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Momenta Pharmaceuticals Inc. (MNTA)
Q4 2011 Earnings Call
February 9, 2012 10:00 am ET
Beverly Holley - Director, IR
Craig Wheeler - President & CEO
Rick Shea - SVP & CFO
Sumant Kulkarni - Bank of America
Duane Nash - Wedbush Securities
Alan Sonnenfeld - Sanford Bernstein
Ritu Baral - Canaccord
Ami Fadia - UBS
Joseph Schwartz - Leerink Swann
Jami Rubin - Goldman Sachs
Imran Babar - Cowen & Co
Previous Statements by MNTA
» Momenta Pharmaceuticals CEO Hosts Investor Conference Call to Discuss Follow-On Biologics Collaboration with Baxter (Transcript)
» Momenta Pharmaceuticals' Management Presents at Deutsche Bank BioFEST 2011 - Event Transcript
» Momenta Pharmaceuticals' CEO Discusses Q3 2011 Results - Earnings Call Transcript
Thank you and good morning. I want to welcome all of you to Momenta’s conference call to discuss financial results for the fourth quarter and full-year 2011 and provide a corporate update. With me on the call today with prepared remarks are Craig Wheeler, President and Chief Executive Officer, and Rick Shea, Chief Financial Officer. Following our remarks, we’ll open the call to questions.
Before we begin, I’d like to mention that our call today will contain forward-looking statements about management’s future expectations, beliefs, plans and prospects. These forward-looking statement include comments about our enoxaparin sodium injection commercial prospects and our generic competitors’ prospects for approval and commercialization; our generic Copaxone program, ANDA review and patent litigation expectations; and our other project development plans and expectations, including our future development, partnering and commercialization potential for our development programs.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to on the company’s quarterly report on Form 10-Q for the quarter ended June 30, 2011 filed with the Securities and Exchange Commission under the section risks factors as well as other documents that maybe filed by Momenta from time to time with the Securities and Exchange Commission.
As a result of such risks, the company’s actual results may differ materially from those we will be discussing. We’re providing the information on this conference call as of today’s date and we assume no obligation to update these comments.
With that, I will now turn this call over to Craig Wheeler, Momenta’s President and Chief Executive Officer.
Thank you, Beverly. Good morning everyone and thank you for joining us on the Q4 call. Today I’ll start with an update on enoxaparin which has seen a few changes lately and then I’ll move on to recap 2011 with a focus on our two yearend deals and what they will mean for our company going forward. After that Rick will give an overview of our financials and provide some guidance and then we’ll take the Q&A.
Enoxaparin is now a multi-generic market after at risk launch from Watson and Amphastar following the stay of the preliminary injunction by the appellate court. We were disappointed with the court’s decision, but until a final decision is issued we won’t know for sure the reasons for staying the preliminary injunction. Whether the PI will be reinstated or most importantly how the CAFC ruling might impact the district court’s proceeding.
But I can confirm that Watson and Amphastar have launched and their product is on the market. Competition is a fact of life in the generic business and this is not entirely unexpected. We are very proud of the fact that Momenta Sandoz was the sole provider of generic Lovenox for over 18 months. In their ground-breaking approval of the generic Lovenox ANDA, the FDA established a framework and criteria that we expect will be used to review other complex drugs such as Copaxone and biosimilars. Although the ANDA was filed over two years after our competitors, our advanced analytics and process capabilities provide our application to lead the way for the approval of this first complex generic. We invested heavily in developing the methods to analyze and produce enoxaparin and continue to believe that our IP will protect our proprietary methods for manufacturing this product.
We are aggressively pursuing this patent claims for damages and a permanent injunction in the District Court suit filed by us against Watson and Amphastar. Their launch is at risk, pending the result of that patent litigation and we continue to have confidence in the strength of our case. The trial is currently set for October and preparations are proceeding.
Rick will discuss the enoxaparin economics more fully in his remarks, but I can confirm that we are now in a royalty scenario. As of the recent launch by Watson Amphastar, Sandoz will pay Momenta a royalty on its net sales of enoxaparin.
In each contract year, which begins on July 1, for net sales up to a predesigned sales threshold, the royalty is payable at a 10% rate and for net sales above the sales threshold the royalty rate increases to 12%. It is too early to give you a sense of how competition will evolve with the entry of Watson Amphastar, but we expect to be able to provide more visibility in the next quarter.
I have one other bit of news on enoxaparin. We were pleased that earlier this week, the US District Court in Washington DC ruled that the FDA acted within its authority when approving the Sandoz-Momenta generic Lovenox ANDA. As a reminder, in July of 2010, Sanofi sued the FDA alleging that it exceeded its statutory authority when it approved a generic version of the Sanofi drug Lovenox. This decision reaffirms the FDA’s right to approve ANDAs for complex generic drugs such as enoxaparin and Copaxone based on the totality of the evidence provided to them.