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Totally agree it's a great play here. I have an out-sized position in my portfolio in anticipation of further gains. I would not assume we will have to wait until Oct 5 to hear news. They could announce an ex-US partnership here any time. FDA could also announce approval of Duvelicib prior to October 5. The drug got Priority Review and that could drive approval ahead of date. In terms of the sales force, I think they want to hit the ground running when they get approval, and if they thought they may get approval early, it makes total sense. They are well financed with $200M shelf in July if they need it. Price action here over the last few days is positive with new highs. The thing is Defactinib may be even bigger but it's going to take a few quarters to determine that. GL.
Am using this drop to pick up as many new shares as I can. I consider this just a 30-45 day delay (at most), nothing more. The science is still intact and the lead branch voted in favor of approval. It was the consulting branch that did not, and time expired on their application. What was strange during the CC Wed was the CEO said that while the consulting branch did not grant approval, they did not cite anything specifically wrong or that needed to be corrected before granting approval. The CEO said the lead branch reached out to PAVM and said "we are quite confused as to why the consulting branch did not give the nod and we want to work with you to get this thing going." He mentioned this a few times during the CC. He also indicated they were talking to FDA late this week to determine what they need to do for approval. CEO said they have gone above and beyond what was originally asked for and all data came back highly supportive of approval. He also indicated if it was something simple, it could maybe be taken care of in a matter of days, not weeks. While disappointing, in the end, I think they will secure approval shortly. All JMO GLTA.
EMEA Strategic Pricing Manager on JNJ website...... "The post holder will lead the pricing strategy at an EMEA level for Imbruvica & Imetelstat"
https://jobs.jnj.com/jobs/00001DCC?lang=en-us
Wow - things seem to be coming together now....GLTA
Dilution is virtually assured for investors in small bio-tech so that should be no surprise to anyone investing in them. Dilution in and of itself is not necessarily a bad thing in the medium to longer term. It's what the funds received are used for and how the company best utilizes them. If they are used to grow the company's product line, or expand their business and revenues (as opposed to paying payroll just to keep the company afloat), then the return can be far greater than the extra shares (which is what I'm hoping is the case here).
A big component with raises is executive history and trust. This management team so far has been spot on in terms of execution. They are conservative in their guidance as evidenced by the recent raise in revenue for the year. There is nothing to support that the purpose of the recent raise is to line executives' pockets. VCEL reported positive operating cash flow in Q1. Management still has my confidence at least until they show otherwise. If people want to invest only where there is no dilution, there are certainly larger, very profitable companies with which to do that.
While the first inclination is frustration and blaming management, in many cases these actions can greatly benefit shareholders (e.g TNDM), though typically not in the few days or weeks after a raise. I am not a trader so my perspective is in the medium to longer term, so I don't mind some dilution if the funds are eventually earmarked for something that tangibly benefits shareholders.
I wish I had the foresight you did to buy in the low $2s. I bought in after the MACI approval - mid $3's to $4 - and continue to hold, looking for great things to unfold over the next few quarters when they put those funds to use. GL
Company submitted additional data in late July to FDA in support of CarpX and expects a decision the end of August to mid Sept (but could come any time). The new data provided additional support for approval of their device in the $1+ billion carpal tunnel market. They also have an improved device for collecting cells to look for cancer of the esophagus that they plan to take to FDA for approval late this year (also a $1+ billion market). They are well funded and indicate no new raises are necessary to launch these two devices. They also have others in their pipeline. Below is a good update by management yesterday. I am very high on this company at $1.40 as if both devices get approved (and it is easier to get a device approved than a drug), this could be a 10 or 20 bagger in a year or so. If one or both don't get approved or are delayed, stock could take a hit but I view this as an outsized reward / risk situation. JMO.
https://finance.yahoo.com/news/pavmed-reports-second-quarter-2018-113000387.html
Just my personal opinion but that may not be a bad strategy, because in some cases, especially with smaller companies, the execution risk after approval is as great (or greater) as getting the drug thru the FDA in the first place (financing, marketing, sales, meeting sales projections, competition, Dr. training, etc.). It's a whole different dynamic after approval and some companies are better than others at it. The reason I am more confident about VSTM than other small companies getting their first drug approved is that executive leadership has a lot of experience with large pharma - Genzym, Lilly, Novartis, Schering, and others. So they have been through process of not only getting a drug approved but getting it in the market.
