Driven by the robust demand for Darzalex and higher-than-expected milestone income, Genmab reported a revenue beat in Q2. Topped with the lower-than-expected R&D and selling expenses, mainly due to timing/ phasing issues, profitability’s outperformance was also encouraging. Given the strong show, the full-year outlook has been raised. Importantly, with the recent launch of Rybrevant and the upcoming approval of tisotumab, Genmab’s recurring revenue generation capability should strengthen further
Companies: Genmab A/S (GMAB:CPH)Genmab A/S (GMAB:CSE)
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
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.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Genmab A/S.
We currently have 0 research reports from 0
Full-year results were in line with the trading update of 21 July, with revenues of £31m (-2%), reflecting the impact of COVID-19 on out-patient procedure rates, resulting in 14% and 24% declines in adjusted EBITDA and pre-tax profit, respectively. Lower than expected procedure growth rates and the decision to discontinue non-core (non-chlorine dioxide products) reduces forecast revenues by c.£3m to £33m in FY 2022. However, higher gross profit and tight control of costs (+6%) results in an unch
Companies: Tristel Plc
No Joiners Today.
No Leavers Today.
What’s cooking in the IPO kitchen?
Devolver Digital to join AIM, an award-winning digital video games publisher and developer in the indie games space. Recently awarded indie 'Publisher of the Year 2021' by GamesIndustry.biz. Offer TBA. Due early Nov.
Life Science REIT to join AIM raising up to £100m. This will be the first London listed real estate investment trust (REIT) focused on UK life science properties providing investors with exposure
Companies: SYS1 ARE SO4 SNG TMG TMT OHG IDE KIBO MRL
Recruitment resumed the Phase 2a trial of the lead programme hRPC in retinitis pigmentosa (RP) with the treatment of the first UK-patient in Oxford. The protocol gives greater infection control after the safety issue (a possible infection) in June. Five patients were treated up to mid-October and the remaining four could be treated by December 2021. By late March 2022, ReNeuron expects to give an interim update. The full data set should be available around mid-2022. This will enable regulatory d
Companies: ReNeuron Group plc
Companies: WAND SDX SEMP BMK LVCG MOS ACC
IXICO has announced that one of its clients has put an indefinite halt on a clinical trial for which the company was providing its artificial intelligence medical image analysis. The halt is the result of unexpected preclinical data. IXICO had expected the contract to deliver £0.8m of revenues in FY22E and it represented £3.3m of the £18.8m order book as of the close September 2021. While this news is disappointing, clearly the trial halt has no reflection on the capability of IXICO's technology
Companies: IXICO Plc
No Joiners Today
No Leavers Today
What’s cooking in the IPO kitchen?
Arrow Exploration Corp. (AIM: AXL ; TSXV: AXL) , the oil and gas exploration and production company, has conditionally raised approximately £8.8m and is due to complete its dual listing on AIM on 25 Oct. Market cap c£13.1m.
Devolver Digital to join AIM, an award-winning digital video games publisher and developer in the indie games space. Recently awarded indie 'Publisher of the Year 2021' by GamesIndustry.biz.
Companies: ZYT CIC DMTR GILD LMS MMAG PYC SMRT SBI
IXICO has provided an upgraded trading statement for FY21E following its previous update in August 2021. Revenues are now expected to be £9.2m (vs £8.7m previously), broadly in line with FY20A, which we see as a strong result given the pandemic and Huntington's Disease (HD) trials de-scope. EBITDA is expected to be materially ahead of FY20A's £1.3m, supported by strong Q4/21 trading, cost control and positive one-offs. The company has ended FY21 with a strong order book (£18.8m) and cash positio
CareTech is a specialist social care and educational services provider. This morning, the group has announced an update for the year to 30 September pointing to the fact that results will be in line with market expectations. The net debt position of £259m illustrates a further reduction since the end of H1 (31 March £263.1m) and implying a reduction to 2.7x adjusted EBITDA. During the year, seven new developments have opened, with a further eight properties purchased in H2. The group's freehold
Companies: CareTech Holdings PLC
H1 EBITDA declined by 45% YoY, albeit this was slightly better than we had anticipated after the pre-close update in August. The beat was cost related (efficiencies/savings). There was a significant gross margin drag though and, while transitory in nature and diminishing in H2, this means further savings need to be realised to hit full year forecasts. This is our view and we retain a good level of confidence in next year’s forecasts. Having de-rated, valuation looks very undemanding now on just
Companies: Venture Life Group Plc
SkinBioTherapeutics has announced it will launch its lead commercial product, AxisBiotix-Ps on World Psoriasis Day, 29 October 2021. To support the launch, the company has begun to receive, and store finished product in the Netherlands (close to its manufacturing partner) ahead of initial launches in the UK and US. Clearly the launch of its first product is a significant step for SkinBioTherapeutics, marking the transition from development company to commercial operation. We are encouraged by th
Companies: SkinBioTherapeutics Plc
Synairgen reported interim results to 30 June in which the adjusted net loss was £32.8m with period-end cash of £46.2m. Substantial pre-commercial progress and manufacturing activities have made in the half, although slower country approvals for trial sites will result in Phase III data readout slipping into Q1 2022. With increasing evidence of the need for a broad-spectrum antiviral delivered to the lungs and recognition that vaccines don’t provide complete protection against hospitalisations d
Companies: Synairgen plc
*A corporate client of Hybridan LLP
No joiners today.
Conduity Capital has left AIM.
What’s cooking in the IPO kitchen?
Softline the global solutions and services provider in digital transformation and cybersecurity, with its headquarters in London, is considering proceeding with a potential initial public offering of global depositary receipts representing its ordinary shares. The Company is considering applying for admission of the GDRs to the standard listing segm
Companies: SEN SEMP DNORD DNORD FAB MAST SAR CZA MRL
No Joiners Today.
Cambria Autos has left the AIM following a takeover.
What’s cooking in the IPO kitchen?
Light Science Tech Holdings, the controlled environment agriculture technology and contract electronics manufacturing Group to join AIM. Raising £5m. Expected mkt cap £17.4m. Due 15 Oct.
Harmony Energy Income Trust to join the Specialist Fund Segment of the Main Market raising up to £230m. The Company's investment objective is to provide investors with an attractive and susta
Companies: VRS ORPH SNG MRL EBQ AVG
Hikma’s H1 20 top-line acceleration was driven by COVID-19-related demand in Injectables and Generics and the economic recovery in Algeria propelled growth in the Branded segment. Combined with a favourable product-mix, the operating margin was up 1.5ppt. In the near term, new launches across segments should provide some respite against the ongoing pricing pressure. Given the company’s thin R&D pipeline and a robust balance sheet, M&A (probably in the biosimilars space) seems on the cards.
Companies: Hikma Pharmaceuticals Plc
The oncology consultancy using mathematical models to support the development of cancer treatment regimens and personalised medicine solutions yesterday announced it has entered into a partnership with Tabula Rasa HealthCare® (TRHC) (NASDAQ: TRHC), a healthcare technology Company advancing the field of medication safety. Through this initiative, Physiomics' personalised docetaxel model will be integrated into TRHC's market-leading precision dosing solution, DoseMeRx®. Both parties expect positiv
Companies: Physiomics Plc