We should hear news about one of the trials first half of 2015 (if six months is enough time based on estimated complete date). Omeros is not the sponsor but a collaborator.
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Not sure when this will be released maybe this year or next year.
Pioglitazone for Heroin and for Nicotine Dependence
Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
surprised it help the price, seen 20 thousand shares push this stock 50 cents before. Maybe the owner selling shares to raise cash, his 60 days to exercise the option will or has ended. We should hear about the options as what was done. My guess the board gave him an extension.
I have admired your due diligence and insights re OMER and Omidria; but am reminded of the phrase "a little bit of knowledge is a dangerous thing". I have yet to see real-world validation of this story from either medical or pharmaceutical professionals. It would be welcome especially in light of the stunningly arrogant silence of this management.
I will have more questions on the event of any pop in this stock when "they" provide the 'shock & awe' theatrics re Q4/early intro,, Euro situation, etc.
they should ask the patient not the physician. Compounds are not FDA approved as there is no trial. As a consumer I would go with the FDA approved drug that is proven to be the better drug. A physician has nothing to gain by using compounds just days of defending their decision. We will know once the product is available on the acceptance of the omidria. We need to see 1 Q of sales data. Since the drug is paid 100% and Medicare is paying and additional % for the paperwork I would bet that majority of the physician will accept the drug. Saves time on compound request and the omidria trial data is excellent.
after launch we will know what % do not like to break hold habits. The younger physician will use the newer drugs as they are current on developments in the fields, and X number of the older ones will want to hold out (but without another FDA approved drug to use the holdouts might be small. It would be harder to capture market share if there was an FDA drug omeros was trying to take market share from).
With the long wait for the launch and about 4 mil procedures (1 mil a Q on average with over half government, would be 465mil) I expect a full Q revenue to be from 100-300mil. The 100mil would be getting close to 50% of the Medicare business for the Q. The 300 mil would be if the physician were to accept the drug without a major fight. I do not see 100% usage as the company is targeting the larger physician groups. Sales under 100mil after 6 months of market will be disappointing. The sales will support what the physician acceptance will be at launch. With worldwide approval imo we will break the peak sales given by analyst.
It will take time for doctors to begin to use it. Old habits are difficult to break and nobody wants to be the first to try something. The reason Omer is targeting larger clinics is because it's more cost effective and if you can get these doctors on board others will need to follow suit. The reimbursement is huge as that will help get quicker adoption of Omidria.
Building a world class biotech here, it takes some time
We should remember that most of these surgeries are done by high volume doctors, so they get into a comfort pattern. Something new, even if better requires a change. Even the billing change will cause issues as they find out which insurers will pay for Omidria. Also compounding is not that bad, there have been millions of surgeries and as far as I can tell not a lot of major adverse results from using the compounds. Watch late night TV and you will see a lot of commercials by attorneys suing on FDA approved drugs and products.
Omidria will succeed, but it may take time, many months/ few years before Omidria is the dominant drug.
As it was said by one of the paid consultants by omeros, that the good doctors will use this product for the benefit of the patient and physician. The stupid ones will retire or find a new career. If I was an attorney I would try to get the omeros sales list of physicians and target any physician not on there. Now an attorney may not be able to this data but the DOJ can if they want to press charges.
in the past drugs have come out only to be pulled after a few weeks or a few years where there were major problems not seen in the trials. Also, they may not want to learn something new (not all of them)
logical answer, and how do you know surgeons are a conserv group by nature ? if they are conservative, then i believe they would use the SAFER and APPROVED alternative ?
so, that is where the SALES people come in - I hope they are well trained, to get the doc's up to speed on this.
what tc16 said.
Just takes one patient that is unhappy getting a second option from a doctor that uses omidria to bring a lawsuit no using the FDA approved drug, the witch brews are okay if there is no FDA approved drug or the FDA approved drug would cause harm to a patient. A physician can use a which brew but it is an uphill battle when taken to court to prove why the FDA was wrong and the two phase III trails are wrong (will cost the physician tens of millions to prove this as trials are needed, but it does not excuse the physician from not following the requirement of using FDA approved drugs). The pass thru from CMS is a push for physician to use it.
Because they are use to using the "witches brew" and it has worked for them for millions of operations. Surgeons are a conservative group by nature, so don't be surprise if they wait for the leaders to trail blaze the path of using and billing for Omidria. The good thing is that once they are use to using Omidria they will be less likely to stop using it.
why would they keep using their home made witches brew ? plus they will get reimbursed for Omidria, plus the new lwas about mixing all the solutions together - any reason why they would choose not to use ? tyia
ambulance chasing attorneys will wait till there is a backlog of claims before we can start seeing commercials (may take years). Did you have cataract surgery? Was there a complication in the procedure? Were you in pain?
Now omidria is not for everyone and it will be documented in the patient file. But the physicians that still use compounds versus the FDA approved drug will have legal fees and may lose their malpractice insurance (if I was a insurance carrier I would boot physician that do not use the best product and puts me at risk).
They do not say directly of the potential but they do mention with 20mil procedures at 200. Maybe omer gets some love
Valuation and price target
Analysts are expecting Omidria peak sales around $500 million, which makes the stock a bargain at the current price. The peak sales potential might be even higher, since analysts were projecting a $200 to $250 price tag, and Omidria's WAC was established at $465. This means that the potential peak sales could be even higher than $500 million. If we take a net margin around 30% and the (most likely conservative) peak sales estimate of $500, we get $150 million in net income and applying a conservative multiple of 10 to 15, we get a market cap of $1.5 billion to $2.2 billion with zero value assigned to the pipeline. This means that the Omeros' upside is between 80% and almost 200% if we just take Omidria into account.
I am initiating Omeros with a strong buy and a $47 price target, based on the middle of the expected market-cap range. I believe that the long-term upside is more significant, and that the stock could exceed $60 in two to three years, and this will be mostly dependent on the success of Omidria and on pipeline developments to some extent. I am not the only bull in Omeros' camp, and some analysts have even more aggressive PTs. Wedbush's PT is $52 while WBB's is the highest at $60 while the median analyst price target is $38.
There are several catalysts that might drive Omeros closer to my price target:
- EU launch. The company is looking for a partner to launch Omidria in Europe and the announcement should be made before the end of 1H 2015. The announcement and the subsequent Omidria launch in the EU should be a catalyst for a higher share price.
- Pipeline announcements could both positively and negatively affect the share price, but given the company's low market cap, I believe that the positive developments should have a deeper impact on the share price than the negative ones.
- Evidence of strong Omidria uptake. If and when we see strong sales of Omidria, the stock should advance significantly. This will most