Let's take a look at three stocks -- Auxilium Pharmaceuticals (NASDAQ: AUXL), Johnson & Johnson (NYSE:JNJ), and Synergy Pharmaceuticals (NASDAQ: SGYP) -- which could all loom large in health care headlines this Wednesday morning.
Auxilium lowers its full year guidance on lower demand for Testim
Auxilium Pharmaceuticals has fallen more than 15% in pre-market trading this morning, after lowering its full year guidance for 2014 due to lower-than-expected sales of its Testim testosterone gel. The company now expects revenues between $380 million to $420 million for the year -- down from the $450 million to $490 million it had originally projected. On the bottom line, it now expects a net loss of between $15 million to break even, down from its earlier forecast of a profit of $45 million to $50 million.
Testim is one of Auxilium's two most important products; the other one is Xiaflex, a treatment for Dupuytren's contracture. Last quarter, U.S. sales of Testim accounted for 45% of the company's net revenue while U.S. sales of Xiaflex accounted for 16%. For the first quarter of 2014, Auxilium expects Testim to generate worldwide sales of $11 million to $13 million -- down sharply from sales of $45.5 million in the prior year quarter.
The company attributes its bleak expectations for Testim sales to a shrinking market for testosterone replacement therapy (TRT) gels, litigation regarding the marketing of TRT products, and the FDA's plans to investigate the safety of TRT products. As a result, Auxilium expects total prescription volume for the TRT gel market to fall 25% year-over-year in 2014.
Prior to the announcement, shares of Auxilium had rallied more than 70% over the past 12 months.
Johnson & Johnson suspends worldwide sales of its power morcellators
Meanwhile, Johnson & Johnson just suspended worldwide sales of a device used for fibroid surgery due to concerns about the device's potential to spread undetected cancer beyond the uterus. The device, known as a laparoscopic power morcellator, is sometimes used to remove fibroids during surgery. The device divides uterine tissue into smaller pieces so fibroids can be removed through an incision in the abdomen.
The FDA issued an advisory on April 17 which discouraged doctors from using the power morcellators in that manner, due to the risk of worsening a hidden cancer. In a letter to customers and shared by Reuters, J&J stated that the devices always included warnings about "the potential spread of malignant tissue".
Sales of the device have been suspended, but they have not been recalled, since the FDA acknowledged that the use of power morcellators is still the best option for certain patients following a proper risk evaluation and informed consent.
Although power morcellators are only a small part of J&J's Medical Device business, the segment has received negative press over the past year due to a faulty hip implant recall which cost the company over $4 billion. The segment, which accounts for 39% of J&J's top line, posted flat year-over-year sales growth last quarter.
Synergy announces positive top line data for plecanatide
Last but not least, shares of Synergy are up nearly 6% in pre-market trading after the company announced positive top-line data from a phase 2b study assessing the study of plecanatide, a treatment for irritable bowel syndrome with constipation (IBS-C).
The company stated that the trial met its primary objective of determining that plecanatide was effective, safe, and well tolerated. It also reported statistically significant improvement in dealing with complete spontaneous bowel movements and abdominal pain. Based on that positive data, Synergy plans to initiate phase 3 trials in the second half of the year.
The IBS-C indication, however, isn't the most advanced indication for plecanatide. The drug is also in phase 3 trials for chronic idiopathic constipation (CIC). Synergy's other drug, SP-333, is currently in phase 2 trials for opioid-induced constipation (OIC) and phase 1 trials for ulcerative colitis (UC).
Shares of Synergy, which does not have any marketed products, have fallen 4% over the past 12 months.