But to your point, I can think of a couple situations where that was the case. I came across VCEL after approval for MACI and saw the stock wasn't doing anything even though they had just been approved for it. It sounded like a great procedure with no competition and there were several months after approval where the stock didn't do anything. I bought in around $3.50 to $4.00 and rode it up to just past $12 and sold. Got back in around $10 here. Management is rock solid, conservative in their guidance (they just raised revenue guidance this week by about 10%), and they are well funded. The other one is SRNE which is a little more problematic. The got their lidocaine patch approved back in Feb but their stock is 50% of where it was then because of delays getting it to market, etc. They have a pretty good pipeline though and are supposed to start getting their patch to market in Q4. They are in CAR-T and I think has a pretty good future, but they have stumbled out of the gate here on their approved product.
My plan for VSTM is if it runs up to $12 or so prior to FDA decision, I will sell half and keep half through the decision. If it stays below that, I will just wait it out and hold all through decision as it looks like very favorable at this point - data was excellent, they continue hiring (57 new employees with stock inducements yesterday), and they have funding in place. Would love to see a few more days like today! GL.
Stock inducement grants to 57 people for just over 1 million shares is significant. Really ramping up in preparation of approval - Oct 5 at latest, could be earlier based on Priority Review and strong data. Balance sheet is set, hiring is underway....just waiting for the FDA approval as the starter's gun to get the race to real revenues and patient benefits started.
https://finance.yahoo.com/news/verastem-oncology-announces-inducement-grants-203000481.html
A reputable poster on Yahoo message board posted that Clinicaltrials.gov was updated Aug 1 that defactinib trial is going to completion with primary completion still expected in Nov. The poster speculates "with only 4 months left in this open level trial, VSTM must surely already know if the defactinib + avelumab combo is working. Good indication that in this open label setting they have evaluated as of this date and are continuing study to completion (hints at success)." It also certainly helps explain the $200M shelf they may need to draw from to move forward, not a coincidence. Company has a plan and positive catalysts may be on the horizon (including approval of duvelicib by Oct 5 PDUFA date, hopefully before). GL.
Agree Eagle - floundering for most of the day and made a nice comeback at the end. I am not too worried about day to day fluctuations here as the next catalyst in late Aug - mid September (approval of CarpX for carpal tunnel in US) could send this up significantly higher. They are also working on lining up partners for outside the US and are preparing a European filing for late this year. I already have an oversize position for me and may try and add a little more if it dips at all. GL
Risk / reward here is greatly outsized in favor of reward with their two lead products addressing $1+ billion markets each, plus their other potential products. Devices are easier to get approved than drugs and their two lead devices offer excellent improvements to existing products and each addresses a large market. With recent funding completed and company saying funds in hand will get them through commercialization for both products, positive rulings here could mean big things for SP. Recently hired Chief Commercial Officer to bring products to market which indicates company is confident in approval (otherwise they would have waited the 30-60 days and hired him after approval, but they want to start getting this to market ASAP - and if you were taking that position, wouldn't you want some type of confidence from the company that they would have something for you to market shortly?). Low float and they communicate well with shareholders. A positive outcome for these two devices (second one isn't scheduled until 1st Q 2019) would, I think, propel the SP significantly.
Wish the company was a little more specific about the "large customer" that is leaving them and how material the impact will be to their revenues.
In their May 11, 2018 10-Q, on page 13 they had 3 customers with greater than 10% of revenues for the 3 months ending March 31, 2018:
- Customer A - 34%
- Customer B - 24%
- Customer C - 17%
Even worst case and it's Customer A - if they are growing at 75% this year, it seems they should be able to make up for this next year with everything they have going. Yes, it's a blow, but the fact they are taking a 40% haircut this morning seems somewhat excessive in light of their products and prospects with other customers. Thinking seriously about dipping my toe in just a little here at the $1.30 level as I think their longer term future is bright (1-2 years).
