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.
Companies: Oxford Biomedica Plc
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.
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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 VAL 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 VAL 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.
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 (CGT). OXB has numerous value streams, including manufacturing, royalties and milestones on partnered product sales. Its technology and R&D pipeline have been validated by numerous partnerships (Novartis’s CAR-T Kymriah, Axovant deal for AXO-Lenti-PD). We believe the greatest opportunity lies in OXB’s own gene therapy R&D capabilities; higher investment now is imperative to reap future economic returns in this highly innovative and potentially lucrative therapy area. We value OXB at £649m.
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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
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
Alliance Pharma’s H1 interims are relatively robust, with trading conforming to recent commentary. Whilst there has been an impact in some areas of the business in H1 (Prescription Medicine) as expected per the trading update in July, the rest of the business particularly Kelo-cote, has proved very resilient and highlights the defensive nature of the business, and underlying adj. PBT (excl. amortisation and impairment charges) was solid in H1 2020 at £16.3m (+7% YoY). We anticipate some push and pulls in H2 2020 but net we anticipate a better performance as demand recovers, and the Board have reiterated that full year results are expected to be in line with market expectations. The reinstatement of an interim dividend of 0.536p signals confidence in this. We have used today’s announcement to reinstate our forecasts, which are broadly in line with guidance and consensus. Our new FY’20 forecasts are c.10% below our previous estimates prior to the Covid-19 pandemic with YoY revenue and adj. EBITDA growth rates of -6.5% and -10.1%. We forecast a return to growth in FY’21 and have used the opportunity to introduce our FY’22 numbers looking for ‘see-through’ revenue of £153.2m and adj. EBITDA of £41.5m. Our main ongoing concern is that growth is highly dependent on Kelo-cote, a situation that has been augmented during the Covid-19 pandemic, and the Group needs to turn once again to deal-making to supplement organic growth to grow the portfolio. On our revised estimates, our new DCF/Peer group multiple derived target price is 91p/share and we move from Hold to Buy.
Companies: Alliance Pharma Plc
IXICO has been selected as the image collection and analysis partner for the Bio-Hermes trial, co-ordinated by the Global Alzheimer's Platform Foundation (GAP). The trial, aiming to assess Alzheimer's Disease (AD) biomarkers, will see IXICO analyse the brain scans of 1,000 patients with early stage AD. While participation will deliver revenues to IXICO in subsequent years, we believe the enhanced profile amongst the trial participants and GAP industry partners will deliver significant ‘intangible' benefits to the company. We maintain our Buy recommendation.
Companies: IXICO Plc
Yourgene has announced it has appointed IBL-America as a non-exclusive distributor for its range of PCR-based reproductive health and oncology products, including the DPYD assay which tests whether cancer patients are at risk from the administration of a common chemotherapy agent. These will be initially sold into the Research Use Only market in the US. As such, initial revenues are likely to be modest, but will act as an important test bed for establishing potential demand in the clinical setting. If the reception is positive, products will be submitted for FDA registration, potentially unlocking a £30m addressable market opportunity. We make no change to our forecasts, but view this another positive step to generating meaningful revenues in the world’s largest market, which remains a largely greenfield opportunity for Yourgene.
Interim results to 30 June 2020 showed a 38% increase in revenues, despite COVID-related disruption to clinical trials, illustrating the clear commercial focus that has been brought to bear on its range of digital technologies and solutions. Together with an 18% reduction in operating expenses, adjusted LBITDA and pre-tax loss improved by £1.3m to -£0.29m and -£0.36m, respectively. Period-end cash was £1.96m, with cash burn falling £1.1m to £0.2m in the period. Break-even in Q4 2020 is still anticipated. The contracted order book increased 35% to c.£10m at 31 August (vs. 30 June 2020), providing increased visibility of revenues in H2 and FY 2021 (c.108% and 57% of current forecasts, respectively). Due to the changing working patterns that are emerging as a result of the COVID pandemic, we believe that Cambridge Cognition is well positioned to be a long-term beneficiary of the trend of running virtual trials. We leave forecasts unchanged, but in light of the strong order book and potential for future upgrades, we raise target to 80p, which implies a 2021 EV/sales multiple of 3.4x.
Companies: Cambridge Cognition Holdings Plc
Tiziana Life Sciences PLC (LON:TILS, NASDAQ:TLSA) has expanded the range of indications — which include severe inflammatory and autoimmune diseases — of its lead therapy fully human anti-CD3 monoclonal antibody Foralumab, signing a new collaboration in Brazil to develop the nasal formulation of For
Companies: Tiziana Life Sciences 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).
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
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
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.
Verona Pharma is delisting and cancelling its Ordinary shares from trading on AIM. It is consolidating trading on the NASDAQ market where it will retain its listing of American Depositary Shares (ADSs) under the ticker symbol VRNA. No general meeting is required to complete the AIM Delisting, which is expected to occur market close 29 October 2020. Each ADS represents eight Ordinary shares and are denominated in $. As per the company’s website, there are three options available now for VRP Ordinary shareholders: 1) convert the Ordinary shares into ADSs tradable on NASDAQ, if completed prior to the AIM delisting shareholders will not incur any charges; 2) hold their Ordinary shares, although they will no longer be publicly tradable, and to trade Ordinary shares would require the conversion into ADSs which after the delisting will incur charges; or 3) to sell their AIM-quoted Ordinary shares prior to AIM delisting.
Companies: Verona Pharma 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
Whilst headline H1 revenue growth of 23% is eye-catching, for us the most comforting factor is the robust performance of the underlying business in the most challenging of circumstances. Sales of the Primestore MTM sample collection device contributed £6.5m, meaning the core business was -8% in the period, well ahead of internal expectations. Highlights include strong performances from BhB, DiaSpect Tm and the Clinical Chemistry portfolio, all of which grew revenues in the period. Whilst there were challenges in certain geographies, this is a very creditable performance and testament to the strength and defensiveness of the core business. We make no further change to our forecasts at this stage, having upgraded regularly in recent months. Given we have only included firm orders for Primestore up until the end of this month, we remain confident further upgrades are likely for the rest of this year and into next. In the meantime, latent growth potential in the core business is building with, inter alia, Chinese approval of Quo-Test, strong momentum with DiaSpect Tm, the Trellus health investment and a variety of contract manufacturing orders in the Central Lab/Life Sciences segment adding to the medium term growth outlook. Given the continuing scope for upgrades, we continue to see upside potential in the shares – EKF remains one of our Best Ideas for 2020 (up 66% YTD).
Companies: EKF Diagnostics Holdings Plc