- BioTime, Inc. (BTX) dosed its first patient with the Orbit Subretinal Delivery System as well as with a new Thaw-and-Inject formulation of OpRegen, the company's retinal pigment epithelium transplant therapy, in its ongoing Phase I/IIa clinical study for the treatment of dry age-related macular degeneration, a leading cause of adult blindness in the developed world.
- If approved, it would be the first therapy for dry AMD, which could be a $22 billion market in the United States.
- Renevia CE Mark submitted to be approved to market in Europe.
- AgeX spin-off being planned to unlock value.
BioTime (NYSEMKT:BTX) is a regenerative medicine company that has two products in its pipeline that could potentially be commercialized within a few years: Renevia and OpRegen. Renevia is a medical device that was developed as a replacement for hole adipose tissue in cell assisted lipotransfer (CAL) procedures by recreating many aspects of the adipose tissue extracellular matrix. OpRegen is a therapy in development for the dry form of age-related macular degeneration. It is currently in Phase I/IIa.
Also in the pipeline are delivery methods HySTem-BDNF, ReGlyde, and Orthopedic (Ankle Fracture).
BioTime also has significant ownership in several companies including OncoCyte (NYSEMKT:OCX).
Given progress and near-possibility of near-term approval of Renevia in Europe, AgeX going public, and OpRegen to report positive results, we believe there is significant upside on the price of BioTime which is currently undervalued.
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Dry macular degeneration is a common eye disorder among people over 65 that caused blurred or reduced central vision. Below are some statistics on dry macular degeneration as a gauge of the potential market size.
- As many as 11 million people in the United States have some form of age-related macular degeneration. This number is expected to double to nearly 22 million by 2050.
- The number of people living with macular degeneration is expected to reach 196 million worldwide by 2020 and increase to 288 million by 2040.
- Estimates of the global cost of visual impairment due to age-related macular degeneration are $343 billion, including $255 billion in direct health care costs (BrightFocus).
There is currently no treatment or cure for dry macular degeneration, but there are drugs aimed at delaying progression of the disease. These include EYLEA (aflibercept), Lucentis (ranibizumab injection), Macugen (pegaptanib sodium injection, laser photocoagulation). The revenues for Lucentis alone were $1.48 billion in 2017. There was no specific segmented data on revenues for EYLEA or Macugen.
EYLEA costs $50 per dose, Lucentis costs $2,000, and Macugen costs $800 per dose. Going off the logic that the most expensive of these products doesn't specifically treat dry macular degeneration, it makes sense that BioTime would be able to charge a premium for an FDA approved treatment. Using $2,000 as the cost per dose of OpRegen and multiplying by the 11 million people in the U.S. gives a market size of $22 billion. Of course, BioTime could charge less per dose and the full market might not be attainable.
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