Momenta Pharmaceuticals, Inc. (MNTA)
Q2 2013 Earnings Call
August 1, 2013 10:00 AM ET
Lora Pike - Senior Director of IR and Corporate Communications
Craig Wheeler - President and CEO
Richard Shea - CFO
Ritu Baral - Canaccord Genuity
Sumant Kulkarni - Bank of America
Ritu Baral - Canaccord Genuity
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I would now like to turn the call over to your host, the Senior Director of Investor Relations and Corporate Communications, Ms. Lora Pike. Ma’am, you may begin.
Thank you, operator, and good morning everyone. We thank you for joining us today for Momenta’s conference call to provide a corporate update and review our financial results for the second quarter of 2013.
Today’s call is being webcast and you can view the slides that we will be presenting in the investors section of our website at momentapharma.com. Joining me on the call today are Craig Wheeler, President and Chief Executive Officer, and Rick Shea, Chief Financial Officer.
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 statements include comments about our corporate goals and strategies, expectations regarding the company’s future revenues including enoxaparin revenue and milestone revenue, expenses and results of operations, our profitability, expectations regarding the view of M356 ANDA by the FDA, expected or planned achievement of product development milestones, the timing of legal developments and decisions, and plans for future research and development investments, and/or other product development and research plans.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31st, 2013 which is filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the SEC. As a result of such risks, the Company’s actual results may differ materially from those what we discussing. We are 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 the call over to Craig.
Thank you, Lora, and welcome everybody. This morning I’ll update the status of our programs and then Rick will discuss the financial results for the second quarter of 2013.
I am pleased to begin this call with comments on M356, our generic version of Copaxone. Last week, the Court of Appeals for the Federal Circuit issued a written opinion on the Copaxone patent litigation. The Federal Circuit partially reversed the District Court’s ruling and determined that several patents asserted in the case are invalid including the only patent asserted in the case that was set to expire in September 2015. The decision was an important win for Momenta and Sandoz as it offers the potential to launch generic Copaxone after the remaining patents expire on May 24th, 2014. With the legal position now understood the strategy for the program is clear and we will continue to work with the FDA to advance their review of the ANDA.
In addition to the Appellate Court case, Teva also filed a claim against us and Sandoz alleging infringement of patents that involve molecular weight markers for Copaxone. These patents have been referred to as the Gad patents. On July 16th, the District Court ruled in favor of Momenta and Sandoz and granted our motion to dismiss the case in its entirety. The opinion is public and it can be accessed on the New York district’s web site. It is possible Teva will appeal this ruling.
The ANDA for generic Copaxone is under active review at the FDA. I should note that we are now operating under the new review procedures that the FDA’s office at generic drugs adopted under the generic drug user agreement with industry last year.
Under the new procedures, the FDA’s communication with applicants is well defined but also more formal. So, we expect to see less informal feedback from the FDA than we were getting prior to the PDUFA implementation.
We've always been reluctant to give specific guidance on the timing of end of approval because review process has not fully transparent nor is it our control, that being said, we remain confident the M356 ANDA is approvable under the 505(j) pathway as an interchangeable generic Copaxone and we are fully committed to working with the FDA to support their continued review and approval of the ANDA.
I will now discuss enoxaparin, for the second quarter of 2013; we reported enoxaparin product revenue of $1.6 million. Sandoz reported second quarter enoxaparin net sales of $57 million which is an increase from the net sales of $47 million reported by the Sandoz’s in the first quarter of this year. While we are pleased with the increase and their comments during their second quarter earnings call, Sandoz noted that the market is competitive with continuing pressure on pricing. In addition, our second quarter enoxaparin product revenue was reduced from the calculative growth the amount of 5.4 million to 1.6 million due a $3.8 million annual adjustment made under our collaboration agreement with Sandoz that relates to the repayment of our share of pre-commercial development and other expenses.