grade 3 toxicity in an ovarian cancer patient and one Grade 4 toxicity in a MM patient. The observed toxicities might indicate that the NKR CAR T-cells are attacking the cancer.

Toxicities in approved CAR-T therapies have been linked to an immune attack on the cancer burden. However, there is no clear link between toxicities and response in CAR-T therapies like Kymriah; this might be because of preconditioning which may be a confounding factor.

Readout

As THINK is an open-label study, Celyad will report significant events as they happen. The six-month dose data are possible in H218. The two-year primary endpoint data could be due in mid-2020. However, the revised clinical strategy may mean that these dates vary for different cancer indications.

Aspect

Dose level

Dosing

Preconditioning – lymphodepletion

Dose ranging phase

Cohort expansion phase

Haematological indications

Solid cancers

Toxicity seen to date

Readout

comment

3x108, 1x109, 3x109 of the natural killer receptor CAR T-cell product, CYAD-01.

Three doses of cells are given, each 14 days apart.

Preconditioning is not used with CYAD-01 although potential combinations will eventually be explored.

Prior chemotherapy is essential for standard CAR-T therapies such as Kymriah (tisagenlecleucel, Novartis) and Yescarta (Axicabtagene Ciloleucel, Gilead (Kite)). Preconditioning enables rapid expansion of the transfused CAR T-cells and also reduces the tumour burden of the patient.

This phase is at least 12 patients each in the haematological and solid cancer arms, respectively. If toxicity is seen, extra patient is recruited at that dose level. If the dose is safe, the next dose cohort is recruited. At the highest dose, an extra three patients are recruited.

Once a dose is established, the trial is planned to expand into separate cohorts, each with specific cancer indications. One of these cohorts will now definitely be colorectal cancer. The plan sizes 14 patients at the highest dose per cancer. However, with the revised clinical trial emphasis, it is possible that only some of these cancers will be pursued in the near term. In theory, this stage of the trial should have 98 patients in total made of 86 further patients plus the 12 at the highest dose cohort. However, under the revised strategy, not all these indications may be pursued initially.

The haematological arm of the trial will recruit AML and multiple myeloma (MM) patients. Priority will now be given to AML patients.

The trial is recruiting patients in the dose escalation phase with colorectal, ovarian, pancreatic, bladder and triple-negative breast cancers. So far, colorectal, pancreatic and ovarian cancer patients have been recruited. The dose escalation phase will now preferentially recruit colorectal cancer patients.

To date, Celyad has reported one Grade 3 toxicity in an ovarian cancer patient and one Grade 4 toxicity in a MM patient. The observed toxicities might indicate that the NKR CAR T-cells are attacking the cancer.

Toxicities in approved CAR-T therapies have been linked to an immune attack on the cancer burden. However, there is no clear link between toxicities and response in CAR-T therapies like Kymriah; this might be because of preconditioning which may be a confounding factor.

As THINK is an open-label study, Celyad will report significant events as they happen. The six-month dose data are possible in H218. The two-year primary endpoint data could be due in mid-2020. However, the revised clinical strategy may mean that these dates vary for different cancer indications.

Source: Edison Investment Research based on Celyad reports and management information

THINK cohort expansion in colorectal cancer and AML will start once a clear dose has been established. Unlike the cautious safety-first approach in dose escalation, cohort expansion should be relatively rapid as there is no need for significant delays between patient dosing. AML in particular is an intractable condition. So far, T-cell therapies are early in development with no other reported therapies impact. If the pattern of complete response is maintained at higher doses, then Celyad should have no trouble in recruiting patients. Currently, Celyad has no complete responses in colorectal cancer – but then CAR T-cell therapy has no complete responses in any solid tumour type at present.

The issues around solid tumour therapy and the probable need for combination therapy are explored in detail in the report T-cell cancer therapies. Part 1 of this report provides an overview. Part 2 provides detailed investigation into multiple aspects of T-cell therapies including in solid tumours.

