Pharming Group reports third quarter 2025 financial results with significant growth in revenue, profitability and cash flow




Pharming Group reports third quarter 2025 financial results with significant growth in revenue, profitability and cash flow

• Total third quarter 2025 revenues increased by 30% to US$97.3 million, compared to third quarter 2024
• RUCONEST® third quarter revenue increased by 29% to US$82.2 million, compared to third quarter 2024, reflecting sustained growth in patients and prescribers
• Joenja® (leniolisib) third quarter revenue increased by 35% to US$15.1 million, compared to third quarter 2024, reflecting strong growth in patients on therapy
• FDA granted priority review of sNDA for leniolisib for children aged 4 to 11 years with APDS with decision expected by January 2026
• Third quarter operating profit increased by 285% to US$15.8 million, compared to US$4.1 million in the third quarter 2024
• Generated US$32.0 million in cash flow from operations during the quarter and US$44.0 million year to date
• 2025 total revenue guidance raised to US$365 – US$375 million, up from prior US$335 – US$350 million
• Leverne Marsh appointed Chief Commercial Officer, effective January 1, 2026; Stephen Toor to step down as CCO at year-end and remain an advisor to the company
• Pharming to host a conference call today at 13:30 CET (7:30 am ET)

Leiden, the Netherlands, November 6, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary (unaudited) financial report for the three months ended September 30, 2025.

Chief Executive Officer, Fabrice Chouraqui, commented:
“We delivered another strong quarter, with significant growth in revenue and profitability, reinforcing our confidence in the business.

We continue to drive the performance of RUCONEST® in the competitive U.S. HAE market, fueled by new patient enrollments and an expanding prescriber base, even amid the launch of a new oral on-demand therapy in July. Joenja® also delivered significant revenue growth, driven by a 25% year-over-year increase in patients on paid therapy and consistently high adherence rates. Looking ahead, we expect continued uptake amongst APDS patients aged 12 and older and new sources of growth including the anticipated pediatric label expansion for patients aged 4 to 11, the reclassification of variants of uncertain significance, or VUSs, and regulatory approvals enabling launches in several major markets.

Our pipeline is advancing well, unlocking potential new indications for leniolisib in broader primary immunodeficiency populations and addressing significant unmet needs in primary mitochondrial disease with KL1333.

To capitalize on these growth catalysts and pipeline opportunities, we recently announced a significant reduction in general and administrative headcount to optimize capital deployment to high growth initiatives. This disciplined approach combined with strong operating results — US$32 million in third-quarter operating cash flow — reinforces our ability to accelerate Pharming’s development and create value for our stakeholders and shareholders.

Based on this strong performance and our outlook for the final quarter of the year, we are raising our full-year revenue guidance.

I am pleased to welcome Leverne Marsh as Chief Commercial Officer, effective January 1, 2026, succeeding Stephen Toor. Leverne brings a strong track record of high impact launches and deep experience across the commercial spectrum, which will be instrumental as we continue executing our strategy to become a leading global rare disease company. I would like to thank Steve for his contributions to Pharming over the past nine years and for his legacy in building a uniquely patient-focused culture.

I want to thank our teams for their dedication and resilience in driving our mission forward.”

Third quarter highlights

Commercialized assets
RUCONEST® marketed for the treatment of acute HAE attacks

Strong RUCONEST® growth continued in the third quarter of 2025, with revenue of US$82.2 million, a 29% increase compared to the third quarter of 2024. Revenue for the first nine months of 2025 was US$231.2 million, a 34% increase compared to the same period in 2024.

In the U.S. market, we continued to grow the patient and prescriber base during the quarter, notwithstanding the market entry of a new oral on-demand HAE product in early July. Significant patient growth over the prior year was driven by patients who rely on RUCONEST® for its efficacy, reliability and rapid onset via IV administration. Unit sales volume in the U.S. increased by 24% in the third quarter and 28% in the first nine months.

Pharming has made the strategic decision to withdraw RUCONEST® from registration and/or commercialization in all non-US markets. These markets contributed only US$1.1 million, or 1.3% of total RUCONEST® revenue in the current quarter and have never demonstrated financial sustainability. Ensuring continuity of care and minimizing the impact on patients during this transition remain our highest priorities. This decision also enables Pharming to reallocate resources toward pipeline opportunities with greater long-term growth potential.

Joenja® (leniolisib) marketed for the treatment of APDS

Joenja® revenue increased to US$15.1 million in the third quarter of 2025, a 35% increase compared to the third quarter of 2024. Revenue for the first nine months of 2025 was US$38.4 million, a 20% increase compared to the same period in 2024. Unit sales volume increased by 34% in the third quarter of 2025, driven by a significant increase in patients on paid therapy in the U.S. and the U.K. launch in April 2025.

The U.S. market contributed 89% of third quarter revenue, while the EU and Rest of World (RoW) contributed 11%. The significant increase in EU and RoW revenue was primarily driven by strong patient uptake in the U.K.

As of September 30, 2025, we had 116 patients on paid therapy in the U.S., representing a 25% increase from the 93 patients at the end of the third quarter of 2024. The number of U.S. patients diagnosed with APDS that we have identified increased by 13 in the third quarter of 2025 and 36 year-to-date.

APDS patient finding

As of September 30, 2025, we have identified 990 diagnosed APDS patients of all ages globally, including 270 patients in the U.S. Of the identified patients in the U.S., 175 patients are 12 years of age or older and currently eligible for treatment with Joenja®, while 54 are between 4 and 11 years of age and would become eligible pending regulatory approval expected in January 2026.

VUS patient reclassification

There are currently over 1,400 known U.S. patients with a variant of uncertain significance, or VUS, in the PIK3CD and PIK3R1 genes implicated in APDS. We estimate that 20% of VUS patients could ultimately be diagnosed with APDS, thereby expanding the addressable patient population for Joenja®. Genetic testing laboratories are currently evaluating data from a study published in June 2025 in the leading peer-reviewed journal Cell, by researchers at Columbia University, to determine the process and potential to reclassify patients to APDS.

Joenja® (leniolisib) development
Leniolisib for APDS

As of September 30, 2025, there are 180 APDS patients in either a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a named patient program.

Pediatric label expansion

On July 31, 2025, we submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for leniolisib for the treatment of children aged 4 to 11 years diagnosed with APDS. On October 1, 2025, we announced that the FDA had accepted the sNDA and granted Priority Review of the application and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. Assuming a positive decision, we plan a commercial launch for this pediatric age group in the first quarter of 2026.

The Phase III clinical trial evaluating a new pediatric formulation of leniolisib in children 1 to 6 years of age diagnosed with APDS completed enrollment in April 2025. We expect to report results from this study in the coming months and if the data are supportive we plan to seek regulatory approval for this younger pediatric population.

Organizational updates

On September 2, 2025, we announced the appointment of Kenneth Lynard as Chief Financial Officer, effective October 1, 2025, strengthening our financial leadership as we continue to execute on our growth strategy. Mr. Lynard is a seasoned finance executive with over 20 years of global leadership experience in the life sciences industry.

On October 6, 2025, we announced the implementation of an organizational restructuring aligned with our previously announced plan to reduce general and administrative (G&A) expenses, to optimize capital deployment to our significant growth opportunities. The restructuring includes a 20% net reduction in non-commercial and non-medical headcount, primarily at our Netherlands headquarters. We remain on track to reduce total G&A expenses by 15% or US$10 million annually and anticipate one-time restructuring costs of approximately $7 million to be recorded in the fourth quarter of 2025 in connection with the headcount reduction.

