News Release
ZymoGenetics Reports Fourth Quarter and Year End 2008 Financial Results
February 11, 2009
- Increased Product Sales, License and Collaboration Revenues -
SEATTLE--(BUSINESS
WIRE)--Feb. 11, 2009-- ZymoGenetics,
Inc. (NASDAQ:ZGEN) today reported its financial results for the fourth
quarter and year ended December 31, 2008. For the fourth quarter,
the company's net loss declined to $9.2 million, or $0.13
per share, from $38.6 million, or $0.56 per share,
for the prior year period. For full year 2008, the company reported a net loss
of $116.2 million, or $1.69 per share, compared
to a net loss of $148.1 million, or $2.17 per
share, for the prior year. The decreased losses for the quarter and the year
resulted from increases in revenues as well as decreased research and development
expenses.
As of December 31, 2008, the company had $89.9 million
of cash, cash equivalents and short-term investments. The company's cash position
will be strengthened through amounts expected to be received from Bristol-Myers
Squibb under the recently announced PEG-Interferon lambda collaboration.
More specifically, $105.0 million is expected to be received
this quarter, after completion of United States Federal Trade Commission
review, and an additional $95.0 million in milestone payments
will be due related to the start of Phase 2 clinical testing for PEG-Interferon
lambda, which is expected later this year. The company also has a funding arrangement
with Deerfield Management that allows the company to borrow up to an additional
$75.0 million through January 2010, with repayment
of outstanding amounts in June 2013.
"We achieved many significant milestones in 2008, including the approval of
RECOTHROM(R) and the encouraging early PEG-Interferon lambda clinical
trial results in Hepatitis C that led to our strategically important collaboration
with Bristol-Myers Squibb," said Douglas E. Williams, Ph.D., Chief Executive
Officer of ZymoGenetics.
"We expect another year of important progress in 2009, continuing to build the
sales of RECOTHROM, advancing PEG-Interferon lambda into Phase 2, working to
execute additional partnering transactions, and continuing to optimize the company's
cost structure to achieve our long-term financial objectives."
Business Highlights
During the fourth quarter of 2008 and in early 2009, ZymoGenetics
made significant progress in executing its business plan, including the following
highlights:
RECOTHROM(R) Thrombin, topical (Recombinant)
Sales momentum in fourth quarter 2008 was enhanced by the adoption of a more
competitive pricing structure in October. Based on the resulting increased level
of purchase commitments received, this momentum is expected to carry into 2009.
Data from a Phase 3b study was presented at the American Society of Hematology
annual meeting in December providing further support regarding the safety and
immunogenicity profile of RECOTHROM in patients who are likely to have had prior
exposure to bovine thrombin. The company's partner, Bayer Healthcare,
filed for regulatory approval in Canada
in November 2008 and continued to work toward gaining approval
in the EU based on its August 2008 Marketing Authorization Application
filing.
PEG-Interferon lambda
In early January 2009, a global collaboration with Bristol-Myers
Squibb was completed, which will provide the company with substantial
funding, establish a co-development program in the US and the EU and a co-commercialization
relationship in the US, and provide for development and commercialization by
Bristol-Myers Squibb in the rest of the world. This transaction was
enabled by progress in a Phase 1b study in subjects chronically infected with
hepatitis C. Data from the first three cohorts in the study using single agent
PEG-Interferon lambda were presented at the annual meeting of the American
Association for the Study of Liver Diseases in November 2008,
which showed robust anti-viral activity without evidence of the tolerability
issues which are generally associated with other interferons.
Interleukin-21 (IL-21)
In October 2008, interim data from a Phase 2 renal cell carcinoma
study was presented at the EORTC-NCI-AACR Symposium on Molecular Targets and
Cancer Therapeutics, demonstrating favorable tumor response and disease
control rates when IL-21 is administered in combination with Nexavar(R)
(sorafenib) tablets. Enrollment continued in the single agent Phase 2
melanoma study toward the goal of completing enrollment in 2009. In January
2009, the company announced that it acquired the rights to IL-21 outside
North America from Novo
Nordisk, which had previously announced the discontinuation of its oncology
programs, giving ZymoGenetics
worldwide rights.
Financial
The company received $21.0 million in November 2008
from Bristol-Myers Squibb after entering into a nonexclusive license
agreement under the company's patents on Ig fusion proteins, which is unrelated
to the PEG-Interferon lambda collaboration. In November, the first $25.0
million was drawn on the company's $100.0 million funding
arrangement with Deerfield Management.
