EX-99.1 2 psnl-ex99_1.htm EX-99.1 EX-99.1

第99.1展示文本

 

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personalis報告2024年第二季度財務結果

由生物製藥業務帶動,年度營業收入強勁增長35%,其中生物製藥業務增長117%。

提高2024年全年營業收入指引

 

加利福尼亞州弗裏蒙特 - 2024年8月7日 - Personalis, Inc.(納斯達克:PSNL),一家在精準腫瘤基因組學領域領先的公司,今天公佈了截至2024年6月30日的第二季度財務業績,並介紹了最近的業務成就。

 

最近的業務成就

NeXt Personal®在美國臨床腫瘤學會(ASCO)五月份會議上的臨床表現備受關注。
o
Isaac Garcia-Murillas博士(倫敦癌症研究所)和Nicolas Turner教授(Royal Marsden NHS Foundation Trust,英國)發佈了引人注目的乳腺癌檢測結果。在這項研究中,他們發現:
NeXt Personal大約在影像檢測前15個月檢測到癌症復發
100%的復發患者通過NeXt Personal被檢測出,100%的ctDNA陰性患者在隨訪時間點無癌症。
o
巴爾德龍腫瘤研究所的Rodrigo Toledo博士的演講強調了NeXt Personal在免疫療法監測中的重要性。這些數據顯示:
基線 ctDNA 水平和 NeXt Personal 檢測到的變化可預測晚期癌症患者在接受免疫療法時的治療反應和臨床結果
NeXt Personal平均在影像檢查前81天檢測到癌症進展
在2024年第二季度共完成561項分子檢測,較上一季度增長66%,並與Tempus人工智能公司(Tempus)合作開展NeXt Personal Dx商業化工作。
宣佈與Myriad Genetics, Inc.達成跨許可協議,涵蓋了腫瘤相關方法專利領域,可用於檢測最小殘留疾病(MRD)
成功解決了與Foresight Diagnostics, Inc.(Foresight)的知識產權訴訟,Foresight同意許可Personalis的MRD專利。

與2023年第二季度相比,2024年第二季度的結果

 

2024年第二季度報告的公司總營業收入爲2260萬美元,相比1670萬美元增長了35%
o
2024年第二季度,製藥測試與服務的營業收入爲1320萬美元,較610萬美元增長了117%。

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2024年第二季度企業客戶的營業收入爲800萬美元,較740萬美元增長了8%
o
2024年第二季度,美國退伍軍人事務部百萬退伍軍人計劃的人口測序營業收入爲130萬美元,與300萬美元相比下降了57%。
2024年第二季度的其他收入爲300萬美元,其中包括與發給Tempus的未行使權證的公允價值會計相關的300萬美元的非現金收益。
2024年第二季度淨損失1280萬美元,與2400萬美元相比下降47%
截至2024年6月30日,現金、現金等價物和$8700萬的短期投資

 

營業收入增長反映出客戶對我們的技術和平台的信心不斷增強。重要的是,我們臨床測試成交量的增長意味着我們可以看到對患者生活的影響。現在,我們的合作伙伴已經提出了令人信服的NeXt Personal臨床證據,我們期待利用這一點來獲取Medicare報銷,並顯著增加我們可以幫助的患者人數。”首席執行官克里斯·霍爾表示:「隨着我們繼續執行我們的Win-in-MRD策略,我們對自己推動廣泛採用患者檢測的能力比以往任何時候都更有信心。」

 

2024年第三季度和修訂後的全年展望

personalis期望2024年第三季度如下:

 

公司總營業收入在21.0到2200萬美元區間
來自制藥測試、企業銷售和其他客戶的營業收入在區間17.0到1800萬美元
人口測序的營業收入約爲400萬美元

personalis預計在2024年整年會有以下表現:

 

