Andrx Reports 2003 Fourth Quarter and Full Year Results.Business Editors/Health/Medical Writers FORT LAUDERDALE Fort Lauderdale (lô`dərdāl), residential, commercial, and resort city (1990 pop. 149,377), seat of Broward co., SE Fla., on the Atlantic coast; settled around a fort built (c.1837) in the Seminole War, inc. 1911. , Fla.--(BUSINESS WIRE)--Feb. 25, 2004 Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or the "Company") today announced its financial results for the fourth quarter and year ended December 31, 2003, summarized as follows (in thousands, except per share amounts):
Three Months Ended Years Ended
December 31, December 31,
----------------------- -----------------------
2003 2002 2003 2002
----------- ----------- ----------- -----------
Total revenues $281,684 $218,097 $1,046,338 $770,980
Income (loss) before
income taxes $25,329 $(49,331) $78,208 $(152,643)
Net income (loss) $15,603 $(31,912) $48,177 $(91,817)
Total net income (loss)
allocated to Andrx(1) $15,603 $(31,912) $48,177 $(86,399)
Andrx diluted earnings
(loss) per share(1) $0.21 $(0.45) $0.66 $(1.22)
Total net loss
allocated to Cybear(1) $(5,418)
Cybear diluted loss per
share(1) $(0.80)
(1) See Note 1 in the accompanying Unaudited Condensed Consolidated
Statements of Income.
Commenting on the 2004 operating results, Andrx's Chief Executive Officer, Thomas (language) Thomas - A language compatible with the language Dylan(TM). Thomas is NOT Dylan(TM). The first public release of a translator to Scheme by Matt Birkholz, Jim Miller, and Ron Weiss, written at Digital Equipment Corporation's Cambridge Research Laboratory runs P. Rice, said: "For the first time in our history, in 2003 Andrx achieved revenues in excess of $1 billion, led by the strong performances of our distribution and bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. businesses, both of which achieved record revenues. Our R&D efforts in the generic arena resulted in the filing of 12 ANDAs, some of which we believe will be awarded first-to-file exclusivity, four tentative tentative, adj not final or definite, such as an experimental or clinical finding that has not been validated. and 13 final product approvals, and generated over $255 million in revenues. We also entered into an alliance for our generic OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). Claritin Clar·i·tin A trademark for the drug loratadine. loratadine Alavert, Claritin, Claritin RediTabs, Clarityn (UK) Pharmacologic class: Histamine1-receptor antagonist (second-generation) products, and agreements that enabled us to market all strengths of generic Glucotrol Glu·co·trol A trademark for the drug glipizide. glipizide Warning - High-alert drug! Glucotrol, Glucotrol XL, Glibenese (UK), Minodiab (UK) XL(R) and enhance the value of our line of oral contraceptives Oral Contraceptives Definition Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills. ." Mr. Rice continued, "I believe the Company is uniquely positioned in the industry with its distribution, generic and brand businesses. These businesses complement each other and we will focus on both internal and external growth for each of them in 2004 and beyond. The current plans for our brand business include the launch of Fortamet(TM), an extended release metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus. met·for·min n. product, and Pfizer's Cardura Car·dur·a A trademark for the drug doxazosin mesylate. doxazosin mesylate Cardura, Doxadura (UK) Pharmacologic class: Sympatholytic, peripherally acting antiadrenergic (R) XL product, which we hope to market later this year. With these product launches and an increased focus on cost management, we anticipate improving the financial performance of our brand business. And for the longer term, we are very optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op about the prospects and rewards to be generated by our alliance with Takeda to commercialize an extended release metformin and Actos Actos® Pioglitazone, see there (R) combination product, which evolved through our formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation expertise. "We are proud of the Company's 2003 accomplishments, and we will continue to work diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d to build each component of our business," concluded Mr. Rice.
