Innovive, LLC Appoints Jamie S. Blose, Pharm.D, MBA, JD as Chief Executive Officer




Innovive, LLC Appoints Jamie S. Blose, Pharm.D, MBA, JD as Chief Executive Officer

SAN DIEGO–(BUSINESS WIRE)–Innovive, LLC, a pioneer and leader in disposable caging and preclinical research solutions, today announced a change in executive leadership with the appointment of Jamie S. Blose, Pharm.D., MBA, JD, as Chief Executive Officer. As a life science executive, Dr. Blose has over 30 years of global experience in the biopharmaceutical industry, bringing a wealth of expertise in preclinical and clinical drug and medical device development, commercialization, and strategic acquisitions and partnerships.

“We are thrilled to have Jamie lead Innovive during the company’s next pivotal growth phase,” said Dee Conger, Innovive’s Founder and Chairman of the Board. “Jamie has a proven track record of scaling successful biopharma companies, and her experience and leadership align perfectly with Innovive’s corporate mission. Jamie’s powerful combination of drug and medical device development knowledge, along with her financial and legal acumen, will help drive our innovation and growth to continue serving the research industry.”

Dr. Blose earned her Doctor of Pharmacy degree from the University of Arizona, her international MBA from Thunderbird, her post-doctoral fellowship in drug development at the University of North Carolina, and her Juris Doctor degree from the University of San Diego School of Law. Dr. Blose is both a licensed pharmacist and a licensed attorney.

“Joining Innovive is an exciting opportunity to work with an exceptionally talented team in transforming how preclinical research is done,” commented Dr. Blose. “Together, we will continue to provide comprehensive support for the research community while expanding our global reach.”

In April, Dr. Blose joined Innovive as the Chief Business Officer. Prior to joining Innovive, she served in leadership positions at both public and private companies including Rain Oncology, Genentech, Amylin Pharmaceuticals, NovaQuest, Quintiles and Glaxo Wellcome. She has also served on various advisory boards, steering committees, and as legal counsel and an advisor to entrepreneurs and start-up companies. Her notable career includes extensive international experience and a commitment to driving innovation and optimization at critical junctures in a company’s evolution.

About Innovive

Founded in 2004, Innovive is recognized as a ground-breaking leader in the development of disposable, recyclable caging for research vivariums. The company provides a comprehensive solution for the global research community, including exceptional vivarium support and management services. Headquartered in San Diego, CA, Innovive’s patented Research-Ready disposable IVC System significantly accelerates the path to scientific discovery by eliminating cage washing and allowing customers to optimize their resources — saving time, space, capital, and labor. Additionally, the company uses sustainability principles in the manufacturing, distribution, use, and disposal of its products. To learn more about Innovive’s unique products and breadth of services, visit innovive.com.

Contacts

Robin Gaffney

Media Relations

Innovive, LLC

Email: rgaffney@innovive.com

Insulet Announces Array of Activities to Support National Diabetes Awareness Month and World Diabetes Day in November  




Insulet Announces Array of Activities to Support National Diabetes Awareness Month and World Diabetes Day in November  

Key events feature the Nasdaq closing bell ceremony, a panel discussion hosted by the American Diabetes Association, the debut of a new podcast, and various employee initiatives to further raise awareness  

ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced plans to recognize National Diabetes Awareness Month and World Diabetes Day with a series of activities in November.

“People with diabetes must make dozens of decisions every day to manage their condition, which can be incredibly stressful, overwhelming at times, and get in the way of enjoying life. This impact often extends to family members and caregivers, a burden the general public largely underappreciates,” said Jim Hollingshead, President and Chief Executive Officer, who noted that an estimated 500 to 600 million adults are living with diabetes, which is forecasted to grow to more than 640 million by 2030. “At Insulet, where many of us have personal connections to diabetes, we all get to do something special, improving lives through our important work.”

Nasdaq Closing Bell Ceremony:

On November 12, Mr. Hollingshead, along with members from the Company’s leadership team and global employees, will be joined by five Omnipod users (Podders) from the United States, Canada, Germany, and the UK to ring the Nasdaq Stock Market closing bell at 4:00 p.m. ET. The Podders represent the hundreds of thousands of people with diabetes who use Omnipod around the world. On behalf of the five Podders and as part of the Insulet for Good initiative, the Company will make charitable contributions to diabetes organizations of their choice. The Nasdaq closing bell ceremony will be aired live on the Nasdaq website and broadcast on CNBC and MSNBC TV.

ADA Panel Discussion:

Insulet is sponsoring the American Diabetes Association’s® (ADA) two-day community event focused on empowering communities to combat diabetes and obesity on November 22 – 23 at Roxbury Community College in Boston, MA. The State of Diabetes event will include a panel discussion with Dr. Trang Ly, MBBS, FRACP, PhD, Senior Vice President and Chief Medical Officer, on diabetes-related health equity topics such as diabetes prevention and education, access, cost of diabetes, advocacy efforts, and policy changes. Insulet will also exhibit at the ADA Community Day of Access, which includes free healthcare screenings and more.

“Insulet teams around the world are laser focused on delivering innovations and bringing research-led insights that empower people with diabetes to live their best lives,” said Dr. Ly. “We are proud to support ADA’s State of Diabetes event, and I look forward to joining in the conversation and sharing our perspectives with others who also care deeply about advancing diabetes care and making the healthcare community stronger.”

