Halozyme Therapeutics, Inc 8-K, filed Jan 10, 2023
Halozyme Therapeutics, Inc. (HALO)
8-K
2023-01-10
For: 2023-01-10
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Added on
April 11, 2026
About this 8-K
Halozyme Therapeutics, Inc filed this 8-K on January 10, 2023.
Items reported
- Item 2.02: Financial results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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
| Date of Report (Date of Earliest Event Reported): | ||||||||
(Exact name of registrant as specified in its charter)
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Commission File Number 001-32335
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
| (Zip Code) | ||||||||
| (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 (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
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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 2.02 Results of Operations and Financial Condition.
On January 10, 2023, Halozyme Therapeutics, Inc., a Delaware corporation (“Halozyme”), issued a press release (the “Press Release”) which contained information related to Halozyme’s expected financial results of a completed fiscal period. A copy of the Press Release is attached hereto as Exhibit 99.1.
On January 10, 2023, Halozyme presented at the annual JP Morgan Healthcare Conference to provide a corporate update on certain strategic programs and to provide financial guidance for 2023. The slides used by Halozyme in making the presentation contained information related to Halozyme’s expected financial results for a completed fiscal period. A copy of the slides used by Halozyme is attached hereto as Exhibit 99.2.
Exhibits 99.1 and 99.2 are furnished under Item 2.02 of this report and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 7.01 Regulation FD Disclosure.
The copy of the slides used by Halozyme in making the JP Morgan Healthcare Conference presentation attached hereto as Exhibit 99.2 is incorporated herein by reference and is expected to be used in subsequent presentations to interested parties, including analysts and stockholders.
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.
Please refer to page 2 of the presentation attached hereto as Exhibit 99.2 for a discussion of certain forward-looking statements included therein and the risks and uncertainties related thereto.
Item 9.01 Financial Statements and Exhibits.
Exhibits
| Exhibit No. | Description | |||||||
Press release dated January 10, 2023 | ||||||||
Halozyme Therapeutics, Inc. corporate update presentation, dated January 10, 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.
| HALOZYME THERAPEUTICS, INC. | ||||||||||||||
| January 10, 2023 | By: | /s/ Nicole LaBrosse | ||||||||||||
| Name: | Nicole LaBrosse | |||||||||||||
| Title: | Senior Vice President, Chief Financial Officer | |||||||||||||
Halozyme Provides 2023 Financial Guidance and Outlook
2023 Total Revenue Guidance of $815 to $845 Million Representing >20% Growth Over Expected 2022 Revenue
2023 Recurring Revenues from Royalties Projected to Grow by >20% to $445 to $455 Million
2023 EBITDA Projected to Grow by >30% Year-Over-Year to $415 to $440 Million
2023 Non-GAAP Diluted EPS Guidance of $2.50 to $2.65
SAN DIEGO, January 10, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced its 2023 financial guidance and commented on its outlook for the upcoming year.
“In 2022, we project we achieved record revenue of greater than $655 million and we completed the acquisition of Antares Pharma, opening up an expanded set of opportunities for our subcutaneous drug delivery business,” said Dr. Helen Torley, president and chief executive officer. “In 2023, we project record revenue of $815 to $845M and greater than 30% growth in EBITDA to $415 to $440 million. As our ENHANZE pipeline advances, we are excited about the future royalty revenue opportunities represented in 2023 by the potential for two new commercial launches, SC efgartigimod and SC atezolizumab.”
Anticipated 2023 Key Events:
•Projected growth of >20% in the Company’s high-margin, recurring revenue stream from royalties to approximately $445 to $455 million driven by continued strength in Wave 2 products, including DARZALEX® SC (daratumumab) and Phesgo® (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE® technology, as well as full year auto-injector royalty contribution.
•Two ENHANZE® subcutaneous (SC) approvals and commercial launches by collaboration partners, including SC efgartigimod and SC atezolizumab.
•Four Phase 3 study data readouts from products utilizing ENHANZE® by the Company’s collaboration partners
•SC efgartigimod in CIDP, ITP and Pemphigus (autoimmune disorders of the nervous system, blood and skin)
•SC ocrelizumab for certain patients with multiple sclerosis
•At least 2 new products utilizing ENHANZE® entering Phase 1 development by the Company’s collaboration partners.
•At least one new collaboration and licensing agreement for ENHANZE®, for a partner to test our developmental large volume auto-injector plus ENHANZE®, and for our small volume auto-injector.
•Initiation of a clinical study to continue to evaluate the feasibility testing of our large volume auto-injector.
•Up to $150 million in share repurchases, dependent on market conditions and other factors, as part of the $750 million three-year share repurchase plan authorized by Halozyme’s board of directors in December 2021 demonstrating the Company’s continued commitment to a balanced capital allocation strategy.
2023 Financial Guidance:
•Revenue: Halozyme expects total revenue of $815 million to $845 million, representing growth of >20% over 2022 expected total revenue. The Company expects revenue from royalties to increase >20% over expected revenue from royalties in 2022, to a range of $445 million to $455 million.
•EBITDA: Halozyme expects EBITDA of $415 million to $440 million, representing growth of >30% over 2022 expected EBITDA and excludes the impact of amortization costs in 2023 related to the Antares Pharma acquisition.
•Earnings per Share: Halozyme expects Non-GAAP diluted earnings per share of $2.50 to $2.65. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.
Table 1. 2023 Financial Guidance
| Guidance Range | |||||
| Total Revenue | $815 to $845 million | ||||
| Royalty Revenue | $445 to $455 million | ||||
| EBITDA | $415 to $440 million | ||||
| Non-GAAP Diluted EPS | $2.50 to $2.65 | ||||
About Halozyme Therapeutics, Inc.
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.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation and amortization (EBITDA) and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discount, debt extinguishment expense, intangible asset amortization, changes in contingent liabilities, transaction costs for business combinations and certain adjustments to income tax expense. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of Halozyme's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Halozyme considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs.
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 2022 and 2023) and expectations
for future growth, profitability, total revenue and royalty revenue, net income, EBITDA and earnings-per-share and to repurchase shares under its share repurchase program and expand the Company’s platform through potential acquisitions. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of larger volumes of injectable medications through subcutaneous delivery and the Company’s plans to develop a large volume auto-injector. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and readouts, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new collaborations and collaborative targets, potential partnership to test our planned large volume auto-injector and regulatory review and potential approvals of new partnered or proprietary products. 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 delays in the execution of the Company's share repurchase program or planned platform expansion, unexpected results or delays in the growth of the Company's business including any delays in entering into new collaboration agreements, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, unexpected delays in the Company’s plans to develop a large volume auto-injector, including any potential delays caused by the current COVID-19 global pandemic, 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 and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@antarespharma.com
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@antarespharma.com
Dawn Schottlandt / Claudia Styslinger
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Halozyme Confidential and Proprietary 1 41st Annual J.P. Morgan Healthcare Conference Dr. Helen Torley, President and CEO January 10, 2023
Halozyme Confidential and Proprietary 2 Forward Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company’s expected future financial performance (including the Company's financial outlook for 2022 and 2023) and expectations for profitability, revenue (including expectations for future royalties and product sales), cash flow, operating income, and earnings-per-share, and the Company’s plans to repurchase shares under its share repurchase program and to potentially expand the Company's platform through acquisitions. Forward-looking statements regarding the Company’s ENHANZE® drug delivery technology include the possible benefits and attributes of ENHANZE® including its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of larger volumes of injectablemedications through subcutaneous delivery and potential to decrease treatment burden and decrease healthcare costs. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated new clinical trial starts, study readouts, ENHANZE® product approvals and launches and the timing related to these events), projections for future sales revenue of our collaborators’ products, potential new ENHANZE® collaborations, collaborative targets and indications for ENHANZE® products, co-formulation intellectual property and the Company’s plans to develop a large volume auto-injector and new formulations of its API for longer intellectual property protection. 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 expectationscontained in these forward-looking statements as a result of several factors, including unexpected levels of revenues (including royalty and milestone revenue received from our collaboration partners and product sales), expenditures and costs, unexpected delays in the execution of the Company’s share repurchase program or planned platform expansion, unexpected results or delays in the growth of the Company’s ENHANZE® business (including as a result of unexpected conversion rates), obtaining new co-formulation intellectual property, or in the development, regulatory review or commercialization of new formulations of the Company’s API or its partners’ ENHANZE® products, unexpected delays in the Company’s plans to develop a large volume auto-injector, including any potential delays caused by the current COVID-19 global pandemic, 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 and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Non-GAAP Financial Measures: In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), these materials contain certain non- GAAP financial measures. The Company reports EBITDA and non-GAAP diluted earnings per share and expectations of those measures in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. The Company does not prov ide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, share-based compensation expense and the effects of any discrete income tax items. Note: This presentation contains product names, trademarks and registered trademarks that are property of their respective owners.
