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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Akili Inc | NASDAQ:AKLI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0243 | -5.47% | 0.4201 | 0.23 | 0.47 | 0.4447 | 0.42 | 0.4431 | 231,279 | 05:00:02 |
FY 2023 total revenues of $1.7M, a 420% increase over FY 2022 as EndeavorOTCⓇ gained traction in the market following June 2023 product release
Reports fourth quarter 2023 total revenues of $749 thousand, representing 7% growth over the third quarter of 2023, and positive gross margins of 66%, representing a 6 percentage point increase over the third quarter of 2023
Akili partner Shionogi releases positive Phase 3 trial results and submits Akili’s digital therapeutic SDT-001 for marketing approval in Japan
Company lowers FY 2024 non-GAAP total operating expense guidance to between $38 million and $43 million and reaffirms gross margins guidance of 60-70% by late 2025; ends FY 2023 with $75.2 million in cash and cash equivalents and reaffirms cash runway into 2H 2025
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today reported its financial results for the quarter and full year ended December 31, 2023, and provided an update on business progress.
“We continue to see clear demand for our innovative, digital therapeutics, particularly amidst the ongoing mental health crisis and increasing awareness of adult ADHD prevalence,” said Matt Franklin, Chief Executive Officer at Akili. “Our mid-year shift to a leaner, customer-centric model has yielded strong initial results, with revenue growth and gross margin improvement in 2023, that we believe will strengthen our ability to achieve profitability over time.”
Business Update
FY 2023 Financial Highlights
Fourth Quarter 2023 Financial Highlights
Financial Guidance
For additional information, please see the tables below, which include a reconciliation of the historical non-GAAP financial measures to GAAP financial measures.
Non-GAAP Financial Measures
In addition to financial information prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), this press release includes the following non-GAAP financial measures: EndeavorOTC billings on a historical basis, total billings on a historical basis, non-GAAP total operating expenses on a historical basis, non-GAAP net loss on a historical basis and non-GAAP total operating expenses on a projected basis. Akili derives these non-GAAP financial measures by excluding or adjusting certain expenses and other items from the respective GAAP financial measure that is most directly comparable to each non-GAAP financial measure. Specifically, EndeavorOTC billings is defined as EndeavorOTC revenues plus the change in deferred revenue; total billings is defined as total revenues plus the change in deferred revenue during the period; 2022 non-GAAP total operating expenses on a historical basis excludes stock-based compensation expense and transaction costs allocated to earn-out shares; 2023 non-GAAP total operating expenses on a historical basis excludes stock-based compensation expense, an impairment loss on certain assets associated with our sublease and severance and termination-related costs associated with the workforce reductions during the year; 2022 non-GAAP net loss excludes transaction costs allocated to earn-out shares, stock based compensation expense, and the change in estimated fair value of earn-out liabilities; 2023 non-GAAP net loss excludes stock-based compensation expense, an impairment loss on certain assets associated with our sublease, severance and termination-related costs associated with the workforce reductions announced during the year, and the change in estimated fair value of earn-out liabilities; and 2024 non-GAAP total operating expenses on a projected basis excludes stock-based compensation expense. Akili’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly-named measures used by other companies. A reconciliation of the historical non-GAAP financial measures to GAAP financial measures is included in the attached financial tables. However, a quantitative reconciliation of projected non-GAAP total operating expenses to projected GAAP operating expenses is not available, nor is the probable significance of such reconciling information, due to Akili’s inability to predict with reasonable certainty the amount of future stock-based compensation expense at this time.
EndeavorOTC Indication and Overview
EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8 - 17. EndeavorOTC is available under the U.S. Food and Drug Administration’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food and Drug Administration for its indications. It is recommended that patients speak to their health care provider before starting EndeavorOTC treatment. No serious adverse events have been reported in any of our clinical studies. To learn more, visit EndeavorOTC.com.
EndeavorRx Indication and Overview
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.
About Akili
Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “prepare,” “pursue,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, without limitation, statements in this press release related to: our use of the STARS-ADHD-Adult study data in a regulatory submission with FDA to obtain regulatory authorization for our over-the-counter product, EndeavorOTC; our expectations regarding our ability to continue to be able to market EndeavorOTC under the relevant FDA guidance; our expectations regarding our ability to use EndeavorOTC to directly and efficiently engage with adults struggling with attention issues and ADHD; our expectation that the label expansion of EndeavorRx will more than double the number of pediatric patients who are now eligible for EndeavorRx; our plans to request FDA authorization of the conversion of EndeavorRx to over-the-counter labeling and to submit data to FDA in 2024; our expectations regarding our partner SHIONOGI’s Phase 3 clinical trial results and its plans and timing regarding its regulatory submission in Japan of our SDT-001 product for pediatric ADHD patients; our expectations regarding our ability to achieve profitability; our expectations regarding our FY 2024 non-GAAP total operating expenses; our expectations regarding our future gross margin percentage; our expectations that our cash, cash equivalents, and short-term investments will be sufficient to fund our current and planned operations into the second half of 2025; and our expectations regarding our continued strong demand from individuals struggling with ADHD. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: our ability to obtain and maintain over-the-counter FDA authorization for EndeavorOTC; our ability to continue to commercialize EndeavorOTC under relevant FDA guidance; our ability to obtain regulatory authorization from FDA to convert our EndeavorRx product to over-the-counter-labeling; our ability to successfully create, and navigate, a new category of medicine and to achieve broad adoption of digital therapeutics among customers and healthcare providers; our ability to continue to advance our clinical development pipeline; our ability to defend our intellectual property and satisfy various FDA and other regulatory requirements in and outside of the United States; the risk of adverse macroeconomic or political changes and a changing regulatory landscape in the highly competitive industry in which we operate; the timing and results expected from our and our partners’ clinical trials and our reliance on third parties for certain aspects of our business; our ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in our current filings and any subsequent filings made with the Securities and Exchange Commission (SEC). We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Akili, Inc.
