Last week was dominated by earnings announcements with some major biotech companies reporting fourth quarter results.
A Look at Some Earnings Reports & Expectations: Biotech major Amgen (AMGN) kicked off last week with strong fourth quarter results. The big news from Amgen was that it could be in a position to file for approval of its PSCK9 inhibitor, evolocumab, this year. Early approval would give Amgen’s experimental drug a head start (over other PSCK9 inhibitors in development) in the multi-billion dollar cholesterol market.
Amgen’s guidance for 2014 was a tad disappointing. Not only were estimates towards the lower end of the guidance range, the revenue guidance provided by the company implies a slower growth rate. But if we go by Amgen’s past record, guidance could well prove to be conservative – last year, too, the company had started off with a conservative guidance which was increased through the course of the year.
Biogen (BIIB) also topped expectations with its new multiple sclerosis drug, Tecfidera, continuing to shine. Biogen’s revenue guidance was well above expectations though earnings guidance fell short. The company could see three new product launches this year – hemophilia drugs Eloctate and Alprolix, and multiple sclerosis drug Plegridy. But we don’t expect much contribution from the hemophilia drugs this year – the hemophilia market is historically a slow-moving market with both physicians and patients being reluctant to switch therapies without real-world experience.
Logistical hurdles also exist. So this year, it will mainly be Tecfidera that will drive growth at Biogen with some help from other multiple sclerosis drugs like Avonex and Tysabri.
Meanwhile, investors ignored Vertex’s (VRTX) fourth quarter results and instead focused on the company’s plans for its cystic fibrosis (CF) program. Despite posting a wider loss, Vertex saw its shares gaining 4.2%. While hepatitis C (:HCV) drug, Incivek, will continue to see a decline in sales, Kalydeco (CF) should keep growing this year thanks to launch in additional markets and label expansion. Investor focus will remain on data from a couple of phase III studies (TRAFFIC and TRANSPORT) evaluating Kalydeco in the delta 508 homozygous population.
Celgene (CELG) had announced preliminary results earlier this year so the company’s earnings report was not a surprise. Investor focus will remain on the regulatory status of Otezla which is under FDA review for psoriatic arthritis and psoriasis.
Alexion (ALXN) was a huge gainer last week with the company reporting strong results and guiding above expectations. Soliris is doing well with its first approved indication (paroxysmal nocturnal hemoglobinuria) and the second indication (atypical hemolytic uremic syndrome) is surpassing expectations. Shares were up 21.3% on the company’s fourth quarter results and guidance. The company will be benefiting from lower tax rates.
Medivation Prevails in PREVAIL Study: Medivation (MDVN) and partner Astellas continue to come out with positive data on their prostate cancer therapy, Xtandi. The companies came out with pretty impressive final data on Xtandi in the chemo-naïve patient population. The 17-month delay in the time to initiation of chemotherapy should help Xtandi gain share once it is approved for the pre-chemo patient population. Shares were up 11.2%.
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Biogen Sets its Sights on Asia: Biogen is extending its reach to new markets. The company has signed up with UCB allowing the latter to commercialize its products in South Korea, Hong Kong, Thailand, Singapore, Malaysia and Taiwan. Moreover, UCB gained rights to develop and market Biogen’s products in China.
Competitor-Related News Leaves InterMune Investors Jittery: InterMune investors got jittery on news reports that potential competitor Boehringer Ingelheim’s idiopathic pulmonary fibrosis (IPF) candidate has performed well in phase III studies. InterMune’s IPF treatment, Esbriet, which is currently approved in the EU, is yet to gain U.S. approval.
Shares slipped 17.8% on the news. However, with top-line results from InterMune’s phase III ASCEND study due in the second quarter, investor reaction looks a bit overdone. ASCEND results, if positive, will be used to apply for U.S. approval.
Another Tivozanib-Related Setback for AVEO: AVEO and partner Astellas have decided to discontinue a phase II study evaluating experimental cancer treatment, tivozanib, in patients suffering from locally recurrent or metastatic triple negative breast cancer. The study is being discontinued due to insufficient enrollment. AVEO, which has faced tivozanib-related setbacks earlier, saw its shares decline 5.6%.
Safety Issues for Progenics (PGNX): Shares of Progenics nosedived 27.4% after safety issues related to its most promising pipeline candidate, prostate-specific membrane antigen antibody drug conjugate (PSMA ADC), were revealed in an abstract ahead of the American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium Meeting. Two instances of death due to sepsis were reported in patients receiving the 2.5 mg/kg dose of PSMA ADC. The toxicity issue puts a question mark on the future of this program.
KaleBios Hit by Asthma Data: KaloBios shares plunged 28.4% with the company saying that its asthma candidate, KB003, failed to meet the primary endpoint in a mid-stage study. The company said that it will not evaluate the experimental drug for severe asthma.
The Week So Far:
CRL for RedHill Biopharma: The FDA issued a complete response letter (CRL) for RedHill Biopharma and IntelGenx Corp.’s VersaFilm Oral Film Product for the treatment of acute migraines. Although disappointing, the good news is that no additional studies are needed. The main issues raised by the agency relate to third party Chemistry, Manufacturing and Controls and the packaging and labeling of the product.
EU Win for Biogen’s Tecfidera: Biogen’s oral multiple sclerosis drug Tecfidera gained EU approval. The drug, which has been performing exceptionally well in the U.S., will be launched in Germany shortly.
Gilead’s Sovaldi Impresses: Gilead reported fourth quarter results this week. HCV drug, Sovaldi, is off to a strong start and is poised to drive sales.
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