Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on Crossject. We currently have 14 research reports from 2 professional analysts.
Crossject recently announced that it has received regulatory approval to launch the bioequivalence study for Zeneo Midazolam (being developed for the acute treatment of epileptic seizures) in healthy volunteers. This puts the company on track for the expected H218 EU filing and the H119 US filing. Due to this milestone, Crossject has received €2.9m from Bpifrance as part of the Programme des Investissements d’Avenir (PIAVE). Also, the company has successfully completed a €5m rights offering.
The capital increase was 137% subscribed, raising the group equity by some €4.98m gross after the exercise of the 15% extension clause.
We have not changed our assumptions and the apparent higher EPS only stems from the fact the company is still loss-making (thus the loss per share is lower after the capital increase).
Crossject released its FY16 results. Revenues reached €1.43m vs €2.73m in FY15 (-48%), operating result €-7,291k (vs €-7,013k), and the net result €-6,663k (vs €-5,687k). Net cash at the end of FY16 amounted to €2.6m (vs €5.2m a year before). The company also announced a capital increase (€4.3m at €4.5 per share with subscription rights), which is 75% underwritten by the main shareholder, Gemmes Ventures.
As part of its revised strategic plan, Crossject has expanded its partnership with CENEXI to fill and finish all of Crossject’s products in all regions for a period of five years, with a potential extension up to 10 years. Also, the timelines for its expected regulatory submissions have shifted across the board; most notably, the EU filing for ZENEO Methotrexate has been pushed back from H216 to H218 due to its non-emergency nature and higher requirement for manufacturing resources than other products. As a result, we reduce our valuation to €9.91 per share (from €12.07).
A strategic review… and some adjustments to our forecasts TARGET CHANGE CHANGE IN TARGET PRICE€ 19.3 vs 24.4 -21.0% Our target price goes down, mainly due to the lower DCF valuation after the group presented its new strategy in mid-november, which is based on a focus on emergency products, the US and a larger agreement with Cenexi, which should spend over €5m to bring total capacities to over 10m units a year (vs 2m). Timing remains the main issue and is of course the first reason behind our lower valuation, which also captures the disappointment after the group postponed again the market launch of Zeneo, by at least a year (2019 at the earliest vs late 2017 previously). CHANGE IN EPS2016 : € -0.90 vs -0.90 2017 : € -0.50 vs -0.36 ns Our EPS goes marginally down for FY17, where we initially had the first revenues stemming from Methotrexate, which are now postponed to FY19. Other than this, we have not changed our short–term forecasts. CHANGE IN NAV€ 24.5 vs 28.7 -14.7% Our SOTP valuation also goes down, since it is computed on average sales over the first year after each product reaches the market (FY19-21). In particular, sales are lower per product since US sales will typically come a year after first European sales, while average prices are higher in the US, explaining the bulk of the lower valuation obtained through this method, which leads to very similar results to the DCF. CHANGE IN DCF€ 23.0 vs 31.6 -27.2% We have revised our forecasts, based on later-than-expected product launches (with, for each product, a first launch in Europe and a year later in the US). We have also lowered the level of capex from 2017 onwards, since the bulk of capex will be spent by Cenexi, the group’s global industrial partner. We have so far considered that the level of margins is unchanged compared to the scenario where Crossject was investing and producing Zeneo devices instead of subcontracting. Our valuation, unsurprisingly, goes down, in line with our view that timing is the biggest issue the group currently has to face and despite a lower future capex level.
Crossject held a presentation at the end of last week to disclose its new strategy, in particular in the light of its extended patnership with Cenexi.
Crossject released H1 16 results. Revenues reached €1.6m vs €1,238k in H1 15 (+29%), the operating result was €-2,279k (vs €-3,765k), and the net result €-2,831k (vs €-3,558k). Net cash at the end of H1 16 amounted to €3.2m (€5.2m).
Mylan’s EpiPen was subject to fierce criticism from politicians including “President-to-be” Hillary Clinton after the generics maker raised the price of its emergency allergy injector by some 500% (!) in the past five years to over US$300 per unit (i.e. over US$600 for a pack of two, sold for €76 in France for instance).
Recently, Crossject disclosed the identity of the product behind its L15 programme. L15 is its needle-free version of hydrocortisone, which Crossject will develop for the treatment of acute adrenal insufficiency, a potentially fatal condition. The company expects the commercial launch of the product in H118, although we believe peak sales will be a modest €9m as it is a niche market with little pricing power.
Crossject has developed a deep pipeline of products that are based on its proprietary needle-free injection system, ZENEO, across a variety of indications. The benefits of ZENEO include no need for needles, as well as a simple and quick (~1/10th of a second) delivery of the drug. Its first commercial product, ZENEO Methotrexate for rheumatoid arthritis, should reach the market in 2017. We value the company at €11.96 per share, which is based on the value of four of its nearer-term disclosed programmes.
Crossject develops proprietary versions of generic drugs to be used with its needle-free injection system, ZENEO, a drug delivery and manufacturing platform for multiple potential products, including biologics and vaccines. Crossject's needle-free, pre-filled, single-use ZENEO injection systems are designed to be self-administered and can be tailored to deliver drugs via intradermal, subcutaneous and intramuscular routes, allowing the system to be used in a broad range of indications. A 2014 study by the University of Texas showed that fewer than 20% of patients used their epipens correctly. ZENEO has been successfully tested in more than 10,000 humans, including seven preclinical and eight clinical trials. Crossject has seven products in development including products for rheumatoid arthritis, anaphylactic shock, migraine, Parkinson’s and epileptic seizures.
Recommendation and upside We initiate coverage of Crossject, a new entrant in the New Therapeutic Entities field. Its differentiating feature is its delivery mechanism, Zeneo, a pretty unique injection system. Crossject has completed clinical trials on a first well-known molecule, Methotrexate, with another six to go in the pipeline. The current market capitalisation stands at c. €50m based on a share price of €7.5, while we see a massive potential upside (over 220%), with a target price of €24.5, reflecting the company’s huge growth prospects. Business and Trend Today, Crossject has a portfolio of seven products under development: Methotrexate (anti-rheumatic), Sumatriptan (acute migraine), Epinephrin (treatment of anaphylactic shocks), Naloxone (opioid overdoses), Apomorphine (Parkinson disease) Midazolam (epilepsy) and L15 (name and indication confidential). The first sales are expected in FY17 (Methotrexate in H2, with clinical studies already done), while clinical studies are currently being carried out for Sumatriptan, which should get market approval and be commercially launched in H1 18 as well as for L15, while Midazolam should be filed in H2 17 for a market launch in FY18. Epinephrin should be on shelves in FY18 and Apomorphine a year later together with Naloxone. Based on our estimates, Crossject should be able to generate total turnover of over €190m as soon as 2021, which should breakdown as follows: Need to know Zeneo, an automatic, single-use needle-free injection device was orginally developed within Laboratoires Fournier in its « drug delivery » division, together with SNPE (Société Nationale des Poudres et Explosifs, which is a shareholder of Crossject). In 2001, the technology was sold to the newly-created Crossject. GSK was originally the main partner of Crossject, with a view to developing a solution for its vaccines. This market was ultimately considered as too risky in terms of investment needs, low margins and the high volumes required. Therefore, Crossject was restructured in 2011-13, with a change in the group’s strategy: the goal of Crossject is no longer to sell a device to the Big Pharmas to market their own chemical entities, but to provide the market with its own pre-filled devices, on the basis of New Therapeutic Entities, using a known drug (generic) with an innovative delivery system. New industrial partnerships were also signed with Hirtenberger (for the pyrotechnical and mechanical sides) and Cenexi (aseptic filling and final packaking). Today, the Zeneo device is protected by over 400 patents covering 80% of the market (including the US, Europe and Japan) valid until 2035.
Crossject develops new therapeutic entities (proprietary versions of generic drugs) to be used with its needle-free injection system, ZENEO. ZENEO is a drug delivery and manufacturing platform for multiple potential products, including biologics and vaccines, and has the potential to improve therapeutic delivery, safety, patient compliance and comfort for many conditions. In November, Crossject received a €6.7m grant to expand development and manufacturing capabilities to include new ZENEO products for drug overdose, Parkinson’s disease and epileptic seizures.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Crossject. We currently have 14 research reports from 2 professional analysts.
