Bionano Reports Third Quarter 2024 Results and Highlights Recent Business Progress
- Q3 2024 revenue was
$6.1 million , which comprises$6.6 million in core product and software sales which is offset by$0.5 million because of a write-down of aged receivables tied to discontinued clinical service products. Q3 2024 revenue represents a 35% decrease from Q3 2023 - Total installed base of 368 optical genome mapping (OGM) systems as of Q3 2024, which represents a 22% increase over Q3 2023
- Sold 7,835 nanochannel array flowcells in Q3 2024, which represents a 27% increase from the number of flowcells sold in Q3 2023
- Conference call today,
November 13, 2024 at4:30 PM ET
Our results in the third quarter reflect improving momentum for OGM utilization and sales of flowcells, despite overall revenues coming in below our expectations, again driven by a small number of system orders taking longer than expected to come through. Importantly, cash burn for the quarter was significantly lower than the prior year period, which has been a consistent trend now for several quarters due to our reorganization plan to decrease expenses and is a key element in our shift toward securing revenue and growth from our installed base of customers using OGM and VIA software and away from aggressively growing the installed base, which proved to be costly in the constrained environment for capital expenditures in the market. As a result of the restructuring, we have taken a number of charges, which elevated operating expense, but a substantial amount of that comprises one-time non-cash charges we don’t expect to see to the same degree going forward,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. “Indeed, our disciplined and systematic approach to mitigating operational expenses and cash burn has been painful at times, but we believe it is necessary. I am proud of the team’s execution to reduce the overall cash needs of the business as we prepare for new opportunities in the future."
Q3 2024 Company Highlights
- CPT code implementation and pricing announcement on schedule following the category 1 CPT code approval by the
American Medical Association (AMA) inMay 2024 . The new CPT Code is for the use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations related to hematological malignancies. The final Clinical Lab Fee Schedule (CLFS) for 2025 is expected to publish before year end. - Announced a registered direct offering and concurrent private placement of clinical milestone-linked Series A and Series B warrants:
- Upfront gross proceeds to the Company of approximately
$10.0 million , before deducting the placement agent’s fees and other offering expenses payable by the Company; funds will be used for general corporate purposes. - Potential additional gross proceeds of up to
$20.0 million upon the cash exercise (at an exercise price of$0.571 per share and subject to stockholder approval) in full of the Series A and Series B warrants to purchase an aggregate of 35,026,272 shares.
- Upfront gross proceeds to the Company of approximately
- Adjournment of Special Shareholder Meeting due to lack of Quorum
- The Special Meeting will reconvene at
10 a.m. (PT) onNovember 27, 2024 in hopes of reaching the quorum requirements for a meeting. As ofOctober 30 th, approximately 2.2 million additional votes were needed to reach a quorum.
- The Special Meeting will reconvene at
- Announced Publication of First Multi-Site Study to Analyze the Utility of OGM in Multiple Myeloma
- The study conducted by researchers at
University of Texas MD Anderson Cancer Center and TheJohns Hopkins Hospital , researchers concurrently analyzed 45 PCN samples using karyotype (KT), fluorescence in situ hybridization (FISH), OGM and next-generation sequencing (NGS). - OGM uniquely identified complex genomic rearrangements that are associated with cancer proliferation and progression, resulting in a change in prognostication beyond that indicated by traditional cytogenetic analysis in 18% of cases. In at least five cases (11%), OGM’s unique findings provided precise information to predict response to target therapies like BCMA monoclonal antibody, CAR-T, or GPRC5D targeted therapies, which may have therapeutic implications.
- The study results highlight OGM’s ability to provide researchers with a highly sensitive, accurate genome-wide analysis that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT.
- The study conducted by researchers at
- Installed base of OGM systems totaled 368 at the end of the third quarter of 2024, which represents a 22% increase over the 301 installed systems reported at the end of the third quarter of 2023.
- 7,835 nanochannel array flowcells sold during the third quarter of 2024, which represents a 27% increase over the 6,176 flowcells sold during the third quarter of 2023.