Revenues and Gross Profit (Loss)
Three Months Ended Years Ended
December 31, December 31,
($ in thousands) ($ in thousands)
----------------------- -----------------------
2003 2002 2003 2002
----------- ----------- ----------- -----------
Distributed Products
Revenues $172,641 $153,051 $657,098 $534,618
Gross profit 31,673 28,504 120,229 100,968
Gross margin 18.3% 18.6% 18.3% 18.9%
Andrx Products -
Bioequivalent
Revenues $85,994 $38,524 $255,014 $183,873
Gross profit (loss) 32,495 (4,621) 119,440 37,848
Gross margin (loss) 37.8% (12.0%) 46.8% 20.6%
Andrx Products - Brand
Revenues $16,058 $7,186 $46,638 $25,534
Gross profit 11,046 3,192 33,794 12,271
Gross margin 68.8% 44.4% 72.5% 48.1%
Andrx Products - Total
Revenues $102,052 $45,710 $301,652 $209,407
Gross profit (loss) 43,541 (1,429) 153,234 50,119
Gross margin (loss) 42.7% (3.1%) 50.8% 23.9%
TOTAL PRODUCT SALES
Revenues $274,693 $198,761 $958,750 $744,025
Gross profit 75,214 27,075 273,463 151,087
Gross margin 27.4% 13.6% 28.5% 20.3%
LICENSING AND ROYALTIES
Revenues $6,425 $16,931 $80,080 $17,340
Gross margin 100.0% 100.0% 100.0% 100.0%
OTHER
Revenues $566 $2,405 $7,508 $9,615
Gross profit (loss) 566 (11,168) (7,606) (17,516)
Gross margin (loss) 100.0% (464.4%) (101.3%) (182.2%)
TOTALS
Revenues $281,684 $218,097 $1,046,338 $770,980
Gross profit 82,205 32,838 345,937 150,911
Gross margin 29.2% 15.1% 33.1% 19.6%
In the 2003 fourth quarter, distributed products generated net revenues of $172.6 million and gross profit of $31.7 million, with a gross margin of 18.3%. The results include the Company's participation in the distribution of generic Paxil Pax·il A trademark for the drug paroxetine. paroxetine hydrochloride Paxil, Paxil CR, Seroxat (UK) Pharmacologic class: Selective serotonin reuptake inhibitor (SSRI) (R), which will enjoy the benefit of limited competition until the 180-day exclusivity period expires in March 2004. In the 2002 fourth quarter, distributed products generated net revenues of $153.1 million and gross profit of $28.5 million, with a gross margin of 18.6%. For the 2003 fourth quarter, revenues from Andrx's bioequivalent products increased by 123.2% to $86.0 million, compared to $38.5 million for the 2002 fourth quarter. These results include the November 20, 2003, launch of generic Glucotrol XL, licensed from Pfizer, Inc. ("Pfizer"), which generated $20.1 million in net revenues. The gross margin for bioequivalent products was 37.8% in the 2003 fourth quarter, compared to a negative 12.0% for the 2002 fourth quarter. Gross profit for bioequivalent products for the fourth quarter of 2003 includes $8.6 million in charges to cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold , of which $4.7 million related to charges for production write-offs from certain of the Company's products and product candidates, and $3.9 million related to the write-off Write-Off A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues. of manufacturing machinery and equipment at Andrx's Florida manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. . The 2002 fourth quarter includes charges to cost of goods sold of $26.3 million, primarily relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the write-off of pre-launch inventory of Andrx's bioequivalent versions of Wellbutrin Well·bu·trin A trademark for the drug bupropion hydrochloride, used to treat depression. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban SR(R)/Zyban(R). Revenues from Andrx's brand products in the 2003 fourth quarter increased to $16.1 million, from $7.2 million in the 2002 fourth quarter. This increase primarily resulted from net revenues of Altocor Al·to·cor A trademark for the drug lovastatin. (TM) of $10.9 million and the launch of two reformulated Entex(R) cough cough, sudden, forceful expiration of air from the lungs caused by an involuntary contraction of the muscles controlling the process of breathing. The cough is a response to some irritating condition such as inflammation or the presence of mucus (sputum) in the and cold products, partially offset by decreases in revenues from Andrx's other brand products. The gross margin for the 2003 fourth quarter was 68.8%, compared to 44.4% for the 2002 fourth quarter. The fourth quarters of 2003 and 2002 each include charges to cost of goods sold of approximately $1.0 million related to production write-offs. Licensing and royalties revenues for the 2003 fourth quarter were $6.4 million, which includes $5.5 million of estimated licensing revenues from Kremers Urban Development Company's ("KUDCo") 2003 fourth quarter net profits, as defined, from KUDCo's sale of its bioequivalent version of Prilosec Pri·lo·sec A