RedHill Biopharma - Termination of coverage

Edison Investment Research is terminating coverage on China Water Affairs Group (855), CREALOGIX Group (CLXN), FCR Immobilien (FC9), HarbourVest Global Private Equity (HVPE), Marble Point Loan Financing (MPLF), Paion (PA8), PDL Biopharma (PDLI), Redhill Biopharma (RDHL) and Targovax (TRVX). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.

RedHill Biopharma - Rapid COVID-19 Ph II/III programme progress

RedHill’s COVID-19 programme is progressing well with two clinical trials ongoing, a Phase II study (n=40) in the US and an international Phase II/III study (n=270). If results are promising, RedHill plans to apply for emergency use authorisation as soon as possible. The commercial highlight this year was the acquisition of Movantik (for opioid-induced constipation) from AstraZeneca on 1 April 2020. Q220 was the first full quarter of RedHill promoting Movantik with booked sales of $20.9m (AstraZ

RedHill Biopharma - First quarter with significant sales; Cosmo deal

RedHill booked $20.9m in Q220 sales (vs $1.6m a year ago) with Movantik accounting for $20.0m. Q220 was the first full quarter of RedHill promoting Movantik for opioid-induced constipation (acquired from AstraZeneca on 1 April 2020). AstraZeneca reported sales of $96m in FY19. It is worth noting that Q220 saw the peak of COVID-19 lockdowns in the US, so promotional activities were limited. With lifting of restrictions, RedHill is also ramping up the promotion of its recently launched Talicia. Th

RedHill Biopharma - Rapid progress with COVID-19 programme

RedHill’s global Phase II/III programme with opaganib against COVID-19 is progressing rapidly. An ongoing Phase IIa study in the US should complete patient recruitment in August, while in July the international Phase II/III study should start enrolment in several other countries. If these studies are successful, RedHill could file for emergency use as soon as Q420. Extensive preclinical studies describe opaganib’s rather unique mechanism of action. It not only has an anti-viral effect, but can a

RedHill Biopharma - Movantik acquisition completed; sales booked

RedHill is now promoting Aemcolo for travellers’ diarrhoea (since December 2019), Talicia for H. pylori eradication (since March 2020) and the most recent addition, Movantik, for opioid-induced constipation (acquired from AstraZeneca on 1 April 2020). Movantik is an established product and AstraZeneca reported 2019 sales of $96m in the US, so it is a significant addition to RedHill’s portfolio. In April, the company booked $7.3m Movantik sales, which seems a good result given this was the peak m

RedHill Biopharma - COVID-19 challenges and opportunities

The ongoing COVID-19 pandemic is causing unprecedented challenges for most companies. According to the latest business update (25 March), the impact on RedHill's activities remains limited, but the global crisis also provides a significant opportunity for the company. RedHill has identified its anti-cancer/anti-inflammatory asset opaganib (Yeliva, formerly ABC294640) as a potential treatment for COVID-19. It has managed to fast-track compassionate use programmes where opaganib is now offered to

RedHill Biopharma - Transforming into a commercial pharma company

With two specialty GI products launched and a third one, Movantik, about to be acquired from AstraZeneca, RedHill is transforming into a fully integrated pharma company. RedHill is now promoting Aemcolo for travellers’ diarrhoea (since December 2019) and Talicia for H. pylori eradication (since March 2020). About to be in-licensed, Movantik is an established product for opioid-induced constipation and AstraZeneca reported 2019 sales of $96m in the US, so it is a significant addition to RedHill’s

RedHill Biopharma - 2020 set to be a commercially transformative year

On 22 November 2019, RedHill held an investor and analyst day in New York with the focus on the two new products about to be launched in the US. Talicia and Aemcolo are to be launched imminently (Q419 and Q120 respectively) and could be major products for RedHill. From a commercial perspective, this makes 2020 a potentially transformative year for RedHill, and good sales uptake could be a positive catalyst for the stock. The recent strategic investment of $36.3m by Cosmo Pharmaceuticals means th

RedHill Biopharma - FDA approves Talicia for H. pylori

RedHill Biopharma announced yesterday that the FDA has approved Talicia for the treatment of H. pylori infection in adults. The label is broad and potentially positions Talicia to compete as a front-line treatment. Talicia now is the only rifabutin-based combination antibiotic treatment approved by the FDA. In two Phase III clinical trials conducted by RedHill, no resistance to rifabutin was observed, which will be the key competitive advantage compared to standard-of-care clarithromycin-based H

RedHill Biopharma - Cosmo deal – new asset, stronger balance sheet

On 18 October 2019, RedHill announced a strategic investment and in-licensing deal with Cosmo Pharmaceuticals, a European specialty GI pharma and diagnostics company (sales of €66m in 2018). RedHill will receive an exclusive licence for the US rights to a branded antibiotic, Aemcolo (rifamycin), which was approved by the FDA for the treatment of traveller’s diarrhoea in November 2018. In return, RedHill will pay Cosmo the stock equivalent of $12m upfront, a royalty percentage on net sales in the

RedHill Biopharma - TALICIA will dominate newsflow in H219

RedHill’s Q219 results released on 23 July 2019 described steady progress across its pipeline, with TALICIA the centre of attention as the PDUFA date (2 November 2019) approaches. Based on the data released, we assign a high likelihood of FDA approval due to the clean dataset from the Phase III trials. From a commercial perspective, RedHill also appears to be ready with a US team in operation since mid-2017. Although potential approval and launch of TALICIA will dominate H219 newsflow, other not

RedHill Biopharma - FDA accepts TALICIA’s NDA

On 3 July 2019, RedHill announced that the FDA has accepted for review the new drug application (NDA) for TALICIA for the treatment of Helicobacter pylori infection. As TALICIA is a designated Qualified Infectious Disease Product (QIDP), the FDA also granted a priority review, which will shorten the usual review time from the standard 10 months to six months. As a result, 2 November 2019 was set as the target Prescription Drug User Fee Act (PDUFA) date. Based on the data released, we assign a hi

Shield Therapeutics - FY 2023A results, we introduce FY2024 forecasts

STX has released FY2023A results, with no surprises versus the Q1 2024 update on 30 April 2024. Total product revenues were $13.1m, (US Accrufer sales $11.6m, ex-US revenues $1.5m (mainly Germany and the US) and other income $4.4m (largely Viatris-related milestones). Total 2023A US Accrufer scrips were 77k, more than tripling versus 2022A, and evidence that having the Viatris deal and extra sales reps fully deployed from May 2023 is having a positive impact. The 2023 operating loss was $31.1m,

ANGLE: Gathering momentum in Pharma Services

Three new Pharma Services agreements with large cap pharma in 2024 demonstrate that ANGLE’s business development activities are successfully translating into customer income. These deals will make a valuable contribution to near-term revenues and also have the potential for more sizeable future revenues. Successful development of the underlying Parsortix-based assays could mean a transition into longer-term contracts for larger later-stage clinical studies, perhaps ultimately becoming companion

Morning Note – 13 May 2024

Zeus Industrials Round-Up - 9 May 2024

Economic and industrial data has started the second quarter on slightly weaker grounds than Q1 as Manufacturing PMI in the UK, Eurozone and US all reported April indexes below March levels. Cracks seem to be appearing as recent drops in new orders and rising input costs are quickly dampening confidence. Inflation did, however, fall MoM across the board with the exception of the US, where volatile energy prices caused a modest MoM increase in the inflation rate.

