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FY Revenue of $291.3 million, up 9% over 2023;

Delivered FY 2024 net income of $12.5 million or 4% margin;

FY adjusted EBITDA increased 23% over 2023 and was $92.3 million or 32% margin;

Revenue in Q4 from CTV more than doubled year over year and represented 20% of total revenue;

Supply Path Optimization represented 53% of total activity in 2024;

Repurchased 4.3 million shares in 2024, representing 7.9% of fully diluted shares as of December 31, 2024

NO-HEADQUARTERS/REDWOOD CITY, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) — PubMatic, Inc. (Nasdaq: PUBM), an independent technology company delivering digital advertising’s supply chain of the future, today reported financial results for the fourth quarter and fiscal year ended December 31, 2024.

“Revenue growth in the year more than doubled over 2023, driven by strength in CTV, emerging revenue streams, and marquee customers choosing PubMatic to build and scale their ad businesses. Our revenue mix is evolving; in the fourth quarter, CTV more than doubled to 20% of total revenue. These achievements mark an inflection point in our underlying business that highlights critical scale on our platform and a significant shift in ad buying toward channels with the highest consumer engagement such as CTV, mobile app and commerce media,” said Rajeev Goel, co-founder and CEO at PubMatic. “Today, our omnichannel platform serves publishers, media buyers, commerce media networks, and curation/data providers, all of which are turning to sell side technology for critical end-to-end solutions needed to build their ad businesses. As we look to 2025, we expect accelerated growth in our underlying business as ad buyers seek premium, brand safe, curated inventory in the open internet.”

Fiscal Year 2024 Financial Highlights

• Revenue for the full year 2024 was $291.3 million, an increase of 9% over $267.0 million in 2023;
• Gross profit was $190.2 million, or 65% margin, an improvement of 250 basis points over 2023;
• Revenue from omnichannel video in 2024 grew 37% over the same period last year;
• Net dollar-based retention¹ was 107% for the year ended December 31, 2024;
• GAAP net income was $12.5 million with a margin of 4%, or $0.23 per diluted share in 2024, an increase over net income² of $8.9 million with a margin of 3%, or $0.16 per diluted share in 2023;
• Adjusted EBITDA was $92.3 million, or 32% margin, an increase over adjusted EBITDA of $75.3 million, or 28% margin, in 2023;
• Non-GAAP net income was $42.5 million, or $0.78 per non-GAAP diluted share in 2024, an increase over non-GAAP net income of $32.0 million, or $0.57 per non-GAAP diluted share in 2023;
• Net cash provided by operating activities in 2024 was $73.4 million, compared to $81.1 million in the full year 2023;
• Generated free cash flow of $34.9 million in 2024, down 34% over 2023;
• Ended 2024 with total cash, cash equivalents, and marketable securities of $140.6 million with no debt, a decrease of 20% over the full year 2023; and
• Through December 31, 2024, used $134.6 million in cash to repurchase 8.3 million shares of Class A common stock with $40.4 million available from the 2024 repurchase program.

Fourth Quarter 2024 Financial Highlights

• Revenue in the fourth quarter of 2024 was $85.5 million, an increase of 1% over $84.6 million in the same period of 2023;
• GAAP net income was $13.9 million with a margin of 16%, or $0.26 per diluted share in the fourth quarter, compared to GAAP net income of $18.7 million with a margin of 22%, or $0.34 per diluted share in the same period of 2023;
• Adjusted EBITDA was $37.6 million, or 44% margin, compared to $38.9 million, or 46% margin in the same period of 2023;
• Non-GAAP net income was $21.4 million, or $0.41 per non-GAAP diluted share in the fourth quarter, compared to non-GAAP net income of $24.4 million, or $0.45 per non-GAAP diluted share in the same period of 2023; and
• Net cash provided by operating activities was $18.0 million, compared to $28.7 million in the same period of 2023.

The section titled “Non-GAAP Financial Measures” below describes our usage of non-GAAP financial measures. Reconciliations between historical GAAP and non-GAAP information are contained at the end of this press release following the accompanying financial data.

“In 2024, we delivered record share of revenue for CTV, mobile app and emerging revenues, and achieved an all-time high of Supply Path Optimization activity. We also significantly expanded our margins, once again, demonstrating the strength of our durable model and our strategic commitment to steward both operational excellence and targeted investments for growth,” said Steve Pantelick, CFO at PubMatic. “In Q4, strong growth in the underlying business helped offset softer spending from the large DSP buyer we previously called out mid year. Going forward, we are taking a conservative approach as it relates to this buyer, and expect total revenues to grow year over year in the second half of the year once we lap this impact at the end of Q2 2025. Our underlying business, which excludes revenue from this DSP and political, is targeted to grow 15%+ and represent over two thirds of total company revenues in 2025.”

Business Highlights

Omnichannel platform drives revenue in key secular growth areas

• Full year revenue from high value formats and channels, mobile and omnichannel video³, grew 17% over 2023.
• In Q4, revenue from omnichannel video, which includes CTV, grew 37% year-over-year.
• CTV reached scale, and was 20% of revenue in the fourth quarter, driven by growing inventory supply, SPO relationships, and strength in political advertising.
• Revenue from mobile app grew 16% over 2023 as we scaled to over 900 mobile app publishers.

High consumer engagement channels fuel ad demand and sell-side data curation

• New and expanded partnerships announced in 2024 with premium streaming brands including Roku, Dish Media, Disney+ Hotstar, TCL and Xumo. We now work with 80% of the top 30 streaming publishers.
• The number of Activate customers grew nearly 6x over 2023.
• Supply Path Optimization represented 53% of total activity on our platform in 2024, up from 45% in 2023.
• Connect drives more performant, targeted ad campaigns across the open internet, offering 190 data sets to ad buyers on PubMatic. Connect is a leading platform for data providers and curators to integrate first-party data, package inventory, sell to, and optimize outcomes for ad buyers.

Focused investments drive long-term growth opportunities

• More than doubled total addressable market to over $120 billion via products that address four key stakeholders across the digital advertising ecosystem: publishers, media buyers, curators and data providers, and commerce media networks.
• Contribution from emerging revenue streams, which expand beyond ad monetization services, doubled from 2023.

Recent product launches

• Launched CTV Marketplaces, offering ad buyers pre-curated CTV inventory available only on PubMatic, built directly from our sell side technology. CTV Marketplaces allows publishers to unlock more value from their inventory and provides ad buyers off-the-shelf, easy to buy premium content and targeted audiences, including curated live sports inventory.
• Launched Creative Category Manager, a generative AI solution that scans and classifies each video ad creative on granular criteria. First used to unlock millions of dollars in political ad spend, it drove significant CTV revenue. This gen AI solution will soon expand to other use cases and verticals.
• Launched PubMatic Assistant, a gen AI powered reporting tool that allows publishers to request any report or data using simple plain language text queries. As a result, publishers can streamline analytics, enhance productivity and unlock new growth opportunities by uncovering insights in big data. This powerful tool removes barriers to adoption and drives increased platform usage.

2024 operating priorities drove profitable growth

• Aligned with our growth investments, increased global headcount in 2024 by 11% over 2023, adding new team members across product management, engineering and go-to-market teams to accelerate long-term revenue growth.
• Infrastructure optimization initiatives and investments drove nearly 263 trillion impressions processed in 2024, an increase of 25% over 2023.
• Cost of revenue per million impressions processed decreased 18% on a trailing twelve month period, as compared to the prior period.
• Scaled adoption of generative AI drove increased engineering productivity by 15%+ which led to faster software development, testing and release processes.

Financial Outlook

Q1 outlook includes the continued headwind from one of our top DSP buyers that revised its auction approach in late May 2024. Adjusted EBITDA expectation assumes a negative FX impact predominately from Euro and Pound Sterling expenses. It also assumes that general market conditions do not significantly deteriorate as it relates to current macroeconomic and geopolitical conditions.

Accordingly, we estimate the following:

For the first quarter of 2025, we expect the following:

• Revenue to be in the range of $61 million to $63 million.
• Adjusted EBITDA to be in the range of $5 million to $7 million.

Although we provide guidance for adjusted EBITDA and free cash flow, we are not able to provide guidance for net income, the most directly comparable GAAP measure. Certain elements of the composition of GAAP net income, including stock-based compensation expenses, are not predictable, making it impractical for us to provide guidance on net income or to reconcile our adjusted EBITDA guidance to net income without unreasonable efforts. For the same reason, we are unable to address the probable significance of the unavailable information.

Conference Call and Webcast details

PubMatic will host a conference call to discuss its financial results on Thursday, February 27, 2025 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). A live webcast of the call can be accessed from PubMatic’s Investor Relations website at https://investors.pubmatic.com. An archived version of the webcast will be available from the same website after the call.

