CVTX CC part 2
Lange, CV Therapeutics - Chairman, CEO [13]
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I think it is fairly widespread knowledge, Mark, that the new commissioner, Dr.
McClellan, is reaching out to a number of constituencies in academics and NIH to
bring new ideas into the FDA, and so it is actually very exciting to see those
initiatives. And I cannot really tell where he's going to go next, but I think
we're all very excited to see more money coming into the FDA under PDUFA 3,
hiring additional headcount, which would be into the hundreds (ph) over the
five-year program, and new ideas coming in as well.
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Mark Monane, Needham & Company - Analyst [14]
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Thanks very much for the update.
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Operator [15]
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Jim Birchenough of Lehman Brothers.
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Jim Birchenough, Lehman Brothers - Analyst [16]
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A couple of questions. Just on CVT-3146, I'm just wondering if you can remind
us of the status there, whether it is you or Fujisawa that is responsible for
development. I think it's you. How many patients have been treated to date was
CVT-3146? And what a Phase III trial might look like in terms of patient numbers
-- how many do you think you'll have to treat to satisfy the FDA?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [17]
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As you probably recall, CVT invented this molecule and part of it with Fujisawa
several years ago. Fujisawa reimburses its (ph) 75 percent of development costs,
but run and control development. There are milestones over and above that 75
percent reimbursement. And they (indiscernible) undertake in the U.S. sales and
marketing -- that's an extremely attractive royalty rate to us. I don't have the
exact patient numbers, but it has gone through two Phase II studies; there will
be some additional data presented in November, so you can tune in for that. The
Phase III program has been discussed and negotiated with the FDA over the last
little while, and we will plan to make an announcement when we enroll the first
patient in Phase III and give more details of the trial. We expect that to be
this year, Jim.
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Jim Birchenough, Lehman Brothers - Analyst [18]
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Okay, great. I have to ask the question, and I apologize if you can't answer
it. But to get PDUFA extension, it seems the FDA requires information that would
be deemed a major amendment. And I am just not asking what the information is,
but have you provided information to them that you think could be reasonably
deemed a major amendment?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [19]
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Jim, throughout the entire regulatory procedure there is a lot of change on a
regular basis between the FDA. But the FDA has the total call of something being
a major amendment or not. It is not up to the Company whatsoever. And I think
they deem that important for one reason or another that is known to them, but
not known to us.
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Jim Birchenough, Lehman Brothers - Analyst [20]
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Great. Thanks for taking my question.
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Operator [21]
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Chris Neek (ph) from Merrill Lynch.
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Chris Neek, Merrill Lynch - Analyst [22]
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Hi, guys. Lou, I've got two questions. One, you said that you have active
discussions with the FDA on the NDA. Are these daily discussions or are you just
sitting back and waiting for the PDUFA letter or the action letter?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [23]
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We're just not going to comment on any of our interactions with the FDA at this
point. It has been very active throughout the approximately 10-month period. We
are so close to the PDUFA date that anything we say will be pure speculation at
this point. We would like to wait and see what the letter has to say.
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Chris Neek, Merrill Lynch - Analyst [24]
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So you're waiting for the letter. Dan, I had a quick request for you. That is,
on the Acqua Wellington issue of the $15 million of shares. Was that at Acqua
Wellington's request or was that at CVTX's request?
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Dan Spiegelman, CV Therapeutics - SVP, CFO [25]
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We're the one -- it was at our request. We are the only ones, if you will, that
in fact can do a request.
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Chris Neek, Merrill Lynch - Analyst [26]
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I thought I had seen something about you had waived an early time period or a
time frame for the evaluation of those shares, and I just did not know whether
that was something --
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Dan Spiegelman, CV Therapeutics - SVP, CFO [27]
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Our agreement (indiscernible) -- the contractual agreement is an 18-day pricing
period, and we used (ph) a five-day pricing period (indiscernible).
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Chris Neek, Merrill Lynch - Analyst [28]
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I see. Thank you very much. Anxiously awaiting the FDA.
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Dan Spiegelman, CV Therapeutics - SVP, CFO [29]
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As are we all.
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Operator [30]
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(OPERATOR INSTRUCTIONS) Dennis Harp from Deutsche Bank.
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Dennis Harp, Deutsche Bank Securities, Inc - Analyst [31]
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Hi. Lou, in your prepared remarks, you outlined three possibilities --
approval, rejection, or approvable letter. I was wondering why didn't you bring
up the possibility of an extension? Is that off the table at this point?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [32]
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No, nothing is off the table. That is just with respect to the action letter.
The FDA can really do a number of different paths, and we're just trying to
paint the picture, Dennis -- at this point, as far as we know, they are all
open.
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Dennis Harp, Deutsche Bank Securities, Inc - Analyst [33]
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You also said in the prepared remarks that you would expect an answer on or
around the 30th, which is the PDUFA deadline. I guess my question would be, why
do you think the FDA would need to go right up to the eleventh hour,
potentially?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [34]
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I have no idea. Honestly, we could -- that is why we said "on or about," and
the key word there is "about." About could be early, it could be late. These
dates are only guidances. In PDUFA 3, the target is that 90 percent of the time
they will hit them; i.e. 10 percent of the time they won't. And that 10 percent
could be early or it could be late. We are not privy to what their time frame
is.
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Dennis Harp, Deutsche Bank Securities, Inc - Analyst [35]
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I guess if an extension were in the works, why wouldn't that be something that
the FDA would decide rather quickly? Why would they need to use all of the time
up to October 30th just to decide in the end that they are going to make a final
decision in January?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [36]
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I guess the reason for that potentially, Dennis, is that there is a chain of
command at the FDA. And eventually somebody has to sign the letter. And when
somebody has to sign the letter, they have to take ultimate responsibility for
that. And they may decide at the last minute that they want to do something a
little bit different. There is no ironclad statutory that they have to hit a
date or hit all of their guidances and so forth. We expect them to hit their
PDUFA date or about that, because that is what they have done with most
companies and they're sort of marching down that road, but it's honestly up to
the FDA.
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Dennis Harp, Deutsche Bank Securities, Inc - Analyst [37]
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Assuming you are approved on October 30th, how quickly could you launch?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [38]
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The goal there, as I said before, Dennis, is to do a very high-quality,
expeditious launch, but not to launch it as fast as probably one could, because
we really want to get this right. We're at parallel pathing now, as I said.
We're preparing for potential adviser committees if we get invited to them.
We're preparing to launch. We've been hiring folks, manufacturing material, and
getting ready to go. But, we have got the product, I think, well-positioned to
do very well in the marketplace, and we just have to wait for the final
information from FDA potentially.
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Dennis Harp, Deutsche Bank Securities, Inc - Analyst [39]
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Great. Thank you very much.
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Operator [40]
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Ben Stuller (ph) HS Capital.
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Ben Stuller, HS Capital - Analyst [41]
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Hi, guys. How are you? On the Acqua Wellington, it that -- do they have to sign
off on being put to stock or can you just unequivocally put it to them without
their buy-in?
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Dan Spiegelman, CV Therapeutics - SVP, CFO [42]
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We can unequivocally put it to them as long as the price is above a minimum
level (ph).
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Ben Stuller, HS Capital - Analyst [43]
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How is that minimum level determined?
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Dan Spiegelman, CV Therapeutics - SVP, CFO [44]
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It's in the contract -- I don't -- is that minimum level a public number,
Chris, do you know?
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Chris Chai, CV Therapeutics - Treasurer, Exec. Dir. IR [45]
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(indiscernible)
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Dan Spiegelman, CV Therapeutics - SVP, CFO [46]
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It is in the -- I don't recall what that number is off the top of my head. I
apologize.
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Ben Stuller, HS Capital - Analyst [47]
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Very good. Good luck with the PDUFA -- keep our fingers crossed. Thanks, guys.
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Operator [48]
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Allan Shei (ph) from R&C Corporation.
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Allan Shei, R&C Corporation - Analyst [49]
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You guys already have so much cash. Why do you guys continue issuing
shareholder (indiscernible) diluting potential future shareholders' value?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [50]
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The philosophy at CVT has been to keep the balance sheet strong, and as we go
potentially into launch year next year and with other indications of ranolazine
and outstanding pipelines, we believe that Acqua Wellington line of credit
offers us an opportunity to fine-tune the balance sheet, if you will.
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Allan Shei, R&C Corporation - Analyst [51]
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Okay. As I see it, you guys have more than 400 million outstanding and continue
issuing share, and so I am just curious about --
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [52]
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We believe the use of proceeds for pipeline development is what we should be
doing with our cash and we are doing that. As you know, we kept our rights to
ranolazine and the goal there is to try to return as much as we can to our
investors and build a great new (indiscernible) company (indiscernible).
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Allan Shei, R&C Corporation - Analyst [53]
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Let's say (indiscernible) approved. What's our estimation or what's our cost --
(indiscernible) involved in production of the drug?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [54]
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I'm sorry. I didn't understand the question.
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Allan Shei, R&C Corporation - Analyst [55]
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Let's say you guys get approval of the FDA. And what's the potential cost of
producing -- 100 million, 200 million? What is the estimate you guys have?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [56]
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You mean with respect to manufacturing Ranexa? Is that the question?
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Allan Shei, R&C Corporation - Analyst [57]
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Exactly.
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [58]
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We won't do the manufacturing ourselves. We have put together a supply chain, a
third party manufacturing supplier. So, we don't -- other than the cost of
inventory, we don't have substantial capital requirements with respect to plant
and equipment for the drug.
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Dan Spiegelman, CV Therapeutics - SVP, CFO [59]
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That's one of the great things about being a small molecule company. We don't
have to build a protein facility and pay all of this patent expenses that other
kinds of protein companies have. So we are in a great position there.
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Allan Shei, R&C Corporation - Analyst [60]
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Okay. I'm kind of suspicious. (indiscernible) companies (indiscernible) and you
guys have 400 something million on (indiscernible) securities and
(indiscernible), and you guys don't need so much money to manufacture the
pipeline you guys have. I think it is more than sufficient money to -- for the
use of future pipeline?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [61]
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Okay. Thanks.
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Operator [62]
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At this time, there are no further questions. Do you have any closing remarks?
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Dr. Lou Lange, CV Therapeutics - Chairman, CEO [63]
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No, we just want to thank everybody for tuning in. And when we hear
definitively from the FDA, we will share that information with our investors.
Thanks a lot. |
