Bionano Genomics Reports Second Quarter 2021 Financial Results and Highlights Recent Business Progress
- 226% year-over-year total revenue increase driven by growth in the Saphyr installed base
- All 2021 milestones on track
- Strong balance sheet with
$333 million in cash as ofJune 30, 2021 - Conference call today,
Wednesday, August 4 , at4:30 pm ET
“We had a strong quarter to cap off the first half of 2021, which we believe was one of the most transformational periods in Bionano’s history. For the quarter ended
Key Business Highlights
The Company executed on its commercialization strategy, continued to build scientific momentum by presenting data at key scientific meetings and drove utilization of Saphyr at key institutions across the globe, with the following highlights:
- Shipped 13 Saphyr systems in the quarter ended
June 30, 2021 , compared to 6 systems shipped in the same quarter in 2020. Installations completed in the quarter brought the total number of Saphyr systems installed to 121 as ofJune 30, 2021 .
- Sold 2,742 nanochannel array flow cells during the quarter ended
June 30, 2021 , representing Bionano’s highest quarter for such sales ever. The increase represents 93% growth over the same quarter in 2020.
- Gained Saphyr adoption at several notable cytogenetics laboratories in
the United States , including Children’s Hospital ofCincinnati , which is using OGM to identify structural variations in pediatric leukemias. Outside the US, Saphyr was adopted inKorea ,Europe ,Africa andChina , including at Medicover inGermany , one of the largest commercial diagnostic companies inEurope and at NuProbe inChina , a cutting-edge company developing cancer diagnostic assays.
- In the
United Kingdom , Saphyr was adopted by two large laboratories belonging to theNational Health System (NHS ): King’sCollege Hospital inLondon and theNHS Regional Genetics Laboratory inBelfast City Hospital .
- The rise in publications and presentations featuring OGM data that began in Q1 continued in Q2. Bionano experienced its largest presence to-date at the 2021 Annual Clinical Genetics Meeting of the
American College of Medical Genetics and Genomics (ACMG), which was heldApril 13-16 . The meeting featured a total of sixteen presentations by Saphyr customers and Bionano scientists, almost three times the number presented last year and nearly all based on work done inthe United States .
- Two peer-reviewed studies from world renowned scientists and clinicians from prestigious institutions in
Europe , includingRadboud University Medical Center ,Cochin Hospital inParis , Hospices Civils inLyon and theUniversity Hospital of Clermont-Ferrand , were published back-to-back in theAmerican Journal of Human Genetics . The papers outlined the utility of OGM as a superior alternative to traditional methods for structural variant analysis.
- Bionano customers delivered a record number of presentations featuring OGM data at the 2021
European Cytogenomics Conference , which helps support the increased adoption of Saphyr inEurope and shows the wide range of clinical research applications for OGM. The data presented in the talks from leading key clinicians and posters showcased OGM as a superior solution for genomic analysis in leukemia and genetic disease compared to traditional techniques.
- Bionano’s
Dr. Alka Chaubey and Cancer Genomics Consortium President Dr.Yassmine Akkari presented on the significant role of OGM and its potential to transform the cytogenetics market at the 2021International Conference of the Board of Genetic Counseling .
- Enhanced senior management team with the appointments of
Jason Priar as Chief Commercial Officer andRichard Shippy as Chief Business Officer.
- On
May 4 th, 2021, Bionano was issued theU.S. patent “METHODS AND DEVICES FOR SINGLE-MOLECULE WHOLE GENOME ANALYSIS,” which covers novel labeling methods that complement Bionano’s whole-genome mapping approach by allowing the targeting in certain areas of the genome and provide a higher level of resolution below the typical 500 bp cutoff of OGM with Saphyr.
- Bionano was added as a member of the US small-cap Russell 2000® index on
June 28, 2021 , which means Bionano’s share performance is now included in a leading benchmark for institutional investors. Membership in the Russell 2000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index.