Q3 2024 Financial Results
- Total revenue for the third quarter of 2024 was
$6.1 million , a decrease of 35% compared to the third quarter of 2023. Revenues included$6.6 million in sales of core products and software offset by a$0.5 million write-down of aged receivables fromBionano Laboratories clinical service offerings, which were discontinued in March of 2024. The write-down was treated as a reversal of revenue. - GAAP gross margin for the third quarter of 2024 was (139)%, compared to 30% for the third quarter of 2023. Third quarter 2024 non-GAAP gross margin was 26%, compared to 32% for the third quarter of 2023. Third quarter 2024 non-GAAP gross margin excludes
$82,000 in stock-based compensation,$139,000 of restructuring expense, and$9.8 million of impairment and disposal of reagent rentals and inventory. Third quarter 2023 GAAP to non-GAAP reconciliation can be found in the reconciliation table accompanying this press release. - Third quarter 2024 GAAP operating expense was
$35.5 million , and$16.1 million on a non-GAAP basis, which is a decrease of 69% and 49%, respectively, from the third quarter of 2023. Non-GAAP operating expense in the third quarter of 2024 excludes restructuring costs, stock-based compensation, and other adjustments as detailed in the reconciliation table accompanying this press release. Third quarter 2023 GAAP to non-GAAP reconciliation can be found in the same table in this release. - Cash, cash equivalents, available-for-sale securities, and restricted cash were
$23.4 million as ofSeptember 30, 2024 . As ofSeptember 30, 2024 ,$11.4 million was subject to certain restrictions. - As of
September 30, 2024 , the aggregate principal amount of senior secured convertible debentures outstanding was$17.0 million . - Bionano raised net proceeds of approximately
$0.1million from ATM sales during the third quarter. An additional$1.2 million was raised in net proceeds from ATM sales subsequent to the end of the third quarter 2024.
Recent Highlights
- Announced closing of an additional
$3.0 million registered direct offering- Upfront gross proceeds to the Company of approximately $3.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company; funds will be used for general corporate purposes.
- Potential additional gross proceeds of up to
$6.0 million upon the cash exercise (at an exercise price of$0.3039 per share and subject to stockholder approval) in full of the Series C and Series D warrants to purchase an aggregate of 19,762,226 shares.
- Recent Peer-reviewed highlighted applications of OGM in blood cancers
- Publication in
Blood Cancer Journal by a group of researchers at the Korea College of Medicine in South Korea showing that optical genome mapping (OGM) can resolve rearrangements in the MYC gene in multiple myeloma (MM), which represent highly actionable biomarkers in cancer. - Data demonstrated the potential for wider adoption and use of OGM across all blood cancers as an alternative to traditional methods like KT and FISH.
- Publication in
Conference Call & Webcast Details
| Date: | |
| Time: | |
| Participant Link: | Registration - Click Here |
| Webcast Link: | https://edge.media-server.com/mmc/p/dmabxin9 |
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 optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its
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 and accompanying conference call 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 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; the anticipated benefits and success of our collaboration efforts; 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; any potential proceeds from the exercise of the Series A, Series B, Series C and Series D warrants; our plans to hold a special meeting of stockholders; our cost savings and strategic productivity initiatives; our expectation of a reduction in non-cash charges in the future; 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) | ||||||||
