Re: Farmas USA
GLYC
Dejo un nombre interesante sobre el que he estado investigando. Ha bajado un 30% por un estudio que se esperaba por parte de algunos que fuera más rápido. Ojo que también el objetivo principal es OS (como en la competencia, esto es normal) y no PFS y que parece que hay una rama placebo (no confirmada) con lo que el reclutamiento podría ser más lento. Muy buenos resultados en fase 1/2 y gran potencial.
En el AH -25%. Parece que podría caer hasta $15 en el corto plazo pero todo esto puede cambiar según lo que digan en la rueda de prensa de las 8:30 allá.
Pongo la información que he recopilado por si a alguien le interesa. Principalmente es de biotech2k en IV y algo también de @Lblegend33 en Twitter.
GLYC get 4.41 stars
1. Management: 4.66 stars
- Clinical Development: 5 stars (One Breakthrough Therapy drug)
- Manufacturing: N/A (Not Commercial Yet)
- Financial Management: 4 stars (Still not profitable)
- Commercial Sales: N/A (Not Commercial Yet)
- Good Communications: 5 stars
2. Science: 5 stars
They have a Phase 3 program partnered with Pfizer in Vasso-Occlusive Crisis. They have breakthrough therapy for GMI-1271 in AML. They also have an ongoing phase 1 trial for GMI-1271 in Multiple Myeloma. They have GMI-1359 in early trials.
3. Potential: 5 stars (+1531% over 10 years = 153.1% annual)
Rivipansel = $250 million @ 20% royalty
GMI-1271 = $1.5 billion
GMI-1359 = ?
Total Peak Sales = $1.75 million * 8 P/S = $14 billion Market Cap peak
4. Financials: 4 stars (Still not profitable)
Cash = $112 million
Burn rate = $35 million
3 years of cash
5. Risks: 3.4 stars
-Diversified Pipeline: 5 stars (3 drugs in pipeline)
-Stage of Development: 3 stars (Phase 3)
-Commercial: N/A (Not commercial yet)
-Secondaries: 4 stars (3 years of cash)
-Clinical Failures: 5 stars (No failures yet)
Total Ranking: 4.41 stars
-
They are a selectins science company. Selectins are critical in trafficking immune cells and are expressed by immune cells and endothelial cells (blood vessel cells). They can play a key role in hematology and immunology indications.
GLYC has a lead drug in Rivipansel which is a pan selecting inhibitor for Sickle Cell Vaso-Occlusive Crisis. It is in Phase 3 right now and should read out later this year. They are partnered with PFE for 20% royalty on global sales. This indication could be worth up to $2 billion for PFE or $400 mill in royalties for GLYC. They had phase 2 data that show time to resolution of VOC was reduced from 132 hour to 69 hours. They also showed a reduction in need for opoid drug use of 83% during the VOC.
They have GMI-1271 which is an E-selectin Inhibitor. They have breakthrough therapy designation for AML. They just released the details of this trial for phase 3 to start in Q3 this year and read out at the end of 2020. The phase 2 data showed that when GMI-1271 was added to Chemo therapy. They showed a 41% complete response rate in Relapsed patients and a 68% complete response in newly diagnosed patients. They also showed that adding GMI-1271 to Chemo did not increase toxicity. In fact, It actually reduced toxicity resulting in 75% reduction in the reported mucositis rate. AML is about a $1.5 billion drug market. I think with this data it could easily do $1 billion worth of sales.
They also have GMI-1271 in a phase 1 trial for Multiple Myeloma. There is no data read out yet on this one. It is expected in early 2019 by their press release. I thought it was going to read out in June. My mistake I guess. The mechanism of action of Multiple Myeloma suggests that this could be even better in MM then it was in AML. The data still has to prove that out. The MM market is worth about $2 billion a year.
Now you have to look at the valuation. They are trading about $625 million market cap based on the after hours price. This company could be commercial by the end of 2019 an trades at less then many phase 1 companies. They have over $100 million in cash and burn about $35 million per year. I expect that cost to go up with a second phase 3 trial starting. I think their only big mistake was not to raise more cash up at the high when they had the chance.
-
I love GLYC on valuation. I think it still could double and still be cheap. It has a phase 3 in Vaso-Occlusive crisis coming later this year that is partnered with Pfizer. That could be worth about $200 to $250 mil in royalties. Pays the bills. They have breakthrough therapy and rockstar data in AML. That indication could be worth $1.5 billion ish. Just on that we should be at $1.5 billion market cap. Then we have the upside of a potential good read out in Multiple Myeloma coming this summer. I think ASCO or EHA maybe. If any company should be at $3 billion market cap, it should be GLYC. I would say it has higher potential then ARRY, BPMC, and LOXO and they are all at $3 billion market caps or more.
RGNX has epic potential with wet AMD. That would be $5 - $10 billion in one time sales. They have the safety data. Now they have to deliver the goods on efficacy later this year.
-
My GLYC numbers are:
Rivipansel = $250 million @ 20% royalty from PFE
GMI-1271 for AML is $1 billion
GMI-1271 for Multiple Myeloma is $2 billion depends on data
My current numbers are $1.25 billion for Rivipansel and GMI-1271 for just AML. I used an 8x peak sales to get a rough $10 billion peak market cap long term. I would want to see some data out of MM before I try and figure that one out for sure. It is about double the size of the AML market. I seen some analysts use 3x to 5x to estimate peak valuations. Even at the low ball of 3x you get to $3 billion market cap or more then 300% upside.
I expect comparable data to AML. I think it was about 50% in second line and in the 60% range for first line patients. I would also love to see the same reduction in toxic side effects like in AML. I think anything better then that is a big win and anything less would disappoint.
The entire company is still less then a billion dollars. How in the world does BPMC trade at $4 billion when GLYC with bigger potential gets less then $1 billion market cap. This brought my DCA up to $11.33. I think I can live with that now that I have filled my core position to 4.16%. One more buy would fill my core position completely. I am thinking about hoping for $17.24 for that bid. I think GLYC could be worth $30 before the Multiple Myeloma data and up to $60 if the data is near the efficacy that it showed in AML.
--
Let’s compare $glyc aml Data vs $cpxx which was bought out.
OS was very similar. CR+CRi was better at 68% vs 48%. Also $glyc safer w less se. cpxx also got fast track and $glyc has gotten BTD.
Given that GMI-1271 is being evaluated in combination with MEC, our base case assumes that the pivotal r/r AML trial will be a randomized active control trial with an OS endpoint. In fact, we believe that positive OS data in the r/r AML setting could provide supporting data across earlier lines of treatment and GLYC could potentially use frontline AML data from consortium- funded trials (one recently initiated in Europe, see HERE, and another could start in the U.S. soon) to expand the label. We believe this strategy could enable a broad label on a faster timeline than doing a full blown ~500 patient Phase III trial (being conducted by other companies) in the frontline setting and should be received positively by the Street.
OS Is The Most Common Primary Endpoint In Phase III Trials In AML
