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Momenta Pharmaceuticals, Inc. (MNTA)
Bank of America Merrill Lynch Health Care Conference Call
May 15, 2013 7:20 PM ET
Rick Shea – SVP and CFO
Sumant Kulkarni – Bank of America/Merrill Lynch
Sumant Kulkarni – Bank of America/Merrill Lynch
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Thank you very much, Sumant. Before I begin my presentation, I would like to draw your attention towards Safe Harbor statement, and the risk factors included in our SEC filings. Momenta was founded based on technologies for enhanced analytics and analysis of complex mixture products, and we use these enhanced analytics, both to make generic versions of brand drugs, complex products, as well as improved versions of complex novel products.
And we have a portfolio that includes complex generics drugs that were originally approved as NDAs as well as biosimilars and novel drugs. So within the complex generics, we have a Generic Lovenox which is approved on the market, Generic Copaxone which is under review with the FDA. We have a biosimilar collaboration with Baxter for up to six products.
With respect to our novel drug program, we have M402, a novel oncology candidate in Phase 1. And we are working with sialylated version of IVIG, that’s a very interesting opportunity for that product. So with respect to enoxaparin, this is a program that we started early in the company’s history as a way to accelerate product revenues, to fund our novel development program, and ANDA on this product was filed in 2005. And the product was approved by FDA in July of 2010. In the first 2.5 years on the market, we generated over $400 million of free cash flow from profit share and royalties from our collaboration with Sandoz on this product.
This product was really a proof-of-concept of our approach. And the approach being that, enhanced analytics would provide differentiation with the FDA. And that in fact was the case, we were the first and only generic on the market for the first 15 months of that product. And through our process in working on this product, it’s really given us a window into how the FDA is looking at complex products, like Copaxone, like biosimilars and we continue to believe that our approach gives us a differentiation.
So most recently in the first quarter, Sandoz reported net sales of $47 million that was down from $85 million in the fourth quarter of 2012, as market continues, at this point, to be a competitive market. There is pricing pressure and market share pressure. IMS data most recently Sandoz’s enoxaparin market share in that 36% to 38% range.
So at this run rate we continue to get important royalties from enoxaparin, but it’s again not the significant product that it was during 2011, but I will mention that we’re going through some litigation with respect to process patents that we had on enoxaparin. And we believe this litigation is important because we have similar patents for Copaxone for our biosimilar program. And the history of this litigation is that we filed under these two process patents for an injunction keeping Amphastar off the market, following their approval in September 2011.
And in fact at this record level, we did receive an injunction. The injunction however was overturned at the appeals court level on the basis that we have broadened view of the Safe Harbor, the Hatch-Waxman Safe Harbor. We continue to strongly believe that that interpretation is overly broad, and we are going to – we have appealed that to the Supreme Court.
And in addition, that has been sent back to the district court for some re-judgment on the basis of the Safe Harbor ruling, but again we believe that there is arguments that we can make at the district court level. So the upshot of all of this is that litigation is continuing and probably will continue for sometime. So there is always the possibility down the road of winning some damages in this case, but again the main purpose of the litigation is to protect our ability to enforce process patents that we develop on products that we develop.
So our next product in the pipeline importantly is the generic version of Copaxone, we have this MS product. And this again is a product that was approved as an NDA, it’s a synthetic polypeptide. It’s not a biologic, it doesn’t fall under the biosimilars legislation. And so therefore we filed an ANDA, and we continue to believe that the FDA will approve this application as 505(j) interchangeable product.
And we continue to have productive dialog with the FDA in their review. We believe the FDA’s bias and this is through not only their public commentary, but also our dialog with them, they continue to have a bias to approve this product as an ANDA. But we are working through and as always with the FDA, in this particular case, there is no PDUFA so therefore the timetable for approval is uncertain.
Teva has filed Citizen’s petitions requesting that the FDA not approve an ANDA for Generic Copaxone without clinical studies. The FDA has rejected four of these Citizen’s petitions. And it’s more than perfunctory. If you actually read the most recent denial of Citizen’s petition, the FDA makes some substantive arguments for its jurisdiction in this area. And again, we believe that these comments reflect their bias, and ultimately their intention to approve this ANDA as an interchangeable generic.