trademark for the drug omeprazole. omeprazole Losec (CA) (UK), Heartburn Relief (UK), Prilosec, Prilosec OTC, Zegerid, Zanprol (UK) Pharmacologic class: Proton pump inhibitor (R). Licensing and royalties revenue for the 2002 fourth quarter were $16.9 million, which includes $16.6 million of licensing revenues from KUDCo. Other revenues for the fourth quarter of 2003 consist primarily of revenues for services provided by the Physicians' Online ("POL") web portal See portal. through December 23, 2003, when the POL web portal was sold. Other revenues for 2002 were generated primarily from the contract manufacturing of aerosols at the Company's Massachusetts Massachusetts (măsəch `sĭts), most populous of the New England states of the NE United States. manufacturing operation, which was sold in October 2003,
and from the POL web portal. In the fourth quarter of 2002, cost of
goods sold related to other revenues included a $10.7 million charge for
an excess facilities lease and related leasehold improvements Leasehold ImprovementImprovements on a leased asset that increase the value of the asset. Notes: A leasehold improvement is classified as an asset that must be depreciated over time. , excess aerosol aerosol (âr`əsōl,–sŏl): see colloid. aerosol System of tiny liquid or solid particles evenly distributed in a finely divided state through a gas, usually air. product inventories, equipment and severance The act of dividing, or the state of being divided. The term severance has unique meanings in different branches of the law. Courts use the term in both civil and criminal litigation in two ways: first, when dividing a lawsuit into two or more parts, and second, when from Andrx's Massachusetts aerosol manufacturing operation. Selling, General and Administrative ("SG&A") Expenses SG&A expenses of $48.3 million in the 2003 fourth quarter decreased from $53.8 million in the 2002 fourth quarter, primarily due to a decrease in brand product sales and marketing expenses offset by increases in corporate overhead. The Company had approximately 250 brand sales representatives at December 31, 2003, compared to approximately 400 at December 31, 2002. The 2003 fourth quarter also includes a $1.1 million charge for severance due to the December 2003 reduction of approximately 100 brand sales personnel. Research and Development ("R&D") Expenses R&D expenses, primarily related to the Company's bioequivalent R&D program, were $13.7 million in the 2003 fourth quarter, compared to $17.9 million for the 2002 quarter. The fourth quarter of 2003 includes a charge of approximately $1.4 million for costs associated with the reorganization of Andrx's New Jersey brand clinical research operations, including a related decrease in headcount. For the year ended December 31, 2003, Andrx submitted 12 Abbreviated New Drug Applications abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") to the 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. ") and presently has approximately 30 ANDAs and two New Drug Applications ("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 ") pending at the FDA. R&D expenses for the fourth quarter of 2002 include a milestone payable to Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. Pharmaceuticals, Inc. (now known as Sandoz Inc.) of $3.0 million for Fortamet (metformin XT). 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. Settlements and Other Charges Litigation settlements and other charges in the 2003 fourth quarter include a $1.3 million charge related to previously disclosed litigation matters. Litigation settlements and other charges in the 2002 fourth quarter include a $5.0 million charge relating to legal claims asserted against the Company and a $7.8 million charge for the impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. of goodwill and intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. related to the POL web portal. Other Income, net Other income, net includes, among other things, a $344,000 gain on the sale of the POL web portal, a $750,000 gain on the sale of certain brand product rights and a $3.7 million gain on the sale of the Company's Massachusetts aerosol manufacturing operation. Years Ended December 31, 2003 and 2002 Revenues for 2003 exceeded $1.0 billion compared to $771.0 million in 2002. Distributed products revenue increased $122.5 million to $657.1 million in 2003, compared to $534.6 million in 2002. The 2003 year includes revenues from the launch of bioequivalent products including generic versions of Tiazac Tiazac® Diltiazem, see there (R), Claritin-D(R) 24, which is marketed as an over-the-counter ("OTC") product by L. Perrigo Company ("Perrigo"), and