Cytokinetics, Incorporated (CYTK)

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Cytokinetics Inc. (CYTK)

Q4 2009 Earnings Call

February 03, 2010 04:30 pm ET


Sharon Barbari - SVP, Finance and CFO

Robert Blum - President and CEO

Andy Wolff - SVP of Clinical Research and Development and CMO


Michael Aberman - Credit Suisse

Joel Sendek - Lazard Capital

Mark Monane - Needham & Company

Ritu Baral - Canaccord



Good afternoon and welcome, ladies and gentlemen, to the Cytokinetics fourth quarter and year end 2009 conference call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the request of the company we will open up the call for questions and answers after the presentation. I will now turn the call over to Sharon Barbari, Cytokinetics' Executive Vice President of Finance and CFO. Please go ahead.

Sharon Barbari

Good afternoon and thank you for joining the Cytokinetics senior management team on this conference call today. Also present during this call are Robert Blum, our President and Chief Executive Officer; and Dr. Andrew A. Wolff, Senior Vice President of Clinical Research and Development and Chief Medical Officer. Following the forward-looking statements Robert will provide an overview of the past quarter, along with an update on the advancement of our development pipeline focused on the biology of muscle function.

Andy will then provide highlights and details of the progress of the company's clinical development program. I will then provide some brief comments with respect to our financials and our investment in research and development activities. Robert will then conclude the call with additional comments regarding our recent activities and discuss the projected company milestones for 2010.

We'll then open the call for a brief question-and-answer session. The following discussion, including our responses to questions contain statements that constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings including our most recent annual report on Form 10-K, our quarterly reports on Form 10-Q, and current reports on Form 8-K.

Copies of these documents may be obtained from the SEC or by visiting the Investor Relations section of our website. These forward-looking statements speak only as of today. You should not rely on them as representing our views in the future. We undertake no obligation to update these statements after this call. Now I'll turn the call over to Robert.

Robert Blum

Thank you, Sharon. Beginning with our restructuring in late 2008, and throughout 2009, Cytokinetics steadfastly executed a highly focused business plan, firmly rooted in and focused on the biology of muscle function. In the last 12 months, we have been winding down our activities related to our prior interests in oncology and doubled down on research and development activities directed to muscle biology. Why? Quite simple, we believe that our best path forward, both in terms of return on risk capital and in terms of how best to exploit our competitive advantages in science and drug development, requires us to embrace both the opportunities and responsibilities presented by our novel innovations in modulating muscle function.

We have had here to a carefully constructed blueprint that has informed how best to prosecute a promising portfolio of novel mechanism compounds that may offer significant therapeutic advantages in treating several grievous medical conditions that are increasing in prevalence with our aging population. These potential therapeutic advantages may allow us to better navigate the expected seismic shifts in the regulatory, reimbursement and clinical environments in which we operate.

In 2009, Cytokinetics progressed the development of our omecamtiv mecarbil our novel cardiac myosin activator through the completion of our Phase II A program clinical trials program informing Amgen's exercise of its options to this novel drug candidate in May of last year, another major milestone for Cytokinetics. In the second half of 2009, under our partnership, Cytokinetics transitioned key activities to Amgen. Together we also laid the groundwork for additional clinical and nonclinical development activities for omecamtiv mecarbil which we will share with you in more detail on this call.

We are very pleased that Amgen continues to share our excitement for the potential of our drug candidate and we believe that their diligent commitment is evident in multiple ways that we can elaborate with the steps we are taking together in 2010. Amgen's option exercise afforded us the necessary capital and unleashed other important internal resources to enable us to push forward our nonclinical and clinical program for CK 2017357 or CK 357, CK 357 our fast twitch skeletal muscle troponin activator has a novel mechanism of action that has been observed to directly amplify muscle response to motor neuron input, increase muscle power and prolong the time to muscle fatigue. We believe these properties differentiate this program from perhaps complimentary approaches being pursued by others that are more targeted at increasing muscle mass.

Embarking on this novel area of clinical research required that we remain diligent in our underlying translational research conferring with the appropriate medical and scientific leaders and as will you hear shortly, think more creatively about how we might demonstrate an appropriate proof of mechanism for this compound in humans.

As we unveiled in September at our R&D day, we are defining a new pharmacology in our non clinical studies of CK-357 were designed and executed to map forward a strategy that could translate the compound's novel pharmacodynamic effects from in vivo models to healthy volunteers and hopefully to patients confronting unmet clinical needs.

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