UNITED STATES
SECURITIES AND EXCHANGE COMMISION
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.
| 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 Registrants Common Stock outstanding, par value $0.001 per share.
This quarterly report on Form 10-Q consists of 33 pages.
1
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. | Managements 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
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
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
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
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 | |||||||||||||||||||||||||||||