SCHAFFHAUSEN, Switzerland, Oct. 29, 2026 (GLOBE NEWSWIRE) — Monolithic Power Systems, Inc. (“MPS” or the “Company”) (Nasdaq: MPWR), a fabless global company that provides high-performance, semiconductor-based power electronics solutions, today announced the appointments of Tony Balow as Vice President, Chief Financial Officer (“CFO”) and Robert Dean as Vice President, Chief Accounting Officer (“CAO”), effective immediately.

“I am very pleased to appoint Tony as our new CFO and Rob as our new CAO,” said Michael Hsing, CEO and founder of MPS. “In the past few years, Tony and Rob have become an integral part of the management team. Their deep knowledge of MPS’s business operations and their financial acumen make them highly qualified to take on the CFO and CAO roles and lead our finance team.”

Mr. Balow served as the Company’s Vice President of Finance from September 2023 to October 2026. Prior to joining the Company, Mr. Balow spent 23 years at Intel, a global semiconductor company, and held a number of senior positions. Mr. Balow holds a Bachelor of Science and a Master of Science in Aerospace, Aeronautical and Astronautical Engineering from the University of Illinois Urbana-Champaign, and a Master of Business Administration from the University of Arizona.

Mr. Dean served as the Company’s Interim Chief Financial Officer from February 2026 to October 2026, and Corporate Controller from June 2016 to February 2026. Prior to joining the Company, Mr. Dean held various senior finance and accounting roles for other publicly traded companies, including Netflix, Varian and Applied Materials. Mr. Dean holds a Bachelor of Science in Accounting from San Jose State University and a Master of Business Administration from Santa Clara University.

About Monolithic Power Systems

Monolithic Power Systems, Inc. is a fabless global company that provides high-performance, semiconductor-based power electronics solutions. MPS’s mission is to reduce energy and material consumption to improve all aspects of quality of life and create a sustainable future. Founded in 1997 by our CEO Michael Hsing, MPS has three core strengths: deep system-level knowledge, strong semiconductor design expertise, and innovative proprietary technologies in the areas of semiconductor processes, system integration, and packaging. These combined advantages enable MPS to deliver reliable, compact, and monolithic solutions that are highly energy-efficient, cost-effective, and environmentally responsible, while providing a consistent return on investment to our stockholders. MPS can be contacted through its website at www.monolithicpower.com or its support offices around the world. 

Monolithic Power Systems, MPS, and the MPS logo are registered trademarks of Monolithic Power Systems, Inc. in the U.S. and trademarked in certain other countries. 

Contact:
Tony Balow
Vice President, Chief Financial Officer
Monolithic Power Systems, Inc.
MPSInvestor.Relations@monolithicpower.com

  • Reports third-quarter revenue of $1.36 billion, representing 36.7% year-over-year growth
  • Grows health plan membership 31.2% year-over-year to 301,200 members
  • Issues fourth-quarter guidance and lowers full-year 2026 adjusted gross profit and adjusted EBITDA guidance

ORANGE, Calif., Oct. 29, 2026 (GLOBE NEWSWIRE) — Alignment Healthcare, Inc. (NASDAQ: ALHC), today reported financial results for its third quarter ended Sept. 30, 2026.

“Our third-quarter membership and revenue growth demonstrate continued demand for Alignment’s products and services, while medical trends ran higher than expected,” said John Kao, chairman and CEO. “We are taking a prudent approach to the fourth quarter and lowering our outlook based on current headwinds. Our revised guidance does not assume any benefit from the actions underway. We are confident we can deliver against these expectations. Our focus now is on execution and taking the steps necessary to drive more consistent performance as we scale and deliver profitable growth over the long term.”

Third Quarter 2026 Financial Highlights
All comparisons, unless otherwise noted, are to the three months ended September 30, 2025.

  • Health plan membership at the end of the quarter was approximately 301,200, up 31.2% year-over-year
  • Total revenue was $1,358.3 million, up 36.7% year-over-year
  • Adjusted gross profit* was $142.2 million, up 11.6% year-over-year, and loss from operations was $3.8 million
    • Adjusted gross profit excludes depreciation and amortization of $8.1 million and selling, general, and administrative expenses of $136.4 million (which includes $16.0 million of equity-based compensation). Adjusted gross profit also excludes $1.5 million of equity-based compensation recorded within medical expenses
    • Medical benefits ratio based on adjusted gross profit was 89.5%, an increase of approximately 240 basis points year-over-year. The medical benefits ratio result reflects previously expected changes in Part D seasonality and timing of clinical investments, along with higher costs from elevated appeals and disputes and increased costs within catastrophic cases and skilled nursing categories
  • Adjusted EBITDA* of $21.8 million represented an adjusted EBITDA margin of 1.6% and declined 32.8% year-over-year, while net loss was $8.1 million, compared to net income of $3.7 million the year prior

* Please see “Third Quarter 2026 Non-GAAP Reconciliation Tables” below for more information on the non-GAAP financial measures reported here as supplemental information.

Outlook for Fourth Quarter and Fiscal Year 2026
Full-year health plan membership and revenue guidance was raised to reflect continued sales momentum, while adjusted gross profit and adjusted EBITDA guidance was lowered to reflect higher medical costs experienced during the third quarter.

    Three Months Ending
December 31, 2026
  Twelve Months Ending
December 31, 2026
 
$ Millions No Less Than   No Less Than  
Health Plan Membership 305,000   305,000  
Revenue $1,316   $5,245  
Adjusted Gross Profit(1) $104   $575  
Adjusted EBITDA(1) $(28)   $100  
           
           
           
(1) Adjusted gross profit and adjusted EBITDA are non-GAAP financial measures presented as supplemental disclosure. We cannot provide estimated ranges for the most directly comparable GAAP measures without unreasonable efforts because of the uncertainty around certain items that may impact such GAAP measures, including equity-based compensation expense and depreciation and amortization, that are not within our control or cannot be reasonably predicted. See “Third Quarter 2026 Non-GAAP Reconciliation Tables” for additional information.
   

Third Quarter 2026 Non-GAAP Reconciliation Tables

Adjusted Gross Profit(1) is reconciled as follows:

    Three Months Ended September 30,   Nine Months Ended September 30,  
    2026   2025   2026   2025  
(dollars in thousands)                          
Income (loss) from operations $ (3,794 )   $ 7,681   $ 53,809   $ 25,036  
Add back:                          
  Equity-based compensation (medical expenses)   1,511       1,775     4,815     4,521  
  Depreciation (medical expenses)   7       8     33     74  
  Depreciation and amortization(2)   8,108       7,977     23,801     22,574  
  Selling, general, and administrative expenses   136,373       110,015     388,514     317,643  
  Total add back   145,999       119,775     417,163     344,812  
Adjusted gross profit $ 142,205     $ 127,456   $ 470,972   $ 369,848  
                             
(1) Adjusted gross profit is a non-GAAP financial measure that is presented as supplemental disclosure, that we define as income (loss) from operations before depreciation and amortization, medical equity-based compensation expense, and selling, general, and administrative expenses.
                             
(2) Amortization expense for the nine months ended September 30, 2025, includes $0.6 million in impairment expense related to the remeasurement of goodwill associated with one of our subsidiaries. There was no impairment expense for the three months ended September 30, 2025.
                             

Adjusted EBITDA(1) is reconciled as follows:

    Three Months Ended September 30,   Nine Months Ended September 30,  
    2026   2025   2026   2025
 
(dollars in thousands)                              
Net income (loss) $ (8,052 )   $ 3,729   $ 39,924     $ 10,028    
Less: Net loss attributable to noncontrolling
interest
  —       —     —       (254 )  
Adjustments:                              
  Interest expense   4,280       3,950     12,617       11,850    
  Depreciation and amortization(2)   8,115       7,985     23,834       22,648    
  Income tax expense   (22 )     2     1,269       3,247    
  Equity-based compensation(3)   17,487       16,227     49,680       48,967    
  Litigation costs(4)   —       546     481       1,608    
  Gain on sale of property and equipment   —       —     (1 )     (72 )  
Adjusted EBITDA $ 21,808     $ 32,439   $ 127,804     $ 98,530    
                                 
(1) Adjusted EBITDA is a non-GAAP financial measure that is presented as supplemental disclosure, that we define as net income (loss) before interest expense, income taxes, depreciation and amortization expense, certain litigation costs, gains or losses on sale of property and equipment, and equity-based compensation expense.
                                 
(2) Amortization expense for the nine months ended September 30, 2025 includes $0.6 million in impairment expense related to the remeasurement of goodwill associated with one of our subsidiaries. There was no impairment expense for the three months ended September 30, 2025.
                                 
(3) Represents equity-based compensation related to grants made in the applicable year.
                                 
(4) Represents litigation costs considered outside of the ordinary course of business based on the following considerations which we assess regularly: (i) the frequency of similar cases that have been brought to date, or are expected to be brought within two years, (ii) complexity of the case, (iii) nature of the remedies sought, (iv) litigation posture of the Company, (v) counterparty involved, and (vi) the Company’s overall litigation strategy.
   

Conference Call Details
The company will host a conference call at 5 p.m. EDT today to discuss these results and management’s outlook for future financial and operational performance. A live audio webcast will be available online at https://ir.alignmenthealth.com/. At the start of the conference call, participants may access the webcast at the following link: https://edge.media-server.com/mmc/p/o7dsxqqm. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web links, and will remain available for approximately 12 months.

About Alignment Health
Alignment Health is championing a new path in senior care that empowers members to age well and live their most vibrant lives. A consumer brand name of Alignment Healthcare (NASDAQ: ALHC), Alignment Health’s mission-focused team makes high-quality, low-cost care a reality for its Medicare Advantage members every day. Based in California, the company partners with nationally recognized and trusted local providers to deliver coordinated care, powered by its customized care model, 24/7 concierge care team and purpose-built technology, AVA®. As it expands its offerings and grows its national footprint, Alignment upholds its core values of leading with a serving heart and putting the senior first. For more information, visit www.alignmenthealth.com.

Forward-Looking Statements
This 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, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements include statements regarding our future growth and our financial outlook for the quarter and year ending Dec. 31, 2026. Forward-looking statements are subject to risks and uncertainties and are based on assumptions that may prove to be inaccurate, which could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance. Important risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully execute our business plan and achieve anticipated operational improvements and financial results; our ability to manage changes in medical costs and healthcare utilization, and our ability to accurately estimate, price for and manage such costs and utilization; our ability to attract new members and enter new markets, including the need for certain governmental approvals; our ability to achieve and maintain a high rating for our plans on the Five Star Quality Rating System; our ability to develop and maintain satisfactory relationships with care providers that service our members; risks associated with being a government contractor, including potential federal reductions in MA funding; changes in laws and regulations applicable to our business model; risks related to our indebtedness; changes in market or industry conditions and receptivity to our technology and services; results of litigation or a security incident; and the impact of shortages of qualified personnel and related increases in our labor costs. For a detailed discussion of the risk factors that could affect our actual results, please refer to the risk factors identified in our Annual Report on Form 10-K for the year ended Dec. 31, 2025, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 and the other periodic reports we file with the SEC. All information provided in this release and in the attachments is as of the date hereof, and we undertake no duty to update or revise this information unless required by law.

Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
(Unaudited)
 
  September 30,
2026
  December 31,
2025
 
Assets                
Current Assets:                
Cash and cash equivalents $ 727,694     $ 575,817    
Accounts receivable (less allowance for credit losses of $699 at September 30, 2026 and
   $833 at December 31, 2025)
  242,545       253,207    
Investments – current   15,260       28,413    
Prepaid expenses and other current assets   192,808       94,140    
Total current assets   1,178,307       951,577    
Property and equipment, net   66,439       64,251    
Right of use asset, net   7,206       7,019    
Goodwill   32,060       32,060    
Intangible assets, net   4,550       4,550    
Other assets   8,301       6,329    
Total assets $ 1,296,863     $ 1,065,786    
Liabilities and Stockholders’ Equity                
Current Liabilities:                
Medical expenses payable $ 621,746     $ 474,569    
Accounts payable and accrued expenses   34,562       33,284    
Accrued compensation   32,744       49,013    
Total current liabilities   689,052       556,866    
Long-term debt, net of debt issuance costs   324,497       323,176    
Long-term portion of lease liabilities   6,202       6,467    
Total liabilities   1,019,751       886,509    
Stockholders’ Equity:                
Preferred stock, $0.001 par value; 100,000,000 shares authorized as of
   September 30, 2026 and December 31, 2025, respectively; no shares issued and
   outstanding as of September 30, 2026 and December 31, 2025
  —       —    
Common stock, $0.001 par value; 1,000,000,000 shares authorized as of
   September 30, 2026 and December 31, 2025; 209,152,387 and 204,153,619 shares
   issued and outstanding as of September 30, 2026 and December 31, 2025,
   respectively
  209       205    
Additional paid-in capital   1,245,996       1,188,089    
Accumulated deficit   (969,093 )     (1,009,017 )  
Total stockholders’ equity   277,112       179,277    
   Total liabilities and stockholders’ equity $ 1,296,863     $ 1,065,786    
 

Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
 
  Three Months Ended September 30,   Nine Months Ended September 30,  
  2026   2025   2026   2025  
Revenues:                              
Earned premiums $ 1,348,256     $ 983,681   $ 3,901,447     $ 2,907,927    
Other   10,034       10,014     27,673       27,988    
Total revenues   1,358,290       993,695     3,929,120       2,935,915    
Expenses:                              
Medical expenses   1,217,603       868,022     3,462,996       2,570,662    
Selling, general, and administrative expenses   136,373       110,015     388,514       317,643    
Depreciation and amortization   8,108       7,977     23,801       22,574    
Total expenses   1,362,084       986,014     3,875,311       2,910,879    
Income (loss) from operations   (3,794 )     7,681     53,809       25,036    
Other expenses:                              
Interest expense   4,280       3,950     12,617       11,850    
Other income, net   —       —     (1 )     (89 )  
Total other expense   4,280       3,950     12,616       11,761    
Income (loss) before income taxes   (8,074 )     3,731     41,193       13,275    
Provision (benefit) for income taxes   (22 )     2     1,269       3,247    
Net income (loss) $ (8,052 )   $ 3,729   $ 39,924     $ 10,028    
Less: Net loss attributable to noncontrolling interest   —       —     —       (254 )  
Net income (loss) attributable to Alignment Healthcare,
  Inc.
$ (8,052 )   $ 3,729   $ 39,924     $ 10,282    
                               
Net income (loss) per share attributable to Alignment
  Healthcare, Inc.:
                             
Basic   (0.04 )     0.02     0.19       0.05    
Diluted   (0.04 )     0.02     0.19       0.05    
Weighted-average common shares outstanding:                              
Basic   208,556,942       199,026,808     207,132,468       197,007,141    
Diluted   208,556,942       208,927,980     214,815,296       208,439,200    
 

Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
 
  Nine Months Ended September 30,  
  2026   2025  
Operating Activities:                
Net income $ 39,924     $ 10,028    
Adjustments to reconcile net income to net cash provided by operating activities:                
Provision for credit loss   699       548    
Gain on sale of property and equipment   (1 )     (72 )  
Depreciation and amortization   23,834       22,648    
Amortization-investment discount   (478 )     (1,041 )  
Amortization-debt issuance costs   1,790       1,321    
Equity-based compensation   49,680       48,967    
Non-cash lease expense   1,439       1,178    
Changes in operating assets and liabilities:                
   Accounts receivable   9,963       (66,451 )  
   Prepaid expenses and other current assets   (98,668 )     (84,326 )  
   Other assets   (9 )     (47 )  
   Medical expenses payable   147,177       239,008    
   Accounts payable and accrued expenses   1,004       11,185    
   Accrued compensation   (16,269 )     8,349    
   Lease liabilities   (1,690 )     (993 )  
       Net cash provided by operating activities   158,395       190,302    
Investing Activities:                
Purchase of investments   (32,510 )     (45,194 )  
Sale of property and equipment   —       75    
Maturities of investments   46,135       57,995    
Sale of business   —       1,065    
Acquisition of property and equipment   (25,952 )     (21,752 )  
       Net cash used in investing activities   (12,327 )     (7,811 )  
Financing Activities:                
Debt issuance costs   (2,397 )     (26 )  
Proceeds from stock option exercises   8,231       2,771    
       Net cash provided by financing activities   5,834       2,745    
Net increase in cash   151,902       185,236    
Cash, cash equivalents and restricted cash at beginning of period   577,937       434,942    
Cash, cash equivalents and restricted cash at end of period $ 729,839     $ 620,178    
Supplemental disclosure of cash flow information:                
       Cash paid for interest $ 7,013     $ 6,740    
Supplemental non-cash investing and financing activities:                
       Acquisition of property in accounts payable $ 9     $ 79    
 

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets to the total above:

  September 30,
2026
  September 30,
2025
 
Cash and cash equivalents $ 727,694   $ 618,067  
Restricted cash in other assets   2,145     2,111  
Total $ 729,839   $ 620,178  
 

Non-GAAP Financial Measures

Certain of these financial measures are considered “non-GAAP” financial measures within the meaning of Item 10 of Regulation S-K promulgated by the SEC. We believe that non-GAAP financial measures provide an additional way of viewing aspects of our operations that, when viewed with the GAAP results, provide a more complete understanding of our results of operations and the factors and trends affecting our business. These non-GAAP financial measures are also used by our management to evaluate financial results and to plan and forecast future periods. However, non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may differ from the non-GAAP measures used by other companies, including our competitors. To supplement our consolidated financial statements presented on a GAAP basis, we disclose the following non-GAAP measures: Medical Benefits Ratio, Adjusted EBITDA and Adjusted Gross Profit as these are performance measures that our management uses to assess our operating performance. Because these measures facilitate internal comparisons of our historical operating performance on a more consistent basis, we use these measures for business planning purposes and in evaluating acquisition opportunities.

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure that we define as net income (loss) before interest expense, income taxes, depreciation and amortization expense, certain litigation costs, gains or losses on sale of property and equipment, and equity-based compensation expense.

Adjusted EBITDA should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of Adjusted EBITDA in lieu of net income (loss), which is the most directly comparable financial measure calculated in accordance with GAAP.

Our use of the term Adjusted EBITDA may vary from the use of similar terms by other companies in our industry and accordingly may not be comparable to similarly titled measures used by other companies.

Medical Benefits Ratio (MBR)

We calculate our MBR by dividing total medical expenses, excluding depreciation, and medical equity-based compensation, by total revenues in a given period.

Adjusted Gross Profit

Adjusted gross profit is a non-GAAP financial measure that we define as income (loss) from operations before depreciation and amortization, medical equity-based compensation expense, and selling, general, and administrative expenses.

Adjusted gross profit should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted gross profit in lieu of income (loss) from operations, which is the most directly comparable financial measure calculated in accordance with GAAP.

Our use of the term adjusted gross profit may vary from the use of similar terms by other companies in our industry and accordingly may not be comparable to similarly titled measures used by other companies.

Investor Contact
Harrison Zhuo
hzhuo@ahcusa.com

Media Contact
Jerry Slowey
publicrelations@ahcusa.com

SCHAFFHAUSEN, Switzerland, Oct. 29, 2026 (GLOBE NEWSWIRE) — Monolithic Power Systems, Inc. (“MPS”) reported its results after market close on October 29, 2026 and will host a question-and-answer webinar at 2:00 p.m. PT / 5:00 p.m. ET. The webinar can be accessed from the Investor Relations section of the MPS website at www.monolithicpower.com. 

Q3 2026 Financial Summary (Unaudited)

GAAP  
                     
  Q3’26   Q2’26   Q3’25   QoQ Change   YoY Change  
Revenue ($M) $1,202.4   $980.6   $737.2   22.6%   63.1%  
Gross Margin 55.4%   55.2%   55.1%   0.2 pts   0.3 pts  
Opex ($M) $307.9   $237.2   $211.0   29.8%   45.9%  
Operating Margin 29.7%   31.0%   26.5%   (1.3) pts   3.2 pts  
Net income ($M) $271.1   $257.3   $179.8   5.4%   50.8%  
Diluted EPS $5.51   $5.22   $3.74   5.6%   47.3%  

Non-GAAP  
                     
  Q3’26   Q2’26   Q3’25   QoQ Change   YoY Change  
Revenue ($M) $1,202.4   $980.6   $737.2   22.6%   63.1%  
Gross Margin 55.7%   55.6%   55.5%   0.1 pts   0.2 pts  
Opex ($M) $205.3   $177.6   $148.3   15.6%   38.4%  
Operating Margin 38.6%   37.5%   35.4%   1.1 pts   3.2 pts  
Net income ($M) $402.7   $320.1   $227.1   25.8%   77.3%  
Diluted EPS $8.19   $6.50   $4.73   26.0%   73.2%  
Tax Rate 15.0%   15.0%   15.0%   Flat   Flat  

Revenue by End Market
                             
    Revenue   % Change   % of Revenue
End Market ($M)   Q3’26   Q2’26   Q3’25   QoQ   YoY   Q3’26   Q2’26
Enterprise Data   $506.7   $380.6   $191.5   33.2%   164.6%   42.1%   38.8%
Storage & Computing   192.2   199.8   186.6   (3.8%)   3.0%   16.0   20.4
Communications   187.4   131.5   79.9   42.5%   134.7%   15.6   13.4
Automotive   180.7   157.1   151.5   15.0%   19.2%   15.0   16.0
Industrial   71.4   54.8   55.3   30.2%   29.0%   6.0   5.6
Consumer   64.0   56.8   72.4   12.6%   (11.6%)   5.3   5.8
Total   $1,202.4   $980.6   $737.2   22.6%   63.1%   100%   100%


Ongoing Business Conditions

In Q3, MPS achieved another significant milestone exceeding $1 billion in quarterly revenue for the first time. Q3 revenue of $1.2 billion was 22.6% higher than the second quarter of 2026 and 63.1% higher than the third quarter of 2025.

During the quarter:

  • Our capacity surpassed $6 billion dollars in annual revenue support. We expect to have $8 billion of capacity in place by the second half of 2027 on our way to $10 billion in support of our rapidly expanding business.

In our enterprise data end market:

  • We saw strong demand across our existing customers which we expect to continue into 2027.
  • In addition, using our in-house developed AI design tools we significantly expanded our customer base in traditional areas, as well as in new applications such as desktop AI designs.

