Bionano Reports First Quarter 2024 Results and Highlights Recent Business Progress
- Q1 2024 revenue was
$8.8 million , which represents an 18% increase over Q1 2023 - Total installed base of 347 optical genome mapping (OGM) systems as of Q1 2024, which represents a 34% increase over Q1 2023
- Sold 8,249 nanochannel array flowcells in Q1 2024, which represents a 58% increase over the number of flowcells sold in Q1 2023
- Efforts to reduce cash burn and operating expense continued with the
March 2024 announcement of expanded cost savings initiatives; since the initial cost savings initiative announced inMay 2023 , the Company plans to have reduced headcount by approximately 200 people by the end of Q2 2024 and to have reduced annualized non-GAAP operating expenses by about$65.0 to$75.0 million by Q1 2025 - Conference call today,
May 8 th, 2024 at4:30 PM ET
Recent Highlights
- Announced a strategic partnership with
Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), an assisted reproductive technology company based inChina ; the joint endeavor aims to commercialize the first ever cytogenetic workflow that integrates OGM plus artificial intelligence (AI) chromosome karyotype analysis for clinical use in reproductive health. - Announced a registered direct offering priced at-the-market under Nasdaq rules, with gross proceeds to the Company of approximately
$10 million , before deducting the placement agent’s fees and other offering expenses payable by the Company; funds will be used for general corporate purposes. - Advancements to the Company’s suite of comprehensive software analysis tools for cancer are planned for
May 2024 ; enhancements include a novel aneusomy caller feature, Phred-like quality scores for detected variants, enhanced visualization with VIA circos plots, and customizable reporting options.
- Additional updates and improvements to the Company’s end-to-end workflow are underway, with a pre-commercial version of the Ionic® Purification System for isolation of DNA for OGM analysis to be evaluated at 3 customer sites and the full commercial launch anticipated for the third quarter of 2024; improvements to data analysis processing time on the Stratys™ Compute, a high-performance workstation developed in collaboration with NVIDIA, are anticipated for the third quarter of 2024.
- Published an implementation study which compared OGM to traditional cytogenetic methods for the detection of structural variants (SVs) in bone marrow aspirate samples; results showed that OGM detected variants that were missed by traditional methods, and that targeted Cas9-directed nanopore sequencing was able to validate the variants detected with OGM and define the breakpoints at the base pair level efficiently and at high resolution.
- Reiterated full year 2024 revenue guidance of
$37.0 to$41.0 million ; revenue for the second quarter of 2024 is expected to be$7.8 to$8.2 million .
Q1 2024 Highlights
- Continued efforts to reduce cash burn and operating expense with the
March 2024 announcement of expanded cost savings initiatives; since the initial cost savings initiative announced inMay 2023 , the Company plans to have reduced headcount by approximately 200 people by the end of the second quarter of 2024 and to have reduced annualized non-GAAP operating expenses by about$65.0 to$75.0 million by the first quarter of 2025. - Installed base of OGM systems totaled 347 at the end of the first quarter of 2024, which represents a 34% increase over the 259 installed systems reported at the end of the first quarter of 2023.
- 8,249 nanochannel array flowcells sold during the first quarter of 2024, which represents an increase of 58% over the 5,226 flowcells sold during the first quarter of 2023.
- Key publications support OGM’s utility:
- In a study on hereditary breast and ovarian cancer syndrome, researchers used OGM to detect SVs in tumors that may be linked to mutated genes and altered signaling pathways, which may correlate to tumor progression, prognosis and chemotherapy resistance. OGM also detected chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods.
- A peer-reviewed publication in Cancers found that that the use of OGM for SV detection combined with drug sensitivity data for the same samples can identify potentially pathogenic SVs that may be drivers of drug sensitivity or resistance.
