Columbia Laboratories Receives Significant Increase in Orders for Crinone 8%.AVENTURA
Aventura is a Dominican-American Bachata-R&B music group based in Bronx, New York. , Fla.--(BW HealthWire)--March 23, 1999-- Demand for Crinone Crinone® Gynecology A topical progesterone used to manage infertility and 2º amenorrhea. See Hormone replacement therapy. Should Return Columbia to Profitability 1998 Fourth Quarter and Full Year Financial Results Announced Columbia Laboratories, Inc. (AMEX AMEX See: American Stock Exchange :COB) announced today that it expects to approach break even in the first quarter and to be profitable in the second quarter 1999 based on increased orders received for Crinone 8%, its natural progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. vaginal vag·i·nal adj. 1. Of or relating to the vagina. 2. Relating to or resembling a sheath. vaginal pertaining to the vagina, the tunica vaginalis testis, or to any sheath. gel used to assist women in becoming pregnant. "Recently we have begun seeing a surge in Crinone 8% prescriptions over 1998 levels," said Mr. Norman M. Meier, Columbia's President and Chief Executive Officer. During the first two months of 1999, new prescriptions grew 67% and total prescriptions were up 51%. This has resulted in an increased demand for Crinone 8% which has caused the Wyeth-Ayerst division of American Home For the American mortgage lender, see . The American Home is a center of intercultural exchange located in Vladimir, Russia. The home is designed to model a typical American suburban home and its main focus is the ESL school that provides lessons for Russian students. Products ("Wyeth-Ayerst") to place orders to date for approximately $2.4 million in the first quarter, $4.8 million in the second quarter and $1.6 million in July 1999. "Filling these incoming orders, by itself, will be sufficient to restore the Company to profitability by the second quarter of 1999," said David L. Weinberg, Columbia's Chief Financial Officer. Mr. Weinberg also indicated that with the proceeds from the $6.6 million private placement finalized See finalization. in January 1999, and the orders in hand, the Company has ample financial resources to sustain its growth and new product development. For the fourth quarter of 1998, Columbia reported net loss of $5,279,043 or $0.18 per share, compared to a net income of $348,811 or $0.01 per share, for the fourth quarter of 1997. Revenues for the 1998 fourth quarter were $2,325,150, compared to $6,417,087 for the same period in 1997. For the year ended December 31, 1998, Columbia reported a net loss of $13,859,734, or $0.48 per share, compared to a net income of $762,906, or $0.03 per share, for 1997. Revenues for the full-year 1998 were $10,017,644, compared to $16,547,411 for the full-year 1997. "The Company's performance in 1998 was impacted by the lack of sales of Crinone, due to the large inventory building orders for Crinone in the second half of 1997 by Wyeth-Ayerst, our strategic alliance partner. However in 1998, Crinone, the Company's most important product and its first 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. approved Rx drug, was not launched in a timely or adequate manner, nor marketed as effectively as we expected it would be by Wyeth-Ayerst. Milestone payments received from AHP AHP Assistant House Physician. in 1997 was another contributing factor impacting the year-to-year earnings comparison," Mr. Meier said. Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company, dedicated to the development of women's prescription and over-the-counter products, including those which help prevent sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely . Columbia's research in reproductive endocrinology Reproductive endocrinology and infertility (REI) is a surgical subspecialty of obstetrics and gynecology that addresses hormonal functioning as it pertains to reproduction. has also led to the development of a product to treat "Andropause andropause /an·dro·pause/ (an´dro-pawz) a variable complex of symptoms, including decreased Leydig cell numbers and androgen production, occurring in men after middle age, purported to be analogous to menopause in women. " in men. Columbia's products primarily utilize the Company's patented bioadhesive delivery system. This press release contains statements which constitute 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. within the meaning of Section 27A of the Securities Act of 1933, as amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. , and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management team. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, competitive, economic and regulatory factors in the pharmaceutical and health care industry, general economic conditions, the risk that orders received may not be fulfilled ful·fill also ful·fil tr.v. ful·filled, ful·fill·ing, ful·fills also ful·fils 1. To bring into actuality; effect: fulfilled their promises. 2. and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. -0-
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Unaudited
Year Ended Three Months Ended
December 31, December 31,
1998 1997 1998 1997
NET SALES $10,017,644 $16,547,411 $2,325,150 $6,417,087
COST OF GOODS
SOLD 5,707,814 6,630,820 1,867,419 2,548,320
Gross profit 4,309,830 9,916,591 457,731 3,868,767
OPERATING EXPENSES:
Selling and
distribution 4,099,446 2,908,504 1,349,436 618,913
General and
administrative 5,785,895 3,972,077 1,755,108 1,515,296
Research and
development 7,821,642 9,135,573 2,514,058 2,548,063
Total operating
expenses 17,706,983 16,016,154 5,618,602 4,682,272
Loss from
operations (13,397,153) (6,099,563) (5,160,871) (813,505)
OTHER INCOME
(EXPENSE):
License fees 73,088 7,038,853 - 1,288,853
Interest income 141,564 70,664 6,891 21,514
Interest expense (599,773) (24,186) (188,838) (4,766)
Other income
(expense), net (77,460) (137,862) 63,775 (58,285)
(462,581) 6,947,469 (118,172) 1,247,316
Income (loss)
before income
taxes (13,859,734) 847,906 (5,279,043) 433,811
Provision for
income taxes - 85,000 - 85,000
Net income
(loss) $(13,859,734) $762,906 $(5,279,043) $348,811
INCOME (LOSS)
PER COMMON
SHARE - BASIC
AND DILUTED $ (0.48) $ 0.03 $ (0.18) $ 0.01
WEIGHTED AVERAGE
NUMBER OF COMMON
SHARES
OUTSTANDING
BASIC 28,679,000 28,350,000 28,685,000 28,527,000
DILUTED 28,679,000 29,982,000 28,685,000 30,013,000
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