Document
false0001159036 0001159036 2020-02-24 2020-02-24



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):
 
February 24, 2020
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 2.02 Results of Operations and Financial Condition.
On February 24, 2020, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the fourth quarter end December 31, 2019. A copy of the press release is attached as Exhibit 99.1, which is 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 9.01 Financial Statements and Exhibits.
Exhibit No.
Description
 
 
 
 
Press release dated
February 24, 2020
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.
  
 
 
 
 
February 24, 2020
 
By:
 
/s/ Masaru Matsuda
 
 
 
 
 
 
 
Name:
 
Masaru Matsuda, Esq.
 
 
Title:
 
Senior Vice President, General Counsel and Corporate Secretary



 Exhibit


Exhibit 99.1




HALOZYME REPORTS FOURTH QUARTER AND FULL YEAR 2019 RESULTS

- Halozyme Reiterates 2020 Guidance of $230 to $245 Million in Revenues and $0.60 to $0.75 Earnings Per Share with Profitability Beginning in Second Quarter -

-Two ENHANZE® Partnered Drugs Now Under US and EU Regulatory Review with Potential US Launches in 2020 -

- $200 Million of Shares Repurchased Under $550 Million Board Authorization with plans to Repurchase up to An Additional $150 Million in 2020 -

SAN DIEGO, February 24, 2020 - Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on its recent corporate activities and outlook.

“I am pleased to report 2020 is off to a strong start as we have substantially completed our actions to reposition the company to focus on ENHANZE®,” said Dr. Helen Torley, president and chief executive officer. “As a result of our decisive actions, we expect to become sustainably profitable in the second quarter. In addition, we anticipate multiple events that will grow the value of our ENHANZE® technology in 2020. Both the subcutaneous formulation of Darzalex® and the fixed-dose combination of Perjeta®-Herceptin® are under regulatory review in the U.S. and EU with potential approvals and launches expected this year. We anticipate three ENHANZE® pipeline candidates to begin Phase 3 testing, one to begin Phase 2, and at least five new Phase 1 trial starts. With these key developments, a transition to profitability and plans for continued return of capital, Halozyme has never been in a stronger position to deliver value for our shareholders. With a target of 19 products in clinical development or already commercialized by the end of this year, we continue to see the potential for our royalty revenues to achieve $1 billion by 2027.”

Fourth Quarter 2019 and Recent Highlights Include:
•
In December, Janssen selected for development with ENHANZE® the targets EGFR and cMET on an exclusive basis as part of the bispecific antibody (JNJ-61186372), which is being studied in solid tumors.

•
Halozyme recently completed $200 million worth of share repurchases under the Board of Directors authorized capital return program to repurchase up to $550 million of the Company's outstanding common stock over the next three years. This repurchase plan was first authorized by the Board of Directors in November 2019 and has $350 million remaining under the authorization. The company plans to repurchase up to an additional $150M worth of shares in 2020.





•
In November 2019, Halozyme completed the sale of $460.0 million aggregate principal amount of Convertible Senior Notes due 2024. A portion of the net proceeds from the offering were used to repurchase $200 million of the Company's stock and $26.1 million to repay all outstanding amounts under loan agreements with Oxford Finance and Silicon Valley Bank.

•
In November 2019, Halozyme announced strategic actions to reposition the Company with a focus on its ENHANZE® drug delivery technology and immediately implemented a restructuring following the announcement of results of the HALO-301 clinical study. Since then, the Company has completed the majority of the restructuring and remains on track to become a sustainably profitable company beginning in the second quarter of 2020.

•
In October 2019, collaboration partner Roche nominated one new undisclosed target to be studied utilizing the ENHANZE® technology, triggering a $10 million milestone payment to Halozyme.

•
In October 2019, collaboration partner Bristol-Myers Squibb initiated a Phase 1 study of relatlimab in combination with nivolumab utilizing the ENHANZE® technology.

Fourth Quarter and Full Year 2019 Financial Highlights

•
Revenue for the fourth quarter was $53.7 million compared to $60.2 million for the fourth quarter of 2018. The year-over-year decrease was primarily driven by a $25 million upfront payment from Roche in the year ago period 2018 related to the expansion of Roche's collaboration with Halozyme, partially offset by higher API sales to our partners in the current period. Revenue for the quarter included $17.2 million in royalties, which compared to $19.3 million in the prior year period.

Total revenues for the full year were $196.0 million, compared with $151.9 million in 2018, representing growth of 29% year over year.

•
Research and development expenses for the fourth quarter were $45.1 million, compared to $36.7 million for the fourth quarter of 2018. The increase in expenses was due to $17.2 million in restructuring and one-time charges related to the shift in strategic focus to the Company's ENHANZE® drug delivery technology, partially offset by $9.4 million lower PEGPH20 clinical trial related costs.

Research and development expenses for the full year were $140.8 million, compared with $150.3 million in 2018.

•
Selling, general and administrative expenses for the fourth quarter were $23.9 million, compared to $18.0 million for the fourth quarter of 2018. The increase is due to restructuring and other one-time charges of $11.2 million, partially offset by lower personnel costs.

Selling, general and administrative expenses for the full year were $77.3 million, compared with $60.8 million in 2018.

•
Net loss for the fourth quarter was $34.4 million, or 0.24 per share, compared to a net loss in the fourth quarter of 2018 of $2.1 million, or $0.01 per share.





Net loss for the full year was $72.2 million or $0.50 per share, compared to $80.3 million or $0.56 per share in 2018.