RKDA basically selling for cash on balance sheet - you get the rest of the company with strong prospects in the next few quarters for free. Super low float as only about 10% of their shares (less than 500k) are tradable as the rest are owned by management and institutions. Several catalysts on the horizon including SONOVA for cat food, GoodWheat (higher fiber and reduced gluten) commercialization, and HB4 improved soybean yields. Sufficient cash into 2020 may be enough to become CF positive. Recently brought on key new member of Board (Albert Bolles) who has significant industry experience and contacts. Any good news could really make this pop. This is a speculate stock however. The SA article below has lots of additional information and comments (on both sides) on the company. GL
https://seekingalpha.com/article/4187488-arcadia-biosciences-speculative-pure-play-genome-editing-agricultural-space
Short term trade aside - this could be a tremendous longer term investment looking at the three different branches of this company - 1) the Streamway disposal system, 2) Helomics and what they paid for it versus possible future value, and 3) TumorGenesis. Management needs to prove they can deliver but the foundation for a huge upside could be in place if they do....even on two of the three. The shorts pounced after the news of the Euro patent and I added to my position after the pullback here. I think there will be more news in the next 2 quarters, and at some point the shorts will have to capitulate. If they deliver, and that's a big "IF", this 14M company could be worth 10 or 20 times more. The risk / reward here to me is worth a few thousand shares. Do the DD and GLTA.
With the positive data presented and Priority Review, I think approval may happen before 10/5. That is just my opinion based on the data and potential patients it could help. It needs to be out in the market.
I think it depends on your investment horizon. Tough to see short term gains (prior to next CC) unless there is news, but for medium to longer term investors, the story is still very positive. Management has been quiet, but it doesn't make sense there was no earmark for that last equity raise. I am giving management the benefit of the doubt here and holding until they prove otherwise. The next month or two will tell a story.....and I think it will be a positive one.
I agree this is an exciting time for $vstm. No clue if FDA approval means a buyout but what I am hoping for is approval prior to the Oct 5 PDUFA date, which is possible due to Priority Review status. The company has said they could do $300 million with their eyes closed on Duvelisib. They recently filed for 200,000 shares for inducement grants of stock options for 9 people which could indicate a ramp up in sales. Plus they have continuing trials in Defactinib, which may turn out to be bigger than Duvelisib but it's too early to tell. I would think using $400M in Duvelisib sales plus continued satisfactory trials in Defactinib, you could argue this company would be worth at least $2 billion to a buyer at minimum. With 74 million shares out, that equates to a price of $27. I think that's pretty conservative, but also assumes FDA approval and continued progress on Defactinib. Management has lots of experience in big pharma (Genzyme, Lilly, Shering Plough, Novartis) so they know how to navigate FDA. Good luck.
Inducement grants of 200,000 shares to 9 people 90 days ahead of October 5 PDUFA date with a price of $6.95 vesting over 4 years (for 8 of the people). Looks like they could be ramping up sales force?
Duvelisib has Fast Track status for patients with CLL or peripheral T-cell lymphoma (PTCL) who have received at least one prior line of therapy and for FL patients who have received at least two prior therapies. It also has Orphan Drug status in the U.S. and Europe for CLL, SLL and FL.
Things seem to be progressing nicely.
https://finance.yahoo.com/news/verastem-oncology-announces-inducement-grants-200500900.html
Love rkda at these levels after capital raise. Super low float as only a small percentage of the 5M total shares is available for trading as the rest is owned by management and institutions. Company has around $7 share in cash now after offering a couple weeks ago. Hired key new Board member with significant industry experience and contacts. CVI Investments just reported a 7.8% stake in RKDA (372,500 shares). Low float also makes it volatile however. Risk / reward looks favorable at this price.
