- Watson Pharma held 3q2011 earnings conference call 11/1/2011 - click here for transcript.
- With regards to BiotechDueDiligence stocks, WPI licensed Anturol from AIS and is to market Amphstar's generic Lovenox in competition with MNTA, pending the legal case.
- See excerpts from the call and my notes below:
"We also licensed in another product in the overactive bladder category through an agreement with Antares Pharma. This oxybutynin gel product will provide the OAB product line with dosing and delivery enhancements and has a PDUFA date of December 8 of this year"
"Given the recent court decision, LOVENOX continues to be excluded from our guidance for 2011." [Hat tip to DewDiligence on iHub for noticing this language, indicating that Lovenox revenue was never in WPI guidance for 2011]
Question and Answer session discussion re Lovenox:
My first one is on LOVENOX, Paul. I know it's excluded from guidance, but can you walk us through the possible timeline and outcomes, and of course, your personal view on what's likely to happen?
Sure. I think, as you probably know, an appeal has been filed. I think that process is going to take some time even if we get an expedited review or an expedited treatment of that appeal. I think we -- as from what we can see, I think we believe we're going to -- we have a strong case on appeal, and we'll take it from there. What I -- timeline here is really going to be dependent on what the Federal Circuit is -- how quickly they're going to move on this. So I think we still stand ready to launch the product as soon as possible, and we'll wait and see. But at the moment, as you said, we have excluded it from guidance for the rest of 2011.
Just to frame the book ends, would you say it's a couple of months fastest case and maybe a couple of years longer case? Is that reasonable? Or could it be faster?
I think it's probably as fast as probably 3 months, and longest case could be a year.
And then the second question I have was just on the LOVENOX opportunity. How large is the retail market? And what is the current generic penetration there?
So if I take the LOVENOX thing is in the retail market, I don't have the accurate -- the size of the market in millions of dollars, but overall in the retail market, the generic penetration is about 80%. Sandoz has about 80% penetration in retail. Sanofi is about 21%. Also, Sanofi announced that they are launching an AG, so there will be a 3-player market plus the brand if and when we launch our generic to the market.
First on LOVENOX, Momenta is out there saying that their expectations for timing is 12 to 18 months, and basically, a patent trial, I presume, would go to the District Court level. You guys are talking about somewhere in the range of 3 to 12 months, and I guess a legal process going to the Federal Circuit. So maybe if you can just help reconcile those timing differences
On the LOVENOX, I think our assumption on the timing is 3 months as would assume that the Federal Circuit grants expedited review for the preliminary injunction. 12 months would be the assumption to get through a District Court judgment. And so I think that was the range that we are talking about. Naturally, if there's a District Court judgment after 12 months, reasonable to expect the side that did not win to file an appeal to the Federal Circuit, so that would take longer.
Q&A discussion re branded expansion, business development:
"However, as you know, we've been very aggressive at looking for additional opportunities in Urology and Women's Health, and in some cases, even on the oncology side. So we continue to aggressively pursue opportunities to add products to our Brand portfolio"
"And a part of that strategy includes the appointment of that cash we have, and we'll be deploying that cash over the next few months for Biologics, for brand opportunities, as well generic opportunities. So for the foreseeable future, no dividend policy, no dividend at all, I think, but we certainly see growth."
"Let me start with sales force structure. Yes, we actually just added about 42, 43 representatives in October. They're actually out now promoting. It was a very rapid process of hiring representatives. They got into the company pretty quickly, and we're pleased that they're out there in the streets right now promoting. They were actually added to our Euro primary care sales force that brings that group up to just under 150. There are 175 that are doing urology and OB/GYN coverage. That will be the group that will launch PROCHIEVE to the OBs. And just to remind you, we have a 55-person SAS team, strategic accounts specialist team, that call on the key specialists in those areas, meaning urologists, infertility specialists, and now the maternal-fetal medicine. That essentially will be the group that we see launching PROCHIEVE and also carrying the ball on to continue to grow RAPAFLO, launching ANDRODERM, too, and a series of other things that we have in our bag"
"And Michael, you asked about, I guess, M&A. And you're right, we do continue to look at all the opportunities that are presented in the market. There are some that are out there and that have been intriguing, and we've looked that hard. I don't think we're shying away from any regions, really."
[I see both WPI and TEVA as dark horse potential partners for BPAX LibiGel]