In addition to our rapid Enterprise Data growth:

  • In Automotive, we received first orders for our 48V power solutions and expect design wins for 48V and Zonal architectures to be a driver of growth in 2027.
  • We started ramping robotics solutions with sensor and motor control products across multiple geographies.
  • We landed our first large data converter design win which we expect to ramp 2027.
  • We continued to increase our SAM with the ramp of our high speed memory products.
  • We continued to build out our high voltage portfolio and began sampling GAN based solutions for use in 800V data center architectures complementing our existing SiC based designs.

Our diversified market strategy remains unchanged:

  • MPS focuses on innovation and solving our customers’ most challenging problems.
  • We consistently invest in new technologies that open new end markets and applications.
  • We continue to transform from a chip-only semiconductor supplier to a full service solution provider.
  • We continuously expand and diversify our global supply chain allowing us to capture future growth opportunities, maintain supply stability, and rapidly adapt to market changes as they occur.

“Overall, we see accelerated growth. Our diversified growth strategy is paying off,” said Michael Hsing, CEO and founder of MPS.

Q3 2026 Revenue Results

We had record revenue of $1,202 million in the third quarter, 22.6% higher than the second quarter of 2026 and 63.1% higher than revenue in the third quarter of 2025. Compared with the second quarter of 2026, sales improved sequentially across Communications, Enterprise Data, Industrial, Automotive and Consumer end markets.

In our Communications end market, third quarter revenue of $187.4 million was up 42.5% from the second quarter primarily as a result of higher sales of power solutions for optical modules and switches. Third quarter Communications revenue was up 134.7% year over year. Communications sales represented 15.6% of our total third quarter revenue compared with 13.4% in the second quarter of 2026.

Third quarter Enterprise Data revenue of $506.7 million increased 33.2% from the second quarter. The sequential increase was driven by higher sales of our power management solutions for AI and server applications. Third quarter Enterprise Data revenue was up 164.6% year over year. Enterprise Data revenue represented 42.1% of our total third quarter revenue compared with 38.8% in the second quarter of 2026.

Third quarter Industrial revenue of $71.4 million increased 30.2% from the second quarter primarily as a result of higher sales for power sources. Third quarter Industrial revenue was up 29.0% year over year. Industrial revenue represented 6.0% of our total third quarter revenue compared with 5.6% in the second quarter of 2026.

Third quarter Automotive revenue of $180.7 million increased 15.0% from the second quarter primarily from higher sales of ADAS power solutions. Third quarter Automotive revenue was up 19.2% year over year. Automotive revenue represented 15.0% of our third quarter revenue compared with 16.0% in the second quarter of 2026.

Third quarter Consumer revenue of $64.0 million increased 12.6% from the second quarter. Third quarter Consumer revenue was down 11.6% year over year. Consumer revenue represented 5.3% of our total third quarter revenue compared with 5.8% in the second quarter of 2026.

Third quarter Storage and Computing revenue of $192.2 million decreased 3.8% from the second quarter. Third quarter Storage and Computing revenue was up 3.0% year over year. Storage and Computing revenue represented 16.0% of MPS’s third quarter revenue compared with 20.4% in the second quarter of 2026.

Q3 2026 Gross Margin & Operating Income

GAAP gross margin was 55.4%, 0.2 percentage points higher than the second quarter of 2026. Our GAAP operating income was $357.7 million compared to $303.9 million reported in the second quarter of 2026.

Non-GAAP gross margin for the third quarter of 2026 was 55.7%, 0.1 percentage points higher than the second quarter of 2026. Our non-GAAP operating income was $464.5 million compared to $367.7 million reported in the second quarter of 2026.

Q3 2026 Operating Expenses

GAAP operating expenses were $307.9 million in the third quarter of 2026 compared with $237.2 million in the second quarter of 2026. Non-GAAP operating expenses were $205.3 million, up from $177.6 million in the second quarter of 2026.

The differences between non-GAAP operating expenses and GAAP operating expenses for the quarters discussed here are primarily stock-based compensation and related expenses and deferred compensation plan income (expense).

Total stock-based compensation and related expenses, including approximately $3.7 million charged to cost of goods sold, was $106.3 million in the third quarter of 2026 compared with $53.5 million in the second quarter of 2026.

The Bottom Line

Third quarter 2026 GAAP net income was $271.1 million or $5.51 per fully diluted share, compared with $257.3 million or $5.22 per fully diluted share in the second quarter of 2026.

Third quarter 2026 non-GAAP net income was $402.7 million or $8.19 per fully diluted share, compared with $320.1 million or $6.50 per fully diluted share in the second quarter of 2026.

Third quarter 2026 non-GAAP tax rate of 15% was flat to the second quarter of 2026.

There were 49.2 million fully diluted shares outstanding at the end of the third quarter of 2026.

We repurchased $453.4 million of our stock in the third quarter, compared to $4.0 million in the second quarter of 2026.

Balance Sheet and Cash Flow

Cash, cash equivalents and short-term investments were $1,091 million at the end of the third quarter of 2026 compared to $1,414 million at the end of the second quarter of 2026. For the third quarter of 2026, MPS generated operating cash flow of $289.9 million compared with second quarter of 2026 operating cash flow of $227.9 million.

Accounts receivable at the end of the third quarter of 2026 were $461.6 million, representing 35 days of sales outstanding, which was 3 days higher than the 32 days reported at the end of the second quarter of 2026.

Our internal inventories at the end of the third quarter of 2026 were $764.9 million, up from $675.8 million at the end of the second quarter of 2026. Days of inventory of 130 days at the end of the third quarter of 2026 was 10 days lower than at the end of the second quarter of 2026.

Comparing current inventory levels using next quarter’s projected revenue, days of inventory at the end of the third quarter of 117 days was 2 days higher than at the end of the second quarter of 2026.

Selected Balance Sheet and Inventory Data (Unaudited)  
             
  Q3’26   Q2’26   Q3’25  
Cash, Cash Equivalents, and Short-Term Investments $ 1,091.2 M   $ 1,413.8 M   $ 1,269.5 M  
Operating Cash Flow $ 289.9 M   $ 227.9 M   $ 239.3 M  
Accounts Receivable $ 461.6 M   $ 343.6 M   $ 241.6 M  
Days of Sales Outstanding 35 Days   32 Days   30 Days  
Internal Inventories $ 764.9 M   $ 675.8 M   $ 505.7 M  
Days of Inventory (current quarter revenue) 130 Days   140 Days   139 Days  
Days of Inventory (next quarter revenue) 117 Days   115 Days   137 Days  


Q4 2026 Business Outlook

For the fourth quarter of 2026 ending December 31, we are forecasting:

  • Revenue in the range of $1,315 million to $1,385 million.
  • GAAP gross margin in the range of 55.2% to 55.8%.
  • Non-GAAP gross margin in the range of 55.5% to 56.1%, which excludes the impact from stock-based compensation and related expenses as well as the impact from amortization of acquisition-related intangible assets.
  • Total stock-based compensation and related expenses in the range of $121.0 million to $125.0 million including approximately $3.8 million that would be charged to cost of goods sold.
  • GAAP operating expenses between $334.0 million and $342.0 million.
  • Non-GAAP operating expenses in the range of $216.8 million to $220.8 million. This estimate excludes stock-based compensation and related expenses in the range of $117.2 million to $121.2 million.
  • Interest and other income in the range from $7.8 million to $8.2 million before foreign exchange gains or losses.
  • Non-GAAP tax rate of 15% for 2026.
  • Fully diluted shares outstanding in the range of 48.9 to 49.3 million shares.

Furthermore, in October 2026, our Board of Directors authorized an additional $500 million for stock repurchases, bringing our total current authorization to $1 billion after repurchases made during the third quarter of 2026.

For further information, contact:

Tony Balow
Vice President, Chief Financial Officer
Monolithic Power Systems, Inc.
MPSInvestor.Relations@monolithicpower.com

Safe Harbor Statement

This earnings commentary contains, and statements that will be made during the accompanying webinar will contain, forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, that should not be unduly relied upon, including under the “Q4 2026 Business Outlook” section herein, the quote from our Chief Executive Officer regarding our growth and success of our business strategy, our statements regarding our business focus, expected capacity growth and the timing thereof, expected strong demand across our existing customers into 2027, expected design wins as a driver of growth for our Automotive end market in 2027, increasing sales of robotic solutions across multiple geographies, increasing sales of large data converters in 2027, the continued increase in our SAM through increasing sales of our high speed memory products, the build out of our high voltage portfolio and GAN based solutions, investments in new technologies that open new end markets and applications, and the expansion and diversification of our supply chain to allow us to capture future growth opportunities, maintain supply stability and swiftly adapt to market changes as they occur, including, among other things, (i) projected revenue, GAAP and non-GAAP gross margin, GAAP and non-GAAP operating expenses, stock-based compensation and related expenses, amortization of acquisition-related intangible assets, other income before foreign exchange gains or losses, and fully diluted shares outstanding, (ii) our outlook for the fourth quarter of fiscal year 2026 and the near-term, medium-term and long-term prospects of MPS, including our ability to adapt to changing market conditions, performance against our business plan, our ability to grow despite the various challenges facing our business, our industry and the global economic environment, potential new business segments, our continued investment in research and development (“R&D”), expected revenue growth, customers’ acceptance of our new product offerings, the prospects of our new product development, our expectations regarding market and industry trends and prospects, and our goal to expand our capacity and the impact it may have on our business, (iii) our ability to penetrate new markets and expand our market share, (iv) our ability to reduce our expenses, and (vi) statements regarding the assumptions underlying or relating to any statement described above. These forward-looking statements are not historical facts or guarantees of future performance or events, are based on current expectations, estimates, beliefs, assumptions, goals, and objectives, and involve significant known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from the results expressed by these statements. Readers of this earnings commentary and listeners to the accompanying conference call are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Factors that could cause actual results to differ include, but are not limited to, continued uncertainties in the global economy, including due to current and potential global conflicts, global tariffs, export controls and retaliatory measures and announcements regarding same, inflation, consumer sentiment and other factors; adverse events arising from orders or regulations of governmental entities, including such orders or regulations that impact our customers or suppliers, and adoption of new or amended accounting standards; adverse changes in laws and government regulations such as tariffs on imports of foreign goods, export regulations and export classifications, and tax laws or the interpretation of same, including in foreign countries where MPS has offices or operations; the effect of export controls, trade and economic sanctions regulations and other regulatory or contractual limitations on our ability to sell or develop our products in certain foreign markets, particularly in China; our ability to obtain governmental licenses and approvals for international trading activities or technology transfers, including export licenses; acceptance of, or demand for, our products, in particular the new products launched recently, being different than expected; our ability to increase market share in our targeted markets; difficulty in predicting or budgeting for future customer demand and channel inventories, expenses and financial contingencies (including as a result of any impact from current and potential global conflicts); our ability to efficiently and effectively develop new products and receive a return on our R&D expense investment; our ability to attract new customers and retain existing customers; our ability to meet customer demand for our products due to constraints on our third-party suppliers’ ability to manufacture sufficient quantities of our products or otherwise; our ability to expand manufacturing capacity to support future growth; adverse changes in production and testing efficiency of our products; any political, cultural, military, regulatory, economic, foreign exchange and operational changes in China, where a significant portion of our manufacturing capacity comes from; any market disruptions or interruptions in our schedule of new product development releases; our ability to manage our inventory levels; adequate supply of our products from our third-party manufacturing partners; adverse changes or developments in the semiconductor industry generally, which is cyclical in nature, and our ability to adjust our operations to address such changes or developments; the ongoing consolidation of companies in the semiconductor industry; competition generally and the increasingly competitive nature of our industry; our ability to realize the anticipated benefits of companies and products that MPS acquires, and our ability to effectively and efficiently integrate these acquired companies and products into our operations; the risks, uncertainties and costs of litigation in which MPS is involved; the outcome of any upcoming trials, hearings, motions and appeals; the adverse impact on our financial performance if its tax and litigation provisions are inadequate; our ability to effectively manage our growth and attract and retain qualified personnel; the effect of epidemics and pandemics on the global economy and on our business; the risks associated with the financial market, economy, global tariffs, export controls and retaliatory measures and announcements regarding same, and geopolitical uncertainties, including current and potential global conflicts; the Company’s ability to timely and adequately remediate its material weakness; and other important risk factors identified under the caption “Risk Factors” and elsewhere in our Securities and Exchange Commission (“SEC”) filings, including, but not limited to, our Annual Report on Form 10-K filed with the SEC on February 27, 2026. MPS assumes no obligation to update the information in this earnings commentary or in the accompanying webinar.

