Let's take a quick look at four stocks -- Johnson & Johnson (NYSE:JNJ), Teva (NYSE:TEVA), Mylan (NASDAQ:MYL), and Dynavax (NASDAQ:DVAX) -- which could all loom large in health care news this Tuesday morning.
Johnson & Johnson reports first quarter earnings, raises full-year guidance
Johnson & Johnson just reported its first quarter earnings, topping analyst estimates on both the top and bottom lines. J&J's first quarter revenue climbed 3.5% year-over-year to $18.1 billion while adjusted earnings per share climbed 6.9% to $1.54. Analysts had expected the diversified medical giant to earn $1.48 per share on revenue of $18 billion.
J&J's Pharmaceuticals segment was the standout performer during the quarter, reporting that revenue increased 10.8% year-over-year jump to $7.5 billion. Pharmaceuticals revenue growth was fueled by strong demand for the psoriasis treatment Stelara, the antipsychotic Invega Sustenna/Xeplion, the HIV treatment Prezista, and the multiple myeloma treatment Velcade. Newer products like the hepatitis C treatment Olysio/Sovriad, prostate cancer drug Zytiga, the blood thinner Xarelto, and the diabetes drug Invokana also generated strong sales growth during the quarter.
Revenue from J&J's Medical Devices Diagnostics unit came in flat at $7.1 billion, while the Consumer Segment slid 3.2% to $3.6 billion. However, J&J raised its full year earnings forecast to a range between $5.80 to $5.90, up from a prior estimate of $5.75 to $5.85 per share. Shares of J&J are up more than 2% in pre-market trading.
Momenta, Novartis, and Mylan take on Teva over generic Copaxone
Momenta, Novartis' Sandoz unit, and Mylan asked the U.S Supreme Court to allow Copaxone generics to be sold while it considers the Copaxone patent. Teva had previously asked Chief Justice John Roberts to block sales of generic Copaxone while the Supreme Court resolves a patent claim which could shield Copaxone from generic competition until September 2015.
Copaxone is Teva's top-selling drug with $3.2 billion in annual U.S. sales, and accounts for more than half of its profit. The patents protecting Copaxone were originally expected to expire on May 24.
Momenta, Sandoz, and Mylan claimed that they would suffer "immense harm" if they were barred from selling generic versions of Teva's blockbuster multiple sclerosis (MS) drug Copaxone next month. The three companies haven't stated if they will launch generic Copaxone before the Supreme Court reaches a decision early next year.
However, they stated that blocking generic versions for such a long period would "decide this litigation for Teva" by giving the company time to switch patients over from a 20 mg dose to a 40 mg dose currently covered by other patents before generic competition begins.
Mylan signs a partnership with Prosonix to market generic Flixotide and Flovent
Meanwhile, Mylan just announced a partnership with specialty pharmaceutical company Prosonix to develop for its leading inhaled respiratory products, PSX1001 and PSX1050. Those two drugs are being developed as generic versions of GlaxoSmithKline's asthma treatments Flixotide and Flovent, which generated sales of approximately $1.3 billion in fiscal 2013.
Prosonix expects the first market authorization application for PSX1001 to be submitted in Europe this year. Under the terms of the agreement, Prosonix will file PSX1001 in the EU and retain marketing rights in some areas. Mylan will get the marketing rights for PSX1001 and PSX1050 in the U.S., Canada, the EU, and the Russian Federation, as well as several other countries. The financial terms of the deal were confidential.
Dynavax initiates HBV-23 for Heplisav-B
Last but not least, Dynavax just announced the initiation of a new phase 3 clinical trial for Heplisav-B, its investigational adult hepatitis B vaccine, known as HBV-23. The study, which includes approximately 8,250 patients aged 18 to 70, is intended to address safety concerns outlined in the complete response letter the company received from the FDA last February. The company expects that all subjects will be enrolled by the end of 2014.
The larger study is intended to provide better clarity regarding the vaccine's safety profile by expanding the database of vaccinated subjects. Heplisav-B has demonstrated a higher degree of seroprotection (an anti-hepatitis B concentration of 10 mIU/mL or greater) than Engerix-B in two previous trials (HBV-10 and HBV-16).
Dynavax issued a secondary offering last October to raise $125 million to fund HBV-23. If approved, analysts expect Heplisav to generate peak sales of up to $775 million by 2020. Dynavax does not currently have any marketed products.