Member Info for Ivyspivey

Yes met the guy st the AGM.They are covering ROW and is on different timeline to US given the EMA Approval proces

Not in here but I/v with Pharma Times

http://www.pharmatimes.com/magazine/2018/september_2018/smartpeople_lisa_anson

The one from 21st Aug is not listed on LSE site but here it is.

https://www.motifbio.com/news/motif-bio-notes-statement-from-amphion-innovations-3/

Yes ODR there is tha.
All have a good day.Off to watch the Spurs game tonight so probably need a nice RNS here in the morning to improve my mood lol

Few interesting bits Re TCR

http://www.pharmatimes.com/magazine/2018/september_2018/company_focus_adaptimmune

Oh now have my permission to slap me for posting on the wrong boards.This is the 2nd time I have done this Sorry

Useful background in this space

http://www.pharmatimes.com/magazine/2018/september_2018/company_focus_adaptimmune

I have looked again at this from 2015 produced in conjunction with MTFB and was used by Invesco in 2015 to originally invest in 2015.

The peak sales of Iclaprim ( based on them commercialising in US themselves) for ABSSSI only were $310m and the global total for ABSSSI was $582m.
For HABP the global peak sales of Iclaprim are $276m.

Things have obviously changed since then so you have to take that into account but the major change was the extra 9 years patent protection of the optimal dose of Iclaprim. So if for eg in 2029 sakes of Iclaprim are still near their peak levels then normally the introduction of generic competition in 2029 would reduce sales in subsequent years down to 10 or 20% of previous level hence the patent cliff effect.
But now the extra patent protection has been given then you can possibly maintain a very high level of Iclaprim sales for a further 9 years.
When you are calculating deals and the value and attractiveness of Iclaprim then this is of major significance imo but as I keep on saying we will get major clues to firm up this value in the next few months

Evening Laggan,,
Agree that the reason why Company’s claim a high cost of bringing a new product to market(when I was doing my Corporate presentations for Merck they used a figure of $1.5bn) is principally due to R&D cost and associated risk.
As for predicting sales forecasts yes it is both set and science but all pharma as you know will have 5 year plans with sales forecasts based exactly on the criteria like size of target market/ predicted market share and likely cost of treatment.
Obviously the short term forecasts are more likely to be accurate so 2019 and 2020 but all these figures are consistent with the original equity research numbers produced by MTFB and consistent with the numbers of TMs etc that GL has said we’re in the original plan.
I have deliberately tried to steer away from when peak sales would occur and whether it is 2023/4/5/6 is immaterial and is heavily dependent on who is chosen as the US partner.
We are all speculating on likely numbers and it is based on incomplete information as I have already posted until we know the Commercial plan But Zacks would have produced their thoughts in line with what MTFB anticipate.
Even if peak sales are only in order of $250m pa in US ABSSSI and that is only about 80k patients say peaking in 2025 then it is still likely that cumulative sales will be in order of $2-2.5bn plus ROW and then the HABP sales.
As I reiterate as we get to know more bits of info in the coming months then we can firm up on these numbers but again think we are agreed that we are seriously undervalued here.
You can see from the cost of sales estimates that the profit margins on Iclaprim will be substantial and that the PGM will be very attractive to potential partners.
Like you I am of the opinion that the current most likely option in US is with a Company who is already revenue generating and with complementary therapeutic products.
However there is still the possibility of a global deal and that could be a real game changer but we still have to see how this will play out but the clues will be there imo

Puddy if this comes good I will be your wingman.
The only thing guaranteed to be free is the advice my wife will give me if this fails to provide a nice return.

Puddy think you had all your Xmas presents at your works do a couple of years back at that Club.
You did not expect more from Zaza like the rest of us

A reminder from 2012 of how much it can cost to bring a new drug to market.
$4bn on average and yes you can argue with that figure but gives a good indication of how much a drug like a Iclaprim could be worth and how attractive it may be to potential partners.
Not bad for a Company like MTFB with less than 10 permanent employees and current market cap.