generic Glucotrol XL, licensed from Pfizer, as well as revenues from the Company's generic versions of Cardizem Car·di·zem A trademark for the drug diltiazem hydrochloride. diltiazem hydrochloride Adizem (UK), Angitil (UK), Apo-Diltiaz (CA), Apo-Diltiazem (CA), Calcicard (UK), Cardizem, Cardizem CD, Cardizem LA, Cartia XT, (R) CD, Dilacor Di·la·cor A trademark for the drug diltiazem hydrochloride. (R) XR, Glucophage Glu·co·phage A trademark for the drug metformin. metformin hydrochloride Warning - High-alert drug! (R), K-Dur K-Dur A trademark for an oral preparation of sustained-release potassium chloride. potassium chloride Warning - High-alert drug! (R), Ventolin Ven·to·lin A trademark for the drug albuterol. albuterol (salbutamol) Proventil, Ventolin Pharmacologic class: Sympathomimetic (beta2-adrenergic agonist) (R) metered dose inhalers and Naprelan(R), all of which also generated revenues during 2002. Generic Cardizem CD continued to contribute significant revenues and gross profits. Revenues for 2003 from brand products include a full year of sales of Altocor, which totaled $32.0 million. Licensing and royalties revenue for 2003 and 2002 include $76.7 million and $16.6 million, respectively, of revenues from Andrx's agreement with KUDCo related to generic Prilosec, which began in December 2002. The 2003 gross profit was $345.9 million with a gross margin of 33.1%, compared to the 2002 gross profit of $150.9 million with a gross margin of 19.6%. The significant improvement in gross profit was primarily due to the launch of new products in 2003 and the reduction in charges to cost of goods sold compared to 2002. Cost of goods sold for 2003 includes charges of approximately $18.4 million from the write-off of inventory for the Company's products and product candidates, including $5.7 million from Wellbutrin SR/Zyban placed into production after December 31, 2002, charges of $3.9 million from the write-off of certain manufacturing related machinery and equipment and $4.7 million from under-utilization and inefficiencies at the Company's Florida and North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures Area, 52,586 sq mi (136,198 sq km). Pop. manufacturing facilities. Cost of goods sold also includes charges of $12.1 million relating to the write-down Write-Down Reducing the book value of an asset because it is overvalued compared to the market value. Notes: This is usually reflected in the company's income statement as an expense, thereby reducing net income. of certain assets, including inventory, and under-utilization and inefficiencies at the Massachusetts manufacturing operation. Cost of goods sold for 2002 includes charges of $41.0 million to fully reserve the pre-launch inventory related to Andrx's bioequivalent version of Prilosec as a result of an adverse court decision that the Andrx product infringes certain patents. The Company also recorded charges of $37.7 million related to production of its bioequivalent and brand products and product candidates, including Andrx's generic version of Wellbutrin SR/Zyban. The Company also incurred charges of $5.8 million due to under-utilization and inefficiencies at its Florida manufacturing facilities. SG&A for 2003 increased from 2002 as a result of increases in brand sales and marketing efforts, the growth of the distribution business, including a full year of operations of Andrx's Ohio distribution center and increases in corporate overhead. SG&A expenses for 2002 included a charge of $4.0 million related to an understatement of the Company's allowance for doubtful accounts Allowance for Doubtful Accounts An estimation made by a company and documented on its balance sheet for receivables that might go uncollected. Notes: It is standard practice for a company to have funds set aside for money that cannot be collected. receivable during the years ended December 31, 2001, 2000 and 1999, due to the unauthorized actions of a single, lower-level employee who made numerous improper