Showing good resilience here after a huge run-up yesterday and an overall down market today. While higher than normal volume, it is much less than yesterday. I was expecting a $.50 or so drop today, but it is fighting back this afternoon. Indicative of good strength and higher prices to come. Consonance Capital didn't pay a 10% premium on its $43M investment to get out here. Very happy to maintain current position.
Not sure if placebo was part of the reported testing but but they announced "statistically significant improvement" with a p-value of <.0001 which indicates extremely high confidence the drug works. In the link below are all the poster presentations and study details.
Title: The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension Study
Lead author: Dr. Peter Hillman, St. James University Hospital, Leeds, UK
Final Abstract Code: PF354
Summary: In the previously reported Phase 3 DUO™ study oral duvelisib monotherapy achieved a statistically significant improvement in median progression-free survival (mPFS) compared to ofatumumab in patients with relapsed or refractory CLL/ SLL (13.3 months versus 9.9 months, respectively; HR=0.52; p<0.0001), along with a manageable safety profile (Flinn, ASH 2017).
http://www.verastem.com/media/publications/posters/
well said, and thanks for some background on the previous raise. I don't think they need the money this minute, so I hope you are right they wait to do the offering to reduce dilution. And as you say, every quarter they wait means more profits and therefore less needed. I went back through the last transcript again and I do think management is pretty sharp, just took some time to right-size the business in terms of expenses versus revenues. You can tell reading through it they are very concerned about expenses and dilution, plus provide conservative guidance. Usually it's the reverse for a company this size. Agree this can be a multi-bagger with continuing trends - I think we could look back on this in a year and be very pleased!
I agree hweb - incredibly cheap here, even with the $10M offering, which I think is the drag right now. They should earn $.25 this year (or about $2M) based on 1st Q results and rev growth. If $10M was raised at today's price, share count would go to 14 million from 8 million. So even at today's price PE would still 12 for this year ($2M NI / 14M shares = $.14 or 12 PE). Hard to find a 12 PE company growing revenues "in excess of 75%" this year per CEO. Moving from losses to profitability will catch attention, plus they beat estimates every Q. Margins increased significantly in 1st Q and I think the guidance they gave may be conservative (based on history). They are very concerned about costs (from CC transcript below). I am also assuming this $10M raise will be put to good use to help grow the business, pay down debt, etc. I wish they had more PR but I think they are on the cusp of really proving they can take this higher in the next few qtrs.
https://seekingalpha.com/article/4172685-mosys-mosy-ceo-len-perham-q1-2018-results-earnings-call-transcript?page=8
I would tend to agree that it could trend sideways until Sept. but I am holding about 1/2 the position I want just in case something happens before then, which it could, and I don't want to be totally left out or I may pull a "Ken Giles" on myself (google it if you don't get the reference). Once we hit August and into Labor Day, if it's similarly priced to today, I will start buying again as I see this running up as the decision deadline approaches (assuming no negatives).
Confirmation in the article below this could be a good time to enter SOXL. Interesting read......
https://seekingalpha.com/article/4165935-best-leveraged-odds-etf-money-maker-today
Totally agree - way oversold. I picked up some this am at 121 and expecting 30% gain to about 160 in next 30-45 days (about half of the drop from highs around 200).
Positive comments from Investor Day below in SA post - increasing uses for MACI and Epicel, expanding margins, possible acquisition of medical products that complement MACI and Epicel. Only negative was a question on IxCell - "Assume nothing is coming this year."
https://seekingalpha.com/article/4164945-bullish-takeaways-vericels-analyst-investor-day
Update on TNDM below...... not mentioned in the article is that I think TNDM is due a decision on Canada distribution by May 6 at the latest. Could be another catalyst coming up shortly here.
https://seekingalpha.com/article/4164371-pivotal-point-tandem-diabetes-care
Volume low today, story hasn't changed. Days like this will happen, but mean nothing if it plays out like it looks like it will. I sold a portion of one of my big winners (TNDM) and put it in GERN. It's like free shares and diversifies the portfolio. I will average down if I can but wanted some position here, as I do feel this a volcano ready to erupt....just don't know when.