https://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/

Morning Sheltie,
Would guess $100m more like 2021 and would expect peak sales to be 2023/24.
Think Hannibal’s 3-4 years are a fair estimate but that would normally be with a much bigger commercial operation do may take a smaller Company a bit longer.
Still think many are missing the big points.To get true value it is not mainly about when they will make a profit as until the HABP Trial is finished may take a while to break even.
You can get a pretty fair idea of how much they will sell and the timeline BUT this needs to be fully understood.
1.The Zacks numbers are very conservative ie 20% of 3.6m patients with ABSSSI with renal impairment rather than the normally accepted 26%.
2.It takes no account of other indications outside of the main target market such as use either as montherapy or in
Combo vs drug resistant strains.
3.All about proof of concept so once the patient treatment cost of $3k and the e o o IC model is proven to work the numbers are more about the level of commercial support.
4.Until we know the exact commercial option and/or choice of partner and the exact labelling the figures are going to be very conservative.
5.Lastly and probably the main point the true Value of MTFB which is largely determined by Iclaprim in ABSSSI ATM is based on cumulative sales and the number of years of patent/QIDP protection this could easily be in order of $4-5bn in ABSSSI in US alone.
This will be what determines the value of the deal and makes it potentially so attractive to potential partners.
Again as we move through the next few months we should be able to firm up on several of these assumptions and get a pretty good prognostic indicator for the way ahead.
ATB

Hi Rebarm,
These figures imo would largely have come from MTFB estimates.I know that some will only focus on estimated revenues in 2019 and 2020 but you need to see the bigger picture.
Also think the point about no AdComm request so far is an extra little bit of layering in terms of Approval of Iclaprim.That plus the comment from GL about they are ready to answer any FDA questions during the next 6 montys would lead me to the probability that an AdComm will not be required but no worries if it as swing the pooled data from the Revive trials allays any concerns

FYI.when trying to calculate the value of Iclaprim for any deal you try and ascertain the cumulative sales over the period it is protected from potential generic competitors.
So up to 10 years from Approval for each separate indication so for ABSSSI until 2029 under QIDP then an extra 8 or 9 years protection on last Approved patients at fixed 80 mg dose.so 2037.
Same logic behind HABP.
So even if peak sales for ABSSSI in US is not for several years and Zacks are saying potentially $500m per year.
You can see what cumulative total will be.
Then add in $225m peak from ROW for ABSSSI and then all the HABP and see the kind of rewards and valuations that can be placed here.

Hi Sheltie,
That is therir figure for now so similar to U.K. broker estimates.
Real value in report is firstly odds on an AdComm meeting are less so shows FDA are less likely not to Approve.
However still time to call one but should be straightforward anyway.
Also projected leak sales and profit margins look very good with extended patent protection.
Yes it may take some time for this to come to fruition but if a global deal or buy out then this is wherevthese numbers are huge.
Also will largely determine US deal.
Looking at cost of sales on future reinforces view that NTFB are going to partner in US and not go it alone and these figures eoukd be based on MTFB estinates

Sorry wrong board and had not realised
Too much moving between twitter and here and barking dogs.
Wrists slapped

http://s1.q4cdn.com/460208960/files/News/2018/Zacks_SCR_Research_08212018_MTFB_Bautz.pdf

Conclusion
We’re glad to see that the FDA has accepted the NDA filing for iclaprim and that a PDUFA data of Feb. 13, 2019 has been assigned. The FDA has not indicated that an advisory committee (“AdComm”) meeting will be taking place for iclaprim, but it is not inconceivable that one will end up being scheduled. However, with the strong data from both REVIVE-1 and REVIVE-2, we don’t believe that an AdComm, were it to take place, would be a negative.
There are an estimated 3.6 million people hospitalized with ABSSSI every year. We conservatively estimate that 20% of patients have renal insufficiency, based on published data (Halilovic et al., 2012). We believe iclaprim could attain peak market share among these patients of 20%. We model for a full course of treatment costing $3000 and an inflation rate of 2%, which leads to peak sales of approximately $500 million in the U.S. Outside the U.S., we believe Motif will sign a commercialization agreement that will result in an average 15% royalty on net sales, which we estimate will peak at approximately $225 million. Using a 90% probability of approval and a 15% discount rate leads to a net present value for iclaprim in ABSSSI of $475 million. After factoring in the company’s cash position, potential cash from the exercise of outstanding warrants, and dividing by the fully diluted ADS share count of 18.6 million leads to a valuation of $28 per share. The stock continues to trade at a significant discount to our valuation, thus offering investors plenty of upside at the current price.

Will be best current estimate of potential sales.

http://s1.q4cdn.com/460208960/files/News/2018/Zacks_SCR_Research_08212018_MTFB_Bautz.pdf