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Edison Investment Research is terminating coverage on BONESUPPORT, Orexo, Transcontainer and UmweltBank. Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Previously published reports can still be accessed via our website.
Companies: Orexo AB
On 17 March 2020 Orexo held a capital markets day at which it provided an update on its programs and estimates of the impact of COVID-19 on its business. In short, Orexo is predicting a limited impact from the virus, which is consistent with our estimates. It also highlighted its development pipeline, which will be a major focus of the company. It will be launching its next product, vorvida for problem drinking, in Q320 if the FDA signs off.
Orexo announced on 6 March 2020 that it has submitted an application to the FDA for its vorvida digital therapy for the treatment of heavy drinking. It expects a hearing from the FDA on the approval status of the program in Q220 and to commercialize the product in H220 if it is cleared. The product uses cognitive behavioral therapy coupled with machine learning and has been vetted in a randomized, controlled study to reduce problematic drinking episodes.
Orexo continues to weather the shift in its payer base away from exclusivity to the open market well. It has managed to maintain 4% sequential growth in Zubsolv sales from Q3 to Q419 (SEK190.5m), in the context of a 3% decline in units. Growth in the open market strongly resembles overall market trends (14% AGR for 2019). The company intends to use some of these Zubsolv revenues to advance its pipeline, which will have five products advancing in 2020.
Orexo reported a record performance for Q319 with revenue of SEK231.2m (+6.7% year-on-year). The top line was lifted by a combination of factors including currency and a shift in the reimbursement landscape for Zubsolv in the US toward higher-margin business, translating into a record EBIT of SEK105.9m, over three times that of Q318, and SEK135.7m in operating cash flow. Orexo ended the period with SEK813m in cash (SEK524m net), which we expect the company will reinvest in new assets and its pip
Orexo has announced a partnership for the digital therapy of opioid use disorder (OUD) with GAIA, a global leader in digital therapeutics. The partnership will use GAIA’s expert system technology platform, broca, to develop a treatment management and support a product tailored to individual OUD patients.
After a strong Q119, which is seasonally the weakest quarter, Orexo also had a higher bar to beat Q218 due to milestone income making it one of its best ever quarters. Nevertheless, total Q219 revenues rose 0.8% to SEK201.2m. Zubsolv continued to perform well with Q219 sales of SEK184.4m, even against generic film and sublingual tablet competition.
Orexo’s Q119 results reinforced its continuing profitability with total revenues rising 25% y-o-y to SEK174.3m. Zubsolv led the revenue charge comprising 93% of total revenues and growing 23% y-o-y despite the seasonally weak first quarter of the opioid use dependency market. The effect on US Zubsolv (which increased in price by 4% from January 2019) from four Suboxone film generic entrants is so far minor.
Orexo’s FY18 results demonstrated continuing profitability derived from its lead product, Zubsolv, responsible for 21.7% y-o-y net sales growth driven by US Zubsolv Q418 prescription and revenue growth of 22% and 31.8%, respectively. The weakness in partnered products compared to our targets (although FY18 partnered sales were SEK125.4m) and higher Q4 investment (including litigation) reduced FY18 EPS compared to our estimate by SEK1.8. We have tempered our revenue growth expectations for FY19 u
Orexo’s capital markets day (CMD) emphasised the scale of the US opioid crisis. We have forecast 8.2% market growth pa for US opioid dependency in FY19 and FY20, although external speakers at the CMD suggested this may be higher. Orexo’s marketed product Zubsolv, sales of which grew 37% y-o-y in Q318 in SEK, and its other products in development, form a treatment franchise in the growing markets of opioid dependency and related disorders. The recent return of EU Zubsolv rights defers the royalti
The growing US Zubsolv franchise continues to drive Orexo’s quarterly performance. Total Q3 revenue growth of c 30% puts Orexo in an attractive position with potential business development partners. Orexo’s Q318 results were the first since Zubsolv’s exclusivity was strengthened for another 13 years in the US, so with Zubsolv sales growing by 1.2% q-o-q in Q3, against the backdrop of a 0.3% decline in the buprenorphine/naloxone market volumes, and continued material CoGS improvements, Orexo is m
Orexo’s appeal of the US District Court’s invalidation of the ‘330 patent, which had been anticipated for some months, has been successful. Zubsolv is Orexo’s largest and fastest-growing product – we anticipate sales of c SEK620m and over 25% growth in FY18. The initial invalidity of the ‘330 patent had weighed on the shares since 2014 and this overhang has now been removed. The exclusivity of the Zubsolv patents runs until 2019 and 2032. We have updated our valuation ahead of the Q318 results.
