Fenster schließen  |  Fenster drucken

Nun poste ich noch die Aussichten für das Jahr 2001...
____________________________________________________________

GUILFORD PHARMACEUTICALS INC filed this 10-Q on 05/14/2001.
[...]


Outlook

During the year 2001, we expect net product sales of GLIADEL® Wafer to be between $19.0 million and $22.0 million. Sales from GLIADEL® Wafer may be greater if we receive a first surgery label in the United States and internationally, especially if GLIADEL® Wafer were to achieve “standard of care” acceptance by the neurosurgical community.

We plan to seek additional revenues from partnering activities in 2001. From time to time, we are in discussions with potential partners regarding international rights to our products and product candidates, including GPI 5693. As a result of the adoption of SAB 101, we are not able to define the extent to which any up-front payments received in 2001 from partnering activities would be recorded as revenue.

We expect that our total expenses for 2001 will increase over 2000, primarily due to costs related to establishing and supporting our commercial operations and increased research and development costs as we advance multiple product candidates through clinical development.

We currently anticipate that research and development expenses in 2001 will increase by approximately $10.0 million to $12.0 million when compared to 2000. As we stated above, most of this increase will be related to increased clinical development costs. We anticipate that general and administrative costs will be consistent with 2000, adjusted for modest cost of living increases. We expect marketing, sales and distribution costs for GLIADEL® Wafer to be between $14 million to $15 million for 2001, which includes $1.0 million in non-cash expense, representing the amortization of capitalized reacquisition costs for GLIADEL® Wafer. We expect that cost of sales as a percentage of net product sales will range from 10% to 15% and we anticipate that cost of sales as a percentage of sales will decrease in the future, assuming both our unit sales estimates are achieved and production levels increase to support such sales.


In April 2001, we filed a supplemental New Drug Application with the FDA for GLIADEL® Wafer for the first surgery indication. We expect to obtain FDA approval of that supplemental New Drug Application, if any, around the fourth quarter of 2001 or the first quarter 2002. Also later in 2001, we expect to report results from our Phase I clinical trials of GPI 5693, AQUAVAN TM Injection and PACLIMER® Microspheres and the Phase II NIL-A clinical trial.

We anticipate our cash burn rate will be in the range of approximately $30 million to $35 million for 2001. Our cash burn may be significantly greater if we are unable to meet sales targets for GLIADEL® Wafer, consummate corporate collaborations and manage the timing and amount of expenditures. We expect our capital expenditures in 2001 will be between $2.0 million and $2.5 million.

Except for the historical information contained in this report, the matters discussed in this report are by their nature forward-looking. Reference is made in particular to forward-looking statements regarding the following matters: (1) our efforts to market, sell and distribute GLIADEL® Wafer in the United States and internationally; (2) our efforts to expand the labeled uses for GLIADEL® Wafer, including our efforts to obtain additional United States and international regulatory clearances for such uses; (3) our efforts to develop polymer drug delivery product line extensions and new polymer drug delivery products; (4) our research programs related to our FKBP neuroimmunophilin ligand technology partnered with Amgen Inc. (“Amgen”), NAALADase inhibition, PARP inhibition, polymer drug delivery (including LIDOMERTM Microspheres) and other technologies; (5) our clinical development activities related to our polymer-based drug delivery products and product candidates (including GLIADEL® Wafer and PACLIMER® Microspheres) and our pharmaceutical product candidates, including NIL-A (partnered with Amgen), GPI 5693, AQUAVANTM Injection and any future lead compounds in our PARP program; (6) our efforts to scale-up product candidates from laboratory bench quantities to commercial quantities; (7) our efforts to secure adequate supply of the active pharmaceutical ingredients for clinical development and commercialization; (8) our efforts to manufacture drug candidates for clinical development and eventual commercial supply; (9) our strategic plans; (10) anticipated expenditures and the potential need for additional funds; and (11) specific guidance we give in the section entitled “Outlook,” regarding our current expectations of our future operating results.

Any of the statements we make in this report that are forward-looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We wish to caution you that our actual results may differ significantly from the results we discuss in the forward-looking statements.

We discuss factors that could cause or contribute to such differences in the “Risk Factors” section of our annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2000. In addition, any forward-looking statements we make in this report speak only as of the date of this report, and we do not intend to update any such forward-looking statements to reflect events or circumstances that occur after that date.

[...]
____________________________________________________________
 
aus der Diskussion: GUILFORD PHARMACEUTICALS - PART III
Autor (Datum des Eintrages): Maiestro  (13.06.01 18:55:27)
Beitrag: 23 von 66 (ID:3731995)
Alle Angaben ohne Gewähr © wallstreetONLINE