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8-K - FORM 8-K - SANTARUS INC | a58872e8vk.htm |
Exhibit 99.1
COMPANY CONTACT:
|
INVESTOR CONTACT: | |
Martha L. Hough
|
Lippert/Heilshorn & Associates, Inc. | |
VP Finance & Investor Relations
|
Jody Cain (jcain@lhai.com) | |
(858) 314-5824
|
Bruce Voss (bvoss@lhai.com) | |
Debra P. Crawford
|
(310) 691-7100 | |
Chief Financial Officer |
||
(858) 314-5708 |
For Immediate Release
SANTARUS REPORTS FOURTH QUARTER AND FULL YEAR 2010 FINANCIAL RESULTS
2010 total revenues and bottom-line exceed company guidance
Expands 2011 financial outlook
Conference call to begin at 5:00 p.m. Eastern time today
SAN DIEGO (March 3, 2011) Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical
company, today reported financial and operating results for the quarter and full year ended
December 31, 2010.
Key financial results for the 2010 fourth quarter:
| Total revenues of $25.9 million. |
| Net loss of $2.1 million, or $0.03 per share, which included approximately $5.4 million in success-based milestones expensed in the quarter. |
Key financial results for the 2010 full year:
| Total revenues of $125.4 million. |
| Net loss of $18.5 million, or $0.31 per share, which included approximately $7.1 million in one-time restructuring charges, a $15.0 million upfront fee paid for North American rights to RHUCIN® (recombinant human C1 inhibitor) and approximately $5.4 million in success-based milestones. |
| Cash, cash equivalents and short-term investments of $60.8 million as of December 31, 2010. |
Following a series of business development transactions during the second half of last year, we
now are well positioned to increase near-term revenues with two promoted products for the large and
growing type 2 diabetes market. We also broadened our development pipeline and have a blend of
late-stage and earlier-stage product candidates in our portfolio to drive medium to longer-term
revenue growth, said Gerald T. Proehl, president and chief executive officer of Santarus.
Santarus senior vice president and chief financial officer Debra P. Crawford said, We are focused
on growing revenues and returning to profitability while advancing development of our promising
product pipeline. We expect in 2011 to achieve total revenues of approximately $110 million and
net income of at least breakeven on a GAAP basis.
Business Highlights
Key fourth quarter accomplishments and recent business highlights include the following:
| Launched CYCLOSET® (bromocriptine mesylate) tablets in November 2010 with promotion focusing on its consistent glycemic control and cardiovascular safety profile, which were demonstrated in a 3,000-patient clinical study. CYCLOSET is a unique centrally acting dopamine agonist prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, both as monotherapy and in combination with other antidiabetic agents. |
| Resumed promotion of GLUMETZA® 500 mg (metformin HCl extended release tablets) following the resupply of the product to wholesalers and retailers by Depomed, Inc. in January 2011. GLUMETZA is a once-daily prescription drug approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. GLUMETZA is available in 500 mg and 1000 mg tablets. |
| Reported statistically significant top-line results from two Phase III clinical studies evaluating the safety and efficacy of budesonide MMX® 9 mg for the induction of remission of mild or moderate active ulcerative colitis. Santarus expects to complete (last patient last visit) an extended use study in May 2011 with top-line data available in the second half of 2011 and to submit a New Drug Application (NDA) to the FDA at the end of 2011. |
| Announced that the companys partner, Pharming Group NV (NYSE Euronext: PHARM), has initiated an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming expects to enroll approximately 50 patients in the study, which is being undertaken to provide additional data for RHUCIN at the 50 U/kg dose and prospective validation of the visual analog scale used in measuring the clinical effects of RHUCIN. |
| Announced that Pharming received a refusal to file letter from the FDA for the RHUCIN Biologics License Application (BLA) that was submitted by Pharming in late December. In the letter the FDA indicated that the BLA was not sufficiently complete to enable a critical medical review and that they will provide additional feedback on the design of the recently initiated Phase IIIb clinical study. Both Santarus and Pharming intend to meet with the FDA at the earliest opportunity to discuss the issues raised in the FDA letter and to reach a more comprehensive understanding of what would be required for the BLA to be accepted for review. |
Fourth Quarter 2010 Financial Results
Total revenues for the fourth quarter of 2010 were $25.9 million, consisting of $25.0 million in
product-related revenue, and $0.9 million in royalty revenue. Total revenues for the fourth
quarter of 2009 were $62.4 million, consisting of $38.9 million in product-related revenue and
$23.5 million in other license revenue, which included a $20.0 million one-time milestone received
for FDA approval of ZEGERID OTC®.
