10-Q 1 j2056_10q.htm 10-Q Prepared by MERRILL CORPORATION

 

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 10-Q

ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the quarterly period ended September 30, 2001

 

Commission File Number 0-15313

 

BIO–TECHNOLOGY GENERAL CORP.
(Exact name of registrant as specified in its charter)

 

Delaware

 

13–3033811

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer
Identification No.)

 

 

 

70 Wood Avenue Sound, Iselin, New Jersey 08830

(Address of principal executive offices)

 

(732) 632-8800

(Registrant’s telephone number, including area code)

 

(Former name, former address and former fiscal year,
if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes

ý

 

No

o

 

 

 

 

 

Indicate the number of shares outstanding of each of the issuer’s classes of Common Stock, as of the latest practicable date.

 

Common Stock, par value $.01 per share, outstanding as of November 5, 2001:  58,243,096

 


INDEX

 

 

 

Part I.

Financial Information

 

 

 

 

Item 1.

Financial Statements:

 

 

 

 

 

Consolidated Balance Sheets at
September 30, 2001 and December 31, 2000

 

 

 

 

 

Consolidated Statements of Operations
for the three and nine months ended
September 30, 2001 and 2000

 

 

 

 

 

Consolidated Statement of Changes in
Stockholders’ Equity for the nine
months ended September 30, 2001

 

 

 

 

 

Consolidated Statements of Cash Flows
for the nine months ended
September 30, 2001 and 2000

 

 

 

 

 

Notes to Consolidated Financial Statements

 

 

 

 

Item 2.

Management’s Discussion and Analysis
of Financial Condition and Results
of Operations

 

 

 

 

Part II.

Other Information

 

 

 

 

Item 5.

Other Information

 

 

 

 

Item 6.

Exhibits and Reports on Form 8-K

 

 


PART I. FINANCIAL INFORMATION

 

 

CONSOLIDATED BALANCE SHEETS
(In thousands except share data)

 

 

September 30,
2001(Unaudited)

 

December 31, 2000

 

 

 

 

 

 

 

ASSETS:

 

 

 

 

 

Current Assets

 

 

 

 

 

Cash and cash equivalents

 

$

68,476

 

$

26,353

 

Short-term investments

 

56,172

 

93,217

 

Accounts receivable

 

25,853

 

39,188

 

Inventories

 

12,491

 

9,880

 

Deferred income taxes

 

931

 

2,445

 

Prepaid expenses and other current assets

 

2,523

 

989

 

Total current assets

 

166,446

 

172,072

 

 

 

 

 

 

 

Deferred income tax

 

11,933

 

5,745

 

Account receivable

 

1,703

 

1,703

 

Severance pay funded

 

2,342

 

2,321

 

Property and equipment, net

 

44,484

 

27,819

 

Other assets

 

9,072

 

3,565

 

Total assets

 

$

235,980

 

$

213,225

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Deferred revenues

 

$

1,153

 

$

1,153

 

Accounts payable

 

11,832

 

6,420

 

Other current liabilities

 

13,381

 

11,155

 

Total current liabilities

 

26,366

 

18,728

 

 

 

 

 

 

 

Negative goodwill

 

16,324

 

---

 

Long-term debt

 

20,127

 

20,000

 

Deferred revenues

 

9,686

 

10,551

 

Provision for severance pay

 

5,090

 

4,593

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock - $.01 par value; 4,000,000 shares authorized; no shares issued

 

---

 

---

 

Common stock - $.01 par value; 150,000,000 shares authorized; issued: 58,168,000 (54,765,000 at  December 31, 2000)

 

581

 

547

 

Capital in excess of par value

 

205,785

 

179,586

 

Deficit

 

(39,508

)

(14,817

)

Accumulated other comprehensive loss

 

(8,471

)

(5,963

)

Total stockholders’ equity

 

158,387

 

159,353

 

Total liabilities and stockholders’ equity

 

$

235,980

 

$

213,225

 

 

The accompanying notes are an integral part of these consolidated balance sheets.


CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands except per share data)

 

 

Nine Months Ended September 30,

 

Three Months Ended September 30,

 

 

 

2001

 

2000*

 

2001

 

2000*

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

70,731

 

$

44,795

 

$

15,541

 

$

18,206

 

Contract fees

 

865

 

9,764

 

289

 

213

 

Royalties

 

3,370

 

2,158

 

1,677

 

778

 

Other revenues

 

1,129

 

1,169

 

718

 

276

 

Interest income

 

5,979

 

5,175

 

1,906

 

1,983

 

 

 

82,074

 

63,061

 

20,131

 

21,456

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

18,677

 

16,468

 

5,562

 

5,436

 

Cost of product sales

 

11,668

 

7,097

 

2,710

 

2,850

 

General and administrative

 

7,980

 

10,159

 

2,062

 

3,531

 

Marketing and sales

 

12,344

 

12,936

 

3,046

 

4,365

 

Royalties

 

1,448

 

1,173

 

533

 

255

 

Finance

 

122

 

91

 

109

 

44

 

Write-off of in-process research and development acquired

 

45,600

 

--

 

--

 

--

 

 

 

97,839

 

47,924

 

14,022

 

16,481

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

(15,765

)

15,137

 

6,109

 

4,975

 

Income taxes

 

8,926

 

4,036

 

1,664

 

555

 

Income (loss) before cumulative effect of change in accounting principle

 

(24,691

)

11,101

 

4,445

 

4,420

 

Cumulative effect of change in accounting  principle

 

---

 

(8,178

)

---

 

---

 

Net income (loss)

 

$

(24,691

)

$

2,923

 

$

4,445

 

$

4,420

 

 

 

 

 

 

 

 

 

 

 

Earnings per common share:

 

 

 

 

 

 

 

 

 

Basic:

 

 

 

 

 

 

 

 

 

Income (loss) before cumulative effect of  change in accounting principle

 

$

(0.43

)

$

0.20

 

0.08

 

$

0.08

 

Cumulative effect of change in accounting principle

 

---

 

(0.15

)

---

 

---

 

Net income (loss)

 

$

(0.43

)

$

0.05

 

$

0.08

 

$

0.08

 

 

 

 

 

 

 

 

 

 

 

Diluted:

 

 

 

 

 

 

 

 

 

Income (loss) before cumulative effect of change in accounting principle

 

$

(0.43

)

$

0.19

 

0.07

 

$

0.08

 

Cumulative effect of change in accounting principle

 

---

 

(0.14

)

---

 

---

 

Net income (loss)

 

$

(0.43

)

$

0.05

 

$

0.07

 

$

0.08

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common and

 

 

 

 

 

 

 

 

 

common equivalent shares

Basic

 

56,871

 

54,186

 

58,078

 

54,493

 

Diluted

 

56,871

 

57,336

 

59,411

 

56,963

 


* See Note 3

The accompanying notes are an integral part of these consolidated statements.


CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Capital in

 

 

 

Other

 

Total

 

 

 

Common Stock

 

Excess of

 

 

 

Comprehensive

 

Stockholders’

 

 

 

Shares

 

Par Value

 

Par Value

 

Deficit

 

Loss

 

Equity

 

Balance, December 31, 2000

 

54,765

 

$

547

 

$

179,586

 

$

(14,817

)

$

(5,963

)

$

159,353

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for nine months ended September 30, 2001

 

 

 

 

 

 

 

(24,691

)

 

 

(24,691

)

Unrealized loss on marketable securities, net

 

 

 

 

 

 

 

 

 

(2,508

)

(2,508

)

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(27,199

)

Issuance of common stock in Myelos acquisition

 

2,345

 

24

 

19,009

 

 

 

 

 

19,033

 

Issuance of common stock

 

202

 

1

 

1,545

 

 

 

 

 

1,546

 

Exercise of stock options

 

856

 

9

 

5,645

 

 

 

 

 

5,654

 

Balance, September 30, 2001

 

58,168

 

$

581

 

$

205,785

 

$

(39,508

)

$

(8,471

)

$

158,387

 

 

The accompanying notes are an integral part of this consolidated statement.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)

 

 

Nine Months Ended September 30,

 

 

 

2001

 

2000

 

Cash flows from operating activities:

 

 

 

 

 

Net income (loss)

 

$

(24,691

)

$

2,923

 

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

Cumulative effect of accounting change, net

 

---

 

8,178

 

Depreciation and amortization

 

2,717

 

2,229

 

Amortization of negative goodwill

 

(1,948

)

---

 

Provision for severance pay

 

497

 

602

 

Write-off of in-process research and development acquired

 

45,600

 

---

 

Loss (gain) on sales of short-term investments

 

(303

)

238

 

Loss (gain) on sales of fixed assets

 

22

 

(16

)

Common stock issued as payment for services

 

52

 

45

 

Changes in: Receivables

 

13,335

 

(5,534

)

 

Inventories

 

(2,611

)

(1,533

)

 

Prepaid expenses and other current assets

 

(1,760

)

3

 

 

Deferred revenue

 

(865

)

211

 

 

Accounts payable

 

8,159

 

(617

)

 

Other current liabilities

 

2,029

 

618

 

Net cash provided by operating activities

 

40,233

 

7,347

 

Cash flows from investing activities:

 

 

 

 

 

Short-term investments

 

(1,614

)

(33,962

)

Capital expenditures

 

(18,713

)

(6,453

)

Changes in other assets

 

(1,185

)

(718

)

Severance pay funded (used)

 

(21

)

(169

)

Proceeds from sales of fixed assets

 

179

 

44

 

Net cash paid in acquisition

 

(15,358

)

---

 

Other investment

 

(5,000

)

---

 

Proceeds from sales of short-term investments

 

36,454

 

12,751

 

Net cash used in investing activities

 

(5,258

)

(28,507

)

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Long term loan

 

---

 

10,000

 

Proceeds from issuance of common stock

 

7,148

 

9,146

 

Net cash flows from financing activities

 

7,148

 

19,146

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

42,123

 

(2,014

)

Cash and cash equivalents at beginning of period

 

26,353

 

18,703

 

Cash and cash equivalents at end of period

 

$

68,476

 

$

16,689

 

Supplementary Information

 

 

 

 

 

 

Other information:

 

 

 

 

 

Income tax paid

 

$

2,144

 

$

1,800

 

Interest paid

 

$

867

 

---

 

Acquisition of Myelos Corporation:

 

 

 

 

 

Assets acquired

 

$

8,258

 

$

---

 

Liabilities assumed

 

(1,125

)

---

 

Negative goodwill

 

(18,275

)

---

 

Equity issued

 

(19,033

)

---

 

In-process research and development acquired

 

45,600

 

---

 

Cash paid (including acquisition costs of $1,387)

 

15,425

 

---

 

Less – cash acquired

 

(67

)

---

 

Net cash paid

 

$

15,358

 

$

---

 

The accompanying notes are an integral part of these consolidated statements.


NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1:

Basis of Presentation

 

 

 

                In the opinion of management, the condensed consolidated financial statements include all adjustments, consisting of only normal recurring accruals, considered necessary for a fair presentation.  Due to fluctuations in quarterly revenues earned, operating results for interim periods are not necessarily indicative of the results that may be expected for the full year.  The accounting policies continue unchanged from December 31, 2000.  For further information, refer to the Consolidated Financial Statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000.

 

 

Note 2:

Acquisition and Investment

 

 

 

 

 

Acquisition of Myelos Corporation

 

 

 

 

 

                On March 19, 2001, BTG acquired Myelos Corporation, a privately-held biopharmaceutical company focused on the development of novel therapeutics to treat diseases of the nervous system.  Under the terms of the acquisition agreement, BTG paid Myelos shareholders $35,000,000 in a combination of cash and stock ($14,000,000 in cash and $21,000,000 through the issuance of approximately 2,344,700 shares of the Company’s common stock (based on a value of $8.9564, representing the average closing price of BTG’s common stock for the 20 trading day period ending one day prior to February 21, 2001, the date the acquisition agreement was executed)).  In addition, BTG has agreed to pay the Myelos shareholders an additional $30,000,000 if BTG is able to file a New Drug Application with respect to Prosaptide to treat neuropathic pain or neuropathy, of which at least $14,000,000 will be paid through the issuance of shares of BTG common stock.  The remaining $16,000,000 can be paid, at BTG’s option, in cash, shares of BTG common stock or a combination thereof.  BTG has also agreed that if Prosaptide is approved by the United States Food and Drug Administration for the treatment of neuropathic pain or neuropathy, BTG will pay the Myelos shareholders 15% of net sales of Prosaptide during the 12 month period beginning on the earlier of (i) the 25th full month after commercial introduction of Prosaptide in the United States for the treatment of neuropathic pain or neuropathy and (ii) April 1, 2010.  At least 50% of this payment must be in shares of BTG common stock, with the remainder payable, at BTG’s option, in cash, shares of BTG common stock or a combination thereof.  In no event is BTG required to issue more than 10,962,000 shares of its common stock; any equity required to be issued in excess of that amount will be issued in shares of BTG preferred stock.  The preferred stock would be non-voting, non-convertible, non-transferable, non-dividend paying (except to the extent a cash dividend is paid on the BTG common stock), with no mandatory redemption for a period of 20 years and one day from the closing date of the acquisition, and a right to share in proceeds in liquidation, up to the liquidation amount.

 

 

 

 

 

                The transaction was treated as a “purchase” for accounting purposes.  The purchase price for accounting purposes is approximately $34,387,000 (including acquisition costs of $1,387,000), based on a value for the approximately 2,344,700 shares of Company common stock issued in the acquisition of $8.1172, representing the average closing price of the Company’s common stock for the four day period preceding the date the terms of the acquisition were agreed to (February 21, 2001).  In connection with the merger and based on an independent valuation, BTG allocated $45,600,000 to in-process research and development projects of Myelos, representing the estimated fair value based on risk-adjusted cash flows of the acquired technology.  At the date of the merger the technology acquired in the acquisition was not fully commercially developed and had no alternative future uses.  Accordingly, the value was expensed as of the acquisition date.  The Company recorded negative goodwill of $18,275,000 on its balance sheet, primarily because the amount written off as in-process research and development acquired exceeded the purchase price for accounting purposes.  This negative goodwill is being amortized over its expected useful life of five years.  In accordance with SFAS No. 142, amortization of the negative goodwill will cease beginning January 1, 2002, and the balance remaining will be maintained as a deferred credit until it is either netted against the contingent payments or reflected in net income as an extraordinary item should the contingent payments not become due because the technology did not meet the milestones which trigger payment.

 


 

 

                The Company allocated values to the in-process research and development based on an independent valuation of the research and development project.  The value assigned to these assets was determined by estimating the costs to develop the acquired technology into a commercially viable product, estimating the resulting net cash flows from the product, and discounting the net cash flows to their present value.  The revenue projection used to value the in-process research and development was based on estimates of relevant market size and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by the Company and its competitors.  The resulting net cash flows from such product are based on management’s estimates of cost of sales, operating expenses and income taxes from such product.  The Company believes that the assumptions used in the forecasts were reasonable at the time of the merger.  No assurance can be given, however, that the underlying assumptions used to estimate sales, development costs or profitability, or the events associated with such product, will transpire as estimated.  For these reasons, actual results may vary from projected results.  The most significant and uncertain assumptions relating to the in-process research and development relate to the ability to successfully develop a product and the projected timing of completion of, and revenues attributable to, that product.

 

 

 

                The following pro forma consolidated results of operations for the nine month period ended September 30, 2001 were prepared assuming the acquisition of Myelos occurred on January 1, 2001.  The pro forma results of operations are not necessarily indicative of the consolidated results which actually would have occurred if the acquisition had been consummated at the beginning of the year presented, nor does it purport to represent the results of operations for future periods.

 

 

 

Nine months ended September 30, 2001

 

 

 

(In thousands except per share data)

 

 

 

 

 

 

 

 

 

As Reported

 

Pro Forma

 

 

 

 

 

 

 

Total revenues

 

$

82,074

 

$

82,074

 

 

 

 

 

 

 

Net loss

 

$

(24,691

)

$

(25,023

)

 

 

 

 

 

 

Loss per share (basic and diluted)

 

$

(0.43

)

$

(0.44

)

 

 

 

The pro forma results include the effect of the amortization of negative goodwill.

 

 

 

Investment in Omrix Biopharmaceuticals, Inc.

 

 

 

                In January 2001, in order to obtain a period of exclusivity to negotiate a possible strategic relationship with Omrix Biopharmaceuticals, Inc., BTG loaned $2,500,000 to Omrix and agreed to convert the loan into, and to purchase an additional $2,500,000 of, shares of Omrix preferred stock if it did not pursue a relationship.  BTG determined not to pursue a strategic relationship with Omrix, and on March 31, 200l converted the existing loan into, and purchased an additional $2,500,000 of, shares of Omrix preferred stock, which is convertible into approximately 4.5% of Omrix common stock (on a fully-diluted basis).  Omrix is a privately-held company that develops and markets a unique surgical sealant and a number of immunology products based on blood plasma processing technology.  Omrix currently sells its products in Europe, South America and the Middle East.

 

 

Note.3:

SAB 101

 

 

 

                Effective January 1, 2000, the Company adopted Staff Accounting Bulletin 101 (“SAB 101”) issued by the Securities and Exchange Commission in December 1999.  As a result of adopting SAB 101, the Company changed the way it recognizes revenue from contract fees for the license of marketing and distribution rights where the consideration is a one-time nonrefundable payment.  Prior to the issuance of SAB 101, the Company recorded revenue from the license of marketing and distribution rights when the rights were licensed and/or when these payments were received.  In accordance with SAB 101, the related revenues are now being recognized over the term of the related agreements.  Effective January 1, 2000, the Company recorded a cumulative effect of change in accounting principle related to contract revenues recognized in prior years in the amount of $12,558,000, net of income taxes of $4,380,000.  Contract fees that have been received but not yet recognized as revenue are recorded as deferred revenue on the balance sheet.


 

 

        Following is a reconciliation of the information for the three and nine months ended September 30, 2000 as reported:

 

 

 

 

 

 

 

 

 

        For the three months ended September 30, 2000:

 

 

 

 

 

 

 

 

 

As reported

 

Adjustments

 

As Adjusted

 

 

 

(In thousands except per share data)

 

 

Contract fees

 

$

--

 

$

213

 

$

213

 

 

Income taxes

 

$

476

 

$

79

 

$

555

 

 

Earnings per common share:

 

 

 

 

 

 

 

 

Basic

 

$

0.08

 

$

--

 

$

0.08

 

 

Diluted

 

$

0.08

 

$

(0.01

)

$

0.07

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

        For the nine months ended September 30, 2000:

 

 

 

 

 

 

 

 

 

As reported

 

Adjustments

 

As Adjusted

 

 

 

(In thousands except per share data)

 

 

 

 

 

 

Contract fees

 

$

9,975

 

$

(211

)

$

9,764

 

 

Income taxes

 

$

4,115

 

$

(79

)

$

4,036

 

 

Cumulative effect of change in
accounting principle

 

$

--

 

$

(8,178

)

$

(8,178

)

 

Earnings (loss) per common share:

 

 

 

 

 

 

 

 

Basic

 

$

0.21

 

$

(0.16

)

$

0.05

 

 

Diluted

 

$

0.20

 

$

(0.15

)

$

0.05

 

 

Note 4:  New Accounting Statements:

 

                In June 2001, the FASB approved SFAS Nos. 141 and 142 entitled “Business Combinations” and “Goodwill and Other Intangible Assets”, respectively.  SFAS No. 141, among other things, eliminates the pooling of interests method of accounting for business acquisitions entered into after June 30, 2001.  SFAS No. 142 requires companies to use a fair-value approach to determine whether there is an impairment of existing and future goodwill.  SFAS No. 141 is applied to all business combinations initiated after June 30, 2001.  SFAS No. 142 is effective for fiscal years beginning after December 15, 2001.  As a result of the adoption of SFAS No. 142, beginning in 2002 the Company will no longer amortize the negative goodwill resulting from the Myelos acquisition, which reduced general and administrative expense by approximately $1,000,000 per quarter for financial reporting purposes.  Under SFAS No. 142, the negative goodwill balance remaining at December 31, 2001 will be maintained on the Balance Sheet as a deferred credit until it is either netted against the contingent payments, if any, made to the former Myelos shareholders or reflected in net income as an extraordinary item should the contingent payments not become due. The adoption of SFAS No. 141 had no impact on the Company’s consolidated financial statements.  The only impact of the adoption of SFAS No. 142 on the Company’s consolidated financial statements is that the negative goodwill recorded in connection with the Myelos acquisition will no longer be amortized.  The amortization of negative goodwill during 2001 reduced the Company’s reported general and administrative expense.


MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS

 

Three and nine months ended September 30, 2001
compared with three and nine months ended September 30, 2000

 

Statements in this Quarterly Report on Form 10-Q concerning the Company’s business outlook or future economic performance; anticipated profitability, revenues, expenses or other financial items; introductions and advancements in development of products, and plans and objectives related thereto; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements” as that term is defined under the Federal Securities Laws.  Forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements.  Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, changes and delays in product approval and introduction, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, changes in healthcare reimbursement, risk of operations in Israel, risk of product liability, governmental regulation, dependence on third parties to manufacture products and commercialize products, general economic conditions, as well as other risks detailed in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2000.

Overview

BTG is engaged in the research, development, manufacture and marketing of biopharmaceutical products. Through a combination of internal research and development, acquisitions, collaborative relationships and licensing arrangements, BTG has developed a portfolio of therapeutic products, including eight products that have received regulatory approval for sale, all of which are currently being marketed, four products that are in registration or clinical trials and several products that are in pre-clinical development.  BTG pursues the development of both products with broad markets as well as products with specialized niche markets where BTG can seek Orphan Drug designation and potential marketing exclusivity.

BTG was founded in 1980 to develop, manufacture and market novel therapeutic products.  BTG’s overall administration, licensing, human clinical studies, marketing activities, quality assurance and regulatory affairs are primarily coordinated at its headquarters in Iselin, New Jersey.  Pre-clinical studies, research and development activities and manufacturing of the Company’s genetically engineered and fermentation products are primarily carried out through its wholly owned subsidiary in Rehovot, Israel.

BTG anticipates product sales for the year of approximately $85 million and total revenues of approximately $100 million, although fourth quarter earnings per share is expected to be lower than third quarter earnings per share.

Acquisition of Myelos Corporation

On March 19, 2001, BTG acquired Myelos Corporation, a privately-held biopharmaceutical company focused on the development of novel therapeutics to treat diseases of the nervous system.  Under the terms of the acquisition agreement, BTG paid Myelos shareholders $35 million in a combination of cash and stock ($14 million in cash and $21 million through the issuance of approximately 2,344,700 shares of BTG common stock (based on a value of $8.9564, representing the average closing price of BTG’s common stock for the 20 trading day period ending one day prior to the February 21, 2001 date the acquisition agreement was executed)).

In the event that (i) BTG publicly announces that it will file a New Drug Application (“NDA”) related to the use of Prosaptide to treat neuropathic pain or neuropathy, (ii) BTG receives United States Food and Drug Administration (“FDA”) minutes stating that the clinical data possessed by BTG is sufficient for an NDA filing for the use of Prosaptide to treat neuropathic pain or neuropathy without requiring any further testing or (iii) BTG initiates preparation of an NDA for Prosaptide for the treatment of neuropathic pain or neuropathy (the date the earliest of the foregoing occurs being the “Payment Trigger Date”), then BTG will pay to the Myelos shareholders an additional $30 million, at least approximately $14 million of which must be paid in shares of BTG common stock, valued at the average of the closing prices of BTG common stock during the 20 trading days ending on the Payment Trigger Date, and the remainder can be paid in cash, shares of BTG common stock, or a combination thereof, as determined by BTG in its sole discretion.


In addition, in the event that the FDA approves the sale of Prosaptide for the treatment of neuropathic pain or neuropathy, BTG will pay the Myelos shareholders 15% of the net sales of Prosaptide for the treatment of neuropathic pain or neuropathy during the 12 month period beginning on the earlier of (i) the 25th full month after commercial introduction of Prosaptide in the United States for the treatment of neuropathic pain or neuropathy and (ii) April 1, 2010.  At least 50% of this payment must be paid in shares of BTG common stock, valued at the average of the closing prices of BTG common stock during the 20 days ending one day prior to the payment, and the remainder can be paid in cash, shares of BTG common stock, or a combination thereof, as determined by BTG in its sole discretion.

In no event will BTG be obligated to issue in aggregate to the Myelos shareholders more than 10,962,000 shares of BTG common stock.  Any amount of the contingent payments that cannot be paid in shares of BTG common stock shall instead be paid in shares of BTG’s preferred stock.  The preferred stock will be non-voting, non-convertible, non-transferable, non-dividend paying (except to the extent a cash dividend is paid on the BTG common stock), with no mandatory redemption for a period of 20 years and one day from the closing date of the acquisition, and a right to share in proceeds in liquidation, up to the liquidation amount.

The transaction was treated as a “purchase” for accounting purposes.  The purchase price for accounting purposes is approximately $34,387,000 (including acquisition costs of $1,387,000), based on a value for the approximately 2,344,700 shares of Company common stock issued in the acquisition of $8.1172, representing the average closing price of the Company’s common stock for the four day period preceding the date the terms of the acquisition were agreed to (February 21, 2001).  In connection with the merger and based on an independent valuation, BTG allocated $45,600,000 to in-process research and development projects of Myelos, representing the estimated fair value based on risk-adjusted cash flows of the acquired technology.  At the date of the merger the technology acquired in the acquisition was not fully commercially developed and had no alternative future uses.  Accordingly, the value was expensed as of the acquisition date.  The Company recorded negative goodwill of $18,275,000 on its balance sheet, primarily because the amount written off as in-process research and development acquired exceeded the purchase price for accounting purposes.  This negative goodwill is being amortized over its expected useful life of five years.  In accordance with SFAS No. 142, amortization of the negative goodwill will cease beginning January 1, 2002, and the balance remaining will be maintained as a deferred credit until it is either netted against the contingent payments or reflected in net income as an extraordinary item should the contingent payments not become due because the technology did not meet the milestones which trigger payment.

The Company allocated values to the in-process research and development based on an independent valuation of the research and development project.  The value assigned to these assets was determined by estimating the costs to develop the acquired technology into a commercially viable product, estimating the resulting net cash flows from the product, and discounting the net cash flows to their present value.  The revenue projection used to value the in-process research and development was based on estimates of relevant market size and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by the Company and its competitors.  The resulting net cash flows from such product are based on management’s estimates of cost of sales, operating expenses and income taxes from such product.  The Company believes that the assumptions used in the forecasts were reasonable at the time of the merger.  No assurance can be given, however, that the underlying assumptions used to estimate sales, development costs or profitability, or the events associated with such product, will transpire as estimated.  For these reasons, actual results may vary from projected results.  The most significant and uncertain assumptions relating to the in-process research and development relate to the ability to successfully develop a product and the projected timing of completion of, and revenues attributable to, that product.


Results of Operations

The following tables set forth for the fiscal periods indicated the percentage of revenues represented by certain items reflected on the Company’s statements of operations.

 

 

 

Nine Months Ended September 30,

 

Three Months Ended September 30,

 

 

 

2001

 

2000

 

2001

 

2000

 

Revenues:

 

 

 

 

 

 

 

 

 

Products sales

 

86.2

%

71.0

%

77.2

%

84.9

%

Contract fees

 

1.0

 

15.5

 

1.4

 

1.0

 

Royalties

 

4.1

 

3.4

 

8.3

 

3.6

 

Other revenues

 

1.4

 

1.9

 

3.6

 

1.3

 

Interest income

 

7.3

 

8.2

 

9.5

 

9.2

 

Total

 

100.0

 

100.0

 

100.0

 

100.0

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

22.8

 

26.1

 

27.6

 

25.3

 

Cost of product sales

 

14.2

 

11.3

 

13.5

 

13.3

 

General and administrative

 

9.7

 

16.1

 

10.3

 

16.5

 

Marketing and sales

 

15.0

 

20.5

 

15.1

 

20.3

 

Royalties

 

1.8

 

1.9

 

2.7

 

1.2

 

Finance

 

0.1

 

0.1

 

0.5

 

0.2

 

Write-off of in-process research and development acquired

 

55.6

 

---

 

---

 

---

 

Total

 

119.2

 

76.0

 

69.7

 

76.8

 

Income (loss) before income taxes

 

(19.2

)

24.0

 

30.3

 

23.2

 

Income taxes

 

10.9

 

6.4

 

8.3

 

2.6

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before cumulative effect of change in
accounting principle

 

(30.1

)

17.6

 

22.0

 

20.6

 

Cumulative effect of change in accounting principle

 

--

 

13.0

 

--

 

--

 

Net income (loss)

 

(30.1)

%

4.6

%

22.0

%

20.6

%


The following tables set forth for the fiscal periods indicated the Company’s pro forma statement of operations excluding the effect resulting from the Myelos acquisition of (i) the write-off of in-process research and development acquired in the nine months ended September 30, 2001 and (ii) the amortization of negative goodwill in the three and nine months ended September 30, 2001.  The tables also set forth for the fiscal periods indicated the pro forma percentage of revenues represented by these items.

 

 

 

Nine Months Ended September 30, 2001

 

Three Months Ended September 30, 2001

 

 

 

(dollars in thousands)

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

70,731

 

86.2

%

$

15,541

 

77.2

%

Contract fees

 

865

 

1.0

 

289

 

1.4

 

Royalties

 

3,370

 

4.1

 

1,677

 

8.3

 

Other revenues

 

1,129

 

1.4

 

718

 

3.6

 

Interest income

 

5,979

 

7.3

 

1,906

 

9.5

 

 

 

82,074

 

100.0

 

20,131

 

100.0

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

18,677

 

22.8

 

5,562

 

27.6

 

Cost of product sales

 

11,668

 

14.2

 

2,710

 

13.5

 

General and administrative

 

9,928

 

12.1

 

2,977

 

14.8

 

Marketing and sales

 

12,344

 

15.0

 

3,046

 

15.1

 

Royalties

 

1,448

 

1.8

 

533

 

2.7

 

Finance

 

122

 

0.1

 

109

 

0.5

 

 

 

54,187

 

66.0

 

14,937

 

74.2

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

27,887

 

34.0

 

5,194

 

25.8

 

Income taxes

 

8,926

 

10.9

 

1,664

 

8.3

 

Net income

 

$

18,961

 

23.1

%

$

3,530

 

17.5

%

 

 

BTG has historically derived its revenues from product sales as well as from collaborative arrangements with third parties, under which the Company may earn up-front contract fees, may receive funding for additional research (including funding from the Chief Scientist of the State of Israel), is reimbursed for producing certain experimental materials, may be entitled to certain milestone payments, may sell product at specified prices, and may receive royalties on sales of product.  The Company anticipates that product sales will continue to constitute the majority of its revenues in the future.  Revenues have in the past displayed and will in the immediate future continue to display significant variations due to changes in demand for its products, the operational needs of its customers, new product introductions by the Company and its competitors, the obtaining of new research and development contracts and licensing arrangements, the completion or termination of such contracts and arrangements, the timing and amounts of milestone payments, and the timing of regulatory approvals of products.

Sales of Oxandrin in the first nine months of 2000 and 2001 were $22,301,000 and $39,154,000, respectively, representing 50% and 55%, respectively, of total product sales in those periods.  Sales of Oxandrin in the first, second and third quarters of 2001 were $16,692,000, $17,887,000 and $4,575,000, respectively, compared to $5,009,000, $6,403,000 and $10,889,000 in the first, second and third quarters of 2000, respectively.  Quarterly fluctuations in sales of Oxandrin can have a significant impact on our quarterly results of operations.

BTG’s sales of Oxandrin consist mainly of sales to Gentiva Health Services, Inc. (“Gentiva”), its wholesale and retail distributor of Oxandrin in the United States, and the Ross Products Division of Abbott Laboratories (“Ross”). The increase in Oxandrin sales in each of the first three quarters of 2000 was due to Gentiva’s completion, in May 2000, of its Oxandrin inventory reduction, which Gentiva began in April 1999.  The increase in Oxandrin sales during the first half of 2001 was due to: (i) the commencement, in September 2000, of sales by Ross for the long-term care market for the treatment of patients with involuntary weight loss, including stocking activity by wholesalers in connection with the launch of this product in the long-term care market; (ii) stocking by certain wholesalers in anticipation of a price increase; (iii) increased purchases by Gentiva following its completion, in May 2000, of a reduction in the amount of Oxandrin inventory it carries, which reduction began in April 1999; and (iv) increased wholesaler sales of Oxandrin by Gentiva.


Upon completion of its inventory reduction in May 2000, Gentiva began to purchase, on a monthly basis, an amount of Oxandrin equal to the average end-user (i.e., wholesaler) sales during the preceding three months. However, because of the significant increase in Oxandrin purchases by wholesalers in the first quarter of 2001 in anticipation of a price increase and in connection with the launch of Oxandrin into the long-term care market, Gentiva’s purchases of Oxandrin in the second quarter were higher than the levels of its sales of Oxandrin to wholesalers in that period.  As a result, Gentiva’s inventory of Oxandrin increased beyond the desired level.  Accordingly, BTG and Gentiva amended their distribution arrangement effective August 2001 to provide for reduced purchases of Oxandrin until Gentiva’s inventory was reduced to desired levels and thereafter to ensure that sales of Oxandrin by BTG to Gentiva more accurately reflected end-user demand.  As a result, sales of Oxandrin in the third quarter of 2001 were $13,312,000 lower than in the second quarter of 2001 and $6,314,000 lower than in the third quarter of 2000.

Gentiva’s reduction in Oxandrin inventory adversely affected the growth in BTG’s product sales and revenues and BTG’s results of operations in 1999 and 2000.  Reductions in wholesaler purchases of Oxandrin from Gentiva in the second and third quarters of 2001 and significantly reduced purchases of Oxandrin by Gentiva in the third quarter of 2001 adversely affected the growth in BTG’s product sales and revenues and BTG’s results of operations in the third quarter of 2001 and will continue to adversely affect fourth quarter product sales, revenues and results of operations.  Because purchases by wholesalers fluctuate from month to month and quarter to quarter based on their own operating strategies (including desired levels of inventories, purchases by their customers and stocking in advance of anticipated price increases), BTG’s sales to Gentiva and Ross will fluctuate from quarter to quarter.  There can be no assurance that Gentiva will not determine to further reduce its Oxandrin inventory levels.

The launch of Oxandrin in late 2000 by Ross into the long-term sector for the treatment of patients with involuntary weight loss led to a 30% increase in prescriptions in the first nine months of 2001 compared to the corresponding nine months of 2000.  However, prescriptions remained essentially flat in the months of June through August 2001 and decreased in September 2001, due, at least in part, to sales force changes in the long-term care sector.  The long-term care field force contingent detailing physicians, nursing homes, assisted living facilities and geriatric hospitals was streamlined in the spring of 2001 in an effort to achieve greater efficiency.  BTG believes this inadvertently resulted in a reduction in the number of Oxandrin calls and details being made, which only recently came to its attention.  The Company understands that corrective measures have been taken to increase the number of calls and details being made.  To date the average prescription written for the long-term care market involves a significantly lower dose of Oxandrin than the average prescription written for other markets.

The following table summarizes the Company’s sales of its commercialized products as a percentage of total product sales for the periods indicated:

 

 

 

Nine Months Ended September 30,

 

Three Months Ended September 30,

 

 

 

 

2001

 

2000

 

2001

 

2000

 

 

Oxandrin

 

55.4

%

49.8

%

29.4

%

59.8

%

 

Human growth hormone

 

27.2

 

35.6

 

52.3

 

33.6

 

 

BioLon

 

9.8

 

10.5

 

18.1

 

6.6

 

 

Delatestryl

 

7.0

 

3.0

 

---

 

---

 

 

Other

 

0.6

 

1.1

 

0.2

 

---

 

 

Total

 

100.0

%

100.0

%

100.0

%

100.0

%

 

The Company believes that its product mix will vary from period to period based on the purchasing patterns of its customers and the Company’s focus on: (i) increasing market penetration of its existing products; (ii) expanding into new markets; and (iii) commercializing additional products.


The following table summarizes the Company’s U.S. and international product sales as a percentage of total product sales for the period indicated:

 

 

Nine Months Ended September 30,

 

Three Months Ended September 30,

 

 

 

2001

 

2000

 

2001

 

2000

 

 

United States

 

63.9

%

50.8

%

32.0

%

54.4

%

 

International

 

36.1

 

49.2

 

68.0

 

45.6

 

 

Total

 

100.0

%

100.0

%

100.0

%

100.0

%

 

Comparison of Nine Months Ended September 30, 2001 and September 30, 2000.

Revenues.  Total revenues increased 30% in the nine months ended September 30, 2001 to $82,074,000 from $63,061,000 in the same period in 2000.  The increase in total revenues from the comparable prior period was mainly due to the substantial increase in product sales partially offset by a substantial decrease in contract fees.

Product sales increased by $25,936,000, or 58%, in the nine months ended September 30, 2001 from the comparable prior period.  Oxandrin sales in the nine months ended September 30, 2001 were $39,154,000, an increase of $16,853,000, or 76%, from the nine months ended September 30, 2000.  As discussed above, the increase in Oxandrin sales was due to: (i) the commencement, in September 2000, of sales by the Ross Products Division of Abbott Laboratories for the long-term care market, including stocking activity by wholesalers in connection with the launch of this product in the long-term care market; (ii) stocking by certain wholesalers in anticipation of a price increase; (iii) increased purchases by Gentiva following its completion, in May 2000, of a reduction in the amount of Oxandrin inventory it carries, which reduction began in April 1999; and (iv) increased wholesaler sales of Oxandrin by Gentiva.  Product sales of human growth hormone and BioLon in the period were $19,226,000 and $6,921,000, respectively, an increase of $3,293,000 and $2,211,000, respectively, or 21% and 47%, respectively, over the comparable period in 2000.  These increases reflect, respectively, (a) increased penetration of the Japanese and European human growth hormone markets and (b) increased sales of BioLon in the U.S. following an upgrade in our manufacturing process (which had negatively impacted 2000 BioLon sales while being implemented).  Delatestryl sales in the nine months ended September 30, 2001 were $4,976,000, an increase of $3,646,000, or 174%, over the comparable period of 2000.  All of the Delatestryl sales in 2001 occurred in the first quarter.  Gentiva, which acts as BTG’s wholesale distributor of Delatestryl in the United States, reduced its Delatestryl inventory during 2000, which BTG believes was in anticipation of the FDA permitting the production of a competing injectable testosterone product used to treat men with hypogonadism (testosterone deficiency) which the FDA had previously stopped.  To date the FDA has not permitted the commencement of production of this competing product.

Contract fees in the nine months ended September 30, 2001 decreased by $8,889,000, or 91%, from the comparable prior period.  Contract fees earned in the nine months ended September 30, 2001 represent contract fees received in prior periods but recognized in the nine months period ended September 30, 2001 in accordance with SAB 101. Of the contract fees earned in the nine months ended September 30, 2000, $5,000,000, or 51% of total contract fees, was earned in respect of the license of worldwide distribution rights of Bio-Hy to DePuy Orthopedics, a Johnson & Johnson company, $2,500,000, or 26% of total contract fees, was earned as a milestone payment under its strategic alliance with Teva Pharmaceutical Industries Ltd. focusing on the development and global commercialization of several generic recombinant therapeutic products and the license of distribution rights in the United States for the Company’s human growth hormone and $1,475,000, or 15% of total contract fees, was earned as milestone payments under its license and development and distribution agreements with Swiss Serum relating to BTG’s Hepatitis-B vaccine.

Royalties were $3,370,000 in the nine months ended September 30, 2001, as compared to $2,158,000 in the same period last year.  These revenues consist mainly of royalties from the licensee of the Company’s Mircette product.

                Other revenues were primarily generated from partial research and development funding by the Chief Scientist of the State of Israel.


Interest income for the nine months ended September 30, 2001 increased $804,000, or 16%, over the comparable prior period, primarily as a result of increased cash balances (including short-term investments) resulting mainly from cash flow from operations and proceeds from a $20,000,000 loan borrowed to finance construction of the Company’s new manufacturing facility in Israel. This was partially offset by lower interest rates, the use of approximately $15,358,000 to acquire Myelos, the use of approximately $21,121,000 to fund construction of the Company’s new manufacturing facility after September 30, 2000 and the use of $5,000,000 to purchase shares of Omrix Biopharmaceuticals.

Research and Development Expense. Research and development expense increased 13% in the nine months ended September 30, 2001 to $18,677,000 from $16,468,000 in the same period of 2000.  The increase in research and development expenditures resulted mainly from the increase in research and development personnel and legal fees related to patent maintenance and patent interference proceedings, as well as the addition of research and development activities for Prosaptide following the acquisition of Myelos.

Cost of Product Sales.  Cost of product sales increased by 64% in the nine months ended September 30, 2001 to $11,668,000 from $7,097,000 in the nine months ended September 30, 2000, primarily due to the 58% increase in product sales.  Cost of product sales as a percentage of product sales increased slightly to 16.5% as compared to 15.8% in the comparable period last year.  Cost of product sales as a percentage of product sales increased due to the mix of products.  Oxandrin and human growth hormone have a relatively low cost of manufacture as a percentage of product sales, while BioLon has the highest cost to manufacture as a percentage of product sales.  Cost of product sales as a percentage of product sales varies from year to year and quarter to quarter depending on the quantity and mix of products sold.

General and Administrative Expense.  General and administrative expense decreased by 21% in the nine months ended September 30, 2001 to $7,980,000 from $10,159,000 in the comparable prior period.  The decrease in general and administrative expense was due primarily to the amortization of $1,948,000 of negative goodwill resulting from the Myelos acquisition.  On a pro forma basis to exclude the effect of the amortization of negative goodwill, general and administrative expense for the nine months ended September 30, 2001 was $9,928,000, a slight decrease of 2% from the comparable period in 2000. The decrease in general and administrative expense (excluding the effect of the amortization of negative goodwill) was primarily due to a decrease in legal fees (litigation) as compared to 2000, when legal fees increased primarily due to the reactivation in the fourth quarter of 1998 of the Company’s declaratory judgment action against Genentech in respect of the Company’s human growth hormone product in the United States.  The decrease was partially offset by increased compensation costs and expenses associated with merger and acquisition activities. As a percentage of revenues, general and administrative expense (excluding the effect of the amortization of negative goodwill) decreased to 12.1% in the nine months ended September 30, 2001 from 16.1% in the nine months ended September 30, 2000.  The substantial decrease in general and administrative expense as a percentage of revenues derived principally from the substantial increase in total revenues.

Marketing and Sales Expense.  Marketing and sales expense decreased 5% in the nine months ended September 30, 2001 to $12,344,000 from $12,936,000 for the prior year period.  These expenses primarily related to the sales and marketing force in the United States that the Company established to promote distribution of Oxandrin in the United States.  The decrease was primarily due to decreased advertising, promotional and market research activities partially offset by increased personnel, principally sales force, and other expenses associated with these personnel.

                Royalties.  Royalties were $1,448,000 in the nine months ended September 30, 2001, as compared to $1,173,000 in the nine months ended September 30, 2000.  These expenses consist primarily of royalties to entities from which the Company licensed certain of its products and to the Chief Scientist.


                Income Taxes.
  Provision for income taxes for the nine months ended September 30, 2001 was $8,926,000, representing approximately 32% of income before income taxes (on a pro forma basis excluding the write-off of in-process research and development acquired and amortization of negative goodwill, which are not taken into account in computing income taxes), as compared to $4,036,000, or 27% of income before income taxes, in the comparable period last year.  The Company’s effective tax rate in the first nine months of 2000 was favorably affected by the increase in revenues, principally contract fees, generated by BTG-Israel, which is entitled to certain Israeli tax benefits.  BTG’s consolidated effective tax rate differs from the statutory rate because of Israeli tax benefits, tax credits and similar items which reduce the effective tax rate.


Write-off of In-Process Research and Development Acquired.  In the nine months ended September 30, 2001 BTG wrote-off $45,600,000 as in-process research and development acquired relating to the acquisition of Myelos Corporation.  In connection with the acquisition BTG allocated $45,600,000 to in-process research and development projects of Myelos, representing the estimated fair value based on risk-adjusted cash flows of the acquired technology based on an independent valuation.  At the date of the merger the technology acquired in the acquisition was not fully commercially developed and had no alternative future uses.  Accordingly, the value was expensed as of the acquisition date.

Earnings per Common Share.  BTG had approximately 2.7 million additional basic weighted average shares outstanding for the nine month period ended September 30, 2001 as compared to the same period in 2000.  The increased number of basic shares was primarily the result of the issuance, subsequent to September 30, 2000, of shares upon the exercise of options and the issuance of approximately 2.3 million shares to the former shareholders of Myelos in March 2001. For 2001 diluted weighted average shares outstanding does not include dilutive securities because the effect would be anti-dilutive.

On a pro-forma basis, excluding the write-off of in-process research and development acquired and amortization of negative goodwill, net income would have been $18,961,000, or $0.33 per share on both a basic and diluted share basis.  Diluted weighted average shares outstanding would have been 58,072,000, an increase of 0.7 million shares from the comparable period in 2000, primarily as a result of the higher basic weighted average shares outstanding for the nine months ended September 30, 2001, partially offset by the fact that less outstanding options were considered common equivalents because their exercise price was above the average fair market value of the common stock for the nine months ended September 30, 2001, which average fair market value was lower than in the same period last year.

Comparison of Three Months Ended September 30, 2001 and September 30, 2000.

Revenues.  Total revenues decreased 6% in the third quarter of 2001 to $20,131,000 from $21,456,000 in the third quarter of 2000.  The decrease in total revenues from the comparable prior period was due to the decrease in product sales, partially offset by an increase in royalties and other revenues.

Product sales decreased by $2,665,000, or 15%, in the three months ended September 30, 2001 from the comparable prior period in 2000.  Oxandrin sales in the three months ended September 30, 2001 were $4,575,000, a decrease of $6,314,000, or 58%, from the three months ended September 30, 2000.  The decrease in Oxandrin sales was due to reduced purchases of Oxandrin by Gentiva in response to increased inventory levels resulting from over-stocking by wholesalers during the first six months of 2001.  Product sales of human growth hormone and BioLon were $8,133,000 and $2,810,000, respectively, in the third quarter of 2001, an increase of $2,015,000, and $1,615,000, resepectively, or 33% and 135%, respectively, over the comparable period in 2000.  There were no sales of Delatestryl in the three months ended September 30, 2000 and 2001.

Contract fees in the three month periods ended September 30, 2001 and 2000 represent contract fees received in prior periods but recognized in the third quarter of 2001 and 2000 in accordance with SAB 101.

Royalties were $1,677,000 in the third quarter of 2001, as compared to $778,000 in the same period last year.  These revenues consist mainly of royalties from the licensee of the Company’s Mircette product.

                Other revenues were primarily generated from partial research and development funding by the Chief Scientist of the State of Israel.

 

                Interest income decreased $77,000, or 4%, over the comparable prior period, primarily as a result of lower interest rates, the use of $15,358,000 to acquire Myelos, the use of approximately $21,121,000 to fund construction of the Company’s new manufacturing facility after September 30, 2000 and the use of $5,000,000 to purchase shares of Omrix Biopharmaceuticals.


Research and Development Expense.  Research and development expense increased 2% in the third quarter of 2001 to $5,562,000 from $5,436,000 in the third quarter of 2000.  The increase in research and development expenditures resulted mainly from the increase in research and development personnel and legal fees related to patent maintenance and patent interference proceedings, partially offset by less expenditures associated with development of a new formulation of the Company’s Oxandrin product in 2001 as compared to 2000.

Cost of Product Sales.  Cost of product sales decreased by 5% in the three months ended September 30, 2001 to $2,710,000 from $2,850,000 in the three months ended September 30, 2000, primarily as a result of the 15% decrease in product sales.  Cost of product sales as a percentage of product sales increased to 17.4% as compared to 15.7% in the comparable period last year.  Cost of product sales as a percentage of product sales increased due to the mix of products.  Oxandrin and human growth hormone have a relatively low cost of manufacture as a percentage of product sales, while BioLon has the highest cost to manufacture as a percentage of product sales.  Cost of product sales as a percentage of product sales varies from year to year and quarter to quarter depending on the quantity and mix of products sold.

General and Administrative Expense.  General and administrative expense decreased by 42% in the three months ended September 30, 2001 to $2,062,000 from $3,531,000 in the comparable prior period.  The decrease in general and administrative expense was due mainly to the amortization of $915,000 of negative goodwill resulting from the Myelos acquisition.  On a pro forma basis to exclude the effect of the amortization of negative goodwill, general and administrative expense for the three months ended September 30, 2001 was $2,977,000, a decrease of 16% from the comparable period in 2000.  The decrease in general and administrative expenses (excluding the effect of the amortization of negative goodwill) was primarily due to the timing of payment of bonuses as well as a reduction of legal fees (litigation) as compared to 2000, when legal fees increased primarily due to the reactivation in the fourth quarter of 1998 of the Company’s declaratory judgment action against Genentech in respect of the Company’s human growth hormone product in the United States.  As a percentage of revenues, general and administrative expense (excluding the effect of the amortization of negative goodwill) decreased to 14.8% in the three months ended September 30, 2001 from 16.5% in the three months ended September 30, 2000.

Marketing and Sales Expense.  Marketing and sales expense decreased 30% in the second quarter of 2001 to $3,046,000 from $4,365,000 for the prior year period.  As a percentage of revenues, marketing and sales expense decreased to approximately 15.1% from 20.3% for the third quarter of 2000.  These expenses primarily related to the sales and marketing force in the United States that the Company established to promote distribution of Oxandrin in the United StatesThe decrease was primarily due to the timing of advertising, promotions and market research expenses and decreased incentive compensation costs.

Royalties.  Royalties were $533,000 in the three months ended September 30, 2001, as compared to $255,000 in the three months ended September 30, 2000.  These expenses consist primarily of royalties to entities from which the Company licensed certain of its products and to the Chief Scientist.

                Income Taxes.  Provision for income taxes for the three months ended September 30, 2001 was $1,664,000, representing approximately 32% of income before income taxes (on a pro forma basis excluding the amortization of negative goodwill, which is not taken into account in computing income taxes), as compared to $555,000, or 11% of income before income taxes, in the comparable quarter last year.  The Company’s effective tax rate in the third quarter of 2000 was favorably affected by the increase in revenues, principally contract fees, generated by BTG-Israel, which is entitled to certain Israeli tax benefits, and an increase in the research and experimental tax credits available to BTG as compared to the third quarter of 2001.  BTG’s consolidated effective tax rate differs from the statutory rate because of Israeli tax benefits, tax credits and similar items which reduce the effective tax rate.

 

Earnings per Common Share.  BTG had approximately 3.6 million additional basic weighted average shares outstanding for the three month period ended September 30, 2001 as compared to the same period in 2000.  The increased number of basic shares was primarily the result of the issuance, subsequent to September 30, 2000, of shares upon the exercise of options and the issuance of approximately 2.3 million shares to the former shareholders of Myelosin March 2001. BTG had approximately 2.4 million additional diluted weighted average share outstanding for the three month period ended September 30, 2001, as compared to the same period in 2000, primarily as a result of the higher basic weighted average shares outstanding for the three months ended September 30, 2001, partially offset by the fact that less outstanding options were considered common equivalents because their exercise price was above the average fair market value of the common stock for the three months ended September 30, 2001, which average fair market value was lower than in the same period last year.


On a proforma basis, excluding the amortization of negative goodwill, net income would have been $3,530,000 or $0.06 per share on both a basic and diluted share basis.

Liquidity and Capital Resources

The Company’s working capital at September 30, 2001 was $140,080,000, as compared to $153,344,000 at December 31, 2000, due primarily to a decrease in accounts receivable.

The cash flows of the Company have fluctuated significantly due to the impact of net income, capital spending, working capital requirements, the issuance of common stock and other financing activities.  BTG expects that cash flow in the near future will be primarily determined by the levels of net income and financings, if any, undertaken by the Company.  Net cash increased (decreased) by $42,123,000 and $(2,014,000) in the nine months ended September 30, 2001 and 2000, respectively, in large part due to the sale of short-term investments in 2001 and purchase of short-term investments in 2000. Cash, cash equivalents and short-term investments increased by $5,078,000 and $18,764,000 in the nine months ended September 30, 2001 and 2000, respectively.

Net cash provided by operating activities was $40,233,000 and $7,347,000 in the nine months ended September 30, 2001 and 2000, respectively.  Net income (loss) was $(24,691,000) and $2,923,000 in the same periods, respectively.  In the nine months ended September 30, 2001 the Company had net cash provided by operating activities despite the net loss mainly due to the write-off of in-process research and development acquired of $45,600,000, a decrease in accounts receivable of $13,335,000, an increase in accounts payable and other current liabilities of $8,159,000 and $2,029,000, respectively, and depreciation and amortization of $2,717,000, partially offset by an increase in inventories and prepaid expenses and other current assets of $2,611,000 and $1,760,000, respectively, and the amortization of negative goodwill of $1,948,000.  In the nine months ended September 30, 2000 BTG had net cash provided by operating activities greater than net income mainly due to the cumulative effect of change in accounting principle, net of $8,178,000 as a result of the adoption of SAB 101 and depreciation and amortization in the amount of $2,229,000, partially offset by an increase in inventories and receivables in the amount of $1,533,000 and $5,534,000, respectively.

Net cash used in investing activities was $5,258,000 and $28,507,000 in the nine months ended September 30, 2001 and 2000, respectively.  Net cash used in investing activities included capital expenditures of $18,713,000 and $6,453,000 in these periods, respectively, primarily for the new manufacturing facility, as well as a $5,000,000 investment in Omrix in the nine months ended September 30, 2001.  In the nine months ended September 30, 2001, BTG paid net cash of $15,358,000 in connection with the acquisition of Myelos. The remainder of the net cash used in investing activities was primarily for purchases and sales of short-term investments.

Net cash provided by financing activities was $7,148,000 and $19,146,000 in the nine months ended September 30, 2001 and 2000, respectively, which are net proceeds from issuance of common stock primarily resulting from the exercise of stock options in both periods and borrowings $10,000,000 under its revolving credit facility in the 2000 period.

                In April 1999, BTG purchased a manufacturing facility in Israel for approximately $6,250,000.  The Company will move its production activities to this facility.  The Company expects that construction will be completed by the end of 2001.  Following completion of the construction, BTG will begin the validation process, which is currently expected to be completed in the second half of 2002 for all products.  BTG expects it will cost approximately $40,000,000 to complete the production facility (excluding the cost of purchasing the facility and the cost of post-completion validation), of which approximately $29,000,000 had been expended through September 30, 2001.  As of September 30, 2001 BTG had outstanding commitments of approximately $8,000,000 related to completion of this facility.  In addition, the Company has agreed to purchase additional property adjacent to the new manufacturing facility for approximately $2,000,000, of which approximately $400,000 has been paid to date.  This property will allow the Company to locate its principal research and development activities adjacent to the manufacturing facility.


In June 2000 Bio-Technology General (Israel) Ltd., BTG’s wholly-owned subsidiary (“BTG-Israel”), entered into a $20,000,000 revolving credit facility with Bank Hapoalim B.M. to finance a portion of the cost of completing its new production facility.  Short-term borrowings under the facility are due 12 months from the date of borrowing and long-term borrowings are due five years from the date of borrowing.  Loans under the facility bear interest at the rate of LIBOR plus 0.5% in the case of short-term borrowings and LIBOR plus 1% in the case of long-term borrowings.  Amounts repaid under the facility can be reborrowed.  The credit facility is secured by the assets of BTG-Israel and has been guaranteed by the Company.  At September 30, 2001 the Company had outstanding long-term borrowings of $20,000,000 under the facility.

BTG maintains its funds in money market funds, commercial paper and other liquid debt instruments.

BTG manages its Israeli operations with the objective of protecting against any material net financial loss in U.S. dollars from the impact of Israeli inflation and currency devaluation on its non-U.S. dollar assets and liabilities.  The cost of the Company’s operations in Israel, as expressed in dollars, is influenced by the extent to which any increase in the rate of inflation in Israel is not offset (or is offset on a lagging basis) by a devaluation of the Israeli Shekel in relation to the U.S. dollar.  The consumer price index (which is used to measure the rate of inflation) decreased approximately 0.5% in the nine months ended September 30, 2000, while the Shekel’s value in relation to the U.S. dollar increased by approximately 3%.  For the full year of 2000, the rate of inflation was unchanged while the Israeli Shekel’s value in relation to the U.S. dollar increased by approximately 3%.  In the nine months ended September 30, 2001 the consumer price index increased by 2% and the Shekel’s value in relation to the U.S. dollar decreased by approximately 8%.  As a result, for those expenses linked to the Israeli Shekel, such as salaries and rent, this resulted in corresponding increase in these costs in U.S. dollar terms in 2000 but a decrease in these costs in U.S. dollar terms in the nine months ended September 30, 2001.  To the extent that expenses in Shekels exceed BTG’s revenues in Shekels (which to date have consisted primarily of research funding from the Chief Scientist and product sales in Israel), the devaluation of Israeli currency have been and will continue to be a benefit to BTG’s financial condition.  However, should BTG’s revenues in Shekels exceed its expenses in Shekels in any material respect, the devaluation of the Shekel will adversely affect BTG’s financial condition.  Further, to the extent the devaluation of the Shekel with respect to the U.S. dollar does not substantially offset the increase in the costs of local goods and services in Israel, BTG’s financial results will be adversely affected as local expenses measured in U.S. dollars will increase.

The Company believes that its remaining cash resources as of September 30, 2001, together with anticipated product sales, scheduled payments to be made to BTG under its current agreements with pharmaceutical partners, the proceeds from sales of equity and continued funding from the Chief Scientist at current levels, will be sufficient to fund the Company’s current operations for the foreseeable future.  There can, however, be no assurance that product sales will occur as anticipated, that scheduled payments will be made by third parties, that current agreements will not be canceled, that the Chief Scientist will continue to provide funding at current levels, or that unanticipated events requiring the expenditure of funds will not occur.  The satisfaction of the Company’s future cash requirements will depend in large part on the status of commercialization of the Company’s products, the Company’s ability to enter into additional research and development and licensing arrangements, and the Company’s ability to obtain additional equity investments, if necessary.  There can be no assurance that the Company will be able to obtain additional funds or, if such funds are available, that such funding will be on favorable terms.

Market Risk

Market risk is the exposure to loss resulting from changes in interest rates, foreign currency exchange rates, commodity prices and equity prices.  To date BTG’s exposure to market risk has been limited and it is not currently hedging any market risk, although it may do so in the future.  BTG does not hold or issue any derivative financial instruments for trading or other speculative purposes.

BTG’s obligations under its $20,000,000 revolving credit facility bear interest at floating rates and, therefore, BTG is impacted by changes in prevailing interest rates.  A 100 basis point increase in market interest rates on the $20,000,000 outstanding under this facility at September 30, 2001 would result in an increase in its annual interest expense of $200,000.  Because these borrowings relate to the construction of BTG’s new facility, interest expense is currently being capitalized.


 

BTG’s material interest bearing assets consist of cash and cash equivalents and short–term investments consisting primarily of investments in commercial papers, time deposits and mutual funds which invest in short–term instruments.  BTG’s interest income is sensitive to changes in the general level of interest rates, primarily U.S. interest rates and other market conditions.

 As discussed above under “Liquidity and Capital Resources,” BTG manages its Israeli operations with the objective of protecting against any material net financial loss in U.S. dollars from the impact of Israeli inflation and currency devaluation on its non–U.S. dollar assets and liabilities.  All of BTG’s revenues are in U.S. dollars except for payments from the Chief Scientist and sales of its products in Israel, which are denominated in Israeli Shekels.

 

Part  II. OTHER INFORMATION

 

Item 5.    Other Information

In September 2001, the United States Court of Appeals for the Federal Circuit reinstated a Genentech, Inc. patent relating to a method for producing recombinant human growth hormone (“hGH”) and a preliminary injunction against BTG’s product made by a particular process.  The Genentech patent was invalidated on January 18, 2000, following a trial to a jury in the United States District Court for the Southern District of New York.  The Federal Circuit did not decide the issue of infringement by BTG of the reinstated patent.  BTG has requested a rehearing before the full Court of Appeals.  BTG has never used the expression system charged with infringement in the Genentech litigation to manufacture hGH for U.S. sale.  Moreover, BTG has developed a new expression system for our hGH that was approved by the FDA in 1999.  Genentech has never contended that this new expression system infringes any of its patents.  BTG plans to manufacture any hGH intended for the U.S. market using this alternate expression system.  BTG has requested a rehearing before the full Court of Appeals.  BTG is currently engaged in a patent interference action with Novo Nordisk which, if adversely determined, could adversely affect BTG’s ability to sell in the U.S. market hGH manufactured using this alternate expression system.

 

Item 6.

 

Exhibits and Reports on Form 8-K

 

 

 

 

 

(1)

Exhibits

 

 

 

 

 

 

 

 

None

 

 

 

 

 

 

(2)

Reports on Form 8-K

 

 

 

 

 

 

 

 

None

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

BIO-TECHNOLOGY GENERAL CORP.

 

 

 

                (Registrant)

 

 

 

 

 

 

 

By:

/s/ Sim Fass

 

 

Sim Fass

 

 

Chairman and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

/s/ John Bond

 

 

John A. Bond

 

 

Senior Vice President-Finance and Treasurer

 

 

(Principal Financial and Accounting Officer)

Dated: November 12, 2001