UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Securities registered pursuant to Section 12(b) of the Act:
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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. ☐
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Item 2.02 |
Results of Operations and Financial Condition. |
On May 4, 2022, Adaptive Biotechnologies Corporation (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended March 31, 2022. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 and the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
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Description |
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99.1 |
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104 |
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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 thereunto duly authorized.
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Adaptive Biotechnologies Corporation |
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Date: May 4, 2022 |
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By: |
/s/ Kyle Piskel |
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Kyle Piskel |
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Interim Chief Financial Officer and Principal Accounting Officer |
EXHIBIT 99.1
Adaptive Biotechnologies Reports First Quarter 2022 Financial Results
SEATTLE, May 4, 2022 (GLOBE NEWSWIRE) – Adaptive Biotechnologies Corporation (“Adaptive Biotechnologies”) (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today reported financial results for the quarter ended March 31, 2022.
“We started the year strong and completed a strategic reorganization of our company around two key business areas: MRD and Immune Medicine,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “I am encouraged by the solid momentum across both business areas as we optimize our resource allocation to capitalize on the multiple opportunities ahead.”
Recent Highlights
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• |
Revenue of $38.6 million for the first quarter 2022, representing a 0.5% increase from the first quarter 2021. |
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clonoSEQ test volume in the first quarter 2022 grew 45% versus the first quarter of prior year and 12% over the fourth quarter of 2021. |
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Signed expanded MRD pan-portfolio agreement with major partner in MM and CLL for the use of MRD status as a clinical endpoint. |
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Recognized $3.0 million in MRD regulatory milestone revenue resulting from a biopharmaceutical partner who used data from our MRD assay to support its drug approval. |
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Completed analysis from immuneSense Lyme blinded data from 990 participants, confirming T-Detect Lyme is nearly twice as sensitive as the current standard of care (54% T-Detect Lyme vs 30% STTT sensitivity, both at 99% specificity). T-Detect Lyme offering to be made available during 2022 Lyme season. |
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Entered a new T-MAP collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson to map T cell responses to RSV to support Janssen’s RSV vaccine program. |
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Announced the appointment of Tycho Peterson as chief financial officer, who brings several decades of financial leadership and experience within the life science and diagnostic industries. |
First Quarter 2022 Financial Results
Revenue was $38.6 million for the quarter ended March 31, 2022, representing a 0.5% increase from the first quarter in the prior year. Immune Medicine revenue was $20.8 million for the quarter, representing a 4% increase from the first quarter in the prior year. MRD revenue was $17.8 million for the quarter, representing a 3% decrease from the first quarter in the prior year.
Operating expenses were $101.7 million for the first quarter of 2022, compared to $79.7 million in the first quarter of the prior year, representing an increase of 28%.
Net loss was $62.8 million for the first quarter of 2022, compared to $40.6 million for the same period in 2021.
Cash, cash equivalents and marketable securities was $500.7 million as of March 31, 2022.
2022 Financial Guidance
Adaptive Biotechnologies reiterates full year 2022 revenue to be in the range of $185 million to $195 million.
Webcast and Conference Call Information
Adaptive Biotechnologies will host a conference call to discuss its first quarter 2022 financial results after market close on Wednesday, May 4, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at http://investors.adaptivebiotech.com. The webcast will be archived and available for replay at least 90 days after the event.
About Adaptive Biotechnologies
Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics and drug discovery. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
Forward-Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts and other matters regarding our business strategies, use of capital, results of operations and financial position and plans and objectives for future operations.
In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
ADAPTIVE MEDIA
Laura Cooper
205-908-5603
media@adaptivebiotech.com
ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
investors@adaptivebiotech.com
Adaptive Biotechnologies
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended March 31, |
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2022 |
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2021 |
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Revenue |
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$ |
38,620 |
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$ |
38,442 |
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Operating expenses |
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Cost of revenue |
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13,192 |
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9,991 |
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Research and development |
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37,839 |
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33,772 |
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Sales and marketing |
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26,093 |
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20,604 |
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General and administrative |
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24,144 |
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14,936 |
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Amortization of intangible assets |
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419 |
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419 |
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Total operating expenses |
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101,687 |
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79,722 |
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Loss from operations |
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(63,067 |
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(41,280 |
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Interest and other income, net |
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271 |
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638 |
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Net loss |
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(62,796 |
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(40,642 |
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Add: Net loss attributable to noncontrolling interest |
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60 |
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— |
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Net loss attributable to Adaptive Biotechnologies Corporation |
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$ |
(62,736 |
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$ |
(40,642 |
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Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
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$ |
(0.44 |
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$ |
(0.29 |
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Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
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141,697,252 |
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138,967,754 |
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Adaptive Biotechnologies
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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March 31, 2022 |
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December 31, 2021 |
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(unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
114,805 |
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$ |
139,065 |
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Short-term marketable securities (amortized cost of $250,448 and $214,115, respectively) |
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248,757 |
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213,996 |
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Accounts receivable, net |
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22,518 |
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17,409 |
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Inventory |
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21,002 |
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19,263 |
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Prepaid expenses and other current assets |
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12,038 |
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13,015 |
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Total current assets |
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419,120 |
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402,748 |
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Long-term assets |
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Property and equipment, net |
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85,994 |
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85,262 |
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Operating lease right-of-use assets |
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85,634 |
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87,678 |
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Long-term marketable securities (amortized cost of $140,202 and $218,163, respectively) |
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137,110 |
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217,145 |
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Restricted cash |
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2,382 |
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2,138 |
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Intangible assets, net |
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8,107 |
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8,526 |
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Goodwill |
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118,972 |
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118,972 |
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Other assets |
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874 |
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875 |
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Total assets |
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$ |
858,193 |
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$ |
923,344 |
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Liabilities and shareholders’ equity |
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Current liabilities |
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Accounts payable |
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$ |
5,959 |
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$ |
3,307 |
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Accrued liabilities |
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10,407 |
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9,343 |
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Accrued compensation and benefits |
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6,651 |
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15,642 |
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Current portion of operating lease liabilities |
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8,545 |
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5,055 |
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Current portion of deferred revenue |