We announce today that Ms. Leverne Marsh has been appointed Chief Commercial Officer (CCO), effective January 1, 2026, succeeding Stephen Toor, who will leave on December 31 and remain an advisor to the company. Ms. Marsh brings extensive experience across the commercial landscape, which will be instrumental as we continue executing our strategy to become a leading global rare disease company. At Novartis, she led major specialty care product launches and BD&L transactions in multiple franchise head roles in the US, ultimately serving as Chief Product Officer and Head of Strategy. Most recently, as Executive Vice President, Marketing for Dexcom, a leading medical technology company, Ms. Marsh drove accelerated growth in a fast-paced health tech environment and supported the expansion of the international footprint of the business. Her expertise in leveraging AI and analytics to advance commercial execution, will be a key asset as we advance our mission in rare diseases.

Corporate highlights

Pharming was promoted from the Euronext AScX® (Small Cap) to the AMX® (MidCap) index, effective from September 22, 2025, reflecting our growing market capitalization and trading activity. The Euronext Amsterdam AMX index comprises 25 companies based on free-float market capitalization and liquidity.

We are working on options to mitigate the impact of recently announced U.S. tariffs. Although some uncertainties remain, such as potential tariff exclusions, we do not expect a material impact on our business or growth.

Financial Summary

Underlying figures are unrounded. Therefore, totals may differ slightly from the sum of individual items due to rounding effects in the presentation of this press release.

Financial highlights

Third quarter 2025

For the third quarter of 2025, total revenues increased by US$22.4 million, or 30%, to US$97.3 million, compared to US$74.8 million in the third quarter of 2024. RUCONEST® revenues amounted to US$82.2 million, a 29% increase compared to the third quarter of 2024. This increase in RUCONEST® revenues was primarily driven by a volume increase in the U.S. Joenja® revenues amounted to US$15.1 million in the third quarter of 2025, a 34% increase compared to the third quarter of 2024. This increase in Joenja® revenues was primarily driven by an increase in volume.

Gross profit increased by US$22.2 million or 33% to US$90.2 million (3Q 2024: US$68.0 million), mainly due to the increase in revenues.

The operating profit increased 285% and amounted to US$15.8 million compared to US$4.1 million in the third quarter of 2024. Adjusted to exclude US$0.2 million of non-recurring Abliva acquisition-related expenses, the operating profit amounted to US$16.0 million. The improved operating result was primarily driven by an increase in revenues, partially offset by higher operating expenses.

The net finance result amounted to a loss of US$2.8 million compared to a loss of US$2.2 million in the third quarter of 2024. This was primarily driven by lower interest income due to a lower average overall cash position and decreased interest rates.

The Company had a net profit of US$7.5 million, compared to a net loss of US$1.0 million in the third quarter of 2024. The change was primarily driven by increased revenues, partially offset by higher operating expenses.

Cash generated from operations amounted to US$32.0 million, compared to US$9.7 million in the third quarter of 2024. Cash and cash equivalents, including restricted cash and marketable securities, increased from US$130.8 million at the end of the second quarter of 2025 to US$168.9 million at the end of the third quarter of 2025. This increase was primarily driven by the net cash flows generated from operating activities.

Nine months 2025

Total revenues increased 32% during the first nine months of 2025 to US$269.6 million, versus US$204.5 million during the first nine months of 2024. Total RUCONEST® revenues were 34% higher at US$231.2 million, compared to revenues of US$172.6 million for the first nine months of 2024. The increase in RUCONEST® revenues was primarily driven by an increase in volume. Joenja® revenues amounted to US$38.4 million in the first nine months of 2025, a 20% increase compared to the first nine months of 2024. This increase in Joenja® revenues was primarily driven by an increase in volume.

Gross profit increased by US$63.9 million or 35% to US$245.2 million (9M 2024: US$181.3 million), mainly due to the increase in revenues.

The operating profit amounted to US$19.6 million compared to an operating loss of US$15.3 million in the first nine months of 2024. Adjusted to exclude US$10.1 million of non-recurring Abliva acquisition-related expenses, of which US$8.0 million is included in General and administrative expenses and US$2.1 million is included in Research and development expenses, the operating profit amounted to US$29.7 million. The improved operating result was primarily driven by an increase in revenues, partially offset by higher operating expenses which include a total of US$20.4 million in Abliva-related expenses. Excluding these Abliva-related expenses, operating expenses increased by 4% compared to the first nine months of 2024.

The net finance result amounted to a loss of US$11.3 million compared to a gain of US$1.4 million in the first nine months of 2024. This decline was mainly driven by the absence of a one-time fair value gain recognized in the second quarter of 2024 following the reclassification of the convertible bond-related derivative to equity, as well as by unfavorable EUR/USD exchange rate movements in the nine months of 2025.

The Company had a net loss of US$2.8 million, compared to a net loss of US$14.7 million in the first nine months of 2024. The change was primarily driven by increased revenues, partially offset by a change in the net finance result and higher operating expenses, including US$10.1 million non-recurring Abliva acquisition-related expenses, most of which are not tax-deductible.

Cash generated from operations amounted to US$44.0 million, compared to US$11.1 million used in operations in the first nine months of 2024. Cash and cash equivalents, including restricted cash and marketable securities, decreased by US$0.5 million to US$168.9 million from US$169.4 million at the end of 2024, primarily driven by purchases of Abliva shares totaling US$68.0 million and non-recurring Abliva acquisition-related expenses totaling US$10.1 million, primarily offset by US$44.0 million of cash generated from operations.

Outlook/Summary
For 2025, the Company anticipates:

• Total revenues between US$365 million and US$375 million (23% to 26% growth).
• Total operating expenses between US$304 million and US$308 million, assuming constant currency, including US$10.2 million non-recurring Abliva-related transaction and integration expenses, but excluding one-time restructuring costs of approximately $7 million to be recorded in the fourth quarter of 2025.
• Continued growth of RUCONEST® in the acute HAE market.
• Significant growth in APDS patients on paid Joenja® (leniolisib) therapy in the U.S.
• Increasing ex-U.S. revenues for leniolisib, driven by funded access programs and commercial availability in the U.K.
• Progress towards additional regulatory approvals for leniolisib for APDS patients 12 years of age or older and for pediatric label expansion in key global markets.
• Advancing the two ongoing Phase II clinical trials in PIDs with immune dysregulation to significantly expand the long-term commercial potential of leniolisib.
• Advancing the ongoing pivotal FALCON clinical study for KL1333 in mitochondrial DNA-driven primary mitochondrial disease.
• Continued focus on potential acquisitions and in-licensing of clinical stage opportunities in rare diseases.

No further specific financial guidance for 2025 is provided.

Additional information
Presentation
The conference call presentation is available on the Pharming.com website from 07:30 CET today.

Conference Call
The conference call will begin at 13:30 CET/07:30 ET on Thursday, November 6. A transcript will be made available on the Pharming.com website in the days following the call.

Please note, the Company will only take questions from dial-in attendees.

Webcast Link:
https://edge.media-server.com/mmc/p/vb724dzx

Conference call dial-in details:

https://register-conf.media-server.com/register/BI1b6a1a63294c427f91ab7b24a7c6484b

Additional information on how to register for the conference call/webcast can be found on the Pharming.com website.

