Momentas' CEO Discusses Q2 2012 Results - Earnings Call Transcript

Momenta Pharmaceuticals Inc. (MNTA)

Q2 2012 Results Earnings Call

August 2, 2012 10:00 AM ET

Executives

Lora Pike – Senior Director, Investor Relations and Corporate Communication

Craig Wheeler – President and CEO

Rick Shea – Chief Financial Officer

Analysts

Ronny Gal – Bernstein

Sumant Kulkarni – Bank of America

Ritu Baral – Canaccord

Joseph Schwartz – Leerink Swann

Ami Fadia – UBS

Imran Babar – Cowen

Presentation

Operator

Good day, ladies and gentlemen, and thank you for your patience. You’ve joined the Momenta Pharmaceuticals’ Second Quarter 2012 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. As a reminder, this conference maybe recorded.

I would now like to turn the call over to your host, the Senior Director of Investor Relations and Corporate Communication, Ms. Lora Pike. Ma’am, you may begin.

Lora Pike

Thanks, Al, and good morning, everyone. We thank you for joining us today for Momenta’s conference call to discuss financial results for the second quarter of 2012. Today’s call is being webcast and you can view the slide that we will be presenting in the Investor section of our website at momentapharma.com.

Joining me on the call with prepared remarks are Craig Wheeler, President and Chief Executive Officer, who will provide an update on our major program, followed by Rick Shea, Chief Financial Officer, who will provide a brief review of our second quarter results.

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 Enoxaparin sodium injection commercial prospects, our generic Copaxone program, ANDA review and patent litigation expectations and our other product development plans and expectations, including expectations of timing for clinical data results and 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 in the company’s quarterly report on Form 10-Q for the quarter ended March 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 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 the call over to Craig.

Craig Wheeler

Thank you, Lora, and welcome, everyone. A lot is happening in Momenta this year and in the second quarter we made exciting progress on a number of fronts, although, we were very disappointed by the court ruling on the Copaxone patent.

In this call, I’ll first discuss the current status and near-term outlook of Enoxaparin and generic Copaxone programs, and then I’ll focus on the growth opportunities of our follow-on biologics and new drug programs.

Turning first to Enoxaparin, in the second quarter we reported $19.4 million in Enoxaparin product revenues, based on Sandoz reported net sales of $156 million. Rick will rung through detail but I want to emphasis that Enoxaparin royalties will continue to be an important source of cash flow for us.

While we have significant upside opportunity, if we are successful in enforcing our Enoxaparin related patents and the litigation against Amphastar/Watson and against Teva. Sandoz is facing increasing competition and pricing pressure, which could impact future Enoxaparin revenues.

In the Enoxaparin litigation on June 26th, the District Court issued a claim construction order also called a Markman decision in the patent infringement cases against Amphastar/Watson and against Teva.

We are very pleased with the decision. A Markman decision is considered a critical event in a patent lawsuit, as it defines the disputed patent claim terms and therefore informs many aspects of the litigation.

In the order, the court adopted the Momenta and Sandoz claim term definitions for a substantial majority of the disputed claim. The District Court trial with Amphastar/Watson was rescheduled from October 2012 to January 7, 2013. The trail with Teva -- in the Teva case is scheduled for February 4, 2013.

Regarding the ruling from the Court of Appeals stayed temporary injunction that have prevented Amphastar/Watson from launching. The CAFC has not yet issued their ruling explaining that decision. So we continue to move forward in the District Court and continue to believe that our Enoxaparin related patents are valid, enforceable and entrenched.

Now turning to M356, our generic version of Copaxone. On June 22nd the District Court rules that Teva’s Copaxone patents are valid and entrenched. We are certainly disappointed by the ruling. However, we view this as round one in the patent litigation since we view the District Court ruling as a first step along the pathway final decision in the Court of Appeals.

We clearly disagree with the District Court and after a thorough view of the decision, we believe that there are substantial ground for appeal. The appeal was filed on July 26th, soon after the District Court’s final judgment, which was issued on July 24th. We can expect the CAFC decision in 12 to 18 months.

As expected, as a result of the District Court ruling on the Copaxone patent, Teva hasn’t granted a permanent injunction. Final approval of any generic Copaxone and is by the FDA is in joint through May 24, 2014. The expiration of the Orange Book patents. Separately, Momenta and Sandoz are in joint for marketing a generic Copaxone through September 1, 2015, the expirations of the one non-Orange Book patent.

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