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Agreed Amigo... Why would they wait until the absolute last minute to file.
Cysonic- That is what I am coming up with too. Probably break even or cash flow positive third quarter as they will likely see full quarter of Seroquel sales. Here are my estimates again:
Q1: slightly over $1M which shows improvement
Q2: Same as Q1 unless we see a taste of additional Focalin doses and/or Seroquel launches early enough in May that we see some revenue from that
Q3: Should be the first full quarter of Seroquel sales so we will see great improvement. I am hoping to be at least break even this quarter. But am also optimistic we will actually maybe show a small profit.
Sprot- I have asked IPCI on the manufacturer and given you their answer before at least twice. They can get a tentative approval without naming a manufacturer. They need to name the manufacturer for full approval. Stop beating a dead horse buddy...
doog- I made the same comment as you a couple of times... The day of Glucophage approval it appeared way to many shares were changing hands and I figured it was wash trading as well.
Doog- Grunenthal is a prime candidate as well.
Tek- If I were to guess on who the top Rexista partners could be I would say MNK or TEVA.
Tek- I came up with my numbers based on a market size of $800M. I lowered the size as generic presence may lower overall market. I then looked at what percentage of the Focalin 15 and 20mg market IPCI was getting. Then I did some crude adjustments based on that. I came up with $3-6M or $4-8M per quarter. But these were done with a very analysis so I just threw out my low end number of $3M. It will be interesting to see where these numbers end up as I am cautiously optimistic.
Does anyone have any estimates on what they feel the first full quarter of Seroquel revenue will be? I think that possibly Q3 could be this quarter. I am struggling to come up with a number but feel that the low end for first full quarter of Seroquel sales may be $3M. Does anyone else have some estimates?
tek and wimike- I posted a while back what IPCI told me. They could get a tentative approval on Rexista without naming a manufacturer. To get full approval they will need to name a manufacturer. I do not know what their plans are and they did not drop any hints but my guess is they wait until closer to approval. The MNK deal was inked right around the approval date, so I am guessing they will hold off and get the best deal possible. But like I said, those are just my opinions/guesses.
Immediate release opiod ADF features are likely quite different than extended release opiods ADF features. As extended release opiods can be abused to release a dose intended for an extended period of time instantaneously. Immediate release does this by definition. So these are substantially different technologies with differing requirements. There are likely more ADF features in an extended release product.
Numbers- I hope you are right and I am wrong but here is what I get for q1:
1. 15 & 30mg revenues 450-550k
2. Mnk $3m amortized over 10 years - 75k
3. 25 & 35mg doses were not on ipci Anda so no milestone and regular profit share percentage. Also sandos is competition in a low volume market. So I estimate 400-700k for these doses.
So I am coming up with a range of 0.925k-1.325M for total of q1 revenues. So I expect a little more than 1M and would be ecstatic with 1.5M.
Q2 I see flat unless we see par launch the other doses soon. Also if seroquol launches in early may we could see some of that as well
Q3 I see a large improvement as we will probably see a full quarter of all focalin doses on the market. I expect that to be about 1.25-1.75M of revenue for that quarter. We also should have a full quarter of seroquol sales there. I don't have an estimate on that yet. But I am wondering if you have one Numbers? Or anyone else?
Aloha aloha - now put 2 and 2 together and speculate what is going on. Mnk largest opioid manufacturer, ipci with adf and podras tech that may be applied to an array of products.
Yes... I am sure it is...
Tek- So I guess you have an idea who put the block up for sale
I agree, no buyers at the level shares are for sale and no sellers at the level people will pay.
Amigo- Like I say first full year of all Focalin XR doses on the market(roughly mid 2017-mid 2018) will be roughly $5-7M. Second full year(roughly mid 2018-mid 2019)will be roughly $4.3-6.3M.
2017Q1 about $1M in revenue- maybe a little more. 2017Q2 will be flat unless additional Focalin doses hit market soon or we get another source of revenue like upfront payment, etc.
Doog- I am just trying to keep peoples expectations in check. I know we will see improvement for sure. I don't think we will quite hit $1.5M in Q1 revenue but am hoping... Like I said should be a little more than a $1M which is about double previous quarter. When all the doses hit the market, I fully expect 1st year of those sales to be between $5-7M. Q2 probably will be flat but the Seroquel launch hopefully happens in early May. Then Q3 should be a real pleasant surprise!
Amigo- You are not who I was referring to. Many people have been expecting $2-3M in Q1.
