The cancer burden is growing globally. Each year >18 million people are diagnosed, nearly 10 million die and the estimated economic cost exceeds $1 trillion. From early diagnosis to late-stage disease, cancer care often involves inappropriate or unnecessary interventions that drive costs but provide limited clinical benefit. Coupled with an increased understanding of cancer biology and rapid technological advances, this has been driving momentum for precision medicine, leading to patient and societal benefits. The use of biomarkers and sophisticated diagnostics is facilitating early intervention through robot-enabled minimally invasive surgery and locally delivered radiotherapy. Immuno-oncology has revolutionised cancer care, with the focus now on identifying combinations that further improve long-term outcomes. Liquid biopsies and companion diagnostics are increasingly being used to personalise therapy.
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With H1/2018A numbers much in line with our expectations, MDxH is building momentum with sustained growth of its Confirm- and SelectMDx prostrate cancer diagnostics. While ConfirmMDx will continue to be the main driver in the shorter term, SelectMDx looks increasingly like the major value driver. Increasing evidence should supports the clinical and economic benefits of SelectMDx throughout prostate cancer therapy from early diagnosis through longer term treatment management and monitoring; a potential multi-billion dollar market. The company remains attractive at current levels. We maintain and reiterate both our OUTPERFORM recommendation and €9 target price per share.
Companies: MDxHealth S.A.
Data published today at the Global Congress on Prostate Cancer demonstrates the potential of the MDxH SelectMDx urine-based test to reduce the need for expensive and complex MRI, as well as to help guide physicians in deciding for and against prostate biopsies in clinical practice. These positive results reinforce our view of SelectMDx as a substantial value driver for MDxHealth. We reiterate our OUTPERFORM recommendation and €9 / share target price.
Strong growth in both test volumes and revenues reported in Q1 indicates that MDxHealth is back on track after the disappointments of 2017. Following a successful $44m fundraising, topline growth at current levels promises to exceed our previous estimates. The company remains attractive at current levels. We reiterate our OUTPERFORM recommendation and €9 / share target price.
Announcement today that the prostate cancer liquid biopsy SelectMDx is to be included in the European Urological Association ("EUA") guidelines is clearly good news. Designed to allow the identification of patients with aggressive disease prebiopsy, inclusion of the test in the EUA guidelines should facilitate adoption of the test by physicians and payers across Europe. This is the first of a number of upcoming catalysts for MDxHealth that we highlighted in our recent company update report ( Growth in prospect a compelling opportunity). We reiterate our OUTPERFORM recommendation and €9 price target.
Disappointment especially in H2/2017 hit the shares. MDxHealth's potential in prostate cancer diagnosis remains intact; creating a significant opportunity for investors. Test volumes of marketed diagnostics are growing and should accelerate with a fully installed US salesforce and expanding European distribution network. Broadening US reimbursement and product coding should see ConfirmMDx volumes translate into revenues as payment collection accelerates. Data expected during 2018 supporting the use SelectMDx in both primary diagnosis and patient monitoring should highlight the potential of this powerful prostate diagnostic and drive adoption in key clinical guidelines. With this growth and catalysts in prospect, we reinstate our OUTPERFORM recommendation (from Under Review) with a new target price of €9.
The substantial downgrade in guidance from 45% - 55% to 10% - 15% 2017 top line growth is clearly very disappointing. We believe the decrease largely results from smaller than anticipated sample volumes and delays in a large Medicare-funded ConfirmMDx post-marketing study as well as contractual delays related to the flow of billable cases from one or more of its larger customers with whom it has service agreements. The company will provide a more detailed analysis and hopefully better guidance at the time of its FY results expected February 22nd. We remain positive as to the longer term prospects for the MDxH's prostate cancer tests Confirm- and SelectMDx. However, given the immediate uncertainty, we are placing our forecasts, target price and recommendation under review.
With the agreement now reached with Unilabs, MDxH's SelectMDx will now be widely available across major European markets. A Swiss-based laboratory service provider with over 200 laboratories and imaging facilities in nine countries including the major markets - France, UK, Italy, Scandinavia as well as Switzerland, this distribution agreement appears to be a further endorsement of SelectMDx IVD following the first agreement with the German laboratory group Limbach. With ConfirmMDx now reimbursed by >60 payers and pushed by a near doubling of the salesforce in the US, SelectMDx is expected to drive growth in Europe and RoW. We are optimistic that, following a sluggish H1, the company will see growing sales momentum over the next 12 months. We reiterate both our OUTPERFORM recommendation and €6.50 target price.
After a disappointing H1 MDxHealth will have to work hard to achieve its 55%-75% sales growth guidance. With a historically stronger H2, we are confident that it has now assembled all the elements to fuel the growth of its prostate cancer test ConfirmMDx from the H2 / 2017. Included in key clinical guidelines, ConfirmMDx is now reimbursed by >60 public and private payers, as well as the subject of a number of service agreements with substantial US healthcare networks. A near doubling of the salesforce should enable MDxHealth to drive the rapid adoption of the product by urologists. Growth will also be boosted by marked improvement in revenue recognition as a result of the adoption of the CPT code. Momentum is also growing behind the recently launched SelectMDx with increasing US reimbursement and adoption by a variety of important European distributors and laboratory networks, sustaining growth in the long term. We reiterate our OUTPERFORM recommendation and our TP of €6.50.
MDxHealth has achieved a number of significant milestones in the 1H/2017. The company continues to gain traction for its products amongst key US healthcare providers. It has expanded its product offering through the launches of AssureMDx for bladder and the IVD version of SelectMDx for prostate cancer; an agreement is already in place with a major laboratory service provider to supply the IVD test in Germany. After a positive first four month trading statement in May, we are optimistic that first half numbers due next week (31/08) will indicate MDxH is on track for its 55% - 75% product revenues growth guidance. We reiterate both our OUTPERFORM recommendation and €6.50 target price.
With products for urological and colon cancers already on the market, MDxHealth and Exact Sciences (NASDAQ: EXAS) have already demonstrated their respective expertise in the development of epigenetic molecular diagnostics. The new five year collaboration announced with Exact will enable MDxHealth to leverage its epigenetic expertise outside its core urological focus, as well as build on a decade long relationship with Exact. Exact's acquisition of key MDxH patents related to Exact's Cologuard colon cancer faecal screen will bring some expected royal payments forwards, strengthening the company's balance sheet as it rolls out its pipeline of urology diagnostics. We reiterate our OUTPERFORM recommendation and our target price of €6.50.
With FY2016 numbers much in-line with our expectations, MDxHealth is becoming a leader in diagnosis of prostate and other urological cancers. Its lead product ConfirmMDx reducing the need for unnecessary biopsies continues to grow as it is increasingly adopted by US urologists and reimbursed by public and private payers. Its first urine-based biopsy SelectMDx is gaining traction through MDxHealth's existing laboratory and commercial platform. The anticipated launch of an IVD SelectMDx kit for Europe and other markets worldwide combined with a non-invasive test for bladder cancer AssureMDx, promise to drive growth during 2017. We reiterate our OUTPERFORM recommendation and increase our target price to €6.50 from €6/share.
Results published in the Journal of Urology further highlight the high performance of MDxHealth's bladder cancer test and its potential to allow patients to avoid 77% of the costly, invasive and frequently unnecessary cystoscopies that they are currently subject to. In light of the recent €20m fund-raising, the company appears on track for full US launch of the product in early 2017. With recent Q3 results also in line with our forecasts, we reiterate both our OUTPERFORM recommendation and target price of €6/share.
MDxHealth announced this morning that it had achieved a further US reimbursement milestone by obtaining a Category I CPT code for its prostate cancer diagnostic ConfirmMDx. This, together with the announcement last week of coverage of the product by the fourth largest US health insurer US Health Care Services Corporation (HCSC), should extend the reimbursement of ConfirmMDx in the US further strengthening the company's established commercial platform and ability to create substantial further value from its two follow on products exploiting substantial opportunities in the US, Europe and other international markets. We reiterate both our OUTPERFORM recommendation and target price of €6/share.
MDxHealth has already established a robust commercial platform for cancer diagnostics. Focussed on prostate and bladder cancer, MDxHealth's diagnostic tests relieve the clinical burden on the patient and economic burden on the health provider by reducing the need for the risky, expensive and often unnecessary procedures such as needle biopsies that are regularly performed on patients after a positive primary cancer screen. With sales of its first product growing strongly in the US, the company looks well placed to create substantial further value from its two follow on products exploiting substantial opportunities in the US, Europe and other international markets. We initiate with an OUTPERFORM recommendation and a target price of €6/share.
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Although 2020 will probably go down in history as one of the most challenging years experienced during our lifetime, it will also likely be chronicled as one of the best years for the recognition and appreciation of science. As we entered 2020, the COVID-19 pandemic was in its infancy. However, it rapidly evolved through the exponential rise in infections and mortality globally. Much has been achieved during the past 12 months in the fight against COVID-19, but, as we enter 2021, there are considerable concerns about the emergence of a mutant version of the virus and the second wave that we are now facing.
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Q4 trading has led sales to guidance being raised 8%. This has been driven by better than expected UK sales, incl. success with new customers like Wilko/Tesco. Some of the benefit is offset by a non-cash FX debit, but it still leads to an upgrade and higher net cash. As a result of successful trials in Tesco Express, W7 is also being rolled out to 469 more stores. This, and previously announced distribution gains, bodes well for incremental sales/PBT in 2021, and underlines the appeal of its value-for-money brands. On 11x 2019 cash-adjusted EV/EBITDA, valuation is undemanding, particularly with the added attraction of dividends/income.
Companies: Warpaint London PLC
Ongoing strength in the key China market has prompted a positive trading update, indicating FY21 revenues and EBITDA will be significantly ahead of (already upgraded) expectations. Demand for Aivlosin in China in particular has remained strong throughout Q3 and is expected to remain so in Q4. We upgrade our FY21 revenue forecasts by 12% to £91.9m, which flows through to a 30% PBT upgrade to £10.1m. Whilst there is some caution expressed over the sustainability of this demand, we now forecast a flat performance YoY in FY22, but this is still 10% ahead of our previous estimates at the PBT level. The shares remain suspended pending the publication of the delayed FY20 results, which will be released as soon as possible alongside the H1’21 interims.
Companies: ECO Animal Health Group plc
Synairgen (SNG.L): Completion of recruitment for at home trial | Sensyne Health (SENS.L): Research agreement with The Royal Wolverhampton NHS Trust
Companies: Synairgen plc (SNG:LON)Sensyne Health Plc (SENS:LON)
Foresight Group , the award-winning infrastructure and private equity investment manager to IPO on the Main Market (premium). The Offer will primarily comprise a sale of shares by existing shareholders (c.80% of the Offer) with a smaller offering of new shares (c.20% of the Offer) to be issued by the Company. Details TBA. Cornish Metals (TSX-V: CUSN) intends to list on AIM. The Company is proposing to raise £5 million by way of private placement of new Common Shares (the "Fundraising") to advance the United Downs copper-tin project. The Company expects that Admission will become effective in February 2021. The Company's Common Shares will continue to be listed and trade on the TSX-V in Canada. VH Global Sustainable Energy Opportunities plc, a closed-ended investment Company focused on making sustainable energy infrastructure investments, today announces intends to launch an initial public offering of shares on the Official List (Premium) of the Main Market of the London Stock Exchange. Due by Early Feb.
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ANGLE raised £19.6m (gross) to capitalise on the first-mover advantage that the FDA clearance for Parsortix will create, catalysing ANGLE’s ability to exploit the emerging multi-billion dollar liquid biopsy market. It will enable ANGLE to pursue multiple parallel revenue streams: (i) as a service provider to the pharma industry particularly looking to improve on immunotherapy patient outcomes (companion diagnostics) and (ii) to develop a number of specific clinical applications. Not only does it strengthen the balance sheet ahead of partner discussions but it provides the resources to develop in parallel relevant laboratory developed tests and fund the necessary clinical utility studies that will accelerate clinical adoption. We re-introduce forecasts and raise our target price to 150p (c.£310m EV), which is supported by risk-adjusted DCF and peer group analyses.
Companies: ANGLE plc
Robust FY21 performance forecast, despite pandemic
Companies: SDI Group plc
Cambridge Cognition provided a positive FY 2020 trading update, with revenues (+34%), net losses and cash all ahead of expectations, and delivering an EBITDA-positive Q4. After a year of record order intake (£12.7m) and with a year-end order book of £11.2m (+96% on the prior year), the company is positioned to deliver another year of strong growth. This update provides further evidence of (i) the commercial focus that the CEO has instigated, (ii) the cross-selling opportunities for its newer digital solutions, and (iii) the prospect of a period of sustained strong growth in what are large (c.£1.2bn) and high growth (c.20%) addressable markets for digital solutions for clinical trials. We increase FY 2021 revenues by 18% to £8.5m, implying 26% growth and raise our target price 31% to 105p.
