FORM 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For quarterly period ended September 30, 2003 | Commission File Number 0-22962 |
HUMAN GENOME SCIENCES, INC.
Delaware (State of organization) |
22-3178468 (I.R.S. Employer Identification Number) |
14200 Shady Grove Road, Rockville, Maryland 20850-7464
(Address of principal executive offices and zip code)
(301) 309-8504
(Registrants telephone Number)
(Former address 9410 Key West Avenue, Rockville, Maryland 20850-3331)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes X No
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes X No
The number of shares of the registrants common stock outstanding on September 30, 2003 was 129,239,581.
TABLE OF CONTENTS
Page | |||||||
Number | |||||||
PART I |
FINANCIAL INFORMATION |
||||||
Item 1 |
Financial Statements |
||||||
|
Consolidated Statements of Operations for the three and nine months |
||||||
ended September 30, 2003 and 2002 |
3 | ||||||
|
Consolidated Balance Sheets at September 30, 2003 and December 31, 2002 |
4 | |||||
Consolidated Statements of Cash Flows for the nine months |
|||||||
|
ended September 30, 2003 and 2002 |
5 | |||||
Notes to Consolidated Financial Statements |
7 | ||||||
Item 2 |
Management's Discussion and Analysis of |
||||||
Financial Condition and Results of Operations |
12 | ||||||
Item 3 |
Quantitative and Qualitative Disclosures About Market Risk |
17 | |||||
Item 4 |
Controls and Procedures |
18 | |||||
PART II |
OTHER INFORMATION |
||||||
Item 6 |
Exhibits and Reports on Form 8-K |
19 | |||||
|
Signatures |
20 | |||||
Exhibit Index | Exhibit Volume |
2
PART I. FINANCIAL INFORMATION
HUMAN GENOME SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Three months ended | Nine months ended | |||||||||||||||||
September 30, | September 30, | |||||||||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||||||||
(dollars
in thousands, except share and per share amounts) |
||||||||||||||||||
Revenue
research and development collaborative contracts |
$ | 1,242 | $ | 1,642 | $ | 3,526 | $ | 2,926 | ||||||||||
Costs
and expenses: |
||||||||||||||||||
Research
and development |
48,352 | 47,993 | 142,432 | 142,283 | ||||||||||||||
General
and administrative |
10,785 | 10,449 | 30,116 | 34,016 | ||||||||||||||
Total
costs and expenses |
59,137 | 58,442 | 172,548 | 176,299 | ||||||||||||||
Income
(loss) from operations |
(57,895 | ) | (56,800 | ) | (169,022 | ) | (173,373 | ) | ||||||||||
Interest
income |
15,812 | 19,817 | 50,104 | 63,478 | ||||||||||||||
Interest
expense |
(5,605 | ) | (5,932 | ) | (17,479 | ) | (17,818 | ) | ||||||||||
Charge
for impaired investment |
| (32,158 | ) | | (32,158 | ) | ||||||||||||
Income
(loss) before taxes |
(47,688 | ) | (75,073 | ) | (136,397 | ) | (159,871 | ) | ||||||||||
Provision
for income taxes |
| | | | ||||||||||||||
Net
income (loss) |
$ | (47,688 | ) | $ | (75,073 | ) | $ | (136,397 | ) | $ | (159,871 | ) | ||||||
Net
income (loss) per share, basic and diluted |
$ | (0.37 | ) | $ | (0.58 | ) | $ | (1.06 | ) | $ | (1.24 | ) | ||||||
Weighted
average shares outstanding, basic and diluted |
129,186,271 | 128,700,714 | 129,046,364 | 128,523,971 | ||||||||||||||
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.
3
HUMAN GENOME SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
September 30, | December 31, | ||||||||||
2003 | 2002 | ||||||||||
(dollars in thousands, except | |||||||||||
Assets | share and per share amounts) | ||||||||||
Current assets: |
|||||||||||
Cash and cash equivalents |
$ | 10,071 | $ | 25,205 | |||||||
Short-term investments |
1,039,327 | 1,261,183 | |||||||||
Prepaid expenses and other current assets |
4,118 | 10,528 | |||||||||
Total current assets |
1,053,516 | 1,296,916 | |||||||||
Long-term investments |
27,632 | 15,071 | |||||||||
Property, plant and equipment (net of accumulated
depreciation and amortization) |
157,483 | 126,437 | |||||||||
Restricted investments |
266,140 | 205,352 | |||||||||
Other assets |
19,804 | 18,411 | |||||||||
TOTAL ASSETS |
$ | 1,524,575 | $ | 1,662,187 | |||||||
Liabilities and Stockholders Equity |
|||||||||||
Current liabilities: |
|||||||||||
Current portion of long-term debt |
$ | 448 | $ | 448 | |||||||
Current portion of capital lease obligation |
266 | 241 | |||||||||
Accounts payable and accrued expenses |
26,721 | 34,570 | |||||||||
Accrued payroll and related taxes |
10,923 | 7,911 | |||||||||
Deferred revenues |
2,568 | 2,568 | |||||||||
Total current liabilities |
40,926 | 45,738 | |||||||||
Long-term debt, net of current portion |
503,020 | 503,020 | |||||||||
Capital lease obligation, net of current portion |
46 | 261 | |||||||||
Deferred revenues |
8,345 | 10,271 | |||||||||
Other liabilities |
8,427 | 2,344 | |||||||||
Total liabilities |
560,764 | 561,634 | |||||||||
Stockholders equity: |
|||||||||||
Preferred stock |
| | |||||||||
Common stock |
1,292 | 1,289 | |||||||||
Additional paid-in capital |
1,760,666 | 1,757,685 | |||||||||
Unearned portion of compensatory stock options |
| (229 | ) | ||||||||
Accumulated other comprehensive income (loss) |
39,797 | 43,355 | |||||||||
Retained deficit |
(837,944 | ) | (701,547 | ) | |||||||
Total stockholders equity |
963,811 | 1,100,553 | |||||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 1,524,575 | $ | 1,662,187 | |||||||
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.