Halozyme Confidential and Proprietary 3 What We Do: License Drug Delivery Platforms to Partners, and Commercialize Specialty Products Commercially-Validated Sub-Cutaneous Delivery • 5 approved partnered products • Approved in 100+ countries • >600,000 patients have received ENHANZE®- enabled treatments Commercialized & development stage devices for broad application ENHANZE® Auto-Injectors Specialty Products Drug Delivery Platform Technologies Commercial Portfolio
Halozyme Confidential and Proprietary 4 2023 Select Financial Guidance Highlights $655M - $685MTotal Revenue 2022 Royalty Revenue 2023 $350M - $360M $815M - $845M $445M - $455M >20% YoY growth >20% YoY growth EBITDA $310M - $335M $415M - $440M >30% YoY growth Excludes impact of amortization costs in 2023 related to the Antares acquisition
Halozyme Confidential and Proprietary 5 Halozyme Investment Highlights Profitable, high-growth biopharma company with diversified revenue streams New Potential Royalty Revenue Opportunity • 2 Potential ENHANZE® SC Approvals in 2023 • 2 Additional Potential ENHANZE® SC Approvals by 2025 New Opportunity 2023: ENHANZE® plus large volume auto-injectors (LVAI)
Halozyme Confidential and Proprietary 6 01 02 03 04 Differentiated Growth Platforms >$1B ENHANZE® Opportunity Specialty Product Opportunity Durable Revenue and Financial Strength Halozyme: Delivering Strong & Durable Growth
Halozyme Confidential and Proprietary 7 The World Needs More Subcutaneous Large and Small Molecule Drug Delivery ▪ Decreased treatment burden – Hours to minutes2 ▪ Improved patient experience – Prefer SC vs. IV1 – Optionality5 ▪ Lower infusion related reactions IRRs3,4,6 ▪ Potential to decrease healthcare costs: – Less use of more costly hospital/ infusion centers7 – Greater patient throughput for clinics – Decrease HCP time in administration7 – Decreased drug wastage8 (fixed vs. weight-based dosing) Sources: 1 Piv ot X, Gligorov J, Müller V, et al. “Patients’ Preference for SC v s. IV”, Annals of Oncology, 2014; 3:4. 2 Stephen P. Knowles, Marie A. Printz, David W. Kang, Michael J. LaBarre & Renee P. Tannenbaum (2021): Safety of recombinant human hyaluronidase PH20 for subcutaneous drug d elivery, Expert Opinion on Drug Deliv ery, DOI: 10.1080/17425247.2021.1981286. 3 Chari A, Nahi H, Mateos M-V, et al. Presented at: ASH Annual Meeting; Dec 9-12, 2017; Atlanta, GA. 3 Lancet Haematol. “Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicen ter, open- label, non-inferiority, randomised, phase 3 trial”; 2020. 4 Wasserman RL, Melamed I, Stein M, et al. Meeting of the ACAAI; Nov 3-8, 2011; Boston, MA. 5 Rummel M, Kim TM, Av ersa F, et al. “Preference for subcutaneous or intravenous administration”, Annals of Oncology 28 , no 4 (2016): 836,838. 6 Chari A, Nahi H, Mateos M- V, et al. Presented at: ASH Annual Meeting; Dec 9-12, 2017; Atlanta, GA. 7 Sanchez, ClinicoEconomics and Outcomes Research: 2019: 695. 8 Hendrikx,“Fixed Dosing of Monocolonic Antibodies in Oncology” The Onoclogist 2017; 22; 1212-122. Potential benefits for Patient and Caregivers Potential benefits for Healthcare System (providers, nurses, pharmacists, payers)
Halozyme Confidential and Proprietary 8 ENHANZE®: Patented, De-risked, Commercial Platform Technology Enabling Rapid, Large Volume Subcutaneous Delivery of IV Drugs What it does: ENHANZE® creates temporary space for SC fluid dispersion which returns to normal; reduces backpressure ENHANZE® Uniquely enables rapid SC delivery • 5-15mL over 2-5 minutes • 300-600mL at 5 mL/min Decreased injection site swelling and induration Aids absorption leading to increased bioavailability versus subcutaneous without ENHANZE®1 Potential for decreased systemic infusion related reactions 1 Morcos International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 7/2013 (537-548)
