Jazz Pharmaceuticals plc (NASDAQ:JAZZ), a global biopharmaceutical company and manufacturer of Epidolex, announced its financial results late Tuesday for the full year and fourth quarter of 2021 and provided financial guidance for 2022.

“2021 was a transformative year for Jazz, delivering over $3 billion in revenue for the first time. Our talented team achieved our goal of five key launches through 2020 and 2021, delivering innovative medicines to patients in critical need. We also acquired and integrated GW Pharmaceuticals, which expanded our commercial portfolio with Epidiolex®, enhanced our R&D capabilities and talent, and added the industry-leading GW cannabinoid platform,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals in a recent press release.

“These accomplishments underscore a significant advance in Jazz’s evolution to an innovative global biopharmaceutical company. We expect these achievements, coupled with our expanded capabilities and disciplined capital allocation, to drive sustainable growth and enhanced value as part of Vision 2025, which we announced in January. As we begin 2022, we remain focused on growing and diversifying our revenue, investing in our pipeline of novel therapies, and delivering innovative therapies for patients,” added Cozadd.

“In 2021, our R&D organization advanced key programs across our portfolio, further broadening our pipeline into disease areas with significant unmet patient need and market potential,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “Our R&D productivity, which has been strengthened by investment in our organization and the addition of GW programs and expertise, positions us well to deliver at least five additional novel product approvals by the end of the decade, a key component of Vision 2025.”

Financial Highlights

GAAP net income (loss) for 2021 was ($329.7 million), or ($5.52) per diluted share, compared to $238.6 million, or $4.22 per diluted share, for 2020.

GAAP net income (loss) for 4Q21 was ($35.4 million), or ($0.57) per diluted share, compared to $133.4 million, or $2.33 per diluted share, for 4Q20.

Non-GAAP adjusted net income for 2021 was $992.8 million, or $16.23 per diluted share, compared to $704.0 million, or $12.46 per diluted share, for 2020.

Non-GAAP adjusted net income for 4Q21 was $262.0 million, or $4.21 per diluted share, compared to $228.7 million, or $4.00 per diluted share, for 4Q20.

Total Revenues

Total revenues increased 31% in 2021 and 35% in 4Q21 compared to the same periods in 2020.

Neuroscience net product sales in 2021 increased 31% to $2,335.4 million compared to 2020 primarily driven by Epidiolex/Epidyolex net product sales in 2021 of $463.6 million, following the GW Acquisition.

Balance Sheet

As of December 31, 2021, cash and cash equivalents were $591.4 million, and the outstanding principal balance of the Company’s long-term debt was $6.4 billion compared to $6.6 billion as of September 30, 2021.

In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million. For the year ended December 31, 2021, the Company generated $778.5 million of cash from operations.

Epidiolex/Epidyolex (cannabidiol):

Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: the United Kingdom, Germany, Italy, and Spain, with an anticipated launch in France in 2022. The Company has made significant progress on its European rollout with launches in Spain, Italy, and Switzerland in 3Q21 and Ireland in 1Q22.

Epidiolex/Epidyolex net product sales were $463.6 million in 2021, or $658.3 million on a proforma basis, and $193.8 million in 4Q21.

On a proforma basis, these net product sales represent growth of 29% and 35% compared to 2020 and 4Q20 respectively.

Net product sales in 4Q21 were favorably impacted by approximately $18 million, compared to 3Q21, relating to a temporary increase in specialty pharmacy inventory levels.

The Company continues to strengthen the IP durability of Epidiolex. The U.S. FDA Orange Book Listed patent (US 11,207,292) was granted in December 2021 and extends through 2039. This patent covers the composition of the botanically-derived cannabidiol (CBD) preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.

Image By Ilona Szentivanyi.