With Biogen Idec Inc. (NASDAQ:BIIB) releasing numbers today, Amgen, Inc. (NASDAQ:AMGN) about to report numbers, and Nektar Therapeutics (NASDAQ:NKTR) beginning a new Phase II study; "Important" drug makers are having a strong summer 2012.
Depending on how you look at things, profit-taking today based on Moody's Germany downgrade could be seen as a window into some expensive stocks; stocks that I might add however which are as fundamental to many portfolios as energy 'plays' with dividends and treasuries.
BIIB released its Q2 numbers today with revenues increasing 18% to $1.4 billion YOY. Individual product performers posted TYSABRI with revenues were $280 million, in-line YOY, AVONEX revenues increased 16% year-over-year to $762 million, and RITUXAN revenues from Biogen Idec's unconsolidated joint business arrangement were $285 million for the quarter, an increase of 31% YOY.
Non-GAAP diluted EPS for the second quarter of 2012 were $1.82, an increase of 34% YOY and Non-GAAP net income attributable to Biogen Idec for Q2 2012 was $439 million, an increase of approximately 32% YOY. In some financial guidance, the Company said 2012 Non-GAAP diluted EPS is expected to be above $6.20 and GAAP diluted EPS is expected to be above $5.44.
"At the midpoint of a pivotal year, we continue to succeed in the marketplace and track against our goals," said George A. Scangos, Ph.D., the company's CEO. "AVONEX (to treat multiple sclerosis) performance was particularly strong in the second quarter.
"There has been strong uptake of the AVONEX PEN and AVOSTARTGRIP titration dosing kit in both the US and EU. We have a busy nine months ahead of us preparing for the BG-12 launch and four pivotal trial data readouts; for our long-lasting blood factors VIII and IX for hemophilia, dexpramipexole for ALS and PEGylated interferon beta-1a for multiple sclerosis.
"We continued to strengthen our early-stage pipeline and stepped up the pace of revitalizing our discovery efforts. We had a very productive quarter, delivering both revenue and earnings growth, while continuing to invest in the company's future."
Last week, the first patient was enrolled in a BIIB Phase 2a study for STX-100 in IPF. IPF is a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis of the lung. More than 200,000 patients in the United States and Europe have IPF, and there is no FDA-approved treatment for the disease at this time. STX-100 is a novel humanized monoclonal antibody that selectively disrupts the TGF-beta pathway, which plays a central role in fibrotic disease.
Amgen has announced that it will report its second quarter financial results on Thursday, July 26, 2012, after the close of the U.S. financial markets.
What I like about AMGN these days is that the Company in late June launched Chemotherapy: Myths or Facts, an awareness campaign for cancer patients and their caregivers featuring Emmy-nominated actress and breast cancer survivor Maura Tierney.
In 2009, Tierney was diagnosed with and treated for an aggressive form of breast cancer. Almost three years after successfully completing treatment, she is reflecting back on her cancer journey and its impact on her life with the hope of helping others.
"When I was going through my cancer treatment, I learned that you can never ask a stupid question. I asked every single question that came to my mind, and I believe that helped to calm my own anxiety," said Tierney. "The Chemotherapy: Myths or Facts campaign encourages patients and caregivers to ask a lot of questions, arming themselves with as much information as possible to take charge of their journey."
Today in San Francisco, Nektar Therapeutics announced the start of enrollment in its Phase II study of NKTR-181, a novel opioid analgesic molecule, for treatment of chronic pain.
NKTR-181 is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce other CNS-mediated side effects, such as sedation and respiratory depression.
The Phase 2 study will utilize a double-blind, placebo-controlled, randomized withdrawal study design to assess the efficacy, safety and tolerability of NKTR-181 in patients with moderate to severe chronic pain from osteoarthritis of the knee. Approximately 200 patients will be randomized to receive either NKTR-181 or placebo in the study.
"We are extremely pleased to be part of this Phase 2 clinical study of NKTR-181 in chronic pain patients," said Jeffrey Gudin, MD, Director of Pain Management and Palliative Care, Englewood Hospital & Medical Center and Clinical Instructor of Anesthesiology at Mt. Sinai School of Medicine.
"NKTR-181 exhibited highly differentiated properties in its Phase 1 development, which include slow penetration across the blood-brain barrier into the CNS. This slow rate of entry may allow us to effectively address pain while reducing some of the most troubling opioid CNS effects such as euphoria, sedation, and respiratory depression. NKTR-181 represents a potential paradigm shift in the way we think about opioid analgesia."
"As a new mu-opioid analgesic molecule, NKTR-181 has the potential to transform the treatment of chronic pain by using a molecular approach to reduce the risk of traditional opioid therapy while preserving its analgesic benefit," said Robert Medve, MD, the company's SVP and Chief Medical Officer. "We are excited to be advancing this molecule into Phase 2 testing in chronic pain patients."
Trading lower today NKTR is at $9.07; shares on June 1 were trading at $6.53; a gain of 38.8% in a little less than two months.
Also trading lower today AMGN is at $77.11; shares on June 11 were $67.79; a gain of 13.7% in less than six weeks.
BIIB is trading today in the $139.46 range; shares on June 1 were $126.73; a gain of 10% in a little less than two months.
I haven't, don't, and do not intend on holding any of the companies mentioned in this article.
