Genomic testing firm Veracyte Inc. is eyeing 2021 for the launch of its noninvasive nasal swab classifier for early lung cancer detection and diagnosis, following preliminary clinical data demonstrating high sensitivity in low-risk patients and high specificity in high-risk patients with known lung nodules. The South San Francisco-based company is developing the nasal swab test in collaboration with Johnson & Johnson Inc.'s Lung Cancer Initiative, part of a long-term strategic collaboration that also aims to speed commercialization of Veracyte's Percepta genomic sequencing classifier.
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
It was a standout quarter for San Diego-based Resmed Inc., which saw revenues jump to $681.1 million, with the U.S., Canada and Latin America serving as bright spots. "We have started fiscal year 2020 right where we left off with 2019," Michael Farrell, Resmed's CEO, said during a call on the results. "Our team achieved another quarter of the balanced growth across the portfolio, driven by continued strong performance in the mask category."
Edwards Lifesciences Corp. has been unstoppable so far this year, driven by the rapidly expanding adoption of transcatheter heart valve therapy. It beat expectations in its third-quarter earnings report, drawing praise and even higher expectations from Wall Street analysts. The Irvine, Calif.-based company recently received an expanded FDA indication for its Sapien 3 and Sapien 3 Ultra TAVR systems to treat surgical low-risk patients with severe aortic stenosis. (See BioWorld MedTech, Aug. 19, 2019.)
Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent such as a semi-annual filing like many reporting companies based in Europe have implemented?
Alexion Pharmaceuticals Inc., of Boston, reported second-quarter revenues of $1.2 billion, a 15% increase compared to $1 billion in the same period last year.
Seattle Genetics Inc., of Bothell, Wash., reported U.S. and Canadian sales of Adcetris (brentuximab vedotin), its antibody-drug conjugate targeting CD30 for lymphoma, totaling $159 million for the second quarter, marking a 30% increase over net sales in the second quarter of 2018 and topping consensus estimates by roughly 7%.
