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Halozyme(HALO) - 2023 Q1 - Earnings Call Transcript
2023-05-10 00:50
Financial Data and Key Metrics Changes - The company reported total revenue of $162 million for Q1 2023, a 38% increase year-over-year from $117.3 million in Q1 2022 [10][17] - Royalty revenue for the quarter was $99.6 million, representing a 43% increase compared to $69.6 million in the prior year period [32][126] - EBITDA for the quarter was $74.3 million, compared to $76.4 million in Q1 2022, reflecting a $25 million milestone payment in the previous year that did not recur [20][19] - GAAP diluted earnings per share was $0.29, while non-GAAP diluted earnings per share was $0.47 [20] Business Line Data and Key Metrics Changes - The ENHANZE royalty business is experiencing strong growth, with expectations to add three new agreements in 2023 [3][6] - XYOSTED revenue is projected to reach approximately $100 million in 2023, representing a 20% increase from the run rate following the acquisition [7] - The company anticipates continued strength in ENHANZE wave 2 products, with royalty revenue expected to increase between 23% to 26% over 2022 [21][126] Market Data and Key Metrics Changes - Roche reported Q1 2023 revenues of CHF1.6 billion for OCREVUS, a 14% year-over-year increase, with annualized sales exceeding $7 billion [12] - The subcutaneous formulation of DARZALEX has achieved an 88% market share in the US and over 80% outside the US, driving significant revenue growth [128] - Phesgo sales reached approximately CHF240 million in Q1 2023, a 72% year-over-year increase, with 85% of patients preferring subcutaneous administration [129] Company Strategy and Development Direction - The company aims to expand its product pipeline and advance products through development to regulatory approval, targeting multiple new royalty revenue streams [13][136] - There is a strong focus on enhancing the competitiveness of products through subcutaneous delivery, which is expected to reduce treatment times and improve patient experience [102][124] - The company is actively evaluating M&A opportunities to enhance revenue growth and durability [116] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving goals for 2023, including new ENHANZE deals and continued growth in royalty revenue [6][11] - The company anticipates reaching approximately $1 billion in royalty revenue by 2027, with potential for growth beyond that [104] - Management noted that current partners are awaiting more details from CMS regarding IRA guidance, which has not significantly impacted discussions [24][120] Other Important Information - The company completed $150 million in share repurchases in Q1 2023, fully utilizing the allocated amount for the year [16][90] - Research and development expenses increased to $18 million in Q1 2023, primarily due to a larger workforce and planned investments in ENHANZE [19] Q&A Session Summary Question: How is the IRA guidance impacting conversations with potential partners? - Management indicated that there is still too little detail available to assess any impact, and IRA has not been a frequent topic in discussions with potential partners [24][120] Question: What is the expected impact of the Antares acquisition on earnings? - The Antares acquisition is expected to be accretive to revenue and non-GAAP EPS for the full year 2023 [90] Question: Can you provide more details on planned investments in ENHANZE? - Planned investments focus on developing a high-yield rHuPH20 and a room temperature stable version, which may be suitable for small molecules [88][89] Question: What is the current IV to subcutaneous conversion rate trajectory for other products? - The company expects a target conversion rate of around 60% after three years, with positive progress noted for products like Phesgo [80][95]
Halozyme(HALO) - 2023 Q1 - Quarterly Report
2023-05-09 20:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32335 ___________________________ HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ___________ ...
Halozyme Therapeutics (HALO) Investor Presentation - Slideshow
2023-03-22 19:02
• 13-20% YoY growth • Excludes impact of future share repurchases | --- | --- | --- | --- | --- | |---------------|---------|-----------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | Total Revenue | $660.1M | $815M ...
Halozyme(HALO) - 2022 Q4 - Earnings Call Presentation
2023-02-22 01:56
NASDAQ: HALO February 21, 2023 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 2023) and expectations for profitability, revenue (including expectations for future royalties, milestones and product sales), EBITDA and earnings-per-share, and the Company's plans to repurchase shares under ...
