IMPAX Reports Third Quarter Financial Results; Company Continues to Post Record Quarterly Revenues; Four FDA Approvals Received in the Quarter.Business Editors/Health/Medical Writers HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 5, 2003 IMPAX Laboratories, Inc. (Nasdaq:IPXL) today reported financial results for the three months and nine months ended September 30, 2003. Total revenues for the third quarter of 2003 were $16,497,000, up more than 119% compared with revenues of $7,538,000 in the prior year's third quarter, and up more than 17% compared with total revenues of $14,067,000 in the second quarter of 2003. The significant year-over-year increases were primarily due to shipments of over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) Loratadine loratadine /lor·at·a·dine/ (lah-rat´ah-den) a nonsedating antihistamine used in the treatment of allergic rhinitis, chronic idiopathic urticaria, and asthma. lor·at·a·dine n. and Pseudoephedrine Sulfate pseudoephedrine sulfate Drixoral Nasal Decongestant, Drixoral Non-Drowsy Formula Pharmacologic class: Sympathomimetic Therapeutic class: Decongestant (systemic) Pregnancy risk category C (5mg/120mg) 12-hour Extended Release Tablets to Schering-Plough and to Wyeth during the third quarter of 2003; and higher sales of Fludrocortisone fludrocortisone /flu·dro·cor·ti·sone/ (floo?dro-kor´ti-son) a synthetic adrenal corticoid with effects similar to those of hydrocortisone and desoxycorticosterone, administered as the acetate salt. Tablets, Minocycline minocycline /mi·no·cy·cline/ (mi-no-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, used as the hydrochloride salt.minocycline a second-generation, highly lipid-soluble derivative of tetracycline. Capsules, and the LIPRAM product family. The net loss for the 2003 third quarter was $3,608,000, or $(0.07) per share, compared with a net loss of $5,210,000, or $(0.11) per share, in the prior-year third quarter and a net loss of $2,284,000, or $(0.05) per share, in the 2003 second quarter. The year-over-year net loss narrowed due to higher sales, but increased on a sequential quarter basis due to increased expenses related to ramping up production for upcoming new product introductions, including, but not limited to, additional personnel, supplies, and training costs. For the nine months ended September 30, 2003, the Company reported total revenues of $41,989,000 compared with $16,115,000 in the comparable period of the previous year. The net loss through the third quarter of 2003 was $9,105,000, or $(0.18) per share. This compares with a net loss of $16,569,000, or $(0.35) per share, in the nine months ended September 30, 2002. Unrestricted cash, cash equivalents, and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments were $22.5 million at September 30, 2003, compared to $10.2 million at December 31, 2002. The increase in the cash balance was primarily due to a $25 million private placement completed in May of this year. "We are delighted to report that this is our fifth consecutive quarter of record revenues," said Barry R. Edwards, Co-Chief Executive Officer of IMPAX. "In addition to receiving final U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval for our generic versions of Urispas(R), Claritin Clar·i·tin A trademark for the drug loratadine. loratadine Alavert, Claritin, Claritin RediTabs, Clarityn (UK) Pharmacologic class: Histamine1-receptor antagonist (second-generation) (R) Reditabs, and Aralen(R), we also received tentative tentative, adj not final or definite, such as an experimental or clinical finding that has not been validated. approvals of a generic version of OxyContin Ox·y·con·tin A trademark for the drug oxycodone. oxycodone hydrochloride ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA) Pharmacologic class: Opioid agonist (R) Controlled Release Tablets, 80mg." Mr. Edwards continued, "Also in the quarter, we entered into an Exclusivity Transfer Agreement with Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) and a subsidiary of Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (Nasdaq:TEVA) 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 pending 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 (ANDAs) for 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. versions of Wellbutrin(R) SR and Zyban(R) (Bupropion Hydrochloride bu·pro·pi·on hydrochloride n. A drug used to treat depression and nicotine dependence. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban ) 100mg and 150mg Extended Release Tablets filed by Andrx, as well as by IMPAX. We believe that this agreement with Andrx and Teva will provide us with an opportunity to bring our products to the market earlier than would be possible alone." "We filed two ANDAs, as well as one Investigational New Drug application (IND), with the FDA during the quarter and we remain comfortable that we will meet our goal of filing at least six applications this year," said Larry Hsu, Ph.D., President of IMPAX. "This, our first IND filing, represents a significant milestone in the development of our branded pharmaceuticals program for products intended to treat disorders of the Central Nervous System (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). )." IMPAX has eighteen applications pending at the FDA, including three tentatively ten·ta·tive adj. 1. Not fully worked out, concluded, or agreed on; provisional: tentative plans. 2. Uncertain; hesitant. approved, that address approximately $7 billion in U.S. branded product sales for the twelve months ended August 31, 2003. Fourteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. IMPAX Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, Calif., and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com. As previously announced, the Company has scheduled a conference call to discuss this announcement beginning at 9:00 a.m. Eastern Time today. To participate in the call, a few minutes prior to the start time, please dial 888-803-7396 in the U.S. or 706-634-1052 for international callers. Those unable to participate are invited to listen to a recording of the call and Question and Answer session from 10:00 a.m. Eastern Time, November 5, 2003, through 11:59 p.m. Eastern Time, November 7, 2003, by dialing 800-642-1687 in the U.S. or 706-645-9291 for international callers, and entering reservation code 3626714. Alternatively, individuals may listen to the call by visiting the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's Web site at www.impaxlabs.com. To listen to the live call, please go to the Web site 15 minutes prior to its start to register, download To receive a file transmitted over a network. In any communications session, "download" means receive, and "upload" means send. The download/upload often implies a big/little scenario, in which data is being downloaded from the "big" server into the "little" user's computer. , and install the necessary audio software. A recording of the call will be available for 14 days on the site beginning on November 5, 2003. "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 under 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: To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such 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. . Such risks and uncertainties include, but are not limited to, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent 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. , the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results, and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur, or otherwise.
IMPAX LABORATORIES, INC.
STATEMENTS OF OPERATIONS
(unaudited)
(dollars in thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2003 2002 2003 2002
Net Sales $ 15,908 $ 7,283 $ 40,434 $ 15,860
Other revenues 589 255 1,555 255
Total revenues 16,497 7,538 41,989 16,115
Cost of sales 12,976 5,153 30,444 12,274
Gross margin 3,521 2,385 11,545 3,841
Research and
development 4,203 4,533 12,305 11,899
Less: Teva
payments (93) (182) (247) (486)
Research and
development, net 4,110 4,351 12,058 11,413
Selling expenses 546 697 1,552 2,001
General and
administrative
expenses 2,321 2,084 6,526 6,193
Other operating
income (expense),
net 4 (30) 25 (39)
Net loss from
operations (3,452) (4,777) (8,566) (15,805)
Interest income 87 138 199 540
Interest expense (243) (571) (738) (1,304)
Net loss (3,608) (5,210) (9,105) (16,569)
Net loss per share
(basic and
diluted) $ (0.07) $ (0.11) $ (0.18) $ (0.35)
Weighted average
common shares
outstanding 52,610,356 47,778,512 50,382,455 47,302,950
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(unaudited)
(in thousands)
Sept. 30, Dec. 31,
2003 2002
ASSETS
Cash and cash equivalents $ 22,482 $ 10,219
Accounts receivable, net 7,899 6,524
Inventory 19,863 10,478
Restricted cash (a) 10,000 10,000
Property, plant and equipment, net 37,696 37,065
Goodwill and intangibles, net 28,049 28,337
Other assets 2,067 1,780
Total assets $ 128,056 $ 104,403
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 30,955 $ 23,248
Refundable deposit (b) 8,500 22,000
Long-term debt, net of current portion 9,035 9,105
Deferred revenues and other liabilities 2,441 1,486
Mandatorily redeemable convertible
preferred stock 7,500 7,500
Stockholders' equity 69,625 41,064
Total liabilities and stockholders'
equity $ 128,056 $ 104,403
(a) Represents cash held as collateral for the $25 million revolving
credit facility and term loan with Congress Financial.
(b) As of the date of this press release, we expect to pay the
refundable deposit to Teva in IMPAX common stock. In September
2003, we issued 888,918 shares of common stock to Teva, paying
$13.5 million of the original $22 million refundable deposit.
|
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion