Momenta Pharmaceuticals, Inc. (MNTA)

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Momenta Pharmaceuticals, Inc. (MNTA)

Q3 2013 Earnings Conference Call

November 5, 2013 10:00 AM ET

Executives

Lora Pike - Senior Director of IR and Corporate Communications

Craig Wheeler - President and CEO

Rick Shea - Chief Financial Officer

Analysts

Chris kuehnle - Leerink Swann

Ritu Baral - Canaccord Genuity

Mark Goodman - UBS

Ronny Gal - Sanford Bernstein

Difei Yang - R.F. Lafferty

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Momenta Pharmaceuticals Third Quarter 2013 Earnings Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions). As a reminder, this call will be recorded.

I would now like to introduce your host for today’s conference. Ms. Lora Pike. You may begin.

Lora Pike

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 third 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 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 potential M356 revenue and milestone revenue, expenses and results of operations, our profitability, expectations regarding the review of M356 ANDA by the FDA, for launch of M356 and it’s commercial potential, expected or planned achievement of product development milestones, timing of legal developments and decisions, and plans for future research and development investments, and/or 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 June 30, 2013 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 we will be 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.

Craig Wheeler

Thank you, Lora, and welcome everybody. This morning I will update on the status of our programs and Rick will discuss financial results for the third quarter of 2013. I will begin with comments on M356 our generic version of Copaxone. On October 18th the U.S. Federal Circuit Court denied Teva’s request to rehear the July decision that invalidated several Copaxone patents to certify Teva.

As a reminder the ruling narrowed a 2012 District Court decision clearing the way for market entry of M356 as early as May 24, 2014 the expiration date of the remaining patents. We are pleased with this action as it reaffirms that these patents will not interfere with our ability to launch the product next year, and with Sandoz, we are looking forward to bringing the cost effective version of this essential medicine to patients in the U.S. The ANDA for generic Copaxone is under active FDA review and we are fully committed to working with the FDA to support this review.

As we discussed in our two previous calls under the new GDUFA procedures OGD has implemented and what formal process regarding a less frequent communication with applicant. But we are comfortable that the review is progressing. I should note that in connections with the new GDUFA procedures the FDA has commented that it is tracking and prioritizing applications based on part and the dates of halved explorations.

They have also acknowledged that they are aware of the May 2014 patent expiration under remaining Capaxone patents. We continue to be confident that M365 will be approved under the 505 pathway as an interchangeable generic Capaxone and our plan is to be ready to launch when the patents expire.

I will now discuss during our enoxaparin results. For the third quarter of 2013, we reported we reported enoxaparin product revenue of $4.8 million. Sandoz reported third quarter enoxaparin net sales of $58 million inline with net sales of $57 million reported by the Sandoz in the second quarter of this year. We are pleased that it appears the market is stabilized but I will caution that the market continuous to be competitive.

Turning to biosimilars. To date Baxter plugged its three products for the collaboration. The first is M923 a biosimilar for a brand and biologic indicated for autoimmune and anti-inflammatory indications. We plan to submit an IND for M923 in the second half of 2014. Acceptance of the IND will trigger two milestone payments from Baxter. Also under development we have M511 an oncology antibody and MA34 another autoimmune anti-inflammatory product.

Both of these products have targeted to achieve development advantages in 2014 that would generate milestone payment obligations from Baxter. If all of these milestones are achieved, we would be eligible to receive an aggregate of $26 million. Although we have not disclosed the brand of products we are targeting, I can say that we are making excellent progress, with all three of the programs.

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