公司總營業收入在79.0到8100萬區間,比76.0到7800萬有所增加
製藥檢測、企業銷售和所有其他客戶的營業收入在71.0至7300萬元區間內,較先前的指導範圍68.0至7000萬元有所增加
人口測序的營業收入約爲800萬美元
非普通會計淨損失約7500萬美元,較我們此前的指引減少200萬美元,不包括因向Tempus發行的未行使權證而產生的任何非現金收益或損失
現金使用約爲6000萬美元,較我們先前的指導下降了2億美元

網絡廣播和電話會議信息


personalis將在2024年8月7日週三美國太平洋時間下午2點(東部時間下午5點)收盤後舉行電話會議,討論2024年第二季度的財務業績,以及2024年的計劃。請撥打800-717-1738(國內用戶)或646-307-1865(國際用戶)參與直播。直播網絡研討會可在 https://investors.personalis.com。電話會議結束後不久將提供網絡研討會的回放,並將存檔在公司網站上。


關於Personalis公司。

 

在personalis,我們通過突破性的個性化測試改變癌症的積極管理。我們的目標是推動癌症管理的新範式,從活檢到患者的一生。我們的高度敏感的檢測結合腫瘤和正常的基因組特徵分析,配合專有算法,提供先進的見解

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癌症在不斷進化的同時。我們的產品旨在檢測最小殘留疾病(MRD)和早期復發,根據超全面的基因組分析進行靶向治療選擇,並加強藥物開發的生物標誌物策略。Personalis總部位於加利福尼亞弗裏蒙特。要了解更多,請訪問 www.personalis.com並通過LinkedIn和X (推特).

 

非通用會計準則財務指標

 

爲了補充我們根據GAAP制定的財務指導,我們提供了截至2024年12月31日全年預期的非GAAP淨損失,其中不包括來自於向Tempus發行的未行使權證所產生的收入和費用。我們排除了與Tempus發行的未行使權證公允價值相關的收入和費用,因爲這些是非現金財務指標,需要根據截至每個報告日期的本公司普通股的當時交易價格進行公允價值重估,因此在預測Tempus權證在未來測量日期的公允價值時存在重大不確定性。基於這個原因,我們沒有提供我們前瞻性的非GAAP淨損失與GAAP淨損失(最直接可比的GAAP財務指標)的調和,依賴於適用法規中規定的「不合理費力」的例外情況。

前瞻性聲明


This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “anticipate,” “estimate,” “expect,” “if,” “may,” “future,” “will” or similar expressions. These statements include statements relating to: Personalis’ third quarter and full year 2024 outlook for revenue, non-GAAP net loss, and cash usage, the attributes, advantages or clinical validity of the NeXT Personal Dx test, broad adoption of the NeXT Personal Dx test for patient testing and the benefits to patients from use of the same, and Personalis’ obtaining Medicare coverage. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the timing and pace of new orders from customers, including from Natera and the U.S. Department of Veterans Affairs Million Veterans Program; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter-over-quarter and year-over-year; Personalis’ ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal Dx test, the rate of adoption of the NeXT Personal Dx test, Personalis’ ability to obtain Medicare coverage and reimbursement, Personalis’ achievement of milestones set forth in the collaboration and co-commercialization agreement with Tempus, the success of Personalis’ clinical sales team and Tempus’ sales and marketing efforts, the expected benefits or success of Personalis’ relationships with research collaborators, the impact of Personalis’ abstract presentations at the American Society of Clinical Oncology medical conference in May, and the adoption and use of the NeXT Personal Dx test by oncologists. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, as updated by Personalis’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, being filed with the SEC today. 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.

