Same safety data presented end of February causes stock to spike 20%. Today, put in the form of an abstract causes stock to fall 15%. Did anyone bother to actually read the conclusions of the same exact abstract?
Damage is done. Perfect. This is going to cause a long runway to accumulate a lot of shares leading up to NDA filing and Roclatan top line in Q3.
Sounded fantastic. Even though this was a 12-month safety trial, the efficacy data was very important. Basically, on the safety side, no changes from 3 months and no new adverse events - perfect. On the efficacy side, the bear case was debunked as many who looked at the 3-month data had thought efficacy would fall into 12 months. Instead, efficacy held steady relative to 3 month at 12 months and was better than Timolol that loses efficacy over time. The home run would have been a further drop in IOP at 12 months. We didn't get it but I will take level IOP at 3 and 12 months. Overall, rhopressa is stacking up as, at a minimum, an alternative to Timolol and better yet, superior given stable efficacy, good safety profile and only a once per day application.
The real home run and a potential blockbuster is going to be Rocaltan as the first combination therapy (rhopressa and lantanoprost) in the US with a once per day application. Once a day is really important as glaucoma patients are notorious for lack of compliance - they tend to be older folks - what do you expect!! This could be a $1-2 B drug therapy in the US alone. Gloablly, who knows.
Lots of data to come out through the year and was covered on the call. What wasn't covered on the call is the potential to cut development/clinical/distribution deals in Europe and Japan. Upfront capital to AERI, milestone payments and a royalty stream on sales outside the US. Of course, this could all not come to pass if a large pharma just decides to buy the whole thing.
Herein lies our biggest upside risk - it gets taken away from us too early!!
I can easily get to $40 - 50 and you don't need to use much imagination to get to upwards of $80 with share count going to 30 MM.
Suggar, you are correct regarding negative sentiment toward pharma pricing in an election year. However, eventually the market will also sort out the companies that do indeed have pricing risk from those who do not. In the case of AERI, management is forecasting that the once a day therapy Rhopressa/Roclatan will be priced at $125 per month. This is well below the threshold that will come under attack. Furthermore, glaucoma is a lifelong chronic disease requiring drug therapy.
The human eye did not keep up with evolution. The eye was not designed for a human that lives 80+ years but one who had a lifespan of only 30 years or so.
big position in AERI. Once per day drug therapy for a chronic lifelong disease, glaucoma. Drug therapy Roclatan has blockbuster sales potential in Phase 3 now. Rhopressa phase 3 this quarter and NDA in 3Q. Looks like a $40 - $50 stock trading at $19........
Chronic life long diseases are a pharma company's dream come true and glaucoma is one of them. Cancer is a really tough disease, obviously for the patient, but also for the pharma company. It is really hard to get a treatment approved given the need to prove efficacy, safety and tolerability. Furthermore, cancer's routinely mutate causing the drug therapy to lose efficacy. And lastly, and again unfortunately, the patient many times passes away halting treatment. Oddly enough, next, a nightmare for the pharma company but a dream come true for the patient, are drugs that cure a disease like hepatitis C.
All three scenarios have drug pricing consequences. Obviously, a drug that cures over a short time frame needs to be priced very high to justify investment. Cancer therapies are second most expensive. Lastly, chronic lifelong disease therapies like glaucoma and diabetes price the lowest. This is why AERI is so attractive as its treatment for glaucoma is lifelong and only costs the patient at most $125 per month. These drug therapies will never catch the attention of politicians, like Hillary.
Lifelong low cost treatments provide an opportunity for significant P/E multiples given long and predictable cash flows. There were 30 MM prescriptions for glaucoma in the US last year alone! Combining rhopressa with the current standard of care lantanoprost and branding the therapy Roclatan is brilliant. A once per day drug for glaucoma will be a first in the USA with significant IOP lowering and possibly disease slowing/halting progression properties. Roclatan has block buster potential with patent protection until 2030! We are talking $1 B of sales in the US alone and $2 B likely globally. This has the potential to trade at 4-5X sales, or $5 - $10 B market cap given it's 2020 - 2022 sales potential.
If the share count creeps up to 30 MM over time, that gets you to Regeneron like numbers of $165 - $330 per share! My 2016-17 price target is $40 - $100 - enjoy!
Yes, ARRY's stock is lingering around 52 week lows. Unfortunately, the start of 2016 has been sloppy for the overall market and biotech, and specifically small-cap biotech, has very high beta. Large scale ETF's just exacerbate the trading issue. I also suspect some large holders are facing redemption activity as well. The good news is we have a fairly liquid stock trading about 2 MM shares per day. Speaking of facts, the market cap of our company is about $518 MM, just under $300 MM net of cash we hold on our balance sheet. This is very cheap relative to our pipeline and likely revenue. At these levels, it could indeed attract buy-out interest. This would be unfortunate as it would take away the upside for those of us who have been holders depending on the take-out price.
