Modivcare Reports First Quarter 2025 Financial Results
DENVER--(BUSINESS WIRE)--Modivcare Inc. (the 'Company' or 'Modivcare') (Nasdaq: MODV), a technology-enabled healthcare services company that provides a platform of integrated supportive care solutions focused on improving health outcomes, today reported financial results for the three months ended March 31, 2025.
"In Q1, we continued to advance our strategic objectives and operational initiatives,' said L. Heath Sampson, President and CEO. 'Company-wide alignment on key initiatives—securing new contracts, laying the groundwork for scalable automation, reducing G&A, strengthening our working-capital discipline, and progressing toward divestiture readiness—positions us to deliver enhanced performance and long-term value. We are making steady progress that reflects the team's focus on these priorities. We look forward to maintaining this positive momentum and building a stronger, more connected Modivcare."
First Quarter 2025 Summary:
Service revenue of $650.7 million, down 4.9% year-over-year
Net loss of $50.4 million, or negative $3.52 per diluted common share; adjusted net loss (1) of $24.5 million and adjusted loss per share (1) of $1.71 per diluted common share
Adjusted EBITDA (1) of $32.6 million, representing 5.0% of service revenue
$105.0 million in new financing executed in Q1 to support ongoing transformation efforts
Targeted cost reduction actions expected to generate greater than $20.0 million in annualized G&A savings
First Quarter 2025 Results
Revenue was $650.7 million, compared to $684.5 million in the prior-year period, primarily reflecting contract attrition in the NEMT segment and lower volumes in PCS and Monitoring. Net loss and Adjusted EBITDA (1) were $50.4 million and $32.6 million, compared to $22.3 million and $32.1 million in Q1 2024, respectively.
By segment:
NEMT revenue was $449.0 million, down 6.3% year-over-year, a 3.9% net income margin and a 6.2% Adjusted EBITDA margin (1) — up 50 basis points.
PCS revenue was $181.8 million, down 1.0%, with net income of $2.4 million and an Adjusted EBITDA (1) of $12.2 million — up 8.5% year-over-year.
Monitoring revenue was $18.1 million, down 9.8%, a 6.0% net loss margin and a 28.8% Adjusted EBITDA margin (1).
Net contract receivables increased to $108.5 million, up from $95.2 million last quarter, primarily due to higher utilization on shared risk contracts. Modivcare ended the quarter with $116.0 million in cash and remained fully drawn on its revolver. Operating cash flow was a use of $82.1 million and Free cash flow (2) was negative $86.2 million, reflecting working capital build and higher interest expense. The Company has taken targeted actions to accelerate collections and improve working capital efficiency.
Conference Call Information
Modivcare will host a conference call today, May 8, 2025, at 5:00 p.m. ET to discuss its financial results. Participants may access the call via:
A replay will be available on the Company's investor relations website following the conclusion of the call.
About Modivcare
Modivcare Inc. ("Modivcare" or the "Company") is a technology-enabled healthcare services company that provides a suite of integrated supportive care solutions for public and private payors and their members. Modivcare's value-based solutions address the social determinants of health (SDoH) by connecting members to essential care services. By doing so, Modivcare helps health plans manage risks, reduce costs, and improve health outcomes. Modivcare serves as a provider of non-emergency medical transportation (NEMT), personal care services (PCS), and in-home monitoring solutions (Monitoring). To learn more about Modivcare, please visit www.modivcare.com.