4
HUMAN GENOME SCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine months ended | |||||||||||
September 30, | |||||||||||
2003 | 2002 | ||||||||||
(dollars in thousands) | |||||||||||
Cash flows from operating activities: |
|||||||||||
Net income (loss) |
$ | (136,397 | ) | $ | (159,871 | ) | |||||
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities: |
|||||||||||
Accrued interest on short-term and restricted investments |
7,066 | 12,050 | |||||||||
Depreciation and amortization |
17,413 | 12,997 | |||||||||
Charge for impaired investment |
| 32,158 | |||||||||
Loss (gain) on disposal of fixed assets |
435 | 314 | |||||||||
Compensation expense related to stock options |
229 | 249 | |||||||||
Changes in operating assets and liabilities: |
|||||||||||
Prepaid expenses and other current assets |
6,410 | (261 | ) | ||||||||
Other assets |
1,149 | 3,580 | |||||||||
Accounts payable and accrued expenses |
(9,413 | ) | 91 | ||||||||
Accrued payroll and related taxes |
3,012 | 2,723 | |||||||||
Deferred revenues |
(1,926 | ) | (1,926 | ) | |||||||
Other liabilities |
189 | 282 | |||||||||
Net cash provided by (used in) operating activities |
(111,833 | ) | (97,614 | ) | |||||||
Cash flows from investing activities: |
|||||||||||
Capital expenditures property, plant and equipment |
(58,982 | ) | (44,889 | ) | |||||||
Proceeds from sale of property, plant and equipment |
15,000 | | |||||||||
Purchase of short-term investments and marketable securities |
(581,380 | ) | (495,897 | ) | |||||||
Proceeds from sales and maturities of investments and marketable securities |
778,911 | 616,135 | |||||||||
Net cash provided by (used in) investing activities |
153,549 | 75,349 | |||||||||
Cash flows from financing activities: |
|||||||||||
Proceeds from sale of restricted investments |
22,247 | | |||||||||
Restricted investments |
(81,891 | ) | (48,652 | ) | |||||||
Payments on capital lease |
(190 | ) | (156 | ) | |||||||
Proceeds from issuance of common stock (net of expenses) |
2,984 | 3,541 | |||||||||
Net cash provided by (used in) financing activities |
(56,850 | ) | (45,267 | ) | |||||||
Net increase (decrease) in cash and cash equivalents |
(15,134 | ) | (67,532 | ) | |||||||
Cash and cash equivalents beginning of period |
25,205 | 88,319 | |||||||||
Cash and cash equivalents end of period |
$ | 10,071 | $ | 20,787 | |||||||
Supplemental disclosures of cash flow information: |
|||||||||||
Cash paid during the period for: |
|||||||||||
Interest |
$ | 21,470 | $ | 21,475 | |||||||
Income taxes |
$ | | $ | |
5
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES (DOLLARS IN THOUSANDS):
In February 2003, the Company tendered its equity interest in Vascular Genetics, Inc. (VGI), a privately-held company, in exchange for approximately an 18% equity interest in Corautus Genetics Inc., a publicly-traded company that resulted from the merger of VGI and GenStar Therapeutics Corporation. As of the date of this exchange, the Company had no carrying value in its equity interest in VGI. Immediately following this transaction, the market value of the Companys investment in Corautus was approximately $5,659.
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.
6
HUMAN GENOME SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Quarter Ended September 30, 2003
Note 1. Interim Financial Statements
The accompanying unaudited consolidated financial statements of Human Genome Sciences, Inc. (the Company) have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. In the opinion of the Companys management, the consolidated financial statements reflect all adjustments necessary to present fairly the results of operations for the three and nine month periods ended September 30, 2003 and 2002, the Companys financial position at September 30, 2003, and the cash flows for the nine month periods ended September 30, 2003 and 2002. These adjustments are of a normal recurring nature.
Certain notes and other information have been condensed or omitted from the interim consolidated financial statements presented in this Quarterly Report on Form 10-Q. Therefore, these financial statements should be read in conjunction with the Companys 2002 Annual Report on Form 10-K and the Companys March 31, 2003 and June 30, 2003 Quarterly Reports on Form 10-Q.
The results of operations for the three and nine month periods ended September 30, 2003 are not necessarily indicative of future financial results.
