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Regeneron (REGN) to Buy Decibel, Gains on Hearing Loss Therapies
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it would acquire clinical-stage biotechnology company Decibel Therapeutics, Inc. for $213 million to expand its gene therapy programs for hearing loss.
Per the terms, Regeneron will acquire Decibel for $4.00 per share of Decibel’s common stock, payable in cash at closing. The deal will also give Decibel shareholders an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods.
Decibel’s lead investigational gene therapy, DB-OTO is in a phase I/II study.
The contingent payments to CVR holders include $2.00 payable in cash upon the fifth participant being administered with DB-OTO in a clinical trial on or prior to Dec 31, 2024.
An additional $1.50 in cash is due either when the first participant is administered with DB-OTO in a registration-enabling trial or acceptance for review of a biologics license application by the FDA, a Marketing Authorization Application by the European Medicines Agency or the U.K. Medicines and Healthcare Products Regulatory Agency or an equivalent application by the applicable national regulatory authority in any other country like Germany, France, Italy or Spain for DB-OTO, whichever occurs first, on or prior to Dec 31, 2028; provided the DB-OTO Milestone is achieved on or prior to Dec 31, 2024.
The transaction is expected to close in the third quarter of 2023.
Shares of Decibel surged 80.29% on Aug 9 following the acquisition news, as a merger with a bigwig like Regeneron will accelerate the development of candidates with much-needed cash infusion and expertise.
We remind investors that both companies initially collaborated in 2017 to discover and develop new potential therapeutics to protect, repair and restore hearing. Thereafter, in 2021, Regeneron extended the research term of its collaboration with Decibel to discover and develop gene therapies for hearing loss to Nov 15, 2023.
As a result, both companies are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. DB-OTO, which is currently in the global phase I/II CHORD study, is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin-related hearing loss.
Regeneron’s shares have gained 10.4% so far this year against the industry’s decline of 12.1%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base.
Last week, the company reported better-than-expected second-quarter 2023 results even though lead drug Eylea’s sales declined. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Nevertheless, the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) , maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Image: Bigstock
Regeneron (REGN) to Buy Decibel, Gains on Hearing Loss Therapies
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it would acquire clinical-stage biotechnology company Decibel Therapeutics, Inc. for $213 million to expand its gene therapy programs for hearing loss.
Per the terms, Regeneron will acquire Decibel for $4.00 per share of Decibel’s common stock, payable in cash at closing. The deal will also give Decibel shareholders an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods.
Decibel’s lead investigational gene therapy, DB-OTO is in a phase I/II study.
The contingent payments to CVR holders include $2.00 payable in cash upon the fifth participant being administered with DB-OTO in a clinical trial on or prior to Dec 31, 2024.
An additional $1.50 in cash is due either when the first participant is administered with DB-OTO in a registration-enabling trial or acceptance for review of a biologics license application by the FDA, a Marketing Authorization Application by the European Medicines Agency or the U.K. Medicines and Healthcare Products Regulatory Agency or an equivalent application by the applicable national regulatory authority in any other country like Germany, France, Italy or Spain for DB-OTO, whichever occurs first, on or prior to Dec 31, 2028; provided the DB-OTO Milestone is achieved on or prior to Dec 31, 2024.
The transaction is expected to close in the third quarter of 2023.
Shares of Decibel surged 80.29% on Aug 9 following the acquisition news, as a merger with a bigwig like Regeneron will accelerate the development of candidates with much-needed cash infusion and expertise.
We remind investors that both companies initially collaborated in 2017 to discover and develop new potential therapeutics to protect, repair and restore hearing. Thereafter, in 2021, Regeneron extended the research term of its collaboration with Decibel to discover and develop gene therapies for hearing loss to Nov 15, 2023.
As a result, both companies are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. DB-OTO, which is currently in the global phase I/II CHORD study, is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin-related hearing loss.
Regeneron’s shares have gained 10.4% so far this year against the industry’s decline of 12.1%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base.
Last week, the company reported better-than-expected second-quarter 2023 results even though lead drug Eylea’s sales declined. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Nevertheless, the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) , maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.