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Thursday, 08/01/2019 10:20:02 AM

Thursday, August 01, 2019 10:20:02 AM

Post# of 4817
Interesting report at Zacks on LPCN. A recent study demonstrated a link between non-alcoholic steatohepatitis (NASH) and low free testosterone. As the disease progresses, the hormone levels decline. This mean that there may be a MUCH larger market for Xyosted.

I don’t want to repost too much of the report here but it’s worth a read. He also had this to say as it relates to Antares:

“As Lipocine advances its newest candidate, it appears that the environment for TRT is also moving in the right direction. In May, TLANDO received a November 9, 2019 Prescription Drug User Fee Act (PDUFA) goal date, as provided by the FDA. This was preceded by two other TRT therapy approvals including Antares Pharma’s injectable testosterone enanthate, branded Xyosted. Xyosted was approved in October 2019 and was launched in November 2018.

Antares’ new and experienced sales team combined with a strong marketing push and less competitive pressure from previous generations of testosterone has created the setting for a strong launch. As generic options have emerged in the gels, restrictive contracts with payors appear to be fading. Xyosted sales of $70,000 in the month of December, grew to almost $2 million in the month of May. Weekly total prescriptions exited 2018 at 26 rising to 980 by the last week of June 20196. The 26% growth in weekly prescriptions from May to June suggests a similar increase in month over month sales. This strong performance out of the gate points to a favorable environment for new and improved testosterone therapies. We think Lipocine’s oral option is the most convenient for patients compared to injection, patches or gels. If approved, a fixed dose oral option would be easy to use for patients as it would not require additional dose adjustments or related doctor visits. It should also be less confusing for prescribers as it is not prone to titration decision errors and predictable from a cost perspective for payors relative to products that need significant up-titration in dose.”

https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2019/LPCN-Poster-Demonstrates-NASH-and-Free-T-Link/default.aspx