Note 2. Stock-Based Compensation
In accordance with Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based Compensation Transition and Disclosure (SFAS No. 148), the effect on net loss and net loss per share if the Company had applied the fair value recognition provisions of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No. 123) to stock-based employee compensation is as follows:
Three months ended | Nine
months ended |
||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net
income (loss), as reported |
$ | (47,688 | ) | $ | (75,073 | ) | $ | (136,397 | ) | $ | (159,871 | ) | |||||
Deduct:
Total stock-based employee compensation expense determined under fair
value based method for all awards, net of related tax effects |
(17,024 | ) | (26,877 | ) | (71,436 | ) | (91,304 | ) | |||||||||
Add:
Stock-based non-employee compensation included in included in net income
(loss) |
| 216 | 229 | 249 | |||||||||||||
Pro
forma net income (loss) |
$ | (64,712 | ) | $ | (101,734 | ) | $ | (207,604 | ) | $ | (250,926 | ) | |||||
Net
income (loss) per share: Basic and diluted as reported |
$ | (0.37 | ) | $ | (0.58 | ) | $ | (1.06 | ) | $ | (1.24 | ) | |||||
Basic
and diluted pro forma |
$ | (0.50 | ) | $ | (0.79 | ) | $ | (1.61 | ) | $ | (1.95 | ) |
The effect of applying SFAS No. 123 on the three and nine month periods
ended September 30, 2003 and 2002 pro forma net loss and net loss per share
as stated above, is not necessarily representative of the effects on
reported net loss for future years due to, among other things, (1) the
vesting period of the stock options and (2) the fair value of additional
stock options in future years.
7
HUMAN GENOME SCIENCES, INC. Note 3. Comprehensive Income (Loss)
SFAS No. 130, Reporting Comprehensive Income, requires unrealized gains or
losses on the Companys available-for-sale short-term and restricted
securities, and on the Companys long-term investments in Transgene, S.A.
(Transgene), Cambridge Antibody Technology (CAT), Corautus Genetics Inc.
(Corautus) and Ciphergen Biosystems, Inc. (Ciphergen), along with the
activity for the Companys Foreign Currency Translation Adjustment, to be
included in other comprehensive income.
During the three and nine month periods ended September 30, 2003 and 2002,
total comprehensive income (loss) amounted to:
In September 2002, the Company reduced the carrying value of its investment
in CAT in the amount of $32,158 and reversed the previously-recorded
unrealized loss relating to this investment due to the significant
reduction in market value of CATs shares that the Company believed may not
be temporary. As a result, the Company had an adjusted cost of $13,080 as
determined by the current market value of CATs publicly-traded common
stock and no unrealized loss as of this same date.
Realized gains and losses on securities sold before maturity, which are
included in the Companys net income (loss) for the three and nine month
periods ended September 30, 2003 and 2002, and their respective net
proceeds were as follows:
8
HUMAN GENOME SCIENCES, INC. Note 4. Commitments and Other Matters
The Company leases all of its research and development and administrative
facilities. The Companys primary research and development and
administrative facility, located on the Traville site, is owned by Wachovia
Development Corporation (WDC). As a result of a restructuring of the
lease relating to this site in June 2003, the Company entered into an
approximately seven-year operating lease (the Traville lease) with WDC.
WDC, a wholly-owned subsidiary of Wachovia Corporation, is primarily engaged
in real estate finance, development and leasing activities. The total
projected financed cost of the Traville lease facility is approximately
$200,000. As of September 30, 2003, the total projected financed cost of
the Traville facility relative to WDCs total direct real estate investments
and net real estate lease investments was below the level requiring
consolidation of WDC into the Companys consolidated financial statements.
The construction of the research and development and administrative facility
is on schedule and the facility is expected to be completed by the end of
2003, at which time the rent obligations under the Traville lease will
commence. The Companys rent obligation will approximate the lessors debt
service costs plus a return on the lessors equity investment. The
Companys rent obligation under the Traville lease is floating and is based
primarily on short-term commercial paper, but the lessor can lock in a fixed
interest rate at any time at the Companys request. The floating rate was
approximately 1.1% as of September 30, 2003.
In addition, the Company leases a research facility, located at 9800 Medical
Center Drive (the 9800 MCD lease), as a result of a seven-year lease
entered into in October 2001 with a trust controlled by third parties
established solely for that purpose. As a result of a lease restructuring
in June 2003, the Company continues to operate under this same lease, which
was assigned to the owner of the facility. The total financed cost of the
facility covered under the 9800 MCD lease is approximately $76,000. The
Companys rent obligation began in 2001 and will approximate the lessors
debt service costs. As of September 30, 2003, the lessor had fixed the
interest rate on the total financed cost at a weighted-average interest rate
of approximately 4.3%.
The Companys restricted investments with respect to the Traville lease, the
9800 MCD lease and other leases for the existing process development and
manufacturing facility could reach approximately $295,000, assuming the full
amount committed is used for construction purposes. The Company will be
required to restrict investments equal to 102% of the full amount of the
approximately $200,000 financed project cost for the Traville lease, or
$204,000, by the conclusion of the construction period, and 100% of the full
amount of the approximately $76,000 financed project cost for the 9800 MCD
lease as collateral for the duration of the leases. In addition, the
Company is also required to maintain up to a maximum of $15,000 in
restricted investments with respect to the process development and
manufacturing facility leases. The Companys restricted investments were
$266,140 and $205,352 as of September 30, 2003 and December 31, 2002,
respectively. As of December 31, 2002, restricted investments also included
approximately $21,636 that related to the construction of the Companys
large-scale manufacturing facility. As a result of the lease restructurings
in June 2003, the Company no longer maintains any restricted investments
with respect to this facility.
Under the Traville and 9800 MCD lease agreements, which the Company has
accounted for as operating leases, the Company has the option to purchase
the properties, during or at the end of the lease terms, at an aggregate
amount of approximately $276,000, assuming the full amount of the financings
is used for construction activities. Alternatively, the Company can cause
the properties to be sold to third parties.
