Genomic Health, Inc. (GHDX)

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Genomic Health, Inc. (GHDX)

Q1 2009 Earnings Call

May 05, 2009 4:30 pm ET


Kimberly Popovits - President and CEO

Dean Schorno - VP of Finance

Brad Cole - COO and CFO

Randy Scott - Executive Chairman

Steve Shak - CMO

Joffre Baker - CSO


Scott Gleason - Stephens Inc.

Eric Criscuolo - Thomas Weisel Partners

Charles Duncan - JMP Securities

David Clair - Piper Jaffray

Bruce Cranna - Leerink Swann

Abigail Davis - JPMorgan

George Zavoico - Westport Capital Markets

Mathew Scalo - Cannacord Adams



At this time, I would like to welcome everyone to Genomic Health’s First Quarter 2009 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answer session. (Operator Instruction)

I would now like to turn the call over to Mr. Dean Schorno, Vice President of Finance. Sir, you may begin your conference.

Dean Schorno

Thank you. Good afternoon everyone and welcome to Genomic Health’s first quarter 2009 financial results conference call.

Before we begin, I would like to remind you that various remarks that we make on this call that are not historical, including those about our future financial and operating results, future plans and prospects, the success of our business strategy, the impact of clinical data on demand for our tests, economic benefits and value to payers of our tests, growth opportunities, future products, product enhancements and our product pipeline, demand for our tests and drivers of demand, payer coverage and progress in patient access, our investment in our product pipeline and commercial organization, clinical outcomes and timing of clinical studies, our growth potential, our plans for international expansion, the impact of the economy on our business, and our expectations regarding our ability to comply with potential FDA regulation, constitute forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act.

We refer you to our annual report on Form 10-K for the year ended December 31, 2008 filed with the SEC, in particular to the section entitled, Risk Factors, for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date hereof and we disclaim any obligation to update these forward-looking statements.

With that, I’ll turn the call over to Kim Popovits, President and CEO of Genomic Health.

Kimberly Popovits

Thanks, Dan. And good afternoon everyone, and welcome. Also with us today are Randy Scott, our Executive Chairman: Brad Cole, our Chief Financial Officer and Chief Operating Officer, Steve Shak, our Chief Medical Officer and Joffre Baker, our Chief Scientific Officer.

I will begin today with highlights and accomplishments from our first quarter. Brad will them discuss our commercial progress and review our 2009 financial results. Finally, I will conclude the comments about our pipeline and upcoming date of presentation, including the recently announced positive results on the QUASAR colon validation study.

We had a strong first quarter. Total revenue grew 45% for the first quarter, compared to last year. In addition, we have reduced our net loss to $4.6 million from over $6.6 million in the first quarter of 2008.

We attribute these results to our progress and making Oncotype DX standard practice in breast cancer treatment planning. With this in mind, we believe that the training of 28 additional sales representatives in the quarter will allow us to reach beyond the 50% of women in the US with node negative permanent receptor positive breast cancer to currently benefit from Oncotype DX.

Further, we are encouraged by the growing use of Oncotype DX in treatment planning for patients of micrometastasis and node positive disease. These two additional populations represent approximately 30,000 patients, bringing the total addressable US patients to over 100,000.

With coverage agreements, policies or contracts in place for over 90% of US insured lives for reimbursement of Oncotype DX in patients with node negative breast cancer, we are now concentrating on gaining similar coverage for appropriate node positive patients and those patients with micrometastasis.

We are pleased to report that over the last several quarters we have secured reimbursement for approximately 40% of patients with lymph node micrometastasis and will continue to focus our efforts on limiting this disease, so they spread to 1,2,3 lymph nodes.

As Oncotype DX continues to gain recognition in standard of care in the United States, we believe there is increasing potential for us to bring us demonstrated clinic utility to patients around the world.

During the first quarter we again expanded our international network through the establishment of distribution agreements in Brazil and Venezuela, bringing our total number of international partners to 10. We are now receiving breast cancer samples from more than 40 countries.

In April at the 2009 Kyoto Breast Cancer Consensus Conference International Convention an independent group of Japanese researchers presented results of a multi-cancer study demonstrating that Oncotype DX breast cancer test, was able to predict the likelihood of disease recurrence in Japanese women with estrogen receptor positive early stage breast cancer. This represents the first Oncotype DX breast cancer study focused on a specific ethnic population and provides additional evidence of the clinical utility of Oncotype DX.

As we have mentioned in past calls, we believe our international success will follow a pathway similar to the one pioneered in the US. Namely, we continue to believe that to secure reimbursement with National HealthCare systems, we may need to conduct country specific studies demonstrating the clinical utility of the Oncotype DX breast cancer test. In this regard, we believe these study results will help to lay the foundation for adoption and reimbursement in Japan.

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