•
Cash, cash equivalents and marketable securities were $421.3 million at December 31, 2019, compared to $354.5 million at December 31, 2018.

Financial Outlook for 2020

Halozyme is reiterating its 2020 financial guidance ranges as first announced on January 14, 2020. For 2020 Halozyme expects:

•
Revenues of $230 million to $245 million, representing growth of 17% to 25%;

•
Earnings per share on a GAAP basis of $0.60 to $0.75 with the first quarter of sustainable profitability beginning in Q2 2020.

The guidance earnings per share does not reflect any potential impact from the Company's plans to repurchase an additional number of shares, up to $150 million worth, during 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2019 today, Monday, February 24, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 1266162.

About Halozyme

Halozyme Therapeutics is a biotechnology company focused on novel biological and drug delivery approaches. Halozyme’s proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids and potentially reduce the treatment burden of other drugs to patients. Halozyme has licensed its rHuPH20 technology, called ENHANZE®, to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company’s partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.


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 2020) and expectations for




profitability, revenue, expenses and earnings-per-share and the Company’s plans to continue its share repurchase program. 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 of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® 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, unexpected results or delays in the growth of the Company’s ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, regulatory approval requirements, unexpected adverse events 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.

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com






Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
 
 
Three Months Ended
 
Twelve Months Ended
 
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
 
Royalties
 
$
17,230

 
$
19,338

 
$
69,899

 
$
78,981

Product sales, net
 
22,693

 
10,681

 
66,048

 
28,234

Revenues under collaborative agreements
 
13,742

 
30,213

 
60,045

 
44,647

Total revenues
 
53,665

 
60,232

 
195,992

 
151,862

Operating expenses:
 
 
 
 
 
 
 
 
Cost of product sales
 
16,687

 
5,622

 
45,546

 
10,136

Research and development
 
45,111

 
36,650

 
140,804

 
150,252

Selling, general and administrative
 
23,929

 
18,031

 
77,252

 
60,804

Total operating expenses
 
85,727

 
60,303

 
263,602

 
221,192

Operating loss
 
(32,062
)
 
(71
)
 
(67,610
)
 
(69,330
)
Other income (expense):
 
 
 
 
 
 
 
 
Investment and other income, net
 
1,333

 
2,017

 
6,986

 
7,578

Interest expense
 
(3,731
)
 
(3,755
)
 
(11,627
)
 
(18,041
)
Net loss before income taxes
 
(34,460
)
 
(1,809
)
 
(72,251
)
 
(79,793
)
Income tax expense
 
(63
)
 
317

 
(11
)
 
537

Net loss
 
$
(34,397
)
 
$
(2,126
)
 
$
(72,240
)
 
$
(80,330
)
 
 
 
 
 
 
 
 
 
Net loss per share:
 
 
 
 
 
 
 
 
Basic
 
$
(0.24
)
 
$
(0.01
)
 
$
(0.50
)
 
$
(0.56
)
Diluted
 
$
(0.24
)
 
$
(0.01
)
 
$
(0.50
)
 
$
(0.56
)
 
 
 
 
 
 
 
 
 
Shares used in computing net loss per share:
 
 
 
 
 
 
 
 
Basic
 
141,046

 
144,203

 
144,329

 
143,599

Diluted
 
141,046

 
144,203

 
144,329

 
143,599





Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
 
 
December 31,
2019
 
December 31,
2018
ASSETS
 
 
 
 
Current assets:
 
 
 
 
Cash and cash equivalents
 
$
120,179

 
$
57,936

Marketable securities, available-for-sale
 
301,083

 
296,590

Accounts receivable, net
 
59,442

 
30,005

Inventories
 
29,359

 
22,625

Prepaid expenses and other assets
 
33,373

 
20,693

Total current assets
 
543,436

 
427,849

Property and equipment, net
 
10,855

 
7,465

Prepaid expenses and other assets
 
11,083

 
4,434

Restricted cash
 
500

 
500

Total assets
 
$
565,874

 
$
440,248

 
 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
 
Current liabilities:
 
 
 
 
Accounts payable
 
$
6,434

 
$
4,079

Accrued expenses
 
55,649

 
49,529

Deferred revenue, current portion
 
4,012

 
4,247

Current portion of long-term debt, net
 
19,542

 
91,506

Total current liabilities
 
85,637

 
149,361

 
 
 
 
 
Deferred revenue, net of current portion
 
1,247

 
5,008

Long-term debt, net
 
383,045

 
34,874

Other long-term liabilities
 
4,180

 
2,118

 
 
 
 
 
Stockholders’ equity:
 
 
 
 
Common stock
 
137

 
145

Additional paid-in capital
 
695,066

 
780,457

Accumulated other comprehensive income (loss)
 
240

 
(277
)
Accumulated deficit
 
(603,678
)
 
(531,438
)
Total stockholders’ equity
 
91,765

 
248,887

Total liabilities and stockholders’ equity
 
$
565,874

 
$
440,248







v3.19.3.a.u2
Cover Page
Feb. 24, 2020
Cover page.  
Document Type 8-K
Document Period End Date Feb. 24, 2020
Entity Registrant Name HALOZYME THERAPEUTICS, INC.
Entity File Number 001-32335
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 88-0488686
Entity Address, Address Line One 11388 Sorrento Valley Road
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92121
City Area Code 858
Local Phone Number 794-8889
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value
Trading Symbol HALO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001159036