UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________________________________________
FORM 8-K
_____________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

			
Date of Report (Date of earliest event reported):	 	September 4, 2019	
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
________________________
Commission File Number 001-32335

			
Delaware	 	88-0488686	
(State or other jurisdiction of incorporation or organization)	 	(I.R.S. Employer Identification No.)	
 	 	
11388 Sorrento Valley Road	 	92121	
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.)
________________________
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:

			
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	
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 September 4, 2019, Halozyme Therapeutics, Inc., a Delaware corporation (“Halozyme”), presented at the 2019 Wells Fargo Healthcare Conference to provide a corporate update on certain strategic programs. Attached hereto as Exhibit 99.1, and incorporated herein by reference, is a copy of the slides used by Halozyme in making the presentation that are 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 the slide deck attached 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.

		
Exhibit No.	Description	
 	 	
99.1	Halozyme Therapeutics, Inc. corporate update presentation dated September 4, 2019	

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.	
  	 	 	 	 	
September 4, 2019	 	By:	 	/s/ Harry J. Leonhardt, Esq.	
 	 	 	 	 	
 	 	Name:	 	Harry J. Leonhardt, Esq.	
 	 	Title:	 	Senior Vice President, General Counsel and Corporate Secretary	

2019 Wells Fargo Healthcare Conference Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO September 4, 2019

 

Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include possible activity, benefits and attributes of PEGPH20, future product development and regulatory events and goals, anticipated clinical trial results and strategies, product collaborations, our business intentions and financial estimates and results, including projected revenue amounts. These statements are based upon management’s current plans and expectations and are subject to a number of risks and uncertainties which could cause actual results to differ materially from such statements. A discussion of the risks and uncertainties that can affect these statements is set forth in the Company’s annual and quarterly reports filed from time to time with the Securities and Exchange Commission under the heading “Risk Factors.” The Company disclaims any intention or obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise. 1

 

Two Engines for Growth ENHANZE® PEGPH20 Proven ‘IV to Sub Q’ Late Stage Targeted Partnering Platform Oncology Asset Phase 3 Data Accelerating Partner Readout Currently Investment for Approvals Projected in Q4 2019 High Potential: Potential ~$1B Global ~$1B Annual Royalty Pancreas Indication Revenue Projection in 2027 with Additional Pan- ~$1B in Lifetime Milestones tumor Potential 2

 

ENHANZE® 3

 

ENHANZE® Offers Four Potential Paths for Differentiation and Value Creation for Partners Reduced Treatment Burden 1 and Healthcare Costs DARZALEX® ALXN 1810 2 Potential for Competitive Differentiation BMS I/O Portfolio ARGX-113 3 New Intellectual Property and Exclusivity DARZALEX® Changing U.S. Reimbursement OPDIVO® 4 and Care Landscape 4

 

ENHANZE ® High-Growth Business 9 Agreements signed to date: Bristol-Myers Squibb Roche (Genentech), Baxalta, Agreement Terms Pfizer, Janssen, Eli Lilly, Abbvie Number of 11 BMS, Alexion, and argenx Targets Upfront $105M Milestones/ 3 Approved Products $160M Target 8 Targets in development today Royalties Mid-single digit >20 Target slots available to current average partners across all agreements 5

 

Near Term Catalysts: Project 3 Potential Blockbuster Programs in Phase III in 2019 2017 2018 2019 6 Products 11 Products 15 Products(1) 3 1 2 3 3 3 2 6 9 Approved and Commercialized Phase III 3 Commercialized Products Phase I 3 Products in Phase III 1 Projected by year-end as of January 9, 2019 6

 

Three Products Successfully Commercialized in Global Markets US ROW 7

 

ENHANZE® Development Pipeline Partner Product/Target Janssen DARZALEX® / Undisclosed Phase III in Undisclosed 2019 Regulatory Applications Ongoing Submitted Initiating BMS Anti-CD73 OPDIVO® ALXN1810 Phase I in argenx 2019 ARGX-113 Undisclosed PLUS 3 Potential New Phase I Starts in 2019 8

 

