Momenta Pharmaceuticals, Inc. ( MNTA)

Q3 2011 Earnings Call

November 07, 2011 10:00 am ET

Executives

Beverly Holley - Director, IR

Craig Wheeler - President & CEO

Rick Shea - CFO

Analysts

Ritu Baral - Canaccord

Eric Schmidt - Cowen and Company

Sapna Srivastava - Goldman Sachs

Joseph Schwartz - Leerink

Bret Holley - Oppenheimer Securities

Duane Nash - Wedbush Securities

Ami Fadia - UBS

Avik Roy - Monness, Crespi

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Momenta Pharmaceuticals third quarter 2011 earnings conference call. At this time, all participants are in a 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 conference is being recorded.

I would now like to introduce your host for today, Ms. Beverly Holley, Director of Investor Relations. Ma’am, please go ahead.

Beverly Holley

Thank you and good morning. I want to welcome all of you to Momenta’s conference call to discuss financial results for the third quarter of 2011 and to provide a corporate update. With me on the call today with prepared remarks, Mr. Craig Wheeler, President and Chief Executive Officer, and Rick Shea, Chief Financial Officer. Following our remarks, we’ll 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 statement including comments about our enoxaparin sodium injection commercial prospects and our generic competitors’ prospects for approval and commercialization; our generic Copaxone program, ANDA review and litigation expectations; and our other product development plans and expectations, including 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 June 30, 2011 filed with the Securities and Exchange Commission under the section risks factors as well as documents that maybe filed by Momenta from time to time with the Securities and Exchange Commission.

As a result of such risks, the company’s actual results may different materially from those we will be discussing. We’re providing the information on this conference call as of today’s date and assume no obligation to update these comments.

With that, I will now turn this call over to Craig Wheeler, Momenta’s President and Chief Executive Officer.

Craig Wheeler

Thank you, Beverly and I must I really do like your streamlined forward-looking statements. Good morning everyone and thank you for joining us on the Q3 call. This morning I will be providing an update on recent corporate developments of Momenta and after that Rick will give an overview of our financials and we’ll take the questions.

This was a very eventful quarter for us and I’d like to walk you through what has transpired with enoxaparin and provide you with our perspective. First, from a financial standpoint, we reported that net income for the quarter exceeded $60 million. Earnings per fully diluted share were $1.18 and at quarter’s end, we had a cash balance of $308 million and $85 million in accounts receivable. Clearly, we enjoyed a very strong quarter.

Let me provide a synopsis of where we are with enoxaparin commercially right now. As you know, on October 28, we obtained a preliminary injunction against Amphastar and Watson preventing them from marketing their version of enoxaparin. I’ll briefly walk you through the events leading up to that ruling.

On September 19, Amphastar pharmaceuticals received FDA approval of its ANDA for enoxaparin sodium injection. Amphastar is partnered with Watson pharmaceuticals. On September 21, we sued Amphastar, Watson and Amphastar subsidiary International Medical Systems in the US District court for the District of Massachusetts for infringement of two Momenta patents. The patents cover innovative methods for producing enoxaparin which ensure that the commercial product meets standards for identity and quality.

On September 30, we filed for a temporary restraining order and preliminary injunction against the same parties seeking to prevent their launch of enoxaparin. On October 7, we were granted a temporary restraining order pending a hearing on October 20. Following the October 20 hearing, the court extended the TRO to October 28. And finally on October 28, the court granted our request for a preliminary injunction preventing Amphastar and Watson from launching their version of enoxaparin. The key basis for this ruling is the court’s finding that we have a reasonable likelihood of proving that our 866 patents is valid and is infringed by Amphastar Watson.

In his ruling, the judge noted that the defendants failed to raise a substantial question regarding the validity of the 866 patent. The Court also required a security bond of $100 billion to be deposited by November 13 th to maintain the preliminary injunction. Sandoz and Momenta are responsible for funding this bond.

As we expect on October 28 Amphastar Watson filed a Notice of Appeal of the preliminary injunction and on November 2 filed an Emergency Motion to dissolve or stay the preliminary injunction. The Motion is now before the Court and preparations for trial will ordinarily proceed in parallel with the appeal.

This decision to grant the PI is a clear positive for us. It prevents Amphastar Watson for launching their product until a district court decision is reached or it is otherwise state dissolved to reverse on appeal, thereby preserving our current hybrid financial arrangement with Sandoz.

It is also significant endorsement of the value of our technology and the patents that protect it. Needless to say we are very pleased with the ruling.

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