LIPOSOME CO INC
10-Q, 1999-11-05
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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S E C U R I T I E S   A N D   E X C H A N G E   C O M M I S  ;S I O N

 

Washington, D. C.  20549

 

FORM 10-Q

 

Quarterly Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

For the Quarterly Period ended October 3, 1999

 

Commission file number  0-14887

 

T H E   L I P O S O M E   C O M P A N Y,   I N C.

(Exact name of registrant as specified in its charter)

 

 

           Delaware            

(State or other jurisdiction of

incorporation or organization)

 

 

  22-2370691  

(IRS Employer

Identification No.)

 

One Research Way, Princeton Forrestal Center, Princeton, N.J.  08540

(Address of principal executive offices)                  (Zip Code)

 

Registrant's telephone number, including area code:

  (609) 452-7060  

 

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     X           No           

 

The number of shares outstanding of each of the issuer's classes of Common Stock as of the latest practicable date:

Class

Common Stock, $.01 par value

October 26, 1999

39,156,861

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

 

PAGE NO.

Part I.  FINANCIAL INFORMATION    

         ITEM 1 - Financial Statements

         Consolidated Balance Sheets as of

         October 3, 1999 and January 3, 1999

 

         Consolidated Statements of Operations

         For the Three and Nine Month Periods Ending

         October 3, 1999 and September 27, 1998

 

 

         Consolidated Statements of Cash Flows

         for the Nine Month Periods Ending

         October 3, 1999 and September 27, 1998

 

 

         Notes to Consolidated Financial Statements

6-9 

         ITEM 2

         Management's Discussion and Analysis of Financial

         Condition and Results of Operations

 

10-18 

Part II. OTHER INFORMATION

19 

Signatures

20 

 

*********************************************************

 

Note concerning trademarks:  

Certain names mentioned in this report are trademarks owned by The Liposome Company, Inc. or its affiliates or licensees.  ABELCET® is a registered trademark of The Liposome Company, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 2 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

ASSETS

   

Current assets:

 10/3/99  

 1/3/99  

  Cash and cash equivalents

$ 17,983 

$  8,074 

  Short-term investments

  44,403 

  34,339 

  Accounts receivable, net of allowance for doubtful

    accounts ($789 for 1999, $579 for 1998)

   

4,183 

   

5,340 

  Inventories

   7,185 

   5,566 

  Prepaid expenses

     784 

   1,266 

  Other current assets

     560 

     560 

       Total current assets

  75,098 

  55,145 

     

 

Property, plant and equipment, net

  20,786 

  23,165 

Restricted cash

   5,522 

  11,930 

Intangibles, net

     306 

     334 

       Total assets

$101,712 

$ 90,574 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

Current liabilities:

 

    Accounts payable

$  3,983 

$   3,991 

    Accrued expenses and other current liabilities

   8,031 

    7,357 

    Current obligations under capital leases

   2,234 

    2,093 

    Current obligations under note payable

     -- 

      303 

       Total current liabilities

  14,248 

   13,744 

     

 

Long-term obligations under capital leases

   2,816 

    4,509 

Long-term obligations under note payable

     -- 

      580 

       Total liabilities

 17,064 

   18,833 

Commitments and contingencies

 

Stockholders' equity:

 

Capital stock:

 

  Common Stock, par value $.0l; 120,000 shares authorized;

    39,076 and 38,327 shares issued and outstanding

     

392 

     

383 

Additional paid-in capital

 270,626 

 265,254 

Treasury Stock at cost

    (950)

      -- 

Accumulated other comprehensive loss

    (163)

    (366)

Accumulated deficit

(185,257)

(193,530)

       Total stockholders' equity

  84,648 

  71,741 

   

       Total liabilities and stockholders' equity

$101,712 

$ 90,574 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.

Page 3 of 20

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands except per share data)

(Unaudited)

 

 

Three Months Ended

Nine Months Ended

 

10/3/99

9/27/98

10/3/99

9/27/98

Product sales

$ 21,801 

$ 17,638 

$ 63,060

$ 52,885 

Interest, investment and other income

   1,615 

  1,009 

4,788 

   3,081 

     Total revenues

  23,416 

 18,647 

 67,848 

 55,966 

Cost of goods sold

   5,069 

  5,220 

14,855 

  15,243 

Research and development expense

   7,063 

  5,520 

20,084

  21,293 

Selling, general and administrative

  expense

   

7,760 

   

8,027 

23,894 

  

25,063 

Interest expense

     133 

     188 

    442 

     599 

     Total expenses

  20,025 

  18,955 

59,275 

62,198 

Income/(loss)before taxes

$  3,391 

$   (308)

