 Interesting- a sceptic would think they've cobbled together acquisitions to mitigate the revenue shortfall (not sure how practical that is in a relatively short space of time)
Cavendish
"hVIVO has announced the €10m cash acquisition of two Clinical Research Units of CRS, an early-phase CRO based in Germany, which will expand the company’s footprint in Europe and is the first step in the company’s M&A strategy of combining acquisitive and organic growth to deliver on its ambition of £100m revenues by 2028. While early phase trials offer typically lower EBITDA margins vs hVIVO’s existing HCT platform, we believe the deal offers pipeline and customer diversification, with business opportunities in indication areas highly complementary to the current operation. Meanwhile, the company’s FY24 trading update sees the group expecting to report record revenues of £62.7m, ahead of our estimate of £62.0m, with EBITDA margin of 26% also ahead of our 24.4% estimate. Year-end cash of £44.2m (our estimate £45.1m) provides balance sheet strength, not only to accommodate the CRS deal but also the longer-term ambitions for organic growth plus M&A. We update our forecasts, noting the combined group will be looking to “mid-high teens” EBITDA and introduce a new target price of 35p (prev. 42p), equivalent to c.15.9x FY25E EV/EBITDA, falling to 11.0x FY26E."
"Updated guidance: Given the enlarged base of the company, management has issued FY25 revenue guidance of £73m with full-year EBITDA margins anticipated to be “mid-high teens” (excluding one- off costs). While this implies that hVIVO has not been immune to the challenges of the wider biopharma spending backdrop in recent months, we believe the long-term opportunity remains compelling. We update forecasts and our new target price – underpinned by DCF – of 35p represents c.15.9x FY25E EV/EBITDA, falling to 11.0x FY26E, which we consider as an excellent entry point for investors and offers compelling value. " |
It's really a bit of a profit warning underlying, Inaminute. If you strip out the new acquisition, the guidance is pretty weak for 2025
£73m of revenues, but with probably £15m of the new acquisition in there, so maybe £58m excluding that, which is down on £62.7m in 2024.
£58m compares to consensus of £68m, so a £10m miss.
If you say a 17% EBITDA margin, then you're talking guidance now of about £12.4m. Even with the acquisition where they'll be excluding integration costs, that's a miss against consensus at £15.9m
A 23% miss on EBITDA. It doesn't really look like this is just the acquisition, the core business guidance is well below what analysts were expecting.
Eric |
Large cut in Cavendish forecasts - prior to today they were forecasting £67.4m rev for FY25 with Adj. EBITDA of £16.1m. After the €10m acquisition they are now forecasting £73.2m rev with £11.7m Adj. EBITDA.
You wouldn't have a clue about the above from reading today's releases...
Price target cut by 7p to 35p. |
https://www.londonstockexchange.com/news-article/HVO/acquisition-two-clinical-research-units-from-crs/16874136 |
Phase 3 trials
Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.
Phase III
Phase III studies are conducted at multiple centers with several hundred to several thousand patients for whom the drug is intended. Massive testing of a drug provides continued generation of data on a drug's safety and efficacy. As in Phase II, most Phase III studies are randomized and blinded.
Phase III trials provide the bulk of information needed for the package insert and labeling of a medicine, after it has been FDA approved.
A drug in this phase can be studied for several years and may be one of 25-30 percent that pass Phases I, II and III. Once a Phase III study is completed, a pharmaceutical company can request FDA approval to market the drug. This is called a New Drug Application (NDA). The NDA contains all the scientific data that the company has gathered throughout the phases in all trials.
Sam |
Some breaking news..........RFK Jnr not anti vaccine? I thought this had halved because of his potential appointment.......interesting times |
PR on Proactive brown-nosers as well as Vox.
Must be a raging buy then. |
Pierre
"If anyone has a more informed view than my informed guess, could they explain further? (Dr Bio?)"
Obviously only an answer from a mate will do.
Why not ask him directly? |
 Chica, thx, but it didn't answer my question which was about the bed situation given often 10k people are needed for phase 3.
I think I've worked it out, but not certain. Anyone know better?
All the beds HVO has will be occupied by volunteers, who will all get a jab infecting them with whooping cough. A few days later the infections will be confirmed and they'll be jabbed with the new treatment drug. They'll all be tested again for whooping cough several times over the next days and weeks. The data collected will be enough to show/not show the efficacy of the candidate drug - how well it works , how long it takes etc etc. All this time will obviously be spent in isolation in hvo's beds.
In parallel, there's a safety phase 3 going on, not managed by hvo, which afaics, needs hundreds of people, similar to traditional phase 3. I think (but not sure) the numbers out in the population may be much less than traditionally (due to hvo's contribution).
If anyone has a more informed view than my informed guess, could they explain further? (Dr Bio?)
The main thing if this is all correct means hvo's beds are occupied 24/7 for 1/2/3 weeks. Maybe for several repetitions. |
HVO featured in the Irish Times https://www.irishtimes.com/business/2025/01/27/hvivo-to-tackle-whooping-cough-with-its-biggest-ever-human-trial/ |
There will be 2 trials running side by side.
