There was a lot of information in this cc, I will mention the highlights regarding the late stage drugs in this post. I'll cover the mid and early stage drugs in a subsequent post.
1. Financials: final tally on the offering after completing the oversubscribed portion is $103.5M. CLDX has $189M in cash and 80.6 million shares outstanding after the offering. Current CLDX valuation based on these numbers is $845M.
- pivotal ACTIV trial is enrolling well at 142 centers internationally
- accrual will be completed YE'13
- BLA filing in '15
- product launch preparations: market assessment shows that oncologists are very likely to prescribe Rindo to their GBM pts upon approval. Also, a survey of payers showed that rindo is well positioned as far as reimbursement.
- pivotal accelerated approval trial will start in 2H'13
- 300 pts high GPNMB/TNBCm, randomized 2:1: 200 pts CDX-011: 100 pts Xeloda (Xeloda suboptimal as monotherapy even as first line, even less effective as 2/3rd line- shrewd choice by CLDX to use this as comparator)
- "either/or" endpoints of PFS or ORR for accelerated approval (CDX011 needs to hit only one of these endpoints for approval)
- 75-100 academic and community centers will participate
- accrual will take 14-18 months
- BLA submitted late '15/early '16
- accelerated approval trial will be followed by large PIII trial that will be expanded to all high GPNMB BC pts
4. Pricing guidance:
- Rindo: $80-100k (based primarily on cost of Avastin in GBM)
- CDX-011: $90-100k (based on last 2 drugs approved as ADC's)
Bottom line: effective drugs, robust cash position to push them through regulatory pathway to market, oncologists eager to prescribe them and payers willing to pay top dollar. Plus I like the tough talk regarding partnerships, this will yield great terms for CLDX down the line!
Thanks Long! Perfect summary CC post that should be ritical reading for all Celldex investors. Your attention to detail and sage-like viewpoint are of great value. None of the other $1BB cap biotechs have anywhere near this much going for them. You have to look at 2-2.5 greater market cap companies to get anything that even looks close to Celldex potential and financials. Even then in some cases there is an argument that Celldex's potential is actually more attractive than other biotech with more than double the market caps due to the fact that Celldex's targeted therapeutics impart a higher probability of success in the Net Present Enterprise Valuation (NPV) models!