SuperGen Inc. Q1 2010 Earnings Call Transcript

SuperGen Inc. Q1 2010 Earnings Call Transcript
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SuperGen Inc. (SUPG)

Q1 2010 Earnings Call Transcript

April 26, 2010 4:30 pm ET

Executives

Timothy Enns – SVP, Corporate Communications and Business Development

James Manuso – Chairman, President and CEO

Michael Molkentin – CFO and Corporate Secretary

Mohammed Azab – Chief Medical Officer

Analysts

George Zavoico – MLV

Aaron Reames – Wells Fargo Securities

Robin Davison – Edison Investment

Krishna Gaurdi [ph] – JP Morgan

Presentation

Operator

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Good afternoon. My name is Stephanie and I will be your conference operator today. At this time, I would like to welcome everyone to the SuperGen Q1 2010 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remark, there will be a question-and-answer session. (Operator Instructions) Thank you. I would now like to turn the conference over to Timothy Enns, Senior Vice President of Corporate Communications and Business Development. Please go ahead sir.

Timothy Enns

Thank you, operator. Good afternoon and thank you for joining us today for SuperGen's 2010 first quarter financial results. With me today are Dr. James Manuso, President and Chief Executive Officer, Michael Molkentin, Chief Financial Officer, Dr. Mohammed Azab, Chief Medical Officer and Michael McCullar, Senior Vice President, Strategy and Discovery Operations.

In a few moments, Jim Manuso and Michael Molkentin will deliver remarks on the 2010 first quarter financial results and provide a summary of our business outlook. After our prepared comments, we will open the line for questions. Earlier today, we issued a press release of our financial results. A copy of the press release is available in the Investor Relations section of our website at www.supergen.com. In addition, this call is being webcast and may be accessed via the Investor Relations section of our website. A webcast replay will be available for 30 days.

During the call, we will make projections and forward-looking statements that are based on management's current expectations. Actual results may differ materially from these forecasts and projections due to various factors. There are significant risks and uncertainty in biotechnology research and development. There can be no guarantee that our projects, products or product candidates will progress pre-clinically or clinically as we expect or that they will ultimately obtain approvals for the indications that we seek.

Moreover, even if our products or product candidates are approved in the future we cannot not guarantee they will be commercially successful. The company's results may also be affected by a variety of factors, such as competitive development, launches of new products, the timing of anticipated regulatory approvals or other regulatory actions, the actions of our strategic partners and collaborators with respect to the products we license or codevelopment – or codevelop and patent disputes and litigation.

For additional information and discussion concerning the risk factors that affect the company's business, please refer to the company's filings with the Securities and Exchange Commission, including reports on the most recently filed Form 10-K. The company undertakes no duty to update forward-looking statements.

In the coming months, we'll be presenting at several investor conferences, including the Rodman & Renshaw Global Investment Conference May 16 to 18, the Jefferies Global Science Conference, June 8 to 11 and Needham Healthcare Conference, June 9 and 10. Live and archived webcasts of these presentations will be posted in the Investor Relations section of our corporate website. We will also host our annual shareholders meeting here at our Dublin headquarters on June 10. I will now turn the call over to Dr. James Manuso, who will provide highlights of our accomplishments during the 2010 first quarter. Jim.

James Manuso

Thank you, Tim. Good afternoon and thank you for joining us today for SuperGen's 2010 first quarter conference call. SuperGen started 2010 with a fine first quarter. We ended the quarter with a net profit of $4.7 million, bringing our unrestricted cash, cash equivalents and current and non-current marketable securities balance as of March 31 to approximately $106 million. Our strong financial position will enable us to readily advance the discovery and development of our first-in-class pipeline products.

We are pleased that our two products in the clinic were the subject of poster presentations at last week's American Association for Cancer Research or AACR, conference held in Washington DC. Fourth-quarter 2009 Dacogen sales in over twenty countries were reported by Eisai and Johnson & Johnson and are recognized as first quarter 2010 royalty revenues by SuperGen. Taken together, our partners logged Dacogen sales that generated an increase in royalty revenue of approximately 11% during our 2010 first quarter when compared to the same period last year.

We anticipate the release of data from the Phase III elderly AML Dacogen trial later in our second quarter. The primary endpoint of this trial is survival. The protocol for the Phase III elderly AML trial underwent a Special Protocol Assessment or SPA with the Food and Drug Administration. This means that if the trial achieves its primary objective of significant survival improvement with acceptable safety then the drug would have fulfilled the requirements for approval by FDA.

Dacogen could become the only drug in the United States approved for the elderly AML indication. Eisai and Johnson & Johnson have guided to FDA and EMEA submissions for Dacogen respectively in the second half of 2010.

As I mentioned earlier, SuperGen's two clinical programs were featured in posters at the AACR meeting last week. Final clinical data of the amuvatinib Phase I single agent clinical trial were presented, along with pharmacokinetic data from the new lipid formulation of the product.

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