Shield Therapeutics — 2019 a landmark year

Shield Therapeutics (AIM: STX)

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Research: Healthcare

Shield Therapeutics — 2019 a landmark year

Today’s 2019 business and trading update highlights a landmark year for Shield Therapeutics. Feraccru/Accrufer (oral ferric maltol) is making inroads in Europe, with sales volumes growing 67% through commercialisation partner, Norgine. Importantly, the AEGIS head-to-head study proved Feraccru/Accrufer to be non-inferior to IV iron therapy, a strong marketing tool for an oral treatment. In July 2019, the FDA approved the product for the treatment of iron deficiency in patients with any underlying cause – the broadest possible label. Momentum has continued into 2020 with an out-licensing deal with China-based Beijing Aosaikang Pharmaceutical (ASK Pharm) that covers China, Hong Kong, Macau and Taiwan. The next key inflection point is a US partnering deal, which we assume will occur in the next 12 months. We value Shield at £345m.

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Written by

Healthcare

Shield Therapeutics

2019 a landmark year

Business update

Pharma & biotech

27 January 2020

Price

164.5p

Market cap

£192m

£0.76/US$; £0.91/€

Estimated net cash (£m) at 31 December 2020

8.5

Shares in issue

116.4m

Free float

29%

Code

STX

Primary exchange

AIM

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(9.4)

(10.8)

304.2

Rel (local)

(8.8)

(14.6)

260.2

52-week high/low

196.0p

42.4p

Business description

Shield Therapeutics is a commercial-stage pharmaceutical company. Its proprietary product, Feraccru, is approved by the EMA and FDA for the treatment of iron deficiency. Feraccru is marketed through partners Norgine, AOP Orphan and Ewopharma.

Next events

Out-licensing US rights to Feraccru

2020

Launches in the US and additional EU states as covered by Norgine

2020/21

Analyst

Dr Susie Jana

+44 (0)20 3077 5700

Shield Therapeutics is a research client of Edison Investment Research Limited

Today’s 2019 business and trading update highlights a landmark year for Shield Therapeutics. Feraccru/Accrufer (oral ferric maltol) is making inroads in Europe, with sales volumes growing 67% through commercialisation partner, Norgine. Importantly, the AEGIS head-to-head study proved Feraccru/Accrufer to be non-inferior to IV iron therapy, a strong marketing tool for an oral treatment. In July 2019, the FDA approved the product for the treatment of iron deficiency in patients with any underlying cause – the broadest possible label. Momentum has continued into 2020 with an out-licensing deal with China-based Beijing Aosaikang Pharmaceutical (ASK Pharm) that covers China, Hong Kong, Macau and Taiwan. The next key inflection point is a US partnering deal, which we assume will occur in the next 12 months. We value Shield at £345m.

Year end

Revenue (£m)

PBT*
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

12/17

0.64

(18.42)

(15.2)

0.0

N/A

N/A

12/18

11.88

(5.15)

(1.5)

0.0

N/A

N/A

12/19e

2.92

(7.82)

(5.2)

0.0

N/A

N/A

12/20e

11.74

0.27

1.3

0.0

N/A

N/A

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

US and further European launches lie ahead

The company expects FY19 revenues of £2.9m (2018 £11.8m) with £2.3m from milestones and £0.6m in sales-related revenues. The original approved European label for Ferracru was narrower and there have been reimbursement constraints related to this. Norgine is focusing its field-based detailing on the AEGIS H2H study and is in the process of submitting pricing and reimbursement applications to key European markets. Under the China deal ASK Pharm will complete any required clinical trials and file the marketing authorisation for the treatment of iron deficiency in all territories covered by the deal; we forecast China launch in 2023. The US is a key market and Shield is in detailed discussions with potential commercial partners. We expect Accrufer launch later this year once a partner has been found.

Financials: Cash runway extended into 2021

Shield reported a FY19 cash position of £4.1m, but the post period end upfront payment of $11.4m from ASK Pharma extends the cash runway into 2021.We expect a US partnering deal (2020) and associated upfront licensing payment to strengthen the balance sheet, further reducing the requirement for a capital increase. With ongoing growth in Europe and a US launch on the horizon, we forecast that sustainable profitability is achievable from 2022, with gross margins nearing c 50–60% in the long term.

Valuation: £344.7m or 294p/share

Our revised valuation is £344.7m or 294p/share vs £346.8m or 296p/share (derived from an rNPV model). Our base assumptions for Shield remain unchanged and our valuation reflects an end-2020 net cash forecast of £8.5m and we have updated for FX and rolling forward our model. Our NPV calculation is based on Feraccru achieving peak sales of €133m in Europe, $420m in the US and $126m in China.

