The Medicines Company Reports Fourth Quarter and Full Year 2000 Financial Results.Business/Health Editors CAMBRIDGE, Mass.--(BW HealthWire)--Feb. 14, 2001 The Medicines Company (Nasdaq: MDCO) announced today its financial results for the fourth quarter and the full year ended December 31, 2000. In December 2000 the U.S. Food and Drug Administration (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 ANGIOMAX(R) (bivalirudin), The Medicines Company's lead product, for use as an anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). in patients with unstable angina un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. undergoing percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ). Additionally in 2000, The Medicines Company consummated con·sum·mate tr.v. con·sum·mat·ed, con·sum·mat·ing, con·sum·mates 1. a. To bring to completion or fruition; conclude: consummate a business transaction. b. its initial public offering (IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard. ) in which it sold 6.9 million shares of its common stock at a price of $16.00 per share, including the underwriters' overallotment option overallotment option See greenshoe. . Financial highlights for 2000, including the three months ended December 31, 2000: - The pro forma net loss attributable to common stockholders for the full year 2000 of $51.9 million, or $2.10 per share, and $22.2 million, or $0.74 per share, for the three months ended December 31, 2000, compared to a pro forma net loss attributable to common stockholders of $34.5 million, or $1.94 per share, for the full year of 1999 and $6.1 million, or $0.33 per share, for the three months ended December 31, 1999. The pro forma adjustments reflect the conversion of convertible preferred stock, accrued dividends, convertible notes and accrued interest effective upon the closing of the Company's initial public offering and exclude i) interest expense of $19.0 million for the full year ended December 31, 2000, most of which represented non-cash amortization of the remaining discount associated with convertible notes, and ii) a non-cash dividend of $25.5 million associated with the issuance in May 2000 of convertible preferred stock containing a beneficial conversion feature. - The Medicines Company reported a net loss attributable to common stockholders for the full year 2000 of $101.6 million, or $8.43 per share, and $22.2 million, or $0.74 per share, for the three months ended December 31, 2000 compared to a net loss attributable to common stockholders of $40.6 million, or $80.08 per share, for the year ended December 31, 1999 and $7.9 million, or $13.45 per share, for the three months ended December 31, 1999. The full year 2000 results include interest expense of $19.0 million a non-cash dividend of $25.5 million and, which is predominantly non-cash. - The Company also reported an increase in the loss from operations to $54.6 million for the year ended December 31, 2000 from $35.4 million for the same period in 1999 and an increase in the loss from operations to $23.8 million for the three months ended December 31, 2000 from $6.2 million for the same period in 1999. These increases were due to an increase in sales, general and administrative expenses primarily from the Company's expansion of its sales and marketing capabilities in preparation for the commercial launch in the United States of ANGIOMAX(R)(bivalirudin) which occurred in January 2001 and from an increase in research and development expenses primarily due to increased clinical trial and manufacturing development activities related to ANGIOMAX. - At December 31, 2000, The Medicines Company had cash, cash equivalents and marketable securities of $80.7 million. Business highlights for 2000, including the three months ended December 31, 2000: - In December 2000, the FDA approved ANGIOMAX for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). This indication includes patients with unstable angina as defined by either a new onset of severe or accelerated angina Angina Definition Angina is pain, "discomfort," or pressure localized in the chest that is caused by an insufficient supply of blood (ischemia) to the heart muscle. or rest pain within the month prior to study entry or angina or ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic rest pain which developed between four hours and two weeks after a heart attack. - The Medicines Company established a commercial management team and signed a commercialization agreement with Innovex Inc. to promote ANGIOMAX 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. . Innovex provides the ANGIOMAX sales force, a sales territory management system and operational support for the launch of ANGIOMAX. - The Medicines Company raised total net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $101.4 million from the IPO. The Company sold 6.9 million shares of its common stock at a price of $16.00 per share, including the underwriters' overallotment option. - The Company initiated a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Phase 3b trial program in angioplasty angioplasty (ăn`jēōplăs'tē), any surgical repair of a blood vessel, especially balloon angioplasty or percutaneous transluminal coronary angioplasty, a treatment of coronary artery disease. comparing ANGIOMAX(R) (bivalirudin) to heparin heparin (hĕp`ərĭn), anticoagulant produced by cells in many animals. A polysaccharide, heparin is found in the human body and occurs in greatest concentration in the tissues surrounding the capillaries of the lungs and the liver. , with and without GP IIb/IIIa inhibitors. - The Company began