Momenta Pharmaceuticals, Inc. (MNTA)
Q1 2013 Earnings Call
April 30, 2013 10:00 am ET
Lora L. Pike – Head-Investor Relations
Craig A. Wheeler – President, Chief Executive Officer and Director
Richard P. Shea – Chief Financial Officer and Senior Vice President
Ami Fadia – UBS
Ritu Baral – Canaccord Genuity
Sumant Kulkarni – Bank of America/Merrill Lynch
Eric Schmidt – Cowen & Company
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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, please go ahead.
Thank you, Karen, and good morning everyone. We thank you for joining us today for Momenta’s conference call to discuss our corporate update and financial results for the first quarter of 2013.
Today’s call is being webcast and you can view the slides we will be presenting in the investors section of our website at momentapharma.com. Joining me on the call are Craig Wheeler, President and Chief Executive Officer, and Rick Shea, Chief Financial Officer. Dr. Jim Roach, our Chief Medical Officer is also with us today and will be available to answer questions following our prepared remarks.
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 our view of M356 ANDA by the FDA, expected or 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 Annual Report on Form 10-K for year ended December 31, 2012 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 results we discussed in. We are providing 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.
Craig A. Wheeler
Thank you, Lora, and welcome everybody. And before I begin, I just want to everybody know, we have a power outage here in Cambridge. So, I huddled around the phone, so the sound quality isn’t as good as normal, I apologize.
This morning I’ll update the status of our programs and Rick will discuss financial results for the first quarter of 2013. I’ll start within enoxaparin. Enoxaparin market continues to face competitive headwinds. For the first quarter of 2013, we reported enoxaparin product revenue of $5.4 million.
Sandoz reported first quarter enoxaparin net sales of $47 million, a significant decrease from Sandoz’s fourth quarter 2012 enoxaparin net sales of $85 million. The decrease primarily reflects the continued impact of competitive pricing and lower unit sales. Rick will provide additional context in his remarks, but clearly the enoxaparin market remains competitive.
In the enoxaparin litigation with Amphastar and Actavis, as a result of the appellate court ruling that Amphastar’s use of our patented manufacturing method is protected by the Hatch-Waxman Safe Harbor, the case was remanded to the District Court; Amphastar filed a motion for summary judgment earlier this year as did Teva in a parallel suit. The District Court is considering our discovery motions prior to considering Amphastar’s motion for summary judgment. The schedule for briefing that motion has not been set. Both arguments on Teva’s motion is scheduled for May.
In February, we filed for third petition for Supreme Court review and in April the Supreme Court issued a request to Amphastar to respond and their response is due in May. We intend as planned to continue our efforts to overturn the Appellate Court’s Safe Harbor Ruling. However, there is no guarantee that we’ll be successful on our appeals and it is clear that the additional process will take a considerable amount of time.
Turning now to M356, our generic version of Copaxone, the ANDA is under active FDA review and we remain confident that M356 is approvable under the 505(j) pathway as an interchangeable generic Copaxone. We are fully committed to working with the FDA to support their continued review of the ANDA.
We are also engaging with the review staff to assure that the review process is not adversely impacted by the ongoing changes of the FDA. As you may know, the FDA has named Kathleen Uhl as the new head of the office of generic drugs and is reorganizing some departments and shifting the reporting relationships to a good number of the review staff. Announced actions include the elevation of OGD to a super office and the formation of a new office of pharmaceutical quality to oversee drug quality throughout a product lifecycle.
Janet Woodcock has stated the intent of the reorganization and took buying skills in the agency to ensure higher quality execution and focus, and to better strengthen the management structures as FDA began to add new staff funded by the generic and biosimilar user fees. While change can create some uncertainty, we are communicating with the FDA and are hopeful these changes will not impact the timing and profit of the ANDA review.