Sarepta Therapeutics
SRPT
#4355
Rank
$2.43 B
Marketcap
$23.23
Share price
4.97%
Change (1 day)
-57.32%
Change (1 year)
Sarepta Therapeutics is an American medical research company dedicated to the discovery and development of precisely effective gene therapeutics for the treatment of rare neuromuscular diseases.

Sarepta Therapeutics - 10-Q quarterly report FY


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


FORM 10-Q


(Mark One)

 
/x/
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2000

OR

/ /TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT

For the transition period from                to                

Commission file number 0-22613


AVI BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Oregon
(State or other jurisdiction of
incorporation or organization)
 93-0797222
(I.R.S. Employer Identification No.)
 
One SW Columbia Street, Suite 1105,
Portland, Oregon

(Address of principal executive offices)
 
 
 
97258
(Zip Code)

Issuer's telephone number, including area code: 503-227-0554


    Check whether the issuer (1) 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 the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

Common Stock with $.0001 par value
(Class)
 21,447,931
(Outstanding at October 31, 2000)



AVI BIOPHARMA, INC.

FORM 10-Q

INDEX

 
  
 Page
 
PART I—FINANCIAL INFORMATION
 
Item 1.
 
 
 
Financial Statements
 
 
 
 
 
 
 
 
 
Balance Sheets—September 30, 2000 and December 31, 1999
 
 
 
3
 
 
 
 
 
Statements of Operations—Three and Nine Months Ended September 30, 2000 and 1999 and from July 22, 1980 (Inception) to September 30, 2000
 
 
 
4
 
 
 
 
 
Statements of Cash Flows—Nine Months Ended September 30, 2000 and 1999 and from July 22, 1980 (Inception) to September 30, 2000
 
 
 
5
 
 
 
 
 
Notes to Financial Statements
 
 
 
6
 
Item 2.
 
 
 
Management's Discussion and Analysis
 
 
 
8
 
 
PART II—OTHER INFORMATION
 
Item 6.
 
 
 
Exhibits and Reports on Form 8-K
 
 
 
10
 
Signatures
 
 
 
 
 
 
 
11
 
 
 
 
 
 
 
 
 
 

2


AVI BIOPHARMA, INC.

(A Development Stage Company)

BALANCE SHEETS

 
 September 30,
2000

 December 31,
1999

 
Assets       
Current Assets:       
 Cash and cash equivalents $29,554,775 $8,683,005 
 Short-term securities—available-for-sale  8,592,886  2,937,500 
 Other current assets  121,556  31,242 
  
 
 
  Total Current Assets  38,269,217  11,651,747 
Property and Equipment, net of accumulated depreciation and
  amortization of $2,637,250 and $2,518,494
  811,975  403,303 
Patent Costs, net of accumulated amortization of $529,268
  and $418,268
  903,721  844,731 
Other Assets  29,847  29,847 
  
 
 
  Total Assets $40,014,760 $12,929,628 
    
 
 
 
Liabilities and Shareholders' Equity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Current Liabilities:       
 Accounts payable $1,014,102 $727,673 
 Accrued liabilities  302,223  312,481 
  
 
 
  Total Current Liabilities  1,316,325  1,040,154 
 
Shareholders' Equity:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Preferred Stock, $.0001 par value, 2,000,000 shares authorized;
  none issued and outstanding
     
 Common stock, $.0001 par value, 50,000,000 shares authorized;
  21,444,132 and 16,236,428 issued and outstanding
  2,144  1,624 
 Additional paid-in capital  105,286,681  62,901,227 
 Accumulated other comprehensive income (loss)  (9,304,114) 40,500 
 Deficit accumulated during the development stage  (57,286,276) (51,053,877)
  
 
 
  Total Shareholders' Equity  38,698,435  11,889,474 
  
 
 
  Total Liabilities and Shareholders' Equity $40,014,760 $12,929,628 
    
 
 

The accompanying notes are an integral part of these balance sheets

3


AVI BIOPHARMA, INC.

