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Investor Presentation, Feb‐17

Investor Presentation, Feb‐17 - Shield Therapeutics · 2017. 3. 3. · • Maltol is a sugar derivative that strongly chelates iron in the ferric form so that it is stable, remaining

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  • Investor Presentation, Feb‐17

  • DisclaimerThe information contained in these slides has been prepared by Shield Therapeutics plc (the "Company"). It has not been approved by the United Kingdom Listing Authorityunder the Prospectus Rules (made under Part VI of the Financial Services and Markets Act 2000) or otherwise, or by the London Stock Exchange plc. Nothing in these slides,nor in any information communicated to you in the presentation of these slides, constitutes or forms part of any offer for sale or solicitation of any offer to buy or subscribefor any securities nor shall these slides, such presentation or any part of them form the basis of or be relied on in connection with, or act as any inducement to enter into,any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information or opinions contained in these slides or thepresentation of them or on the completeness, accuracy or fairness thereof.No undertaking, representation, warranty or other assurance, express or implied, is or will be made or given by or on behalf of the Company or its directors, officers,partners, employees, agents or advisers or any other person as to the accuracy or completeness of the information or opinions contained in these slides and/or thepresentation of them and no responsibility or liability is accepted by any such person for any such information or opinions or for any errors, omissions or misstatements,negligent or otherwise, nor for any other communication written or otherwise. In addition, the Company undertakes no obligation to update or to correct any inaccuracieswhich may become apparent. Notwithstanding the aforesaid, nothing in this paragraph shall exclude liability for any representation, warranty or other assurance madefraudulently.The statements contained in these slides and/or the presentation of them may include "forward‐looking statements" that express expectations as to future events or results.Forward‐looking statements can be identified by the use of forward‐looking terminology, including the terms "believes", "estimates", "anticipates", "projects", "expects","intends", "may", "will", "seeks" or "should" or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives,goals, future events or intentions. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend uponcircumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from thoseexpressed or implied by such forward‐looking statements. Any of the assumptions underlying forward‐looking statements could prove inaccurate or incorrect and thereforeany results contemplated in forward‐looking statements may not actually be achieved. Nothing contained in these slides and/or the presentation of them should beconstrued as a profit forecast or profit estimate. Investors and any other recipients of such communications are cautioned not to place reliance on any forward‐lookingstatements. The Company undertakes no obligation to update or revise (publicly or otherwise) any forward‐looking statement, whether as a result of new information,future events or other circumstances.Neither these slides nor the presentation of them should be considered a recommendation by the Company or its directors, officers, employees, agents or advisers inconnection with any purchase of or subscription for securities of the Company.These slides should not be copied or distributed by recipients and, in particular, should not be distributed by any means, including electronic transmission, to persons withaddresses in the United States of America, Canada, Australia, South Africa or Japan, their possessions or territories or to any citizens thereof, or to any corporation,partnership or such entity created or organised under the laws thereof. Any such distribution contrary to the above could result in a violation of the laws of such countries.These slides and their contents are confidential and are being supplied to you solely for your information and may not be reproduced, re‐distributed or passed on, directly orindirectly, to any other person or published in whole or in part for any purpose. By accepting receipt of this document, you agree to be bound by the limitations andrestrictions set out above.

    2

  • Paul StecklerVP Commercial Operations  Paul has more than 17 years of pharmaceutical experience across a broad range of therapeutic areas

    Prior to Shield, launched Jinarc (in polycystic kidney disease) for Otsuka, and has worked across multiple therapy areas at Pfizer

    Dr Jackie MitchellVP Regulatory Affairs Jackie has over 20 years’ experience in regulatory affairs

    Prior to Shield, worked in regulatory affairs for large, medium and small pharmaceutical companies

    Angela Hildreth UK Finance Director Angela has served as the Group’s Financial Controller since 2011 and the UK Finance Director since 2015

    Instrumental in setting up, managing and running all financial processes across UK, Germany and Switzerland

    Mark SampsonChief Medical Officer Mark was appointed as VP, Medical Affairs at Shield in 2015 and transitioned into the role of CMO

    More than 25 years of medical practice, pharmaceutical development and commercialisation experience

    Shield Therapeutics – Our Executive TeamCarl Sterritt CEO and Founder Carl has 20 years of management and executive level experience in pharmaceutical development and commercialisation

    Prior to Shield, Carl held senior management roles at United Therapeutics and Encysive Pharmaceuticals, working on innovative therapies for the treatment of pulmonary arterial hypertension

    3

    David ChildsDirector of Product Supply David has over 18 years of experience in chemical and pharmaceutical development

    Successfully led teams of scientists in the development of synthetic processes and analytical methodologies

  • Note:(1) Financial data as of 10th February 2017(2) Internal company financial model; GfK research(3) Includes 9 member German sales team contracted through InVentiv

    Commercial Stage Specialty Pharmaceutical 

    Company

    • EU marketing approval for Feraccru 02/2016 for IDA with IBD

    • Launched in UK and Germany

    • Second asset, PT20 for Hyperphosphatemia –highly complementary

    • Attractive pricing achieved in EU

    Low Risk Pipeline

    • Geographic and label expansion pathways defined in EU and US 

    • Supported by ongoing pivotal trials and secondary market filings underway

    • Addressable market to grow from a near‐term opportunity of 4.3 million patients to overall opportunity of 34 million patients across all disease states with IDA(2)

    Company History

    • Founded in 2008

    • IPO on AIM in Q1 2016, raising £32.5m

    • Approx. 60 staff currently, with c.20 personnel in sales and marketing(3)

    • c.£28m of working capital as of 30 June, 2016

    Shield Therapeutics – Overview

    0

    100

    200

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    1.00

    1.20

    1.40

    1.60

    1.80

    2.00

    Feb‐16 Apr‐16 Jun‐16 Aug‐16 Oct‐16 Dec‐16 Feb‐17

    Volume Price (£)

    Price (£) Volume (000s)

    IPO Price of £1.50

    90 Day VWAP £1.7190 Day ADTV 6,049

    50%

    12%

    9%

    5%

    4%

    4%

    16%W. Health LP (Inventages)

    Irorph Gmbh (AOP)

    Carl Sterritt

    Christian Schweiger

    JPMorgan Asset Management UK

    Aviva Investors Global Services

    Other

    Share Price Performance Since IPO(1)

    Key Shareholders

    4

  • Investment Highlights

    Note:(1) http://www.who.int/nutrition/topics/ida/en/(2)       Internal company financial model; GfK research

    5

    Feraccru: Approved, Launched and Highly Differentiated• First indication – Iron Deficiency Anaemia (IDA) in Inflammatory Bowel Disease (IBD) adult patients• Highly bioavailable / efficient absorption• Good tolerability, safety profile, and cost effective• Attractive pricing already achieved in Europe• Chronic Kidney Disease (CKD) label enabling study ongoing, Data 2H 2017

    1

    Iron Deficiency Anaemia: A Large Established Market Opportunity that Remains Underserved• According to WHO – “The world’s most common and widespread nutritional disorder”(1)• Associated with IBD, CKD, congestive heart failure, women’s health, surgery – An estimated 34

    million patients globally(2)• Failure to treat leads to lethargy and more serious complications• Up to 70% of patients for whom oral iron is prescribed report gastro side effects• Hospital based IV iron administration expensive and also impacted by further limitations

    2

    Phase 3 Ready Asset: PT20 for Hyperphosphatemia • Successful Phase 2b Pivotal trial – one more pivotal study required for approval• Potential advantages: Good safety and tolerance, lower pill burden and opportunity to treat

    resistant patients

    3

    Experienced Team with Proven Execution Track Record• 150 years of combined experience and proven ability to develop and commercialise ‘spec pharma’ products• Collectively have brought multiple novel molecules to market

    4

  • …Addressed With a Phased Approach 

    Note: EU‐10 denotes Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain, UK.Source: Company estimates 

    1.1m2.3m

    4.3m

    8.2m

    33.8mGeographic expansion

    Indication expansion

    EU/USPaediatricIndication

    US CKD (1.3m)

    US IBD (0.7m)

    EU‐10 CKD

    EU‐10 IBD

    Global Potential Patient Numbers – All Indications…

    Medium to longer termNear term addressable market

    Total:5.8 million

    EU‐10 IBD1.1 million

    US CKD1.3 million

    US IBD0.7 million

    EU‐10 CKD1.2 million

    CKD other1.1 million

    IBD other0.4 million

    Womens’ Health12.5 million

    Congestive Heart Failure3.8 million

    Paediatric (all causes)4.9 million

    Elderly (all causes)3.6 million

    Surgery (PBM)1.1 million

    Oncology2.0 million

    Total:33.8 million

    Initial targetpopulation4.3 million

    6

    Iron Deficiency AnaemiaA Significant Market Opportunity That Remains Underserved

  • 7

    EU‐10 Prevalent population with IBD 2.5 million

    % ID

    A 40

    % (1

     million)

    % receiving oral iron therapy 31% (310,000)

    % receiving IV iron therapy 24% (240,000)

    % receiving no iron therapy 45% (c.450,000)

    Market Expansion• Dissatisfied patients have access to well tolerated oral therapy

    • Increasing capacity in hospital clinics increases access to untreated patients

    2nd Line Treatment• Feraccru becomes first option for ferrous intolerant patients in treatment guidelines

    • Reduces the requirement for IV therapy

    Switch and Step Down• Capacity limits help switch from IV to Feraccru

    • Patients can be sent home with Feraccruto treat anaemia

    Source: GFK market research 2015

    Feraccru – Access to Full IDA Patient PoolFeraccru has a significant opportunity to take share in all market segments

  • US Opportunity for Feraccru(1)IBD and CKD indications only

    Note:(1)   GfK research, Company estimates

    8

    Market access• Price 10%‐20% below IV (c.$3,600 p.a.) = uptake• Tier 3 strategy ensures uptake and higher price

    • OFPs not currently reimbursed on most schemes• Pre‐authorisation limited to simple electronic 

    verification• Step edit may be introduced, positioning Feraccru 

    after OFPs and before IV iron

    Revenue assessment• Peak sales opportunity in IBD and CKD approx. £300M • Penetration into the currently untreated CKD 

    population could add c. £200M to US revenue• General IDA label significantly adds to revenue

    Next steps• Recruit small US‐based team of c. 5 people to start 

    market prep & prelaunch activities• Initially build on relationships being built via ongoing 

    clinical trials of Feraccru• Detailed commercial analysis to further understand 

    positioning and data requirements

    PLACE IN THERAPY

    Mild to moderate IDA

    IBD CKD

    KOLChronic

    treatment duration

    until failure

    PAYERChronic

    treatment duration

    until failure

    IV Iron Therapy IV Iron Therapy

    IV Iron Therapy

    30% 70%

    Oral Iron

    Oral Iron

    Potential to be used 1st line as experience increases, even without trial data

  • Feraccru Overview – A Novel Oral Ferric IronA Compelling Alternative to IV Iron and Addresses Need from Intolerant Oral Iron Patients

    Oral Iron Tolerant

    • Able to take oral ferrous iron products (OFP)

    • Many patients are intolerant of OFP, especially those with other diseases (e.g. IBD, CKD)

    Intravenous Iron (IV)

    Simple oral administration Efficient absorption Rapid Hb rise Placebo‐like safety Cost effective Can be taken without food

    • Iron directly into the blood• But:

    – Potential allergic reactions– Iron overload– Hospital only– Resuscitation team required– High overall cost

    • No patients in long term study of Feraccru required interventional IV therapy

    • IDA arises in diseases like Inflammatory Bowel Disease (“IBD”), Chronic Kidney Disease (“CKD”), Congestive Heart Failure (“CHF”) and in women with excessive uterine bleeding etc. 

    • Failure to treat leads to lethargy as well as much more serious consequences (e.g. immune & heart complications)

    Fe2+

    Fe2+

    Insoluble complexes

    +Radicals

    Gut damage side effects

    Patient diagnosed with Iron Deficiency Anaemia 

    (IDA)

    Oral Iron Intolerant

    Up to 70% with gastro side effects

    Oral Iron

    9

  • Feraccru Structure and FunctionFeraccru’s Chelated Structure Remains Stable in the Intestinal Lumen

    Iron remains chelated, soluble and ready for absorption if patient is iron deficient.

    • Feraccru is a complex of ferric iron (Fe3+) and three maltol ligands(1)‐(2)

    – This is unlike pre‐existing oral iron formulations which contain ferrous iron (Fe2+) which must be in free form to be absorbed

    • Maltol is a sugar derivative that strongly chelates iron in the ferric form so that it is stable, remaining in solution and available for absorption(2)

    – Without a chelating agent, inorganic iron will hydrolyse to insoluble complexes in the neutral to alkaline pH of the small intestine(3)

    • Remains tightly bound at higher pH of the small intestine, minimizing free ironexposure to the gut which leads to poor tolerabilityChemical Structure of Ferric Maltol(2)

    Ferric (3‐hydroxy‐2‐methyl‐4H‐pyrane‐4‐one)

    Chemical structure of ferric maltol reproduced from Stallmach A, Büning C. (2015)(2); mechanism figure adapted from Andews AC (2000). DMT1, divalent metal transporter 1; GI, gastrointestinal. (1) European Medicines Agency. Feraccru (ferric maltol) Summary of Product Characteristics. Revised 18 March 2016. (2) Stallmach A, Büning C. Expert Opin Pharmacother 2015;16:2859–67. (3) Barrand MA, et al. J Pharm Pharmacol 1987;39:203–11. (4) Andrews AC. Nat Rev Genet 2000;1:208–17. (5) Barrand MA, Callingham BA. Br J Pharmacol 1991;102:408–14. (6) Barrand MA, et al. Br J Pharmacol 1991;102:723–9. (7) Barrand MA, et al. J Pharm Pharmacol 1987;39:203–11. (8) Barrand MA, et al. J Pharm Pharmacol 1990;42:279–82. (9) Bokemeyer B. Drug Discov Today 2015;20:1037–9. (10) European Medicines Agency. Feraccru. Assessment report, 17 December 2015. (11) Singh S, Hider RC. Anal Biochem 1988;171: 47–54. (12) Stallmach A, Büning C. Expert Opin Pharmacother 2015;16:2859–67. 10

    The Ferric Iron and Maltol Complex Completely Dissociates Before Iron is Rapidly Absorbed via an Endogenous Pathway(4)‐(12)

    Fe3+

    Fe2+

    Ferroportin1

    Iron TransportMechanism

    Fe3+

    Transferrin 

    Fe2+

    Most iron enters the liver and bone marrow

  • 11

    12

    13

    14

    0 4 8 12

    Absolute Hb (g/dl)

    Duration of treatment (weeks)Feraccru Placebo

    • A clinically relevant haemoglobin (Hb) increase is considered to be 1g/dL

    – Feraccru delivered highly relevant and rapid 2.3g/dL rise inside 12 weeks with 1g/dL in only 4 weeks

  • Ongoing Phase 3 Head to Head Study Design in EU and USHead to Head Against Injectafer/Ferinject IV Iron (Ferric Carboxy Maltose; FCM)

    Prospective, Multicentre, Randomized, Controlled Phase 3b Study

    Study duration (weeks)

    Screening(Up to 14 Days)

    R(n=242)

    Ferric Maltol 30 mg BID (n=121)

    IV iron administered as per the local summary of product characteristics (SPC) (n=121)

    130 26 52

    Post‐treatment safety follow‐up: 14 days after Week 52 or 

    premature discontinuation of Ferric Maltol or FCM

    39

    Study Endpoints

    Primary efficacy endpoint:

    Number of subjects achieveing either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at week 12

    Secondary efficacy endpoints:

    Change in Hb concentration from baseline to Week 12 / Proportion of subjects experiencing change from baseline in Hb concentration >1.0, or >2.0 g/DL at Wk 12

    Change in mean serum ferritin from baseline to Week 1

    Long term efficacy endpoints & treatment‐emergent Adverse Events

    12

    Data Expected: H2‐2017

    Primary endpoint @ Wk12

  • Ongoing Phase 3 Study Design in CKD in USStudy Designed to Allow EU Label Expansion and aid US Approval

    Study duration (weeks)

    Screening R(n=162)

    Ferric Maltol 30 mg BID (n=108)

    Placebo(n=54)

    40 8 16

    Open‐label extension with

    Ferric Maltol(52 weeks)(2)

    12

    Inclusion Criteria:• Ensure that subjects have true 

    IDA, which enhances clinical effectiveness

    • Excludes EPO, reducing chance of Hb rise in placebo arm due to EPO effect

    Study Endpoints

    13

    Primary efficacy endpoint:

    Change in Hb concentration from baseline to Week 16

    Secondary efficacy endpoints:

    Ensure that effect at different Hb elevation can be evaluated

    Data Expected: H2‐2017

    Primary endpoint

  • Significant Progress Made Since IPO

    EU Marketing Approval  • Achieved for Feraccru in February 2016

    Commercial Launch

    • Launched in the UK in June 2016 with activities continuing to accelerate as per plan – Nine member sales team interacting daily with UK customers– Formulary access and approvals by CCGs increasing

    • Launched in Germany in October 2016– Nine member in‐country team initially being managed by CSO 

    (InVentiv) with HQ and in‐country office support from Shield

    Pricing / Reimbursement

    • Achieved attractive price points in the UK and Germany– £47.60 per 28‐day treatment pack in UK– €64.00 per 28‐day treatment pack in Germany

    IPR • Key Composition of Matter patent granted meaning IPR on Feraccru strengthened and extended to at least 2034

    Revenues • 1st revenues from sales of Feraccru achieved in the UK

    • First sales in Germany delivered as planned in October 2016

    Corp Development / R&D

    • Head to head and CKD Phase 3 studies of Feraccru progressing• Discussions progressing well with potential licensing partners in non‐core 

    markets • PT20 and PT40 activities continue in‐line with plan

    14

  • Shield core markets

    Inward enquires

    AOP Pharma (Partner)

    Non‐core markets

    Active discussions

    Launched

    Commercialize in EU‐5 and US Markets, Local Partners ElsewhereFeraccru Global Strategy 

    15

  • PT20 – A Novel Phosphate Binder for Hyperphosphatemia

    16

  • PT20 Overview

    • PT20 is a novel iron‐based phosphate binder for the treatment of hyperphosphatemia related to dialysis or non‐dialysis dependent CKD

    • Orally administered adipic acid doped, iron oxide based phosphate binder– Acts as a high capacity phosphate sponge

    • Demonstrated high safety efficacy in successful pivotal phase 2b study

    • Discovered in the UK at Cambridge University, and developed by the Medical Research Council

    • Strong IP protection until at least 2028‐2029

    – Without SPC/PTE benefits platform technology patent expires in February 2028, except for in the US, which expires in August 2029(1)

    – Phosphate binder technology expires in August 2029(2)

    17

    Note:(1)   Application PCT/GB2008/000408 filed on 6 February 2008 claiming priority from GB0702270.0 and US 60/888,386, both filed on 6 February 2007(2) Application PCT/GB2009/001931 filed on 5 August 2009 claiming priority from GB0814326.5 and US 61/086,244, both filed on 5 August 2008

  • Successfully Completed PT20 Pivotal Phase 2b Study

    Results

    • Primary endpoint met with a p value of 90%

    Difference in Ferritin scores after removing IV iron for 14 days

    Source: Company Phase 2b results

    28 day change in serum phosphate baseline 

    (60)

    (40)

    (20)

    ‐‐

    20

    40

    60

    PT20 Placebo

    Ferritin ng

    /mL

    Screening up to 14 days

    Washout period up to 28 days

    Pre‐treatment up to 7 days

    Treatment period 29 days

    Follow up 14 days

    Stop phosphate‐binder Randomise

    Start study medication

    Complete treatment period

    Placebo 400mg tid 800mg tid 1600mg tid 3200mg tid

    (2.0)

    (1.5)

    (1.0)

    (0.5)

    ‐‐

    Serum pho

    spha

    te m

    g/dL

    18

  • Planned PT20 Phase 3 Study Design Post‐FDA

    Screening up to 14 days

    Washout up to 28 days

    Pre Treatment 

    Period up to 7 days

    OLE up to 32 weeks

    Placebo (n=50)

    PT20 (n=50)

    PT20 (n=500)Dose titration of 

    1‐4g tid

    Sevelamer hydrochloride 

    (n=250)Dose titration as PI

    First 100 subjects with controlled serum phosphate level of 

  • Key Strategies

    Expand EU Footprint and Label of Feraccru

    Drive Feraccru Adoption and Sales

    Further Develop PT20 to Commercialization

    Partner Outside Key Territories / In‐License Additional Complementary Assets/Seek M&A Opportunities

    Commercialize Feraccru in US

    1

    2

    3

    4

    5

    20

  • EMA approval of Feraccru

    Feraccru launches in UK in 

    IBD (first reference price)

    H2H study starts Phase 3b 12 week data (H2H vs. IV) primary dataFeraccru launches 

    in Germany (second reference 

    price)

    PT20 out‐licensing opportunities

    Feraccru US label Phase 3 data readoutPhase 3 CKD study in US out to H2 2017

    Feraccru US approval

    2016 2017 2018 2019H1 H2 H1 H2 H1 H2 H1 H2

    CKD study starts

    Feraccru launch commences in distributor markets

    Feraccru to launch across a wider set of European markets

    1st non‐core market out‐

    licensing deals for Feraccru

    Shield Therapeutics – Key Value Driving Events Through 2019(1)

    21

    H2H LT Data

    Feraccru US NDA for CKD/IBD

    EU Paediatric MAAUS Paediatric NDA

    Label expansion in Europe based on 

    further clinical data

    EU paediatric studies conducted

    Feraccru 

    Composition of Matter IP

    Note:(1)   Current targeted dates and subject to change

  • • Successful completion of an IPO on AIM raising £32.5m (gross) and further potential gross proceeds of £17.5m, subject to the full exercise of warrants

    • First reported UK revenues in H1 2016

    • Net loss for H1 2016 of £8.9m on an IFRS basis; Adjusted net loss H1 2016 of £5.1m(1)

    • 30 June 2016 cash balance of £28.4m

    Note: (1)   The Company’s 2016 interim results include certain items relating to the structure of the group pre‐IPO and pre‐acquisition of Phosphate Therapeutics Limited which completed in February 2016.

    Financial Information(1)

    H1’16£’000

    H1’15£’000

    2015£’000

    Revenue 240 ‐ ‐

    Gross Profit 186 ‐ ‐

    Operating costs (S,G &A) (5,004) (574) (1,371)

    Other operating income 40 120 221

    Reseach and development (787) (1,215) (5,284)

    Operating loss (5,565) (1,669) (6,434)

    Financing costs1 (18,054)

    Net Loss (8,851) (30,027) (24,488)

    Adjusted net loss (5,081) N/A (5,279)