Non-GAAP Financial Measures

In addition to our results determined in accordance with U.S. generally accepted accounting principles (GAAP), including, in particular operating income, net cash provided by operating activities, and net income, we believe that adjusted EBITDA, adjusted EBITDA margin, non-GAAP net income, non-GAAP earnings per share and free cash flow, each a non-GAAP measure, are useful in evaluating our operating performance. We define adjusted EBITDA as net income adjusted for stock-based compensation expense, depreciation and amortization, unrealized loss and impairment of equity investment, interest income, acquisition-related and other expenses, and provision for income taxes. Adjusted EBITDA margin represents adjusted EBITDA calculated as a percentage of revenue. We define non-GAAP net income as net income adjusted for unrealized loss on equity investments, stock-based compensation expense, acquisition-related and other expenses, and adjustments for income taxes. We define non-GAAP free cash flow as net cash provided by operating activities reduced by purchases of property and equipment and capitalized software development costs.

In addition to operating income and net income, we use adjusted EBITDA and non-GAAP net income as measures of operational efficiency. We believe that these non-GAAP financial measures are useful to investors for period to period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

• Adjusted EBITDA and non-GAAP net income are widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expense, depreciation and amortization, interest expense, and provision for income taxes that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired; and,
• Our management uses adjusted EBITDA and non-GAAP net income in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.

Our use of non-GAAP financial measures has limitations as an analytical tool, and you should not consider them in isolation or as a substitute for analysis of our financial results as reported under GAAP. Some of these limitations are as follows:

• Adjusted EBITDA does not reflect: (a) changes in, or cash requirements for, our working capital needs; (b) the potentially dilutive impact of stock-based compensation; or (c) tax payments that may represent a reduction in cash available to us;
• Although depreciation and amortization expense are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and adjusted EBITDA does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; and
• Non-GAAP net income does not include: (a) unrealized losses resulting from our equity investment; (b) the potentially dilutive impact of stock-based compensation; (c) income tax effects for stock-based compensation and unrealized losses from our equity investment; or (d) acquisition-related and other expenses.

Because of these and other limitations, you should consider adjusted EBITDA and non-GAAP net income along with other GAAP-based financial performance measures, including net income and our GAAP financial results.

Forward Looking Statements

This press release contains “forward-looking statements” regarding our future business expectations, including our guidance relating to our revenue and adjusted EBITDA for the first quarter of 2025, our expectations regarding our adjusted EBITDA, free cash flow, capital expenditures, future hiring, future market growth, our long-term revenue growth, target revenue and our ability to gain market share. These forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions and may differ materially from actual results due to a variety of factors including: our dependency on the overall demand for advertising and the channels we rely on; our existing customers not expanding their usage of our platform, or our failure to attract new publishers and buyers; our ability to maintain and expand access to spend from buyers and valuable ad impressions from publishers; the rejection of the use of digital advertising by consumers through opt-in, opt-out or ad-blocking technologies or other means; our failure to innovate and develop new solutions that are adopted by publishers; the war between Ukraine and Russia and the resumption of conflict between Israel and Palestine, and the related measures taken in response by the global community; the impacts of inflation as well as fiscal tightening and volatile interest rates; public health crises, including the resulting global economic uncertainty; limitations imposed on our collection, use or disclosure of data about advertisements; the lack of similar or better alternatives to the use of third-party cookies, mobile device IDs or other tracking technologies if such uses are restricted; any failure to scale our platform infrastructure to support anticipated growth and transaction volume; liabilities or fines due to publishers, buyers, and data providers not obtaining consents from consumers for us to process their personal data; any failure to comply with laws and regulations related to data privacy, data protection, information security, and consumer protection; and our ability to manage our growth. Moreover, we operate in a competitive and rapidly changing market, and new risks may emerge from time to time. For more information about risks and uncertainties associated with our business, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of our SEC filings, including but not limited to, our annual report on Form 10-K and quarterly reports on From 10-Q, copies of are available on our investor relations website at https://investors.pubmatic.com and on the SEC website at www.sec.gov. All information in this press release is as of February 27, 2025. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

About PubMatic

PubMatic is an independent technology company maximizing customer value by delivering digital advertising’s supply chain of the future. PubMatic’s sell-side platform empowers the world’s leading digital content creators across the open internet to control access to their inventory and increase monetization by enabling marketers to drive return on investment and reach addressable audiences across ad formats and devices. Since 2006, PubMatic’s infrastructure-driven approach has allowed for the efficient processing and utilization of data in real time. By delivering scalable and flexible programmatic innovation, PubMatic improves outcomes for its customers while championing a vibrant and transparent digital advertising supply chain.

CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (unaudited)
		December 31, 2024				December 31, 2023
ASSETS
Current assets
Cash and cash equivalents		$	100,452			$	78,509
Marketable securities			40,135				96,835
Accounts receivable, net			424,814				375,468
Prepaid expenses and other current assets			10,145				11,143
Total current assets			575,546				561,955
Property, equipment and software, net			58,522				60,729
Operating lease right-of-use assets			44,402				21,102
Acquisition-related intangible assets, net			4,284				5,864
Goodwill			29,577				29,577
Deferred tax assets			24,864				13,880
Other assets, non-current			2,324				2,136
TOTAL ASSETS		$	739,519			$	695,243
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	386,602			$	347,673
Accrued liabilities			26,365				25,684
Operating lease liabilities, current			5,843				6,236
Total current liabilities			418,810				379,593
Operating lease liabilities, non-current			39,538				15,607
Other liabilities, non-current			3,908				3,844
TOTAL LIABILITIES			462,256				399,044
Stockholders’ Equity
Common stock			6				6
Treasury stock			(146,796	)			(71,103	)
Additional paid-in capital			275,304				230,419
Accumulated other comprehensive loss			(636	)			(4	)
Retained earnings			149,385				136,881
TOTAL STOCKHOLDERS’ EQUITY			277,263				296,199
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	739,519			$	695,243

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) (unaudited)
		Three Months Ended December 31,						Year Ended December 31,
			2024			2023			2024			2023
Revenue		$	85,502		$	84,600		$	291,256		$	267,014
Cost of revenue(1)			24,935			24,208			101,027			99,229
Gross profit			60,567			60,392			190,229			167,785
Operating expenses:(1)
Technology and development			7,831			6,846			33,263			26,727
Sales and marketing			23,763			20,353			95,369			82,803
General and administrative(2)			14,171			12,780			57,670			56,219
Total operating expenses			45,765			39,979			186,302			165,749
Operating income			14,802			20,413			3,927			2,036
Total other income, net			3,618			2,632			13,847			8,469
Income before income taxes			18,420			23,045			17,774			10,505
Provision for income taxes			4,521			4,343			5,270			1,624
Net income		$	13,899		$	18,702		$	12,504		$	8,881
Net income per share attributable to common stockholders:
Basic		$	0.29		$	0.37		$	0.25		$	0.17
Diluted		$	0.26		$	0.34		$	0.23		$	0.16
Weighted-average shares used to compute net income per share attributable to common stockholders:
Basic			47,993			50,659			49,213			51,760
Diluted			52,623			54,940			54,294			56,027

(1)Stock-based compensation expense includes the following:
STOCK BASED COMPENSATION EXPENSE (In thousands) (unaudited)
		Three Months Ended December 31,						Year Ended December 31,
			2024			2023			2024			2023
Cost of revenue		$	438		$	383		$	1,855		$	1,472
Technology and development			1,625			1,137			6,313			4,346
Sales and marketing			3,247			2,589			13,407			10,462
General and administrative			4,099			3,228			16,101			12,582
Total stock-based compensation		$	9,409		$	7,337		$	37,676		$	28,862

⁽²⁾On June 30, 2023, a Demand Side Platform buyer of our platform filed for Chapter 11 bankruptcy. As a result of this bankruptcy, we recorded incremental bad debt expense of $5.7 million which is reflected in our GAAP net income and adjusted EBITDA results for the year ended December 31, 2023.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (In thousands) (unaudited)
		December 31,
			2024				2023
CASH FLOW FROM OPERATING ACTIVITIES:
Net Income		$	12,504			$	8,881
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization			45,352				44,770
Stock-based compensation			37,676				28,862
Provision for doubtful accounts			—				5,675
Deferred income taxes			(10,984	)			(13,406	)
Accretion of discount on marketable securities			(4,117	)			(4,093	)
Non-cash lease expense			6,801				6,145
Other			(25	)			45
Changes in operating assets and liabilities:
Accounts receivable			(49,345	)			(75,716	)
Prepaid expenses and other current assets			(5,826	)			3,918
Accounts payable			38,096				79,687
Accrued liabilities			9,627				3,035
Operating lease liabilities			(6,531	)			(5,789	)
Other liabilities, non-current			197				(893	)
Net cash provided by operating activities			73,425				81,121
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of and deposits on property and equipment			(17,592	)			(10,601	)
Capitalized software development costs			(20,936	)			(17,687	)
Purchases of marketable securities			(142,016	)			(140,603	)
Proceeds from sales of marketable securities			—				18,873
Proceeds from maturities of marketable securities			202,858				111,000
Net cash provided by (used in) investing activities			22,314				(39,018	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of business combination indemnification claims holdback			(2,148	)			—
Proceeds from issuance of common stock for employee stock purchase plan			2,368				1,869
Proceeds from exercise of stock options			1,765				1,549
Principal payments on finance lease obligations			(131	)			(126	)
Payments to acquire treasury stock			(75,332	)			(59,268	)
Net cash used in financing activities			(73,478	)			(55,976	)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS			22,261				(13,873	)
Effect of foreign currency on cash			(318	)			—
CASH AND CASH EQUIVALENTS – Beginning of year			78,509				92,382
CASH AND CASH EQUIVALENTS – End of year		$	100,452			$	78,509