Executive Management
In accordance with the company's succession plan, Douglas E. Williams,
Ph.D., former President and Chief Scientific Officer, was promoted to the position
of CEO, effective January 2, 2009. At that time, Bruce L.A. Carter,
Ph.D. retired from the CEO position, and he continues to serve as Chairman of
the Board of Directors in a non-executive capacity. Dr. Williams also was appointed
to the Board of Directors in January 2009. In addition, Stephen
W. Zaruby was hired as President.
Financial Results
Revenues for full year 2008 were $74.0 million compared to
$38.5 million for the prior year. For fourth quarter 2008, revenues
were $36.0 million compared to $20.5 million for
fourth quarter 2007. The annual and fourth quarter increases were primarily
due to increased collaboration and license revenues and sales of RECOTHROM in
the United States, which
began in January 2008 following FDA approval.
RECOTHROM net sales were $8.8 million for full year 2008 and
$4.7 million for fourth quarter 2008. Fourth quarter net sales
increased 164% compared to net sales in the third quarter; however, fourth quarter
sales included incremental wholesaler inventory build of approximately $0.8
million.
Collaboration and license revenues were $58.9 million for full
year 2008 and $29.9 million for fourth quarter 2008 compared
to $32.2 million and $19.3 million, respectively,
for the same periods in 2007. For the full year, the increase was primarily
attributable to a nonexclusive license of the company's Ig fusion patents to
Bristol-Myers Squibb for $21.0 million and $11.8
million of increased revenue from the Bayer license and collaboration
related to RECOTHROM, the effects of which were partially offset by reduced
milestone revenue. For the fourth quarter, the increase was due to the license
of the Ig fusion patents partially offset by reduced milestone revenue.
Cost of product sales include only the manufacturing, packaging and distribution
costs for RECOTHROM that were incurred subsequent to the initial FDA
approval in January 2008. All costs of manufacturing RECOTHROM
that were incurred prior to the initial FDA approval were expensed
to research and development as incurred. In fourth quarter 2008, in addition
to costs related to product sold in the quarter, a provision of $3.8
million was recorded for inventory that is projected to become obsolete.
Research and development expenses for full year 2008 were $126.7 million
compared to $142.3 million in 2007, and for fourth quarter 2008,
these expenses were $24.2 million compared to $46.0 million
for the prior year quarter. For full year 2008, the decrease was primarily attributable
to reduced contract manufacturing expenses, as all RECOTHROM manufacturing costs
were recorded as inventory instead of research and development expense subsequent
to FDA approval, and reduced salary and benefit costs resulting from
the company's February 2008 headcount reductions. These decreases
were partially offset by increased atacicept development costs prior to the
restructuring of the Merck Serono co-development relationship at the end of
August 2008. For fourth quarter 2008, the decrease was primarily
due to reduced contract manufacturing costs, reduced salary and benefit costs,
and reduced development costs associated with atacicept.
Selling, general and administrative expenses in 2008 were $60.2 million
for the full year and $14.6 million for the fourth quarter, which
compares to $46.9 million for the prior year and $13.5
million for the prior year fourth quarter. The primary factors driving
these increases were the deployment of the RECOTHROM sales force in the second
half of 2007, marketing costs associated with the RECOTHROM launch in early
2008, and commissions paid to Bayer on U.S. sales of RECOTHROM.
Net other income (expense) in 2008 totaled $2.4 million of
income for the full year and an expense of $1.7 million for the
fourth quarter as compared to $2.6 million and $0.3 million
of income for the 2007 full year and fourth quarter, respectively. The primary
differences for the year were reduced investment income in 2008 due to lower
invested balances and lower rates of return on those invested balances, offset
by a $7.1 million gain on the sale of land which occurred in
third quarter 2008. For fourth quarter 2008, the overall expense resulted from
lower investment income caused by reduced amounts available to invest and lower
rates of return on those investments, as well as increased interest expense
related to the first $25.0 million draw on the Deerfield Management
debt financing in November 2008.
Outlook for 2009
The company's operating plan for 2009 includes the following key business
objectives:
RECOTHROM:
- Continue increased sales momentum from fourth
quarter 2008 to meet or exceed 2009 sales targets.
- Maximize the potential of the existing RECOTHROM
business and pursue strategies for expansion through line extensions, licensing
or co-promotion.
