Celgene (CELG)

Q2 2012 Earnings Call

July 26, 2012 9:00 am ET

Executives

Patrick E. Flanigan III

Robert J. Hugin - Chairman, Chief Executive Officer, President and Chairman of Executive Committee

Jacqualyn A. Fouse - Chief Financial Officer, Chief Accounting Officer and Executive Vice President

Mark J. Alles - Chief Commercial Officer and Executive Vice President

Analysts

Yaron Werber - Citigroup Inc, Research Division

Mark J. Schoenebaum - ISI Group Inc., Research Division

Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Eric Schmidt - Cowen and Company, LLC, Research Division

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Ying Huang - Barclays Capital, Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

Marshall Urist - Morgan Stanley, Research Division

Michael J. Yee - RBC Capital Markets, LLC, Research Division

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Matthew Roden - UBS Investment Bank, Research Division

Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division

Presentation

Operator

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Good morning, and welcome to Celgene's Second Quarter 2012 Earnings Conference Call. [Operator Instructions] I would like to remind you that this call is being recorded.

I would now like to turn the conference over to Patrick Flanigan, Vice President of Investor Relations at Celgene.

Patrick E. Flanigan III

Thanks, Elly, and welcome, everyone to Celgene Corporation's Second Quarter Earnings Conference Call. The press release reporting our second quarter results, in addition to the presentation for today's webcast, can be accessed by going to the Investor Relations section of the corporate website at www.celgene.com.

Joining me in the room today with prepared remarks are Bob Hugin, our Chairman and Chief Executive Officer; Jackie Fouse, our Chief Financial Officer; and Mark Alles, who is our Chief Commercial Officer.

As a reminder, during today's call, we will be making forward-looking statements regarding our financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent 10-Q on file with the SEC. These statements speak only as of today's date, and we undertake no duty to update or revise them. Finally, a reconciliation of the non-GAAP financial measures to the most comparable GAAP measure are available as part of the earnings release.

I would now like to turn the call over to Bob.

Robert J. Hugin

Thank you, Patrick, and thank you, everyone, for joining us this morning. I appreciate the opportunity to review the results of the second quarter and our outlook for the remainder of the year.

The financial results for the quarter were outstanding, highlighted by annual total revenue growth of 16%, and 37% growth in non-GAAP earnings per share. Our global commercial teams produced strong results across all geographies. Jackie and Mark will provide greater detail on our financial and commercial performance in a few minutes.

In addition to achieving these excellent commercial results, we advanced key strategic initiatives during the first half of the year. I will shortly outline some of the important accomplishments strengthening our hematology and oncology businesses, developing our inflammation and neurology franchise and advancing our deep and diverse clinical and research pipeline. We're making investments that position us for sustained long-term growth while we deliver strong near-term financial results.

Based on these results and our outlook for the remainder of the year, we're increasing our earnings-per-share guidance to $4.85 per share and are reaffirming our full year guidance for total revenue in REVLIMID sales.

Early in the year, we outlined numerous important clinical and regulatory milestones with transformative potential. Let me now review our progress on achieving these milestones. As depicted on this updated slide, we have accomplished a number of important milestones. Had a delay in newly-diagnosed myeloma and advanced multiple programs to decision points during the first half of the year.

Pomalidomide is one of the most high potential assets in our pipeline and accelerating its development is of tremendous value. During the quarter, we've submitted regulatory applications for relapsed refractory multiple myeloma in both the United States and Europe with both applications now under active review. And with the completion of enrollment in both our Phase III myelofibrosis study and MM-003, our international Phase III myeloma study, we expect data from these trials by the end of the year. Pomalidomide has the potential to become a major therapeutic advance for patients and to become our next global hematology blockbuster.

Other hematology programs, including REVLIMID in lymphoma and leukemia are progressing well. We are on track to submit our sNDA for mantle cell lymphoma in the fourth quarter and expect to complete enrollment of our first Phase III CLL study by the end of the year. In addition, our pivotal registration studies for CC-486, oral azacitidine in AML and MDS are on track to initiate by the end of the year.

Substantial progress is being achieved in our ABRAXANE programs. We are now preparing for launch of ABRAXANE's new indication in non-small cell lung cancer in the United States with FDA approval anticipated in October. We are also expecting data from our Phase III melanoma study in the next several months and data from our pivotal study in pancreatic cancer in late 2012 or early '13.

Advancing earlier-stage research program is essential to ensuring sustained long-term growth. Excellent progress has been achieved in multiple early clinical development programs in both oncology and inflammatory diseases. Collaborations have both been added and strengthened with 2 new INDs submitted by our team and our partners with additional new compounds targeted for clinical study by year-end.

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