Conference Call Notes @ BDSI
Collective effort to get most of the details.
Summary: The future is very upbeat given the relationship with FDA, large pool of cash $27M coming ASAP, and other drugs in the pipeline that extend beyond cancer. Also, a partnership agreement interest mentioned for 2010...no details.
Impressed with the CEO's level of confidence in running the company to knowing his products!
Noted: They normally wouldn't announce news in mid-trading day.
FDA went live within 30 minutes of their notifying the company...(was
not happy with this)
Lets not let it distract from the accomplishment of the company, and
"Most significant milestone in company's history"
Being the 1st pharma to have REMS approal - very important
Major accomplishment for company size - ONLY THE BEGINNING
BEMA platform and future BEMA products, and amplifies future pipeline.
We have capability, pipeline and finances to build ....
Commended MEDA pharma, will help go forward with launch and
commercialization
Went over the payments from the Onsolis approval...27 million from
MEDA
double digit royalties, potential to receive another milestone payment
of 30 million.
Expect to close out 09 cash flow positive
Allows to dedicate for aggressively advancing the other products in
pipeline, substantial future value for our shareholders
Onsolis: currently only 2 brands of fentanyll for cancer breakthrough
pain....with many limitations, it is 700 million industry, expected to
become a 1.3 billion in few years. There is much untapped market
potential
majority of patients are given oral tablets to treat rapid onset pain,
takes up to 60 minutes. But Onsolis is rapid acting...
Want to educate key end users to use the product for breakthrough
cancer pain.
Onsolis is high priority for MEDA
Tagline for Onsolis: "adheres, dissolves and delivers"
The delievery system, uses proprieteary BEMA which works quickly.
> Easy, convenient
> There are 5 strengths of the drug - broad range.
> There is predictability for linear dose increase
> well tolerated in oral cavity.
Will launch Onsolis in early 4th qtr of this year, with help from
MEDA.
Meda is ideal commercial partner, one of the fasted growing companies
in pharma.
Not an unrecognized name in the pain arena - good for physicians, etc.
In addition to sales effort, their clinical devlpt team is looking to
find uses outside of cancer for Onsolis. Clinic set up Jan of next
year, if approved, this will contribute substantially to future sales
of onsolis.
They have validated this platform (bema).
POSITIVELY TALKED ABOUT OTHER PRODUCTS IN PIPELINE...ESPECIALL BEMA
BUPENORPHINE
Bema bupenorphine...acute and chronic pain....class 3 narcotic. Less
abuse and addiction, a significant attribute. Similar to morphine, but
less abuse.
Can get it to market more quickly, like they did with Onsolis.
Have an established working relationship with this division with the
FDA - very important.
On track for Phase 3 for Bema Bupemorphine for early next year...
Importantly partnership announcement expected next year. Driven by
Phase 2 clinical data of Bema Buphemorphine.
Company believes market will be 500million to 1billion range (massive)
GAME CHANGING OPPORTUNITY.
Also in early stages of evaluating treatments migraine, nausea
vomiting, expect forumlated and clinic next year (?)
Bioral amphotericin Phase 2 sometime in 2010.
Could become 1st oral fungicide in the world?
Look forward to have new data on pipeline later this year.
Pain and supportive care, sustained future growth, value for future
sharefholders.
We can aggressively move pipeline for first time in company's history.
1)bema technology
2)financial
3)pipeline
