"Strong demand for Protein A ligands and our growth factor products as well as increased interest in our OPUS ® chromatography columns contributed to the revenue gains during our first quarter. We view all of our bioprocessing products as well positioned to benefit from the expected continued growth in demand worldwide for monoclonal antibodies and other biologic drugs," said Walter C. Herlihy, Ph.D., President and CEO of Repligen. "During the first quarter, we also realized improvements in capacity utilization at Repligen Sweden. Combined, these achievements advance the Company toward our goal to be a best-in-class life sciences company focused on the development, production and delivery of high-quality consumables used in the manufacture of biologic drugs."
First Quarter Business Highlights:
- We experienced increased demand from existing and new customers across multiple products including several Protein A ligands and our growth factor product LONG ®R3IGF-1 - a more biologically potent alternative to insulin for optimizing cell growth and productivity during the fermentation stage of biomanufacturing. We also benefited from increased interest in our larger (process-scale) OPUS ® chromatography columns which we launched in 2012.
- We participated in key industry conferences, including IBC's Biopharmaceutical Development and Production Week, where we gave a presentation highlighting the time- and cost-savings achieved by adopting the OPUS ® line of pre-packed chromatography columns for biologic drug purification. We continued to build our market presence through selective advertising, conference presentations and other initiatives to support our sales and marketing efforts.
- We announced in January a worldwide licensing agreement with Pfizer Inc. for our spinal muscular atrophy (SMA) program, in alignment with our strategic goal to outlicense our portfolio of therapeutic assets.
- Under the terms of this agreement, Repligen is entitled to receive from Pfizer up to $65 million in milestones as well as royalties on future sales.
- We completed the second cohort of an active Phase 1 trial in spinal muscular atrophy, positioning the SMA program to be fully transitioned to Pfizer pursuant to the terms of the license agreement.
- We completed dosing in a Phase 1 trial of our product candidate RG2833, an HDAC inhibitor, in Friedreich's ataxia patients. The analysis of both pharmacology and biomarker activity in this clinical trial is currently ongoing.
Financial Guidance for 2013
The Company is reiterating its financial guidance for fiscal year 2013. This guidance is based on expectations for our existing business and does not include the impact on our revenue and expenses of potential milestone payments from Pfizer, additional out-licensing agreements for our remaining clinical assets, potential bioprocessing acquisitions or foreign currency exchange rates.
- Total revenue for the full year 2013 is expected 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.
- Bioprocessing product revenue for the full year 2013 is expected to be $46-$48 million, reflecting product sales growth of 10%-15%.
- Net income for the full year 2013 is expected to be $18-$20 million.
- We expect to end the year 2013 with approximately $65 million in cash and investments.
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|Three months ended March 31,|
|Product revenue||$ 11,934,269||$ 9,342,601|
|Royalty and other revenue||4,521,724||3,481,860|
|Cost of product revenue||6,896,608||5,272,543|
|Cost of royalty and other revenue||576,857||462,088|
|Research and development||2,183,404||2,808,463|
|Selling, general and administrative||3,308,099||3,428,536|
|Contingent consideration - fair value adjustments||(53,974)||--|
|Gain on bargain purchase||--||(314,244)|
|Total operating expenses||12,910,994||11,657,386|
|Income (loss) from operations||3,544,999||1,167,075|
|Other (expense) income||29,081||109,261|
|Income (loss) before income taxes||3,622,068||1,285,379|
|Income tax (benefit) provision||1,283,832||58,907|
|Net income (loss)||$ 2,338,236||$ 1,226,472|
|Earnings (loss) per share:|
|Basic||$ 0.07||$ 0.04|
|Diluted||$ 0.07||$ 0.04|
|Weighted average shares outstanding:|
|Comprehensive income (loss)||$ 2,100,007||$ 2,314,297|
|Balance Sheet Data:||March 31, 2013||December 31, 2012|
|Cash, cash equivalents and marketable securities*||$ 54,055,228||$ 49,969,871|
|*does not include restricted cash|
CONTACT: Sondra S. Newman Director Investor Relations Repligen Corporation (781) 419-1881 firstname.lastname@example.org
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