Non-GAAP Financial Measures and Adjustments
In addition to the financial measures prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP"), the information contained herein may include presentations for the Company and its segments (as noted and applicable) of: (1) EBITDA, Adjusted EBITDA, Adjusted G&A expense, Adjusted EBITDA margin, Adjusted Net Income (Loss), and Adjusted Earnings (Loss) Per Share, all of which are non-GAAP financial measures considered by management to be performance measures; and (2) free cash flow, which is a non-GAAP financial measure considered by management to be a liquidity measure. EBITDA is defined as net income (loss) before: (1) interest expense, net; (2) provision (benefit) for income taxes; and (3) depreciation and amortization. Adjusted EBITDA is calculated as EBITDA before (as applicable): (1) restructuring and related costs; (2) transaction and integration costs; (3) settlement related costs; (4) stock-based compensation; and (5) equity in net (income) loss of investee, net of tax. Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by service revenue, net. Adjusted Net Income (Loss) is calculated as net income (loss) before (as applicable): (1) restructuring and related costs; (2) transaction and integration costs; (3) settlement related costs; (4) stock-based compensation; (5) equity in net (income) loss of investee, net of tax; (6) intangible asset amortization expense; and (7) the income tax impact of such adjustments. Adjusted Earnings (Loss) Per Share is calculated as Adjusted Net Income (Loss) divided by the diluted weighted-average number of common shares outstanding as calculated for Adjusted Net Income (Loss). Adjusted G&A expense is calculated as G&A expense before (as applicable): (1) restructuring and related costs; (2) transaction and integration costs; (3) settlement related costs; and (4) stock-based compensation. Free cash flow is calculated as cash flow from operations less our applicable capital expenditures included in our purchase of property and equipment line in our Consolidated Statements of Cash Flows.
Reconciliations of the non-GAAP financial measures used herein to their most directly comparable GAAP financial measures that are not included in the discussion above are included below. Our non-GAAP performance measures exclude expenses and amounts that are not driven by our core operating results and may be one time in nature. Excluding these expenses makes comparisons with prior periods as well as to other companies in our industry more meaningful. We believe such measures allow investors to gain a better understanding of the factors and trends affecting the ongoing operations of our business. We consider our core operations to be the ongoing activities to provide services from which we earn revenue, including direct operating costs and indirect costs to support these activities. As a result, our net income or loss in equity investee is excluded from these measures, as we do not have the ability to manage the venture, allocate resources within the venture, or directly control its operations or performance. Our free cash flow presentation (as applicable) reflects an additional way of viewing our liquidity that, when viewed together with our GAAP results, provides management, investors, and other users of our financial information with a more complete understanding of factors and trends affecting our cash flows. Our use of the term free cash flow is not intended to imply, and no inference should be made, however, that any reported amounts are free to be used without restriction for discretionary expenditures, as our use of these funds may be restricted by the terms of our outstanding indebtedness, including our credit facility, and otherwise earmarked for other non-discretionary expenditures.
Our non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in our industry, as other companies in our industry may calculate non-GAAP financial measures differently. In addition, there are limitations in using non-GAAP financial measures because they are not prepared in accordance with GAAP, may be different from non-GAAP financial measures used by other companies, and exclude expenses that may have a material impact on our reported financial results. The presentation of non-GAAP financial measures is not intended to be considered in isolation from or as a substitute for the most directly comparable financial measures prepared in accordance with GAAP. We urge you to review the reconciliations of our non-GAAP financial measures to their most directly comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate our business.
Forward-Looking Statements
Certain statements contained in this press release constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are predictive in nature and are frequently identified by the use of terms such as 'may,' 'will,' 'should,' 'expect,' 'believe,' 'estimate,' 'intend,' and similar words indicating possible future expectations, events or actions. The updated guidance discussed herein constitutes forward-looking statements. Such forward-looking statements are based on current expectations, assumptions, estimates and projections about our business and our industry, and are not guarantees of our future performance. These statements are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond our ability to control or predict, which may cause actual results to be materially different from those expressed or implied herein, including but not limited to: government or private insurance program funding reductions or limitations; implementation of alternative payment models or the transition of Medicaid and Medicare beneficiaries to Managed Care Organizations; our inability to control reimbursement rates received for our services; cost containment initiatives undertaken by private third-party payors and an inability to maintain or reduce our cost of services below rates set forth by our payors; the effects of a public health emergency; inadequacies in, or security breaches of, our information technology systems; changes in the funding, financial viability or our relationships with our payors; pandemics and other infectious diseases; delays in collection, or non-collection, of our accounts receivable; any impairment of our goodwill and long-lived assets; any failure to maintain or to develop reliable, efficient and secure information technology systems; any inability to attract and retain qualified employees; any disruptions from acquisition or acquisition integration efforts; estimated income taxes being different from income taxes that we ultimately pay; weakening of general economic conditions, including the impact of inflationary pressures, rising interest rates, labor shortages, higher labor costs and supply chain challenges; any failure to successfully implement our business plan, including planned strategic