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UNITED STATES
SECURITIES AND EXCHANGE COMMISION

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, 2003
     
o   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
000-50438

Myogen, Inc.

(Exact name of Registrant as specified in its charter)
     
     
Delaware
(State or other jurisdiction of
incorporation or organization)
  84-1348020
(I.R.S. Employer
Identification No.)

7575 West 103rd Avenue, Suite 102
Westminster, CO 80021
(303) 410-6666

(Address, including zip code, and telephone number,
including area code, of principal executive offices)

     Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes o       No x

     Check whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes o       No x

     As of December 3, 2003 there were 26,457,927 shares of the Registrant’s Common Stock outstanding, par value $0.001 per share.

This quarterly report on Form 10-Q consists of 33 pages.

1


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF CASH FLOWS
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 2. Changes in Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Submission of Matters to a Vote of Security Holders.
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
EXHIBIT INDEX
EX-31.1 Certification-Principal Executive Officer
EX-31.2 Certification-Principal Financial Officer
EX-32.1 Section 1350 Certification


Table of Contents

MYOGEN, INC.
FORM 10-Q

INDEX

                 
            Page
            Number
           
PART I. Financial Information     3  
ITEM 1.   Consolidated Financial Statements (unaudited)     3  
       
Consolidated Balance Sheets— as of December 31, 2002 and September 30, 2003
    3  
       
Consolidated Statements of Operations— for the three and nine months ended September 30, 2002 and 2003 and the cumulative period from June 10, 1996 (date of inception) through September 30, 2003
    4  
       
Consolidated Statements of Cash Flows— for the nine months ended September 30, 2002 and 2003 and the cumulative period from June 10, 1996 (date of inception) through September 30, 2003
    5  
       
Consolidated Statements of Stockholders’ Deficit– for the nine months ended September 30, 2003
    6  
       
Notes to Consolidated Financial Statements
    7  
ITEM 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations     13  
ITEM 3.   Quantitative and Qualitative Disclosures About Market Risk     26  
ITEM 4.   Controls and Procedures     27  
PART II. Other Information     28  
ITEM 1.   Legal Proceedings     28  
ITEM 2.   Changes in Securities and Use of Proceeds     28  
ITEM 3.   Defaults Upon Senior Securities     29  
ITEM 4.   Submission of Matters to a Vote of Security Holders     29  
ITEM 5.   Other Information     30  
ITEM 6.   Exhibits and Reports on Form 8-K     30  
SIGNATURE     31  
EXHIBIT INDEX     32  

2


Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED BALANCE SHEETS
(Unaudited)

                         
            September 30,   December 31,
            2003   2002
           
 
            (Unaudited)        
       
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 7,239,045     $ 6,993,146  
 
Short-term investments
    43,062,015       26,804,619  
 
Accounts receivable
    1,240,418       741,852  
 
Inventories, net
    833,552       860,200  
 
Prepaid expenses and other current assets
    616,144       1,018,353  
 
 
   
     
 
     
Total current assets
    52,991,174       36,418,170  
Property and equipment, net
    1,255,298       1,691,931  
Other assets
    34,290       33,590  
 
 
   
     
 
     
Total assets
  $ 54,280,762     $ 38,143,691  
 
 
   
     
 
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current liabilities:
               
 
Accounts payable
  $ 5,419,441     $ 2,748,647  
 
Accrued liabilities
    1,023,625       938,102  
 
Current portion of capital lease obligations
    35,762       25,968  
 
Current portion of notes payable, net of discount
    1,733,943       954,004  
 
 
   
     
 
     
Total current liabilities
    8,212,771       4,666,721  
Capital lease obligations, net of current portion
    130,877       106,870  
Notes payable, net of current portion and discount
    2,287,525       3,633,152  
Commitments and contingencies
               
Mandatorily redeemable convertible preferred stock
    158,084,965       106,565,591  
Stockholders’ deficit:
               
