Consolidated Statements of Income
Balance Sheet Data
Sales for the Quarter ended September 30
Jerusalem, Israel, November 7, 2000 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today reported that Net income for the third quarter 2000 reached $46.6 million or $0.36 per share, up 29% and 26% respectively as compared with the third quarter of 1999 (before a one-time charge in respect of acquired in-process R&D in the comparable quarter). The geographic breakdown of third quarter Total sales of $450.1 million (+40%) is: North America 59%, Europe 22%, Israel 14% and others 5%.
Eli Hurvitz, President and CEO, commented: "We are pleased to be reporting another record quarter. In this quarter we have proven again the benefits of globalization as we have compensated for our eroded European top line with increased sales in North America to achieve a balanced growth".
The consolidation of Copley and Novopharm accounted for about two thirds of the increase in North American pharmaceutical sales with the balance coming from internal growth and new products.
During the quarter, Teva received final approvals and launched Etodolac ER 500 & 600 mg, the generic version of Lodine XL ® and Enalapril Maleate, the generic version of Vasotec ® . In addition Teva received final approvals for Nifedipine XL 60mg, the generic version of Procardia XL ® 60mg, which was launched subsequent to the end of the quarter and for Amoxicillin 500 & 875mg, the generic version of Amoxil ® . Further, Teva received 3 tentative approvals, all of which are Paragraph IV filings (Nifedipine XL 30mg, Etodolac ER 400mg and Loratadine 10mg, the generic version of Claritin ® ). Subsequent to the end of the quarter Teva received final approval for Doxazosin, the generic version of Cardura ® . Teva currently has 49 generic products pending FDA approval (including 13 tentative approvals) about half of which are Pharagraph IV filings. Branded annual sales of this pipeline total over $ 14 billion.
Third quarter Pharmaceutical sales in Europe increased in Euro terms by 10%; however, due to the 14% quarter-to-quarter devaluation of the Euro, sales decreased in U.S. dollar terms by 2%. While sales in Europe were fully exposed to the weakening Euro, the impact on net income was mitigated by the fact that most of the sales in Europe were produced in Europe, where costs in dollar terms also declined. Additional natural hedging is achieved by purchases of European raw materials for use in non-European production. Sales in the U.K. and Hungary were subject to severe governmental price constraints, which were partially offset by the consolidation of Human, the Hungarian subsidiary of Novopharm.
At the end of the quarter, 138 product applications were awaiting approval from the Regulatory Authorities in various countries in Europe, mainly in Hungary, the U.K., Germany and the Netherlands.
Global in-market sales of Copaxone ® , Teva's leading product, increased as compared with the third quarter of 1999 by 59% to $66 million. Copaxone ® continues to be the fastest growing multiple sclerosis therapy in the U.S. outpacing the overall MS drug market in percentage increase of both new and total prescriptions. In August of this year, Teva received marketing approval for Copaxone ® in the U.K. and is currently preparing the filing under the European Mutual Recognition Procedure to make Copaxone ® available in the other European Union countries.
The patient enrollment of two major Copaxone ® phase III clinical studies has been completed: CORAL – a multinational trial evaluating the efficacy of an oral form of Copaxone ® , and PROMISE – the largest ever study in primary progressive MS.
Higher gross profit margins in Teva USA due to new product launches and synergies resulting from prior acquisitions, compensated both for lower margins in the UK (due to the governmental price constraints) and the impact of the consolidation of Human which has relatively low gross profit margins.
Generic R&D expenses accounted for $17 million, up 79% from the 1999 third quarter. The advanced development stage of our two Copaxone ® projects, and of the two Parkinsons' projects demand substantial resources, thus Innovative R&D expenses grew by 65% to a total of $16.4 million. Net R&D expenses increased at a lower rate than total R&D expenses due to significantly higher third party participation in Innovative R&D, reflecting Teva's strategy of limiting the burden of innovative R&D on our P&L.
During the quarter Teva raised $135 million from a syndicate of European Banks in a five-year multi-currency term loan facility and subsequent to the end of the quarter, raised $550 million by the issuance of five-year Senior Convertible Debentures with an interest rate of 1.5% and a conversion price of $86.23. These funds partially replace short term credit lines.
It has been recommended that the Board of Directors at their meeting on November 13, 2000 declare a regular cash dividend of NIS 0.225 (approx. 5.4¢) per ADR with respect to the third quarter of 2000.