Net product sales were $17.3 million for the fourth quarter of 2010, compared with net product
sales of $32.2 million for the fourth quarter of 2009. For the fourth quarter of 2010, net product
sales consisted of ZEGERID brand prescription products, sales of the authorized generic version of
ZEGERID Capsules and sales of CYCLOSET. For the fourth quarter of 2009, net product sales
consisted of sales of ZEGERID brand products. Net product sales for the fourth quarter of 2010
were favorably impacted by lower than expected rebates due to decreased utilization, as well as the
termination of certain of the companys managed care and other contracts associated with ZEGERID
brand products.
Promotion revenue for the fourth quarter of 2010 associated with GLUMETZA was $7.7 million,
compared with promotion revenue of $6.7 million for the fourth quarter of 2009. GLUMETZA promotion
revenue was negatively impacted for the fourth quarter of 2010 by the suspension of GLUMETZA 500 mg
product shipments following Depomeds voluntary recall and supply interruption of GLUMETZA 500 mg
from June 2010 through early January 2011.
Santarus reported a net loss of $2.1 million, or $0.03 per share, for the fourth quarter of 2010,
compared with net income of $24.5 million, or $0.40 per diluted share, for the fourth quarter of
2009.
The cost of product sales was $1.2 million for the fourth quarter of 2010, compared with $2.3
million for the fourth quarter of 2009, both of which were approximately 7% of net product sales.
Santarus reported license fees and royalties of $7.3 million for the fourth quarter of 2010, which
included a milestone payment to Cosmo Technologies, Ltd. for successful completion of two Phase III
clinical studies with budesonide MMX. Cosmo elected to receive payment through the issuance of
972,132 shares of the companys common stock at a value of approximately $2.7 million.
Additionally, license fees and royalties for the 2010 fourth quarter included an accrual of
approximately $2.7 million related to a sales milestone payable to Depomed. Santarus expects to
pay Depomed the sales milestone of $3.0 million in March 2011 based on achievement of GLUMETZA net
product sales that exceeded $50.0 million for the 13-month period ending January 31, 2011.
License fees and royalties were $2.3 million for the fourth quarter of 2009.
Research and development (R&D) expenses were $3.4 million for the fourth quarter of 2010, compared
with $6.4 million for the fourth quarter of 2009. The decrease in R&D expenses was primarily
attributable to a decrease in costs associated with the budesonide MMX phase III clinical program.
Selling, general and administrative (SG&A) expenses were $16.1 million for the fourth quarter of
2010, and $25.5 million for the fourth quarter of 2009. The $9.4 million decrease in SG&A expenses
was primarily attributable to a reduction in compensation, benefits and related employee costs and
a decrease in promotional spending related to the decision to cease promotion of ZEGERID products.
These decreases in SG&A expenses were offset in part by an increase in advertising and promotional
spending related to the launch of CYCLOSET.
Full Year 2010 Financial Results
The company reported total revenues of $125.4 million for the year ended December 31, 2010,
compared with total revenues of $172.5 million for the year ended December 31, 2009.
Product-related revenue was $121.6 million for the year ended December 31, 2010 compared with
$142.9 million in product-related revenue for the prior year. Product-related revenue for 2010 was
negatively impacted by the mid-year availability of generic versions of ZEGERID Capsules and
Depomeds voluntary recall and related suspension of GLUMETZA 500 mg product shipments from June
2010 through early January 2011. Santarus reported $3.6 million in royalty revenue and $0.2
million in other license revenue for 2010. The company reported $29.6 million in other license
revenue for the prior year. Total costs and expenses were $143.4 million for 2010 and $138.4
million for 2009.
