Connetics Reports Fourth Quarter Revenues of $41.3 Million and EPS of $0.40.PALO ALTO Palo Alto, city, California Palo Alto (păl`ō ăl`tō), city (1990 pop. 55,900), Santa Clara co., W Calif.; inc. 1894. Although primarily residential, Palo Alto has aerospace, electronics, and advanced research industries. , Calif. -- Provides First Quarter 2006 Financial Guidance; Completes Acquisition of PediaMed Sales Organization Connetics Corporation (Nasdaq:CNCT CNCT Connect CNCT Certified Network Computer Technician ), a specialty pharmaceutical company that develops and commercializes dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. products, today reported net income for the quarter ended December 31, 2005 of $15.1 million, or $0.40 earnings per share on a diluted "If-Converted" basis. This compares with net income of $6.0 million, or $0.16 earnings per share on a diluted basis, for the comparable quarter in 2004. The results in the 2005 fourth quarter include a positive impact of $0.25 per diluted share from recording a tax asset of $9.9 million, as previously announced. Total revenues for the fourth quarter of 2005 were $41.3 million, compared with total revenues of $43.8 million in the fourth quarter of 2004. Fourth quarter 2005 product revenues included OLUX(R) sales of $14.7 million, Soriatane(R) sales of $13.6 million, Evoclin(TM) sales of $6.9 million and Luxiq(R) sales of $5.6 million. Selling, general and administrative (SG&A) expenses decreased to $20.6 million in the fourth quarter of 2005 from $23.5 million in the fourth quarter of 2004. SG&A expenses were higher in the fourth quarter of 2004 over the 2005 period largely due to launch costs of Evoclin at the end of 2004. Research and development (R&D) expenses in the 2005 fourth quarter were $8.7 million, compared with $5.8 million in the 2004 fourth quarter. The increase reflects the Company's late-stage clinical activities, including Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials with Primolux(TM) and Extina(R). In addition, the 2005 fourth quarter results include a $1.0 million payment to Astellas Pharma Astellas Pharma Inc. (アステラス製薬株式会社 Europe B.V. to license remaining worldwide rights to Velac(R). "Evoclin reached record market share levels during the quarter, and our other brands remain solid performers in increasingly competitive markets and against new entrants," said Thomas G. Wiggans, Chief Executive Officer of Connetics. "We are delighted that two of our partners, Pfizer and Novartis, recently received approvals to market products that incorporate Connetics' patented topical delivery technologies. With the breadth of our commercial portfolio, the expected introduction of Desilux in the fourth quarter of this year, and our expanded sales presence, we believe Connetics is positioned for continued growth in 2006." Connetics also announced the acquisition of the PediaMed sales organization closed today, as expected. "The PediaMed sales team is a terrific fit with our product portfolio and commercialization strategy," said Greg Vontz, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "Pediatricians prescribe more than $580 million annually in topical dermatology products, a level second only to dermatologists. That number includes more than $147 million in acne acne, common inflammatory disease of the hair follicles and sebaceous glands characterized by blackheads, whiteheads, pustules, nodules and, in the more severe forms, by cysts and scarring. The lesions appear on the face, neck, back, chest, and arms. products and $93 million in topical steroids steroids, class of lipids having a particular molecular ring structure called the cyclopentanoperhydro-phenanthrene ring system. Steroids differ from one another in the structure of various side chains and additional rings. . We see immediate opportunity in this market for Evoclin and Luxiq, and later this year for Desilux, if 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 is obtained. The PediaMed representatives and sales managers sales manager n → gerente m/f de ventas sales manager n → directeur commercial sales manager sale n → are participating in our national sales meeting sales meeting n → reunión f de ventas later this week, will continue an intensive sales training program in February and will be in the field by the beginning of March." Significant activities in the fourth quarter of 2005 and subsequent weeks include the following: --Connetics obtained positive final results from the Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the evaluating Primolux(TM), a super high-potency topical steroid, formulated with 0.05% clobetasol propionate clobetasol propionate (klōbā´t emulsion Mixture of two or more liquids in which one is dispersed in the other as microscopic or ultramicroscopic droplets (see colloid). Emulsions are stabilized by agents (emulsifiers) that (e.g. foam delivery vehicle. The Primolux clinical program consisted of two Phase III trials; the psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the trial was completed with positive results announced in October 2005 and the atopic dermatitis Atopic Dermatitis Definition Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and trial was completed in November 2005 with positive results. In both psoriasis and atopic dermatitis, Primolux demonstrated statistically significant positive results for all endpoints. --The Company authorized a $50 million share repurchase Share Repurchase A program by which a company buys back its own shares from the marketplace, reducing the number of outstanding shares. This is usually an indication that the company's