HALOZYME THERAPEUTICS, INC. 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(TM) 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(TM) 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(TM) 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, December 31,
2016 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.