SHRINK

The Celyad natural killer (NKG2D) receptor CAR T-cell approach, CYAD-01, targets the ubiquitous stress ligands expressed by many cancers. These stress ligands are upregulated in response to chemotherapy. However, they are also expressed by normal cells exposed to toxic agents, if only for a short period. Chemotherapy might make the tumour more stressed and so more susceptible to CYAD-01 targeting. It might also expose some normal tissues to CYAD-01, so timing of dosing is important to allow enough normal tissue recovery post chemotherapy. In the real world, most solid cancer patients will receive chemotherapy and knowing how to combine standard chemotherapy with CAR T-cell therapy is crucial. If it proves to be synergistic, it would be a major cancer therapy breakthrough as most chemotherapy regimens show limited survival gains in a minority of patients.

The SHRINK trial is being in metastatic colorectal cancer, which is located in the liver. About 20-30% of colorectal cancer cases are found to have metastatic disease on diagnosis. SHRINK has not yet been posted on the clinical trials databases but is approved by the Belgian regulator.

Exhibit 2: SHRINK detail

Aspect

comment

Dose level

CYAD-01 doses will be adjusted to body weight and escalate from 3x108 to 1x109 to 3x109.

Dosing

Three doses of cells are given, each 14 days apart.

Preconditioning – lymphodepletion

Preconditioning is not used to deplete the patient’s immune system. However, this trial combines CYAD-01 with chemotherapy which should deplete the tumour burden.

Combination

Patients will be given prior treatment with FOLFOX chemotherapy. FOLFOX is a combination of folinic acid (leucovorin), fluorouracil (5FU) and Oxaliplatin. FOLFOX is not a regimen that targets the immune system, unlike the preconditioning regimen used in B-cell CAR T-cell therapies.

Dose ranging phase

This phase will recruit at least 18 patients, six at each dose level. If the dose is safe, the next dose cohort is recruited. Note that timing between FOLFOX and CYAD-01 will also be evaluated.

Cohort expansion phase

Once a dose is established, the trial is planned to expand to 21 patients at the highest dose.

Readout

Unknown, but this trial will be a priority. Overall survival will be crucial for widespread use, but will take some years to determine. FOLFOX alone gives median overall survival of about two years vs six months on supportive care.

Aspect

Dose level

Dosing

Preconditioning – lymphodepletion

Combination

Dose ranging phase

Cohort expansion phase

Readout

comment

CYAD-01 doses will be adjusted to body weight and escalate from 3x108 to 1x109 to 3x109.

Three doses of cells are given, each 14 days apart.

Preconditioning is not used to deplete the patient’s immune system. However, this trial combines CYAD-01 with chemotherapy which should deplete the tumour burden.

Patients will be given prior treatment with FOLFOX chemotherapy. FOLFOX is a combination of folinic acid (leucovorin), fluorouracil (5FU) and Oxaliplatin. FOLFOX is not a regimen that targets the immune system, unlike the preconditioning regimen used in B-cell CAR T-cell therapies.

This phase will recruit at least 18 patients, six at each dose level. If the dose is safe, the next dose cohort is recruited. Note that timing between FOLFOX and CYAD-01 will also be evaluated.

Once a dose is established, the trial is planned to expand to 21 patients at the highest dose.

Unknown, but this trial will be a priority. Overall survival will be crucial for widespread use, but will take some years to determine. FOLFOX alone gives median overall survival of about two years vs six months on supportive care.

Source: Edison Investment Research

Revised value

Although we have not made any substantive changes to the currently broad cancer indications forecast, we have adjusted our valuation and made some detailed adjustments to some probabilities and timings and also to price expectations. In addition, we have rebased evaluation to January 2018. These changes makes a substantial difference to the indicative value.

The changes are as follows:

■

AML has an increase in the probability of success from 20% to 25%. The revised probability is still cautious as only one near complete response has so far been seen. A consistent pattern of complete responses at higher doses would encourage us to raise this probability further. The expected launch date remains at 2022, although noting that the FDA has rapidly reviewed the first two CAR T-cell therapies does raise the possibility that a more rapid approval could be obtained if the clinical data warrants it, particularly as refractory AML is an intractable condition.

■

Colorectal cancer was formerly treated as one of five solid tumours, for which an average weighted value was estimated. As it has become a priority for Celyad, it is now treated separately. The probability was adjusted in August 2017 from 10% to 20% in view of two stable disease cases reported in June. As yet, no complete responses have been seen in colorectal cancer so this probability is maintained for the moment, but we would expect to increase this if complete responses are seen at higher dose levels. In this context, the AML response is very encouraging but there is no guarantee of a direct read-across. The expected colorectal launch date remains 2023. Since colorectal cancer is a major solid tumour indication, splitting it out from the average of solid tumours has a high impact on the overall indicative value. Only refractory colorectal cancer is taken into account.

