Everyone's situation is different. I first owned UNIS in Feb 2013. I took profits in May 2013 with the first run-up. In the ensuing months, I swing-traded the stock four times as the SP vacillated between $3.00 - $3.50. Finally, in Oct, 2013 I bought in and have held since then (yes, even through the spike to $5.80). For me though, what matters at this point isn't what happened during the last year.... it's what lies ahead.
In that regard, I feel more confident in Unilife's direction and prospects during the coming months than I ever have. Production has begun, with more to follow. Ocu-ject is coming. Anyone who's kept informed knows that wearable injector contracts are coming. The recipe is there. It just needs to bake.
In the meantime, the various swings up and down don't bother me, as I'm not selling.
Nuts, Sorry, but I still believe that UNIS is a great long-term play. I know many investors have held it for years and are understandably frustrated, but in the coming months things will change. Past contract announcements, plus the dozens of companies currently working with Unilife are clear evidence that more contracts are coming. In my opinion, revenues are the key... and we're just beginning to see them ramp up with Hikma and will soon add Sanofi to the mix. I look forward to where Unilife is in six months. By that time we should hear a couple of announcements (perhaps including a blockbuster) and sales will increase. Add another six months and the stock will be downright lucrative and many will wish they had bought in for the long haul.
toobig12 and tda.invest, Collectively I think you both have summed it up nicely. I absolutely agree with tda, that one or two lucrative supply agreements could provide the critical mass needed to propel the share price to new levels and blunt the shorts continuing influence. I also agree with toobig12's admonishment to be skeptical of what you see and hear. Clearly there have been numerous occasions where Unilife's immediate prospects have been oversold. I guess the trick is to weigh the actual progress being made against the hype and determine which carries the most weight at any given time.
darbylshaw, No doubt, if you were an early investor, say five years in, you would be justifiably frustrated, if not downright bitter, at this point. But, within the broader biotech market, Unilife's 5-year chart looks very familiar. The initial offering is met with much enthusiasm and promise, only to slowly give way to the realization that progress will be measured in years, not months. Those who bought in five years ago have watched the share price slowly devolve, from $8.00 to $6.00, $4.00 until bottoming at $1.85 in May 2013. However, recent history tells a much different story.
Two, three or four years ago Unilife had a concept and a lead product that would eventually be abandoned. Today they have a stable of high-tech devices, designed to take advantage of the pharmaceutical industry's move to biologics.
Equating five years of development; the move to the U.S., listing on NASDAQ, the building of a factory the creation of an array of targeted devices to meet changing market needs, the signing of five programs with leading pharmaceutical companies (four if you discount Biodel) and a dozen currently customers currently in development to "stamp collecting" represents an extraordinarily simplistic view.
Commercial sales for Hikma have begun. Sales of Rita and Nexis for Sanofi will begin in the coming months. Support of clinical trials, drug stability studies, human factor studies, etc. will generate upfront fees, milestone payments and device sales to support them. Sales will come from FDA approval of the drug/device combinations, as well as existing, approved drugs, as is the case with Hikma generics.
Ultimately, how a given investor fares depends on their personal investment goals. During the coming months, swing traders will likely be able to sell on spikes and lock in profits. Shorts will continue to capitalize on perceived weaknesses. And, in my opinion, those who are patient for the coming two years will be richly rewarded.
Having watched UNIS daily for the past 1.5 years, the SP consistently drifts off in the absence of news. We've see a few spikes, resulting from one announcement or another, but the delays erode confidence and interest in some investors, giving shorts and opportunity to play on fears.
Looking forward, I think the next round of announcements will have a more lasting effect. In my opinion, the first announcements, i.e. Sanofi, MedImmune etc. served to validate the business model and lend a needed degree of credibility to the company. I believe the next round of announcements will play differently. Rather than simply establishing that the company is capable of courting large pharmas, future deals will be seen in terms of real, long-term revenue potential.
Wearable injectors are a high-ticket item. Given the apparent, increased interest from pharmas, an announcement of a long-term wearable injector contract would have a galvanizing effect on investors, as they could reasonably anticipate several similar announcements in the following months.
In a more speculative vein, the announcement a blockbuster deal, such as Eylea or Alirocumab could have a transformational effect on investor confidence. I personally believe that this is what Alan was referring to when he mentioned the "strategic" effect of some of the future deals. It's just pure speculation on my part, but speculation's part of the game.
Anyway (and I can't believe I'm saying this), I appreciate your comments :)
Itsalongroad75, Funny, you and I picked up on the same reference to "strategic." I can easily be proven wrong, but I don't think he was referring to the eventual announcement of a "good" deal. I think he was referring to an upcoming "blockbuster" deal.
Part 2 of 2 continues...