New Podcast Launch:

A new Insulet-sponsored podcast, “TypeCast: Life Between the Lines,” is set to launch in November. Hosted by Omnipod Ambassador Natalie Balmain, it will share different stories and life experiences of people with diabetes from around the world, one of several podcasts that Insulet supports to raise awareness.

Employee Engagement:

Throughout the month and part of Insulet for Good, employees will write notes of support and encouragement to recently diagnosed people (and their families), an effort that is being coordinated with Breakthrough T1D (formerly JDRF).

Lastly, for World Diabetes Day on November 14, the Company will host fun, informative, and interactive employee activities globally to share customer stories on various platforms to further raise awareness about diabetes and engagement around the Company’s unifying mission—to improve the lives of people with diabetes.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

©2024 Insulet Corporation. Omnipod and Podder are registered trademarks of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners.

Contacts

Investor Relations:
Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:
Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Bristol Myers Squibb Reports Third Quarter Financial Results for 2024




Bristol Myers Squibb Reports Third Quarter Financial Results for 2024

Performance Reflects Continued Focus on Near-Term Execution and Building a Foundation for Long-Term Sustainable Growth

• Third Quarter Revenues were $11.9 Billion, increasing 8% (+10% Adjusting for Foreign Exchange)
• Growth Portfolio Revenues were $5.8 Billion, increasing 18% (+20% Adjusting for Foreign Exchange)
• GAAP EPS was $0.60 and Non-GAAP EPS was $1.80; Includes Net Impact of $(0.09) Per Share for GAAP EPS and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
• Achieved U.S. Approval of Cobenfy, the First New Pharmacological Approach to Treat Schizophrenia in Decades
• Raising 2024 Revenue Guidance to Approximately +5% (+6% Adjusting for Foreign Exchange), Non-GAAP EPS Range Increased to $0.75 to $0.95

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today reports results for the third quarter of 2024.

“We made important strides in the third quarter with the landmark U.S. approval of Cobenfy in schizophrenia, continued sales momentum, strong cash flow generation and key pipeline achievements,” said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. “We’re focused on closing out the year with strong execution as we deliver on our Growth Portfolio, prioritize high-growth opportunities and continue delivering transformational results for patients.”

THIRD QUARTER RESULTS

All comparisons are made versus the same period in 2023 unless otherwise stated.

• Bristol Myers Squibb posted third quarter revenues of $11.9 billion, an increase of 8%, or 10% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and Eliquis, partially offset by generic erosion of Sprycel due to the loss of exclusivity.
• U.S. revenues increased 9% to $8.2 billion, and International revenues increased 7% to $3.7 billion, primarily due to the Growth Portfolio and higher demand for Eliquis, partially offset by generic erosion of Sprycel due to the loss of exclusivity. The negative impact from foreign exchange on International revenues was 4%.
• On a GAAP basis, gross margin decreased from 77.1% to 75.1%, and on a non-GAAP basis decreased from 77.3% to 76.0%, primarily due to product mix.
• On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $2.0 billion.
• On a GAAP basis, research and development expenses increased 6%, and 8% on a non-GAAP basis, to $2.4 billion, primarily due to recent acquisitions.
• On a GAAP and non-GAAP basis, Acquired IPRD increased to $262 million from $80 million. On a GAAP and non-GAAP basis, licensing income was $25 million compared to $12 million.
• On a GAAP basis, amortization of acquired intangible assets increased 7% to $2.4 billion, primarily due to the RayzeBio acquisition in 2024 and approval of Augtyro in the fourth quarter of 2023.
• On a GAAP basis, the effective tax rate increased from 9.5% to 27.5%, and on a non-GAAP basis increased from 11.6% to 18.5%, primarily due to jurisdictional earnings mix and adjustments in 2023 to reflect IRS income tax guidance issued in 2023 regarding deductibility of certain non-U.S. research and development expenses.
• On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $1.2 billion, or $0.60 per share, during the third quarter of 2024 compared to $1.9 billion, or $0.93 per share, for the same period a year ago. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.7 billion, or $1.80 per share, during the third quarter of 2024 compared to $4.1 billion, or $2.00 per share, for the same period a year ago. In addition to the items above, GAAP and non-GAAP earnings per share were impacted by higher interest expense.

THIRD QUARTER PRODUCT REVENUE HIGHLIGHTS

Growth Portfolio

Growth Portfolio worldwide revenues increased to $5.8 billion compared to $4.9 billion in the prior year period, representing growth of 18% on a reported basis or 20% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Reblozyl, Breyanzi, Camzyos and Opdualag.

Legacy Portfolio

Revenues for the Legacy Portfolio in the third quarter were $6.1 billion compared to $6.0 billion in the prior year period, representing growth of 1% on a reported basis and when adjusted for foreign exchange impacts. Legacy Portfolio revenues were primarily driven by higher demand for Eliquis, partially offset by a decline in demand for Sprycel due to generic erosion.

PRODUCT AND PIPELINE UPDATE

Bristol Myers Squibb recently achieved several important clinical and regulatory milestones, including the U.S. approval of Cobenfy and the disclosure of long-term cardiovascular and oncology data that underscore the strength of the company’s science.

With Cobenfy, the company is re-establishing its presence in neuroscience and introducing the first new pharmacological approach to treat schizophrenia in decades.

Today, the company is providing an update on data from two Phase 3 oncology trials, CheckMate -8HW and CheckMate -901. Please see the table below for more information.

Neuroscience

Cardiovascular

Oncology

Hematology

Immunology

Financial Guidance

Bristol Myers Squibb is raising its 2024 line-item guidance as noted below.

The 2024 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the “Investors” section. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See “Cautionary Statement Regarding Forward-Looking Statements” and “Use of Non-GAAP Financial Information.”

Environmental, Social & Governance (ESG)

As a leading biopharmaceutical company, Bristol Myers Squibb’s passion for making an impact extends beyond the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. To learn more about our priorities and goals, please visit our latest ESG report.

Conference Call Information

Bristol Myers Squibb will host a conference call today, Thursday, October 31, 2024, at 8:00 a.m. ET, during which company executives will review quarterly financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.

Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on October 31, 2024, through 11:30 a.m. ET on November 14, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 9624003.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X (formerly Twitter), YouTube, Facebook, and Instagram.

corporatefinancial-news

Use of Non-GAAP Financial Information

In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expenses excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expenses excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results.

This earnings release and the accompanying tables also provide certain revenues and expenses, as well as non-GAAP measures, excluding the impact of foreign exchange (“Ex-Fx”). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results.

Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwinding of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments and release of income tax reserves relating to the Celgene acquisition.

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at www.bms.com. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers.

Contacts

For more information, contact:
Media Relations: media@bms.com
Investor Relations: investor.relations@bms.com

Read full story here

Merck Announces Third-Quarter 2024 Financial Results




Merck Announces Third-Quarter 2024 Financial Results

• Total Worldwide Sales Were $16.7 Billion, an Increase of 4% From Third Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 7%
  • KEYTRUDA Sales Grew 17% to $7.4 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21%
  • WINREVAIR Sales Were $149 Million; U.S. Launch of WINREVAIR Gaining Momentum; Received Approval in the EU
  • Animal Health Sales Grew 6% to $1.5 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 11%
• GAAP EPS Was $1.24; Non-GAAP EPS Was $1.57; GAAP and Non-GAAP EPS Include a Net Charge of $0.79 per Share Related to Certain Business Development Transactions
• Achieved Significant Milestones in Vaccine Programs
  • CAPVAXIVE Recommended by the CDC’s ACIP for Pneumococcal Vaccination in Adults 50 Years of Age and Older
  • Presented Positive Results From Clinical Studies Evaluating Clesrovimab (MK-1654), an Investigational RSV Preventative Monoclonal Antibody for Infants Entering Their First RSV Season
• Data Presented for Four Approved Medicines and Six Pipeline Candidates in More Than 20 Types of Cancer at ESMO Congress 2024, Including Overall Survival Data From KEYNOTE-522 and KEYNOTE-A18
• Completed Acquisition of Investigational B-Cell Depletion Therapy, CN201 (MK-1045), From Curon Biopharmaceutical
• Full-Year 2024 Financial Outlook
  • Narrows Expected Worldwide Sales Range To Be Between $63.6 Billion and $64.1 Billion
  • Now Expects Non-GAAP EPS To Be Between $7.72 and $7.77; Outlook Reflects a Net Negative Impact of $0.24 per Share Related to Business Development Transactions With Curon Biopharmaceutical and Daiichi Sankyo

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2024.

“Our third-quarter results were strong, as we continue to make progress heading into 2025 and beyond,” said Robert M. Davis, chairman and chief executive officer, Merck. “Our pipeline is advancing and expanding, demonstrating our success in creating a sustainable innovation engine, and positioning Merck with a more diversified portfolio to drive growth. I continue to remain confident in the strength of our business and our ability to execute, and I want to thank our colleagues across the globe for their focus and commitment as we work to create lasting value for patients, shareholders and all our stakeholders.”

Financial Summary

In the third quarter of 2024, total worldwide sales were $16.7 billion, an increase of 4% compared with the third quarter of 2023; excluding the impact of foreign exchange, growth was 7%. Sales growth in the third quarter of 2024 was primarily due to increased usage of KEYTRUDA globally, contributions from new launches, including WINREVAIR and CAPVAXIVE, and strong growth in Merck’s Animal Health business. Revenue growth in the third quarter of 2024 was partially offset by lower sales of JANUVIA and JANUMET, lower combined sales of GARDASIL/GARDASIL 9 and lower sales of LAGEVRIO. Third-quarter GARDASIL/GARDASIL 9 sales declined year-over-year due to reduced demand in China; outside of China, the company achieved double-digit sales growth for GARDASIL/GARDASIL 9 in almost every major region globally.

For the third quarter of 2024, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.24 and non-GAAP EPS was $1.57. The declines in GAAP and Non-GAAP EPS in the third quarter of 2024 versus the prior year were largely due to a net charge of $0.79 per share in the aggregate for the acquisition of Eyebiotech Limited (EyeBio) and a related development milestone, the acquisition of CN201 (now known as MK-1045) from Curon Biopharmaceutical (Curon), as well as a payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement. There were no significant business development transaction charges in the third quarter of 2023.

Non-GAAP EPS in both periods excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investments in equity securities.

Year-to-date results can be found in the attached tables.

Third-Quarter Sales Performance

The following table reflects sales of the company’s top products and significant performance drivers.

Third-Quarter Expense, EPS and Related Information

The table below presents selected expense information.

GAAP Expense, EPS and Related Information

Gross margin was 75.5% for the third quarter of 2024 compared with 73.3% for the third quarter of 2023. The increase was primarily due to the favorable impact of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9), partially offset by higher restructuring costs (primarily reflecting asset impairment charges), as well as higher amortization of intangible assets.

