Oryzon Genomics — Clinical ramp in Q3; several catalysts approaching

Oryzon Genomics (BME: ORY)

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Research: Healthcare

Oryzon Genomics — Clinical ramp in Q3; several catalysts approaching

Oryzon Genomics reported Q322 results that are largely in line with our expectations. The clinical ramp up of its key assets, iadademstat and vafidemstat, has meant R&D expenses were higher than our estimates, largely offset by the higher R&D tax rebates. The Q322 net loss of US$0.6m (€0.7m) brought the 9M22 net loss to US$1.9m (€2.0m). As a result, we expect FY22 operating losses to decrease to €5.0m versus our previous estimates (€7.0m), reflecting the timing of R&D spend and associated tax rebates. Oryzon closed the quarter with a gross cash position, including marketable securities, of US$27.1m, implying an annual cash burn of approximately €14m, which assuming full drawdown of the €20m convertible debt facility, will see the company through into Q224 (including outstanding debts repayments). We value Oryzon at €861m or €16.2 per share, up from €802m or €15.1/share previously.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Oryzon Genomics

Clinical ramp in Q3; several catalysts approaching

Q322 update

Pharma and biotech

3 November 2022

Price

€2.13

Market cap

€113m

US$1.01/€

Estimated net cash (€m) at end-September 2022

9.7

Shares in issue

53.1m

Free float

80%

Code

ORY

Primary exchange

Madrid Stock Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

2.9

(17.5)

(33.1)

Rel (local)

(3.6)

(16.1)

(23.5)

52-week high/low

€3.29

€2.07

Business description

Oryzon Genomics is a Spanish biotech focused on epigenetics. Iadademstat is being explored for acute leukaemias and SCLC. Vafidemstat, its CNS asset, has completed several Phase IIa trials and a Phase IIb trial in borderline personality disorder is now the lead study, but Oryzon is rapidly expanding its CNS R&D pipeline.

Next events

Phase II PORTICO interim data

Q123

Phase II ALICE final readout

Q422

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Oryzon Genomics is a research client of Edison Investment Research Limited

Oryzon Genomics reported Q322 results that are largely in line with our expectations. The clinical ramp up of its key assets, iadademstat and vafidemstat, has meant R&D expenses were higher than our estimates, largely offset by the higher R&D tax rebates. The Q322 net loss of US$0.6m (€0.7m) brought the 9M22 net loss to US$1.9m (€2.0m). As a result, we expect FY22 operating losses to decrease to €5.0m versus our previous estimates (€7.0m), reflecting the timing of R&D spend and associated tax rebates. Oryzon closed the quarter with a gross cash position, including marketable securities, of US$27.1m, implying an annual cash burn of approximately €14m, which assuming full drawdown of the €20m convertible debt facility, will see the company through into Q224 (including outstanding debts repayments). We value Oryzon at €861m or €16.2 per share, up from €802m or €15.1/share previously.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/20

9.5

(4.8)

(0.07)

0.0

N/A

N/A

12/21

10.6

(7.2)

(0.09)

0.0

N/A

N/A

12/22e

14.4

(5.2)

(0.06)

0.0

N/A

N/A

12/23e

15.9

(6.1)

(0.07)

0.0

N/A

N/A

Note: *PBT and EPS is normalised, excluding amortisation of acquired intangibles, other income and exceptional items

Positive safety data for PORTICO

The most significant Q322 clinical news for Oryzon came in form of interim safety data from its Phase IIb PORTICO study, investigating the use of vafidemstat for the treatment of borderline personality disorder. The company reported that no serious adverse events have been observed from patients enrolled in the trial and that approval for the study to continue had been granted by the PORTICO independent data monitoring committee. This positive development means the trial is on track for interim readouts in Q123, which we see as a potential catalyst for share price.

Strong cash position past key readouts

At end Q322, Oryzon had a gross cash position including securities of US$27.1m (€27.3m) and has combined short- and long-term debt obligations of €17.6m (c €6m due in FY23 and €4.5m in FY24). The company has entered a convertible bond financing agreement where it can raise up to €20m over 30 months. Based on our annual cash burn projections, we estimate that at the current annual burn rate of around €14m (c €7m cash burn rate in H122), and assuming execution of all convertible notes, will provide a cash runway into Q224 (including outstanding debts repayments).

Valuation: €861m or €16.2/share

We value Oryzon at €861m or €16.2/share, based on a risk-adjusted NPV analysis using a 12.5% discount rate and Q322e net cash of c €9.7m. The valuation has increased as we have rolled our model forward four months, updated our exchange rate assumption to $1.01/€ (from $1.05/€) and updated our estimates, but our underlying long-term assumptions remain unchanged.

A period of catalysts on the horizon

Oryzon is gearing up for what is anticipated to be a busy six months for the clinical development of both iadademstat and vafidemstat.

