InKine Reports First Quarter 2001 Financial Results.Business Editors BLUE BELL, Pa.--(BUSINESS WIRE)--April 19, 2001 - First Quarter Highlights - -- Launched Visicol(TM) with first quarter results exceeding expectations. -- Entered into eighteen month co-promotion agreement with Procter & Gamble Pharmaceuticals (P&GP), yielding the largest sales force in the purgative product marketplace. -- Signed agreement with established pharmaceutical manufacturer to develop and market IBStat(TM), an immediate release, antispasmodic product for acute treatment of spasm in the colon. -- Received FDA consensus for planned pivotal study of Colirest(TM) in patients with active Crohn's disease. -- Granted orphan drug designation by FDA for Hematrol(TM) in the treatment of idiopathic thrombocytopenic purpura (ITP). InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today reported first time product sales of $1.6 million and a reduced loss per share of $0.08. Net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of Visicol(TM), launched commercially in the fourth week of January, totaled $1.6 million for the first quarter of 2001. Visicol(TM) is the Company's first product and is indicated for bowel bowel: see intestine. cleansing prior to colonoscopy Colonoscopy Definition Colonoscopy is a medical procedure where a long, flexible, tubular instrument called the colonoscope is used to view the entire inner lining of the colon (large intestine) and the rectum. . Net sales represents product sales of Visicol(TM) to pharmaceutical wholesalers and large drug store chains, not Visicol(TM) prescriptions to consumers. These sales are affected by a number of factors, including wholesaler inventory stocking patterns, which may not accurately reflect underlying trends in the demand for Visicol(TM). There were no product sales in the same period a year ago. The net loss during the first quarter of 2001 was $2.9 million or $0.08 per share compared to a net loss of $1.8 million or $0.06 for the same period a year ago. Net loss in the previous quarter ended December 31, 2000 was $3.7 million or $0.11 per share. InKine's Chairman and Chief Executive Officer Leonard S Leon·ard , Ray Charles Known as "Sugar Ray." Born 1956. American boxer who won the 1976 Olympic light welterweight title. He held five world titles as both a welterweight and middleweight between 1979 and 1987. Noun 1. . Jacob, M.D., Ph.D., today described the first quarter of commercial operations as a significant achievement for InKine. "We have successfully transitioned ourselves to a commercial operation and have exceeded first quarter expectations for both product sales and earnings per share. All of the major drug wholesalers placed initial stocking orders for Visicol(TM). We also achieved distribution in the top drug store chains and independent pharmacies An independent pharmacy is a retail pharmacy that is not directly affiliated with any chain pharmacy, such as CVS/pharmacy, Walgreens or Eckerd. However, owners of independent pharmacies will often form alliances with other independents and use their power in numbers to bargain for across the country. Furthermore, re-orders from major wholesalers and large drug store chains were placed at the end of the quarter and continue to be placed." Gross Profit was $834,000 for the quarter ended March 31, 2001 as compared to no gross profit for the same period a year ago. Cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold for the quarter ended was solely attributable to commercial sales of Visicol(TM), including product costs associated with the establishment of reserves for initial returns and allowances. Distribution expense for the current quarter includes costs related to contracted warehousing, tracking and shipping of product to our Visicol(TM) customers. Royalty expense represents amounts due to the inventor INVENTOR. One who invents or finds out something. 2. The patent laws of the United States authorize a patent to be issued to the original inventor; if the invention is suggested by another, he is not the inventor within the meaning of those laws; but in that of Visicol(TM) and is based on the volume of net sales. Gross profit is expected to increase in the future as less promotional and launch related incentives are offered to customers and manufacturing costs per unit are reduced. Research and development expenses decreased for the quarter ended March 31, 2001, as compared to the same period a year ago. This reduction was the result of decreased development costs associated with Visicol(TM), partially offset by costs associated with clinical trials of Colirest(TM) in inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. and Phase IV marketing studies of Visicol(TM). Sales and marketing costs of $1,917,000 were incurred for the quarter ended March 31, 2001, as compared with no sales and marketing costs for the same period a year ago. The increase is the result of new personnel and marketing activities associated with the launch of Visicol(TM). "InKine now has the largest sales force in the bowel evacuant evacuant /evac·u·ant/ (e-vak´u-ant) 1. emptying. 2. cathartic (1, 2). 