RECONCILIATION OF GAAP NET INCOME TO NON-GAAP ADJUSTED EBITDA AND NON-GAAP NET INCOME (In thousands, except per share amounts) (unaudited)
		Three Months Ended December 31,								Year Ended December 31,
			2024				2023				2024				2023
Reconciliation of net income:
Net income		$	13,899			$	18,702			$	12,504			$	8,881
Add back (deduct):
Stock-based compensation			9,409				7,337				37,676				28,862
Depreciation and amortization			11,421				11,039				45,352				44,770
Interest income			(1,604	)			(2,515	)			(8,477	)			(8,828	)
Provision for income taxes			4,521				4,343				5,270				1,624
Adjusted EBITDA1		$	37,646			$	38,906			$	92,325			$	75,309
Revenue		$	85,502			$	84,600			$	291,256			$	267,014
Adjusted EBITDA margin			44	%			46	%			32	%			28	%

		Three Months Ended December 31,								Year Ended December 31,
			2024				2023				2024				2023
Reconciliation of net income per share:
Net income		$	13,899			$	18,702			$	12,504			$	8,881
Add back (deduct):
Stock-based compensation			9,409				7,337				37,676				28,862
Adjustment for income taxes			(1,865	)			(1,590	)			(7,728	)			(5,695	)
Non-GAAP net income1		$	21,443			$	24,449			$	42,452			$	32,048
GAAP diluted EPS		$	0.26			$	0.34			$	0.23			$	0.16
Non-GAAP diluted EPS		$	0.41			$	0.45			$	0.78			$	0.57
GAAP weighted average shares outstanding—diluted			52,623				54,940				54,294				56,027
Non-GAAP weighted average shares outstanding—diluted			52,623				54,940				54,294				56,027

SUPPLEMENTAL CASH FLOW INFORMATION COMPUTATION OF FREE CASH FLOW, A NON-GAAP MEASURE (In thousands) (unaudited)
		Three Months Ended December 31,								Year Ended December 31,
			2024				2023				2024				2023
Reconciliation of cash provided by operating activities:
Net cash provided by operating activities		$	18,048			$	28,674			$	73,425			$	81,121
Less: Purchases of property and equipment			(4,324	)			(5,177	)			(17,592	)			(10,601	)
Less: Capitalized software development costs			(4,868	)			(3,962	)			(20,936	)			(17,687	)
Free cash flow		$	8,856			$	19,535			$	34,897			$	52,833

¹ Net income, Adjusted EBITDA, and Non-GAAP net income for the twelve months ended December 31, 2024 include other income of $4.0 million related to our efforts to build and test integrations with the Google Privacy Sandbox.

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¹ Net dollar-based retention is calculated by starting with the revenue from publishers in the trailing twelve months ended December 31, 2023 (“Prior Period Revenue”). We then calculate the revenue from these same publishers in the trailing twelve months ended December 31, 2024 (“Current Period Revenue”). Current Period Revenue includes any upsells and is net of contraction or attrition, but excludes revenue from new publishers. Our net dollar-based retention rate equals the Current Period Revenue divided by Prior Period Revenue. Net dollar-based retention rate is an important indicator of publisher satisfaction and usage of our platform, as well as potential revenue for future periods.
² Fiscal year 2023 GAAP net income includes approximately $5.7 million of incremental bad debt expense related to the bankruptcy of a Demand Side Platform buyer of our platform.
³ Omnichannel video spans across desktop, mobile and CTV devices.

Investors:
The Blueshirt Group for PubMatic
[email protected]

Press Contact:
Broadsheet Communications for PubMatic
[email protected]

Promising preliminary Phase 2b (ASCEND) pancreatic cancer data (Cohort A) reported with Cohort B data anticipated in the coming months

Enrollment completed in Qilu’s Phase 2 trial evaluating certepetide for the treatment of first-line mPDAC

Advancing development portfolio with multiple milestones projected over the next 12+ months

Cash runway extending into the second quarter of 2026 with no debt

Conference call scheduled for today at 4:30 p.m. Eastern Time

BASKING RIDGE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) — Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provides a business update and reports financial results for the twelve months ended December 31, 2024.

“Throughout 2024 and now into early 2025, we continue to advance our development portfolio centered around our novel product candidate, certepetide,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “Following the encouraging preliminary results from the ASCEND and iLSTA trials reported at this year’s ASCO-GI Symposium, we remain committed to exploring the broad application of certepetide’s unique mechanism of action. Our development portfolio encompasses multiple clinical and preclinical trials evaluating certepetide for the treatment of various solid tumors, including pancreatic cancer, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer, and melanoma. In addition, we are exploring certepetide’s versatility in non-cancerous settings such as endometriosis. For Lisata, we expect 2025 to be a data-rich year and we look forward to sharing key developments as they become available.”

Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents

Certepetide (formerly LSTA1) is an internalizing RGD, or iRGD, (arginylglycylaspartic acid) cyclic peptide designed to selectively activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care (SoC) chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing or planned clinical studies being conducted globally across several solid tumor types in combination with a variety of anti-cancer regimens, including:

• ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial is being conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, is expected in the coming months with a final analysis of both cohorts available thereafter. The exact timing is dependent on accumulating the requisite number of endpoint events in Cohort B and is not something that can be accurately predicted.
• BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort has been added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort, with enrollment completion targeted for later this year.
• CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. CENDIFOX data are expected in the coming months; however, given this is an investigator-initiated study, the exact timing is not in Lisata’s control. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.
• Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in the coming months.
• iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., is evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. An interim analysis of the iLSTA trial, presented at the 2025 ASCO GI Symposium, showed preliminary results from the first 17 of the 30 targeted patients, corroborating preclinical data that certepetide enhances the effectiveness of immunotherapy. With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025.
• A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is targeted for the second half of 2025.
• FORTIFIDE: Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study in the U.S. evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with SoC in subjects with first-line mPDAC. As part of this study, Lisata has engaged Haystack Oncology to use its MRD™ technology to measure circulating tumor DNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. The Company expects to enroll the first patient in the study in the first half of 2025. However, in parallel, management is investigating a potentially faster and more cost-effective approach to achieving the study objective, which may become the preferred strategy.

Lisata has entered into multiple research collaborations, including a sponsored research agreement with the University of Cincinnati to assess certepetide in combination with bevacizumab (a VEGF inhibitor) in a preclinical murine model for the treatment of endometriosis. Lisata is also partnering with Valo Therapeutics (ValoTx) to investigate the benefits of combining certepetide with ValoTx’s platform technology, PeptiCRAd, an oncolytic virus, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.

In November 2024, Lisata entered into an Exclusive License and Collaboration Agreement with Kuva Labs, Inc. (“Kuva”), in which Lisata granted Kuva an exclusive license to explore the synergistic potential of certepetide as a targeting and delivery agent for Kuva’s NanoMark™ imaging technology in solid tumors. Under the agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while Lisata will be responsible for supplying certepetide pursuant to a Clinical Supply Agreement. As consideration for the license, the Company is to receive a $1.0 million upfront license fee and is eligible for certain development and commercial milestone payments of up to $19.0 million, as well as a single-digit percentage royalty on net sales.

Full Year 2024 Financial Highlights

For the year ended December 31, 2024, revenue totaled $1.0 million in connection with an upfront license fee related to the Exclusive License and Collaboration Agreement with Kuva Labs, Inc. The Company did not have any revenue for the year ended December 31, 2023.

For the year ended December 31, 2024, operating expenses totaled $23.4 million compared to $25.7 million for the year ended December 31, 2023, representing a decrease of $2.3 million or 8.9%.

Research and development expenses were approximately $11.3 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023, representing a decrease of approximately $1.4 million, or 11.0%. This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year, lower spend on chemistry, manufacturing and controls, and lower equity expense.

General and administrative expenses were approximately $12.1 million for the year ended December 31, 2024, compared to $13.0 for the year ended December 31, 2023, representing a decrease of approximately $0.9 million or 6.9%. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expenses, a decrease in directors’ and officers’ insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement related costs and an increase in consulting expenses.

