SAN DIEGO, Nov. 10, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial
results for the third quarter ended September 30, 2014. Financial highlights for the
third quarter include revenues of $14.6
million and a net loss of $20.3
million, or $0.16 per share.
This compares to revenues of $16.0
million and a net loss of $19.3
million, or $0.17 per share,
for the third quarter of 2013.
"The third quarter was notable for completion of a review and
update to our corporate strategy based on a portfolio assessment.
The recent Fast Track and Orphan Drug designations for PEGPH20, new
pre-clinical data further supporting the pan-tumor potential for
PEGPH20 and strong investigator interest in both pancreatic and
lung cancer trials have confirmed this as our priority proprietary
product for investment. The growth in the number of approvals for
ENHANZE™ – based products and the launch success
of Roche's Herceptin SC affirms our confidence in the growth
potential of the ENHANZE platform," stated Dr. Helen Torley, President and Chief Executive
Officer. "Our pursuit of Hylenex® in Type
1 diabetes is a potential opportunity to expand the indication and
increase sales of Hylenex. While discussions with the
FDA are ongoing, we have learned that the FDA will likely request
additional clinical data for a label update translating to
potentially higher projected costs and longer time to market than
had originally been anticipated. In the ongoing weeks, we
intend to continue to seek clarity with FDA on what data will be
required, if any. Once we have gained clarity as to the
regulatory requirements for a label update, we intend to enter into
collaborations with third parties or explore other strategic
alternatives in order to exploit this opportunity. I am
excited by the opportunity to focus our resources on advancing
PEGPH20 and to expand utilization of our ENHANZE platform."
Third Quarter 2014 Highlights
- Royalty revenues of $2.9
million represent over 70% growth from second
quarter: Royalty revenues represent April to June sales
as a result of the one quarter lag in royalty reports. The
Herceptin SC launch is progressing well with approximately 20%
market share in the markets launched through October. A
notable recent milestone for Herceptin SC is the recent
reimbursement approval and launch in France, traditionally one of the largest EU
oncology markets.
- HYQVIA® approved by the FDA and
launched in the U.S.: In September, the U.S. Food and Drug
Administration (FDA) approved HYQVIA for the treatment of primary
immunodeficiency (PI) in adults and Baxter began commercial introduction of the
product on October 20th.
HYQVIA is the first subcutaneous immune globulin (IG) treatment
approved for PI patients with a dosing regimen requiring only one
infusion up to once per month (every three to four weeks) and one
injection site per infusion to deliver a full therapeutic dose of
IG.
- PEGPH20 (PEGylated recombinant human hyaluronidase)
received Fast Track and Orphan Drug designation for
pancreatic cancer: The FDA has granted Fast Track designation
for Halozyme's program investigating PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of patients with
metastatic pancreatic cancer. The FDA Office of Orphan
Products Development also granted Orphan Drug status for PEGylated
recombinant human hyaluronidase for the treatment of pancreatic
cancer which grants this designation to medical products that
demonstrate promise for the treatment of rare diseases or
conditions.
- PEGPH20 (PEGylated recombinant human hyaluronidase)
enrollment progressing: 42 of 44 sites have received IRB
approval for the Study 202 protocol amendment. A total of 25 of the
target of approximately 100 new patients have been enrolled to
date.
- SWOG resumes clinical trial of PEGPH20 in combination with
modified FOLFIRINOX for advanced pancreatic cancer: SWOG Cancer
Research has resumed patient enrollment and dosing of PEGPH20 in
its ongoing Phase 1b/2 clinical trial (S1313). The trial is
designed to evaluate PEGPH20 in combination with modified
FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic
pancreatic adenocarcinoma. The study has resumed under a
revised protocol approved by the Independent Review Boards at the
participating clinical trial sites.
- CONSISTENT 1 trial of Hylenex in patients with Type1
diabetes to be ended after first year: While discussions with
FDA are ongoing, we have determined that with all patients having
completed 12 months on the trial at this time, we do not need
additional data contribution from the second year of CONSISTENT 1
and we will be stopping the study.
- Second disclosed program under the Halozyme-Pfizer
collaboration: Pfizer intends to investigate a subcutaneous
formulation using Halozyme's Enhanze technology with rivipansel.
Rivipansel is an investigational compound under evaluation for the
treatment of vaso-occlusive crisis in individuals with sickle cell
disease.
- Reduction in force of approximately 13% completed in
November 2014 to align with strategic
priorities: We completed a corporate reorganization to
align with strategic priorities. This reorganization resulted in a
workforce reduction of 22 employees. We will incur a one-time
charge in the fourth quarter of 2014 that will be largely offset by
reduced compensation expenses during the quarter.
Third Quarter and Nine Months 2014 Financial
Highlights
- Revenues for the third quarter of 2014 were $14.6 million,
compared to $16.0 million for the third quarter of 2013.
Revenues in the third quarter included $5.8
million in product sales of bulk rHuPH20 for use in
manufacturing Roche's collaboration products, $3.6 million in Hylenex product sales,
$2.9 million in royalty revenue from
sales of products under our collaborations and $2.1 million in collaboration revenues.
Revenues for the nine months were $45.0
million compared to $42.3
million for the same period in the previous year.
- Research and development expenses for the third quarter of 2014
were $19.9 million, compared to $25.7
million for the third quarter of 2013. The decrease was
primarily due to the inclusion in this quarter of manufacturing
expenses in cost of product sales instead of research and
development expenses as in the prior period last year.
- Selling, general and administrative expenses for the third
quarter of 2014 were $8.6 million, compared to $8.1 million for the third quarter of 2013. The
increase was mainly due to an increase in patent expenses.