Halozyme Confidential and Proprietary 9 5 Approved Products 100+ Countries >600,000 Patients have received ENHANZE®–enabled SC products 2 Partner Products in Regulatory Review 4 Partner Products in/soon to start Phase 3 8 Partner Products in/ completed Phase 1 Established Drug Delivery Leadership: 5 Globally-Approved Partner Products, Robust and Diverse Pipeline
Halozyme Confidential and Proprietary 10 In Multiple Target Opportunities Open for ENHANZE® Therapeutic Area Targets Taken Exclusively Available IV High Volume Targets* Oncology 9 23 CNS 1 10 Hematologic 1 11 Autoimmune Diseases 4 8 Cardiovascular/Metabolic 0 6 Infectious Disease 5 5 TOTAL 20 63 Sources: Evaluate Ltd and Citeline Pharmaprojects
Halozyme Confidential and Proprietary 11 Halozyme Differentiated Proprietary and Partner Small Volume Auto-Injectors (SVAI),Commercially Available and Widely Licensable 1 mL and 2.25 mL SC or IM QuickShot™ and BigShot™ Auto Injectors 1 mL SC or IM VIBEX™ Auto Injectors 2.25 mL SC or IM VAI™ Auto Injectors 1.5 mL and 3.0 mL multi-dose, disposable Pen Injector Systems 8M units in 2022 Note: All product names, trademarks and registered trademarks are property of their respective owners. Undisclosed Selatogrel Generic ImitrexGeneric EpiPen Assertio Holdings ATRS-1902 (development stage) Generic Forteo
Halozyme Confidential and Proprietary 12 NEW in 2023: ENHANZE® Plus Auto-Injector Facilitates >5mL to 10mL Auto-Injector + Halozyme Auto-Injector Technology and Know How Large Volume >5mL Auto-Injector • Creates space for fluid dispersion • Reduces backpressure • Reduces leakage to deliver planned dose Customizable technology to meet partner needs 2023: Complete clinical feasibility testing
Halozyme Confidential and Proprietary 13 01 02 03 04 Differentiated Growth Platforms >$1B ENHANZE® Opportunity Specialty Product Opportunity Durable Revenue and Financial Strength Halozyme: Delivering Strong & Durable Growth
Halozyme Confidential and Proprietary 14 ENHANZE®: Durable Revenue Potential and Strong Future Growth Opportunities Waves 1 & 2 5 Globally-Approved Products Wave 3 Efgartigimod SC* Atezolizumab SC** Nivolumab SC Ocrelizumab SC Wave 4 8 in/completed Phase 1 2 in/soon to start Phase 3 Wave 5 New nominations from current and new partners Launch Potential 2023-2025 Launch Potential 2025-2027 Launch Potential 2027+ Revenue drivers 2023-2025 Revenue drivers 2021+ Revenue drivers 2025-2027 Revenue drivers 2027+ * Submitted for regulatory approval ** Submission to regulatory authorities ongoing 1 Includes development, commercial and upfront milestones and other collaboration revenue 4 Product Candidates 10 Product Candidates 2021-2023 milestone revenue now projected to be $330-360M1 2022-2024 milestone revenue projection unchanged at $450-$500M1
Halozyme Confidential and Proprietary 15 ENHANZE®: A Royalty Growth Story 2022 Estimate 2027 Potential 2031 Potential $1B 2027 projection based on approved products and assumes global approval and launches of approximately 20 additional products in multiple indications. Includes projections for subcutaneous versions for targets not currently approved or commercially available. Assumes approved and under rev iew co-formulation patents, Innovator revenues based on Bloomberg or Evaluate Ltd analyst -based estimates when available. Conversion rates based on Halozyme internal projections. Royalty revenue projections includes targets selected and not yet disclosed. Projected royalty revenue is not risk-adjusted. Royalty rate mid-single digit range across all products Projected Royalty Revenue Potential $350-360M Drivers Waves 1, 2, 3 and 4 ENHANZE® Products Granted and submitted co- formulation patents Current Portfolio Drivers Wave 5 ENHANZE® Products Co-formulation patents submitted 2022-2027 NEW rHuPH20 with extended room temp. stability, longer IP +
