pill-1884775_960_720

Efmody launched in the EU and UK

Diurnal Group 29 September 2021 Update
Download PDF

Diurnal Group

Efmody launched in the EU and UK

Company update

Pharma & biotech

29 September 2021

Price

56.2p

Market cap

£95m

US$1.39/£

Net cash (£m) at 30 June 2021

34

Shares in issue

168.9m

Free float

68.1%

Code

DNL

Primary exchange

LSE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(6.2)

(12.6)

(22.9)

Rel (local)

(4.2)

(12.6)

(36.8)

52-week high/low

89p

48p

Business description

Diurnal Group is a specialty pharma company developing new formulations of hormone-based products for the treatment of endocrine disorders. Its product Alkindi is marketed for paediatric (AI) in the US and EU. Efmody is approved for the treatment of CAH in the EU and UK.

Next events

Chronocort pivotal trial initiation

Q4 CY21

Analyst

Maxim Jacobs

+1 646 653 7027

Diurnal Group is a research client of Edison Investment Research Limited

Efmody (also called Chronocort), an oral long-acting formulation of hydrocortisone, has been approved in the EU and UK to treat congenital adrenal hyperplasia (CAH) in individuals aged 12 years and older. The company has started the commercial launch of the product with a rollout in Germany, Austria and the UK at the beginning of September. CAH is an orphan disease caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. The total addressable EU market is worth $268m based on the price of Plenadren, a long-acting hydrocortisone.

Year end

Revenue (£m)

PBT*
(£m)

EPS*

(p)

DPS
(p)

P/E
(x)

Yield
(%)

06/20

6.3

(5.1)

(4.1)

0.0

N/A

N/A

06/21

4.4

(11.1)

(6.6)

0.0

N/A

N/A

06/22e

7.9

(18.2)

(7.3)

0.0

N/A

N/A

06/23e

16.1

(13.2)

(5.1)

0.0

N/A

N/A

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

Diurnal marketing Efmody directly in Europe

Diurnal launched Efmody in the EU (specifically in Germany and Austria) and the UK for CAH. There are an estimated 41,000 patients in the EU/UK. The company is launching the product with its own salesforce and distributors.

SPA to de-risk the US Chronocort pivotal trial

In July, Diurnal reached a Special Protocol Assessment (SPA) agreement with the US FDA, which includes the trial design, endpoints and statistical analyses in the planned pivotal trial CONnECT (which can also be used for registration purposes in Japan). This randomised, double-blind, active-controlled Phase III trial will enrol 150 CAH patients 16 years and over. The treatment period is 12 months. There are an estimated 16,000 patients in the United States. The trial is expected to commence in Q4 CY21.

Alkindi up 18% in core commercial markets

Diurnal’s total revenue for FY21 was £4.4m, with Alkindi sales of £2.3m, down slightly from FY20 due to a negative impact from Diurnal’s Nordic partner. Proforma sales in the core markets of the UK, Germany, Italy and Austria were up 18% despite the negative impact of the COVID-19 pandemic.

Valuation: £251m or 149p per basic share

We have increased our total valuation to £251m from £230m mainly due to higher net cash and rolling forward our NPV. However, the valuation per share fell from 166p to 149p mainly due to a higher number of shares outstanding, primarily resulting from the £20.7m (gross) capital raise completed in May 2021. Net cash as of 30 June 2021 was £34.0m. Diurnal now has a clear cash runway to complete Efmody development in the United States and commercialise Efmody in the EU/UK.

Two approved products and a promising pipeline

Diurnal is an emerging endocrine company that has improved formulations of hydrocortisone in both Alkindi and Efmody with unique characteristics that can provide the patient with convenient dosing and improved efficacy. Its second product Efmody (an extended-release formulation of hydrocortisone) was recently approved in patients with CAH in the EU and UK, and subsequently launched in the UK and certain EU countries (namely Germany and Austria) in the first half of September. CAH is an orphan condition that is caused by enzyme deficiencies, most commonly 21-hydroxylase, which is an enzyme needed to produce the adrenal steroid hormone cortisol. Without cortisol, an over production of male hormones (androgens) occurs. This condition is inherited at birth and affects both males and females. Diurnal plans to begin a Phase III trial in the United States in Q4 CY21. Efmody has orphan disease designation for CAH in the United States, which provides seven years of market exclusivity.

The company’s first launched product is Alkindi, a formulation of hydrocortisone intended to treat adrenal insufficiency (AI) in paediatric patients. Before its approval in the EU in 2018 and the United States in 2020, there were no hydrocortisone products provided in paediatric doses. Additional formulation improvements in the product include it being provided in a sprinkle format, which eases administration in children and has a taste masking layer. Eton Pharmaceuticals is the partner in the United States. Alkindi was approved by the FDA in September 2020 and marketing began in November 2020. Eton has not reported actual sales numbers yet.

The company’s third product candidate is DITEST, a novel oral formulation of testosterone for the treatment of hypogonadism. It is thought that two-thirds of patients have poor control on current treatments. Testosterone products are usually topically applied since oral formulations have been difficult to develop. DITEST has completed Phase I trials in the UK. The company intends to file an IND in H221 and initiate a multiple ascending dose (MAD) study shortly thereafter in the United States. Diurnal has secured an abbreviated 505(b)(2) route to a new drug application (NDA). This pathway is for products where the active pharmaceutical ingredient (in this case testosterone) has already been approved and allows the sponsor to use data from these previous applications in its clinical data package.

Exhibit 1: Diurnal’s pipeline and addressable markets

Product

Drug

Indication

Status EU

Status US

Annual addressable market EU & US ($m)

Alkindi/Alkindi Sprinkle

Hydrocortisone

Paediatric AI

Approved 2018

Approved 2020

514

Chronocort/Efmody

Controlled release hydrocortisone

CAH

Approved 2021

Phase III ready

2,767

AI

Pivotal study ready

Phase II

DITEST

Testosterone

Hypogonadism

Phase I complete

Phase I complete

4,830

Not named

T3 modified release

Hypothyroidism

Preclinical

Preclinical

1,000

Not named

Oligonucleotide

Cushing's Disease

Preclinical

Preclinical

480

Source: Diurnal, Edison Investment Research


Plans for Efmody commercialisation

On 28 May, Diurnal received approval from the European Commission (EC) for Efmody, which treats adult and adolescent patients with CAH. The company is launching the product with its own salesforce and distributors.

In July 2021, Efmody received marketing approval in the UK for the treatment of CAH patients 12 years and older. The countries of England, Scotland and Wales are estimated to have approximately 5,000 CAH patients. After discussion with the UK Medicines and Healthcare Products Regulatory Agency (MHRA), Diurnal decided not to pursue orphan drug status for Efmody in the UK since it would probably delay the launch. This was consistent with the approach Diurnal took in the European Economic Area. Orphan drug designation would normally give 10 years of market exclusivity, but Diurnal believes its current patents will provide protection until at least 2033 in the UK.

In May, Diurnal expanded its existing partnership with China-based Citrine Medicine to also include Efmody. Diurnal received an upfront payment of $1.0m and would be entitled to receive $28.75m in additional cash payments when certain Efmody regulatory milestones and sales milestones based on annual sales thresholds are met. Citrine now has rights for Alkindi and Efmody in China, Hong Kong, Taiwan and Macau. Citrine plans to file an NDA with the National Medical Products Administration in H221 for Alkindi. It is estimated that CAH occurs in one in 6,084 births in China. In June, Diurnal received an additional $1.25m payment from Citrine as a result of the EC’s approval of Efmody and certain milestones achieved by Citrine in China for Alkindi.

In June, Diurnal expanded its partnership with Er-Kim to market both Alkindi and Efmody in Romania and Bulgaria. The estimated combined market opportunity is over $13m. Diurnal signed the original agreement, which was for Turkey, in January.

In January, Diurnal teamed up with Consilient Health to distribute Efmody in the Nordic region, which includes Sweden, Norway, Denmark, Finland and Iceland. This region has approximately 2,300 individuals with CAH and Diurnal estimates it to be worth 11.5m annually. In September 2020, Diurnal signed a deal with Consilient Health to market Alkindi and Efmody in the Benelux Union (the Netherlands, Belgium and Luxemburg).

US CONnECT Efmody trial to begin in calendar Q421

The SPA agreement with the FDA was announced in July 2021. The SPA determines that the trial design adequately meets objectives that would support a US regulatory filing. The pivotal study is called ‘A randomised, double-blind, active-controlled, Phase 3 study of Chronocort compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with CAH (CONnECT)’. Study start-up activities have already begun, since the study is planned to start in the fourth quarter of calendar 2021. The trial design is pictured below. It will enrol up to 150 patients with CAH, who will be treated for 52 weeks.

