Shield Therapeutics’ (STX’s) interim results highlight the progress made year to date. Re-analysis of the Feraccru/Accrufer AEGIS-H2H data show it is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. With the product out-licensed in China to partner ASK Pharm, all eyes remain on the announcement of a US commercial partner (expected this year). Royalties received from H120 sales of the product (UK and Germany) by partner Norgine are slowly building, but pricing and reimbursement discussions resuming in Europe could lead to ongoing rollouts in key countries (France, Spain and Italy) in 2021. STX’s cash runway extends into Q121, an upfront licensing payment from a US deal would ameliorate the need for further capital. We value Shield at £379.1m.
Companies: Shield Therapeutics Plc
STX is a commercial-stage company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). Feraccru/Accrufer has been approved by the regulators in both Europe and the US. The company has an established commercial relationship with Norgine for Europe and signed a licensing deal with ASK Pharm for the Chinese market in 1H’20. Management has indicated that several discussions are ongoing to secure an optimal commercial deal for the US, which reassured the market. Meanwhile, on current assumptions, STX has a cash runway into 1Q’21.
Futura Medical (FUT.L): Interim results | Shield Therapeutics (STX.L): Interim results
Companies: Futura Medical Plc Shield Therapeutics Plc
KRM22 (KRM): Corp Interims to June 2020 | Shield Therapeutics (STX): Corp Interims in line, awaiting US partner
Companies: Shield Therapeutics Plc KRM22 Plc
Interim results to 30 June largely reflected the licensing income from ASK Pharm in China. Revenues were £8.9m, with royalties of c.£0.2m despite disruptions due to COVID-19 and £8.7m of milestone payments. This resulted in an adjusted net profit of £4.4m (vs a loss of £3.4m in H1 2019). A net cash inflow of £2.4m in the period resulted in cash at 30 June of £6.5m, providing a cash runway to Q1 2021. The figure excludes potential significant up-front payments and milestones for the US, for which a licensing deal is still expected. An order to its contract manufacturer for US launch stocks for delivery by year-end should provide comfort despite the understandable shortage of information pertaining to licensing discussions. We leave our forecasts unchanged (excludes potential upfront payments from US licensing deal) and reiterate our 350p target price.
The COVID-19 pandemic has had a significant impact globally in many areas. While primarily a health issue, it has had wide-ranging implications for stock markets, which have now rallied after the plunge in share prices in mid-March when the full severity of the emerging pandemic became more widely appreciated. Nonetheless, the FTSE 100 Index remains almost 20% off its late February 2020 figure.
Companies: AVO ARBB ARIX CLIG DNL GDR ICGT NSF PCA PIN PXC PHP RECI STX SCE TRX SHED VTA YEW
Shield Therapeutics (LON:STX) has provided further conclusions from its analysis of data from the AEGIS-H2H study comparing the company’s oral iron replacement treatment Feraccru to intravenous (IV) iron. The outcomes of the analysis are strongly supportive of ongoing discussions for the global com
Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.
Shield Therapeutics (STX): Corp Re-analysis of H2H data
Re-analysis of the AEGIS H2H study showed that Ferracru/Accrufer is a credible alternative to IV therapy for iron deficiency anaemia and that it corrects anaemia and maintains haemoglobin (Hb) levels over the long term. Although Feraccru did not technically achieve non-inferiority versus IV iron at 12 weeks, the long-term benefits and health economic arguments for using Feraccru remain as strong as ever. The regulatory status of Feraccru is unaffected by this result and is unlikely, in our view, to affect the outcome of the anticipated US licensing deal. If anything, it should re-enforce Shield’s position. We reiterate our 350p target price, and look forward to the prospect of the company completing a US licence deal.
Much has been written about the effects of the virus on the world and on the stock market. Here is one analyst’s take on some of the likely impacts on the way we should look at companies. This article was originally produced as a blog, “10 Changes Post Virus”, which was published a few weeks ago.
Companies: AGY ARBB ARIX DNL GDR NSF PCA PIN PHNX PHP RE/ RECI STX SCE SIXH TRX SHED VTA
Research Tree provides access to ongoing research coverage, media content and regulatory news on Shield Therapeutics Plc.
We currently have 132 research reports from 8
Venture Life Group has reported on a very strong H1/20A period. Revenues were up 80% with operational leverage delivering c100% growth in gross profit and +350% adjusted EBITDA growth. Performance was supported by the acquisition of PharmaSource, strong sales to China, sales of new brand, DISINPLUS, and the group's ability to maintain production at its Italian manufacturing facility. With this report we have introduced FY21E forecasts, expecting the company to maintain its growth momentum and deliver 10% revenue growth. Venture Life is delivering a strong performance, we maintain our Buy recommendation.
Companies: Venture Life Group Plc
Today’s interims are in line with management’s expectations with losses before tax in the period of £15.7m (vs. £14.1m prior year). Cash was reported to be £10.0m, which after accounting for the post period-end £7.7m (gross) fundraising provides sufficient cash runway into Q1 2021 and through multiple key milestones across the pipeline. Whilst Covid-19 has impacted the timeline of data for two trials (asthma and pancreatic cancer), in the coming weeks we eagerly await full Phase II topline results for Blautix in IBS, a data catalyst that could potentially unlock significant value either through possible partnering discussions or independently. The IBS opportunity is vast with estimates of up to 45m IBS sufferers in the US; a patient population underserved with 2/3rd of patients dissatisfied with their current therapy’s ability to treat their symptoms and no FDA-approved disease-modifying therapy available on the market. Blautix has the potential to be that first disease-modifying therapy for moderate to severe IBS, offering physicians a sophisticated therapy option to address both IBS-diarrhoea and IBS-constipation patients.
Companies: 4D Pharma Plc
Synairgen reported interim results to 30 June in which the adjusted net loss was £3.9m with period-end cash of £10.9m. A fuller analysis and disclosure of the Phase II trial of inhaled interferon (SNG001) in hospitalised COVID-19 patients confirms the earlier optimism we had at the time of its first headline disclosure in July. The announcement that Clinigen is to launch a Managed Access Program (MAP) in the UK and Europe for SNG001 is a significant step enabling treatment of hospitalised COVID-19 patients under certain circumstances ahead of regulatory approval. With plans to scale manufacturing to c.100,000 treatment courses per month in 2021, Synairgen is clear in its ambitions. Based on pricing points for Rebif and Avonex and Gilead’s remdesivir, future supplies suggest significant potential revenues in 2021. We leave forecasts unchanged for the time being until we have greater visibility over the uptake of the MAP as well as the regulatory path. We reiterate our price target of 360p.
Companies: Synairgen Plc
Advanced Oncotherapy ("AVO") reported a wider H1 net loss of £12.2m (+8% YoY) as tightened administrative expenses of £9.8m (H1/2019: £11.0) were offset by increased finance cost totaling £2.4m (H1/2029: £0.59m) and a lack of tax credits (H1/2019: £0.38m). Despite the ongoing pandemic, we note that AVO has made good progress regarding both the development and initial commercialisation of LIGHT in 2020. We continue to believe in the potential for the LIGHT system to disrupt the radiotherapy market as a result of the proven clinical superiority of proton therapy ("PT"), combined with the implied economic advantages associated with linear accelerators. Now largely de-risked from a technical perspective, we see a number of important inflection points in the coming 6 - 12 months for AVO, maintaining our OUTPERFORM recommendation and GBp 135 target price.
Companies: Advanced Oncotherapy Plc
Novacyt (NCYT.L): R&D update
Companies: Novacyt SAS
Allergy Therapeutics reported full-year 2020 results that were marginally ahead of expectations, driven by lower overhead costs (COVID-related) and lower R&D. This underpinned 25% growth in pre-R&D EBIT to £14.2m on 7% CER revenue growth and continued, albeit smaller, market share gains. Year-end net cash was £33.2m, providing the company with the financial resources to execute on current research programmes. The outlook remains characterised by the start of the Phase III Grass MATA MPL trial in US/Europe, enhanced by a broadening pipeline of opportunities and continued commercial traction in core European markets. We have made small upward adjustments to our forecasts and raise our target price to 45p, which is underpinned by the current commercial operations, with potential upside in Grass MATA MPL in the US (c.21p on risk-adjusted DCF), Polyvac peanut vaccine and the recently broadened VLP technology licence.
Companies: Allergy Therapeutics Plc
Allergy Therapeutics delivered a solid 6% revenue growth for FY20 to £78.2m, from £73.7m, despite COVID-19 impacts taking a 2% toll. The well-established European commercial platform produced operating profit before R&D of £14.2m, from £11.3m, with R&D spend of £9.0m, from £13.2m. Pollinex Quattro Grass is set to start a pilot Phase III study before initiating full registration trials. The promising VLP-based peanut vaccine reported highly encouraging preclinical data which, if maintained, could be transformational for future prospects. The fruits of the development portfolio are expected to enable the market entry into the commercially attractive US. Cash resources of £37.0m are ample to fund near-term requirements. We initiate coverage with a £325m (51p a share) valuation.
Yourgene continues to progress across all areas of the business, with core trading on track. Demand has been increasing for Yourgene’s Covid-19 testing services, and is expected to reach 10k/month from early October onwards. This would equate to a £3.0m boost to revenues in the year to Mar-21 and we upgrade forecasts accordingly, with outer year estimates unchanged for now. We view this as a base level of demand, with scope for further upgrades if demand continues to increase and/or lasts beyond March. Our underlying estimates for the core are unchanged.
Companies: Yourgene Health Plc
CVS had what we regard as a good FY20 – showing excellent progress during the first 8 months, highlighting a keen focus on the core business, and then recovering strongly as lockdown conditions eased. This reflects very favourably on the new exec team and the underlying resilience / attractions of the veterinary sector. Pleasingly positive momentum has continued into Q1-21 with LFL sales growth of 3.9% (8.0% comp) and an improved EBITDA margin. In the current climate the veterinary sector has attractive defensive growth qualities, with CVS very well positioned to both protect earnings and take advantage of a positive environment for acquisitions. Ongoing CV19 uncertainty means guidance remains suspended but the broad thrust of today’s results underpin the premium rating.
Companies: CVS Group Plc
SDI reported full-year results to 30 April that were slightly ahead (+2%) of the trading update issued by the company on 23 April with net debt of £4.0m comparing favourably to our forecast of £4.3m. Underlying organic growth of 3.7% organic growth, despite the COVID-19 disruption in Q4, was supplemented by growth from acquisitions in FY 2019 and FY 2020. Adjusted pre-tax profit rose 44% to £4.3m with adjusted EPS up 21% to 3.4p. Net debt at 30 April was £4.0m. With evidence of trading activity normalising and the positive outlook statement, indicating adjusted pre-tax profit to be at least as good as FY 2019, we reinstate forecasts. We re-introduce a target price of 100p, which implies the stock trading on FY 2021 P/E of 27.5x falling to 24.6x in FY 2022 – in line with its peer group (e.g. Judges Scientific which trades on 33.8x, falling to 27.5x for slightly lower growth) and underpinned by a FY 2020 free cashflow yield of 3.2%.
Companies: SDI Group Plc
While disruption was significant in H1, Warpaint still made a small profit and generated cash. Crucially, even with some ongoing weakness in markets like the US, trading has recently bounced back to pre-CV19 budgeted levels. This is a function of the brand and range development work, and broadening distribution in the UK (Tesco/Wilko). It also highlights the appeal of its value-for-money on-trend brands. Improved visibility around the full year outcome has led to PBT guidance being reinstated for FY20, and dividends being proposed. This is likely to be well received by the market.
Companies: Warpaint London Plc
Creo Medical has reported strong H1/20A and post-period performance. While COVID has impacted the company's ability to market its products in hospitals, at commercial events and provide training during 2020 Creo has continued to book commercial orders, provide remote training, receive regulatory clearances for new devices and complete a significant acquisition. We believe that as healthcare systems begin to recover from the impact of the pandemic, the benefits of Creo's technology could come to the fore, offering shorter procedure times and outpatient treatments. The company closed H1/20A with cash of £70.6m.
Companies: Creo Medical Group Plc
The oncology consultancy using mathematical models and its Virtual Tumour™ technology to support the development of cancer treatment regimens and personalised medicine solutions has announced FY June 2020 results with total income including grants up 7% to £841.6k, driven by an 11.1% increase in revenue to £799k. Losses after tax fell 38% to £64.4k, with prudent cost management helping to keep net operating expenses of £976k marginally bellow FY June 2019 levels, and the Company continuing to enjoy R&D tax credits with £69k recognised in the period, down from £97k.
Companies: Physiomics Plc
Cambridge Cognition reported encouraging interim results to June, with revenues up +39% to £3.0m and the Pre-Tax Loss sharply reduced to £0.4m. The company has made strong progress on its commercialisation strategy this year and, having announced £4.9m of contract wins in H1, a major win for a schizophrenia trial has since increased this to £8.4m. Although CV19 led to some contracted clinical trials being delayed in H1, this has been offset by new contract wins and going forwards we see a structural shift to virtual clinical trials which plays to CamCog's strength in remote clinical testing. We raise our FY20 revenue forecast to £6.3m (was £6.2m), which we view as conservative given the sales contracted for 2H20, though we are mindful of possible delays due to CV19. We continue to model a FY20 loss of -£0.7m, with CamCog moving into profit in Q4. We forecast the group to be profitable for FY21 and believe profits can build materially given the tailwind of 17-20% industry growth. We retain our Buy recommendation and raise our target price to 80p (was 75p).
Companies: Cambridge Cognition Holdings Plc
Diurnal is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its products are targeting rare conditions where medical need is currently unmet, with the long-term aim of building an “Adrenal Franchise”. Alkindi® was approved by the European regulators in September 2018, and has been launched in 10 countries. Now it has been approved for the US market, with Diurnal receiving formal approval from the FDA. This is an important valueinflection milestone that only two other AIM-listed companies have reached. Marketing partner, Eton Pharmaceuticals (Eton), has high US sales expectations.
Companies: Diurnal Group plc