divestitures of certain assets; historical operating losses and negative cash flow and any failure to improve our financial condition; significant turnover of our senior management team and across our organization; ongoing negotiations related to new capital investments may require a substantial portion of time from our management; our contracts not surviving until the end of their stated terms, or not being renewed or extended; our failure to compete effectively in the marketplace; our not being awarded contracts through the government's requests for proposals process, or our awarded contracts not being profitable; any failure to satisfy our contractual obligations or to maintain existing pledged performance and payment bonds; any failure to estimate accurately the cost of performing our contracts; the extended collection periods and uncertainty concerning the timing of the collection of outstanding contract receivables; any misclassification of the drivers we engage as independent contractors rather than as employees; significant interruptions in our communication and data services; not successfully executing on our strategies in the face of our competition; any inability to maintain relationships with existing patient referral sources; certificates of need laws or other regulatory and licensure obligations that may adversely affect our personal care integration efforts and expansion into new markets; any failure to obtain the consent of the New York Department of Health to manage the day to day operations of our licensed in-home personal care services agency business; changes in the case-mix of our personal care patients, or changes in payor mix or payment methodologies; our loss of existing favorable managed care contracts; our experiencing labor shortages in qualified employees and management; labor disputes or disruptions, in particular in New York; becoming subject to malpractice, professional negligence or other similar claims; our operating in the competitive in-home patient monitoring industry, and failing to develop and enhance related technology applications; any failure to innovate and provide services that are useful to customers and to achieve and maintain market acceptance; our lack of sole decision-making authority with respect to our minority investment in Matrix and any failure by Matrix to achieve positive financial position and results of operations; any legal challenges to the relationships or arrangements between our virtual clinical care management services and the unaffiliated physician-owned professional corporation through which such services are provided; any failure to comply with applicable data interoperability and information blocking rules; the lapse of temporary telehealth flexibilities currently permitted under the Consolidated Appropriations Act of 2023; the cost of our compliance with laws; changes to the regulatory landscape applicable to our businesses; changes in budgetary priorities of the government entities or private insurance programs that fund our services; regulations relating to privacy and security of patient and service user information; actions for false claims or recoupment of funds; civil penalties or loss of business for failing to comply with bribery, corruption and other regulations governing business with public organizations; increasing scrutiny and changing expectations with respect to environmental, social and governance matters; changes to, or violations of, licensing regulations; our contracts being subject to audit and modification by the payors with whom we contract; a loss of Medicaid coverage by Medicaid beneficiaries as a result of any state Medicaid eligibility determination processes; our existing debt agreements containing restrictions, financial covenants and cross-default provisions that limit our flexibility in operating our business; our substantial indebtedness and ability to generate sufficient cash to service our indebtedness; the expiration of our existing credit agreement or any loss of available financing alternatives; our ability to incur substantial additional indebtedness or to issue additional equity; our substantial doubt about our ability to meet our obligations as they come due within one year from the date of issuance of the financial statements for fiscal year 2024; any failure to successfully remediate any control deficiency or material weakness in our internal control over financial reporting; our dependence on our subsidiaries to fund our operations and expenses; anti-takeover provisions discouraging a change of control; and any stock price volatility.
The Company has provided additional information about the foregoing and other risks facing our business in our annual report on Form 10-K and subsequent periodic and current reports filed with the Securities and Exchange Commission that could impact future performance. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made and are expressly qualified in their entirety by the cautionary statements set forth herein and in our filings with the Securities and Exchange Commission, which you should read in their entirety before making an investment decision with respect to our securities. We undertake no obligation to update or revise any forward-looking statements contained in this release, whether as a result of new information, future events or otherwise, except as required by applicable law.
Modivcare Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
March 31, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
115,963
$
112,581
Accounts receivable, net
239,545
222,317
Contract receivables
124,359
117,795
Other current assets (1)
53,562
42,686
Total current assets
533,429
495,379
Property and equipment, net
79,038
82,409
Long-term contract receivables
10,989
—
Goodwill
680,252
680,252
Intangible assets, net
266,232
282,320
Equity investment
27,899
31,427
Operating lease right-of-use assets
33,390
36,597
Other long-term assets
45,934
45,948
Total assets
$
1,677,163
$
1,654,332
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable
$
57,659
$
83,068
Accrued contract payables
26,854
22,639
Accrued expenses and other current liabilities
153,452
139,176
Accrued transportation costs
76,855
96,745
Current portion of operating lease liabilities
8,281
8,616
Revolving credit facility
270,661
269,000
Short-term debt
73,889
5,250
Total current liabilities
667,651
624,494
Long-term debt, net of deferred financing costs
1,016,889
986,436
Operating lease liabilities, less current portion
31,053
32,905
Other long-term liabilities (2)
49,203
48,971
Total liabilities
1,764,796
1,692,806
Stockholders' equity (deficit)
Stockholders' equity (deficit)
(87,633
)
(38,474
)
Total liabilities and stockholders' equity (deficit)
$
1,677,163
$
1,654,332
Expand
(1)
Includes other receivables, prepaid expenses and other current assets and short-term restricted cash.