The study design is a bit complex. There is four weeks of screening followed by a four-week run-in period in which patients switch to immediate release hydrocortisone (IRHC) 30mg daily prior to beginning the double-blind, placebo-controlled, 12-month treatment. The proposed primary endpoint is biochemical responder non-inferiority of Efmody twice-daily versus twice daily immediate release hydrocortisone after 52 weeks of randomised treatment. The company has estimated that the trial could be completed in 2023, with an NDA filing in 2024. We have similar timelines in our model. We will monitor the CONnECT trial as it proceeds to see if enrolment is in line with our estimates.

Exhibit 2: US pivotal trial schema

Source: Diurnal

Diurnal also plans to conduct a head-to-head Phase II study in Europe comparing Efmody to Plenadren to seek to demonstrate superiority in order to potentially get a line extension to AI in adults. Plenadren is a modified release hydrocortisone; however, it does not mimic the circadian rhythm and is not approved for CAH. Plenadren is approved in Europe for AI in patients over 18 years old. The trial is expected to commence in Q4 CY21.

Valuation

We have increased our total valuation to £251m from £230m mainly due to higher net cash and rolling forward our NPV. However, the valuation per share fell from 166p to 149p mainly due to a higher number of shares outstanding following a £20.7m (gross) offering that was completed in May.

Exhibit 3: Diurnal valuation

Product

Indication

Geography

Clinical stage

Prob. of success

Launch year

Peak sales ($m)

rNPV
(£m)

Alkindi

Paediatric AI

Europe

Approved

100%

2018

16

7.63

US

Approved

100%

2020

10

4.93

Chronocort

Adult CAH

Europe

Approved

100%

2021

63

93.52

US

Phase III

50%

2024

84

31.02

Adult AI

Europe

Pivotal study

50%

2023

131

47.04

US

Phase II

30%

2026

150

21.38

Ditest

Hypogonadism

US

Phase II

25%

2025

70

11.38

Total

216.89

Net cash and deposits (as of 30 June 2021) (£m)

34.04

Total firm value (£m)

250.93

Total basic shares (m)

168.90

Value per basic share (p)

149

Dilutive options (m)

4.83

Total diluted shares (m)

173.73

Value per diluted share (p)

145

Source: Edison Investment Research

Exhibit 4 highlights milestones that we believe will drive the valuation of Diurnal over the rest of CY21. We believe the most significant is the execution of the Efmody launch in the in the EU and the initiation of the Efmody CONnECT trial in the United States.

Exhibit 4: Diurnal 2021 milestones

Outlook

Approval of Efmody in European Economic Area

Done

Conclude Efmody SPA in US

Done

First commercial launch of Efmody in Europe

Done

Submission of DITEST IND in US

Begin Efmody/Plenadren comparative trial

Start DITEST multiple ascending dose study in the US

Start Efmody Phase III study in the US

Source: Diurnal, Edison Investment Research

Financials

Diurnal recently reported FY21 results, which featured revenues of £4.4m, down from £6.3m in FY20 primarily due to a fall in licensing income from £3.9m in FY20 to £2.1m in FY21. The licensing figure for FY20 included a $5m upfront payment from Eton Pharmaceuticals. The company’s operating loss increased to £11.6m from £5.4m due to the fall in revenues, increased investment in clinical development and Efmody launch preparations.

Net cash as of 30 June 2021 was £34.0m. The company completed an offering in May in which Diurnal issued 29.6m shares at a price of 70p and raised approximately £20.7m (gross). The funds will be used to fund the Efmody pivotal trials in the United States through to registration for the CAH indication. In addition, some of the funds may be used to support the earlier stage pipeline. In July an additional 973,682 shares at a price of 5p were issued to management, which brings the total shares outstanding to 168.9m.

The company now has a clear cash runway to commercialise Efmody in the EU/UK and conduct the CONnECT trial in the United States, and it expects the cash on hand to last to profitability in 2024.

We still forecast a raise of £25m (modelled as illustrative debt) in FY22 prior to our forecast of profitability in 2024. The size of the offering is hard to predict due to possible licensing and/or partnerships. We think the raise will be necessary to advance the pipeline.