The Company recorded charges of $8.8 million and $65.0 million for 2003 and 2002, respectively, to litigation settlements and other charges related to previously disclosed legal matters. Also included for 2002 was a $7.8 million charge for the impairment of goodwill and intangible assets related to the POL web portal, which was sold in December 2003. Balance Sheet As of December 31, 2003, the Company had approximately $205 million in cash, cash equivalents and investments available-for-sale, $355 million of working capital and $172 million available under the Company's $185 million secured credit facility, which had no borrowings outstanding. Andrx is currently in compliance with all covenants under the credit facility, however the borrowing base limits Andrx's borrowing availability to $172 million as of December 31, 2003. For the year ended December 31, 2003, the Company invested approximately $34 million in the purchase of property, plant and equipment and incurred approximately $29 million of depreciation and amortization expense. Outlook Growth in distributed product revenues will continue to be primarily a function of the Company's participation in the distribution of new generic products launched by other generic manufacturers, offset by the net price declines typically associated with the distribution of existing generic products. In particular, generic Paxil could experience price erosion if new competitors enter the market at the end of the exclusivity period, which ends in March 2004. Growth in revenues of bioequivalent products will primarily result from the launch of new products. The Company launched its OTC bioequivalent version of Claritin RediTabs(R) in January 2004 through Perrigo. The Company also launched its bioequivalent versions of Lotensin Lo·ten·sin A trademark for the drug benazepril hydrochloride. benazepril hydrochloride Lotensin Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor Therapeutic class: (R) and Lotensin HCT Hct abbr. hematocrit HCT Hematocrit, see there (R) in February 2004, along with numerous other competitors. The Company hopes to launch other products throughout 2004, including its generic version of Vicoprofen(R), OTC bioequivalent version of Claritin-D(R) 12 through Perrigo and certain of its oral contraceptive oral contraceptive n. A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill. products through Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd ("Teva"). These oral contraceptive products include the Company's generic version of Ortho Tri-Cyclen(R), which the FDA tentatively ten·ta·tive adj. 1. Not fully worked out, concluded, or agreed on; provisional: tentative plans. 2. Uncertain; hesitant. approved in January 2004, and Ortho-Cyclen 28(R), which has received final FDA approval. Andrx's bioequivalent version of Cardizem CD continues to generate significant net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight and gross profit. Additional competitors for generic Cardizem CD and generic Tiazac may surface by mid-2004, which could significantly adversely affect net revenue and gross profit of Andrx's versions of either or both of these products. Revenue of Andrx's current bioequivalent products is also subject to market conditions and other factors, including historically high levels of competition in the industry for market share and significant price erosion. The Company continues its efforts to commercialize the value of its ANDAs for bioequivalent versions of Wellbutrin SR/Zyban, whether through the commercial sale of its products or through revenues to be generated from the July 2003 Exclusivity Transfer Agreement it entered into with Impax Corporation ("Impax") and a subsidiary of Teva. Though the agreement originally extended to both the 100mg and 150mg strengths of Wellbutrin SR, the Company now has learned that it does not enjoy a market exclusivity period for the 100mg strength, as it was not the first to file an ANDA for such strength. Consequently, the Company will not share in any of the profits from the sale of Impax's 100mg strength of this product, which was approved for sale in January 2004. Under the provisions of the agreement, Impax and Teva may share certain profits for a 180-day period with Andrx from the sale of the Impax 150mg product, which has received tentative FDA approval and has been determined by an appellate court A court having jurisdiction to review decisions of a trial-level or other lower court. An unsuccessful party in a lawsuit must file an appeal with an appellate court in order to have the decision reviewed. not to infringe in·fringe v. in·fringed, in·fring·ing, in·fring·es v.tr. 1. To transgress or exceed the limits of; violate: infringe a contract; infringe a patent. 