logo-loader

Shield Therapeutics : US Opportunity Awaits

Last updated: 13:55 11 Mar 2021 GMT, First published: 12:55 11 Mar 2021 GMT

Shield Therapeutics : US Opportunity Awaits

STX is preparing to launch prescription iron replacement treatment Accrufer in the US, a market estimated to be worth US$1.2bn pa, the largest global market for iron replacement treatment. A self-launch can provide STX with the lion’s share of projected profits, peak sales estimate of up to US$400mln by year six, and is timely given the opportunity to gain traction given the unmet need for a well-tolerated, effective and convenient treatment for Iron Deficiency (ID). STX estimates that funding of US$40mln (£29mln) will enable it to rapidly ramp up revenues, sufficient to reach break-even at the 18-month point. The projected strategy, 90% margin product profile and promising conclusions from market research with top ten US payers suggest the potential for significant cash generation. The US launch on its own, if executed in line with STX's internal projections, can more than justify the market capitalisation of the company, even applying conservative projections.

STX has appointed a marketing leadership team of four, headed up by pharma industry veteran Brian Groch, and will use financing proceeds up to £29mln gross to cover launch costs, including appointing an initial team of 30 representatives (reps). STX estimates that it can reach more than 80% of the target high volume and super prescribers by recruiting up to 60 reps, supplemented by a successful sales and marketing reach through digital interactions targeting break-even at 18-months. Launch planning includes extensive analysis of the market to gain insight enabling STX to target the top prescribers for maximum impact. The characteristics of Accrufer position it to take a substantial share of the overall market to achieve an annual peak sales target of US$300-400mln by year six.

Accrufer is well-positioned compared to poorly tolerated first-line oral iron salts and offers a convenient and safer alternative to intravenous (IV) iron. Lockdown restrictions on administering IV iron infusions in a clinic widens the window of opportunity for Accrufer given that it can be safely administered at home. Overall use of IV iron has been falling alongside lockdown restrictions according to market reports from leading IV iron companies. STX will employ remote and e-detailing technology to directly carry out a proportion of physician interactions to maximise efficiency.

Ferracru, known as Accrufer in the US, is a prescription-based oral iron replacement treatment, to treat iron deficiency. Evidence from three Phase III clinical studies shows it is an effective and well-tolerated long-term treatment for maintaining the body’s iron stores. Iron deficiency leading to iron deficiency anaemia (IDA) can cause serious and potentially fatal complications particularly in patients with underlying chronic diseases. There are about 10 million IDA patients in the US, which is the largest and the most receptive market in the world for novel pharmaceutical treatments.

The next inflexion points for Ferracru/Accrufer include updates on progress towards the US launch planned in June. Prospects in non-US markets include leveraging the reanalysed AEGIS head-to-head trial data to gain reimbursement in existing markets, and to target larger European markets in fiscal 2021 (FY 2021). The China launch is anticipated for 2023 on trial completion. Licensing agreements are being negotiated in other countries. The report from the reformulation study for the paediatric population is imminent, and cash flow generated in the US will be used to finance a study to broaden the label to the 1.6 million children/adolescent population for a planned mid-2021 start.

Conclusions: The projected targeting of top US iron replacement prescribers, apparent receptiveness to branded pricing and a 90% gross margin product profile suggests the potential for significant cash generation on meeting internal financial estimates. In contrast, the shares have fallen back 60% since the announcement of the intention to commercialise Accrufer independently. Prospects of renewed traction in other markets also underpin the company valuation.

Focused on US launch

STX is preparing to launch the prescription iron replacement treatment Accrufer in the US - a market estimated to be worth US$1.2bn pa. It seeks to leverage the features of Feraccru/Accrufer and seize the opportunity to gain traction in this large and receptive market, given the unmet need for a well-tolerated, effective and convenient treatment for iron deficiency (ID). Payer research covering 200 million lives is supportive of product positioning and pricing.

The estimated size of the addressable patient pool in IDA is around 10 million patients and is poorly penetrated since only around 50% are being treated. STX has generated market research and pricing data enabling it to build a market strategy for self-launch in the US, which is the largest addressable iron replacement market in the world.

While efforts to find suitable partners have not borne fruit, the successful execution of the strategy would mean that it can derive much higher value independently than via a co-promotion or partnered strategy, and has the potential for significant cash generation. The company is preparing for the US launch in June 2021 and the proceeds from its current £29mln funding would enable it to attain break-even by 18 months after launch, according to internal financial projections.

Financing and cash reach

STX is raising up to £29.2mln gross in a placing, subscription and open offer of up to 97,279,730 new shares at 30 pence per share.

  • Number of placing shares to be issued is 66,398,720
  • Number of subscription shares to be issued is 16,934,613
  • Basis of the open offer: 2 for 17 ordinary shares
  • Maximum number of open offer shares to be issued is 13,946,397

This would take the maximum number of shares in issue to 215,824,109 and the new shares will form 45% of the enlarged share capital if issued in full.

Existing shareholders participate

AOP, a major shareholder of the company, will subscribe for 14,333,333 subscription shares. Dr Christian Schweiger, a non-executive director of the company and a major shareholder, and Tim Watts, the chief executive officer of the company, have also agreed to subscribe for 1,301,280 and 1,000,000 subscription shares, respectively.

Use of proceeds
  • The proposed use of proceeds from the subscription and placing is to fund the self-launch of lead product Feraccru, which is known as Accrufer in the US market.
  • US launch costs to cover the expense of sales representatives, market research and data analysis, marketing spend and other US operational costs.
  • It is anticipated that US$30-40mln (c £21-29mln) should provide the finance necessary to reach the break-even point by 18 months following the launch in the second quarter (Q2) of 2021.

The side effects of oral iron salts and the cost, inconvenience and safety risk of IV iron underline the clinical rationale of Accrufer

A compelling clinical rationale

Shield Therapeutic’s lead product is Feraccru, which will be marketed as Accrufer in the US, an oral prescription-only treatment for iron deficiency. In cases of severe iron deficiency anaemia, the first-line prescription treatments are oral iron salts e.g. ferrous sulphate, ferrous fumarate, ferrous gluconate. Nausea, heartburn, pain, constipation, and diarrhoea are the most commonly reported side effects, occurring in up to 40% of people receiving iron supplementation, across all types of iron preparation, frequently limiting compliance. Iron salts tend to be poorly absorbed particularly if there is inflammation, which can limit efficacy in case of some types of diseases.

Iron salts dissolve and sit in the GI tract and cause side effects, and this can often exacerbate the underlying disease. More than 90% of ingested iron remains unabsorbed. (source: Management of iron deficiency anaemia in inflammatory bowel disease; Stein and Dignass, Annals of Gastroenterology).

IV iron therapy is recommended as a second-line treatment for iron-deficient patients who do not tolerate or do not respond to oral treatments within the first two weeks of treatment in cases of severe anaemia or those with certain underlying disease. The therapy is also recommended for those receiving erythropoiesis-stimulating agents, to stimulate the production of red blood cells.

IV iron is administered as one or two infusions of 500-1000mg, always in a hospital or clinic setting because it carries the risk of a severe and potentially fatal allergic reaction, adding to the existing burden and costs for patients. IV Iron is considered to be invasive and many physicians are reluctant to prescribe given the safety risk, exacerbated by the COVID pandemic. The Swiss company, Vifor Pharma (VIFN) sells the market-leading branded injectable iron Ferinject, known as Injectafer in the US.

The side effects of oral iron salts and the cost, inconvenience and safety risk of IV iron underline the clinical rationale of Accrufer.

Differentiated mechanism is key

The active substance in Feraccru is ferric maltol, an iron-containing compound that is orally administered and absorbed by the cells of the intestines. Iron is released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency, to correct haemoglobin production, treat anaemia and its symptoms.

Feraccru is designed to be activated in line with the patient’s iron levels via a mechanism that releases the iron as required, minimising side effects such as GI issues that are common and treatment-limiting in first-line iron salts.

The product is available as 30mg capsules with a recommended dose of one capsule taken twice a day. Treatment duration depends on the severity of the iron deficiency, but generally, at least 12 weeks of treatment are required and then a further four weeks’ maintenance or top-up is recommended.

 
 
Source: Company presentation

Feraccru is approved in the EU, Switzerland and the US for a broad label which includes ID and IDA (the ID patient population is two to three times the size of the anaemia group) as an alternative to first-line treatment if the patient is not responsive or cannot tolerate oral iron salts, and as a much more convenient and potentially lower cost, safer alternative to intravenous iron. Accrufer received Food and Drug Administration (FDA) approval in July 2019 for the treatment of iron deficiency in adults.

Commonly ID is the precursor to IDA so that treatment of the first signs of ID can prevent progression

Overview of iron deficiency and iron deficiency anaemia

Iron deficiency (ID) and iron deficiency anaemia (IDA) are caused by low levels of iron in the body leading to a lack of red blood cells. IDA is a common disorder: anaemia affects around 33% of the world’s population, and about half the cases are due to iron deficiency. Children and women are among the groups most affected. Commonly ID is the precursor to IDA so that treatment of the first signs of ID can prevent progression. Iron is an essential building block for haemoglobin the protein responsible for transporting oxygen from the lungs to cells in the body. The body can produce more haemoglobin and correct anaemia once iron stores are replenished.

  • Anaemia is defined as haemoglobin (Hb) less than 13 g per decilitre (g/dl) for men, less than 12g/dl for women.

The most common reasons for ID are insufficient iron intake in the diet, an inability to absorb iron well in the body and/or loss of iron in the blood through bleeding. Moderate to severe IDA may cause fatigue or tiredness, breathing problems or chest pain. Treating ID and IDA - which are common and often serious complications in people suffering from chronic heart or kidney disease, cancers or gastrointestinal diseases - can help improve what are often serious and life-threatening complications, relieve symptoms and improve quality of life. The most serious complications of IDA if untreated include:

  • Heart problems
  • Raised risk of infection
  • Depression
  • In children, IDA can cause physical and cognitive developmental delay

There are 10 million people affected in US alone.

A large patient pool

There are around 30 million affected worldwide including 10 million in the US alone and the highest risk cases are those linked to underlying health conditions. Diseases such as CKD, IBD and cancer are among the major chronic diseases linked to IDA. So resolving or preventing anaemia in such cases is a clear need to minimise the risk of complications. For example, individuals suffering from IBD are unable to absorb sufficient iron owing to chronic intestinal inflammation, and they also suffer from excessive bleeding. Up to 80% of IBD patients suffer from ID and a third of these are likely to suffer anaemia, which is sufficient in many cases to lead to hospitalisation and its clinical and cost burden. Another key high-risk sub-group addressable is in the field of women’s health, particularly linked to menstruation and post-partum blood loss.

Disease subgroups IDA

 
 
Source: Company presentation

Feraccru is well tolerated and effective over the long term.

Clinical data

Feraccru received marketing approval based on evidence from two Phase III placebo-controlled clinical studies, in patients suffering from inflammatory bowel disease (IBD) and chronic kidney disease (CKD), which demonstrated that Feraccru/Accrufer increases Hb levels by clinically relevant amounts over 12/16 weeks, maintains Hb levels over the long term and is well tolerated, meeting the primary endpoints in each study.

A third Phase III trial, the AEGIS head-to-head study measured Feraccru longer term up to 52 weeks, against the leading IV iron, Injectafer, demonstrating its efficacy, a clinically relevant increase and maintenance of Hb levels, as well as long term tolerability in mild to moderate IDA. There was a clinically meaningful response at 12 weeks, although it was not non-inferior, and on a long term basis, it appears to outperform IV iron since many patients in the IV iron relapsed requiring re-infusion providing important support for clinical, commercial and reimbursement negotiations.

Pivotal study highlights

 
 
Source: Company presentation
 
 

Feraccru is a ‘credible alternative to IV iron’ and as a long term treatment it appears to outperform IV iron

AEGIS Head to Head study

Conducted over a 52-week period with measurements taken at weeks 4, 12, 24, 36 and 52. The patients included in the study had low baseline haemoglobin (Hb) levels in some cases as low as 8.0g/dL compared to the World Health Organization (WHO) definition of normal Hb of 12g/dL for women and 13g/dL for men. The primary endpoint of the study was non-inferiority measured as the response rate at Week 12, defined as normalisation of Hb levels or an increase of at least 2g/dL in Hb from patients’ baseline levels in both the intention to treat (ITT) and per-protocol (PP) groups compared to the IV iron arm. ITT includes all patients including those who drop out and is considered to more accurately reflect a real-world setting than the PP group, which only includes those who remain in the study for its duration.

The 12-week response rate was clinically significant in terms of the mean rise in Hb levels although the overall response rate was not non-inferior to IV iron; treatment outcomes for the short term at the end of the 12-week period showed that in the Feraccru arm, 67% of the intention to treat (ITT) population and 68% of the per-protocol (PP) population had responded to treatment. In the IV arm, 84% of the ITT population and 85% of the PP population had responded meaning that Feraccru did not achieve non-inferiority at 12 weeks in the primary endpoint in either population; however, there was a clinically significant response rate measured as the mean increase in Hb levels per patient in the Feraccru arm of 2.45 g/dL for the ITT population and 2.57 g/dL in the PP population, compared with 3.04 g/dL and 3.05 g/dL respectively for IV-treated patients.

Longer-term the comparison of Hb between the Feraccru and IV arms (using the ITT population) provided a more favourable comparison with little difference between the patient groups at week 24, when 65% Feraccru of patients had achieved normal levels of Hb and therefore were non-anaemic, compared with 68% of IV patients.

The measurement of mean increases in Hb levels at weeks 24, 36 and 52, suggest that Feraccru outperformed IV iron; the mean increases in Hb levels were 2.93 g/dL, 3.16 g/dL and 2.72 g/dL in the Feraccru arm, compared with 2.84 g/dL, 2.70 g/dL and 2.79 g/dL in the IV arm. Secondly, on a longer-term basis, Feraccru demonstrated a durable effect, based on a twice-daily dosing regime, versus IV iron. This was reflected in the higher mean increases in Hb at 24, 36 and 52 weeks from baseline compared to IV. In fact, in many cases, patients in the IV arm relapsed requiring re-infusion, whereas no patients in the Feraccru group relapsed. So these factors underline that Feraccru is a ‘credible alternative to IV iron’ and that as a long term treatment it appears to outperform IV iron.

In US there is a significant and recognised unmet market need for an effective, well-tolerated oral iron

 
 
Source: Company presentation

The US, a sizeable and receptive market

STX is preparing to execute a launch in the US, which provides a substantial market opportunity for Accrufer where there is a significant and recognised unmet market need for an effective, well-tolerated oral iron therapeutic option. The estimated size of the addressable patient pool in IDA is around 10 million patients and is poorly penetrated since only around 50% are being treated.

The US addressable market is estimated to be worth at least US$1.2bn pa

Accrufer presents an effective and well-tolerated oral iron treatment, the US addressable market is estimated to be worth at least US$1.2bn pa and is, therefore, the largest global market for iron replacement treatment. Accrufer provides an alternative for individuals unable to tolerate oral iron and for those who prefer not to go to hospital for an IV infusion, potentially expanding the size of the market to include some of the five million untreated patients.

This is where its convenience can be a real advantage by avoiding admission to hospital or clinic, which is a particularly attractive option given that many people with underlying conditions are also the most susceptible to COVID-19.

An opportunity to gain traction through convenience and efficacy

The Swiss company, Vifor Pharma (VIFN) sells the market-leading branded injectable iron Ferinject, known as Injectafer in the US and holds around 50% of the global IV iron market segment by value. Vifor reports that its US partner recorded FY 2020 net sales for Injectafer of US$415.5mln, a decline of 6.6% compared to the prior year and that global FY 2020 Ferinject/Injectafer sales were affected by COVID-19 restrictions, which limited infusions.

This provides STX with an unprecedented opportunity to gain traction and raise awareness. We have seen that those with underlying conditions account for over 80% of the patient pool, offering a compelling commercial and clinical rationale for the Accrufer launch.

STX has generated market research and pricing data enabling it to build a market strategy for self-launch in the US which is the largest addressable iron replacement market in the world. Efforts to find suitable partners have not been successful; however, the successful execution of the strategy would mean that it can derive much higher value independently than via a co-promotion or partnered strategy, and has the potential for significant cash generation. The company is preparing for the US launch in June 2021 and the proceeds from its current £29mln funding would enable it to attain break-even within 18 months according to internal financial projections.

Accrufer is positioned to take a substantial market share worth up to US$400mln per annum

Targeting a market worth over $1bn

Around 5mln of the estimated 10mln IDA receive prescription treatment annually in the US. STX is targeting the segment who cannot tolerate or do not respond to oral iron salts; this number can vary between 10-40% of the 10 million pool, plus a proportion of those switching from IV iron, or indeed additional take-up by patients currently untreated, expanding the overall market.

In the US, each year there are around 10 million prescriptions for first-line oral iron salts and around 2.3 million IV doses infused. There are about 2.3 million IV infusions per annum with net sales of US$1.2bn or roughly US$500 per infusion. The characteristics of Accrufer position it to take a substantial share of this market up to 8% worth up to US$400mln per annum, and it could increase in size if the untreated population opts to take up treatment.

Market research supports pricing and clinical rationale

STX has completed market research with the top ten US payers covering more than 200 million lives leading to very promising conclusions. The features of Accrufer meet unmet needs of efficacy and tolerability and the clinical data compared favourably both with oral and IV therapies reaching the following conclusions:

  • Price point is acceptable and is higher than pricing in European markets.
  • Allows potential for first-line usage if accepted by insurance plans.
  • Payer research has indicated that Accrufer should have few restrictions and non-preferred formulary status at tested price points, cost-sharing up to 40% paid by the patient, allowing good patient access.

STX estimates that funding of US$40mln (£29mln) will enable it to rapidly ramp up revenues, enabling it to reach break even at the 18-month point

Peak sales potential up to US$400mln per annum

STX estimates that funding of US$40mln (£29mln) will enable it to rapidly ramp up revenues, enabling it to reach break-even at the 18-month point. The projected strategy, high margin profile and good feedback from market research suggest the potential for significant cash generation on meeting these estimates. The company intends to recruit an initial team of 30 reps in the US, building up to 60 to target the roughly 11,000 top prescribers including primary care physicians and specialists.

The key assumptions and projections are as follows:

  • A net pack price of US$250 per pack, four packs per annum, gives an average annual net treatment cost of US$1,000 per patient, in line with the recommended regimen to restore and maintain Hb levels.
  • Assumes a rapid build towards 2% penetration, equivalent to 100k patients, providing annual sales of 100k x US$1,000 = US$100,000,000 (400k prescriptions) by year three, targeting break-even in the US at 15-18 month mark (1% penetration).
  • The company estimates that its market share will grow by year 5 or 6 to 6-8% of the current population at revenues of between US$300 -400mln.
  • Initial planned annual SG&A (general and administration) costs of US$25-30mln rising to US$45mln in year 3 on revenue of US$300k, implies an operating margin of c 50%.
  • Patent protection on Accrufer until 2035.

We calculate that a base salary plus bonus per rep of around US$250k implies an annual sales force cost of US$7.5mln for 30 reps or around US$15mln for 60 reps.

Our back of the envelope calculation, using a 12% cost of capital, a 70% risk adjustment and 50% steady-state operating margin, suggests a net present value (NPV) of £184mln for the US opportunity (standalone) using the inputs above.