For iadademstat in oncology, preliminary final data from the Phase II ALICE study will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2022. The study is investigating iadademstat in combination with azacitidine in acute myeloid leukaemia (AML) and has continued to show encouraging safety and efficacy data; the most recent readouts reported objective responses (OR) in 81% of patients.

In our view, final positive readouts from ALICE would bode well for Oryzon’s Phase Ib FRIDA trial investigating iadademstat in combination with gilteritinib (FDA-approved FLT3 inhibitor) for treating patients with relapsed/refractory (r/r) FLT3-mutated AML in a second-line setting. The latest ALICE data reported that patients possessing the FLT3 mutation also responded to treatment, providing promise for this further sub-population of AML patients in FRIDA. Having received IND approval, Oryzon will look to discuss with the FDA the plans for trial initiation, but has communicated that it expects the first patient to be recruited (FPI) in FRIDA in H222.

The IND for the Phase Ib/II STELLAR study in extensive disease small cell lung cancer (ED-SCLC) with iadademstat in combination with an immune checkpoint inhibitor (ICI) is also expected in in H222. If approved, we anticipate FPI in H123. In our view, ICI combination studies are critical in the development of new oncology treatment regimes. Additionally, Oryzon is planning a further combination Phase II trial for iadademstat in platinum r/r SCLC and extrapulmonary high-grade neuroendocrine tumours (NET); it expects FPI in H222.

In addition to the upcoming interim readouts from the PORTICO study, the most significant development for vafidemstat will be the initiation of the Phase Ib/II HOPE study in Kabuki syndrome. An IND is expected to be submitted in H222, with FPI in H123. The HOPE study represents Oryzon’s first clinical efforts in developing a precision medicine approach in tackling a monogenic central nervous system (CNS) indication. With the clinical successes achieved in targeting monogenic CNS diseases and potential upside from pursuing an orphan indication, we believe this represents a significant opportunity for Oryzon. For more information, please see our recent sector report on the field of neuroscience.

Valuation

We value Oryzon at €861m or €16.2/share, based on a risk-adjusted NPV analysis using a 12.5% discount rate and Q322e net cash of c €9.7m. Our underlying long-term assumptions remain unchanged, and we roll our model forward in time by four months. We have also updated our fx assumptions to $1.01/€ (from $1.05/€). Our model includes five rNPV projects (Exhibit 2, for more details see our Outlook note).

Exhibit 1: Valuation of Oryzon

Product

Indication

Launch

Peak sales ($m)

Value
(€m)

Probability

rNPV
(€m)

NPV/share (€/share)

Iadademstat

2L AML

2026

490

771.7

30%

225.7

4.3

1L SCLC

2026

720

814.5

25%

197.4

3.7

Vafidemstat

BPD

2027

1,580

1,271.2

20%

243.3

4.6

Schizophrenia, negative symptoms

2027

690

640.2

15%

88.1

1.7

Aggression in Alzheimer’s disease

2028

890

681.8

15%

97.7

1.8

Estimated net cash end Q322

9.7

100%

9.1

0.2

Valuation

 

 

 

3,931.2

861

16.2

Source: Edison Investment Research

Financials

As a result of Oryzon’s ramp up in clinical development activities, the company reported research and development (R&D) expenses for Q322 of US$4.3m (€4.4m), bringing total R&D expenses for FY22 to date up to US$11.9m (€12.0m). With the increase in R&D spend, Oryzon will receive income associated with R&D tax credits, which we estimate will reach €14.4m by end FY22. In light of the quarterly update, we have updated our full year estimates and now forecast total operating expenses for FY22 to amount to €18.9m (previously €16.4m), with R&D expenses totalling €15.6m (previously €12.0m). We estimate free cash outflows of c €15.9m in FY22 and €17.1m in FY23, in line with current spending in operations and increased R&D activity. In our model, we project that Oryzon will launch its first product into the market in FY26. Based on the current annual cash burn projections (c €14m), we estimate that it will be required to raise a further c €30m, in addition to the €20m convertible bond financing, to continue to fund operations up to this point, which we model as illustrative debt. Based on our annual cash burn projections, we estimate that excluding debt repayment obligations and assuming execution of all convertible notes, Oryzon has a cash runway into Q224 (including outstanding debts repayments).