■

Multiple myeloma remains unchanged but as it is potentially a lower priority project. We have pushed the launch date back to 2024. Probability remains at 20% given that other CAR-T therapies, notably Bluebird’s bb2121, have shown good success to date in multiple myeloma. Our assessment of multiple myeloma will be adjusted as more clinical data is disclosed. There was Grade 4 toxicity seen which is an indicator that the infused CYAD-01 cells might be having some clinical effect.

■

The remaining four solid cancers are still treated as a weighted average with unchanged probabilities. There have been some signs of efficacy with a Grade 3 toxicity in ovarian cancer. Two other cancer types, bladder and triple-negative breast cancer have not as yet been explored as no patient has yet been recruited. We have pushed all these cancer indications back to an expected launch date of 2025; this will be regularly reviewed.

■

The price assumed was $150k as this approximated to immunomodulatory checkpoint inhibitor therapies. However, with Kymriah listed at $475K and Yescarta at $373k, this price is clearly too low. The eventual pricing of CAR T-cell therapies is going to be complex and will relate to efficacy, as yet unknown. We have therefore used $200k as a current target price for CYAD-01 but this will be revised as further data emerges.

■

We have taken the decision to put a nominal value for the C-Cure cardiac therapy into the model. The Phase III data showed a subgroup where efficacy was noted. Celyad decided to explore strategic options for the project and put development on hold although a US Phase III trial has been approved. The value was €162m but as no deal has been concluded we have reduced this to a nominal €10m. This will be revised when further information is available.

■

We have not made any adjustments to expected trial costs as management has indicated that current financial resources are adequate to pursue the revised clinical programme. However, we note that a broader programme with faster recruitment to develop the large potential of NKR CAR T-cells therapy could perhaps be pursued if greater financial resources were available.

■

The financial model has been rebased to January 2018. This has a significant impact by itself as the discount rate is 12.5% before probability adjustment.

Exhibit 3 shows the cancer numbers and revised NPV values. Note that the other four solid cancers are weighted as we are not at this time clear that they will all progress.

Exhibit 3: Revised CYAD-01 NPV estimates

Indication

Deaths

Peak share

Peak US sales ($m)

Probability

NPV (US)

Global (€)

Lead indications

AML

10,460

39%

851

25.0%

178

201

Colorectal

50,310

36%

3,628

20.0%

500

565

 

Exploratory

MM

11,240

39%

915

20.0%

113

128

Solid tumours, weighted average

Ovarian

14,180

69%

1,951

20.0%

217

245

Bladder

16,390

69%

2,255

10.0%

125

142

Breast

40,000

36%

2,884

10.0%

157

178

Pancreatic

39,590

69%

5,448

5.0%

151

171

Total other solid cancers

110,160

12,539

651

736

Weighted average

158

179

Source: Edison Investment Research

The revised valuation based on these numbers is shown in Exhibit 4.

Exhibit 4: Revised valuation

Item

 

Probability

Value (€m)

Lead projects

AML

25.0%

201

 

Colorectal

20.0%

565

 

 

 

Exploratory trials

MM

20.0%

128

 

Solid tumours (average of 4)

Variable

179

 

Allogeneic

 

50.

Total CAR value

 

 

1,123

C-Cure Partnered value (milestones plus royalties)

 

Nominal

10

Net operating costs

(Risk adjusted 2018-2023)

 

-107

Additional royalties

 

21

Total indicative value

 

 

1,047

Shares

 

 

9.86

Warrants and options

 

 

0.30

Core value per share (€)

 

 

103

Source: Edison Investment Research

A faster and more comprehensive clinical development up to 2023 could be more expensive but benefit from a higher payback rate.

The value has risen significantly indicating €103 per share (formerly €51.6), but this is mostly due to the change in price assumption from $150k to $200k. If the price was left at $150k, the value would be about €77/share. If the efficacy is robust, the price could be higher than this.

