Interneuron Pharmaceuticals Announces Fiscal 2001 Year End and Fourth Quarter Results.Business Editors and Health/Medical Writers LEXINGTON, Mass.--(BW HealthWire)--Dec. 7, 2001 Interneuron interneuron /in·ter·neu·ron/ (-noor´on) 1. a neuron between the primary sensory neuron and the final motoneuron. 2. Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : IPIC IPIC Intellectual Property Institute of Canada IPIC Indianapolis Private Industry Council IPIC International Petroleum Investment Co (Abu Dhabi) IPIC Inventory Price Index Computation IPIC Information Processing Interagency Conference ) today announced its consolidated results of operations for the fiscal year and the three-month period ended September 30, 2001. The Company reported a consolidated net loss of $1,491,000, or $0.03 per share (diluted), for fiscal 2001, compared to consolidated net income of $19,956,000, or $0.46 per share (diluted), for fiscal 2000. For the three-month period ended September 30, 2001, the Company reported consolidated net income of $7,951,000, or $0.17 per share (diluted), compared to consolidated net income of $4,798,000, or $0.11 per share (diluted), for the three-month period ended September 30, 2000. In the fourth quarter of fiscal 2001, the Company adopted the Securities and Exchange Commission's Staff Accounting Bulletin (SAB) No. 101, "Revenue Recognition in Financial Statements." As a result, for the first quarter of fiscal 2001, the Company retroactively recorded a one-time, non-cash charge Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. of $10,000,000 to reflect the cumulative effect of a change in accounting principle to defer revenue previously recognized in fiscal 2000. The Company recognized this revenue of $10,000,000 in the fourth quarter of fiscal 2001. The adoption of SAB 101 did not have any impact on net loss for fiscal 2001. At the end of fiscal 2001, the Company had consolidated cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaling $32,171,000. "Positive developments during fiscal year 2001 have added value Added value in financial analysis of shares is to be distinguished from value added. Used as a measure of shareholder value, calculated using the formula:
When a person begins a civil lawsuit, the person enters into a process called litigation. with American Home For the American mortgage lender, see . The American Home is a center of intercultural exchange located in Vladimir, Russia. The home is designed to model a typical American suburban home and its main focus is the ESL school that provides lessons for Russian students. Products (AHP AHP Assistant House Physician. ). "We are pleased that Pfizer's development of pagoclone moved forward during fiscal 2001 with the advancement of a Phase III clinical trial 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 in panic disorder Panic Disorder Definition A panic attack is a sudden, intense experience of fear coupled with an overwhelming feeling of danger, accompanied by physical symptoms of anxiety, such as a pounding heart, sweating, and rapid breathing. and multiple Phase II trials in generalized anxiety disorder Generalized Anxiety Disorder Definition Generalized anxiety disorder is a condition characterized by "free floating" anxiety or apprehension not linked to a specific cause or situation. ," said Dr. Cooper. "These trials are part of a larger, comprehensive clinical development program building upon previous pre-clinical and clinical results showing that pagoclone holds promise in treating these disorders. We believe that the treatment of anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. with pagoclone may potentially offer advantages over benzodiazepines Benzodiazepines Definition Benzodiazepines are medicines that help relieve nervousness, tension, and other symptoms by slowing the central nervous system. Purpose Benzodiazepines are a type of antianxiety drugs. and serotonin reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. inhibitors by avoiding common side effects Side effects Effects of a proposed project on other parts of the firm. seen with these drugs. The substantial resources of Pfizer are focused on defining the product profile of pagoclone and its potential to make a significant impact on these markets. "In December 2000, we filed our IND (Investigational New Drug application) for trospium, a product for the treatment of overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description ," said Dr. Cooper. "In September, we initiated a 500-patient, 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 trial at over 50 sites in the U.S., comparing the reduction in micturitions and incontinence episodes among trospium-treated patients versus placebo patients during a 12-week period. We expect to complete the Phase III trial early next fall, and, if successful, file a New Drug Application (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 ) by the end of 2002 including this present study and data from eight European placebo and active controlled studies among over 2,000 patients. We believe clinical data on this drug suggest a profile that will differentiate it from current treatments for overactive bladder that have side effects leading to significant patient discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance rates. Trospium is currently marketed in Europe, where it is one of the leading drugs to treat overactive bladder. "Results of a Phase I/II clinical trial of PRO 2000 presented in June 2001 at the International Congress of Sexually Transmitted Infections showed that this topical microbicide topical microbicide Infectious disease A chemical that can be applied to the surface of the body to kill microorganisms was safe and well tolerated by healthy, sexually active women and HIV-infected, sexually abstinent women," said Dr. Cooper. "Additional trials with PRO 2000 planned to begin in 2002 include a European Commission-funded Phase II safety trial in at-risk African women and an NIH-sponsored Phase II/III pivotal trial scheduled in Africa and India to determine the efficacy and safety of this product candidate in blocking male-to-female HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. transmission. "We expanded our product pipeline in September 2001 with the acquisition of worldwide marketing rights to dersalazine, a compound to treat inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. (IBD IBD abbr. inflammatory bowel disease Inflammatory bowel disease (IBD) Disease in which the lining of the intestine becomes inflamed. Mentioned in: Amebiasis IBD 