11. Net operating losses were reduced by 20%, reflecting a trend in the right direction.
12. As of June 30, 12 customer programs are currently generating income across six platforms.
13. 10 active programs in May. 12 programs by June 30th. Additional programs have commenced since July 1st.
14. A number of programs already underway prior to the signing of long-term supply agreements.
15. Alan spoke to the "magnitude" of upcoming long-term agreements and their commercial and strategic importance.
16. During the past year hiring has accelerated, with 80% of 200+ employees actively engaged on customer programs.
17. While future dilution is possible, it's clear that Alan is counting on undisclosed upfront fees to offset most operating expenses.
18. When announced, Alan indicated that the Ocu-ject deal would be lucrative, fueling speculation of an Eylea deal.
If anyone takes the above observations as ramping, you're missing the point. Clearly, Unilife is a speculative stock and there is never a guarantee that the company will execute flawlessly. That said, there are, nevertheless, multiple indications that real progress and growth are taking place. Shorts want you to ignore the facts and will never carry on an objective discussion on the merits of the company's progress.
Keeping things in perspective...
For the past year, Tesla Motors has been the "darling" of the investment community. You couldn't swing a dead cat without hitting a broadcaster or print journalist extolling the virtues of the company. To its credit, Tesla stock rose 69% in the last year. The consensus 12 month price target for UNIS is currently $6.88, representing a potential 175% increase in SP!
We're all familiar with the comments. They lack substance.They're emotionally charged, and uniformly negative by nature. Most of all, they're predictable. They start to appear a few days in advance of any quarterly report or conference call. They peak in the hours and days immediately following the call with all-too-familiar refrains... "Come on Alan, throw us a bone!", "AS/BS", "More BS from AS". "It doesn't matter what he says, blah blah blah." Their goals? To capture the narrative and dominate the discussion by speaking louder and more often than anyone else. They are modern-day, digital magicians, frantically waving their hands in the air to distract you from seeing what's really going on. What is it that don't they want you to see? Everything, big and small!
1. Revenue increased 400% year-over-year. $14.7 mil may not be a lot, but the trend is finally going in the right direction.
2. Deferred revenue of $13.3 mil has been collected and will be recognized in the coming 24 months.
3. Cash receipts from customers totaled $23.7 mil for FY 2014, representing an 1,875% increase of over the previous year.
4. G&A expenses were pared as a percentage of last year's expenses, in line with Alan's projection.
5. The recent spike in R&D expenses reflected an increase in customer demand.
6. Lucrative wearable injectors are taking front stage, with customers doubling and quadrupling their programs.
7. Commercial sales began in July, a significant milestone for any manufacturer.
8. Commercial sales of Finesse and Nexis are to being in the coming months (mid-2015).
9. Clean rooms have been expanded in anticipation of future demand.
10. Additional manufacturing lines are being configured and/or are in the process of being qualified.
End of Part 1 of 2
Too cool!!! Honesty, I obviously like Unilife, or I wouldn't be invested to the degree I am. After watching the stock for 1 1/2 years and trying to become better informed on the risk/reward it presents, I am equally weary of unsubstantiated ramping or bashing...
dannychokers, I am long UNIS and believe that the contracts they will eventually reveal will transform the company and the share price. That said, I spent about 20 hours during the recent holiday weekend researching Sanofi-Regeneron's Alirocumab and Regeneron's Eylea. While I certainly hope that Unilife has been chosen to provide the pre-filled syringe and disposable injector for Alirocumab, I have seen nothing that would validate the statement "we now have enough information to confidently say Sanofi/Regeneron will be using Unifill for their PCSK9 drug." Neither have I discovered any "significant signs that Ocu-ject is Regeneron/EYLEA."
Am I hopeful that Unilife has been chosen. Absolutely. Will Sanofi's longstanding relationship with Unilife tip the scales in our favor for Alirocumab? That's the hope. Did the approval of Eylea and the subsequent announcement that Unilife had signed a significant deal for their Ocu-ject device with a leading pharma give cause for optimism? Again, absolutely. But, in my opinion, nothing is a done-deal until announced.
As for your assertion that a deal will be announced on the day of the CC, that would be great and, as others have mentioned, prior announcements have similarly announced in the past. But in the end, we don't know.
As we approach the CC, a familiar pattern starts once again. Speculation ramps up on whether an announcement will be timed for release in the days before the CC. There's an increase in the number of posts following the theme of "come on Al, give us something." "New" posters suddenly appear to suggest the CEO should be replaced. Others play the old refrain "this thing's going to $2.00, or $1.00!" Regardless of what is said during the CC, or whether an new contract is announced, paid hacks, like "The Analyst" will let loose a barrage of posts, manipulating the data to support their agenda. None of this is new, or original. It happens on message boards every day. Build expectations... add some fake indignation for flavor... plant seeds of doubt... control the message and undermine confidence.
