40th Annual J.P. Morgan Healthcare Conference
Dr. Helen Torley, President and CEO
January 10, 2022
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 financial estimates for 2021 and outlook for 2022) and expectations for profitability, revenue (including expectations for future milestones and royalty growth), operating income and earnings-per-share and the Company's plans to continue its share repurchase program and to potentially expand its platform through acquisitions. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery or larger volumes of injectable medications through subcutaneous delivery, and lowering the treatment burden for patients and health care system 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, number of products in development and ENHANZE® product approvals and launches), projections for future market share gains of partner SC products using ENHANZE®, projections for future sales revenue of our collaborators' products, potential new ENHANZE® collaborations, collaborative targets, indications for ENHANZE® products, co-formulation intellectual property and the Company's plans to develop 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 expectations contained 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), 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, 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, 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 non-GAAP net income 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. Reconciliations between GAAP and non-GAAP financial measures are included in these materials.
Note: This presentation contains product names, trademarks and registered trademarks are property of their respective owners
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2022 Financial Guidance Highlights
2021 | 2022 | |||
• | ~23-26% growth | |||
Total Revenue | $430M-$445M | $530M-$560M | • Includes one new deal upfront milestone | |
• | API and milestone revenue overall similar to | |||
2021 | ||||
• First time annual revenue >$500M | ||||
Royalty Revenue | ~$200M (est.) | ~$300M | • Project ~50% YoY Growth | |
• | Second year of projected increase of ~$100M | |||
• | ~32-36% growth | |||
Operating Income | $265M-$280M | $350M-$380M | • | >65% Operating Margin |
• | Includes incremental $20M Op-Ex Investment to | |||
maximize ENHANZE® and extend Royalty | ||||
Revenue durability | ||||
• 2021 GAAP Diluted EPS includes $142M one- | ||||
GAAP Diluted EPS | $2.60-$2.70 | $1.90-$2.05 | time benefit from reversal of tax valuation | |
allowance, representing ~$0.97 per share | ||||
• 2022 represents first year of income tax expense | ||||
projected to be ~$0.55-0.60 per share | ||||
• 2021 Non-GAAP Diluted EPS excludes $142M | ||||
Non- GAAP Diluted EPS | $1.90-2.00 | $2.05-$2.20 | one-time benefit from reversal of tax valuation | |
allowance | ||||
• 2022 represents first year of income tax expense |
projected to be ~$0.55-0.60 per share
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Capital Allocation Priorities
Invest to Maximize | Return Capital | Identify | ||||
ENHANZE® Growth | to Shareholders | Opportunities for | ||||
and Durability | External growth | |||||
Potential M&A expanding | ||||||
platform technologies | ||||||
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ENHANZE®
A Royalty Growth Story
2021 an inflection point year
DARZALEX FASPRO® with | DARZALEX® SC with | All time high number of |
ENHANZE® #1 in US sales | ENHANZE® ex-US uptake, | partnered products |
of Daratumumab1 | follows prior successes2 | in development |
- Source : Symphony Health October subscription data (presented with permission)
- Source: Q2 2021 Johnson & Johnson earnings call transcript
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Halozyme Therapeutics Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 14:57:04 UTC.