PSNL Personalis Inc.
Latest News
-
View Full Article Hide Full Article
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.
First Quarter Highlights
- Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
- Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
- Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
- Announced a collaboration with MapKure, LLC, a company jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., LLC for use of the NeXT PlatformTM for clinical trials and companion diagnostic development
- Added approximately $162 million of cash to balance sheet from public offering of common stock financing in the first quarter of 2021; ended the quarter with cash, cash equivalents, and short-term investments of $353.4 million as of March 31, 2021
"I'm proud to say that we were able to report record revenue once again this quarter and achieved our nineteenth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Biopharma and all other customer revenue grew 74% year-over-year, and orders from customers exceeded revenues reported once again this quarter," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera in the field of personalized oncology, and a companion diagnostics collaboration with MapKure. Both collaborations further validate our NeXT platform as a leading front end tissue-sequencing platform, capable of detecting cancer cell mutations that conventional exome tests often miss. Our tissue offering complements our whole exome liquid biopsy product that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct revenue opportunities in the rapidly growing cancer monitoring market."
First Quarter 2021 Financial Results
Revenues were $20.9 million in the three months ended March 31, 2021, up 9% from $19.2 million in the same period of the prior year.
Gross margin was 35.6% in the three months ended March 31, 2021, compared with 21.1% in the same period of the prior year.
Operating expenses were $19.9 million in the three months ended March 31, 2021, compared with $13.7 million in the same period of the prior year.
Net loss was $12.4 million in the three months ended March 31, 2021 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 42.3 million, compared with a net loss of $9.1 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.3 million in the same period of the prior year.
Business Outlook
Personalis expects the following for the second quarter of 2021:
- Total Company revenues to be approximately $21.3 million
- Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $7.3 million to $7.7 million
- Net Loss to be in the range of $16 million to $17 million; estimated outstanding shares of 43 million
Personalis expects the following for the full year of 2021:
- Total Company revenues to be approximately $85 million
- Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $30 million to $32 million
- Net Loss to be in the range of $70 million to $75 million; estimated outstanding shares of 44 million
Webcast and Conference Call Information
Personalis will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 5, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 6587766. The live webinar can be accessed at https://investors.personalis.com.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenues and net loss for the second quarter and full year of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis' whole exome liquid biopsy product; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenues from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations, and including those with Natera and the MapKure; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 that will be filed after this earnings release, and risk factors included within the Annual Report on Form 10-K filed on February 25, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
Three Months Ended March 31,
2021
2020
Revenues
$
20,881
$
19,161
Costs and expenses
Costs of revenues
13,454
15,122
Research and development
9,496
6,390
Selling, general and administrative
10,421
7,274
Total costs and expenses
33,371
28,786
Loss from operations
(12,490
)
(9,625
)
Interest income
95
510
Interest expense
—
(2
)
Other income (expense), net
(12
)
8
Loss before income taxes
(12,407
)
(9,109
)
Provision for (benefit from) income taxes
(3
)
30
Net loss
$
(12,404
)
$
(9,139
)
Net loss per share, basic and diluted
$
(0.29
)
$
(0.29
)
Weighted-average shares outstanding, basic and diluted
42,265,596
31,345,029
PERSONALIS, INC.
SUPPLEMENTAL REVENUE INFORMATION (unaudited)
(in thousands)
Three Months Ended March 31,
2021
2020
VA MVP
$
13,210
$
14,756
All other customers
7,671
4,405
Total
$
20,881
$
19,161
PERSONALIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands, except share and per share data)
March 31,
December 31,
2021
2020
Assets
Current assets
Cash and cash equivalents
$
137,089
$
68,525
Short-term investments
216,340
134,765
Accounts receivable, net
8,053
6,349
Inventory and other deferred costs
5,579
5,639
Prepaid expenses and other current assets
5,607
5,441
Total current assets
372,668
220,719
Property and equipment, net
11,152
11,834
Operating lease right-of-use assets
9,899
10,271
Other long-term assets
1,787
2,018
Total assets
$
395,506
$
244,842
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable
$
6,522
$
8,301
Accrued and other current liabilities
13,805
11,301
Contract liabilities
18,237
21,034
Total current liabilities
38,564
40,636
Long-term operating lease liabilities
8,162
8,541
Other long-term liabilities
360
720
Total liabilities
47,086
49,897
Commitments and Contingencies
Stockholders' equity
Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued
—
—
Common stock, $0.0001 par value — 200,000,000 shares authorized; 43,798,661 and 39,105,548 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
4
4
Additional paid-in capital
542,694
376,788
Accumulated other comprehensive income (loss)
(5
)
22
Accumulated deficit
(194,273
)
(181,869
)
Total stockholders' equity
348,420
194,945
Total liabilities and stockholders' equity
$
395,506
$
244,842
View source version on businesswire.com: https://www.businesswire.com/news/home/20210505005187/en/
-
View Full Article Hide Full Article
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210429005154/en/
-
View Full Article Hide Full Article
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.
Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210421005028/en/
-
View Full Article Hide Full Article
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021.
These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.
Following are details and links to the scientific posters that will be presented at the online meeting.
Poster Number, Session Category and Session Title
Title & Presenter
Date
Location
399
Clinical Research (Excluding Trials)
Biomarkers Predictive of Therapeutic Benefit
Pan-cancer survey of HLA loss of heterozygosity using a robustly validated NGS-based machine learning algorithm
Presenter: Rachel Marty Pyke, PhD
April 10, 2021
555
Clinical Research (Excluding Trials)
Liquid Biopsies: Circulating DNA
Longitudinal exome-scale liquid biopsy monitoring of evolving therapeutic resistance mechanisms in head and neck squamous cell carcinoma patients receiving anti-PD-1 therapy
Presenter: Charles Abbott, PhD
April 10, 2021
1898
Immunology
TumorAntigenicity/Processing and Presentation
Accurate modeling of antigen processing and MHC peptide presentation using large-scale immunopeptidomes and a novel machine learning framework
Presenter: Rachel Marty Pyke, PhD
April 10, 2021
2227
Molecular and Cellular Biology / Genetics
Genomic Profiling of Tumors
Pan-cancer shedding patterns of tumor circulating cell free DNA
Presenter: Fábio Navarro, PhD
April 10, 2021
2241
Molecular and Cellular Biology / Genetics
Genomic Profiling of Tumors
Profiling tumor-infiltrating immune cells using an augmented transcriptome
Presenter: Eric Levy, PhD
April 10, 2021
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
Forward-Looking Statements
All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210408005927/en/
-
View Full Article Hide Full Article
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.
As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure's Phase 1a/1b dose escalation and expansion clinical trial. Additionally, MapKure will benefit from the breadth of the NeXT Platform, which enables broad tumor immunogenomic profiling of the tumor and consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample, which will help MapKure understand if other biomarkers are clinically relevant to BGB-3245.
"With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer treatment. Our NeXT Platform provides biotechnology companies, like MapKure, with comprehensive genomic information from the entire exome and transcriptome, and provides information that can support the identification of new, advanced biomarkers. Once these biomarkers have been selected by MapKure, we expect to develop them as a companion diagnostic for regulatory submission and approval. We look forward to working with MapKure to accelerate the development of their cancer therapy in the clinic by utilizing the results from our NeXT Platform," said John West, CEO at Personalis.
Financial terms of the collaboration were not disclosed.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
About MapKure
MapKure is a clinical-stage company created in 2019 to develop precision medicines for patients with life-threatening diseases, with an initial focus on cancer. By focusing on genetically defined disease drivers, MapKure is positioned to advance the development of transformative medicines to patients whose unmet medical needs are largely unaddressed. MapKure is jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., and is currently developing BGB-3245 under an exclusive license from BeiGene in solid tumor patients harboring specific B-RAF driver mutations and fusions, as well as in patients who have developed resistance to first-generation B-RAF inhibitors.
Forward-Looking Statements
All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform or the NeXT Dx Test, the expected benefits (including the potential for clinical trial use, companion diagnostic development and regulatory filings based on the company's NeXT Platform or the NeXT Dx Test) of the company's collaboration with MapKure, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210329005734/en/