I thought I'd go over the last EC we had and drag out some points made back then (Nov - wow long time ago) so we may see if we get any update on these points this time around, plus any others that people want to bring up. I'm only looking to the November call because that was when management had its hands tied by OrbiMed with what they can/can't do, needing their approval on things such as spending etc so I'd have to think it was probably the closest to the truth in any EC we have had. I'll put up the comments made by the company and then add my 2 cents worth after:
"So after a lot of work on both sides, the customization phase of this lead wearable injector program with MedImmune is now nearing completion. Device production is underway and we are shipping wearable injectors to MedImmune this quarter. In addition to development and material fees already paid by MedImmune, we will begin generating revenue from the sale of these devices in the current quarter of this fiscal year"
OK so we only saw about $2.5m received from customers in the last quarter so I wonder how much of that was from sales to MedImmune, I'd like to hear that sales will be steadily climbing for this but do realise that this is for Clinical trials so no great volumes as such.
"We are also making great progress regarding the additional programs with other customers. For example, we expect to commence the shipment of wearable injector devices and related materials to various customers through fiscal 2016 for using their scheduled human clinical drug trials. We have also observed an expansion in our overall market opportunity for wearable injectors"
Great let's hear much more about these (additional to MedImmune) programs because we are in May now and Fiscal 16 is coming to an end, so we should hear that there are more clinical trials that our wearables are to be used in soon enough, if not now! I'd also like to hear of the expansion in overall opportunity but back then they could have been talking of Amgen as they did sign a Master Feasibility and Customisation agreement on December 2, 2015 after these comments - which they said was in addition to the recent agreement.
"Customer programs for the use of various products from our Unifill platform of prefilled syringes also continue to move forward. Device batches that we have shipped to customers are being used for activities including drug stability studies and fill-finish integration. Additional manufacturing lines are scheduled to be installed over the coming months that will further support the commercial rollout schedules of our customers. We expect device shipments and milestones based fees from our Unifill platform will increase as commercial ramp schedules accelerate"
OK so we should be hearing that the additional lines have been installed by now as it has been almost 7 months since the call, my understanding is two lines with approx 25m pa capacity each?, these should be validated by now one would like to think? Commercial ramp to accelerate, see next one?
"In addition, I can advice that anticipated annual unit volume requirements for one strategic customer between 2015 and 2020 have increased significantly per year compared to the original estimates. We consider this increase is not only a strong indication that customers expect our product will help to accelerate demand for their therapies, but that we are consistently executing to project timelines"
Now who would this be? I'd say Sanofi with the Finesse, so hopefully the 150m minimum is now more in the vicinity of their total sales for Lovenox, or at least their full European volumes where they are still doing OK, hopefully ROW volumes too. I'd like to hear that more lines are going in to facilitate this expected higher demand, I remember something about another 180m unit line to come mid 2016 or thereabouts and then another at the end 16 calendar year or start 2017.
"We also continue to support various pharmaceutical companies who are seeking to utilize devices from our ocular and novel platforms to deliver drugs to the eye and other products of the human body. There is an attractive mix of approved and pipeline drugs being targeted for use with our products. In most cases, anticipated commercial demand for these ocular or novel therapies will range between a few hundred thousand units and the few million units per year.
However, with typical commercial pricing for such devices ranging between $75 and $250 per unit, these platforms have the potential to generate meaningful revenue with attractive operating margins over time"
It would be great to get an update on the Ocular space at least, we had the Depot-ject announcement with unnamed Pharma back in December 2014 (an approved drug) where they said that after a 12-24 month customisation period they expected commercial availability of the device, only 7 months until the 24 months is up!
"More than the dozen pre-commercial engagements are currently at various stages of negotiation, including several supply agreements with existing and perspective customers. We may receive additional payments from customers including in some cases exclusivity or access fees upon the anticipated signing of these agreements.
In regards to AbbVie, I am pleased to provide a following update. This quarter Unilife delivered to AbbVie customized electronic reusable auto-injectors based on the LISA device platform on schedule for use in human factor studies. Unilife will recognize $1.2 million in revenue in the second quarter of fiscal 2016 from AbbVie for completion of the LISA feasibility program, in addition to payments received for earlier achieved milestones under that program.
The exclusivity period for the LISA device platform granted by Unilife under the definitive global strategic agreement signed with AbbVie on January 15, 2015, commences with Unilife's completion of the deliverables under the feasibility program. The milestones tied to the exclusive period for the Unifill Finesse prefilled syringe have also been successfully completed. The parties are also working on agreements for other delivery systems, and the relationship between Unilife and AbbVie continues to be strong"
So we have a very strong relationship with AbbVie and I'd like to hear that this continues to be the case, remembering that there is a time limit set now for a supply agreement after the delivery of the AI's to AbbVie - well I'm hoping that this is still the case of course and would love to hear as such!
Keith Markey
Just wondering, when you complete the deliverables, meaning I assume the shipment of the LISA automatic injector, does that set a time limit start ticking for the signing of a supply agreement with AbbVie? And if so what would be the timing on that?
Ramin Mojdeh
The answer to that is, yes, it does. I can't specify what that time limit is, but there is a time limit for the exclusivity. Within that time period, we anticipate to negotiate that deal with AbbVie.
So anyway these are just a few things I thought I'd throw up and out there. Obviously an update on expected volumes through calendar 2016 and then 2017 onwards would be great for each platform, it doesn't need to have breakdowns or exactly who it's all for just expected total prefills, AI's (maybe), wearables etc would be great. Then obvious cash management etc etc. How much we get who knows, I know pharma don't want specific launch plans revealed but there are ways it can be communicated by blending in all wearable volumes for multiple customers and all syringe volumes for multiple etc etc.
I am actually looking forward to hearing from these two guys as I have met them both and they are highly impressive. I have heard in recent times that both new management, and old, really rate these guys as they are the ones in the thick of it all dealing directly with pharma and landing deals etc. Have a look at Ian Hanson who initiated and led the wearables development and Mike Ratigan leading Unilife into multiple strategic collaborations!
Ian Hanson, Senior Vice President and General Manager of Unilife's Wearable Injector and Auto Injector business unit, joined Unilife in 2011 from Medtronic Diabetes, where he held senior leadership roles in the development and commercialization of insulin delivery devices and diabetes management systems. At Unilife, Mr. Hanson initiated and led the development of Unilife’s industry-leading wearable injector platform and team.
Michael Ratigan, Senior Vice President and Chief Commercial Officer, joined Unilife in 2011 from Becton Dickinson where he was a global commercial leader for Self-Injection Systems and also led commercial efforts for Pre-Filled Syringes in the North American market. Since joining Unilife Mr. Ratigan has led Unilife’s commercial efforts, including the entry into multiple strategic collaborations with leading pharmaceutical and biopharmaceutical companies.
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