Lee's Pharmaceutical Holdings Selects WuXi PharmaTech (Cayman) Inc as Supplier of Laboratory Testing Services
Aug 26 15
WuXi PharmaTech (Cayman) Inc. and Lee's Pharmaceutical Holdings Ltd. announced that the two companies have signed an agreement whereby WuXi's Laboratory Testing Division (LTD) will be the exclusive supplier of laboratory testing services for Lee's Pharm. These services will include Ltd.'s entire portfolio of discovery and IND/NDA package services, including chemistry analytical services, in vitro and in vivo biology, oncology, immunology, in vitro ADME, pharmacokinetic /pharmacodynamic studies, toxicology, and clinical bioanalysis. LTD will provide dedicated program management, streamline project coordination across WuXi, and allocate the necessary resources and R&D development efforts for Lee's Pharm programs.
WuXi PharmaTech Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months of 2015; Provides Earnings Guidance for the Second Half and Full Year of 2015
Aug 13 15
WuXi PharmaTech reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported adjusted net income attributable to shareholders decreased 21.3% to USD 27.7 million. Adjusted EPS fell 21.6% year-over-year to USD 0.38. Capital expenditures was USD 39.4 million in second quarter, mainly relating to small-molecule manufacturing expansion in Changzhou and construction of commercial-scale biologic manufacturing facility in Wuxi city. Free cash flow was negative USD 12.2 million in the quarter. Total net revenues were USD 194,138,000 compared to USD 163,354,000 a year ago. Operating income was USD 17,055,000 compared to USD 28,003,000 a year ago. This was mainly due to investments in new businesses, including increased selling and marketing, general and administrative, and research and development expenses and transaction expenses related to the proposed privatization, partially offset by the 8.4% increase in gross profit. Income before income taxes was USD 22,871,000 compared to USD 36,011,000 a year ago. Net income attributable to the shareholders was USD 18,872,000 or USD 0.26 diluted per share compared to USD 29,336,000 or USD 0.41 per diluted share a year ago. This was due to the 39.1% year-over-year decrease in operating income, an adverse change in realized gains on settled foreign-exchange forward contracts. Non-GAAP operating income was USD 26,366,000 compared to USD 33,924,000 a year ago. This was due to investments in new businesses, including increased selling and marketing, general and administrative, and research and development expenses and transaction expenses related to the proposed privatization, partially offset by the 11.6% increase in non-GAAP gross profit. Non-GAAP net income was USD 28,391,000 compared to USD 35,241,000 a year ago, mainly due to the 22.3% year-over-year decrease in operating income, an adverse change in realized gains on settled foreign-exchange forward contracts. Non-GAAP diluted earnings per ADS attributable to the shareholders decreased 21.6% year over year to USD 0.38 against USD 0.49 due to the 21.3% decrease in net income attributable to the shareholders and a higher number of outstanding ADSs as a result of share issuances relating to the XenoBiotic Laboratories acquisition and vesting of restricted stock units, partially offset by the impact of share purchases in 2014.
For the six months, revenues were USD 374,182,000 compared to USD 310,071,000 a year ago. Operating income was USD 34,046,000 compared to USD 51,414,000 a year ago. Income before income taxes was USD 44,901,000 compared to USD 57,700,000 a year ago. Net income attributable to the shareholders was USD 36,656,000 or USD 0.51 diluted per share compared to USD 47,158,000 or USD 0.65 diluted per share a year ago. Non-GAAP operating income was USD 51,639,000 compared to USD 61,797,000 a year ago. Non-GAAP net income was USD 54,011,000 compared to USD 57,508,000 a year ago. Non-GAAP diluted earnings per ADS attributable to the shareholders was USD 0.74 against USD 0.79 a year ago. Capital expenditures were USD 78 million in the first half.
For the full year 2015, the company continues to expect revenues of USD 790 million to USD 800 million. The company continues to expect full year CapEx spending of USD 180 million to USD 200 million.
Capital expenditures will accelerate further in the second half of 2015. The company expects free cash flow to continue to be negative for the second half of 2015 and beyond, to strong investments. The company withdraws its full-year 2015 guidance for GAAP and non-GAAP diluted EPS because of uncertainties regarding currency exchange-rate volatility and potential significant costs associated with several transactions under consideration. The rapid depreciation of the RMB against the U.S. dollar could result in significant mark-to-market losses and realized losses on foreign-exchange forward contracts.
WuXi PharmaTech (Cayman) Inc. and TruTag Technologies, Inc. Complete Testing of Edible On-Dose Authentication Solution for Pharmaceuticals
Aug 10 15
WuXi PharmaTech (Cayman) Inc. and TruTag Technologies, Inc. announced the completion of joint testing of TruTag's on-dose authentication solution. TruTags have a number of benefits for pharmaceutical manufacturers that were confirmed in this joint testing: TruTags can be applied to qualifying solid oral dosage form (SODF) products using a consistent, repeatable process. No new manufacturing equipment and changes in manufacturing processes are needed. After application on manufactured tablets, TruTags are successfully detected using TruTag's proprietary optical detection device. Apart from this detection process, TruTags are covert and not visually identifiable and remain with the tablet for its entire life. Once applied, the TruTag solution did not affect the stability or dissolution properties of API drugs in completed accelerated open and closed bottle testing. Implementing the TruTag solution on existing drugs requires minimal regulatory reporting changes for drug manufacturers and complies with the physical-chemical identifier (PCID) guidance issued by the U.S. Food and Drug Administration in 2011. WuXi and TruTag will now begin further testing of TruTags on additional API products.