2024 |
2023 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,794,000 | $ | 17,948,000 | ||||
| Investments | 3,160,000 | 48,823,000 | ||||||
| Accounts receivable, net | 5,316,000 | 9,319,000 | ||||||
| Inventory | 14,323,000 | 22,892,000 | ||||||
| Prepaid expenses and other current assets | 4,387,000 | 6,019,000 | ||||||
| Restricted investments | 11,000,000 | 35,117,000 | ||||||
| Total current assets | 46,980,000 | 140,118,000 | ||||||
| Restricted cash, net of current portion | 400,000 | 400,000 | ||||||
| Property and equipment, net | 19,995,000 | 23,345,000 | ||||||
| Operating lease right-of-use asset | 2,833,000 | 5,633,000 | ||||||
| Financing lease right-of-use asset | 3,351,000 | 3,503,000 | ||||||
| Intangible assets, net | 11,045,000 | 33,974,000 | ||||||
| Other long-term assets | 2,758,000 | 7,431,000 | ||||||
| Total assets | $ | 87,362,000 | $ | 214,404,000 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,700,000 | $ | 10,384,000 | ||||
| Accrued expenses | 5,883,000 | 8,089,000 | ||||||
| Contract liabilities | 1,195,000 | 783,000 | ||||||
| Operating lease liability | 1,956,000 | 2,163,000 | ||||||
| Finance lease liability | 263,000 | 272,000 | ||||||
| Purchase option liability (at fair value) | — | 8,534,000 | ||||||
| Convertible debentures and |
14,953,000 | 69,803,000 | ||||||
| Total current liabilities | 32,950,000 | 100,028,000 | ||||||
| Operating lease liability, net of current portion | 1,730,000 | 3,590,000 | ||||||
| Finance lease liability, net of current portion | 3,551,000 | 3,585,000 | ||||||
| Contingent consideration | — | 10,890,000 | ||||||
| Long-term contract liabilities | 263,000 | 154,000 | ||||||
| Total liabilities | 38,494,000 | 118,247,000 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 9,000 | 5,000 | ||||||
| Preferred Stock | — | — | ||||||
| Additional paid-in capital | 720,425,000 | 677,337,000 | ||||||
| Accumulated deficit | (673,100,000 | ) | (581,208,000 | ) | ||||
| Accumulated other comprehensive income (loss) | 1,534,000 | 23,000 | ||||||
| Total stockholders’ equity | 48,868,000 | 96,157,000 | ||||||
| Total liabilities and stockholders’ equity | $ | 87,362,000 | $ | 214,404,000 | ||||
| Condensed Consolidated Statement of Operations (Unaudited) |
|||||||||||||||
| Three Months Ended |
Nine Months Ended |
||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue: | |||||||||||||||
| Product revenue | $ | 6,021,000 | $ | 6,456,000 | $ | 19,359,000 | $ | 18,512,000 | |||||||
| Service and other revenue | 52,000 | 2,862,000 | 3,254,000 | 6,883,000 | |||||||||||
| Total revenue | 6,073,000 | 9,318,000 | 22,613,000 | 25,395,000 | |||||||||||
| Cost of revenue: | |||||||||||||||
| Cost of product revenue | 14,251,000 | 5,105,000 | 23,858,000 | 13,714,000 | |||||||||||
| Cost of service and other revenue | 268,000 | 1,464,000 | 1,792,000 | 4,553,000 | |||||||||||
| Total cost of revenue | 14,519,000 | 6,569,000 | 25,650,000 | 18,267,000 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 4,717,000 | 13,785,000 | 21,329,000 | 42,331,000 | |||||||||||
| Selling, general and administrative | 9,464,000 | 24,896,000 | 40,109,000 | 77,809,000 | |||||||||||
| — | 77,280,000 | — | 77,280,000 | ||||||||||||
| Intangible assets and other long-lived assets impairment | 19,504,000 | — | 19,951,000 | — | |||||||||||
| Restructuring costs | 1,770,000 | — | 7,616,000 | — | |||||||||||
| Total operating expenses | 35,455,000 | 115,961,000 | 89,005,000 | 197,420,000 | |||||||||||
| Loss from operations | (43,901,000 | ) | (113,212,000 | ) | (92,042,000 | ) | (190,292,000 | ) | |||||||
| Other income (expenses): | |||||||||||||||
| Interest income | 376,000 | 730,000 | 1,876,000 | 2,122,000 | |||||||||||
