The following information should be read in conjunction with the condensedconsolidated financial statements and the accompanying notes included in Part I,Item 1 of this Quarterly Report on Form 10-Q, and the "Risk Factors" included inPart I, Item 1A of our Quarterly Report on Form 10-Q for the quarter ended March31, 2020, and as updated by Part II, Item 1A of our 2019 10-K, as updated byPart II, Item 1A of this Quarterly Report on Form 10-Q.
SAFE HARBOR CAUTIONARY STATEMENT
risks and uncertainties relating to market demand and acceptance of ourproducts and technology, including ARIES, MultiCode, xMAP, xMAP INTELLIFLEX,VERIGENE, VERIGENE II, Guava, Muse, Amnis, and NxTAG products;
timing of and process for regulatory approvals;
our ability to scale manufacturing operations (particularly with respect to ourproducts that recently received U.S. Food and Drug Administration (FDA)Emergency Use Authorization (EUA) clearance) and manage operating expenses,gross margins and inventory levels;
potential shortages, or increases in costs, of components or other disruptionsto our manufacturing operations;
our ability to obtain and enforce intellectual property protections on ourproducts and technologies;
our ability to successfully develop and launch new products in a timely manner;
competition and competitive technologies utilized by our competitors;
dependence on strategic partners for development, commercialization anddistribution of products;
reliance upon the accuracy and completeness of the information received fromstrategic partners to determine the appropriate financial reporting;
risks and uncertainties associated with implementing our acquisition strategy,and our challenge to identify acquisition targets, including our ability toobtain financing on acceptable terms;
our ability to integrate acquired companies or selected assets into ourconsolidated business operations, and the ability to fully realize the benefitsof our acquisitions;
our ability to comply with applicable laws, regulations, policies andprocedures;
changes in principal members of our management staff;
our increasing dependency on information technology to enable us to improve theeffectiveness of our operations and to monitor financial accuracy andefficiency;
implementation, including any modification, of our strategic operating plans;
uncertainty regarding the outcome or expense of any litigation brought againstor initiated by us;
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reliance on third party distributors for distribution of specificLuminex-developed and manufactured assay products; and
risks related to the issuance of the Notes and with respect to the ConvertibleNote Hedge Transactions.
OVERVIEW
Flexibility/scalability
Both protein and nucleic acid applications on a single platform
High throughput
Ease of use
Most xMAP-based assays are simple to perform. A test sample is added to asolution containing microspheres that have been coated with reagents. Thesolution is then processed through one of our xMAP Systems, which incorporateproprietary software to automate data acquisition and analysis in real-time.
Cost-effective
Our Amnis/Guava Technologies
Our Non-Automated Technologies
We have multiple assay development activities ongoing and these activities arefocused in the areas of infectious disease, human genetics and pharmacogenomics.
Our ARIES Technology
Our Market Approach
Second Quarter 2020 Highlights
Record revenue, profitability and cash flow generation in the quarterended June 30, 2020.
Consolidated revenue was $109.5 million for the quarter ended June 30, 2020, a32% increase over the prior year period.
Total assay revenue increased to $61.2 million for the quarter ended June 30,2020, a 95% increase over the prior year period.
Sample-to-answer assay revenue increased to $25.8 million for the quarterended June 30, 2020, a 56% increase over the prior year period.
Profitability increased to $12.5 million for the quarter ended June 30, 2020,an increase of more than 350% vs. the prior year period.
Issued $260.0 million principal amount of Notes due in May 2025.
Cash generation of approximately $31.0 million for the quarter ended June 30,2020, before the net proceeds of $217.6 million from the issuance of the Notes.
Received FDA EUA for the ARIES SARS-CoV-2 Assay on April 6, 2020.
Submitted EUA request to the FDA for the xMAP SARS-CoV-2 Multi-Antigen IgGAssay on June 29, 2020, which was subsequently issued on July 16, 2020.
COVID-19 Considerations
BARDA Contracts
Consumables Sales and Royalty Revenue Trends
Growth in Inventory
We expect our areas of focus over the next twelve months to be:
delivering on our revenue growth goals;
accelerating development and commercialization of the assays on oursample-to-answer diagnostic systems;
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Table of Contentscompleting development and commercialization of the next generationsample-to-answer system, VERIGENE II, our next generation xMAP System, xMAPINTELLIFLEX, and our next generation Guava instrument, Guava Next Gen;
improvement of ARIES and VERIGENE gross margins;
placements of our VERIGENE and ARIES Systems, our sample-to-answer platformsand assays;
increasing the growth of our LTG revenue through enrichment of our existingpartner relationships and the addition of new partners;
maintenance and improvement of our existing products and the timelydevelopment, completion and successful commercial launch of our pipelineproducts;
adoption and use of our platforms and consumables by our customers for theirtesting services; and
expansion and enhancement of our installed base of systems and our marketposition within our identified target market segments.