For further public information, contact:

Investor Relations
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com

Media Relations
Global: Saskia Mehring, Corporate Communications Manager
T: +31 6 28 32 60 41
E: media.relations@pharming.com

U.S.: Ethan Metelenis (Precision AQ on behalf of Pharming)
T: +1 (917) 882-9038

Netherlands: Leon Melens (LifeSpring Life Sciences Communication on behalf of Pharming)
T: +31 6 53 81 64 27

About Pharming Group N.V.

Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the U.S.

For more information, visit www.pharming.com and find us on LinkedIn.

Auditor’s involvement
The Condensed Consolidated Interim Financial Statements have not been audited by the Company’s statutory auditor.

Forward-looking Statements

This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming’s preclinical studies and clinical trials of its product candidates, Pharming’s clinical and commercial prospects, and Pharming’s expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming’s clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming’s 2024 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming’s actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.

Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

Pharming Group N.V.

Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)

For the period ended September 30, 2025

• Condensed consolidated interim statement of income
• Condensed consolidated interim statement of comprehensive income
• Condensed consolidated interim balance sheet
• Condensed consolidated interim statement of changes in equity
• Condensed consolidated interim statement of cash flows

Attachment

• Pharming Group reports 3Q 2025 financial results_EN_06NOV25

Pharming Group reports third quarter 2025 financial results with significant growth in revenue, profitability and cash flow




Pharming Group reports third quarter 2025 financial results with significant growth in revenue, profitability and cash flow

• Total third quarter 2025 revenues increased by 30% to US$97.3 million, compared to third quarter 2024
• RUCONEST® third quarter revenue increased by 29% to US$82.2 million, compared to third quarter 2024, reflecting sustained growth in patients and prescribers
• Joenja® (leniolisib) third quarter revenue increased by 35% to US$15.1 million, compared to third quarter 2024, reflecting strong growth in patients on therapy
• FDA granted priority review of sNDA for leniolisib for children aged 4 to 11 years with APDS with decision expected by January 2026
• Third quarter operating profit increased by 285% to US$15.8 million, compared to US$4.1 million in the third quarter 2024
• Generated US$32.0 million in cash flow from operations during the quarter and US$44.0 million year to date
• 2025 total revenue guidance raised to US$365 – US$375 million, up from prior US$335 – US$350 million
• Leverne Marsh appointed Chief Commercial Officer, effective January 1, 2026; Stephen Toor to step down as CCO at year-end and remain an advisor to the company
• Pharming to host a conference call today at 13:30 CET (7:30 am ET)

Leiden, the Netherlands, November 6, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary (unaudited) financial report for the three months ended September 30, 2025.

Chief Executive Officer, Fabrice Chouraqui, commented:
“We delivered another strong quarter, with significant growth in revenue and profitability, reinforcing our confidence in the business.

We continue to drive the performance of RUCONEST® in the competitive U.S. HAE market, fueled by new patient enrollments and an expanding prescriber base, even amid the launch of a new oral on-demand therapy in July. Joenja® also delivered significant revenue growth, driven by a 25% year-over-year increase in patients on paid therapy and consistently high adherence rates. Looking ahead, we expect continued uptake amongst APDS patients aged 12 and older and new sources of growth including the anticipated pediatric label expansion for patients aged 4 to 11, the reclassification of variants of uncertain significance, or VUSs, and regulatory approvals enabling launches in several major markets.

Our pipeline is advancing well, unlocking potential new indications for leniolisib in broader primary immunodeficiency populations and addressing significant unmet needs in primary mitochondrial disease with KL1333.

To capitalize on these growth catalysts and pipeline opportunities, we recently announced a significant reduction in general and administrative headcount to optimize capital deployment to high growth initiatives. This disciplined approach combined with strong operating results — US$32 million in third-quarter operating cash flow — reinforces our ability to accelerate Pharming’s development and create value for our stakeholders and shareholders.

Based on this strong performance and our outlook for the final quarter of the year, we are raising our full-year revenue guidance.

I am pleased to welcome Leverne Marsh as Chief Commercial Officer, effective January 1, 2026, succeeding Stephen Toor. Leverne brings a strong track record of high impact launches and deep experience across the commercial spectrum, which will be instrumental as we continue executing our strategy to become a leading global rare disease company. I would like to thank Steve for his contributions to Pharming over the past nine years and for his legacy in building a uniquely patient-focused culture.

I want to thank our teams for their dedication and resilience in driving our mission forward.”

Third quarter highlights

Commercialized assets
RUCONEST® marketed for the treatment of acute HAE attacks

Strong RUCONEST® growth continued in the third quarter of 2025, with revenue of US$82.2 million, a 29% increase compared to the third quarter of 2024. Revenue for the first nine months of 2025 was US$231.2 million, a 34% increase compared to the same period in 2024.

In the U.S. market, we continued to grow the patient and prescriber base during the quarter, notwithstanding the market entry of a new oral on-demand HAE product in early July. Significant patient growth over the prior year was driven by patients who rely on RUCONEST® for its efficacy, reliability and rapid onset via IV administration. Unit sales volume in the U.S. increased by 24% in the third quarter and 28% in the first nine months.

Pharming has made the strategic decision to withdraw RUCONEST® from registration and/or commercialization in all non-US markets. These markets contributed only US$1.1 million, or 1.3% of total RUCONEST® revenue in the current quarter and have never demonstrated financial sustainability. Ensuring continuity of care and minimizing the impact on patients during this transition remain our highest priorities. This decision also enables Pharming to reallocate resources toward pipeline opportunities with greater long-term growth potential.

Joenja® (leniolisib) marketed for the treatment of APDS

Joenja® revenue increased to US$15.1 million in the third quarter of 2025, a 35% increase compared to the third quarter of 2024. Revenue for the first nine months of 2025 was US$38.4 million, a 20% increase compared to the same period in 2024. Unit sales volume increased by 34% in the third quarter of 2025, driven by a significant increase in patients on paid therapy in the U.S. and the U.K. launch in April 2025.

The U.S. market contributed 89% of third quarter revenue, while the EU and Rest of World (RoW) contributed 11%. The significant increase in EU and RoW revenue was primarily driven by strong patient uptake in the U.K.

As of September 30, 2025, we had 116 patients on paid therapy in the U.S., representing a 25% increase from the 93 patients at the end of the third quarter of 2024. The number of U.S. patients diagnosed with APDS that we have identified increased by 13 in the third quarter of 2025 and 36 year-to-date.

APDS patient finding

As of September 30, 2025, we have identified 990 diagnosed APDS patients of all ages globally, including 270 patients in the U.S. Of the identified patients in the U.S., 175 patients are 12 years of age or older and currently eligible for treatment with Joenja®, while 54 are between 4 and 11 years of age and would become eligible pending regulatory approval expected in January 2026.

VUS patient reclassification

There are currently over 1,400 known U.S. patients with a variant of uncertain significance, or VUS, in the PIK3CD and PIK3R1 genes implicated in APDS. We estimate that 20% of VUS patients could ultimately be diagnosed with APDS, thereby expanding the addressable patient population for Joenja®. Genetic testing laboratories are currently evaluating data from a study published in June 2025 in the leading peer-reviewed journal Cell, by researchers at Columbia University, to determine the process and potential to reclassify patients to APDS.

Joenja® (leniolisib) development
Leniolisib for APDS

As of September 30, 2025, there are 180 APDS patients in either a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a named patient program.