I'm a long only guy, but I would think there are much better companies out there to short than this one right now. TNDM just released good preliminary numbers, has a couple catalysts on horizon, and seems to be gaining visibility as evidenced by increasing volume the last two months. Yes, it is overbought right now by just about every measure, but that doesn't mean it can't go higher, or it gets another big pop with an announcement of some kind. JMO of course. GL.
Got some wild numbers floating around here with no corroboration. According to the WSJ link below - short interest as of 3/15/18 was 918,579 shares, or 9% of float. This was an 11% increase in short interest from the previous reporting. Not that difficult to actually go and verify. If someone has more current numbers, post a link.
http://quotes.wsj.com/AIPT
3-8-18 - Verastem (NASDAQ:VSTM) initiated with Buy rating and $15 (341% upside) price target at B. Riley FBR. This follows Oppenheimer raising their target price to $15 from $6 previously to reflect decreased risk of failure, now that details of the DUO data have been released and were excellent.
Thanks for posting. I own AIPT but missed this on Seeking Alpha. This will be an interesting year for the company.
Very nice move today on good volume. Earnings to be released Tuesday am before market. If anything like last qtr and sales momentum continues, could be another great report.
There is already one in Yahoo:
https://finance.yahoo.com/quote/xiv/?p=xiv
SVXY and UVXY are based on VIX futures, not the spot price. The futures did not spike as much as the spot price, which is probably what saved SVXY from liquidition.
I have been in and out a few times over the past year or so, but never held for more than a couple weeks to a month, and always came out ahead.......until now. I think this will be very difficult to make much money on until the 15th, when the distribution amount is set at the indicative value. As time goes on here, I expect the share price to converge with the indicative value and track it pretty closely. That is not to say the indicative value won't go up in the next week, and it's already pretty close now, but I've resigned myself just to get back what the value is next week.
I agree it will take time. The problem is weighing the probability of a big spike in the futures (which conceivably can happen any time), wiping out 90% or more of your NAV, versus what has historically been a fairly mild volatility landscape. Also, futures did not spike like the daily did on Monday, which probably saved the fund - Feb futures topped at 33 while the daily got to 50. I'm nibbling a bit here, but only small amounts that can afford to lose. GLTA.
7 trading days counting today until Accelerated Valuation Date on which the distribution is based - unless reading the below incorrectly. It's a little confusing as they talk about Acceleration Date and Accelerated Valuation Date. The way I read it is the Indicative Value (not what the last trade is) is calculated after business on Feb 15 ($5.32 as of yesterday and is the accelerated valuation date). That amount per share then gets distributed on the 21st (acceleration date). This was from C/S directly:
"The acceleration date is expected to be February 21, 2018. The date of the delivery of the irrevocable call notice, which is expected to be February 15, 2018, will constitute the accelerated valuation date, subject to postponement due to certain events. The acceleration date for XIV is expected to be February 21, 2018, which is three business days after the accelerated valuation date. On the acceleration date, investors will receive a cash payment per ETN in an amount equal to the closing indicative value of XIV on the accelerated valuation date. The last day of trading for XIV is expected to be February 20, 2018."
I don't think it will be the closing price from last night, I wish it was. Here is from an earlier post with the official CS release language. It sounds like the distribution will be the "indicative value" as of the "accelerated valuation date" of Feb 15 and then payable Feb 21 after the 3 day settlement period. The indicative value as of last night was $4.22.
http://www.velocitysharesetns.com/xiv
"The acceleration date is expected to be February 21, 2018. The date of the delivery of the irrevocable call notice, which is expected to be February 15, 2018, will constitute the accelerated valuation date, subject to postponement due to certain events. The acceleration date for XIV is expected to be February 21, 2018, which is three business days after the accelerated valuation date. On the acceleration date, investors will receive a cash payment per ETN in an amount equal to the closing indicative value of XIV on the accelerated valuation date. The last day of trading for XIV is expected to be February 20, 2018.