KEY PERFORMANCE INDICATORS
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Table of ContentsRevenues, disaggregated by revenue source, into the following primarycategories:
The Company's ability to meet anticipated product development timelines and todeliver on our planned commercial product launches.
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RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2020 COMPARED TO THREE MONTHS ENDED JUNE 30, 2019
The following table presents our revenues disaggregated by revenue source forthe three months ended June 30, 2020 and 2019 as follows:
SIX MONTHS ENDED JUNE 30, 2020 COMPARED TO SIX MONTHS ENDED JUNE 30, 2019
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LIQUIDITY AND CAPITAL RESOURCES
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Edgar Online, source Glimpses
Link:
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- Do not learn Dvorak! - November 7th, 2009 [November 7th, 2009]
- You Can’t Solve Problems By Making It Illegal To Have The Problem - November 7th, 2009 [November 7th, 2009]
- A Force Fix for Healthcare - November 7th, 2009 [November 7th, 2009]
- Yahble, HIT, Bubblecon, BIZDEV!, Solid State - November 7th, 2009 [November 7th, 2009]
- 15 things that suck about the Palm Pre - November 7th, 2009 [November 7th, 2009]
- What an Indie Genomics Lab Looks Like - November 7th, 2009 [November 7th, 2009]
- Practice Fusion: Class D Felony? - February 26th, 2010 [February 26th, 2010]
- Practice Fusion Responds - March 7th, 2010 [March 7th, 2010]
- Practice Fusion: Do the math: $44,000 is a LIE - March 10th, 2010 [March 10th, 2010]
- How Much Until Doctors Approve of 23andMe? - March 10th, 2010 [March 10th, 2010]
- Biochemicals as Media, Not Methods - March 10th, 2010 [March 10th, 2010]
- More Practice Fusion Reality Distortion - March 10th, 2010 [March 10th, 2010]
- Same Test Results: 23andMe is Myriad is BRCA is Medicine - March 12th, 2010 [March 12th, 2010]
- BRCA is 23andMe is Myriad is Medicine - March 13th, 2010 [March 13th, 2010]
- Getting Serious About Genomics as Common Medical Practice - March 15th, 2010 [March 15th, 2010]
- The New John Mackey of Genetics: Linda Avey? - March 15th, 2010 [March 15th, 2010]
- Keep the Medical, Well, Medical - March 16th, 2010 [March 16th, 2010]
- If 23andMe shuts down, it won’t be for some mundane reason like the bills weren’t paid - March 16th, 2010 [March 16th, 2010]
- If I Run A Medical Practice, How Do I Use A 23andMe? - March 17th, 2010 [March 17th, 2010]
- 23andMe Contract in Bad Faith - March 19th, 2010 [March 19th, 2010]
- Doctors CANNOT Use 23andMe Due To 23andMe’s Bad Faith Contract - March 20th, 2010 [March 20th, 2010]
- Pathway Compared to 23andMe and Navigenics - March 22nd, 2010 [March 22nd, 2010]
- There’s a Word for “Views Differ” When One View Is The State - March 24th, 2010 [March 24th, 2010]
- Association for Molecular Pathology, et al. v. USPTO, et al. – Opinion - March 29th, 2010 [March 29th, 2010]
- Birth of a Super Villain - April 3rd, 2010 [April 3rd, 2010]
- “Medical Products” like 23andMe must not become the new “Financial Products” - April 4th, 2010 [April 4th, 2010]
- How I Would Apply Genomic Technology In Clinical Use Today - April 5th, 2010 [April 5th, 2010]
- Gmail Enterprise: World’s Best EMR - April 6th, 2010 [April 6th, 2010]
- Brief Primer on Health Law Compliance - April 9th, 2010 [April 9th, 2010]
- Spoiler: You ARE the “Valids” - April 9th, 2010 [April 9th, 2010]
- Rachel Lehmann-Haupt Line by Line Take Down - April 9th, 2010 [April 9th, 2010]
- Is Medicare Bankrupt? What the Hell Is Going On? - April 17th, 2010 [April 17th, 2010]
- The Big Shuffle: Medicare Cuts Rates by 21.3% (but not “technically”) - April 17th, 2010 [April 17th, 2010]
- “Tech Hiring Binge” == “Fear for Your Job, Nerds” - April 18th, 2010 [April 18th, 2010]
- How Bad is Bad? $.20 on the Private Medical Insurance Dollar - April 20th, 2010 [April 20th, 2010]
- Update: How Bad is Bad? It Used to Be $.45 on the Medical Insurance Dollar - April 20th, 2010 [April 20th, 2010]