Pediatric label expansion

On July 31, 2025, we submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for leniolisib for the treatment of children aged 4 to 11 years diagnosed with APDS. On October 1, 2025, we announced that the FDA had accepted the sNDA and granted Priority Review of the application and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. Assuming a positive decision, we plan a commercial launch for this pediatric age group in the first quarter of 2026.

The Phase III clinical trial evaluating a new pediatric formulation of leniolisib in children 1 to 6 years of age diagnosed with APDS completed enrollment in April 2025. We expect to report results from this study in the coming months and if the data are supportive we plan to seek regulatory approval for this younger pediatric population.

Organizational updates

On September 2, 2025, we announced the appointment of Kenneth Lynard as Chief Financial Officer, effective October 1, 2025, strengthening our financial leadership as we continue to execute on our growth strategy. Mr. Lynard is a seasoned finance executive with over 20 years of global leadership experience in the life sciences industry.

On October 6, 2025, we announced the implementation of an organizational restructuring aligned with our previously announced plan to reduce general and administrative (G&A) expenses, to optimize capital deployment to our significant growth opportunities. The restructuring includes a 20% net reduction in non-commercial and non-medical headcount, primarily at our Netherlands headquarters. We remain on track to reduce total G&A expenses by 15% or US$10 million annually and anticipate one-time restructuring costs of approximately $7 million to be recorded in the fourth quarter of 2025 in connection with the headcount reduction.

We announce today that Ms. Leverne Marsh has been appointed Chief Commercial Officer (CCO), effective January 1, 2026, succeeding Stephen Toor, who will leave on December 31 and remain an advisor to the company. Ms. Marsh brings extensive experience across the commercial landscape, which will be instrumental as we continue executing our strategy to become a leading global rare disease company. At Novartis, she led major specialty care product launches and BD&L transactions in multiple franchise head roles in the US, ultimately serving as Chief Product Officer and Head of Strategy. Most recently, as Executive Vice President, Marketing for Dexcom, a leading medical technology company, Ms. Marsh drove accelerated growth in a fast-paced health tech environment and supported the expansion of the international footprint of the business. Her expertise in leveraging AI and analytics to advance commercial execution, will be a key asset as we advance our mission in rare diseases.

Corporate highlights

Pharming was promoted from the Euronext AScX® (Small Cap) to the AMX® (MidCap) index, effective from September 22, 2025, reflecting our growing market capitalization and trading activity. The Euronext Amsterdam AMX index comprises 25 companies based on free-float market capitalization and liquidity.

We are working on options to mitigate the impact of recently announced U.S. tariffs. Although some uncertainties remain, such as potential tariff exclusions, we do not expect a material impact on our business or growth.

Financial Summary

Underlying figures are unrounded. Therefore, totals may differ slightly from the sum of individual items due to rounding effects in the presentation of this press release.

Financial highlights

Third quarter 2025

For the third quarter of 2025, total revenues increased by US$22.4 million, or 30%, to US$97.3 million, compared to US$74.8 million in the third quarter of 2024. RUCONEST® revenues amounted to US$82.2 million, a 29% increase compared to the third quarter of 2024. This increase in RUCONEST® revenues was primarily driven by a volume increase in the U.S. Joenja® revenues amounted to US$15.1 million in the third quarter of 2025, a 34% increase compared to the third quarter of 2024. This increase in Joenja® revenues was primarily driven by an increase in volume.

Gross profit increased by US$22.2 million or 33% to US$90.2 million (3Q 2024: US$68.0 million), mainly due to the increase in revenues.

The operating profit increased 285% and amounted to US$15.8 million compared to US$4.1 million in the third quarter of 2024. Adjusted to exclude US$0.2 million of non-recurring Abliva acquisition-related expenses, the operating profit amounted to US$16.0 million. The improved operating result was primarily driven by an increase in revenues, partially offset by higher operating expenses.

The net finance result amounted to a loss of US$2.8 million compared to a loss of US$2.2 million in the third quarter of 2024. This was primarily driven by lower interest income due to a lower average overall cash position and decreased interest rates.

The Company had a net profit of US$7.5 million, compared to a net loss of US$1.0 million in the third quarter of 2024. The change was primarily driven by increased revenues, partially offset by higher operating expenses.

Cash generated from operations amounted to US$32.0 million, compared to US$9.7 million in the third quarter of 2024. Cash and cash equivalents, including restricted cash and marketable securities, increased from US$130.8 million at the end of the second quarter of 2025 to US$168.9 million at the end of the third quarter of 2025. This increase was primarily driven by the net cash flows generated from operating activities.

Nine months 2025

Total revenues increased 32% during the first nine months of 2025 to US$269.6 million, versus US$204.5 million during the first nine months of 2024. Total RUCONEST® revenues were 34% higher at US$231.2 million, compared to revenues of US$172.6 million for the first nine months of 2024. The increase in RUCONEST® revenues was primarily driven by an increase in volume. Joenja® revenues amounted to US$38.4 million in the first nine months of 2025, a 20% increase compared to the first nine months of 2024. This increase in Joenja® revenues was primarily driven by an increase in volume.

Gross profit increased by US$63.9 million or 35% to US$245.2 million (9M 2024: US$181.3 million), mainly due to the increase in revenues.

The operating profit amounted to US$19.6 million compared to an operating loss of US$15.3 million in the first nine months of 2024. Adjusted to exclude US$10.1 million of non-recurring Abliva acquisition-related expenses, of which US$8.0 million is included in General and administrative expenses and US$2.1 million is included in Research and development expenses, the operating profit amounted to US$29.7 million. The improved operating result was primarily driven by an increase in revenues, partially offset by higher operating expenses which include a total of US$20.4 million in Abliva-related expenses. Excluding these Abliva-related expenses, operating expenses increased by 4% compared to the first nine months of 2024.

The net finance result amounted to a loss of US$11.3 million compared to a gain of US$1.4 million in the first nine months of 2024. This decline was mainly driven by the absence of a one-time fair value gain recognized in the second quarter of 2024 following the reclassification of the convertible bond-related derivative to equity, as well as by unfavorable EUR/USD exchange rate movements in the nine months of 2025.

The Company had a net loss of US$2.8 million, compared to a net loss of US$14.7 million in the first nine months of 2024. The change was primarily driven by increased revenues, partially offset by a change in the net finance result and higher operating expenses, including US$10.1 million non-recurring Abliva acquisition-related expenses, most of which are not tax-deductible.

Cash generated from operations amounted to US$44.0 million, compared to US$11.1 million used in operations in the first nine months of 2024. Cash and cash equivalents, including restricted cash and marketable securities, decreased by US$0.5 million to US$168.9 million from US$169.4 million at the end of 2024, primarily driven by purchases of Abliva shares totaling US$68.0 million and non-recurring Abliva acquisition-related expenses totaling US$10.1 million, primarily offset by US$44.0 million of cash generated from operations.