Overall, net losses were $20.0 million and $20.8 million for the years ended December 31, 2024 and 2023, respectively.

Balance Sheet Highlights

As of December 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $31.2 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the second quarter of 2026.

Net Operating Loss Sale

Earlier this year Lisata received $0.9 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by the New Jersey Economic Development Authority (NJEDA). The Program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations with a lifetime cap on the tax benefit sales of $20.0 million. To date, under the Program, the Company has sold $19.6 million in tax benefits for net proceeds of $18.4 million.

Conference Call Information

Lisata will hold a live conference call today, February 27, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update, and answer questions.

Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, the Company encourages participants to dial into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the second quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.

Forward-Looking Statements

This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.

Lisata Therapeutics Contact:

Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: [email protected]

Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: [email protected]

– Tables to follow –

Lisata Therapeutics, Inc.
Selected Financial Data
(in thousands, except per share data)
	Year Ended December 31,
		2024				2023
(in thousands, except per share data)
Statement of Operations Data:
Revenue	$	1,000			$	–
Research and development		11,334				12,734
General and administrative		12,075				12,974
Total operating expenses		23,409				25,708
Operating loss		(22,409	)			(25,708	)
Investment income, net		1,883				2,724
Other expense, net		(257	)			(186	)
Net loss before benefit from income taxes and noncontrolling interests		(20,783	)			(23,170	)
Benefit from income taxes		(798	)			(2,330	)
Net loss		(19,985	)			(20,840	)
Less – net income (loss) attributable to noncontrolling interests		–				–
Net loss attributable to Lisata Therapeutics, Inc. common stockholders	$	(19,985	)		$	(20,840	)
Basic and diluted loss per share attributable to Lisata Therapeutics, Inc. common stockholders	$	(2.40	)		$	(2.58	)
Weighted average common shares outstanding		8,329				8,073
	December 31, 2024				December 31, 2023
Balance Sheet Data:
Cash, cash equivalents and marketable securities	$	31,245			$	50,535
Total assets		35,002				54,694
Total liabilities		5,685				6,800
Total equity		29,317				47,894

This press release was published by a CLEAR® Verified individual.

Q4 2024 Net Income of $141 thousand and Adjusted EBITDA of $1.2 million

Inuvo management to host conference call today at 4:15 PM ET

LITTLE ROCK, Ark., Feb. 27, 2025 (GLOBE NEWSWIRE) — Inuvo, Inc. (NYSE American: INUV), a leading provider of artificial intelligence AdTech solutions, today provided a business update and announced its financial results for the fourth quarter and full year ended December 31, 2024.

Fourth Quarter 2024 Financial Highlights:

• Revenue was a record $26.2 million, a 26% increase compared to $20.8 million in Q4 2023
• Gross profit increased 20% to $21.8 million, compared to $18.2 million in Q4 2023
• Net income was $141 thousand, compared to net loss of $2.4 million for Q4 2023
• Adjusted EBITDA was $1.2 million, compared to a loss of $1.2 million for Q4 2023

Full Year 2024 Financial Highlights:

• Revenue increased 13% to $83.8 million, compared to $73.9 million in 2023
• Gross profit increased 13% to $71.8 million, compared to $63.4 million in 2023
• Net loss decreased by 45% to a loss of $5.8 million, compared to a net loss of $10.4 million in 2023
• Adjusted EBITDA loss improved sixfold to $816,000 compared to $5.3 million in 2023
• $230,000 in Net Cash from Operating activities was generated in 2024

2024 Operational Highlights:

• Secured a Master Services Agreement with one of the largest retailers in the world
• Signed 33 new agencies/brands and one new platform during the year
• Secured a $10.0 million credit line in July
• Launched enhancements to the IntentKey Self-Serve Platform, an advanced AI agent specifically designed for audience modeling

Richard Howe, CEO of Inuvo, stated, “Q4 2024 was a record-breaking quarter, delivering 26% year-over-year growth and generating $26.2 million in revenue—our largest quarter ever. This strong performance contributed to a 13% revenue increase for the full fiscal year. Over the past 18 quarters, we have sustained an approximately 7% compounded quarterly growth rate. This year, all our key financial metrics had strong year-over-year improvements. Notably, in Q4, we achieved positive net income and adjusted EBITDA.”

Mr. Howe continued, “We made a number of significant technological advancements in 2024, most notably the enhancements to the IntentKey Self-Serve Platform. This groundbreaking innovation democratizes advertising by allowing anyone of any caliber to describe and then immediately execute targeting, giving the AI nothing other than some simple audience descriptions.”

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2024

Net revenue for the fourth quarter of 2024 totaled $26.2 million, compared to $20.8 million for the same period last year, a 26% year-over-year increase. The higher revenue was due to increasing demand within both Platforms and Agencies & Brands. Net revenue for the year ended December 31, 2024 totaled $83.8 million, compared to $73.9 million during the same period in 2023, a 13% year-over-year increase.

Cost of revenue for the fourth quarter of 2024, totaled $4.4 million compared to $2.6 million for the same period last year. Cost of revenue for the full year ended December 31, 2024, totaled $12.0 million, as compared to $10.5 million for the same period last year. The increase in the cost of revenue for the three months and full year ended December 31, 2024, as compared to the same period last year, was due to higher revenue within a Platform client this year.

Gross profit for the fourth quarter of 2024 and full year ended December 31, 2024 totaled $21.8 million and $71.8 million, respectively, as compared $18.2 million and $63.4 million, respectively, for the same periods last year. Gross profit margin for the fourth quarter of 2024 and the full year ended December 31, 2024 was approximately 83.1% and 85.6%, respectively, as compared to 87.3% and 85.8%, respectively, for the same periods last year.

Operating expenses for the fourth quarter of 2024 totaled $21.5 million, compared to $20.6 million for the same period last year. Operating expenses for the full year ended December 31, 2024 totaled $77.3 million, compared to $73.8 million for the same period last year. The higher operating expenses for the year ended December 31, 2024 was primarily driven by a 14.8% increase in Marketing costs compared to the same period in 2023. This increase was largely attributable to higher revenue from Platform advertisers.

Net interest expense/income for the fourth quarter of 2024 and the full year ended December 31, 2024 was approximately an expense of $103 thousand and an income of $267 thousand, respectively, compared to an income of approximately $8 thousand and an expense of $30 thousand for the same periods last year, respectively. The higher interest expense this year was due to increased borrowing from our line of credit.

Other expense/income for both the fourth quarter of 2024 and the full year ended December 31, 2024 was income of approximately $27 thousand, respectively, compared to income of approximately $0 and $15 thousand for the same periods last year, respectively. The income for this year was due to setup charges for new Platform partners. Last year’s income was due to unrealized and realized gains on trading securities.

Net income for the fourth quarter of 2024 was $141 thousand, or $0.00 per basic and diluted share, as compared to net loss of $2.4 million, or $0.02 per basic and diluted share, for the same period last year. Net loss for the full year ended December 31, 2024 totaled $5.8 million, or $0.04 per basic and diluted share, as compared to net loss of $10.4 million, or $0.08 per basic and diluted share, for the same period last year.

Adjusted EBITDA [see reconciliation table below] was approximately $1.2 million in the fourth quarter of 2024, compared to an Adjusted EBITDA loss of approximately $1.2 million for the same period last year. Adjusted EBITDA was a loss of approximately $816 thousand for the full year ended December 31, 2024, compared to a loss of approximately $5.3 million for the same period last year.

Liquidity and Capital Resources:

On December 31, 2024, Inuvo had $2.5 million in cash and cash equivalents, an unused working capital facility of $10.0 million and no debt.

As of February 21, 2025, Inuvo had 142,795,483 common shares issued and outstanding.

Conference Call Details: 

Date: Thursday, February 27, 2025
Time: 4:15 p.m. Eastern Standard Time 
Toll-free Dial-in Number: 1-800-717-1738
International Dial-in Number: 1-646-307-1865
Conference ID: 11158080
Webcast Link: HERE

A telephone replay will be available through Thursday, March 13, 2025. To access the replay, please dial 1- 844-512-2921 (domestic) or 1-412-317-6671 (international). At the system prompt, please enter the code 11158080 followed by the # sign. You will then be prompted for your name, company, and phone number. Playback will then automatically begin.

About Inuvo

Inuvo^®, Inc. (NYSE American: INUV) is a market leader in Artificial Intelligence built for advertising. Its IntentKey AI solution is a first-of-its-kind proprietary and patented technology capable of identifying and actioning to the reasons why consumers are interested in products, services, or brands, not who those consumers are. To learn more, visitwww.inuvo.com.