Unaudited Condensed Consolidated Balance Sheets
December 31,
September 30,
December 31,
2023
2023
2022
Assets
Current assets:
Cash and cash equivalents
$75,150
$73,799
$54,097
Restricted cash
305
305
305
Short-term investments
-
12,482
82,034
Accounts receivable
300
442
41
Prepaid expenses and other current assets
2,275
3,608
4,565
Total current assets
78,030
90,636
141,042
Property and equipment, net
680
644
919
Operating lease right-of-use asset
1,577
1,753
2,596
Prepaid expenses and other long-term assets
96
109
—
Total assets
$80,383
$93,142
$144,557
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$1,285
$1,217
$2,681
Accrued expenses and other current liabilities
3,326
3,385
5,616
Deferred revenue
100
173
106
Operating lease liability
756
774
826
Note payable, short term
7,500
7,500
4,375
Total current liabilities
12,967
13,049
13,604
Note payable, long term
3,445
5,209
10,442
Operating lease liability, net of current portion
1,730
1,928
2,485
Corporate bond, net of bond discount
2,054
1,999
1,834
Earn-out liabilities
1,632
1,841
5,513
Other long-term liabilities
23
22
-
Total liabilities
21,851
24,048
33,878
Commitments and contingencies
Stockholders' equity
Common stock
8
8
8
Additional paid-in capital
358,305
357,720
350,980
Accumulated deficit
(299,781)
(288,634)
(240,288)
Accumulated other comprehensive loss
-
-
(21)
Total stockholders' equity
58,532
69,094
110,679
Total liabilities and stockholders’ equity
$80,383
$93,142
$144,557
Akili, Inc.
Unaudited Condensed Consolidated Statements of Operations
Three Months Ended December 31,
Years Ended December 31,
Three Months Ended September 30,
2023
2022
2023
2022
2023
Revenues
$749
$111
$1,678
$323
$702
Cost of revenues
252
125
819
441
280
Gross profit (loss)
497
(14)
859
(118)
422
Operating expenses:
Research and development
4,296
7,642
19,925
28,858
4,912
Selling, general and administrative
7,824
14,451
45,419
61,701
13,936
Total operating expenses
12,120
22,093
65,344
90,559
18,848
Operating loss
(11,623)
(22,107)
(64,485)
(90,677)
(18,426)
Other income, net
529
5,311
5,045
82,732
2,550
Income tax expense
(53)
(19)
(53)
(19)
-
Net loss
$(11,147)
$(16,815)
$(59,493)
$(7,964)
$(15,876)
Akili, Inc.GAAP to Non-GAAP Reconciliation
Three Months Ended December 31,
Years Ended December 31,
Three Months Ended September 30,
2023
2022
2023
2022
2023
GAAP Total Operating Expenses
$12,120
$22,093
$65,344
$90,559
$18,848
Transaction costs allocated to earn-out shares
-
-
-
(3,046)
-
Stock-based compensation
(556)
(2,117)
(6,807)
(9,309)
(1,655)
Impairment loss on sublease
-
-
(384)
-
-
Expenses related to workforce reduction
-
-
(4,730)
-
(2,461)
Non-GAAP Total Operating Expenses
$11,564
$19,976
$53,423
$78,204
$14,732
GAAP Net Loss
$(11,147)
$(16,815)
$(59,493)
$(7,964)
$(15,876)
Transaction costs allocated to earn-out shares
-
-
-
3,046
-
Stock-based compensation
556
2,117
6,807
9,309
1,655
Impairment loss on sublease
-
-
384
-
-
Expenses related to workforce reduction
-
-
4,730
-
2,461
Change in estimated fair value for earn-out liabilities
(181)
(4,842)
(3,363)
(82,734)
(2,128)
Non-GAAP Net Loss
$(10,772)
$(19,540)
$(50,935)
$(78,343)
$(13,888)
Total Revenues
$749
$111
$1,678
$323
$702
Deferred revenue, end of period
100
106
100
106
173
Deferred revenue, beginning of period
(173)
(109)
(106)
(96)
(176)
Total Billings
$676
$108
$1,672
$333
$699
EndeavorOTC Revenues
$596
$ -
$1,155
$ -
$553
Deferred revenue, end of period
-
-
-
-
-
Deferred revenue, beginning of period
-
-
-
-
(20)
EndeavorOTC Billings
$596
$ -
$1,155
$ -
$533
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229955450/en/
Investor Contact: Matt Franklin Chief Executive Officer InvestorRelations@akiliinteractive.com
Media Contact: Caty Reid VP, Marketing & Communications PR@akiliinteractive.com
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