Outlook/Summary
For 2025, the Company anticipates:

• Total revenues between US$365 million and US$375 million (23% to 26% growth).
• Total operating expenses between US$304 million and US$308 million, assuming constant currency, including US$10.2 million non-recurring Abliva-related transaction and integration expenses, but excluding one-time restructuring costs of approximately $7 million to be recorded in the fourth quarter of 2025.
• Continued growth of RUCONEST® in the acute HAE market.
• Significant growth in APDS patients on paid Joenja® (leniolisib) therapy in the U.S.
• Increasing ex-U.S. revenues for leniolisib, driven by funded access programs and commercial availability in the U.K.
• Progress towards additional regulatory approvals for leniolisib for APDS patients 12 years of age or older and for pediatric label expansion in key global markets.
• Advancing the two ongoing Phase II clinical trials in PIDs with immune dysregulation to significantly expand the long-term commercial potential of leniolisib.
• Advancing the ongoing pivotal FALCON clinical study for KL1333 in mitochondrial DNA-driven primary mitochondrial disease.
• Continued focus on potential acquisitions and in-licensing of clinical stage opportunities in rare diseases.

No further specific financial guidance for 2025 is provided.

Additional information
Presentation
The conference call presentation is available on the Pharming.com website from 07:30 CET today.

Conference Call
The conference call will begin at 13:30 CET/07:30 ET on Thursday, November 6. A transcript will be made available on the Pharming.com website in the days following the call.

Please note, the Company will only take questions from dial-in attendees.

Webcast Link:
https://edge.media-server.com/mmc/p/vb724dzx

Conference call dial-in details:

https://register-conf.media-server.com/register/BI1b6a1a63294c427f91ab7b24a7c6484b

Additional information on how to register for the conference call/webcast can be found on the Pharming.com website.

For further public information, contact:

Investor Relations
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com

Media Relations
Global: Saskia Mehring, Corporate Communications Manager
T: +31 6 28 32 60 41
E: media.relations@pharming.com

U.S.: Ethan Metelenis (Precision AQ on behalf of Pharming)
T: +1 (917) 882-9038

Netherlands: Leon Melens (LifeSpring Life Sciences Communication on behalf of Pharming)
T: +31 6 53 81 64 27

About Pharming Group N.V.

Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the U.S.

For more information, visit www.pharming.com and find us on LinkedIn.

Auditor’s involvement
The Condensed Consolidated Interim Financial Statements have not been audited by the Company’s statutory auditor.

Forward-looking Statements

This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming’s preclinical studies and clinical trials of its product candidates, Pharming’s clinical and commercial prospects, and Pharming’s expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming’s clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming’s 2024 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming’s actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.

Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

Pharming Group N.V.

Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)

For the period ended September 30, 2025

• Condensed consolidated interim statement of income
• Condensed consolidated interim statement of comprehensive income
• Condensed consolidated interim balance sheet
• Condensed consolidated interim statement of changes in equity
• Condensed consolidated interim statement of cash flows

Attachment

• Pharming Group reports 3Q 2025 financial results_EN_06NOV25

BillionToOne Announces Pricing of Upsized Initial Public Offering




BillionToOne Announces Pricing of Upsized Initial Public Offering

MENLO PARK, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — BillionToOne, Inc. (Nasdaq: BLLN), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the pricing of its upsized initial public offering of 4,551,100 shares of its Class A common stock, at a public offering price of $60.00 per share. In addition, BillionToOne has granted the underwriters a 30-day option to purchase up to an additional 682,665 shares of its Class A common stock at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the Nasdaq Global Select Market on November 6, 2025, under the ticker symbol “BLLN.” The gross proceeds from the offering are expected to be approximately $273.1 million, without giving effect to the underwriters’ option to purchase additional shares and before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on November 7, 2025, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Piper Sandler, Jefferies and William Blair are acting as joint book-running managers for the offering. Stifel, Wells Fargo Securities and BTIG are also acting as book-running managers for the offering.

A registration statement on Form S-1 related to these securities has been filed with the U.S. Securities and Exchange Commission and has become effective. The offering is being made only by means of a prospectus. Copies of the prospectus, when available, may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email: prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, by telephone at (800) 747-3924, or by email at prospectus@psc.com; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at (800) 621-0687 or by email at prospectus@williamblair.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BillionToOne

Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company’s patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level.

Investor Contact
ir@billiontoone.com

Media Contact
billiontoone@moxiegrouppr.com

BioCardia to Host Q3 2025 Corporate Update and Financial Results Conference Call on November 12, 2025




BioCardia to Host Q3 2025 Corporate Update and Financial Results Conference Call on November 12, 2025

SUNNYVALE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — BioCardia^®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will provide a corporate update and report its financial results for the three and nine months ended September 30, 2025 by conference call on Wednesday, November 12, 2025 at 4:30 PM EDT. Following management’s formal remarks, there will be a question-and-answer session.

Participants can register for the conference by navigating to https://dpregister.com/sreg/10204565/1005a9b26d8.

Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to join the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=v3qWCosD.

A webcast replay of the call will be available approximately one hour after the end of the call through approximately November 26, 2025 at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will also be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada), 1-412-317-0088 (international toll) by using access code 4273038.

About BioCardia^®
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit www.biocardia.com.

CONTACT: MEDIA CONTACT:
Miranda Peto, Investor Relations 
mpeto@biocardia.com 
(650) 226-0120

INVESTOR CONTACT:
David McClung, Chief Financial Officer
investors@biocardia.com 
(650) 226-0120

LifeMD Reschedules Third Quarter 2025 Earnings Release and Conference Call to November 17




LifeMD Reschedules Third Quarter 2025 Earnings Release and Conference Call to November 17

NEW YORK, Nov. 05, 2025 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual healthcare services and pharmacy, today announced that the Company has rescheduled its third quarter 2025 earnings release and conference call to Monday, November 17, 2025. The Company expects to file a Form 12b-25, as needed, notifying the U.S. Securities and Exchange Commission of a late filing of its Form 10-Q for the period ended September 30, 2025.

The change to LifeMD’s third quarter 2025 earnings release date relates to corrections the Company identified related to the recognition of revenue with offsetting related balance sheet accounts for the twelve months ended December 31, 2023, December 31, 2024 and the six months ended June 30, 2025. The cumulative impact of these changes will be approximately $4.6 million, or approximately 1.4% of cumulative revenue reported for the twelve months ended December 31, 2024 and six months ended June 30, 2025. Based on the Company’s assessment, these required adjustments will not materially impact how reported revenue results compared to guidance for the reporting periods during this timeframe. The required adjustments will not impact the Company’s cash flow or cash position.

LifeMD expects to issue its third quarter 2025 earnings press release on or around 4:05 p.m. Eastern time on Monday, November 17, 2025 followed by the conference call at 4:30 p.m. Eastern time. Information for the rescheduled conference call is as follows:

Conference Call & Webcast Details

About LifeMD, Inc.

LifeMD^® is a leading provider of virtual primary care. LifeMD offers telemedicine, access to laboratory and pharmacy services, and specialized treatment across more than 200 conditions, including primary care, men’s and women’s health, mental health, and weight management. The Company leverages a vertically integrated, proprietary digital care platform, a 50-state affiliated medical group, a state-of-the-art affiliated compounding pharmacy, and a U.S.-based patient care center to increase access to high-quality and affordable care. For more information, please visit LifeMD.com.

Cautionary Note Regarding Forward Looking Statements

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended; Section 21E of the Securities Exchange Act of 1934, as amended; and the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the impact of recently discovered errors that originated in prior periods and were identified by the Company in the preparation of its third quarter 2025 financial statements that the Company is evaluating, including the potential impact of these matters on internal control over financial reporting. Forward-looking statements contained in this news release may be identified by the use of words such as: “believe,” “expect,” “anticipate,” “project,” “should,” “plan,” “will,” “may,” “intend,” “estimate,” “predict,” “continue,” and “potential,” or, in each case, their negative or other variations or comparable terminology referencing future periods. The preliminary determinations above are subject to adjustment as the Company prepares its financial statements and disclosures for the three and nine months ended September 30, 2025, and such adjustments may be significant. The Company’s auditors have not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary determinations described above. Factors that could materially affect these forward looking statements include, but are not limited to: the completion of the review of the accounting matters identified, including the potential impact on internal control over financial reporting, as well as those factors set forth in our Form 10-K (and other forms) filed with the Securities and Exchange Commission.

