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Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Payment Type By Week
MALLINCKRODT P...
Payment Type 11/10/2017 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/201
Total 744.00 726.00 699.00 735.00 768.00 770.0
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View NRX Dollars By Payment Type By Week
MALLINCKRODT P...
11/10/2017 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/201
Total 221.43k 228.88k 239.17k 232.82k 249.11k 264.72
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Count By Payment Type By Week
PAR PHARMA
Payment Type 11/10/2017 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/201
Total 6.40k 6.21k 6.28k 6.16k 6.10k 5.98
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Dollars By Payment Type By Week
PAR PHARMA
Payment Type 11/10/201 711/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/201
Total 1.71M 1.65M 1.68M 1.64M 1.62M 1.58
Source: Symphony Health Solutions
I did exactly that but no numbers showed up - I can try again and maybe it will work.
I cannot figure out quickly if I can break it out separately, unfortunately.
Here are the Focalin competitors
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Count By Manufacturer By Week
Manufacturer 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/2017
Total 83.60k 84.98k 83.89k 83.26k 83.23k 84.66k
NOVARTIS 21.76k 22.31k 21.81k 21.69k 21.57k 22.39k
TEVA USA 19.08k 19.41k 19.29k 18.85k 18.98k 18.92k
SANDOZ INC 12.44k 12.81k 12.60k 12.74k 12.73k 13.24k
IMPAX GENERICS 8.43k 8.30k 8.10k 7.71k 7.83k 7.65k
PAR PHARMA 6.21k 6.28k 6.16k 6.10k 5.98k 6.20k
KVK-TECH INC 5.39k 5.38k 5.59k 5.54k 5.64k 5.41k
TRIS PHARMA INC 3.93k 4.02k 3.87k 4.04k 3.91k 4.03k
MYLAN 3.69k 3.70k 3.86k 3.84k 3.85k 4.01k
SUN PHARMA 2.22k 2.32k 2.17k 2.21k 2.23k 2.24k
GAVIS PHARMA 350.00 365.00 327.00 420.00 370.00 411.00
ACTAVIS PHARMA 92.00 100.00 105.00 130.00 148.00 162.00
AHP 1.00 1.00
REPACKER 1.00 1.00 3.00
Source: Symphony Health Solutions
There are more below Mallinckrodt, bu they are pretty small
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Manufacturer By Week
Manufacturer 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/2017
Total 311.68k 307.03k 305.46k 306.04k 315.86k 304.23k
ACCORD HEALTHCA 98.73k 95.71k 95.96k 94.94k 98.11k 95.21k
LUPIN PHARMA 51.27k 50.55k 51.31k 51.83k 52.83k 49.84k
ASCEND LABS 41.35k 41.29k 40.08k 40.83k 41.53k 39.01k
TEVA USA 38.62k 37.59k 37.92k 37.34k 37.98k 37.58k
NORTHSTAR RX LL 26.82k 26.77k 25.92k 25.98k 27.51k 26.53k
BLUEPOINT LABS 11.65k 12.19k 11.14k 11.14k 12.23k 11.81k
ASTRAZENECA 9.93k 10.20k 10.07k 10.33k 11.02k 10.51k
PAR PHARMA 6.93k 6.87k 6.82k 7.03k 7.16k 7.16k
MACLEODS PHARMA 6.78k 6.28k 6.34k 6.25k 6.62k 6.56k
APOTEX CORP 5.45k 5.61k 5.86k 5.84k 6.28k 6.33k
SUN PHARMA GLOB 4.06k 4.10k 4.28k 4.41k 4.44k 4.03k
WEST-WAR/ROXAN 3.40k 3.38k 3.47k 3.84k 3.61k 3.40k
TRUPHARMA, LLC. 3.14k 3.03k 2.96k 2.89k 2.93k 2.85k
DR.REDDY'S LAB 1.04k 1.05k 951.00 962.00 1.08k 1.05k
SANDOZ INC 860.00 782.00 786.00 735.00 822.00 722.00
UNICHEM PHARMA 730.00 760.00 702.00 721.00 747.00 809.00
MALLINCKRODT PH 726.00 699.00 735.00 768.00 770.00 653.00
AUROBINDO PHARM 98.00 77.00 76.00 94.00 99.00 76.00
Source: Symphony Health Solutions
Focalin sales are steady
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Count By Payment Type By Week
PAR PHARMA
Payment Type 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/201
Total 6.21k 6.28k 6.16k 6.10k 5.98k 6.20
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Dollars By Payment Type By Week
PAR PHARMA
Payment Type 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/201
Total 1.65M 1.68M 1.64M 1.62M 1.58M 1.63
Source: Symphony Health Solutions
A bit of a rebound for Seroquel at least in terms of prescriptions - dollars were flat
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Payment Type By Week
MALLINCKRODT P...
