Those are weekly sales, so the overall market for products is running at a 2+ billion run rate right now. Generics have really been unable to improve their position over the past few months. Interesting market place right now with a steady stream of new patients entering treatment and a strong patient preference towards film.
I really think Bunavail is well positioned to quickly take some market share and achieve some free cash flow later in 2015. Pricing and reimbursement will be key as always.
Not sure what Orexo's strategy was with Zubsolv... it's so similar to the generic tablet on the market... but then again they don't have a thin film technology. Even with their product they're running at a 50+mm run rate.
All BDSI needs is 100mm in sales to generate some good earnings and cash flow.
Sentiment: Strong Buy
If we're ever going to make that run to the 20's, we need to let a little air out of the balloon.
Things will be quiet through early September. I'm looking for comparative Rx trends of Bunavail vs. Zubsolv during it's launch phase. Clonidine data is another big event.. I'm not quite so sure how this trial will readout, but I think they've done a good job designing this study and enriching the enrollment with good patients for this drug.
If Bunavail get's off to a moderately successful (Targeting conservative peak sales of 175MM in 2018) launch during the first 6 months with favorable reimbursement, this stock will be off to the races with a consistent stream of buyers coming in as additional catalysts move forward next year. For now, we're in a quiet zone where short-sighted traders will move the stock as they please.
This is one of those times where you should step away from the quotrons and enjoy the rest of summer.
Sentiment: Strong Buy
As nice as that would be... I see no indication that they've even discussed that possibility with FDA.
Hopefully we get the all-clear to wrap up the safety study and begin compiling data for the filing at the end of the year.
at new highs... which means there is a steady stream of new, enthusiastic buyers that see value at these levels. Although we may retreat or trade sideways at any time.. check back towards the end of this year and we'll be near $20. Forward looking... seeing earnings of 3 and 4.20 per share in the years 2017 and 2018.
Very happy to see the company executing their plan and now gaining some investor attention.
Shorts must be very frustrated and if they're not careful, this could really accelerate against them.
and I thought Jim did a good job of doing his homework and asking good questions. They didn't even mention Bunavail and it's a compelling story just with Bema-Bup and Clonidine. The next 6-12 months will be transformational for the company, and if you're patient enough, I think we can double from here.
I'm happy to wait.
like our post Bunavail approval. Bema-Bup now has a very likely chance of FDA approval later next year. Investors will eventually key into the value there... in my opinion it could be the perfect opioid product for chronic pain.
44 job postings up on Quintiles for the Bunavail launch. Things should be quiet from now until late August.
Maintaining my opinion that BDSI will touch $20 in the next 6 months. Maybe higher if the Clonidine trial reads out well.
not really. Endo's expectations from the investor community have been much higher over the past year. Most people will see the Endo news and see who BDSI is and what we do.
I wouldn;t expect Endo to trade much higher based on today's news. The impact on the overall business greatly favors BDSI.
Nice p value, and the side effects look pretty. Maybe doc can add more. Pre-NDA meeting with Endo and FDA scheduled for this month. Sounds like Endo is really pushing this forward.
Complete turnaround from the failure in 2011 thanks to Endo and the new study design.
The initial REMS was out of their control. This caused product to be sitting on shelves for over 18 months. When FDA inspected their product they had found the color fading issue. Since then, MEDA is in charge of resubmission and honestly their is not much incentive for either company to get this drug on the market. If there was no REMS, there would be no product sitting around for 2 years with color fading issues. The thing with Aveva was non-related to Onsolis.
If you're a business like BDSI, you don't work for 8 years to develop products without making improvement to the manufacturing and formulation process. If they are still making these mistakes in the future... that's just a shame.
Endo agree to manufacture pay for cost of goods for Bema-Buprenorphine. Why would they include this in the contract if they couldn't manufacture it properly? This takes a huge burden off of BDSI.
BDSI has put text on the films for Bunavail to avoid any possible color fading in the future. Also the film looks a little bit different than Onsolis. This to me, shows that they've learned from their errors with Onsolis.
Onsolis was never going to be a significant piece of the valuation in the first place, and you can how little priority MEDA has placed with getting it back on the market.
Classic consolidation here.. been seeing some big bets on calls lately, but you can see the lack of volatility is eroding the premium on those.
Placing 70% chance on positive data next week. With the new study design and "insurance policy" interim analysis, I like the odds.
Believe that Bema-Buprenorphine and Clonidine Topical Gel are vastly under appreciated by the finance community... that should change soon.
Hope everyone has a safe and happy holiday weekend.
Sentiment: Strong Buy
Yes... hopefully Sirgo keeps his eyes forward and the business rolling. Wouldn't be surprised to see a $30-45million offering if we get good data. Sounds like he has his eyes on a few other products for BDSI.
Bema-Bup data in 2-3 weeks. Analyst event/ Bunavail Launch in late September. Clonidine gel data this winter. Bema-Bup NDA filing in Q1. Throw some $20mm of milestones in there too to help keep the coffers full as they aggressively get Bunavail on the market.
Excited to see what else Sirgo is going to add to the pipeline.
Stock should begin to go parabolic after p3 data and as Bunavail launch approaches. Profitable cash flow and trading on a forward multiple are within grasp.
Keep on chugging, Sirgo.
According to regsho there has been very few shorts initiating a position the last 7-8 days.
You've got the right idea. I actually expect Sirgo to raise some more cash if data is positive in July. Give them another $50mm and they can really start to go after more in-licenses and aggressively move the pipeline forward.
The biggest risk to the story is manufacturing. Can they keep up with the demand? You would think that after 10 years of developing the BEMA technology they've got a good handle on what it takes to meet market demand.
As long as the story keeps chugging along and there are no IP issues, FDA manufacturing issues, then this stock is just beginning to see it's potential for the long-term.
Very exciting times and I think we've got the right management team in place to see us through.
Sentiment: Strong Buy
You raise a good point on the interim analysis. However, had they run the same study from 2011 and simply would have removed the lowest dose, with the 284 patients randomized, they should've been okay this time.
With all of the tweaks they've made to the study, adding more patients after the interim analysis is simply insurance policy (measure twice, cut once). I think they want to really get an impressive p value for the medical community.
What do you think about clonidine gel? Seems like the thesis and rationale is there. I sure hope this first Phase III is positive... seems like a nice product for BDSI to partner and co-promote with a few sales reps down the road.
Greater than 70%. The first study back in 2011 was nearly statistically significant in this same group of patients.. with the improvements in trial design, dosing, severity of pain and an interim analysis as an insurance policy, this study should read out well for Endo and BDSI,
If I believe positive data was baked in already, I would no longer be holding the stock. BDSI could double from here and still be undervalued on their current course as a business. Looking forward to results next month.
He sold 125k out of a position of 2.25 million shares.... 5.5% of his position.
Endo is NOT buying out BDSI. They would love too, but they're not in a financial position to do it (overleveraged and they have stated they are looking at opportunities in the 250-500mm range).
I'm more than confident to allow Sirgo to run the ship another few years and get this thing about $25.
I never day-trade, or use options with stocks. Looks like shorts were churning out, as previous buyers that didn't get a quick pop, exited.
Very excited for Bema-Buprenorphine data next month. If positive, we gap above previous resistance.
BDSI should have a market cap north of $800mm this summer.
Sentiment: Strong Buy