Sls
Yeah that would be helpful, but they disclose some of their clients and trial info on their Twitter feed.
With regard to near-term commercialization; this is from the Q1 conference call:
“The industry anticipates several commercial filings and/or launches during the current year, which include Kite’s KTE-C19, Spark Therapeutics’ Voretigene Neparvovec, Novartis’ CTL-019, TiGenix’s Cx601, and Kiadis Pharma’s ATIR101, many of which Cryoport is actively supporting. . .
We are now actively supporting one commercial program; have been selected as primary cryogenic logistics provider for three late stage Phase III programs, which are tracking towards commercialization; and, if progression takes place as anticipated, adding at least another four additional Phase III programs to our support portfolio over fiscal year 2017.
Of the 18 Phase III programs, we are engaged in commercialization discussions with several of these companies regarding their respective commercial launch requirements, three of which have already been awarded to Cryoport.”
Off the top of my head, Spark Therapeutics has a PFDU in January for its gene therapy for an eye disease with a patient population ~3k. TiGenix’s Cx601 is a stem cell therapy that has filed for approval in Europe and has a SPA from the FDA for its phase 3 in the US. I think Kiadis Pharma has already filed for approval in Europe.
I won’t speculate on which of those companies are Cryoport clients or the probability of approval or potential revenues. I’m much more interested in what is known but COMPLETELY underestimated:
Novartis CTL-019 (Kymriah) is approved in pediatric r/r ALL with a patient population ~1k and sales beginning this year. They completed a phase 2 trial with positive results and have breakthrough status and likely will be approved for r/r DLBCL and begin sales in 2018. The patient population is about 9000 but will likely be shared with KITE’s KTE-C19 (axi-cel). Peak sales for CYRX for the first indication are estimated to be $8-10 million and could be reached by 2020. Peak sales for the second indication is believed to be at least $8-10 million (probably higher) and could be reached by 2020-2021. NVS plans to file this year for r/r ALL and r/r DLBCL in Europe which has patient population of ~7,000 and also likely to be shared with KITE. This market is also likely to have peak sales for Cryoport of at least $8-10 million. In addition, NVS is conducting studies for Kymriah in adult ALL, CLL, TFL, MCL and PMBCL.
Kite’s KTE-C19 (axi-cel) is currently under priority review for r/r NHL with a FDA decision expected on or before Nov 29th. Approval is almost certain with the FDA forgoing an adcom meeting. Kite is looking to get Axi-Cel approved for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications. A regulatory application for Axi-Cel was also filed in Europe in July. Other trials include a phase II study (ZUMA-2) in MCL and two additional pivotal studies (phase I/II) for ALL - ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL. The ZUMA-5 is a phase ii study in patients with indolent NHL.
With multiple indications, and a patient population of ~32,000, the contracts with KITE could be considerably larger than Novartis.
Do you know what some analysts are modeling for revenues from NVS in 2017? (0) 2018 ($500k) 2019? ($1M) 2020? ($2M)
For KITE? 2017 (0) 2018 (0) 2019 (0) 2020 (0)
For ANY of the other companies above? (0)
For Big Pharma global cold chain logistics support? (0)
Larry Smith combined NVS/KITE 2020 revenues? ($19M) price target $20
Yes, it will take some time for revenues to ramp, but this is why I say that these analyst’s price targets of $8-10 are a joke.