| Other income (expense) | (697,000 | ) | (45,000 | ) | (1,694,000 | ) | (334,000 | ) | |||||||
| Total other income (expense) | (321,000 | ) | 685,000 | 182,000 | 1,788,000 | ||||||||||
| Loss before income taxes | (44,222,000 | ) | (112,527,000 | ) | (91,860,000 | ) | (188,504,000 | ) | |||||||
| Provision for income taxes | (24,000 | ) | (39,000 | ) | (32,000 | ) | (98,000 | ) | |||||||
| Net loss | $ | (44,246,000 | ) | $ | (112,566,000 | ) | $ | (91,892,000 | ) | $ | (188,602,000 | ) | |||
| Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) | |||||||||||||||
| Three Months Ended |
Nine Months Ended |
||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| GAAP gross margin: | |||||||||||||||
| GAAP revenue | $ | 6,073,000 | $ | 9,318,000 | $ | 22,613,000 | $ | 25,395,000 | |||||||
| GAAP cost of revenue | 14,519,000 | 6,569,000 | 25,650,000 | 18,267,000 | |||||||||||
| GAAP gross profit | (8,446,000 | ) | 2,749,000 | (3,037,000 | ) | 7,128,000 | |||||||||
| GAAP gross margin % | (139 | )% | 30 | % | (13 | )% | 28 | % | |||||||
| Adjusted non-GAAP gross margin: | |||||||||||||||
| GAAP revenue | $ | 6,073,000 | $ | 9,318,000 | $ | 22,613,000 | $ | 25,395,000 | |||||||
| GAAP cost of revenue | 14,519,000 | 6,569,000 | 25,650,000 | 18,267,000 | |||||||||||
| Stock-based compensation expense | (82,000 | ) | (187,000 | ) | (338,000 | ) | (531,000 | ) | |||||||
| COGS restructuring | (139,000 | ) | — | (157,000 | ) | — | |||||||||
| Impairment and disposal of reagent rentals and inventory | (9,822,494 | ) | — | (9,822,494 | ) | — | |||||||||
| Adjusted non-GAAP cost of revenue | 4,475,506 | 6,382,000 | 15,332,506 | 17,736,000 | |||||||||||
| Adjusted non-GAAP gross profit | 1,597,494 | 2,936,000 | 7,280,494 | 7,659,000 | |||||||||||
| Adjusted non-GAAP gross margin % | 26 | % | 32 | % | 32 | % | 30 | % | |||||||
| GAAP operating expense | |||||||||||||||
| GAAP selling, general and administrative expense | $ | 9,464,000 | $ | 24,896,000 | $ | 40,109,000 | $ | 77,809,000 | |||||||
| Stock-based compensation expense | (1,675,000 | ) | (2,556,000 | ) | (5,732,000 | ) | (7,368,000 | ) | |||||||
| Intangible asset amortization | (1,713,000 | ) | (1,792,000 | ) | (5,219,000 | ) | (5,377,000 | ) | |||||||
| Change in fair value of contingent consideration | 5,774,000 | (310,000 | ) | 10,890,000 | (2,528,000 | ) | |||||||||
| Transaction related expenses | — | (929,000 | ) | — | (929,000 | ) | |||||||||
| Adjusted non-GAAP selling, general and administrative expense | 11,850,000 | 19,309,000 | 40,048,000 | 61,607,000 | |||||||||||
| GAAP research and development expense | $ | 4,717,000 | $ | 13,785,000 | $ | 21,329,000 | $ | 42,331,000 | |||||||
| Stock-based compensation expense | (445,000 | ) | (1,249,000 | ) | (1,730,000 | ) | (3,907,000 | ) | |||||||
| Adjusted non-GAAP R & D expense | 4,272,000 | 12,536,000 | 19,599,000 | 38,424,000 | |||||||||||
| GAAP goodwill impairment | $ | — | $ | 77,280,000 | $ | — | $ | 77,280,000 | |||||||
| — | (77,280,000 | ) | — | (77,280,000 | ) | ||||||||||
| Adjusted non-GAAP goodwill impairment | — | — | — | — | |||||||||||
| GAAP intangible assets and other long-lived assets impairment | $ | 19,504,000 | $ | — | $ | 19,951,000 | $ | — | |||||||
| Intangible assets, and other long-lived assets impairment | (19,504,000 | ) | — | (19,951,000 | ) | — | |||||||||
| Adjusted non-GAAP intangible assets and other long-lived assets impairment | — | — | — | — | |||||||||||
| GAAP restructuring costs | $ | 1,769,000 | $ | — | $ | 7,616,000 | $ | — | |||||||
| Restructuring costs | (1,769,000 | ) | — | (7,616,000 | ) | — | |||||||||
| Adjusted non-GAAP restructuring costs | — | — | — | — | |||||||||||
| Total adjusted non-GAAP operating expense | $ | 16,122,000 | $ | 31,845,000 | $ | 59,647,000 | $ | 100,031,000 | |||||||
Source: Bionano Genomics