Medivation (MDVN) Misses Q1 EPS by 12c, Sales Miss; Reaffirms

Medivation (NASDAQ: MDVN) reported Q1 EPS of $0.11, $0.12 worse than the analyst estimate of $0.23. Revenue for the quarter came in at $182.5 million versus the consensus estimate of $196.61 million.

"Medivation is off to a strong start in 2016 as we continue to expand our leadership position in oncology, extend XTANDI's reach into urology and other areas, and advance our robust late-stage pipeline," said David Hung, M.D., Founder, President and Chief Executive Officer of Medivation. "The first quarter of 2016 represented a landmark quarter for Medivation as for the first time we claimed more than 50% market share of the novel hormonal therapy prostate cancer market in the U.S."

"As we look ahead, we believe there are a number of positive trends and milestones that will allow us to accelerate our momentum and create additional shareholder value," added Dr. Hung. "For example, as XTANDI is increasingly used as first-line therapy in metastatic castration resistant prostate cancer, we expect the duration of treatment to continue to increase beyond the nearly eight months that we saw at the end of 2015. Furthermore, with the Committee for Medicinal Products opinion to include TERRAIN data in the European XTANDI label and the upcoming U.S. PDUFAdate on October 22, 2016, we believe that we are poised to achieve even greater penetration of the urology market where the largest commercial opportunity lies for XTANDI. In addition to our plans to grow XTANDI, our wholly-owned assets, talazoparib and pidilizumab, represent compelling pipeline opportunities that we plan to develop and commercialize to drive long-term value appreciation for our shareholders."

Medivation reaffirmed FY2016 guidance.

 MEDIVATION FULL-YEAR 2016 FINANCIAL GUIDANCE                

                                                                            

                                               Year Ending December 31, 2016

                                               -----------------------------

U.S. net sales of XTANDI                        $1.425 to $1.525 billion(1) 

Non-GAAP collaboration revenue                    $900 to $970 million(2)   

Non-GAAP operating expenses                       $555 to $600 million(3)   

  Non-GAAP R&D expenses                           $280 to $300 million(4)   

  Non-GAAP SG&A expenses                          $275 to $300 million(5)   

Non-GAAP tax rate                                       35.5% - 36%         

Non-GAAP diluted earnings per share                    $1.30 - $1.40   

For earnings history and earnings-related data on Medivation (MDVN) click here.

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