Merck’s women’s health-focused spinoff Organon officially launched last June. On Feb. 17, the company announced results for the fourth quarter and full year ending Dec. 31, 2021.

Organon‘s total net revenue came in at $6.3 billion for 2021. Compared with 2020, that marks a 3% decrease as-reported and 6% ex-FX.

According to the company, that dip reflects decreases across certain markets in the Established Brands unit, mostly as a result of competition after loss of exclusivity.

However, Organon said that decline was offset by increased sales for Women’s Health products (up 4% as-reported and 2% ex-FX), higher sales of biosimilars (up 28% as-reported and 25% ex-FX) and the favorable impact of foreign exchange.

Established Brands revenue was down 10% as-reported and 13% ex-FX. Organon said the decline was due largely to the June 2020 loss of exclusivity of Zetia in Japan; excluding that impact the segment posted an 8% ex-FX revenue decrease. In China, as well, the portfolio was subject to negative impacts from a third round of Volume-Based Procurement–policies aimed at encouraging generics and brining down the cost of drugs that have passed exclusivity — the largest so far for the company, Organon said.

Brand growth in the hospital channel — not affected by VBP — helped to offset the declines, according to the company, as did the beginning of a rebound in the respiratory market and retail segment growth, which Organon said accounts for approximately half of total sales of Established Brands in China.

Gross margin for Organon dropped for full-year 2021, according to the company, reflecting the costs of establishing its independence, including those related to manufacturing agreements with former parent company Merck. In 2021, gross margin was 62.2% as-reported and 64.7% on an adjusted basis, compared with 67.6% as-reported and 69.1% on an adjusted basis in 2020.

Adjusted EBITDA margin was 37.7% for 2021 compared with 47.8% in 2020. The company said that change also reflects costs incurred to establish Organon as a stand-alone entity.

Net income from continuing operations for 2021 was $1.351 billion, or $5.31 per diluted share, compared with $2.3 billion, or $8.90 per diluted share in 2020, the company reported.

“In 2021 we delivered on our financial objectives across the board,” said CEO Kevin Ali in a statement accompanying the financials. “Organon has taken significant steps to advance our vision to become a leader in women’s health through meaningful business development that addresses areas of significant unmet need for women and society.”

Jersey City-based Organon has a portfolio of more than 60 medicines and products, a global footprint with commercial capabilities and approximately 9,500 employees

And in the past year, the company has completed four acquisitions.

“We continue to balance our growth objectives against our commitment to lower leverage, and in the fourth quarter we repaid $100 million of our term loans,” Ali said. “Overall, we are well positioned as we head into 2022.”

In this new year, Organon’s guidance projects adjusted revenues of $6.1 billion to $6.4 billion, with an adjusted EBITDA margin of 34% to 36%, all on a non-GAAP basis.