$ 8,573

$ (6,232)

Provision for income taxes

     300 

--

    300 

--

Net income/(loss)

$  3,091 

$ (308)

$  8,273 

$ (6,232)

Net income/(loss) per share (basic)

$   0.08 

$  (0.01)

$   0.21 

$  (0.16)

Net income/(loss) per share (diluted)

$   0.08 

$  (0.01)

$   0.21 

$  (0.16)

Weighted average number of shares

outstanding (basic)

 

  38,958 

  38,050 

  38,648 

  37,963 

Weighted average number of shares

outstanding (diluted)

 

  40,587 

  38,050 

  40,203 

  37,963 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.

Page 4 of 20

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

    

     

  Nine Months Ended  

 10/3/99 

 9/27/98 

Cash flows from operating activities:

     

   

   Net income/(loss)

$ 8,273 

$(6,232)

   Adjustments to reconcile net income/(loss) to net

     cash provided by operating activities:

 

     Depreciation and amortization

3,137 

4,529 

Provision for bad debts

210

302

     Other

2,131 

 1,721 

     Changes in assets and liabilities

 

          Accounts receivable

947

442

          Inventories

(1,619)

  5,223 

          Prepaid expenses

482 

 86 

          Other current assets

-- 

  (347) 

          Accounts payable

(8) 

  (416)

          Accrued expenses and other current liabilities

     674 

   1,033 

     

 

     Net cash provided by operating activities

  14,227 

   6,341 

     

Cash flows from investing activities:

     

 

  Purchases of short- and long-term investments

(41,144)

(8,315)

  Sales of short- and long-term investments

30,818 

 13,694 

  Restricted cash

6,408 

     -- 

  Purchases of property, plant and equipment

(1,256)

  (1,288)

     

 

     Net cash (used)/provided by investing activities

  (5,174)

   4,091 

     

Cash flows from financing activities:

     

 

  Exercises of stock options

3,776 

   63 

  Purchase of Treasury Stock

(950)

-- 

  Principal payments under note payable

(883)

   (227)

  Principal payments under capital lease obligations

  (1,552)

  (1,424)

     

 

     Net cash provided/(used) by financing activities

     391 

  (1,588)

     

 

Effects of exchange rate changes on cash

     465 

   80 

     

 

Net increase in cash and cash equivalents

   9,909 

   8,924 

     

 

Cash and cash equivalents at beginning of the period

   8,074 

  15,236 

     

 

Cash and cash equivalents at end of the period

$ 17,983 

$ 24,160 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.

Page 5 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1.  Basis of Presentation

The information presented at October 3, 1999, and for the three and nine month periods then ended is unaudited, but includes all adjustments (consisting only of normal recurring accruals) that management at The Liposome Company, Inc. (the "Company") believes to be necessary for the fair presentation of results for the periods presented.  The January 3, 1999 balance sheet was derived from audited financial statements. These financial statements should be read in conjunction with the Company's audited financial statements for the year ended January 3, 1999, which were included as part of the Company's Annual Report on Form 10-K.  Certain reclassifications may have been made to the prior year financial statement amounts to conform with the presentation in the current year financial statements.

 

2.  Common Stock Outstanding and Per Share Information

The basic earnings per share calculation is based upon the weighted average number of common shares outstanding during a period.  The diluted earnings per share calculation is based upon the weighted average number of common shares outstanding and the dilutive common stock equivalents outstanding during a period.  Common stock equivalents are outstanding options under the Company's stock option plans and outstanding warrants.

Below is summary of the shares used in calculating basic and diluted earnings per share.

    

    Three Months Ended    

  10/3/99  

  9/27/98  

     Weighted average number of shares of 

      common stock outstanding

38,958,000 

38,050,000 

     Dilutive stock options and warrants

  1,629,000 

         -- 

     

     Shares used in calculating

      diluted earnings per share

 

 40,587,000 

 

 38,050,000 

     

 

     Nine Months Ended     

  10/3/99  

  9/27/98  

     Weighted average number of shares of 

      common stock outstanding

 38,648,000 

37,963,000 

     Dilutive stock options and warrants

  1,555,000 

        -- 

     

     Shares used in calculating

      diluted earnings per share

 40,203,000 

 37,963,000 

Weighted average number of shares of common stock outstanding for the three and nine month periods ended October 3, 1999 and September 27, 1998, increased by 908,000 and 685,000 shares, respectively.  The increases are primarily due to the impact of the exercises of stock options, issuance of restricted stock, 401(K) contributions, partially offset by the purchase of treasury stock.

On April 23, 1997, the Company issued 1,000,000 shares at $20.875 per share to a private investor for cash of $20,875,000.  At October 26, 1999, this investor has reported total holdings of approximately 22.85% of the Company's outstanding Common Stock.

 

 

 

 

 

Page 6 of 20

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

2.  Common Stock Outstanding and Per Share Information (continued)

Options and warrants to purchase 5,238,493 shares of Common Stock at a range of $1.19 to $27.63 per share were outstanding at October 3, 1999.  These options and warrants expire on various dates from November 30, 1999 to September 27, 2009.  Options and warrants to purchase 260,250 and 265,250 of shares of common stock were excluded from the diluted earnings per share calculation for the three and nine month periods ended October 3, 1999 respectively, as their effect would have been anti-dilutive.

Common Stock equivalents were not included in the computation of diluted earnings per share for the prior year period ended September 27, 1998 because the effect would be anti-dilutive to the net loss.

 

3.  Comprehensive Income

The following table details "Comprehensive Income" as defined in Statement of Financial Standards ("SFAS") No. 130 for the three and nine month periods ended October 3, 1999 and September 27, 1998.

    

     

  Three Months Ended  

  10/3/99 

  9/27/98 

Net income/(loss)

$ 3,091 

$  (308) 

Other comprehensive income/(expenses):

 

     Net unrealized investment (loss)/gain

   (30)

 1

     Foreign currency translation adjustment

 267 

   186 

     

Comprehensive net income/(loss)

$ 3,328 

$  (121) 

     

     

     

     

  Nine Months Ended  

10/3/99

9/27/98

Net income/(loss)

$  8,273 

$  (6,232)

Other comprehensive income/(expenses):

   

     Net unrealized investment (loss)/gain

   (262)

98

     Foreign currency translation adjustment

     465 

  80  

     

Comprehensive net income/(loss)

$ 8,476 

$ (6,054)

 

4.  Inventories

Inventories are carried at the lower of actual cost or market and cost is accounted for on the first-in first-out (FIFO) basis.  The components of inventories are as follows:

     

     

October 3,

    1999     

January 3,

    1999    

     Finished goods

$3,627,000 

$2,710,000 

     Work in process

  487,000 

 1,271,000 

     Raw materials

 2,832,000 

 1,374,000 

     Supplies

   239,000 

   211,000 

     

$7,185,000 

$5,566,000 

 

 

 

 

 

 

 

 

 

Page 7 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

5.  Supplemental Disclosure of Cash Flow Information

 

  Nine Months Ended:  

     

 10/3/99

 9/27/98

     

     Cash paid during the year for interest

$481,000 

$654,000 

6.  Legal Proceedings

The Company is a party in an adversarial proceeding filed in the United States Bankruptcy Court in Delaware by a chapter 7 bankruptcy trustee for the estate of the FoxMeyer Corporation, et al.  The complaint seeks to avoid and recover purported preferential transfers pursuant to 11 U.S.C. Sec. 547 and Sec. 550 from the Company in the amount of $2.3 million.  The Company believes it has meritorious defenses regarding this claim.

The Company is currently a party to various other legal actions arising out of the normal course of business, none of which are expected to have a material effect on the Company's financial position or results of operations.  

 

7.  Geographic Segment Data

The Company's biopharmaceutical operations are classified into two geographic areas: Domestic (United States) and International (primarily Western Europe and Canada).  Financial data (in thousands of dollars) for the three and nine months of 1999 and 1998 is as follows:

1999:

Three Months Ended October 3, 1999

 

Domestic

International

  Total  

Sales to unaffiliated customers

$ 17,823 

$ 3,978

$ 21,801 

Interest, investment and other income/(expense).

   1,720 

    (105)

   1,615 

       

     Total revenue

$ 19,543 

$   3,873_

$ 23,416 

   

Net income

$  3,091 

$   --

$  3,091 

Nine Months Ended October 3, 1999

 

Domestic

International

  Total  

Sales to unaffiliated customers

$ 50,906 

$ 12,154 

$ 63,060 

Interest, investment and other income/(expense).

