[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 Enabling PCs to be monitored from a central console, it was superseded by the DMTF's Common Information Model (see CIM).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.
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion