Good point about Amgen's upfront fees. Next quarter may even show a profit it they record it at 100%.
Also, PODD indicates that their R&D is going to increase to $50M per quarter to catch up for not keeping up with the demand and needs for biologic drug delivery. Their technology has to be improved if they want to continue to compete with Unilife
Nothing new to contribute so we wait for Management to execute. If they do so successfully, I expect to have a lot more discussion on growth prospects here.
Macole, Why don't you mention what Hikma did write in the annual report regarding their growth strategy on Page 24:
Just because they don't have an approval YET on a PFS/drug combo doesn't mean that anything is going wrong or they gave up on the idea, but you seem to be wanting to make a point to inject fear to suspect that the FDA had issues without any facts to back it up.
Macole, no need to take my DD as personal to yourself where you have to take a jab at me to wonder what planet I am from. Why do I offend you by sharing what anyone can hear from the Imperium cal? Either you believe what the execs said or you don't. I didn't make it up.
Also, this was a question on that 7/30/15 CC:
Would it help to accelerate market delivery of device if Unilife pursued 510K FDA regulatory process?
This is the answer:
Ian Hanson mentioned it would not work with their partners; Unilife will be taking the lead of partner to maximize the therapy from their point of view
Continued usability studies are underway formatively and with partner as a combination product.
Furthermore, Ramin indicates that there are existing pumps that are do not go through FDA process; so it is their belief that approval is not necessary; they do not think the process is onerous at all.
al28b, it is not clear that FDA approval of a drug/device combo is necessary. It was indicated on the Imperium conference call that it is up to the Pharma company to decide the effective route it wants to take to get their product to market. Ut was noted that there are devices used for drug delivery that do not have FDA approval and that it is not necessary. Obviously, a Big Pharma would want to reassure patients that a device is FDA approved along with its drug, but Unilife made it clear that they would follow their customer's strategy and that it would be THEIR decision to pursue what clinical path it takes it marketing its product.
The problem with Praluent is that Sanofit lost to Amgen on a patent law suit. Obviously, they are going to appeal but Amgen may try to force an injunction in the meantime.
Charmed...LOL...you should be a career counselor. You want to promote a career CFO to CEO. Thank goodness you are not on the Board. I'm done arguing with you because you have no business sense in this matter.
Charmed, you obviously have no experience with Sarbanes Oxley and Audit Principles 101. The CFO cannot be CEO for many reasons, but the most basic one is "segregaton of duties". You cannot have the man who spends the money also run the business in a public company.,. This is not a Mom and Pop business where you can do whatever you want with your own money.
BTTX, that is not an actual conversion of Amgen convertible note. Read the footnotes. The SEC filing From 3 states it is a Convertible note (derivative) convertible into 24M shares at 2/22/2015 and the 13G specifies that the 24M shares would represent 12.6% of outstanding UPON conversion. So the 12.6% is calculated on a proforma basis AS IF the transaction occurred to disclose the potential dilutive effect as of date of deal.
Personally, I think the SEC reporting process is confusing when it comes to stock grants, options and convertible notes. It requires you to file as if all the transactions occurred when they didn't. A good example is when an officer of a company gets option grants that vests in the next 4 years. That officer has to file a Form 3 which would show all four years options as if they were executed write away. Then the financial rags come out in response to the filing and say that the executive was overpaid that year without understanding that it is 4 years worth of incentives due to the nature of the employment contract being negoitiated for several years. It seems to cause confusion. There should be another form exclusively for derivatives IMO.
I agree Itsa. Amgen was the icing on this cake. They came out of nowhere, but realistically they have been negotiating/working with Unilife for many months prior to even the MS review IMO. I expected it to be an Imperium deal for Sanofi and BAM! came an even more interesting deal and the creation of a new 1.5ml WI that was surely ( in my mind) developed at the request of Amgen months ago. What other pleasant confidential surprises lie ahead? I personally am eager to hear about how many deals come out of Imperium, will it be exclusive to Sanofi or will we have other parties like Medtronic, Eli Lily or Novartis interested?