   4,992 

   (204)

   4,788 

       

     Total revenue

$ 55,898 

$ 11,950 

$ 67,848 

Net income/(loss)

$  8,747 

$  (474)

$  8,273 

   

Identifiable assets at October 3, 1999

$ 96,739 

$  4,973 

$101,712 

 

 

 

 

 

 

 

 

 

 

 

 

Page 8 of 20

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

 

1998:

Three Months Ended September 27, 1998

 

Domestic

International

  Total  

Sales to unaffiliated customers

$ 14,361 

$  3,277 

$ 17,638 

Interest, investment and other income

   1,000 

     9 

   1,009 

       

     Total revenue

$ 15,361 

$  3,286 

$ 18,647 

       

Net loss

$   (214)

$   (94)

$   (308)

Nine Months Ended September 27, 1998

 

Domestic

International

  Total  

Sales to unaffiliated customers

$ 42,555 

$ 10,330 

$ 52,885 

Interest, investment and other income

   3,068 

      13 

   3,081 

       

     Total revenue

$ 45,623 

$ 10,343 

$ 55,966 

       

Net loss

$ (4,336)

$ (1,896)

$ (6,232)

       

Identifiable assets at September 27, 1998

$ 81,603 

$  4,930 

$ 86,533 

 

8.  Major Customer Revenue Data

In the United States, the Company sells ABELCET® primarily to national and regional wholesalers who in turn re-sell the product to hospitals and other service providers.  Internationally, sales are primarily made directly to marketing partners pursuant to marketing/distribution agreements with the Company who then re-sell the product to hospitals.

For the nine months ended October 3, 1999 and September 27, 1998 sales to wholesalers or other customers in excess of 10% of the Company's product revenues in any period were as follows:

 

    

Nine Months Ended

     

October 3, 1999

September 27, 1998

Customer A

21%

21%

Customer B

21%

23%

Customer C

13%

15%

Customer D

13%

13%

Customer E

10%

8%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 9 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

The following discussion may contain trend information and other forward-looking statements.  The Company's actual results could differ materially from the Company's historical results of operations and those discussed in the forward-looking statements.  Factors that could cause actual results to differ materially include, but are not limited to, those identified in "Certain Risk Factors."  All period references are to the Company's three and nine month periods ended October 3, 1999 and September 27, 1998 and the fiscal year ended January 3, 1999, unless otherwise indicated.  All per share amounts are presented on a diluted basis unless otherwise stated.

The following discussion and analysis should be read in conjunction with the Financial Statements and related notes thereto contained elsewhere herein, as well as the Company's 1998 Form 10-K and from time-to-time the Company's other filings with the Securities and Exchange Commission.

Overview

The Liposome Company, Inc. (the "Company") is a biopharmaceutical company engaged in the discovery, development, manufacturing and marketing of proprietary lipid- and lipid-based pharmaceuticals, primarily for the treatment of cancer and other related life-threatening illnesses. ABELCET® (Amphotericin B Lipid Complex Injection), the Company's first commercialized product, has been approved for marketing for certain indications in the United States and 24 foreign markets and is the subject of marketing application filings in several other countries.  In the United States, ABELCET® has been approved for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy.  International approvals have been received for primary and/or refractory treatment of these infections.  Currently all product sales are derived from ABELCET®.

The Company markets ABELCET® in the U.S. and Canada, with its own sales force.  For other countries, the Company's general strategy is to market ABELCET® through marketing partners.  Specific marketing partnerships are determined on a country-by-country basis.  In addition, sales are realized on a "named patient" basis in certain countries where marketing approvals have not yet been received. On August 31, 1999, the Company received approval from the U.S. Food and Drug Administration ("FDA") for a new vial size of ABELCET®, which was launched in late September 1999. The ABELCET® 50 milligram size is also available in the UK and Spain, with additional approvals forthcoming. Previously, ABELCET® was only available in the 100-milligram vial size. The 50 milligram size is expected to provide economies in dosing for hospitals, particularly for pediatric patients.

The Company is developing EVACETTM (formerly TLC D-99), liposomal doxorubicin, as a treatment for metastatic breast cancer and potentially other cancers. Three Phase III clinical studies of EVACETTM have been completed by the Company. The Company filed a New Drug Application ("NDA") for EVACETTM with the FDA in December 1998. The Company has also filed for marketing clearance of EVACETTM in the European Union and Canada in June 1999 and July 1999, respectively. On September 16, 1999, the Oncologic Drugs Advisory Committee ("ODAC") to the FDA found that there was not sufficient evidence to recommend for approval the Company's NDA for EVACETTM for the first-line treatment of metastatic breast cancer in combination with cyclophosphamide. After consulting with the FDA, the Company, on October 14, 1999, announced that it was withdrawing its original NDA for EVACETTM. The Company plans a resubmission of the NDA by the end of this year and will address the issues raised by the ODAC panel.