Payment Type 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/201
Total 726.00 699.00 735.00 768.00 770.00 653.0
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Dollars By Payment Type By Week
MALLINCKRODT P...
Payment Type 11/03/2017 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/201
Total 491.69k 491.35k 488.68k 533.87k 526.00k 463.58
Source: Symphony Health Solutions
Looks like that was a back pocket post - ignore it.
IPCI has been disappointed with MNK. After the deal was done, MNK decided to sell the portion of their business that IPCI was connected with and lost focus. They got off to a very slow start as a result. WHile things have gotten a bit better, if you lose out on some of those original opportunities to competitors, you can't get them back very easily.
There is definitely a chance the numbers are off but I am not sure they would be "way off". Symphony is the source of the Bloomberg data.
Focalin steady as she goes
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Count By Payment Type By Month
PAR PHARMA
Payment Type 09/30/2017 08/31/2017 07/31/2017 06/30/2017 05/31/2017 04/30/201
Total 24.99k 24.88k 19.35k 20.93k 24.10k 23.79
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Dollars By Payment Type By Month
PAR PHARMA
Payment Type 09/30/2017 08/31/2017 07/31/2017 06/30/2017 05/31/2017 04/30/201
Total 6.62M 6.69M 5.19M 5.75M 6.61M 6.40
Source: Symphony Health Solutions
Heading the wrong way right now on volume but pricing ticked up a bit allowing total revenues to tick up.
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Payment Type By Week
MALLINCKRODT P...
Payment Type 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/201
Total 699.00 735.00 768.00 770.00 653.00 658.0
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Dollars By Payment Type By Week
MALLINCKRODT P...
Payment Type 10/27/2017 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/201
Total 491.35k 488.68k 533.87k 526.00k 463.58k 453.48
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Count By Payment Type By Week
PAR PHARMA
Payment Type 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/2017 09/15/201
Total 6.16k 6.10k 5.98k 6.20k 6.07k 5.78
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule DEXMETHYLPHENIDATE HCL
View TRX Dollars By Payment Type By Week
PAR PHARMA
Payment Type 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/2017 09/15/201
Total 1.64M 1.62M 1.58M 1.63M 1.61M 1.56
Source: Symphony Health Solutions
Looks like the Seroquel momentum has slowed
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Payment Type By Week
MALLINCKRODT P...
Payment Type 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/2017 09/15/201
Total 735.00 768.00 770.00 653.00 658.00 615.0
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Dollars By Payment Type By Week
MALLINCKRODT P...
Payment Type 10/20/2017 10/13/2017 10/06/2017 09/29/2017 09/22/2017 09/15/201
Total 488.68k 533.87k 526.00k 463.58k 453.48k 400.63
Source: Symphony Health Solutions
Your posts reflects a blind spot many on this board have about the impact of finances on the stock price. The company can have great data but the stock can still fall if they have to raise a ton of money at low prices. The company can do well even as the stock doesn't due to dilution. That is why I have said buying during/after the last big stock offering may be the best approach.
The top line interim PE data is the first hump and it would be very surprising if CYDY does not get over that one easily. The second hump is the financing and the positive data will help them get over that one too. The issue with this hump is how that will impact current shareholders. The company will likely make it over this hump but will shareholders get hammered in the process? It is hard to see how they won't get hurt and they could get trampled, depending on how the company decides to proceed. The third hump is just all the FDA filing stuff that needs to get done and that just takes time. They need to get a manufacturing and marketing partner as well and get the FDA to define how PRO 140 will be labeled. This is only the beginning. It will be a long time before the company is cash flow positive - think mid 2020 at the earliest.
I have not had a chance to listen to the call yet but your expectation for the approval to come through by 1Q2019 is really far off. Here is a more realistic timeline:
1.) Primary endpoint for full 50 patients hits in early December assuming they recruit the final 10 patients over next 5-6 weeks (PE data will be reported later after the data is compiled). I can see this being delayed by finances. They need to raise money to pay for this.