Make your own investment decisions. Trust you instincts, rely on your own due diligence and be skeptical of those who suddenly appear, or reappear, to "help you." Their goal is to further THEIR agenda, nothing more.
Dupilumab is another potential Sanofi-Regeneron blockbuster that announced Ph2 results in early July. I know you read HC. Here's what IndiJo said: "Dapilumab is the one we really want to fall our way. Weekly administration vs monthly and a few more positive signs that this molecule is going down that road. It too is a monoclonal antibdy drug (mAb) and seems anything greater than 300mg and self administration out of the clinic is party time for patch pumps."
IndiJo also suggests researching "IL-17a players" with regards to pumps.
Note to self: I REALLY need to get a life :)
Just a quick follow-up. On the Sanofi-Regeneron slide presentation accompanying this morning's call, the following is mentioned on page 13 (referring to the devices used in the study):
"State-of-the-art drug delivery systems"
* Patient friendly single use, 1mL, disposable pen device"
* Ready-to-use, 1mL pre-filled syringe"
Note: Unilife's "RITA" auto-injector is disposable. To watch a 1 minutes video of the Rita device, Google "unilife rita" and the YouTube video is listed in the results.
As many of you are aware, Sanofi-Regeneron recently completed four Ph3 trials for Alirocumab (psck9). Sanofi-Regeneron purchased a "priority review voucher" from Biomarin Pharmaceuticals that will cut four months off of the typical 10-month FDA review process and likely place them in front of Amgen.
PCSK9 has blockbuster potential, even in a crowded market. In trials, Alirocumab lowered cholesterol in excess of 60% and, importantly, demonstrated preliminary data showing a 54% reduction in cardiac events i/e/ heart attacks, strokes, etc.
During the trials, Alirocumab was administered with a pre-filled syringe and a pre-filled pen. There has been no mention of the device(s) manufacturer. However, and it's pure speculation, given Unilife's relationship with Sanofi it is at least possible that Unilife is providing the devices.
In that spirit, the following are excerpts from the Q&A in this morning's Sanofi-Regeneron call:
Question: Barclays – “Will both the devices; the syringe as well as the pen be available for the launch immediately?”
Answer: In terms of the device question, what I would emphasize is that, in our clinical development program have developed a product with a patient-friendly 1Ml dose, in both the pre-filled syringe as well as in a pen. In terms of whether they’ll be available at launch, it’s premature to discuss our regulatory strategy.
Question: Goldman Sachs – “and then the second question was, just any feedback anecdotally from your patients on the injection and your expectations on how patients will adhere to this over time?”
Answer: “We’re doing these trials and, of course injections are new to the cholesterol field, but they’re extremely well tolerated and actually the patients really like them. It’s kind of a high-tech, cool way to treat their cholesterol.(chuckle)“ Very surprising actually. I think all of us investigators have been surprised at the uptake, and the injections are very well tolerated.”
That's certainly the hope. To your point, the only thing I could find was a reference in an article published on BioProcess International "Highly Concentrated Protein Formulations: Finding Solutions for the Next Generation of Parenteral Biologics", dated May, 2014. While discussing the competitive advantages of developing a good formulation and delivery method for PCSK9 the article states:
"The companies (Amgen, Pfizer, Sanofi & Regeneraon et al) are all developing injection devices that they hope will be easy for patients to use
while minimizing injection volume. Amgen is taking a dual track with a springloaded auto-injector and a disposable topical device.The latter will include an adhesive backing that allows patients to place it on their skin and then press a button to inject the drug.
Sanofi is developing an autoinjection pen and a prefilled syringe, both of which it will be testing in clinical trials."
Given Sanofi's long-standing relationship with Unilife, it might not stretch credulity too much to assume that, when they say "Sanofi is developing an autoinjection pen and a prefilled syringe", it might mean "Sanofi, in association with Unilife, is developing..."
Just conjecture at this point, but intriguing.
Good morning. The ESC website posted three press releases and three accompanying slide presentations for (1) ODYSSEY FHI & II, (2) ODYSSEY COMBO II and (3) ODYSSEY LONG TERM pcsk9 lipid-lowering trials. The only information I could find that conceivably relate to Unilife was the mention of self-administered injections, via prefilled pen and syringe. See below:
Odyssey FHI and FH II - "Alirocumab 75 mg Q2W SC with potential to 150 mg Q2W SC (single 1-mL injection using prefilled pen for self-administration)"
Odessey Combo II - "Alirocumab 75 mg with potential to 150 mg Q2W SC + placebo ezetimibe PO (single 1-mL injection using prefilled pen for self administration)"
Odessey Long Term - Alirocumab 150 mg Q2W SC (single 1-mL injection using prefilled syringe for self-administration)"
Of course, nothing in the above indicates Unilife as the provider of the devices. Perhaps Tuesday's PC will give a hint.