The earnings season was in full swing this week. Pfizer, Inc. (PFE - Free Report) and Allergan plc’s (AGN - Free Report) strong fourth-quarter results were overshadowed by weak outlook for 2019. Others like AbbVie, Inc. (ABBV - Free Report) and Novartis (NVS - Free Report) also reported their fourth-quarter results. In other news, Roche (RHHBY - Free Report) halted two studies on an Alzheimer’s candidate while Pfizer/Eli Lilly’s (LLY - Free Report) investigational candidate, tanezumab succeeded in the second osteoarthritis pain study.
Recap of the Week’s Most Important Headlines
Earnings in Full Swing: Pfizer and Allergan beat estimates for fourth-quarter earnings as well as sales. However, both the companies’ 2019 forecast disappointed investors.
Loss of exclusivity of some drugs including its key drug Lyrica in the United States in June 2019 as well as currency headwinds is expected to significantly pull down Pfizer’s 2019 revenues.
Similarly, Allergan’s revenues are also expected to be hurt by loss of exclusivity of many key products. While generic version of Alzheimer’s treatment, Namenda XR and Estrace cream have been launched, that of blockbuster dry-eye drug, Restasis, is expected to be launched in 2019.
AbbVie missed estimates for both earnings and sales and gave a weak revenue guidance for 2019. Sales rose 7.3% as higher sales of Humira in the United States and hematological/oncology products, Imbruvica and Venclexta offset weak Humira sales in international. Launch of several direct biosimilar drugs in Europe and other markets hurt Humira’s international sales.
Novartis also missed estimates for both earnings and sales. The Innovative Medicines division recorded sales growth of 9%. Oncology franchise grew 11% while sales at the Sandoz division declined 5% due to price erosion in the United States. The company said that net sales in 2019 should grow in a mid-single digit range.
Roche Discontinues Studies on Alzheimer’s Candidate: Roche announced its decision to discontinue mid-stage studies evaluating its anti-beta-amyloid molecule crenezumab for the treatment of early (prodromal to mild) sporadic Alzheimer’s disease (AD). Data from a pre-planned interim analysis conducted by Independent Data Monitoring Committee indicated that the study was unlikely to meet the primary goal. Roche is developing crenezumab in partnership with AC Immune SA , which declined sharply on the news.
Roche, however, will continue with other Alzheimer’s studies including late-stage GRADUATE studies with gantenerumab and mid-stage TAURIEL study with the anti-tau molecule RG6100. Also, Alzheimer’s Prevention Initiative (API) study evaluating crenezumab in familial AD patient population will continue
Pfizer/Lilly’s Tanezumab Succeeds in 2nd Osteoarthritis Pain Study: Pfizer and partner Lilly announced top-line data from the second phase III study evaluating tanezumab (2.5 mg or 5 mg) for the treatment of osteoarthritis (OA) pain.
Top-line data from the study showed that treatment with tanezumab 5 mg led to statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA – the three primary endpoints – compared to placebo at 24 weeks. The 2.5 mg dose demonstrated a statistically significant improvement in pain and physical function. However for the third primary endpoint, overall assessment of their OA, a statistical difference was not observed. Tanezumab is also being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
AbbVie Gets FDA Nod for Imbruvica+Gazyva in First-Line CLL/SLL: AbbVie announced FDA approval for Imbruvica plus Roche’s Gazyva (obinutuzumab) for the first-line treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). With the FDA approval, Imbruvica plus obinutuzumab becomes the first chemotherapy-free CD20 combination in first-line CLL treatment.
J&J’s Label Expansion Study on Erleada Meets Endpoints: J&J’s (JNJ - Free Report) late-stage label expansion study on prostate cancer drug, Erleada was unblinded following the achievement of the dual primary endpoints, of significant improvement in radiographic progression-free survival (rPFS) and overall survival (OS). The decision was based on the recommendation of Independent Data Monitoring Committee. The phase III TITAN study was evaluating Erleada plus androgen deprivation therapy (ADT) in patients with newly-diagnosed metastatic castration-sensitive prostate cancer (mCSPC). Erleada is presently marketed for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Regulatory applications looking for FDA approval to treat this expanded patient population are expected to be filed this year.
J&J also signed a collaboration and license agreement with MeiraGTx to develop gene therapy programs for inherited retinal diseases (IRD) for an upfront payment of $100 million. Per the deal, J&J will co-develop MeiraGTx’s leading IRD gene therapy programs while the latter will also explore new potential targets for these diseases. J&J also gets an exclusive option to license programs coming out of this research collaboration at the time of clearance of an Investigational New Drug (IND) application.
Merck’s Pneumonia Vaccine Gets FDA’s Breakthrough Status: Merck announced that the FDA has granted Breakthrough Therapy designation to V114, its investigational 15-valent polyvalent conjugate vaccine for the prevention of invasive pneumococcal disease (IPD) in infants, children, and adolescents. V114is being developed in late-stage studies for prevention of IPD in children while also being studied in another study for the same indication in adults.
The NYSE ARCA Pharmaceutical Index rose 2.1% in the last five trading sessions.
All the stocks were in the green in the last five trading sessions. While J&J recorded the highest gain of 4.7%, Bristol-Myers recorded the minimum gain of 0.7%.
In the past six months, Lilly (LLY - Free Report) has been the biggest gainer (19.6%) while Bristol-Myers declined the most (16.7%).
(See the last pharma stock roundup here: JNJ & BMY’s Q4 Earnings, Study Failures at LLY & ABBV )
What's Next in the Pharma World?
Watch out for fourth-quarter and full year 2018 earnings results by Lilly, Glaxo, Sanofi and others and pipeline and regulatory updates next week.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>