Trinity Delta Lighthouse: HUTCHMED

Trinity Delta view: Partner Takeda has executed an impressive initial launch of Fruzaqla in the US, which provides confidence in future successful launches in Europe and Japan (once regulatory approvals are secured), and for Fruzaqla’s longer-term growth prospects with expansion to additional indications. Fruzaqla’s commercial prospects are a key contributor to HUTCHMED’s path to profitability, which is supported by the growing traction and market share capture of its China oncology products, pl

Avon Protection (AVON LN) - Initiation: plenty of potential

Avon Protection is now on the right path strategically, focused on core body protection systems. We initiate coverage with a valuation of 1,100p against a current share price of 916p (+20%). The investment case is finely balanced. Global defence stocks have outperformed with rising conflict and bigger government budgets. We may now see a period of reflection for the sector as investors refocus on pipeline conversion and margins. Avon has performed well but somewhat lagged the global sector. The

Warpaint London+ (W7L, House Stock at 470p) - Outstanding FY23A - Upgrades!

Oxford Cannabinoid Technologies - Early signs of revival in clinical activity

Oxford Cannabinoid Technologies (OCT) has announced its H124 results (to end-October 2023), an eventful period for the company, marked by successful clinical progression of lead asset OCT461201, albeit with some funding challenges. Key highlights included the initiation and subsequent positive safety data from OCT’s first Phase I clinical trial (Programme 1) and a foray into oncology (Programme 4). Tight funding conditions halted subsequent clinical progress, although the recently announced £1.3

Avon Protection - Unmasking its growth potential

Avon Protection’s capital markets day highlighted its continued focus on medium-term margin expansion (targeting operating margin of 14–16%), concentrating on its core business of respirators and head protection. The unwinding of the armour business, alongside the consolidation of Team Wendy (acquired in H220) should enable Avon to benefit from rising global defence spending. Its strong relationship with the US DoD, and organic growth opportunities with recurring revenue from necessary product r

Creo Medical - NHS data validates Speedboat’s economic merit

Creo Medical has presented real-world evidence of the economic utility of its minimally invasive electrosurgical devices, based on NHS data from 130 submucosal dissection procedures using Creo’s flagship Speedboat Inject device. The data demonstrated net cash savings of £687k for the NHS trust, driven by a significant reduction in both hospitalisation and critical care costs. We believe this provides external validation to Creo’s pursuit of improving patients’ outcomes through its novel suite of

Hardman & Co Healthcare Index: 2023 – Capital demands dent performance

The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (

REVB: 1Q Results Reveal Solid Cash Balance

Revelation Biosciences is a life sciences company whose development of immunologic-based therapies is based on the well-established biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system. The company announced 1Q2024 results and we remind investors that the company has begun Phase I trials on its Gemini project and has funding needs met through 2024, which is extremely positive for a clinical stage company.

Hybridan Small Cap Feast - 09 May 2024

9th May 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: E-Therapeutics (ETX.L) has left AIM. Advanced Oncotherapy (AVO.L) has left AIM. What’s baking in the oven? ** Potential**** Initial Public Offerings: 7th May: Time To ACT plc, an engineering business focused on technology for the energy transition sector, has a

Abingdon Health (ABDX) - Boots branded pregnancy test launch a key endorsement of self-testing

The launch is a key strategic step for ABDX in the context of demonstrating its expertise in provision of a full lateral flow CDMO service offering to customers - specifically the capability to advance a product from the development stage to full manufacturing scale up and distribution. It comes after ABDX acquired Kent-based IVDeology Holdings, announced May, strengthening its regulatory service offering and providing contract extension and cross-selling opportunities.

4basebio - Interims – scaling to meet anticipated commercial traction

4basebio’s half-year results for the period ended 30 June 2023 reflect continued progress towards its main objective of producing GMP-grade synthetic DNA, with a focus on building out its commercial footprint. It generated revenues of £0.24m (+57%, with all growth coming from the sale of DNA and Hermes™ nanoparticles) with an adjusted net loss of £3.5m (H1 2022: £2.4m, +46%) and period-end cash of £3.6m, having drawn a further €4m from its €23m loan facility that gives it a cash runway into 2025