Strategy and next steps

STX has appointed a team of four US pharma commercial executives, headed up by Brian Groch who has over 30 years’ experience in commercial strategy, partnering, sales and distribution operations in the North American pharmaceutical industry. STX is addressing the crucial areas needed to ensure traction:

  • Market access, pricing, reimbursement, value
  • Marketing to clinicians and consumers
  • Medical affairs, interaction with key opinion leaders
  • Supply chain, establishing an end to end manufacturing and supply; launch stocks of Accrufer have been manufactured and are ready to be shipped to the US and first sales are expected to be made in Q2 2021.

The company will employ a combination of in-person and remote/e-detailing technology, to communicate directly with physicians, which has proven to be an effective method of directing resources efficiently as well as being one that is increasingly in favour with prescribers versus face-to-face interactions, particularly under the restrictions of lockdown.

There has been a decline in face to face access to physicians from around 80% in 2008 to just 46% by 2017, with higher physician workloads and administrative duties being part of the trend and supporting the trend in favour of digital engagement, along with the move towards patient consulting via digital apps.

STX intends to win a significant proportion of the business it needs to contribute to its 18-month target of break even, by focusing in on a narrower range of prescribers

Detailed analysis of prescriber data for targeted promotion of Accrufer

The company has identified that of the 460k total iron replacement therapy prescribers, around 11k are responsible for 30% of all oral iron prescriptions, averaging 252 each per annum. These professionals are likely to fall into the category of specialists as well as primary care physicians, therefore including prescriptions for patients across the various sub-groups. There is an additional group of so-called super prescribers, collectively writing 100,000 scripts a year.

STX intends to win a significant proportion of the business it needs to contribute to its 18-month target of break-even, by focusing on a narrower range of prescribers.

STX’s move to self-commercialise Accrufer appears timely given the opportunity to gain early traction by meeting:

  • Unmet need for well-tolerated effective oral iron, giving the option to avoid hospital admission for IV iron. The overall use of IV iron has been highly (inversely) correlated with the intensity of lockdown measures according to Vifor.
  • Generally speaking, the US is a privately insured pharma market and tends to be more tolerant of branded pricing, which can enable the STX team to gain better traction than seen in Europe to date.
  • The US IV iron market is poorly penetrated so by reaching a portion of the 50% unpenetrated market it can therefore increase the value of the overall size if there is a good take-up of Accrufer.

STX estimates that it can reach more than 80% of the target high volume and super prescribers by recruiting 60 reps supplemented by successful sales and marketing reach through digital interactions.

Other factors that could support Accrufer adoption include a forthcoming approval decision on a new class of oral treatment for anaemia in severe chronic kidney disease (CKD).

An indication in which a well-tolerated oral iron therapy such as Accrufer could have particular advantages over IV iron

Roxadustat a potential companion product

New advances in treating severe anaemia in CKD patients including the imminent approval decision on Hypoxia-Inducible Factor Prolyl hydroxylase (HIF-PH) inhibitor Roxadustat Fibrogen / AstraZeneca by the FDA can be a catalyst for the adoption of Accrufer in this indication. The former is a first in class oral treatment and can increase the need for iron therapy. This is an indication in which a well-tolerated oral iron therapy such as Accrufer could have particular advantages over IV iron. With at-home care of CKD one of the goals outlined in the recent executive order, ‘Advancing American Kidney Health’, exacerbated by lockdown measures, Accrufer appears to be an attractive companion product in this regard, given the additional burden on CKD dialysis patients of accessing a transfusion clinic and IV administration. Fibrogen estimates that around 5 million of the 37 million CKD patients in the US have anaemia.

Future perspectives for paediatric treatment

As already noted, children are particularly susceptible to IDA which can severely impair growth and development. A regulator requirement for Feraccru/Accrufer is a post-approval commitment to evaluating the safety and tolerability of the product in the infant, child and adolescent populations. The first stage has been completed and the results of the evaluation of a liquid formulation have been tested to check bioequivalence to the oral capsule. Results are due to be reported imminently.

The study is expected to start recruiting 110 subjects in mid-2021, costing around £4.5mln over 30 months. A successful outcome could lead to the product’s label being expanded to include children. There are about 1.6 million children in Europe and the US in the IDA population.

The paediatric study and other non-US expenditure are expected to be partly funded out of gross margin generated by STX in the US and from royalty revenues generated through its European partner, Norgine.