2.) Secondary endpoint completed sometime in May 2018. Data on secondary endpoints reported in middle or end of June. Let's assume they are able to get the safety data from the mono trial by now. If not, they will need to wait until they get that. Again, getting the safety data in a timely fashion from the mono trial requires them raising the money to pay for those patients to go through the trial.
3.) At least three months for the BLA to be put together. It took TaiMed 6 months to get the BLA filed so 3 months is being pretty generous. So this takes us to September 2018.
4.) It will take at least a year for the FDA to review the BLA. So, earliest approval seems likely to be September 2019. Now, this assumes no further delays, which is not a wise assumption based on history with this drug and with drugs generally. My best guess, factoring in normal delays would be year-end 2019.
5.) This also assumes the FDA does not require a second phase III for combo. We are all assuming this will not be required but don't be surprised if the FDA does require it.
Not sure why the FDA is asking for more with PRO 140 than with Ibaizumab. I would guess it might be related to the fact that the FDA sees PRO 140 as a drug that will address a wider market than just the MDR market. Which is good news if combo gets approved.
No, I am just an investor in TH. The phase III you saw was the second one that effectively was just an extended access program.
The FDA only required 30 for the Ibalizumab phase III and the company went ahead and recruited 40 because the patients were so sick. Indeed, 4 of them died before the trial was completed and another 4 dropped out for their own reasons if I remember correctly. So, they had 32 patients to evaluate.
Those Trx dollar numbers I believe are based on the list price. I think if you look down the same dropdown box on Bloomberg, you will find something called Manufacturers Benchmark Price which I believe is the discounted price. But I am not sure about that, it is just my guess as I have never looked into it closely. There are also other dropdown boxes with other sales numbers in them (institutional, integrated). Again, I am not sure which is the number we actually want but I wanted to make sure you knew I thought the Trx Dollars was list price and the real revenues being generated were one of those other data points.
2 phase III trials are the norm. The FDA would almost certainly require it. There would need to be a good reason for there only to be one required, which normally means the drug is desperately needed. Since the HIV population is already well served with current meds, there is no need to rush PRO 140. They will likely require the second trial to be sure the issue of resistance does not arrive.
The combo trial has been performed on what is known as multi-drug resistant (MDR) patients. Almost all MDR patients have a form of HIV that PRO 140 does not work. That is why it has been so hard for the company to find even 30 patients who fit the criteria for the combo trial. So, the market size for PRO 140 is likely to be so minimal that they will have trouble attracting a marketing partner. Now, if the FDA grants a label that is broader than the combo trial's requirements, then the combo indication could be a very meaningful drug. But the FDA does not typically do that. In this case they probably should do that, but there is not much indication so far of anything like that happening. So, it seems the company's hopes fall mostly on the mono trial. If they get approved for mono therapy, that would truly be huge. But it will not be easy and will likely require a second phase III test after the current one is completed. The reason a minimum of three HIV medicines are used to ward off the effects of the HIV virus is because the virus is crafty and easily develops resistance to just one medication so three are used to essentially keep it confused. If mono therapy with PRO 140 can show that the HIV virus cannot develop a resistance to it, that is a very big deal. But the FDA will likely want two phase III's before approving it as a mono therapy.
You should probably re-read my post rather than distort my legit concern about resistance.
No, I am not a buyer yet. One reason is I am not a believer in the idea the company is going to be purchased by a big pharma company. So, I just do not take that into consideration. Having been around boards like these for a while, I have seen how that is often used as a crutch for investors who are not willing to accept reality. Now, in this case, I will admit it is a possibility if the mono data looks very good but that is a big leap. The issue with mono is that the virus is pretty smart and has always found a way to build up a resistance when just one drug is used. If the mono data shows no indication of resistance a buyout is possible but I suspect a buyer, and the FDA, would want a whole lot of data on that and acquiring will mean more time and a second phase III for mono.
So, if you are not willing to assume a buyout and you don't yet know about the resistance issue with mono, buying now is a challenge. The finances of the company are a disaster (not just the lack of cash but the mind-numbing number of warrants and the payments required to earlier owners of PRO 140). If you don't have a buyout, I suspect you will need at least $100 million more in equity to get the mono trials completed and get revenues flowing in from that source (and that assumes the resistance issue does not crop up in the meantime).