Safe Harbor / Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, without limitation risks detailed from time to time in our filings with the Securities and Exchange Commission (the “SEC”), and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in Inuvo, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 as filed on February 27, 2025, and our other filings with the SEC. Inuvo cannot provide assurances that the assumptions upon which these forward-looking statements are based will prove to have been correct. Should one of these risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those expressed or implied in any forward-looking statements, and investors are cautioned not to place undue reliance on these forward-looking statements, which are current only as of this date. Inuvo does not intend to update or revise any forward-looking statements made herein or any other forward-looking statements as a result of new information, future events or otherwise. Inuvo further expressly disclaims any written or oral statements made by a third-party regarding the subject matter of this press release. The information which appears on our websites and our social media platforms is not part of this press release.

Inuvo Company Contact:

Wally Ruiz
Chief Financial Officer
Tel (501) 205-8397
[email protected]

Investor Relations:

David Waldman / Natalya Rudman
Crescendo Communications, LLC
Tel: (212) 671-1020
[email protected]

(tables follow)

INUVO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
	Three Months Ended								Twelve Months Ended
	December 31				December 31				December 31				December 31
		2024				2023				2024				2023
Net revenue	$	26,189,924			$	20,842,095			$	83,793,859			$	73,911,528
Cost of revenue		4,433,905				2,643,543				12,033,777				10,477,272
Gross profit		21,756,019				18,198,552				71,760,082				63,434,256
Operating expenses:		83.1	%			87.3	%			85.6	%			85.8	%
Marketing costs		17,122,706				15,212,600				59,663,061				51,982,572
Compensation		2,703,309				3,591,109				12,065,783				13,793,309
General and administrative		1,709,887				1,821,821				5,545,049				8,050,590
Total operating expenses		21,535,902				20,625,530				77,273,893				73,826,771
Operating income (loss)		220,117				(2,426,978	)			(5,513,811	)			(10,392,515	)
Interest expense (income), net		102,910				(7,884	)			266,772				29,570
Other income		26,812				–				26,812				14,668
Income tax expense (benefit)		2,678				(17,764	)			8,030				(17,764	)
Net income (loss)		141,341				(2,401,330	)			(5,761,801	)			(10,389,653	)
Other comprehensive income:
Unrealized loss on marketable securities		–				–				–				84,868
Comprehensive income (loss)	$	141,341			$	(2,401,330	)		$	(5,761,801	)		$	(10,304,785	)
Net loss per share, basic and diluted	$0.00				($0.02		)		($0.04		)		($0.08		)
Weighted average shares outstanding:
Basic		140,494,192				127,381,051				139,968,374				131,116,370
Diluted		140,494,192				127,381,051				139,968,374				131,116,370

INUVO, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
	December 31				December 31
	2024				2023
Assets
Cash and cash equivalent	$	2,459,245			$	4,440,454
Accounts receivable, net		12,545,771				9,226,956
Prepaid expenses and other current assets		639,805				1,076,121
Total current assets		15,644,821				14,743,531
Property and equipment, net		1,792,903				1,680,788
Goodwill		9,853,342				9,853,342
Intangible assets, net of accumulated amortization		3,897,875				4,664,791
Other assets		1,006,990				1,431,692
Total assets	$	32,195,931			$	32,374,144
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	8,422,351			$	6,432,120
Accrued expenses and other current liabilities		9,463,537				8,100,354
Total current liabilities		17,885,888				14,532,474
Long-term liabilities		835,271				859,484
Total stockholders’ equity		13,474,772				16,982,186
Total liabilities and stockholders’ equity	$	32,195,931			$	32,374,144

RECONCILIATION OF LOSS FROM CONTINUING OPERATIONS BEFORE TAXES TO ADJUSTED EBITDA
(unaudited)
	Three Months Ended								Twelve Months Ended
		December 31			December 31				December 31				December 31
		2024				2023				2024				2023
Net income (loss)		141,341				(2,401,330	)		$	(5,761,801	)		$	(10,389,653	)
Interest expense (income), net		102,910				(7,884	)			266,772				29,570
Income tax expense (benefit)		2,678				(17,764	)			8,030				(17,764	)
Depreciation and amortization on PP&E		446,608				425,106				1,745,261				1,670,868
Amortization		123,412				264,523				824,272				1,080,690
EBITDA		816,949				(1,737,349	)			(2,917,466	)			(7,626,289	)
Stock-based compensation		413,911				514,613				1,501,444				1,986,296
Non recurring items:
Unrealized loss on marketable securities														14,668
Doubtful account reserve														361,097
Impairment & amortization of services agreement										600,000
Adjusted EBITDA		1,230,860				(1,222,736	)			(816,022	)			(5,264,228	)

Reconciliation of Operating Loss to EBITDA and Adjusted EBITDA 

We present EBITDA and Adjusted EBITDA as a supplemental measure of our performance. We defined EBITDA as Net loss plus (i) interest expense, (ii) income tax expense, (iii) depreciation, and (iv) amortization. We further define Adjusted EBITDA as EBITDA plus (v) stock-based compensation and (vi) certain identified expenses that are not expected to recur or be representative of future ongoing operation of the business. These adjustments are itemized above. You are encouraged to evaluate these adjustments and the reasons we consider them appropriate for supplemental analysis. In evaluating EBITDA and Adjusted EBITDA, you should be aware that in the future we may incur expenses that are the same or similar to some of the adjustments in the presentation. Our presentation of EBITDA and Adjusted EBITDA should not be construed as an inference that our future results will be unaffected by unusual or non-recurring items.

Commercial Preparations On-Track Ahead of September 25, 2025 PDUFA Date Including Regulatory Review Process, Organizational Build, and Key Stakeholder Engagement Efforts

Expecting to Initiate Four Late-Stage Trials and Additional Early-Stage Trials from Development Pipeline in 2025

Strong Financial Position with $1.4B Cash with Runway into 2029

Management Hosting Conference Call at 4:30 p.m. ET Today

SAN DIEGO, Feb. 27, 2025 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the fourth quarter and full year ended December 31, 2024.

“2024 was a year of significant progress and execution across all fronts,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “The acceptance of our NDA for paltusotine in acromegaly was a key achievement, and under the leadership of our new chief commercial officer, Isabel Kalofonos, our commercial team is preparing for the expected launch, which will be a truly significant milestone for the company. Our ongoing clinical programs continue to yield promising results, paving the way to initiate four late-stage trials this year. We’re also advancing four new candidates toward IND filing, underscoring the power of our internal research and development engine. Our balance sheet empowers us to execute our strategic vision over the next several years, and we are excited to bring on board a new chief financial officer, Toby Schilke, to provide financial leadership during this next stage of growth. Building on the strong foundation we’ve established, 2025 is positioned to be a transformative year for Crinetics.”

Full Year 2024 and Recent Highlights:

• Strengthened leadership team with key appointments across finance, commercial, medical and clinical development to strengthen organization ahead of launch. In February 2025, Crinetics appointed Tobin “Toby” Schilke as Chief Financial Officer. In December 2024, Crinetics appointed Isabel Kalofonos as Chief Commercial Officer. In April 2024, Crinetics appointed Lise Kjems, M.D., Ph.D. as Senior Vice President of Endocrinology Clinical Research, and in October 2024, appointed Bin Zhang, M.D., M.Sc. as Senior Vice President of Oncology Clinical Development. In May 2024, Crinetics appointed Robert M. Cuddihy, M.D., as Senior Vice President of Medical Affairs.
• New Drug Application (NDA) for paltusotine for the treatment of acromegaly filed and accepted for review by U.S. Food and Drug Administration (FDA). This submission was based on positive topline results from the PATHFNDR-1 trial reported in September 2023 and from the PATHFNDR-2 trial reported in March 2024.
• European Medicines Agency
  (EMA) granted paltusotine Orphan Drug Designation (ODD) for the treatment of acromegaly. Designation was given following a positive recommendation from the EMA Committee for Orphan Medicinal Products, highlighting the potential impact of paltusotine for acromegaly patients in the EU.
• Phase 2 open-label study of paltusotine in carcinoid syndrome reported positive results. In March 2024, Crinetics reported positive topline results; paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
• Phase 2 TouCAHn open-label study of atumelnant in congenital adrenal hyperplasia (CAH) reported positive results. In January 2025, Crinetics reported positive topline results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in A4 levels, the key biomarker for disease control. Atumelnant was well-tolerated and treatment with atumelnant was associated with significant clinical improvements.  
• Debut of novel Nonpeptide Drug Conjugate (NDC) platform. Presented data from CRN09682 at the North American Neuroendocrine Tumor Society (NANETS) Annual Meeting in November 2024.
• Development candidates nominated in multiple programs. Crinetics has identified an oral thyroid stimulating hormone (TSH) receptor antagonist development candidate for the potential treatment of Graves’ disease, including hyperthyroidism and thyroid eye disease (TED); an oral parathyroid hormone (PTH) antagonist development candidate for the treatment of hyperparathyroidism; and an SST3 agonist development candidate for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
• Strengthened balance sheet. Current cash position of $1.4B is expected to support our business activities into 2029.