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Contacts:

Investor Relations Contact:

Caroline Corner

investors@personalis.com

646-277-1279

Media:

pr@personalis.com

 

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PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

22,580

 

 

$

16,699

 

 

$

42,105

 

 

$

35,559

 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,543

 

 

 

11,907

 

 

 

28,575

 

 

 

26,037

 

Research and development

 

 

12,957

 

 

 

17,852

 

 

 

25,728

 

 

 

34,425

 

Selling, general and administrative

 

 

11,973

 

 

 

12,134

 

 

 

23,575

 

 

 

26,231

 

Restructuring and other charges

 

 

 

 

 

152

 

 

 

 

 

 

4,037

 

Total costs and expenses

 

 

39,473

 

 

 

42,045

 

 

 

77,878

 

 

 

90,730

 

Loss from operations

 

 

(16,893

)

 

 

(25,346

)

 

 

(35,773

)

 

 

(55,171

)

Interest income

 

 

1,136

 

 

 

1,465

 

 

 

2,495

 

 

 

2,718

 

Interest expense

 

 

(9

)

 

 

(39

)

 

 

(18

)

 

 

(86

)

Other income (expense), net

 

 

2,968

 

 

 

1

 

 

 

7,537

 

 

 

(25

)

Loss before income taxes

 

 

(12,798

)

 

 

(23,919

)

 

 

(25,759

)

 

 

(52,564

)

Provision for income taxes

 

 

4

 

 

 

36

 

 

 

11

 

 

 

50

 

Net loss

 

$

(12,802

)

 

$

(23,955

)

 

$

(25,770

)

 

$

(52,614

)

Net loss per share, basic and diluted

 

$

(0.24

)

 

$

(0.50

)

 

$

(0.50

)

 

$

(1.11

)

Weighted-average shares outstanding, basic and diluted

 

 

52,394,678

 

 

 

47,669,513

 

 

 

51,536,632

 

 

 

47,204,891

 

 

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PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(in thousands)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Pharma tests and services

 

$

13,197

 

 

$

6,083

 

 

$

23,009

 

 

$

12,416

 

Enterprise sales

 

 

7,958

 

 

 

7,386

 

 

 

15,930

 

 

 

16,844

 

Population sequencing

 

 

1,280

 

 

 

3,000

 

 

 

2,780

 

 

 

6,005

 

Other

 

 

145

 

 

 

230

 

 

 

386

 

 

 

294

 

Total revenue

 

$

22,580

 

 

$

16,699

 

 

$

42,105

 

 

$

35,559

 

 

 

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PERSONALIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(in thousands, except share and per share data)

 

 

 

June 30, 2024

 

 

December 31, 2023

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

47,747

 

 

$

56,984

 

Short-term investments

 

 

39,225

 

 

 

57,195

 

Accounts receivable, net

 

 

12,921

 

 

 

17,730

 

Inventory and other deferred costs

 

 

9,164

 

 

 

10,474

 

Prepaid expenses and other current assets

 

 

4,046

 

 

 

4,361

 

Total current assets

 

 

113,103

 

 

 

146,744

 

Property and equipment, net

 

 

52,662

 

 

 

57,366

 

Operating lease right-of-use assets

 

 

17,166

 

 

 

17,852

 

Other long-term assets

 

 

2,571

 

 

 

3,137

 

Total assets

 

$

185,502

 

 

$

225,099

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

9,936

 

 

$

14,920

 

Accrued and other current liabilities

 

 

19,248

 

 

 

23,941

 

Contract liabilities

 

 

4,174

 

 

 

3,288

 

Short-term warrant liability

 

 

775

 

 

 

5,085

 

Total current liabilities

 

 

34,133

 

 

 

47,234

 

Long-term operating lease liabilities

 

 

36,524

 

 

 

38,321

 

Long-term warrant liability

 

 

1,513

 

 

 

4,942

 

Other long-term liabilities

 

 

1,060

 

 

 

5,161

 

Total liabilities

 

 

73,230

 

 

 

95,658

 

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; 53,052,847 and 50,480,694 shares issued and outstanding, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

606,863

 

 

 

598,364

 

Accumulated other comprehensive loss

 

 

(120

)

 

 

(222

)

Accumulated deficit

 

 

(494,476

)

 

 

(468,706

)

Total stockholders’ equity

 

 

112,272

 

 

 

129,441

 

Total liabilities and stockholders’ equity

 

$

185,502

 

 

$

225,099

 

 

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