UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

|X| Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended September 30, 2004

OR

|_| Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

For the transition period from _______ to _______.

Commission File Number 000-23186

BIOCRYST PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

DELAWARE

 

62-1413174

(State of other jurisdiction of
incorporation or organization)

 

(I.R.S. employer identification no.)

2190 Parkway Lake Drive; Birmingham, Alabama 35244
(Address of principal executive offices)

(205) 444-4600
(Registrant’s telephone number, including area code)

NONE
(Former name, former address and former fiscal year, if changed since last report)

Indicate by a 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 a check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).  Yes  |_| No  |X|.

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 21,727,564 shares of the Company’s Common Stock, $.01 par value, were outstanding as of October 31, 2004.


BIOCRYST PHARMACEUTICALS, INC.

INDEX

 

Part I.  Financial Information

Page No.

 

 


 

 

2

 

3

 

4

 

5

7

20

21

 

Part II.  Other Information

 

22

22

22

22

22

22

 

24

1


PART I.  FINANCIAL INFORMATION

Item 1.  Financial Statements

BIOCRYST PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
September 30, 2004 and December 31, 200
3
(In thousands, except per share data)

 

 

2004
(Unaudited)

 

2003
(Note 1)

 

 

 


 


 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

13,809

 

$

11,941

 

Securities held-to-maturity

 

 

9,144

 

 

8,087

 

Prepaid expenses and other current assets

 

 

571

 

 

676

 

 

 



 



 

 

Total current assets

 

 

23,524

 

 

20,704

 

Securities held-to-maturity

 

 

11,171

 

 

5,704

 

Furniture and equipment, net

 

 

2,948

 

 

3,508

 

Patents

 

 

242

 

 

179

 

 

 



 



 

 

Total assets

 

$

37,885

 

$

30,095

 

 

 



 



 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Accounts payable

 

$

2,024

 

$

640

 

Accrued expenses

 

 

1,244

 

 

708

 

 

 



 



 

 

Total current liabilities

 

 

3,268

 

 

1,348

 

Deferred revenue

 

 

300

 

 

300

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock:  shares authorized – 5,000

 

 

 

 

 

 

 

 

Series A Convertible Preferred stock, $.01 par value; shares authorized – 1,800; shares issued and outstanding – none

 

 

 

 

 

 

 

 

Series B Junior Participating Preferred Stock, $.001 par value; shares authorized – 21.5; shares issued and outstanding - none

 

 

 

 

 

 

 

 

Common stock, $.01 par value; shares authorized - 45,000; shares issued and outstanding - 21,728 in 2004 and 17,871 in 2003

 

 

217

 

 

179

 

 

Additional paid-in capital

 

 

154,575

 

 

132,928

 

 

Accumulated deficit

 

 

(120,475

)

 

(104,660

)

 

 



 



 

 

Total stockholders’ equity

 

 

34,317

 

 

28,447

 

 

 



 



 

 

Total liabilities and stockholders’ equity

 

$

37,885

 

$

30,095

 

 

 



 



 

See accompanying notes to condensed financial statements.

2


BIOCRYST PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
Periods Ended September 30, 2004 and 200
3
(In thousands, except per share)
(Unaudited)

 

 

Three Months

 

Nine Months

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 


 


 


 


 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaborative and other research and development

 

$

116

 

$

0

 

$

159

 

$

0

 

Interest and other

 

 

154

 

 

222

 

 

509

 

 

796

 

 

 



 



 



 



 

 

Total revenues

 

 

270

 

 

222

 

 

668

 

 

796

 

 

 



 



 



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,838

 

 

3,105

 

 

14,168

 

 

8,559

 

General and administrative

 

 

728

 

 

526

 

 

2,315

 

 

1,687

 

 

 



 



 



 



 

 

Total expenses

 

 

5,566

 

 

3,631

 

 

16,483

 

 

10,246

 

 

 



 



 



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(5,296

)

$

(3,409

)

$

(15,815

)

$

(9,450

)

 

 



 



 



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amounts per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss (Note 2)

 

$

(.24

)

$

(.19

)

$

(.75

)

$

(.53

)

 

 



 



 



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding (Note 2)

 

 

21,706

 

 

17,685

 

 

20,973

 

 

17,671

 

See accompanying notes to condensed financial statements.

3


BIOCRYST PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
Nine Months Ended September 30, 2004 and 200
3
(In thousands)
(Unaudited)

 

 

2004

 

2003

 

 

 


 


 

Operating activities:

 

 

 

 

 

 

 

Net loss

 

(15,815

)

$

(9,450

)

Depreciation and amortization

 

 

726

 

 

853

 

Non-monetary compensation

 

 

329

 

 

91

 

Changes in operating assets and liabilities, net

 

 

2,025

 

 

16

 

 

 



 



 

 

Net cash used in operating activities

 

 

(12,735

)

 

(8,490

)

 

 



 



 

 

 

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

 

 

Purchases of furniture and equipment

 

 

(166

)

 

(33

)

Purchases of patents and licenses

 

 

(63

)

 

(18

)

Purchases of marketable securities

 

 

(15,223

)

 

(11,574

)

Maturities of marketable securities

 

 

8,699

 

 

17,081

 

 

 



 



 

 

Net cash (used in) provided by investing activities

 

 

(6,753

)

 

5,456

 

 

 



 



 

 

 

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

 

 

Proceeds from sale of common stock

 

 

21,356

 

 

39

 

 

 



 



 

 

Net cash provided by financing activities

 

 

21,356

 

 

39

 

 

 



 



 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

 

1,868

 

 

(2,995

)

Cash and cash equivalents at beginning of period

 

 

11,941

 

 

13,824

 

 

 



 



 

Cash and cash equivalents at end of period

 

$

13,809

 

10,829

 

 

 



 



 

See accompanying notes to condensed financial statements.

4


BIOCRYST PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

Note 1.  Basis of Preparation

          The condensed balance sheet as of September 30, 2004, the condensed statements of operations for the three months and nine months ended September 30, 2004 and 2003, and the statements of cash flows for the nine months ended September 30, 2004 and 2003 have been prepared by the Company in accordance with accounting principles generally accepted in the United States and have not been audited. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the financial position at September 30, 2004, the results of operations for the three months and nine months ended September 30, 2004 and 2003, and cash flows for the nine months ended September 30, 2004 and 2003. There were no adjustments other than normal recurring adjustments. Preparing financial statements requires management to make estimates and assumptions that affect the reported amount of assets, liabilities, revenues and expenses. Examples include accrued clinical and preclinical expenses. Actual results may differ from these estimates.

          These condensed financial statements should be read in conjunction with the financial statements for the year ended December 31, 2003 and the notes thereto included in the Company’s 2003 Annual Report on Form 10-K. Interim operating results are not necessarily indicative of operating results for the full year. The condensed balance sheet as of December 31, 2003 has been derived from the audited financial statements included in the previously mentioned Annual Report.

Note 2.  Net Loss Per Share

          The Company computes net loss per share in accordance with Statement of Financial Accounting Standards No. 128, Earnings Per Share. Net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted loss per share includes common equivalent shares from unexercised stock options and common shares expected to be issued under the Company’s employee stock purchase plan. For all periods presented, diluted loss per share does not include the impact of potential common shares outstanding, as the impact of those shares is anti-dilutive.

Note 3.  Stock-Based Compensation

          The Company accounts for stock-based compensation under Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (“APB No. 25”).  Under APB No. 25, the Company’s stock option and employee stock purchase plans qualify as non-compensatory plans.  Under Financial Accounting Standards Board Interpretation 44, Accounting for Certain Transactions Involving Stock Compensation, an Interpretation of APB No. 25, outside directors are considered employees for purposes of applying APB No. 25, if they are elected by the stockholders.  Consequently, no compensation expense for employees and directors is recognized unless there has been a modification to their grants as was the case for the directors in May 2004, resulting in a recognized expense of $290,000 in the quarter ending June 30, 2004. Stock issued to non-employees is compensatory and compensation expense is recognized under Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (“Statement No. 123”) as amended by Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure (“Statement No. 148”).

5


          The following table illustrates the pro forma effect on net loss and net loss per share had the Company applied the fair value recognition provisions of Statement No. 123 for the three and nine month periods ended September 30, 2004 and 2003. 

 

 

 

Three Months Ended 
September 30

 

Nine Months Ended 
September 30

 

 

 

 


 


 

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

 


 


 


 


 

 

Net loss as reported

 

$

(5,296

)

$

(3,409

)

$

(15,815

)

$

(9,450

)

 

Add: Stock-based employee compensation expense included in reported net loss

 

 

1

 

 

1

 

 

292

 

 

2

 

 

Stock-based employee compensation expense determined under Statement No. 123

 

 

(462

)

 

(440

)

 

(1,045

)

 

(191

)

 

 

 



 



 



 



 

 

Pro forma net loss

 

$

(5,757

)

$

(3,848

)

$

(16,568

)

$

(9,639

)

 

 

 



 



 



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amounts per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, as reported

 

$

(.24

)

$

(.19

)

$

(.75

)

$

(.53

)

 

Pro forma net loss per share

 

$

(.27

)

$

(.22

)

$

(.79

)

$

(.55

)

          On March 31, 2004, the FASB issued an Exposure Draft (“ED”), Share-Based Payment - An Amendment of FASB Statements No. 123 and 95. The proposed Statement addresses the accounting for transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments. The proposed Statement would eliminate the ability to account for share-based compensation transactions using APB No. 25, and generally would require instead that such transactions be accounted for using a fair-value based method. As proposed, companies would be required to recognize an expense for compensation cost related to share-based payment arrangements including stock options and employee stock purchase plans. As proposed, the new rules would be applied on a modified prospective basis as defined in the ED, and would be effective for public companies for fiscal years beginning after June 15, 2005. We are currently evaluating option valuation methodologies and assumptions in light of the evolving accounting standards related to employee stock options. Current estimates of option values using the Black-Scholes method (as shown above) may not be indicative of results from valuation methodologies ultimately adopted in the final rules.

Note 4.  Stockholders’ Equity

          On February 4, 2004, the Company entered into a Placement Agency Agreement with Leerink Swann & Company in connection with a registered direct offering of 3,571,667 shares of its common stock at an offering price of $6.00 per share. The common stock was issued pursuant to a prospectus supplement filed with the Securities and Exchange Commission pursuant to Rule 424(b)(2) of the Securities Act of 1933, as amended, in connection with a shelf takedown from the Company’s registration statement on Form S-3 (333-111226), filed on December 16, 2003, and which became effective on January 5, 2004.

          On February 17, 2004, the Company entered into a Stock Purchase Agreement with Caduceus Private Investments II, LP, Caduceus Private Investments II (QP), LP and UBS Juniper Crossover Fund, L.L.C.  As part of this agreement, Registrant has granted these investors the right to appoint a member to its board of directors effective as of the closing of the offering.  On February 18, 2004, the Company announced it had completed a $21.4 million registered direct offering of 3,571,667 shares of its common stock to a group of institutional investors.

          In addition to the 3,571,667 shares issued in the registered direct offering in February 2004, the Company issued an additional 45,641 shares during the three months ended September 30, 2004 as a result of exercises related to the Company’s stock option plan and employee stock purchase plan.  For the nine months ended September 30, 2004, a total of 284,608 additional shares have been issued for both the stock option plan and the employee stock purchase plan.

6


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains certain statements of a forward-looking nature relating to future events or the future financial performance of the Company. Such statements are only predictions and the actual events or results may differ materially from the results discussed in the forward-looking statements. Factors that could cause or contribute to such differences include those discussed below as well as those discussed in other filings made by the Company with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K.

Overview

          Since our inception in 1986, we have been engaged in research and development activities and organizational efforts, including:

 

identification and licensing of enzyme targets;

 

 

 

 

drug discovery;

 

 

 

 

structure-based design of drug candidates;

 

 

 

 

small-scale synthesis of compounds;

 

 

 

 

conducting preclinical studies and clinical trials;

 

 

 

 

recruiting our scientific and management personnel;

 

 

 

 

establishing laboratory facilities; and

 

 

 

 

raising capital.

          Our revenues have generally been limited to license fees, milestone payments, interest income, and collaboration research and development fees. The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin No. 104, Revenue Recognition (“SAB No. 104”). Research and development revenue on cost-reimbursement agreements is recognized as expenses are incurred, up to contractual limits. Research and development fees, license fees and milestone payments are recognized as revenue when the earnings process is complete, the Company has no further continuing performance obligations and has completed its performance under the terms of the agreement, in accordance with SAB No. 104. License fees and milestone payments received under licensing agreements that are related to future performance are deferred and taken into income as earned over the estimated drug development period. The Company has not received any revenues or royalties from the sale of licensed pharmaceutical products. It could be several years, if ever, before we will recognize significant revenue from royalties received pursuant to our license agreements or revenue directly from product sales. Future revenues, if any, are likely to fluctuate substantially from quarter to quarter.

          We have incurred operating losses since our inception. Our accumulated deficit at September 30, 2004 was $120.5 million. We will require substantial expenditures relating to the development of our current and future drug candidates. During the three years ended December 31, 2003, we spent 34.1% of our research and development expenses on contract research and development, including:

 

payments to consultants;

 

 

 

 

funding of research at academic institutions;

 

 

 

 

large scale synthesis and formulation of compounds;

 

 

 

 

preclinical studies;

 

 

 

 

engaging investigators to conduct clinical trials;

7



 

hiring contract research organizations for regulatory and clinical functions; and

 

 

 

 

using statisticians to evaluate the results of clinical trials.