9
HUMAN GENOME SCIENCES, INC. Note 4. Commitments and Other Matters (continued)
With respect to the Traville lease, upon completion the Company will have a
residual value guarantee of 87.75% of the total financed cost at lease
termination. In the event of default, the Company is responsible for 100%
of the total financed cost of the project. During the construction period,
except under certain limited circumstances, recourse to the Company is
limited to approximately 89.9% of the financed cost incurred. Because the
lessor is responsible for servicing and repaying the debt financings to
various parties, the Company has made the residual value guarantee to the
lessor. In the event the lessor defaults to the lender, the Company has the
right to cure the default or exercise its option to acquire the property.
At any time during the lease term, the Company has the option to purchase
legal and/or beneficial interest in the project for 100% of the lease
balance plus any unpaid indemnity amounts. As of September 30, 2003,
recourse against the Company for the Traville lease was approximately
$149,574 as compared to the potential maximum guarantee of $175,500,
assuming the full amount of the lease is used for construction activities.
With respect to the 9800 MCD lease, the Company has a residual value
guarantee of 85% of the total financed cost at lease termination. In the
event of default, the Company is responsible for 100% of the total financed
cost of the project. Because the lessor is responsible for servicing and
repaying the debt financings to various parties, the Company has made the
residual value guarantee to the lessor. In the event the lessor defaults to
the lender, the Company has the right to cure the default or exercise its
option to acquire the property. At any time during the lease term, the
Company has the option to purchase legal and/or beneficial interest in the
project for 100% of the lease balance plus any unpaid indemnity amounts. As
of September 30, 2003, the Companys residual value guarantee for the 9800
MCD lease had reached the full maximum amount of $64,600.
In connection with the Traville lease, the Company must maintain minimum
levels of unrestricted cash, cash equivalents and marketable securities and
certain debt ratios. In connection with the 9800 MCD lease, the Company
must maintain minimum levels of unrestricted cash, cash equivalents and
marketable securities, as well as comply with certain dividend restrictions.
In accordance with the provisions of Financial Accounting Standards Board
Interpretation No. 45, Guarantors Accounting and Disclosure Requirements
for Guarantees, Including Indirect Guarantees of Indebtedness of Others
(FIN 45), the Company recorded the estimated fair market value of the
maximum residual value guarantee of the Traville lease during the second
quarter of 2003. The Company estimated the fair market value of the
guarantee as approximately $4,400 and is amortizing this amount on a
straight-line basis over the term of the lease. As of September 30, 2003,
the unamortized amount of approximately $4,200 was recorded within Other
assets and Other liabilities on the Companys consolidated balance sheet.
There are no recourse provisions under either the Traville or 9800 MCD
leases that would enable the Company to recover from third parties any of
the amounts paid under the guarantees. The Company has set aside collateral
in the form of restricted investments sufficient to satisfy all current
obligations under the guarantees. In addition, the Company has the right to
cause the sale of the properties covered by the leases and may recover all
or a portion of the money paid under the guarantees.
10
HUMAN GENOME SCIENCES, INC. Note 5. Fair Value of Financial Instruments
The carrying amounts for the Companys cash and cash equivalents,
investments, other assets, accounts payable and accrued expenses and other
accrued expenses reflected in the consolidated balance sheets at September
30, 2003 and December 31, 2002 approximate their respective fair values.
The carrying value of the Companys debt was approximately $504,000 as of
both September 30, 2003 and December 31, 2002. The fair value of the
Companys long-term debt is based primarily on quoted market prices. The
quoted market prices of the Companys convertible debt increased as of
September 30, 2003 as compared to December 31, 2002, and accordingly, the
fair value of the Companys debt increased to approximately $446,000 as of
September 30, 2003 from $344,000 as of December 31, 2002.
11
MANAGEMENTS DISCUSSION AND ANALYSIS OF Three Month and Nine Month Periods Ended September 30, 2003 and 2002
Overview
Human Genome Sciences goal is to build a global biopharmaceutical company
that discovers, develops, manufactures and markets gene-based drugs to treat
and cure disease. The success of our drug discovery efforts derives from our
expertise in genomics, the systematic collection and understanding of human
genes and their functions, and from our exclusive focus on developing human
protein and antibody drugs. We focus our internal product development efforts
on novel human protein and antibody drugs discovered through genomics-based
research, and on new improved long-acting versions of existing protein drugs
created using our albumin fusion technology.
Ten of our products are in clinical development. Additional products are
in clinical trials by companies with which we are collaborating. We continue
to evaluate new drugs for advancement into clinical development.
We have established strategic partnerships with a number of leading
pharmaceutical and biotechnology companies to leverage our strengths and to
gain access to complementary technologies and sales and marketing
infrastructure. Some of these partnerships provide us with milestone and
royalty payments as products are developed and commercialized. We also are
entitled to certain co-promotion, co-development, revenue sharing and other
product rights.
We have not received any significant product sales revenue or royalties
from product sales and any significant revenue from product sales or from
royalties on product sales in the next several years is uncertain. To date,
all of our revenue relates to payments made under our collaboration agreements
with GlaxoSmithKline and, to a lesser extent, other agreements. The initial
research term associated with the GlaxoSmithKline collaboration agreement and
many of our other collaboration agreements expired in 2001 and the agreements
will only generate additional milestone and royalty payments if our
collaborators successfully develop drugs based on our technology. We may not
receive any of these payments and may not be able to enter into additional
collaboration agreements.