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83,504 |
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80,460 |
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Total current liabilities |
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115,066 |
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113,807 |
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Long-term liabilities |
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Operating lease liabilities, less current portion |
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104,978 |
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106,685 |
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Deferred revenue, less current portion |
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84,894 |
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98,750 |
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Total liabilities |
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304,938 |
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319,242 |
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Commitments and contingencies |
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Shareholders’ equity |
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Preferred stock: $0.0001 par value, 10,000,000 shares authorized at March 31, 2022 and December 31, 2021; no shares issued and outstanding at March 31, 2022 and December 31, 2021 |
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— |
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— |
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Common stock: $0.0001 par value, 340,000,000 shares authorized at March 31, 2022 and December 31, 2021; 142,183,258 and 141,393,865 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively |
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14 |
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14 |
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Additional paid-in capital |
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1,339,601 |
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1,324,006 |
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Accumulated other comprehensive loss |
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(4,783 |
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(1,137 |
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Accumulated deficit |
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(781,627 |
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(718,891 |
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Total Adaptive Biotechnologies Corporation shareholders’ equity |
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553,205 |
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603,992 |
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Noncontrolling interest |
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50 |
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110 |
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Total shareholders’ equity |
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553,255 |
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604,102 |
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Total liabilities and shareholders’ equity |
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$ |
858,193 |
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$ |
923,344 |
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Revenue Reclassification and clonoSEQ Test Volume
We previously disclosed revenue bifurcated into sequencing and development financial statement captions and now present total revenue on our unaudited condensed consolidated statements of operations.
The following table presents the amount of sequencing revenue and development revenue recognized under our Immune Medicine and MRD market opportunities for the periods presented (in thousands, unaudited):
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Three Months Ended |
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December 31, 2021 |
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September 30, 2021 |
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June 30, 2021 |
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March 31, 2021 |
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Immune Medicine revenue |
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Sequencing revenue |
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$ |
6,860 |
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$ |
8,170 |
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$ |
5,404 |
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$ |
4,048 |
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Development revenue |
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14,514 |
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15,445 |
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17,635 |
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16,057 |
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Total Immune Medicine revenue |
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21,374 |
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23,615 |
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23,039 |
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20,105 |
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MRD revenue |
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Sequencing revenue |
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16,201 |
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13,936 |
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13,151 |
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11,126 |
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Development revenue |
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355 |
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1,916 |
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2,315 |
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7,211 |
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Total MRD revenue |
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16,556 |
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15,852 |
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15,466 |
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18,337 |
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Total revenue |
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$ |
37,930 |
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$ |
39,467 |
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$ |
38,505 |
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$ |
38,442 |
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Three Months Ended |
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December 31, 2020 |
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September 30, 2020 |
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June 30, 2020 |
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March 31, 2020 |
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Immune Medicine revenue |
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Sequencing revenue |
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$ |
3,310 |
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$ |
3,691 |
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$ |
2,036 |
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$ |
3,170 |
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Development revenue |
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17,155 |
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12,438 |
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12,856 |
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11,077 |
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Total Immune Medicine revenue |
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20,465 |
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16,129 |
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14,892 |
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14,247 |
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MRD revenue |
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Sequencing revenue |
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9,399 |
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7,585 |
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5,949 |
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6,299 |
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Development revenue |
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321 |
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2,585 |
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147 |
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364 |
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Total MRD revenue |
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9,720 |
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10,170 |
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6,096 |
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6,663 |
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Total revenue |
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$ |
30,185 |
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$ |
26,299 |
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$ |
20,988 |
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$ |
20,910 |
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We also previously disclosed the number of clonoSEQ reports provided to ordering physicians in the United States, referred to as “clinical sequencing volume” or “clinical sequencing volume, excluding T-Detect COVID volume” in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of certain of our SEC filings. We now present the number of clonoSEQ reports and results we have provided to ordering physicians in the United States and international technology transfer sites, collectively referred to as “clonoSEQ test volume.” Our clonoSEQ test volume does not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services.
The following table presents our clonoSEQ test volume for the periods presented:
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Three Months Ended |
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December 31, 2021 |
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September 30, 2021 |
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June 30, 2021 |
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March 31, 2021 |
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Clinical sequencing volume, excluding T-Detect COVID volume |
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6,356 |
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5,928 |
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5,475 |
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4,757 |
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clonoSEQ reports or results provided to international technology transfer sites |
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494 |
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413 |
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422 |
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543 |
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clonoSEQ test volume |
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6,850 |
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6,341 |
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5,897 |
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5,300 |
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Three Months Ended |
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December 31, 2020 |
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September 30, 2020 |
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June 30, 2020 |
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March 31, 2020 |
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Clinical sequencing volume |
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4,509 |
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4,023 |
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3,136 |
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3,518 |
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clonoSEQ reports or results provided to international technology transfer sites |
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704 |
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375 |
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310 |
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238 |
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clonoSEQ test volume |
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5,213 |
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4,398 |
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3,446 |
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3,756 |
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