The $5-7M is my estimate for first year when ALL DOSES(8 total) of Focalin XR are on the market. So if they hit the market mid 2017. I am saying $5-7M from mid 2017 to mid 2018. I then estimate each year after, the revenue numbers will drop by roughly 10%.
I was on board with you that we would see closer to $2M in 2017Q1 until I reevaluated a couple things:
1. The new doses with exclusivity are low volume doses. The currently marketed 15 and 30mg doses are high volume doses.
2. We will only see two months of sales for these doses in the Q1 numbers.
3. I am now convinced there will be no milestone payments on a PAR ANDA. Numbers is right.
4. Prices of Focalin XR were much higher right after launch and first few months saw better profits than we are likely to see now.
Thus I stand by my revised estimate of 2017Q1 Focalin XR sales being about $1M or possibly a little more. We will see soon. I would love to see them be more but I am being realistic and also trying to keep everyone's expectations in check.
Lastly, you are probably right that 2017Q2 will be flat and about the same as 2017Q1. The additional increase in revenue will occur when these two things happen:
1. Other PAR Focalin doses hit the market(could be seen in Q2 but more likely mid year).
2. Seroquel XR is launched.
Angelo- Agreed...
I like the comment on StockTwits where the guy said "can't even pull off a decent pump and dump anymore" LOL
Doog- I agree they are not standing still.
I have been doing a little thinking and have updated some revenue estimates for the near term:
1. I think Q1 will show improvement with the addition of the new Focalin doses. Two months of sales will likely be included in Q1. These new doses are lower volume doses. So the $3M number people are throwing around is just too high. I also now believe what Numbers has said that there will be no milestone payments on these doses. So I am estimating Q1 revenues show improvement and come in at slightly higher than $1M.
2. I do think the remainder of the Focalin doses will be on the market by mid year. I estimate total Focalin XR revenue of doses in 1st year to be about $5-7M. each subsequent year we will see a decline of maybe 10%. So year two would be roughly $4.5M-$6.5M.
I would like to hear others opinions on this.
Samsa_ I think I see Tek's point. I do believe we should be higher than this though. I think $3-4 would be reasonable but still on the low side.
Remember when we were trading at $4, the thing that really brought us down was that the additional Focalin doses did not get approval. That really hurt the companies valuation. The second thing that hurt us was the dilution last year that included warrants.
Going forward, I see very positive, near sure bet catalysts coming as follows:
1. 2017Q1 revenues show nice improvement
2. PAR should release the rest of the Focalin doses in 2017H1.
3. Launch of Seroquel XR should happen some time in May 2017.
If all those things happen, revenues will be on the rise each quarter of 2017. 2018 should be a very good year as well.
One thing that would really help is a near term approval of Pristiq. That drug is partnered and we would see immediate benefit.
Lastly, the thing that is unfortunate is the market gives no value to Rexista or PODRAS. Hopefully by year end we will see some value added because of them.
Numbers- Those are some interesting numbers on Pristiq. Hopefully IPCI can get that approval sooner rather than later and get in while the price is still somewhat high.
Now I have a question for you. Do you feel once generics come on the market and price goes down, volume of prescriptions usually goes up?
Tek- I do appreciate your posts. You seem very knowledgeable and please continue contributing.
Amigo Mike and Tek- The day Gluco was approved we traded millions and millions of shares... But the price barely went up. I wish I knew how many actually changed hands that day but I get the feeling it was not anywhere near the number that was traded. I sense there was a big effort by someone to keep the share price in check and thus they wash traded to keep the price in check. I also highly suspect they lost a few shares that day. Thus, their short position increased. This is just a guess on my part but I do think that day is when an increase in short positions indeed happened.
Mike- In reality, when compared to other low float bios, the percentage of short shares is actually kind of low for IPCI. Who are the people that are short? If I had to guess I would say the market makers, maybe the holder of warrants/offering buyers and others??? I would like to hear what everyone else feels about who is short too. I don't think there are too many people just shorting IPCI as a long term trade however... If they actually did, they might be surprised when earnings start to improve... All this talk about short squeeze and percentage of short shares traded on a daily basis may be a little overblown. I hope everyone knows those numbers reported as short on a daily basis do include transactions that are really long. The way I understand it is they were actually only short momentarily and then covered immediately. I used to try and look at those sites that report short shares traded daily but you need to use so much interpretation it does not help that much. Lastly, short squeezes rarely happen and with the way traders sell the news on IPCI, I would venture to guess the last place a real short squeeze happens is IPCI.
Amigo- Will you be going to the annual meeting?
Tek- Here is my take on what I think IPCI is trying to do. I think they will apply their ADF tech and PODRAS tech to other pain medications. For example like hydrocodone, acetominephin, etc. These will go down the NDA 505b regulatory pathway. Which hopefully can rely on bio-equivalency tests to avoid costly PH3 trials. NDA means new drug application. So these are technically new drugs with a brand name but are actually just generic drugs with new features. Regabatin is currently going down the NDA pathway as well as there is no extended release Lyrica currently on the market. So in my opinion, IPCI emphasis will be on applying their ADF/PODRAS technology to pain related products.
Tek- First, I believe IPCI has the same issues as everyone with FDA approval:
1. The FDA was real slow at responding for a while. And some of their applications suffered because of it. So did many other companies as well.
2. Regulatory approval is a back and forth game and the FDA asks for more info, issues CRLs, etc. So some applications take longer. All companies face these problems as well. However, larger companies have the FDAs ear readily available and the capital to rerun tests, etc. and the ability to get the FDA to look at the new results quickly.
3. In my opinion, if you miss the first round of generic approval for some reason, it can put you at a disadvantage as the FDA has moved onto other drugs. From what I have witnessed, they may take their sweet time before getting back to the next round of approvals of a particular generic.
Lastly, I DO NOT believe any of the current ANDAS have ADF features. If they did, it is my opinion the company would be marketing this feature. The guy that wrote the SA article with those claims did very poor research and wrote an article with several inaccuracies.
Tek- Yes ADF technology can be applied to drugs like Focalin, etc. But I am guessing once you add these features it would become a NEW DRUG and would go down the NDA pathway similar to Rexista.
Angelo- I guess I am not sure on milestone payments. Hopefully we get them... But I tend to agree with Numbers interpretation of the contract and no milestone payments.
In any event, they are saying Q12017 earnings will show improvement.
Angelo- If you look at the latest presentation on page 30 they say:
"Anticipate higher Q1 2017 revenues due to 25 and 35mg launch of Focalin XR".
http://files.shareholder.com/downloads/ABEA-43EQSZ/553024327x0x932986/D2EE6E4B-4FBA-478C-8D00-56A4BC4B11C0/Company_Presentation_March_2017.pdf
Tek- Seems to me the sellers backed off after the rumor came out yesterday. Have to wonder if the guys who started the rumor were the guys selling and now are pumping. Seems to me they have to be connected somehow. Or once the rumor came out people started buying and the sellers backed off pretty hard. Either way, I think you are right.
As of February 27th they reported this:
As of November 30, 2016, we had a cash balance of $4.1 million. As of the date of this annual information form, our cash balance was $2.7 million. We currently expect to satisfy our operating cash requirements until June 2017 from cash on hand. However, we may need to obtain additional funding prior to that time as we pursue the development of our product candidates and if we accelerate our product commercialization activities. If necessary, we expect to utilize our at-the-market offering program to bridge any funding shortfall in the first and second fiscal quarters of 2017. In the second half of fiscal 2017, we expect revenues to improve as we prepare for the launch of our tentatively approved generic Seroquel XR® (quetiapine fumarate extended release tablet) on the expiry of the first filer exclusivity periods of Par Pharmaceutical, Inc. (“ Par ”) and Accord Healthcare (“ Accord ”) in May 2017
bbhuey- Yep everyone was talking about that this morning. Go look back at the posts.
He said because they have no partner it is worth $0... That is absolutely ridiculous! For God's sake, they filed an NDA... It has to be worth more than $0! But then again he assigned a pretty good amount to Regabatin. Which he says may be 8-10 years out... The PDUFA for Rexista is this year. Even with delays it should be out in 2018. But it is worth $0 and a drug that is 8-10 years out- with no partner as well- is worth substantially more!
doog- That article was absolutely pathetic and showed EXTREMELY POOR RESEARCH. He alludes the only ANDAs that will be worth anything are the ones with abuse deterrent technology like Focalin XR... Correct me if I am wrong, but NONE of IPCI's ANDAs contain abuse deterrent technology!
Tek- Thanks for sharing that article. It did point out how some analysts would arrive at a valuation. But did you notice the writer said the only ANDAs that may gain market share are the ones with abuse deterrent properties like Focalin XR... As far as I know NONE of the ANDAs have abuse deterrent properties! I don't know if this guy is an analyst or not... But it sure showed he did very poor company research and just about anything can be published on Seeking Alpha.