Indevus Pharmaceuticals Announces Fiscal 2005 Year End and Fourth Quarter Results; Company Acquires Rights to Delatestryl(R); Company Finalizes NDA Submission Plans for NEBIDO(R).LEXINGTON, Mass. -- Indevus 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 : IDEV IDEV International Development ) today announced its consolidated results of operations for the fiscal year and the three-month period ended September 30, 2005. The Company reported a consolidated net loss of $53.2 million or $1.13 per share for fiscal 2005, compared to a consolidated net loss of $68.2 million or $1.43 per share for fiscal 2004. For the three-month period ended September 30, 2005, the Company reported a consolidated net loss of $12.6 million or $0.27 per share, compared to a consolidated net loss of $27.9 million or $0.58 per share for the three-month period ended September 30, 2004. At September 30, 2005, 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 approximately $101.2 million. "Fiscal 2005 was a year of significant accomplishment for Indevus," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "During the year, we have delivered on multiple elements of our strategy. We have had significant development activity on each of the products in our pipeline and have added two products that fit very well into our urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. , gynecology and men's health Men's Health Definition Men's health is concerned with identifying, preventing, and treating conditions that are most common or specific to men. franchise. We now have six products within our core focus area that are either on the market or in development." "In fiscal 2005, SANCTURA(R), our first marketed product in urology, had approximately 300,000 prescriptions written for patients suffering from overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description and sales to pharmacies in the fiscal year totaled $23 million," said Dr. Cooper. "Despite extensive competition from large pharmaceutical companies, SANCTURA has achieved an important position among key prescribers." "The pipeline is very robust with three products at the 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 stage as well as one Phase II product and two earlier stage products. Moving into 2006, we look forward to building on our accomplishments and continuing the development of the products currently in our pipeline while identifying new opportunities to acquire and in-license candidates that fit our core area," continued Dr. Cooper. "One of the most significant events of 2005 was the in-licensing of U.S. rights to NEBIDO from Schering AG, in July," said Dr. Cooper. "NEBIDO, a long-acting injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the preparation for the treatment of male hypogonadism Noun 1. male hypogonadism - the state of being a eunuch (either because of lacking testicles or because they failed to develop) eunuchoidism hypogonadism - incompetence of the gonads (especially in the male with low testosterone); results in deficient , is the first therapy of its kind requiring dosing only once every three months. The product fits perfectly within our late-stage pipeline and within our focus area - urology, gynecology and men's health. The addition of NEBIDO allows us to leverage our capabilities and resources and address a market of meaningful size with an innovative and differentiating product." "NEBIDO has been studied in multiple clinical trials including studies where patients have been treated for over one year's duration," said Dr. Cooper. "These trials have formed the basis of approval in over 40 countries in Europe and around the world. Following a pre-IND meeting with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , the Company will conduct a single pharmacokinetic study following 100 hypogonadal men for approximately six months to supplement the existing clinical database. The protocol for this trial will be submitted under a Special Protocol Assessment in order to ensure that the trial satisfies FDA requirements." "After meeting with the FDA we have received clear guidance regarding the agency's regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. for NEBIDO. We are confident that with the successful completion of a relatively small, short-term trial we will have an 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 package that will pass regulatory scrutiny," stated Dr. Cooper. "We anticipate starting this trial in the first quarter of 2006 and filing an NDA in the first quarter of 2007." Additionally, the Company announced today that it has reached a definitive agreement to acquire Delatestryl (testosterone enanthate testosterone enanthate Warning - Hazardous drug! Delatestryl Pharmacologic class: Hormone Therapeutic class: Androgenic and anabolic steroid, antineoplastic ) from Savient Pharmaceuticals, Inc. Delatestryl is a marketed injectable testosterone preparation for the treatment of male hypogonadism. "Delatestryl is a well established testosterone replacement therapy testosterone replacement therapy Androgen replacement therapy, see there and fits nicely into the Indevus portfolio of urology, gynecology and men's health products," stated Dr. Cooper. "Our sales force is already positioned to effectively promote Delatestryl and with our future product plans surrounding NEBIDO, we can accelerate the building of our market presence in testosterone replacement therapy." "We believe Delatestryl provides several immediate