- The net loss for the third quarter of 2014 was $20.3
million, or $0.16 per share, compared to a net loss for
the third quarter of 2013 of $19.3 million, or $0.17 per
share. The net loss for the nine months to date totaled
$63.1 million, or $0.52 per share, compared to a net loss of
$61.5 million, or $0.55 per share, for the first nine months of
2013.
- Cash, cash equivalents and marketable securities
were $134.5 million at September 30, 2014, compared to
$147.6 million at June 30, 2014. Net cash used in the third quarter
of 2014 was approximately $13.1 million.
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call
today, November 10, 2014 at
4:30 p.m. EDT/1:30 p.m. PDT. During the call, management will
discuss the financial results for the third quarter of 2014 and
provide a business update. To listen to the live webcast please
visit the "Investors" section of Halozyme's corporate website at
www.halozyme.com. A webcast replay will be available shortly after
the call at the same address. To participate by phone, please dial
(866) 710-0179 (domestic callers) or (334) 323-7224 (international
callers) using passcode 769890. A telephone replay will be
available shortly after the call by dialing (877) 919-4059
(domestic callers) or (334) 323-0140 (international callers) using
replay ID number 45298549.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company
dedicated to developing and commercializing innovative products
that advance patient care. With a diversified portfolio of enzymes
that target the extracellular matrix, the company's research
focuses primarily on a family of human enzymes, known as
hyaluronidases, which increase the dispersion and absorption of
biologics, drugs and fluids. Halozyme's pipeline addresses
therapeutic areas, including oncology, diabetes and dermatology
that have significant unmet medical need today. The company markets
Hylenex® recombinant (hyaluronidase human
injection) and has partnerships with Roche, Pfizer and
Baxter. Halozyme is headquartered
in San Diego. For more information on how we are
innovating, please visit our corporate website at
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 enrollment of patients in Study 202 for PEGPH20, the
development and commercialization of product candidates including
planned clinical trials, the potential benefits and attributes of
such product candidates, gaining clarity as to the regulatory
pathway for updating the Hylenex® label for
use in Type 1 diabetes, entering into new collaborations and
potential royalty revenue from products from collaborations) 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 from collaborators, unexpected
results or delays in development 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 10, 2014.
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
$ 9,617
|
|
$
10,025
|
|
$ 27,679
|
|
$ 14,634
|
|
Royalties
|
2,895
|
|
-
|
|
5,382
|
|
-
|
|
Revenues under
collaborative agreements
|
2,094
|
|
5,988
|
|
11,896
|
|
27,667
|
|
|
Total
revenues
|
14,606
|
|
16,013
|
|
44,957
|
|
42,301
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
5,141
|
|
683
|
|
16,585
|
|
2,706
|
|
Research and
development
|
19,904
|
|
25,689
|
|
59,968
|
|
75,714
|
|
Selling, general and
administrative
|
8,587
|
|
8,135
|
|
27,589
|
|
22,991
|
|
|
Total operating
expenses
|
33,632
|
|
34,507
|
|
104,142
|
|
101,411
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(19,026)
|
|
(18,494)
|
|
(59,185)
|
|
(59,110)
|
|
|
|
|
|
|
|
|
|
|
Investment and other
income, net
|
122
|
|
52
|
|
287
|
|
165
|
Interest
expense
|
(1,376)
|
|
(850)
|
|
(4,203)
|
|
(2,547)
|
Net Loss
|
$ (20,280)
|
|
$
(19,292)
|
|
$ (63,101)
|
|
$ (61,492)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.16)
|
|
$
(0.17)
|
|
$ (0.52)
|
|
$ (0.55)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per
share
|
124,041
|
|
112,765
|
|
122,157
|
|
112,554
|
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2014
|
|
2013
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
46,375
|
|
$
27,357
|
|
Marketable
securities, available-for-sale
|
88,089
|
|
44,146
|
|
Accounts receivable,
net
|
8,275
|
|
9,097
|
|
Inventories
|
6,916
|
|
6,170
|
|
Prepaid expenses and
other assets
|
8,945
|
|
8,425
|
|
|
Total current
assets
|
158,600
|
|
95,195
|
Property and
equipment, net
|
3,249
|
|
3,422
|
Prepaid expenses and
other assets
|
2,277
|
|
2,676
|
Restricted
cash
|
500
|
|
500
|
|
|
Total
Assets
|
$
164,626
|
|
$
101,793
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
4,342
|
|
$
3,135
|
|
Accrued
expenses
|
15,023
|
|
14,369
|
|
Deferred revenue,
current portion
|
5,153
|
|
7,398
|
|
Current portion of
long-term debt, net
|
10,075
|
|
-
|
|
|
Total current
liabilities
|
34,593
|
|
24,902
|
Deferred revenue, net
of current portion
|
47,572
|
|
45,745
|
Long-term debt,
net
|
39,762
|
|
49,772
|
Other long-term
liabilities
|
2,759
|
|
1,364
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
125
|
|
115
|
|
Additional paid-in
capital
|
485,014
|
|
361,930
|
|
Accumulated other
comprehensive (loss) income
|
(46)
|
|
17
|
|
Accumulated
deficit
|
(445,153)
|
|
(382,052)
|
|
|
Total stockholders'
equity (deficit)
|
39,940
|
|
(19,990)
|
|
|
Total Liabilities and
Stockholders' Equity (Deficit)
|
$
164,626
|
|
$
101,793
|
|
|
|
|
|
|
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath
Francis
212-301-7182
sfrancis@w2ogroup.com
Logo -
http://photos.prnewswire.com/prnh/20100302/LA63139LOGO
SOURCE Halozyme Therapeutics, Inc.