Investguy... We've been around here for awhile and I respect you and your bullish views a ton. The price decline has everything to do with the company.
BDSI is in a great deal of trouble right now. Belbuca revenues won't hit the P/L until Q2 or Q3 next year and Bunavail is sinking this company each week the launch continues.
Play with numbers here- TN Care deal will get them to 3k per week. $80 per script = ~3.1mm per quarter. Take out $1-2mm for COGs... and you're only taking in about $2mm per quarter.
Okay, now assume they can get Bunavail to 5k by end of next year (A very aggressive number since they could only get to 1500 at the end of year one before they landed the TN care deal). 5k per week, $80 per script = $5mm per quarter. Take out your $1-2mm for COGs... vs your SGA spend of $14mm and you're still burning 9mm on this drug.
This is not an attractive stock to buy or hold at these levels.
Why aren't the insiders buying down here, near 52 week lows/3 year lows?
I hate to see you throw more money at this... you are betting that one year post-launch, the trajectory does a 180... something that became very unlikely after about 6 months. If anything, the trajectory will begin to flatline once the TN care deal absorbs. Doctors don't feel a NEED to prescribe Bunavail over Suboxone or Generics, hence the awful market share one year post launch.
The cash burn is crippling. We are a clone of XNPT at this point.
It took twelve months for BDSI to "ramp" up to 2000 scripts and that included a preferred deal (which so far they've botched with the supply issues). Patients don't like the product- they prefer Suboxone.
Bought from 2009-2014, as low #$%$88 and as high as $15. Cost basis was in the mid-three's eventually. My premise was based on Bunavail sales of 35, 90, 140, 190mm in the years of 2015-2018 respectively. So far Bunavail has sold about $3mm in it's first 9 months. The story has changed. Longs that try to spin or rationalize this are just as guilty as my confirmation bias.
Sold some at $12 before TCG bomb, sold some at $10.50, sold some at $8.... bought some back in the high 7's, sold those for a loss at $6.
Overall gain was six figures, recent loss was about 8k. Time to leave this stock alone. My last trade was a bust.
This company is likely headed to a perilous fate (back to $3-4 range) within 18 months. Any quick moves to the upside are profit taking opportunities. I spent years following and researching this company. Trust me, I wish I were wrong and my thesis would've played out.
Advice to company- Scrap Bunavail or partner it away, trim staff to 20, collect Belbuca royalties to get to breakeven, develop TCG and Depot, sell the company for $8.50 fully diluted.
They're not gaining ANY traction outside of the tenncare deal. Is that not concerning? 1 year post launch and they've flat-lined outside of MA and TN. 26% increase? Who fricken cares? 26% increase over a miniscule number is still.... a miniscule number.
1.2mm this quarter- maybe 2.5 in Q4 with TennCare deal.... Bunavail peaks at about $30mm in 2018. An absolute embarrassment that they continue to destroy shareholder value with this launch and it's the reason this stock is going nowhere.
Belbuca will help but when you're burning $20mm a quarter... it's not nearly enough. Convenient how Sirgo always touts the strong cash position.... but he leaves out the $30mm in debt that will be coming due over the next few years. Sirgo needs to go.
Buying the stock here is reckless.
We've sold $1.5mm of product through 6 months of launch... let that sink in.
How in the world do you expect them to sell even $50mm in a year? I was wrong again and tried to play the bounce into the PDUFA. Took a small loss and won't look back.
It's what I've been trying to say.
Bunavail is killing this stock. If Sirgo ever wants to maximize shareholder value, he will divest the asset in early 2016, get rid of the sales force and extra staff at BDSI, cut the burn rate, and continue to develop the pipeline. I think we could fetch $25-40mm cash for Bunavail.
With a leaner operating model, Belbuca royalties could support the majority of business functions.
I wouldn't touch BDSI with a 10 foot pole as long as they continue with the slow launch of Bunavail. Very unfortunate that we've wasted a major catalyst opportunity (Belbuca) because we're too stubborn to shift strategies with Bunavail.
I really don't understand and I have no interest owning this any more until they shift their strategy.