          The above expenditures for contract research and development for our current and future drug candidates will vary from quarter-to-quarter depending on the status of our research and development projects. For example, during the first quarter of 2004, we entered a Phase II trial for our lead drug candidate, forodesine hydrochloride (BCX-1777), an inhibitor of purine nucleoside phosphorylase (PNP). In addition, during the fourth quarter of 2004, we initiated a Phase I trial for forodesine hydrochloride in cutaneous t-cell lymphoma (CTCL) and a Phase I trial with BCX-4208 in healthy volunteers. As these trials progress and additional trials are started in other indications, our costs for clinical studies will increase significantly. In addition, the costs associated with the manufacturing of forodesine hydrochloride and BCX-4208 will increase as we scale up to the larger production runs required for both clinical development and additional toxicology studies.

          Changes in our existing and future research and development and collaborative relationships will also impact the status of our research and development projects. Although we may, in some cases, be able to control the timing of development expenses, in part by accelerating or decelerating certain of these costs, many of these costs will be incurred irrespective of whether we are able to discover drug candidates or obtain collaborative partners for commercialization. As a result, we believe that quarter-to-quarter comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. If we fail to meet the research, clinical and financial expectations of securities analysts and investors, it could have a material adverse effect on the price of our common stock.

Results of Operations (three months ended September 30, 2004 compared to the three months ended September 30, 2003)

          Collaborative and other research and development revenue increased to $116,000 for the quarter ended September 30, 2004 compared to $0 for the same quarter in 2003, due to revenue from the National Institutes of Health (NIH) related to the grant received for our hepatitis C inhibitor program. This increase was partially offset by decrease in interest and other income by 30.6% to $154,000 in the third quarter of 2004 compared to $222,000 in the third quarter of 2003. This decrease was due to the lower interest rate environment in 2004, which offset the higher cash balance.

          Research and development expenses increased 55.8% to $4,838,000 in the three months ended September 30, 2004 from $3,105,000 in the three months ended September 30, 2003. The increase is primarily attributed to the costs associated with the continued development of our lead drug candidate, forodesine hydrochloride. These costs include the ongoing clinical studies and manufacturing of compound on a larger scale.

          General and administrative expenses for the three months ended September 30, 2004 increased 38.4% to $728,000 as compared to $526,000 for the same period in 2003. This increase is primarily related to an increase in professional fees, including fees related to Sarbanes-Oxley compliance work and strategies for the development of forodesine hydrochloride.

Results of Operations (nine months ended September 30, 2004 compared to the nine months ended September 30, 2003)

          Collaborative and other research and development revenue increased from $0 to $159,000 in the nine months ended September 30, 2004 due to revenue from the National Institutes of Health related to the grant received for our hepatitis C inhibitor program. Interest and other income decreased 36.1% to $509,000 for the nine months ended September 30, 2004 compared to $796,000 for the nine months ended September 30, 2003, due to a substantially lower interest rate environment in 2004, more than offsetting the higher cash balances.

          Research and development expenses increased 65.5% to $14,168,000 in the nine months ended September 30, 2004 from $8,559,000 for the nine months ended September 30, 2003. The increase is primarily attributed to the costs associated with the continued development of forodesine hydrochloride, which includes the ongoing clinical studies and manufacturing of compound on a larger scale and the preclinical development of BCX-4208, our second generation inhibitor of PNP.

8


          General and administrative expenses for the nine months ended September 30, 2004 increased 37.2% to $2,315,000 as compared to $1,687,000 for the same period in 2003. This increase is primarily related to a non-cash expense for directors’ stock options as a result of the amendment to our stock option plan, approved by the stockholders in May and additional professional fees related to compliance with the Sarbanes-Oxley Act and the development of forodesine hydrochloride.

Liquidity and Capital Resources

          Cash expenditures have exceeded revenues since the Company’s inception. Our operations have principally been funded through various sources, including the following:

 

public offerings and private placements of equity and debt securities,

 

 

 

 

equipment lease financing,

 

 

 

 

facility leases,

 

 

 

 

collaborative and other research and development agreements (including licenses and options for licenses),

 

 

 

 

research grants and

 

 

 

 

interest income.

          In addition, we have attempted to contain costs and reduce cash flow requirements by renting scientific equipment and facilities, contracting with other parties to conduct certain research and development and using consultants. We expect to incur additional expenses, potentially resulting in significant losses, as we continue to pursue our research and development activities and undertake additional preclinical studies and clinical trials of compounds which have been or may be discovered. We also expect to incur substantial expenses related to the filing, prosecution, maintenance, defense and enforcement of patent and other intellectual property claims.

          The Company invests its excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limits the amount of credit exposure at any one institution. These investments are generally not collateralized and mature within three years. The Company has not realized any losses from such investments. In addition, at September 30, 2004, approximately $8.3 million was invested in the Merrill Lynch Premier Institutional Fund, which invests primarily in commercial paper, U.S. government and agency bills and notes, corporate notes, certificates of deposit and time deposits. The Merrill Lynch Premier Institutional Fund is not insured. At September 30, 2004, our cash, cash equivalents and securities held-to-maturity were $34.1 million, an increase of $8.4 million from December 31, 2003, principally due to the fact that we raised an additional $21.3 million of capital during February 2004 through a registered offering of our common stock to selected institutional investors. This offering, net of expenses was approximately $20.3 million. Our cash used in operations during the first nine months of 2004 was approximately $13 million.

          We have financed some of our equipment purchases with lease lines of credit. We currently have a $500,000 general line of credit with our bank, secured by a pledge of $600,000 in marketable securities. There was nothing drawn against this line as of September 30, 2004. In July 2000, we renegotiated our lease for our current facilities, which will expire on June 30, 2010. We have an option to renew the lease for an additional five years at the current market rate in effect on June 30, 2010, and a one-time option to terminate the lease on June 30, 2008 for a termination fee of approximately $124,000. The lease, as amended effective July 1, 2001 for an additional 7,200 square feet, requires us to pay monthly rent starting at $33,145 per month in July 2001 and escalating annually to a minimum of $47,437 per month in the final year, plus our pro rata share of operating expenses and real estate taxes in excess of base year amounts. As part of the lease, we have deposited a U.S. Treasury security in escrow for the payment of rent and performance of other obligations specified in the lease. This pledged amount is currently $265,000, which will be decreased by $65,000 annually throughout the term of the lease. Currently, we have approximately 14,000 square feet of space available for sublease, of which 3,600 square feet is currently being leased.

9


          At December 31, 2003, we had long-term operating lease obligations, which provide for aggregate minimum payments of $594,897 in 2004, $605,139 in 2005 and $573,031 in 2006. These obligations include the future rental of our operating facility.

          We plan to finance our needs principally from the following:

 

our existing capital resources and interest earned on that capital;

 

 

 

 

payments under collaborative and licensing agreements with corporate partners; and

 

 

 

 

lease or loan financing and future public or private financing.

          We believe that our available funds will be sufficient to fund our operations at least through 2005. However, this is a forward looking statement, and there may be changes that would consume available resources significantly before such time. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including:

 

the progress of our research, drug discovery and development programs;

 

 

 

 

changes in existing collaborative relationships;

 

 

 

 

our ability to establish additional collaborative relationships;

 

 

 

 

the magnitude of our research and development programs;

 

 

 

 

the scope and results of preclinical studies and clinical trials to identify drug candidates;

 

 

 

 

competitive and technological advances;

 

 

 

 

the time and costs involved in obtaining regulatory approvals;

 

 

 

 

the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

 

 

 

 

our dependence on others for development and commercialization of our product candidates, and

 

 

 

 

successful commercialization of our products consistent with our licensing strategy.

          In 2003, our operations consumed approximately $1,000,000 per month, but we expect that our monthly cash used by operations will continue to increase for the next several years. Through September 2004, our average cash used by operations has been approximately $1,500,000 per month. We are continuing to expand our existing clinical programs with forodesine hydrochloride and plan to initiate another clinical program with BCX-4208, a second generation PNP inhibitor to potentially be used for the treatment of psoriasis, during the fourth quarter 2004. These additional trials and the related manufacturing, personnel resources and testing required to support these studies will consume significant capital resources and significantly increase our expenses and our net loss. We expect our monthly burn rate to increase to approximately $2 million during the fourth quarter of 2004. This monthly burn rate could increase more in future years depending on many factors, including our ability to raise additional capital, the progress of our current and proposed clinical trials for forodesine hydrochloride and BCX-4208, and the progression of our discovery programs.

          We will be required to raise additional capital to complete the development and commercialization of our current product candidates. Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners or from other sources, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs. Our plan is to raise additional capital during 2005 to provide the resources necessary to continue the development of our existing programs, while prudently managing our cash position.

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Off-Balance Sheet Arrangements

          As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPEs”) or variable-interest entities (“VIEs”), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.  As of September 30, 2004, we are not involved in any material unconsolidated SPE or off-balance sheet arrangements. 

Contractual Obligations

          A summary of our obligations to make future payments under contracts existing as of December 31, 2003 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2003. For the nine months ended September 30, 2004, the Company has entered into various contracts in the ordinary course of business for several R&D related items, including manufacturing of various compounds, additional toxicology studies and clinical trials and has already paid for some of the obligations disclosed at December 31, 2003. The net effect of these changes was to increase the purchase obligations disclosed at December 31, 2003 by a total of approximately $9.3 million of which $3.6 million would be expected to be incurred in the current year and $5.7 million in the following year. These obligations could change during the course of the year depending on the status of each of our development programs.

Critical Accounting Policies

          We have established various accounting policies that govern the application of accounting principles generally accepted in the United States, which were utilized in the preparation of our financial statements. Certain accounting policies involve significant judgments and assumptions by management that have a material impact on the carrying value of certain assets and liabilities; management considers such accounting policies to be critical accounting policies. The judgments and assumptions used by management are based on historical experience and other factors, which are believed to be reasonable under the circumstances. Because of the nature of the judgments and assumptions made by management, actual results could differ from these judgments and estimates, which could have a material impact on the carrying values of assets and liabilities and the results of operations.

          We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

Revenue Recognition

          The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin No. 104, Revenue Recognition (“SAB No. 104”). Research and development revenue on cost-reimbursement agreements is recognized as expenses are incurred, up to contractual limits. Research and development fees, license fees and milestone payments are recognized as revenue when the earnings process is complete, the Company has no further continuing performance obligations and has completed its performance under the terms of the agreement, in accordance with SAB No. 104. License fees and milestone payments received under licensing agreements that are related to future performance are deferred and taken into income as earned over the estimated drug development period. Recognized revenues and profit are subject to revisions as these contracts or agreements progress to completion. Revisions to revenue or profit estimates are charged to income in the period in which the facts that give rise to the revision become known.

Valuation of Financial Instruments

          We carry our held-to-maturity securities at amortized cost, as adjusted for other-than-temporary declines in market value. In determining if and when a decline in market value below amortized cost is other-than-temporary, we evaluate the market conditions and other key measures for our held-to-maturity investments. Future adverse changes in market conditions could result in losses or an inability to recover the carrying value of the held-to-maturity investments that may not be reflected in an investment’s current carrying value, thereby possibly requiring an impairment charge in the future.

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Deferred Taxes

          We have not had taxable income since incorporation and, therefore, we have not paid any income tax. We have deferred tax assets related to net operating loss carryforwards and research and development carryforwards, and have recorded a valuation allowance to reduce our deferred tax assets to the amount that is more likely than not to be realized. While we have considered future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for the valuation allowance, in the event we were to determine that we would be able to realize the deferred tax assets in the future in excess of the net recorded amount, an adjustment to the deferred tax asset would increase income in the period such determination was made. Likewise, should we determine that we would not be able to realize all or part of the net deferred tax asset in the future, an adjustment to the deferred tax asset would be charged to income in the period such determination was made.

Patents and Licenses

          Patents and licenses are recorded at cost and amortized on a straight-line basis over their estimated useful lives or 20 years, whichever is lesser. These costs are reviewed periodically in accordance with Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets (“Statement No. 144”) to determine any impairment that needs to be recognized.

Research and Development Expenses

          Major components of R&D expenses consist of personnel costs, including salaries and benefits, clinical, regulatory and toxicology services performed by contract research organizations (CRO’s), materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. We charge clinical and preclinical study costs to expense when incurred, consistent with Statement No. 2, Accounting for Research and Development Costs. These costs are a significant component of R&D expenses.  Most of our clinical and preclinical studies are performed by third-party CRO’s. We accrue costs for studies performed by CRO’s over the service periods specified in the contracts and adjust our estimates, if required, based upon our on-going review of the level of services actually performed by the CRO.

Certain Risk Factors That May Affect Future Results, Financial Condition and the Market Price of Securities

          An investment in our stock involves a high degree of risk. You should consider carefully the following risks, along with all of the other information included in our other filings with the Securities and Exchange Commission, before deciding to buy our common stock. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also impair our business operations. If we are unable to prevent events that have a negative effect from occurring, then our business may suffer. Negative events are likely to decrease our revenue, increase our costs, make our financial results poorer and/or decrease our financial strength, and may cause our stock price to decline. In that case, you may lose all or a part of your investment in our common stock.