I will listen to the conference call with an open mind. But I have always maintained the time to buy it is when the last big, dilutive financing that will hopefully get the company over the finish line is completed. We clearly are not there yet.
I am also thinking the FDA could easily require a second phase III test for combo. So, to the extent some revenues could be generated from that source (and I am not sure many can if you remember some of my older posts, it could easily be 2021 before the first sales for combo are seen.
I agree with much of what you have said here. There is little doubt the interim results will be good. The key issues now are how long it will take to recruit the needed patients (an estimated 10 for combo and an estimated 150 for mono) and how much money will need to be raised to get there and beyond.
They need to raise the money first since recruiting and treating patients costs money and hopefully, we will hear more about that on 10/19. How much will the raise and at what price? Clearly the capital raise will come after the interim PR result is released as that should help the share price and encourage new buyers to take a chance on investing in CYDY.
So, let's take a guess at timing. I suspect the interim PE results can be completed by 11/5. A fundraising should happen within one week of that. The additional 10 patients in the combo might take another 2 months but that really is not likely to be the controlling issue. That will be how long it takes to get the extra 150 patients in mono. I am going to say that takes at least six months. Hopefully I am wrong about that and maybe the only reason they don't have more already is that they simply did not have the money needed to recruit more faster. Using the six months, however, puts you in April 2018 or so. Then you need the last patient to complete 24 weeks. So that puts you in the September/October 2018 time frame. Then you have to put together the BLA and you should probably assume at least three months for that (could be longer if Theratechnologies is a relevant indicator as it took them about 6 months). So, we are now at the beginning of 2019. If the FDA does not agree to some form of speedy review, you are looking at an FDA decision at the end of 2019/early 2020.
They will need a considerable sum of money to get there. I doubt very much they will try to raise all of what would be required anytime soon but they will likely need to raise a significant amount of money. Maybe $20 million now and the rest later? The dilution will hurt but the deal will hopefully be done at a higher share price post the interim PE results.
For those who have been waiting a long time already for your ship to come in on CYDY, you likely are looking at more than 2 additional years before PRO 140 finally generates revenues (assuming the FDA does not mess with them anymore by changing criteria or asking for additional info). But if they can raise the needed money, they should make it to commercialization. While the FDA has toyed with them on the combo study, they gave them a much needed helping hand with the ability to announce the interim PE data.
I am pretty sure you can just ignore the lawsuits. The company did nothing wrong and they had so much legal language in all of their reports effectively saying you can't trust anything we say, I don't see how the cases will not be thrown out of court, assuming they make it that far.
When I read that statement, it did not give me a warm fuzzy feeling. What I heard is that they pretty explicitly expect the FDA to require more from them to get the combo trial over the hump. The question now is exactly how much the FDA expects. We will know very soon.
I am still thinking about it all. One thing we have not been told is how much it is going to cost to do the HAL/HAP studies. Will the $4 million plus the reduced cash burn over the next three quarters (until the company thinks it reaches cash flow positive status) be enough to pay for those studies and the burn? If not there is another raise in our future. But, we also don't know anything about the potential for new ANDA's being approved during the next nine months or other deals being done that could provide cash. I am not sure yet if I am ready to average down but I am certainly closer to that point since the cash gives them some possibility of getting to cash flow breakeven without another raise.
I am pleased we were not thrown under the bus. The opposite side of that coin, however, is progress on Regbatin, PODRAS and whatever else Odidi might be working on that holds a lot of promise for shareholders is postponed again.
So, right now, we have a company which will likely only have sales and hopefully earnings from ANDA's between now and late 2019 when perhaps RExista will finally start generating revenues (Mackie says not until 2020). That is a long time to wait. A Rexista approval and partnership deal with Purdue or someone else would certainly help make the wait seem shorter but there are no guarantees on either front. The stock will not get a decent PE multiple until Rexista is a reality or PODRAS gets further down the line. Hopefully, some of the $4 million can be spent on advancing PODRAS and a partnership opportunity from that can arise faster than we now think likely.
Like I said, I am still trying to sort it all out. The stock is still dirt cheap even if all we have is ANDA's for the next 18-24 months. But I have to believe there will be more than that. I just would like more communication from the company about everything and I certainly would like to feel more confident about the number of shares the company will have outstanding in 2019.