Key Upcoming Milestones:

• FDA Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025 for paltusotine NDA for the treatment and maintenance therapy of acromegaly.
• Enrollment of the first patient in the pivotal Phase 3 trial of paltusotine in carcinoid syndrome is anticipated in the second quarter of 2025.
• Crinetics expects to begin enrollment of patients in two pivotal studies of atumelnant in CAH: Phase 3 in adults and Phase 2b/3 in pediatrics.
• Crinetics is also planning a study of atumelnant in Cushing’s disease. Enrollment of patients is expected to begin in late 2025 or early 2026.
• Four novel IND filings expected in 2025 for the development candidates nominated in 2024.

Fourth Quarter and Full Year 2024 Financial Results:

• Research and development expenses were $66.6 million and $240.2 million for the three months and full year ended December 31, 2024, compared to $45.6 million and $168.5 million for the same periods in 2023. The increases were primarily attributable to an increase in personnel costs of $12.6 million for the quarter ended December 31, 2024 and $43.4 million for the year ended December 31, 2024, and increased clinical and preclinical development activities of $5.1 million and $10.2 million for the quarter and year ended December 31, 2024, respectively.
• General and administrative expenses were $28.2 million and $99.7 million for the three months and full year months ended December 31, 2024, compared to $17.1 million and $58.1 million for the same periods in 2023. The increases were primarily driven by an increase in personnel costs of $5.4 million for the quarter ended December 31, 2024 and $23.8 million for the year ended December 31, 2024.
• Net loss for the three months ended December 31, 2024, was $80.6 million, compared to a net loss of $60.1 million for the same period in 2023. For the year ended December 31, 2024, the company’s net loss was $298.4 million compared to a net loss of $214.5 million for the year ended December 31, 2023.
• There were no revenues for the three months ended December 31, 2024 or 2023. Revenues were $1.0 million for the full year ended December 31, 2024, compared to $4.0 million for the same period in 2023. Revenues for 2024 were primarily derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. License revenues for 2023 were derived from licensing agreements with Sanwa Kagaku Kenkyusho Co., Ltd. and Cellular Longevity, Inc.
• Cash, cash equivalents, and investments totaled $1.4 billion as of December 31, 2024, compared to $558.6 million as of December 31, 2023. This includes gross proceeds of $350 million from the February 2024 private placement equity financing and $575 million from the October 2024 public offering. Based on current projections, Crinetics expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2029. For 2025, we anticipate our cash used in operations to be between $340 and $380 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, February 27 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ4. To access the webcast, the direct link (HERE) or visit the Events section of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

About Crinetics Pharmaceuticals  
Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Atumelnant is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. All of the company’s drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the expected timing of the PDUFA target action date for our NDA submission to the FDA for paltusotine for the treatment or maintenance of treatment of acromegaly in the United States, and the plans and timelines for the commercial launch paltusotine if approved; the expected timing of initiation of a Phase 3 program of paltusotine for carcinoid syndrome and FDA consultation; the expected timing of enrollment in two additional studies of atumelnant in CAH; the potential for and expected timing of further studies in Cushing’s disease; the therapeutic potential for our development candidates; the expected timing for IND-enabling studies and potential IND-filings in our development candidates to transition to clinical development; the expected timing of additional research pipeline updates; and the expected timing through which our cash, cash equivalents, and short-term investments will fund our operating plans. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

CRINETICS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA (In thousands, except per share data) (Unaudited)
	Three months ended December 31,								Twelve months ended December 31,
STATEMENTS OF OPERATIONS DATA:	2024				2023				2024				2023
Revenues	$	—			$	—			$	1,039			$	4,013
Operating expenses:
Research and development		66,566				45,580				240,156				168,527
General and administrative		28,179				17,078				99,737				58,094
Total operating expenses		94,745				62,658				339,893				226,621
Loss from operations		(94,745	)			(62,658	)			(338,854	)			(222,608	)
Total other income, net		14,150				6,762				40,916				13,277
Loss before equity method investment		(80,595	)			(55,896	)			(297,938	)			(209,331	)
Loss on equity method investment		—				(4,201	)			(470	)			(5,198	)
Net loss	$	(80,595	)		$	(60,097	)		$	(298,408	)		$	(214,529	)
Net loss per share – basic and diluted	$	(0.88	)		$	(0.90	)		$	(3.69	)		$	(3.69	)
Weighted-average shares – basic and diluted		91,494				67,146				80,783				58,071

BALANCE SHEET DATA:	December 31, 2024				December 31, 2023
Cash, cash equivalents and investments	$	1,354,069			$	558,555
Working capital	$	1,315,704			$	530,211
Total assets	$	1,434,592			$	635,353
Total liabilities	$	109,787			$	96,247
Accumulated deficit	$	(952,110	)		$	(653,702	)
Total stockholders’ equity	$	1,324,805			$	539,106

Investors:

Gayathri Diwakar
Head of Investor Relations
[email protected]
(858) 345-6340

Media:

Natalie Badillo
Head of Corporate Communications
[email protected]
(858) 345-6075

CANTON, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) — Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today reported financial results for the fourth quarter and the year ended December 31, 2024.

Fourth Quarter 2024 Financial Results Summary:

• Net revenue of $126.7 million for the fourth quarter of 2024, an increase of $27.0 million compared to net revenue of $99.7 million for the fourth quarter of 2023. Net revenue for the fourth quarter of 2024 consists of:
  • Net revenue from Advanced Wound Care products of $118.6 million, an increase of 27% from the fourth quarter of 2023.
  • Net revenue from Surgical & Sports Medicine products of $8.1 million, an increase of 24% from the fourth quarter of 2023.
• Net income of $7.7 million for the fourth quarter of 2024, compared to net loss of $0.6 million for the fourth quarter of 2023, an increase in net income of $8.3 million.
• Adjusted EBITDA of $18.2 million for the fourth quarter of 2024, compared to Adjusted EBITDA of $7.5 million for the fourth quarter of 2023, an increase of $10.7 million.
• Adjusted net income of $8.8 million for the fourth quarter of 2024, compared to adjusted net income of $1.9 million for the fourth quarter of 2023, an increase of $6.8 million.

Fiscal Year 2024 Financial Results Summary:

• Net revenue of $482.0 million for the year ended December 31, 2024, an increase of $48.9 million compared to net revenue of $433.1 million for the year ended December 31, 2023. Net revenue for the year ended December 31, 2024 consists of:
  • Net revenue from Advanced Wound Care products of $453.6 million, an increase of 12% year over year.
  • Net revenue from Surgical & Sports Medicine products of $28.4 million, an increase of 3% year over year.
• Net income of $0.9 million for the year ended December 31, 2024, compared to net income of $4.9 million for the year ended December 31, 2023, a decrease of $4.0 million.
• Adjusted EBITDA of $49.8 million for the year ended December 31, 2024, compared to Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, an increase of $7.2 million.
• Adjusted net income of $20.5 million for the year ended December 31, 2024, compared to adjusted net income of $12.7 million for the year ended December 31, 2023, an increase of $7.8 million.

“Our 2024 results exceeded expectations in a difficult environment, underscoring our strong execution, brand equity and the trust of our customers to help them navigate this complex market,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. “In 2025, we will continue to focus on our customers while we collaborate with policy and law makers to craft a solution that addresses spending while ensuring access to safe and effective therapies for all patients.”

Mr. Gillheeney, Sr. continued: “We expect to meet a key strategic milestone in 2025 by delivering the ReNu BLA submission by the end of the year. We believe this is a transformational opportunity for Organogenesis in that, if approved, ReNu will potentially address an unmet clinical need for all patients suffering from knee OA. ”

Fourth Quarter 2024 Financial Results:

	Three Months Ended December 31,								Change
	2024				2023				$				%
	(in thousands, except for percentages)
Advanced Wound Care	$	118,585			$	93,165			$	25,420				27	%
Surgical & Sports Medicine		8,071				6,486				1,585				24	%
Net revenue	$	126,656			$	99,651			$	27,005				27	%

Net revenue for the fourth quarter of 2024 was $126.7 million, compared to $99.7 million for the fourth quarter of 2023, an increase of $27.0 million, or 27%. The increase in net revenue was driven by an increase of $25.4 million, or 27%, in net revenue for Advanced Wound Care products, and an increase of $1.6 million, or 24%, in net revenue for Surgical & Sports Medicine products.

Gross profit for the fourth quarter of 2024 was $95.6 million, or 75% of net revenue, compared to $71.9 million, or 72% of net revenue for the fourth quarter of 2023, an increase of $23.7 million, or 33%.

Operating expenses for the fourth quarter of 2024 were $85.4 million compared to $73.2 million for the fourth quarter of 2023, an increase of $12.2 million, or 17%. R&D expense was $11.5 million for the fourth quarter of 2024, compared to $11.8 million for the fourth quarter of 2023, a decrease of $0.3 million, or 3%. Selling, general and administrative expenses were $73.9 million for the fourth quarter of 2024, compared to $61.4 million for the fourth quarter of 2023, an increase of $12.5 million, or 20%.