(2)
Includes other long-term liabilities and deferred tax liabilities.
Expand
Modivcare Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
Three months ended March 31,
2025
2024
Operating activities
Net loss
$
(50,377
)
$
(22,300
)
Depreciation and amortization
23,519
27,103
Stock-based compensation
1,244
2,010
Equity in net loss of investee
3,295
1,056
Deferred income taxes
(85
)
(3,778
)
Reduction of right-of-use asset
3,385
2,947
Other non-cash items (1)
5,288
1,407
Changes in operating assets and liabilities:
Contract receivables
(6,563
)
9,280
Contract payables
4,215
10,910
Long-term contract receivables
(10,989
)
(19,598
)
Other changes in operating assets and liabilities (2)
(55,023
)
523
Net cash provided by (used in) operating activities
(82,091
)
9,560
Investing activities
Purchase of property and equipment
(4,061
)
(7,856
)
Net cash used in investing activities
(4,061
)
(7,856
)
Financing activities
Net proceeds from short-term debt
—
7,200
Issuance of long-term debt
30,000
—
Issuance of short-term debt
75,000
—
Repayment of long-term debt
(1,313
)
—
Payments of debt issuance costs
(10,711
)
(756
)
Other financing activities
(26
)
(64
)
Net cash provided by financing activities
92,950
6,380
Net change in cash, cash equivalents and restricted cash
6,798
8,084
Cash, cash equivalents and restricted cash at beginning of period
113,116
2,782
Cash, cash equivalents and restricted cash at end of period
$
119,914
$
10,866
Expand
(1)
Includes amortization of deferred financing costs and debt discount.
(2)
Includes accounts receivable and other receivables, prepaid expenses and other current assets, accounts payable and accrued expenses, accrued transportation costs and other changes in operating assets and liabilities.
Expand
Modivcare Inc.
Unaudited Reconciliation of Non-GAAP Financial Measures
Segment Information and Adjusted EBITDA
(in thousands)
Three months ended March 31, 2025
Service revenue, net
$
449,007
$
181,787
$
18,125
$
1,735
$
650,654
Operating expenses:
Service expense
396,014
147,518
7,673
1,783
552,988
General and administrative expense
27,784
22,584
5,408
22,813
78,589
Depreciation and amortization
7,556
9,434
6,050
479
23,519
Total operating expenses
431,354
179,536
19,131
25,075
655,096
Operating income (loss)
17,653
2,251
(1,006
)
(23,340
)
(4,442
)
Interest expense, net
—
—
—
38,837
38,837
Income (loss) before income taxes and equity method investment
17,653
2,251
(1,006
)
(62,177
)
(43,279
)
Income tax benefit (provision)
1,117
173
(77
)
(4,760
)
(3,547
)
Equity in net income (loss) of investee, net of tax
(1,063
)
—
—
(2,488
)
(3,551
)
Net income (loss)
17,707
2,424
(1,083
)
(69,425
)
(50,377
)
Interest expense, net
—
—
—
38,837
38,837
Income tax provision (benefit)
(1,117
)
(173
)
77
4,760
3,547
Depreciation and amortization
7,556
9,434
6,050
479
23,519
EBITDA
24,146
11,685
5,044
(25,349
)
15,526
Restructuring and related costs (1)
2,331
409
168
6,547
9,455
Transaction and integration costs
264
—
—
521
785
Settlement related costs
—
134
—
1,971
2,105
Stock-based compensation
—
—
—
1,174
1,174
Equity in net (income) loss of investee, net of tax
1,063
—
—
2,488
3,551
Adjusted EBITDA
$
27,804
$
12,228
$
5,212
$
(12,648
)
$
32,596
Expand
(1)
Restructuring and related costs include professional fees for strategic initiatives, organizational consolidation costs and severance, as well as professional services fees and legal fees related to various debt transactions during the period.
