Oxford Biomedica (OXB) is a pioneer and global leader in the development and manufacture of commercial-scale lentiviral vectors (LVVs), a critical component of cell and gene therapies (CGTs). An investment in OXB gives a broad exposure to this emergent industry. During the past 12 months, OXB has effectively doubled its CDMO partner programmes to 20, while broadening its own gene therapy R&D portfolio offering. Partner Axovant expects to report six-month efficacy data on AXO-Lenti-PD (end 2020), durability of its effect in Parkinson’s disease is key. Longevity to the OXB investment case rests on the growing diversity of its revenue streams and maintaining its position as an innovator. We expect OXB to lead the industrialisation of LVV manufacturing. This is critical to opening up new treatment areas where much higher vector quantities are required, especially for in vivo treatments. We value OXB at £711m.
Companies: Oxford BioMedica plc
Oxford Biomedica (OXB) has signed a five-year collaboration agreement with the Vaccines Manufacturing and Innovation Centre (VMIC), a non-profit organisation established as the UK’s response to emerging infectious diseases. The agreement focuses on the scale up and GMP manufacture of the adenovirus-based COVID-19 vaccine candidate AZD1222 (previously ChAdOx1 nCoV-19), which is in a Phase II/III study. Initial data from the precursory Phase I/II study are expected in Q320. AstraZeneca is now responsible for the global development, manufacture and distribution of the vaccine and in May signed a one-year clinical and commercial supply agreement with OXB for multiple batches expected in 2020. Our OXB forecasts and valuation of £709m are unchanged.
Oxford Biomedica’s (OXB) FY19 results highlight strong operational momentum despite capacity constraints. OXB is investing for future growth and its 84,000 sq ft state-of-the-art bioprocessing facility OxBox is on track to produce commercial grade batches in Q220. Deals made include expansion of its commercial supply agreement with Novartis by five years and R&D partnerships with Santen and Microsoft, followed post period with the BMS/Juno licence and supply agreement. We expect further platform deals to be announced in 2020, as OXB exploits its position as the only FDA-approved, commercial-scale lentiviral vector (LVV) manufacturer in the US. In the long term, much value resides in OXB’s ability to develop and monetise its own gene therapies, an out-licence deal is also on the cards and OXB plans to move several proprietary gene therapy assets into the clinic in the next 12 to 18 months.
Following the 2017 commercial launch of partner Novartis’s Kymriah (a CD19-targeting CAR-T that is approved for pALL and DLBCL), Oxford Biomedica (OXB) is the only FDA-approved lentiviral vector manufacturer worldwide. Validation of its capabilities continues with the recent licence and clinical supply agreement (LSA) with Juno Therapeutics (part of BMS group), a pioneer in cell and gene therapy research. The LSA grants Juno a non-exclusive licence to OXB’s LentiVector platform for its application in a number of novel CAR-T and TCR-T programmes. This is a significant deal, albeit early stage, in terms of multiple programmes and further diversifies OXB’s revenue streams. As these assets move towards approval, commercial manufacturing supply provides further upside. Our valuation of OXB increases to £718m.
Oxford Biomedica (OXB) is a pioneer and global leader in the development and manufacture of commercial-scale lentiviral vectors (LVV), a critical component of cell and gene therapies. Ongoing investment in manufacturing capacity and R&D is imperative to reap economic returns in this highly innovative and potentially lucrative therapy area, which has witnessed a step up in investment globally. Multiple deals in 2019 included an expansion of its commercial supply agreement with Novartis by five years and R&D partnerships with Santen and Microsoft. We expect further platform deals to be announced in 2020, as OXB exploits its position as the only FDA-approved commercial-scale LVV manufacturer. In the long term, much value resides in OXB’s ability to develop and monetise its own gene therapies. We value OXB at £692m.
Oxford Biomedica (OXB) has announced the expansion of its commercial supply agreement with Novartis by five years. While expected, this removes any uncertainty around the future of the partnership and is a validation of OXB’s investment in new manufacturing facilities. Novartis is now committed to paying OXB a minimum of $75m (for vector batches) in manufacturing revenue over the five-year extension. Additionally, OXB will be paid a mid-single digit £m facility reservation fee. As part of this, OXB will dedicate some of its new 7,800m2 manufacturing facility (OxBox) to Novartis while also ensuring that at least two of its GMP facilities are capable of commercial supply, essentially ensuring a dual-sourced supply if the need arose. We value OXB at £692m vs £673m previously.
Oxford BioMedica (OXB) is a gene-based medicine viral-vector biopharma company. It offers vector manufacturing and development services, while developing proprietary therapies, with its LentiVector® platform. Growth in gross income and profitability were driven by new licensing deals in 2018. Despite steady growth in 1H’19 group sales (bioprocessing and commercial development), a reduction in licensing income resulted in a first-half operating loss; the absence of significant deals in 2019 has also dampened the shares. Although interim results were in line with our expectations, they highlight the importance of 2H’19 for a full-year profit.
Oxford Biomedica’s (OXB) interim results highlight strong operational and financial momentum to date. The Novo Holdings equity investment (£53.5m) in May has enabled OXB to fully repay the debt facility, effectively strengthening the balance sheet. It is investing ahead of increasing demand for its lentiviral vector manufacturing capacity with the build-out of OxBox. The new facility will more than double capacity and is expected to be ready for commercial vector production in H120. Top-line growth continues to benefit from the near-term ramp-up of Kymriah and rapid advancement of partnered asset AXO-Lenti-PD (Axovant), crystallising in a $15m development milestone payment. We value OXB at £673m.
Oxford BioMedica’s (OXB’s) interim results were broadly in line with our expectations for 2019. The decrease in H119 revenues to £32.1m (-9%) largely reflects the exceptional performance in the previous period, which was bolstered by strong licence income (H119: £13.3m vs H118: £19.9m) primarily from upfront payments with the Axovant and Bioverativ deals signed (£18.5m combined). Importantly, in H119 bioprocessing revenues grew 23% to £18.8m, which we expect was driven by the continued uptake of Novartis’s CAR-T Kymriah. Typically, bioprocessing revenues are back-end loaded so a stronger performance can be expected in the second half of the year. With OXB transitioning one of its GMP suites across to bioreactor processing in H119 and its new OxBox bioprocessing facility expected to be fully operational in Q220, we expect this growth to continue in the near term. We retain our valuation of £649m.
The challenges associated with value creation drive all investors. Any investment professional is eager to make their mark by picking organisations that are able to deliver superior returns. Increasingly investors look into how organisations are governed and how effective the top decision-making bodies of organisations really are. In this white paper, we shed light on research findings and reveal the seven hallmarks of effective boards. The seven hallmarks are proven to create more effective boards and are set to be the next lever in the value creation process. Better Boards has created advanced board evaluation tools designed to motivate and inspire and above all, contribute to superior value creation.
Companies: AVO AJB AGY CLIG DNL DPP FLTA GTLY GDR KOOV MUR NSF OXB PCA PHP RE/ RMDL STX SCE TRX TON SHED VTA W7L
The introduction of IFRS 2 in 2004 generated considerable debate about the best approach for handling ‘share-based payments’ (SBP). While it is clearly a cost to shareholders, which should be included in the statutory reporting lines through the P&L account, the question arose as to whetherit should be part of our underlying EBIT calculation.
Companies: AVO AJB AGY ARBB CLIG DNL DPP FLTA GTLY GDR KOOV MCL MUR NSF OXB PCA PHP RE/ REDX RMDL STX SCE TRX TON SHED VTA W7L
When advisers first start looking at business relief (BR) products, there is much to take in: the rules governing such products; the investment strategies being used; and what the investment risk is. It is easy to lose sight of the fact that, for non-AIM products, the investment is being made directly into a company or partnership, rather than a fund. It is, therefore, essential that governance is part of the diligence process.
Companies: AVO AJB AGY ARBB CLIG DNL DPP FLTA GTLY KOOV LWRF MCL MUR NSF OXB PCA PHP RE/ REDX RMDL STX SIXH TRX TON SHED VTA W7L
Oxford BioMedica (OXB) is a specialist, advanced therapy, viral-vector biopharma company. It offers vector manufacturing and development services, while developing proprietary drug candidates, with its LentiVector® platform. 2018 saw significant growth in gross income, the majority through licensing deals. A new R&D collaboration deal with Santen, coupled with the recent equity financing and debt repayment, demonstrate OXB’s deal-making ability and its strategy to secure future, long-term potential. Near term, this R&D arrangement will provide modest additional profit, adding confidence to OXB’s new net cash status in 2019.
Oxford Biomedica (OXB) and Santen Pharmaceutical have entered into an R&D collaboration to develop gene therapy vectors for an undisclosed inherited retinal disease. The collaboration will focus on generating preclinical proof of concept and includes a licence to OXB’s LentiVector platform, in addition to access to its manufacturing capabilities. OXB is entitled to an undisclosed milestone payment on Santen exercising the option to the LentiVector platform, as well as development milestones and an up to 10% royalty on net sales. This new collaboration continues to demonstrate OXB’s track record of signing partnerships and again validates its position as a leading global developer of lentiviral vectors. We retain our valuation of OXB at £649m. We do not currently include the Santen deal in our valuation, but will reassess this once more details on financial terms and development strategy (including indication) are available.
Oxford BioMedica (OXB) is a specialist, advanced therapy, viral-vector biopharma company. It offers vector manufacturing and development services, while developing proprietary drug candidates, with its LentiVector® platform. 2018 saw significant growth in gross income, primarily through licensing deals, to deliver OXB’s first underlying operating profit. OXB is, however, carrying a significant loan of $55m, which is relatively expensive with an interest rate of 9% plus US LIBOR, and also exposes it to forex risk. Equity financing of £53.5m from Novo Holdings A/S has been agreed, allowing repayment of the loan and securing a strategic partner.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Oxford BioMedica plc.
We currently have 181 research reports from 8
Venture Life has developed significant momentum through 2020, reflected in the strong share performance over the year. Building on this momentum, the company has announced it is conditionally raising £34m via an equity raise to help it secure additional M&A opportunities. At this time, Venture Life has identified three opportunities, which we estimate could deliver significant earnings accretion if all are completed. We have updated our forecasts to reflect the raise but at this time have left our underlying assumptions unchanged. We expect Venture Life to maintain the momentum it has developed, supported by the proposed raise and M&A opportunities; we re-iterate our Buy recommendation.
Companies: Venture Life Group Plc
Oxford University and AstraZeneca announced the first interim analysis from the Phase III study of its COVID-19 vaccine candidate, which was found to be 70% effective in preventing COVID-19. This follows similar announcements from Moderna, and Pfizer/BioNTech in the previous two weeks, and the caveats we mentioned at the time remain the same. While all of these results have been highly encouraging, we reiterate that they do not diminish the urgent need for COVID-19 treatments and testing, which will be required for years to come. We consider Synairgen, Avacta, genedrive, Omega Diagnostics and Open Orphan to offer good buying opportunities.
Companies: AVCT ODX SNG GDR ORPH
ReNeuron, a UK-based stem-cell therapy developer, has announced today a fundraising of up to £17.5m (gross) through the means of a placing, subscription and open offer. The Company has also announced its FY’21E interim results as well as the latest data from its lead candidate hRPC in the ongoing Phase I/IIa clinical trial for Retinitis Pigmentosa (RP). The additional funding aims to provide liquidity for the next 18 months, and through key clinical development milestones for the hRPC programme and exosome collaborations. **** As joint broker to ReNeuron, we are restricted and can therefore provide factual comment only. Shareholder approval for the transaction will be sought at the General Meeting to be held on the 11th December 2020 ****
Companies: ReNeuron Group plc
ReNeuron Group (RENE.L): Interim results
EKF has confirmed it expects a strong Q4 from both the core business and ongoing demand for the Primestore MTM sample collection device. As a result, FY20 performance is now expected to comfortably exceed market expectations, which have already been upgraded several times through the year. We upgrade our FY20 EBITDA forecasts by a further 6% to £24.4m and look forward to further updates in due course. EKF is a Best Idea for 2020 and we expect strong momentum to continue.
Companies: EKF Diagnostics Holdings plc
President Trump likes to project himself as a highly successful businessman, but surprisingly little is known about his true financial position. Various articles, including a 2016 in-depth analysis by The Wall Street Journal, have speculated about his income and asset base. All sorts of claims and counter-claims have been made about his wealth – by Trump himself, pitching his fortune at some $9bn, and by journalist Timothy O'Brien, suggesting that it is as “low” as $150m-$250m. It is doubtful whether we shall ever know the truth, but we can use Trump’s UK corporate filings to gain an insight into his businesses in Scotland.
Companies: AVO ARBB ARIX CLIG DNL FLTA ICGT PCA PIN PHP RECI STX SCE TRX SHED VTA YEW
Venture Life aims to become a global leader in the self-care branded product market, where there are a number of structural growth drivers. It has a unique and scalable platform to develop, manufacture and distribute products, including its own brands and international customers’ brands. What is already a high margin business is poised to deliver a compelling mixture of top line growth with significant operating leverage. Performance in H1 (EBITDA +347%) highlights the potency of VLG’s model. Acquisitions can also leverage the platform to drive growth, and management has a very strong track record here. On top of this exciting growth play, there is also a chance that its Dentyl dual-action mouthwash could have applications to slow/reduce CV19 transmission, adding to the upside potential.
FAB is a specialised Contract Research Organisation operating in monoclonal antibody engineering and production and supply. The company generated a 9% increase in H121 revenue driven by core antibody engineering expertise and demand for supply services. FAB’s trusted reputation, the continuing significance of antibodies for therapies and diagnostics, and operational continuity adjustments, together created encouraging resilience to the pandemic’s impact. The pace of progress in developing its differentiated Mammalian antibody library, OptiMALTM, translates into a commercial launch target in FY22.
Companies: Fusion Antibodies Plc
Moderna announced the first interim analysis from the Phase III study of its COVID-19 vaccine candidate, which was found to be c.95% effective in preventing symptomatic COVID-19 disease. This follows a similar announcement from Pfizer/BioNTech last week, and the caveats we mentioned at that time remain the same. AstraZeneca-Oxford University are also due to announce initial results this month. While these results are highly encouraging, we reiterate that they do not diminish the urgent need for COVID-19 treatments and testing, which will still be required for years to come, and we outline why. We consider Synairgen, Avacta, genedrive, Omega Diagnostics and Open Orphan to offer good buying opportunities.
After Pfizer and Moderna, AstraZeneca-Oxford reported (preliminary) late-stage results for their COVID-19 vaccine candidate. Based on logistics and pricing, Astra’s vaccine has clear advantages.
However, with results for other (major) countries still awaited and considering past safety concerns, it is pre-mature to decide if Astra has won this race. Also, considering the firm’s ‘no-profit’ commitment as long as the pandemic is on, any major earnings uptick seems unlikely.
Companies: AstraZeneca PLC
RUA have announced an earlier than expected update on the testing of its Elast-Eon-coated tri-leaflet artificial heart valve from its pilot pulsatile flow program. This testing is meant to simulate not just the flow of blood through the valve, but the viscous patterns that occur during the opening and closing of the valve, in the simulation of typical natural conditions. Not only have the minimum ISO Standard performance requirements been easily surpassed, but there were indications of reproducibility and ease of manufacture.
