here are my notes from the agm. i know that i have missed some things here, maybe your questions will jolt my horrible ageing memory!
Vivagel:
An NDA will be submitted to the FDA using the 2012 Phase 3 data and they think that the approval should be quick due to the GAIN Act incentivising new antimicrobial agents.
The change of the FDA guidance has changed the dynamics of the Vivagel deal making. They were looking for a pan-european company with complimentary products that would become a 'marketing partner' not just a distributor. but after the FDA change global pharma companies with womens health portfolio are interested. and as such negotiations are bit complicated and they are looking for a global deal. Jackie also said that they will look to recoup R&D cost, so an upfront of $15-20mil.
Jackie said to expect a global Vivagel for BV deal in the next 'couple of months'. Confident that it'll make them cash flow positive. She also said that the point at which SPL gets paid is when they 'send the product to the partner, not when the product is sold' so that revenue will be realised pretty soon after launch.
They said they have been hitting the TGA hard to expedite the BV approval. The TGA have been very slow and both Jackie and Turvey have been in contact 'with the relevant government minister' to help speed up the process. They said they really expected approval in aus before this and had planned on having it on shelves before christmas. This is not looking likely anymore and launch will be in 2017. They also said that it will be about 4 wks from approval to launch so quite quick. product is manufactured and everything ready to go.
Dommies:
Very upbeat bout this Chinese deal. They insinuated that it may bring decent revenue. dunno how legit that is.They also talked about Ansell doing a crappy job and they are not happy with them. They might look for alternatives. They are also dont know whats up with the Japanese regulators which they described as very frustrating organisation to deal with lol.
Dep-Docetaxel:
Jackie was asked when the phase 1 will be done and she said that it depends on recruitment but she is expecting 2-3 months for topline data.
The new centre is a large teaching hospital in London. The type of cancer that they wanted to recruit more of is nsclc. they said that it was quite hard to recruit these patients in aus because of the lack of nsclc and also the competition for patients. no one asked what are the other types of cancer they were particularly interested in. they blamed the slow recruitment on the competition for patients. they said that the r&d tax incentive and low aussie dollar have resulted in a lot of big pharma doing their trials in aus.
they said that the phase 2 will begin very quickly after the phase 1. everything is in place for the phase 2 and they have already manufactured everything for it. the london centre will be a key centre for it and it sounded like will add additional centres in europe. the said that the phase 2 will cost about $6 million. they sounded like they could fund that without new cap raise but ill take that with a grain of poo.
jackie said that they will look to license it after the completion of the first part of the phase 2 or at the end of phase 2 unless a great deal is offered before.
AZ deal:
They said that we can expect 1 milestone payment this FY (jan/feb) and another one jun/jul. i was very surprised that they would provide such exact timings on the milestone payments. jackie seemed very confident of this.
they said the first product in the az deal was for this molecule that az could not get to work. they said that it was too toxic and now with dep they have got it to work. said that was pretty amazing and az were quite impressed. jackie mentioned several times that she wishes she could show us the data because it is very impressive.
the new collab agreeemnt (one announced in july) came from a meeting between jackie and the CEO of AZ (pascal). from the first meeting to signing the deal was like 7 weeks which jackie emphasised as it being really good. the deal is for an old AZ product that is about to go off patent so its 'life cycle management' strategy. they mentioned several times the importance of this as it means they can do less trials to get the product approved and the optionality of it was massive. i got the impression that this product was an anti-inflammatory drug, but i could be wrong. they used the example of abraxane as a what this strategy could mean for spl. essentially abraxane was bought for $2.9nbil in 2003. attached is a good link of what abraxane compared to taxol (the original drug) is:
http://www.medscape.com/viewarticle/465645
this is eerie close to what spl is doing with docetaxel! taxol is another taxane (paclitaxel). that company took it, removed the solvent by attaching it to a nanoparticle scaffold and improved both toxicity and efficacy. reduced neutropenia from 22% to 9% etc etc when u compare this to spl which has reduced neutropenia from ~75% to 0%. i mean $2.9bil! thats a multiple (after converting to AUD) of 16.5 of spls current market cap or a share price of $11.27
Target Dep:
said that the 2 deals are signed with 2 of the top4 antibody conjugate companies. turvy really emphasised that these partners are of the 'highest quality'. from this i inferred that 1 of them was roche and the other pzifer or az but this is just my conjecture.
they also said they wish they could show us the preclin data because it was described as 'speculator' by these partners.
they werent specific on when these will turn into licensing deals and dollars which makes me think we still 1yr away from this. more preclin trials and what not to do.
Misc:
they said that they will push dep-cabazitaxel into phase 1 early next yr and just finishing up the final preclin stuff.
dep-irinotecan will announced once the trial is finished. the reason why it was just in this presso is because its interim data from a trial that is still ongoing.
they are hiring more staff due to the increasing enquiries from pharma. they said that they are getting more interest and thus require to produce specific data to talk with partners about. i very much liked the sound of that lol
they seemed to be fairly confident that cashflows from vivagel and milestone payments will negate the need for a cap raise in the near future but once again i wont bank on that.
something that really surprised me was when jackie said that az might just buy spl out instead of paying the milestones and royalties. apparently she was told by pascal that if spl was an unit of az then they would be working on 20 products. this comment took me off guard and makes me think that there may be something in the wind around this. im not gonna bank on it tho in the short term.
In conclusion, i was very happy i flew down to melbourne for this agm. the actual presentation by jackie provided much much more detail and specifics than just the slides. i was becoming quite jaded and pissy at spl but after this i am very confident that spl will be something bloody special in the not too distant future.
