Momenta Pharmaceuticals, Inc. (MNTA)
Q4 2012 Earnings Conference Call
February 15, 2013; 10:00 a.m. ET
Craig Wheeler - President & Chief Executive Officer
Rick Shea - Chief Financial Officer
Lora Pike - Senior Director of Investor Relations & Corporate Communications
Ronny Gal - Sanford Bernstein
Sumant Kulkarni - Bank of America/Merrill Lynch
Ami Fadia - UBS
Eric Schmidt - Cowen & Co.
Whitney Ijem - Canaccord
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I would like to turn the call over to our host, the Senior Director of Investor Relations and Corporate Communications, Ms. Lora Pike. Ma’am, you may begin.
Thank you Karen and good morning everyone. We thank you for joining us today for Momenta’s conference call, to discuss financial results for the 2012 fourth quarter and full year. Today’s call is being webcast and you can view the slides 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; and Rick Shea, Chief Financial Officer. Following our remarks we will 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 statements include comments about enoxaparin sodium injection commercial prospects and revenues, including comments regarding the fourth quarter revenue as indicative of future enoxaparin revenue and anticipated achievement of milestones and revenue in 2014 under the Baxter collaboration.
These forward-looking statements also comment on future operating expenses, cash burn and total operating expense for 2013. Our generic Copaxone program, ANDA review and patent litigation, timing 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 Sep 30, 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 are providing this information on this conference call today 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. Today I’ll start out with a quick review of the numbers for the fourth quarter and for the full year, which Rick will cover in more depth in his section. Then I’ll provide an overview of the current status of our key programs, and I’ll finish with a few reflections on the past year and my expectations for 2013.
2012 was a transition year for Momenta, as we built out and balanced the company in our three core areas; complex generics, biosimilars and novel drugs. Exciting areas where we have more opportunities than ever before to scale our business.
Our results for the full year were a net loss of $59 million, driven by our total enoxaparin revenues of $55 million and total operating costs of $124 million. We are pleased to report $10.8 million in product revenue to enoxaparin in the fourth quarter, based on Sandoz’s reported net sales of $85 million. We expected that the fourth quarter enoxaparin net sales would recover from the third quarter levels, which were negatively impacted by the competitive pricing pressures.
For the fourth quarter Sandoz reported stable market share in pricing and we are hopeful that that will continue; however, the enoxaparin market continues to remain competitive and Rick will have more information on our expectations for financial performance for 2013 in his prepared remarks.
I’ll start my program updates with enoxaparin, specifically our ongoing litigation with Amphastar and Watson, which is now an activist. In August of last year, the Court of Appeals issued an opinion explaining its decision to state the preliminary injunction that had prevented Amphastar, an activist from launching their generic lovenox.
The appellate court ruled that Amphastar’s use of our patented method was protected by the Hatch-Waxman’s Safe Harbor. In November our request for an en banc appellate review of the ruling was denied and we are now planning to file a cert petition in the next few days for Supreme Court review.
As a result of the appellate court ruling, the case has been remanded to the District Court and Amphastar has filed a motion for summary judgment. A schedule for briefing that motion has been set.
We believe that the appellate court’s safe harbor ruling is contrary to the language and the intent of Hatch-Waxman, so we and Sandoz plan to continue our efforts to over turn this ruling; however, it’s clear that the judicial process could 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 it can be approved under the 505(j) pathway as an interchangeable generic to Copaxone.