Halozyme Confidential and Proprietary 16 01 02 03 04 Total Royalties: Projecting Record Royalty Revenue in 2023 W A V E Projecting >20% growth in 2023 Annual Total Royalty Revenue* ($M) $69.9 $88.6 $203.9 $350-$360 2019 2020 2021 2022E 2023E $445-$455 *Includes auto-injector royalt ies
Halozyme Confidential and Proprietary 17 01 02 03 04 Wave 2: Launch Growth Drivers DARZALEX SC/FASPRO® Share and Revenue Growth Continues W A V E 1 Analysts’ consensus from Evaluate Ltd October 2022 2 2022 Symphony Health (subscription data presented with permission) 66% 72% 76% 80% 83% 85% Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 DARZALEX FASPRO® Share of Total US DARZALEX®Sales2 $4.2 $6.0 $8.0 $9.5 $10.9 $12.0 $13.0 $13.8 $14.5 0 2 4 6 8 10 12 14 16 Total DARZALEX® Sales IV+SC ($B) 1
Halozyme Confidential and Proprietary 18 01 02 03 04 Wave 2: Launch Growth Drivers Phesgo® Share and Revenue Growth Continues W A V E 1 Analysts’ consensus from Evaluate Ltd October 2022 2 Roche's Third Quarter 2022 Results *Phesgo® conversion rate is based on volumes (vials) and includes all launch countries after the 2nd quarter after the launch (25 countries). Total Perjeta® Sales ($B) 1 Phesgo®2 $4.3 $4.4 $4.5 $4.6 $4.6 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 2021 2022E 2023E 2024E 2025E
Halozyme Confidential and Proprietary 19 Wave 3: Four Potential Launches 2023-2025 Products Disease Areas Milestones Potential Launch1 Efgart igimod IV APPROVED (gMG) gMyasthenia Gravis Other Indications Completed SC with ENHANZE® BLA submission in September 2022 Addit ional SC with ENHANZE® data readouts projected in 2023 2023 for gMyasthenia Gravis Atezolizumab IV APPROVED Phase 3 in Non-Small Cell Lung Cancer2 Submission to regulatory authorit ies ongoing 2023 Ocrelizumab IV APPROVED Mult iple Sclerosis Phase 3 data readout projected in 2023 2024 Bristol Myers Squibb Nivolumab IV APPROVED Phase 3 studies in: Clear Cell Renal Cell Carcinoma Melanoma Phase 3 ongoing TBD 1 Halozyme assessment based on company statements on pivotal data availability. Assumes 6 months for BLA submission filing and 10-month FDA review. 2 Roche pursuing label for multiple indications 01 02 03 04W A V E
Halozyme Confidential and Proprietary 20 First-in-class anti-FcRn Approved as IV for Generalized Myasthenia Gravis Potential to address unmet need in ~15 indications Analysts’ projections: ~$4.7B in 20281 Number 1 Multiple Sclerosis treatment US and EU 52 Widely studied with long term data Analysts’ projections: ~$8.2B in 20281 Efgartigimod Atezolizumab Ocrelizumab Wave 3: Developing SC Versions of Diverse, Blockbuster Products Leading anti-PDL1 Currently approved in 5 cancer types Analysts’ projections: ~$7.0B in 20281 Nivolumab Currently approved in 10+ cancer types Analysts’ projections: ~$13.4B in 20281 Parent Products Projected at >$30B in 20281 01 02 03 04W A V E 1 Analysts’ consensus from Evaluate Ltd October 2022 2 Roche's Third Quarter 2022 Results
Halozyme Confidential and Proprietary 21 Efgartigimod SC: Potential to Transform Treatment Approach for Patients with Autoimmune Diseases 1 Analysts' consensus and projections from Evaluate Ltd October 2022 ENHANZE® Potential Impact Extensive SC Development and Large Opportunity Efgartigimod sales $4.7B in 2028, with significant ex-US sales1 SC IV SC status WW Total Opportunity Projection 20281 gMyasthenia Gravis US PDUFA date: March 20, 2023 Submitted EMA $2.1B CIDP Phase 3 SC data: Q2 2023 $1.2B ITP Positive IV data Phase 3 SC data: 2H 2023 $0.5B Pemphigus Phase 3 SC data: 2H 2023 $0.3B Bullous Pemphigoid Phase 2/3 ongoing $0.4B Myositis Phase 2/3 ongoing • Rapid, SC injection ~1 minute versus 60 minutes for IV • May facilitate penetration into early disease patients 01 02 03 04W A V E $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 $3.0 $3.5 $4.0 $4.5 $5.0 ‘23 ‘24 ‘25 ‘26 ‘27 ‘28 WW Sales BILLIONS