We expect that any significant revenue or income for at least the next
several years may be limited to interest income, payments under various
collaboration agreements to the extent milestones are met, payments from the
sale of product rights and other payments from other collaborators and
licensees under existing or future arrangements, to the extent that we enter
into any future arrangements. We expect to continue to incur substantial
expenses relating to our research and development efforts, as we focus on
preclinical and clinical trials required for the development of therapeutic
protein, antibody and fusion protein product candidates. As a result, we expect
to incur continued and significant losses over the next several years unless we
are able to realize additional revenues under existing or new collaboration
agreements. The timing and amounts of such revenues, if any, cannot be
predicted with certainty and will likely fluctuate sharply. Results of
operations for any period may be unrelated to the results of operations for any
other period. In addition, historical results should not be viewed as
indicative of future operating results.
Results of Operations
Revenues. Revenues were $1.2 million for the three months ended September
30, 2003 compared to revenues of $1.6 million for the three months ended
September 30, 2002. Revenues for the three months ended September 30, 2003
represent $0.6 million in revenue recognized from Transgene, S.A. (Transgene)
and an aggregate of $0.6 million in revenue recognized from Genentech, Inc.
(Genentech) and from MedImmune, Inc. (MedImmune). Revenues for the three
months ended September 30, 2002
12
Results of Operations (continued)
included a $1.0 million milestone payment earned and received from
GlaxoSmithKline (GSK) and $0.6 million in revenue recognized from Transgene.
Revenues were $3.5 million for the nine months ended September 30, 2003
compared to revenues of $2.9 million for the nine months ended September 30,
2002. Revenues for the nine months ended September 30, 2003 represent $1.9
million in revenue recognized from Transgene, a $1.0 million milestone payment
earned and received from GSK and an aggregate of $0.6 million in revenue
recognized from Genentech and from MedImmune. Revenues for the nine months
ended September 30, 2002 represented $1.9 million in revenue recognized from
Transgene and $1.0 million for a milestone payment earned and received from
GSK.
Expenses. Research and development expenses were $48.4 million for the
three months ended September 30, 2003 compared to $48.0 million for the three
months ended September 30, 2002. Research and development expenses were $142.4
million for the nine months ended September 30, 2003 compared to $142.3 million
for the nine months ended September 30, 2002. We track our research and
development expenditures by type of cost incurred discovery, drug
development, manufacturing and clinical development costs.
Our discovery costs decreased to $8.8 million for the three months ended
September 30, 2003 from $12.0 million for the three months ended September 30,
2002. Discovery costs decreased to $25.2 million for the nine months ended
September 30, 2003 from $34.8 million for the nine months ended September 30,
2002. The decrease in discovery costs for both the three and nine month
periods ended September 30, 2003 is primarily due to reduced activity in gene
discovery and in the study of preclinical therapeutic protein drug candidates.
Our drug development costs increased to $14.2 million for the three months
ended September 30, 2003 from $13.0 million for the three months ended
September 30, 2002. Drug development costs increased to $41.4 million for the
nine months ended September 30, 2003 from $40.0 million for the nine months
ended September 30, 2002. The increase in drug development costs for both the
three and nine month periods ended September 30, 2003 is primarily due to
increased process development activity, where we are evaluating ways to develop
or improve our product candidates and production processes.
Our manufacturing costs increased to $14.9 million for the three months
ended September 30, 2003 from $14.1 million for the three months ended
September 30, 2002. Manufacturing costs increased to $46.1 million for the
nine months ended September 30, 2003 from $42.4 million for the nine months
ended September 30, 2002. The increase in manufacturing costs for both the
three and nine month periods ended September 30, 2003 is due to the increased
production activities within our process development and manufacturing
facilities needed to support our increased clinical activities.
Our clinical development costs increased to $10.5 million for the three
months ended September 30, 2003 from $8.9 million for the three months ended
September 30, 2002. Clinical development costs increased to $29.7 million for
the nine months ended September 30, 2003 from $25.1 million for the nine months
ended September 30, 2002. The increase in clinical development costs for both
the three and nine month periods ended September 30, 2003 is primarily due to
the cost of continuing ongoing trials from 2002 as well as initiating new
trials in 2003.
General and administrative expenses slightly increased to $10.8 million
for the three months ended September 30, 2003 from $10.4 million for the three
months ended September 30, 2002. General and administrative expenses decreased
to $30.1 million for the nine months ended September 30, 2003 from $34.0
million for the nine months ended September 30, 2002. The decrease for the
nine months ended September 30, 2003 resulted primarily from lower legal
expenses associated with filing and prosecuting patent applications relating to
genes and proteins we discovered, partially offset by higher facility and other
costs.
13
Results of Operations (continued)
Interest income decreased for both the three and nine month periods ended
September 30, 2003, compared to the three and nine month periods ended
September 30, 2002, due to lower average cash balances as a result of our net
losses in 2003 and 2002 and our capital expenditures during this period, as
well as a reduced yield on our investments. We believe interest income will
continue to be lower than the prior year as our short-term investments mature
and are reinvested at rates lower than previously obtained. Interest expense
decreased for both the three and nine month periods ended September 30, 2003
due to a reduction in our capital lease obligation for 2003 compared to 2002
and due to interest capitalized of $0.3 million for both the three and nine
month periods ended September 30, 2003 relating to the construction of our
large-scale manufacturing facility. Assuming the cost of this facility reaches
approximately $210.0 million by 2005 when construction is complete, capitalized
interest could approximate $7.0 million. Total interest expense, before
capitalized interest, was $5.9 million and $17.8 million for the three and nine
months ended September 30, 2003, respectively.