Halozyme(HALO) - 2022 Q4 - Annual Report
2023-02-21 21:27
PART I [Business](index=8&type=section&id=Item%201.%20Business) Halozyme Therapeutics licenses its ENHANZE® drug delivery technology and expanded its portfolio with the 2022 Antares Pharma acquisition, focusing on a capital-light model - The company's core business is licensing its ENHANZE® drug delivery technology, which uses the rHuPH20 enzyme to convert intravenous (IV) drugs to subcutaneous (SC) injections, to major biopharmaceutical companies[27](index=27&type=chunk) - In 2022, Halozyme acquired Antares Pharma, Inc., adding advanced auto-injector technologies and a portfolio of commercial products (XYOSTED®, TLANDO®, NOCDURNA®) to its business[28](index=28&type=chunk)[380](index=380&type=chunk) - The company operates a capital-light model by outsourcing all manufacturing of its rHuPH20 enzyme and device components to third-party contract manufacturing organizations like Avid Bioservices, Catalent, and Phillips-Medisize[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) - As of February 14, 2023, the company had **393 full-time employees**, with a workforce composition of **45% female** and **31% non-white/Caucasian**[105](index=105&type=chunk)[109](index=109&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from partner dependence, technology concentration, debt, and Antares acquisition integration challenges - A primary risk is the heavy reliance on partners (e.g., Roche, Janssen) to successfully develop and commercialize products using ENHANZE® technology; failure or termination of these collaborations would significantly harm the business[130](index=130&type=chunk) - The business is highly concentrated on the rHuPH20 enzyme; any adverse development, such as safety issues or manufacturing disruptions with contract manufacturers (Avid, Catalent), could impact the entire ENHANZE® platform and Hylenex®[127](index=127&type=chunk)[131](index=131&type=chunk) - The company has significant debt, totaling approximately **$1.5 billion** as of December 31, 2022; this includes multiple series of convertible notes and covenants under a credit agreement, which could restrict operations and require substantial cash for debt service[149](index=149&type=chunk)[150](index=150&type=chunk) - Failure to successfully integrate the Antares business, or underperformance of its products and technologies, could adversely impact future business, operations, and the ability to realize anticipated revenue diversification and growth[141](index=141&type=chunk)[142](index=142&type=chunk) [Unresolved Staff Comments](index=45&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[210](index=210&type=chunk) [Properties](index=46&type=section&id=Item%202.%20Properties) Halozyme operates from approximately 194,000 square feet of leased facilities across San Diego, Ewing, and Minnetonka - The company leases all its facilities, totaling approximately **194,000 square feet** as of December 31, 2022[211](index=211&type=chunk) - Key locations include administrative and research facilities in San Diego, CA, an office in Ewing, NJ, and a multi-purpose facility (office, lab, manufacturing, warehouse) in Minnetonka, MN[211](index=211&type=chunk) [Legal Proceedings](index=46&type=section&id=Item%203.%20Legal%20Proceedings) Halozyme is not currently involved in any legal proceedings expected to materially impact its financial position - As of the report date, Halozyme is not a party to any legal proceedings expected to have a material adverse effect on the company[212](index=212&type=chunk) [Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[213](index=213&type=chunk) PART II [Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=47&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Halozyme's common stock trades on NASDAQ, with a focus on share repurchases rather than dividends, and strong stock performance - The company's common stock is listed on the NASDAQ Global Select Market under the symbol **"HALO"**[216](index=216&type=chunk) - Halozyme has never paid dividends and does not intend to in the foreseeable future, prioritizing reinvestment and share repurchases[217](index=217&type=chunk) - In December 2021, the Board authorized a new three-year, **$750 million** share repurchase program; as of December 31, 2022, the company had repurchased **8.4 million shares** for **$350.0 million** under this program[219](index=219&type=chunk) Q3 2022 Share Repurchase Details | Period | Total Number of Shares Purchased | Weighted Average Price paid Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | Q3 2022 | 4,500,216 | $44.44 | $200,000 | [(Reserved)](index=50&type=section&id=Item%206.%20%28Reserved%29) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Halozyme's 2022 revenues grew significantly due to royalties and Antares acquisition, though operating income slightly decreased due to increased expenses [Results of Operations](index=55&type=section&id=7.1%20Results%20of%20Operations) Halozyme's 2022 financial performance saw strong royalty and product sales growth, but increased operating expenses and a one-time tax benefit reversal impacted net income Financial Performance Summary | Financial Metric (in thousands) | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$660,116** | **$443,310** | **48.9%** | | Royalties | $360,475 | $203,900 | 76.8% | | Product sales, net | $191,030 | $104,224 | 83.3% | | Revenues under collaborative agreements | $108,611 | $135,186 | (19.7)% | | **Total operating expenses** | **$392,585** | **$167,408** | **134.5%** | | Cost of sales | $139,304 | $81,413 | 71.1% | | Amortization of intangibles | $43,148 | $0 | N/A | | Research and development | $66,607 | $35,672 | 86.7% | | Selling, general and administrative | $143,526 | $50,323 | 185.2% | | **Operating income** | **$267,531** | **$275,902** | **(3.0)%** | | **Net income** | **$202,129** | **$402,710** | **(49.8)%** | - The significant decrease in net income from **$402.7 million** in 2021 to **$202.1 million** in 2022 was primarily due to a one-time income tax benefit of **$154.2 million** in 2021 from the release of a valuation allowance, compared to an income tax expense of **$46.8 million** in 2022[245](index=245&type=chunk)[365](index=365&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=7.2%20Liquidity%20and%20Capital%20Resources) Halozyme maintains strong liquidity with $362.8 million in cash, managing cash flows from operations, investing, and financing activities - The company held **$362.8 million** in cash, cash equivalents, and marketable securities as of December 31, 2022[247](index=247&type=chunk) Cash Flow Activities | Cash Flow Activity (in millions) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $240.1 | $299.4 | | Net cash used in investing activities | ($487.0) | ($406.3) | | Net cash provided by financing activities | $362.4 | $77.9 | - Material future cash requirements include long-term debt service, lease payments (**$47.0 million**), third-party manufacturing obligations (**$97.8 million**), and other purchase commitments (**$48.7 million**)[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk) [Long-Term Debt](index=58&type=section&id=7.3%20Long-Term%20Debt) Halozyme's long-term debt primarily consists of convertible senior notes, with recent issuance of 2028 notes and repayment of other facilities Convertible Notes Summary | Convertible Note Series | Principal Amount (in millions) | Interest Rate | Maturity Date | | :--- | :--- | :--- | :--- | | 2028 Notes | $720.0 | 1.00% | Aug 15, 2028 | | 2027 Notes | $805.0 | 0.25% | Mar 1, 2027 | | 2024 Notes | $13.5 | 1.25% | Dec 1, 2024 | - In August 2022, the company issued **$720.0 million** of **1.00% Convertible Senior Notes due 2028** and entered into Capped Call Transactions for **$69.1 million** to reduce potential dilution upon conversion[258](index=258&type=chunk)[516](index=516&type=chunk) - The company completed induced conversions of its 2024 notes, paying down **$77.4 million** in principal in August 2022 and **$369.1 million** in March 2021[270](index=270&type=chunk)[271](index=271&type=chunk) - In August 2022, the company repaid its entire outstanding term loan facility and all outstanding loans under its revolving credit facility; the revolving credit facility was increased to **$575 million** and was undrawn as of December 31, 2022[276](index=276&type=chunk)[277](index=277&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=64&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its investment portfolio, which management deems immaterial - The primary market risk is interest rate fluctuations affecting the value of the company's cash equivalents and marketable securities portfolio[284](index=284&type=chunk) - Management estimates that a hypothetical **10% change** in interest rates would not have a material impact on the company's financial results[284](index=284&type=chunk) - The company does not hold or issue derivative instruments for speculative or trading purposes[285](index=285&type=chunk) [Financial Statements and Supplementary Data](index=64&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements and the independent auditor's report for 2022 - This section includes the audited consolidated financial statements and the report from the independent registered public accounting firm, Ernst & Young LLP[286](index=286&type=chunk)[299](index=299&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=64&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting principles or financial disclosure - None reported[287](index=287&type=chunk) [Controls