Exhibit 2: Financial summary

Accounts: Year end 31 December (€000s)

2019

2020

2021

2022e

2023e

INCOME STATEMENT

 

 

 

 

 

Total revenues

10,278

9,521

10,615

14,418

15,860

Cost of sales

(430)

(526)

(746)

(473)

(497)

Gross profit

9,847

8,995

9,869

13,945

15,363

Gross margin %

96%

94%

93%

97%

97%

SG&A (expenses)

(2,983)

(3,541)

(3,782)

(3,513)

(3,864)

R&D costs

(11,322)

(11,075)

(13,023)

(15,607)

(17,253)

Other income/(expense)

779

1,476

73

6

6

Exceptionals and adjustments

(11)

(5)

(4)

0

0

Reported EBITDA

(3,690)

(4,149)

(6,866)

(5,169)

(5,748)

Depreciation and amortisation

150

145

144

180

179

Reported EBIT

(3,839)

(4,294)

(7,011)

(4,989)

(5,569)

Finance income/(expense)

(737)

(485)

(169)

(236)

(511)

Other income/(expense)

0

0

0

0

0

Reported PBT

(4,576)

(4,779)

(7,180)

(5,225)

(6,080)

Income tax expense (includes exceptionals)

892

1,379

2,493

2,138

2,316

Reported net income

(3,685)

(3,400)

(4,687)

(3,087)

(3,764)

Basic average number of shares, m

45.8

53.1

53.1

53.0

53.0

Basic EPS (€)I

(0.09)

(0.07)

(0.09)

(0.06)

(0.07)

 

 

 

 

 

 

Adjusted EBITDA

(3,679)

(4,145)

(6,862)

(5,169)

(5,748)

Adjusted EBIT

(3,829)

(4,290)

(7,007)

(4,989)

(5,569)

Adjusted PBT

(4,566)

(4,774)

(7,176)

(5,225)

(6,080)

Adjusted EPS (€)

(0.1)

(0.1)

(0.1)

(0.1)

(0.1)

Adjusted diluted EPS (€)

(0.1)

(0.1)

(0.1)

(0.1)

(0.1)

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

Property, plant and equipment

631

644

682

677

674

Intangible assets

39,938

49,216

60,254

70,811

81,216

Investments

67

66

29

29

29

Deferred tax assets

1,721

1,803

1,812

1,812

1,812

Total non-current assets

42,357

51,729

62,778

73,330

83,731

Cash and equivalents

35,111

39,605

28,725

15,394

9,075

Trade and other receivables

2,071

2,351

3,645

2,998

3,321

Inventories

289

317

104

104

104

Other current assets

267

105

132

132

132

Total current assets

37,738

42,377

32,606

18,628

12,633

Deferred tax liabilities

1,721

1,803

1,812

1,812

1,812

Long term debt

6,699

8,680

13,354

13,354

21,354

Other non-current liabilities

0

0

285

285

285

Total non-current liabilities

8,420

10,483

15,451

15,451

23,451

Trade and other payables

4,000

2,839

3,518

3,179

3,349

Short term debt

6,547

4,854

4,306

4,306

4,306

Other current liabilities

0

0

847

847

847

Total current liabilities

10,546

7,693

8,672

8,332

8,502

Equity attributable to company

61,129

75,931

71,262

68,175

64,411

 

0

0

0

0

0

CASH FLOW STATEMENT

 

 

 

 

 

Profit before tax

(4,576)

(4,779)

(7,180)

(5,225)

(6,080)

Cash from operations (CFO)

(3,934)

(4,817)

(3,626)

(2,599)

(3,739)

Capex

(9,585)

(9,223)

(11,761)

(10,732)

(10,580)

Acquisitions & disposals net

0

0

0

0

0

Acquistion of intangible assets

(9,469)

(9,070)

(11,586)

(10,557)

(10,404)

Other investing activities

8

142

37

0

0

Cash used in investing activities (CFIA)

(19,046)

(18,152)

(23,310)

(21,289)

(20,984)

Net proceeds from issue of shares

18,374

18,181

0

0

0

Movements in debt

(4,112)

200

4,123

0

8,000

Other financing activities

0

0

0

0

0

Cash from financing activities (CFF)

14,262

18,382

4,123

0

8,000

Increase/(decrease) in cash and equivalents

791

4,494

(10,880)

(13,331)

(6,318)

Currency translation differences and other

40

11

348

0

0

Cash and equivalents at start of period

34,320

35,111

39,605

28,725

15,394

Cash and equivalents at end of period

35,111

39,605

28,725

15,394

9,075

Net (debt) cash

21,866

26,071

11,065

(2,266)

(24,584)

Source: Oryzon Genomics, Edison Investment Research. Note: Oryzon reports in Spanish GAAP. *Includes cash outflows related to development costs that were capitalised.

General disclaimer and copyright

This report has been commissioned by Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2022 Edison Investment Research Limited (Edison).

Australia

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New Zealand

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. 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 (i.e. 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.

United Kingdom

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This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

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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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

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NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2022 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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Research: Real Estate

Foxtons Group — Strong markets and strategic initiatives shine

The tight London lettings market has resulted in a significant increase in rental rates to values that exceed pre-pandemic levels, which has further benefited Foxtons as it has concentrated M&A activity in this area. It has also witnessed positive trends from strategic initiatives to focus on higher-value properties in both the Lettings and Sales divisions, as well as investment in Financial Services. We have raised our FY22 estimates, but have retained FY23 and FY24 forecasts, given the economic uncertainty, and maintained our 128p/share valuation.

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