2. Glaxo SmithKline's patents. Brand division revenue and gross profit performance is dependent upon the continued growth in the number of prescriptions for Altocor, as well as the success of the launches of Fortamet and Cardura XL. Though the Fortamet NDA used immediate release Glucophage as its reference listed drug, FDA recently advised the Company it must make a patent certification with respect to the Orange Book patents listed for Glucophage XR(R). Accordingly, the timing of the FDA's approval of Fortamet depends upon whether the NDA holder initiates patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. litigation within the 45-day period following its receipt of the Company's patent notice, among other things. Andrx believes that its product does not infringe such patents and notes that the NDA holder did not initiate patent infringement litigation against the Company or others with respect to the many ANDAs that were filed for Glucophage XR. The Company is required to pay Sandoz Inc. additional milestones of $2.0 million upon FDA approval and $3.0 million upon the launch of Fortamet, as well as royalties on net revenues from this product. The launch of Cardura XL is dependent upon FDA approval in 2004 of the product with certain minimum labeling requirements at which time Andrx will pay an additional $25 million to Pfizer and Andrx will be committed to purchase certain annual minimum quantities of this product from Pfizer for a three-year period. The $10.0 million Andrx paid to Pfizer in the 2003 fourth quarter, upon entering into the agreement, is refundable Refundable Eligible for refunding under the terms of a bond indenture. under certain circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or . In December 2003, the Company reorganized re·or·gan·ize v. re·or·gan·ized, re·or·gan·iz·ing, re·or·gan·iz·es v.tr. To organize again or anew. v.intr. To undergo or effect changes in organization. its brand sales force structure to comprise 325 primary care territories and reduced the number of brand sales representatives by approximately 100 representatives. Overall prescription levels for Altocor for January 2004 were lower than those of December 2003. The Company anticipates that the reorganization of its brand sales force structure and its enhanced focus on cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. , balancing risks and rewards, and other measures it is adopting will enhance the longer term performance of the Company's brand business and its contribution to the Company's operating results. Andrx presently has approximately 235 brand sales force representatives. The Company will review and adjust the number of sales representatives it maintains based on the needs of its business and products. As expected, Andrx's quarterly licensing revenue from KUDCo decreased significantly during 2003, due to increased competition as a result of the third quarter 2003 launch of two additional bioequivalent versions of Prilosec and the decrease in the net profit percentage due Andrx under the KUDCo agreement (from 15% to 9% on June 9, 2003). Pursuant to the agreement, the Andrx licensing rate on KUDCo's profits will be further reduced from 9% to 6.25%, as a result of the December 2003 appellate court decision reaffirming the decision that Andrx's bioequivalent version of Prilosec infringed patents issued to AstraZeneca plc. Additional price erosion may be experienced in the generic Prilosec marketplace during 2004 from current or potential new competitors. Andrx is attempting to commercialize the value of its ANDA for the 40mg strength of Prilosec, for which it was awarded 180-day exclusivity rights. Andrx is renovating its manufacturing facility in Morrisville, North Carolina Morrisville is a town in Wake County, North Carolina, USA. The population was 5,208 at the 2000 census. A Special Census was conducted by the United States Census Bureau in March 2004, when the population was enumerated at 11,915. so that certain operations can commence at that facility in 2005. The Company also continues to pursue measures to improve its manufacturing efficiencies and capacities at its Davie, Florida Davie is a town in Broward County, Florida, United States. In 2006, the U.S. Census Bureau estimated the city's population at 84,350.[3] It is part of the South Florida metropolitan area, which is home to 5,463,857 people. manufacturing facilities. Until all of its efforts come to fruition fru·i·tion n. 1. Realization of something desired or worked for; accomplishment: labor finally coming to fruition. 2. Enjoyment derived from use or possession. 3. , Andrx will continue to incur To become subject to and liable for; to have liabilities imposed by act or operation of law. Expenses are incurred, for example, when the legal obligation to pay them arises. An individual incurs a liability when a money judgment is rendered against him or her by a court. charges directly to cost of goods sold related to its North Carolina facility and inefficiencies at its Davie, Florida facility. The Company may also incur additional charges directly to cost of goods sold in the manufacture of its currently marketed products and product commercialization activities. Andrx anticipates that its R&D expenses for 2004 will be approximately $55 million and will focus primarily on bioequivalent products. Major factors affecting the Company's operating results include net revenues of its bioequivalent versions of Cardizem CD, and, to a lesser extent, its line of OTC Claritin products, Glucophage, Glucotrol XL, Tiazac, net sales of its Altocor brand product, the launches of Fortamet and Cardura XL and KUDCo licensing revenue. Future operating results also will be affected by revenues to be generated from the Exclusivity Transfer Agreement with Impax and Teva, future bioequivalent and brand product introductions, the value and timing of which are dependent on a number of factors including successful scale-up, final FDA marketing approval, satisfactory resolution of patent and antitrust Antitrust The antitrust laws apply to virtually all industries and to every level of business, including manufacturing, transportation, distribution, and marketing. They prohibit a variety of practices that restrain trade. litigation, manufacturing capabilities and capacities, commencement of commercial operations at the North Carolina facility, competition and the other factors described in Andrx's SEC filings. The Company anticipates investing approximately $100 million in capital expenditures for the year 2004, which it intends to pay for with net cash provided by operating activities. Webcast Investors will have the opportunity to listen to management's discussion of this release in a conference call to be held on February 26, 2004, at 8:00 AM Eastern Time. This call is being webcast and can be accessed at Andrx's website http://www.andrx.com. The webcast will be available for replay. About Andrx Corporation Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx's distribution operations purchase primarily generic pharmaceuticals manufactured by third parties and sells them primarily to independent pharmacies An independent pharmacy is a retail pharmacy that is not directly affiliated with any chain pharmacy, such as CVS/pharmacy, Walgreens or Eckerd. However, owners of independent pharmacies will often form alliances with other independents and use their power in numbers to bargain for , pharmacy pharmacy, art of compounding and dispensing drugs and medication. The term is also applied to an establishment used for such purposes. Until modern times medication was prepared and dispensed by the physician himself. In the 18th cent. chains, pharmacy buying groups and physicians' offices. Forward Looking Statements 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. (statements which are not historical facts) in this release are made pursuant to 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 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. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality gen·er·al·i·ty n. pl. gen·er·al·i·ties 1. The state or quality of being general. 2. An observation or principle having general application; a generalization. 3. of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the Company's dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other litigation and future product launches; whether the Company will be awarded any market exclusivity period and, if so, the precise dates thereof; government regulation generally; competition; manufacturing capacities and output; the Company's ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; Andrx's inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally, including Fortamet; exclusion of Andrx's brand products from formularies; the consolidation or loss of customers; Andrx's relationship to its suppliers; the success of Andrx's joint ventures; difficulties in integrating, and potentially significant charges associated with, acquisitions of technologies, products and businesses; the inability to obtain sufficient supplies from key suppliers; the impact of returns, allowances and chargebacks; product liability claims; rising costs and limited availability When customers of the PSTN make telephone calls, they commonly make use of a telecommunications network called a switched-circuit network. In a switched-circuit network, devices known as switches are used to connect the caller to the callee. of product liability and other insurance; the loss of key personnel; failure to comply with environmental laws; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's 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, 2002 and Forms 10-Q for the quarters ended March 31, 2003, June 30, 2003 and September 30, 2003. Andrx disclaims any responsibility to update the forward-looking statements contained herein. This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com.
