SAN DIEGO, Nov. 7, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today
reported financial results and recent highlights for the third quarter ended September 30.
"The third quarter was highlighted by Genentech's BLA filing for rituximab in a subcutaneous formulation using Halozyme's
ENHANZE platform in multiple blood cancers, a development that adds to the potential for our royalty revenue and highlights the
benefits of our business model," said Dr. Helen Torley, president and chief executive officer. "In
our oncology pillar, we continued initiation of our global sites in our phase 3 study of PEGPH20 and are making progress toward
dose expansion in our study with Keytruda, all as we anticipate reporting topline results from stage 2 of our HALO-202 study once
the data is mature."
Halozyme was recently informed by the independent statistician for the data monitoring committee of its HALO-202 study that
progression-free survival data are not yet mature for analysis. As a result, the company now expects the reporting of data may
move into 2017, depending on when it is mature for analysis.
Third Quarter 2016 and Recent Highlights include:
- The inclusion of PEGPH20 in the Pancreatic Cancer Action Network's Precision Promise initiative, a broad industry
and pancreatic cancer community coalition established to study pancreatic cancer therapies in patients based on the molecular
profile of their tumors. The clinical trial plans to enroll patients at 12 consortium sites in the U.S. beginning in spring
2017.
- Continuing to initiate sites in the HALO-301 | Pancreatic study toward the goal of having approximately 90 percent
of centers ready to screen patients by the end of 2016.
- Progressing in dose escalation of the ongoing phase 1b clinical study evaluating PEGPH20 in combination with
KEYTRUDA® (pembrolizumab) in relapsed non-small cell lung and gastric cancer patients. The company continues to
project that the study will move to the dose expansion phase by the end of 2016.
- U.S. Food and Drug Administration (FDA) filing a Biologics License Application (BLA) to support approval for the
subcutaneous formulation of Rituximab in multiple blood cancer indications. Including all approved indications, Roche
reported total 2015 sales of rituximab in the United States of 3.76
billion CHF.
- Pfizer announcing discontinuation of the global clinical development program for bococizumab, its investigational
PCSK9 inhibitor. The development of a subcutaneous version on the Halozyme ENHANZE platform has also been discontinued. Pfizer
also made a portfolio decision to discontinue development of rivipansel with the ENHANZE platform even though the technology
performed as intended. Pfizer continues to develop an additional program with the ENHANZE platform for an undisclosed
target.
Third Quarter 2016 Financial Highlights
- Revenue for the third quarter was $31.9 million compared to $20.8
million for the third quarter of 2015, driven primarily by royalties from partner sales of Herceptin® SC,
MabThera® SC and HYQVIA®, API sales to partners, and manufacturing and clinical supply reimbursements
from ENHANZE™ partners.
Revenue for the third quarter included $13 million in royalties, an increase of 58 percent from
the prior-year period, $9.6 million in sales of bulk rHuPH20 primarily for use in manufacturing
collaboration products and $3.7 million in HYLENEX® recombinant (hyaluronidase human
injection) product sales.
- Research and development expenses for the third quarter were $33.9 million, compared to
$27.6 million for the third quarter of 2015. The planned increases were primarily due to a ramp
in spending associated with the HALO-301 study, personnel expenses, and manufacturing and clinical supply expenses that are
reimbursed by ENHANZE™ partners.
- Selling, general and administrative expenses for the third quarter were $11.6 million,
compared to $10.2 million for the third quarter of 2015. The increase was primarily due to
personnel expenses, including stock compensation, for the period.
- Net loss for the third quarter was $28.9 million, or $0.23 per
share, compared to a net loss in the third quarter of 2015 of $24.5 million, or $0.19 per share.
- Cash, cash equivalents and marketable securities were $221.1 million at September 30 compared to $230 million at June 30,
2016.
Financial Outlook for 2016
For the full year 2016, the company updated and narrowed its financial guidance, now expecting:
- Net revenue of $145 million to $150 million, raising the lower end of its prior $140 million to $150 million range;
- Operating expenses of $240 million to $245 million, from the prior $245 million to $260 million range;
- Cash flow of $75 million to $85 million, from the prior range of $65
million to $85 million;
- Year-end cash balance of $180 million to $190 million, raising the lower end of its prior
$170 million to $190 million range.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the third quarter 2016 today, Monday,
November 7 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. The call will be webcast live through
the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call.
To access the webcast and additional documents related to the call, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and
install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling
(877) 410-5657 (domestic callers) (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be
available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID
number 22039188.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that
target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach
to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models.
PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic
breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to
its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies
including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. 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 above include forward-looking statements (including, without
limitation, statements concerning the Company's future expectations and plans for growth in 2016, the development and
commercialization of product candidates and the potential benefits and attributes of such product candidates and expected
financial outlook for 2016) that involve risk and uncertainties that could cause actual results to differ materially from those
in the forward-looking statements. The 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. Actual results could differ materially from
the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and
costs, unexpected fluctuations or changes in revenues, including revenues from collaborators, unexpected results or delays in
development of product candidates and regulatory review, 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
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2016.
Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
|
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product sales, net
|
|
$
|
13,331
|
|
|
$
|
10,301
|
|
|
$
|
39,970
|
|
|
$
|
32,503
|
|
|
Royalties
|
|
13,036
|
|
|
8,274
|
|
|
36,695
|
|
|
21,431
|
|
|
Revenues under collaborative agreements
|
|
5,486
|
|
|
2,205
|
|
|
31,023
|
|
|
28,896
|
|
|
Total revenues
|
|
31,853
|
|
|
20,780
|
|
|
107,688
|
|
|
82,830
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product sales
|
|
9,134
|
|
|
6,180
|
|
|
25,204
|
|
|
20,818
|
|
|
Research and development
|
|
33,863
|
|
|
27,611
|
|
|
109,493
|
|
|
65,490
|
|
|
Selling, general and administrative
|
|
11,599
|
|
|
10,226
|
|
|
33,626
|
|
|
29,439
|
|
|
Total operating expenses
|
|
54,596
|
|
|
44,017
|
|
|
168,323
|
|
|
115,747
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
(22,743)
|
|
|
(23,237)
|
|
|
(60,635)
|
|
|
(32,917)
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest and other income, net
|
|
334
|
|
|
78
|
|
|
960
|
|
|
267
|
|
|
Interest expense
|
|
(5,253)
|
|
|
(1,301)
|
|
|
(14,378)
|
|
|
(3,899)
|
|
|
Net loss before income taxes
|
|
(27,662)
|
|
|
(24,460)
|
|
|
(74,053)
|
|
|
(36,549)
|
|
|
Income tax expense
|
|
1,284
|
|
|
—
|
|
|
1,584
|
|
|
—
|
|
|
Net loss
|
|
$
|
(28,946)
|
|
|
$
|
(24,460)
|
|
|
$
|
(75,637)
|
|
|
$
|
(36,549)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.23)
|
|
|
$
|
(0.19)
|
|
|
$
|
(0.59)
|
|
|
$
|
(0.29)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
128,154
|
|
|
126,921
|
|
|
127,886
|
|
|
126,127
|
|
|
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
September 30,
2016
|
|
December 31,
2015
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
61,207
|
|
|
$
|
43,292
|
|
|
Marketable securities, available-for-sale
|
|
159,845
|
|
|
65,047
|
|
|
Accounts receivable, net
|
|
17,679
|
|
|
32,410
|
|
|
Inventories
|
|
12,852
|
|
|
9,489
|
|
|
Prepaid manufacturing costs
|
|
14,960
|
|
|
16,155
|
|
|
Prepaid expenses and other assets
|
|
6,062
|
|
|
5,379
|
|
|
Total current assets
|
|
272,605
|
|
|
171,772
|
|
|
Property and equipment, net
|
|
4,407
|
|
|
3,943
|
|
|
Prepaid expenses and other assets
|
|
4,986
|
|
|
5,574
|
|
|
Restricted cash
|
|
500
|
|
|
500
|
|
|
Total assets
|
|
$
|
282,498
|
|
|
$
|
181,789
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,641
|
|
|
$
|
4,499
|
|
|
Accrued expenses
|
|
25,733
|
|
|
26,792
|
|
|
Deferred revenue, current portion
|
|
9,892
|
|
|
9,304
|
|
|
Current portion of long-term debt
|
|
12,394
|
|
|
21,862
|
|
|
Total current liabilities
|
|
52,660
|
|
|
62,457
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion
|
|
40,849
|
|
|
43,919
|
|
|
Long-term debt, net
|
|
199,803
|
|
|
27,971
|
|
|
Other long-term liability
|
|
1,178
|
|
|
4,443
|
|
|
|
|
|
|
|
Stockholders' (deficit) equity:
|
|
|
|
|
|
Common stock
|
|
129
|
|
|
128
|
|
|
Additional paid-in capital
|
|
545,751
|
|
|
525,628
|
|
|
Accumulated other comprehensive income
|
|
83
|
|
|
(99)
|
|
|
Accumulated deficit
|
|
(557,955)
|
|
|
(482,658)
|
|
|
Total stockholders' (deficit) equity
|
|
(11,992)
|
|
|
42,999
|
|
|
Total liabilities and stockholders' (deficit) equity
|
|
$
|
282,498
|
|
|
$
|
181,789
|
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SOURCE Halozyme Therapeutics, Inc.