Selling, general and administrative (SG&A) expenses were $2.7 billion in the third quarter of 2024, an increase of 8% compared with the third quarter of 2023. The increase was primarily due to higher administrative, promotional, selling, and acquisition-related costs, partially offset by the favorable impact of foreign exchange.

Research and development (R&D) expenses were $5.9 billion in the third quarter of 2024, an increase of 77% compared with the third quarter of 2023. The increase was primarily due to a charge of $1.35 billion for the acquisition of EyeBio and a $100 million charge for a related development milestone, as well as a charge of $750 million to acquire CN201 (MK-1045) from Curon. The increase in R&D expenses was also driven by higher compensation and benefit costs, as well as higher clinical development spending. The increase in R&D expenses was partially offset by the favorable impact of foreign exchange.

Other (income) expense, net, was $162 million of income in the third quarter of 2024 compared with $126 million of expense in the third quarter of 2023. The favorability was primarily due to a $170 million payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement, lower exchange losses and lower net interest expense.

The effective tax rate of 22.7% for the third quarter of 2024 includes a 7.2 percentage point combined unfavorable impact related to the EyeBio and Curon transactions.

GAAP EPS was $1.24 for the third quarter of 2024 compared with $1.86 for the third quarter of 2023. GAAP EPS in the third quarter of 2024 includes a net charge of $0.79 per share in the aggregate for the EyeBio, Curon and Daiichi Sankyo transactions. There were no significant business development transaction charges in the third quarter of 2023.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 80.5% for the third quarter of 2024 compared with 77.0% for the third quarter of 2023. The increase was primarily due to the favorable impact of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9).

Non-GAAP SG&A expenses were $2.7 billion in the third quarter of 2024, an increase of 8% compared with the third quarter of 2023. The increase was primarily due to higher administrative, promotional and selling costs, partially offset by the favorable impact of foreign exchange.

Non-GAAP R&D expenses were $5.8 billion in the third quarter of 2024, an increase of 77% compared with the third quarter of 2023. The increase was primarily due to a charge of $1.35 billion for the acquisition of EyeBio and a $100 million charge for a related development milestone, as well as a charge of $750 million to acquire CN201 (MK-1045) from Curon. The increase in R&D expenses was also driven by higher compensation and benefit costs, as well as higher clinical development spending. The increase in R&D expenses was partially offset by the favorable impact of foreign exchange.

Non-GAAP other (income) expense, net, was $193 million of income in the third quarter of 2024 compared with $133 million of expense in the third quarter of 2023. The favorability was primarily due to a $170 million payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement, lower exchange losses and lower net interest expense.

The non-GAAP effective tax rate of 21.9% for the third quarter of 2024 includes a 6.0 percentage point combined unfavorable impact related to the EyeBio and Curon transactions.

Non-GAAP EPS was $1.57 for the third quarter of 2024 compared with $2.13 for the third quarter of 2023. Non-GAAP EPS in the third quarter of 2024 includes a net charge of $0.79 per share in the aggregate for the EyeBio, Curon and Daiichi Sankyo transactions. There were no significant business development transaction charges in the third quarter of 2023.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

Pipeline and Portfolio Highlights

In the third quarter, Merck continued to develop and augment its strong, diverse pipeline and achieve key regulatory and clinical milestones.

In cardiovascular disease, Merck continued to build on positive momentum in its U.S. launch of WINREVAIR. As of the end of September 2024, more than 3,700 patients have been prescribed WINREVAIR. The company also received the European Commission’s (EC) approval of WINREVAIR, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of adult patients with PAH with World Health Organization (WHO) functional Class II to III. WINREVAIR is the first activin signaling inhibitor approved for the treatment of PAH in Europe. WINREVAIR has launched in Germany and Merck is working to obtain reimbursement for WINREVAIR in other countries in the EU, which should occur in most other major European markets in the second half of 2025.

In oncology, Merck continued to reinforce its leadership in women’s and earlier stages of cancers and demonstrate progress in its research pipeline. At the European Society for Medical Oncology (ESMO) Congress 2024, three of the company’s data presentations were highlighted during Presidential Symposium sessions. These included overall survival (OS) data from the Phase 3 KEYNOTE-522 trial in high-risk, early-stage TNBC and from the Phase 3 KEYNOTE-A18 trial (also known as ENGOT-cx11/GOG-3047) in high-risk, locally advanced cervical cancer. In addition, new positive data on investigational candidates from Merck’s pipeline were presented, including for patritumab deruxtecan (HER3-DXd), an antibody-drug conjugate (ADC) being developed in collaboration with Daiichi Sankyo, and for sacituzumab tirumotecan (sac-TMT), an anti-TROP2 ADC being developed in collaboration with Kelun-Biotech.

The company also achieved several regulatory milestones, including new approvals for KEYTRUDA-based regimens in the U.S., Europe and Japan. In addition, Merck recently announced top-line results from the KEYNOTE-689 trial, which marks the first positive trial in two decades for patients with resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

In vaccines, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted in October 2024 to recommend CAPVAXIVE for individuals 50 to 64 years of age. This decision expanded upon the initial unanimous recommendation in June 2024 for use of CAPVAXIVE in adults age 65 and older, among other cohorts.

At IDWeek 2024, Merck presented positive results from the Phase 2b/3 trial of clesrovimab (MK-1654), an investigational respiratory syncytial virus (RSV) preventative monoclonal antibody for infants. These results support the potential for clesrovimab to become the first and only single-dose immunization designed to protect infants with the same dose, regardless of weight, for the duration of their first RSV season (six months).

In immunology, long-term efficacy and safety data for tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), from the Phase 2 ARTEMIS-UC and APOLLO-CD studies in ulcerative colitis (UC) and Crohn’s disease (CD), were presented at the United European Gastroenterology (UEG) Week 2024 Congress. Both studies showed that, at week 50, maintenance of treatment efficacy was generally observed in 12-week induction responders. Phase 3 studies in UC and CD are ongoing.

In addition, Merck continued to expand and diversify its pipeline by securing strategic business development opportunities. Merck completed its acquisition of CN201 (MK-1045), a next-generation CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, from Curon. Merck also announced the expansion of the global development and commercialization agreement with Daiichi Sankyo to include MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager. The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with small cell lung cancer (SCLC), as well as other potential combinations.

Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows.

Contacts

Media Contacts:

Robert Josephson

(203) 914-2372

robert.josephson@merck.com

Michael Levey

(215) 872-1462

michael.levey@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Steven Graziano

(732) 594-1583

steven.graziano@merck.com

Read full story here

Compass Pathways Announces Third Quarter 2024 Financial Results and Business Updates




Compass Pathways Announces Third Quarter 2024 Financial Results and Business Updates

• Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025
• COMP006 data will now be announced after 26-week time point, expected in the second half of 2026
• Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30%
• Cash position of $207 million
• Conference call October 31 at 8:00 am ET (12:00 pm UK)

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2024 and an update on recent business progress.

“Ensuring the success of our lead COMP360 program is our absolute priority. We remain confident that COMP360 can be an effective therapy for patients with serious mental illness and our focus on delivering new treatment options for patients living with treatment-resistant depression remains paramount,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “The shift in the phase 3 pivotal program timeline has forced us to look carefully at our operations and ensure that every resource is focused on this goal. As such, we have made the difficult decision to reduce our workforce and exit activities that are not directly tied to the completion of the trials, regulatory filing and commercialization if approved. These are necessary strategic decisions that we believe will position the COMP360 program for success.”

Business highlights

COMP360 psilocybin treatment in TRD

The phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line pivotal COMP005 trial data is expected in the second quarter 2025. In addition, as a result of the increased regulatory scrutiny on functional unblinding, the company has decided to shift the data release for COMP006 until after the 26-week time point and the completion of the blinded portion has been reached for all patients to protect against the risk of unblinding. With this change, Compass now expects data for COMP006 in the second half of 2026.

Prioritization of resources

As a result of changing timelines for the phase 3 trials, we will be reducing our workforce by approximately 30%, including eliminating some senior management positions, to further focus the organization and its capital resources on successfully delivering the COMP360 program. Our non-COMP360 preclinical efforts will be stopped and we are exploring a potential externalization for our digital health tools.

Financial highlights

• Net loss for the three months ended September 30, 2024, was $38.5 million, or $0.56 loss per share (including non-cash share-based compensation expense of $5.0 million), compared with $33.4 million, or $0.67 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $4.4 million).
• Net loss for the nine months ended September 30, 2024, was $111.8 million, or $1.67 loss per share (including non-cash share-based compensation expense of $15 million), compared with $85.9 million, or $1.81 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $13.1 million).
• Research and development expenses were $32.9 million for the three months ended September 30, 2024, compared with $21.5 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
• Research and development expenses were $86.9 million for the nine months ended September 30, 2024, compared with $60.4 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
• General and administrative expenses were $15.0 million for the three months ended September 30, 2024, compared with $12.5 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
• General and administrative expenses were $42.9 million for the nine months ended September 30, 2024, compared with $38.1 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
• Cash and cash equivalents were $207 million as of September 30, 2024, compared with $220.2 million as of December 31, 2023.
• Debt was $29.8 million as of September 30, 2024, compared with $28.8 million as of December 31, 2023.

Financial Guidance

Fourth quarter 2024 net cash used in operating activities is expected to be in the range of $37 million to $43 million. The full-year 2024 net cash used in operating activities is expected to be in the range of $114 million to $120 million. The cash position at September 30, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements at least into 2026.

Conference call

The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. A live webcast of the call will be available on the Compass Pathways website at Third Quarter 2024 Financial Results. The webcast will also be on the Investors section of the Compass Pathways website for 30 days.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological support. We have completed an open label phase 2 study of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD), and we are currently conducting a phase 2 clinical study in anorexia nervosa.

Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing.

Availability of other information about Compass Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “will”, “could”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “potential” and “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our financial guidance; our business strategy and goals, our expectations and projections about the company’s future cash needs and financial results; our plans for a strategic reorganization, including a reduction in workforce, and our expectations regarding impact and cost savings from our planned reduction in workforce; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; our expectations regarding the benefits of our investigational COMP360 psilocybin treatment; and our plans, expectations and ability to achieve our goals related to the research collaboration agreements. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: we will require substantial additional funding to achieve our business goals, including to repay the term loan facility, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials and research and development efforts; the availability of future tranches under the term loan facility is dependent, in part, on the approval of the lender, achievement of certain milestones and other factors; clinical development is lengthy and outcomes are uncertain, and therefore our phase 3 clinical trials in TRD and our other clinical trials may be delayed or terminated; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; the risk that our research collaborations will not continue or will not be successful; and our efforts to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in our most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”) , which are available on the SEC’s website at www.sec. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on our current expectations and speak only as of the date hereof.

Contacts

Enquiries
Media: Sally Bain, sally.bain@compasspathways.com, + 1 781 458 0443

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

AiCuris Initiates First-in-Human Phase 1 Trial With Antiviral Agent AIC468 to Address BK Virus Infections in Kidney Transplant Recipients




AiCuris Initiates First-in-Human Phase 1 Trial With Antiviral Agent AIC468 to Address BK Virus Infections in Kidney Transplant Recipients

WUPPERTAL, Germany–(BUSINESS WIRE)–AiCuris Anti-infective Cures AG today announced the initiation of its Phase 1, first-in-human trial of AIC468, a novel antisense oligonucleotide. AIC468 is an antiviral agent which aims to treat BK virus (BKV) infections in kidney transplant (KT) recipients. BKV reactivation in KT recipients is an area of high unmet medical need with no approved drug treatments. This Phase 1 trial (2023-510074-13-00) will evaluate the safety, tolerability and pharmacokinetics of AIC468 in healthy volunteers.

“BK virus infections remain an urgent threat to transplant recipients, leading to graft loss and other serious complications,” said Cynthia Wat, MD, CMO of AiCuris. “Advancing AIC468 into clinical trials brings us one step closer to providing a targeted therapeutic option that directly inhibits BK virus replication, that addresses this critical unmet medical need. Our team remains committed to improving outcomes for patients dealing with the challenges of post-transplant viral infections.”

“This trial marks another significant milestone in our mission to develop innovative therapies for patients with weakened immune systems, who are particularly vulnerable to serious viral infections like BK virus infections,” said Larry Edwards, CEO of AiCuris. “The initiation of this trial demonstrates the strength and diversity of our pipeline as we continue to advance cutting-edge solutions for high-risk patient populations. With multiple programs now in the clinic, we are confident that our approach can make a meaningful impact on the lives of immunocompromised patients.”

The randomized, double-blind, placebo-controlled first-in-human trial will assess the safety, tolerability, and pharmacokinetics of AIC468 in 72 healthy volunteers. Conducted in Germany, the trial includes both single and multiple ascending doses of AIC468. Topline data readout from the single ascending dose part of the study is expected in 2025.

About BKV

BK virus (BKV) is a common polyomavirus that infects most people in early childhood, typically without symptoms. In immunocompromised individuals, such as organ transplant recipients, BKV can reactivate, leading to serious health issues. In kidney transplant (KT) patients, BKV reactivation can cause BK virus-associated nephropathy (BKVAN), affecting up to 10%¹ of recipients and potentially resulting in graft loss. Current management involves reducing immunosuppressive therapy, which increases the risk of graft rejection. Despite its prevalence, there is no approved antiviral treatment specifically for BKV.

About AiCuris

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS^®, marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

¹ Imlay H. et al., Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials, Clinical Infectious Diseases, 2022, https://doi.org/10.1093/cid/ciac071

Contacts

Trophic Communications
Dr. Stephanie May and Dr. Charlotte Spitz

Phone: +49 171 3512733

Email: aicuris@trophic.eu

Quantum-Si to Host Investor & Analyst Event in New York City on November 20th, 2024




Quantum-Si to Host Investor & Analyst Event in New York City on November 20th, 2024

BRANFORD, Conn.–(BUSINESS WIRE)–Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company™, today announced that the Company will host an Investor & Analyst event in New York City on November 20^th, 2024.

Quantum-Si’s management team will provide updates on the Company’s evolving technology roadmap, emerging applications for protein sequencing and the expanding commercial opportunities that these innovations create.

A live question and answer session will follow the formal presentations.

EVENT DETAILS:

WHEN: Wednesday, November 20, 2024 | 10AM – 12PM EST

WHERE: Westin NY Times Square, 270 West 43^rd Street, New York, NY, 10036

REGISTRATION LINK (both in-person & virtual*): QSI Investor Day 2024

*In-person attendance is limited to invited research analysts and institutional investors only. All other guests are invited to view the live or archived webcast virtually on the Investor Relations section of Quantum-Si’s website at https://ir.quantum-si.com/. The archived webcast will be available for at least 90 days following the event.

About Quantum-Si Incorporated

Quantum-Si, The Protein Sequencing Company™, is focused on revolutionizing the growing field of proteomics. The Company’s Platinum® instrument enables Next-Generation Protein Sequencing™ that advances proteomic research, drug discovery, and diagnostics beyond what has been possible with existing proteomic tools. Learn more at quantum-si.com or follow us on LinkedIn or X.

Contacts

Investor Contact
Doug Farrell, VP, Investor Relations

ir@quantum-si.com

Media Contact
Katherine Atkinson, SVP, Commercial Marketing

media@quantum-si.com

TME Pharma Awarded €2.4 Million German Federal Grant to Support NOX-A12 Phase 2 Trial in Brain Cancer




TME Pharma Awarded €2.4 Million German Federal Grant to Support NOX-A12 Phase 2 Trial in Brain Cancer

• The grant program run by the German Federal Ministry of Education and Research (BMBF) supports SMEs working on innovative projects in biomedicine
• Non-dilutive support for planned phase 2 trial now totals over €7 million

BERLIN–(BUSINESS WIRE)–Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that it is awarded a non-refundable grant of €2.4 million from the KMU-innovativ funding program run by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF).

The non-dilutive non-refundable funding will support TME Pharma’s planned Phase 2 randomized controlled study evaluating its lead asset, the CXCL12 inhibitor NOX-A12, for use in the treatment of aggressive adult brain cancer, glioblastoma. Funds will be disbursed after the relevant costs in the trial have been incurred. This grant complements other non-dilutive support worth approximately €5 million for study aspects that are out of the scope of the BMBF grant.

KMU-innovativ (“Innovative SMEs”) is the leading funding program of the BMBF specifically designed to support small and medium-sized enterprises (SMEs) in Germany in the realization of innovative projects. The NOX-A12 Phase 2 study met the objectives of the KMU-innovativ Biomedicine program to strengthen the innovative power of SMEs in medical biotechnology and to promote the development of drugs in Germany that lead to the cure, alleviation or prevention of diseases.

“We are pleased that the scientific review by experts at the BMBF recognized the potential of our lead asset in the difficult-to-treat indication of aggressive adult brain cancer and are very grateful to the BMBF for this significant grant of financial support to TME Pharma’s trial,” said Aram Mangasarian, CEO of TME Pharma. “The award of this grant is based on the robust study design of our upcoming Phase 2 trial, underpinned by the substantial clinical results NOX-A12 has already achieved showing extraordinary potential as a therapy for glioblastoma. The fact that this funding is non-dilutive is positive news for our existing shareholders. This complements other non-dilutive support TME has secured for different aspects of the trial that will also be provided once the trial has started.”

In the Phase 2 study design, approved by the US Food and Drug Administration (FDA) and the German regulator, glioblastoma patients will be treated in five different arms that will address questions of dosing and assess the contribution of the NOX-A12 and bevacizumab components to the overall efficacy of the combination therapy. TME Pharma will be able to optimize late phase development by selecting the best performing treatment arm against standard of care. The Phase 2 results will serve as a basis for discussions with regulatory authorities on the design of the further development strategy, up to market approval, and for discussions with potential partners, such as pharmaceutical companies.

About TME Pharma

TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA Phase 1/2 clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. US FDA has approved the design of a randomized Phase 2 trial in glioblastoma and TME Pharma was awarded fast track designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in France, Spain and the United States. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.

TME Pharma® and the TME Pharma logo are registered trademarks.

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

Visit TME Pharma on LinkedIn and X.

About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab.

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain “forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.

Contacts

TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO

Tel. +49 (0) 30 16637082 0

investors@tmepharma.com

Investor and Media Relations:


LifeSci Advisors
Guillaume van Renterghem

Tel. +41 (0) 76 735 01 31

gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé

Tel. +33 (0) 1 44 71 00 15

arouille@newcap.fr

Kyowa Kirin Announces Changes in Top Leadership Positions to Strengthen Operations as a Global Specialty Pharmaceutical Company




Kyowa Kirin Announces Changes in Top Leadership Positions to Strengthen Operations as a Global Specialty Pharmaceutical Company

• Masashi Miyamoto to be named Chairman and CEO
• Abdul Mullick to be named President and COO
• Changes designed to further deliver on company’s 2030 Vision and commitment to advancing novel treatments for Bone/Mineral, Intractable Hematological Diseases/Hemato-Oncology and Rare Diseases

TOKYO–(BUSINESS WIRE)–Japan-based Global Specialty Pharmaceutical Company Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto.) (TOKYO:4151) today announced that Masashi Miyamoto, Ph.D. will take the role of Chairman and CEO, after serving as President for the past 7 years. Abdul Mullick, Ph.D., the current Chief International Business Officer (CIBO), will become President and Chief Operating Officer. The changes will come into effect following approval at the Ordinary General Meeting of Shareholders and the Board of Directors meeting in March 2025.

These changes reflect a new dual CEO-COO leadership structure to help support the business’ continued growth. Miyamoto, as Chairman and CEO, will lead discussions on Kyowa Kirin’s direction and overall strategy and maintain key relationships with stakeholders, while Mullick, as President and COO, will oversee the execution of all business operations at the global level, enhancing collaboration across regions and functions and advancing the management strategy. Additional details regarding the structure will be shared post-approval.

“Our vision for 2030 is to deliver life-changing value to patients in our focus disease areas, by leveraging novel research, innovative modalities and the global capabilities we’ve built for in-house delivery and strategic partnering opportunities,” said Dr. Miyamoto. “I am pleased to work alongside Dr. Mullick in his new role to guide the next stage of our ongoing transformation, so we can realize our vision as healthcare systems continue to evolve globally. In his six years with the company, Dr. Mullick has brought exceptional leadership, building on his extensive experience across multiple companies, cultures, and geographies, and I am confident he will bring even more value in his new role.”

Dr. Mullick added: “I am honored to be nominated as the next President and COO of Kyowa Kirin. Helping Kyowa Kirin transform into a true Japan-based global specialty pharmaceutical company that makes people smile has been one of the greatest privileges of my life, and I am confident that the journey we are on to achieve our Vision 2030 will deliver even greater opportunities for our business, for our employees, and most important, for the patients who count on us.”

Mullick will be based in the company’s Global headquarters in Tokyo, where he has lived since 2023. He is originally from the United Kingdom and holds a Ph.D. in Molecular Biology from the University of Bristol, and a BSc in Molecular Biology from Kingston University, both in the UK.

The changes of the representative directors were agreed at the Board of Directors meeting held today. It also was announced that Yutaka Osawa, Executive Vice President and Chief Compliance Officer (CCO), will retire in March 2025.

About Kyowa Kirin

Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe.

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

Contacts

Contacts for Kyowa Kirin Co., Ltd.
Wataru Suzuki

Corporate Communications Department – Global

media@kyowakirin.com

Lauren Walrath

Vice President, Public Affairs – North America

lauren.walrath.g4@kyowakirin.com

Stacey Minton

Senior Vice President, Corporate Affairs – EMEA

stacey.minton@kyowakirin.com

Takeda Announces Strong First Half FY2024 Results and Raises Full Year Outlook




Takeda Announces Strong First Half FY2024 Results and Raises Full Year Outlook

• Revenue Growth of +13.4% at Actual Exchange Rates (AER); +5.0% at Constant Exchange Rate (CER) Driven by Continued Advancement of Growth & Launch Products (+18.7% at CER)
• Core Operating Profit Increase of +12.9% at CER; Core Operating Profit Margin of 30.2%
• Double-Digit Revenue Growth of ENTYVIO^® at CER Driven by Launch of ENTYVIO^® Pen in the U.S.
• Geographical Expansion with Approvals of ADZYNMA^® in EU and FRUZAQLA^® in Japan
• Late-Stage Pipeline Advances with the Start of Phase 3 Trial of TAK-861 in Narcolepsy Type 1
• Company will Hold R&D Day for Investors and Media on December 12 (Eastern) / 13 (Japan)

OSAKA, Japan–(BUSINESS WIRE)–Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first half of fiscal year 2024 (six months ended September 30, 2024), with continued momentum in its Growth & Launch Products driving growth. The company has upgraded its full year forecasts and Management Guidance to reflect stronger than anticipated first-half performance (including milder than anticipated generic erosion of VYVANSE^® in the U.S.) and revised foreign exchange assumptions.

The strong performance of Takeda’s Growth and Launch Product portfolio, which grew 18.7% at CER and represented 47% of total revenue, reinforces the company’s confidence in returning to sustainable revenue and profit growth.

The initiation of TAK-861’s Phase 3 trial in August for narcolepsy type 1 demonstrates Takeda’s strength in advancing its promising late-stage pipeline to develop life-transforming treatments. More details on the company’s R&D strategy and pipeline updates, including commercial prospects, will be presented at Takeda’s R&D Day taking place on December 12 (EST) / 13 (JST), 2024.

Takeda chief executive officer, Christophe Weber, commented:

“In the first half of fiscal year 2024, we made further progress in advancing our pipeline, including the initiation of our TAK-861 Phase 3 trial for narcolepsy type 1. Our late-stage programs continue to advance, with several in Phase 3 development this fiscal year, and have the potential to transform the lives of patients around the world.

“Our commercial execution has positioned us for sustainable growth despite a dynamic and competitive environment. Bolstered by the continued strong performance of our Growth & Launch Products, including a return to double-digit growth of ENTYVIO^®, lifecycle management approvals and successful launches of new products such as FRUZAQLA^® in our oncology portfolio, our business and long-term outlook remains strong.”

Takeda chief financial officer, Milano Furuta, commented:

“We are upgrading our FY2024 full year outlook, reflecting stronger than anticipated first half performance as well as updated foreign exchange assumptions for the year. Full-year guidance reflects our intention to increase R&D investment in the second half to support our late-stage pipeline.

“We remain confident in delivering sustainable growth with our Growth & Launch Products and promising late-stage pipeline. Implementation of our multi-year program to improve our efficiency through organizational agility, procurement savings and data, digital and technology is progressing as planned. We continue to drive these initiatives to improve our Core Operating Profit Margin from FY2025 towards our low-to-mid 30s% target.”

FY2024 Outlook

Updating Full Year Management Guidance, and Reported and Core Forecasts

Takeda’s FY2024 Management Guidance has been upgraded, primarily due to milder than anticipated generic erosion of VYVANSE and strong business momentum. Furthermore, also reflecting expected foreign exchange rates during the remaining second half of FY2024, Takeda’s FY2024 reported and Core forecasts have been revised from the original forecast.

Additional Information About Takeda’s FY2024 H1 Results

For more details about Takeda’s FY2024 H1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2024 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q2 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/)

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Financial information and Non-IFRS Measures

Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).

This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2024 Q2 investor presentation (available at www.takeda.com/investors). Beginning in the quarter ended June 30, 2024, Takeda (i) changed its methodology for CER adjustments to results of subsidiaries in hyperinflation countries to present those results in a manner consistent with IAS 29, Financial Reporting in Hyperinflation Economies, (ii) re-named Free Cash Flow as previously calculated as “Adjusted Free Cash Flow” (with “Free Cash Flow” to be reported as Operating Cash Flow less Property, Plant and Equipment), and (iii) re-named Net Debt as previously calculated as “Adjusted Net Debt” (with “Net Debt” to be reported as the book value of bonds and loans less cash and cash equivalents).

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Please refer to slide 5 of Takeda’s FY2024 Q2 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

Contacts

Investor Relations
Christopher O’Reilly

Christopher.oreilly@takeda.com
+81 (0) 90-6481-3412

Media Relations
Brendan Jennings

Brendan.jennings@takeda.com
+81 (0) 80-2705-8259

(Outside Japan business hours)

Media_relations@takeda.com