Craig Wheeler ..
"On the novel drug side, our lead program, necuparanib is in Phase 2 and we expect to have top-line data in the first half of 2017. If these data are very strong we could seek accelerated approval at this point. If not, we will be on track for our first novel drug launch in 2020 or 2021." !!!..
previous CCs he was saying that data will come in as early as late 2016... this little aberration or change indicates that patients overall survival is longer. One, two, or three months tacked on to OS is a big improvement in the oncology world.... I think... mooo k
I think the president's response is gobbledygook speak...
"On Copaxone, let me -- Copaxone has -- we all knew it's a complex product and everything is not black and white and there's a little bit of gray." ... ??? maybe red and magenta and green and blue too? how about yellow?
"The [citizens] petition response and Momenta's approval gave us a lot of confidence that fundamentally, we are on the same page." ???... same page as ?
"The last bit of questions, the clarifying questions are around fine tuning --"... ???... is he thinking of cooking the books or turning the #$%$?
"I will not call exactly the fine tuning but there are some different methodologies which we have used and we're trying to give them more information about some of the aspects want to see more clarity." ??? ... oh I think he is a good politician!
"We just received questions." ??? .. what are the questions?
"We're in the process of turning it around in the next couple of days..." ???... Wha-what? he make it seem like they've just received the CRL when Momenta got approved in April.
"and then we'll be working very closely with the FDA to take it to the next logical stage.” ??? ... logical stage? seems like there are many more steps before approval! ... moo k
From their CC, Mylan reveals that they've scrubbed guidance for generic Copaxone for the rest of the year. Apparently they’ve received a CRL from the FDA in regards to their generic Copaxone... Mylan acknowledged this when Mark Goodman from UBS asked this question... (same UBS that rates MNTA a sell because we've doubled and they expect Mylan to come out with genericCopax shortly)…
"Good morning. So Rajiv, you have talked about Copaxone. I just want to make sure I understand. You said you got feedback from the FDA and in those comments there were not any concerns around the sameness of your products. So there obviously were some other issues. Can you tell us what they were? Were they just minor procedural things that you quickly gave responses to and you feel really comfortable that the FDA has now gotten everything that they need? Were the things they asked, were they surprising? I'm just trying to understand. I think we can understand why you would take it out of this year's numbers to be conservative, but it doesn't seem to make sense that you would be taking it out completely given the commentary there."...
Response from Mylan’s president....
"On Copaxone, let me -- Copaxone has -- we all knew it's a complex product and everything is not black and white and there's a little bit of gray. The [citizens] petition response and Momenta's approval gave us a lot of confidence that fundamentally, we are on the same page. The last bit of questions, the clarifying questions are around fine tuning -- I will not call exactly the fine tuning but there are some different methodologies which we have used and we're trying to give them more information about some of the aspects to see more clarity. We just received questions. We're in the process of turning it around in the next couple of days and then we'll be working very closely with the FDA to take it to the next logical stage.” (courtesy to Thomson Reuters),
Well, well, well... like Rousey, MNTA throws a counter punch that may knock out Amphastar...
"Oral Argument at 51:57 (Judge Moore: “Are you required to perform the patented process by the FDA, or are you required to determine whether or not it is 15-25% compliant?” Amphastar’s counsel: “It is the latter. And the way that Amphastar satisfies the latter is by doing the official USP test.”); id. at 52:48 (Judge Moore: “But let me go back to my question one more time. Are you required to perform the patented process by the FDA?” Amphastar’s counsel: “No, your honor. We perform that to satisfy the FDA requirement that it satisfy the 15-25% requirement.”).
Amphastar on a tizzy...
hits mat feeling dizzy...
and the crowd goes crazy
one!.... two!.... three!
shouts the referee!!!...
but Amphastar goes zzzzzz....
oops! sorry!... make that $168 Mill since the profit coming to MNTA is actually $28 million... $14 Mill x 12 weeks $168 Mill.. and if MNTA stays within its spending guidance of ~$40 million each quarter for the next 2 quarters then we are looking at $128 Million income per quarter!... divide that by outstanding shares and we have positive earnings up the yin-yang!!!!... is there something wrong with this picture?... k
wow!... amazing talent... is it safe to assume that since MNTA received $19 Million in two weeks ...without even considering ramp up, they will get at least $114 Million in 12 weeks or 3rd quarter?... k
Perfect guess by Dew Diligence.
Total revenues for the second quarter of 2015 were $44.9 million compared to $11.0 million for the same period in 2014.
Total revenues for the second quarter of 2015 include $19.2 million in product revenue, which represents 50% of contractual profit earned from net sales of Glatopa by Sandoz, net of a deduction of $9.0 million in reimbursement to Sandoz of the Companys share of pre-launch Glatopa-related legal expenses.
Sentiment: Strong Buy
Nice!... And in this Glatopa franchise, MNTA does not need to do anything except look at their bank account grow... k
These are all the prescription numbers available on GLATOPA to date since launch (from the IMS numbers posted on the MNTA IHUB board) -- Thanks to Pollyvonwog
Prescription Numbers from 7/24
TRX: Copax = 10,777 Glatopa = 957
NRX: Copax = 3,324 Glatopa = 755
NRX Quantity: Copax = 67,971 Glatopa = 26,198
Prescription Numbers from 7/17
TRX: Copax = 10,977 Glatopa = 939
NrX: Copax = 3,008 Glatop = 794
NRX Quantity Counts for 6-26, 7-2, 7-10
7/10: Copaxone = 58,173 Glatopa = 28,056
7/2: Copaxone = 50,551 Glatopa = 16,075
6/26: Copaxone = 53,193 Glatopa = 600
NRX / TRX Counts for 6-26, 7-2, 7-10
7-10: copax 10,724 glatopa 963
7-2: copax 9866 glatopa 526
6-26 copax 11337 glatopa 20
NRX is New Prescriptions or renewals
TRX is Total Prescriptions.
NRX Quantity for GLATOPA should be 30 (31) syringes / prescription (One month supply)
NRX Quantity for Copaxone is a mix of the 20 mg / 40 mg prescriptions -- 30 (31) syringes for the 20 mg prescription and about 13 (14) syringes for the thrice weekly 40 mg
The TRX counts for GLATOPA should go up to 2,000 and beyond in a couple of weeks as renewals start kicking in.
My guess is that in a few months we get to about 3,000- 4,000 in TRX for GLATOPA and about 7,000 - 8,000 for Copaxone. Getting a bigger share would then depend on what happens with the patent for the Copaxone 40 mg. If that is invalidated, GLATOPA should get to 50-60% of total sales.
MNTA should slowly start going up in price as people start realizing that this is going to mean real money coming in. There will always be an overhang with a possible approval for Mylan/NATCO's generic. However, it should not be as big an overhang when people thought that TEVA would get a generic Lovenox approval 3-4 years ago (Amphastar did and Teva didn't then). That is because the profit sharing agreement for generic Copaxone is always 50-50 regardless of how many generics there are.
Sentiment: Strong Buy
The more sales for Copaxone, the larger the market for Glatopa! Glatopa was launched two weeks before the end of Q2. We will have to wait for full Q numbers, but early indications are very good. And, no competition until the end of 2016 or beyond.
Sentiment: Strong Buy
Global sales of Copaxone® (20 mg/mL and 40 mg/mL), the leading multiple sclerosis therapy in the U.S. and globally, amounted to $1.1 billion, an increase of 12% compared to the second quarter of 2014.
In the United States, sales of Copaxone® amounted to $870 million, an increase of 31% compared to the second quarter of 2014. The increase was mainly due to higher sales volume in the second quarter of 2015 as well as price increases in August 2014 and January 2015. In addition, our U.S. Copaxone® revenues in the second quarter of 2014 were relatively low following the launch of Copaxone® 40 mg/mL in January 2014. At the end of the second quarter of 2015, according to June 2015 IMS data, our U.S. market shares for the Copaxone® products in terms of new and total prescriptions were 23.8% and 31.2%, respectively. Copaxone® 40 mg/mL accounted for 68.5% of total Copaxone® prescriptions in the U.S.
In June 2015, Sandoz launched its once daily generic version of Copaxone® 20 mg/mL, Glatopa®, in the United States. They sure like to raise prices. Think we will be fine
As expected Amphastar throws a tantrum, files a protest, wants an instant replay... In reading the files I see that two other companies are named defendants... International Medication Systems Inc. and AMPH partner Watson who became Actavis and I think is now Allergan... This is important... AGN has money... the can pay what Amphastar can't should they be found guilty...
The heat is on!... At least now MNTA will have a chance to present their case...it's a long time coming... Big Bucks on the line... moo k
closed $85 down wiping out $21Billion market cap... they could have bought MNTA for that much... :)
in a question from analyst Robyn of Deutsche Bank if Glatopa has anything to do with the flat lining of Tecfidera's sales... here's the reply, "it's Tony. First, on Glatopa, generic Copaxone. Absolutely to date, within our expectations, which I think we have talked about for awhile now, is we think that product largely has an impact within the Copaxone molecule category. Last I looked, which was probably a couple weeks back to early July there were 400 or 500 Rxs, 90%-plus of them were switches. 97% of those switches were from Cop QD, so to date, absolutely where we expected it to be. You've seen the WAC, which is 63,000, 64,000. Don't have clarity on what their contracting strategy will be, but absolutely within the expectation that we had."...
I think what he fails to account is the 10% new patients... 50 patients that could have been theirs becomes Glatopa's... the 3%(15 patients) non-Capaxone switches were most likely theirs - which means they aren't immune to the impending exodus of patients to Glatopa... It's early in the game and as more and more doctors get's comfortable with the drug they will prescribe more of it... it's the nature of the game... those small numbers will become significant... they claim that they will step up efforts in getting more patients, which is good for the industry, ultimately it's the price that decides and payers will try to funnel them into the cheaper go to drug Glatopa... moo K
the drug accounts 34% of revenue for the quarter - raking in an astronomical $883 million!...
this is a sizable target for MNTA/Sandoz as they/we have the competing drug...
This gorilla is beginning to eat somebody's lunch...
now down ~ 19% ($73.00)... wiping out ~$18 Billion in BIIB's market cap...
if there's such a thing as 'zero sum game'... a good portion of that money should be going to MNTA's market cap... my opinion only k
AP reports.... "CAMBRIDGE, Mass. (AP) -- Biogen cut its full-year adjusted profit forecast Friday as sales of one of its multiple sclerosis drugs, Tecfidera, slow down."
I think this is good news for us... Glatopa is making an impact... moo k
Hmmm... that's an idea... a vacation home in the mainland, a car of my choice and a boat!... MNTA will deliver, I know it will... varroooom!.... k
Maui. Yeah got a ticket on the big island 2 years ago. Low speed limit also. Your Porsche will have the same problem . Lets hope things really pick up and you can buy a place on the mainland to house your car of choice. Ever think of a nice offshore boat?