Personalis(PSNL)
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Personalis(PSNL) - 2022 Q4 - Annual Report
2023-02-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______. Commission File Number 001-38943 Personalis, Inc. (Exact name of Registrant as specified in its Charter) Delaware 27-5411038 (State or other jurisdiction ...
Personalis(PSNL) - 2022 Q3 - Earnings Call Transcript
2022-11-03 02:49
Financial Data and Key Metrics Changes - Total company revenue for Q3 2022 was $14.9 million, a decrease of 33% compared to the same period last year, primarily due to a $13.7 million decline in VA MVP revenue [29] - Oncology business revenue increased by 73% year-over-year, driven mainly by volume increases from Natera, which accounted for half of the oncology revenue in the quarter [29] - Gross margin was 16.7% for Q3 2022, down from 36.2% in the same period last year, primarily due to under absorbed overhead costs from decreased VA MVP revenue and increased expenses to support growing oncology revenue [30] - Net loss for Q3 was $26.5 million, compared to a net loss of $17.7 million for the same period last year, with a net loss per share of $0.58 [33] Business Line Data and Key Metrics Changes - All revenue in Q3 2022 came from the oncology business, which saw a significant increase in revenue [29] - The company recognized approximately $1.5 million from an exome-scale liquid biopsy project for a leading global pharmaceutical company [23] Market Data and Key Metrics Changes - The company has seen growing interest in its NeXT Personal platform from pharmaceutical companies in the U.S., Europe, and China, with two pharma placing orders over $1 million each [19] - The Veterans Administration Million Veterans Program (VA MVP) has begun to enroll veterans again, with a goal of reaching 1 million enrollees in 2023 [24] Company Strategy and Development Direction - The centerpiece of the company's oncology business is the NeXT Personal MRD test, which aims to provide highly sensitive and informative cancer monitoring [6] - The company plans to launch its MRD test as a lab-developed test (LDT) in 2023 and has been building a commercial team to support this initiative [20] - The company is focused on personalized diagnostics, integrating tumor characterization capabilities into its MRD test to provide actionable insights for oncologists [12] Management's Comments on Operating Environment and Future Outlook - Management noted a slowdown in biopharma demand due to budget concerns and macroeconomic conditions, particularly affecting smaller biotechs [40] - The company anticipates that the current challenging environment may continue into early 2023, but remains optimistic about the long-term need for cancer solutions [40] - Management expects gross margins to improve in the long term as oncology revenue scales up [31] Other Important Information - The company has a strong balance sheet with cash and short-term investments of $192.8 million, providing more than two years of cash runway [34] - The company has initiated a brand evolution to align with its strategy of creating highly personalized cancer diagnostic tests [22] Q&A Session Summary Question: Concerns about tightening budgets among large pharma customers - Management acknowledged a slowdown in biopharma demand due to budget concerns, particularly affecting smaller biotechs, and anticipates this trend may continue into early 2023 [40] Question: Impact of staffing shortages on sample shipments - Management confirmed that sample shipments are slower due to staffing shortages affecting patient enrollments and sample collections [44] Question: Implications of FDA requests for additional clinical data on MRD efforts - Management believes their test's performance and data from extensive collaborations will position them favorably compared to competitors facing similar FDA scrutiny [46] Question: Timing and strategy for refreshing sequencing infrastructure - Management indicated that new sequencing technologies could significantly reduce costs, with expectations for