Non-GAAP Financial Measures

This earnings commentary contains references to certain non-GAAP financial measures. Non-GAAP net income, non-GAAP net income per share, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP operating income, non-GAAP other income, net, and non-GAAP income before income taxes differ from net income, net income per share, gross margin, operating expenses, operating income, other income, net, and income before income taxes determined in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). Non-GAAP net income and non-GAAP net income per share exclude the effect of stock-based compensation and related expenses, which include stock-based compensation expense and employer payroll taxes in relation to the stock-based compensation, amortization of acquisition-related intangible assets, net deferred compensation plan expense, and related tax effects. Non-GAAP gross margin excludes the effect of stock-based compensation and related expenses, amortization of acquisition-related intangible assets and deferred compensation plan expense. Non-GAAP operating expenses exclude the effect of stock-based compensation and related expenses, amortization of acquisition-related intangible assets and deferred compensation plan income (expense). Non-GAAP operating income excludes the effect of stock-based compensation and related expenses, amortization of acquisition-related intangible assets and deferred compensation plan expense. Non-GAAP other income, net excludes the effect of deferred compensation plan expense (income). Non-GAAP income before income taxes excludes the effect of stock-based compensation and related expenses, amortization of acquisition-related intangible assets and net deferred compensation plan expense. Projected non-GAAP gross margin excludes the effect of stock-based compensation and related expenses, and amortization of acquisition-related intangible assets. Projected non-GAAP operating expenses exclude the effect of stock-based compensation and related expenses. These non-GAAP financial measures are not prepared in accordance with GAAP and should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. MPS utilizes both GAAP and non-GAAP financial measures to assess what it believes to be its core operating performance and to evaluate and manage its internal business and assist in making financial operating decisions. MPS believes that the inclusion of non-GAAP financial measures, together with GAAP measures, provides investors with an alternative presentation useful to investors’ understanding of MPS’s core operating results and trends. Additionally, MPS believes that the inclusion of non-GAAP measures, together with GAAP measures, provides investors with an additional dimension of comparability to similar companies. However, investors should be aware that non-GAAP financial measures utilized by other companies are not likely to be comparable in most cases to the non-GAAP financial measures used by MPS. See the GAAP to Non-GAAP reconciliations in the tables set forth below.

About Monolithic Power Systems

MPS is a fabless global company that provides high-performance, semiconductor-based power electronics solutions. MPS’s mission is to reduce energy and material consumption to improve all aspects of quality of life and create a sustainable future. Founded in 1997 by our CEO Michael Hsing, MPS has three core strengths: deep system-level knowledge, strong semiconductor design expertise, and innovative proprietary technologies in the areas of semiconductor processes, system integration, and packaging. These combined advantages enable MPS to deliver reliable, compact, and monolithic solutions that are highly energy-efficient, cost-effective, and environmentally responsible, while providing a consistent return on investment to our stockholders. MPS can be contacted through its website at www.monolithicpower.com or its support offices around the world.

Monolithic Power Systems, MPS, and the MPS logo are registered trademarks of Monolithic Power Systems, Inc. in the U.S. and trademarked in certain other countries.

Monolithic Power Systems, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except par value)
  September 30,   December 31,
  2026   2025
ASSETS          
Current assets:          
Cash and cash equivalents $ 560,544     $ 1,099,302    
Short-term investments   530,690       157,243    
Accounts receivable, net   461,633       255,626    
Inventories   764,879       564,649    
Other current assets   54,024       106,982    
Total current assets   2,371,770       2,183,802    
Property and equipment, net   821,573       627,689    
Acquisition-related intangible assets, net   7,929       8,790    
Goodwill   25,944       25,944    
Deferred tax assets, net   1,183,003       1,182,883    
Other long-term assets   262,362       165,091    
Total assets $ 4,672,581     $ 4,194,199    
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable $ 236,469     $ 138,272    
Accrued compensation and related benefits   136,528       85,963    
Other accrued liabilities   267,657       145,130    
Total current liabilities   640,654       369,365    
Income tax liabilities   75,022       75,022    
Deferred tax liabilities   90,316       90,480    
Other long-term liabilities   132,849       127,835    
Total liabilities   938,841       662,702    
Commitments and contingencies          
Stockholders’ equity:          
Common stock and additional paid-in capital: $0.001 par value; shares authorized: 150,000; shares issued and outstanding: 48,792 and 48,709, respectively   690,429       936,998    
Retained earnings   3,034,058       2,609,651    
Accumulated other comprehensive income (loss)   9,253       (15,152 )  
Total stockholders’ equity   3,733,740       3,531,497    
Total liabilities and stockholders’ equity $ 4,672,581     $ 4,194,199    

Monolithic Power Systems, Inc.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except per share amounts)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Revenue $ 1,202,409     $ 737,176     $ 2,987,236     $ 2,039,304  
Cost of revenue   536,870       330,948       1,335,562       913,830  
Gross profit   665,539       406,228       1,651,674       1,125,474  
Operating expenses:                      
Research and development   140,581       98,173       359,765       286,666  
Selling, general and administrative   167,271       112,872       389,176       310,108  
Total operating expenses   307,852       211,045       748,941       596,774  
Operating income   357,687       195,183       902,733       528,700  
Other income, net   8,936       10,392       32,801       27,743  
Income before income taxes   366,623       205,575       935,534       556,443  
Income tax expense   95,556       25,809       213,943       106,616  
Net income $ 271,067     $ 179,766     $ 721,591     $ 449,827  
                       
Net income per share:                      
Basic $ 5.53     $ 3.75     $ 14.70     $ 9.40  
Diluted $ 5.51     $ 3.74     $ 14.66     $ 9.37  
Weighted-average shares outstanding:                      
Basic   49,052       47,898       49,097       47,879  
Diluted   49,184       48,042       49,230       48,022  

RECONCILIATION OF NET INCOME TO NON-GAAP NET INCOME
(Unaudited, in thousands, except per share amounts)
  Three Months Ended September 30,   Nine Months Ended September 30,
  2026   2025   2026   2025
Net income $ 271,067     $ 179,766       $ 721,591     $ 449,827    
                       
Adjustments to reconcile net income to non-GAAP net income:                      
Stock-based compensation and related expenses   106,288       60,875         208,375       174,966    
Amortization of acquisition-related intangible assets   320       320         960       960    
Deferred compensation plan expense, net   544       423         1,129       698    
Tax effect   24,489       (14,270 )       42,043       (3,344 )  
Non-GAAP net income $ 402,708     $ 227,114       $ 974,098     $ 623,107    
                       
Non-GAAP net income per share:                      
Basic $ 8.21     $ 4.74       $ 19.84     $ 13.01    
Diluted $ 8.19     $ 4.73       $ 19.79     $ 12.98    
                       
Shares used in the calculation of non-GAAP net income per share:                      
Basic   49,052       47,898         49,097       47,879    
Diluted   49,184       48,042         49,230       48,022    

RECONCILIATION OF GROSS MARGIN TO NON-GAAP GROSS MARGIN
(Unaudited, in thousands)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Gross profit $ 665,539       $ 406,228       $ 1,651,674       $ 1,125,474    
Gross margin   55.4 %       55.1 %       55.3 %       55.2 %  
                       
Adjustments to reconcile gross profit to non-GAAP gross profit:                      
Stock-based compensation and related expenses   3,702         1,917         7,151         5,538    
Amortization of acquisition-related intangible assets   287         287         861         861    
Deferred compensation plan expense   261         500         1,731         942    
Non-GAAP gross profit $ 669,790       $ 408,932       $ 1,661,418       $ 1,132,815    
Non-GAAP gross margin   55.7 %       55.5 %       55.6 %       55.5 %  

RECONCILIATION OF OPERATING EXPENSES TO NON-GAAP OPERATING EXPENSES
(Unaudited, in thousands)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Total operating expenses $ 307,852     $ 211,045     $ 748,941     $ 596,774  
               
Adjustments to reconcile total operating expenses to non-GAAP total operating expenses:              
Stock-based compensation and related expenses   (102,586 )     (58,958 )     (201,224 )     (169,428 )
Amortization of acquisition-related intangible assets   (33 )     (33 )     (99 )     (99 )
Deferred compensation plan income (expense)   72       (3,715 )     (6,386 )     (7,778 )
Non-GAAP operating expenses $ 205,306     $ 148,339     $ 541,233     $ 419,469  

RECONCILIATION OF OPERATING INCOME TO NON-GAAP OPERATING INCOME
(Unaudited, in thousands)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Total operating income $ 357,687     $ 195,183     $ 902,733     $ 528,700  
                       
Adjustments to reconcile total operating income to non-GAAP total operating income:                      
Stock-based compensation and related expenses   106,288       60,875       208,375       174,966  
Amortization of acquisition-related intangible assets   320       320       960       960  
Deferred compensation plan expense   189       4,215       8,117       8,720  
Non-GAAP operating income $ 464,484     $ 260,593     $ 1,120,185     $ 713,346  

RECONCILIATION OF OTHER INCOME, NET, TO NON-GAAP OTHER INCOME, NET
(Unaudited, in thousands)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Total other income, net $ 8,936     $ 10,392       $ 32,801       $ 27,743    
                       
Adjustments to reconcile other income, net to non-GAAP other income, net:                      
Deferred compensation plan expense (income)   355       (3,792 )       (6,988 )       (8,022 )  
Non-GAAP other income, net $ 9,291     $ 6,600       $ 25,813       $ 19,721    

RECONCILIATION OF INCOME BEFORE INCOME TAXES TO NON-GAAP INCOME BEFORE INCOME TAXES
(Unaudited, in thousands)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2026     2025     2026     2025
Total income before income taxes $ 366,623     $ 205,575     $ 935,534     $ 556,443  
                       
Adjustments to reconcile income before income taxes to non-GAAP income before income taxes:                      
Stock-based compensation and related expenses   106,288       60,875       208,375       174,966  
Amortization of acquisition-related intangible assets   320       320       960       960  
Deferred compensation plan expense, net   544       423       1,129       698  
Non-GAAP income before income taxes $ 473,775     $ 267,193     $ 1,145,998     $ 733,067  

2026 FOURTH QUARTER OUTLOOK
RECONCILIATION OF GROSS MARGIN TO NON-GAAP GROSS MARGIN
(Unaudited)
  Three Months Ending
  December 31, 2026
  Low   High
Gross margin 55.2 %     55.8 %  
Adjustment to reconcile gross margin to non-GAAP gross margin:          
Stock-based compensation and other expenses 0.3       0.3    
Non-GAAP gross margin 55.5 %     56.1 %  

RECONCILIATION OF OPERATING EXPENSES TO NON-GAAP OPERATING EXPENSES
(Unaudited, in thousands)
  Three Months Ending
  December 31, 2026
  Low   High
Operating expenses $ 334,000     $ 342,000  
Adjustments to reconcile operating expenses to non-GAAP operating expenses:      
Stock-based compensation and other expenses   (117,200 )     (121,200 )
Non-GAAP operating expenses $ 216,800     $ 220,800  

– $353.2 million in total third quarter revenues, primarily comprised of $253.2 million of U.S. Attruby net product revenue (up approximately $31 million sequentially and $145 million year over year). Loss from operations was $11.6 million, driven by increased revenue and a one-time $75.0 million BEYONTTRA sales milestone from Bayer. Cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026, fully funding all three launches and expansion indications

– Attruby growth was again led by the treatment-naïve segment, with both the number of newly diagnosed patients starting treatment and Attruby’s share of those starts increasing

– Real-world evidence continues to differentiate acoramidis from tafamidis on outcomes that matter to patients, physicians, and payers: (i) an independent Epic COSMOS analysis of 2,684 patients found an 18% lower risk of death, hospitalization, new atrial fibrillation or diuretic escalation (p<0.01) with a 25% lower risk of hospitalization with acoramidis (p<0.001); (ii) the first peer-reviewed real-world comparison of TTR stabilizers found 34% less clinical worsening with acoramidis (p=0.046)

– Cardiac MRI from ATTRibute-CM and its extension showed evidence of potential reversal of structural damage and functional decline through 42 months for patients on acoramidis, with up to half of completers achieving clinically meaningful improvement in heart function. The first participant was dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby

– BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review. Launch preparation is well advanced, with 70% of patients concentrated at MDA Care Centers, over 70% of which the field team has reached with a 90% target by PDUFA. Based on interactions with EU national health authorities, the Company intends to submit an MAA to the EMA in the first half of 2028

– Oral infigratinib for achondroplasia has a February 4, 2027 PDUFA date, with Priority Review. The MAA is now under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with the U.S. field team fully staffed. In hypochondroplasia, the Phase 2/3 ACCEL study is expanding to higher doses to find the optimal dose, supported by safety data from PROPEL 3 and PROPEL OLE

– Encaleret for ADH1 has a May 8, 2027 PDUFA date, with Priority Review, and the MAA is under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with >600 genetically confirmed patients identified, up from approximately 500 last quarter, and the U.S. field team is fully deployed

– The first participant was dosed in RECLAIM-HP, the Phase 3 study for encaleret in chronic hypoparathyroidism. Topline data are expected in early 2028, representing a potential second indication in an estimated population of 200,000 patients in the U.S. and EU

PALO ALTO, Calif., Oct. 29, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the third quarter ended September 30, 2026, and provided an update on Attruby’s commercial progress.

Pipeline Overview:

Program Status Next expected milestone
Acoramidis for ATTR-CM Approved in U.S., EU, Japan, Switzerland, Brazil, U.K., and Australia New data to be shared at AHA 2026
BBP-418 for LGMD2I/R9 PDUFA date set for November 27, 2026, with Priority Review U.S. launch upon FDA approval
Oral infigratinib for achondroplasia PDUFA date set for February 4, 2027, with Priority Review; MAA submitted to EMA U.S. launch upon FDA approval
Encaleret for ADH1 PDUFA date set for May 8, 2027, with Priority Review; MAA submitted to EMA U.S. launch upon FDA approval
Encaleret for chronic hypoparathyroidism First participant dosed in RECLAIM-HP, registrational Phase 3 study Topline data anticipated early 2028
Oral infigratinib for hypochondroplasia Enrolling additional dose cohorts for Phase 2 study Initiation of dosing in additional dose cohorts
Depleter (BBP-717) for ATTR-CM Development candidate nomination Submit IND to the FDA in 2027
     

“I’m heartened by how consistently the evidence for acoramidis keeps pointing in the same direction,” said Neil Kumar, Chief Executive Officer of BridgeBio. “This quarter we added two more large real-world comparisons to a growing body of data showing acoramidis outperforming tafamidis on the outcomes that matter most to patients: survival and hospitalizations. This is exactly what you would expect from the only near-complete stabilizer on the market, and it is deeply gratifying to see it borne out in the real world. This is also a particularly special moment for the company. Three PDUFA dates fall within the next seven months, each with the potential to be a first for communities that have waited far too long: BBP-418 for LGMD2I/R9, where no approved therapy exists; infigratinib as the first oral option for achondroplasia; and encaleret for ADH1, which has never had a therapy of its own.”

Commercial Updates:
The third quarter total revenues, net totaled $353.2 million, comprised of $253.2 million of U.S. Attruby net product revenue, $0.1 million of Rest of World Attruby net product revenue, $20.5 million from royalty revenue, and $79.3 million in license and services revenue.

“Attruby delivered another quarter of sequential growth, driven by continued gains in first-line share, and the real-world evidence emerging across independent datasets continues to reinforce its position as the stabilizer of choice,” said Matt Outten, Chief Commercial Officer of BridgeBio. “This is a pivotal moment for BridgeBio as we stand weeks away from the potential approval of BBP-418, the first and only treatment for LGMD2I/R9, followed by infigratinib in February and encaleret in May. Our field teams for all three programs are hired and ready to serve these communities from day one.”

Pipeline Updates:
Attruby (acoramidis) – First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):

  • Acoramidis significantly reduced the risk of early clinical worsening versus tafamidis in the first peer-reviewed, contemporary real-world comparative effectiveness study of TTR stabilizers, published in Cardiology and Therapy1 using U.S. claims data, with a statistically and clinically significant 34% reduction in composite clinical worsening (HR 0.66; p=0.046) and a 43% reduction in diuretic intensification (HR 0.57; p=0.021). Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time.
  • BridgeBio presented2 an independent, real-world, propensity score-matched analysis of 2,684 individuals with ATTR-CM from a contemporary population in the Epic COSMOS U.S. electronic health record database at the Heart Failure Society of America Annual Scientific Meeting 2026. Compared with tafamidis, acoramidis was associated with an 18% lower risk of a composite of death, all-cause hospitalization, new-onset atrial fibrillation, and diuretic intensification (HR 0.82; p<0.01), as well as a 27% lower risk of cardiovascular hospitalization, a 27% lower risk of heart failure hospitalization and a 25% lower risk of all-cause hospitalization (all p<0.001).
  • These comparative effectiveness findings continue to build on consistent results from several other analyses, including the independent TriNetX propensity score-matched analysis published in JSCAI, the ReplicATTR trial-emulation study, and the anchored matching-adjusted indirect comparison presented at ESC-HF 2026.
  • New data at the European Society of Cardiology Congress 2026 provided evidence of a potential reversal of cardiac structural disease progression in ATTR-CM, with serial CMR imaging from ATTRibute-CM and its open-label extension showing clinically meaningful improvement in left ventricular systolic function in 54% of acoramidis-treated participants versus 20% of placebo-treated participants at Month 30 and in 53% of continuous-acoramidis participants at Month 42 in a completer analysis. Participants treated with acoramidis also gained an unprecedented 65 additional days alive and out of the hospital by Month 36. Month 54 data across variant ATTR-CM subgroups, published simultaneously in the European Journal of Heart Failure3, showed a more than two-fold mortality difference favoring continuous acoramidis within the p.Val142Ile subgroup.
  • Building on the ESC data, BridgeBio dosed the first participant in ASCEND-ATTR. This Phase 3b/4 study is designed to determine whether acoramidis is associated with sustained improvement in cardiac structure, function, and amyloid burden, as measured by cardiac MRI and echocardiography over 36 months.
  • Additional data on the benefit of acoramidis for individuals with ATTR-CM will be shared at the upcoming American Heart Association (AHA) 2026 Scientific Sessions.

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

  • BridgeBio believes BBP-418 is positioned to become the first and only approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD.
  • On May 27, 2026, the FDA accepted the Company’s New Drug Application (NDA) for BBP-418 and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. No advisory committee meeting is currently planned.
  • BridgeBio presented4 new exploratory cardiac data from the Phase 3 FORTIFY trial of BBP-418 in LGMD2I/R9 at the World Muscle Society (WMS) Congress 2026. Cardiac involvement is an important driver of morbidity and mortality in LGMD2I/R9 and an area of significant unmet need. At Month 12, 100% of BBP-418-treated participants with baseline elevated high-sensitivity troponin I, a blood marker of heart muscle injury, returned to the normal range, compared with 40% on placebo (p=0.0248). In addition, 54% of BBP-418-treated participants had stable or improved heart pumping function (LVEF), compared with 25% on placebo (p=0.0262). These results demonstrate potential to ameliorate cardiac dysfunction by targeting the disease at its source with BBP-418 treatment.
  • Additionally, a poster shared5 at the WMS Congress 2026 showed that BBP-418 increased mean glycosylated αDG above asymptomatic carrier levels by Month 12, suggesting it can restore glycosylated αDG to unaffected levels. Together with functional improvement from baseline rather than stabilization, this pattern of biomarker normalization is consistent with the potential for BBP-418 to be a disease-modifying therapy.
  • About one month from the PDUFA date, the Company has identified more than 500 unique patients with LGMD2I/R9 in the U.S. through claims, genetic testing, and account profiling. About 70% of individuals living with LGMD2I/R9 receive care through the Muscular Dystrophy Association (MDA) Care Center Network. Since entering the field in August 2026, the Company’s Neuromuscular Account Managers have reached more than 70% of MDA centers and are expected to reach at least 90% of these centers by the PDUFA date.
  • After multiple positive, highly collaborative interactions with national health authorities in the European Union (EU), the Company intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2028. The MAA will be based on the final analysis of the Phase 3 FORTIFY study at Month 36, with topline results expected late 2027/early 2028. Europe has the highest prevalence of LGMD2I/R9 globally, with more than 4,000 patients, due to a founder mutation most often found in people of Northern European ancestry.
  • To raise disease awareness and increase genetic testing, BridgeBio launched Type Hype, a patient-facing campaign that encourages people with suspected LGMD to ask their doctor about genetic testing. The Company also took part in a Lifetime feature, along with Kelly Brazzo, CEO and Founder of CureLGMD2i Foundation, on The Balancing Act for LGMD Awareness Day.
  • The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals who are less than 12 years of age in the first half of 2027, and in LGMD2M/R13 and LGMD2U/R20 in the near future.

Oral infigratinib – FGFR3 inhibitor for achondroplasia and hypochondroplasia:

  • BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia.
  • The FDA accepted the Company’s NDA for oral infigratinib and granted Priority Review, assigning a PDUFA target action date of February 4, 2027. Oral infigratinib has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations from the FDA, and Orphan Drug Designation from both the FDA and the EMA. Oral infigratinib is the only therapeutic option in development for achondroplasia to hold Breakthrough Therapy Designation.
  • The Company submitted an MAA to the EMA for oral infigratinib in achondroplasia, which is now under review, with potential EU approval in the second half of 2027.
  • BridgeBio presented6 new exploratory data from the Phase 3 PROPEL 3 trial at the Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2026, showing favorable trends in health outcomes beyond height for children living with achondroplasia. Over 52 weeks, children treated with oral infigratinib had a 38% lower rate of ear infections (otitis media) than placebo, and sleep apnea measures stayed stable compared with a 49% increase on placebo. Longer-term PROPEL program data showed sustained gains in growth and body proportionality through three years of treatment, with no new safety signals.
  • Additionally, BridgeBio shared7 a poster at the ASBMR 2026 Annual Meeting, featuring data showing a lack of peripheral FGFR1 inhibition at clinically relevant infigratinib exposures, supporting the safety profile observed in children with achondroplasia in the PROPEL clinical program.
  • BridgeBio fully staffed its U.S. field team for oral infigratinib. The team brings deep experience across growth disorders, including achondroplasia, rare genetic conditions, and competitive launches.
  • The Company is actively enrolling participants for its achondroplasia program from birth to under 3 years of age.
  • In hypochondroplasia, the Phase 2/3 ACCEL study is expanding to higher doses to find the optimal dose, supported by safety data from PROPEL 3 and PROPEL OLE.

Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:

  • BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1, in both the U.S. and EU.
  • The FDA accepted the Company’s NDA for encaleret and granted Priority Review, assigning a PDUFA target action date of May 8, 2027. No advisory committee meeting is currently planned.
  • BridgeBio submitted an MAA to the EMA for the use of encaleret in ADH1, which is now under review, with potential EU approval in the second half of 2027.
  • New Phase 3 CALIBRATE data presented at the American Society of Nephrology Kidney Week 2026 showed8 that encaleret was associated with a significant increase in kidney function (eGFR) at Week 24 compared with conventional therapy (+11 vs. +3 mL/min/1.73m²; p<0.05), suggesting that encaleret may preserve or improve kidney function in an ADH1 patient population that is at risk of kidney complications when managed with conventional therapy.
  • Additionally, at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting, new Phase 3 CALIBRATE data showed9 encaleret increased bone turnover, based on its action to recover the body’s own PTH production, and 100% of encaleret participants reported improvement in at least one ADH1 symptom (vs. 46% on standard of care).
  • The U.S. field team dedicated to encaleret has been trained and deployed, and continues to expand diagnosis through disease state education and no-cost genetic testing. There are now >600 genetically confirmed patients identified, up from approximately 500 last quarter.
  • CALIBRATE-PEDS, the registrational Phase 2/3 study of encaleret in pediatric ADH1, is ongoing and has completed enrollment in the first of four cohorts (adolescents 12 to 17 years of age).
  • The first participant was dosed in RECLAIM-HP, the registrational Phase 3 study of encaleret in chronic hypoparathyroidism. Topline results from the study are anticipated in early 2028. Chronic hypoparathyroidism affects approximately 200,000 patients in the U.S. and EU and represents a substantial expansion of the encaleret opportunity beyond ADH1. Encaleret is the only oral therapy in development being evaluated to normalize both blood and urine calcium in this population.

BBP-717 – Monoclonal antibody depleter for ATTR-CM:

  • BridgeBio nominated BBP-717 as a development candidate. BBP-717 is a next-generation monoclonal antibody designed to deplete amyloid deposits in patients with ATTR-CM. The Company plans to submit an Investigational New Drug (IND) application to the FDA in 2027.
  • BBP-717 builds on BridgeBio’s leadership in ATTR-CM and is designed to complement near-complete TTR stabilization by clearing existing amyloid deposits.

Financial Updates:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $1.5 billion and $587.5 million as of September 30, 2026 and December 31, 2025, respectively.

Total Revenues, Net

  Three Months Ended September 30,
  Nine Months Ended September 30,
  2026
  2025
  2026
  2025
  (in thousands)  
Net product revenue $ 253,346     $ 108,111     $ 656,382     $ 216,351  
License and services revenue   79,314       8,311       89,537       125,441  
Royalty revenue   20,511       4,278       45,443       6,106  
Total revenues, net $ 353,171     $ 120,700     $ 791,362     $ 347,898  
                               

Total revenues, net for the three months ended September 30, 2026 were $353.2 million compared to $120.7 million for the same period in 2025. The $232.5 million increase was primarily driven by a $145.2 million increase in Attruby net product revenue, a $71.1 million increase in license and services revenue primarily due to recognition of a $75.0 million sales milestone under the Bayer License Agreement achieved during the third quarter of 2026, and a $16.2 million increase in royalty revenue primarily earned from net product sales of BEYONTTRA in the EU and Japan.

Total revenues, net for the nine months ended September 30, 2026 were $791.4 million compared to $347.9 million for the same period in 2025. The $443.5 million increase was primarily driven by a $440.0 million increase in Attruby net product revenue and a $39.3 million increase in royalty revenue primarily earned from net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a $35.8 million decrease in license and services revenue. This decrease was primarily due to recognition of $105.0 million of regulatory milestone-related revenues during the nine months ended September 30, 2025, partially offset by recognition of a $75.0 million sales milestone under the Bayer License Agreement achieved during the third quarter of 2026.

Total Operating Costs and Expenses

  Three Months Ended September 30,
  Nine Months Ended September 30,
  2026
  2025
  2026
  2025
  (in thousands)
Total cost of revenues $ 20,450     $ 6,563     $ 45,435     $ 12,855  
Research and development   143,506       112,874       419,590       335,536  
Selling, general and administrative   200,854       137,621       551,011       373,140  
Restructuring, impairment, and related charges   —       8,841       —       10,216  
Total operating costs and expenses $ 364,810     $ 265,899     $ 1,016,036     $ 731,747  
                               

Total operating costs and expenses for the three months ended September 30, 2026 were $364.8 million, compared to $265.9 million for the same period in 2025. The $98.9 million increase was primarily driven by a $63.2 million increase in selling, general and administrative (SG&A) expenses, reflecting continued investment in both the ongoing commercialization of Attruby and the pre-commercial activities for BridgeBio’s late-stage product candidates, a $30.6 million increase in research and development (R&D) expenses to support the development of late-stage product candidates, and a $13.9 million increase in total cost of revenues primarily due to higher sales volume of Attruby.

Total operating costs and expenses for the nine months ended September 30, 2026 were $1.0 billion, compared to $731.7 million for the same period in 2025. The $284.3 million increase was primarily driven by a $177.9 million increase in SG&A expenses, reflecting continued investment in both the ongoing commercialization of Attruby and the pre-commercial activities for BridgeBio’s late-stage product candidates, an $84.1 million increase in R&D expenses to support the development of late-stage product candidates, and a $32.6 million increase in total cost of revenues primarily due to higher sales volume of Attruby.

Stock-based compensation expenses included in operating costs and expenses for the three months ended September 30, 2026 were $39.9 million, of which $24.6 million, $14.9 million, and $0.4 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Stock-based compensation expenses included in operating costs and expenses for the same period in 2025 were $35.3 million, of which $21.9 million, $12.3 million, $0.7 million, and $0.4 million were included in SG&A expenses, R&D expenses, restructuring, impairment, and related charges, and cost of goods sold, respectively.

Stock-based compensation expenses included in operating costs and expenses for the nine months ended September 30, 2026 were $117.7 million, of which $73.2 million, $42.5 million, and $2.0 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Stock-based compensation expenses included in operating costs and expenses for the same period in 2025 were $102.0 million, of which $63.1 million, $37.6 million, $0.7 million, and $0.6 million were included in SG&A expenses, R&D expenses, restructuring, impairment, and related charges, and cost of goods sold, respectively.

Total Other Income (Expense), Net

Total other income (expense), net for the three and nine months ended September 30, 2026, was $(47.6) million and $(157.0) million, respectively, compared to $(41.3) million and $(153.9) million, respectively, for the same periods in 2025.

The increase in total other income (expense), net of $6.3 million for the three months ended September 30, 2026, compared to the same period in 2025 was primarily driven by a $7.8 million decrease in nonrecurring noncash income from an equity method investment recognized in 2025, a $5.9 million increase in noncash interest expense related to deferred royalty obligations, and a $4.2 million decrease in other income resulting from changes in the valuation of the embedded derivative liability component of our deferred royalty obligation. These changes were partially offset by an $8.5 million decrease in net loss from equity method investments and a $6.9 million increase in interest income.

The increase in total other income (expense), net of $3.1 million for the nine months ended September 30, 2026, compared to the same period in 2025 was primarily driven by a $37.0 million increase in noncash interest expense related to deferred royalty obligations, a $7.8 million decrease in nonrecurring noncash income from an equity method investment recognized in 2025, a $4.9 million decrease in net gains on foreign currency transactions, and a $4.0 million decrease in other income resulting from changes in the valuation of the embedded derivative liability component of our deferred royalty obligation. These changes were partially offset by a $21.2 million decrease in loss on extinguishment of debt recognized in the first quarter of 2025, a $19.5 million decrease in net loss from equity method investments, and a $10.5 million increase in interest income.

Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share

For the three and nine months ended September 30, 2026, the Company recorded a net loss attributable to common stockholders of BridgeBio of $83.0 million and $399.3 million, respectively, compared to $182.7 million and $532.1 million, respectively, for the same periods in 2025.

For the three and nine months ended September 30, 2026, the Company reported a net loss per share of $0.42 and $2.04, respectively, compared to $0.95 and $2.79, respectively, for the same periods in 2025.

 
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
       
  Three Months Ended September 30,   Nine Months Ended September 30,
  2026   2025   2026   2025
  (Unaudited)   (Unaudited)
Revenues:              
Net product revenue $ 253,346     $ 108,111     $ 656,382     $ 216,351  
License and services revenue   79,314       8,311       89,537       125,441  
Royalty revenue   20,511       4,278       45,443       6,106  
Total revenues, net   353,171       120,700       791,362       347,898  
Operating costs and expenses:              
Cost of revenues:              
Cost of goods sold   12,317       4,028       30,577       8,910  
Cost of license, services, and royalty revenue   8,133       2,535       14,858       3,945  
Total cost of revenues   20,450       6,563       45,435       12,855  
Research and development   143,506       112,874       419,590       335,536  
Selling, general and administrative   200,854       137,621       551,011       373,140  
Restructuring, impairment, and related charges   —       8,841       —       10,216  
Total operating costs and expenses   364,810       265,899       1,016,036       731,747  
Loss from operations   (11,639 )     (145,199 )     (224,674 )     (383,849 )
Other income (expense), net:              
Interest income   13,105       6,239       26,010       15,522  
Interest expense   (13,255 )     (11,739 )     (39,475 )     (41,467 )
Noncash interest expense on deferred royalty obligations   (42,282 )     (36,410 )     (123,500 )     (86,460 )
Net loss from equity method investments   (7,312 )     (15,834 )     (32,030 )     (51,579 )
Loss on extinguishment of debt   —       —       —       (21,155 )
Other income, net   2,116       16,461       11,956       31,240  
Total other expense, net   (47,628 )     (41,283 )     (157,039 )     (153,899 )
Loss before income taxes   (59,267 )     (186,482 )     (381,713 )     (537,748 )
Provision for (benefit from) income taxes   1,229       (1,545 )     1,229       555  
Net loss   (60,496 )     (184,937 )     (382,942 )     (538,303 )
Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests   3,786       2,194       9,973       6,235  
Net loss attributable to BridgeBio   (56,710 )     (182,743 )     (372,969 )     (532,068 )
Preferred stock dividends and accretion   26,293       —       26,293       —  
Net loss attributable to common stockholders of BridgeBio $ (83,003 )   $ (182,743 )   $ (399,262 )   $ (532,068 )
Net loss per share attributable to common stockholders of BridgeBio, basic and diluted $ (0.42 )   $ (0.95 )   $ (2.04 )   $ (2.79 )
Weighted-average shares used in computing net loss per share attributable to common stockholders of BridgeBio, basic and diluted   196,029,851       191,854,152       195,539,752       190,845,133  
                               