    H1’16£’000

    H1’15£’000

    2015£’000

    Intangible assets 27,550 514 530

    Current assets 29,883 3,803 2,330

    Total assets 57,433 4,317 2,860

    Current liabilities (3,159) (13,171) 3,575

    Non‐current liabilities (3,159) (52,790) (17,928)

    Total Liabilities (3,159) (52,790) (21,503)

    Net Assets/(Liabilities) 54,274 (48,473) (18,643)

    H1 ‘16 Results ‐ P&L H1’16 Results ‐ Balance sheet

    22

  • Summary

    23

    Feraccru: Approved, Launched and Highly Differentiated1

    Iron Deficiency Anaemia: A Large Established Market Opportunity that Remains Underserved

    2

    Phase 3 Ready Asset: PT20 for Hyperphosphatemia 3

    Multiple Value Driving Catalysts on the Horizon4

    Experienced Team with Proven Execution Track Record5

  • Supplementary Information

    24

  • Source: Stratagem’s patent report

    25

    2015 2017 2019 2021 2023 2025 2027 2029 2031 2033 2035

    P004 (Ferrous Iron + Maltol)

    P005 (Method of manufacture)

    P007 (Method of use – high gastric pH)

    P009 (Alternate process)

    P010 (Dosing regimen – 30mg)

    P011 (Liquid composition)

    P012 (Crystalline form)

    P014 (Dosing regimen)

    Data and Marketing Exclusivity in Europe

    Fully 

    Granted

    Partially 

    Granted

    Pend

    ing

    SPC & Paeds Term Extension

    Feraccru IPRobust Patent Portfolio and Legislation Enable Lengthy Market Exclusivity Periods

  • Product Indication Pre‐clinical

    Phase 1 Phase 2 Phase 3 Filed Marketed Launch  Target peak annual sales

    IDA in IBD (Inflammatory bowel disease)

    2016

    IDA in CKD (chronic kidney disease)

    2018

    IDA in IBD + CKD 2019

    IDA in Paediatrics2019+

    PT20Hyperphosphataemia

    2020

    PT30 Advanced IV iron formulation

    PT40 Generic IV iron formulation

    Note:(1) Average of peak sales estimates from independent research estimates of GFK market research, RBC Equity Research, Canaccord Equity Research and Liberum Equity Research(2) GFK market research 2015

    c.£500m(1)opportunity

    £200m+(2)opportunity

    £100m+(2)opportunityUSA ANDA regulations

    26

    Product PortfolioCommercial Stage With Several Complementary Assets on the Horizon

  • Significant Shareholders

    No. of Shares (000s) %OSW. Health LP (Inventages) 54,063 49.99%Irorph Gmbh (AOP) 12,544 11.60%Carl Sterritt 10,053 9.30%Christian Schweiger 5,623 5.20%JPMorgan Asset Management UK 4,109 3.80%Aviva Investors Global Services 4,001 3.70%

    Total Shares in Issue 108,135

    Shield Therapeutics Plc Capital Structure

    27

    AIM TICKER STX

    Market Cap £186m (168.5p)

    Ordinary Shares 108M

    Since IPO price range 149.5p‐188p

    Avg daily volume (since IPO) 7,092

    Free Float 20%

    Directors’ Beneficial Interests

    No. ofShares (000s) %Capital

    Carl Sterritt 10,053 9.30%

    Andrew Heath 86 0.08%

    Options on issue

    No. ofOptions(000s) Strike Expiry

    Employees 1,523 1.5p 2026

    Warrants on issue

    No. ofWarrants(000s) Strike Expiry

    Total number of warrants 11,667 150p H1 2017 

    0

    100

    200

    300

    400

    500

    1.00

    1.20

    1.40

    1.60

    1.80

    2.00

    Feb‐16 Apr‐16 Jun‐16 Aug‐16 Oct‐16 Dec‐16 Feb‐17

    Volume Price (£)

    Price (£) Volume (000s)

    90 Day VWAP £1.7190 Day ADTV 6,049

    IPO Price of £1.50