Santarus Reports First Quarter 2006 Financial Results; Conference Call to Begin at 5:00 p.m. Eastern Time Today.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Santarus, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : SNTS SNTS Society for New Testament Studies SNTS Standalone NMD Training System ), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today reported financial and operating results for the quarter ended March 31, 2006. E[acute accent acute accent n. A mark (´) indicating: a. that a vowel is close or tense, as é in French été. b. that a vowel or syllable has a high or rising pitch, as in Chinese or Ancient Greek. c. ]Key financial results and highlights for the first quarter of 2006 included: E[acute accent]--Total first quarter revenue of $6.5 million, including net product sales of $5.8 million E[acute accent]--Net loss of $19.9 million in the first quarter, or $0.45 per share, including approximately $2.4 million, or $0.05 per share, in stock-based compensation expense E[acute accent]--U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ZEGERID(R) (omeprazole/sodium bicarbonate bicarbonate or hydrogen carbonate, chemical compound containing the bicarbonate radical, -HCO3. The most familiar of such compounds is sodium bicarbonate (baking soda). See carbonate. ) Capsules in late February. ZEGERID Capsules are indicated for the treatment of heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink. and other symptoms associated with gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. (GERD GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD ), the short-term treatment and maintenance of healing of erosive e·ro·sive adj. Causing erosion. esophagitis esophagitis /esoph·a·gi·tis/ (e-sof?ah-ji´tis) inflammation of the esophagus. chronic peptic esophagitis reflux e. , and the short-term treatment of duodenal duodenal /du·o·de·nal/ (doo?o-de´n'l) (doo-od´ah-n'l) of or pertaining to the duodenum. Duodenal Refers to the duodenum, or the first part of the small intestine. and gastric ulcers. E[acute accent]--FDA approval of an NDA for ZEGERID with Magnesium Hydroxide magnesium hydroxide: see milk of magnesia. (omeprazole/sodium bicarbonate/magnesium hydroxide hydroxide (hīdrŏk`sīd), chemical compound that contains the hydroxyl (−OH) radical. The term refers especially to inorganic compounds. ) Chewable Tablets in late March for the same indications as ZEGERID Capsules E[acute accent]--Reported favorable top-line results from a comparative Phase IV clinical trial Noun 1. phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier with ZEGERID Powder for Oral Suspension in reducing the occurrence of nocturnal acid breakthrough E[acute accent]--Commercial launch of ZEGERID Capsules in late March E[acute accent]"We believe the availability of ZEGERID Capsules will significantly improve our competitive position in the $12 billion proton pump inhibitor proton pump inhibitor n. A class of drugs that inhibit gastric acid secretion by interfering with the movement of hydrogen ions across cell membranes and are used mainly to treat peptic ulcers, gastroesophageal reflux disease, and esophagitis. (PPI (1) (Pixels Per Inch) The measurement of the resolution of a monitor or scanner. For example, a monitor that is 16 inches wide and displays 1600 pixels across its width would have a resolution of 100 ppi (1600 divided by 16). ) market," said Gerald T. Proehl, president and chief executive officer of Santarus. "Initial feedback from our sales force and early prescription trends for the capsule dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. are encouraging. With just five weeks of data since the commercial launch of ZEGERID Capsules, total prescriptions for the ZEGERID brand, as reported by market research firm IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. , have grown approximately 27 percent over the total prescriptions in the preceding five-week period." E[acute accent]First Quarter 2006 Financial Results E[acute accent]Net product sales for the first quarter of 2006 were $5.8 million, a 300 percent increase over net product sales of $1.4 million in the first quarter of 2005. In the first quarter of 2006, net product sales consisted primarily of sales of ZEGERID Powder for Oral Suspension, as ZEGERID Capsules were commercially launched in late March 2006. First quarter 2005 net product sales consisted of sales of ZEGERID Powder for Oral Suspension 20 mg, which was commercially launched in October 2004, and sales of ZEGERID Powder for Oral Suspension 40 mg, which was commercially launched in late February 2005. E[acute accent]Product sales are recognized net of allowances for product returns, contractual allowances and other discounts. Given the company's recent product launches and limited sales history, sales allowances have been established for potential product returns based on an analysis of product shipments to wholesale distributors in excess of prescription demand for ZEGERID Capsules and ZEGERID Powder for Oral Suspension. E[acute accent]Total revenues for the first quarter of 2006 were $6.5 million, consisting of the $5.8 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. Total revenues for the first quarter of 2005 were $12.2 million, consisting of $1.4 million in net product sales, $714,000 in co-promotion revenue from Otsuka America, and a $10.0 million milestone payment received from TAP Pharmaceutical Products Inc. (TAP), under a sublicense agreement that was subsequently terminated in March 2006. E[acute accent]Santarus reported a net loss of $19.9 million, or $0.45 per share, for the first quarter of 2006, compared with a net loss of $13.6 million, or $0.37 per share, for the first quarter of 2005. The 2006 first quarter results include approximately $2.4 million, or $0.05 per share, in stock-based compensation expense. E[acute accent]Effective January 1, 2006, the company adopted the fair value recognition provisions of Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment (SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System No. 123R) using the modified prospective transition method. Under this transition method, Santarus is not adjusting its historical financial statements to reflect the impact of SFAS No. 123R stock-based compensation expense. E[acute accent]The cost of sales was $931,000 for the first quarter of 2006 and $258,000 for the first quarter of 2005, or approximately 16% and 18% of net product sales, respectively. E[acute accent]Santarus reported license fees and royalties of $810,000 in the first quarter of 2006, which consisted of royalties payable to the University of Missouri and to Otsuka America based on net product sales. Santarus reported license fees and royalties of $1.7 million in the first quarter of 2005, which consisted of $1.5 million paid to the University of Missouri, representing 15% of the milestone fee received from TAP, and royalties payable to the University of Missouri and to Otsuka America based on net product sales. E[acute accent]Research and development expenses for the first quarter of 2006 were $2.4 million, compared with $3.1 million for the first quarter of 2005. The decrease in research and development expenses was primarily attributable to a decrease in manufacturing development activities associated with ZEGERID Chewable Tablets and a decrease in compensation costs associated with a reduction in headcount, primarily in drug development. E[acute accent]Selling, general and administrative expenses were $23.0 million for the first quarter of 2006, compared with $23.4 million for the first quarter of 2005. The decrease in selling, general and administrative expenses was primarily attributable to decreased compensation costs associated with sales and marketing personnel resulting from a decrease in headcount, decreased travel and entertainment expenses Travel and entertainment expense Funds spent on business travel and entertainment that qualify for a tax deduction of 50% of the amount claimed. and decreased advertising and promotional expenses. These decreases in selling, general and administrative expenses were offset in part by approximately $1.7 million of additional stock-based compensation expense recognized upon the company's adoption of SFAS No. 123R. E[acute accent]Interest and other income in the period ended March 31, 2006 of $712,000 decreased approximately $2.0 million when compared with the first quarter of 2005 primarily due to interest income awarded to Santarus in connection with the $10.0 million milestone payment received from TAP in February 2005 after the company prevailed in an alternative dispute resolution Procedures for settling disputes by means other than litigation; e.g., by Arbitration, mediation, or minitrials. Such procedures, which are usually less costly and more expeditious than litigation, are increasingly being used in commercial and labor disputes, Divorce proceeding. E[acute accent]As of March 31, 2006, Santarus had cash, cash equivalents and short-term investments of $59.9 million, compared with $69.4 million as of December 31, 2005, a decrease of $9.5 million. This decrease resulted primarily from the company's net loss for the three months ended March 31, 2006, offset in part by net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $7.6 million received from a draw down under the committed equity financing Equity Financing The act of raising money for company activities by selling common or preferred stock to individual or institutional investors. In return for the money paid, shareholders receive ownership interests in the corporation. facility (CEFF CEFF Colorado Environmental Film Festival ) entered into in February 2006 with Kingsbridge Capital Limited, a private investment group. Under the CEFF, the company may be able to sell up to the lesser of an additional $67.2 million or 7,534,964 shares of common stock, subject to certain conditions, over a three year period. The CEFF is designed to allow Santarus to raise capital, at its discretion, to support Santarus' corporate activities. E[acute accent]Conference Call E[acute accent]Santarus has scheduled an investor conference call regarding this announcement at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) today, May 4, 2006. 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 the conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 8232967. The live conference call also will be available via the Internet by visiting the Investor Relations Investor relations The process by which the corporation communicates with its investors. 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. E[acute accent]About Santarus E[acute accent]Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients. The company's products are immediate-release formulations of omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with , a widely prescribed PPI. The company's marketed products include ZEGERID Capsules (launched in late March 2006) and ZEGERID Powder for Oral Suspension. Santarus received FDA approval for its third dosage form, ZEGERID with Magnesium Hydroxide Chewable Tablets, in March 2006. More information about Santarus is available on the company's Web site at www.santarus.com. E[acute accent]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 successfully launch and drive market demand for ZEGERID Capsules, as well as continue to generate commercial sales of ZEGERID Powder for Oral Suspension and any other products that may be marketed; 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 Side effects Effects of a proposed project on other parts of the firm. or inadequate therapeutic efficacy of Santarus' products 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 Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. ; other difficulties or delays relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the development, testing, manufacturing and marketing of Santarus' products; Santarus' ability to obtain additional financing as needed as needed prn. See prn order. to support its operations; and other risks detailed in Santarus' prior press releases as well as in public periodic filings with the Securities and Exchange Commission. E[acute accent]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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 21E of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. E[acute accent]Santarus(R) and ZEGERID(R) are trademarks of Santarus, Inc.
Santarus, Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)
March 31, December 31,
2006 2005
---------------- -----------------
Assets
Current assets:
Cash and cash equivalents and
short-term investments $59,897 $69,367
Accounts receivable, net 7,820 2,663
Inventories, net 3,350 3,133
Other current assets 1,567 1,253
---------------- -----------------
Total current assets 72,634 76,416
Long-term restricted cash 1,700 1,950
Property and equipment, net 553 617
Other assets 890 952
---------------- -----------------
Total assets $75,777 $79,935
================ =================
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued
liabilities $12,035 $9,485
Allowance for product returns 8,033 4,464
Current portion of deferred
revenue 2,857 2,857
Current portion of long-term
debt 22 38
---------------- -----------------
Total current liabilities 22,947 16,844
Deferred revenue, less current
portion 7,857 8,571
Total stockholders' equity 44,973 54,520
---------------- -----------------
Total liabilities and
stockholders' equity $75,777 $79,935
================ =================
Santarus, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended
March 31,
--------------------------
2006 2005
----------- -----------
Revenues:
Product sales, net $5,790 $1,449
Sublicense and co-promotion
revenue 714 10,714
----------- -----------
Total revenues 6,504 12,163
Costs and expenses:
Cost of sales 931 258
License fees and royalties 810 1,703
Research and development 2,372 3,118
Selling, general and
administrative 23,028 23,411
----------- -----------
Total costs and expenses 27,141 28,490
----------- -----------
Loss from operations (20,637) (16,327)
Interest and other income, net 712 2,760
----------- -----------
Net loss $(19,925) $(13,567)
=========== ===========
Basic and diluted net loss per share $(0.45) $(0.37)
=========== ===========
Weighted average shares outstanding to
calculate basic and diluted net
loss per share 44,670,257 36,230,843
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