1) ESTABLISH-2 data. 90+% chance of success. March or April. Run-up target $7. Should hit $8 with great data.
2) NDA filing for skin and soft tissue infection indication. Middle of 2013 and due to GAIN-ACT should have priority review putting FDA approval of this indication in early 2014.
3) Start additional phase 3 trial for pneumonia- first half 2013.
4) Start bacteremia trial in 2nd half 2013. This is the $$$ indication as this type of treatment is typically longer and physicians will use the best drug possible due to the severity of the patient's condition. Other off-label uses will garner more $$$ for Trius as well such as VRE, endocarditis etc.
5) European partnerships and/or other territories- anytime after ESTABLISH-2 data. Look for a better deal than what they had with Bayer with larger upfront payments and cost sharing for additional trials. This makes dilution risk minimal if management can negotiate this type of deal.
How much should Trius be worth? I use the example of OPTR (Optimer pharmaceuticals) as a close example. Optimer has dificid for treatment of clostridium difficile infection. Drug costs would probably be on par with tedizolid. Dificid competes against 2 generics- oral vancomycin (sound familar?) and metronidazole. These 2 treatments are cheap and right now dificid is reserved for the tougher to treat cases of c. diff. OPTR has a market cap of roughly 500 million. Both companies are very similar in their situations. Should Trius get a similar market cap, we're at $10+/share. However, I believe the global market for Trius is much larger than OPTR and analysts have a correct valuation IMO in the range of $12-15/share which is roughly a triple from current levels.
Many of the bears tout generic Zyvox hindering tedizolid sales. There's no arguing that might have some affect. However, keep in mind tedizolid is differentiated from Zyvox-- better side effect profile, short duration of treatment which may have pharmacoeconomic savings, is bactericidal thereby having less chance of resistance issues versus being bacteriostatic and is more potent than Zyvox and active against Zyvox resistant strains of MRSA. There is also speculation that Zyvox may not go generic until 2016 due to some patent lawsuits Pfizer was working on. This would give tedizolid almost 2 years to establish it's footprint in the MRSA space without generic competition which is huge. Additionally, we also have a ton of data for similar situations in which more than 1 antibiotic in the same family was generic while there was brand name antibiotics still doing well. For example, generic ciprofloxacin and brand Levaquin (levofloxacin). Brand name Z-pack (azithromycin) was available in the prescence of generic erythromycin and Biaxin (clarithromycin). Additionally the cephalosporins i.e. Omnicef, Cefzil, Suprax went through a similar stage. Brand name antibiotics were able to compete due to improved side effect profiles, resistance issues and other advantages such as dosing schedules etc.
I agree with you, Brandon. We have just been early on this one as we seem to know more than laypersons. For OPTR, it was already run way up in price just before it's PDUFA. I held through the PDUFA on that one and then OPTR was all over the place in price since the approval. If we buy in at these levels there is still much potential to appreciate in price for each new catalyst as you outlined above. I looked at the structures of Zyvox vs. Tedizolid. One striking difference is the amide in Zyvox vs. the primary alcohol in Ted. The alcohol is likely helping to improve pharmaceutical properties in Ted and maybe potency. Also, there are cases where Ted kills Zyvox resistant strains and 6 days vs. 10 days of treatment is also very important, I don't care what anybody else says. All of these factors will help drive the success of Ted in the future.
What is your purpose here? The stock will go up significantly at some point. This isn't the only stock we can own, you know? I have a bunch of different ones including over 150 k in SNTS shares I bought for an average of $3.34 / share in 2011 (look what happened now and I waited to make all that profit). I also have 40 k shares TSRX and will wait on that to appreciate - 1 month - 3 months, or even 1 year; I don't really give a frick what you think about that). I am up $1.4 million on SNTS alone, you small little beaver pie.