Companies: RUA Life Sciences Plc
A positive AGM update from CVS this morning, illustrating a continuation of solid trading momentum since the Sept finals. LFL sales in the first four months were ahead by 5.1% vs a stiff 8% comp. This implies an acceleration to 6.3% over Sep-Oct - an excellent showing, reflecting resilience and ongoing self-help to optimise revenue generation. Significantly, this flows through to a healthy EBITDA margin back above 15%. Trading during the current lockdown has not been much impacted and this bodes well for any future restrictions. The balance sheet has further deleveraged. With guidance remaining suspended we hold off reinstating forecasts, but on our illustrative analysis the shares are trading on an FY21/FY22 EV/EBITDA rating of 14x/13x and a P/E of 22x/21x. Given the structural tailwind, underlying momentum and sector M&A at >15x EV/EBITDA, we see scope for rating expansion.
Companies: CVS Group plc
In the positive trading update today, ReNeuron announced that patient dosing has commenced in the US in the expanded Phase IIa clinical trial for the lead hRPC candidate for Retinitis Pigmentosa (RP). We are pleased to see the trial is under away given the backdrop, and we expect data from the expanded cohort over the next 12 months. This data alongside previously announced highly positive hRPC data aims to be sufficient for ReNeuron to seek regulatory approval in H2 2021 to commence a single pivotal clinical study programme (i.e. potentially one trial off regulatory approval). A milestone that could pave the way for licensing agreements. We continue to believe the hRPC programme is highly novel programme that is differentiated against peers, and we forecast peak global sales potential of £880m. We also note that ReNeuron has signed its fourth research evaluation agreement with a leading biotech to evaluate the use of ReNeuron’s exosomes for the delivery of novel therapeutics. Whilst these deals are initial modest, they aim to produce proof-of-concept data that could pave the way to more lucrative licensing agreements for the exosome technology. Lastly, after the retirement of John Berriman, it was announced that Dr Tim Corn will become Chairman heading a significantly leaner Board. We make no forecast changes and reiterate our intrinsic value implied from our valuation analysis of 177p/share.
4D pharma has announced a merger with the Longevity Acquisition Corporation (NASDAQ: LOAC), a Special Purpose Acquisition Company that provides a NASDAQ listing and $14.6m (gross) of cash for 4D pharma shareholders. The statement notes that this additional capital is expected to extend the current operational runway another 6 months into early Q3 2021 (vs. Q1 2021 previously) providing capital to support the ongoing clinical development of its pipeline. 4D pharma will maintain its AIM listing and will remain headquartered in the UK. The merger was agreed at an valuation of £1.10 per 4D pharma ordinary share, representing a 18% premium to last night’s close of £0.93. Post-completion, 4D pharma will issue approx. 19,783,827 new ordinary shares, and 4D pharma shareholders will own approx. 86.9% of the issued share capital of the enlarged group. The merger is expected to become effective in early 2021, subject to shareholder meetings for both companies, and approval of all necessary US / SEC documentation
Companies: 4d Pharma PLC
Full-year results for the year to 30 June were in line with the 10 July trading update, with FY 2020 revenues of £1.1m (-55%) with an adjusted pre-tax loss of £6.5m (-18%) and year-end cash of £8.2m (+134%). They reflect a year which brought notable challenges, but also significant opportunities, which genedrive has responded to. While regulatory delays have thus far prevented material revenues from COVID-19 testing, they have the potential to be transformational in FY 2021. GDR confirmed that it is in advanced negotiations to sole supply a MoH in Europe, which could be worth low double-digit millions of pounds. Whilst we have reduced our FY 2021 revenue forecast (£2.7m to £1.8m, -33%), this excludes any revenues from the high-throughput SARS-CoV-2 test, or the POC test, as modelling their impact is not possible at the moment, which leaves significant room for upside. We leave our target price under review.
Companies: Genedrive Plc