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.
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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
Venture Life has announced its interim results for the six months to June 2021. As previously announced in the August trading statement, revenues were down YoY due to lower HSG sales and sales to the Chinese partner, though revenues are expected to grow subsequently, benefiting from the two recent acquisitions. H1/21 gross margin was impacted by a number of factors including supply chain costs and stockholding costs; however, the company expect margins to improve in H2/21E. Despite the set-backs
Cambridge Cognition has announced strong interims which are consistent with our recently upgraded forecasts. Revenue increased 50% YoY, which outstripped growth in admin expenses leading the group to swing to a net profit. Demand for the company's software & services to support clinical trials continues to be strong, with a contracted order book of £15.2m at the end of H1 21 (+36% HOH; +105% YoY). Contract prepayments aided strong cash generation which led net cash to increase +37% versus FY20 Y
Companies: Cambridge Cognition Holdings Plc
After the exceptional trading conditions in China last year comes the hangover. A further softening in pork prices highlighted at the July trading statement has led to conditions in China continuing to ease in Q2. Revenues YTD in that market are now significantly below management expectations and down YoY. Whilst some recovery is expected in H2, there looks to be much to do to make up the shortfall. More encouragingly, trading in the group’s other markets remains in line with expectations. We re
Companies: ECO Animal Health Group plc
Momentum is building in Circassia, with the recovery from the pandemic gaining traction and actions taken by management to focus the business having a material impact on the bottom line. Having already upgraded in July, we are upgrading forecasts again today to reflect the further progress on reducing fixed costs. We now expect the group to trade close to EBITDA breakeven this year and for significantly improved profitability and cash generation from next year onwards.
Companies: Circassia Group PLC
Companies: SourceBio International Plc
Warpaint’s interim results for the six months ended 30th June demonstrate a highly encouraging rebound in sales and profitability as the markets have reopened post various degrees of Coronavirus lockdown. Strong strategic progress has been made, with the relationship with Tesco expanded and an 84-store trial with the UK’s leading cosmetics retailer Boots confirmed; this is very good news to us. Whilst ahead of our expectations for H1, we leave FY21 forecasts unchanged reflecting the very well do
Companies: Warpaint London PLC
Full year PBT is 4% ahead of our expectations and strong trading momentum has continued into FY22 (14.4% LFL). The strength of the results reflects favourably on the strategy new management put in place in 2019 to focus on optimal patient care and to make CVS an employer of choice. Having shown remarkable resilience through the pandemic, CVS is emerging as a stronger business with excellent ongoing growth prospects. Its integrated veterinary model is ideally positioned to capitalise on sector ta
Companies: CVS Group plc
Exactly one year ago, the FTSE 100 closed at 5,862, having fallen 100 points on the day, the lowest point since mid-May 2020, due in part, to the strength of sterling vs US$ at $1.34. One year on, the FTSE 100 has risen to 7,119, a rise of 21%, it remains 7% below the peak in January 2020. From an international viewpoint, US and European markets continue to trade at record highs. The US Federal Reserve is close to withdrawing some of its economic support this year as inflation picks up and the e
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Interim results to 30 June 2021 were in line with the trading update issued on 3 August, which resulted in upgrades to our forecasts and target price. On the back of a 50% (£1.5m) rise in revenues to £4.5m, adjusted EBITDA increased £0.5m to £0.2m, illustrating the operational leverage of 80% gross margin software & services. Period-end cash increased 38% (+£1.2m) in the period to£ 4.2m. Cambridge Cognition is well positioned to be a long-term beneficiary of the trend of running virtual decentra
Allergy Therapeutics reported FY 2021 results that were 95% (+£2.1m) ahead of adjusted pre-tax profit expectations, driven by lower than forecast overhead costs. This underpinned 20% growth in pre-R&D EBIT to £16.9m on 6% CER revenue growth. Year-end net cash was £36.9m, providing the company with the financial resources to complete both its Grass MATA MPL Phase III trial and complete the VLP Peanut Phase I trial. The readout of the exploratory Phase III (G309) Grass MATA MPL study in the autumn
Companies: Allergy Therapeutics plc
Deltex has reported 2021 interim results which reflect the challenges of the current healthcare environment with COVID cases causing disruption to the Company's core elective surgery market. That said, the Company has demonstrated it is able to keep costs low to match the current low activity, in anticipation of improving activity in 2022.
Companies: Deltex Medical Group plc
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Eurowag confirms its intention to undertake an initial public offering on the Main Market (Premium). The Offer would be expected to comprise both (i) new Ordinary Shares to be issued by the Company, raising gross proceeds of approximately EUR200m to support Eurowag's growth strategy and (ii) existing Ordinary Shares to be sold by existing Eurowag shareholders. Eurowag is a leading pan-European
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Synairgen reported FY 2020 results that showed an adjusted net loss of £13.7m, with year-end cash of £75.0m, some £27m higher than our expectations. The delta can largely be accounted for by delays in starting enrolment into the Phase III trial as well as the treatment of prepayments for drug substance and nebulisers: the latter reflected in working capital rather than expensed through the income statement. Near-term focus remains on the outcome of the Phase III study (SG018), and with the enrol
Companies: Synairgen plc
Fusion showed solid FY21 revenue growth of 7% to £4.2m (vs £3.9m), particularly as client projects were delayed by the COVID-19 pandemic. Operating loss rose marginally from £1.1m to £1.2m (reported net profit in FY21 was distorted by a £1.7m non-cash, accounting charge). This reflects strong R&D investment in the new OptiMAL service; this is due to gain commercial revenues in FY23. Fusion should then experience narrowing losses on the trajectory to profitability. After a £3m gross capital raise
Companies: Fusion Antibodies Plc