Santarus reported a net loss of $18.5 million, or $0.31 per share, for the year ended December 31,
2010, compared with net income of $32.1 million, or $0.54 per diluted share, for the year ended
December 31, 2009.
As of December 31, 2010, Santarus had cash, cash equivalents and short-term investments of $60.8
million, compared with $93.9 million as of December 31, 2009.
Financial Outlook for 2011
The company expects the following for 2011:
| Total revenues of approximately $110 million. |
| License fee expenses to include a sales milestone of $3 million payable to Depomed if annual GLUMETZA net product sales exceed $80 million during the calendar year. |
| R&D expenses of approximately $20 million to $23 million, which includes estimated costs associated with the extended use study with budesonide MMX and the planned submission of the NDA, the Phase III clinical |
program with rifamycin SV MMX®, and the Phase I clinical study with SAN-300, as well as other development costs. |
| SG&A expenses of up to approximately $70 million. |
| Achievement of at least breakeven on a GAAP net income basis for the full 2011 year, which includes $3 million in expense associated with a success-based milestone. For the first quarter of 2011, the company expects to report a net loss due to seasonality of prescription demand and promotional launch costs associated with CYCLOSET. |
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, March 3, 2011. 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 43448596. The live conference call also will be available via the
Internet by visiting the Investor Relations section of the companys website at www.santarus.com
and a recording of the call will be available on the companys website for 14 days following the
completion of the call.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and
commercializing proprietary products that address the needs of patients treated by physician
specialists. The companys current commercial efforts are focused on GLUMETZA®
(metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine
mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control
in adults with type 2 diabetes.
Santarus also has a diverse development pipeline, including three product candidates in Phase III
clinical programs: budesonide MMX® for induction of remission of active ulcerative
colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of
hereditary angioedema and rifamycin SV MMX® for treatment of travelers diarrhea, in
addition to other earlier-stage development programs. More information about Santarus is available
on the companys website at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements. These forward-looking statements include
statements regarding projected revenues, expenses and bottom-line financial results, the potential
to achieve a success-based milestone, and expected timing for the budesonide MMX extended use study
and submission of the NDA.
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 generate revenues from GLUMETZA and CYCLOSET; Santarus
ability to successfully advance the development of, obtain regulatory approval for and ultimately
commercialize, its development product candidates; Santarus ability to maintain patent protection
for its products, including the difficulty in predicting the timing and outcome of the GLUMETZA,
ZEGERID and ZEGERID OTC patent litigation; Santarus ability to continue to generate revenues from
its branded and authorized generic ZEGERID prescription products and the impact on Santarus
business and financial condition of the ongoing generic competition for ZEGERID; Santarus ability
to achieve continued progress under its strategic alliances, and the potential for early
termination of, or reduced payments under, these agreements; the impact on Santarus business of
significant change, and the risk that Santarus may not be successful in integrating its marketed
products and development-stage products into its existing operations or in realizing the planned
results from its corporate restructuring or its expanded product portfolio and pipeline;
adverse side effects or inadequate therapeutic efficacy of Santarus products or products Santarus
promotes that could result in product recalls, market withdrawals or product liability claims;
competition from other pharmaceutical or biotechnology companies and evolving market dynamics;
other difficulties or delays relating to the development, testing, manufacturing and marketing of,
and obtaining and maintaining regulatory approvals for, Santarus and its strategic partners
products; fluctuations in quarterly and annual results; Santarus ability to obtain additional
financing as needed to support its operations or future product acquisitions; the impact of
healthcare reform legislation and the recent turmoil in the financial markets; 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® , ZEGERID® and ZEGERID OTC® are trademarks of Santarus,
Inc. GLUMETZA® is a trademark of Biovail Laboratories International S.r.l. licensed
exclusively in the United States to Depomed, Inc. CYCLOSET® is a trademark of
VeroScience LLC. MMX® is a trademark of Cosmo Technologies Limited. RHUCIN®
is a trademark of Pharming Group NV.