Companies: Cambridge Cognition Holdings Plc
Cambridge Cognition ("COG") has provided a trading update for the year ended 31 December 2020 that is ahead of our expectations. Group Revenues grew +34% to £6.7m (2019: £5.0m) and were +7% ahead of DCe of £6.3m. COG delivered significant revenue growth from digital solutions for clinical trials as it increased its focus on commercialisation. The strong beat in Revenue is due to an improved commercial execution across a wider portfolio of products as the Group has placed a key emphasis on crossselling CANTAB with newer electronic Clinical Outcome Assessment (eCOA) and digital solutions for frequent, remote testing of patients outside of the clinic setting. The Group's order intake for the year closed at a record £12.7m, up +158% on the previous year's order intake of £4.9m and maintaining the growth trajectory reported in the interim results. The Group experienced a mixed effect due to Covid-19 as some orders and revenue recognition was delayed in the year. However, the pandemic has provided an impetus for an industry shift towards evaluating virtual clinical trials, which opened new opportunities for the Group. We move our target price to 89p (from 80p).
Interim results were in line with the 28 October trading update, reflecting the impact of the pandemic, with sales down 27% and LBITDA of £1.3m. However, c.10% LFL growth for Health & Nutrition (HN) in October and November is encouraging and points to long-term growth. Together with confirmation that first shipments against the initial 1m order for AbC-19 rapid antibody tests have taken place as well as first shipments of VISITECT CD4 Advanced Diseases tests to Africa, we expect a strong H2 (c.75% of FY sales), with potential upside driven by a currently poorly visible, yet anticipated long-term opportunity from its three key value drivers: Food Detective in China, VISITECT CD4 and COVID-19 lateral flow devices (LFDs). We leave our forecasts unchanged until we have further clarity on the unfolding COVID-19 opportunities. Whilst this implies c.£9.4m sales in H2, this is still eminently achievable given that supply has the ability to generate in excess of £9m of sales in Q4 FY 2021, should the demand materialise.
Companies: Omega Diagnostics Group PLC
On 30th December 2020, RUA reported that shareholders had approved resolutions regarding the placing along with a strongly oversubscribed Open Offer. RUA now start 2021 with the resources and mandate to accelerate the development of its products, where we anticipate reports of progress during the year. We have slightly increased our R&D and CapEx spend for FY 2022 to reflect this investment and the cash utilization. RUA’s issued share capital now comprises 22,184,797 shares and the increases in FY 2022 investment in its products, modestly change our valuation by about £2.0m to £113.2m for the Company, equating to 510p per share.
Companies: RUA Life Sciences Plc
After an eventful 2020, ReNeuron released updated 12-month Phase ll data in January on its lead human retinal progenitor cell (hRPC) project. This continues to show a consistent and robust, sustained average gain in visual acuity in retinitis pigmentosa (RP). A continuation study in nine patients using two million cells is underway with three- and six-month data due over H2 CY21 and the first three patients treated. This will facilitate partnering negotiations. A pivotal hRPC study may start in 2022. Deals are possible in CY21 on the exosome genetic drug delivery platform, which could be very valuable. The valuation remains at £190m with strong cash.
Companies: ReNeuron Group 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. For various reasons, STX has been unable to secure a commercial partner for Accrufer in the US. Consequently, the board is now considering an STX-led launch option, thereby retaining all the US profits. Financial modelling shows the logic of this option, but it would necessitate financing the working capital requirements covering the next two years in the region of £25m-£30m.
Companies: Shield Therapeutics Plc
IXICO has reported its financial results to the end of September 2020. Over the period, revenues grew 26% to £9.5m while EBITDA of £1.3m was more than double FY19A's £0.5m (October Trading update: revs £9.5m, EBITDA ‘at least' £1.1m). The order book closed at £21.7m, a record high, and we note subsequent confirmed orders post the year end, indicating strong business development. IXICO has invested through the year and maintains a strong balance sheet to continue investing through FY21E. We have made minor adjustments to our FY21E expectations and maintain our Buy recommendation.
Companies: IXICO Plc
Whilst the H1 outturn reflected the difficulties caused by the pandemic, investors should not lose sight of the substantial strategic progress made in recent months. This has not only built resilience and agility within the business, allowing it to react to the extraordinary market conditions, but strengthened the medium term growth prospects. We make no change to our headline forecasts at this stage, but mindful of the substantial H2 weighting, provide an illustration of the mix changes and a bridge to our FY21 estimates in this note.
Companies: Yourgene Health Plc