  Three Months Ended September 30,
  Nine Months Ended September 30,
Stock-based Compensation 2026
  2025
  2026
  2025
  (Unaudited)     (Unaudited)  
Cost of goods sold $ 374     $ 361     $ 2,029     $ 578  
Research and development   14,921       12,328       42,504       37,582  
Selling, general and administrative   24,562       21,866       73,209       63,077  
Restructuring, impairment and related charges   —       709       —       755  
Total stock-based compensation $ 39,857     $ 35,264     $ 117,742     $ 101,992  
                               

 
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)
       
  September 30,
2026
  December 31,
2025
  (Unaudited)   (1)
Assets      
Cash, cash equivalents and marketable securities $ 1,538,855     $ 587,482  
Accounts receivable, net   375,089       139,444  
Inventories   59,718       26,753  
Prepaid expenses and other current assets   70,944       44,070  
Total current assets   2,044,606       797,749  
Equity method investments   47,783       79,972  
Property and equipment, net   5,042       5,366  
Operating lease right-of-use assets   15,746       8,149  
Intangible assets, net   25,923       28,077  
Other assets   22,686       16,712  
Total assets $ 2,161,786     $ 936,025  
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit      
Accounts payable $ 88,258     $ 36,228  
Operating lease liabilities, current portion   1,987       6,192  
Deferred revenue, current portion   4,744       7,190  
2027 Notes, net   548,430       —  
Accrued and other current liabilities   333,818       238,361  
Total current liabilities   977,237       287,971  
Operating lease liabilities, net of current portion   14,645       3,811  
Deferred revenue, net of current portion   8,968       13,080  
2027 Notes, net   —       547,015  
2029 Notes, net   742,437       740,890  
2031 Notes, net   566,013       564,565  
2033 Notes, net   620,533       —  
Deferred royalty obligations, net   884,053       855,030  
Other long-term liabilities   1,405       244  
Redeemable convertible noncontrolling interests   (1,363 )     (570 )
Series A preferred stock   942,478       —  
Common stock   207       202  
Treasury stock, at cost   (580,775 )     (323,276 )
Additional paid-in capital   2,170,006       2,057,646  
Accumulated other comprehensive income (loss)   (95 )     12  
Accumulated deficit   (4,194,163 )     (3,821,194 )
Noncontrolling interests   10,200       10,599  
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit $ 2,161,786     $ 936,025  
               

 
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
   
  Nine Months Ended September 30,
  2026   2025
  (Unaudited)
Operating activities:      
Net loss $ (382,942 )   $ (538,303 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Noncash interest expense on deferred royalty obligations   123,500       86,460  
Stock-based compensation   117,171       98,385  
Net loss from equity method investments   32,030       51,579  
Change in fair value of the embedded derivative associated with the deferred royalty obligation   (7,098 )     (11,062 )
Amortization of debt discount and issuance costs   5,670       4,515  
Depreciation and amortization   3,308       3,999  
Noncash lease expense   4,714       3,443  
Loss on extinguishment of debt   —       21,155  
Noncash income from an equity method investment   —       (7,769 )
Other noncash adjustments, net   2,233       (1,217 )
Changes in operating assets and liabilities:      
Accounts receivable, net   (235,646 )     (111,796 )
Inventories   (35,641 )     (23,356 )
Prepaid expenses and other current assets   (26,872 )     (17,527 )
Other assets   (5,849 )     568  
Accounts payable   51,993       9,084  
Accrued compensation and benefits   (9,049 )     3,212  
Accrued research and development liabilities   13,583       347  
Operating lease liabilities   (5,494 )     (4,757 )
Deferred revenue   (6,558 )     (9,480 )
Other liabilities   48,397       53,030  
Net cash used in operating activities   (312,550 )     (389,490 )
Investing activities:      
Purchases of marketable securities   (63,937 )     (10,876 )
Maturities of marketable securities   76,500       8,000  
Proceeds from special cash dividends received from an investment in equity securities   —       2,302  
Payment for intangible assets   —       (8,495 )
Purchases of property and equipment   (802 )     (1,064 )
Net cash provided by (used in) investing activities   11,761       (10,133 )
Financing activities:      
Proceeds from issuance of 2033 Notes   632,500       —  
Issuance costs and discounts associated with 2033 Notes   (13,227 )     —  
Proceeds from issuance of 2031 Notes   —       575,000  
Issuance costs and discounts associated with 2031 Notes   —       (12,034 )
Repayment of term loans   —       (459,000 )
Proceeds from royalty obligation under Royalty Purchase Agreement (as described in Note 9)   —       300,000  
Issuance costs associated with royalty obligation under Royalty Purchase Agreement   —       (3,010 )
Repayments of deferred royalty obligations   (62,507 )     (6,896 )
Proceeds from issuance of preferred stock   933,900       —  
Issuance costs associated with preferred stock   (1,342 )     —  
Payment of preferred stock dividends   (2,694 )     —  
Repurchase of common stock   (252,502 )     (48,276 )
Proceeds from stock option exercises, net of repurchases   33,712       14,523  
Proceeds from common stock issuances under ESPP   9,728       6,414  
Repurchase of RSU shares to satisfy tax withholding   (13,431 )     (6,796 )
Transactions with noncontrolling interests   —       1,550  
Net cash provided by financing activities   1,264,137       361,475  
Net increase (decrease) in cash, cash equivalents, and restricted cash   963,348       (38,148 )
Cash, cash equivalents, and restricted cash at beginning of period   572,140       683,244  
Cash, cash equivalents, and restricted cash at end of period $ 1,535,488     $ 645,096  
               

  Nine Months Ended September 30,
  2026   2025
  (Unaudited)
Supplemental Disclosure of Cash Flow Information:      
Cash paid for interest $ 43,135     $ 43,670  
Supplemental Disclosures of Noncash Investing and Financing Information:      
Accretion of preferred stock $ 9,920     $ —  
Accrued cash dividends on preferred stock $ 13,679     $ —  
Accrual for repurchase of common stock $ 4,997     $ —  
Transfers to noncontrolling interests $ (8,765 )   $ (4,734 )
Reconciliation of Cash, Cash Equivalents and Restricted Cash:      
Cash and cash equivalents $ 1,533,363     $ 642,951  
Restricted cash — Included in “Prepaid expenses and other current assets”   550       126  
Restricted cash — Included in “Other assets”   1,575       2,019  
Total cash, cash equivalents and restricted cash at end of periods shown on the condensed consolidated statements of cash flows $ 1,535,488     $ 645,096  
               

Webcast Information
BridgeBio will host a conference call and webcast to discuss third quarter financial results today, October 29, 2026, at 4:30 pm ET. This event can be accessed at https://events.q4inc.com/attendee/463906479 or by visiting the “Events & Presentations” page within the Investors section of the BridgeBio website at investor.bridgebio.com. A replay of the webcast will be available on the BridgeBio website for 30 days following the event.

About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the continued commercial success and market potential of Attruby/Beyonttra (acoramidis); the Company’s expectations regarding timing of regulatory submissions and target action dates, approvals and commercial launches in the U.S. and Europe, including for BBP-418 for LGMD2I/R9, encaleret for ADH1, and oral infigratinib for achondroplasia; the Company’s expectations regarding the timing and outcome of pre-commercial activities, including activities designed to support three potential launches; the timing of the Company’s clinical trials, milestones and expected updates for its various programs and pipeline; the safety and the potential benefits of the Company’s product and product candidates; the Company’s anticipated presentations of data; and the Company’s belief that its cash, cash equivalents and marketable securities will enable the Company to fund its three potential launches and expansion indications across its pipeline. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the Company’s pre-commercial activities, commercial launches or operational execution not occurring on anticipated timelines or not supporting planned launches as expected, real-world experience with Attruby/Beyonttra not being consistent with observed biochemical differentiation or not translating into differentiated clinical, commercial or market outcomes, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the Company’s share repurchase program being modified, suspended or discontinued, or share repurchases not delivering the anticipated benefits or proving to be a more attractive use of capital than other alternatives, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650)-789-8220

BridgeBio Investor Contact:
BridgeBio Investor Relations
ir@bridgebio.com


1 https://link.springer.com/article/10.1007/s40119-026-00476-2
2 https://investor.bridgebio.com/news/news-details/2026/Acoramidis-Associated-with-Significantly-Improved-Clinical-Outcomes-Versus-Tafamidis-in-ATTR-CM-in-an-Independent-Real-World-Study-of-U-S–Electronic-Health-Records/default.aspx
3 https://academic.oup.com/eurjhf/advance-article/doi/10.1093/ejhf/xuag258/8770437
4 https://investor.bridgebio.com/news/news-details/2026/BBP-418-Demonstrates-Potential-to-Be-Disease-Modifying-Therapy-Restoring-Cardiac-and-Disease-Markers-to-Unaffected-Levels/default.aspx
5 https://s205.q4cdn.com/224494602/files/doc_presentations/2026/Oct/02/BBIO-BBP-418-WMS-2026-aDG-in-FKRPCarriers-of-LGMD2I-R9.pdf
6 https://investor.bridgebio.com/news/news-details/2026/Oral-Infigratinib-Shows-Meaningful-Benefits-Beyond-Growth-Within-52-Weeks-in-Children-with-Achondroplasia-in-the-Phase-3-PROPEL-3-Trial/default.aspx
7 https://cdn.sanity.io/files/fcrea868/production/5e74345c1aaf6a6d0fad7f29253e02727b05948c.pdf
8 https://s205.q4cdn.com/224494602/files/doc_presentations/2026/Oct/24/BBIO-Encaleret-ASN-2026-CALIBRATE-renal-Sayer.pdf
9 https://investor.bridgebio.com/news/news-details/2026/Encaleret-Increased-Bone-Turnover-and-Improved-Participant-Reported-Symptoms-in-the-Phase-3-CALIBRATE-Trial-in-ADH1/default.aspx

WILMINGTON, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) — Symbotic Inc. (Nasdaq: SYM), a leader in A.I.-enabled robotics technology for the supply chain, today announced it will release fourth quarter and fiscal year 2026 financial results after the market close on Monday, November 23, 2026. The press release will also be available on the Symbotic Investor Relations website: www.ir.symbotic.com. The company will host a live webcast to discuss its financial results for the quarter and fiscal year at 5:00 p.m. ET on the same date.

To listen to the live webcast, register at https://edge.media-server.com/mmc/go/symbotic-q4-2026. The webcast will be available for replay on the Symbotic Investor Relations website at: www.ir.symbotic.com.

Please direct any questions regarding obtaining access to the webcast to Symbotic Investor Relations at ir@symbotic.com.