The charge for impaired investment of $32.2 million for the three and nine
month periods ended September 30, 2002 related to the reduction made to the
carrying value in our equity investment in Cambridge Antibody Technology
(CAT). During the third quarter of 2002, we reduced the carrying value of
this investment to $13.0 million from $45.2 million due to the significant
reduction in market value of CATs shares that we believed may not be
temporary.
Net Income (Loss). We recorded a net loss of $47.7 million, or $0.37 per
share, for the three months ended September 30, 2003 compared to a net loss of
$75.1 million, or $0.58 per share, for the three months ended September 30,
2002. We recorded a net loss of $136.4 million, or $1.06 per share, for the
nine months ended September 30, 2003 compared to a net loss of $159.9 million,
or $1.24 per share, for the nine months ended September 30, 2002. The
decreased loss for the three months ended September 30, 2003 reflects the
absence of a charge for impaired investment, partially offset by reduced net
interest income. The decreased loss for the nine months ended September 30,
2003 reflects the absence of a charge for impaired investment and decreased
general and administrative expenses, partially offset by reduced net interest
income.
Excluding the charge for impaired investment of $32.2 million, or $0.25
per share, incurred in 2002, our net loss of $47.7 million, or $0.37 per share,
for the three months ended September 30, 2003 would have compared to a pro
forma net loss of $42.9 million, or $0.33 per share, for the three months ended
September 30, 2002 with the increased loss primarily due to reduced net interest income.
Excluding the charge for impaired investment of $32.2
million, or $0.25 per share, incurred in 2002, our net loss of $136.4 million,
or $1.06 per share, for the nine months ended September 30, 2003 would have
compared to a pro forma net loss of $127.7 million, or $0.99 per share, for the
nine months ended September 30, 2002 with the increased loss primarily due to reduced net
interest income. These pro forma financial measures are not prepared in
accordance with generally accepted accounting principles (GAAP). We refer to
these non-GAAP financial measures in making operational decisions instead of
net income (loss) because they provide meaningful supplemental information
regarding our operational performance and facilitate comparisons to our
historical operating results.
Liquidity and Capital Resources
We had working capital of $1.01 billion and $1.25 billion at September 30,
2003 and December 31, 2002, respectively. The reduction in our working capital
during the nine months ended September 30, 2003 is primarily due to our net
loss, along with a net increase in our restricted investments and capital
expenditures during this period.
We expect to continue to incur substantial expenses relating to our
research and development efforts, which may increase relative to historical
levels as we focus on development and clinical trials required for the
development of therapeutic protein, antibody and fusion protein product
candidates.
14
Liquidity and Capital Resources (continued)
The amounts of expenditures that will be needed to carry out our business
plan are subject to numerous uncertainties, which may adversely affect our
liquidity and capital resources. We are proceeding with numerous clinical
trials. We have several Phase 1 and Phase 2 trials underway and expect to
initiate additional trials in the future. Completion of these trials may
extend several years or more, but the length of
time generally varies considerably according to the type, complexity, novelty
and intended use of the drug candidate. We estimate that the completion
periods for our Phase 1, Phase 2 and Phase 3 trials could span one year, one to
two years and two to four years, respectively. The duration and cost of our
clinical trials are a function of numerous factors such as the number of
patients to be enrolled in the trial, the amount of time it takes to enroll
them, the length of time they must be treated and observed, and the number of
clinical sites and countries for the trial.
We identify our potential drug candidates by conducting numerous
preclinical studies. We may conduct multiple clinical trials to cover a
variety of indications for each drug candidate. Based upon the results from
our trials, we may elect to discontinue clinical trials for certain indications
or certain drugs in order to concentrate our resources on more promising drug
candidates.
We are advancing many drug candidates, including therapeutic proteins,
antibodies and albumin fusion proteins, in part to diversify the risks
associated with our research and development spending. In addition, our
manufacturing plants have been designed to enable multi-product manufacturing
capability. Accordingly, we believe our future financial commitments,
including those for preclinical, clinical or manufacturing activities, are not
substantially dependent on any single drug candidate. Should we be unable to
sustain a multi-product drug pipeline, our dependence on the success of one or
a few drug candidates would increase.
We must receive FDA clearance to advance each of our products into and
through each phase of clinical testing. Moreover, we must receive FDA
regulatory approval to launch any of our products commercially. In order to
receive such approval, the FDA must conclude that our clinical data establish
safety and efficacy and that our products and the manufacturing facilities meet
all FDA requirements. We cannot be certain that we will establish sufficient
safety and efficacy data to receive regulatory approval for any of our drugs or
that our drugs and the manufacturing facilities will meet all FDA requirements.
In addition, part of our business plan includes collaborating with others.
For example, GSK is developing products discovered by GSK as part of our
collaboration with them. We have no control over the progress of GSKs
development plans. While we have received an aggregate of $2.0 million from
GSK in connection with development milestones met by GSK during 2003 and 2002,
we cannot forecast with any degree of certainty the likelihood of receiving
future milestone or royalty payments. We also cannot forecast with any degree
of certainty whether any of our current or future collaborations will affect
our drug development efforts and therefore, our capital and liquidity
requirements.
Because of the uncertainties discussed above, the costs to advance our
research and development projects are difficult to estimate and may vary
significantly. We expect that our existing funds and interest income will be
sufficient to fund our operations for the next several years.
Our future capital requirements and the adequacy of our available funds
will depend on many factors, including scientific progress in our research and
development programs (including our discovery and development activities), the
magnitude of those programs, the ability to establish collaborative and
licensing arrangements, the cost involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and competing technological and market
developments. There can be no assurance that any additional financing required
in the future will be available on acceptable terms, if at all.
