On January 14, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported an update on its outlook for 2020, including financial guidance (Press release, Halozyme, JAN 14, 2020, View Source [SID1234553164]).
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"We have made tremendous progress repositioning the company to focus solely on driving the growth and profitability of our ENHANZE business," said Dr. Helen Torley, president and chief executive officer. "Looking ahead, we anticipate a number of value-creating financial and ENHANZE-related milestones will be achieved during 2020."
Anticipated 2020 ENHANZE Key Events
U.S. Food and Drug Administration (FDA) decision on the approval of the Biologics License Application submitted by ENHANZE collaboration partner Janssen Biotech, Inc. (Janssen) in July 2019 for Daratumumab SC.
European Medicines Agency (EMA) decision on the approval of the extension application submitted by Janssen-Cilag International NV (Janssen) in July 2019 for Daratumumab SC.
Completion in Q1 2020 of regulatory submissions to the FDA and EMA by Roche seeking approval for the fixed-dose combination of Perjeta and Herceptin utilizing ENHANZE in combination with intravenous chemotherapy.
At least 3 new Phase 3 and 1 Phase 2 clinical trial initiations by ENHANZE collaboration partners.
Initiation of at least five new Phase 1 clinical trials with partner products utilizing the ENHANZE drug delivery technology.
Update on Capital Return Program
On November 4, 2019 the Company announced its Board of Directors approved a plan to repurchase up to $350 million in stock over the next three years. Subsequently, on November 12, 2019 the Company announced the Board further approved the repurchase of an additional $200 million worth of shares in conjunction with an offering of convertible senior notes, due 2024, resulting in a total three-year share repurchase authorization of up to $550 million.
As of December 31, 2019, the Company had repurchased 8.5 million shares of Halozyme stock under this program. In addition, 2.1 million shares had been delivered to the Company as part of a $50 million Accelerated Share Repurchase (ASR), which is expected to be completed in the first quarter of 2020. Following completion of the ASR, the Company will have repurchased a total of $200 million worth of shares. As of December 31 2019, the Company had 136.7 million shares outstanding.
The Company plans to repurchase an additional number of shares, up to $150 million worth, during 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.
2020 Financial Guidance
For 2020, Halozyme expects revenues of $230 million to $245 million, representing growth of 18% to 26% over the 2019 expected revenue of approximately $195 million.
The Company expects sustainable profitability beginning in the second quarter of 2020. Also, the Company continues to project annualized operating expenses, excluding cost of goods sold, of between $65 million and $75 million will be achieved by the fourth quarter of 2020.