BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR. Upon closing, this transaction will add an attractive late-stage asset to LEO Pharma’s pipeline in medical dermatology. The deal is subject to certain closing conditions including, but not limited to, Timber Pharmaceuticals’ shareholder approval.

The deal represents a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million, and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones.

Timber Pharmaceuticals’ lead investigational product candidate, TMB-001, is a topical reformulation of the active ingredient, isotretinoin, which is aimed at treating congenital ichthyosis – a rare skin disease with significant unmet need and no approved prescription therapies available.

Isotretinoin is an API that today only exists in an oral formulation in the U.S. The reformulation, TMB-001, has received an orphan and breakthrough designation by the FDA, and is on track with an action date as early as mid-2025. TMB-001 has shown positive results in Phase 2, with Phase 3 recruitment currently on-going in the US and in Europe.

Christophe Bourdon, CEO of LEO Pharma commented:

“Signing an agreement to acquire Timber Pharmaceuticals and TMB-001, which is still subject to certain closing conditions, is an additional step in delivering on our strategy. We will add an attractive late-stage asset to our medical dermatology pipeline and strengthen our team in the US. And most importantly, we will add an asset with promising outlook to be able to help patients suffering from a debilitating disease that today have no proper treatment options.”

John Koconis, Chairman and Chief Executive Officer of Timber Pharmaceuticals, said:

“We are very pleased to deliver a transaction that will maximize long term value for Timber Pharmaceuticals’ shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber Pharmaceuticals’ portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease.”

The transaction is pending final Timber Pharmaceuticals’ shareholder approval and certain other closing conditions before the transaction can be closed, which is expected to happen in the 4^th quarter of 2023.

Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,600 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. LEO Pharma generally identifies forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. LEO Pharma has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond LEO Pharma’s control. Actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with meeting the conditions required to consummate the proposed merger transaction and the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed merger transaction will not occur; (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (iii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement, (iv) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners and competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed merger transaction; (v) the CVR payments are tied to our ability to obtain regulatory approvals or commercialize the TMB-001 product, including the results of any ongoing or future clinical trials which may not satisfy U.S. regulatory authorities; (vi) the regulatory approval process is expensive, time consuming and uncertain and (vii) those risks detailed in Timber Pharmaceuticals’ most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by Timber Pharmaceuticals from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. LEO Pharma cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, LEO Pharma undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

For further information, visit:

www.leo-pharma.com

www.timberpharma.com

Contacts

Media contact:
Henrik Heskjær
+45 3140 6180
hdtdk@leo-pharma.com

Source:- Businesswire