Key Developments: Repligen Corp (RGEN.OQ)
10.23USD
1 Aug 2013
$0.06 (+0.59%)
$10.17
$10.46
$10.68
$10.11
101,040
84,065
$10.68
$3.90
Latest Key Developments (Source: Significant Developments)
Repligen Corp Raises FY 2013 Revenue Guidance; Reaffirms FY 2013 EBIT Guidance; Lowers FY 2013 Net Income Guidance
Repligen Corp announced that total revenue for fiscal 2013 is expected to be $65-$67 million, an increase from its prior guidance of $63-$65 million. This projection includes the receipt of royalties from Bristol-Myers Squibb on its U.S. sales of Orencia which the Company will no longer receive after December 31, 2013. Total operating income (EBIT) for fiscal 2013 is expected to be $20-$22 million, consistent with its prior guidance. Total net income for fiscal 2013 is expected to be $16-$18 million, a decrease from the Company's prior guidance of $18-$20 million, due primarily to a non-cash increase in tax expense. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $65 million and net income of $18 million for fiscal 2013. Full Article
Repligen Corp Reiterates FY 2013 Guidance
Repligen Corp reiterated fiscal 2013 guidance and expects total revenue to be $63-$65 million, including the receipt of royalties from Bristol-Myers Squibb on its U.S. sales of Orencia(R) which the Company will no longer receive after December 31, 2013 and Net income to be in the range of $18-$20 million. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $63.36 million for fiscal 2013. Full Article
Repligen Corp Issues FY 2013 Guidance
Repligen Corp announced that for fiscal 2013, it expects total revenue to be $63-$65 million, including the receipt of royalties from Bristol-Myers Squibb on its U.S. sales of Orencia which the Company will no longer receive after December 31, 2013. Net income for fiscal 2013 is expected to be $18-$20 million. Full Article
Repligen Corp Enters Into Exclusive Worldwide Licensing Agreement With Pfizer Inc
Repligen Corp announced that it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. to advance Repligen's spinal muscular atrophy (SMA) program, originally in-licensed from Families of SMA (FSMA). Under the terms of the agreement, Repligen is responsible for completing the first two cohorts of an active Phase 1 trial evaluating RG3039 in healthy volunteers, which it anticipates will occur during the first quarter of 2013. Repligen will also provide certain technology transfer services to Pfizer who will then assume full responsibility for the SMA program moving forward, including the conduct of any registration trials necessary for product approval. Repligen has previously received U.S. Orphan Drug and Fast Track designations for RG3039 for the treatment of SMA, as well as Orphan Medicinal Product designation in the EU. Full Article
Repligen Corp Reaffirms FY 2012 Guidance
Repligen Corp reaffirmed fiscal 2012 guidance and expects revenue in the range of $55-$57 million and net profit in the range of $5-$7 million. Full Article
Repligen Corp Appoints Jonathan I. Lieber As CFO
Repligen Corp announced that the appointment of Jonathan I. Lieber to the position of Chief Financial Officer (CFO) and Treasurer, effective immediately. Full Article
Repligen Corp Raises FY 2012 Guidance
Repligen Corp raised fiscal 2012 guidance and expects revenue from its previous estimate of $52 million to $55 million to its current estimate of $55 million to $57 million. The Company is also adjusting its estimate for net profit to $5 million to $7 million for fiscal 2012. Full Article
Repligen Corp Reaffirms FY 2012 Guidance-Conference Call
Repligen Corp announced that for fiscal 2012, it is reiterating $52 million to $55 million in total revenue, of which about $40 million comes from bioprocessing product sales and about $13 million to $14 million from royalties received from Bristol Myers on Orencia sales, some technology licensing years ago, as well as grants from Muscular Dystrophy and other organizations. The Company also announced that it expects net income of $4 million to $6 million for fiscal 2012. Full Article
Repligen Corp Receives Complete Response Letter from FDA for RG1068 NDA
Repligen Corp announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA. There were no specific safety concerns cited in the CRL, although safety will continue to be monitored in conjunction with any future clinical trial. No deficiencies were cited in the CRL with respect to the manufacturing, pharmacology or toxicology sections of the NDA. Repligen filed its NDA for RG1068 on December 21, 2011 based on the re-read of Phase 3 clinical trial data. On February 21, 2012, the FDA accepted the NDA filing and granted it priority review based on its prior Fast Track designation. In addition, on March 5, 2012, Repligen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) that was successfully validated for full review by the EMA’s Committee for Medicinal Products for Human Use. Full Article
Repligen Corp Reaffirms FY 2012 Revenue Guidance; Issues FY 2012 Net Income Guidance-Conference Call
Repligen Corp announced that for fiscal 2012, it expects total revenue of approximately $52 million to $55 million and GAAP net income of $4 million to $6 million. Full Article

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