Benefiting from the strong uptake of the subcutaneous formulation and continued market share gain across lines, Darzalex reported better-than-expected sales in Q1 21 with the ex-US region leading the momentum. Higher revenue trickled down and combined with higher financial income (driven by unrealised foreign exchange rate gains) led to a strong beat on earnings. Despite these good results, management has refrained from upgrading the guidance as there is uncertainty with respect to new cancer pa
Companies: Genmab A/S (GMAB:CPH)Genmab A/S (GMAB:CSE)
FY20 sales and operating profit targets were exceeded, led by higher Darzalex royalties and lower R&D costs. Given its convenience dosing, Darzalex should hit the $5bn sales mark in FY21 (vs. FY20: $4.19bn). Although profitability could come under pressure, increasing R&D spend signal that the pipeline is rapidly maturing. Moreover, investments into the commercial infrastructure should make Genmab launch-ready for the next phase (two drug launches expected soon). Nonetheless, the legal battle wi
Better than expected performance of Tepezza and the upcoming launch of Amivantamab should bolster Genmab’s top line in the near term. Moreover, encouraging clinical data for pipeline assets, particularly, Epcoritamab and DuoBody PD-L1×4-1BB, bodes well for the mid-term.
Companies: Genmab A/S
After a soft Q2 due to COVID-19, Darzalex hit the blockbuster mark in Q3 driven by the robust uptake of the subcutaneous formulation and the resulting market share gain in the frontline multiple myeloma setting. Given its convenient administration, the drug should be a key growth driver going forward. Moreover, the recently-approved Kesimpta could help Genmab make a mark in the multiple sclerosis space. More details on the R&D pipeline at the Capital Markets Day next week.
Genmab has initiated a legal fight with partner Janssen over royalty payments for multiple myeloma drug, Darzalex. There are two bones of contention – royalties for the subcutaneous formulation and the tenure of the payments. In a worst case scenario, wherein Genmab’s loses both the battles, the Danish firm’s value could reset lower by c.20%.
Despite being slightly impacted by COVID-19 in Q2, Darzalex continued to gain share in the multiple myeloma market. Given the encouraging launch of the subcutaneous formulation, we anticipate a steady uptake in the coming quarters. Interestingly, given the strong launch of Tepezza, management has upgraded the FY20 targets marginally. Note that the R&D pipeline has progressed quite well ytd – positive top-line data in amyloidosis and cervical cancer space – and this bodes well for the mid-term.
Genmab and AbbVie have entered into an oncology partnership to develop and commercialise jointly three of Genmab’s early-stage assets, along with a R&D pact to create four additional cancer drugs. Genmab would receive $750m upfront and $3.15bn in potential milestones and the strengthened financial position would help accelerate R&D activities on other promising assets. Interestingly, Genmab has retained 50% commercialisation rights in the US and Japan, thereby moving a step closer to its vision
Q1 was strong with sales for Darzalex increasing 12.9% qoq – led by the sustained share gain in frontline and second-line indications and significant new patient starts in the third-line+ setting. While Q2 has started on a weak note due to COVID-19-related issues, we foresee this as a temporary phenomenon given the seriousness of blood cancer disease. Fortunately, the launch of the convenient and time-saving subcutaneous formulation, that can also be given at home, bodes well for elderly patient
FY19 ended on a high as sales and operating profit exceeded management’s pre-set targets – driven by royalties and the sales milestone of Darzalex. Given its robust traction, Darzalex should achieve the $4bn sales mark in FY20 (vs. FY19: $3bn). While operating profit could come under pressure as the company accelerates development of potential next winners, we are less concerned as the focused R&D approach bodes well for the mid/long term. An announcement of a partnership for Epcoritamab could b
Darzalex continued to gain market share in Q3, while Arzerra was once again a disappointment. Given the favourable development in FX, the revenue guidance was upgraded by DKK300m and, as operating expenses remain stable, the operating profit target also gets an uplift of similar magnitude. Considering that Arzerra has reported positive results in the multiple sclerosis setting, a turnaround might be on the cards, but Roche’s Ocrevus would be a threat.
Driven by steady demand for Darzalex in the US, Europe and Japan, total revenue surged by 51.8% in Q2 19. Growth in operating expenses was even higher (+70%), due to higher investments into R&D and, as a consequence, operating income was largely flat vs. Q2 18. Given that the Darzalex-Revlimid combo is now approved in the US in the frontline MM indication, the upgraded FY19 guidance seems within reach.
Genmab’s collaboration partner, J&J, has released better than expected sales numbers for Darzalex for Q2, but the beat was largely due to one-off adjustments. On a separate note, Genmab plans to raise c.$500m, through the listing of ADSs in the US, to fund its R&D investments and be commercially launch-ready.
While sales for Darzalex were a tad below expectations in Europe, the US performed well with a sustained share gain in the second-line MM setting. Given the upcoming approval in the frontline indication, the $3bn targets for the drug for FY19 remain within reach. Also, as the full-year profitability outlook was reiterated, the higher R&D expense for Q1 appears a timing issue. As long as the swelling cost base is well funded by the Darzalex royalty flow, we remain optimistic.
While sales for Darzalex were a tad below estimates, total revenue exceeded expectations in FY18 on the back of higher milestone income. Robust revenue acceleration is anticipated for FY19 as well, though operating profit would continue to be weighed down by higher investments into R&D. Given that the multi-blockbuster potential of Darzalex is still intact, we reiterate our ‘Buy’ recommendation.
Impacted by a one-off adjustment in Europe and modest growth in the third-line and fourth-line MM setting in the US, sales for Darzalex came in below our expectations. However, given the continuous market share gain in the second-line regimen and upcoming approval in frontline, we believe that the growth momentum would accelerate in the coming years. Though increased investment into the commercial infrastructure is a short-term FCF dampener, it is expected to create value in the long run.
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OptiBiotix has reported its final results for the year to December 2020, which are largely in-line with the financials reported with the recent ‘Strategy and commercial update'. 2020 was a strong year for the company as its two operational divisions achieved EBITDA profitability supported by increased commercialisation of the group's product range. This commercial moment has continued into 2021, as the company looks to scale its first-generation product sales with new product lines and new terri
Companies: OptiBiotix Health PLC
CareTech is a specialist social care and educational services provider. This morning, the group has announced interim results to 31 March 2021, which illustrate another positive six month period, particularly when considering the present wider backdrop. An increase in underlying PBT of 31.6% against the prior year benefited from organic growth, as well as the acquisition of Smartbox, transfer in of The Huntercombe Group facilities and a full period contribution from the Middle East. As reported
Companies: CareTech Holdings PLC
As midsummer’s day looms (where has this year gone?), there is greater optimism, in general, than may have been anticipated a few months ago. A post-pandemic, ‘vaccine-driven’ recovery demonstrated by increased consumer spending as lockdown measures are lifted has been one of the catalysts. The FTSE 100 has been range-bound in the last month 6,900-7,100. We have seen a combination of broadly positive company results across a range of sectors, further examples of M&A activity and a sequence of ne
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Evgen reported full-year results to 31 March that were c.£0.3m better than expected, with an adjusted net loss of £2.8m resulting in year-end cash of £11.6m (FC est. £11.3m), which provides a cash runway to at least mid-2023. The company continues to progress SFX-01 in glioma (brain cancer) and metastatic breast cancer (mBC) pre-clinical models, with the aim of commencing a Phase Ib/II trial in Q2 2022 (glioma) and potentially a Phase IIb trial in mBC patients who have become resistant to first-
Companies: Evgen Pharma Plc
Further to yesterday's announcement, NetScientific, the international life sciences and sustainability technology investment and commercialisation group, has announced that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), is to issue c.5.3m new shares of common stock to raise gross proceeds of c.$45m. NetScientific currently owns 1,278,000 shares of PDS' common stock, representing 5.7% of its fully diluted share capital prior to the issue.
Companies: NetScientific plc
The UK market showed a continued recovery in the first quarter albeit the indices are still well short of their all-time peaks, unlike many of their international peers. The FTSE 100 has risen by 1,186 points (21.4%) since the end of October and the FTSE 250 by 4,304 points (25.0%). The comparable performance since the start of the year is less spectacular- the FTSE 100 has risen by 253 points (3.9%) and the FTSE 250 has risen by 1,070 points (5.0%). The factors behind the sustained rally are fa
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AVO’s goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology developed originally at the world-renowned CERN. Over the past two years, important technical milestones have significantly derisked the project. Now, AVO is working on the verification and validation phase, prior to LIGHT being used on the first patients to support CE marking. In its recent technical update, the company highlighted progress made over the past three months towards a ful
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Trading has strengthened significantly since restrictions eased in April, especially in the UK. UK brand sales are now up 64% YTD (+18% vs 2019). Further distribution gains are being made, including in the USA and online sales have tripled, albeit off a small base. Net cash has increased to £6.6m (Dec’20, £4.9m). Risk appears to lie to the upside vs prudent forecasts. The re-rating looks well supported to us, and we look forward to the H1 update in July
Companies: Warpaint London PLC
Calnex Solutions has announced record results for FY21 following customer orders up across all product types and within all regions, with FY21 revenue up 31% to £18.0m and adjusted PBT up 43% to £5.1m. Calnex has firmly established a trusted reputation worldwide, launching multiple first to market telecoms and network testing solutions. Calnex continues to accelerate its investment in R&D and expand its product roadmap, adding increased engineering, sales and customer support capacity in order t
Companies: Calnex Solutions Plc
SDI Group has published a second positive trading update ahead of July’s FY21E results announcement. Management’s guidance for revenue and adjusted PBT is approximately £35.3m and £7.4m respectively, ahead of our previous FY21E estimates (and previous guidance) of £34.0m and £6.7m. We upgrade our FY21E forecasts accordingly, with a 10% uplift to our fully adjusted PBT forecast. Current base guidance for FY22E remains unchanged with revenue of £42m and adjusted PBT of £8.7m. Consequently, we are
Companies: SDI Group plc
Venture Life Group has announced the acquisition of BBI Healthcare, a leading Women's Health and Energy Management/Diabetes company. Venture Life will pay up to £36.0m for the business, which generated revenues of £10.2m and adjusted EBITDA of £2.6m in FY20A. We believe the acquisition will fit well within Venture Life, significantly expanding the group's own brand revenues and providing a number of revenue growth and operational leverage opportunities. The acquisition has been financed by exist
Companies: Venture Life Group Plc
In an encouraging sign of building US momentum, Yourgene has announced it has signed a multi-year licence and supply agreement with a major US precision medicine company to enable it to offer a new reproductive health screening service from its own laboratories. The agreement encompasses a non-exclusive licence to Yourgene’s proprietary bioinformatics Flex analysis software and a supply agreement for sample preparation reagents and instrumentation. Notably, this includes the Ranger sample enrich
Companies: Yourgene Health Plc
NetScientific, the international life sciences and sustainability technology investment and commercialisation group, has announced that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has itself announced (after trading hours 14 June) that it is commencing an underwritten public offering of shares of its common stock. PDS intends to use a portion of the net proceeds for the development of its clinical pipeline and the balance for general corporate / working capital purposes.
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 soc
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In line with the recent FCA announcement, Venture Life, in conjunction with its auditor has taken the decision to delay the release of its FY19 results, though the company notes it was in position to release them. Also, with this announcement, the group has provided a strong trading update, noting that all business units are still operating as of now. Specifically, Venture Life points to orders of over €7m from its Dentyl partner in China for 2020 (versus €0.5m for 2019), with at least €2m for d