Risks Relating to Our Business

We have incurred substantial losses since our inception in 1986, expect to continue to incur such losses and may never be profitable

          Since our inception in 1986, we have not been profitable. We expect to incur additional losses for the foreseeable future, and our losses could increase as our research and development efforts progress. As of September 30, 2004, our accumulated deficit was approximately $120.5 million. To become profitable, we must successfully develop drug candidates, enter into profitable agreements with other parties and our drug candidates must receive regulatory approval. We or these other parties must then successfully manufacture and market our drug candidates. It could be several years, if ever, before we receive royalties from any future license agreements or revenues directly from product sales.

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If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates or continue our research and development programs.

          To date, we have financed our operations primarily from sale of our equity securities and, to a lesser extent, revenues from collaborations and interest. In 2003, our operations consumed approximately $1,000,000 per month, but we expect that our monthly cash used by operations will continue to increase for the next several years. Through September 2004, our cash used by operations averaged approximately $1,500,000 per month.  We are continuing to expand our existing clinical programs with forodesine hydrochloride and plan to initiate another clinical program with BCX-4208, a second generation PNP inhibitor to potentially be used for the treatment of psoriasis, during the fourth quarter  2004. These additional trials and the related manufacturing, personnel resources and testing required to support these studies will consume significant capital resources and significantly increase our expenses and our net loss.

          As of September 30, 2004, we had $34.1 million in cash, cash equivalents and securities. We expect our monthly burn rate to increase to approximately $2 million during the fourth quarter 2004. This monthly burn rate could increase more in future years depending on many factors, including our ability to raise additional capital, the progress of our current and proposed clinical trials for forodesine hydrochloride and BCX-4208, and the progression of our discovery programs. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including:

 

the progress of our research, drug discovery and development programs;

 

 

 

 

changes in existing collaborative relationships;

 

 

 

 

our ability to establish additional collaborative relationships;

 

 

 

 

the magnitude of our research and development programs;

 

 

 

 

the scope and results of preclinical studies and clinical trials to identify drug candidates;

 

 

 

 

competitive and technological advances;

 

 

 

 

the time and costs involved in obtaining regulatory approvals;

 

 

 

 

the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

 

 

 

 

our dependence on others for development and commercialization of our product candidates; and

 

 

 

 

successful commercialization of our products consistent with our licensing strategy.

          We will be required to raise additional capital to complete the development and commercialization of our current product candidates. Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners or from other sources, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs. Our plan is to raise additional capital during 2005 to provide the resources necessary to continue the development of our existing programs, while prudently managing our cash position. However, we cannot assure you that we will be able to obtain additional capital during the expected time frame on favorable terms or at all.

We have not commercialized any products or technologies and our future revenue generation is uncertain

          We have not yet commercialized any products or technologies, and we may never be able to do so. Our revenue from collaborative agreements is dependent upon the status of our preclinical and clinical programs. If we fail to advance these programs to the point of being able to enter into successful collaborations, we will not receive any future milestone or other collaborative payments.

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          Any future revenue directly from product sales would depend on our ability to successfully complete clinical studies, obtain regulatory approvals, manufacture, market and commercialize any approved drugs.

If our development collaborations with other parties fail, the development of our drug candidates will be delayed or stopped

          We rely heavily upon other parties for many important stages of our drug development programs, including:

 

discovery of proteins that cause or enable biological reactions necessary for the progression of the disease or disorder, called enzyme targets;

 

 

 

 

licensing or design of enzyme inhibitors for development as drug candidates;

 

 

 

 

execution of some preclinical studies and late-stage development for our compounds and drug candidates;

 

 

 

 

management of our clinical trials, including medical monitoring and data management;

 

 

 

 

management of our regulatory function; and

 

 

 

 

manufacturing, sales, marketing and distribution of our drug candidates.

          Our failure to engage in successful collaborations at any one of these stages would greatly impact our business. If we do not license enzyme targets or inhibitors from academic institutions or from other biotechnology companies on acceptable terms, our product development efforts would suffer. Similarly, if the contract research organizations that conduct our initial or late-stage clinical trials or manage our regulatory function breached their obligations to us, this would delay or prevent the development of our drug candidates.

          Even more critical to our success is our ability to enter into successful collaborations for the late-stage clinical development, regulatory approval, manufacturing, marketing, sales and distribution of our drug candidates. Our general strategy is to rely upon other parties for all of these steps so that we can focus exclusively on the key areas of our expertise. For some smaller niche markets, we may perform these steps ourselves and outsource those functions where we do not have the internal expertise. This heavy reliance upon third parties for these critical functions presents several risks, including:

 

these contracts may expire or the other parties to the contract may terminate them;

 

 

 

 

our partners may choose to pursue alternative technologies, including those of our competitors;

 

 

 

 

we may have disputes with a partner that could lead to litigation or arbitration;

 

 

 

 

our partners may not devote sufficient capital or resources towards our drug candidates; 

 

 

 

 

our partners may not comply with applicable government regulatory requirements; and

 

 

 

 

our manufacturing partners may not be able to manufacture our compounds in the quantities required or to the specifications required by the regulatory authorities.

          Any problems encountered with our current or future partners could delay or prevent the development of our compounds, which would severely affect our business, because if our compounds do not reach the market in a timely manner, or at all, we may never receive any milestone, product or royalty payments.

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If the clinical trials of our drug candidates fail, our drug candidates will not be marketed, which would result in a complete absence of product related revenue

          To receive the regulatory approvals necessary for the sale of our drug candidates, we or our licensees must demonstrate through preclinical studies and clinical trials that each drug candidate is safe and effective. If we or our licensees are unable to demonstrate that our drug candidates are safe and effective, our drug candidates will not receive regulatory approval and will not be marketed, which would result in a complete absence of product related revenue. The clinical trial process is complex and uncertain. Because of the cost and duration of clinical trials, we may decide to discontinue development of product candidates that are either unlikely to show good results in the trials or unlikely to help advance a product to the point of a meaningful collaboration. Positive results from preclinical studies and early clinical trials do not ensure positive results in clinical trials designed to permit application for regulatory approval, called pivotal clinical trials. We may suffer significant setbacks in pivotal clinical trials, even after earlier clinical trials show promising results. Any of our drug candidates may produce undesirable side effects in humans. These side effects could cause us or regulatory authorities to interrupt, delay or halt clinical trials of a drug candidate. These side effects could also result in the FDA or foreign regulatory authorities refusing to approve the drug candidate for any targeted indications. We, our licensees, the FDA or foreign regulatory authorities may suspend or terminate clinical trials at any time if we or they believe the trial participants face unacceptable health risks. Clinical trials may fail to demonstrate that our drug candidates are safe or effective.