 
Series B convertible preferred stock, $0.001 par value, 810,000 shares authorized and 803,606 shares issued and outstanding as of December 31, 2002 and September 30, 2003; aggregate liquidation preference of $1,104,958 as of December 31, 2002 and September 30, 2003
    804       804  
 
Common stock, $0.001 par value; 17,375,000 and 24,221,913 shares authorized and 1,024,361 and 1,055,294 shares issued and outstanding as of December 31, 2002 and September 30, 2003, respectively
    1,057       1,025  
 
Deferred stock-based compensation
    (8,676,149 )     (1,726,692 )
 
Other comprehensive income
    23,357       225,420  
 
Deficit accumulated during the development stage
    (105,784,445 )     (75,329,200 )
 
 
   
     
 
     
Total stockholders’ deficit
    (114,435,376 )     (76,828,643 )
 
 
   
     
 
     
Total liabilities, mandatorily redeemable convertible preferred stock and stockholders’ deficit
  $ 54,280,762     $ 38,143,691  
 
 
   
     
 

The accompanying notes are an integral part of these consolidated financial statements.

3


Table of Contents

MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

                                             
                                        Cumulative
                                        Period from
        For the Three Months Ended   For the Nine Months Ended   June 10, 1996
        September 30,   September 30,   (Inception) to
        2002   2003   2002   2003   September 30, 2003
       
 
 
 
 
Sales
  $ 635,229     $ 707,013     $ 1,657,128     $ 2,071,823     $ 6,649,824  
Cost of product sold
    224,783       220,192       661,001       654,138       2,455,679  
 
   
     
     
     
     
 
Gross profit
    410,446       486,821       996,127       1,417,685       4,194,145  
 
   
     
     
     
     
 
Operating expenses:
                                       
 
Research and development (excluding stock-based compensation expense of $184,176, $501,467, $207,201, $1,243,861 and $1,726,682, respectively)
    8,421,399       7,052,067       17,698,708       24,621,961       75,977,053  
 
Selling, general and administrative (excluding stock-based compensation expense of $106,970, $339,949, $106,970, $862,441 and $1,112,846, respectively)
    1,460,212       662,738       3,706,544       2,564,309       16,016,423  
 
Stock-based compensation expense
    291,146       841,416       314,171       2,106,302       2,839,528  
 
   
     
     
     
     
 
   
Total operating expenses
    10,172,757       8,556,221       21,719,423       29,292,572       94,833,004  
 
   
     
     
     
     
 
Loss from operations
    (9,762,311 )     (8,069,400 )     (20,723,296 )     (27,874,887 )     (90,638,859 )
Interest income (expense), net
    251,589       (55,125 )     744,103       (63,379 )     2,472,507  
 
   
     
     
     
     
 
Loss before income taxes
    (9,510,722 )     (8,124,525 )     (19,979,193 )     (27,938,266 )     (88,166,352 )
Income taxes
    7,199       5,530       10,779       16,165       37,616  
 
   
     
     
     
     
 
Net loss
    (9,517,921 )     (8,130,055 )     (19,989,972 )     (27,954,431 )     (88,203,966 )
Accretion of mandatorily redeemable convertible preferred stock
    (3,670,935 )     (4,243,618 )     (11,012,805 )     (11,583,987 )     (30,896,369 )
Deemed dividend related to beneficial conversion feature of preferred stock
          (39,935,388 )           (39,935,388 )     (39,935,388 )
 
   
     
     
     
     
 
Net loss attributable to common stockholders
  $ (13,188,856 )   $ (52,309,061 )   $ (31,002,777 )   $ (79,473,806 )   $ (159,035,723 )
 
   
     
     
     
     
 
Basic and diluted net loss per common share
  $ (12.95 )   $ (50.29 )   $ (30.27 )   $ (76.99 )        
 
   
     
     
     
         
Weighted average common shares outstanding
    1,018,718       1,040,108       1,024,361       1,032,200          
 
   
     
     
     
         

The accompanying notes are an integral part of these consolidated financial statements.