Not sure why anyone thought Belbuca would get rejected. It's a well known molecule and the studies were well-designed with a clean safety profile. The FDA is also under pressure to have safer alternatives to CII opioids/tablets available. If BDSI were submitted the NDA on their own, I'd say 90% chance of approval the first time, considering it was a joint effort with another company, my odds were closer to 99%.
The approval process with FDA is a dialogue... back and forth communication. I'm sure Endo and BDSI knew approval was coming weeks ago if there were no lingering questions which would require another study.
Either way, I'm sure BDSI had a few bottles of champagne to celebrate the occasion yesterday evening, with a formal announcement coming from Endo and BDSI monday morning. And in a few weeks, a nice payment from Endo to the tune of $40-50mm.
There is no reason to believe Belbuca won't be approved. PR will likely be released on Monday pre-market (assuming the FDA has given them their decision).
Seriously can't believe people here are taking their cues from a guy on Twitter.
The drop is justified only if Bunavail gross-net continues to suck-wind.
This is a risk off environment, unfortunately, and BDSI has not done themselves any favors over the past 12 months. Surprised we didn't raise money earlier this year.... that's going to hurt.
1) I expect mid-day halt and approval for Belbuca tomorrow (chance of after hours notification as well)
2) Milestone from Endo will be closer to $40mm (read the details about previous reimburseable research expenses being credited to some extent against the milestone payment).
3) I expect Belbuca to be used off-label for opioid dependence taper patients (not significant enough to drive sales, but it'll happen).
The biggest questions for me is: what will Bunavail gross-net evolve to over the next two quarters? That is the only thing that matters at this point. I am not optimistic we will see big improvement after following Orexo for several years and their discounting troubles.
For those buying the stock today at these levels, you're getting a decent amount of speculative upside with clonidine gel next year.
This last cash infusion from Endo should be Sirgo's last chance to make this thing work in 2016.
Sirgo should be done. It's no wonder insiders haven't been buying the stock lately at 52 weeks lows.
All the work to ramp up market share to a measly 1% will soon be wiped away. TN Care could be an epic failure depending on the length of this product shortage. Looked like we were turning a corner with the sales uptick-- but now sales will drop meaningfully over the next month.... then you have to spend another month ramping back up to the benchmark.
Patience.... no more. Wipes away all the shine from an exciting Belbuca event next week.
There are ~7500 monthly prescriptions written for buprenorphine/naloxone products that are eligible to be converted to Bunavail in the Tenncare deal.
I model that this gradually happens over the course of two months. I model that we see a bump of ~100 to ~150 prescriptions each week from the deal until we have saturated that patient base. I also assume we continue our trajectory of about 25 new Bunavail prescriptions per week rest of country (might be a little conservative but that's been the trend so far).
Here are my estimates for the next three weeks ending 10/2, 10/9, and 10/16.
10/2- 1510 (Last week was 1417, base model is 1450 + 60 from TN care first two days)
What are yours?
Reason #1 to choose the sidelines: Launches are hard. Very few drug launches occur without flaws. It is even harder for companies launching a drug for the first time (such as BioDelivery). We note positive signs for BioDelivery, including heavy wholesaler orders. However, in our opinion, most the time investors get a second opportunity to invest in drug launches.
"Make no mistake—BioDelivery is executing very well. The company has had a tremendous year including: 1) advancing Buprenorphine for pain towards a filing; 2) obtaining approval for Bunavail; and 3) moving Clonidine [high blood pressure] gel through the clinic.
Reason #2: Buprenorphine and Clonidine gel are 2015 events. Buprenorphine remains a strong pain asset that is partnered with Endo International ( ENDP ). However, we expect that a filing is already in the share price, and the next material catalyst of an approval decision remains a late 2015 event. Clonidine gel phase III data is earlier, but still a late first-quarter 2015 event.
Scott nailed his downgrade in October last year ahead of the Bunavail launch. Basically citing initial launches do not go very well for small companies like BDSI and that there would be a second chance for investors to buy in. He was right 100%.
Let's hope he's right again this time.
TN Medicaid is about 7500 prescriptions for month, Bunavail is the preferred product and is exclusive for those patients. Capturing that pull through would double our current sales volume.
Sirgo is making over a million dollars (with stock options) per year to run company that is on track to produce only $10mm on t's own revenues in 2016. Must be nice...