REPLIGEN CORP annual report, FY2014

Repligen Corporation — FY2014 Form 10-K

Reporting period: Fiscal year ended December 31, 2014. The filing also provides unaudited fourth-quarter results; it is an annual report, not a standalone Q4 filing.

Business context

Repligen develops and sells bioprocessing products, including Protein A, growth factors, OPUS chromatography columns, ATF cell-filtration systems and quality-control products. In June 2014, it acquired Refine Technology’s ATF business, expanding its product range and direct sales presence. The company continued its strategic shift away from therapeutic drug development toward bioprocessing.

Financial performance and position

MetricFY2014FY2013
Total revenue$63.5 million$68.2 million
Bioprocessing product revenue$60.4 million$47.5 million
Royalty and other revenue$3.1 million$20.7 million
Gross margin54%53%
Operating income$10.7 million$22.9 million
Net income$8.2 million$16.1 million
Diluted EPS$0.25$0.50
Cash from operating activities$18.4 million$25.9 million
Cash and marketable securities$62.0 million$73.8 million
Working capital$70.3 million$75.0 million

FY2014 operating margin was approximately 16.8% and net margin approximately 12.9%, compared with approximately 33.6% and 23.6%, respectively, in FY2013. Cash and marketable securities comprised $35.4 million of cash and equivalents and $26.6 million of marketable securities at year-end. Total current liabilities were $10.7 million. The filing reports $5.9 million of other long-term liabilities; it does not clearly identify this amount as debt. Interest expense was approximately $50,000.

FY2014 investing activities used $19.8 million, including $21.2 million for the Refine acquisition and $5.6 million of property and equipment purchases, partly offset by net marketable-security redemptions. Financing activities provided $1.7 million, primarily from stock-option exercises.

Fourth quarter: Revenue was $16.4 million, including $15.4 million of product revenue. The quarter recorded a $0.4 million net loss, or $0.01 per diluted share, and $61,000 of operating income. A $1.9 million fair-value charge for contingent consideration was recorded in the quarter.

Material changes versus the prior comparable period

  • Total revenue declined 7% year over year, despite 27% growth in product revenue. Product growth was primarily driven by ATF sales following the Refine acquisition.
  • Royalty and other revenue fell 85%, principally because Bristol-Myers Squibb’s Orencia royalty agreement expired at the end of 2013. No Orencia royalties were recorded in 2014.
  • Net income was approximately halved. Higher SG&A, acquisition-related contingent-consideration charges and the loss of Orencia royalties more than offset product growth and a slightly improved gross margin.
  • Operating cash flow decreased by $7.5 million to $18.4 million. Cash and marketable securities declined by $11.8 million, reflecting the acquisition, facility investment and other cash flows.
  • Foreign-currency translation reduced other comprehensive income by $7.7 million in 2014, versus a positive translation adjustment in 2013.

Outlook, risks and unusual items

  • Management expected 2015 operating expenses to increase as the company expanded its bioprocessing business and customer-facing commercial organization; SG&A was expected to rise, R&D to increase slightly, and capital expenditures to decrease.
  • Absent additional acquisitions, management believed available cash was adequate for at least the next 24 months. Future acquisitions or investment could require additional financing and potentially dilute shareholders.
  • GE Healthcare accounted for 38% of 2014 revenue. Two other bioprocessing customers represented 20% and 13%, respectively, highlighting customer concentration. Reliance on major customers, distributors and supply agreements creates revenue risk.
  • On January 26, 2015, Pfizer gave notice terminating its SMA license, effective April 26, 2015. Repligen said it would not further fund SMA development. BioMarin’s HDACi agreement offers up to $160 million in potential milestones plus royalties, but payments depend on BioMarin’s development and commercialization outcomes.
  • The Refine acquisition included up to $10.9 million in sales-based contingent payments and up to $7.5 million tied to certain patent-opposition proceeds. The estimated fair value of total contingent consideration was $3.8 million at year-end; related remeasurement expense was $2.1 million in 2014.
  • A Massachusetts tax audit could result in assessments relating to research credits and prior intellectual-property settlement payments. Repligen recorded $125,000 in 2014 for a research-credit matter; it recorded no additional provision for the disputed apportionment issue, which it contests.
  • Other material risks include competition, a sole supplier for certain ATF consumables, foreign-exchange exposure (not hedged), environmental and biosafety compliance, and integration of acquisitions. Management and the auditor reported effective internal controls, but Refine’s controls were excluded from the assessment; ERP implementation also involved modified manual controls.
  • No material adverse legal proceedings were identified. The company paid no dividends and did not repurchase shares in 2014.

Important facts for investors to verify

  • Whether ATF and other bioprocessing products can sustain growth and improve earnings as the legacy Orencia royalty stream has ended.
  • The extent of revenue dependence on GE Healthcare and other large customers, and the terms and renewal/termination risks of key supply agreements.
  • Actual Refine sales, integration performance, contingent-payment obligations and any developments in the related patent disputes.
  • Progress and potential economics of BioMarin’s HDACi program following Pfizer’s termination of the SMA agreement.
  • Resolution of the Massachusetts tax audit, including the potential assessment exposure and adequacy of recorded reserves.
  • Cash conversion, foreign-currency impacts and execution of the stated 2015 expense and capital-spending outlook.