Momenta Pharmaceuticals' Management Presents At Bank Of America Merrill Lynch 2012 Health Care Conference (Transcript)

Momenta Pharmaceuticals, Inc.(MNTA)

Bank of America Merrill Lynch 2012 Health Care Conference Call

May 16, 2012 8:00 pm ET


Richard P. Shea – Senior Vice President and Chief Financial Officer


Sumant S. Kulkarni – Bank America/Merrill Lynch


Sumant S. Kulkarni – Bank America/Merrill Lynch

Good afternoon everyone. I’m very pleased to have Momenta here with us today. Thanks for taking the time and sticking around for this last presentation it’s going to be an interesting one because this is a really interesting company in the generic pharmaceuticals space. For those of you who that don’t know me I’m Sumant Kulkarni and I’m part of the specialty pharmaceuticals in U.S. major pharmaceuticals team here at the firm. So we have Rick Shea, who is the CFO and who is back with us this year and Lora Pike, who is with us for the first time this year is the IR for Momenta. Thanks.

Richard P. Shea

Thanks very much Sumant. I will draw your attention to our risk factors particularly as included within our SEC filings. Momenta was founded and built based on analytical technologies for deconvolution and characterizing complex mixture drugs and these complex mixture drugs include polysaccharides heparin based drugs, polypeptides as well as biologics which includes glycosylated proteins and antibodies and technology that we use is by understanding the drug and understanding the chemical structure of the drug we are able to analyze and recreate exact copies of a complex drug in order to make a generic version or a biosimilar version. But we are also able to do structure activity relationship analysis and whether to understand how to engineer novel drugs based on this technology.

So our highlights are we have a marketed product generic Enoxaparin was approved by the FDA in July of 2010 it was the most successful generic launch in history and it’s first running quarters have generated more than $1 billion in net sales by our partner Sandoz and we continue Sandoz continues to sell that product for us. We recently signed a significant follow on biologic collaboration with Baxter we received a $33 million upfront payment and have the potential for over $400 million in option fees and milestones as well as downstream royalties from this follow on biologics collaboration.

We have an ANDA under review for a generic Copaxone and we also have initiated a proof of concept clinical study for a novel product M402 a novel oncology product, which we are initiating a trial for in pancreatic cancer. We use intellectual property to protect our proprietary methods and approaches both to developing generic products as well as novel products and along those lines we have a litigation protecting our generic Lovenox and M-Enoxaparin product and that litigation is underway and we are also waiting litigation, offensive litigation against Teva’s Copaxone product in our generic Copaxone program.

We recently acquired technology relating to Sialic Switch, which this is slightly changing of the properties in this case a plasma product but also could be applied to antibodies with the Sialic Switch technology. It’s a platform that we can use in novel drug discovery. We have a strong cash position that was generated from the cash flow from the marketed generic Lovenox. At the end of the first quarter we had $382 million in cash in marketable securities and in addition $17.5 million of restricted cash with a total of just under $400 million in cash at the end of the first quarter. So our product portfolio includes generic products and marketed generic Lovenox, generic Copaxone, which we have an ANDA under review, follow on biologics or biosimilars in which we are working on up to six biosimilar products with Baxter and we are working on a couple of novel drug programs the M402 novel oncology product candidate as well as the Sialic Switch technology, which we are applying to IVIG.

So first to talk about our marketed products Enoxaparin sodium it’s being sold by Sandoz, the Sandoz generic division of Novartis on our behalf. In July 2010, when that product was launched we were the sole generic and under our collaboration agreement with Sandoz we are receiving a 45% profit share. This past January a competitor product was launched and that triggered a change in the economics to a straight royalty. So that market is changing it’s becoming more competitive and our economics have changed so our revenues that we are getting from generic Lovenox have declined substantially from the $75 million to $85 million a quarter range down to $22 million this past quarter.

However, we mentioned that we are litigating some manufacturing process message patents against these competitors. So there is still a possibility that at some point in the future we could restore our sole generic status. I will add to that we had approved a bio formulation of the product, which we launched in April and at that time the FDA approved that drug they granted us six months exclusivity on that product formulation.

M356 is our generic version of Teva’s MS drug Copaxone, Copaxone is a complex polypeptide it’s a synthetic polypeptide and it’s manufactured using four amino acids, which are then polymerized and depolymerized in a chemical manufacturing process. There are seven orange book patents and two non-orange book patents relating to Copaxone. We are litigating all nine of these patents and the trial for that litigation was held last September, September 2011 and we anticipate that the ruling from that litigation could be issued by the judge the district court judge sometime over the next two to four months.

Read the rest of this transcript for free on