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[0] DepoMed, Inc. Reports Second Quarter Results; Metformin GR and Ciprofloxacin GR Clinical Advancements and $12.3 Million Financing Highlight Quarter.


Business Editors/Health & Medical Writers

MENLO PARK Menlo Park.

1 Residential city (1990 pop. 28,040), San Mateo co., W Calif.; inc. 1874. Electronic equipment and aerospace products are manufactured in the city. Menlo College and a Stanford Univ. research institute are there.

2 Uninc.
, Calif.--(BW HealthWire)--Aug. 14, 2001

DepoMed, Inc. (AMEX AMEX

See: American Stock Exchange
:DMI (Desktop Management Interface) The first desktop management standard from the DMTF. Enabling PCs to be monitored from a central console, it was superseded by the DMTF's Common Information Model (see CIM). ) today announced a net loss of $4,934,000, or $0.56 per share, for the quarter ended June 30, 2001, compared to a net loss of $2,179,000, or $0.33 per share, for the quarter ended June 30, 2000. Cash and investment balances at June 30, 2001 were approximately $11,218,000.

For the second quarter of 2001, the Company reported revenues of $838,000, compared to $586,000 for the same period of 2000. The increase in revenue is primarily due to amounts earned under an interim feasibility agreement with an undisclosed New York Stock Exchange New York Stock Exchange (NYSE)

World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City.
 listed pharmaceutical company. Research and development expense for the quarter ended June 30, 2001 was $4,192,000 compared to $1,716,000 during the quarter ended June 30, 2000. The increase was primarily due to expenses for clinical trials with DepoMed proprietary products, including Phase II and 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  trials with Metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
 GR(TM), a once-daily metformin product for Type II diabetes Type II diabetes
Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise.

Mentioned in: Diabetic Ketoacidosis
 that uses the Company's proprietary gastric retention technology.

During the second quarter, DepoMed completed a financing of $12.3 million. The financing consisted of the sale of 2.91 million shares of common stock and warrants to purchase 1.45 million shares to new and existing investors, led by Easton Hunt Capital Partners, L.P. and OrbiMed Advisors. Other investors included S Squared Technology Corp. and Special Situations Funds. In April 2001, the Company also announced that GATX GATX General American Transportation Corporation  Ventures, Inc. would provide up to $2 million in financing for the purchase of laboratory equipment and the completion of DepoMed's Menlo Park facilities including the Company's clinical scale cGMP manufacturing laboratory.

"This quarter's financing puts DepoMed in a comfortable position from a balance sheet perspective. With this cash on hand, we have sufficient funds to continue our clinical work as well as enter into further collaborations," commented John F. Hamilton, DepoMed's chief financial officer.

In the second quarter, the Company began 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  for Metformin GR. The Phase III trial will be held at 60 sites throughout the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Later in the second quarter, final data from the 163-patient Phase II trial was announced. The analysis of the trial data confirmed interim findings indicating the safety, efficacy and improved tolerability tol·er·a·ble  
adj.
1. Capable of being tolerated; endurable.

2. Fairly good; passable. See Synonyms at average.



tol
 of the product.

Additionally, a recent study sponsored by the National Institute of Health and the American Diabetes Foundation found that taking Metformin showed a 31% reduction in the risk of developing diabetes. This was the first time that Metformin has been shown to be effective in preventing the onset of the disease.

"This may effectively expand the market for oral glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 agents, including our Metformin GR, to include prevention of diabetes in high-risk individuals. Of course, we would have to seek approval from 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.
, but the potential is very exciting," said John W. Fara, Ph.D., DepoMed's chairman, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

"With our Metformin GR product in Phase III trials and our Ciprofloxacin ciprofloxacin /cip·ro·flox·a·cin/ (sip?ro-flok´sah-sin) a synthetic antibacterial effective against many gram-positive and gram-negative bacteria; used as the hydrochloride salt.

cip·ro·flox·a·cin
n.
 GR product about to enter Phase II trials, we are continuing to move closer to our goal of commercializing DepoMed's proprietary products," said Fara. "Our cash plus our expanding pipeline put us in a position of strength as we evaluate potential marketing partners for Metformin GR."

Ciprofloxacin GR(TM), the Company's other lead product, is scheduled to begin Phase II clinical trials 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
 in the third quarter of 2001. DepoMed's once-daily formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating.

American Law Institute Formulation
 was found to have comparable bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
 and had a significantly extended blood plasma blood plasma
n.
The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended.
 concentration profile compared with CIPRO Cip·ro

A trademark for ciprofloxacin and its hydrochloride derivative.


ciprofloxacin hydrochloride

Ciloxam, Cipro, Cipro I.V.
(R), which is taken two times per day. The Phase I human trial compared the internally developed, Ciprofloxacin GR with the currently marketed immediate release CIPRO(R). CIPRO is a registered trademark of Bayer AG Bayer AG

German chemical and pharmaceutical company. Founded in 1863 by Friedrich Bayer (1825–1880), it now operates plants in more than 30 countries. Bayer has originated scores of pharmaceuticals, chemicals, and synthetic materials; it was the first developer and
.

DepoMed's Gastric Retention (GR) System is a patented oral drug delivery technology designed specifically for drugs preferentially pref·er·en·tial  
adj.
1. Of, relating to, or giving advantage or preference: preferential treatment.

2.
 absorbed high in the gastrointestinal tract gastrointestinal tract
n.
The part of the digestive system consisting of the stomach, small intestine, and large intestine.


Gastrointestinal tract 
. Using normal physiological physiological /phys·i·o·log·i·cal/ (-loj´i-kal) pertaining to physiology; normal; not pathologic.

phys·i·o·log·i·cal or phys·i·o·log·ic
adj. Abbr. phys.
1.
 processes by which the stomach retains large objects for further digestion digestion

Process of dissolving and chemically converting food for absorption by cells. In the mouth, food is chewed, mixed with saliva, which begins to break down starches, and kneaded by the tongue into a ball for swallowing.
, the GR System swells following ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth.

in·ges·tion
n.
1. The act of taking food and drink into the body by the mouth.

2.
 and is retained in the stomach for a number of hours, while it continuously releases the incorporated drug at a controlled rate to absorption sites in the upper intestinal in·tes·ti·nal
adj.
Of, relating to, or constituting the intestine.



intestinal

pertaining to the intestine.


intestinal accident
 tract. The controlled release of the drug at the preferred absorption site optimizes delivery of the drug and potentially maximizes its therapeutic benefits. Upon completion of drug delivery, the GR System dissolves and is completely and safely eliminated through the intestine.

DepoMed, Inc., a development stage company, is applying its innovative oral drug delivery systems to the development of novel oral products and improved formulations of existing oral drugs. In addition to developing products jointly with other companies, DepoMed is developing its own line of proprietary products based on off-patent and over-the-counter drugs over-the-counter drug A therapeutic agent that does not require a prescription, which the FDA feels can be safely self-prescribed by non-physicians. Cf Prescription drug, Under-the-counter. . Additional information about DepoMed may be found at the company's web site at http://www.depomedinc.com.

"Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The statements that are not historical facts contained in this release are 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 including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, disputes arising from collaborative arrangements, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.


                             DEPOMED, INC.
                     (A Development Stage Company)

                       STATEMENTS OF OPERATIONS
                              (Unaudited)



                           Three Months               Six Months
                           Ended June 30,           Ended June 30,
                        2001          2000         2001        2000
                       --------------------      -------------------
Revenue:
 Collaborative
  agreements          $393,017     $     --     $671,272     $     --
 Collaborative
  agreements with
  affiliates           444,944      585,562      804,111      961,980
                     ---------     --------    ---------    ---------

Total revenue          837,961      585,562    1,475,383      961,980

Operating
 expenses:
Research and
 development         4,191,794    1,715,616    6,847,476    2,988,377
General and
 administrative        651,096      494,483    1,237,715      997,076
Purchase of
 in-process
 research
 and development            --           --           --           --
                     ---------    ---------   ----------   ----------

Total operating
 expenses            4,842,890    2,210,099    8,085,191    3,985,453
                    ----------   ----------   ----------   ----------

Loss from
 operations         (4,004,929)  (1,624,537)  (6,609,808)  (3,023,473)

Other income
 (expenses):
   Equity in loss
    of joint
    venture           (821,594)    (659,961)  (1,451,712)    (990,006)
   Interest income
    (expense), net    (107,282)     105,286      (62,135)     186,813

Total other income
 (expenses)           (928,876)    (554,675)  (1,513,847)    (803,193)

Net loss            (4,933,805)  (2,179,212)  (8,123,655)  (3,826,666)

Accretion of
 dividend
 on preferred stock   (224,000)    (210,000)    (444,000)    (371,000)
                    -----------  -----------   ----------    ---------
Net loss available
 to common
 shareholders      $(5,157,805) $(2,389,212)  $8,567,655) $(4,197,666)
                   ============ ============  =========== ============

Basic and diluted
 net loss per
 common share          $ (0.56)     $ (0.33)     $ (0.96)    $  (0.59)
                   ============ ============  =========== ============
Shares used in
 computing basic
 and diluted net
 loss per common
 share               9,161,338    7,189,363    8,891,127    7,110,870
                   =========== ============  ===========  ===========



                              Period From
                               Inception
                               (Aug. 7,
                                 1995)
                                  to
                               June 30,
                                 2001
                              ----------


Revenue:
 Collaborative
  agreements                   $2,494,359
 Collaborative
  agreements with
  affiliates                    2,558,554
                               ----------

Total revenue                   5,052,913

Operating
 expenses:
Research and
 development                   21,514,318
General and
 administrative                 8,610,849
Purchase of
 in-process
 research and
 development                      298,154
                                ---------
Total operating
 expenses                      30,423,321
                               ----------
Loss from
 operations                   (25,370,408)

Other income
 (expenses):
  Equity in loss
   of joint
   venture                    (15,654,339)
  Interest income
    (expense), net                899,806
                              ------------
Total other
 income
 (expenses)                   (14,754,533)

Net loss                      (40,124,941)

Accretion of
 dividend
 on preferred
 stock                         (1,251,000)
                            --------------
Net loss available
 to common
 shareholders               $ (41,375,941)
                            ==============


Basic and diluted net
 loss per common share

Shares used in computing
 basic and diluted net
 loss per common share


                             DEPOMED, INC.
                     (A Development Stage Company)

                            BALANCE SHEETS


                                          June 30,       December 31,
                                            2001             2000
                                         ----------      -----------
                                        (Unaudited)        (Note 1)

ASSETS
Current assets:

    Cash and cash
     equivalents                          $ 7,389,193    $  3,878,354
    Marketable securities                   3,829,190       2,620,525
    Accounts receivable                       321,272          21,775
    Receivable from joint
     venture                                  444,944         432,313

    Prepaid and other current
     assets
                                              133,360         168,666
                                         ------------    ------------
      Total current assets                 12,117,959       7,121,633

Property and equipment, net                 2,074,689       1,317,149
Other assets                                  294,033         293,756
                                         ------------    ------------
                                         $ 14,486,681    $  8,732,538
                                         ============    ============
LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
  Accounts payable                       $  1,566,318    $    797,795
  Accrued compensation                        293,061         245,471
  Other accrued liabilities                    81,098         367,227
  Payable to joint venture                    821,594         684,328
  Capital lease obligation,
   current portion                             32,117          39,434
  Long-term debt, current
   portion                                    298,019         139,181
  Other current liabilities                    26,488         103,928
                                         ------------    ------------
     Total current liabilities              3,118,695       2,377,364

Capital lease obligation,
 non-current portion                            6,352          18,200
Long-term debt,
 non-current portion                          443,250         217,467
Promissory note from
 related party, non-current
 portion                                    2,933,015       1,533,342

Commitments

Shareholders' equity:
  Preferred stock, no par value;
  5,000,000 shares authorized;
  Series A convertible exchangeable
  preferred stock; 25,000 shares
  designated, 12,015 shares issued
  and outstanding at June 30, 2001
  and December 31, 2000                    13,266,000      12,822,000

  Common stock, no par value,
   25,000,000 shares authorized;
   11,526,835 and 8,617,913 shares
   issued and outstanding at
   June 30, 2001 and
   December 31, 2000,
   respectively                            36,099,690      24,600,567
  Deferred compensation                            --         (24,744)
  Deficit accumulated during
   the development stage                  (41,375,941)    (32,808,286)
  Accumulated other comprehensive
   loss                                        (4,380)         (3,372)
                                          ------------   -------------
     Total shareholders' equity             7,985,369       4,586,165
                                          ------------   -------------
                                         $ 14,486,681    $  8,732,538
                                         =============   =============

      Note 1: The balance sheet as of December 31, 2000 was derived from
the audited balance sheet included in the Company's 2000 Annual Report
on Form 10-K filed with the Securities and Exchange Commission.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 14, 2001
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