Forward-looking statements are not historical facts and are not assurances of future performance. Rather, these statements are based on our current expectations, beliefs, and assumptions regarding future plans and strategies, projections, anticipated and unanticipated events and trends, the economy, and other future conditions, including the impact of any of the aforementioned on our future business. As forward-looking statements relate to the future, they are subject to inherent risk, uncertainties, and changes in circumstances and assumptions that are difficult to predict, including some of which are out of our control. Consequently, our actual results, performance, and financial condition may differ materially from those indicated in the forward-looking statements. These risks and uncertainties include, but are not limited to, “Risk Factors” identified in our filings with the Securities and Exchange Commission, including, but not limited to, our most recently filed Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any amendments thereto. Even if our actual results, performance, or financial condition are consistent with forward-looking statements contained in such filings, they may not be indicative of our actual results, performance, or financial condition in subsequent periods.

Any forward-looking statement made in the news release is based on information currently available to us as of the date on which this release is made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required under applicable law or regulation.

Investor Contact
Marc Benathen, Chief Financial Officer
marc@lifemd.com

Media Contact
Jessica Friedeman, Chief Marketing and Product Officer
press@lifemd.com

Tarsus to Participate in Upcoming Investor Conference




Tarsus to Participate in Upcoming Investor Conference

IRVINE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced that management plans to participate in a fireside chat at the Guggenheim 2^nd Annual Healthcare Innovation Conference in Boston, MA on Tuesday, November 11^th, at 11:30 a.m. PT / 2:30 p.m. ET.

Live webcasts and additional information can be accessed on the events section of the Tarsus website. Replays will be available on the Tarsus website within 48 hours and will be archived for a limited time.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY^® (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, all of which are in Phase 2.

Media Contact:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
AKemp@tarsusrx.com

Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
DNakasone@tarsusrx.com

Benitec Biopharma Inc. Announces Proposed Public Offering




Benitec Biopharma Inc. Announces Proposed Public Offering

HAYWARD, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (Nasdaq: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA- directed RNA interference (“ddRNAi”) “Silence and Replace” platform, today announced that it has commenced an underwritten public offering of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and intends to conduct a concurrent registered direct offering of its common stock with long-term investor Suvretta Capital. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to a number of additional shares of its common stock equal to 15% of the total number of shares of common stock (and pre-funded warrants to purchase common stock in lieu thereof) sold in the underwritten offering, on the same terms and conditions. The offerings are expected to close on November 7, 2025, subject to customary closing conditions. The offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Leerink Partners, TD Cowen and Evercore ISI are acting as bookrunning managers for the proposed offering.

The Securities and Exchange Commission (“SEC”) declared effective a registration statement on Form S-3 relating to these securities on September 29, 2025. A prospectus supplement relating to these offerings will be filed with the SEC. The offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, when available, from Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com. Investors may also obtain these documents at no cost by visiting the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Benitec Biopharma Inc.

Benitec Biopharma Inc. (“Benitec” or the “Company”) is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary “Silence and Replace” DNA-directed RNA interference platform combines RNA interference, or RNAi, with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The Company is developing Silence and Replace-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD).

Cautionary Note Concerning Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the completion, timing and size of the proposed public offering and the concurrent registered direct offering and Benitec’s expectations with respect to granting the underwriters a 30-day option to purchase additional shares. No assurance can be given that the offerings discussed above will be completed on the terms described, or at all, or that the proceeds of the offerings will be used as indicated. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described in Benitec’s filings with the SEC. Benitec’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Benitec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Benitec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Investor Relations Contacts: Irina Koffler
LifeSci Advisors, LLC
Phone: (917) 734-7387
Email: ikoffler@lifesciadvisors.com

Source: Benitec Biopharma Inc.

Novo Nordisk Wegovy® users achieved waist and BMI targets linked to improved health and low risk of obesity-related complications




Novo Nordisk Wegovy® users achieved waist and BMI targets linked to improved health and low risk of obesity-related complications

• Unlike many other diseases, there are no set guidelines on treatment targets for obesity, and outcomes often rely on percentage weight loss only
• Body mass index (BMI) and waist-to-height ratio (a measurement of unhealthy waist size) represent important obesity treatment targets, associated with a lower risk of obesity-related complications
• A study of people with obesity (STEP UP trial) showed that more people taking Wegovy^® achieved a BMI under 27 and a waist-to-height ratio of less than 0.53, compared to none of the people taking the placebo¹
• Most people treated with Wegovy^® who achieved both these targets had their blood pressure, cholesterol and blood sugar levels return to healthy levels associated with low risk of cardiovascular disease¹

Bagsværd, Denmark, 5 November 2025 – Today, at ObesityWeek^® taking place on 4-7 November in Atlanta, US, Novo Nordisk presented new findings from the STEP UP phase 3b trial. It showed that, in addition to losing an average of 21% of their body weight, Wegovy^® (the approved semaglutide 2.4 mg dose and investigational higher 7.2 mg dose) enables people with obesity to achieve treatment targets associated with a low risk of obesity-related complications.^1,2

Unlike many other diseases, there are no established guidelines on which treatment targets doctors should use for treating obesity, with outcomes often relying only on percentage weight loss. A primary consideration in the management of obesity should be the prevention of obesity-related complications, such as cardiovascular, kidney and liver diseases, alongside weight loss.³

In the STEP UP sub-analysis, more people with obesity who received Wegovy^® achieved the target BMI of less than 27 and a waist-to-height ratio of less than 0.53 (19.5% for semaglutide 7.2 mg and 13.2% for semaglutide 2.4 mg) compared to placebo (0%).¹ People treated with Wegovy^® who achieved both treatment targets reached healthy levels for two or more cardiovascular risk factors, including blood pressure, cholesterol and blood sugar levels.¹

“These new results demonstrate that most people on Wegovy^® who achieve certain BMI and waist targets also benefit when it comes to lowering their cardiovascular risk factors,” said Emil Kongshøj Larsen, executive vice president and head of International Operations at Novo Nordisk. ”This shows the efficacy of Wegovy^® in not only helping people lose excess weight but also preventing obesity-related complications and improving overall health. The risk of developing serious complications such as cardiovascular, kidney and liver diseases increases for people living with overweight or obesity. The STEP UP trial has also shown that a higher dose of Wegovy^® delivers an average weight loss of 21%, with 1 in 3 people achieving weight loss of 25% or more and will offer a significant new option to help people with obesity achieve their weight and health goals.” 

All participants who achieved both BMI and waist-to-height ratio targets also reached healthy levels for two or more cardiovascular risk factors, and over half reached healthy levels for all four risk factors, indicating a low risk of cardiovascular disease for those treated with Wegovy^®. The results support the use of these BMI and waist-to-height ratio treatment targets in managing obesity and reiterate that Wegovy^® can lower the risk of obesity-related complications, alongside its proven weight loss effect.¹

“The use of BMI and waist-to-height ratio targets has been shown to be associated with a lower risk of obesity-related complications,” said Carel le Roux, University College Dublin, Ireland. “This new STEP UP analysis reinforces the health benefits we have come to expect of semaglutide, such as cardiovascular protection, demonstrating its power in helping people with the disease of obesity achieve meaningful weight loss and health gains.”

The new, higher dose of Wegovy^® (semaglutide 7.2 mg), investigated in two STEP UP trials, is currently under review with the European Medicines Agency (EMA), in the UK and several other countries. In the EU, Novo Nordisk expects a regulatory decision around the turn of the year. Novo Nordisk also expects to submit to the US Food and Drug Administration.

About the STEP UP trials
Novo Nordisk has completed two trials, STEP UP and STEP UP T2D, investigating the efficacy and safety of semaglutide 7.2 mg in people with obesity with or without type 2 diabetes.

The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy and safety of semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included 1,407 adults with a BMI ≥30 kg/m² without diabetes. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key confirmatory secondary endpoints included the number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively. 

The 72-week STEP UP T2D trial investigated semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective of demonstrating superiority of semaglutide 7.2 mg against placebo on weight loss.  

About Wegovy^® 
Injectable semaglutide 2.4 mg is marketed under the brand name Wegovy^®. In the EU, Wegovy^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m² or greater (obesity) or adults with a BMI of 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition.⁴ In the EU, Wegovy^® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95^th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy^® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related (heart failure with preserved ejection fraction) symptoms and physical function, as well as pain reduction related to knee osteoarthritis.⁴

In the US, Wegovy^® is indicated in combination with a reduced-calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight. It is also indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older with obesity as well as in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition.⁵ Wegovy^® is also indicated under accelerated approval for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), in adults with moderate to advanced liver fibrosis.⁵

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. 

Contacts for further information

_______________________

References

1. Le Roux CW, Garvey WT, Kolnes KJ, et al. STEP UP: Efficacy of Semaglutide in Obesity Treatment Targets and Cardiovascular Risk Thresholds. Oral Presentation at ObesityWeek 2025; 4-7 November 2025; Atlanta, US.
2. Wharton S, Freitas P, Hjelmesæth J, et al. Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. Lancet Diabetes Endocrinol. 2025:S2213-8587(25)00226-8.
3. McGowan B, Ciudin A, Baker JL, et al. Framework for the pharmacological treatment of obesity and its complications from the European Association for the Study of Obesity (EASO). Nat Med. 2025. doi: 10.1038/s41591-025-03765-w.
4. Wegovy^® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf. Last accessed: October 2025. 
5. Wegovy^® Prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s024lbl.pdf. Last accessed: October 2025.

Attachment

• PR251105-ObesityWeek-STEP-UP-2230

Catalyst Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update




Catalyst Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update

Reported Q3 2025 Total Revenues of $148.4 Million, Driven by Continued FIRDAPSE® Growth, Strong AGAMREE® Uptake and Growth, and Continued Demand for FYCOMPA®

Raising Full-Year 2025 Total Revenue Guidance to between $565 Million and $585 Million, Reflecting Better than Originally Forecasted Performance

Recently Announced Share Repurchase Program of up to $200 Million, Signaling Confidence in Long-term Outlook

Conference Call and Webcast to be Held on Thursday, November 6, 2025, at 8:30 AM ET

CORAL GABLES, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) today reported financial results for the third quarter of 2025 and provided a business update.

“Throughout 2025, we have continued to execute on our commercial growth initiatives to drive adoption of FIRDAPSE® and AGAMREE®, resulting in another quarter of strong financial performance,” stated Rich Daly, President and CEO of Catalyst. “Our third quarter performance was driven by our best-in-class product portfolio and our focus on creating value for patients taking FIRDAPSE and AGAMREE who participate in our Catalyst Pathways® program. We believe that this program both enhances access as well as contributes to medication compliance and persistence.”

Mr. Daly continued: “Finally, we continue to evaluate strategically aligned opportunities to further strengthen our portfolio and expand our reach to serve more patients living with rare diseases. As signaled by our increased 2025 total revenue guidance and our recently announced share repurchase program, we remain confident in our growth trajectory and look forward to continued value creation.”

Third Quarter 2025 Financial Highlights

• Achieved net product revenues of $148.4 million for Q3 2025, a 17.4% increase over net product revenues for the third quarter of 2024.
• Raising total revenue guidance for full year 2025 to between $565 million and $585 million.
  • Raising 2025 net product revenue guidance for AGAMREE to between $105 million and $115 million.
  • Raising 2025 net product revenue guidance for FYCOMPA® to between $100 million and $110 million.
  • Reaffirming full-year 2025 net product revenue guidance for FIRDAPSE to between $355 million and $360 million.

• Achieved record FIRDAPSE net product revenue in Q3 2025 of $92.2 million, reflecting a 16.2% increase over Q3 2024 net product revenue, driven primarily by sustained organic growth from new patients, enhanced dosing, persistence, and further penetration in the idiopathic and cancer-associated Lambert-Eaton myasthenic syndrome (LEMS) markets.
• Achieved third quarter 2025 net product revenue for AGAMREE of $32.4 million, demonstrating continued demand and further, albeit still early, penetration into nearly all of the Duchenne muscular dystrophy (DMD) centers of excellence.  Catalyst continues to actively enroll patients in the SUMMIT study, an open-label five-year follow-up study designed to evaluate the long-term clinical safety profile of AGAMREE, including potential benefits on behavior, stature, bone health, and cardiovascular health.
• Reported stronger than originally forecasted net product revenue for FYCOMPA of $23.8 million for Q3 2025, a 25.8% decrease compared to Q3 2024 net product revenue. This reflects solid performance following the entry of the first generic tablet version of the product, which entered the market at the end of Q2 2025. Revenues are forecasted to decline in future periods as additional generic competition enters the market.

Financial Highlights

*Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst’s financial statements presented in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst’s current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst’s operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies.

Recent Business Highlights

• On August 26, 2025, Catalyst announced the settlement of FIRDAPSE (amifampridine) patent litigation with Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”). As part of the settlement, Lupin received a license to market generic FIRDAPSE beginning in February 2035, on the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement with the Company. This settlement leaves only one patent case pending against Hetero USA, Inc. A tentative trial date has been set for March 2026, which is prior to the expiration of the automatic 30-month stay on May 26, 2026. There can be no assurance as to the outcome of this matter.
• On October 1, 2025, Catalyst announced that its Board of Directors approved a share repurchase program under which the Company will purchase up to $200 million of its outstanding common stock between October 1, 2025, and December 31, 2026, reflecting Catalyst’s strong balance sheet and confidence in its long-term financial outlook. Catalyst is using cash on hand to fund its share repurchase program and believes it can execute this program without impairing the advancement of its business development strategy. Through November 5, 2025, the Company has repurchased 405,092 shares of its outstanding common stock for an aggregate purchase price of approximately $8.4 million ($20.74 average price per share).
• On October 2, 2025, KYE Pharmaceuticals, Inc. (KYE) issued a press release announcing that Health Canada issued a Notice of Compliance for KYE’s New Drug Submission to commercialize AGAMREE in Canada. This approval marks the first therapy approved to treat DMD and addresses a significant unmet need for DMD patients in Canada.
• Catalyst has reviewed and evaluated over 100 prospective clinical and commercial stage acquisition targets so far this year. The Company continues to focus its efforts on identifying near-term accretive rare disease (orphan) assets that provide a clinically differentiated profile that address unmet medical needs. Catalyst employs a disciplined, comprehensive and exhaustive approach to evaluate opportunities that it believes will add significant value. However, no such agreements have been entered into in 2025.
• As announced yesterday, Catalyst has been recognized among the BioSpace 2026 Best Places to Work for the second consecutive year, ranking number 13 out of 30 of U.S. employers in the small company category.

Third Quarter 2025 Financial Results

Total revenues: Total revenues during the third quarter of 2025 were $148.4 million, compared to $128.7 million for the third quarter of 2024, representing an increase of approximately 15.3%.

Product revenue, net: Product revenue, net for the third quarter of 2025 was $148.4 million, compared to $126.4 million for the third quarter of 2024, representing an increase of approximately 17.4%.

Research and development expenses: Research and development expenses for the third quarter of 2025 were $2.7 million, compared to $3.3 million for the third quarter of 2024.

Selling, general and administrative expenses: Selling, general and administrative expenses for the third quarter of 2025 were $47.5 million, compared to $45.9 million for the third quarter of 2024.

Operating income: Operating income for the third quarter of 2025 was $66.3 million, compared to $50.9 million for the third quarter of 2024, representing an increase of approximately 30.2%.

GAAP net income: GAAP net income for the third quarter of 2025 was $52.8 million ($0.43 per basic and $0.42 per diluted share), compared to GAAP net income of $43.9 million ($0.37 per basic and $0.35 per diluted share) for the third quarter of 2024.

Non-GAAP net income: Non-GAAP net income for the third quarter of 2025 was $86.1 million ($0.70 per basic and $0.68 per diluted share), compared to non-GAAP net income of $71.1 million ($0.60 per basic and $0.57 per diluted share) for the third quarter of 2024.

Cash and cash equivalents

Cash and cash equivalents were $689.9 million as of September 30, 2025. The cash and cash equivalents balance as of September 30, 2025, was impacted primarily by a change in the payment terms resulting from the renegotiation of a contract between the Company and a customer. Under the revisions to the contract with this customer, among other changes, the Company is now paying reduced fees to the customer (which are recorded as a reduction in gross-to-net expenses), but the customer is paying amounts due on its obligations to Catalyst on a monthly basis rather than a semi-monthly basis (as required under the previous contract terms). As a result of this change, the payment of approximately $24.9 million that the Company would have received, based upon the previous due date, at the end of September 2025 under the previous contract terms was received on October 2, 2025.

Catalyst’s Form 10-Q for the third quarter of 2025, which was filed with the U.S. Securities and Exchange Commission on November 5, 2025, provides more detailed financial information and analysis of Catalyst’s financial condition and results of operations.

Conference Call & Webcast Details

The Company will host a conference call and webcast on Thursday, November 6, 2025, at 8:30 AM ET to discuss the financial results and provide a business update.

A webcast will be accessible under the investor section on the Company’s website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days after the event.

About Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst’s website at www.catalystpharma.com. 

Forward-Looking Statements

This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst’s revenue forecasts for 2025 that are included in this press release will prove to be accurate, (ii) whether Catalyst will continue to be profitable and cash flow positive in 2025 and beyond, (iii) whether Catalyst will complete any acquisitions of additional products, and the timing of any such acquisitions, (iv) the impact of the one remaining Paragraph IV lawsuit relating to FIRDAPSE if the results of this litigation are adverse to the Company, (v) the potential impairment of the Company’s intangible asset relating to its acquisition of FYCOMPA if revenues from sales of this product continue to decline, and (vi) those factors described in Catalyst’s Annual Report on Form 10-K for the 2024 fiscal year and Catalyst’s subsequent filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the third quarter of 2025, could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

_{(a) exclusive of amortization of intangible assets}

CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

Source: Catalyst Pharmaceuticals, Inc.

CONTACT: Contact information:

Investor Contact
Melissa Kendis
Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull
Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com

New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System




New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System

Data from over 1 Million Tablo Treatments Among the Findings Presented at the American Society of Nephrology’s Kidney Week 2025

SAN JOSE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced new research findings from over 1 million Tablo hemodialysis treatments across approximately 750 facilities, and 5-year results from the insourcing of dialysis at a large hospital in Florida.

The findings will be presented at the American Society of Nephrology’s Kidney Week 2025 in Houston, which runs November 5-8. The annual event to showcase the latest advancements in kidney care is attended by more than 12,000 professionals from around the world.

Among the highlights:

• AdventHealth will present data from the conversion of their Ocala, Florida site to an insourced dialysis service line with Tablo. These results over 5 years showed a 94% reduction in serious cardiac or respiratory events, a sustained reduction in central-line blood stream infections, a very high nurse retention rate with greater than 95% dialysis staff satisfaction, and a strong return on investment in the first 2 years of operation.
• Data from 1 million Tablo treatments across more than 600 facilities support the clinical effectiveness of insourced dialysis in achieving rigorous treatment goals, including up to 24-hour treatments that generally involve the most critical patients. 
• Data from 10,000 treatments prescribed for more than 23 hours and up to 24 hours, performed at approximately 150 hospitals, showed over 99% achievement of treatment goals with minimal interruptions and rapid resolution of treatment alarms.

“We believe these findings provide additional support for an insourced dialysis service line to elevate the standard of care at hospitals serving patients with compromised renal function,” said Michael Aragon, MD, Chief Medical Officer of Outset Medical. “Outset’s growing base of clinical, financial and operational evidence demonstrates that the advantages of insourcing for acute-care facilities can range from hard clinical benefits to significant cost savings and improved patient outcomes.”

The studies can be read in their entirety on the clinical evidence page of the Outset Medical website. Attendees are invited to visit the Outset booth (#709) during the ASN meeting for more information.

Forward-Looking Statements
This press release may contain 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. These statements include statements regarding Outset’s beliefs, projections and expectations concerning, among other things, the potential impact and implications of the research results discussed in this press release. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results and other events to differ materially from those expressed or implied in such statements. These risks and uncertainties include risks described in the Risk Factors section of Outset’s public filings with the U.S. Securities and Exchange Commission, including its latest annual and quarterly reports. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Outset disclaims any obligation to update these forward-looking statements.

Indications for use
The Tablo^® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration. This device is not indicated for continuous renal replacement therapy (CRRT) and is cleared for use for up to 24 hours. The dialysate generated by this device is not sterile and should not be used for intravenous (IV) infusion.

About Outset Medical, Inc.
Outset is a medical technology company transforming the dialysis experience across the continuum of care with a first-of-its-kind technology. The Tablo^® Hemodialysis System, FDA-cleared for use from hospital to home, is trusted by more than 1,000 U.S. healthcare facilities and has enabled millions of treatments delivered by thousands of nurses. Designed to reduce the cost and complexity of dialysis, Tablo combines water purification and on-demand dialysate production into a single, integrated system that connects seamlessly with Electronic Medical Record systems and a proprietary data analytics platform. This enterprise solution empowers providers to develop an in-house dialysis program where they are in control – enabling better operational, clinical, and financial outcomes. Outset is redefining what’s possible in kidney care through innovation, scale, and a relentless commitment to improving the lives of patients and the professionals who care for them. For more information, visit www.outsetmedical.com. Tablo is a registered trademark of Outset Medical, Inc.

Contact
Jim Mazzola
jmazzola@outsetmedical.com