On May 5, 2020 nvitae Corporation (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the first quarter ended March 31, 2020 (Press release, Invitae, MAY 5, 2020, View Source [SID1234561380]).
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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)
"We started the year with a very strong quarter, delivering record growth in volume and first quarter revenues and giving us strong momentum as we began experiencing impacts from the pandemic. As healthcare has shifted, we have been able to quickly leverage our pre-existing strengths, notably our telehealth offerings and our ability to deliver genetic testing remotely," said Sean George, co-founder and chief executive officer of Invitae. "Looking ahead, our investments in diversified products, services, technologies and geographies mean we are well-equipped to drive growth across an increasing number of customer segments as we drive genetics into mainstream medicine."
First Quarter 2020 Financial Results
Accessioned more than 154,000 samples in the first quarter of 2020, representing a nearly 64% increase over the 94,000 samples in the first quarter of 2019 and more accessioned samples in one quarter than in the full year of 2017. Billable volume exceeded 151,000 in the first quarter of 2020
Generated revenue of $64.2 million in the first quarter of 2020, representing a 58% increase over $40.6 million in revenue in the first quarter of 2019
Reported average cost per sample of $262 in the first quarter of 2020, representing a 16% increase from a $226 average cost per sample in the first quarter of 2019. Average non-GAAP cost per sample was $245 in the first quarter of 2020
Achieved gross profit of $23.8 million in the first quarter of 2020, representing a more than 23% increase from the $19.3 million of gross profit in the first quarter of 2019. Non-GAAP gross profit was $26.5 million in the first quarter of 2020
Total operating expense, excluding cost of revenue, for the first quarter of 2020 was $121.6 million. Non-GAAP operating expense, which excludes amortization of acquired intangible assets and acquisition-related stock-based compensation, was $101.9 million in the first quarter of 2020. Interest and other expense, net and net loss are preliminary and subject to change as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae’s Form 10-Q to be filed with the SEC on or before May 11, 2020.
Preliminary net loss for the first quarter of 2020 was $102.2 million, or $1.03 preliminary net loss per share, compared to a net loss of $37.7 million in the first quarter of 2019, or $0.47 net loss per share. Preliminary non-GAAP net loss was $79.8 million in the first quarter of 2020, or $0.80 preliminary non-GAAP net loss per share.
At March 31, 2020 cash, cash equivalents, restricted cash, and marketable securities totaled $301.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $61.0 million. Cash burn, including various acquisition-related expenses, was $98.5 million for the quarter; $66.2 million when excluding $32.3 million cash paid to acquire Diploid.
In April, the company completed a public offering of common stock, resulting in gross proceeds of $184.0 million and $173.0 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.
COVID-19 Impact
Global stay-at-home orders, lockdowns and shutdown of non-emergency healthcare and elective procedures began impacting Invitae during the second half of March. Invitae took a number of steps in response, including:
Ensured operational continuity in all production facilities, monitored and directed by a dedicated response team. Production facilities experienced no disruptions or shortages and remain fully operational
Leveraged pre-existing platforms for Invitae’s highly distributed workforce to ensure a quick transition for non-production employees to remote working
Implemented robust support for clinicians transitioning to telehealth (see below)
The impact of the pandemic on testing volume has and is likely to continue to vary based on clinical area, geography and clinician type. In response, the company has taken a number of steps to reduce cash burn.
The company is continuing to closely monitor the impact of the COVID-19 pandemic and plans to continue to reduce previously communicated cash burn through the remainder of 2020.
Given the unknown duration and extent of COVID-19’s impact on our business, and the healthcare system in general, Invitae has previously withdrawn its 2020 guidance.
Corporate and Scientific Highlights
Introduced expanded services and support for transition to telehealth across customer types
Launched new capabilities for Gia, the advanced clinical chatbot that became part of Invitae through the acquisition and rapid integration of Clear Genetics. New workflows added to Gia support obstetrician/gynecologists, oncologists, genetic counselors and other clinicians who order genetic testing
Increased support for the use of at-home testing using saliva kits, which do not require an in-person clinician visit
Provided professional education and support for clinicians transitioning to telehealth
Acquired Diploid, developer of an artificial-intelligence engine, to enable clinical diagnosis using exome and whole genome sequencing in minutes, enhancing Invitae’s capabilities to provide rapid answers to patients while further reducing the cost of genetic testing at scale
Acquired YouScript and Genelex in April 2020 to bring best-in-class pharmacogenetic testing, and robust, integrated clinical decision support to Invitae
Submitted research abstracts to the American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting and the World Congress of Cardiology, which were moved to an online format. Among the data shared:
Among 13 abstracts at ACMG, research from the Invitae Detect Prostate Cancer program that found the frequency of actionable genetic findings was similar across stages of disease severity at approximately 13%. The study found more than half of patients with actionable findings showed no family history of disease and suggests that broadening testing criteria identifies patients with actionable findings with clinical implications, such as qualification for approved therapies or clinical trials.
Research shared via the World Congress of Cardiology included a study showing 96% of individuals with genetically-positive cardiomyopathy would be falsely reassured by a negative result provided by limited genotyping testing strategies available in common direct-to-consumer services. The study also showed that comprehensive genetic testing identifies actionable variants in a substantial portion of cardiology patients which may confer eligibility for gene-specific precision therapies and guide implementation of established management recommendations.
Added 12 new biopharma partnerships, bringing the total number of partnership programs to more than 90
Partnered with the Muscular Dystrophy Association (MDA) to offer the Detect Muscular Dystrophy program in MDA’s network of more than 150 care centers in the United States.
Added Axovant Gene Therapies as a sponsor of the Invitae Detect Lysosomal Disorders program, which offers no-charge genetic testing to facilitate faster diagnoses of lysosomal storage disorders, including Tay-Sachs/Sandhoff disease.
Added Biogen, Encoded Therapeutics, Neurogene, Praxis Precision Medicines and PTC Therapeutics to its sponsored testing partnership program, Behind the Seizure, to expand access to testing for pediatric epilepsy to children under eight who experience an unprovoked seizure.
Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 9557177. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.
The live webcast of the call and slide deck may be accessed by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.