CyanConnode* (CYAN): Leader of the narrowband (CORP) | Ideagen* (IDEA): Consistent strength in delivery (CORP) | K3 Capital* (K3C): Director changes (CORP) | Lighthouse Group* (LGT): Trading update (CORP) | Somero Enterprises* (SOM): Strong June trading shows a pick-up in US market activity and affirms FY forecasts (CORP) | Castleton Technology* (CTP): Solid prelims (CORP) | Cello (CLL): Strengthening the offer in Health (BUY) | dotDigital* (DOTD): Yet again – positive trading update (CORP) | Allergy Therapeutics* (AGY): FY trading update drives 7% upgrade (BUY)
Companies: CYAN IDEA K3C LGT SOM CTP CLL DOTD AGY
The AIM market turned twenty-two in June and it is fair to say it has had its fair share of difficultiesH1 2017 saw a further net loss of constituents and we ask what will the rest of 2017 hold in store. Arguably the stability of the UK government, Brexit and the shift in global monetary policy will be the biggest themes for the remainder of the year.
Companies: IDP PEG AMYT SOU EVRH TST VANL W7L G4M
Tristel* (TSTL): Trading update drives upgrades (CORP) | Cello (CLL): On track and investing for growth (BUY) | The People’s Operator* (TPOP): Board changes (CORP) | Tax Systems* (TAX): Trading update: on track (CORP)
Companies: TSTL CLL TPOP TAX
Since its inception in 2010, the Panmure Gordon Conviction List has outperformed the market, returning 284% against a Small Companies index that would have returned 221% over the same period.
Companies: ALD AVON CTH GKN HVN HCM INF NOG OTB POLY SNR SQS STJ
Quiz—Sch 1 from the omni-channel and international own brand in the women's value fast fashion sector. Offer TBA. Expected late July. Last year Quiz posted sales of £87.4m while pre-tax profits grew by 17pc to £5.7m | Arena Events Group -provider of temporary physical structures, seating, ice rinks, furniture and interiors. Raising £60m. Mkt cap £63m. Expected on the Chef’s birthday. 25th July. | Altus Strategies—African focused natural resource Company. Offer TBC. Expected Mid July. | Harvey Nash Group— Provider of professional recruitment and offshore solutions moving to AIM from Main. No capital to be raised. Mkt Cap c. £57.8m. | AnimalCare—RTO of Ecuphar NV, a European animal health company. £30m raise. Ecuphar FY16 rev £68.4m, underlying EBITDA £8.9m. Due 13 July. | NEXUS Infrastructure—£35m vendor sale. Mkt cap £70.5m. Provider of essential infrastructure services to the UK housebuilding and commercial sectors. Expected 11 July. FYSep16 rev £135.7m. | Greencoat Renewables - Schedule 1. Targeting a portfolio of operating renewable electricity generation assets, initially investing in wind generation assets in Ireland. Offer TBC. Due Mid July. | I3 Energy –Schedule 1 Update. Independent oil and gas company with assets and operations in the UK. Offer TBC, Mid July admission. | Verditek— Sch 1 update. The Company's subsidiaries will be involved in advanced solar photovoltaic, filtration and absorption technologies specialising in providing environmental services. Issue price 10p. Admission late June | Rockpool Acquisitions—Northern Ireland based Company seeking strong NI acquisition with an international outlook. Raising £1.5m at 10p. Due 5 July. | Hipgnosis Songs Fund investment company offering pure-play exposure to Songs and associated musical intellectual property rights. Prospectus yet to be published. | Impact Investment Trust—Exposure to a diversified portfolio of funds providing SMEs across developing economies with the growth capital they need to have a positive impact on the lives of the world's poorer populations. Raising up to $150m at $1.00 | Residential Secure Income - social housing REIT raising up to £300m Admission due c.12 July. | Curzon Energy—Report on Proactive Investors of intended LSE float this year with acquisition of coal bed methane assets in Oregon. Looking to raise £3m plus. | NLB Group—financial and banking institution based in Slovenia, with a network of 356 branches. Seeking Ljubliana Stock Exchange listing with GDRs on the LSE. Expected mid June. | Kuwait Energy— has not been able to complete its initial public offering as announced in its Intention To Float of 3 May 2017. However, in light of positive feedback from potential investors, the Company remains committed to obtaining a London listing and continues to explore its options. | Supermarket Income REIT– Up to £200m raise to acquire a diversified portfolio of supermarket real estate assets in the UK, providing long-term RPI-linked income. Due 21 July.