4


Table of Contents

MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

                               
                          Cumulative
          For the Nine Months Ended   Period From
          September 30,   June 10, 1996
         
  (Inception) to
          2002   2003   September 30, 2003
         
 
 
Cash Flows From Operating Activities:
                       
Net loss
  $ (19,989,972 )   $ (27,954,431 )   $ (88,203,966 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
 
Depreciation and amortization
    208,573       307,013       905,726  
 
Amortization of deferred stock-based compensation
    314,171       2,106,302       2,839,528  
 
Amortization of debt discount
    2,939       103,211       114,026  
 
Amortization of investment premium
    165,901       25,560       188,709  
 
Stock exchanged for license
                1,163,229  
 
Loss on disposal of property and equipment
    22,638       11,951       34,589  
 
Changes in operating assets and liabilities:
                       
   
Accounts receivable
    (688,172 )     88,667       (556,735 )
   
Inventories
    34,533       26,648       (833,552 )
   
Prepaid expenses and other assets
    395,591       (191,822 )     (1,200,010 )
   
Accounts payable
    566,072       2,523,938       5,287,833  
   
Accrued liabilities
    825,759       79,277       785,392  
 
   
     
     
 
     
Net cash used in operating activities
    (18,141,969 )     (22,873,687 )     (79,475,231 )
 
   
     
     
 
Cash Flows From Investing Activities:
                       
Acquisitions of property and equipment
    (925,383 )     (144,511 )     (2,305,427 )
Proceeds from sale of property and equipment
    14,272       317,921       332,193  
Purchases of short-term investments
    (54,808,311 )     (51,194,633 )     (259,733,257 )
Proceeds from maturities of short-term investments
    56,419,984       34,945,379       216,666,424  
 
   
     
     
 
     
Net cash provided by (used in) investing activities
    700,562       (16,075,844 )     (45,040,067 )
 
   
     
     
 
Cash Flows From Financing Activities:
                       
Proceeds from related party note
                370,275  
Repayments of related party note
    62,320             (289,887 )
Proceeds from notes payable
                5,250,000  
Payments on notes payable
    (64,186 )     (668,899 )     (918,899 )
Proceeds from issuance of mandatorily redeemable convertible preferred stock, net of issuance costs
    (35,110 )     39,935,387       127,151,603  
Proceeds from issuance of common stock
    100,714       27,446       170,388  
Payments on capital leases
    (18,916 )     (21,760 )     (47,359 )
 
   
     
     
 
     
Net cash provided by financing activities
    44,822       39,272,174       131,686,121  
 
   
     
     
 
Effect of exchange rates on cash
    203,664       (76,744 )     68,222  
Net (decrease) increase in cash and cash equivalents
    (17,192,920 )     245,899       7,239,045  
Cash and cash equivalents, beginning of period
    21,343,285       6,993,146        
 
   
     
     
 
Cash and cash equivalents, end of period
  $ 4,150,365     $ 7,239,045     $ 7,239,045  
 
   
     
     
 
Supplemental Disclosure of Non-Cash Financing Activities:
                       
Acquisition of property and equipment under capital leases
    158,438       72,609       231,046  
Common stock issued in exchange for notes receivable
                81,362  
Convertible preferred stock issued in exchange for license
                1,163,229  
Mandatorily redeemable convertible preferred stock issued in lieu of cash commission on issuance of Series D mandatorily redeemable convertible preferred stock
                928,961  

The accompanying notes are an integral part of these consolidated financial statements.

5


Table of Contents

MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(Unaudited)

                                                                           
      Series B                                           Deficit    
      Convertible                                   Other   Accumulated    
      Preferred Stock   Common Stock   Additional   Deferred   Comprehensive   During the   Total
     
 
  Paid-In   Stock-Based   Income   Development   Stockholders'
      Shares   Amount   Shares   Amount   Capital   Compensation   (Loss)   Stage   Deficit