(A Development Stage Company)

STATEMENTS OF OPERATIONS

 
 Three months ended
September 30,

 Nine months ended
September 30,

  
 
 
 July 22, 1980
(Inception) to
September 30, 2000

 
 
 2000
 1999
 2000
 1999
 
Revenues, from license fees,
  grants and research contracts
 $122,215 $3,558 $1,272,338 $7,783 $2,113,555 
Operating expenses:                
 Research and development  2,155,538  1,739,728  6,575,953  4,709,856  31,303,586 
 General and administrative  557,911  504,607  1,484,159  1,341,099  10,682,827 
 Acquired in-process research
  and development
        61,337  19,545,028 
  
 
 
 
 
 
   2,713,449  2,244,335  8,060,112  6,112,292  61,531,441 
Other Income:                
 Interest income, net  339,130  35,696  555,375  162,784  2,034,860 
 Realized gain on sale of
  short-term investments
          96,750 
  
 
 
 
 
 
   339,130  35,696  555,375  162,784  2,131,610 
    
 
 
 
 
 
Net loss $(2,252,104)$(2,205,081)$(6,232,399)$(5,941,725)$(57,286,276)
    
 
 
 
 
 
Net loss per share—basic and
  diluted
 $(0.11)$(0.17)$(0.35)$(0.45)   
  
 
 
 
    
Weighted average number of
  common shares outstanding for
  computing basic and diluted
  earnings per share
  20,303,112  13,351,206  17,800,160  13,350,597    
  
 
 
 
    

The accompanying notes are an integral part of these balance sheets

4


AVI BIOPHARMA, INC.

(A Development Stage Company)

STATEMENTS OF CASH FLOWS

 
  
  
 For the Period
July 22, 1980
(Inception) to
September 30, 2000

 
 
 Nine months ended September 30,
 
 
 2000
 1999
 
Cash flows from operating activities:          
Net loss $(6,232,399)$(5,941,725)$(57,286,276)
 Adjustments to reconcile net loss to net cash
 flows used in operating activities:
          
  Depreciation and amortization  235,170  222,802  3,288,701 
  Realized gain on sale of short-term
 investments—available for sale
      (96,750)
  Compensation expense on issuance of
 common stock and partnership units
      251,992 
  Compensation expense on issuance of
 options and warrants to purchase common
 stock or partnership units
      562,353 
  Conversion of interest accrued to common
 stock
      7,860 
  Acquired in-process research and
 development
    61,337  19,545,028 
  (Increase) decrease in:          
   Other current assets  (90,314) 478,186  (121,556)
   Other assets      (29,847)
  Net increase (decrease) in accounts payable
 and accrued liabilities
  276,171  (508,806) 1,316,325 
  
 
 
 
    Net cash used in operating activities  (5,811,372) (5,688,206) (32,562,170)
 
Cash flows from investing activities:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Proceeds from sale or redemption of
 short-term investments
      247,750 
 Purchase of property and equipment  (532,842) (133,686) (3,514,728)
 Patent costs  (169,990) (197,651) (1,489,669)
 Acquisition costs    (61,337) (2,377,616)
  
 
 
 
    Net cash used in investing activities  (702,832) (392,674) (7,134,263)
 
Cash flows from financing activities:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Proceeds from sale of common stock,
 warrants, and partnership units, net of
 offering costs, and exercise of options
  27,385,974  15,000  69,636,645 
 Buyback of common stock pursuant to
 rescission offering
      (288,795)
 Withdrawal of partnership net assets      (176,642)
 Issuance of convertible debt      80,000 
  
 
 
 
    Net cash provided by financing activities  27,385,974  15,000  69,251,208 
 
Increase (decrease) in cash and cash equivalents
 
 
 
 
 
20,871,770
 
 
 
 
 
(6,065,880
 
)
 
 
 
29,554,775
 
 
 
Cash and cash equivalents:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Beginning of period  8,683,005  8,510,020   
  
 
 
 
 End of period $29,554,775 $2,444,140 $29,554,775 
    
 
 
 
SUPPLEMENTAL SCHEDULE OF
 NONCASH INVESTING ACTIVITIES
 AND FINANCING ACTIVITIES:
          
  Short-term securities—available-for-sale
 received in connection with the private
 offering
 $15,000,000 $ $17,897,000 
  Unrealized loss on short-term
 securities—available-for-sale
 $(9,344,614)$ $(9,304,114)

The accompanying notes are an integral part of these statements

5


AVI BIOPHARMA, Inc.

