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Genmab Completes Acquisition of ProfoundBio

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Genmab (Nasdaq: GMAB) has completed the acquisition of ProfoundBio, a clinical-stage biotech firm, for USD 1.8 billion in cash. This acquisition grants Genmab global rights to three clinical candidates, including rinatabart sesutecan (Rina-S), and ProfoundBio's novel antibody-drug conjugate (ADC) technology platforms.

Rina-S is a potential best-in-class ADC currently in part 2 of a Phase 1/2 trial for ovarian cancer and other FRα-expressing tumors. The U.S. FDA has granted Fast Track designation for Rina-S in treating high-grade serous or endometrioid platinum-resistant ovarian cancer.

Genmab expects increased operating expenses due to this acquisition but maintains its revenue guidance. The combination of both companies' ADC technology platforms aims to enhance the development of innovative cancer treatments.

Positive
  • Acquisition of ProfoundBio for USD 1.8 billion in cash.
  • Genmab gains global rights to three clinical candidates, including rinatabart sesutecan (Rina-S).
  • Access to ProfoundBio's novel ADC technology platforms.
  • Strengthened oncology portfolio with next-generation ADCs.
  • Rina-S has potential to address a broader patient population than first-generation FRα-targeted ADCs.
  • U.S. FDA Fast Track designation for Rina-S in treating high-grade serous or endometrioid platinum-resistant ovarian cancer.
  • Broadened Rina-S development plans for ovarian cancer and other FRα-expressing solid tumors.
Negative
  • Acquisition increases Genmab's operating expenses, potentially to the upper end of the DKK 12.4 -13.4 billion guidance range.
  • Incremental R&D investment required to support ProfoundBio's clinical programs.
  • Acquisition cost of USD 1.8 billion in cash may impact cash reserves or increase debt.

The acquisition of ProfoundBio for $1.8 billion in cash is a significant move by Genmab, as it immediately impacts the company's financial structure and cost base. The transaction causes an increase in operating expenses to support ProfoundBio’s clinical programs, particularly Rina-S. Investors should recognize that although this will push operating expenses to the upper end or slightly above the guidance range of DKK 12.4–13.4 billion, it can be justified if the acquired assets show strong potential.

The revenue guidance remains unchanged, indicating that Genmab has confidence in absorbing the acquisition without a short-term hit to its top-line figures. It's crucial, however, that investors watch for updates in Q2 2024 earnings reports to see if the financial benefits start materializing. Investors should also consider the cash outflow of $1.8 billion , which might affect Genmab’s liquidity in the near term, though it appears manageable given their current financial standing.

Overall, the acquisition could enhance long-term growth prospects but poses short-term financial adjustments. Monitoring expense management and future revenue contributions from ProfoundBio’s assets will be key.

From a clinical perspective, acquiring ProfoundBio gives Genmab access to promising antibody-drug conjugate (ADC) technologies that can be important in treating difficult cancers. Rina-S, in particular, is noteworthy because of its potential to treat ovarian cancer and other solid tumors effectively. The FDA's Fast Track designation for Rina-S further emphasizes its potential impact. This designation is granted to expedite the review of drugs that treat serious conditions and fill an unmet medical need.

It's important to understand that ADCs represent a cutting-edge approach in oncology. They work by specifically targeting cancer cells while sparing normal cells, potentially reducing side effects compared to traditional chemotherapy. The ongoing clinical trials and broader development plans for Rina-S will need to show definitive positive outcomes to justify the investment. Positive trial results could position Genmab as a leader in the ADC space, making this acquisition a powerful strategic move.

Improvements in patient outcomes and quality of life will gauge the long-term success of this acquisition in the medical community.

The acquisition of ProfoundBio positions Genmab favorably within the competitive oncology market. Gaining worldwide rights to ProfoundBio’s ADC candidates and platforms enhances Genmab’s pipeline, making it more attractive to investors and potential partners. The targeted therapeutic area of ovarian cancer holds a significant market opportunity due to the high unmet need and limited effective treatment options available.

Moreover, the Fast Track status potentially allows Rina-S to reach the market faster, providing a competitive edge. ADCs represent a growing segment in oncology because they offer targeted treatment options that could be more effective and safer compared to traditional therapies. Genmab's decision to invest heavily in this area aligns with market trends favoring personalized and precise cancer treatments.

However, investors should also be aware of the competitive landscape, with other biotech firms also developing ADC technologies. Continuous innovation and successful clinical outcomes will be important for maintaining a competitive edge.

Overall, the strategic benefits and market potential make this acquisition a forward-looking move, but execution risks and competitive pressures exist.

  • Genmab has completed acquisition of ProfoundBio for USD 1.8 billion in cash
  • Acquisition gives Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate technology platforms

COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) announced today that it has completed its acquisition of ProfoundBio, Inc., a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADC)s and ADC technologies for the treatment of cancers in an all-cash transaction of USD 1.8 billion (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

“With the completion of this strategic transaction, we are excited to welcome our new colleagues and their expertise in developing next-generation antibody-drug conjugates to our exceptionally talented R&D team,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “We look forward to unlocking new opportunities as we strengthen our oncology portfolio and continue to work towards our goal of transforming the lives of patients with innovative antibody medicines.”

The acquisition gives Genmab worldwide rights to ProfoundBio’s portfolio of next-generation ADCs, further broadening and strengthening its clinical pipeline. These programs include Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in part 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors. The addition of Rina-S to Genmab’s portfolio enables Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors. Based on the data from the ongoing Phase 1/2 clinical trial, which also indicates that Rina-S has the potential to address a broader patient population than first-generation FRα-targeted ADCs, Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors. In January 2024, the U.S. Food and Drug Administration (U.S. FDA) granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

In addition, the transaction provides Genmab with access to ProfoundBio’s novel ADC technology platforms, which complement Genmab’s already validated suite of proprietary technology platforms. The combination of the companies’ technology platforms could create new opportunities to generate and develop new medicines with the potential to transform the treatment of cancer and improve patients’ lives.

As previously disclosed in Company Announcement No. 26, following the closing of this acquisition, Genmab’s operating expenses, before expenses incurred by it in connection with the transaction, are anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion. Genmab expects to update its guidance no later than in connection with its second quarter 2024 earnings.

About Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®.

Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs

T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Source: Genmab A/S

FAQ

What is the significance of Genmab's acquisition of ProfoundBio?

Genmab's acquisition of ProfoundBio for USD 1.8 billion grants it global rights to three clinical candidates and novel ADC technology platforms, enhancing its oncology portfolio.

What are the key benefits of acquiring ProfoundBio for Genmab?

The acquisition strengthens Genmab's clinical pipeline with next-generation ADCs, including Rina-S, and provides novel ADC technology platforms.

How much did Genmab pay for ProfoundBio?

Genmab paid USD 1.8 billion in cash for the acquisition of ProfoundBio.

What are the potential financial impacts of the ProfoundBio acquisition on Genmab?

The acquisition is expected to increase Genmab's operating expenses to the upper end of the DKK 12.4 -13.4 billion guidance range, requiring additional R&D investment.

What is rinatabart sesutecan (Rina-S)?

Rina-S is a potential best-in-class ADC in part 2 of a Phase 1/2 trial for ovarian cancer and FRα-expressing solid tumors, recently granted U.S. FDA Fast Track designation.

How will the acquisition of ProfoundBio impact Genmab's oncology portfolio?

The acquisition will broaden and strengthen Genmab's oncology portfolio with next-generation ADCs and novel ADC technology platforms.

What is the U.S. FDA Fast Track designation granted to Rina-S?

The U.S. FDA granted Fast Track designation to Rina-S for treating high-grade serous or endometrioid platinum-resistant ovarian cancer.

Will Genmab change its revenue guidance following the ProfoundBio acquisition?

Genmab's revenue guidance remains unchanged and is expected to be in the previously disclosed range of DKK 18.7 – 20.5 billion.

Genmab A/S

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About GMAB

Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.