“We are pleased with our Q1 2024 results, which include significant growth in year-over-year revenue, expansion in the OGM system installed base, and advances to our end-to-end workflow,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. “Our focus remains on strengthening the company's long-term growth profile. As a part of our ongoing evolution, we are continuing to execute on cost savings and strategic productivity initiatives intended to allow us to be more focused and agile, drive efficiency across the company, and prioritize investing in opportunities where we see the greatest potential to increase global adoption and utilization of OGM."
Q1 2024 Financial Results
- Total revenue for the first quarter of 2024 was
$8.8 million , an increase of 18% compared to the first quarter of 2023. - GAAP gross margin for the first quarter of 2024 was 32%, compared to 28% from the first quarter of 2023. First quarter 2024 non-GAAP gross margin was 34%, compared to 30% from the first quarter of 2023. First quarter 2024 non-GAAP gross margin excludes
$128,000 in stock-based compensation and$11,000 of restructuring expense. - First quarter 2024 GAAP operating expense was
$33.9 million , and$24.7 million on a non-GAAP basis. Non-GAAP operating expense in the first quarter of 2024 excludes restructuring costs, stock-based compensation, and other adjustments as detailed in the reconciliation table accompanying this press release. In the first quarter of 2023, GAAP operating expense was$39.9 million and$33.6 million on a non-GAAP basis. First quarter 2023 GAAP to non-GAAP reconciliation can be found in the same table in this release. - Cash, cash equivalents, and available-for-sale securities were
$53.2 million as ofMarch 31, 2024 compared to cash, cash equivalents and available-for-sale securities of$102.3 million as ofDecember 31, 2023 . As ofMarch 31, 2024 ,$24.8 million was subject to certain restrictions compared to$35.5 million as ofDecember 31, 2023 . The$24.8 million subject to certain restrictions is reduced as we pay down the outstanding principal amount on our debt. - Raised
$15.1 million in net proceeds in the first quarter of 2024 through our ATM facility. - The change in total cash balance from
December 31, 2023 toMarch 31, 2024 consists of$19 million cash burn from operating activities excluding interest and debt retirement fees,$9 million in interest and debt retirement fees,$37 million in repaid principal offset by$15 million in net ATM proceeds; in the first quarter of 2023, cash burn from operating activities excluding interest and debt retirement fees was$32 million .
Gülsen Kama, chief financial officer at Bionano added, “Q1 2024 was an important quarter for the Company. Our operating expense and cash burn improved year-over-year as a result of the cost savings initiatives we announced in May and
Conference Call & Webcast Details
| Date: | |
| Time: | |
| Participant Dial-In: | Toll Free: 1-833-630-1956 International: 1-412-317-1837 |
| Webcast Link: | https://edge.media-server.com/mmc/p/5z343pph/ |
Participants may access a live webcast of the call on the Investors page of the Bionano website. A replay of the conference call and webcast will be archived on Bionano’s investor relations website at https://ir.bionano.com/ for at least 30 days.
About Bionano
Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides OGM-based testing for certain laboratory developed tests. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. For more information, visit www.bionano.com and www.bionanolaboratories.com.
Unless specifically noted otherwise, Bionano’s OGM products are for research use only and not for use in diagnostic procedures.
Non-GAAP Financial Measures
To supplement Bionano’s financial results reported in accordance with
Bionano believes that non-GAAP gross margin and non-GAAP operating expense are useful to investors and analysts as a supplement to its financial information prepared in accordance with GAAP for analyzing operating performance and identifying operating trends in its business. Bionano uses non-GAAP gross margin and non-GAAP operating expense internally to facilitate period-to-period comparisons and analysis of its operating performance in order to understand, manage and evaluate its business and to make operating decisions. Accordingly, Bionano believes these measures allow for greater transparency with respect to key financial metrics it uses in assessing its own operating performance and making operating decisions.
These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Bionano in this press release and the accompanying reconciliation table have limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
For a reconciliation of non-GAAP gross margin and non-GAAP operating expense to gross margin and operating expense reported in accordance with GAAP, please refer to the financial tables accompanying this release.