3. a remedy that empties any organ, such as a cathartic, emetic, or diuretic. market in 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. with 105 sales representatives and managers nationwide," said Stephen Casey, Vice President, Sales and Marketing of InKine. "We held our national sales launch meeting in early January and an additional sales launch meeting for our P&GP representatives in early March. All of our representatives are now fully integrated and trained. We are already seeing results from our co-promotion agreement with P&GP, which includes only three weeks of effort during this quarter, and are encouraged by the early prescription adoption trends." General and administrative expenses increased $293,000 for the quarter ended March 31, 2001, as compared to the same period a year ago. This increase is the result of increased administrative personnel and other administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. resulting from the expanded scale of operations associated with the launch of Visicol(TM). Included in general and administrative expenses is amortization of deferred compensation of $292,000 for the quarter ended March 31, 2001. Cash and investment balance at March 31, 2001 was approximately $9 million, which included the proceeds of warrant and option exercises of approximately $375,000 for the quarter ended March 31, 2001. Chief Financial Officer Robert F. Apple of InKine said, "We are pleased with the results of our product launch of Visicol(TM)and are encouraged by the trends we are seeing in prescriptions filled to date. Our cash position remains strong and we expect to see increased cash inflows resulting from future Visicol(TM) sales and the conversion of inventory and receivable balances into cash." The Company will be hosting a conference call at 10:30 AM EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT , Thursday, April 19, 2001, to further discuss the first quarter 2001 financial results. To participate please dial (416) 641-6705 (confirmation # 18602237) about 5-10 minutes prior to the initiation of the teleconference. The conference call will also be available on replay starting at 12:15 PM EDT on April 19, 2001, and ending at 12:15 PM EDT on April 20, 2001. For the replay, please dial (800) 633-8284 (confirmation # 18602237). The access number for the replay for international callers is (858) 812-6440 (confirmation # 18602237). About InKine Pharmaceutical InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. Support of early-stage product opportunities comes through its university-based sponsored research. The Company's first product, Visicol(TM), was launched in January 2001 and is the first and only tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. purgative purgative /pur·ga·tive/ (purg´it-iv) cathartic (1, 2). pur·ga·tive n. An agent used for purging the bowels. adj. Tending to cause evacuation of the bowels. preparation indicated for bowel cleansing prior to colonoscopy. InKine's portfolio also includes three late-stage product candidates, IBStat(TM) in development for the treatment of spasm in the colon colon, in anatomy colon, in anatomy: see intestine. colon, in punctuation colon, in writing: see punctuation. colon Segment that makes up most of the large intestine. , Hematrol(TM), in 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 for the treatment of idiopathic thrombocytopenic purpura Idiopathic Thrombocytopenic Purpura Definition Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood. and Colirest(TM), advancing to pivotal clinical trials for the treatment of Crohn's disease
The treatment of Crohn's disease is sequential: to treat acute disease, and then to maintain remission. Treatment initially involves the use of medications to treat any infection and to reduce inflammation. and completed Phase II trials for the treatment of ulcerative colitis This article concerns the treatment of ulcerative colitis, a form of inflammatory bowel disease (IBD). Ulcerative colitis is a form of colitis, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. . In addition, the Company is developing preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. compounds from its two platform technologies, including Angiocidin(TM), a potent and specific angiogenesis inhibitor angiogenesis inhibitor Oncology A chemotherapy adjuvant which inhibits the angiogenesis required for tumor growth and survive, especially for metastastatic tumors See CAI, CM101, IFN-alpha, IL-12, Marimastat, Pentosan polysulfate, Platelet factor 4, Thalidomide, TNP-470. for potential use in cancer patients. For further information, please visit InKine on their web site http://www.inkine.com. In addition to historical facts or statement of current condition, this press release may contain 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. . Forward-looking statements provide InKine's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. InKine's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties such as those set forth in its reports on Form 10-Q Form 10-Q See 10-Q. and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, InKine does not intend (and it is not obligated ob·li·gate tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates 1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force. 2. To cause to be grateful or indebted; oblige. ) to update publicly any forward-looking statements. This discussion is permitted by 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.
InKine Pharmaceutical Company, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(amounts in thousands, except per share amounts)
Three-Months Ended
March 31,
2001 2000
---- ----
Revenue, net $ 1,601 $ -
Cost of goods sold (674) -
Distribution (61) -
Royalty (32) -
Gross profit 834 -
Research and
development 894 1,100
Sales and marketing 1,917 -
General and
administrative 1,015 722
Operating expenses 3,826 1,822
Loss from operations (2,992) (1,822)
Other income and
expenses 113 62
Net loss $ (2,879) $ (1,760)
Net loss per share -
basic and diluted $ (0.08) $ (0.06)
Weighted average
shares outstanding
- basic and diluted 33,881 28,275
CONDENSED BALANCE SHEETS
(amounts in thousands)
March 31, December 31,
2001 2000
(unaudited)
ASSETS
Cash and cash equivalents $ 9,047 $ 11,520
Accounts receivable 1,475 -
Inventory 1,344 686
Prepaid expenses and
other assets 1,460 743
Fixed assets, net 463 451
Total assets $ 13,789 $ 13,400
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable and
accrued expenses $ 2,680 $ 623
Line of credit 2,293 1,752
Shareholders' equity 8,816 11,025
Total liabilities and
shareholders' equity $ 13,789 $ 13,400
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