Exhibit 1: Financial summary

Year end 31 December

£000s

 

2017

2018

2019e

2020e

2021e

PROFIT & LOSS

Revenue

 

 

637

11,881

2,924

11,746

8,369

Cost of sales

 

 

(155)

(311)

(415)

(1,719)

(4,081)

Gross profit

 

 

482

11,570

2,510

10,028

4,288

Gross margin %

 

 

76%

97%

86%

85%

51%

SG&A (expenses)

 

 

(16,722)

(12,438)

(7,324)

(6,758)

(6,107)

R&D costs

 

 

(4,711)

(4,300)

(3,000)

(3,000)

(3,000)

Other income/(expense)

 

 

0

0

0

0

0

EBITDA

 

 

(18,514)

(2,814)

(5,490)

2,528

(2,712)

Depreciation and amortisation

 

 

(2,437)

(2,354)

(2,324)

(2,258)

(2,107)

Reported Operating Income

 

 

(20,951)

(5,168)

(7,815)

269

(4,819)

Exceptionals and adjustments

 

 

(2,571)

0

0

0

0

Adjusted Operating Income

 

 

(18,380)

(5,168)

(7,815)

269

(4,819)

Finance income/(expense)

 

 

(43)

15

0

0

0

Reported PBT

 

 

(20,994)

(5,153)

(7,815)

269

(4,819)

Profit Before Tax (norm)

 

 

(18,423)

(5,153)

(7,815)

269

(4,819)

Income tax expense

 

 

1,406

3,359

1,800

1,200

600

Reported net income

 

 

(19,588)

(1,794)

(6,015)

1,469

(4,219)

Average Number of Shares Outstanding (m)

 

112.4

116.4

116.4

116.4

116.4

Year-end number of shares, m

 

 

112.4

116.4

116.4

116.4

116.4

Basic EPS (p)

 

 

(17.43)

(2.00)

(5.17)

1.26

(3.62)

EPS - normalised (p)

 

 

(15.2)

(1.5)

(5.2)

1.3

(3.6)

Dividend per share (p)

 

 

0.00

0.00

0.00

0.00

0.00

BALANCE SHEET

 

 

 

 

 

 

 

Property, plant and equipment

 

 

13

8

6

4

3

Goodwill

 

 

0

0

0

0

0

Intangible assets

 

 

29,961

30,957

30,085

28,079

26,223

Other non-current assets

 

 

0

0

0

0

0

Total non-current assets

 

 

29,974

30,965

30,091

28,083

26,226

Cash and equivalents

 

 

13,299

9,776

4,110

8,486

3,523

Inventories

 

 

125

109

456

1,889

2,242

Trade and other receivables

 

 

1,572

1,031

1,440

6,775

12,410

Other current assets

 

 

0

1,500

1,500

1,500

1,500

Total current assets

 

 

14,996

12,416

7,505

18,650

19,675

Non-current loans and borrowings

 

 

0

0

0

0

0

Other non-current liabilities

 

 

0

0

0

0

0

Total non-current liabilities

 

 

0

0

0

0

0

Trade and other payables

 

 

3,501

2,548

2,278

9,445

12,332

Current loans and borrowings

 

 

0

0

0

0

0

Other current liabilities

 

 

262

403

403

403

403

Total current liabilities

 

 

3,763

2,951

2,681

9,848

12,735

Equity attributable to company

 

 

41,207

40,430

34,915

36,885

33,166

CASH FLOW STATEMENT

 

 

 

 

 

 

 

Reported net income

 

 

(19,588)

(1,794)

(6,015)

1,469

(4,219)

Depreciation and amortisation

 

 

2,437

2,354

2,324

2,258

2,107

Share based payments

 

 

560

1,013

500

500

500

Other adjustments

 

 

39

4

0

0

0

Movements in working capital

 

 

(186)

(255)

(1,026)

399

(3,101)

Interest paid/received

 

 

0

0

0

0

0

Income taxes paid/received

 

 

587

(1,500)

0

0

0

Cash from operations (CFO)

 

 

(16,151)

(178)

(4,216)

4,626

(4,713)

Capex

 

 

(3,408)

(3,345)

(1,450)

(250)

(250)

Acquisitions & disposals net

 

 

0

0

0

0

0

Other investing activities

 

 

0

0

0

0

0

Cash used in investing activities (CFIA)

 

 

(3,408)

(3,345)

(1,450)

(250)

(250)

Net proceeds from issue of shares

 

 

11,880

0

0

0

0

Movements in debt

 

 

0

0

0

0

0

Other financing activities

 

 

0

0

0

0

0

Cash from financing activities (CFF)

 

 

11,880

0

0

0

0

Cash and equivalents at beginning of period

 

 

20,978

13,299

9,776

4,110

8,486

Increase/(decrease) in cash and equivalents

 

 

(7,679)

(3,523)

(5,666)

4,376

(4,963)

Cash and equivalents at end of period

 

 

13,299

9,776

4,110

8,486

3,523

Net (debt)/cash

 

 

13,299

9,776

4,110

8,486

3,523

Source: Company accounts, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Shield Therapeutics and prepared and issued by Edison, in consideration of a fee payable by Shield Therapeutics. 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.

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New Zealand

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United Kingdom

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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

1,185 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 Shield Therapeutics and prepared and issued by Edison, in consideration of a fee payable by Shield Therapeutics. 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 2020 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2020. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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

1,185 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

1,185 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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