and Procedures](index=65&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and auditors concluded that disclosure controls and internal control over financial reporting were effective, excluding the recently acquired Antares Pharma - Management concluded that both disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022[290](index=290&type=chunk)[296](index=296&type=chunk) - The assessment of internal control over financial reporting explicitly excluded the operations of Antares Pharma, Inc., acquired in May 2022; Antares constituted **9% of total assets** and **17% of total revenues** for the year[291](index=291&type=chunk)[295](index=295&type=chunk)[302](index=302&type=chunk) - The independent auditor, Ernst & Young LLP, provided an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2022[301](index=301&type=chunk) [Other Information](index=68&type=section&id=Item%209B.%20Other%20Information) The company reports no other information under this item - None[309](index=309&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=68&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) The company reports no information under this item, indicating it is not applicable - None[310](index=310&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=68&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides executive officer biographies and incorporates director and governance information by reference from the 2023 Proxy Statement - Dr. Helen I. Torley has served as President and CEO since January 2014, bringing experience from leadership roles at Onyx, Amgen, and Bristol-Myers Squibb[312](index=312&type=chunk) - Nicole LaBrosse was appointed SVP, Chief Financial Officer in February 2022, having been with the company since 2015 and previously working as an auditor at PricewaterhouseCoopers, LLP[313](index=313&type=chunk) - Information concerning directors, the code of conduct, and board committees is incorporated by reference from the forthcoming 2023 Annual Meeting Proxy Statement[311](index=311&type=chunk) [Executive Compensation](index=69&type=section&id=Item%2011.%20Executive%20Compensation) All executive compensation information is incorporated by reference from the company's 2023 definitive Proxy Statement - All information regarding executive compensation is incorporated by reference from the 2023 Proxy Statement[318](index=318&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=69&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details the company's equity compensation plans, including shares available for future issuance, and incorporates other ownership data by reference Equity Compensation Plan Information | Plan Category | Shares to be Issued (a) | Weighted-Average Exercise Price of Options (b) | Shares Available for Future Issuance (c) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by stockholders | 6,550,450 | $24.99 | 17,413,834 | - The shares available for future issuance include **2,650,103 shares** available under the Employee Stock Purchase Plan (ESPP)[320](index=320&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=70&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the company's 2023 definitive Proxy Statement - All information regarding certain relationships, related transactions, and director independence is incorporated by reference from the 2023 Proxy Statement[323](index=323&type=chunk) [Principal Accounting Fees and Services](index=70&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Details on fees paid to the independent accounting firm are incorporated by reference from the company's 2023 definitive Proxy Statement - All information regarding principal accounting fees and services is incorporated by reference from the 2023 Proxy Statement[324](index=324&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=70&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits included in the Annual Report on Form 10-K - This section provides an index of all financial statements, schedules, and exhibits filed with the 10-K report[326](index=326&type=chunk)[327](index=327&type=chunk)[329](index=329&type=chunk) [Form 10-K Summary](index=73&type=section&id=Item%2016.%20Form%2010-K%20Summary) No summary is provided under this item - None[335](index=335&type=chunk)
Halozyme(HALO) - 2022 Q3 - Earnings Call Transcript
2022-11-09 00:00
Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Tram Bui - Vice President, Investor Relations & Corporate Communication Helen Torley - President & Chief Executive Officer Nicole LaBrosse - Chief Financial Officer Conference Call Participants Michael DiFiore - Evercore ISI Jessica Fye - JPMorgan David Risinger - SVB Securities Jason Butler - JMP Corinne Jenkins - Goldman Sachs Operator Good afternoon. My name is Shantou, and I will b ...
Halozyme(HALO) - 2022 Q3 - Earnings Call Presentation
2022-11-08 21:42
Halozyme Confidential and Proprietary Third Quarter 2022 Financial and Operating Results Nasdaq: HALO November 8, 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 the Company's financial outlook for 2022) and expectations for profitability, revenue (including expectations for future milestone ...
Halozyme(HALO) - 2022 Q3 - Quarterly Report
2022-11-08 21:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32335 ___________________________ HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) _______ ...
Halozyme(HALO) - 2022 Q2 - Earnings Call Transcript
2022-08-09 21:58
Financial Performance Highlights - The company reported second quarter revenues of $152.4 million, a 12% year-over-year increase, resulting in GAAP earnings per share of $0.16 and non-GAAP adjusted earnings per share of $0.53 [9][48] - Royalty revenue for the second quarter was $85.3 million, representing an 86% increase compared to $45.8 million in the prior year period, driven by strong uptake of Janssen's subcutaneous DARZALEX [13][46] - The company raised its full-year 2022 revenue guidance to $655 million to $685 million, up from the previous range of $530 million to $560 million, indicating a growth of 48% to 55% over 2021 [11][49] Business Line Performance - The acquisition of Antares contributed $18.7 million in revenue for the quarter, enhancing the company's product offerings and commercial capabilities [80] - The company expects royalty revenues to increase by greater than 65% over 2021, projecting $340 million to $350 million for the year [50] Market Performance - Janssen's DARZALEX reported worldwide sales of $2 billion in the second quarter, a 46% year-over-year increase, with subcutaneous formulations gaining significant market share [15][16] - Roche's Phesgo, utilizing ENHANZE technology, achieved sales of CHF325 million, a 241% increase year-over-year, indicating strong market adoption [17] Company Strategy and Industry Competition - The acquisition of Antares aligns with the company's strategy to maximize ENHANZE revenue growth and durability while expanding its product portfolio [44][43] - The company is focused on integrating Antares and expanding its commercial infrastructure, with nearly complete expansion of its field footprint to support new product launches [70][71] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the company's diversified portfolio and its ability to navigate potential impacts from drug pricing reforms, noting that biologic drugs would not be affected for 13 years post-launch [61][62] - The company anticipates continued strong operational performance and revenue growth, supported by the integration of Antares and ongoing product launches [56][94] Other Important Information - The company plans to continue its $750 million share repurchase program, with an additional $100 million planned for 2022, depending on market conditions [54][92] - The balance sheet remains strong, with a net debt-to-EBITDA ratio of 3.3 times, expected to reduce to less than three times by year-end [53] Q&A Session Summary Question: Impact of drug pricing reform on finances - Management noted that it is too early to assess the specific impact of drug pricing reform, but the diversified portfolio positions the company well [60][62] Question: Update on Antares integration - Integration activities are on track, with a focus on creating a unique high-volume auto-injector offering [68][69] Question: Non-GAAP EPS impact from Antares - Antares contributed $18.7 million in revenue for the quarter, and the full-year guidance reflects an increase in non-GAAP EPS by $0.05 per share due to the acquisition [80][81] Question: TLANDO launch and business development prospects - The company is focused on market access for TLANDO and has received positive interest from partners regarding new auto-injector options [64][83]
Halozyme(HALO) - 2022 Q1 - Earnings Call Transcript
2022-05-11 02:14
Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants Helen Torley - President & Chief Executive Officer Nicole LaBrosse - Chief Financial Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Mike DiFiore - Evercore Corinne Jenkins - Goldman Sachs Jessica Fye - JPM Chase Anita Dushyanth - Berenberg Capital Markets Operator Good afternoon. My name is Emma, and I will be your conference operator today. At this time, I would ...
Halozyme - filings, earnings calls, financial reports, news - Reportify