Oyster Place Pharma, Inc. (NASDAQ:OYST) has an accepted products, Tyrvaya (OC-01, varenicline resolution) Nasal Spray for managing dry eye illness, and it is also in the pipeline for Neurotrophic Keratopathy Stage 1. NK is a rare disorder characterised by decreased corneal sensitivity and poor corneal healing. For the pipeline plan, the organization claims in its earnings get in touch with:
We carry on to enroll clients in our OLYMPIA Section 2 analyze of OC-01 nasal spray aimed at dealing with Stage 1 NK. We remain on keep track of to be expecting outcomes of this demo in the next 50 % of this yr.
Now, coming to the acceptance, Tyrvaya was accepted in Oct 2021 and commenced in the market place by early November. So this was proficiently the 1st complete quarter of noted earnings for Tyrvaya.
Dry eye illness occurs in around 38 million Us citizens. Recent treatment method alternatives are Allergan’s Restasis and Shire’s Xiidra each are offered as eye drops. Restasis is a gentle immunosuppressant whilst Xiidra is an anti-inflammatory drug. Having said that, presented the formulation that needs offering the drugs instantly to the eye – normally a cumbersome and unpleasant procedure – compliance is reduced. Additionally, these therapies just take months to function from the onset of treatment. The company says there are 7 million sufferers that have experimented with and abandoned the common therapies.
Tyrvaya uses a entirely new supply process, as perfectly as a special mechanism of action. It is utilized as a nasal fall, and it works by triggering the trigeminal nerve which in its turn triggers tear creation. In 3 scientific trials in around 1000 patients in gentle, reasonable and extreme dry eye disease – ONSET-1, ONSET-2 and MYSTIC – the drug has demonstrated protection and efficacy. Patients showed statistically major enhancements in tear movie output as assessed applying the Schirmer’s score at 7 days 4, with additional than 50% sufferers displaying exceptional tear output compared to about 50 percent that number in the placebo group:
TYRVAYA-treated patients confirmed statistically important advancements in tear film creation as assessed employing the anesthetized Schirmer’s score (-35 mm) at 7 days 4. Of the clients taken care of with TYRVAYA, 52% attained ≥10 mm enhance in Schirmer’s score from baseline in the ONSET-1 review, and 47% accomplished ≥10 mm maximize in Schirmer’s score from baseline in the ONSET-2 examine, in contrast to 14% and 28% of vehicle-dealt with clients in the ONSET-1 examine and the ONSET-2 review, respectively at 7 days 4 (p<0.01 in both studies). Of the patients treated with TYRVAYA, the mean change in Schirmer's score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 study and ONSET-2 study, respectively at Week 4.
So the first full quarter revenue is $2.7mn. Around 19,000 prescriptions were filled, and these were written by 4500 unique prescribers. 65% of all patients went for refills. A number of patients have continued using the medicine for 6 months starting from November.
The company has also taken great strides on the mediclaim front. In February, TYRVAYA was placed on Express Scripts National Preferred basic and high performance formularies, which collectively make up around 26 million lives. The company has gone on to add more payers, and now it has commercial coverage for up to approximately 95 million lives, which represents 52% of all U.S. commercial lives.
OYST has a market cap of $134mn and a cash balance of $144mn. This is a terrible state of affairs. There’s a short interest of 22%, which says that the market still thinks the company is overvalued. For a commercial stage company with a clinically successful drug to be in this sorry state is unnerving for investors.
Sales and marketing expenses for the three months ended March 31, 2022, were $27.0 million, General and administrative expenses were $12.9 million, and Research and development expenses were $4.7 million. Net product revenues for the three months ended March 31, 2022, were $2.7 million. At this rate, and ignoring any major improvement in sales, the company hardly has cash for 2 more quarters.
In order to curtail some of these high expenses – high for a small company, that is – the company has gone through a restructuring process. This, it says, will lead to $6M-$8M in savings this year but also include laying off up to 50 workers. The company expects savings of $40-$48mn in 2023. These measures will allow it to commercialize Tyrvaya better, and also put focus on the NK pipeline program. This plan will also include retiring John Snisarenko, Chief Commercial Officer, effective July 1.
The company signed a deal with a Chinese firm last year to commercialize Tyrvaya in China against $17.5mn in upfront payment and a stake in that Chinese company.
I really have nothing to say. Restasis is a billion dollar drug, while Xiidra is a half-a-billion dollar drug. Tyrvaya has an admittedly better mechanism of action and mode of delivery. Yet it is floundering in the market, and I cannot find any reason for that except perhaps lack of execution, which is also difficult to allege given what the company has been doing. All in all, this is a perplexing situation, and when I am perplexed, I tend to avoid buying.
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