In a well-received set of quarterly results, Orexo continued to execute on Zubsolv in the US, which, for the second quarter running, continued to be the only branded product in the category that increased its market share in the face of multiple generics. Zubsolv US revenues of SEK158.4m grew by 27.6% y-o-y, driving total revenues to SEK200m. EBITDA of SEK50.6m, cash flow from operations of SEK39m and a gross cash balance of SEK494.8m made Q218 one of Orexo’s best ever quarters.
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Weekly round-up of AIM-listed healthcare news.
Venture Life Group, GENinCode, Kromek, Alliance Pharma, Polarean Imaging, Benchmark Holdings, Ondine Biomedical, Verici Dx, Faron Pharmaceuticals, Avacta Group, Abingdon Health, Open Orphan, Belluscura, Hutchmed (China), Oxford Biodynamics
Companies: ANIC RUA CREO GENI HEIQ IHC IXI IUG OPTI SBTX VAL VLG
Companies: Futura Medical plc
Full-year results were in line with the preliminary guidance issued in early 2022. Feraccru revenues in Europe increased with a 60% increase in volumes and the US commercialisation of Accrufer continues, with broader insurance coverage (100m lives covered). As with many small cap companies, access to growth capital is currently difficult; however, the group has raised a $10m loan from a major shareholder providing a cash runway till end-2022. Our assumption is that further funding comes from deb
Companies: Shield Therapeutics Plc
OptiBiotix has reported final results for the year to December 2021, with revenues growing 45% to £2.2m and the EBITDA loss increasing to £1.0m, reflecting the increased investment in the business. Post-period end, OptiBiotix has continued to return value to shareholders through the successful spin-out and listing of its ProBiotix Health division. Future growth of the company is supported by commercial agreements with large partners and a substantial pipeline of opportunities through its 2nd gen
Companies: OptiBiotix Health PLC
Companies: Warpaint London PLC
Trading continues to track ahead of expectations, which have been upgraded twice so far YTD. There is clear evidence the growth strategy is bearing fruit. Distribution gains are increasing brand reach both in the UK and overseas. This appears to be an ideal time for its on-trend value-for-money proposition to gain traction, potentially with counter-cyclical characteristics as consumers start trading down. After the recent pull-back, valuation is undemanding for a 3-yr EPS CAGR of 13% with risk p
Singer Capital Markets
Companies: ORPH STX TSTL
Belluscura has announced the launch of the next generation X-PLOR portable oxygen concentrator and expanded distribution through a D2C offering and partnership distribution plan for smaller DMEs.
Companies: Belluscura PLC
Dish of the day
Visum Technologies has joined the AQSE Growth Market. The Company's business is to own and operate an "on-ride" video and photographic camera system that it sells and/or licenses to customers (being theme parks, ride manufacturers, souvenir imaging providers, and other leisure operators).
No Leavers Today.
What’s cooking in the IPO kitchen?
Immediate acquisitions (IME.L) is to re-join AIM via a Reverse Takeover of Fiinu Holdings Limited. Once complete the Compan
Companies: VAST TSTL 7DIG AHT CMX JADE
Companies: Oxford BioDynamics PLC
No Joiners Today.
Tungsten Corp and Sensyne Health have both left AIM. Hibernia REIT has left the Main Market.
What’s cooking in the IPO kitchen?
Visum Technologies seeking admission to The AQSE Growth Market. The Company's business is to own and operate an "on-ride" video and photographic camera system that it sells and/or licenses to customers (being theme parks, ride manufacturers, souvenir imaging providers, and other leisure operators). Due 30 June.
LifeSafe Holdings, a fi
Companies: SOLI REDX POS UFO GML PHC
An update from CVS this morning covering conclusion of the CMA process, a further acquisition and update on trading. The CMA investigation into the acquisition of Quality Pet Care (QPC) is now complete, thereby bringing to an end a 9 month process. As part of the undertaking, CVS yesterday completed the sale of QPC for cash proceeds of c.£9m, implying a c.£12m impairment. Whilst the CMA episode has clearly been a setback, it does not seem to have fundamentally impaired ongoing M&A ambitions give
Companies: CVS Group plc
The strong momentum from Q4-21 has continued into H1-22, with revenues expected to be up by more than 22% YoY. The outlook remains positive supported by strong industry demand and market share gains in the UK, where the group’s sustainability and affordability credentials are increasingly resonating. Whilst some macro pressures remain, these look to be manageable. We therefore make no change to our forecasts at this stage, but are highly encouraged by current trends and remain optimistic for the
Companies: Surgical Innovations Group plc
Companies: SourceBio International Plc
A positive AGM update confirms strong revenue growth has continued YTD and further margin improvement means management again expect EBITDA to be materially ahead of expectations. The business model is now settled, with additional distributors appointed in the US which should help drive further penetration into the Primary Care market there. China revenues were strong and with no sign yet of any slowdown, despite being cognisant of renewed lockdowns there. Gross margins have remained robust on po
Companies: Circassia Group PLC