UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
On November 10, 2022, we issued a press release announcing our financial results for the three months ended June 30, 2022. A copy of the press release and accompanying information is attached as Exhibit 99.1 to this current report.
The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this current report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any such filing, unless we expressly set forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Press Release dated November 10, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Biocept, Inc. | ||||||
| Date: November 14, 2022 | By: | /s/ Samuel D. Riccitelli | ||||
| Samuel D. Riccitelli | ||||||
| Interim President and Chief Executive Officer | ||||||
Exhibit 99.1
Biocept Reports Second Quarter 2022 Financial Results
| • | Included first revenue from biopharma collaborator using CNSide™ in their therapeutics clinical trial |
| • | First site opened for patient enrollment in the FORESEE trial to generate evidence of CNSide’s clinical utility |
| • | Expanded the commercial availability of CNSide to metastatic melanoma |
| • | CNSide™ orders increased 14% over 1Q 2022 and 212% versus 2Q 2021 |
SAN DIEGO (November 10, 2022) – Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reports financial results for the three and six months ended June 30, 2022 and provides a business update.
“Today we are reporting strong progress in positioning Biocept as a leader in neurological tumor diagnostics,” said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. “During the second quarter, we reported the first revenue of $58,000 from a biopharma company using CNSide to support their therapeutics clinical trial. More recently, we opened enrollment in our FORESEE trial, the goal of which is to generate evidence of CNSide’s clinical utility in support of higher reimbursement and faster adoption into patient care guidelines. In October of 2022, we also expanded the commercial availability of CNSide to include metastatic melanoma, the third most common tumor type involved in central nervous system (CNS) metastasis with more than 60% of stage IV melanoma patients developing CNS metastasis. We look for diminishing but cash-flow positive revenue from RT-PCR COVID-19 testing services as demand continues to decline and we do not anticipate COVID-19 testing revenue beyond December 2022,” said Mr. Riccitelli.
Biocept expects to report financial results for the third quarter of 2022 in the coming weeks and to hold an investment community conference call at that time.
Second Quarter Financial Results
Net revenues for the second quarter of 2022 consisted of commercial test revenue of $10.6 million, which included $9.8 million in RT-PCR COVID-19 test revenue. Excluding a $1.1 million increase in reserves for aged accounts receivables in the second quarter of 2021 that reduced net revenues, revenues were $13.1 million and included $12.0 million in RT-PCR COVID-19 test revenue.
Biocept accessioned 77,779 commercial samples during the second quarter of 2022, compared with 104,061 commercial samples during the second quarter of 2021, with the decline due primarily to lower RT-PCR COVID-19 testing volume. The average value per commercial accession for the second quarter of 2022 was $135, up 17% from $115 for the second quarter of 2021, with the increase due to payor mix.
Cost of revenues for the second quarter of 2022 was $8.0 million, compared with $7.5 million for the prior-year period, with the increase related to off-site staffing resources related to our RT-PCT-COVID-19 testing business.
Research and development (R&D) expenses for the second quarter of 2022 were $1.7 million, compared with $1.1 million for the second quarter of 2021. The increase was primarily attributable to additional costs associated with preparing for the FORESEE trial, which opened enrollment during the third quarter of 2022. General and administrative (G&A) expenses for the second quarter of 2022 were $4.3 million, compared with $3.3 million for the second quarter of 2021, with the increase due primarily to legal fees and other costs associated with the sales commission settlement, as well as audit and accounting related fees. Sales and marketing expenses for the second quarter of 2022 were $1.7 million, compared with $1.9 million for the second quarter of 2021, with the decrease due primarily to a reduction in commissions expense.
Net loss attributable to common stockholders for the second quarter of 2022 was $5.3 million, or $0.31 per share on 16.9 million weighted-average shares outstanding. This compares with net loss attributable to common stockholders for the second quarter of 2021 of $1.8 million, or $0.14 per share on 13.5 million weighted-average shares outstanding.
Six Month Financial Results
Net revenues for the first six months of 2022 were $30.6 million, which included $28.4 million of RT-PCR COVID-19 test revenue, compared with net revenues for the first six months of 2021 of $29.8 million, which included $29.0 million of RT-PCR COVID-19 test revenue. Net revenues for the first six months of 2021 includes a $1.1 million increase in reserves for age accounts receivables, which reduced net revenues.
Operating expenses for the first six months of 2022 were $38.4 million, and included cost of revenues of $18.4 million, R&D expenses of $3.6 million, G&A expenses of $11.1 million and sales and marketing expenses of $5.3 million. Operating expenses for the first six months of 2021 were $28.9 million, and included cost of revenues of $16.5 million, R&D expenses of $2.2 million, G&A expenses of $6.4 million and sales and marketing expenses of $3.9 million.
Net loss attributable to common stockholders for the first six months of 2022 was $8.0 million, or $0.48 per share on 16.9 million weighted average shares outstanding. This compares with net income attributable to common stockholders for the first six months of 2021 of $772,000, or $0.06 per diluted share on 13.6 million weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of June 30, 2022 of $22.9 million, compared with $28.9 million as of December 31, 2021.
The U.S. Health Resources and Services Administration (HRSA) informed providers that after March 22, 2022 it would stop accepting claims for COVID-19 testing and treatment for uninsured individuals and that claims submitted prior to that date would be subject to eligibility and availability of funds. HRSA’s procedure for recouping credits due from service providers had been to net these amounts against reimbursements for services provided. Given that no further payments are expected from HRSA, there is no longer a mechanism for recoupments. The Company has therefore recorded a $5.7 million liability for outstanding HRSA credits that were previously netted against accounts receivable.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers. For more information, visit www.biocept.com. Follow Biocept on Facebook, LinkedIn, Twitter, and Instagram.
