With stocks tumbling on Monday, there were plenty of losers to choose from.
Raptor Pharmaceuticals (RPTP) surprisingly tumbled 28% after releasing what seemed to be strong results for its pivotal Phase 3 clinical trial. The company announced that its Phase 3 clinical trial of Delayed Release or DR Cysteamine, known as study drug RP103, for the treatment of nephropathic cystinosis, met the primary endpoint of non-inferiority compared with Cystagon, immediate-release cysteamine bitartrate. The comparison was based on white blood cell ("WBC") cystine levels, the established efficacy surrogate biomarker and sole primary endpoint in the clinical trial. The company also reported that there were no unexpected serious safety concerns experienced by patients in the trial attributable to RP103.
Of 41 patients who completed the Phase 3 protocol, 38 were included in the evaluable data set, 3 not being fully compliant with the protocol. On average, the peak WBC cystine level measured in patients treated with Cystagon was 0.54 +/- 0.05 nmol 1/2 cystine/mg protein, compared with an average peak value of 0.62 +/- 0.05 nmol 1/2 cystine/mg protein for patients treated with RP103. The mean difference was 0.08 nmol 1/2 cystine/mg protein, with a 95.8% confidence interval of 0.00-0.16 (one sided p=0.021). As stipulated in the Statistical Analysis Plan, the non-inferiority endpoint of the clinical trial would be achieved when the upper end of the confidence interval around the mean difference of WBC cystine levels did not exceed an absolute value of 0.3. The upper end of the confidence interval in the Phase 3 clinical trial was determined to be 0.16, thus achieving the non-inferiority endpoint.
Additionally, the endpoint was achieved at a lower average daily dose of RP103, compared with Cystagon. In the course of the study, seven serious adverse events ("SAEs") requiring a visit to the emergency room or hospital, were reported for seven individual patients. Of these seven SAEs, six were determined by the Principal Investigator to be unrelated to either RP103 or Cystagon. One SAE, gastric intolerance, was graded as "possibly related" to RP103 and was subsequently resolved. Further analyses of non-serious adverse events are underway by the company's statistical contractor.
Hollysys Automation Technologies (HOLI) tumbled 18% following a fatal high-speed rail accident in China. The company said that its high-speed rail (HSR) signaling ATPs functioned normally during last weekend's fatal accident. On the evening of July 23, a fatal accident occurred on Wen-Yong Dedicated Passenger Line at Wenzhou area, involving D301 and D3115 trains, both with Hollysys HSR signaling ATPs installed. According to the analysis of data from multiple sources, the ATPs on the two trains provided by Hollysys functioned normally and well, and free of any malfunctions prior to the crash.
Bridgepoint Education (BPI) closed 11% lower after the company filed an S-3 to register the resale of 34,589,220 shares of its common stock held by Warburg Pincus. The company added that it is not selling any common stock in this offering and will not receive any of the proceeds from the sale of common stock by Warburg Pincus. Upon effectiveness of the registration statement, Warburg Pincus, and its permitted transferees or other successors-in-interest, may offer the shares from time to time through public or private transactions at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. The registration will not result in a dilution of shares of common stock currently outstanding.
HCA (HCA) tumbled 19% after its Q2 earnings missed analyst estimates. The company said revenue increased 4% to $8.063 billion while net income totaled $229 million, or $0.43 per diluted share, which includes a pre-tax loss on retirement of debt of $75 million, or $0.08 per diluted share. Analysts expected EPS of $0.60. “While the Company had favorable admissions growth during the quarter, we experienced a shift in service mix from more complex surgical cases to less acute medical cases. This resulted in lower than anticipated revenue growth and earnings,” said Richard Bracken, Chairman of the Board and Chief Executive Officer of HCA.
Silicon Laboratories (SLAB) fell 13% after it announced strong earnings but disappointing revenue guidance. The company reported a 5.5% quarter/quarter increase in Q2 revenue to $126.2 million; EPS was $0.48 cents vs. analyst consensus of $0.40. The company’s performance was driven by growth in all three of its main product lines, Broad-based, Access and Broadcast. The record quarter in Broad-based products was driven primarily by MCUs, with particular strength due to ramps of new products and customer programs. Video and timing products also delivered record revenue in the quarter. New mid-year model wins in video support the anticipated increase in the adoption rate of silicon tuner technology across TV makers, models and geographies.
Despite the good quarter, the company said that it expects revenue for the third quarter to decline by 5-10% quarter/quarter. Analysts had estimated a 6% quarter/quarter increase.