Momenta Pharmaceuticals, Inc. (MNTA)

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Momenta Pharmaceuticals, Inc. (MNTA)

Q4 2013 Earnings Conference Call

February 10, 2014 10:00 ET

Executives

Lora Pike - Senior Director, Investor Relations

Craig Wheeler - President and Chief Executive Officer

Rick Shea - Chief Financial Officer

Analysts

Ritu Baral - Canaccord

Ronny Gal - Bernstein

Jason Gerberry - Leerink Partners

Sumant Kulkarni - Bank of America/Merrill Lynch

Eric Schmidt - Cowen & Company

Chris Hamilton - R.F. Lafferty

Presentation

Operator

Good day, ladies and gentlemen and welcome to the Momenta Pharmaceuticals’ Fourth Quarter 2013 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 follow at that time. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to introduce your host for today’s conference, Lora Pike, Senior Director, Investor Relations. Please go ahead.

Lora Pike - Senior Director, Investor Relations

Thank you, Amanda and good morning everyone. We thank you for joining us today for Momenta’s conference call to discuss financial results for the fourth quarter and full year of 2013. Today’s call is being webcast and you can view the slides we will be presenting in the investor section of our website at monentapharma.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 our enoxaparin sodium injection commercial prospects and revenues , anticipated achievement of development milestones, including milestones and revenue under the Baxter collaboration in 2014, comments regarding future operating expenses, cash burn and total operating expenses for 2014, our generic Copaxone program and a review in patent litigation, timing expectations and our other product research and development plans and expectations, including expectations of timing for clinical data results and our future development decisions, partnering and commercialization potential for our development programs. Such forward-looking statements involve known and unknown risks and uncertainties and other factors referred to in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2013 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 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 - President and Chief Executive Officer

Thanks, Lora and welcome everyone. Today, I will begin with a high level review of our 2013 financial results. Then I will discuss the growth opportunities in 2014 for each of our key programs. Rick will cover our financial results in more depth in his section.

So first, our financial results, for the full year, we reported a net loss of $108 million. Our operating expenses for 2013 were on target at $145 million. Total revenues of $35 million were slightly below plan driven by lower enoxaparin revenues of $16.7 million. For 2013, Sandoz reported enoxaparin net sales of $213 million, down from $451 million for 2012. The decline in product revenues from enoxaparin sales in 2013 was primarily due to decreased prices and lower market share in response to competitive pressures. For the fourth quarter, Sandoz reported stable market share and we are hopeful that will continue.

The successful execution of our 2013 objectives across our businesses has laid the groundwork for our future growth. We are looking for to an eventful 2014 for the company as we expect programs in each of our three businesses: complex generics, biosimilars and novel drugs to hit meaningful development milestones.

In our complex generics business, we and Sandoz are gearing up for what we are hopeful will be a successful launch this year of M356, our generic version of Copaxone. M356 could be the first generic medicine in the multiple sclerosis market. There is considerable anticipation of this launch in the marketplace as the prices of all MS branded medicines have increased dramatically in the past decade. In particular, Copaxone has had a price increase of over 120% in just the last five years. We are also well aware of the emerging competition in the MS market. The oral medicines led by Biogen’s Tecfidera have made inroads against the established injectable therapies. Also two weeks ago, Teva received approval of its three times weekly dosing formulation of Copaxone.

We believe that M356 could perform well despite this competition. And we have been particularly – we will be particularly helped by the high pricing strategy the brand competitors have pursued in the MS space. As a reminder, the collaboration terms with Sandoz on this product provide Momenta with a 50% share of the contractual profits under all possible competitive scenarios.

On the regulatory front, we continue to actively engage with the FDA with regard to our application status. We continue to plan to be ready for launch at the time of patent expiration. As we have said in past conference calls, although we feel our application is progressing well, we like all generic manufacturers are facing a significantly less transparent regulatory environment with the implementation of PDUFA and the FDA shift to the use of the Complete Response Letter and as their primary means of asking questions to sponsors. That said, we know our application is under active review as a high priority and our ANDA based on a few factors.

Read the rest of this transcript for free on seekingalpha.com