Forward-Looking Statements of
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “estimate,” “expect,” “may,” “plan,” “will” 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: our expectations regarding product uptake, revenue growth, market development and increased OGM adoption, including through publications highlighting the utility and applications of OGM; our growth prospects and future financial and operating results; the growth of our installed OGM system base; the sales of our flowcell consumables and the other expectations related thereto; our commercial expectations, including the potential to increase global adoption and utilization of OGM; the anticipated benefits and success of our collaboration efforts, including the opportunities offered by our anticipated collaborations with NVIDIA; continued research, presentations and publications involving OGM and its utility compared to traditional cytogenetics and our technologies; our ability to drive adoption of OGM and our technology solutions; our cost savings and strategic productivity initiative including the expected reduction in headcount and annualized operating expenses; and efforts to extend our cash runway. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the timing and amount of revenue we are able to recognize in a given fiscal period; the impact of adverse geopolitical and macroeconomic events, such as recent and potential future bank failures and the ongoing conflicts between
CONTACTS
Company Contact:
+1 (858) 888-7610
eholmlin@bionano.com
Investor Relations:
+1 (858) 888-7625
IR@bionano.com
| Condensed Consolidated Balance Sheet (Unaudited) | |||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 15,759,000 | $ | 17,948,000 | |||
| Investments | 12,561,000 | 48,823,000 | |||||
| Accounts receivable, net | 8,313,000 | 9,319,000 | |||||
| Inventory | 19,587,000 | 22,892,000 | |||||
| Prepaid expenses and other current assets | 4,945,000 | 6,019,000 | |||||
| Restricted investments | 24,446,000 | 35,117,000 | |||||
| Total current assets | 85,611,000 | 140,118,000 | |||||
| Restricted cash | 400,000 | 400,000 | |||||
| Property and equipment, net | 25,279,000 | 23,345,000 | |||||
| Operating lease right-of-use asset | 4,870,000 | 5,633,000 | |||||
| Financing lease right-of-use asset | 3,453,000 | 3,503,000 | |||||
| Intangible assets, net | 31,734,000 | 33,974,000 | |||||
| Other long-term assets | 6,648,000 | 7,431,000 | |||||
| Total assets | $ | 157,995,000 | $ | 214,404,000 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 9,844,000 | $ | 10,384,000 | |||
| Accrued expenses | 11,028,000 | 8,089,000 | |||||
| Contract liabilities | 1,035,000 | 783,000 | |||||
| Operating lease liability | 2,190,000 | 2,163,000 | |||||
| Finance lease liability | 269,000 | 272,000 | |||||
| Purchase option liability (at fair value) | 5,060,000 | 8,534,000 | |||||
| Convertible notes payable (at fair value) | 29,080,000 | 69,803,000 | |||||
| Total current liabilities | 58,506,000 | 100,028,000 | |||||
| Operating lease liability, net of current portion | 2,755,000 | 3,590,000 | |||||
| Finance lease liability, net of current portion | 3,575,000 | 3,585,000 | |||||
| Contingent consideration | 10,250,000 | 10,890,000 | |||||
| Long-term contract liabilities | 138,000 | 154,000 | |||||
| Total liabilities | 75,224,000 | 118,247,000 | |||||
| Stockholders’ equity: | |||||||
| Common stock | 6,000 | 5,000 | |||||
| Preferred Stock | — | — | |||||
| Additional paid-in capital | 695,411,000 | 677,337,000 | |||||
