It sucks when we have a great quarter and guidance, but the next day, the entire market is down. The PPS for GIMO would have gone thru the roof if today was a good market day. But there's still time, let's see what happens at the end of the day. GLTA.
You may be right. Higher than normal volume and it's in the up direction. Maybe I should have brought more earlier. GLTA.
One of the items on the slide deck is the fact that the drugs are going thru the FDA 505(b)(2) process, rather than the traditional process. It further indicates that this is less riskier than early stage biotech drugs. I had to google what 505(b)(2) was and got the below. But not being an biotech expert, I'm still not sure if going thru this process is any more or less riskier.
One significant advantage a 505(b)(2) NDA enjoys over a standard 505(j) generic new drug application is that the former may be eligible for up to seven years of market exclusivity for an orphan drug and up to three years for applications where one or more of the clinical investigations was essential to approval of the application. Patent protection may allow companies to recoup the substantial development costs and provide profits to support further research efforts.
The Pharmaceutical Research and Manufacturers of America organization (PhRMA) estimates that of 5,000 to 10,000 compounds that come from drug discovery, only one is likely to be approved. Thus, specialized techniques have developed such as 505(b)(2) also called “repurposing” or “repositioning”, to improve the drug substance or formulation, or revise or add therapeutic indications.
Congress hoped that instituting the 505(b)(2) pathway would increase the number of available drugs by easing approval requirements for treatments with significant available data. Beyond the benefits to society of a greater variety of available drugs, 505(b)(2) also represents a substantial marketing opportunity not only for existing patent holders, but also for smaller, even virtual organizations. This includes international drug developers who are looking to additionally gain approval of their product for sale in the United States.
Making 505(b)(2) the foundation of a drug development program is a fast and cost-effective strategy that’s been shown to work.
It does not look like APP has any cash flow, just cash burn, since I do not see that they have any approved products. My question is who/how did our BOD evaluate the viability of the drugs that APP have in the pipeline? Clinical trials cost a lot of money and takes years to bring to market. I can't believe that this merger is a good idea, but will wait for the specific financials to be disclosed about APP. GLTA.
Tommy. I agree with you. I think it is all going to depend on whether or not they can expand the use of Sapphire in non-LED uses. I think there will be a glut in material for a while, so the only hope is to generate enough cash flow from other uses before RBCN burns thru its cash reserve. Like they said in the last CC, the next 6 months will be very important.
Maybe. I also think it may be the buyers who got in at below $1 that are cashing out for a short-term profit. Don't blame them. I think the CEO indicated that we would know by the end of March if they come to an agreement with the banks. At that point, I think the PPS will pop again on an agreement or go to $0 on BK.
From the CC, it seems that they are still in discussions with their lenders to work-out an agreement. They just were not able to conclude it by the 10-K filing. If they do come to an agreement, I think the PPS should pop a bit given they have indicated that they have enough cash and liquidity to operate for the balance of this year.
If they can't come to an agreement, then this company is BK. I brought a few shares thinking that they will be able to come to an agreement. It's a roll of the dice. I can buy a few shares of IPI or just bet on Red at Vegas.
They beat earnings and revenue consensus and have the Ipsen deal. The PPS tomorrow has to go up at least 5%, given today's 5% drop. If not, someone's pulling strings behind the scenes. GLTA.
My guess is that it is related to their new process called SapphirEX. The only Capex they are spending this year is $1.2M for a production tool for SapphirEX that they are expecting in May, 2016.
From the conference call:
"In addition to larger windows, we are developing a Sapphire coating technology, SapphirEX, which is progressing nicely. We are scheduled to take delivery on a production tool in May. This tool will enable us to provide the higher volume samples and pilot production capacity which are required for customers to fully qualify and commercialize new products. Our samples for this product in our initial focus market have performed well in customer testing."
You mentioned that as far as COGS, they are still going thru the old $21M in inventory. In December, 2014, they had $22.7M in inventory compared to $21.3M this past December. Why don't you think they may have already gone thru all of their higher cost inventory during 2015? They did not mention the cost of raw material on this CC as they had in prior CC's.
Dead at least until all of the excess inventory is depleted. And during each CC, there always seem to be excess inventory on the market impacting pricing in the prior quarter.
On the last CC, they projected fourth quarter revenue will likely be limited to $2 million to $3 million with GAAP loss per share of around $0.30.
They got the revenue part right, but their GAAP loss was $0.49 per share this quarter. A $0.19 miss.
You're absolutely right. According to the press release, in FY16, they estimate between $10M to $20M in adjusted EBITDA, which excludes approximately $46.0 million for stock-based compensation. #$%$? The less the company makes, the more management makes? I need a job like that.