          Clinical trials are lengthy and expensive. We or our licensees incur substantial expense for, and devote significant time to, preclinical testing and clinical trials, yet cannot be certain that the tests and trials will ever result in the commercial sale of a product. For example, clinical trials require adequate supplies of drug and sufficient patient enrollment. Delays in patient enrollment can result in increased costs and longer development times. Even if we or our licensees successfully complete clinical trials for our product candidates, we or our licensees might not file the required regulatory submissions in a timely manner and may not receive regulatory approval for the drug candidate.

If we or our licensees do not obtain and maintain governmental approvals for our products under development, we or our partners will not be able to sell these potential products, which would significantly harm our business because we will receive no revenue

          We or our licensees must obtain regulatory approval before marketing or selling our future drug products. If we or our licensees are unable to receive regulatory approval and do not market or sell our future drug products, we will never receive any revenue from such product sales. In the United States, we or our partners must obtain FDA approval for each drug that we intend to commercialize. The FDA approval process is typically lengthy and expensive, and approval is never certain. Products distributed abroad are also subject to foreign government regulation. The FDA or foreign regulatory agencies have not approved any of our drug candidates. If we or our licensees fail to obtain regulatory approval we will be unable to market and sell our future drug products. We have several drug products in various stages of preclinical and clinical development; however, we are unable to determine when, if ever, any of these products will be commercially available. Because of the risks and uncertainties in biopharmaceutical development, our drug candidates could take a significantly longer time to gain regulatory approval than we expect or may never gain approval. If the FDA delays regulatory approval of our drug candidates, our management’s credibility, our company’s value and our operating results may suffer. Even if the FDA or foreign regulatory agencies approve a drug candidate, the approval may limit the indicated uses for a drug candidate and/or may require post-marketing studies.

          The FDA regulates, among other things, the record keeping and storage of data pertaining to potential pharmaceutical products. We currently store most of our preclinical research data at our facility. While we do store duplicate copies of most of our clinical data offsite, we could lose important preclinical data if our facility incurs damage. If we get approval to market our potential products, whether in the United States or internationally, we will continue to be subject to extensive regulatory requirements. These requirements are wide ranging and govern, among other things:

 

adverse drug experience reporting regulations;

 

 

 

 

product promotion;

 

 

 

 

product manufacturing, including good manufacturing practice requirements; and

 

 

 

 

product changes or modifications.

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          Our failure to comply with existing or future regulatory requirements, or our loss of, or changes to, previously obtained approvals, could have a material adverse effect on our business because we will not receive product or royalty revenues if we or our licensees do not receive approval of our products for marketing.

          In June 1995, we notified the FDA that we submitted incorrect data for our Phase II studies of BCX-34 applied to the skin for cutaneous T-cell lymphoma and psoriasis. The FDA inspected us in November 1995 and issued us a List of Inspectional Observations, Form FDA 483, which cited our failure to follow good clinical practices. The FDA also inspected us in June 1996. The focus was on the two 1995 Phase II dose-ranging studies of topical BCX-34 for the treatment of cutaneous T-cell lymphoma and psoriasis. As a result of the investigation, the FDA issued us a Form FDA 483, which cited our failure to follow good clinical practices. BioCryst is no longer developing BCX-34; however, as a consequence of these two investigations, our ongoing and future clinical studies may receive increased scrutiny, which may delay the regulatory review process.

We may be unable to establish sales, marketing and distribution capabilities necessary to successfully commercialize products we may successfully develop

          We currently have no marketing capability and no direct or third-party sales or distribution capabilities. If we successfully develop a drug candidate and decide to commercialize it ourselves rather than relying on third parties, as we currently intend to do in the United States for forodesine hydrochloride, we may be unable to establish marketing, sales and distribution capabilities necessary to commercialize and gain market acceptance for that product.

If our drug candidates do not achieve broad market acceptance, our business may never become profitable

          Our drug candidates may not gain the market acceptance required for us to be profitable even if they successfully complete initial and final clinical trials and receive approval for sale by the FDA or foreign regulatory agencies. The degree of market acceptance of any drug candidates that we or our partners develop will depend on a number of factors, including:

 

cost-effectiveness of our drug candidates;

 

 

 

 

their safety and effectiveness relative to alternative treatments;

 

 

 

 

reimbursement policies of government and third-party payers; and

 

 

 

 

marketing and distribution support for our drug candidates.

          Physicians, patients, payers or the medical community in general may not accept or use our drug candidates even after the FDA or foreign regulatory agencies approve the drug candidates. If our drug candidates do not achieve significant market acceptance, we will not have enough revenues to become profitable.

We face intense competition, and if we are unable to compete effectively, the demand for our products, if any, may be reduced

          The biotechnology and pharmaceutical industries are highly competitive and subject to rapid and substantial technological change. We face, and will continue to face, competition in the licensing of desirable disease targets, licensing of desirable drug candidates, and development and marketing of our product candidates from academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies. Competition may also arise from, among other things:

 

other drug development technologies;

 

 

 

 

methods of preventing or reducing the incidence of disease, including vaccines; and

 

 

 

 

new small molecule or other classes of therapeutic agents.

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Developments by others may render our product candidates or technologies obsolete or noncompetitive.

          We are performing research on or developing products for the treatment of several disorders including T-cell mediated disorders (T-cell cancers, psoriasis, and rheumatoid arthritis), cardiovascular, oncology, and hepatitis C, and there are a number of competitors to products in our research pipeline. If one or more of our competitors’ products or programs are successful, the market for our products may be reduced or eliminated.

          Compared to us, many of our competitors and potential competitors have substantially greater:

 

capital resources;

 

 

 

 

research and development resources, including personnel and technology;

 

 

 

 

regulatory experience;

 

 

 

 

preclinical study and clinical testing experience;

 

 

 

 

manufacturing and marketing experience; and

 

 

 

 

production facilities.

Any of these competitive factors could reduce demand for our products.

If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of those rights would diminish

          Our success will depend in part on our ability and the abilities of our licensors to obtain patent protection for our products, methods, processes and other technologies to preserve our trade secrets, and to operate without infringing the proprietary rights of third parties. If we or our partners are unable to adequately protect or enforce our intellectual property rights for our products, methods, processes and other technologies, the value of the drug candidates that we license to derive revenue would diminish. Additionally, if our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial costs. The U.S. Patent and Trademark Office has issued to us a number of U.S. patents for our various inventions and we have in-licensed several patents from various institutions. We have filed additional patent applications and provisional patent applications with the U.S. Patent and Trademark Office. We have filed a number of corresponding foreign patent applications and intend to file additional foreign and U.S. patent applications, as appropriate. We cannot assure you as to:

 

the degree and range of protection any patents will afford against competitors with similar products;

 

 

 

 

if and when patents will issue; or

 

 

 

 

whether or not others will obtain patents claiming aspects similar to those covered by our patent applications.