Daratumumab IV: Blockbuster Multiple Myeloma Treatment Early Launch Data Compares Analyst Estimates for DARZALEX® Favorably with Other Multiple Myeloma Drug Launches ($ Millions) ($ Millions) Darzalex® 8000 2000 Empliciti® 7000 Kyprolis® 6000 1500 Ninlaro® Pomalyst® 5000 Revlimid® 4000 1000 3000 2000 500 1000 0 0 2018 2019 2020 2021 2022 2023 2024 2025 1Year 1 2 23 3 4 Source: Analyst estimates via Nasdaq IR Insight Source: Bloomberg, company press releases Sell-side analysts estimate >$7 billion in sales by 2025 9

 

Daratumumab SC Regulatory Path Potential Benefits of Subcutaneous Formulation(1) • Faster infusion time being tested (3-5 minutes)(2) compared with 4-6 hour IV infusion, initially weekly • Well tolerated with fewer infusion related reactions (IRRs) than with IV(3) BLA/MAA Submissions Made in July 2019 Based on: • COLUMBA study in Relapsed and Refractory Multiple Myeloma • Achieved 2 primary endpoints: non-inferiority in Response Rate and C trough • Phase 2 PLEIADES Study(4) Multiple Ongoing Phase 3 Trials(1) with ENHANZE® 1 Genmab corporate presentations (Jeffries November 2018, R&D Update and 2018 ASH Data Review December 2018) 2 Subcutaneous Delivery of Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma Pavo, an Open-Label, Multicenter, Dose Escalation Phase 1b Study (Blood 2017) 3 Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter, Phase 1b Study (PAVO) Ajai Chari et al (ASH December 2018) 4 Janssen Pharmaceutical Companies’ press release dated July 12, 2019 10

 

Perjeta®/Herceptin® Fixed Dose Combination with ENHANZE®: Potential Regulatory Submissions First Half 2020 Potential Opportunity • PERJETA® indicated for use with Herceptin ® and Value proposition of Perjeta®/Herceptin® chemotherapy for adjuvant Fixed Dose SC with ENHANZE (3) treatment of patients with HER2+ early-stage breast 3 cancer (EBC) at high risk of recurrence • Target population size(2): ~75,000 in US and EU 5 • Strong IV adoption since launch: ~46% share in high risk early breast cancer in U.S.(1) 1 Roche twelve-month 2018 results 2 Roche HY 2019 Update Presentation 3 Roche Virtual Late Stage Pipeline Event 2018 presentation (September 13, 2019) 11

 

ENHANZE®: ~$1B Royalty Revenue Potential in 2027 2019-2021 Potential Cumulative ~$1 Billion Milestones = $225M-$300M All other partner products Projected Royalties derived from products in phase 3 (2019) Trastuzumab, Rituximab, HyQvia 2018 2027 Projection based on approved products and assumes global approval and launches for 12 additional products in multiple indications. Includes projections for subcutaneous versions of targets not currently approved or commercially available. Innovator revenues based on Bloomberg analyst projections, when available. Conversion rates based on Halozyme internal projections. Royalty revenue projection includes targets selected but not yet disclosed. Projected royalty revenue is not risk–adjusted. 12

 

ENHANZE®: Royalties Exceed Pro Forma ENHANZE-only Operating Expenses 2019-2021 Potential Cumulative ~$1 Billion Milestones = $225M-$300M All other partner products Projected Royalties derived from products in phase 3 (2019) ENHANZE-only Operating Expense Trastuzumab, Rituximab, HyQvia 2018 2027 Projection based on approved products and assumes global approval and launches for 12 additional products in multiple indications. Includes projections for subcutaneous versions of targets not currently approved or commercially available. Innovator revenues based on Bloomberg analyst projections, when available. Conversion rates based on Halozyme internal projections. Royalty revenue projection includes targets selected but not yet disclosed. Projected royalty revenue is not risk–adjusted. Operating expense represents pro-forma expenses that exclude COGS, and all costs related to Hylenex and PEGPH20. 13

 

Accelerating ENHANZE ® Growth New collaboration Daratumumab signed with argenx SC Regulatory 12 Targets in in 1Q 2019 is first Applications Development Existing with development- Submitted to FDA in 2019 Partnerships stage biotech and MAA Potential in Oncology, Pool of Potential New Rare Diseases, Blood Partners and Targets Disorders, Immunology, New Remains Sizable Partnerships CNS and more 14

