On January 11, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported 2021 financial guidance and commented on its outlook for the year (Press release, Halozyme, JAN 11, 2021, View Source [SID1234573793]).
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"2020 was a year of tremendous accomplishment at Halozyme highlighted by our successful transition to revenue growth and profitability, 2 U.S. FDA approvals and 2 European Commission approvals for ENHANZE partner products, and successful completion of $150 million in share repurchases in 2020," said Dr. Helen Torley, president and chief executive officer. "We are delighted with the strong first six months post launch market adoption of DARZALEX FASPRO in the US, which drove a return to royalty revenue growth in 2020. In 2021 we expect continued strong revenue and earnings growth driven by continued uptake of subcutaneous DARZALEX in US and international markets and by uptake of Roche’s Phesgo, which received approval from the European Commission in late December 2020. In addition, we expect to create catalysts for growth well into the future based on the advancement of multiple partners’ ENHANZE drug development programs."
Anticipated 2021 Key Events :
Strong subcutaneous DARZALEX (daratumumab) royalty revenue growth driven by continued US and international market uptake;
Potential Ministry of Health, Labour and Welfare approval in Japan for Janssen’s subcutaneous DARZALEX utilizing ENHANZE;
Potential U.S. FDA approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in light chain amyloidosis;
Strong Phesgo (pertuzumab, trastuzumab and hyaluronidase) royalty revenue growth driven by adoption in US and Europe;
Two new products entering Phase 3 development, resulting in a total of 4 products in Phase 3, including Roche’s TECENTRIQ (atezolizumab) and argenx’s efgartigimod;
Five new Phase 1 trial starts for ENHANZE partner programs resulting in a total of 13 Phase 1 studies completed or ongoing by end of 2021;
Continued commitment to capital return with up to $125 million in share repurchases anticipated in 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme’s board of directors in November 2019.
2021 Financial Guidance
For 2021, Halozyme expects revenues of $375 million to $395 million, representing growth of approximately 40% to 45% over 2020 expected revenue. This revenue guidance, per the Company’s standard practice, excludes any potential new ENHANZE deals. Notably, in comparison to 2020 expected results the Company expects a doubling in revenue from royalties, a significant increase in product sales related to API, and revenue under collaborative agreements in a similar range to the substantial milestones expected in 2020.
The Company further expects GAAP earnings per share of $1.40 to $1.55, representing growth of approximately 55% to 70% over 2020 expected EPS. Guidance includes the impact of an accounting change for convertible notes which eliminates non-cash interest expense.
Table 1. 2021 Financial Guidance
Guidance Range
Net Revenue
$375 million to $395 million
Earnings Per Share (GAAP)
$1.40 to $1.55
The Company plans to report fourth quarter and full year 2020 financial results on February 23, 2021.