- Made significant progress in the field for development of LDTs and accreditation in
Europe , includingBelgium ,Germany andSpain . Two sites in the US,Augusta University and Praxis Genomics, applied for and received proprietary laboratory analysis (PLA) codes. These codes are expected to be used by these institutions to establish reimbursement for OGM tests performed in their laboratories. Pricing for these PLA codes are anticipated to be determined and released by the end of this year.
- At the 2021 Annual
Cancer Genomics Consortium being heldAugust 1-4 th, 2021, which is one of the most important cancer genetics meetings in the world, Bionano customers delivered 10 presentations highlighting the benefits of OGM for clinical research applications in solid tumor analysis, hematological malignancies, products of conception, prenatal and postnatal constitutional genetics.
Financial Highlights
- Total revenue was
$3.9 million for the three months endedJune 30, 2021 , up 226% from$1.2 million in the same period in 2020. Year-over-year, revenue was up in all geographies and across both product and service revenue for the three and six months endedJune 30, 2021 as compared to the same periods in 2020. The increase in global product sales was driven by increased demand for our Saphyr instrument and consumables, while the increase in service revenue was primarily driven by ourLineagen subsidiary.
- Gross margin for the second quarter of 2021 was 37%, up from 33% in the first quarter of 2021, primarily due to a shift in sales, and down 12% from the same period in 2020, due mainly to a substantial increase in revenue contribution from instruments off of the COVID-19-driven low in the second quarter of 2020.
- Second quarter operating expense was
$17.9 million , compared to$12.2 million in the first quarter of 2021 and$8.0 million in the second quarter of 2020. The year-on-year increase was primarily due to expenses from theLineagen acquisition and increased headcount-related spending as we build out all facets of the organization to support our expected commercial progress. In addition, the second quarter of 2020 was affected by the COVID-19 driven cost savings measures, including across the board salary reductions. The sequential increase was mainly due to$3.7 million in increased headcount and related expenses, including a$1.4 million increase in non-cash stock based compensation due to second quarter 2021 employee equity grants amplified by the impact of our higher stock price.
- In other income and expenses, we recorded a net expense of
$2.3 million , which was largely associated with the payment in full of the$16 million outstanding balance on ourInnovatus term loan and the end of term fees and accrued interest,$1.2 million of which was non-cash.
- At
June 30, 2021 , the Company had cash and cash equivalents of$333 million compared to cash and cash equivalents of$38.4 million atDecember 31, 2020 . The increase in cash is due to the equity raises that were completed inJanuary 2021 .
Remaining Anticipated Milestones for 2021 – Initiatives to Drive Global Adoption of Saphyr
3Q21: Commercial release of prenatal assays and expansion of the menu of pediatric assays
4Q21: Interim publication of results from pediatric clinical study
4Q21: Validation of LDTs by 3 sites in both our prenatal clinical study and our pediatric clinical study
4Q21: Initial prototype of next gen high throughput Saphyr
4Q21: Reach installed base of 150 systems to achieve a 50% increase over year end 2020
Conference Call & Webcast Details
Date: | |
Time: | |
Toll Free: | 1-877-407-0784 |
International: | 1-201-689-8560 |
Conference ID: | 13722135 |
Webcast: | https://edge.media-server.com/mmc/p/buc9p49d |
To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.
About
Bionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the significance of Bionano OGM data presented in the publications and presentations discussed in this press release; Bionano OGM’s superiority in genomic analysis as compared to traditional techniques; our efforts and expectations regarding adoption of Saphyr through
CONTACTS |
Company Contact: |
+1 (858) 888-7610 |
eholmlin@bionanogenomics.com |
Investor Relations and |
Media Contact: |
+1 (858) 366-3243 |
amy@juniper-point.com |
Condensed Consolidated Balance Sheet | |||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 332,554,000 | $ | 38,449,000 | |||
Accounts receivable, net | 2,838,000 | 2,775,000 | |||||
Inventory | 4,890,000 | 3,316,000 | |||||
Prepaid expenses and other current assets | 1,683,000 | 2,250,000 | |||||
Total current assets | 341,965,000 | 46,790,000 | |||||
Property and equipment, net | 6,084,000 | 4,910,000 | |||||
Intangible Assets | 1,317,000 | 1,475,000 | |||||
7,173,000 | 7,173,000 | ||||||
Other Long Term Assets | $ | 270,000 | $ | 103,000 | |||
Total assets | $ | 356,809,000 | $ | 60,451,000 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,745,000 | $ | 2,930,000 | |||
Accrued expenses | 6,540,000 | 5,599,000 | |||||
Contract liabilities | 445,000 | 416,000 | |||||
Total current liabilities | 10,730,000 | 8,945,000 | |||||
Long-term debt | — | 16,326,000 | |||||
Long-term contract liabilities | 213,000 | 98,000 | |||||
Total liabilities | 10,943,000 | 25,369,000 | |||||
Stockholders’ equity: | |||||||
Common stock | 28,000 | 19,000 | |||||
Additional paid-in capital | 518,255,000 | 178,747,000 | |||||
Accumulated deficit | (172,417,000 | ) | (143,684,000 | ) | |||
Total stockholders’ equity | 345,866,000 | 35,082,000 | |||||
Total liabilities and stockholders’ equity | $ | 356,809,000 | $ | 60,451,000 |
Condensed Consolidated Statement of Operations (Unaudited) | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue: | |||||||||||||||
Product revenue | $ | 2,496,000 | $ | 940,000 | $ | 4,545,000 | $ | 1,923,000 | |||||||
Service and other revenue | 1,360,000 | 242,000 | 2,479,000 | 395,000 | |||||||||||
Total revenue | 3,856,000 | 1,182,000 | 7,024,000 | 2,318,000 | |||||||||||
Cost of revenue: | |||||||||||||||
Cost of product revenue | 1,869,000 | 515,000 | 3,383,000 | 1,289,000 | |||||||||||
Cost of service and other revenue | 548,000 | 88,000 | 1,159,000 | 170,000 | |||||||||||
Total cost of revenue | 2,417,000 | 603,000 | 4,542,000 | 1,459,000 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 4,086,000 | 2,401,000 | 6,765,000 | 5,075,000 | |||||||||||
Selling, general and administrative | 13,829,000 | 5,613,000 | 23,357,000 | 12,981,000 | |||||||||||
Total operating expenses | 17,915,000 | 8,014,000 | 30,122,000 | 18,056,000 | |||||||||||
Loss from operations | (16,476,000 | ) | (7,435,000 | ) | (27,640,000 | ) | (17,197,000 | ) | |||||||
Other income (expenses): | |||||||||||||||
Interest expense | (210,000 | ) | (561,000 | ) | (748,000 | ) | (1,322,000 | ) | |||||||
Gain on forgiveness of PPP Loan | — | — | 1,775,000 | — | |||||||||||
Loss on debt extinguishment | (2,076,000 | ) | — | (2,076,000 | ) | — | |||||||||
Other expenses | (15,000 | ) | (73,000 | ) | (29,000 | ) | (55,000 | ) | |||||||
Total other income (expenses) | (2,301,000 | ) | (634,000 | ) | (1,078,000 | ) | (1,377,000 | ) | |||||||
Loss before income taxes | (18,777,000 | ) | (8,069,000 | ) | (28,718,000 | ) | (18,574,000 | ) | |||||||
Provision for income taxes | (9,000 | ) | (5,000 | ) | (15,000 | ) | (10,000 | ) | |||||||
Net loss | $ | (18,786,000 | ) | $ | (8,074,000 | ) | $ | (28,733,000 | ) | $ | (18,584,000 | ) |
Source: Bionano Genomics