This is not only a lucrative investment, but it is entertaining to see how the business unfolds. Thank goodness we are past the Discover Fund fiasco, the "short induced" (IMO) whistleblower suit that was magically cleared with an apology (that is the first I have ever seen),and the other hurdles long ago from its beginnings in Australia. All appears as if we are now on solid ground ready to execute for successful commercialization.
For the record of this thread, the 13G filed today was a disclosure of potential ownership and its dilutive effect IF shares were converted at the signing of the deal on 2/22/2016. The convertible note was not converted. This does not change my long term outlook.
IF Amgen had converted right away, that would have made me feel like they wanted to take advantage of the $1.25 price as they knew it would skyrocket in the upcoming weeks with all the announcements underway. This would allow them the opportunity to get 100% shares as they would get less shares based on 90% of 20 day VWAP if price rises.
Now I go back to my initial reaction of the deal. With Amgen holding back from converting on the onset, it allows Unilife time to generate meaningful revenues to offset the dilutive impact. The Company is just now on the verge of commercialization. The revenues to be generated will be lackluster to support dilution of 24M shares and would not be impactful for a rise in share price IMO. Also, Amgen may think that it is more beneficial to offset the cost of their devices by offsetting the convertible note via its discounted sales. Then they have essentially no cash outlay in the launch of their new biologic/device combo as they would record the device expense but credit theri note receivable(instead of cash) on their books at a discounted rate. In this scenario "Cash is King" versus wanting an investment on their books had they converted to shares right away. I think Amgen is thinking about its own operations versus wanting an appreciable investment on its books at this time. It is a smart use of its cash IMO. Amgen would never be allowed to own a majority ownership of Unilife as other Big Pharma would not be willing to have their devices made by its own competitor. Therefore, there are 2 choices (1) Zero cash outlay for devices up to $30M at discounted rates or (2) convert shares and record unrealized gains based on appreciation above $1.25/share. They choose 1
Hmmmmm. now you have me thinking. These SEC documents are so confusing. It is almost like a proforma AS IF they converted but they didn't? Gheeez....they should only have to file when they convert. A 10K adequately discloses conditions of potential dilution.
Right back atcha Itsa! I feel like we won the lottery! I can't contain my excitement for a long future of gains with Unilife. This EQUITY partnership with Amgen is all the information I need to know that we are on our way. This is the first time I may have hit one from the ground floor. Got close on some others but never invested as large as here. I truly have no doubts now so let the market show us for real. They better do it fast or I will keep buying at these ridiculously low prices! LOL
On second thought, I think I am mixing it up with warrants. This is a convertible note, not debt with warrants attached to it. So it does look like they outright convert at the floor price and get the most shares that way (assuming price keeps increasing above 1.25)
Just sit back and relax. We are as good as gold. Congrats all longtimers!
is to enjoy the ride up. After extensive DD into the caliber and demand for UNIS disruptive devices, and the derisking of future poor execution (deep pockets Big Pharma partner Amgen and top premier healthcare financier holding Unilife's hands), long shareholders can sit back and relax. I also plan to trade all the way up to maximize my short term and long term gains. I am feeling like I am finally in a position of power with this stock. Does anyone else feel the same? I am bubbling inside with great expectations in stock price this year, despite all the recent gloom and doom on the HC thread. Albeit, my wait has been 1 year, not 10. But victory/reward is near IMO.Good luck to all long-timers. We will be rewarded for our committed patience here/
Sentiment: Strong Buy
These drops are most likely stop loss hunting and margin calls for weak hands. It can't go on much longer. Marketmakers have overused this tactic and have made little dent in getting cheap shares to cover the large naked short postion. I will be looking to see which institutions take advantage of these dips to acquire new/more shares.