Further Analyst Report States Phase III will start in 1Q 2013
Last week Matt Kaplan from Ladenburg released a new report. He reiterates BUY and 8 USD Price target.
Statement from the report:
PBTH anticipates the adult hGH treatment-native Phase III pivotal safety and efficacy trial will be approximately a 150 patient study which is on track to begin by 1Q 2013 This trial is expected to be a six month study followed by 6-12 month long Term extension (Safety) study. Approximately 150 hGH naive patients will be randomized into two arms, one receiving hGH-CTP once weekly starting at 2mg/week of hgH-CTP and the second arm receiving once weekly placebo. Patents will be dose-titrated to achieve the desired Levels of IGF-1.Patients in both arms will continue in the long term study (if they choose) and all patients will receive hGH-CTP once weekly. The Phase III study's primary endpoint will be improvement in truncal fat with IGF levels(+- 2 standard deviation of mean IGF1 Levels) of a person of that age as a safety endpoint. PBTH believes this study will cost approximately 12 -15 Mio USD.
We expect the study will take approximately 2 years to complete and we expect the completion of the study in 1Q 2015 and NDA filing by 1H 2015.
We utilize a sum of the parts model in our valuation of PBTH as wie believe the company will seek to outlicense/partner its current pipeline candidates. We believe a sum-of-the-parts model better captures the varying terms of each distinct product. While wie attribute minimal value to other pipeline products until clinical data is available and more clarity regarding to program development Details and timelines are confirmed, we believe these programs could provide significant upside to Investors. Our valuation also does not include the technology value of the CTP platform. We incorporate a partnership in our model with PBTH receiving approximately a 27% royalty rate. Based on worldwide revenues a peak of 980 Mio USD and fully dilluted shares of 75 million, we arrive at our price target of 8 USD.
Start Adult hGH CTP Phase III study: 1Q 2013
Start GLP1/Glucagon Phase I study in T2D and Obesity: 1 H 2013
Start Factor VIIa Phase I/IIa study: mid 2013
Start Factor IX Phase I/IIa study: 1H 2014
Start Pediatric Phase III hGH CTP Phase III study: 1H 2014
Complete Adult hGH CTP Phase III stud: 1Q 2015
File Adult hGH CTP NDA: 1H 2015
Approval of hGH CTP in adults: Late 2015
hGH CTP Launch: Late 1Q 2016
Complete Pediatric hGH CTP Phase III study:2H 2016
File Pediatric hGH CTP NDA: 1Q 2017