Momenta Pharmaceuticals Inc. (MNTA)
Q1 2010 Earnings Call
May 06, 2010; 10:00 am ET
Craig Wheeler - President & Chief Executive Officer
Rick Shea - Senior Vice President & Chief Financial Officer
Beverly Holley - Director of Investor Relations
Previous Statements by MNTA
» Momenta Pharmaceuticals, Inc. Q4 2009 Earnings Call Transcript
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» Momenta Pharmaceuticals, Inc. Q2 2009 Earnings Call Transcript
Good day ladies and gentlemen and welcome to the Momenta Pharmaceuticals, first quarter 2010 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)
I would now like to introduce to our host for today’s conference, Ms. Beverly Holley, Director of Investor Relations; ma’am you may begin.
Thank you, and good morning. I want to welcome all of you to Momenta’s conference call to discuss financial results for the first quarter of 2010, and provide a corporate update.
With me on the call today with prepared remarks are Craig Wheeler, President and Chief Executive Officer; and Rick Shea, Senior Vice President and 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. Various remarks that Momenta Pharmaceuticals may make about management’s future expectations beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the FDA’s review and inquiries regarding generic Lovenox, regulatory submissions, our product development plans, the company's revenue expenses and other results of operations, including the quarter and year ended March 31, 2010, and current and future development efforts and commercialization efforts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by terminology such as anticipate, believe, could, could increase the likelihood, hope, target, project, goals, potential, predict, might, estimate, expect, intend, is planned, may, should, will, will enable, would be expected, look forward, may provide, would or similar terms or variations of such terms or the negative of those terms.
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, 2010 filed with the Securities and Exchange Commission, under the section Risk Factors, as well as other documents that maybe filed by Momenta from time-to-time with the Securities and Exchange Commission.
As a result of such risks, uncertainties and factors, the company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein.
Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this, or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
With that, I will now turn this call over to Craig Wheeler, Momenta’s President and Chief Executive Officer.
Thank you Beverly, and good morning everyone, and thank you for joining us. We are going to keep our formal remarks short today. We will provide a quick update on corporate developments and financials, and then move on to Q-and-A.
The M-Enoxaparin ANDA is still under review by the FDA. We have continued to address technical and regulatory questions if they are asked by the FDA, and we remain optimistic that the decision will come in the near term. We believe our application meets all the requirements for approval, and also addresses the issues raised in the Citizen’s Petition.
While approval of the M-Enoxaparin ANDA cannot be assured, we do believe we are well positioned for a positive action. Should an approval be granted, we and Sandoz are prepared to launch and intend to launch as soon as possible following the FDA’s decision.
I will now discuss M356, our generic version of Teva’s Copaxone, which we are developing in collaboration with Sandoz. The ANDA for this product was submitted in 2007, and the FDA review is currently well underway. As we have discussed previously, Teva filed a patent infringement suit against us and Sandoz in August of 2008. The case is in proceeding in the US District Court.
On January 20 a Markman hearing was held, and in the Markman hearing the court considered and then construed the patent claims at issue in the case. As a reminder, there are nine patents in dispute, and they are all related. At the hearing, both Teva and Sandoz Momenta presented arguments concerning the proper definition for several terms in Teva’s patent claims.
In addition some of the Sandoz Momenta testimony centered on whether Teva had adequately defined certain key terms in the patent. Although we are not going to comment on the specifics of the argument, we believe that our attorneys presented a very strong case. We look forward to the judge’s ruling on the Markman hearing.
Because Sandoz Momenta filed a summary judgment motion prior to the hearing, the court also has the opportunity to determine that the patents are invalid, which would negate the need for a full trial. Alternatively the case will move forward to a trial which could be scheduled for the second half of this year.
I’ll now turn to M118, our rationally engineered anticoagulant. In April we announced the results of the M118 eminent clinical trials were published in the journal circulation. The key conclusions in the paper is that the eminent study, M118 was well tolerated, and provided further evidence of its feasibility for use as an anticoagulant in patients undergoing selective percutaneous coronary intervention.