ANDRX CORPORATION AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except share and per share amounts)
Three Months Ended Years Ended
December 31, December 31,
----------------------- -----------------------
2003 2002 2003(2) 2002
----------- ----------- ----------- -----------
Revenues
Distributed products $172,641 $153,051 $657,098 $534,618
Andrx products 102,052 45,710 301,652 209,407
Licensing and
royalties 6,425 16,931 80,080 17,340
Other 566 2,405 7,508 9,615
----------- ----------- ----------- -----------
Total revenues 281,684 218,097 1,046,338 770,980
----------- ----------- ----------- -----------
Operating expenses
Cost of goods sold 199,479 185,259 700,401 620,069
Selling, general and
administrative 48,338 53,758 217,085 193,253
Research and
development 13,682 17,942 52,235 51,479
Litigation settlements
and other charges 1,250 12,833 8,750 72,833
----------- ----------- ----------- -----------
Total operating
expenses 262,749 269,792 978,471 937,634
----------- ----------- ----------- -----------
Income (loss) from
operations 18,935 (51,695) 67,867 (166,654)
Other income, net 6,394 2,364 10,341 14,011
----------- ----------- ----------- -----------
Income (loss) before
income taxes 25,329 (49,331) 78,208 (152,643)
Income tax provision
(benefit) 9,726 (17,419) 30,031 (60,826)
----------- ----------- ----------- -----------
Net income (loss) $15,603 $(31,912) $48,177 $(91,817)
=========== =========== =========== ===========
EARNINGS (LOSS) PER SHARE
ANDRX COMMON STOCK:(1)
Net income (loss)
allocated to Andrx
(includes Cybear
subsequent to the
May 17, 2002
Conversion) $15,603 $(31,912) $48,177 $(85,873)
Premium on Conversion
of Cybear common stock - - - (526)
----------- ----------- ----------- -----------
Total net income (loss)
allocated to Andrx $15,603 $(31,912) $48,177 $(86,399)
=========== =========== =========== ===========
Net income (loss) per
share of Andrx common
stock:
Basic $0.22 $(0.45) $0.67 $(1.22)
=========== =========== =========== ===========
Diluted $0.21 $(0.45) $0.66 $(1.22)
=========== =========== =========== ===========
Weighted average shares
of Andrx common stock
outstanding:
Basic 72,105,000 71,356,000 71,892,000 70,876,000
=========== =========== =========== ===========
Diluted 72,994,000 71,356,000 72,655,000 70,876,000
=========== =========== =========== ===========
CYBEAR COMMON STOCK:(1)
Net loss allocated to
Cybear Group (through
the May 17, 2002
Conversion) $(5,944)
Premium on Conversion
of Cybear common stock 526
-----------
Total net loss
allocated to Cybear $(5,418)
===========
Basic and diluted net
loss per share of
Cybear common stock $(0.80)
===========
Basic and diluted
weighted average
shares of Cybear
common stock
outstanding 6,743,000
===========
(1) Effective May 17, 2002, all outstanding shares of Cybear common
stock were converted to Andrx common stock. For periods subsequent
to the Conversion, Andrx Corporation will only report earnings
(loss) per share for Andrx common stock which includes all of the
former Cybear's operating results from the effective date of the
Conversion and will no longer report separate earnings (loss) per
share for the former Cybear common stock.
(2) Certain prior period amounts have been reclassified.
ANDRX CORPORATION AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31,
-----------------------
2003 2002(1)
----------- -----------
Assets
Cash, cash equivalents and investments
available-for-sale $205,123 $97,394
Accounts receivable, net 138,849 127,698
Inventories, net 209,910 140,625
Income taxes receivable - 33,710
Deferred income tax assets, net 65,153 68,148
Other current assets 29,790 32,360
----------- -----------
Total current assets 648,825 499,935
Property, plant and equipment, net 239,173 227,864
Goodwill, intangibles and other assets, net 70,448 61,680
----------- -----------
Total assets $958,446 $789,479
=========== ===========
Liabilities and Stockholders' Equity
Current liabilities $294,003 $208,087
Non-current liabilities 41,542 15,685
----------- -----------
Total liabilities 335,545 223,772
Commitments and contingencies
Total stockholders' equity 622,901 565,707
----------- -----------
Total liabilities and stockholders' equity $958,446 $789,479
=========== ===========
(1) Certain prior period amounts have been reclassified to conform
to the current period presentation.
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