[Tables to follow]
Santarus, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents and short-term investments |
$ | 60,797 | $ | 93,944 | ||||
Accounts receivable, net |
7,156 | 16,253 | ||||||
Inventories, net |
3,025 | 5,336 | ||||||
Prepaid expenses and other current assets |
6,086 | 3,797 | ||||||
Total current assets |
77,064 | 119,330 | ||||||
Long-term restricted cash |
1,300 | 1,400 | ||||||
Property and equipment, net |
774 | 875 | ||||||
Intangible assets, net |
13,980 | 9,750 | ||||||
Goodwill |
2,913 | | ||||||
Other assets |
6 | 6 | ||||||
Total assets |
$ | 96,037 | $ | 131,361 | ||||
Liabilities and stockholders equity |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities |
$ | 29,472 | $ | 58,676 | ||||
Allowance for product returns |
13,450 | 12,846 | ||||||
Current portion of deferred revenue |
| 245 | ||||||
Total current liabilities |
42,922 | 71,767 | ||||||
Deferred revenue, less current portion |
2,635 | 2,678 | ||||||
Long-term debt |
10,000 | 10,000 | ||||||
Other long-term liabilities |
2,497 | | ||||||
Total stockholders equity |
37,983 | 46,916 | ||||||
Total liabilities and stockholders equity |
$ | 96,037 | $ | 131,361 | ||||
Santarus, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended | Years Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ | 17,322 | $ | 32,210 | $ | 90,170 | $ | 119,242 | ||||||||
Promotion revenue |
7,650 | 6,702 | 31,365 | 23,631 | ||||||||||||
Royalty revenue |
882 | | 3,571 | | ||||||||||||
Other license revenue |
| 23,471 | 245 | 29,620 | ||||||||||||
Total revenues |
25,854 | 62,383 | 125,351 | 172,493 | ||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of product sales |
1,160 | 2,301 | 7,715 | 8,294 | ||||||||||||
License fees and royalties |
7,272 | 2,281 | 28,576 | 7,976 | ||||||||||||
Research and development |
3,447 | 6,430 | 17,431 | 16,244 | ||||||||||||
Selling, general and administrative |
16,117 | 25,455 | 82,581 | 105,838 | ||||||||||||
Restructuring charges |
(176 | ) | | 7,082 | | |||||||||||
Total costs and expenses |
27,820 | 36,467 | 143,385 | 138,352 | ||||||||||||
Income (loss) from operations |
(1,966 | ) | 25,916 | (18,034 | ) | 34,141 | ||||||||||
Other income (expense): |
||||||||||||||||
Interest income |
12 | 15 | 80 | 194 | ||||||||||||
Interest expense |
(116 | ) | (115 | ) | (461 | ) | (460 | ) | ||||||||
Total other income (expense) |
(104 | ) | (100 | ) | (381 | ) | (266 | ) | ||||||||
Income (loss) before income taxes |
(2,070 | ) | 25,816 | (18,415 | ) | 33,875 | ||||||||||
Income tax expense |
(6 | ) | 1,315 | 59 | 1,760 | |||||||||||
Net income (loss) |
$ | (2,064 | ) | $ | 24,501 | $ | (18,474 | ) | $ | 32,115 | ||||||
Net income (loss) per share: |
||||||||||||||||
Basic |
$ | (0.03 | ) | $ | 0.42 | $ | (0.31 | ) | $ | 0.55 | ||||||
Diluted |
$ | (0.03 | ) | $ | 0.40 | $ | (0.31 | ) | $ | 0.54 | ||||||
Weighted average shares outstanding used to
calculate net income (loss) per share: |
||||||||||||||||
Basic |
59,488,634 | 58,179,582 | 58,734,397 | 57,994,506 | ||||||||||||
Diluted |
59,488,634 | 61,636,432 | 58,734,397 | 59,673,866 |
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