Financials

Celyad has reported H117 results. Revenues were €3m in grants with R&D expenses of €11.1m. The operating loss was €13.7m and the net cash burn was €13.8m. On 30 June 2017, Celyad had €68.8m of cash. This is expected by management to be sufficient to fund the company through the first half of 2019. We have not made any changes to financial forecasts (Exhibit 5). Celyad might benefit from an enhanced cash basis to develop its cancer portfolio.

Exhibit 5: Financial summary

€000s

2015

2016

2017e

2018e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

3

8,523

8,280

9,000

Cost of Sales

(1)

(53)

0

0

Gross Profit

2

8,470

8,280

9,000

EBITDA

 

 

(27,844)

(24,065)

(26,720)

(24,700)

Operating Profit (before amort and except)

 

 

(28,117)

(24,825)

(27,480)

(25,460)

Intangible Amortisation

(760)

(756)

(756)

(756)

Other income and charges

0

(521)

0

0

Share-based payments

(795)

493

0

0

Operating Profit

(29,672)

(25,609)

(28,236)

(26,216)

Net Interest

558

1,997

250

250

Profit Before Tax (norm)

 

 

(27,559)

(22,828)

(27,230)

(25,210)

Profit Before Tax (FRS 3)

 

 

(29,114)

(23,612)

(27,986)

(25,966)

Tax

0

6

0

0

Profit After Tax (norm)

(27,559)

(19,482)

(27,230)

(25,210)

Profit After Tax (FRS 3)

(29,114)

(23,606)

(27,986)

(25,966)

Average Number of Shares Outstanding (m)

8.7

9.3

9.5

9.5

EPS – normalised (c)

 

 

(317)

(209)

(286)

(265)

EPS – (IFRS) (€)

 

 

(3.35)

(2.54)

(2.94)

(2.73)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross Margin (%)

N/A

N/A

N/A

N/A

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

 

 

50,105

53,440

73,333

71,967

Intangible Assets

48,789

49,566

70,069

69,313

Tangible Assets

1,136

3,563

2,953

2,343

Investments

180

311

311

311

Current Assets

 

 

109,420

85,366

47,007

21,293

Stocks

0

0

0

0

Debtors

549

1,359

1,359

1,359

Cash (cash plus deposits)

107,513

82,587

44,228

18,514

Other

1,358

1,420

1,420

1,420

Current Liabilities

 

 

(11,490)

(11,275)

(11,017)

(10,487)

Creditors

(10,592)

(9,960)

(9,960)

(9,960)

Deferred revenue

0

0

0

0

Walloon loans and bank loan

(898)

(1,315)

(1,057)

(527)

Long Term Liabilities

 

 

(36,561)

(36,646)

(35,796)

(35,212)

Loans (non-current) Bank and Walloon

(10,484)

(7,866)

(7,016)

(6,166)

Other long term liabilities

(26,077)

(28,780)

(28,780)

(29,046)

Net Assets

 

 

111,474

90,885

73,526

47,561

CASH FLOW

Operating Cash Flow

 

 

(27,862)

(26,689)

(27,192)

(24,578)

Net Interest

558

1,997

861

264

Tax

0

0

0

0

Capex

(838)

(1,782)

(21,409)

(150)

Acquisitions/disposals

(5,186)

(1,561)

0

0

Financing

109,155

0

10,629

0

Dividends

0

0

0

0

Other

(3,287)

3,109

(1,249)

(1,249)

Net Cash Flow

72,540

(24,926)

(38,359)

(25,713)

Opening net debt/(cash)

 

 

(16,078)

(96,131)

(73,406)

(36,155)

HP finance leases initiated

0

0

0

0

Loan and finance movements

7,513

2,201

1,108

1,380

Closing net debt/(cash)

 

 

(96,131)

(73,406)

(36,155)

(11,822)

Source: Edison Investment Research estimates, Celyad reports and announcements. Note: the $25m 2017 payment is treated as an intangible asset expected to be amortised against sales income. The equity component is shown as an equity investment. The actual accounting treatment by Celyad may differ.

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

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Celyad and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. 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The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data are 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 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Celyad and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data are 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 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Research: Industrials

Augean — Near-term expectations reduced

Augean’s (AUG) dispute with HMRC over landfill taxes and tough trading conditions in its key markets creates significant uncertainty. The company has taken decisive steps to reshape its management team and reduce its cost base, in order to provide Augean with a stronger and more dynamic base from which to grow post a resolution to the dispute.

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