Santarus (SNTS) 8-K Santarus Reports Third Quarter 2005 Financial Results

Exhibit 99.1

COMPANY CONTACT:
Martha L. Hough
VP Finance & Investor Relations
(858) 314-5824
Debra P. Crawford
Chief Financial Officer
(858) 314-5708 INVESTOR CONTACT:
Lippert/Heilshorn & Associates, Inc.
Jody Cain (jcain@lhai.com)
Mariann Ohanesian(mohanesian@lhai.com)
(310) 691-7100

For Immediate Release

SANTARUS REPORTS THIRD QUARTER 2005 FINANCIAL RESULTS

Conference call to begin at 5:00 p.m. Eastern Time today

SAN DIEGO (November 7, 2005)— Santarus, Inc. (NASDAQ: SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today reported financial and operating results for the quarter ended September 30, 2005. Key financial results for the third quarter of 2005 included:

• Total revenue of $4.9 million, including net product sales of $4.2 million

• Net loss of $16.1 million, or $0.40 per share

“We grew ZEGERID^® product sales by approximately 35 percent over the second quarter of 2005 and together with our efforts to manage expenses, reduced our net loss by $3.5 million compared to the second quarter of this year,” said Gerald T. Proehl, president and chief executive officer of Santarus. “Through our sales and marketing programs, we are continuing to focus on establishing the differential clinical features of our immediate-release ZEGERID brand with physicians who are high prescribers of proton pump inhibitors (PPIs).”

Third Quarter 2005 Financial Results

Revenues for the third quarter of 2005 were $4.9 million, consisting of $4.2 million in net product sales and $714,000 in co-promotion revenue from the amortization of the $15.0 million upfront payment received from Otsuka America Pharmaceutical, Inc. (Otsuka America) in October 2004. Santarus had no revenues in the third quarter of 2004.

Santarus reported a net loss attributable to common stockholders of $16.1 million, or $0.40 per share, for the third quarter of 2005, compared with a net loss attributable to common stockholders of $21.2 million for the third quarter of 2004.

The cost of sales was $612,000, or approximately 15 percent of net product sales, in the third quarter of 2005.

Santarus reported license fees and royalties of $583,000 in the third quarter of 2005, which consisted of royalties payable to the University of Missouri and to Otsuka America based on net product sales. There were no license fees and royalties in the third quarter of 2004.

Research and development expenses for the quarter ended September 30, 2005 were $2.3 million, compared with $5.8 million for the quarter ended September 30, 2004. The lower expenses in the third quarter of 2005 reflect decreases in each of the following: certain clinical trial costs, expenses associated with the preparation

for commercialization of ZEGERID Powder for Oral Suspension and development activities for ZEGERID Capsules and ZEGERID Chewable Tablets.

Selling, general and administrative expenses were $17.5 million for the quarter ended September 30, 2005, and $14.6 million for the quarter ended September 30, 2004. The increase in selling, general and administrative expenses was primarily attributable to promotional costs for ZEGERID Powder for Oral Suspension and the hiring of sales and marketing personnel during the third quarter of 2004, which were fully burdened expenses for the full three months of the quarter ended September 30, 2005.

For the nine months ended September 30, 2005, the company reported revenues of $20.8 million, consisting of $8.7 million in net product sales and $2.1 million in co-promotion revenue from the amortization of the $15.0 million upfront payment received from Otsuka America, and a $10.0 million milestone payment received from TAP Pharmaceutical Products Inc. during the first quarter of 2005. Santarus reported a net loss attributable to common stockholders of $49.2 million, or $1.31 per share, for the nine months ended September 30, 2005, compared with a net loss attributable to common stockholders of $49.4 million for the nine months ended September 30, 2004.

As of September 30, 2005, Santarus had cash, cash equivalents and short-term investments of $85.8 million, compared with $114.0 million as of December 31, 2004, a decrease of $28.2 million. This decrease resulted primarily from the company’s net loss for the nine months ended September 30, 2005, offset in part by the net proceeds of approximately $29.0 million received in August 2005 upon the completion of the company’s registered direct offering of 7,350,000 shares of common stock.

Key 2005 Third Quarter Accomplishments and Recent Highlights

In addition to continued progress with ZEGERID Powder for Oral Suspension commercialization, key third quarter accomplishments and recent highlights include:

• In July, the FDA accepted for filing the New Drug Application (NDA) for ZEGERID Chewable Tablets 40 mg and 20 mg with a March 26, 2006 PDUFA date. The NDA for ZEGERID Capsules was accepted for filing by the FDA in late June, with a February 26, 2006 PDUFA date.