Operating income for the fourth quarter of 2024 was $10.2 million, compared to an operating loss of $1.3 million for the fourth quarter of 2023, an increase in operating income of $11.5 million, or 905%.

Total other expense, net, for the fourth quarter of 2024 was less than $0.1 million, compared to $0.5 million for the fourth quarter of 2023, a decrease of $0.5 million, or 95%.

Net income for the fourth quarter of 2024 was $7.7 million, or $0.05 per share, compared to a net loss of $0.6 million, or $0.00 per share, for the fourth quarter of 2023, an increase in net income of $8.3 million, or $0.05 per share.

Adjusted EBITDA was $18.2 million for the fourth quarter of 2024, compared to $7.5 million for the fourth quarter of 2023, an increase of $10.7 million, or 143%.

Adjusted net income was $8.8 million for the fourth quarter of 2024, compared to $1.9 million for the fourth quarter of 2023, an increase of $6.8 million, or 354%.

As of December 31, 2024, the Company had $136.2 million in cash, cash equivalents and restricted cash and no outstanding debt obligations, compared to $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in net debt obligations as of December 31, 2023.

Fiscal Year 2024 Financial Results:

	Year Ended December 31,								Change
	2024				2023				$				%
	(in thousands, except for percentages)
Advanced Wound Care	$	453,639			$	405,514			$	48,125				12	%
Surgical & Sports Medicine		28,404				27,626				778				3	%
Net revenue	$	482,043			$	433,140			$	48,903				11	%

Net revenue for the year ended December 31, 2024 was $482.0 million, compared to $433.1 million for the year ended December 31, 2023, an increase of $48.9 million, or 11%. The increase in net revenue was driven by an increase of $48.1 million, or 12%, in net revenue for Advanced Wound Care products and an increase of $0.8 million, or 3%, in net revenue for Surgical & Sports Medicine products.

Gross profit for the year ended December 31, 2024 was $366.3 million, or 76% of net revenue, compared to $326.7 million, or 75% of net revenue for the year ended December 31, 2023, an increase of $39.6 million, or 12%.

Operating expenses for the year ended December 31, 2024 were $367.6 million compared to $314.1 million for the year ended December 31, 2023, an increase of $53.5 million or 17%. R&D expense was $50.3 million for the year ended December 31, 2024, compared to $44.4 million for the year ended December 31, 2023, an increase of $5.9 million, or 13%. Selling, general and administrative expenses were $294.5 million for the year ended December 31, 2024, compared to $269.8 million for the year ended December 31, 2023, an increase of $24.8 million, or 9%. For the year ended December 31, 2024, the Company recorded impairment and write down expenses of $18.8 million and $4.0 million, respectively.

Operating loss for the year ended December 31, 2024 was $1.3 million, compared to operating income of $12.5 million for the year ended December 31, 2023, a decrease in operating income of $13.8 million, or 110%.

Total other expense, net, for the year ended December 31, 2024, was $1.5 million, compared to $2.1 million for the year ended December 31, 2023, a decrease of $0.6 million, or 29%.

Net income for the year ended December 31, 2024 was $0.9 million, or $(0.01) per share, compared to net income of $4.9 million or $0.04 per share, for the year ended December 31, 2023, a decrease in net income of $4.0 million, or $(0.05) per share.

Adjusted EBITDA was $49.8 million for the year ended December 31, 2024, compared to $42.6 million for the year ended December 31, 2023, an increase of $7.2 million, or 17%.

Adjusted net income was $20.5 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023, an increase in adjusted net income of $7.8 million, or 61%.

As of December 31, 2024, the Company had $136.2 million in cash, cash equivalents and restricted cash and no outstanding debt obligations, compared to $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in net debt obligations as of December 31, 2023.

Fiscal Year 2025 Guidance:

For the year ending December 31, 2025, the Company expects:

• Net revenue between $480.0 million and $535.0 million, representing a range of roughly flat to an increase of approximately 11% year-over-year, as compared to net revenue of $482.0 million for the year ended December 31, 2024.
  • The 2025 net revenue guidance range assumes:
    • Net revenue from Advanced Wound Care products between $450.0 million and $500.0 million, a decrease of 1% to an increase of 10% year-over-year as compared to net revenue of $453.6 million for the year ended December 31, 2024.
    • Net revenue from Surgical & Sports Medicine products between $30.0 million and $35.0 million, an increase of 6% to 23% year-over-year as compared to net revenue of $28.4 million for the year ended December 31, 2024.
• Net income between $9.5 million and $38.8 million and adjusted net income between $15.3 million and $44.6 million.
• EBITDA between $27.0 million and $66.6 million and Adjusted EBITDA between $43.6 million and $83.2 million.

Fourth Quarter Earnings Conference Call:

Management will host a conference call at 5:00 p.m. Eastern Time today to discuss the results of the quarter and fiscal year, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year.

ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data)
	December 31,
	2024				2023
Assets
Current assets:
Cash and cash equivalents	$	135,571			$	103,840
Restricted cash		580				498
Accounts receivable, net of allowance for credit losses of $9,576 and $6,860		109,861				81,999
Inventories, net		26,219				28,253
Prepaid expenses and other current assets		13,710				10,454
Total current assets		285,941				225,044
Property and equipment, net		89,128				116,228
Intangible assets, net		12,468				15,871
Goodwill		28,772				28,772
Operating lease right-of-use assets, net		37,110				40,118
Deferred tax asset, net		39,462				28,002
Other assets		5,005				5,990
Total assets	$	497,886			$	460,025
Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity
Current liabilities:
Current portion of term loan	$	—			$	5,486
Current portion of finance lease obligations		1,170				1,081
Current portion of operating lease obligations – related party		3,671				8,413
Current portion of operating lease obligations		4,272				4,731
Accounts payable		28,911				30,724
Accrued expenses and other current liabilities		39,453				30,074
Total current liabilities		77,477				80,509
Term loan, net of current portion		—				60,745
Finance lease obligations, net of current portion		718				1,888
Operating lease obligations, net of current portion – related party		8,283				11,954
Operating lease obligations, net of current portion		25,198				25,053
Other liabilities		894				1,213
Total liabilities		112,570				181,362
Commitments and contingencies (Note 20)
Series A redeemable convertible preferred stock, $0.0001 par value; 130,000 and 0 shares authorized, issued and outstanding at December 31, 2024 and 2023, respectively; liquidation preference of $131,387 and $0 at December 31, 2024 and 2023, respectively.		122,419				—
Stockholders’ equity:
Preferred stock, $0.0001 par value; 870,000 and 1,000,000 shares authorized at December 31, 2024 and 2023, respectively; none issued or outstanding		—				—
Common stock, $0.0001 par value; 400,000,000 shares authorized; 126,458,784 and 132,044,944 shares issued; 125,730,236 and 131,316,396 shares outstanding at December 31, 2024 and 2023, respectively		13				13
Additional paid-in capital		302,994				319,621
Accumulated deficit		(40,110	)			(40,971	)
Total stockholders’ equity		262,897				278,663
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity	$	497,886			$	460,025

ORGANOGENESIS HOLDINGS INC. UNAUDITED  CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)  (amounts in thousands, except share and per share data)
	Three Months Ended December 31,								Year Ended December 31,
	2024				2023				2024				2023
Net revenue	$	126,656			$	99,651			$	482,043			$	433,140
Cost of goods sold		31,051				27,769				115,741				106,481
Gross profit		95,605				71,882				366,302				326,659
Operating expenses:
Selling, general and administrative		73,856				61,381				294,513				269,754
Research and development		11,530				11,770				50,271				44,380
Impairment of property and construction		—				—				18,842				—
Write down of capitalized internal-use software costs		—				—				3,959				—
Total operating expenses		85,386				73,151				367,585				314,134
Income (loss) from operations		10,219				(1,269	)			(1,283	)			12,525
Other expense, net:
Interest expense, net		61				(502	)			(1,544	)			(2,190	)
Other income (expense), net		(27	)			(25	)			20				57
Total other income (expense), net		34				(527	)			(1,524	)			(2,133	)
Net income (loss) before income taxes		10,253				(1,796	)			(2,807	)			10,392
Income tax (expense) benefit		(2,580	)			1,228				3,668				(5,447	)
Net income (loss) and comprehensive income (loss)	$	7,673			$	(568	)		$	861			$	4,945
Accretion of redeemable convertible preferred stock to redemption value		(412	)			—				(412	)			—
Cumulative dividend on redeemable convertible preferred stock		(1,386	)			—				(1,386	)			—
Net income (loss) attributable to common stockholders		5,875				(568	)			(937	)			4,945
Net income (loss), per share:
Basic	$	0.05			$	0.00			$	(0.01	)		$	0.04
Diluted	$	0.04			$	0.00			$	(0.01	)		$	0.04
Weighted-average common shares outstanding
Basic		129,679,843				130,916,950				131,673,278				131,231,317
Diluted		132,162,370				131,857,509				131,673,278				132,746,727

ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS (amounts in thousands, except share and per share data)
	Year Ended December 31,
	2024				2023				2022
Cash flows from operating activities:
Net income	$	861			$	4,945			$	15,532
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		13,623				10,448				5,845
Amortization of intangible assets		3,403				4,918				4,883
Reduction in the carrying value of right-of-use assets		8,348				8,083				7,303
Non-cash interest expense		394				427				434
Deferred interest expense		305				490				501
Deferred tax expense (benefit)		(10,719	)			2,012				1,980
Loss on disposal of property and equipment		1,140				235				4,482
Loss on lease termination		—				559				—
Loss on extinguishment of term loan		215				—				—
Provision recorded for credit losses		3,938				1,297				1,781
Adjustment for excess and obsolete inventories		8,210				6,580				9,648
Stock-based compensation		10,578				8,996				6,552
Impairment of property and construction (Note 8)		18,842				—				—
Write down of capitalized internal-use software costs (Note 8)		3,959				—				—
Changes in operating assets and liabilities:
Accounts receivable		(31,800	)			5,539				(8,770	)
Inventories		(6,204	)			(8,179	)			(9,410	)
Prepaid expenses and other current and other assets		(2,549	)			(10,115	)			(378	)
Operating leases		(14,066	)			(8,439	)			(7,006	)
Accounts payable		(2,372	)			(108	)			3,260
Accrued expenses and other current liabilities		9,164				3,138				(11,850	)
Other liabilities		(1,062	)			91				72
Net cash provided by operating activities		14,208				30,917				24,859
Cash flows from investing activities:
Purchases of property and equipment		(10,032	)			(24,364	)			(33,898	)
Net cash used in investing activities		(10,032	)			(24,364	)			(33,898	)
Cash flows from financing activities:
Term loan repayments under the 2021 Credit Agreement		(66,563	)			(4,688	)			(2,813	)
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs		120,688				—				—
Payments for the repurchase of common stock		(25,479	)			—				—
Principal repayments of finance lease obligations		(1,081	)			(485	)			(200	)
Proceeds from the exercise of stock options		1,247				—				2,070
Payments of withholding taxes in connection with RSUs vesting		(1,175	)			(332	)			(648	)
Payments of deferred acquisition consideration		—				—				(608	)
Net cash provided by (used in) financing activities		27,637				(5,505	)			(2,199	)
Change in cash, cash equivalents and restricted cash		31,813				1,048				(11,238	)
Cash, cash equivalents, and restricted cash, beginning of year		104,338				103,290				114,528
Cash, cash equivalents, and restricted cash, end of year	$	136,151			$	104,338			$	103,290
Supplemental disclosure of cash flow information:
Cash paid for interest	$	4,970			$	5,436			$	2,649
Cash paid for income taxes	$	6,965			$	3,052			$	1,201
Supplemental disclosure of non-cash investing and financing activities:
Cumulative effect adjustment for adoption of ASU No. 2016-13	$	—			$	615			$	—
Deferred acquisition consideration and earnout liability recorded for business acquisition	$	—			$	—			$	828
Change in purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities	$	(432	)		$	841			$	1,928
Right-of-use assets obtained through operating lease obligations	$	5,109			$	5,869			$	1,350
Right-of-use assets obtained through finance lease obligations	$	—			$	3,454			$	—
Redeemable convertible preferred stock issuance costs included in accrued expenses	$	67			$	—			$	—
Prepaid rent reclassified to right-of-use assets	$	230			$	—			$	—
Accretion to redemption value and cumulative dividends on redeemable convertible preferred stock	$	1,798			$	—			$	—

Non-GAAP Financial Measures

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA and Adjusted net income to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA and Adjusted net income help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA and Adjusted net income provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

Adjusted EBITDA

Adjusted EBITDA consists of GAAP net income excluding: (i) interest expense, net, (ii) income tax expense, (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, and (vi) additional infrequently occurring adjustments described in more detail below.

The following table presents a reconciliation of GAAP net income to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented:

	Three Months Ended December 31,								Year Ended December 31,
($, in thousands)	2024				2023				2024				2023
Net income (loss)	$	7,673			$	(568	)		$	861			$	4,945
Interest expense, net		(61	)			502				1,544				2,190
Income tax expense		2,580				(1,228	)			(3,668	)			5,447
Depreciation and amortization		3,615				2,982				13,623				10,448
Amortization of intangible assets		834				1,229				3,403				4,918
EBITDA		14,641				2,917				15,763				27,948
Stock-based compensation expense		2,891				2,366				10,578				8,996
Restructuring charge (1)		—				1,918				—				3,796
Legal fees (2)		—				—				—				1,182
Sales retention (3)		—				272				—				694
Impairment of property and construction (4)		—				—				18,842				—
Write down of capitalized internal-use software costs (5)		—				—				3,959				—
Disposal of construction in progress (6)		645				—				645				—
Adjusted EBITDA	$	18,177			$	7,473			$	49,787			$	42,616

(1)  Amounts reflect employee retention and benefits as well as other exit costs associated with our restructuring activities.

(2)  Amount reflects the legal and consulting fees incurred related to the published and subsequently withdrawn 2023 local coverage determinations, or LCDs.

(3)  Amount reflects the compensation expenses related to retention for those sales employees impacted by the published and subsequently withdrawn 2023 LCDs.

(4)  Amount reflects the impairment of a purchased building and associated unfinished construction work.

(5)  Amount reflects the write-down of costs previously capitalized as construction in progress in the development of internal-use software, that we determined have no future value.

(6)  Amount reflects construction in progress terminated and disposed of at one of our Canton, Massachusetts facilities, resulting from our decision to move certain operations to the Smithfield Facility.

Adjusted net income

Adjusted net income is defined as GAAP net income (loss) plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below, less the estimated tax on these adjustments.

The following table presents a reconciliation of GAAP net income (loss) to non-GAAP Adjusted net income, for the periods presented:

	Three Months Ended December 31,								Year Ended December 31,
($, in thousands)	2024				2023				2024				2023
Net income (loss)	$	7,673			$	(568	)		$	861			$	4,945
Amortization of intangible assets		834				1,229				3,403				4,918
Restructuring charge (1)		—				1,918				—				3,796
Legal fees (2)		—				—				—				1,182
Sales retention (3)		—				272				—				694
Impairment of property and construction (4)		—				—				18,842				—
Write down of capitalized internal-use software costs (5)		—				—				3,959				—
Disposal of construction in progress (6)		645				—				645				—
Tax on above		(399	)			(923	)			(7,249	)			(2,859	)
Adjusted net income	$	8,753			$	1,928			$	20,461			$	12,676

(1)  Amounts reflect employee retention and benefits as well as other exit costs associated with our restructuring activities.

(2)  Amount reflects the legal and consulting fees incurred related to the published and subsequently withdrawn 2023 LCDs.

(3)  Amount reflects the compensation expenses related to retention for those sales employees impacted by the published and subsequently withdrawn 2023 LCDs.

(4)  Amount reflects the impairment of a purchased building and associated unfinished construction work.

(5)  Amount reflects the write-down of costs previously capitalized as construction in progress in the development of internal-use software, that we determined have no future value.

(6)  Amount reflects construction in progress terminated and disposed of at one of our Canton, Massachusetts facilities, resulting from our decision to move certain operations to the Smithfield Facility.

Projected EBITDA and Adjusted EBITDA

The following table presents a reconciliation of projected GAAP net income (loss) to projected non-GAAP EBITDA and projected non-GAAP Adjusted EBITDA included in our guidance for the year ending December 31, 2025:

	Year Ended December 31,
($, in thousands)	2025L				2025H
Net income	$	9,500			$	38,800
Interest income		(4,000	)			(4,000	)
Income tax expense		3,400				13,600
Depreciation and amortization		14,800				14,800
Amortization of intangible assets		3,300				3,300
EBITDA		27,000				66,600
Stock-based compensation expense		12,000				12,000
BLA submission fee to the FDA		4,600				4,600
Adjusted EBITDA		43,600				83,200

Note: Numbers may not foot or recalculate due to rounding.

Projected Adjusted Net Income (Loss)

The following table presents a reconciliation of projected GAAP net loss to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2025:

	Year Ended December 31,
($, in thousands)	2025L				2025H
Net income	$	9,500			$	38,800
Amortization of intangible assets		3,300				3,300
BLA submission fee to the FDA		4,600				4,600
Tax on above		(2,100	)			(2,100	)
Adjusted net (loss) income	$	15,300			$	44,600

Note: Numbers may not foot or recalculate due to rounding.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, net income (loss), Adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2024 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for the Company’s products (including as a result of the recently proposed LCDs scheduled to take effect in April 2025); (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the current period and prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

About Organogenesis Holdings Inc.

Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.