 

PEGPH20 15

 

Tumor HA Overexpression Associated with Shorter Survival in Pancreas Cancer Retrospective Evaluation of Pancreatic Cancer Survival in ~50 Patients(1) HA-Low Median Survival: 24.3 months HA-High Median Survival: 9.3 months H.R. 2.6 p=0.037 1 Whatcott et al: Clin Cancer Res 2015, 21:3561-3568. HA staining by HABP. Scoring algorithm assessed percent staining and intensity. 16

 

PEGPH20 Targets Hyaluronan (HA) in the Tumor Microenvironment In HA-High Tumor Animal Models, Removal of HA by PEGPH20 Demonstrated to: Decrease Decompress Increase Increase Increase intratumoral vasculature perfusion access for access for pressure therapeutics immune cells PEGPH20 17

 

Proprietary Test Developed in Phase II to Identify HA- High Patients for Phase III • Partnered with Roche Tissue Analysis of OS in HA-High, Stage II HALO 202(1) Diagnostics (formerly Ventana) for Companion Diagnostic • Phase II Study HALO 202 key to develop Companion Diagnostic • 279 1L metastatic PDA • PEGPH20 plus Abraxane® and Gemcitabine versus Abraxane® M Estimate M and Gemcitabine alone - K • HA all-comers population • Stage 1: identification of HA algorithm/cut point • >50% score =HA-high • Stage II: validation of cut-point/ algorithm for Phase III • 37 of 133 patients HA-high 1 HALO 202: Randomized Phase II Study of PEGPH20 Plus Nab-Paclitaxel/Gemcitabine Versus Nab- Paclitaxel/ Gemcitabine in Patients With Untreated, Metastatic Pancreatic Ductal Adenocarcinoma 18 Journal of Clinical Oncology, Hingorani et al (December 2017)

 

HALO-301 Study in Metastatic Pancreas Cancer 1L Metastatic PDA PEGPH20 + ABRAXANE® High-HA + gemcitabine (PAG) patients Primary Endpoint: N=~500 • Overall Survival (OS) based on 330 events Double-blind ABRAXANE® + gemcitabine (AG) + placebo 2:1 Randomization Expect topline data announcement by December 2019 19

 

~$1B Potential Opportunity in Pancreas Cancer 65,000 Annual Diagnosed Metastatic Pancreatic Ductal Adenocarcinoma (PDA) U.S. and EU 5(1) ~$1B ~$1B Potential Global Sales Opportunity by 2027 in HA-High 25,000 Metastatic PDA(3,4) Estimated Number of HA-High Patients 35–40% of Population(2) 1 SEER 18 2006-2012, Globocan 2012, DRG Epidemiology data. 2 Halozyme estimates for HA-High %. 20 3 DRG Epidemiology data, Halozyme internal estimates. 4 Final revenue potential dependent on risk-benefit profile.

 

Ongoing Studies Evaluating Pan-tumor Potential of PEGPH20 Tumor Stage Status Pancreas Cancer Phase 1b Dose Finding Enrollment (second-line) Started 2H 2017 completed Gall Bladder Cancer, Enrolling additional Cholangiocarcinoma 15 patients 21

 

2019 Financial Guidance May 2019 August 2019 $205M to $215M Net Revenue No Change -Royalties of $72-74M Operating Expenses $265 to $275M $255 to $265M Operating Expenses (excl. $225 to $235M $215 to 225M COGS) Operating Cash Burn ($45M) to ($55M) ($40M) to ($50M) Debt Repayment ~$90M No Change Year-end Cash $210M to $220M $220M to $230M 22

 

Outlook • Growing ENHANZE momentum – ~$1 billion in annual royalty revenue potential by 2027 – Multiple near-term catalysts in a high margin business • Each pillar offers strong potential upside – ENHANZE: New deals plus up to $1 billion in lifetime milestones – PEGPH20: ~$1 billion global sales opportunity in pancreas cancer • Each pillar has been incrementally de-risked: – ENHANZE: 3 approved products, DARZALEX® SC regulatory applications submitted in July 2019 – PEGPH20: HALO-301 fully enrolled • Expect to end 2019 in strong financial position – Projected post-301 cash balance provides operational flexibility 23