Expand
Modivcare Inc.
Unaudited Reconciliation of Non-GAAP Financial Measures
Segment Information and Adjusted EBITDA
(in thousands)
Three months ended March 31, 2024
Service revenue, net
$
479,306
$
183,568
$
20,102
$
1,475
$
684,451
Operating expenses:
Service expense
423,657
149,438
8,363
2,108
583,566
General and administrative expense
31,820
24,432
5,440
15,485
77,177
Depreciation and amortization
7,359
12,795
6,674
275
27,103
Total operating expenses
462,836
186,665
20,477
17,868
687,846
Operating income (loss)
16,470
(3,097
)
(375
)
(16,393
)
(3,395
)
Interest expense, net
—
—
—
18,686
18,686
Income (loss) before income taxes and equity method investment
16,470
(3,097
)
(375
)
(35,079
)
(22,081
)
Income tax benefit (provision)
(4,274
)
823
67
3,927
543
Equity in net income (loss) of investee, net of tax
(28
)
—
—
(734
)
(762
)
Net income (loss)
12,168
(2,274
)
(308
)
(31,886
)
(22,300
)
Interest expense, net
—
—
—
18,686
18,686
Income tax provision (benefit)
4,274
(823
)
(67
)
(3,927
)
(543
)
Depreciation and amortization
7,359
12,795
6,674
275
27,103
EBITDA
23,801
9,698
6,299
(16,852
)
22,946
Restructuring and related costs (1)
3,239
127
10
1,729
5,105
Transaction and integration costs
52
1,446
—
45
1,543
Stock-based compensation
—
—
—
1,781
1,781
Equity in net (income) loss of investee, net of tax
28
—
—
734
762
Adjusted EBITDA
$
27,120
$
11,271
$
6,309
$
(12,563
)
$
32,137
Expand
(1)
Restructuring and related costs include professional fees for strategic initiatives, organizational consolidation costs, severance and other professional fees.
Expand
(1)
Restructuring and related costs include professional fees for strategic initiatives, organizational consolidation costs, severance and other professional fees.
Expand
N/M - Not Meaningful. Certain figures in the tables above do not provide meaningful percentage comparison, thus, the percentage has been removed.
Expand
Modivcare Inc.
Unaudited Key Statistical and Financial Data
(in thousands, except for statistical data)
PCS Segment
Service revenue, net
$
181,787
$
183,568
(1.0
)%
$
186,603
(2.6
)%
Service expense
147,518
149,438
(1.3
)%
148,209
(0.5
)%
Gross profit
$
34,269
$
34,130
0.4
%
$
38,394
(10.7
)%
Gross margin
18.9
%
18.6
%
20.6
%
G&A expense
$
22,584
$
24,432
(7.6
)%
$
20,586
9.7
%
G&A expense adjustments
Restructuring and related costs
409
127
222.0
%
268
52.6
%
Transaction and integration costs
—
1,446
(100.0
)%
(582
)
(100.0
)%
Settlement related costs
134
—
N/M
—
N/M
Adjusted G&A expense
$
22,041
$
22,859
(3.6
)%
$
20,900
5.5
%
Adjusted G&A expense % of revenue
12.1
%
12.5
%
11.2
%
Net income (loss)
$
2,424
$
(2,274
)
N/M
$
5,062
(52.1
)%
Net income (loss) margin
1.3
%
(1.2
)%
2.7
%
Adjusted EBITDA
$
12,228
$
11,271
8.5
%
$
17,494
(30.1
)%
Adjusted EBITDA margin
6.7
%
6.1
%
9.4
%
Total hours (thousands)
6,818
6,965
(2.1
)%
7,042
(3.2
)%
Revenue per hour
$
26.66
$
26.36
1.1
%
$
26.50
0.6
%
Service expense per hour
$
21.64
$
21.46
0.8
%
$
21.05
2.8
%
Expand
N/M - Not Meaningful. Certain figures in the tables above do not provide meaningful percentage comparison, thus, the percentage has been removed.
Expand
Modivcare Inc.