1. ), from J. Uriach & Cia., S.A., a Spanish pharmaceutical company," said Dr. Cooper. "As a new chemical entity that combines activity against TNF-alpha and other key inflammatory cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. with 5-ASA, current standard first-line therapy for IBD, dersalazine has the potential to be the next-generation first-line therapy for mild to moderate IBD. The Company plans to complete the Phase I clinical program and to initiate Phase II trials with dersalazine in ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. in 2002. "On May 30, 2001, we signed an agreement with American Home Products which provides for complete indemnification for certain product liability cases filed against Interneuron related to Redux Refers to being brought back, revived or restored. From the Latin "reducere." , funding of all future legal costs related to Interneuron's defense of Redux-related product liability cases and additional insurance coverage," said Dr. Cooper. "We believe the indemnification, funding of legal costs and insurance coverage that complements our pre-existing insurance coverage are sufficient to address the Company's potential remaining Redux product liability exposure. "We look forward to reporting additional clinical development progress and business development activities during the coming year," said Dr. Cooper. "We remain highly focused on our business model of acquisition, development and commercialization that has resulted in our current advanced-stage product portfolio and that is expected to fuel our development pipeline in the future." Total consolidated revenues during fiscal 2001 were $15,233,000 compared to revenues of $27,754,000 for fiscal 2000. Fiscal 2001 revenues included $13,000,000 in license fee revenues related to the Company's December 1999 partnership agreement with Takeda Chemical Industries, Ltd. for citicoline. This amount includes the $10,000,000 previously recognized in fiscal 2000, which was deferred upon adoption of SAB 101 as a one-time, non-cash charge to reflect the cumulative effect of a change in accounting principle discussed previously, and $3,000,000 recognized in fiscal 2001 after the expiration of a contingent obligation. Royalty income revenues of $1,952,000 during fiscal 2001 reflected sales of Sarafem(TM). Total consolidated costs and expenses for fiscal 2001 fell 32 percent to $7,655,000 from $11,248,000 in fiscal 2000. Included in fiscal 2001 costs and expenses is a product withdrawal credit of $5,582,000, which includes a reversal of approximately $8,000,000 of accruals related to Redux, partially offset by a $2,336,000 reserve against amounts owed to the Company under a product liability policy issued by Reliance Insurance Company. Reliance is currently in an initial stage of liquidation. Research and development expenses increased 68 percent to $5,301,000 in fiscal 2001 from $3,158,000 in fiscal 2000, primarily due to increased costs for the initiation of the Company's Phase III clinical trial for trospium and increased costs for the development of PRO 2000. General and administrative expenses increased six percent, to $7,238,000 in fiscal 2001 from $6,823,000 in fiscal 2000. Interneuron Pharmaceuticals is engaged in the development and commercialization of a portfolio of products and product candidates for panic/anxiety disorders, overactive bladder, inflammatory bowel disease, liver disease Liver Disease Definition Liver disease is a general term for any damage that reduces the functioning of the liver. Description The liver is a large, solid organ located in the upper right-hand side of the abdomen. , prevention of HIV infection, stroke and other disorders. Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: the early stage of products under development; uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc clinical trials and regulatory approvals; dependence on third parties for manufacturing and marketing; need for additional funds and corporate partners; history of operating losses and expectation of future losses; product liability; risks relating to the Redux-related litigation; government regulation, patent risks and competition.
INTERNEURON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and twelve months ended September 30, 2001 and 2000
(Amounts in thousands except per share amounts)
Three mos. ended Twelve mos. ended
Sept. 30, Sept. 30,
----------------- ------------------
2001 2000 2001 2000
---- ---- ---- ----
Revenues:
Contract and license fees $13,281 $ 4,003 $ 13,281 $ 27,754
Royalties 1,020 - 1,952 -
------- ------- -------- --------
Total revenues 14,301 4,003 15,233 27,754
Costs and expenses:
Cost of revenues 498 949 698 3,024
Research and development 1,641 68 5,301 3,158
General and administrative 1,203 542 7,238 6,823
Product withdrawal, net 2,516 (1,757) (5,582) (1,757)
-------- -------- --------- ---------
Total costs and expenses 5,858 (198) 7,655 11,248
-------- -------- --------- ---------
Income from operations 8,443 4,201 7,578 16,506
Investment income, net 333 565 1,811 1,868
Equity in net income of
unconsolidated subsidiary - 175 - 175
Gain (loss) on disposition
of equity securities - - (43) 1,550
Impairment of equity
securities (810) - (810)
Minority interest (15) (143) (27) (143)
-------- -------- --------- ---------
Income before cumulative
effect of change in
accounting principle 7,951 4,798 8,509 19,956
Cumulative effect of change
in accounting principle - - (10,000) -
-------- -------- --------- ---------
Net income (loss) $ 7,951 $ 4,798 $ (1,491) $ 19,956
======== ======== ========= =========
Net income (loss) per
common share:
Basic: $ 0.18 $ 0.11 $ (0.03) $ 0.47
======== ======== ======== ========
Diluted $ 0.17 $ 0.11 $ (0.03) $ 0.46
======== ======== ======== ========
Weighted average common
shares outstanding:
Basic 43,257 42,774 42,948 42,487
======== ======== ======== ========
Diluted 47,221 43,918 45,628 43,838
======== ======== ======== ========
INTERNEURON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
Sept. 30, Sept. 30,
2001 2000
--------- ---------
Cash, cash equivalents and
marketable securities $ 32,171 $ 33,751
Other assets 2,746 13,075
--------- ---------
Total assets $ 34,917 $ 46,826
========= =========
Liabilities $ 6,160 $ 18,728
Minority interest 97 332
Capital 279,953 277,568
Accumulated deficit (251,293) (249,802)
--------- ---------
Total stockholders' equity 28,660 27,766
--------- ---------
Total liabilities and
stockholders' equity $ 34,917 $ 46,826
========= =========
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