NOTES TO FINANCIAL STATEMENTS

(Unaudited)

Note 1. Basis of Presentation

    The financial information included herein for the three and nine-month periods ended September 30, 2000 and 1999 and the financial information as of September 30, 2000 is unaudited; however, such information reflects all adjustments consisting only of normal recurring adjustments which are, in the opinion of management, necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods. The financial information as of December 31, 1999 is derived from AVI BioPharma, Inc.'s (the Company's) Form 10-K. The interim financial statements should be read in conjunction with the financial statements and the notes thereto included in the Company's Form 10-K. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the full year.

Note 2. Earnings Per Share

    Basic EPS is calculated using the weighted average number of common shares outstanding for the period and diluted EPS is computed using the weighted average number of common shares and dilutive common equivalent shares outstanding. Given that the Company is in a loss position, there is no difference between basic EPS and diluted EPS since the common stock equivalents would be antidilutive.

Three Months Ended September 30,

 2000
 1999
 
Net loss $(2,252,104)$(2,205,081)
Weighted average number of shares of common stock and common
  stock equivalents outstanding:
       
Weighted average number of common shares outstanding for
  computing basic earnings per share
  20,303,112  13,351,206 
Dilutive effect of warrants and stock options after application of the
  treasury stock method
  *  * 
  
 
 
Weighted average number of common shares outstanding for
  computing diluted earnings per share
  20,303,112  13,351,206 
   
 
 
Net loss per share—basic and diluted $(0.11)$(0.17)
   
 
 
 
Nine Months Ended September 30,

 
 
 
2000

 
 
 
1999

 
 
Net loss $(6,232,399)$(5,941,725)
Weighted average number of shares of common stock and common
  stock equivalents outstanding:
       
Weighted average number of common shares outstanding for
  computing basic earnings per share
  17,800,160  13,350,597 
Dilutive effect of warrants and stock options after application of the
  treasury stock method
  *  * 
  
 
 
Weighted average number of common shares outstanding for
  computing diluted earnings per share
  17,800,160  13,350,597 
   
 
 
Net loss per share—basic and diluted $(0.35)$(0.45)
   
 
 

6


    * The following common stock equivalents are excluded from earnings per share calculation as their effect would have been antidilutive:

Three Months Ended September 30,

 2000
 1999
Warrants and stock options 10,298,111 7,077,082
Nine Months Ended September 30,

 2000
 1999
Warrants and stock options 10,298,111 7,077,082

7



Item 2. Management's Discussion and Analysis

Forward-Looking Information

    The Financial Statements and Notes thereto should be read in conjunction with the following discussion. The discussion in this Form 10-Q contains certain forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.


Overview

    From its inception in July 1980, the Company has devoted its resources primarily to fund its research and development efforts. The Company has been unprofitable since inception and, other than limited interest, license fees and grants, has had no material revenues from the sale of products or other sources, and does not expect material revenues for at least the next 12 months. The Company expects to continue to incur losses for the foreseeable future as it expands its research and development efforts. As of September 30, 2000, the Company's accumulated deficit was $57,286,276.


Results of Operations

    Revenues, from license fees, grants and research contracts, increased to $122,215 in the third quarter of 2000 from $3,558 in the third quarter of 1999. Revenues, from license fees, grants and research contracts, increased to $1,272,338 for the nine months ended September 30, 2000 from $7,783 for the comparable period of 1999 due primarily to the receipt of a $1,000,000 fee for expansion of a license for diagnostic applications.

    Operating expenses increased to $2,713,449 in the third quarter of 2000 from $2,244,335 in the third quarter of 1999 and to $8,060,112 for the nine months ended September 30, 2000 from $6,112,292 for the comparable period of 1999 due to increases in research and development staffing and increased expenses associated with outside collaborations and pre-clinical and clinical testing of the Company's technologies. Additionally, increased general and administrative costs were incurred to support the research expansion, and to continue to broaden the Company's investor and public relations efforts. Net interest income increased to $339,130 in the third quarter of 2000 from $35,696 in the third quarter of 1999 and to $555,375 for the nine months ended September 30, 2000 from $162,784 for the comparable period in 1999 due to earnings on increased cash balances.


Liquidity and Capital Resources

    The Company's cash and cash equivalents were $29,554,775 at September 30, 2000, compared with $8,683,005 at December 31, 1999. The increase of $20,871,770 was primarily due to net proceeds of $19,886,619 from the Company's secondary offering completed August 1, 2000, net proceeds of $4,744,720 from the alliance with SuperGen, Inc. for shared development and marketing rights for Avicine and $2,754,635 from the exercise of options and warrants, offset by $5,811,372 used in operations and $702,832 used for investing activities which consist primarily of purchases of property and equipment and patent related costs. In addition the Company's short-term securities increased $5,655,386 to $8,592,886 at September 30, 2000 due to receiving 347,826 shares of SuperGen, Inc. common stock from the alliance with SuperGen, Inc. for shared development and marketing rights for Avicine, offset by unrealized losses in the value of these securities.

    In April 2000, the Company entered into an alliance with SuperGen, Inc. for shared development and marketing rights for Avicine. Under the terms of the agreement, AVI and SuperGen will equally share in future clinical development and FDA registration costs as well as in profits from product sales

8


in the United States. At closing the Company received from SuperGen, Inc. $5,000,000 in cash and 347,826 shares of SuperGen, Inc. common stock in exchange for 1,684,211 shares of AVI common stock and a warrant to purchase 1,665,878 shares of AVI common stock, subject to anti-dilution provisions. Closing of the transaction occurred during the third quarter of 2000.

    In July 2000, the Company completed a secondary offering for 3,000,000 shares of common stock at $7.25 per share. Closing occurred in August 2000. Net proceeds were $19,886,619. In addition, representatives' warrants to purchase 300,000 shares of AVI common stock were issued to the underwriters' of the secondary offering.

    The Company's future expenditures and capital requirements will depend on numerous factors, including without limitation, the progress of its research and development programs, the progress of its pre-clinical and clinical trials, the time and costs involved in obtaining regulatory approvals, the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, competing technological and market developments, the ability of the Company to establish collaborative arrangements and the terms of any such arrangements, and the costs associated with commercialization of its products. The Company's cash requirements are expected to continue to increase significantly each year as it expands its activities and operations. There can be no assurance, however, that the Company will ever be able to generate product revenues or achieve or sustain profitability.

    The Company expects that its cash requirements over the next twenty-four months will be satisfied by existing cash resources.

9



PART II—OTHER INFORMATION

Item 6.  Exhibits and Reports on Form 8-K

(a)
The exhibit filed as a part of this report is listed below and this list constitutes the exhibit index.

Exhibit No

  
27 Financial Data Schedule
(b)
Reports on Form 8-K

The Company did not file any Reports on Form 8-K during the quarter ended September 30, 2000.

10



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.

Date: November 4, 2000 AVI BIOPHARMA, INC.
 
 
 
 
 
By:
 
/s/ 
DENIS R. BURGER, PH.D.   
Denis R. Burger, Ph.D.
Chief Executive Officer and Chairman (of the Board of Directors) (Principal Executive Officer)
 
 
 
 
 
By:
 
/s/ 
MARK M. WEBBER   
Mark M. Webber
Chief Financial Officer (Principal Financial and Accounting Officer)

11



QuickLinks

(Mark One)
Item 2. Management's Discussion and Analysis
Forward-Looking Information
Overview
Results of Operations
Liquidity and Capital Resources
PART II—OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES