Cubist Pharmaceuticals Reports First Quarter 2006 Results; Total Revenues $40.1 Million; Net Product Revenues $37.9 Million.LEXINGTON, Mass. -- GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). Loss $0.11 Per Share Non-GAAP Loss $0.06 Per Share Earnings Conference Call & Webcast Today (With Slides) at 5:00 pm EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today reported results for the first quarter ended March 31, 2006. CUBICIN continued to show strong revenue growth with $37.9 million of net product revenues for the first quarter of 2006 (which includes $0.6 million of international product sales), compared to $20.9 million for the first quarter of 2005, a 79% increase year-over-year, excluding international product sales. Total revenues for the first quarter of 2006 were $40.1 million, compared to $23.7 million for the first quarter of 2005. The increase was attributable primarily to the significant growth in net product sales of CUBICIN. Net loss for the first quarter of 2006 on a GAAP basis was $5.9 million, or $0.11 per share, compared to $12.9 million or $0.25 per share for the first quarter of 2005. GAAP net loss includes $2.6 million, or $0.05 per share, in stock-based compensation expenses as a result of our adoption on January 1, 2006 of Financial Accounting Standards No. 123(R) ("FAS 123(R)"). Non-GAAP net loss, excluding FAS 123(R) stock-based compensation expenses, was $3.3 million, or $0.06 per share. Sales and marketing expense was $14.1 million for the first quarter of 2006, compared to $9.5 million for the first quarter of 2005. This increase is attributable primarily to the expansion of Cubist's sales force in the first quarter of 2006 resulting in higher payroll and other employee related expenses. Use of Non-GAAP Financial Measures Cubist adopted FAS 123(R) on January 1, 2006 using the modified prospective method, which resulted in the recognition of stock compensation expenses in the statement of operations See Income statement. during the quarter ended March 31, 2006 without adjusting the prior year first quarter. Cubist uses non-GAAP net loss and non-GAAP net loss per share data to improve its analysis of operational results and trends. Cubist's management also uses these non-GAAP figures to make financial and operational decisions as these numbers exclude non-operational activities. These measures should not be considered an alternative to measurements required by GAAP, such as net loss and net loss per share, and should not be considered measures of our liquidity. A reconciliation between non-GAAP financial measures and GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed con·dense v. con·densed, con·dens·ing, con·dens·es v.tr. 1. To reduce the volume or compass of. 2. To make more concise; abridge or shorten. 3. Physics a. consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge .
CONFERENCE CALL & WEBCAST INFORMATION
Cubist will host a conference call and live audio webcast today at
5:00 p.m. EDT to discuss its first quarter financial results, the
company's business activities, and financial outlook.
LIVE DOMESTIC & CANADA CALL-IN: (877) 407-0778
LIVE INTERNATIONAL CALL-IN: (201) 689-8565
24-HOUR REPLAY DOMESTIC & CANADA: (877) 660-6853
24-HOUR REPLAY INTERNATIONAL: (201) 612-7415
REPLAY Account # 286 & Conference ID # 196688 (both are needed)
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
www.cubist.com
Replay will be available for 30 days via the Internet.
About Cubist Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective antiinfective /an·ti·in·fec·tive/ (-in-fek´tiv) counteracting infection, or an agent that does this. products that address unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic antibiotic, any of a variety of substances, usually obtained from microorganisms, that inhibit the growth of or destroy certain other microorganisms. Types of Antibiotics in a new class of antiinfectives called lipopeptides. CUBICIN is currently the only once-daily bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria. Bactericidal An agent that destroys bacteria (e.g. antibiotic approved in the U.S. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, (MSSA MSSA Methicillin-Sensitive Staphylococcus Aureus MSSA Microscopy Society of Southern Africa MSSA Maryland Saltwater Sportfishermen's Association MSSA Military Selective Service Act MSSA Mid-South Sociological Association MSSA Minnesota Social Service Association and MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ) in complicated skin and skin structure infections. In September, 2005, Cubist submitted a supplemental New Drug Application (sNDA) for approval to add S. aureus The aureus (pl. aurei) was a gold coin of ancient Rome valued at 25 silver denarii. The aureus was regularly issued from the 1st century BC to the beginning of the 4th century AD, when it was replaced by the solidus. bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. with known or suspected endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. to the indication statement for CUBICIN. The 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. granted this application priority review. On March 6, the Anti-Infective Drugs Advisory Committee recommended approval of an expanded label for CUBICIN. On March 24th, the FDA issued an approvable letter, with action on a label expected by late May. The Cubist product pipeline includes our lipopeptide program, the product candidate HepeX-B and our natural products screening program. Cubist is headquartered in Lexington, MA. Cubist 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. Statement Statements contained herein that are not historical fact may be forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and such statements are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist. These factors include, but are not limited to: (i) whether we will receive, and the potential timing and scope of, regulatory approvals or clearances to market CUBICIN in other countries and for additional indications in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and other countries pursuant to our currently-planned filings and any filings we determine to make in the future, which filings are subject to approval by the applicable regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. or agencies, regardless of our confidence in the results of the clinical trials supporting such filings; (ii) the level of acceptance of CUBICIN by physicians, patients, and the medical community and the availability of reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. from third-party payors, including governments, private insurance plans and managed care providers; (iii) any changes in the current or anticipated market demand or medical need for CUBICIN; (iv) competition, particularly with respect to CUBICIN; (v) whether the FDA accepts proposed clinical trial protocols A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in that may be achieved in a timely manner; (vi) our ability to conduct successful clinical trials in a timely manner; (vii) the ability of our third party manufacturers, including our single source provider of bulk drug substance, to manufacture sufficient quantities of CUBICIN in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. and at an acceptable cost; (viii) our dependence upon pharmaceutical and biotechnology collaborations; (ix) our ability to finance our operations; (x) the effectiveness of our expanded sales force; (xi) potential costs resulting from product liability or other third party claims; (xii) our ability to protect our proprietary technologies; (xiii) our ability to discover, in-license, or acquire drug candidates and develop and achieve commercial success for drug candidates; (xiv) our ability to integrate successfully the operations of any business we may acquire and the potential impact of any future acquisition on our financial results; and (xv) a variety of risks common to our industry, including ongoing regulatory review, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc intellectual property, and legislative or regulatory changes. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.; HepeX-B is a trademark of XTL XTL Crystal XTL Xpress Train Limited XTL Anything-To-Liquids (synthetic fuels) XTL XML Template Language XTL Xml Transformation Language XTL Extensible Transformation Language XTL Executable Temporal Language Biopharmaceuticals Ltd. Additional information can be found at Cubist's web site at www.cubist.com Tables Follow
CUBIST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
March 31, Dec. 31,
2006 2005
--------- ---------
ASSETS
Cash, cash equivalents and investments $92,870 $101,748
Accounts receivable, net 14,805 14,701
Inventory 19,583 16,695
Property and equipment, net 46,528 46,027
Other assets 35,382 38,894
--------- ---------
Total assets $209,168 $218,065
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $25,396 $35,138
Deferred revenue 1,250 1,250
Debt and capital lease obligations 165,049 165,078
--------- ---------
Total liabilities 191,695 201,466
--------- ---------
Total stockholders' equity 17,473 16,599
--------- ---------
Total liabilities and stockholders' equity $209,168 $218,065
========= =========
CUBIST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except share and per share data)
Three months ended
March 31,
-----------------------
2006 2005
----------- -----------
Revenues:
Product revenues, net $37,941 $20,889
Other revenues 2,114 2,793
----------- -----------
Total revenues, net $40,055 $23,682
Costs and expenses:
Cost of product revenues 10,132 6,925
Research and development 13,581 13,743
Sales and marketing 14,068 9,545
General and administrative 6,668 4,762
----------- -----------
Total costs and expenses 44,449 34,975
Operating loss (4,394) (11,293)
----------- -----------
Other expense, net (1,486) (1,589)
----------- -----------
Net loss $(5,880) $(12,882)
=========== ===========
Basic and diluted net loss per common share $(0.11) $(0.25)
Basic and diluted weighted average number of
common shares 54,079,305 51,506,878
CUBIST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - NON-GAAP
UNAUDITED
(in thousands, except share and per share data)
Three months ended
March 31,
-----------------------
2006 2005
----------- -----------
GAAP net loss $(5,880) $(12,882)
Stock-based compensation expense under SFAS
123(R) 2,575 -
----------- -----------
Non-GAAP proforma net loss $(3,305) $(12,882)
=========== ===========
Non-GAAP Basic and diluted net loss per common
share $(0.06) $(0.25)
Basic and diluted weighted average number of
common shares 54,079,305 51,506,878
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