News Release
ZymoGenetics Reports Third Quarter 2009 Financial Results
November 5, 2009
Increased revenues and reduced expenses drive substantial improvement in
quarterly net loss
RECOTHROM sales increase to $8.5 million compared to $1.8 million a year
earlier
SEATTLE--(BUSINESS WIRE)--Nov. 5, 2009--
ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported improved financial
results for the third quarter ended September 30, 2009. The company’s
net loss for the quarter declined substantially to $11.4 million, or
$0.17 per share, from $28.8 million, or $0.42 per share, for the third
quarter of 2008. Revenues for the third quarter of 2009 increased by
131% compared to the third quarter of 2008 as a result of increased
sales of RECOTHROM® Thrombin, topical (Recombinant) and
higher collaboration and license revenues. Expenses for the third
quarter of 2009 decreased by 20% from the third quarter of 2008 largely
as a result of the company’s cost reduction efforts.
“The company is making important strides, both financially and
operationally,” said Douglas E. Williams, Ph.D., Chief Executive Officer
of ZymoGenetics. “RECOTHROM sales trends continue to improve. We
presented final Phase 1b clinical trial results for PEG-Interferon
lambda with positive results for tolerability and antiviral activity,
and the Phase 2 clinical trial is underway, triggering a $70.0 million
milestone payment from our partner Bristol-Myers Squibb.”
Financial Results
RECOTHROM net sales were $8.5 million for the third quarter of 2009
compared to $1.8 million for the third quarter of 2008. The product
continues to gain market share and as of the end of the quarter,
RECOTHROM had an estimated 15% share of the U.S. topical thrombin market
as of September 2009. In the third quarter of 2009, RECOTHROM hospital
unit demand increased approximately 25% from the second quarter of 2009.
Collaboration and license revenues were $18.5 million for the third
quarter of 2009 compared to $8.5 million for the third quarter of 2008.
The primary reason for the increase was incremental revenues from the
PEG-Interferon lambda collaboration with Bristol-Myers Squibb. This
increase was partially offset by reduced revenues from our RECOTHROM
collaboration with Bayer HealthCare.
Research and development expenses for the third quarter of 2009 were
$21.3 million, a decrease of $8.9 million from the third quarter of
2008. The decrease was primarily the result of the elimination of
atacicept co-development collaboration costs and overall reduced
headcount in research and development. These reductions were partially
offset by increased costs related to the PEG-Interferon lambda
collaboration with Bristol-Myers Squibb.
Selling, general and administrative expenses were $13.7 million for the
third quarter of 2009 compared to $15.0 million in the third quarter of
2008. The decrease primarily resulted from reduced personnel-related
costs, stock compensation and legal costs, partially offset by higher
selling commissions payable to Bayer resulting from increased RECOTHROM
net sales.
Net other expense totaled $2.5 million for the third quarter of 2009
compared to $5.3 million of net other income for the third quarter of
2008. In the third quarter of 2008, the company recorded a $7.1 million
gain related to the sale of vacant land next to its corporate
headquarters. The remainder of the difference is largely due to interest
expense on the $25.0 million outstanding under the Deerfield Management
debt facility, which was drawn in November 2008 and must be repaid by
June 2013.
As of September 30, 2009, the company had $103.4 million of cash, cash
equivalents and short-term investments. This amount does not include the
$70.0 million milestone expected to be received this month from
Bristol-Myers Squibb related to the initiation of the PEG-Interferon
lambda Phase 2 clinical trial.
Business Highlights
ZymoGenetics recent business highlights included the following.
PEG-Interferon lambda
Final Phase 1b results were presented at the American Association for
the Study of the Liver Diseases annual meeting on November 3, 2009. The
dose-ranging clinical trial evaluated PEG-Interferon lambda as a single
agent and with ribavirin in relapsed and treatment naïve patients with
hepatitis C. The results indicated that four week treatment with
PEG-Interferon lambda and ribavirin was well tolerated with significant
antiviral activity at all dose levels tested. The company is developing
PEG-Interferon lambda in collaboration with Bristol-Myers Squibb. On
October 26, 2009, a Phase 2 study in treatment naïve patients was
initiated, triggering a $70.0 million milestone payment from
Bristol-Myers Squibb payable within 30 days.
RECOTHROM
RECOTHROM sales continued to increase in the third quarter. Hospital
demand increased by approximately 25% in the third quarter of 2009
compared to the second quarter of 2009.
Interleukin-21 (IL-21)
In August 2009, the company completed enrollment in the Phase 2 study in
metastatic melanoma. The single-agent study is evaluating IL-21 in
patients with no prior systemic therapy for metastatic melanoma. The
company continues to anticipate progression-free survival and overall
survival results to be available in early 2010.
Conference Call and Webcast Information
ZymoGenetics Third Quarter 2009 Financial Results Conference Call will
be held on Thursday, November 5, 2009 at 4:30 p.m. Eastern Time and may
be accessed at www.zymogenetics.com
or by dialing 877-407-0778 (International: 201-689-8565). Participants
should dial in to the call approximately 10 minutes prior to the
scheduled start time to register. A live audio webcast and slide
presentation can be accessed by going to: www.zymogenetics.com.
The webcast will be archived for 60 days.
For replay, please visit www.zymogenetics.com
or use the following information:
-
U.S. callers: 877-660-6853
-
International callers: 201-612-7415
Replay passcode account #: 286
Conference ID #: 334609
About ZymoGenetics
ZymoGenetics is focused on the creation of novel protein drugs to
improve patient care and address unmet medical needs. The company’s
strategy is to discover, develop and commercialize its products
independently, in collaboration with partner companies or through
out-licensing. ZymoGenetics developed and markets RECOTHROM®
Thrombin, topical (Recombinant), a synthetic version of a human
blood-clotting enzyme used to stop bleeding during surgery. The company
is developing a proprietary portfolio of immune-based product
candidates. PEG-Interferon lambda is a novel type-3 interferon in
clinical development for the treatment of chronic hepatitis C infection.
Interleukin-21 is a novel cytokine in clinical development for the
treatment of metastatic melanoma and renal cell carcinoma. Several other
proprietary product candidates are in preclinical development. In
addition, ZymoGenetics has licensed rights to multiple clinical and
preclinical drug candidates being developed by other companies. For
further information, visit www.zymogenetics.com.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to, those related to the
Company’s results of operations and expenses, RECOTHROM sales and
commercialization efforts, milestone payments in connection with
PEG-Interferon lambda development, the Company’s clinical development
programs and the timing and potential benefits thereof and the
ability of ZymoGenetics to successfully partner with third parties to
assist with development and commercialization efforts. These
forward-looking statements are based on the current intent and
expectations of the management of ZymoGenetics. These statements are not
guarantees of future performance and involve risks and uncertainties
that are difficult to predict and that could cause actual results and
the timing and outcome of events to differ materially from those
expressed in or implied by the forward-looking statements. These
risks include, but are not limited to, risks associated with the
Company’s unproven product sales and marketing, manufacturing and
commercialization capabilities, the risk that the Company is not able to
establish, maintain or derive anticipated benefits from strategic
partnerships and collaborations, the risk that the Company’s
revenues generated are smaller than anticipated and that its expenses
and cash needs are greater than anticipated, the risk that the Company
is unable to advance its clinical programs and regulatory applications
and action at the rate it expects or at all, the risk that milestone
payments under partnering or collaboration agreements are not earned
when expected or at all and other risks detailed in the Company's Annual
Report on Form 10-K for the year ended December 31, 2008 and from time
to time in other reports filed by ZymoGenetics with the U.S. Securities
and Exchange Commission. ZymoGenetics undertakes no obligation to update
any forward-looking or other statements in this press release, whether
as a result of new information, future events or otherwise.
RECOTHROM® Thrombin, topical (Recombinant) is a registered
trademark of ZymoGenetics, Inc.
|
ZYMOGENETICS, INC.
|
|
STATEMENTS OF OPERATIONS
|
|
(in thousands, except per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
2009
|
|
|
|
2008
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product sales, net
|
|
$
|
8,492
|
|
|
$
|
1,758
|
|
|
$
|
18,999
|
|
|
$
|
4,129
|
|
|
Royalties
|
|
|
420
|
|
|
|
1,598
|
|
|
|
1,036
|
|
|
|
4,832
|
|
|
Collaborations and licenses
|
|
|
18,544
|
|
|
|
8,520
|
|
|
|
54,838
|
|
|
|
29,009
|
|
|
Total revenues
|
|
27,456
|
|
|
|
11,876
|
|
|
|
74,873
|
|
|
|
37,970
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
Costs of product sales
|
|
1,722
|
|
|
|
695
|
|
|
|
4,101
|
|
|
|
994
|
|
|
Research and development
|
|
21,349
|
|
|
|
30,216
|
|
|
|
75,223
|
|
|
|
102,524
|
|
|
Selling, general and administrative
|
|
13,658
|
|
|
|
15,038
|
|
|
|
45,398
|
|
|
|
45,620
|
|
|
Total costs and expenses
|
|
36,729
|
|
|
|
45,949
|
|
|
|
124,722
|
|
|
|
149,138
|
|
|
Loss from operations
|
|
|
(9,273
|
)
|
|
|
(34,073
|
)
|
|
|
(49,849
|
)
|
|
|
(111,168
|
)
|
|
Other (expense) income, net
|
|
(2,534
|
)
|
|
|
5,283
|
|
|
|
(7,064
|
)
|
|
|
4,103
|
|
|
Net loss before income tax benefit
|
|
(11,807
|
)
|
|
|
(28,790
|
)
|
|
|
(56,913
|
)
|
|
|
(107,065
|
)
|
|
Income tax benefit
|
|
363
|
|
|
|
--
|
|
|
|
363
|
|
|
|
--
|
|
|
Net loss
|
$
|
(11,444
|
)
|
|
$
|
(28,790
|
)
|
|
$
|
(56,550
|
)
|
|
$
|
(107,065
|
)
|
|
Basic and diluted net loss per share
|
$
|
(0.17
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(1.56
|
)
|
|
Weighted-average number of shares used in
|
|
|
|
|
|
|
|
|
computing net loss per share
|
|
69,073
|
|
|
|
68,724
|
|
|
|
68,993
|
|
|
|
68,632
|
|
|
|
|
BALANCE SHEETS
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
103,366
|
|
|
$
|
89,887
|
|
Inventory
|
|
|
57,081
|
|
|
|
28,241
|
|
Other current assets
|
|
|
12,089
|
|
|
|
14,828
|
|
Property and equipment, net
|
|
|
59,651
|
|
|
|
63,676
|
|
Deferred financing costs, net
|
|
|
5,541
|
|
|
|
6,726
|
|
Other assets
|
|
|
5,663
|
|
|
|
6,688
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
243,391
|
|
|
$
|
210,046
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
113,138
|
|
|
$
|
56,968
|
|
Lease obligations
|
|
|
66,918
|
|
|
|
67,366
|
|
Debt obligation
|
|
|
25,000
|
|
|
|
25,000
|
|
Collaboration obligation
|
|
|
26,900
|
|
|
|
---
|
|
Other long-term liabilities
|
|
|
33,196
|
|
|
|
37,353
|
|
Shareholders’ (deficit) equity
|
|
|
(21,761
|
)
|
|
|
23,359
|
|
|
|
|
|
|
|
Total liabilities and shareholders’ equity
|
|
$
|
243,391
|
|
|
$
|
210,046
|
Source: ZymoGenetics, Inc.
Investor and Media Contact
ZymoGenetics,
Inc.
Susan Specht
Director, Corporate Communications
206-442-6592
*****************************************
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.