halo-20230315FALSE000115903600011590362023-03-152023-03-15
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
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| Date of Report (Date of Earliest Event Reported): | | March 15, 2023 |
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Commission File Number 001-32335
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| Delaware | | 88-0488686 |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
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| 12390 El Camino Real | | 92130 |
| San Diego | | (Zip Code) |
| California | | |
| (Address of principal executive offices) | | |
(858) 794-8889
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | |
| Common Stock, $0.001 par value | HALO | The Nasdaq Stock Market LLC | | |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On March 15, 2023, Halozyme Therapeutics, Inc. (the “Company”) issued a press release providing an update on a decision by the Opposition Division of the European Patent Office regarding one of the Janssen Biotech (“Janssen”) co-formulation patents for DARZALEX® (daratumumab) subcutaneous (SC) formulation and reaffirming revenue guidance for 2023 and its total royalty revenue projections of approximately $1 billion by 2027, and thereafter to at least 2030. The Company confirms that the license with Janssen is unique in that co-formulation patents covering DARZALEX SC with Halozyme’s ENHANZE® drug delivery technology do not extend the time for royalty step-down beyond 2024 in Europe and 2027 in the United States.
This information is being furnished pursuant to Item 7.01 of this Report and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by Halozyme, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference. This Report will not be deemed an admission as to the materiality of any information in this Report that is being disclosed pursuant to Regulation FD.
Forward-Looking Statements
Please refer to press release attached hereto as Exhibit 99.1 for a discussion of certain forward-looking statements included therein and the risks and uncertainties related thereto.
Item 9.01 Financial Statements and Exhibits.
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| Exhibit No. | Description | |
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| Press release dated March 15, 2023 |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | | HALOZYME THERAPEUTICS, INC. |
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| March 15, 2023 | | By: | | /s/ Nicole LaBrosse |
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| | | Name: | | Nicole LaBrosse |
| | | Title: | | Senior Vice President, Chief Financial Officer |
Exhibit 99.1
HALOZYME PROVIDES UPDATE ON LICENSEE CO-FORMULATION PATENT HEARING IN EUROPE
Company Anticipates No Impact on U.S. and European Royalty Revenues from DARZALEX FASPRO® and SC through at least 2030
Reiterates 2023 Revenue Guidance of $815 million to $845 million and Royalty Revenue of $445 million to $455 million
SAN DIEGO, March 15, 2023 -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today provides an update on a decision by the Opposition Division of the European Patent Office (“EPO”) regarding one of the Janssen Biotech, Inc. (Janssen) co-formulation patents for DARZALEX® (daratumumab) SC.
“We remain confident in our strong royalty revenue potential across our diverse partner pipeline. Today’s decision in Europe on a single co-formulation patent has no impact on our current full year 2023 revenue guidance. Janssen will continue to pay royalties to Halozyme on U.S. and European sales of DARZALEX FASPRO® and SC, in line with our total royalty revenue projection of approximately $1 billion by 2027, and thereafter to at least 2030. We also do not believe this decision will impact the ability of any other Halozyme licensee to obtain co-formulation patents for their innovations. Furthermore, today’s decision has no impact on the composition of matter patents in the U.S. and Europe for ENHANZE®,” said Dr. Helen Torley, president and chief executive officer of Halozyme.
“We are disappointed with the Opposition Division’s oral decision to revoke Janssen’s European Patent EP3370770B1. We expect a written decision to be provided in the next several months. If an appeal is filed, it would suspend today’s decision and the patent would remain in force until the case is finally decided on any such appeal,” concluded Dr. Torley.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme’s commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 600,000 patient lives in post-marketing use in five commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche,
Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Covis Pharma, Pfizer and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company’s expected future financial performance (including the Company's financial outlook for 2023) and expectations for future growth, profitability, total revenue, and royalty revenue. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty payments driven by our partners' development and commercialization efforts and the potential impact of the decision on a co-formulation patent referenced in this press release on the Company’s 2023 financial guidance, ability of our licensees to obtain co-formulation patents and on certain composition of matter patents and the impact of appealing the decision. These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected impact of the co-formulation patent decision referenced in this press release including unexpected results or delays in our licensees’ ability to obtain co-formulation patents or in appealing the decision, the growth of the Company’s business, or in the development, regulatory review or commercialization of the Company’s partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
Dawn Schottlandt / Claudia Styslinger
Argot Partners
212-600-1902
Media:
David Rosen
Argot Partners
212-600-1902