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UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

ý

Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2004

 

 

 

 

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:  0-24760

 

Orphan Medical, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

41-1784594

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer Identification Number)

 

 

 

13911 Ridgedale Drive, Suite 250, Minnetonka, MN 55305

 

(952) 513-6900

(Address of principal executive office
and zip code)

 

(Registrant’s telephone number,
including area code)

 

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, and (2) has been subject to such filing requirements for the past 90 days.

 

 

Yes ý

No o

 

 

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

 

 

Yes ý

No o

 

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.

 

Common Stock, $.01 par value

 

11,423,211

(Class)

 

(Outstanding at November 1, 2004)

 

 



 

INDEX

 

ORPHAN MEDICAL, INC. ®

 

PART I. FINANCIAL INFORMATION

 

 

 

Item 1.

Financial Statements (Unaudited)

 

 

 

Balance Sheets - September 30, 2004 and December 31, 2003.

 

 

 

Statements of Operations – Three and nine months ended September 30, 2004 and September 30, 2003.

 

 

 

Statements of Cash Flows - Nine months ended September 30, 2004 and September 30, 2003.

 

 

 

Notes to 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

 

 

Antizol®, Antizol-Vet®, Cystadane®, Xyrem®, MedExpand™ “The” Orphan Drug Company™ Orphan Medical®, Inc. and Dedicated to Patients with Uncommon Diseases® are trademarks of the Company.

 

2



 

PART I - FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

ORPHAN MEDICAL, INC.

BALANCE SHEETS

(in thousands except share and per share amounts)

 

 

 

September 30,
2004

 

December 31,
2003

 

 

 

(Unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

14,820

 

$

23,285

 

Restricted cash

 

125

 

128

 

Accounts receivable, less allowance for doubtful accounts of $25 and $112, respectively

 

2,816

 

2,552

 

Inventories

 

1,796

 

1,696

 

Prepaid expenses and other

 

810

 

907

 

Total current assets

 

20,367

 

28,568

 

Office equipment and software

 

562

 

754

 

Total assets

 

$

20,929

 

$

29,322

 

Liabilities and shareholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,073

 

$

2,923

 

Accrued compensation

 

1,314

 

881

 

Deferred revenue

 

1,667

 

2,500

 

Accrued expenses and other

 

3,093

 

2,460

 

Total current liabilities

 

7,147

 

8,764

 

Capital lease obligation-less current maturities

 

48

 

62

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Senior Convertible Preferred Stock, $.01 par value; 14,000 shares authorized; 8,706 shares issued and outstanding; liquidation preference of $8,706

 

 

 

Series B Convertible Preferred Stock, $.01 par value; 5,000 shares authorized; 4,106 and 3,957 shares issued and outstanding; liquidity preference of $4,106 and $3,957

 

 

 

Series C Convertible Preferred Stock, $.01 par value; 4 ,000 shares authorized; 0 shares issued and outstanding

 

 

 

Series D Convertible Preferred Stock, $.01 par value; 1,000 shares authorized; 0 shares issued and outstanding

 

 

 

Common stock, $.01 par value; 25,000,000 shares authorized; 11,422,791 and 10,747,656 issued and outstanding

 

114

 

107

 

Additional paid-in capital

 

80,946

 

76,714

 

Accumulated deficit

 

(67,326

)

(56,325

)

Total shareholders’ equity

 

13,734

 

20,496

 

Total liabilities and shareholders’ equity

 

$

20,929

 

$

29,322

 

 

Note: The Balance Sheet at December 31, 2003 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. See Accompanying Notes.

 

3



 

Orphan Medical, Inc.

Statements of Operations

(in thousands except for per share amounts)

 

(Unaudited)

 

 

 

For the Three Months Ended
September 30,

 

For the Nine Months Ended
September 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Product revenues, net

 

$

6,651

 

$

2,982

 

$

16,049

 

$

11,898

 

Licensing and royalty revenue

 

437

 

 

1,854

 

 

Total revenue

 

7,088

 

2,982

 

17,903

 

11,898

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

884

 

501

 

2,249

 

1,965

 

Product development

 

2,938

 

2,895

 

10,125

 

7,381

 

Sales and marketing

 

3,832

 

3,397

 

12,596

 

11,355

 

General and administrative

 

829

 

1,106

 

3,085

 

3,749

 

Total operating expenses

 

8,483

 

7,899

 

28,055

 

24,450

 

Loss from operations

 

(1,395

)

(4,917

)

(10,152

)

(12,552

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

41

 

41

 

132

 

77

 

Interest expense

 

 

(35

)

(22

)

(84

)

Other income

 

 

34

 

 

34

 

Gain on divestment of products