Clarification achieved on the reanalysis of the AEGIS H2H trial has likely to be a supportive factor in progress towards reimbursement and commercialisation

Partnered markets Europe and China

STX licensed European rights for Feraccru to Norgine in September 2018 and the latter currently markets the product in Germany, UK and Scandinavia. Reimbursement discussions are underway ahead of planned launches in the larger European markets including France, Italy and Spain anticipated in 2021/22 supported by the positive clinical data package for Feraccru.

Progress in Europe to date has been gradual — total volumes increased 70% in FY 2020 and revenues were up 18% to £0.7mln. In our view, this is partly because of price sensitivity in current European markets, even though the clinical and convenience aspects of the product are recognised. Clarification achieved on the reanalysis of the AEGIS head-to-head (H2H) trial has likely to be a supportive factor in progress towards reimbursement and commercialisation.

In China, Ferracru is licensed to Beijing Aosaikang Pharmaceutical Co. Ltd (ASK Pharm). A Phase III bridging study is required for approval expected in 2023.

Commercially-speaking, China offers significant potential since there is a high prevalence of ID/IDA in China by sheer population size, albeit potentially at a lower price point than in the US while having a relatively undeveloped treatment market. In IDA sufferers, the most susceptible sub-groups include those suffering from CKD in which IDA is a major complication and is associated with renal and cardiovascular failure and high mortality. In Asian populations, the incidence of CKD is elevated, associated with high blood pressure and diabetes.

While Feraccru has a broad label for treating ID with or without anaemia, Feraccru is already supported by clinical data specifically in treating IDA in CKD. In all, there are more than 100 million sufferers of CKD in China alone (source: Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet 2012).

The main treatment options after oral irons include Venofer (Vifor pharma) for CKD indications, which is differentiated from Feraccru, has a history of adverse events and needs to be administered in hospital setting via an injection.

Vifor’s market-leading IV iron Injectafer is being targeted for launch in 2021, providing an opportunity for Feraccru to establish early ground alongside it, if approval is gained promptly, and indeed to potentially benefit from the profile-raising and education surrounding the treatment area.

Financials FY 2020 trading statement

  • Trading for the year was in line with market expectations with revenues for 2020 expected to be £9.4mln (2019: £0.7mln) including an £8.7mln upfront payment from ASK Pharm and £0.7mln of royalties on Ferracru revenues from Norgine.
  • Cash position 31 December 2020 was £2.9mln (2019: £4.1mln).

Conclusions

The share price has fallen back c 60% since the announcement of the intention to commercialise Accrufer independently and on notice of the discounted share issue. With commercial execution key in all markets, any improvement in trading sentiment, news on progress of the US launch or winning of reimbursement in new European countries, or negotiation of new licences can be the cause for a stock re-rating. The US opportunity on its own, if executed successfully and in line with STX's internal projections, can more than justify the market capitalisation of the company, even applying a significant risk adjustment for execution.

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities,...

In exchange for publishing services rendered by the Company on behalf of Shield Therapeutics PLC named herein, including the promotion by the Company of Shield Therapeutics PLC...

FOR OUR FULL DISCLAIMER CLICK HERE
LEGAL NOTICE – IMPORTANT – PLEASE READ:

This document is published by Proactive Research and its contents have not been approved as a financial promotion by Proactive Investors Limited or any other FCA authorised person. This communication is made on the basis of the 'journalist exemption' provide for in Article 20 of The Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 and having regard to the FCA rules, and in particular PERG 8.12.

Where the note contains a ‘buy, sell, hold’ recommend, Proactive Investors Limited is authorised to provide investment advice as defined by Article 53 of the RAO

FOR OUR FULL DISCLAIMER CLICK HERE

Shield Therapeutics' pricing will be "key metric" - Proactive Research Analyst

Proactive Research Analyst Robin Davison speaks to Thomas Warner after publishing a new research note on iron defiency-focused commercial-stage specialty pharmaceutical company Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) Davison gives an overview of what readers can expect from the note,...

on 3/10/23