management thinks the shares are undervalued. program allowing for the repurchase of stock Repurchase of stock Technique to pay cash to firm's shareholders that provides more preferential tax treatment for shareholders than dividends. Treasury stock is the name given to previously issued stock that has been repurchased by the firm. in privately negotiated or open market transactions, or under Rule 10b5-1, for a period of up to one year. During the fourth quarter of 2005, the Company repurchased approximately 1.8 million shares for approximately $24.4 million. --Connetics secured remaining worldwide rights to Velac, by way of an amendment to the license agreement with Astellas Pharma Europe B.V. (formerly Yamanouchi Europe B.V.). The original license in 2002 was limited to 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. , Canada and Mexico. The financial results for the 2005 fourth quarter include the $1.0 million payment associated with this amendment. --In 2006, Connetics acquired the 80 territory sales organization of PediaMed Pharmaceuticals, Inc. for $12.5 million in cash. This strategic acquisition leverages Connetics' commercial portfolio into an important market where the Company currently has limited presence, and expands the Company's sales force to approximately 200 representatives calling on dermatologists and pediatricians. --Two of Connetics' partners received regulatory approvals for consumer products incorporating Connetics licensed drug delivery formulations. Novartis launched a new formulation of single-dose Lamisil(R) (terbinafine hydrochloride terbinafine hydrochloride Desenex Max, Lamisil, Lamisil AT Pharmacologic class: Synthetic allylamine derivative Therapeutic class: Antifungal Pregnancy risk category B Action) in Europe using Connetics' Liquipatch(TM) sustained-release gel technology. Lamisil is the top selling over-the-counter antifungal antifungal /an·ti·fun·gal/ (-fung´gal)1. destructive to fungi, or suppressing their reproduction or growth; effective against fungal infections. 2. an agent that so acts. product. Connetics received a $386,000 milestone payment from Novartis in the fourth quarter of 2005 in connection with the launch of this product. In January 2006, Pfizer received FDA approval for Men's Rogaine(R) (minoxidil Minoxidil Definition Minoxidil is a drug available in two forms to treat different conditions. Oral minoxidil is used to treat high blood pressure and the topical solution form is used to treat hair loss and baldness. , 5%) foam using Connetics' VersaFoam(R) technology. Connetics owns U.S. Patent No. 6,946,120, covering minoxidil foam, which was granted in September 2005. Connetics anticipates receiving initial royalties from sales of both products beginning in late 2006. --The Company appointed David E. Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , M.D., to the Company's board of directors. Dr. Cohen is the Director of Allergic, Occupational and Environmental Dermatology at New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the Medical Center. 2005 Full Year Financial Results Net income for 2005 was $34.1 million, or $0.89 per diluted "If-Converted" share, compared with net income of $19.0 million, or $0.51 per diluted share, in 2004. Full year 2005 results include a positive impact of $0.24 per diluted share from recording a tax asset of $9.9 million during the fourth quarter. Total revenues for 2005 rose 28% to $184.4 million, and product revenues increased 29% to $183.4 million, reflecting growth in OLUX and Luxiq, and a full year revenue contribution of Soriatane and Evoclin. SG&A expenses increased to $97.4 million for 2005, compared with $73.2 million for 2004, primarily due to costs associated with a larger sales force, promotional activities for Evoclin and increased headcount. Due to increased formulation and clinical development activities, R&D expenses for 2005 increased to $31.9 million, compared with R&D expenses of $21.5 million in 2004. Connetics' cash and investments, including restricted cash, as of December 31, 2005, totaled $275.2 million. 2006 Full Year and First Quarter Financial Guidance The Company expects first quarter 2006 total revenues to be between $45.5 million and $47.5 million. Consistent with historic experience that expenditures are heaviest in the first quarter of the year, Connetics projects operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , including depreciation, for the first quarter to be $36.5 million to $38.0 million. First quarter expenses reflect a significant presence at dermatology conferences during the quarter, product promotion costs and higher costs associated with a significantly expanded sales force as a result of the recent PediaMed sales force acquisition. Connetics projects earnings per share on a diluted basis for the first quarter of 2006 of $0.02 to $0.03, excluding approximately $0.02 per diluted share impact from expensing stock-based compensation per Financial Accounting Standards No. 123(R). Connetics today affirms 2006 financial guidance, as announced on January 10, 2006. Connetics expects 2006 total revenues to be between $221 million and $225 million, representing an increase of 20% to 22% compared with 2005. Total operating expenses for 2006, including depreciation, are projected to be between $146 million and $148 million. Diluted EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. for 2006 is projected to be in the range of $0.67 to $0.71, excluding the impact of expensing stock-based compensation. This diluted EPS forecast assumes a 38% tax rate and a diluted "If-Converted" share count of approximately 40 million shares. The Company estimates, based on current assumptions, the impact of stock-based compensation expensing to be $0.18 per diluted share. This is higher than previous guidance for stock-based compensation expensing of $0.09 to $0.11 per diluted share, largely due to the determination that this expense will not be eligible for tax deduction Tax deduction An expense that a taxpayer is allowed to deduct from taxable income. tax deduction See deduction. during 2006. GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). EPS for 2006 including the expense for stock based compensation is projected to be in the range of $0.49 to $0.53. In determining the Company's financial guidance, Connetics management considered many factors and assumptions including, but not limited to, current and projected prescription information; sales trend data for the Company's products; the potential generic availability of, and competitive threats to, the Company's products; size, reach and call frequency of the Company's selling organization; status, timing and progression of the Company's development projects; current and projected spending levels to support sales, marketing, development and administrative activities; and other risk factors discussed in Connetics' publicly filed documents. The above guidance does not take into account the potential impact of other components of Connetics' growth strategy, including possible future acquisitions of products, businesses and/or technologies. Conference Call Connetics management will host a conference call to discuss the Company's financial performance today at 4:30 p.m. Eastern time/1:30 p.m. Pacific time. To participate in the live call, domestic callers should dial (888) 328-2575, international callers should dial (706) 643-0459 or the web cast can be accessed from the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's website at www.connetics.com. A telephone replay can be accessed for 48 hours beginning today at 6:30 p.m. Eastern time/3:30 p.m. Pacific time from the U.S., by dialing (800) 642-1687, or (706) 645-9291 from outside the U.S. The Conference ID# is 4520764. The internet replay of the call will be available for 30 days at www.connetics.com. About Connetics Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam(R). The Company's marketed products are OLUX(R) (clobetasol propionate) Foam, 0.05%, Luxiq(R) (betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or valerate) Foam, 0.12%, Soriatane(R) (acitretin) capsules and Evoclin(TM) (clindamycin) Foam, 1%. Connetics is developing Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin tretinoin /tret·i·noin/ (tret´i-noin?) the all-trans stereoisomer of retinoic acid, used as a topical keratolytic in the treatment of acne vulgaris and disorders of keratinization and administered orally in the treatment of acute ) Gel, for treating acne; Desilux(TM) (desonide) VersaFoam-EF, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis; Primolux(TM) (clobetasol propionate) VersaFoam-EF, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; and Extina(R) (ketoconazole ketoconazole /ke·to·co·na·zole/ (ke?to-kon´ah-zol) a derivative of imidazole used as an antifungal agent. ke·to·co·na·zole n. ) VersaFoam-HF, 2%, to treat seborrheic dermatitis Seborrheic Dermatitis Definition Seborrheic dermatitis is a common inflammatory disease of the skin characterized by scaly lesions usually on the scalp, hairline, and face. . Connetics' product formulations are designed to improve the management of dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. diseases and provide significant product differentiation Product Differentiation A source of competitive advantage that depends on producing some item that is regarded to have unique and valuable characteristics. . In Connetics' marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com. Note: Rogaine(R) is a registered trademark of Pfizer, Inc. (formerly Pharmacia Corporation). Lamisil(R) is a registered trademark of Novartis Consumer Health SA. Nothing in this press release should be construed to reflect commercial timing for either product. Forward Looking Statements Except for historical information, this press release includes "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 the Securities 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. Reform Act. All statements included in this press release that address activities, events or developments that Connetics expects, believes or anticipates will or may occur in the future, including, particularly, statements about sales growth of its product portfolio, revenues resulting from product sales and global licenses, the timing and impact of product introductions, the opportunity for our products in the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. marketplace, expenditures in connection with integrating the PediaMed sales force, earnings estimates, future financial performance, and financial guidance, are forward-looking statements. Statements pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to revenue expectations, revenue growth, and regulatory and clinical milestones associated with Connetics' products or product candidates are also forward-looking statements. All forward-looking statements are based on certain assumptions made by Connetics' management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics' control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics' Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2004 and Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2005. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements.
Press Release Code: CNCT-F
CONNETICS CORPORATION
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
------------------- --------------------
Revenues: 2005 2004 2005 2004
--------- --------- --------- ---------
Product $ 40,795 $ 43,495 $ 183,407 $ 142,059
Royalty and contract 483 281 952 2,296
--------- --------- --------- ---------
Total revenues 41,278 43,776 184,359 144,355
Operating costs and expenses:
Cost of product revenues 3,507 4,443 16,438 12,656
Research and development 8,659 5,822 31,896 21,539
Selling, general and
administrative 20,568 23,460 97,435 73,206
Amortization of intangible
assets 3,400 3,400 13,598 11,471
In-process research and
development and milestone
payments 1,000 -- 1,000 3,500
--------- --------- --------- ---------
Total operating costs and
expenses 37,134 37,125 160,367 122,372
Income from operations 4,144 6,651 23,992 21,983
Interest and other income
(expense), net 413 (202) 201 (1,475)
--------- --------- --------- ---------
Income before income taxes 4,557 6,449 24,193 20,508
Provision for (benefit from)
income taxes (10,588) 459 (9,860) 1,493
--------- --------- --------- ---------
Net income $ 15,145 $ 5,990 $ 34,053 $ 19,015
========= ========= ========= =========
Net income per share:
Basic $ 0.44 $ 0.17 $ 0.97 $ 0.54
========= ========= ========= =========
Diluted (1) $ 0.40 $ 0.16 $ 0.89 $ 0.51
========= ========= ========= =========
Shares used to calculate net
income (loss) per share:
Basic 34,570 35,695 35,039 35,036
========= ========= ========= =========
Diluted (1) 39,735 38,172 41,335 37,443
========= ========= ========= =========
(1) In accordance with SFAS No. 128, using the If-Converted
Method, tax-effected interest expense of $690,000 in Q4 and
$2,761,000 for full year has been added back to net income for
purposes of calculating net income per diluted share for the
three and twelve month periods ended December 31, 2005. Shares
used to calculate net income per diluted share for these
periods include the dilutive effect of shares issuable upon
exercise of outstanding stock options and warrants plus the
effect of $90.0 million 2.25% convertible senior notes, which
convert to approximately 4.2 million shares.
CONNETICS CORPORATION
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
December 31, December 31,
2005 2004
------------ -----------
Assets
Assets:
Cash, cash equivalents and
short-term investments $ 271,096 $ 72,383
Restricted cash 4,059 3,963
Accounts receivable and
other current assets 19,620 35,750
Goodwill and other intangible assets, net 115,060 128,659
Property and equipment, net 14,438 11,830
Other long-term assets 22,912 3,707
------------ -----------
Total assets $ 447,185 $ 256,292
============ ===========
Liabilities and Stockholders' Equity
Liabilities and stockholders' equity:
Current liabilities $ 45,800 $ 37,952
Other liabilities 290,517 90,420
Stockholders' equity 110,868 127,920
------------ -----------
Total liabilities and
stockholders' equity $ 447,185 $ 256,292
============ ===========
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