Hvivo will be running the efficacy of the potential vaccine.
Emmes Group will be running the safety of the potential candidate.
From 2:10
hxxps://www.businesswire.com/news/home/20240624899218/en/ILiAD-Biotechnologies-Announces-Planned-Collaboration-with-Emmes-Group-a-New-Mountain-Capital-Portfolio-Company-to-Conduct-Upcoming-Phase-III-Clinical-Trials-of-BPZE1-the-Leading-Next-Generation-Pertussis-Vaccine
From LSE forum |
Expect another jump when the contract from the loi is signed, and that's a 99% probability.Could someone explain the bed situation for phase 3, where iirc, thousands or tens of thousands of subjects are traditionally needed. How is that cut down to 100/200 in a CS? |
HVO CEO spoke with @proactive_UK on the LOI signed with ILiAD Biotechologies for a pivotal phase 3 human challenge trial to assess their whooping cough #vaccine candidate:? World first pivotal Phase 3 Bordetella pertussis HCT? Expanding hVIVO's human challenge model portfolio? Whooping cough unmet medical needhttps://www.youtube.com/watch?v=k6KJwdw3NaI |
The lack of comment from the usual rampers is a red flag in itself.
sikhthetech - 21 Jan 2025 - 15:02:32 - 9210 of 9228 hVIVO plc - HVO
<...>
Really!!
They're diversifying because revenue from core services has declined.
They announced a £16m contract 13 months ago, when the company was being talked up.
Given they had record visibility into 2025 and now this contract also expected to be recognised in 2025, you'd expect their fy2025 revenue expectation to significantly higher than fy2024 of £62m, wouldn't you?.
Where's the £40m of contracts they mentioned, last summer? |
Still awaiting proper trading update that isn’t ‘comfortable with’ or ‘good visibility’. |
Sikh - I have read your negative posts here for so long that I had to register and say ‘Please stop posting - even in the face of what could be (I said could be) you have nothing but negativity’
Just leave it alone |
It's a Letter of Intent...
They don't know the value only EXPECTED to be....You would expect them to either publish the value or make no mention of it.
Announced just before the CEO's huge options are due to start to exercise.
Announced just few weeks before the fy2024 TU!! Previous fy TU published in January but was put back this year!!
Coincidence? |
I am guessing upto £30 million revenue. A challenge study plus model for a Phase 2 trial is over £15 million Phase 3 is larger, more volunteers which is the main cost due to beds, payment, lab services etc, plus its a higher value phase with commercialisation coming if it passes hence my estimate. Its just a bigger version of a phase 2 trail basically. |
The biggest thing to me is that the US regulatory bodies have given approval for a phase 3 challenge study. If all goes well the floodgates will be open.What a benefit to mankind if the drug works. Not that that cuts the mustard with most here.Same old, beds probably fully occupied again in the bigger facility. Anyone done the maths of the revenue and profit for hvo? |
HVO have a letter of intent for a Phase 3 trial of a whooping cough vaccine. This is big news as previously only Phase 2 trails have been done by HVO but now they clearly have been given authorisation to do Phase 3. Phase 3 trails are normally very expensive and time consuming for pharma companies as they have to get a large group of people to vacinate in an area where the disease is prevalent, not easy to find, and monitor them for upto a year. Challenge studies, which HVO is the world leader in by a country mile, means volunteers are kept in isolation and given a safe does of the disease after having been given the vaccine hence the trial is cheaper but crucially very quick, a few months till results are known at most. This is a whole new opportunity for HVO. Phase 3 trials can cost upto £100 million HVO charge £10+ million for a Challenge study. For a phase 3 one they will charge more but even at twice or three times the price it’s a bargain for a pharma and saves huge amounts of time which in the end is money.
So where would you go for a Phase 3 trial, to an expensive time consuming field trials company or a isolation unit based cheaper and quicker challenge trials company. Obviously a company for those that have investment horizons of more than a few days but it is a money making dividend paying company and clearly undervalued. |
Me too..The Phase 3 trial could be the difference here going down the road.
We'll see
Was surprised I could pick up a good chunk just over 20p |
Phase 3 trial, whole new market! Much larger fees as well for Phase 3. This company keeps getting better. |
A potentially whopping whooping contract....
Be nice to get some figures though
Big Mo seems pleased
hxxps://www.voxmarkets.co.uk/articles/addressing-the-rising-threat-of-whooping-cough-015b17f/ |
- “the biggest human Trial Study in the history of the Company” says a lot and it is a Phase III trial which is also significant as if the challenge study proves positive for iLiad they could have saved several years in time to market launch and others will take note. On a forward PE of just 11 and PEG ratio of 0.7 with cash of £37 million it is time to get back in which I have done this morning. |
Well its really good to know that Iliad has raised $100mln. Wtf?
Is this a freebie largest ever hct ?
An LOI is non-binding so why announce? |
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