Doing a big comprehensive deal with Purdue or someone else is the best solution at this point. Odidi would have to give up control on Rexista and maybe more to the new partner but he would have the money to pursue a whole lot of other things he might like to do and he would not have to dilute either himself or us (although, technically giving some of the economic benefits away via a partnership is also dilution). But it is hard to see things coming together that quickly. Hopefully, it does as the stock would scream higher if the terms are just pretty close to normal ones for such deals.
They need good news on Thursday so they have a really credible story to go to the market with the raise just a portion of the funds needed to keep the company moving forward and to pay off the debt that comes due in January. If the news coming out of the FDA meeting is not clearly positive, it will make their job of raising the needed money really, really hard. They have already raised money at the lowest level of the range of financing alternatives and it is hard to see them moving up that range of financing possibilities to something more legitimate without some seriously good news this week. But I would not characterize their chances with the FDA as a long shot. It is probably about a 50-50 proposition that sufficiently good news comes out of the meeting to enable them to raise the needed financing to keep things moving and pay off the debt (assuming it is not converted).
It does not look like anyone has seen this yet:
https://s3.amazonaws.com/content.stockpr.com/sec/0001193125-17-306562/0001193125-17-306562.pdf
There are some additional hints about the situation with the FDA on the combo trial and the desperate need for cash is highlighted. Thursday is a make or break meeting as we have thought all along.
Whenever you meet with the FDA, the possibilities of what can come out of the meeting are more than you think because we really don't know what conversations have been going on between the company and the FDA.
They have a year to get the HAL/HAP tests done and then can request an extension from the FDA if they are not done in time. Of course, that is taking a risk but I have to believe the FDA would grant a request for additional time but I am sure they would rather not ask. So, I am not sure they can delay getting those tests going.
Likely, the best time to have bought the stock was just before the FDA CRL on Rexista. Getting that path forward on Rexista was key as none of their other drugs are close to getting approved. With that in place, the stock rationally jumped as there is hope. Now, the next hoop that has to be jumped through is the balance sheet hoop. With a new CFO in place and an humbled Odidi, the chances of legacy shareholders being thrown under the bus is higher than in the past. Hopefully, that will be avoided. If so, then the stock becomes interesting again. But I have to think they will try to raise at least a little money soon. It is the raising of a large amount of money that concerns me most.
My concern is that they have no choice and have to sell because they have no money and the tests required for Rexista have meaningful costs associated with them. The ANDA's will not help as they need the money now and even if the approvals occurred tomorrow, the would not see any cash from that for several months. Purdue may be a possibility but what incentive do they have to act quickly and cut IPCI a check in the next couple of weeks? I am concerned that a cash raise is not suicide, it is the only way to keep this thing moving forward. So, the company's survival is always going to be more important than our position as shareholders.
Good luck to all who decide to hold onto their shares through the Thursday meeting. Rarely do you see such a consequential meeting as this one. I would expect a big move in one direction or the other. Assuming CYDY gets good news from the FDA, there will certainly be a cash raise of some consequence before too much time passes. If they get bad news, I am not sure what they can do. More than likely, the news will be some mixture of good and bad and it will take a while for both the market and the company to sort it all out and figure out what to do next. Hope you are all cheering on Thursday (or Friday if they don't release the results until then).
We should know a lot more about the prospects for the company, and its shareholders, by the end of this week. Hopefully, we will see a better communications effort by the company but it is possible we will not see that if the company decides to throw us legacy shareholders under the bus and raise a lot of new money. This would signal a big turn in strategy for the company as it would show Odidi is willing to forego a big chunk of his own ownership stake for the sake of preserving the company's chances to take advantage of its science in a timely fashion. If there is not a big equity sale, then we will know the company is confident it can fund the work that needs to be done from the proceeds of Seroquel and Focalin. That seems like a stretch to me, though. Hoping for a good outcome but concerned about being run over by that bus.
Here is the latest update on sales
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE
View TRX Count By Week
MALLINCKRODT P...
Payment Type 09/29/2017 09/22/2017 09/15/2017 09/08/2017 09/01/2017 08/25/201
Total 653.00 658.00 615.00 585.00 504.00 443.0
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
QUETIAPINE FUMARATE
View TRX Dollars By Week
MALLINCKRODT P...
Payment Type 09/29/2017 09/22/2017 09/15/2017 09/08/2017 09/01/2017 08/25/201
Total 463.58k 453.48k 400.63k 415.11k 347.41k 296.82
Source: Symphony Health Solutions
Let me know if you have any questions or get hung up on something.