ABOUT SYMBOTIC

Symbotic is an automation technology leader reimagining the supply chain with its end-to-end, A.I.-powered robotic and software platform. Symbotic reinvents the warehouse as a strategic asset for the world’s largest retail, wholesale, food & beverage, and medical supply distribution companies. Applying next-generation technology, high-density storage and machine learning to solve today’s complex distribution challenges, Symbotic enables companies to move goods with unmatched speed, agility, accuracy and efficiency. As the backbone of commerce, Symbotic transforms the flow of goods and the economics of the supply chain for its customers. For more information, visit www.symbotic.com.

MEDIA CONTACT

Matt Buckley
Vice President, Communications
mediainquiry@symbotic.com

INVESTOR RELATIONS CONTACT

Charlie Anderson
Vice President, Investor Relations & Corporate Development
ir@symbotic.com

ATLANTA, Oct. 29, 2026 (GLOBE NEWSWIRE) — Atlanticus Holdings Corporation (NASDAQ: ATLC) (“Atlanticus,” the “Company,” “we,” “our” or “us”), a financial technology company that enables its bank, retail and healthcare partners to offer more inclusive financial services to millions of everyday Americans, today announced that it will host a conference call and live webcast to discuss its third quarter financial results and operating performance on Thursday, November 5, 2026 at 5:00 p.m. Eastern Time.

The live webcast will be accessible at the Atlanticus Investor Relations website at https://investors.atlanticus.com/events-and-presentations/, along with the Company’s third quarter earnings press release and third quarter investor presentation. An archived version of the webcast will be available on the Atlanticus Holdings Corporation Investor Relations website for 45 days.

About Atlanticus Holdings Corporation

Empowering Better Financial Outcomes for Everyday Americans

Atlanticus Holdings Corporation empowers better financial outcomes for Everyday Americans by enabling bank, retail, and healthcare partners to offer more inclusive financial solutions to consumers. Leveraging proprietary technology and advanced analytics, Atlanticus applies more than 30 years of operating experience, servicing over 23 million customers and more than $53 billion in consumer loans, to support lenders across a broad range of consumer credit products. These offerings span retail and healthcare private-label credit and general purpose credit cards, through an omnichannel platform, including strategic partnerships.

Atlanticus is guided by the principles of responsible lending, smart innovation, and expanding access to credit for consumers working toward a stronger financial future.

For more information, visit www.atlanticus.com.

Contact:
Investor Relations, investors@atlanticus.com
Dan Mauch, daniel.mauch@atlanticus.com
Sara Savarino, sara.savarino@atlanticus.com

Company to issue press release before market open; conference call to follow at 8:30 a.m. ET

WILMINGTON, Del., Oct. 29, 2026 (GLOBE NEWSWIRE) — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, today announced that it will host a conference call at 8:30 a.m. ET on Friday, October 30, 2026, to discuss a regulatory milestone for its Preservative-Free Ketamine program and next steps on the commercial launch. The Company will issue a press release with details before the market opens that morning.

A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants who are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally 1-646-307-1865.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company has been awarded a Abbreviated New Drug Approval (ANDA) for Preservative-Free Ketamine and is seeking New Drug Approval for a presentation of intravenous ketamine (NRX-100) with approved claims for treating depression and suicidality.

In October 2026 the Defense Advanced Research Projects Agency awarded an $11.25 million contract to NRx to conduct a phase 3 trial of its oral drug NRX-101, (D-cycloserine/lurasidone) combined with Robotic Neuronavigated Transcranial Magnetic Stimulation as a one-day treatment for patients with depression. NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:
Brian Korb
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact:
Victoria Verdeja
RXMD
(305) 904-1038
victoria@rxmedyn.com

ISELIN, NJ, Oct. 29, 2026 (GLOBE NEWSWIRE) — Provident Financial Services, Inc. (NYSE:PFS) (the “Company”) Board of Directors declared a quarterly cash dividend of $0.24 per common share payable on November 27, 2026 to stockholders of record as of the close of business on November 13, 2026.

About the Company

Provident Financial Services, Inc. is the holding company for Provident Bank, a community-oriented bank offering “Commitment you can count on” since 1839. Provident Bank provides a comprehensive array of financial products and services through its network of branches throughout New Jersey, Bucks, Lehigh and Northampton counties in Pennsylvania, as well as Orange, Queens and Nassau Counties in New York. The Bank also provides fiduciary and wealth management services through its wholly owned subsidiary, Beacon Trust Company and insurance services through its wholly owned subsidiary, Provident Protection Plus, Inc.

SOURCE: Provident Financial Services, Inc.
CONTACT: Investor Relations, 1-732-590-9300
Web Site: http://www.Provident.Bank

MONTREAL, Oct. 29, 2026 (GLOBE NEWSWIRE) — CN (TSX: CNR) (NYSE: CNI) will issue its third-quarter 2026 financial and operating results at 7:30 a.m. Eastern Time on October 30, 2026.

CN’s senior officers will review the results and the railway’s outlook in a conference call starting at 8:30 a.m. Eastern Time. Tracy Robinson, CN President and Chief Executive Officer, will lead the call.

Parties wishing to participate via telephone may dial 1-800-715-9871 (Canada/U.S.), or 1-647-932-3411 (International), using 5186426 as the passcode. Participants are advised to dial in 10 minutes prior to the call.

CN will provide a live webcast via the Investors section of its website at www.cn.ca/investors. A replay of the webcast will be available following the event.

About CN
CN powers the economy by safely transporting more than 300 million tons of natural resources, manufactured products, and finished goods throughout North America every year for its customers. With its nearly 20,000-mile rail network and related transportation services, CN connects Canada’s Eastern and Western coasts with the U.S. Midwest and the U.S. Gulf Coast, contributing to sustainable trade and the prosperity of the communities in which it operates since 1919. 

Contacts: 
 
   
Media Investment Community
Ashley Michnowski Jamie Lockwood
Senior Manager Vice-President
Media Relations Investor Relations & Special Projects
(438) 596-4329 (514) 399-0052
media@cn.ca investor.relations@cn.ca

– Phase 2 study will evaluate the safety, pharmacokinetics and antiviral activity of ABI-6250 in participants with chronic HDV infection –
– Initial data from the Phase 2 study is expected in the fourth quarter of 2027 –

SOUTH SAN FRANCISCO, Calif., Oct. 29, 2026 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver diseases, today announced dosing of the first two participants in a Phase 2 clinical study of ABI-6250, the company’s investigational oral small-molecule entry inhibitor candidate, in participants with chronic hepatitis delta virus (HDV) infection.

The Phase 2 study is expected to enroll approximately 80 participants with chronic HDV infection and will evaluate two once-daily oral dose levels of ABI-6250. The study will evaluate safety, pharmacokinetics, pharmacodynamics and efficacy, including changes from baseline in HDV RNA and alanine aminotransferase levels. Initial data from the study is expected in the fourth quarter of 2027.

Chronic HDV infection is the most severe form of viral hepatitis and results in more rapid progression to cirrhosis, liver cancer, decompensated liver disease or death than other forms of hepatitis. Treatment options remain limited, with only one approved therapy, a peptide inhibitor of sodium taurocholate cotransporting polypeptide (NTCP) that requires daily injections, underscoring the need for effective oral treatment options.

“Advancing ABI-6250 into Phase 2 represents an important milestone in our efforts to provide people living with chronic HDV infection a convenient, once-daily oral alternative to the currently available daily injectable therapy,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “Supported by encouraging Phase 1a findings, this study will help evaluate the potential of ABI-6250 to deliver meaningful antiviral activity through a differentiated treatment approach.”

In the completed Phase 1a study in healthy participants, ABI-6250 demonstrated a safety and pharmacokinetic profile supporting advancement into Phase 2 development. ABI-6250 had a mean half-life of approximately four days, supporting once-daily oral dosing, and changes in serum bile acids were consistent with NTCP target engagement. The Phase 1a findings were supported by preclinical data demonstrating low nanomolar potency across multiple HDV genotypes in vitro and selectivity for NTCP versus other bile acid transporters.

Under Assembly Bio’s collaboration agreement with Gilead Sciences, Inc. (Gilead), Gilead has the right to obtain an exclusive license for further development and commercialization of ABI-6250 through completion of the Phase 2 study and delivery and review of the related option data package for a $90 million opt-in fee.

About the ABI-6250 Phase 2 Study

ABI-6250-201 is a multicenter, open-label Phase 2 clinical study expected to enroll approximately 80 participants with chronic HDV infection. In the main cohort, approximately 50 participants will receive a low or high dose of once-daily oral ABI-6250 or enter a delayed-treatment group. Following analysis of the main cohort’s Week 16 primary endpoint, a dose will be selected for an expansion cohort of approximately 20 to 30 additional participants. The expansion cohort is designed to provide additional safety data to support potential Phase 3 development.

The study will evaluate safety, pharmacokinetics, pharmacodynamics and antiviral activity, with key efficacy measures including changes from baseline in HDV RNA and alanine aminotransferase levels.

Additional information about the Phase 2 study is available at clinicaltrials.gov using the identifier NCT07762027.

About ABI-6250

ABI-6250 is an investigational first-in-class oral small-molecule inhibitor of the sodium taurocholate co-transporting polypeptide (NTCP), a membrane protein selectively expressed on hepatocytes that facilitates bile acid transport into hepatocytes and also serves as the receptor for hepatitis B virus (HBV) and hepatitis delta virus (HDV) to enter hepatocytes. Assembly Bio is developing ABI-6250 for the treatment of chronic HDV infection, where inhibition of NTCP blocks viral entry and represents a clinically validated therapeutic mechanism. ABI-6250 is also being evaluated in cholestatic liver diseases, such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), where bile acid accumulation in the liver drives liver inflammation and liver injury.

About the Assembly Bio-Gilead Collaboration

In October 2023, Assembly Bio and Gilead entered into a 12-year collaboration to advance the research and development of novel antiviral therapies. Under the collaboration, Gilead has an option to obtain exclusive rights to each of Assembly Bio’s current and future programs, and Assembly Bio is eligible to receive collaboration extension fees, option fees, milestone payments and royalties. Following Gilead’s exercise of an option, Assembly Bio has the right to elect to share profits and costs in the U.S., as well as certain co-promotion rights for future programs.

To date, Gilead has exercised its option for Assembly Bio’s helicase-primase inhibitor program for recurrent genital herpes, and Assembly Bio has elected to participate in a 40% U.S. cost and profit share for the program.

About Assembly Biosciences

Assembly Biosciences is a biotechnology company developing innovative small-molecule therapeutics aimed at advancing the treatment paradigm of serious viral and liver diseases and improving the lives of patients worldwide. Led by an accomplished leadership team in antiviral and liver disease drug development, Assembly Bio is committed to improving outcomes for people living with the chronic impacts of herpesviruses, hepatitis delta virus (HDV) infections, cholestatic liver diseases and hepatitis B virus (HBV). For more information, visit assemblybio.com.

Forward-Looking Statements

The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, including studies conducted by Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of product candidates; clinical and nonclinical data may not differentiate product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investors:
Patrick Till
Meru Advisors
(484) 788-8560
investor_relations@assemblybio.com

Media:
Mike Beyer
Sam Brown LLC
(312) 961-2502
ASMBMedia@sambrown.com

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