improvements in gross margins beginning in early 2024 [50] Question: Revenue expectations from the new Shanghai facility - Management does not anticipate revenue from the Shanghai facility in 2022, with expectations for moderate revenue in 2023 [59] Question: Factors driving gross margin changes - Management attributed the decline in gross margin primarily to decreased VA MVP volume, with expectations for recovery as the program resumes [68] Question: Cash burn expectations for 2023 - Management expects operating cash burn to be below $85 million in 2023, with significant expenditures related to the new facility accounted for in 2022 [78]
Personalis(PSNL) - 2022 Q3 - Quarterly Report
2022-11-01 16:00
PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's nine-month revenue fell 25% to $48.3 million, driving a net loss of $82.2 million and a significant cash decrease [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $317.9 million, driven by a reduction in cash and investments, leading to lower stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,522 | $105,585 | | Short-term investments | $109,234 | $181,479 | | Total current assets | $221,908 | $318,231 | | Total assets | $317,861 | $396,528 | | Total current liabilities | $33,739 | $31,313 | | Total liabilities | $75,462 | $86,227 | | Total stockholders' equity | $242,399 | $310,301 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Nine-month revenue fell 25% to $48.3 million, and net loss nearly doubled to $82.2 million due to higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $14,858 | $22,261 | $48,325 | $64,812 | | Cost of revenue | $12,379 | $14,195 | $37,287 | $41,151 | | Research and development | $14,957 | $13,617 | $48,343 | $34,800 | | Selling, general and administrative | $14,781 | $12,140 | $46,141 | $33,989 | | Loss from operations | $(27,259) | $(17,691) | $(83,446) | $(45,128) | | Net loss | $(26,492) | $(17,670) | $(82,247) | $(45,027) | | Net loss per share | $(0.58) | $(0.40) | $(1.81) | $(1.03) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $53.5 million, with a net cash decrease of $22.1 million for the nine-month period Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(53,471) | $(55,554) | | Net cash provided by (used in) investing activities | $30,686 | $(99,980) | | Net cash provided by financing activities | $855 | $168,353 | - The significant difference in financing activities between 2022 and 2021 is due to the **$162.3 million net proceeds from a follow-on equity offering in January 2021**[28](index=28&type=chunk)[158](index=158&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight significant customer concentration shifts, a patent infringement lawsuit, and stock-based compensation expenses - The company operates as a single reportable segment: the sale of sequencing and data analysis services[31](index=31&type=chunk) Revenue Concentration by Major Customer (Nine Months Ended Sep 30) | Customer | 2022 Revenue % | 2021 Revenue % | | :--- | :--- | :--- | | Natera, Inc. | 38% | <10% | | VA MVP | 16% | 62% | | Merck & Co., Inc. | 12% | <10% | - On August 2, 2022, the company filed a complaint for patent infringement against Foresight Diagnostics Inc, who has filed counterclaims alleging non-infringement and invalidity of the patents[96](index=96&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Q3 revenue decline due to the VA MVP contract completion, offset by growth from other customers - The company is strategically shifting towards the clinical diagnostic market with its NeXT Dx and NeXT Personal tests, anticipating initial revenue from NeXT Dx in Q4 2022[109](index=109&type=chunk)[110](index=110&type=chunk) - In September 2022, Personalis secured a new contract with the VA MVP, but it is **currently under protest by a competitor, leading to an immediate work stoppage**[115](index=115&type=chunk) Revenue by Customer Type (Q3, in thousands) | Customer Type | Q3 2022 | Q3 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | VA MVP | $0 | $13,650 | $(13,650) | (100%) | | All other customers | $14,858 | $8,611 | $6,247 | 73% | | **Total revenue** | **$14,858** | **$22,261** | **$(7,403)** | **(33%)** | - The company is relocating its headquarters to a new 100,000 sq ft facility in Fremont, CA, with expected capital expenditures of **$40-$43 million in 2022** for the expansion[118](index=118&type=chunk)[161](index=161&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from this disclosure as a "smaller reporting company" - As a "smaller reporting company," Personalis is exempt from providing quantitative and qualitative disclosures about market risk[170](index=170&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - The CEO and CFO concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[171](index=171&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[172](index=172&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in a patent infringement lawsuit with Foresight Diagnostics Inc - The company is involved in a patent infringement lawsuit with Foresight Diagnostics Inc, as detailed in Note 9 of the financial statements[175](index=175&type=chunk)[96](index=96&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of losses, customer concentration, supplier reliance, and regulatory uncertainty - **Operational Risk:** The company has a history of losses and expects to incur significant future losses, with **substantial customer concentration** in the VA MVP and Natera[185](index=185&type=chunk)[199](index=199&type=chunk) - **VA MVP Contract Risk:** The new contract with the VA MVP is under protest, requiring an immediate work stoppage, and **may be terminated if the protest is not resolved favorably**[202](index=202&type=chunk) - **Supplier Risk:** The company relies on **Illumina as the sole supplier** for its sequencers and associated reagents, posing a significant operational risk[211](index=211&type=chunk) - **Regulatory Risk:** The company's tests are marketed as Laboratory Developed Tests (LDTs), which could be subject to **more onerous FDA oversight** under future legislative changes like the VALID Act[252](index=252&type=chunk)[254](index=254&type=chunk) - **Litigation Risk:** The company is involved in **expensive and time-consuming patent infringement litigation** with Foresight Diagnostics, with an uncertain outcome[345](index=345&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None[399](index=399&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company amended its bylaws to align with new SEC universal proxy rules - The company amended its bylaws on October 26, 2022, to align with the SEC's new universal proxy rules (Rule 14a-19)[402](index=402&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q
Personalis(PSNL) - 2022 Q2 - Earnings Call Transcript
2022-08-04 02:45
Personalis, Inc. (NASDAQ:PSNL) Q2 2022 Earnings Conference Call August 3, 2022 5:00 PM ET Company Participants Caroline Corner - Investor Relations John West - President & Chief Executive Officer Aaron Tachibana - Chief Financial Officer Conference Call Participants Stephanie Iannetta - Cowen Joseph Conway - Needham & Company Mark Massaro - BTIG Derik De Bruin - Bank of America Arthur He - H.C. Wainwright & Company. Operator Good day, and thank you standing by. Welcome to the Q2 2022 Personalis Earnings Con ...
Personalis(PSNL) - 2022 Q2 - Quarterly Report
2022-08-02 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38943 Personalis, Inc. (Exact Name of registrant as specified in its charter) Delaware 27-5411038 (State or other jurisdict ...
Personalis(PSNL) - 2022 Q1 - Earnings Call Transcript
2022-05-05 03:44
Personalis, Inc. (NASDAQ:PSNL) Q1 2022 Earnings Conference Call May 4, 2022 5:00 PM ET Company Participants Caroline Corner - Investor Relations John West - President and CEO Aaron Tachibana - Chief Financial Officer Conference Call Participants Patrick Donnelly - Citi Max Masucci - Cowen Mark Massaro - BTIG Mike Matson - Needham & Co. Kevin DeGeeter - Oppenheimer Sean Lee - H.C. Wainwright Operator Good day, ladies and gentlemen. And welcome to the Personalis First Quarter 2022 Earnings Conference Call. At ...
