ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I believe the $105 million revenue guidance from Alimera may be low.

According to their ]earnings CC in May

We continue to see growing utilization in the U.K., Portugal, Ireland, Spain and France. In March, the U.K. National Institute for Health and Care Excellence, or NICE, issued final guidance stating that the fluocinolone intravitreal implant is recommended for treating visual impairment caused by chronic diabetic macular edema irrespective of lens sight.

What this means for us is that now faking patients or those that have a natural lens now have access to ILUVIEN. NICE reimbursement to-date has been limited to only pseudophakic patients or those that had undergone cataract surgery. This is a significant expansion of our potential user base among the chronic diabetic macular edema or DME patient population. According to the U.K. Macular Society, safety patients represent up to 75% of the broader DME population in the United Kingdom. We expect the availability of this wider reimbursement to positively impact utilization in the U.K. in the second-half of 2024.

NICE guidance can also impact reimbursement in other countries such as Spain and Italy. We believe that this NICE decision if adopted in other markets will broaden our potential patient base in these countries as well.

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The CEO was reluctant to provide analyst with guidance on sales increases due to the NICE reimbursement update, stating that they would need a couple of quarters to gauge the uptake.

It explains the head count expansion in the UK.

I also liked the following from the CC

For YUTIQ, our sales team now have the three year data from the YUTIQ PIVOTAL 001 study that illustrates the benefit of long-term control for chronic non-infectious uveitis affecting the posterior segment of the eye. It shows that the median time to the first recurrence of uveitis is over 1,000 days for the YUTIQ patient, while it's less than 100 days for the same patient, a substantial benefit

Longer term I like that they are collaborating on a trial titled

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (AL)

A phase 3 trial where Genentech is also collaborating. Primary Completion date is 2026-11-26 with study completion date two years later.

The study plans to include 600 patients with primary choroidal melanoma seeing in treatment with plaque brachytherapy. Over 40% of radiation retinopathy patients have been shown to experience the devastating vision loss associated with radiation retinol within three years of treatment. And currently, there are no FDA approved pharmacotherapies for radiation retinopathy.