a Phase 2 trial program examining the use of ANGIOMAX as an anticoagulant in patients undergoing coronary artery artery, blood vessel that conveys blood away from the heart. Except for the pulmonary artery, which carries deoxygenated blood from the heart to the lungs, arteries carry oxygenated blood from the heart to the tissues. bypass graft bypass graft Surgery A surrogate blood vessel used to reroute blood; BGs may be synthetic–Dacron, or autologous–vein from the Pt's own leg, to substitute for diseased vessel surgery without the use of a bypass pump. - In 2000 over 9,200 patients were recruited into a Phase 3 trial program studying the use of ANGIOMAX for the treatment of patients who have suffered a heart attack. - The Company started a large, randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. of its probiotic pro·bi·ot·ic n. A dietary supplement containing live bacteria or yeast that supplements normal gastrointestinal flora, given especially after depletion of flora caused by infection or ingestion of an antibiotic drug. CTV-05 as an adjunct adjunct (aj´ungkt), n a drug or other substance that serves a supplemental purpose in therapy. adjunct to standard antibiotic antibiotic, any of a variety of substances, usually obtained from microorganisms, that inhibit the growth of or destroy certain other microorganisms. Types of Antibiotics treatment of bacterial vaginosis Bacterial Vaginosis Definition Bacterial vaginosis (BV) is a type of vaginal infection in which the normal balance of bacteria in the vagina is disrupted, allowing the overgrowth of harmful anaerobic bacteria at the expense of protective bacteria. (BV). The trial is funded by National Institutes of Health, National Institute of Allergy allergy, hypersensitive reaction of the body tissues of certain individuals to certain substances that, in similar amounts and circumstances, are innocuous to other persons. Allergens, or allergy-causing substances, can be airborne substances (e.g. and Infectious Disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. , NIAID NIAID National Institute of Allergy and Infectious Diseases. ) and jointly managed by The Medicines Company and NIH, NIAID. "We are pleased with the Company's progress since the beginning of 2000, culminating with the approval of ANGIOMAX by the FDA in December 2000 and the commercial launch of ANGIOMAX in the United States by the Company in January 2001," commented Clive Meanwell, M.D., Ph.D., President and Chief Executive Officer of The Medicines Company. "We continue to advance in our clinical development program for the use of ANGIOMAX in angioplasty and more broadly for the hospital treatment of patients with ischemic heart disease Ischemic heart disease Insufficient blood supply to the heart muscle (myocardium). Mentioned in: Myocarditis ischemic heart disease . We were pleased to have initiated with the NIH a Phase 2 trial for our second product CTV-05, a specialty anti-infective, for the potential prevention and treatment of bacterial vaginosis; we have enrolled over 150 patients into this trial." There will be a conference call later today at 10:30 am. To listen in please dial 1-888-890-6816 and request The Medicines Company Fourth Quarter Earnings Release call. If you are calling from outside of the United States, please dial 1-847-619-6449. If you are unable to listen to the call live, you may dial 1-888-843-8996 from inside the United States and 1-630-652-3044 from outside the U.S. to replay the call. The passcode for the call is 3522340. The recording will be available from approximately one hour after the conclusion of the conference call until 12 a.m. on Friday, February 16, 2001. The Medicines Company was founded in 1996 by a team of experienced pharmaceutical executives to acquire, develop and commercialize selected pharmaceutical products in late stages of development. The Company expects ANGIOMAX(R) (bivalirudin) to be the cornerstone cornerstone Ceremonial building block, dated or otherwise inscribed, usually placed in an outer wall of a building to commemorate its dedication. Often the stone is hollowed out to contain newspapers, photographs, or other documents reflecting current customs, with a view to product of an acute hospital franchise we plan to build. Ongoing clinical programs with ANGIOMAX include the REPLACE Phase 3b study of ANGIOMAX in angioplasty. The Company is also developing ANGIOMAX for additional potential applications for use in the treatment of ischemic heart disease. ANGIOMAX is being examined in patients presenting with acute myocardial infarction acute myocardial infarction ( This press release contains 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 a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in the Company's Registration Statement on Form S-1 which was filed on January 26, 2001 and remains on file with the Securities and Exchange Commission and incorporated herein by reference. These risk factors include risks as to whether and when, if at all, the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , and for which indications, and, if such products receive approval, whether they will be successfully marketed; the Company's dependence on third parties, including parties such as Innovex, on whom the Company will rely to promote ANGIOMAX; whether the Company's products will advance in the clinical trials process, the timing of such clinical trials and whether the clinical trial results will warrant continued product development; and the Company's history of net losses and how long the Company will be able to operate on its existing capital resources.
The Medicines Company
(a company in development stage)
Condensed Consolidated Statements of Operations
Year ended December 31,
---------------------------------------------------
2000 1999
------------------------- -------------------------
Actual Pro Forma(1) Actual Pro Forma(1)
------------ ------------ ------------ ------------
Revenue $ - $ - $ - $ -
Operating Expenses
Research and
development 39,572,297 39,572,297 30,344,892 30,344,892
Sales, general and
administrative 15,033,585 15,033,585 5,008,387 5,008,387
------------ ------------ ------------ ------------
Total operating
expenses 54,605,882 54,605,882 35,353,279 35,353,279
Loss from
operations (54,605,882) (54,605,882) (35,353,279) (35,353,279)
Interest income
(expense), net (16,686,288) 2,704,126 640,384 837,839
------------ ------------ ------------ ------------
Net loss (71,292,170) (51,901,756) (34,712,895) (34,515,440)
Dividends and
accretion to
redemption value
of redeemable
preferred stock (30,342,988) - (5,893,016) -
------------ ------------ ------------ ------------
Net loss
attributable
to common
stockholders $(101,635,158)$(51,901,756)$(40,605,911)$(34,515,440)
============= ============ ============ ============
Basic and diluted
net loss
attributable
to common
stockholders per
common share $ (8.43)$ (2.10)$ (80.08)$ (1.94)
============ ============ ============ ============
Shares used in
computing net
loss attributable
to common
stockholders per
common share:
Basic and diluted 12,059,276 24,719,075 507,065 17,798,755
============ ============ ============ ============
Three months ended December 31,
---------------------------------------------------
2000 1999
------------------------- -------------------------
Actual Pro Forma(1) Actual Pro Forma(1)
------------ ------------ ------------ ------------
Revenue $ - $ - $ - $ -
Operating Expenses
Research and
development 16,068,718 16,068,718 5,228,717 5,228,717
Sales, general and
administrative 7,693,967 7,693,967 926,350 926,350
------------ ------------ ------------ ------------
Total operating
expenses 23,762,685 23,762,685 6,155,067 6,155,067
Loss from
operations (23,762,685) (23,762,685) (6,155,067) (6,155,067)
Interest
income, net 1,579,795 1,579,795 (174,429) 23,026
------------ ------------ ------------ ------------
Net loss (22,182,890) (22,182,890) (6,329,496) (6,132,041)
Dividends and
accretion to
redemption value
of redeemable
preferred stock - - (1,522,246) -
------------ ------------ ------------ ------------
Net loss
attributable
to common
stockholders $(22,182,890)$(22,182,890)$ (7,851,742)$ (6,132,041)
============ ============ ============ ============
Basic and diluted
net loss
attributable to
common stockholders
per common share $ (0.74)$ (0.74)$ (13.45)$ (0.33)
============ ============ ============ ============
Shares used in
computing net loss
attributable to
common stockholders
per common share:
Basic and diluted 30,179,267 30,179,267 583,941 18,768,109
============ ============ ============ ============
Condensed Consolidated Balance Sheets December 31, December 31,
2000 1999
---- ----
Assets (Unaudited)
Cash, cash equivalents and
marketable securities $ 80,718,013 $ 7,237,765
Inventory 1,963,491 -
Fixed assets, net 965,832 430,061
Other assets 715,794 323,572
------------- -------------
Total Assets $ 84,363,130 $ 7,991,398
============= =============
Liabilities and Stockholders'
Equity (Deficit)
Current liabilities $ 15,124,147 $ 11,495,321
Long term liabilities - 91,053,732
Stockholders' equity (deficit) 69,238,983 (94,557,655)
------------- -------------
Total Liabilities and Stockholders'
Equity (Deficit) $ 84,363,130 $ 7,991,398
============= =============
(1) Pro Forma amounts reflect the conversion of all the outstanding
redeemable convertible preferred stock and accrued dividends and all
convertible notes and accrued interest as if this conversion had
occurred at the date of original issuance of the convertible preferred
stock and the convertible notes.
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