15
Liquidity and Capital Resources (continued)
Depending upon market and interest rate conditions, we are exploring, and,
from time to time, may take actions to strengthen further our financial
position. In this regard, in the second quarter of 2003, we restructured
certain of our outstanding lease obligations and may further modify our lease
financings and repurchase or restructure some or all of our outstanding
convertible debt instruments in the future depending upon market and other
conditions.
Our future liquidity and capital resources will be affected by our
contractual obligations, including two seven-year lease agreements that relate
to a research and development and administrative facility and a second research
facility, either acquired or under construction (the Traville lease and the
9800 MCD lease, respectively). None of our directors, officers or employees
has any financial interest with regard to these lease arrangements.
The Traville lease relates to a research and development and
administrative facility located on the Traville site. The total projected
financed cost of the Traville lease facility is approximately $200.0 million.
The construction of the research and development and administrative facility is
on schedule and the facility is expected to be completed during the second half
of 2003, at which time the rent obligations under the Traville lease will
commence. Our rent obligation will approximate the lessors debt service costs
plus a return on the lessors equity investment. The rent under this lease is
currently based on the rate for short-term commercial paper, but the lessor can
lock in a fixed interest rate at any time at our request. To the extent the
lessor does not lock in a fixed interest rate, if interest rates increase, our
rent obligations would also increase. If interest rates decrease, our rent
obligations would decrease. The current floating rate was approximately 1.1%
as of September 30, 2003.
The 9800 MCD lease relates to a $76.0 million research facility located at
9800 Medical Center Drive, near our Traville facility. We are leasing this
property for seven years. The rent under this lease is fixed. As of September
30, 2003, the weighted-average interest rate was approximately 4.3%.
Our restricted investments with respect to the Traville lease, the 9800
MCD lease and other leases for the existing process development and
manufacturing facility could reach approximately $295.0 million, assuming the
full amount committed is used for construction purposes. We will be required
to restrict investments equal to 102% of the full amount of the approximately
$200.0 million financed project cost for the Traville lease, or $204.0 million,
by the conclusion of the construction period, and 100% of the full amount of
the approximately $76.0 million financed project cost for the 9800 MCD lease as
collateral for the duration of the leases. In addition, we are also required
to maintain up to a maximum of $15.0 million in restricted investments with
respect to the process development and manufacturing facility leases. Our
restricted investments for all of these leases aggregated $266.1 million as of
September 30, 2003 compared to $205.4 million as of December 31, 2002. As of
December 31, 2002, restricted investments also included approximately $21.6
million that related to the construction of the Companys large-scale
manufacturing facility. As a result of the lease restructurings in June 2003,
the Company no longer maintains any restricted investments with respect to this
facility.
Under the Traville and 9800 MCD leases, which we have accounted for as
operating leases, we have the option to purchase the properties during and at
the end of the lease terms at an aggregate amount of approximately $276.0
million. Alternatively, we can cause the properties to be sold to third
parties. We are contingently liable for the residual value guarantee
associated with each property in the event the net sale proceeds are less than
the original financed costs of the facilities. Upon completion of the
facilities covered by these leases, assuming the full amount of the leases is
used for construction activities, we will be contingently liable for the
residual value guarantee associated with each property up to an aggregate
amount of $240.1 million. Of this amount, the residual value guarantee for the
Traville lease and the 9800 MCD lease will be approximately $175.5 million and
$64.6 million, respectively, assuming the full amount of the financings is used
for construction activities.
16
Liquidity and Capital Resources (continued)
Our unrestricted and restricted funds may be invested in U.S. Treasury
securities, government agency obligations, high grade corporate debt securities
and various money market instruments rated A or better. Such investments
reflect our policy regarding the investment of liquid assets, which is to seek
a reasonable rate of return consistent with an emphasis on safety, liquidity
and preservation of capital.
We are constructing a large-scale manufacturing facility that we
anticipate completing by 2005 at a cost of approximately $210.0 million.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
Certain statements contained in Managements Discussion and Analysis of
Financial Condition and Results of Operations are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on our current intent, belief and
expectations. These statements are not guarantees of future performance and
are subject to certain risks and uncertainties that are difficult to predict.
Actual results may differ materially from these forward-looking statements
because of our unproven business model, our dependence on new technologies, the
uncertainty and timing of clinical trials, our ability to develop and
commercialize products, our dependence on collaborators for services and
revenue, our substantial indebtedness and lease obligations, our changing
requirements and costs associated with planned facilities, intense competition,
the uncertainty of patent and intellectual property protection, our dependence
on key management and key suppliers, the uncertainty of regulation of products,
the impact of future alliances or transactions and other risks described in
this filing and our other filings with the Securities and Exchange Commission.
