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Post by free air on Jul 8, 2021 19:43:24 GMT
I’ve looked into this and it looks solid by all metrics but is trading like it is about to go bankrupt. The only potential issue I can imagine is patent expiration, I don’t see this after reviewing their patents but I am not familiar with analyzing patents. Can someone comment on there patent protection? I’ve attached a link to there patents: patents.justia.com/assignee/optinose-asThis is from the latest 10k filing. Looks safe. "XHANCE benefits from substantial intellectual property and other technical barriers to entry, including drug delivery complexities. Our XHANCE U.S. patent portfolio consists of 13 issued device and method of use patents expiring from 2021 through 2035 and three issued design patents expiring through 2030, as well as pending patent applications. The 13 issued device and method of use patents are published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. We believe the unique features of our EDS device, as well as its delivery of a topically-acting drug, will present generic and 505(b)(2) new drug application (NDA) competitors of XHANCE with technical and human factors engineering challenges specific to drug-device combination products and chemistry, manufacturing and controls challenges unique to suspension and respiratory products. We also believe that any future substitutable generic competitors may be required to conduct, among other things, non-inferiority clinical trials demonstrating equivalent efficacy and safety outcomes to establish clinical bioequivalence to XHANCE. We believe these clinical trials, if required, would necessitate a significant amount of time and capital investment and present clinical development uncertainties. However, the FDA recently updated the list of product specific guidances for complex generic drug products that the FDA plans to issue in 2021 to include XHANCE, which may provide clarity for generic competitors to develop generic products that competes with XHANCE." Thanks I’m just wanting to make sure the patents expiring in 2021 are not a cause for concern ie a competitor can make a similar product that is functionally the same. Not sure if I’m reading too into it. I just want to make sure this investment is air tight, it’s really rare to find an investment with this much potential and minimal risk.
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Post by magnus123 on Jul 9, 2021 11:22:38 GMT
This is from the latest 10k filing. Looks safe. "XHANCE benefits from substantial intellectual property and other technical barriers to entry, including drug delivery complexities. Our XHANCE U.S. patent portfolio consists of 13 issued device and method of use patents expiring from 2021 through 2035 and three issued design patents expiring through 2030, as well as pending patent applications. The 13 issued device and method of use patents are published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. We believe the unique features of our EDS device, as well as its delivery of a topically-acting drug, will present generic and 505(b)(2) new drug application (NDA) competitors of XHANCE with technical and human factors engineering challenges specific to drug-device combination products and chemistry, manufacturing and controls challenges unique to suspension and respiratory products. We also believe that any future substitutable generic competitors may be required to conduct, among other things, non-inferiority clinical trials demonstrating equivalent efficacy and safety outcomes to establish clinical bioequivalence to XHANCE. We believe these clinical trials, if required, would necessitate a significant amount of time and capital investment and present clinical development uncertainties. However, the FDA recently updated the list of product specific guidances for complex generic drug products that the FDA plans to issue in 2021 to include XHANCE, which may provide clarity for generic competitors to develop generic products that competes with XHANCE." Thanks I’m just wanting to make sure the patents expiring in 2021 are not a cause for concern ie a competitor can make a similar product that is functionally the same. Not sure if I’m reading too into it. I just want to make sure this investment is air tight, it’s really rare to find an investment with this much potential and minimal risk. For a definitive answer, you should reach out to IR. But I don't think that this patent that expired is a problem. They have a lot of patents and again, the 10k is very clear on this matter.
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Post by free air on Jul 16, 2021 20:03:05 GMT
This company reminds me of BABA, great prospects but really trying my patience.
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Post by magnus123 on Jul 24, 2021 9:20:14 GMT
I think I now know why OPTN was so extremely weak recently. There are covenants related to the Pharmakon loan which require the company to generate $80 Million in revenue this year or they will go default with all the implications. I was aware of this, but didn't realize that the market would make such a big thing out of this. IR told me yesterday that they expect more than $80 Million in revenue this year, therefore being compliant with the covenant. The market is not convinced, which lead to the sell offs after Q4 and Q1 numbers despite the guidance. So, achieving those $80 Million + in Xhance revnue will be a massive catalyst, leading to a massive run. If the market gains confidence after Q2 or Q3 numbers, we may see a reversal sooner.
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Post by magnus123 on Jul 28, 2021 19:10:10 GMT
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Post by free air on Aug 2, 2021 3:26:54 GMT
Why is the $221 a bummer? It indicates pricing power.
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Post by magnus123 on Aug 2, 2021 9:28:37 GMT
Why is the $221 a bummer? It indicates pricing power. Yeah this was a mistake. $221 is very strong!
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Post by magnus123 on Aug 11, 2021 15:20:10 GMT
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Post by free air on Aug 11, 2021 16:21:35 GMT
Big money is leaving should we also leave? They probably know something we don’t…
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Post by magnus123 on Aug 11, 2021 16:25:53 GMT
Big money is leaving should we also leave? They probably know something we don’t… It's nothing new. IR told me that the last S3 filing was 3 years old and they had to renew. Avista isn't selling, but the filing allows them to do so.
