Osiris Therapeutics, Inc. (OSIR)

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Osiris Therapeutics Inc. (OSIR)

Q1 2008 Earnings Call

May 9, 2008 9:00 am ET


C. Randal Mills - President and CEO

Phil Jacoby - CFO


Bill Tanner - Leerink Swann

Ted Tenthoff - Piper Jaffray

Eun Yang - Jefferies

Andy Schopick - Nutmeg Securities

Jon Robohm - Gagnon Securities

Gabe Hoffman - Accipiter Capital

Alexander Doman - Caducious Fund



Good morning, everyone. Before we begin I'd like to remind everyone that this conference call may include forward-looking statements that involve uncertainties and risks. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled 'Risk Factors' in our filings with the Securities and Exchange Commission.

As a reminder today's call is being recorded. I would now like to turn the call over to Dr. C. Randal Mills, President and CEO of Osiris Therapeutics.

C. Randal Mills

Good morning and welcome to our first quarter 2008 conference call. Today I will be providing an update of our business, as well as providing further details on the Osteocel transaction we announced yesterday. Phil Jacoby, our CFO will then provide an overview of our financial performance. I'll briefly outline our priorities for the coming months and then we will take your questions. But first, let me provide a quick overview of Osiris for those of you who may be new to the story.

Osiris Therapeutics has established itself as the leader in the exciting field of stem cell medicine. Osiris currently produces and sells Osteocel for regenerating bone in orthopedic indications. Prochymal, an intravenous formulation of adult mesenchymal stem cells or MSCs is currently in Phase III clinical trials for three indications including acute and steroid refractory Graft versus Host Disease as well as Crohn's disease.

Prochymal has been granted fast track status by FDA for all three of these indications. FDA established the Fast Track programs to accelerate the development of drugs that show promise for treating life threatening conditions. Prochymal has also been granted Orphan Drug status by both FDA and EMEA. Orphan Drug designation provides incentives to companies that develop drugs for underserved patient populations.

Osiris has also partnered with Genzyme Corporation to develop Prochymal as a medical counter measure to nuclear terrorism and was recently awarded a contract by the Department of Defense fully valued at $224.7 million to develop and stockpile Prochymal for Acute Radiation Syndrome.

The company's pipeline of other internally developed biologic drug candidates currently in human clinical trials include Chondrogen for arthritis in the knee as well as Phase II programs evaluating MSCs for acute MI in type 1 diabetes. Osiris has developed an extensive intellectual property portfolio to protect the company's technology including 47 US and 253 foreign owned or licensed patents.

Now to our update. To start out let me say that I am very pleased with the exceptional progress Osiris has made since the first of the year and believe that we are squarely on track to help Prochymal become the world's first approved stem cell therapeutics. Therefore let me begin with an update of recent activities in our clinical development programs.

We continue to experience strong enrollment in our ongoing Phase III clinical trials. Let me start with our lead indication for Prochymal steroid refractory Graft versus Host Disease or GvHD. This trial has 77 sites worldwide which are active and treating patients with this life threatening disease. During the quarter, we did not experience a significant drop in enrollment as we thought we might have due to the addition of our Phase III trial evaluating Prochymal as a first line agent for GvHD.

Instead it appears that the few trials are having a more synergistic effect on one another with both programs working together to increase the level of awareness among clinicians about Prochymal. Although the rarity of the disease often leads to sporadic enrollment that prevents us from giving a precise estimate of trial completion, we do now believe that the end is clearly insight for this landmark trial.

We are excited to announce that Osiris has been given clearance by the United States Food and Drug Administration to initiate an expanded access treatment program for Prochymal making the investigational product available to children with life threatening GvHD. So while we complete enrollment and diligently work towards registration of Prochymal for GvHD, we will be able to offer treatment to more children faster through this important program.

The Expanded Access Program was created in a joint effort by FDA and Congress to make promising new drugs more widely available to desperately ill patients. FDA Expanded Access Treatment Programs allow for investigational drugs for life threatening diseases can be made available to patients under certain circumstances during evaluation in late stage clinical trials. To obtain this special status, FDA must determine that the available scientific evidence taken as a whole demonstrates the drug maybe effective or does not pose significant safety risks. Under the program we will be able to treat children two months to 17 years of age inclusive who have GvHD that is not responsive to steroid therapy.

We are excited about this new development and believe it illustrates beautifully the purpose and importance of the Osiris mission. Our Phase III program for the treatment of moderate to severe Crohn's disease that is not responsive to biologic therapy also continues to enroll very well. We now have 55 sites active in the United States and Canada. Trial operations are progressing smoothly and we continue to receive positive feedback from our investigators about the trial and the need for an effective therapy for these patients.

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