Pacific Biosciences Q1 Revenues Soar 86%

 Pacific Biosciences reported after the close of the market on Thursday that its first quarter 2021 revenues rose 86 percent year over year, attributable to higher instrument revenue.

For the three months ended March 31, the Menlo Park, California-based company recognized total revenues of $29.0 million, compared to $15.6 million in Q1 2020, beating analysts' average estimate of $25.6 million.

Instrument revenue was $14.9 million, compared with $4.0 million in Q1 2020, driven by multiple multi-instrument orders delivered to customers around the world, including Labcorp, the Wellcome Sanger Institute, and China's Berry Genomics. Consumables revenue was $10.4 million, compared with $8.3 million for Q1 2020. Service and other revenue was $3.7 million, compared with $3.3 million for Q1 2020.

The company placed 10 Sequel II systems and 31 Sequel IIe systems in the quarter, bringing the total installed base to 244 instruments as of March 31, compared to 125 instruments at the end of the year-ago quarter. Customers upgraded another dozen Sequel II instruments to the IIe, bringing in approximately $500,000 in revenues; about a third of all instruments are now Sequel IIe systems.

On a conference call following the release of results, PacBio CEO Christian Henry said the company's performance exceeded expectations. CFO Susan Kim noted that sequencer utilization levels were at "record highs," driven by some service providers in Asia working through a backlog of projects. She said that 82 percent of consumables sold were for the newer Sequel II and IIe systems, a proportion that she only expects to grow. Annualized consumables pull through was down due to stocking in Q4 2020, she said.

PacBio ended the quarter with 435 employees, with growth across its R&D, sales, marketing, and service and support teams.

PacBio's net loss for the quarter was $87.4 million, or $.45 per share, compared to net income of $1.3 million, or $.01 per share. In the prior year period, PacBio recorded $34 million in continuation payments from Illumina as a result of their abandoned merger; in Q1 2021, PacBio repaid $52 million of those continuation advances as a result of a $900 million investment from SoftBank. PacBio's Q1 loss per share beat the consensus Wall Street estimate of a $.46 loss per share.

The firm's R&D expenses in Q1 2021 were $20.5 million, up 35 percent from $15.3 million in Q1 2020, including $1.1 million in expenses related to the firm's collaboration with Invitae to develop a clinical whole-genome sequencing platform. Its SG&A expenses rose 5 percent year over year to $26.1 million from $25.0 million in Q1 2020. Kim noted that the firm had a $6 million advisory fee a year ago related to the dissolution of the Illumina deal.

As of March 31, 2021, the company had $1.16 billion in cash, cash equivalents, and investments.

Kim said the firm expects second quarter revenues to be flat to moderately higher compared to Q1. Under the terms of its deal with SoftBank, PacBio incurred an interest expense of $1.8 million and the company expects to incur about $3.5 million in interest expense every quarter going forward until the notes either mature or are converted.

PacBio received $4.1 million from Invitae related to its collaboration, Kim said, which it will report as a liability under deferred revenue. Expenses will be recorded as they are incurred; Kim said she expects them to be between $20 million and $25 million for 2021.

https://www.genomeweb.com/business-news/pacific-biosciences-q1-revenues-soar-86-percent

AstraZeneca Lost Money on Its Covid-19 Vaccine

 AstraZeneca PLC said sales of its Covid-19 vaccine -- which it has promised to sell initially without profit -- haven't kept up with its costs, resulting in a hit to earnings and a warning the vaccine effort could continue to affect margins.

The drug giant's booked $275 million in revenue in the first three months of the year from sales of its Covid-19 vaccine, developed in partnership with the University of Oxford. The company delivered 68 million doses globally during the first quarter, far short of targets.

In Europe, AstraZeneca shortfalls totaling tens of millions of doses have inflamed political tensions. This week, the European Union sued the company, alleging failure to satisfy its vaccine contract with the bloc. AstraZeneca has said it is working to catch up with supply pledges.

Most of AstraZeneca's vaccine sales revenue in the quarter, $224 million, came from Europe, with $43 million in sales to emerging-markets countries. The numbers pale in comparison with multibillion-dollar sales forecasts of other vaccine makers including Pfizer Inc. and Moderna Inc.

For AstraZeneca, initially at least, the vaccine effort was a drain on earnings during an otherwise strong quarter. Costs from the effort shaved 3 cents off its per-share earnings for the quarter. Earnings per share came in at $1.18 in the quarter, versus 59 cents in the comparable quarter in 2020.

The company said it cost money to provide "equitable supply" of the vaccine at no profit, resulting in a "significant impact" on overall profit margins. Gross profit margins declined 3 percentage points in the quarter, to 74.6%.

"These variations in gross margin performance between quarters can be expected to continue," AstraZeneca said.

The British-Swedish drugmaker also said Friday it plans to apply to the U.S. Food and Drug Administration for authorization for the vaccine in coming weeks.

AstraZeneca's U.S. rollout plans have faced prolonged delays, after early estimates that the shot might be available in late 2020. The drugmaker said in March this year it would apply for FDA review by mid-April. The Wall Street Journal reported Thursday that AstraZeneca had told U.S. officials in recent days it might need until mid-May to finish its application.

The company has struggled to pull together the full data required for the report, which includes efficacy and safety statistics from almost four months of vaccinations in the U.K., plus data from large-scale U.S. and U.K. human trials, The Journal reported.

Overall first-quarter profit was $1.56 billion, roughly double a year ago, on increased revenue of $7.3 billion. A key benchmark, product sales, increased 15% on strong performance of core cancer drugs and new products in the company's pipeline.

Last year, the company doubled its full-year profit and struck a $39 billion deal to buy Boston-based Alexion Pharmaceuticals Inc., a maker of rare-disease drugs and therapies. But public attention has been heavily focused on the Covid-19 vaccine AstraZeneca brought to market in January, when the first mass vaccinations using the shot took place in the U.K. It is now in use in more than 100 countries.

The vaccine effort has faced a series of hurdles, from confusing clinical-trial results and production delays to questions about the shot's precise efficacy and rare blood-clotting problems among a small percentage of people post-vaccination.

Still, it is a major focus of global hopes for curbing the pandemic, especially among developing countries with less access to more expensive vaccines bought up by wealthier countries. AstraZeneca said the company, together with the Serum Institute of India, has delivered more than 48 million doses to a global funding initiative known as Covax focused on supplying shots to less-wealthy countries.

AstraZeneca reiterated its full-year outlook for total revenue increasing by a low-teens percentage, and core earnings per share rising to $5.00 from $4.00, all at constant exchange rates. The guidance doesn't incorporate revenue or profit impact from Covid-19 vaccine sales or the proposed Alexion acquisition.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Lost-Money-on-Its-Covid-19-Vaccine-33117069/

Bristol Myers Gets FDA Priority Review of Opdivo in Muscle-Invasive Urothelial Carcinoma

 Bristol Myers Squibb Co. Friday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of its blockbuster cancer drug Opdivo as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The New York biopharmaceutical company said the FDA set a target action date of Sept. 3 for the application, which is based on a Phase 3 study in which Opdivo nearly doubled disease-free survival compared to placebo.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Bristol Myers said that if approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in the U.S.

Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Gets-FDA-Priority-Review-of-Opdivo-in-Muscle-Invasive-Urothelial-Carcinoma-33119378/

Bristol-Myers cut to Equal Weight from Overweight by Morgan Stanley

 Target to $62 from $70

https://finviz.com/quote.ashx?t=bmy&ty=c&ta=1&p=d

CryoLife sees business growth in Q1

 First Quarter and Recent Business Highlights:

• Achieved total revenues of $71.1 million in the first quarter 2021 versus $66.4 million in the first quarter of 2020, an increase of 7% on a GAAP basis and 3% on a non-GAAP proforma constant currency basis

• Net loss was ($3.1) million, or ($0.08) per share, in the first quarter of 2021

• Non-GAAP net income was $1.4 million, or $0.03 per share, in the first quarter of 2021

CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2021.

"Despite the ongoing impact of COVID-19 on our business, we saw our business return to growth on both a GAAP and proforma constant currency basis in the first quarter. Growth was driven by our new product launches outside of the U.S., a recovery in procedure volume in the U.S., an improved JOTEC inventory position, and our international expansion efforts, evidenced by double digit revenue growth in both Asia and Europe," commented Pat Mackin, Chairman, President, and Chief Executive Officer.

"Additionally, we made progress on our regulatory strategy and are on-track to file PMAs for PerClot and PROACT Mitral later in 2021, which should help drive growth in 2022 and 2023. We also made solid progress on enrollment in our PROACT Xa clinical trial and advanced R&D programs that should deliver additional growth opportunities beginning in 2024. We are optimistic that the second half of 2021 will be the start of a prolonged period of growth for CryoLife."

https://finance.yahoo.com/news/cryolife-reports-first-quarter-2021-200500397.html

Brooklyn ImmunoTherapeutics Acquires License for mRNA Tech to Develop Genetically Edited Cells

 Brooklyn ImmunoTherapeutics LLC (NYSE American: BTX) ("Brooklyn") today announced it has acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited pursuant to an exercise of a previously announced option.

The license includes use of an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest demonstrate a high degree of efficiency, as well as being non-immunogenic and non-mutagenic.

The licensed platform includes mRNA cell reprogramming, which is considered to be the highest efficiency and footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with mRNA-based gene editing – along with a proprietary gene editing protein – to eliminate off-target effects. It also includes the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

"As a result of the license acquisition, Brooklyn is now poised to become a key player among companies exploring gene editing for cell therapies. This mRNA gene editing technology has the potential to be disruptive given its high efficiency and relatively low manufacturing costs. We look forward to continuing the work begun by Factor Bioscience and Novellus with this platform and to reporting our progress as our products advance towards the clinic," commented Howard J. Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "Our licensing of this technology represents a significant advancement in our approach to treating cancers, blood and other disorders, and transforms us from a single therapeutic company with multiple potential indications to a platform company with multiple products in a pipeline of next-generation engineered cellular medicines."

Brooklyn intends to initiate pre-clinical development programs for sickle cell anemia, other inherited monogenic disorders, and solid and liquid tumors, with the intention of being at the Investigational New Drug (IND) stage for at least one of these disorders by 2024.

https://finance.yahoo.com/news/brooklyn-immunotherapeutics-acquires-license-mrna-113000396.html

Motus GI Gets FDA OK on Pure-Vu System for Upper GI Endoscopy

  Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for a version of the Pure-Vu® System that is compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to remove blood, blood clots and debris in order to provide a clear field-of-view for the endoscopist. This proprietary technology is the latest innovation for the Pure-Vu System platform that is specifically designed to integrate with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.

“We are pleased to receive FDA clearance for the Pure-Vu System now compatible with gastroscopes for the purpose of providing enhanced visibility during upper GI endoscopies. We believe this regulatory milestone broadens our ability to participate in a larger percentage of procedures performed by our key customers, providing us a natural extension of our commercial strategy. In addition, we have received consistent feedback from leading physicians indicating their view that there is a substantial unmet need in this area, particularly for Upper GI Bleed procedures,” stated Tim Moran, Chief Executive Officer of Motus GI. “This FDA clearance is a testament to our innovation team’s ability to deliver on customer needs in a timely manner.”

Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. We believe removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).

https://finance.yahoo.com/news/motus-gi-receives-fda-clearance-113000889.html