| Accumulated deficit | (612,630,000 | ) | (581,208,000 | ) | |||
| Accumulated other comprehensive income (loss) | (16,000 | ) | 23,000 | ||||
| Total stockholders’ equity | 82,771,000 | 96,157,000 | |||||
| Total liabilities and stockholders’ equity | $ | 157,995,000 | $ | 214,404,000 | |||
| Condensed Consolidated Statement of Operations (Unaudited) | |||||||
| Three Months Ended |
|||||||
| 2024 | 2023 | ||||||
| Revenue: | |||||||
| Product revenue | $ | 6,828,000 | $ | 5,447,000 | |||
| Service and other revenue | 1,941,000 | 1,968,000 | |||||
| Total revenue | 8,769,000 | 7,415,000 | |||||
| Cost of revenue: | |||||||
| Cost of product revenue | 4,904,000 | 3,858,000 | |||||
| Cost of service and other revenue | 1,041,000 | 1,487,000 | |||||
| Total cost of revenue | 5,945,000 | 5,345,000 | |||||
| Operating expenses: | |||||||
| Research and development | 9,779,000 | 13,937,000 | |||||
| Selling, general and administrative | 19,536,000 | 25,976,000 | |||||
| Restructuring costs | 4,632,000 | — | |||||
| Total operating expenses | 33,947,000 | 39,913,000 | |||||
| Loss from operations | (31,123,000 | ) | (37,843,000 | ) | |||
| Other income (expenses): | |||||||
| Interest income | 1,044,000 | 704,000 | |||||
| Interest expense | (122,000 | ) | (76,000 | ) | |||
| Other income (expense) | (1,239,000 | ) | 117,000 | ||||
| Total other income (expense) | (317,000 | ) | 745,000 | ||||
| Loss before income taxes | (31,440,000 | ) | (37,098,000 | ) | |||
| Provision for income taxes | 18,000 | (26,000 | ) | ||||
| Net loss | $ | (31,422,000 | ) | $ | (37,124,000 | ) | |
| Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) | |||||||
| Three Months Ended |
|||||||
| 2024 | 2023 | ||||||
| GAAP gross margin: | |||||||
| GAAP revenue | $ | 8,769,000 | $ | 7,415,000 | |||
| GAAP cost of revenue | 5,945,000 | 5,345,000 | |||||
| GAAP gross profit | 2,824,000 | 2,070,000 | |||||
| GAAP gross margin % | 32 | % | 28 | % | |||
| Adjusted non-GAAP gross margin: | |||||||
| GAAP revenue | $ | 8,769,000 | $ | 7,415,000 | |||
| GAAP cost of revenue | 5,945,000 | 5,345,000 | |||||
| Stock-based compensation expense | (128,000 | ) | (146,000 | ) | |||
| COGS restructuring | (11,000 | ) | — | ||||
| Adjusted non-GAAP cost of revenue | 5,806,000 | 5,199,000 | |||||
| Adjusted non-GAAP gross profit | 2,963,000 | 2,216,000 | |||||
| Adjusted non-GAAP gross margin % | 34 | % | 30 | % | |||
| GAAP operating expense | |||||||
| GAAP selling, general and administrative expense | $ | 19,536,000 | $ | 25,976,000 | |||
| Stock-based compensation expense | (1,716,000 | ) | (2,379,000 | ) | |||
| Intangible asset amortization | (1,792,000 | ) | (1,792,000 | ) | |||
| Change in fair value of contingent consideration | 640,000 | (789,000 | ) | ||||
| Loss on intangible asset impairment | (448,000 | ) | — | ||||
| Transaction related expenses | (91,000 | ) | — | ||||
| Adjusted non-GAAP selling, general and administrative expense | 16,129,000 | 21,016,000 | |||||
| GAAP research and development expense | $ | 9,779,000 | $ | 13,937,000 | |||
| Stock-based compensation expense | (1,171,000 | ) | (1,357,000 | ) | |||
| Adjusted non-GAAP research and development expense | 8,608,000 | 12,580,000 | |||||
| GAAP restructuring costs | $ | 4,632,000 | $ | — | |||
| Restructuring costs | (4,632,000 | ) | — | ||||
| Adjusted non-GAAP restructuring costs | — | — | |||||
| Total adjusted non-GAAP operating expense | $ | 24,737,000 | $ | 33,596,000 | |||
Source: Bionano Genomics