Teva Pharmaceutical Industries Ltd. is Israel's largest pharmaceutical company, with over 85% of its sales outside Israel, mainly in North America and Europe. The Company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.
|
Consolidated Statements of Income in thousands, except earnings per ADR) (unaudited)
|
| |
July-September |
January-September |
| |
2000 |
1999 |
2000 |
1999 |
| |
U.S. Dollars |
| SALES |
450,052 |
321,142 |
1,231,383 |
902,502 |
| COST OF SALES |
269,721 |
192,704 |
745,193 |
540,424 |
| GROSS PROFIT |
180,331 |
128,438 |
486,190 |
362,078 |
R & D EXPENSES: Total expenses |
36,294 |
21,648 |
88,681
|
64,467 |
| Less grants & participations |
8,654 |
2,080 |
14,826 |
4,467 |
| R & D EXPENSES - net |
27,640 |
19,568 |
73,855 |
60,000 |
| SELLING, GENERAL AND ADMINISTRATION EXPENSES |
78,271
|
57,202 |
213,078
|
164,694 |
| |
74,420 |
51,668 |
199,257 |
137,384 |
| ACQUISITION OF RESEARCH AND DEVELOPMENT IN PROCESS |
-
|
17,700 |
35,697
|
17,700 |
| OPERATING INCOME |
74,420 |
33,968 |
163,560 |
119,684 |
| FINANCIAL EXPENSES - net |
12,286 |
7,287 |
34,326 |
20,298 |
| OTHER INCOME - net |
498 |
3,976 |
4,753 |
9,690 |
| INCOME BEFORE TAXES |
62,632 |
30,657 |
133,987 |
109,076 |
| TAXES ON INCOME |
14,817 |
12,595 |
39,325 |
32,247 |
| |
47,815 |
18,062 |
94,662 |
76,829 |
| SHARE IN PROFITS (LOSSES) OF ASSOCIATED COMPANIES |
(507)
|
143
|
(1,154)
|
475 |
| MINORITY INTEREST - net |
(700) |
178 |
(41) |
475 |
| NET INCOME |
46,608 |
18,383 |
93,467 |
77,779 |
| EARNINGS PER ADR ($) |
0.36 |
0.15 |
0.72 |
0.62 |
| |
BEFORE DEDUCTING NON-RECURRING EXPENSES: NET INCOME FOR THE PERIOD EARNINGS PER ADR ($) |
46,608 0.36 |
36,083* 0.29 |
129,164** 0.99 |
95,479* 0.76 |
| |
| WEIGHTED AVERAGE NUMBER OF ADR'S |
134,874 |
125,836 |
132,155 |
125,836 |
|
* Before deducting non-recurring expenses of $17.7 million ($0.14 per ADR) ** Before deducting non-recurring expenses of $35.7 million ($0.27 per ADR). Both in respect of acquired R&D in process.
|
|
Balance Sheet Data (in thousands) (unaudited)
|
| |
September 30 |
| |
2000 |
1999 |
| |
U.S. Dollars in thousands |
| ASSETS |
|
|
| CURRENT ASSETS |
1,219,412 |
951,186 |
| INVESTMENTS |
37,354 |
28,822 |
| FIXED ASSETS - net |
544,582 |
480,430 |
| INTANGIBLE ASSETS - net |
569,850 |
286,568 |
| TOTAL ASSETS |
2,371,198 |
1,747,006 |
| |
|
|
| LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
| CURRENT LIABILITIES |
748,200 |
687,529 |
| LONG-TERM LIABILITIES: |
522,002 |
349,842 |
| MINORITY INTEREST |
7,242 |
311 |
| SHAREHOLDERS' EQUITY |
1,093,754 |
709,324 |
| Total Liabilities AND SHAREHOLDERS' EQUITY |
2,371,198 |
1,747,006 |
|
Sales for the Quarter ended September 30 (US $ thousands)
|
| Sales by Geographical Areas |
|
|
|
|
| Sales for the Period |
2000 |
1999 |
% Change |
% of Total |
| Israel |
62,831 |
57,815 |
8.7% |
13.9% |
| North America |
264,481 |
150,525 |
75.7% |
58.8% |
| Europe |
101,078 |
98,200 |
2.9% |
22.5% |
| Rest of the World |
21,662 |
14,602 |
48.3% |
4.8% |
| Total Outside Israel |
387,221 |
263,327 |
47.0% |
86.1% |
| Total |
450,052 |
321,142 |
40.1% |
100.0% |
| |
| Sales by Business Segments |
|
|
|
|
| Sales for the Period |
2000 |
1999 |
% Change |
% of Total |
| Pharmaceuticals |
401,177 |
272,798 |
47.1% |
89.1% |
| A.P.I |
43,680 |
42,701 |
2.3% |
9.7% |
| Veterinary and other |
5,195 |
5,643 |
-7.9% |
1.2% |
| Total |
450,052 |
321,142 |
40.1% |
100.0% |
| |
| Pharmaceutical Sales |
|
|
|
|
| Sales for the Period |
2000 |
1999 |
% Change |
% of Total |
| Israel |
59,491 |
54,067 |
10.0% |
14.8% |
| North America |
244,697 |
127,914 |
91.3% |
61.0% |
| Europe |
79,621 |
81,431 |
-2.2% |
19.9% |
| Rest of the World |
17,368 |
9,386 |
85.0% |
4.3% |
| Total Outside Israel |
341,686 |
218,731 |
56.2% |
85.2% |
| Total |
401,177 |
272,798 |
47.1% |
100.0% |
Safe Harbor Statement: This report contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward looking statements. Important factors that could cause or contribute to such differences include the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched , currently being sold or in development , the impact of restructuring of clients , reliance on strategic alliances , fluctuations in currency, exchange and interest rates , operating results , the impact of the year 2000 issue and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S. Securities and Exchange Commission.