GRAIL Reports Third Quarter 2024 Financial Results
GRAIL (GRAL) reported Q3 2024 financial results with total revenue of $28.7 million, up 38% year-over-year. Galleri revenue grew 52% to $25.4 million, with over 250,000 tests sold since launch. The company posted a net loss of $(125.7) million, including $34.6 million in amortization and $19.0 million in restructuring charges. Gross loss was $(22.2) million, while adjusted gross profit reached $11.8 million. The company maintains a strong cash position of $853.6 million, providing runway into 2028.
GRAIL (GRAL) ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato totale di 28,7 milioni di dollari, in aumento del 38% rispetto all'anno precedente. Il fatturato di Galleri è cresciuto del 52% arrivando a 25,4 milioni di dollari, con oltre 250.000 test venduti dalla sua introduzione. L'azienda ha registrato una perdita netta di (125,7) milioni di dollari, inclusi 34,6 milioni di dollari in ammortamenti e 19,0 milioni di dollari in oneri di ristrutturazione. La perdita lorda è stata di (22,2) milioni di dollari, mentre l'utile lordo rettificato ha raggiunto 11,8 milioni di dollari. L'azienda mantiene una solida posizione di liquidità con 853,6 milioni di dollari, garantendo così una copertura fino al 2028.
GRAIL (GRAL) reportó resultados financieros del tercer trimestre de 2024 con ingresos totales de 28,7 millones de dólares, un aumento del 38% en comparación con el año anterior. Los ingresos de Galleri crecieron un 52% alcanzando 25,4 millones de dólares, con más de 250,000 pruebas vendidas desde su lanzamiento. La compañía reportó una pérdida neta de (125,7) millones de dólares, incluidos 34,6 millones de dólares en amortización y 19,0 millones de dólares en cargos de reestructuración. La pérdida bruta fue de (22,2) millones de dólares, mientras que el ingreso bruto ajustado alcanzó 11,8 millones de dólares. La compañía mantiene una sólida posición de efectivo de 853,6 millones de dólares, asegurando una solvencia hasta 2028.
GRAIL (GRAL)은 2024년 3분기 재무 실적을 발표하며 총 수익이 2,870만 달러로 전년 대비 38% 증가했다고 밝혔습니다. Galleri의 수익은 52% 증가하여 2,540만 달러에 도달하였으며, 출시 이후 250,000건 이상의 테스트가 판매되었습니다. 회사는 (1억 2,570만) 달러의 순손실을 기록했으며, 여기에는 3,460만 달러의 감가상각과 1,900만 달러의 구조조정 비용이 포함되어 있습니다. 총 손실은 (2,220만) 달러였으며, 조정된 총 이익은 1,180만 달러에 도달했습니다. 회사는 8억 5,360만 달러의 강력한 현금 보유액을 유지하고 있어 2028년까지 운영할 수 있는 여유를 확보하고 있습니다.
GRAIL (GRAL) a annoncé ses résultats financiers pour le troisième trimestre 2024 avec un chiffre d'affaires total de 28,7 millions de dollars, en hausse de 38 % par rapport à l'année précédente. Les revenus de Galleri ont augmenté de 52 % pour atteindre 25,4 millions de dollars, avec plus de 250 000 tests vendus depuis le lancement. La société a enregistré une perte nette de (125,7) millions de dollars, incluant 34,6 millions de dollars d'amortissement et 19,0 millions de dollars de charges de restructuration. La perte brute s'élevait à (22,2) millions de dollars, tandis que le bénéfice brut ajusté atteignait 11,8 millions de dollars. L'entreprise maintient une solide position de liquidités de 853,6 millions de dollars, garantissant une marge de manœuvre jusqu'en 2028.
GRAIL (GRAL) hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht, mit einem Gesamtumsatz von 28,7 Millionen Dollar, was einem Anstieg von 38% im Jahresvergleich entspricht. Der Umsatz von Galleri wuchs um 52% auf 25,4 Millionen Dollar, mit über 250.000 verkauften Tests seit dem Start. Das Unternehmen meldete einen Nettoverlust von (125,7) Millionen Dollar, einschließlich 34,6 Millionen Dollar an Abschreibungen und 19,0 Millionen Dollar an Umstrukturierungskosten. Der Bruttoverlust betrug (22,2) Millionen Dollar, während der bereinigte Bruttoertrag 11,8 Millionen Dollar erreichte. Das Unternehmen hält eine starke Liquiditätsposition von 853,6 Millionen Dollar, die bis 2028 reicht.