benefits to Indevus," continued Dr. Cooper. "First, we expect to increase the revenue base of the Company by approximately $3.5 million in calendar 2006 without incurring development costs or significant promotional expenses Noun 1. promotional expense - the cost of promoting a product business expense, trade expense - ordinary and necessary expenses incurred in a taxpayer's business or trade . Second, by having an additional marketed product, we can increase the utilization of our sales force. Finally, we anticipate filing our NDA for NEBIDO in the first quarter of 2007 and having Delatestryl on the market provides us with a unique opportunity to gain valuable market exposure and experience prior to NEBIDO's product launch." "We are excited by the acquisition of Delatestryl and plan to begin our sales force training and promotional activities over the next several weeks. This transaction marks another important step in Indevus' growth and further enhances our presence as a leading urology, gynecology and men's health company," concluded Dr. Cooper. Under the terms of the agreement Indevus will pay Savient $5.0 million upon closing of the transaction and will purchase the Delatestryl inventory over the next 24 months. The transaction is expected to close in January 2006, subject to certain closing conditions. Indevus will pay royalties to Savient for 3 years following the closing of the transaction based upon the 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 of Delatestryl. The royalty rate will be 5% on the first $5 million of cumulative net sales, increasing to 10% on cumulative net sales between $5 million and $10 million, and will rise to 25% on cumulative net sales above $10 million. Additional 2005 Highlights --In February, the Company announced the initiation of a 3,200 women, multi-national clinical trial sponsored by the NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. designed to examine the safety and effectiveness of two candidate topical microbicides topical microbicide Infectious disease A chemical that can be applied to the surface of the body to kill microorganisms , including PRO 2000, the Company's topical microbicide to prevent the sexual transmission of 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. and certain other sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely . --In March, the Company announced that IP 751 has been shown to significantly reduce the bladder overactivity o·ver·ac·tive adj. Active to an excessive or abnormal degree: an overactive child. o in an animal model of interstitial cystitis interstitial cystitis: see cystitis. . The Company believes the product has the potential to treat the larger indications of pain and inflammation and plans to seek a large pharmaceutical partner to bring IP 751 into the clinic for the larger indications. --In May, the Company announced a change in its marketing partner for SANCTURA. The Company entered into an amended agreement with Odyssey Pharmaceuticals whereby the marketing rights were transferred to Esprit Pharma Holding Company, Inc. Indevus' sales force subsidy was increased in duration and amount, its effective royalty rates were increased, and the Company now receives guaranteed minimum royalties for a period of three years. --In July, the Company announced the initiation of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II with pagoclone, a product under development to treat stuttering stuttering or stammering, speech disorder marked by hesitation and inability to enunciate consonants without spasmodic repetition. Known technically as dysphemia, it has sometimes been attributed to an underlying personality disorder. . The Company is currently on track to have results from this trial by mid-year 2006. --In September the Company announced the initiation of the Phase III clinical program for SANCTURA XR(TM), the once-daily formulation of SANCTURA, under development to treat overactive bladder. The Company continues to be on track to file the NDA in the second half of calendar 2006. --In October, the Company announced the initiation of a second large, multi-national clinical trial involving 10,000 women, which is sponsored by the MRC See Maximum return criterion. and designed to examine the safety and effectiveness of PRO 2000. PRO 2000 is the only candidate being tested in this trial. --The Company is continuing to make progress on developing a new formulation for aminocandin, a product for the treatment of serious fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. and expects to resume its Phase I multi-dose trial in 2006. Financial Results Total consolidated revenues during fiscal 2005 were $33.3 million, an increase of 78% from fiscal 2004 revenues of $18.7 million. Fiscal 2005 revenue consisted primarily of $5.8 million of revenues received in connection from product sales of SANCTURA to the Company's partner, $13.9 million from the amortization of upfront and milestone revenue for SANCTURA received from the Company's partner, $6.7 million of SANCTURA royalties, and $6.7 million in sales force subsidy. Cost of product revenue increased 8% to $8.6 million in fiscal 2005 from $8.0 million in fiscal 2004. Fiscal 2005 cost of product revenue relates primarily to sales of SANCTURA, sold to the Company's partner at cost. Also included are royalties owed to the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, related to payments received by the Company from Lilly in connection with Sarafem. Fiscal 2005 research and development expenses were $30.6 million, an increase of 31% compared to $23.3 million in fiscal 2004. Research and development expenses consisted primarily of costs related to the development of the Company's product and product candidates and the $7.5 million up front payment made to Schering AG, Germany for the in-licensing of NEBIDO. Marketing, general and administrative expenses for fiscal 2005 declined 19% to $42.0 million compared to $51.9 million for fiscal 2004. The decrease is primarily due to the fact that in November 2004 the Company transferred to PLIVA approximately 200 sales representatives who were promoting SANCTURA to primary care physicians and certain other specialists. Interest expense for fiscal 2005 included $5.2 million in connection with the Company's July 2003 issuance of Convertible Notes. Conference call and webcast The Company will hold a conference call and webcast to discuss these results at 9:00 AM eastern time on December 13, 2005. The live call may be accessed by dialing 800-659-2056 from the U.S. and Canada, and 617-614-2714 from international locations. The participant passcode is 25022541. A replay of the call will be available beginning at 11:00 AM on December 13, 2005 and lasting until 12:00 AM on December 23, 2005. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 90496997. The press release and the live webcast will be accessible by visiting the Investors section of the Company's website, http://www.indevus.com. An archived version of the call will be accessible at the same web address for 30 days following the live call. About Indevus Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of product candidates primarily focused in the areas of urology, gynecology and men's health. The Company currently markets SANCTURA(R) for overactive bladder and has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO(R) for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections. About SANCTURA SANCTURA is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. , urgency and urinary frequency. The most commonly reported side effects Side effects Effects of a proposed project on other parts of the firm. in Phase III U.S. clinical trials were dry mouth (20.1 percent for SANCTURA vs. 5.8 percent for placebo) and constipation (9.6 percent for SANCTURA vs. 4.6 percent for placebo). Patients who have urinary retention Urinary retention The result of progressive obstruction of the urethra by an enlarging prostate, causing urine to remain in the bladder even after urination. , gastric retention, uncontrolled narrow-angle glaucoma nar·row-an·gle glaucoma n. See angle-closure glaucoma. or hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to SANCTURA should not use SANCTURA. Except for the descriptions of historical facts contained herein, this press release contains 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. 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: dependence on the success of SANCTURA(R) and SANCTURA XR(TM); 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, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing, marketing and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related 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. ; our reliance on intellectual property and having limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and twelve months ended September 30, 2005 and 2004
(Amounts in thousands except per share data)
For the three months For the twelve months
ended September 30, ended September 30,
--------------------------- -----------------------
2005 2004 2005 2004
------------- ------------- ----------- -----------
Total revenues $ 10,103 $ 12,461 $ 33,336 $ 18,726
Costs and
expenses:
Cost of product
revenues 864 7,491 8,593 7,950
Research and
development 13,149 4,665 30,597 23,303
Marketing, general
and
administrative 7,270 27,546 41,983 51,916
------------- ------------- ----------- -----------
Total costs and
expenses 21,283 39,702 81,173 83,169
------------- ------------- ----------- -----------
Loss from
operations (11,180) (27,241) (47,837) (64,443)
Investment income 932 678 3,142 1,396
Interest expense (1,292) (1,292) (5,170) (5,170)
Other 1 - (182) 5
------------- ------------- ----------- -----------
Loss before income
taxes (11,539) (27,855) (50,047) (68,212)
Provision for
income taxes (1,021) - (3,171) -
------------- ------------- ----------- -----------
Net loss $ (12,560) $ (27,855) $ (53,218) $ (68,212)
============= ============= =========== ===========
Net loss per
common share:
Basic and
diluted $ (0.27) $ (0.58) $ (1.13) $ (1.43)
============= ============= =========== ===========
Weighted average
common shares:
Basic and
diluted 47,017 47,826 46,977 47,542
============= ============= =========== ===========
INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
September 30, September 30,
2005 2004
------------- -------------
Cash, cash
equivalents and
marketable
securities $ 101,217 $ 157,008
Other assets 11,314 16,830
------------- -------------
Total assets $ 112,531 $ 173,838
============= =============
Convertible notes 72,000 72,000
Deferred revenue 142,308 143,750
Other liabilities 13,365 21,126
Capital 306,979 305,865
Accumulated
deficit (422,121) (368,903)
------------- -------------
Total
stockholders'
deficit (115,142) (63,038)
------------- -------------
Total
liabilities
and
stockholders'
deficit $ 112,531 $ 173,838
============= =============
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