Unaudited Key Statistical and Financial Data
(in thousands, except for statistical data)
Monitoring Segment
Service revenue, net
$
18,125
$
20,102
(9.8
)%
$
19,164
(5.4
)%
Service expense
7,673
8,363
(8.3
)%
7,728
(0.7
)%
Gross profit
$
10,452
$
11,739
(11.0
)%
$
11,436
(8.6
)%
Gross margin
57.7
%
58.4
%
59.7
%
G&A expense
$
5,408
$
5,440
(0.6
)%
$
4,659
16.1
%
G&A expense adjustments
Restructuring and related costs
168
10
N/M
—
N/M
Adjusted G&A expense
$
5,240
$
5,430
(3.5
)%
$
4,659
12.5
%
Adjusted G&A expense % of revenue
28.9
%
27.0
%
24.3
%
Net income (loss)
$
(1,083
)
$
(308
)
251.6
%
$
823
(231.6
)%
Net income (loss) margin
(6.0
)%
(1.5
)%
4.3
%
Adjusted EBITDA
$
5,212
$
6,309
(17.4
)%
$
6,777
(23.1
)%
Adjusted EBITDA margin
28.8
%
31.4
%
35.4
%
Average monthly members (thousands)
231
249
(7.2
)%
249
(7.2
)%
Revenue per member per month
$
26.15
$
26.91
(2.8
)%
$
25.65
1.9
%
Service expense per member per month
$
11.07
$
11.20
(1.2
)%
$
10.35
7.0
%
Expand
N/M - Not Meaningful. Certain figures in the tables above do not provide meaningful percentage comparison, thus, the percentage has been removed.
Expand
Three months ended
Three months ended
Consolidated Modivcare Inc.
G&A expense
$
78,589
$
77,177
1.8
%
$
74,246
5.8
%
G&A expense adjustments
Restructuring and related costs
9,455
5,105
85.2
%
7,509
25.9
%
Transaction and integration costs
785
1,543
(49.1
)%
163
381.6
%
Settlement related costs
2,105
—
N/M
—
N/M
Stock-based compensation
1,174
1,781
(34.1
)%
1,744
(32.7
)%
Adjusted G&A expense
$
65,070
$
68,748
(5.3
)%
$
64,830
0.4
%
Adjusted G&A expense % of consolidated revenue
10.0
%
10.0
%
9.2
%
Expand
N/M - Not Meaningful. Certain figures in the tables above do not provide meaningful percentage comparison, thus, the percentage has been removed.
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Associated Press
17 minutes ago
- Associated Press
Ono Pharmaceutical and Vertex Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea
OSAKA, Japan & BOSTON--(BUSINESS WIRE)--Jun 23, 2025-- Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; 'Ono') and Vertex Pharmaceuticals Incorporated (Headquarters: Boston, MA, U.S.; CEO: Reshma Kewalramani, M.D.; 'Vertex') today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex's povetacicept in Japan and South Korea. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other serious B cell-mediated diseases. Under the terms of the agreement, Ono will pay Vertex an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex's clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. Following approval, Ono will be solely responsible for commercializing povetacicept in these regions. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications. 'Vertex has a strong track record of developing innovative therapies for serious diseases. Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field, which is a key focus area for Ono,' said Toichi Takino, Representative Director, President and Chief Operating Officer of Ono. 'We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.' 'Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure, and nephrology expertise that make them a perfect partner for Vertex as we look to deliver povetacicept to the thousands of potential patients in these countries,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. 'We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.' The Phase 3 clinical trial is underway in multiple regions, including the U.S., EU and Asia. Specifically, Japanese and South Korean regulatory authorities have approved the Clinical Trial Application (CTA) for RAINIER, where the Phase 3 trial is underway. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. View source version on CONTACT: Ono Pharmaceutical Co., Ltd. Corporate Communications [email protected] more information: Vertex Pharmaceuticals Incorporated Investors: [email protected]: [email protected] or International: +44 20 3204 5275 or U.S.: 617-341-6992 or Heather Nichols: +1 617-839-3607 KEYWORD: NORTH AMERICA UNITED STATES SOUTH KOREA ASIA PACIFIC JAPAN MASSACHUSETTS INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH GENETICS PHARMACEUTICAL CLINICAL TRIALS SOURCE: Ono Pharmaceutical Co., Ltd. Copyright Business Wire 2025. PUB: 06/23/2025 04:00 AM/DISC: 06/23/2025 04:02 AM
Associated Press
18 minutes ago
- Associated Press
Vertex and Ono Pharmaceutical Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea
BOSTON & OSAKA, Japan--(BUSINESS WIRE)--Jun 23, 2025-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Ono Pharmaceutical Co., Ltd. (OTCMKTS: OPHLY) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex's povetacicept in Japan and South Korea. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other B cell-mediated diseases. Under the terms of the agreement, Vertex will receive an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex's clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. Following approval, Ono will be solely responsible for commercializing povetacicept in these regions. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications. 'Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure and nephrology expertise that make them a perfect partner for Vertex as we look to deliver povetacicept to the thousands of potential patients in these countries,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. 'We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.' 'Vertex has a strong track record of developing innovative therapies for serious diseases. Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field, which is a key focus area for Ono,' said Toichi Takino, Representative Director, President and Chief Operating Officer of Ono. 'We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.' About Povetacicept Povetacicept is a recombinant fusion protein therapeutic and a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and calcium modulator ligand interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious B cell-mediated diseases including other autoimmune kidney diseases and autoimmune cytopenias. About IgA Nephropathy (IgAN) IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting approximately 300,000 people in the United States and Europe. It is estimated that there are approximately 33,000 diagnosed patients in Japan. IgAN results from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. Up to 72% of adult IgAN patients progress to end-stage renal disease within 20 years. There are no approved therapies that specifically target the underlying cause of IgAN. About Primary Membranous Nephropathy (pMN) Primary membranous nephropathy is a serious, progressive, life-threatening B cell-mediated chronic kidney disease affecting people worldwide, with approximately 150,000 people diagnosed in the U.S. and Europe. It is estimated that there are approximately 6,000 diagnosed patients with pMN in Japan. pMN is a rare glomerular disease that occurs when the body generates an abnormal immune response, including autoantibodies, against proteins that are part of the kidney. Autoantibodies trigger damage and inflammation, especially within the glomeruli (the parts of the kidney that filter blood), impairing the kidneys' ability to properly filter waste and fluid, eventually causing progressive loss of kidney function. There are no approved therapies that specifically target the underlying cause of pMN. About RAINIER RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104. The Phase 3 clinical trial is underway in multiple regions, including the U.S., EU and Asia. Specifically, Japanese and South Korean regulatory authorities have approved the Clinical Trial Application (CTA) for RAINIER, where the Phase 3 trial is underway. About RUBY-3 RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. About Ono Pharmaceutical Co., Ltd Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of 'Dedicated to the Fight against Disease and Pain,' Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at Vertex Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Reshma Kewalramani M.D., and Toichi Takino, in this press release, and statements about the terms of and expectations for Vertex's collaboration with Ono, statements about potential benefits and results that may be achieved through the collaboration, statements regarding the future activities of the parties pursuant to the collaboration, including Ono's help to advance clinical trials and Ono's responsibility to obtain marketing authorizations in Japan and South Korea and to commercialize povetacicept in the regions, statements regarding upfront and milestone payments, and potential royalties on future products, and statements about Vertex's plans and expectations for the RAINIER and RUBY-3 clinical trials and potential plans to seek accelerated approval in the U.S. based on interim analysis from the RAINIER trial. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the anticipated benefits and potential of the collaboration between Vertex and Ono may not be achieved on the anticipated timeline, or at all, that data may not support further development of the therapies subject to the collaboration due to safety, efficacy, or other reasons, and other risks listed under the heading 'Risk Factors' in Vertex's annual report filed with the Securities and Exchange Commission (SEC) and available through Vertex's website at and on the SEC's website at You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Ono Forward-Looking Statements In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice. View source version on CONTACT: Vertex Pharmaceuticals Incorporated Investors: [email protected] Media: [email protected] or International: +44 20 3204 5275 or U.S.: 617-341-6992 or Heather Nichols: +1 617-839-3607 Ono Pharmaceutical Co., Ltd. Corporate Communications [email protected] KEYWORD: NORTH AMERICA UNITED STATES SOUTH KOREA ASIA PACIFIC JAPAN MASSACHUSETTS INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH GENETICS PHARMACEUTICAL CLINICAL TRIALS SOURCE: Vertex Pharmaceuticals Incorporated Copyright Business Wire 2025. PUB: 06/23/2025 04:00 AM/DISC: 06/23/2025 04:02 AM
