MOUNTAIN VIEW, Calif., May 15 /PRNewswire/ -- Microcide Pharmaceuticals, Inc. (Nasdaq: MCDE - news) today announced financial results for the first quarter ended March 31, 2001.
Total revenues were $2.7 million in the first quarter of 2001 as compared to $1.2 million in the first quarter of 2000. In the first quarter of 2001, increased revenues resulted from the signing of an amendment to the existing research and license agreement with the R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and Ortho McNeil Pharmaceutical, Inc. (OMP), units of Johnson & Johnson, to develop an orally-active, novel cephalosporin, as well as from a new research and license agreement with RWJPRI to discover novel drugs from natural product-derived diversity. Additional revenues from Daiichi Pharmaceutical Co., Ltd., Schering-Plough Animal Health and Pfizer Animal Health offset a reduction in revenues from Pfizer Inc. due to the conclusion of the joint research agreement during the first quarter.
Net loss for the first quarter of 2001 was $2.4 million or $0.21 per share as compared to a net loss of $3.7 million or $0.33 per share in the first quarter of 2000. Operating expenses increased from $4.9 million in the first quarter of 2000 to $5.2 million in the first quarter of 2001, primarily the result of higher general and administrative expenses, for personnel-related costs and outside services.
At March 31, 2001, the Company's cash, cash equivalents and short-term investments were $14.1 million.
``The first quarter of 2001 saw continued strong and broad-based research progress within each of our three technology platforms: Cephalosporin Antibiotics, Efflux Pump Inhibition (in bacteria and fungi) and VALID Microbial Genomics,'' said Jim Rurka, President & CEO of Microcide. ``Our accomplishments are supportive of Microcide's forward integration strategy, which balances the importance of successful external collaborations with progress in generating potential product candidates for our own account. As part of our financing activities, a shelf registration statement was filed and became effective with the Securities and Exchange Commission to allow the Company to raise the first new equity capital since its initial public offering in 1996 -- thereby providing the capital base for successfully carrying out this forward integration strategy.''
Highlights of the quarter's developments in each of Microcide's three technology platforms include:
Cephalosporin Antibiotics:* Johnson & Johnson: The R.W. Johnson Pharmaceutical Research Institute (RWJPRI), a subsidiary of Johnson & Johnson, has decided to advance RWJ-442831, a Microcide-developed prodrug form of the collaboration's lead parenteral cephalosporin product (RWJ-54428) into preclinical toxicology studies, which, if successful, would allow the compound to advance into Phase I clinical trials. Preliminary studies in animals, conducted by Microcide, demonstrated reduced venous irritation at the injection site compared to RWJ-54428. Preclinical development work at RWJPRI continued on a second Microcide parenteral cephalosporin compound, RWJ-333441 (MC-04,546) -- both parenteral agents are intended for treatment of serious, resistant Gram-positive infections in hospitalized patients. Microcide also discovered, and recently partnered with RWJPRI to further develop, a potentially orally-active, novel cephalosporin series for use in both hospital and community settings. This compound series has similar spectrum and potency to the parenteral compounds currently under development.
Efflux Pump Inhibitors:
* Daiichi: Successfully completed the funded preclinical research phase of Microcide's efflux pump inhibitor program with Daiichi Pharmaceutical Co., Ltd. (Tokyo, Japan). Microcide and Daiichi have been working together since 1995 in a program to discover and develop inhibitors able to overcome the effect of efflux pumps in Pseudomonas aeruginosa, a major cause of serious infections. Further preclinical and clinical work on candidate inhibitors will continue at Daiichi. Microcide will receive milestone payments and royalties on worldwide sales of any marketed products resulting from this research, and has retained product co-promotion rights for North America.
* Microcide-owned fungal efflux pump inhibitor product candidate: Substantial progress was made in advancing the recently identified fungal efflux pump inhibitor, currently in the lead optimization stage. The characteristics of this series are well suited for pairing with an existing azole and/or several newer azoles to significantly improve potency and overcome growing resistance to these drugs.
Microbial Genomics:
* Microcide's VALID System: Entered into a non-exclusive licensing agreement with Aurora Biosciences Corporation which gives Aurora access to a specific non-traditional bacterial target. The technology base which generated this patented target is Microcide's VALID (Validated Antimicrobial Lead Identification and Development) System, a proprietary set of integrated microbial genomics and genetics tools, designed to be a novel and productive approach to the discovery of validated compounds from new classes of antibiotics, antifungal agents and antiviral drugs. The VALID System provides important proof that compounds active against the desired gene target can enter the microbe, reach the target and kill the pathogen. The system also includes the full capability to advance these discoveries through drug development and into clinical trials.
* NeoGenesis: Entered into a collaborative research and development agreement with NeoGenesis, Inc. to discover and develop new classes of antibiotics. The collaboration will utilize a specified number of proprietary bacterial in vivo essential gene targets from Microcide's VALID microbial genomics platform, together with NeoGenesis' proprietary ALIS® screening system and its mass-coded NeoMorph® small molecule libraries to identify and optimize chemical compounds with antibacterial activity. Microcide will have worldwide product development and commercialization rights on products that result from the collaboration.
* Microcide-owned antifungal product candidate: Entered into a research collaborative agreement with Discovery Partners International, Inc. to optimize the drug-like qualities of Microcide's recently discovered broad-spectrum antifungal compound series, and to accelerate the lead optimization process. The compound series was derived from the microbial genomics platform using Microcide's proprietary VALID System, and has a defined, selective mechanism of action as well as a broad spectrum of activity against key fungal pathogens.
* Natural Products: Began work with RWJPRI in a collaboration in which RWJPRI will screen Microcide's natural products in order to identify new drug candidates.
Microcide is a biopharmaceutical company committed to the discovery, development and commercialization of novel antimicrobials for the improved treatment of serious bacterial, fungal and viral infections. The Company's three discovery research platforms address the growing problems of antibiotic resistance and the need for improved antifungal and antiviral therapeutics. The Company's Cephalosporin Antibiotics and Efflux Pump Inhibition platforms focus on developing novel antibiotics and antibiotic potentiators (efflux inhibitors) to directly address existing bacterial and fungal resistance problems. Microcide's VALID Microbial Genomics platform utilizes proprietary bacterial, fungal and viral genetics and genomics tools to discover entirely new classes of antimicrobial agents.
The statements contained in this press release which are not historical facts may be deemed to contain forward-looking statements. Actual results may differ materially from those expressed or implied in any forward-looking statement as a result of certain risks and uncertainties including, without limitation, the following. There is no assurance that any compounds discovered will successfully proceed through preclinical development and clinical trials, obtain requisite regulatory approvals for marketing or result in a commercially useful product. There is no assurance that the Company will successfully continue existing corporate collaborations or enter into further collaborations with respect to any of its internally funded research programs or that current collaborators will elect to proceed through the various stages of clinical development as currently anticipated or on the same schedule as we would proceed if we were conducting such trials independently. Also, there can be no assurance that the Company will raise additional equity capital. For a discussion of other risks and uncertainties affecting Microcide's business, see the Company's annual report on Form 10-K/A for the year ended December 31, 2000 and quarterly report Form 10-Q for the quarter ended March 31, 2001 filed on May 15, 2001. Actual results and timing of certain events could differ materially from those indicated in the forward-looking statements as a result of these or other factors.
Investor contact: Donald D. Huffman, VP of Finance and Corporate Development and CFO, 650-428-3557 microcide.com .
Microcide Pharmaceuticals, Inc.
Condensed Statements of Operations
(unaudited)
(in thousands, except per share data)
Three Months Ended
March 31,
2001 2000
Revenues:
Research revenues $1,770 $1,133
License fees and other revenues 892 50
Total revenues 2,662 1,183
Operating expenses:
Research and development 4,071 4,057
General and administrative 1,123 842
Total operating expenses 5,194 4,899
Loss from operations (2,532) (3,716)
Interest and other income, net 171 246
Loss before cumulative effect of change in
accounting principle (2,361) (3,470)
Cumulative effect of change in accounting
principle -- (233)
Net loss $(2,361) $(3,703)
Basic and diluted net loss per share:
Loss before cumulative effect of change in
accounting principle $(0.21) $(0.31)
Cumulative effect of change in accounting
principle -- (0.02)
Net loss per share $(0.21) $(0.33)
Weighted-average shares used in computing
basic and diluted net loss per share 11,463 11,213
March 31,
2001
Cash, cash equivalents and short-term investments $14,076
Total assets 22,526
Notes payable - current and long-term portions 1,522
Stockholders' equity 13,159 |
