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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?


To: clochard who wrote (3233)3/31/1998 4:36:00 PM
From: Kailash  Respond to of 7041
 
Tuesday March 31, 2:09 pm Eastern Time

Company Press Release

Zonagen Reports Fourth Quarter and 1997 Year End Results

THE WOODLANDS, Texas--(BW HealthWire)--March 31, 1998--Zonagen, Inc. (Nasdaq:ZONA - news; Pacific:ZNG) today announced the Company's financial results for the fourth quarter and year ending December 31, 1997.

The Company reported fourth quarter revenues of $12,037,170, as compared to $1,121,126 in the same period last year. Revenues for the period included a license payment of $10 million received from Schering-Plough Corporation [NYSE:SGP - news] for the worldwide marketing rights to Vasomax(TM), the Company's product for male erectile dysfunction. Product sales increased to $998,729 for the fourth quarter of 1997 from $956,375 for the fourth quarter of 1996.

Research and development expenses for the three-month period ended December 31, 1997 increased to $7,719,069 from $3,766,673 for the same period last year, primarily due to costs associated with the development of Vasomax(tm). Net income for the quarter ended December 31, 1997 was $1,879,572, or $0.15 per share, versus a net loss of $4,027,203, or $0.74 per share for the same period last year.

For the year ended December 31, 1997 revenues were $15,416,321 compared to $3,292,846 in 1996. Research and development expenses for the same period were $22,299,099 as compared to $7,936,188 for 1996. The Company reported a net loss of $13,173,375 or $1.46 per share, for the year as compared to a net loss of $9,470,334 or $1.92 per share in 1996.

At December 31, 1997, the Company reported a cash balance of $73,761,823. As of December 31, 1997 common shares outstanding were 11,480,423. On December 12, 1997 the Company announced that the Board of Directors had authorized it to repurchase up to $10,000,000 of common stock. As of March 30, 1998 the Company had repurchased 288,300 shares (including 61,500 shares repurchased in December 1997) at an aggregate average price of $18.42 per share.

As of March 30, 1998 Zonagen had approximately $62 million in cash and 11.3 million shares outstanding.

''These financial results are in line with our expectations,'' said Joseph S. Podolski, president and chief executive officer of Zonagen. ''During the fourth quarter of 1997 we licensed the worldwide marketing rights for our lead product, Vasomax(TM), to Schering-Plough and we expect to submit a New Drug Application (NDA) to the Food and Drug Administration during the first half of 1998.''

Recent Events

Certain purported class action complaints alleging SEC violations have been filed against the Company and certain of its officers and directors. These complaints allege that Vasomax(TM) was not covered by any issued patent and was not patentable, and further allege that the Company has made misleading statements regarding the effectiveness and safety of Vasomax(TM). The Company and the individual defendants believe that these actions are without merit and intend to defend against them vigorously.

On March 19, 1998 Zonagen announced that Schering-Plough had filed a Product Registration Application for Vaxomax(TM) in Mexico.

On March 26, 1998 the Company announced that it had received from the U.S. Patent and Trademark Office a second patent for Vasomax(TM). This patent, known as the Lowrey Patent, describes new rapidly-disintegrating oral formulations of phentolamine and methods of modulating human sexual response. The Lowrey Patent also provides for an on-demand treatment for female sexual dysfunction.

Zonagen, Inc. specializes in products and services for management of reproductive health. Its technologies focus on the areas of urology, female health and contraception. Through its wholly owned subsidiary, Fertility Technologies, Inc. (FTI), Zonagen sells devices, instruments and supplies to the fertility specialist and the OB/GYN.

Any statements that are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including but not limited to those relating to the uncertainties related to the Company's early stage of development, clinical trial results and FDA approval, substantial dependence on one product, history of operating losses, future capital needs and uncertainty of additional funding, uncertainty of protection for patents and proprietary technology, litigation, governmental regulation, limited sales and marketing experience and dependence on collaborators, manufacturing uncertainties and reliance on third parties, competition and technological change, product liability and availability of insurance, and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1997, as filed with the Securities and Exchange Commission.



To: clochard who wrote (3233)3/31/1998 4:38:00 PM
From: Kailash  Respond to of 7041
 
ZONAGEN, INC. AND SUBSIDIARY
(A development stage company)

CONSOLIDATED STATEMENTS OF OPERATIONS

Three Months Ended Twelve Months Ended
December 31, December 31,
1997 1996 1997 1996
----------- ----------- ------------ -----------
(unaudited)
Revenues

Product sales $ 998,729 $ 956,375 $ 3,455,876 $ 3,021,940
License revenue 10,000,000 - 10,000,000 -
Interest income 1,038,441 164,751 1,960,445 270,906
----------- ----------- ------------ -----------
Total revenues 12,037,170 1,121,126 15,416,321 3,292,846

Costs and expenses

Cost of products
sold 659,440 667,186 2,312,003 2,087,007
Research and
development 7,719,069 3,766,673 22,299,099 7,936,188
SG & A 1,720,679 650,534 3,756,305 2,515,509
Interest expense
and amortization
of intangibles 58,410 63,936 222,289 224,476
----------- ---------- ----------- -----------
Total expenses 10,157,598 5,148,329 28,589,696 12,763,180

Net income (loss) $ 1,879,572 $(4,027,203) $(13,173,375) $(9,470,334)
=========== ============ ============= ============

Income (loss) per share
Basic $ 0.16 $ (0.74) $ (1.46) $ (1.92)
======= ========= ========== =========
Diluted $ 0.15 $ (0.74) $ (1.46) $ (1.92)
======= ========= ========== =========

Weighted average
common shares
outstanding
Basic 11,402,322 5,451,372 9,044,382 4,942,623
Diluted 12,352,650 5,451,372 9,044,382 4,942,623

CONSOLIDATED BALANCE SHEETS

December 31, 1997 December 31, 1996

Current assets $ 74,753,877 $ 11,810,347
Fixed assets, net 557,199 311,093
Other assets, net 1,629,404 1,590,320
------------- -------------
Total assets $ 76,940,480 $ 13,711,760
============= =============

Current liabilities $ 5,962,040 $ 2,117,984
Long-term notes payable 2,639 16,799
Shareholders' equity 70,975,801 11,576,977
------------- --------------
Total liabilities and
shareholders' equity $ 76,940,480 $ 13,711,760
============= =============

Contact:

Zonagen Inc., The Woodlands
Jean Anne Mire, 281/367-5892