Personalis(PSNL) - 2022 Q1 - Quarterly Report
2022-05-03 16:00
Financial Performance - Revenue for Q1 2022 was $15,227,000, a decrease of 27% compared to $20,881,000 in Q1 2021[123] - The net loss for Q1 2022 was $28,209,000, compared to a net loss of $12,404,000 in Q1 2021, representing a 128% increase in losses[123] - Total revenue for the first quarter of 2022 was $15.2 million, a decrease of 27% compared to $20.9 million in the same period of 2021[125] - Revenue from VA MVP decreased by $9.7 million to $3.5 million, a decline of 73% year-over-year, while revenue from all other customers increased by 53% to $11.7 million[125][126] - Total costs and expenses increased by 30% to $43.5 million in Q1 2022, compared to $33.4 million in Q1 2021[130] Expenses - Cost of revenue for Q1 2022 was $10,949,000, down from $13,454,000 in Q1 2021, reflecting a 19% decrease[123] - Research and development expenses increased to $17,098,000 in Q1 2022, up 80% from $9,496,000 in Q1 2021[123] - Selling, general and administrative expenses rose to $15,486,000 in Q1 2022, compared to $10,421,000 in Q1 2021, marking a 48% increase[123] - Research and development expenses rose by 80% to $17.1 million, primarily due to new service and product development and increased hiring[132] Cash and Investments - Cash and cash equivalents, along with short-term investments, totaled $266.5 million as of March 31, 2022, down from $287.1 million at the end of 2021[138] - The company incurred a net loss of $28.2 million in Q1 2022, with cash used in operating activities amounting to $11.4 million[143] - As of March 31, 2022, the company had cash and cash equivalents of $91.6 million and short-term marketable debt securities of $175.0 million[157] - The company plans to seek additional funding through equity offerings or debt financing if cash flow from operations is insufficient to meet liquidity requirements[140] Capital Expenditures - Capital expenditures are expected to be between $50 million and $55 million in 2022, primarily for facility renovations and laboratory equipment[148] Revenue Sources - The cumulative value of task orders from the VA MVP is approximately $186 million, with $181.6 million recognized as revenue as of March 31, 2022[105] - Revenue from Natera, Inc. contributed $3.9 million to the increase in revenue from all other customers, driven by strong demand for NeXT Platform services[128] - The company anticipates that revenue from all other customers will constitute the majority of total revenue in fiscal year 2022[129] Operational Capacity - The company has sequenced over 250,000 human samples, including more than 150,000 whole human genomes[104] - The company has the capacity to sequence and analyze approximately 200 trillion bases of DNA per week, which is larger than most cancer genomics companies[104] - The company plans to focus primarily on cancer, given the strong growth experienced in this sector in 2021 and early 2022[106] Headquarters and Expansion - The new headquarters in Fremont, California, will support expansion in laboratory capacity and research and development efforts[107] Financial Policies - There have been no material changes to the company's critical accounting policies and estimates compared to the previous fiscal year[154] - The company’s critical accounting policies include revenue recognition, stock-based compensation, and leases, which have the greatest potential impact on financial statements[153] - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may differ from actual results[152] Interest Rate and Currency Risk - A hypothetical 100 basis point increase in interest rates would result in an approximate $0.9 million decline in the fair value of marketable debt securities[157] - The company does not enter into investments for trading purposes and has not used derivative financial instruments to manage interest rate risk exposure[158] - The majority of the company's revenue and expenses are transacted in U.S. dollars, with minimal impact from foreign currency movements to date[159] Customer Deposits and Loans - Customer deposits amounted to approximately $3.4 million as of March 31, 2022, with $2.8 million from a single customer[151] - The company entered into two noninterest bearing loans totaling $5.6 million for the purchase of computer hardware and software, with payments of $1.86 million due in 2022 and 2023[151]
Personalis (PSNL) Investor Presentation - Slideshow
2022-04-14 16:23
Advanced Genomics Platform for Next-Generation Cancer Therapies Investor Presentation February 2022 Forward-Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this presentation, including statements as to future results of operations, financial condition, business strategy, plans, ...
Personalis(PSNL) - 2021 Q4 - Earnings Call Transcript
2022-02-25 04:05
Personalis, Inc. (NASDAQ:PSNL) Q4 2021 Earnings Conference Call February 24, 2022 5:00 PM ET Company Participants Caroline Corner – Investor Relations John West – President and Chief Executive Officer Aaron Tachibana – Chief Financial Officer Conference Call Participants Kevin DeGeeter – Oppenheimer Patrick Donnelly – Citi Stephanie Yan – Cowen Joseph Conway – Needham Arthur He – H.C. Wainwright Operator Good day, ladies and gentlemen, and welcome to the Personalis Fourth Quarter and Full Year 2021 Earnings ...
Personalis(PSNL) - 2021 Q4 - Annual Report
2022-02-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38943 Personalis, Inc. (Exact name of Registrant as specified in its Charter) Delaware 27-5411038 (State or other jurisdiction of incorporation ...