Associated Press
18 minutes ago
- Associated Press
INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that Apple Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
SAN DIEGO--(BUSINESS WIRE)--Jun 23, 2025-- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Apple Inc. (NASDAQ: AAPL) securities between June 10, 2024 and June 9, 2025, both dates inclusive (the 'Class Period'), have until August 19, 2025 to seek appointment as lead plaintiff of the Apple class action lawsuit. Captioned Tucker v. Apple Inc., No. 25-cv-05197 (N.D. Cal.), the Apple class action lawsuit charges Apple and certain of Apple's top current and former executives with violations of the Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff of the Apple class action lawsuit, please provide your information here: You can also contact attorneysJ.C. SanchezorJennifer N. Caringalof Robbins Geller by calling 800/449-4900 or via e-mail at[email protected]. CASE ALLEGATIONS: The Apple class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) Apple misstated the time it would take to integrate the advanced artificial intelligence ('AI')-based Siri features into its devices; (ii) accordingly, it was highly unlikely that these features would be available for the iPhone 16; (iii) the lack of such advanced AI-based features would hurt iPhone 16 sales; and (iv) as a result, Apple's business and/or financial prospects were overstated. The Apple class action lawsuit further alleges that on March 7, 2025, Apple announced it was indefinitely delaying promised updates to its Siri digital assistant. The Apple class action lawsuit alleges that on this news, the price of Apple stock fell. Then, on March 12, 2025, the Apple class action lawsuit further alleges that Morgan Stanley published a report in which analyst Erik Woodring lowered his price target on Apple from $275 to $252, asserting that the delay in introducing advanced Siri features would impact iPhone upgrade cycles throughout 2025 and 2026, and presenting evidence that roughly 50% of iPhone owners who did not upgrade to the iPhone 16 attributed their decision to such delays. On this news, the price of Apple stock fell further, according to the complaint. Thereafter, the Apple class action lawsuit alleges that on April 3, 2025, the Wall Street Journal published an article titled 'Apple and Amazon Promised Us Revolutionary AI. We're Still Waiting,' which stated, in relevant part, that '[w]ith 'more personal' Siri . . . , the tech giant[] marketed features [it] ha[s] yet to deliver,' and suggested that while 'this is challenging technology and the cost of getting it wrong is devastatingly high, especially for [a] compan[y] like Apple . . . that must build trust with customers,' 'the same responsibility applies to marketing: They shouldn't announce products until they're sure they can deliver them.' On this news, the price of Apple stock fell more than 7%, according to the complaint. Finally, on June 9, 2025, Apple hosted its Worldwide Developer Conference ('WWDC'), almost one year to the day after first announcing the suite of supposedly forthcoming Apple Intelligence features at the 2024 WWDC, and Apple failed to announce any new updates regarding advanced Siri features, according to the complaint. On this news, the price of Apple stock fell further, according to the complaint. Last year, Robbins Geller secured a $490 million recovery in a securities fraud class action case alleging Apple CEO Timothy Cook made false and misleading statements to investors – the third-largest securities class action recovery ever in the Northern District of California and the fifth-largest such recovery ever in the Ninth Circuit. In the order granting final approval of the settlement, the court recognized the 'skill and strategic vision, as well as the risk taken by [Robbins Geller]' in securing the sizeable recovery while efficiently managing the 'uniquely complex' aspects of the case against 'highly sophisticated and experienced counsel and defendants.' Learn more by clicking here. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Apple securities during the Class Period to seek appointment as lead plaintiff in the Apple class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Apple class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Apple class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Apple class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices. View source version on CONTACT: Robbins Geller Rudman & Dowd LLP J.C. Sanchez, Jennifer N. Caringal 655 W. Broadway, Suite 1900, San Diego, CA 92101 800-449-4900 [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: CLASS ACTION LAWSUIT PROFESSIONAL SERVICES LEGAL SOURCE: Robbins Geller Rudman & Dowd LLP Copyright Business Wire 2025. PUB: 06/23/2025 05:25 AM/DISC: 06/23/2025 05:24 AM
