To: DaiS who wrote (10412 ) 7/2/1998 8:23:00 PM From: AlienTech Respond to of 23519
Dais look at INVX.. They make wires used in head assemblies.. With like 70% of the market.. Its in there somewhere with the 'limited/NO experience' paragraphs somewhere. I always wondered what a DD company was going to do with their medical division. Maybe VVUS/APM/INVX can merge and start making necklaces to sell at the grateful dead concerts. Call em TieMuse.. Comes in many many colors.. Ofcourse instead of alprostadil, you need to stick some white powder.. The Company has limited experience in manufacturing and selling MUSE (alprostadil) in commercial quantities. Since the commercial launch of MUSE (alprostadil) in January 1997, the Company has experienced product shortages due to higher than expected demand and difficulties encountered in scaling up production of MUSE (alprostadil). The Company leased 90,000 square feet of space in New Jersey in which it has constructed additional manufacturing and testing facilities. The Company has filed for regulatory authorization of this facility with both the FDA and MCA. In March 1998, the MCA authorized the Company to begin commercial production and shipment of MUSE (alprostadil) from its new facility. In addition, the Company has negotiated a long-term lease for a site in Ireland for construction of a European manufacturing operation. Until the Company receives the required approvals for its new New Jersey facility, domestic and certain international markets will need to be supplied from its current facility at Paco Pharmaceutical Services, Inc. ("Paco"). There can be no assurance that such approvals will be granted in a timely manner, if at all. If international sales increase as anticipated, product available for the domestic market will be reduced and gross margins will be adversely impacted. If the Company encounters further difficulties with its current manufacturing facility or delays in regulatory approvals of its new manufacturing facility, capacity constraints could continue for an extended period of time, which would have a material adverse effect on the Company's business, financial condition and results of operations. Before commercially launching its first product, MUSE (alprostadil), in January 1997, the Company had no experience in the sale, marketing and distribution of pharmaceutical products. The Company is marketing and selling its products initially through a direct sales force in the United States. VIVUS currently employs approximately 75 sales representatives who call upon urologists and other specialists. Effective February 1998, the Company entered into a Sales Force Services Agreement with Innovex Inc. ("Innovex"). While the Sales Force Services Agreement allows for approximately 200 contract sales representatives, the Company has decided to initially add approximately 150 contract sales representatives, the substantial majority of whom will be calling upon primary care physicians. The Company may decide to increase the contract sales force to approximately 200 in the future. As a result of this contract, the Company's ability to increase sales will be highly dependent upon the efforts of Innovex . There can be no assurance that Innovex's sales efforts will be successful or that primary care physicians will recommend the use of MUSE (alprostadil). In the second quarter, the Company anticipates two significant changes in the erectile dysfunction market. First, the launch of sildenafil, a competitive oral product, is expected to dramatically increase the number of men seeking treatment for impotence. Second, indications are that a large number of current and future impotence patients will want to try this new oral therapy. As a result of this and other factors, including higher costs of good sold as the Company ramps up its new manufacturing facility, and higher marketing and sales costs related to the expansion of the Company's sales force, the Company expects an operating loss in the second quarter of 1998. The Company has sought and will continue to seek pharmacologic agents suitable for transurethral delivery for which significant safety data already exists. The Company believes that such agents may progress more rapidly through clinical development and the regulatory process than agents without preexisting safety data. The Company expects to begin a Phase III multi-center trial in 1998 for its second product candidate, a combination of alprostadil and prazosin delivered via the Company's transurethral system for erection. The Company has several other product candidates in preclinical development.