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An In-Depth Look at Ortho Dermatologics in August

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Revenue trends of top products

In the second quarter, Bausch Health Companies’ (BHC) subsidiary Ortho Dermatologics’ top products Elidel, Thermage, and Jublia reported revenues of $25 million, $19 million, and $12 million, respectively, compared to $18 million, $16 million, and $18 million, respectively, in the second quarter of 2017, reflecting a ~39% rise, a ~19% rise, and a 33% fall YoY (year-over-year).

In the second quarter, Ortho Dermatologics’ products Targretin and Retin-A Micro each reported revenue of $9 million compared to $10 million and $8 million, respectively, in the same period last year.

Ortho Dermatologics’ Onexton and Zovirax each reported revenue of $8 million in the second quarter. In the second quarter of 2017, they had each reported revenue of $10 million.

In the second quarter, Ortho Dermatologics’ Siliq and Fraxel each reported revenue of $4 million, while Solodyn reported revenue of $6 million.

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Recent developments

In June, Ortho Dermatologics announced its receipt of a Complete Response Letter from the FDA associated with its NDA (New Drug Application) for Duobrii lotion for the treatment of individuals with plaque psoriasis.

The FDA only asked questions related to pharmacokinetic data and did not specify anything about safety or efficacy. Ortho Dermatologics expects to submit additional data within 30 days, which would be considered a Class II filing. Bausch Health is confident that it will receive approval for the drug and bring it to the market.

Update on Ortho Dermatologics’ clinical pipeline

Ortho Dermatologics has already submitted a regulatory filing for Bryhali, a high-potency topical steroid therapy for the treatment of individuals with plaque psoriasis. The FDA has provided a PDUFA (Prescription Drug User Fee Act) action date of October 5, 2018.

Bausch Health also submitted a regulatory filing to the FDA for Altreno (tretinoin lotion) for its approval as a treatment for acne. The FDA has provided a PDUFA action date of August 27, 2018.

FDA approval for Bryhali and Altreno could boost Ortho Dermatologics’ revenue growth.

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