          If the U.S. Patent and Trademark Office upholds patents issued to others or if the U.S. Patent and Trademark Office grants patent applications filed by others, we may have to:

 

obtain licenses or redesign our products or processes to avoid infringement;

 

 

 

 

stop using the subject matter claimed in those patents; or

 

 

 

 

pay damages.

          We may initiate, or others may bring against us, litigation or administrative proceedings related to intellectual property rights, including proceedings before the U.S. Patent and Trademark Office. Any judgment adverse to us in any litigation or other proceeding arising in connection with a patent or patent application could materially and adversely affect our business, financial condition and results of operations. In addition, the costs of any such proceeding may be substantial whether or not we are successful.

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          Our success is also dependent upon the skills, knowledge and experience, none of which is patentable, of our scientific and technical personnel. To help protect our rights, we require all employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure of confidential information to anyone outside of our company and require disclosure and assignment to us of their ideas, developments, discoveries and inventions. These agreements may not provide adequate protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information, and if any of our proprietary information is disclosed, our business will suffer because our revenues depend upon our ability to license our technology and any such events would significantly impair the value of such a license.

If we fail to retain our existing key personnel or fail to attract and retain additional key personnel, the development of our drug candidates and the expansion of our business will be delayed or stopped

          We are highly dependent upon our senior management and scientific team, the loss of whose services might impede the achievement of our development and commercial objectives. Competition for key personnel with the experience that we require is intense and is expected to continue to increase. Our inability to attract and retain the required number of skilled and experienced management, operational and scientific personnel, will harm our business because we rely upon these personnel for many critical functions of our business. In addition, we rely on members of our scientific advisory board and consultants to assist us in formulating our research and development strategy. All of the members of the scientific advisory board and all of our consultants are otherwise employed and each such member or consultant may have commitments to other entities that may limit their availability to us.

If users of our drug products are not reimbursed for use, future sales of our drug products will decline

          The lack of reimbursement for the use of our product candidates by hospitals, clinics, patients or doctors will harm our business. Medicare, Medicaid, health maintenance organizations and other third-party payers may not authorize or otherwise budget for the reimbursement of our products. Governmental and third-party payers are increasingly challenging the prices charged for medical products and services. We cannot be sure that third-party payers would view our product candidates as cost-effective, that reimbursement will be available to consumers or that reimbursement will be sufficient to allow our product candidates to be marketed on a competitive basis. Changes in reimbursement policies, or attempts to contain costs in the health care industry could limit or restrict reimbursement for our product candidates and would materially and adversely affect our business, because future product sales would decline and we would receive less product or royalty revenue.

If we face clinical trial liability claims related to the use or misuse of our compounds in clinical trials, our management’s time will be diverted and we will incur litigation costs

          We face an inherent business risk of liability claims in the event that the use or misuse of our compounds results in personal injury or death. We have not experienced any clinical trial liability claims to date, but we may experience these claims in the future. After commercial introduction of our products we may experience losses due to product liability claims. We currently maintain clinical trial liability insurance coverage in the amount of $5.0 million per occurrence and $5.0 million in the aggregate, with an additional $2.0 million potentially available under our umbrella policy. The insurance policy may not be sufficient to cover claims that may be made against us. Clinical trial liability insurance may not be available in the future on acceptable terms, if at all. Any claims against us, regardless of their merit, could materially and adversely affect our financial condition, because litigation related to these claims would strain our financial resources in addition to consuming the time and attention of our management.

If our computer systems fail, our business will suffer

          Our drug development activities depend on the security, integrity and performance of the computer systems supporting them, and the failure of our computer systems could delay our drug development efforts. We currently store most of our preclinical and clinical data at our facility. Duplicate copies of most critical data are stored off-site in a bank vault. Any significant degradation or failure of our computer systems could cause us to inaccurately calculate or lose our data. Loss of data could result in significant delays in our drug development process and any system failure could harm our business and operations.

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If, because of our use of hazardous materials, we violate any environmental controls or regulations that apply to such materials, we may incur substantial costs and expenses in our remediation efforts

          Our research and development involves the controlled use of hazardous materials, chemicals and various radioactive compounds. We are subject to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and some waste products. Accidental contamination or injury from these materials could occur. In the event of an accident, we could be liable for any damages that result and any liabilities could exceed our resources. Compliance with environmental laws and regulations could require us to incur substantial unexpected costs, which would materially and adversely affect our results of operations.

Risks Relating to Our Common Stock

Our stock price is likely to be highly volatile and the value of your investment could decline significantly

          The market prices for securities of biotechnology companies in general have been highly volatile and may continue to be highly volatile in the future. Moreover, our stock price has fluctuated frequently, and these fluctuations are often not related to our financial results. For the twelve months ended September 30, 2004, the 52-week range of the market price of our stock was from $4.37 to $11.25 per share. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock:

 

announcements of technological innovations or new products by us or our competitors;

 

 

 

 

developments or disputes concerning patents or proprietary rights;

 

 

 

 

status of new or existing licensing or collaborative agreements;

 

 

 

 

we or our licensees achieving or failing to achieve development milestones;

 

 

 

 

publicity regarding actual or potential medical results relating to products under development by us or our competitors;

 

 

 

 

regulatory developments in both the United States and foreign countries;

 

 

 

 

public concern as to the safety of pharmaceutical products;

 

 

 

 

actual or anticipated fluctuations in our operating results;

 

 

 

 

changes in financial estimates or recommendations by securities analysts;

 

 

 

 

economic and other external factors or other disasters or crises; and

 

 

 

 

period-to-period fluctuations in our financial results.

Because stock ownership is concentrated, you and other investors will have minimal influence on stockholder decisions

          As of September 30, 2004, our directors, executive officers and some principal stockholders and their affiliates beneficially owned approximately 35.4% (directors and officers, together with their relevant affiliates owned 30.1%) of our outstanding common stock and common stock equivalents. As a result, these holders, if acting together, are able to significantly influence matters requiring stockholder approval, including the election of directors. This concentration of ownership may delay, defer or prevent a change in our control.

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We have anti-takeover provisions in our corporate charter documents that may result in outcomes with which you do not agree

          Our board of directors has the authority to issue up to 3,178,500 shares of undesignated preferred stock and to determine the rights, preferences, privileges and restrictions of those shares without further vote or action by our stockholders. The rights of the holders of any preferred stock that may be issued in the future may adversely affect the rights of the holders of common stock. The issuance of preferred stock could make it more difficult for third parties to acquire a majority of our outstanding voting stock.

          In addition, our certificate of incorporation provides for staggered terms for the members of the board of directors and supermajority approval of the removal of any member of the board of directors and prevents our stockholders from acting by written consent. Our certificate also requires supermajority approval of any amendment of these provisions. These provisions and other provisions of our by-laws and of Delaware law applicable to us could delay or make more difficult a merger, tender offer or proxy contest involving us.