Existing and prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of todays date. We
undertake no obligation to update or revise the information contained in this
announcement whether as a result of new information, future events or
circumstances or otherwise.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We do not have operations of a material nature that are subject to risks
of foreign currency fluctuations, nor do we use derivative financial
instruments in our operations or investment portfolio. Our investment
portfolio may be comprised of low-risk U.S. Treasuries, government agency
obligations, high-grade debt having at least an A rating and various money
market instruments. The short-term nature of these securities, which currently
have an average term of approximately 19 months, significantly decreases the
risk of a material loss caused by a market change. We believe that a
hypothetical 100 basis point adverse move (increase) in interest rates along
the entire interest rate yield curve would adversely affect the fair value of
our cash, cash equivalents and short-term and restricted investments by
approximately $20.4 million, or approximately 1.6% of the aggregate fair value
of $1.32 billion, at September 30, 2003. For these reasons, and because these
securities are generally held to maturity, we believe we do not have
significant exposure to market risks associated with changes in interest rates
related to our debt securities held as of September 30, 2003. We believe that
any market change related to our investment securities held as of September 30,
2003 is not material to our consolidated financial statements. However, given
the short-term nature of these securities, the general decline in interest
rates will adversely affect the interest income from our portfolio as
securities mature and are replaced with securities having a lower interest
rate. As of September 30, 2003, the yield on two-year investments was
approximately 1.5%, as compared to our current portfolio yield of approximately
3.8%.
As of September 30, 2003, the carrying values of our equity investments in
Transgene, CAT, Corautus and Ciphergen were approximately $4.7 million, $11.2
million, $9.1 million and $2.6 million, respectively. Our investments in
Transgene, Corautus and Ciphergen are subject to equity market risk. Our
investment in CAT is denominated in pounds sterling and is subject to both
foreign currency risk as well as equity market risk.
17
Item 3. Quantitative and Qualitative Disclosures About Market Risk (continued)
The facility leases we entered into during 2003 and 2001 require us to
maintain minimum levels of restricted investments as collateral for these
facilities. By 2005, our maximum restricted investments for these leases could
be approximately $280.0 million. Together with the requirement to maintain up
to approximately $15.0 million in restricted investments with respect to our
process development and manufacturing facility leases, our overall level of
restricted investments could reach $295.0 million. Although the market value
for these investments may rise or fall as a result of changes in interest
rates, we will be required to maintain this level of restricted investments in
both a rising or declining interest rate environment.
The rent under the Traville lease is based on a floating interest rate.
We can direct the lessor to lock in a fixed interest rate. As of September 30,
2003, such a fixed rate for seven years would be approximately 3.8% compared to
the floating rate as of September 30, 2003 of approximately 1.1%. If interest
rates increase, our rent obligations would also increase, which would result in
an increase in our operating expenses.
During 2002, we established a wholly-owned subsidiary, Human Genome
Sciences Europe GmbH (HGS Europe), that will manage our clinical trials and
clinical research collaborations in European countries. Although HGS Europes
activities are denominated primarily in euros, we believe the foreign currency
fluctuation risks for 2003 to be immaterial to our operations as a whole.
Item 4. Controls and Procedures
Our management, including our principal executive and principal financial
officers, has evaluated the effectiveness of our disclosure controls and
procedures as of September 30, 2003. Our disclosure controls and procedures
are designed to provide reasonable assurance that the information required to
be disclosed in this Form 10-Q quarterly report has been appropriately
recorded, processed, summarized and reported. Based on that evaluation, our
principal executive and principal financial officers have concluded that our
disclosure controls and procedures are effective at the reasonable assurance
level.
Our management, including our principal executive and principal financial
officers, has evaluated any changes in our internal control over financial
reporting that occurred during the quarterly period ended September 30, 2003,
and has concluded that there was no change that occurred during the quarterly
period ended September 30, 2003 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
18
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
19
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Dated: November 12, 2003
20
EXHIBIT INDEX
Exhibit Page Number
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Quarter Ended September 30, 2003
Three months ended
Nine months ended
September 30,
2003
2002
2003
2002
$
(47,688
)
$
(75,073
)
$
(136,397
)
$
(159,871
)
(8,840
)
15,237
(17,259
)
7,308
4,151
(10,619
)
12,561
(28,612
)
(2,138
)
2,221
1,144
2,165
1
(4
)
(6,826
)
6,839
(3,558
)
(19,139
)
32,158
32,158
$
(54,514
)
$
(36,076
)
$
(139,955
)
$
(146,852
)
Three months ended
Nine months ended
September 30,
September 30,
2003
2002
2003
2002
$
3,866
$
1,399
$
8,396
$
5,907
(910
)
(108
)
(1,326
)
(582
)
328,189
131,013
541,767
415,702
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Quarter Ended September 30, 2003
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Quarter Ended September 30, 2003
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Quarter Ended September 30, 2003
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(a)
Exhibits
31.1
Rule 13a-14(a) Certification
of Principal Executive Officer.
Rule 13a-14(a) Certification
of Principal Financial Officer.
Section 1350 Certification
of Chief Executive Officer.
Section 1350 Certification
of Chief Financial Officer.
(b)
Reports on Form 8-K
We filed a Current Report on Form 8-K, on April 24, 2003,
furnishing our financial results for the three months ended March 31, 2003.
We filed a Current Report on Form 8-K, on July 29, 2003,
furnishing our financial results for the three and six months ended June 30, 2003.
We filed a Current Report on Form 8-K, on October 28, 2003,
furnishing our financial results for the three and nine months ended September 30, 2003.
HUMAN GENOME SCIENCES, INC
BY: /s/ William A. Haseltine, Ph.D.
William A. Haseltine, Ph.D.
Chairman and Chief Executive Officer
BY: /s/ Steven C. Mayer
Steven
C. Mayer
Senior Vice President and
Chief Financial Officer
31.1
Rule 13a-14(a) Certification of Principal Executive Officer.
31.2
Rule 13a-14(a) Certification of Principal Financial Officer.
32.1
Section 1350 Certification of Chief Executive Officer.
32.2
Section 1350 Certification of Chief Financial Officer.