Again, we all know the stock is at 52-week lows. I played baseball through college. I always wondered why anyone would tell me I just struck out as I walked back to the dugout while I am holding a bat!! That's how I feel listening to these posters that whine about the CEO, the stock price and posting the so-called facts. Please post information that is helpful!!
For raising the IQ level of this board! Sneaky, donsjoe7 and newceointhehouse lower the collective IQ of the human population each time they post on this board, especially when they claim facts. The only facts I've seen them post is the duration of the CEO's employment, a non-factual post regarding his compensation as they don't know how black-scholes option grants work, and whining about the stock price.
The last discussion about the addressable market for NRAS melanoma is a helpful one. I agree with dcaf7 and burnaka. Immunotherapy is a better option for those who respond as it gives a person about 2 more months of progression free survival from this deadly disease relative to binimetinib. However, only 30% of the population respond to immunotherapy leaving 70% for ARRY. Also, once the immunotherapy stops being effective for those 30% that respond, it's likely they will be given binimetinib to further extend treatment, so ultimately we may touch more than 70% of the population. Having said all this, revenues from this therapy will probably be around $100 MM per year, not a home run but a level that at least supports the current stock price. BRAF melanoma will probably bring in about $200-300 MM of revenue if not more and the likelihood of success is quite high given that two MEK therapies already exist, our phase 2 data was excellent and our tolerability profile is better than existing therapies.
A month or two of life extension does not seem like much but it is a lot for a family going through this disease. This has been the history of cancer treatment in the US. We keep adding a month here and there, learning more as research continues. There are many examples and one that is close to me. Childhood leukemia had a survival rate of less than 20% in 1964. Fifty years later the survival rate is 90% after years and years of incremental improvement - this is how it works - because I was that kid in 1964.......
Just another example of a wonk who only can whine about the CEO and who actually knows very little about the company's fundamentals and what you actually own. The failure you reference related to a very small opportunity for uveal melanoma that affects the human eye.
The Non Small Cell Lung Cancer (NSCLC) referenced above is an opportunity representing about 400,000 patients per year where there are no currently viable treatments. AstraZeneca is the sponsor and we receive milestone payments and royalties if commercialized. I wasn't able to verify the SELECT-1 information above, but if true is very positive. Cutting off recruitment and moving up completion date for data is generally a very good sign for study results.
I couldn't agree more! Not only are they tiresome, they are actually dead wrong. Squarer has actually done a lot for ARRY. A year ago he was able to negotiate with Novartis to get full control of two advanced MEK compounds in phase 3, $80 MM of cash, remove nearly $30 MM of liabilities and largely fund these compounds until commercially viable via Novartis. Furthermore, he just closed a deal with a European partner to distribute and develop the same two compounds for an upfront of $30 MM, milestone payments and a favorable royalty split. Additionally, we are sitting on over $200 MM of cash with not threat of dilution near term from the issuance of more shares.
These idiots - newceointhehouse, sneaky_dna and donsjoe3, among others - rarely mention the company's fundamental prospects but harp and whine about the stock price. In my experience, the stock price ultimately follows the fundamentals and I want a CEO focused on the fundamentals. Those CEO's who are solely focused on the stock price - watch out. Of course, you want a CEO who does both with a heavy weighting towards the fundamental management of the company.
ARRY is my number one pick for 2016. If there were such a thing as a Value biotech stock, ARRY is it. The company's valuation of $600 MM, $400 MM net of cash (oh yeah, forgot about $30 MM of stock owned in LOXO, plus milestone and royalties), is significantly undervalued on both a relative and absolute basis. NRAS melanoma alone supports this valuation and gives no credit to BRAF melanoma (Columbus - phase 3) which has a very high probability of success based on other similar therapies in the market but with much better tolerability. Lastly, I believe the home run is going to be BRAF colorectal where we could be sitting on a $1 B+ sales opportunity. None of this is baked into the current valuation. Once this stock catches a bid, a $2 - $3 B valuation is not out of the question which results in a $15 - $25 stock.
This is very common. The data is made available for peer review and once vetted it is then typically presented in a paper or a conference. The hospital supporting the review is Massachusetts General Hospital, arguably one of the best in the world.
Don't confuse the stock price for the company's fundamental prospects. What we are watching is year-end positioning and tax loss selling. This will all abate in the next day or two and the stock should drift upward without the selling pressure.
I totally agree. We should all band together and put these idiots who constantly bash the CEO on ignore. I rather we share robust information concerning fundamentals and prospects for company's molecules.
Investing dude is about the future, not the past. If you want to look backward go ahead but you will be destined to commit the same mistakes. All stocks discount the future. In this regard, I see ARRY trading at about $2-3 B market cap. I wouldn't be surprised to see the stock at this level in 2016. I'm telling you BRAF colorectal could be a $1 B in sales opportunity. We would be first to market, establishing the standard of care, with no immunotherapy options. We will get another read on this program in 2016 and it could be huge.