T3
I was wrong about the size of the hypothyroidism market…but my error seems to help our analysis. I had said the market was $14 billion. Instead, 14 million people suffer from hypothyroidism (the addressable market).
Looking at Zacks analysis below from March of this year, it’s pretty clear this could be huge with just the US market alone (not even factoring in the EU, with a market just as large), even if you discount Zacks estimates as being overly optimistic.
Number Afflicted
In Western countries approximately 0.3 to 0.4% of the population have overt hypothyroidism. Subclinical hypothyroidism afflicts from 4.3 to 8.5% of the population. The disease is much more common in women than in men, approximately 4 to 5 times10 depending on the definition of the disease. Our model anticipates a population of 14 million hypothyroid sufferers in the United States. Approximately 16% of this number will require T3, either as combination therapy in conjunction with T4 (14%) or as T3 monotherapy (2%). Penetration of Titan s T3 implant is anticipated to start out slowly at 0.4% in the first year of commercialization and rise over 6% over the next several years. In the EU, we see the market as being about twice the size of the US market and assume that the addressable population remains steady at 16%. Penetration into the EU addressable market is expected to begin at 0.3% and rise to 2.2% over the next several years.
--From the terrific results described in the poster, the addressable market is now 100% of the 14 million US hypothyroid sufferers rather than 16%.
--So, at year one, 0.4% of the market would mean 56,000 people using T3 implants
--At maturity, 6.0% of the market would mean 840,000 people using T3 implants.
Pricing
We apply a similar approach for our pricing estimates for T3 as we do for Ropinirole, given that liothyronine is a well understood generic with sufficient supply and is not a controlled substance. Titan has the ability to develop an implant that can release a drug substance for anywhere from three months to twelve months or more. Due to the shorter trial time required to perform trials for a three month therapy, we anticipate four procedures per year for implantable T3. Again, using Braeburn s list for Probuphine of about $5,000 per implant and $10,000 per year, we assume that the revenue per procedure is $7,000 per year, after discounts are taken. We apply a discount to the T3 implant to reflect less complex distribution requirements since it is not a controlled substance and assume $6,000 for a year of treatment. With implants required every 3 months, this equates to $1,500 per procedure. Our estimates for pricing outside the United States call for a 2/3rds price reduction to $500 for four treatments in a year.
--At $6,000 a year, US revenue in year one (0.4% of market) would equal 56,000 x $6,000 = $336 million
--At maturity (6.0% of market) , US revenue would equal 840,000 x $6,000 = $5.05 billion.
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