Halozyme Confidential and Proprietary 22 Atezolizumab SC: Potential to Reduce Treatment Burden, Help Alleviate Infusion Clinic Capacity Constraints ENHANZE® Potential Impact SC OpportunityTotal Atezolizumab sales ~$7B in 2028, with significant ex-US sales1 TECENTRIQ Monotherapy +/- Oral Therapy TECENTRIQ IV Combination Indications FDA Approved Indications FDA Approved Indications Non-Small Cell Lung Cancer Melanoma Alveolar Soft Part Sarcoma Non-Small Cell Lung Cancer Hepatocellular Cancer Small Cell Lung Cancer • Submission to regulatory authorit ies ongoing, seeking approval across all indications • Rapid SC injection over 7 minutes versus 30-60 mins IV • Potential to reduce healthcare utilizat ion and reduce cost in monotherapy and combination sett ing • May be appropriate for out of hospital administrat ion by a healthcare professional $0.0 $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 ‘23 ‘24 ‘25 ‘26 ‘27 ‘28 WW Sales 01 02 03 04W A V E 1 Analysts’ consensus and projections from Evaluate Ltd October 2022 BILLIONS
Halozyme Confidential and Proprietary 23 Nivolumab SC: Potential to Reduce Treatment Burden, Help Alleviate Infusion Clinic Capacity Constraints ENHANZE® Potential Impact Total Nivolumab sales ~$13.4B in 2028, with significant ex-US sales1 $0.0 $2.0 $4.0 $6.0 $8.0 $10.0 $12.0 $14.0 $16.0 ‘23 ‘24 ‘25 ‘26 ‘27 ‘28 WW Sales • Phase 3 SC Opdivomonotherapy studies ongoing • Renal Cell Carcinoma • Melanoma • Phase 3 Nivolumab and Relatlimab SC fixed combination in Melanoma study soon to start 01 02 03 04W A V E 1 Analysts’ consensus and projections from Evaluate Ltd October 2022 BILLIONS
Halozyme Confidential and Proprietary 24 Ocrelizumab SC: Meaningful Reduction in Administration and Observation Schedule Adds to Competitive Profile 1 Analysts’ consensus and projections from Evaluate Ltd October 2022 2 Roche's Third Quarter 2022 Results RMS=relapsing multiple sclerosis; PPMS=primary progressive MS; Q6M=dosing every 6 months ENHANZE® Potential Impact ENHANZE® could reduce administration and observation schedule to 60 mins for first 2 doses and 10 mins for all subsequent doses2 Ocrelizumab sales ~$8.2B in 2028, with significant ex-US sales1 $0.0 $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 $9.0 ‘23 ‘24 ‘25 ‘26 ‘27 ‘28 WW Sales 01 02 03 04W A V E BILLIONS • Final dose monitoring requirements for SC subject to regulatory review
Halozyme Confidential and Proprietary 25 In ON C OLOG Y I M M UN E/ AUTOI M M UN E HI V 01 02 03 04 Wave 4: Multiple Potential Launches W A V E 1 Analysts’ consensus for Wave 1-4 products from Evaluate Ltd. October 2022 excluding, ARGX-117 (argenx), undisclosed (Roche), undisclosed (Chugai), TAK-881 (Takeda) and N6LS(Viiv) Table excludes Roche undisclosed target, Chugai undisclosed target, each in Phase 1 Analysts’ Consensus Revenue For All Parent Products in 2028: >$60B1 Amivantamab (Janssen) IV APPROVED SC in Phase 3 Nivolumab+Relatlimab (BMS) IV APPROVED SC soon to start Phase 3 Teprotumumab-trbw (Horizon) IV APPROVED ARGX-117 (argenx) TAK-881 (Takeda) N6LS bnAb (ViiV) Cabotegravir (ViiV) Oral and IM APPROVED Rilpivirine (Janssen) Oral APPROVED In or have completed Phase 1
Halozyme Confidential and Proprietary 26 01 02 03 04 Differentiated Growth Platforms >$1B ENHANZE® Opportunity Specialty Product Opportunity Durable Revenue and Financial Strength Halozyme: Delivering Strong & Durable Growth
Halozyme Confidential and Proprietary 27 Testosterone Replacement Therapy Portfolio: Targeting to Generate >$100M XYOSTED Revenue in 2023 Once-a-week dosing Virtually painless subcutaneous injection using auto-injector technology 21 Orange Book-listed patents extending to 2038 2X/daily oral administration First oral TRT without titration requirement ~8.5M TRX prescribed for testosterone replacement therapy in 2022 Growing ~5% YOY Switch strategy from IM and gels Each 1% share gain ~$20M in net sales F OC US F OC US OP P ORTUN I TY Launched November 2018 Launched June 2022
Halozyme Confidential and Proprietary 28 01 02 03 04 Differentiated Growth Platforms >$1B ENHANZE® Opportunity Specialty Product Opportunity Durable Revenue and Financial Strength Halozyme: Delivering Strong & Durable Growth
Halozyme Confidential and Proprietary 29 Halozyme Strategic and Capital Allocation Priorities Invest to Maximize Revenue Growth and Durability Continue to Return Capital to Shareholders Identify Opportunities for External Growth • ENHANZE® • Auto-injector innovation • Commercial opportunity Second Plan: December 2021 $750M 3-year share buyback • $350M completed through December 2022 • $150M planned in 2023 pending market conditions and other factors • Focus on integration • Continue to evaluate opportunities to accelerate and extend revenue
Halozyme Confidential and Proprietary 30 2023: Projected Acceleration in Royalty Generating Products WAVE 2 Royalties 2023 2024 2025 DARZALEX® SC Phesgo® PIPELINE Potential Royalties Potential Approval Efgartigimod SC Potential Approval Atezolizumab SC Phase 3 Data Readouts Efgartigimod SC CIDP ITP Pemphigus Multiple Sclerosis Ongoing Phase 3 Nivolumab Nivolumab/Relatlimab, FDC* Amivantimab Goal for New Agreements One ENHANZE® One ENHANZE®/LVAI One SVAI * Phase 3 soon to start Ocrelizumab SC
Halozyme Confidential and Proprietary 31 2023 Financial Guidance Highlights $655M - $685MTotal Revenue 2022 Royalty Revenue EBITDA Non-GAAP Diluted EPS 2023 $350M - $360M $310M - $335M $2.10 - $2.25 $815M - $845M $445M - $455M $415M - $440M $2.50 - $2.65 • >20% YoY growth • Product Sales expected to increase due to full year Antares contribution and increasing ENHANZE API demand • Includes one new deal milestones • Total collaboration revenue expected to be relatively flat compared to 2022 • >20% YoY growth • Continued DARZALEX® and Phesgo® uptake and full year Antares device royalty contribution • >30% YoY growth • Excludes impact of amortization costs in 2023 related to the Antares acquisition • Strong double-digit growth, >10% YoY • Excludes impact of future share repurchases
Halozyme Confidential and Proprietary 32 Appendix
Halozyme Confidential and Proprietary 33 ENHANZE® Partner Product Development Pipeline Current Program/Product Indications Phase 1 Phase 2 Phase 3 Filed Wave 3 Efgartigimod (argenx) MG Atezolizumab (Roche) NSCLC Ocrelizumab (Roche) Multiple sclerosis Nivolumab (BMS) RCC Nivolumab (BMS) Melanoma Efgartigimod (argenx) CIDP Efgartigimod (argenx) Immune thrombocytopenia Efgartigimod (argenx) Pemphigus Efgartigimod (argenx) Bullous Pemphigoid (BP) Efgartigimod (argenx) Myositis Wave 3 Pipeline
Halozyme Confidential and Proprietary 34 Current Program/Product Indications Phase 1 Phase 2 Phase 3 Filed Wave 4 Amivantamab (Janssen) Solid malignancies Nivolumab+Relatlimab (BMS) Solid tumors ARGX-117 (argenx) Multifocal motor neuropathy Teprotumumab-trbw (Horizon) Thyroid Eye Disease Rilpivirine (Janssen) HIV Undisclosed (Roche) Undisclosed TAK-881 (Takeda) Immune Cabotegravir (ViiV) HIV N6LS bnAb (ViiV) HIV (treatment) Undisclosed (Chugai) Undisclosed ENHANZE® Partner Product Development Pipeline Wave 4 Pipeline Phase 3 start 3Q 3022 Phase 3 to start soon