Thursday, August 03, 2017 3:47:13 PM
They have been engaged with this one for over a year, and this drug was already approved and on the market. Maybe, just maybe, earnings are helped this quarter from this?
6/25/16
https://seekingalpha.com/article/3984752-cryoports-cyrx-ceo-jerry-shelton-q4-2016-results-earnings-call-transcript
Of the 13 Phase 3 programs we are heavily engaged in commercialization discussions with six companies under commercial launch needs, the earliest of which is set to launch in late fiscal year 2017 or early fiscal year 2018. In addition, we have just signed our first commercial program with one of the largest pharmaceutical companies in America supporting a $4 billion blockbuster biologic product that is already on the market.
11/13/16
https://seekingalpha.com/article/4023349-cryoports-cyrx-ceo-jerry-shelton-q2-2017-results-earnings-call-transcript?part=single
By developing relationship with Bristol-Myers Squibb, it is of particular note. BMS is pursuing multiple drug platforms in immuno-oncology and gene-therapy treatments among others, and in there is selected CryoPort to support logistics for their cryogenic component of a commercially launched therapy. This program will craze in over coming quarters as a relevant - as the relevant quality and regulatory elements are completed. To underscore the importance of BMS, in 2015, Bristol-Myers Squibb invested $4 billion in R&D, which included the discovery and development of new medicines for patients.
We are delighted to report this relationship at a time when BMS is investing significantly in developing and producing new regenerative medicines. As I reported before, as our clients progress through clinical trial phases, we are poised to experience greater shipping volumes. As a reminder, annualized revenue to CryoPort for Phase I trials typically ranges from $15,000 to $75,000 annually; for Phase II $50,000 to $150,000; for Phase III $200,000 to $1 million, and when commercialized, we anticipate $3 million to $20 million-plus annually. The sequential increases in revenue, as they materialize, will significantly accelerate our growth.
Brian Marckx
Hi guys, and congratulations on the quarter. Very nice and great progress. Jerry, just for clarity on my end, Bristol-Myers is the large pharma client that you had referenced on prior calls. Is that right?
Jerry Shelton
Yes, that's correct. Yes.
Brian Marckx
Okay. So I didn't catch all of your comments regarding that, and I apologize. But wondering if you could just go through again what your relationship is in terms of that, and then, when you think that that will start generating revenue?
Jerry Shelton
Mark, I'm going to turn that question to you.
Mark Sawicki
Sure, happy to answer that. So what we’re seeing is we've been asked to support the cryogenic component of one of their biologic blockbuster drugs. But the exact timing of the ramp-up of that support is going to be heavily dependent on us going through their regulatory and quality approval processes. Ultimately there will be - the ramp rate will be dictated by the progress and the expediency that we can move through those processes themselves.
We are actively supporting certain aspects of the program, but it will ramp and additional components will be added as we clear these quality and regulatory hurdles.
Brian Marckx
Mark, when you talk regulatory, is it already FDA-approved?
Mark Sawicki
This product is, but any time you change any support element of an approved or a clinical program, you have to do, what is known as, a bridging study. And in that bridging study, you have to validate that any change in protocols and that support have to be consistent. And so they have to conduct those types of elements to assuage the regulatory authorities.
Brian Marckx
Okay. So you will be - CryoPort will be involved in the shipping of the product to - from where to where? Can you just help me with that?
Mark Sawicki
I can't tell you more than that at the moment. Sufficed to say, as I had mentioned, we are supporting the cryogenic component of it.
Brian Marckx
Okay.
Mark Sawicki
But I haven't been given authority to disclose anything more than that from them at the moment.
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