Companies: EOG MERC EHP DTG FLK AGQ HAYD PROX ADT OPP
Abzena (ABZA LN) Licence agreement for Abzena’s PSMA antibodies | Clinigen Group (CLIN LN) Fully year update reassuringly in line | dotdigital Group (DOTD LN) Accelerating growth in H2 with strong cash generation | Midatech Pharma (MTPH LN) H1 trading update in line with expectations | NCC Group (NCC LN) Evolution rather than revolution | Scapa Group (SCPA LN) Q1 trading in line | Vernalis (VER LN) Trading update highlights increasing Tuzistra® XR prescriptions
Companies: VER SCPA DOTD SFE CLIN ABZA NCC MTPH
accesso Technology (ACSO LN) TE2 accelerates growth, but does not materially benefit EPS until FY19 | Alliance Pharma (APH LN) In line update; Diclectin UK approval expected Q3 | Cello Group (CLL LN) Trading update | City of London Investment Group (CLIG LN) FuM +7% in Q4, modest positive earnings surprise, better final dividend | Clinigen Group (CLIN LN) Clinigen Group (CLIN LN) | Horizon Discovery Group (HZD LN) Synergistic acquisition and proposed placing | Renold (RNO LN) AGM trading update reiterating expectations for FY18
Companies: CLL CLIG RNO CLIN HZD APH
Having reiterated our Buy on weakness around the interims in March we are delighted with the share price performance since and the confirmation today that all three divisions had a good year. We will revisit our numbers and target price in due course but do not expect to change the former much at this stage. Having now exceeded our TP we will move back to Hold in the short term pending further analysis, but we remain fundamentally very positive on the Clinigen story with multiple growth opportunities both organic and acquisitive.
Companies: Clinigen Group
Allergy Therapeutics has released a strong trading update for the year, building on the tremendous double digit growth as seen at interims, reporting that revenues for the full-year are expected to be ahead of market expectations at £64.1m (2016: £48.5m), ahead of our previous £61.8m estimate. This represents a rate of +15% annual growth on a constant currency basis and +32% reported. A solid performance, upgrades to our revenue estimates and continued market share gains reinforce our Buy recommendation.
Companies: Allergy Therapeutics
Vernalis has provided a year-end trading and operational update ahead of its FY17 results due to be announced on 12 September. Total revenues are expected to be ahead of current market expectations, largely due to higher than anticipated R&D-related milestones. This and tighter cost control means that operating loss for the full year is expected to be lower than consensus estimates. In terms of prescription (Rx) growth, Tuzistra XR continued its steady growth in volumes y-o-y; reported net revenue will depend on the impact of rebates and vouchers on gross revenues for the year. Our valuation remains unchanged at £399m (76p per share).
The QCA, which campaigns for smaller quoted companies, says that the latest MIFID II policy statement by the Financial Conduct Authority (FCA) will enable smaller companies to continue to commission research that can be distributed to fund managers for free. This will include when a smaller company is raising additional cash in order to finance growth. There were worries that the EU’s MIFID II directive could have made it more difficult to make small company research available to investors.
Companies: MLIN RHL ANCR EVG AUTG RLD
OptiBiotix* (OPTI): LP-LDL supply agreement for NZ / Australia (CORP) | Elecosoft* (ELCO): H1 in line with expectations (CORP)
Companies: Optibiotix Health Elecosoft
One golden rule of investing is not to ‘count chickens’. A prudent view that we’ve adopted when modelling Tristel’s application to the EPA/FDA to launch chlorine dioxide (Clo2) based infection, hygiene and contamination control products in the US. Whilst our approach is admirable, there is nonetheless a danger of us being too conservative for too long. Especially when, in Tristel’s case, the opportunity of accessing the world’s biggest healthcare market is now almost within striking distance.
This morning’s trading update highlights that total revenues are expected to be ahead of current market expectations, principally as a result of larger than expected research milestones. The YoY growth in Tuzistra® XR prescriptions remains on a positive trajectory. We continue to look forward to further regulatory updates on CCP-07 (following the non-approval decision by the FDA in April), the expected approval decision for CCP-08 (PDUFA) by 4th August, and the two sets of proof-of-concept data (CCP-05 and CCP-06) expected later this year. However, we maintain a cautious view on the medium-term sales potential of the cough cold franchise, primarily due to its promotion sensitive nature.
As we approach 3rd January 2018 and the coming into force of the MiFID II legislation which changes the landscape for research, we are beginning to see some of the practical implications and complications. Brokers are in the early stages of working out how to structure charging for research, asset managers have already begun cutting their brokers’ lists and a model code of conduct for Research Payment Accounts for institutions has been published.
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