- Opko is now offering a coronavirus test.
- Aurinia declares full-year results.
- JNJ setback with Remicade patent case.
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OPKO Health to Offer Coronavirus Test, Shares Jump
OPKO Health (OPK) reported that it will offer coronavirus tests through its BioReference Laboratories unit. The tests are expected to be available from next week onward. The company also reported that these tests will be offered throughout the United States through the network of patient service centers.
BioReference is currently collaborating with the World Health Organization, US Centers for Disease Control and Prevention, and other public health agencies for identifying and developing diagnostic tests for infectious diseases. Jon R. Cohen, M.D., Executive Chairman of BioReference said:
We want to specifically recognize how engaged and responsive HHS, the CDC and the FDA have been in helping us navigate quickly through the scientific and regulatory issues necessary to make testing available as soon as possible to the U.S. population."
He also added that the laboratory will work closely with the Health and Human Services Department.
The United States has seen a sharp rise in the number of coronavirus cases. President Trump recently authorized a $7.8 billion emergency spending bill to curb the spread of coronavirus. It is estimated that the number of infected people around the world has crossed 100,000-mark while more than 3,400 deaths have been reported.
OPKO Health had a tumultuous past one year where its stock fluctuated between $1.33 and $2.91. However, its latest news regarding the test has provided a positive fillip to the stock price. The company stock has gained over 50 percent this year so far. The company is mainly engaged in the development and commercialization of diagnostic tests. It is operational in a number of countries around the world including the United States, Chile, Mexico, and Israel. For the fourth quarter of 2019, the company had reported its quarterly operating loss at $112.4 million. Its BioReference platform is amongst the largest full-service clinical laboratories in the United States.
Aurinia full-year results
Aurinia Pharmaceuticals Inc. (AUPH) reported its fourth quarter and full-year results. Its revenue for the full year was posted at $318k, down from $118K in the revenue from the previous year. Its net loss for the year jumped from $64 million to $123.7 million. Aurinia reported its loss before income tax at $123.7 million, up from $64 million. The company ended December 31, 2019, with $306 million in cash and cash equivalents. Aurinia also provided corporate updates for its various trials. Peter Greenleaf, President and Chief Executive Officer of Aurinia said:
2019 was a truly transformational year for Aurinia, highlighted by the positive results achieved with voclosporin in the Phase 3 AURORA clinical trial for the treatment of LN. The team works diligently to prepare and file a New Drug Application to the U.S. FDA next quarter."
The company also reported that it recently held a pre-NDA meeting with the Division of Pulmonary, Allergy, and Rheumatology Products of the FDA in February. Aurinia elaborated about its positive efficacy and safety results from pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate and low-dose corticosteroids, for treating LN. The results were reported on December 4, 2019, and the study involved 357 patients with active LN. The trial met its primary endpoint which was the Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control. The company stated that eligible patients completing the AURORA trial had the option to roll over into a 104-week blinded extension study, leading to 216 patients opting for the rollover. The company also recently completed an FDA-requested clinical DDI study in patients with lupus, investigating the potential outcomes of voclosporin on blood levels of mycophenolate acid. Aurinia reported that it spent $52.9 million in research and development expenses for the FY2019. For the previous year, the company's tab for the corresponding class stood at $41.4 million. The company also posted a financial number for the fourth quarter where its consolidated net loss stood at $76.5 million and $0.78 per common share. Aurinia's net loss for the fourth quarter of the previous year was $14.6 million. The company had incurred $13.3 million in research and development expenses during the fourth quarter, up from $10.8 million for the corresponding quarter of the previous year.
Johnson & Johnson Suffers Setback on Remicade Patent Case
Johnson & Johnson (NYSE:JNJ) received a jolt when a US appeals court upheld a lower ruling that Celltrion's biosimilar to the company's Remicade does not violate patent pertaining to the cell culture used in the manufacturing process. Remicade is one of the flagship products for Johnson & Johnson, bringing in more than $4 billion in annual revenue.
The case involved Johnson & Johnson through its subsidiary Janssen. The patent infringement case has a long history behind it. Hospira Healthcare Corporation was also involved in this patent infringement case. Back in 2016, the District of Massachusetts held U.S. Patent No. 6,284,471 for Remicade to be invalid and thus validating the position of Celltrion and Hospira.
Remicade is a prescription medication used for treating various immunological ailments such as Crohn's disease, Pediatric Crohn's disease, ulcerative colitis, and rheumatoid arthritis among other diseases. The medication is also approved for treating Plaque Psoriasis and Ankylosing Spondylitis.
Remicade is an important part of the company's product portfolio. However, due to increased competition from generics and biosimilars, there had been a decline in revenue generated by the drug. In order to fill the void caused by such decline, the company is looking to develop new drugs and also continues the push for expanding the use of Remicade. However, Remicade patent ruling is not the only sore point for Johnson & Johnson. The company has also been hit by a $1.7 million penalty by an Australian court in connection to pelvic mesh class action suit. In November last year, it was found that Ethicon, a Johnson & Johnson subsidiary, sold these products without adequate warning about the "gravity of the risks."
Johnson & Johnson recently reported its fourth quarter and full-year results. The company earned $20.7 billion in revenue for the fourth quarter while its full-year revenue stood at $82.1 billion. It also reported a 33.9 percent increase in its fourth quarter EPS to $1.50 while its adjusted EPS was stated at $1.88. The company also provided guidance for FY2020 where it expects its adjusted operational sales to show 5 to 6 percent growth. Its operational sales will likely range between $85.8 billion and $86.6 billion, showing 4.5 percent to 5.5 percent growth. Johnson & Johnson estimates that its adjusted EPS for the entire year will grow by 3.1 percent to 4.8 percent to hit $8.95 and $9.10 band.
Johnson & Johnson stock showed choppy movements throughout the last year, showing a marginal net gain. This is primarily due to a large number of legal troubles faced by the company which included adverse ruling on its talcum powder case.
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