• Santarus did not receive notice of a patent infringement suit from AstraZeneca plc or related patent holders during the 45-day period following notice of the FDA’s acceptance of the NDAs for ZEGERID Capsules and ZEGERID Chewable Tablets.

• In August, Santarus raised approximately $31.2 million in gross proceeds in a registered direct offering of Santarus common stock.

• A ZEGERID review article authored by Dr. Donald Castell, Professor of Medicine and Director of the Esophageal Disorders Program at the Medical University of South Carolina and past president of the American Gastroenterological Association, was published in the November 2005 issue ofExpert Opinion on Pharmacotherapy, a peer-reviewed journal.

Conference Call

Santarus has scheduled an investor conference call regarding this announcement at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) today, November 7, 2005. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 1506810. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s Web site at

www.santarus.com, and a recording of the call will be available on the company’s Web site for 14 days following the completion of the call.

About Santarus

Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products to enhance the quality of life for patients with gastrointestinal diseases and disorders. The company’s current products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company launched its first product, ZEGERID Powder for Oral Suspension 20 mg, in October 2004 and launched ZEGERID Powder for Oral Suspension 40 mg in February 2005. The company submitted an NDA for ZEGERID Capsules 40 mg and 20 mg to the FDA in April 2005 and submitted an NDA for ZEGERID Chewable Tablets 40 mg and 20 mg to the FDA in May 2005. More information about Santarus is available on the company’s Web site atwww.santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to establish market acceptance and demand for ZEGERID Powder for Oral Suspension and any other products that may be approved for marketing; whether the FDA ultimately approves the pending NDAs for ZEGERID Capsules and ZEGERID Chewable Tablets for one or more of the desired indications in a timely manner or at all; Santarus’ ability to obtain additional financing as needed to support its operations; the scope and validity of patent protection for Santarus’ products and Santarus’ ability to commercialize its products without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID Powder for Oral Suspension or Santarus’ other products under development that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for Santarus’ products; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus^® and ZEGERID^® are trademarks of Santarus, Inc.

[Tables to Follow]

Santarus, Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)

	September 30,		December 31,
	2005		2004
Assets
Current assets:
Cash and cash equivalents and short-term investments	$	85,788	$	114,008
Accounts receivable, net		1,501		801
Inventories, net		3,620		1,962
Other current assets		1,859		2,481
Total current assets		92,768		119,252
Long-term restricted cash		1,950		950
Property and equipment, net		702		949
Other assets		1,041		1,065
Total assets	$	96,461	$	122,216
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued liabilities	$	10,531	$	14,806
Allowance for product returns		5,165		7,057
Current portion of deferred revenue		2,857		2,857
Current portion of long-term debt		54		186
Total current liabilities		18,607		24,906
Deferred revenue, less current portion		9,286		11,429
Long-term debt, less current portion		—		38
Total stockholders’ equity		68,568		85,843
Total liabilities and stockholders’ equity	$	96,461	$	122,216

Santarus, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2005			2004			2005			2004
Revenues:
Product sales, net	$	4,164		$	—		$	8,698		$	—
Sublicense and co-promotion revenue		714			—			12,143			—
Total revenues		4,878			—			20,841			—
Costs and expenses:
Cost of sales		612			—			1,376			—
License fees and royalties		583			—			2,718			5,000
Research and development		2,304			5,751			7,553			15,472
Selling, general and administrative		17,507			14,604			60,494			24,154
Stock-based compensation		594			1,285			1,841			4,424
Total costs and expenses		21,600			21,640			73,982			49,050
Loss from operations		(16,722	)		(21,640	)		(53,141	)		(49,050	)
Interest and other income, net		636			448			3,945			815
Net loss		(16,086	)		(21,192	)		(49,196	)		(48,235	)
Accretion to redemption value of redeemable convertible preferred stock		—			—			—			(1,124	)
Net loss attributable to common stockholders	$	(16,086	)	$	(21,192	)	$	(49,196	)	$	(49,359	)
Basic and diluted net loss per share	$	(0.40	)	$	(0.62	)	$	(1.31	)	$	(2.32	)
Weighted average shares outstanding to calculate basic and diluted net loss per share		39,855,186			33,983,523			37,512,214			21,293,866
The composition of stock-based compensation is as follows:
Research and development	$	195		$	403		$	592		$	1,227
Selling, general and administrative		399			882			1,249			3,197
	$	594		$	1,285		$	1,841		$	4,424

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