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Post by free air on Aug 12, 2021 2:24:16 GMT
Big money is leaving should we also leave? They probably know something we don’t… It's nothing new. IR told me that the last S3 filing was 3 years old and they had to renew. Avista isn't selling, but the filing allows them to do so. Market is pricing in a public offering. While I can see the company making it to break even with their current balance sheet, management may not like to run their operations so close to bankruptcy and may opt for an equity raise. In the long run it won’t matter if sales continue to rise but can result in more downward pressure. It’s ironic because companies with bright prospects rose despite equity offering.
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Post by magnus123 on Aug 12, 2021 8:07:05 GMT
It's nothing new. IR told me that the last S3 filing was 3 years old and they had to renew. Avista isn't selling, but the filing allows them to do so. Market is pricing in a public offering. While I can see the company making it to break even with their current balance sheet, management may not like to run their operations so close to bankruptcy and may opt for an equity raise. In the long run it won’t matter if sales continue to rise but can result in more downward pressure. It’s ironic because companies with bright prospects rose despite equity offering. I'm never suprised by an offering in a small bio stock. I hope that it will not happen at this price.
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Post by magnus123 on Sept 10, 2021 9:28:03 GMT
Talked to IR yesterday to get some data on script growth for the first 8 weeks of Q3. Raw data indicates a growth of 17% compared to the same period of last year.
I suppose now that this growth rate will not change for the full quarter. The growth could be of course lower or higher than 17% for the full Q3.
Q3 20: 69.000
Calculated raw data for full Q3 21: 80.730 (17% raw script growth)
Now, we have to account a lower capture rate in IQVIA. Last year, capture rate was 95%. In Q2 this year, this rate fell to 75-85%, with a final rate of 79%. This can be different in Q3, but I'll use these numbers.
The range between 75%-85% capture rate would result in scripts of appr. 94.500 - 107.000. The final capture rate of 79% in Q2 would result in Q3 scripts of more than 101.000 scripts. If the price per prescription is the same as it was in Q2 ($221), this could result in total net revenues of $20.8 million - $23.6 million. With the Q2 capture rate, it could be $22.3 million.
Final numbers depend on how the growth develops in Sep., the capture rate and price per prescription. I think that raw script growth should accelerate in Sep. and beyond. Analysts consensus estimate for Q3 is similar to my calculation.
Edit: Q3 should be overall good if nothing really bad happens and should bode well to reach the $80 million guidance.
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Post by magnus123 on Sept 30, 2021 13:38:47 GMT
Peter Miller and Keith Goldan held a very nice fireside chat with Cantor on tuesday. Most of it was already known, but the most important line was made by Keith in the last few minutes where he said that they don't need additional cash, that they aren't planning anything and that the current position more than enough. This was the first time where he said this. Peter also said that they expect cash flow break even in a reasonably short term. I guess sometimes next year.
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Post by magnus123 on Nov 15, 2021 22:59:41 GMT
Guidance lowered to $71-75 and announced public offering, likely at $2, based on AH price.
After OPTN and INMB, I'm done forever with Bioshit. It's the worst trash sector. And it has the worst ANALysts ever. Mafia.
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Post by lcd on Nov 16, 2021 0:34:50 GMT
Ugh. I have been sitting on a position with this one wondering if I should bail with a small loss. Now I have to decide if I want to bail with a much larger loss.
It is interesting that the name of this board is Biotech Investor and most of us started following stem cell stocks, then migrated to broader biotech stocks, then almost entirely moved away from biotech. I still have shares of OPTN, INMB, and ATHX, but will be hard pressed to ever sink any sizable money into another early stage biotech.
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Post by selluwud on Nov 16, 2021 1:09:49 GMT
Ugh. I have been sitting on a position with this one wondering if I should bail with a small loss. Now I have to decide if I want to bail with a much larger loss. It is interesting that the name of this board is Biotech Investor and most of us started following stem cell stocks, then migrated to broader biotech stocks, then almost entirely moved away from biotech. I still have shares of OPTN, INMB, and ATHX, but will be hard pressed to ever sink any sizable money into another early stage biotech. Amen, I feel ya!
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Post by magnus123 on Nov 16, 2021 9:27:08 GMT
Ugh. I have been sitting on a position with this one wondering if I should bail with a small loss. Now I have to decide if I want to bail with a much larger loss. It is interesting that the name of this board is Biotech Investor and most of us started following stem cell stocks, then migrated to broader biotech stocks, then almost entirely moved away from biotech. I still have shares of OPTN, INMB, and ATHX, but will be hard pressed to ever sink any sizable money into another early stage biotech. Talked about the trend away from bio stocks with Jham already. We came to the same conclusion. It's simply a trash sector. I'll most likely sell the biggest part of my INMB holding and work on a different strategy. "Now I have to decide if I want to bail with a much larger loss." Yeah... I'd like to dump for at least $2.50...
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Post by JHam on Nov 16, 2021 10:53:27 GMT
I currently own zero biotech stocks. The entire sector is a bit cold at the moment and the old patterns that used to be so easy to predict (buy before data run-up, sell the news) don’t work as well anymore.
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Post by selluwud on Nov 16, 2021 10:59:15 GMT
I currently own zero biotech stocks. The entire sector is a bit cold at the moment and the old patterns that used to be so easy to predict (by before data run-up, sell the news) don’t work as well anymore. New sector: Former Biotech Investors
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