- World’s Best “EMR” for $1000: Google Spreadsheets + iPad - April 21st, 2010 [April 21st, 2010]
- Don’t Insult Me with your “AOL Keyword” Strategy, Google Health - April 21st, 2010 [April 21st, 2010]
- How to Play LAWGAMES - April 23rd, 2010 [April 23rd, 2010]
- Top 4 Predatory Schemes Encroaching on American Medicine: Part 1 - April 25th, 2010 [April 25th, 2010]
- What’s the Big Deal About iPads? - April 27th, 2010 [April 27th, 2010]
- Got Google Android for Google I/O - April 27th, 2010 [April 27th, 2010]
- Google Enterprise meets HIPAA and HITECH Compliant Laws - April 29th, 2010 [April 29th, 2010]
- Pixels of Accuracy CHALENGE: Diagnostic Medical Imaging - April 29th, 2010 [April 29th, 2010]
- 23andMe Launder AlioGenetics Doesn’t Even Bother to Remove 23andMe Logo - April 30th, 2010 [April 30th, 2010]
- Anthem of CT Denies $600 Until “Subscriber Responds to our Coordination of Benefits Questionnaire” - May 1st, 2010 [May 1st, 2010]
- Apple And Google Team Up To Launch Revolutionary Mobile Health System - May 1st, 2010 [May 1st, 2010]
- Funny Pictures from This Year Building the Medical Practice - May 6th, 2010 [May 6th, 2010]
- Remote Medical Video Monitoring on iPad and iPhone - May 7th, 2010 [May 7th, 2010]
- Google Calendar Overhead Waiting Room Display - May 7th, 2010 [May 7th, 2010]
- Various Whiteboards on Solid State Medical Operations - May 7th, 2010 [May 7th, 2010]
- The Raw Facts about Counsyl - May 7th, 2010 [May 7th, 2010]
- Brawndo: Still Mutilating Thirst, Still Not Yet Sold at the Stop-n-Shop Pharmacy - May 9th, 2010 [May 9th, 2010]
- Video: Google Enterprise to Outsource Medical Administration - May 9th, 2010 [May 9th, 2010]
- Gattaca: “The Matrix” of Genomics - May 11th, 2010 [May 11th, 2010]
- 23andMe Now Diagnoses Fatal Tay-Sachs Disease - May 12th, 2010 [May 12th, 2010]
- Why Was Pathway Targeted for FDA Enforcement and Not 23andMe? - May 15th, 2010 [May 15th, 2010]
- John Dolan on Aging and the Horrifying Conclusion of GWAS - May 16th, 2010 [May 16th, 2010]
- Sam R. Riley Wants To Tell You About Practice Fusion - May 17th, 2010 [May 17th, 2010]
- Response to “Genomic Medicine: Lost” - May 19th, 2010 [May 19th, 2010]
- Death And Taxes: CMS to IRS - May 19th, 2010 [May 19th, 2010]
- Please Stop Antagonizing the AMA - May 26th, 2010 [May 26th, 2010]
- Dan Vorhaus, Attorney At Law, Legally Advises Medical Doctors Can Use 23andMe To Provide Medical Advice - May 28th, 2010 [May 28th, 2010]
- Singularity Summit 2010 in San Francisco to Explore Intelligence Augmentation - June 7th, 2010 [June 7th, 2010]
- OpenPCR: DNA amplification for anyone - June 10th, 2010 [June 10th, 2010]
- FDA sends letters to 5 genetic testing companies - June 11th, 2010 [June 11th, 2010]
- Amazon And The NIH Team Up To Put Human Genome In The Cloud - March 31st, 2012 [March 31st, 2012]
- ReproSource Comments on New Study Linking Infertility to Genetics - April 25th, 2012 [April 25th, 2012]
- Genetics 101 Part 1: What are genes? - Video - April 30th, 2012 [April 30th, 2012]
- Red Ice Radio - David Icke - Hour 1 - The Manipulation of Humanity - Video - April 30th, 2012 [April 30th, 2012]
- Genetics Part 5: Human Genetic Disorders - Video - April 30th, 2012 [April 30th, 2012]
- C2CAM - The Nephilim, Genetic Manipulation - April 30th, 2012 [April 30th, 2012]
- Human Nature talk with Robert Sapolsky, Gabor Mate, James Gilligan, Richard Wilkinson - Video - April 30th, 2012 [April 30th, 2012]
- Human Genetic Diseases - Video - April 30th, 2012 [April 30th, 2012]
- Alien Scientist on Genetics, Implants - April 30th, 2012 [April 30th, 2012]
- Research and Markets: Genetics, 6th Edition International Student Version Continues To Educate Today's Students for ... - May 4th, 2012 [May 4th, 2012]
- Myriad Genetics to Present at the Bank of America Merrill Lynch 2012 Health Care Conference - May 4th, 2012 [May 4th, 2012]
- Genetics may explain some people's dislike of meat - May 4th, 2012 [May 4th, 2012]
- 'Blond Genes' May Vary Around the World - May 4th, 2012 [May 4th, 2012]