Horizon Therapeutics sold for $28.3 billion

Amgen to acquire Horizon Therapeutics for $116.50 per share in cash

The board of directors of Horizon Therapeutics (HZNP) and the board of directors of Amgen (AMGN) announced that they have reached agreement on the terms of a cash offer for the company by Pillartree, a newly formed private limited company wholly owned by Amgen, which is unanimously recommended by the company board and pursuant to which acquirer sub will acquire the entire issued and to be issued ordinary share capital of the company.

Under the terms of the acquisition, each company shareholder at the Scheme Record Time will be entitled to receive: $116.50 for each Company Share in cash.

The acquisition represents: a premium of approximately 47.9% to the closing price of $78.76 per company share on November 29 and a premium of approximately 19.7% to the closing price of $97.29 per company share on December 9.

The acquisition values the entire issued and to be issued ordinary share capital of the company at approximately $27.8B on a fully diluted basis and implies an enterprise value of approximately $28.3B.

Amgen has entered into a Bridge Credit Agreement, dated December 12, for an aggregate amount of $28.5B.

Having taken into account the relevant factors and applicable risks, the company board, which has been so advised by Morgan Stanley, which as financial advisor to the company board has rendered a fairness opinion, considers the terms of the acquisition as set out in this announcement to be fair and reasonable.

In providing its advice to the company board, Morgan Stanley has taken into account the commercial assessments of the company directors.

The company board has unanimously determined that the transaction agreement and the transactions, including the scheme, are advisable for, fair to and in the best interests of, the company shareholders.

Accordingly, the company board unanimously recommends that company shareholders vote in favor of the scheme meeting resolution and the Required EGM Resolutions, or, if the acquisition is implemented by a takeover offer, accept or procure acceptance of such takeover offer.

It is agreed that the acquisition will be implemented by way of an Irish High Court-sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act.

The acquisition will be subject to the satisfaction or waiver of the conditions, which are set out in full in Appendix 3 to this announcement, including, in summary: the requisite approval by company shareholders of the scheme meeting resolution and the required EGM Resolutions; the sanction of the scheme by the Irish High Court and the receipt of required antitrust clearances in the United States, Austria and Germany and the receipt of required foreign investment clearances in France, Germany, Denmark and Italy.

It is expected that the scheme document, containing further information about the acquisition and notices of the scheme meeting and the EGM, the expected timetable for completion and action to be taken by company shareholders, will be published as soon as practicable.

It is anticipated that the scheme will, subject to obtaining the necessary regulatory approvals, be declared effective in the first half of 2023. An expected timetable of key events relating to the acquisition will be provided in the scheme document.

Horizon Therapeutics Public Limited Company is an Irish biotechnology company, It focuses on the discovery, development, and commercialization of medicines that address critical needs for people impacted by rare, autoimmune, and severe inflammatory diseases. Its portfolio comprises 12 medicines in the areas of rare diseases, gout, ophthalmology, and inflammation.

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Prometheus Biosciences reports positive data, shares jump!

Prometheus announces results for PRA023 in APOLLO-CD Phase 2 study

Prometheus Biosciences (RXDX) reported results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating strong efficacy and favorable safety results in both studies.

Based on the totality of the data in these two studies, Prometheus intends to advance PRA023 into Phase 3 studies for ulcerative colitis and Crohn’s disease in 2023.

Results from the APOLLO-CD Phase 2a Study: Prometheus’ Phase 2a APOLLO-CD clinical trial was a 12-week open-label study that enrolled 55 patients with moderate-to-severely active CD with endoscopically active disease who had failed conventional or biologic therapy.

Crohn’s Disease

The study enrolled a highly refractory patient population with 70.9% of patients previously treated with at least one biologic therapy and 52.7% treated with two or more biologic therapies.

The results on the key endpoints were as follows: 26.0% of patients on PRA023 achieved endoscopic response; 49.1% of patients on PRA023 achieved clinical remission; PRA023 was well tolerated in the APOLLO-CD study.

There were no treatment-emergent serious adverse events, adverse events leading to discontinuation, or severe AEs assessed as related to PRA023 by the investigator.

The predictive power of the company’s prespecified genetic markers was validated using an alternative Crohn’s-specific CDx algorithm which showed 45.0% endoscopic response relative to all-comers of 26%.

While the original algorithm provided limited benefit on some of the endpoints, the alternative algorithm demonstrated enhanced performance across both clinical and endoscopic outcomes.

As a result of these positive data, Prometheus plans to advance PRA023 into pivotal development in 2023, following discussions with regulators.

Based upon confidence in its precision approach and speed to market, the company conducted an interim companion diagnostic (CDx) analysis of Cohort 1 to evaluate the effectiveness of the CDx candidate in ARTEMIS-UC. Although from limited patient numbers, data from the subset of patients who tested positive on the CDx in Cohort 1 (N=32) demonstrated a placebo-adjusted clinical remission rate of 37.5%, compared with the placebo-adjusted remission rate of 25.0% for all-comers. The expansion cohort (Cohort 2), which is statistically powered to further assess the treatment effect of PRA023 in CDx+ patients will continue to enroll, and the company expects results in the second quarter of 2023.

RXDX is up $17 to $112.86.

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