          In June 2002, our board of directors adopted a stockholder rights plan and, pursuant thereto, issued preferred stock purchase rights (“Rights”) to the holders of our common stock. The Rights have certain anti-takeover effects. If triggered, the Rights would cause substantial dilution to a person or group of persons who acquires more than 15% (19.9% for William W. Featheringill, a Director who currently owns approximately 13%, but owned more than 15% at the time the Rights were put in place) of our common stock on terms not approved by the board of directors.

We have never paid dividends on our common stock and do not anticipate doing so in the foreseeable future

          We have never paid cash dividends on our stock. We currently intend to retain all future earnings, if any, for use in the operation of our business. Accordingly, we do not anticipate paying cash dividends on our common stock in the foreseeable future.

Information Regarding Forward-Looking Statements

          This discussion contains forward-looking statements, which are subject to risks and uncertainties. These forward-looking statements can generally be identified by the use of words such as “may,” “will,” “intends,” “plans,” “believes,” “anticipates,” “expects,” “estimates,” “predicts,” “potential,” the negative of these words or similar expressions. Statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects are also forward-looking statements. Discussions containing these forward-looking statements are principally contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” above, as well as any amendments we make to those sections in filings with the SEC.

          These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Also, these forward-looking statements represent our estimates and assumptions only as of the date of this document.

          You should read this discussion completely and with the understanding that our actual future results may be materially different from what we expect. We may not update these forward-looking statements, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statements.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

          The primary objective of our investment activities is to preserve principal while maximizing the income we receive from our investments without significantly increasing our risk.  We invest excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limit the amount of credit exposure at any one institution. Some of the securities we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, we schedule our investments to have maturities that coincide with our expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, we believe we have no material exposure to interest rate risk arising from our investments. Therefore, no quantitative tabular disclosure is provided.

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Item 4. Controls and Procedures

          We maintain a set of disclosure controls and procedures that are designed to ensure that information relating to BioCryst Pharmaceuticals, Inc. required to be disclosed in our periodic filings under the Securities Exchange Act is recorded, processed, summarized and reported in a timely manner under the Securities Exchange Act of 1934. We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2004, the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by BioCryst in the reports filed or submitted by it under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and include controls and procedures designed to ensure that information required to be disclosed by BioCryst in such reports is accumulated and communicated to the Company’s management, including the Chairman and Chief Executive Officer and Chief Financial Officer of BioCryst, as appropriate to allow timely decisions regarding required disclosure.

          There have been no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2004 that have materially affected, or are reasonably likely to materially affect, BioCryst’s internal control over financial reporting.

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PART II.  OTHER INFORMATION

Item 1. Legal Proceedings:

          None

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds:

          None

Item 3. Defaults Upon Senior Securities:

          None

Item 4. Submission of Matters to a Vote of Security Holders:

          None

Item 5. Other Information:

          None

Item 6. Exhibits:

          a.     Exhibits:

 

Number

 

Description

 

3.1

 

Composite Certificate of Incorporation of Registrant. Incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q for the second quarter ending June 30, 1995 dated August 11, 1995.

       

 

3.2

 

Bylaws of Registrant as amended August 6, 2001.

       

 

4.1

 

Rights Agreement, dated as of June 17, 2002, by and between the Company and American Stock Transfer & Trust Company, as Rights Agent, which includes the Certificate of Designation for the Series B Junior Participating Preferred Stock as Exhibit A and the form of Rights Certificate as Exhibit B.  Incorporated by reference to Exhibit 4.1 to the Company’s Form 8-A dated June 17, 2002.

       

 

10.1

 

1991 Stock Option Plan as amended and restated effective March 8, 2004.  Incorporated by reference to Exhibit 10.1 to the Company’s Form 10-Q for the second quarter ending June 30, 2004 dated August 10, 2004.

       

 

10.2#

 

License Agreement dated April 15, 1993 between Ciba-Geigy Corporation (now merged into Novartis) and the Registrant. Incorporated by reference to Exhibit 10.40 to the Company’s Form S-1 Registration Statement (Registration No. 33-73868).

       

 

10.3

 

Employee Stock Purchase Plan. Incorporated by reference to Exhibit 99.1 to the Company’s Form S-8 Registration Statement dated June 14, 2002 (Registration No. 333-90582).

       

 

10.4#

 

Stock Purchase Agreement dated as of September 14, 1998 between Registrant and Johnson & Johnson Development Corporation. Incorporated by reference to Exhibit 10.24 to the Company’s Form 10-Q for the third quarter ending September 30, 1998 dated November 10, 1998.

       

 

10.5#

 

Stockholder’s Agreement dated as of September 14, 1998 between Registrant and Johnson & Johnson Development Corporation. Incorporated by reference to Exhibit 10.25 to the Company’s Form 10-Q for the third quarter ending September 30, 1998 dated November 10, 1998.

       

 

10.6

 

Warehouse Lease dated July 12, 2000 between RBP, LLC an Alabama Limited Liability Company and the Registrant for office/warehouse space. Incorporated by reference to Exhibit 10.8 to the Company’s Form 10-Q for the second quarter ending June 30, 2000 dated August 8, 2000.

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10.7

 

Termination Agreement dated as of September 21, 2001 between Registrant and The R.W. Johnson Pharmaceutical Research Institute and Ortho-McNeil Pharmaceutical, Inc. Incorporated by reference to Exhibit 10.9 to the Company’s Form 10-Q for the second quarter ending June 30, 2002 dated August 7, 2002. 

       

 

10.8

 

Stock Purchase Agreement, dated as of February 17, 2004, by and among BioCryst Pharmaceuticals, Inc., Caduceus Private Investments II, LP, Caduceus Private Investments II (QP), LP and UBS Juniper Crossover Fund, L.L.C. Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K dated February 17, 2004

       

 

10.9

 

Employment Agreement dated March 17, 2004 between the Registrant and Charles E. Bugg, Ph.D. Incorporated by reference to Exhibit 10.9 to the Company’s Form 10-Q for the first quarter ending March 31, 2004 dated May 11, 2004.

       

 

31.1

 

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

       

 

31.2

 

Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

       

 

32.1

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

       

 

32.2

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.



          # Confidential treatment granted.

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SIGNATURES

          Pursuant to the requirements of Section 13 or 15(d) 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 in the City of Birmingham, State of Alabama, on this 9th day of November, 2004.

 

BIOCRYST PHARMACEUTICALS, INC.

 

 

 

/s/Charles E. Bugg

 


 

 

Charles E. Bugg, Ph.D.

 

Chairman and Chief Executive Officer

 

 

 

 

 

 /s/Michael A. Darwin

 


 

 

Michael A. Darwin

 

Chief Financial Officer (Principal Financial
and Accounting Officer), Secretary and Treasurer

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