- Revenue growth of 38% YoY to $28.7 million
- Galleri revenue increased 52% YoY to $25.4 million
- Strong cash position of $853.6 million providing runway into 2028
- Net loss improved by 86% ($765.8 million) YoY
- Adjusted EBITDA improved by 14% YoY
- Net loss of $125.7 million in Q3
- Gross loss of $22.2 million
- Negative adjusted EBITDA of $108.2 million
- Restructuring charge of $19.0 million
Insights
The Q3 results reveal a mixed financial picture for GRAIL. While
The milestone of 250,000 Galleri tests sold demonstrates market traction, but the gross loss of
The clinical validation data from the REFLECTION study shows promising results with a
The early-stage detection rate (stages I-III) in over half of identified cases is particularly significant, as earlier detection typically correlates with better treatment outcomes. However, the
Galleri Revenue Grew
Commercial Galleri Sales Surpassed 250,000 Tests Since Launch
Cash Balance of
Revenue in the third quarter was
"In our first operating quarter as a public company, GRAIL continued to deliver
For the three months ended September 30, 2024, as compared to the three months ended October 1, 2023, GRAIL reported:
- Revenue: Total revenue, comprised of screening and development services revenue, was
, an increase of$28.7 million or$7.9 million 38% . - Net loss: Net loss was
, an improvement of$125.7 million or$765.8 million 86% . - Gross loss: Gross loss was
, an improvement of$(22.2) million or$4.8 million 18% . - Adjusted gross profit1: Adjusted gross profit was
, an increase of$11.8 million or$4.8 million 68% . - Adjusted EBITDA1: Adjusted EBITDA was
, an improvement of$(108.2) million or$17.9 million 14% . - Cash position: Cash and cash equivalents totaled
as of September 30, 2024.$853.6 million
Recent business highlights include:
- Published results of GRAIL's Galleri Multi-Cancer Early Detection Blood Test in prostate cancer in JCO Precision Oncology. The analysis of the study demonstrated that when Galleri detected prostate cancer, most were high-grade and clinically significant, and usually indicated an aggressive disease where additional diagnostic evaluation is necessary. These data, previously shared at AACR in March, build on earlier findings regarding Galleri's preferential detection of aggressive, deadly cancers.
- Presented early results from REFLECTION real-world experience study of Galleri at the Early Detection of Cancer Conference in October. This initial analysis included data from seven US Department of Veterans Affairs (VA) sites with 180 days of post-test follow-up. The signal detection rate for the veteran cohort was
1.3% and the positive predictive value (PPV) of the test was42.9% . More than half of the cases were identified at early stages (I-III).
Conference Call and Webcast
A webcast and conference call will be held today, November 12, 2024, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL's website at investors.grail.com.
A replay of the webcast will be available on GRAIL's website for 30 days.
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures. |
About GRAIL
GRAIL, Inc. is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
For more information, visit galleri.com.
* Sensitivity in study participants with – Pancreas cancer:
Laboratory/Test Information
GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the
Non-GAAP Disclosure
In addition to our financial results, this press release also includes financial measures that are not calculated in accordance with
- Adjusted Gross Profit/(Loss) is a key performance measure that our management uses to assess our operational performance, as it represents the results of revenues and direct costs, which are key components of our operations. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it reflects the gross profitability of our operations, and excludes the indirect costs associated with our sales and marketing, product development, general and administrative activities, and depreciation and amortization, and the impact of our financing methods and income taxes.
We calculate Adjusted Gross Profit/(Loss) as gross profit/(loss) (as defined below) adjusted to exclude amortization of intangible assets and stock-based compensation allocated to cost of revenue. Adjusted Gross Profit/(Loss) should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other GAAP measures of income (loss) or profitability. The following table presents a reconciliation of gross loss, the most directly comparable financial measure calculated in accordance with GAAP, to Adjusted Gross Profit.
- Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of net income (loss) to Adjusted EBITDA, helps investors make comparisons between our company and other companies that may have different capital structures, different tax rates, different operational and ownership histories, and/or different forms of employee compensation.
Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income or income from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.
Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and otherU.S. GAAP measures of income (loss). Additionally, it is not intended to be a measure of free cash flow for management's discretionary use, as it does not consider certain cash requirements such as interest and tax payments. Further, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable among companies. The following table presents a reconciliation of net loss, the most directly comparable financial measure calculated in accordance withU.S. GAAP, to Adjusted EBITDA on a consolidated basis.
Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form below.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, restructuring and stock-based compensation costs, impact of the restructuring on our operations and growth and anticipated trends in our business.
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the "Form 10-Q"). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
GRAIL | |||
(in thousands, except for per share data) | September 30, 2024 | December 31, 2023 | |
Assets | (unaudited) | ||
Current assets: | |||
Cash and cash equivalents | $ 853,551 | $ 97,287 | |
Accounts receivables, net | 15,211 | 16,942 | |
Supplies | 21,213 | 21,695 | |
Prepaid expenses and other current assets | 19,721 | 20,141 | |
Total current assets | 909,696 | 156,065 | |
Property and equipment, net | 73,886 | 84,995 | |
Operating lease right-of-use assets | 70,625 | 84,386 | |
Restricted cash | 3,918 | 4,225 | |
Intangibles assets, net | 2,051,473 | 2,687,223 | |
Goodwill | — | 888,936 | |
Other non-current assets | 8,356 | 7,984 | |
Total assets | $ 3,117,954 | $ 3,913,814 | |
Liabilities and stockholders'/member's (deficit) equity | |||
Current liabilities: | |||
Accounts payable | $ 7,321 | $ 19,673 | |
Accrued liabilities | 71,830 | 73,806 | |
Incentive plan liabilities | — | 54,513 | |
Operating lease liabilities, current portion | 13,524 | 14,809 | |
Other current liabilities | 1,593 | 809 | |
Total current liabilities | 94,268 | 163,610 | |
Operating lease liabilities, net of current portion | 58,667 | 69,598 | |
Deferred tax liabilities, net | 375,122 | 32,921 | |
Other non-current liabilities | 2,261 | 1,498 | |
Total liabilities | 530,318 | 267,627 | |
Preferred stock, par value of | — | — | |
Common stock | 33 | — | |
Additional paid-in capital | 12,291,681 | — | |
Member's equity | — | 11,421,446 | |
Accumulated other comprehensive income | 2,186 | 1,066 | |
Accumulated deficit | (9,706,264) | (7,776,325) | |
Total stockholders'/member's equity | 2,587,636 | 3,646,187 | |
Total liabilities and stockholders'/member's equity | 3,117,954 | 3,913,814 |
GRAIL | |||||||
Three Months Ended | Nine months ended | ||||||
(in thousands except for per share data) | September 30, | October 1, | September 30, | October 1, | |||
Revenue: | |||||||
Screening revenue | $ 25,374 | $ 16,745 | $ 77,076 | $ 52,344 | |||
Development services revenue | 3,278 | 3,977 | 10,267 | 10,435 | |||
Total revenue | 28,652 | 20,722 | 87,343 | 62,779 | |||
Costs and operating expenses: | |||||||
Cost of screening revenue (exclusive of amortization of intangible | 15,970 | 12,829 | 45,481 | 34,379 | |||
Cost of development services revenue | 1,442 | 1,489 | 3,499 | 4,944 | |||
Cost of revenue — amortization of intangible assets | 33,473 | 33,473 | 100,417 | 100,417 | |||
Research and development | 78,231 | 80,076 | 274,052 | 254,659 | |||
Sales and marketing | 35,625 | 36,597 | 123,433 | 123,169 | |||
General and administrative | 47,418 | 50,183 | 171,745 | 147,534 | |||
Goodwill and intangible impairment | — | 718,466 | 1,420,936 | 718,466 | |||
Total costs and operating expenses | 212,159 | 933,113 | 2,139,563 | 1,383,568 | |||
Loss from operations | (183,507) | (912,391) | (2,052,220) | (1,320,789) | |||
Other income (expense): | |||||||
Interest income | 11,661 | 2,529 | 17,367 | 6,603 | |||
Other expense, net | 561 | 196 | 514 | 421 | |||
Total other income, net | 11,100 | 2,333 | 16,853 | 6,182 | |||
Loss before income taxes | (172,407) | (910,058) | (2,035,367) | (1,314,607) | |||
Benefit from income taxes | 46,719 | 18,610 | 105,428 | 36,449 | |||
Net loss | $ (125,688) | $ (891,448) | $ (1,929,939) | $ (1,278,158) | |||
Net loss per share — Basic and Diluted | $ (3.94) | $ (28.71) | $ (61.61) | $ (41.17) | |||
Weighted average shares of common stock— | 31,880,054 | 31,049,148 | 31,326,117 | 31,049,148 |
GRAIL | |||
Nine Months Ended | |||
(in thousands) | September 30, | October 1, | |
Net cash used by operating activities | $ (483,666) | $ (466,902) | |
Net cash used by investing activities | (4,905) | (8,992) | |
Net cash provided by financing activities | 1,244,300 | 377,780 | |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | 228 | 49 | |
Net increase (decrease) in cash, cash equivalents, and restricted cash | $ 755,957 | $ (98,065) | |
Cash, cash equivalents and restricted cash — beginning of period | $ 101,512 | $ 246,128 | |
Cash, cash equivalents and restricted cash — end of period | $ 857,469 | $ 148,063 |
GRAIL | |||||||
Three Months Ended | Nine Months Ended | ||||||
(in thousands) | September 30, | October 1, | September 30, | October 1, | |||
Gross loss (1) | $ (22,233) | $ (27,069) | $ (62,054) | $ (76,961) | |||
Amortization of intangible assets | 33,473 | 33,473 | 100,417 | 100,417 | |||
Stock-based compensation | 578 | 625 | 1,522 | 1,448 | |||
Adjusted Gross Profit | $ 11,818 | $ 7,029 | $ 39,885 | $ 24,904 |
(1) | Gross profit/(loss) is calculated as total revenue less cost of revenue (exclusive of amortization of intangible assets), cost of revenue—related parties, and cost of revenue—amortization of intangible assets. |
GRAIL | |||||||
Three Months Ended | Nine Months Ended | ||||||
(in thousands) | September 30, | October 1, | September 30, | October 1, | |||
Net loss | $ (125,688) | $ (891,448) | $ (1,929,939) | $ (1,278,158) | |||
Adjusted to exclude the following: | |||||||
Interest income | (11,661) | (2,529) | (17,367) | (6,603) | |||
Benefit from income tax expense | (46,719) | (18,610) | (105,428) | (36,449) | |||
Amortization of intangible assets (1) | 34,583 | 34,583 | 103,750 | 103,750 | |||
Depreciation | 4,647 | 5,216 | 14,865 | 15,018 | |||
Goodwill and intangible impairment(2) | — | 718,466 | 1,420,936 | 718,466 | |||
Illumina/GRAIL merger & divestiture legal | 226 | 2,944 | 22,158 | 11,198 | |||
Stock-based compensation (4) | 17,449 | 25,319 | 72,502 | 72,383 | |||
Restructuring(5) | 19,007 | — | 19,007 | — | |||
Adjusted EBITDA | $ (108,156) | $ (126,059) | $ (399,516) | $ (400,395) |
(1) | Represents amortization of intangible assets, including developed technology and trade names. | |||||||||||||||||||
(2) | Reflects impairment of the goodwill and intangible assets recognized as a result of Illumina's acquisition of the Company in August 2021 ("the Acquisition"). | |||||||||||||||||||
(3) | Represents legal and professional services costs associated with the Acquisition and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and legal and professional services costs associated with the divestiture. | |||||||||||||||||||
(4) | Represents all stock-based compensation recognized on our standalone financial statements for the periods presented. | |||||||||||||||||||
(5) | Represents employee severance, benefits, payroll taxes, and other costs associated with the Restructuring Plan. |
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SOURCE GRAIL, Inc.
FAQ
What was GRAL's revenue growth in Q3 2024?
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