Exhibit 5: Financial summary

£'k

2020

2021

2022e

2023e

Year end 30 June

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

Sales

2390

2267

7802

15856

Royalties & Milestones

3923

2104

137

208

Revenue

 

 

6,313

4,371

7,939

16,064

Cost of Sales

(668)

(779)

(720)

(951)

Gross Profit

5,645

3,592

7,219

15,113

EBITDA

 

 

(5,151)

(11,125)

(18,225)

(13,172)

Normalised operating profit

 

 

(5,176)

(11,149)

(18,249)

(13,196)

Amortisation of acquired intangibles

0

0

0

0

Exceptionals

627

15

0

0

Share-based payments

(843)

(466)

(466)

(466)

Reported operating profit

(5,392)

(11,600)

(18,715)

(13,662)

Net Interest

114

62

62

62

Joint ventures & associates (post tax)

0

0

0

0

Exceptionals

0

0

0

0

Profit Before Tax (norm)

 

 

(5,062)

(11,087)

(18,187)

(13,134)

Profit Before Tax (reported)

 

 

(5,278)

(11,538)

(18,653)

(13,600)

Reported tax

1,206

1,489

3,497

2,549

Profit After Tax (norm)

(3,905)

(9,009)

(14,777)

(10,672)

Profit After Tax (reported)

(4,072)

(10,049)

(15,156)

(11,050)

Minority interests

0

0

0

0

Discontinued operations

0

0

0

0

Net income (normalised)

(3,905)

(9,009)

(14,776)

(10,671)

Net income (reported)

(4,072)

(10,049)

(15,156)

(11,050)

Basic average number of shares outstanding (m)

95

137

203

209

EPS - basic normalised (p)

 

 

(4.1)

(6.6)

(7.3)

(5.1)

EPS - diluted normalised (p)

 

 

(4.1)

(6.6)

(7.3)

(5.1)

EPS - basic reported (p)

 

 

(4.3)

(7.3)

(7.5)

(5.3)

Dividend (p)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,770

240

240

240

Intangible Assets

79

92

92

92

Tangible Assets

23

148

148

148

Investments & other

1,668

0

0

0

Current Assets

 

 

19,206

41,550

51,998

41,919

Stocks

1,241

1,625

1,801

2,377

Debtors

1,337

3,433

1,958

3,961

Cash & cash equivalents

15,434

34,037

45,785

33,126

Other

1,194

2,455

2,455

2,455

Current Liabilities

 

 

(2,555)

(4,163)

(4,301)

(4,806)

Creditors

(2,555)

(4,163)

(4,301)

(4,806)

Tax and social security

0

0

0

0

Short term borrowings

0

0

0

0

Other

0

0

0

0

Long Term Liabilities

 

 

(36)

(63)

(25,063)

(25,063)

Long term borrowings

0

0

(25,000)

(25,000)

Other long term liabilities

(36)

(63)

(63)

(63)

Net Assets

 

 

18,385

37,564

22,874

12,290

Minority interests

0

0

0

0

Shareholders' equity

 

 

18,385

37,564

22,874

12,290

CASH FLOW

Op Cash Flow before WC and tax

(5,151)

(11,125)

(18,225)

(13,172)

Working capital

(380)

(845)

1,438

(2,074)

Exceptional & other

(1,398)

109

0

0

Tax

2,120

1,199

3,497

2,549

Net operating cash flow

 

 

(4,809)

(10,662)

(13,290)

(12,696)

Capex

(45)

(163)

(24)

(24)

Acquisitions/disposals

0

0

0

0

Net interest

114

62

62

62

Equity financing

10,670

28,762

0

0

Dividends

0

0

0

0

Other

0

713

0

0

Net Cash Flow

5,930

18,712

(13,252)

(12,658)

Opening net debt/(cash)

 

 

(9,147)

(15,434)

(34,037)

(20,785)

FX

357

(109)

0

0

Other non-cash movements

0

0

0

0

Closing net debt/(cash)

 

 

(15,434)

(34,037)

(20,785)

(8,126)

Source: company reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by Diurnal Group and prepared and issued by Edison, in consideration of a fee payable by Diurnal Group. Edison Investment Research standard fees are £49,500 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 2021 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

General disclaimer and copyright

This report has been commissioned by Diurnal Group and prepared and issued by Edison, in consideration of a fee payable by Diurnal Group. Edison Investment Research standard fees are £49,500 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 2021 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

Share this with friends and colleagues