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Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like “will,” “expect,” “goal,” “objective,” “believe” or “intend” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements regarding Biocept becoming a leader in neurological tumor diagnostics, our intention to generate evidence of CNSide’s clinical utility in support of higher reimbursement and faster adoption into patient care guidelines, our expectations regarding the lack of future RT-PCR COVID-19 testing revenue, and our expected timing for reporting third quarter financial results, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including risks and uncertainties associated with the continually evolving COVID-19 pandemic; we may be unable to compete successfully with our competitors and increase or sustain our revenues; the results of clinical utility studies may not demonstrate that an assay provides clinically meaningful information and value or have the other benefits that we expect; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; risks related to our need for additional capital; and the risk that our products and services may not perform as expected. These and other factors are described in greater detail under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission (SEC) on May 23, 2022, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, being filed with the SEC today. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC at http://www.sec.gov/.
Investor & Media Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com, (310) 691-7100
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Biocept, Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)
| December 31, 2021 |
June 30, 2022 |
|||||||
| Assets |
(unaudited) | |||||||
| Current assets: |
||||||||
| Cash |
$ | 28,864 | $ | 22,928 | ||||
| Accounts receivable |
13,786 | 17,376 | ||||||
| Inventories, net |
2,651 | 2,249 | ||||||
| Prepaid expenses and other current assets |
391 | 1,225 | ||||||
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|
|
|||||
| Total current assets |
45,692 | 43,778 | ||||||
| Fixed assets, net |
2,401 | 2,699 | ||||||
| Lease right-of-use assets - operating |
9,026 | 8,758 | ||||||
| Lease right-of-use assets - finance |
2,842 | 2,411 | ||||||
| Other non-current assets |
456 | 496 | ||||||
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| Total assets |
$ | 60,417 | $ | 58,142 | ||||
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| Liabilities and Stockholders’ Equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 7,246 | $ | 4,830 | ||||
| Accrued liabilities |
3,018 | 2,737 | ||||||
| Current portion of lease liabilities - operating |
426 | 469 | ||||||
| Current portion of lease liabilities - finance |
1,083 | 1,053 | ||||||
| Supplier financing |
— | 524 | ||||||
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|
|
|||||
| Total current liabilities |
11,773 | 9,613 | ||||||
| Non-current portion of lease liabilities - operating |
9,736 | 9,462 | ||||||
| Non-current portion of lease liabilities - finance |
1,428 | 957 | ||||||
| Other non-current liability |
— | 5,654 | ||||||
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|||||
| Total liabilities |
22,937 | 25,686 | ||||||
| Shareholders’ equity: |
||||||||
| Preferred stock, $0.0001 par value, 5,000,000 shares authorized; 2,106 shares issued and outstanding at December 31, 2021 and June 30, 2022, respectively. |
— | — | ||||||
| Common stock, $0.0001 par value, 150,000,000 shares authorized; 16,849,805 shares and 16,922,868 shares issued and outstanding at December 31, 2021 and June 30, 2022, respectively. |
2 | 2 | ||||||
| Additional paid-in capital |
303,829 | 306,825 | ||||||
| Accumulated deficit |
(266,351 | ) | (274,371 | ) | ||||
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| Total shareholders’ equity |
37,480 | 32,456 | ||||||
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| Total liabilities and shareholders’ equity |
$ | 60,417 | $ | 58,142 | ||||
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Biocept, Inc.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except shares and per share data)
(Unaudited)
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
| 2021 | 2022 | 2021 | 2022 | |||||||||||||
| Net revenues |
$ | 12,047 | $ | 10,611 | $ | 29,803 | $ | 30,555 | ||||||||
| Costs and expenses: |
||||||||||||||||
| Cost of revenues |
7,462 | 8,023 | 16,468 | 18,358 | ||||||||||||
| Research and development expenses |
1,137 | 1,729 | 2,179 | 3,579 | ||||||||||||
| General and administrative expenses |
3,251 | 4,300 | 6,371 | 11,106 | ||||||||||||
| Sales and marketing expenses |
1,945 | 1,656 | 3,868 | 5,316 | ||||||||||||
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| Total costs and expenses |
13,795 | 15,708 | 28,886 | 38,359 | ||||||||||||
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| (Loss) income from operations |
(1,748 | ) | (5,097 | ) | 917 | (7,804 | ) | |||||||||
| Other (expense): |
||||||||||||||||
| Interest expense |
(80 | ) | (155 | ) | (145 | ) | (217 | ) | ||||||||
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| Total other (expense): |
(80 | ) | (155 | ) | (145 | ) | (217 | ) | ||||||||
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| (Loss) income before income taxes |
(1,828 | ) | (5,252 | ) | 772 | (8,021 | ) | |||||||||
| Income tax expense |
— | — | — | — | ||||||||||||
| Net (loss) income and comprehensive (loss) income |
(1,828 | ) | (5,252 | ) | 772 | (8,021 | ) | |||||||||
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| Net (loss) income attributable to common shareholders |
$ | (1,828 | ) | $ | (5,252 | ) | $ | 772 | $ | (8,021 | ) | |||||
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| Weighted-average shares outstanding used in computing net (loss) income per share attributable to common shareholders: |
||||||||||||||||
| Basic |
13,462,329 | 16,906,314 | 13,431,340 | 16,876,841 | ||||||||||||
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| Diluted |
13,462,329 | 16,906,314 | 13,646,789 | 16,876,841 | ||||||||||||
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| Net (loss) income per common share: |
||||||||||||||||
| Basic |
$ | (0.14 | ) | $ | (0.31 | ) | $ | 0.06 | $ | (0.48 | ) | |||||
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| Diluted |
$ | (0.14 | ) | $ | (0.31 | ) | $ | 0.06 | $ | (0.48 | ) | |||||
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# # #
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