- Provide support to partner, Bayer, to gain
regulatory approvals in Europe,
Canada and other significant
ex-US territories.
PEG-Interferon lambda:
- Pursue appropriate activities to ensure
effective collaboration with Bristol-Myers Squibb.
- Complete ongoing Phase 1b clinical trial
in relapsed hepatitis C patients.
- Extend Phase 1b testing to include treatment-naïve
hepatitis C patients.
- Initiate Phase 2 clinical trial to drive
product registration pathway.
IL-21:
- Present data from completed Phase 2 renal
cell carcinoma clinical trial in combination with Nexavar.
- Complete enrollment in Phase 2 metastatic
melanoma clinical trial and present results.
- Initiate partnering discussions to facilitate
late-stage clinical development and commercialization.
Preclinical Pipeline:
- Complete at least one partnering transaction
to support advancement of pipeline into clinical development.
In addition, we expect several important developments in 2009 related to assets
previously licensed to third parties:
- Results of Phase 2 atacicept clinical trial
in rheumatoid arthritis (Merck Serono).
- Initiation of Phase 2 recombinant Factor
XIII clinical trial in cardiac surgery (Novo Nordisk).
- Results of pivotal study of Augment Bone
Graft in foot and ankle fusions (BioMimetic Therapeutics).
2009 Financial Expectations
The company expects to continue the trend of lower net losses in 2009, driven
largely by increased net sales of RECOTHROM and higher collaboration and license
revenues. The following specific guidance for 2009 is based on many assumptions,
including that the global economic situation will not result in significant
deterioration in the company's current business prospects.
- Net RECOTHROM sales are expected to be in
the range of $25-35 million.
- Revenues from collaborations, licenses and
royalties are expected to be in the range of $95-105 million,
which include approximately $50-60 million of anticipated revenue
from the recently announced collaboration arrangement with Bristol-Myers
Squibb.
- Costs of product sales is expected to be
approximately 20-22% of net sales, which reflects a lower percentage than
is expected over the long term due to the expensing of RECOTHROM inventory
costs to research and development prior to FDA approval.
- Research and development expense is expected
to be comparable to that of 2008, at approximately $115-125 million,
with most of the savings from the discontinuation of atacicept cost-sharing
being offset by increased PEG-Interferon lambda development expenses.
- Selling, general and administrative expense
is expected to increase slightly to approximately $60-65 million.
- Projected expenses include noncash stock-based
compensation expense of approximately $16 million, of which
approximately two-thirds is classified as research and development and the
remainder as selling, general and administrative expense.
- Net loss is expected to be in the range
of $55-75 million, or $0.80-1.09 per share.
The company expects to generate positive net cash flow in 2009 due to the
receipt of license fees and milestone payments under the Bristol-Myers
Squibb collaboration totaling $200.0 million. Of this amount,
$105.0 million is guaranteed upon antitrust clearance by the
United States Federal Trade Commission and Department of Justice,
and $95.0 million is receivable as milestone payments related
to Phase 2 clinical testing, currently expected to start in the second half
of the year. The company expects to end 2009 with approximately $120
-140 million of cash and investments. This estimate does not reflect
any further borrowings under the company's Deerfield line of credit; however,
the company has the ability to borrow up to an additional $75.0 million.
All of the preceding financial guidance reflects the company's current cost
structure and revenues only from existing collaborations. It is the company's
intention to complete one or more additional partnering transactions in 2009,
and to further optimize its operating cost structure, which could result in
increased revenues and/or reduced operating expenses.
Conference Call and Webcast Information
ZymoGenetics' Fourth Quarter and Year-End 2008 Financial Results Conference
Call will be held on February 11, 2009 at 4:30 p.m. Eastern Time
and may be accessed at www.zymogenetics.com
or by dialing 1-201-689-8566 (International: 1-201-689-8565). 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: 1-877-660-6853
- International callers: 1-201-612-7415
Replay passcode account #: 286
Conference ID #: 310760
About ZymoGenetics
ZymoGenetics discovers
and develops novel protein therapeutics that are based on the company's research
and biological insights into key disease pathways. The company developed and
markets RECOTHROM(R) Thrombin, topical (Recombinant), which is
the first recombinant, plasma-free thrombin. Other product candidates span a
wide array of clinical opportunities that include cancer, autoimmune and viral
diseases. ZymoGenetics
intends to commercialize product candidates through internal development, collaborations
with partners, and out-licensing of patents from its extensive patent portfolio.
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 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. ZymoGenetics' actual results and the timing and
outcome of events may differ materially from those expressed in or implied by
the forward-looking statements because of risks associated with our unproven
product sales and marketing, manufacturing and commercialization capabilities,
strategic partnering activities, product safety, clinical trials and results,
regulatory oversight, intellectual property claims and litigation, the global
economic situation and other risks detailed in the company's public filings
with the Securities and Exchange Commission, including the company's
most recent Annual Report on Form 10-K for the year ended December 31,
2007 and Quarterly Reports on Form 10-Q. Except as required by law,
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.
Nexavar(R)(sorafenib) tablets is a registered trademark of Bayer
HealthCare Pharmaceuticals, Inc.
|
ZYMOGENETICS, INC. |
|
STATEMENTS OF OPERATIONS |
|
(in thousands, except per share amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
|
|
|
|
December 31, |
|
December 31, |
| |
|
|
|
|
|
2008 |
|
|
|
2007 |
|
|
|
2008 |
|
|
|
2007 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
4,650 |
|
|
$ |
- |
|
|
$ |
8,779 |
|
|
$ |
- |
|
|
Royalties |
|
|
1,459 |
|
|
|
1,245 |
|
|
|
6,290 |
|
|
|
6,259 |
|
|
Collaborations and licenses |
|
|
29,910 |
|
|
|
19,280 |
|
|
|
58,920 |
|
|
|
32,218 |
|
|
Total revenues |
|
|
36,019 |
|
|
|
20,525 |
|
|
|
73,989 |
|
|
|
38,477 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
Costs of product sales |
|
|
4,678 |
|
|
|
- |
|
|
|
5,672 |
|
|
|
- |
|
|
Research and development |
|
|
24,154 |
|
|
|
45,987 |
|
|
|
126,678 |
|
|
|
142,340 |
|
|
Selling, general and administrative |
|
|
14,618 |
|
|
|
13,454 |
|
|
|
60,238 |
|
|
|
46,890 |
|
|
Total costs and expenses |
|
|
43,450 |
|
|
|
59,441 |
|
|
|
192,588 |
|
|
|
189,230 |
|
|
Loss from operations |
|
|
(7,431 |
) |
|
|
(38,916 |
) |
|
|
(118,599 |
) |
|
|
(150,753 |
) |
|
Other (expense) income, net |
|
|
(1,745 |
) |
|
|
349 |
|
|
|
2,358 |
|
|
|
2,609 |
|
|
Net loss |
|
$ |
(9,176 |
) |
|
$ |
(38,567 |
) |
|
$ |
(116,241 |
) |
|
$ |
(148,144 |
) |
|
Basic and diluted net loss per share |
|
$ |
(0.13 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.69 |
) |
|
$ |
(2.17 |
) |
|
Weighted-average number of shares used
in computing net loss per share |
|
|
68,734 |
|
|
|
68,507 |
|
|
|
68,696 |
|
|
|
68,156 |
|
|
BALANCE SHEETS |
|
(in thousands)
(unaudited) |
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2008 |
|
2007 |
| |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
89,887 |
|
$ |
170,941 |
|
Inventory |
|
|
28,241 |
|
|
- |
|
Other current assets |
|
|
14,828 |
|
|
11,841 |
|
Property and equipment, net |
|
|
63,676 |
|
|
70,701 |
|
Deferred financing costs, net |
|
|
6,726 |
|
|
- |
|
Other assets |
|
|
6,688 |
|
|
9,598 |
|
Total assets |
|
$ |
210,046 |
|
$ |
263,081 |
| |
|
|
|
|
|
|
Current liabilities |
|
$ |
56,968 |
|
$ |
63,960 |
|
Lease obligations |
|
|
67,366 |
|
|
67,044 |
|
Debt obligations |
|
|
25,000 |
|
|
- |
|
Other long-term liabilities |
|
|
37,353 |
|
|
17,247 |
|
Shareholders' equity |
|
|
23,359 |
|
|
114,830 |
| |
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
210,046 |
|
$ |
263,081 |
Source: ZymoGenetics, Inc.
Investor and Media Relations
ZymoGenetics, Inc.
Director, Corporate Communications
Susan W. Specht, 206-442-6592
or
Associate Director, Corporate Communications
Michael Fitzpatrick, 206-442-6702
*****************************************
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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.