 

 

 

 

 

 

Page 10 of 20

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Overview (continued)

On October 20, 1999, The Liposome Company's Board of Directors enlarged the Board from 9 to 10 Directors and elected Kenneth E. Johns, Jr. to fill the open position. Mr. Johns is engaged in the private practice of law in Dallas, Texas and is a Special Assistant to the President of Ross Financial Corporation. Ross Financial Corporation is the holder of approximately 22.85% of the Company's stock.

During August 1999, the Company announced it had entered into clinical trial collaborations with Bristol-Myers Squibb ("BMS") and Rhone-Poulenc Rorer Pharmaceuticals, Inc. ("RPRP"). The clinical trial with RPRP is designed to evaluate the safety of EVACETTM in combination with Taxotere® (docetaxel) for the treatment of metastatic breast cancer. The clinical trial collaboration with BMS is designed to evaluate the safety of EVACETTM in combination with Taxol® (paclitaxel) for the treatment of patients with metastatic breast cancer.

On October 27, 1998 the Company announced that the FDA had cleared its Investigational New Drug application for TLC ELL-12 (liposomal ether lipid).  A Phase I clinical trial has been designed to enroll adult patients with advanced solid tumors.  Patient enrollment for this trial commenced in February 1999.

The Company has a continuing discovery research program concentrating on oncology treatment and has a number of products in research.  These products include: the bromotaxols (hydrophobic derivatives of paclitaxel), some of which have shown anticancer activity in several experimental models; ceramides and sphingosines (molecules widely implicated in cell differentiation and apoptosis) certain of which the Company has identified as displaying anticancer activity; and fusogenic liposomes (liposomes specifically designed to fuse to cell membranes), which the Company hopes to use for the efficient delivery of genes to their intended targets.

On April 22, 1998 the Company announced it had entered into a three year contract manufacturing agreement with Astra USA, Inc. ("Astra").  The Company is processing and packaging Astra's M.V.I.®-12 Unit Vial, an injectable multi-vitamin product used by severely ill, hospitalized patients in need of nutritional supplements.  The product is processed and packaged at the Company's Indianapolis facility, taking advantage of its modern, large-scale capabilities.  Under the terms of the agreement, Astra supplies bulk quantities of the vitamin product and the Company sterilizes, fills, packages and performs quality control on M.V.I.®-12 Unit Vial.  

Results of Operations

Revenues

  • Three Months Ended October 3, 1999:

Total revenues for the three months ended October 3, 1999 were $23,416,000 an increase of $4,769,000 or 25.6% compared to $18,647,000 for the quarter ended September 27, 1998.  The primary components of revenues for the Company are product sales of ABELCET® and interest, investment and other income.

Net product sales of ABELCET® for the third quarter ended October 3, 1999 were $21,801,000 compared to $17,638,000 for the third quarter of 1998.  The sales increase of $4,163,000 or 23.6%, is due primarily to higher U.S. and international sales volume.  Unit shipments of ABELCET® worldwide increased by 20.3% over the comparable prior year period.

 

 

 

Page 11 of 20

 

 

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Results of Operations (Continued)

Domestic sales in the third quarter of 1999 were $17,823,000, an increase of $3,462,000 or 24.1% from the comparable prior year period, while unit shipments increased 21.9%. The strong growth is due to the continued market penetration resulting from the successful impact of the tiered pricing program and expansion into the generic amphotericin B marketplace as patients use more drug and are treated for longer periods of time. Based on the latest independent market data available, ABELCET® continues to hold the largest share of the lipid based amphotericin B products sold in the U.S. During 1997, the Company instituted a tiered pricing program by offering discounts to high volume purchasers.  The price reduction is affected by chargebacks paid to wholesalers based on their sales at contract prices to targeted hospitals.  The Company provides a reserve for the impact on sales for rebates and chargebacks and periodically evaluates the estimates used in establishing the reserve. The provision for the three months ended October 3, 1999 was approximately $9,100,000. During September 1999, the Company received FDA marketing clearance and launched a new ABELCET® vial size (50 milligram), which contributed to the U.S. sales increase. The Company expects that this new vial size will encourage more cost-effective utilization of ABELCET® and increase penetration into the market, particularly for pediatric patients.

International product sales were $3,978,000 in the third quarter of 1999 versus $3,277,000 in the third quarter of 1998, an increase of $701,000 or 21.4%, while unit volume increased by 14.4%.  The increase in revenue is primarily due to ABELCET® sales growth in Canada, Australia and Turkey.

Interest, investment and other income for the three months ended October 3, 1999 and September 27, 1998 were $1,615,000 and $1,009,000, respectively.  The increase of $606,000 or 60.1% is primarily due to higher cash balances available for investment during the third quarter of 1999 and the realization of revenues from contract manufacturing activities which were initiated during 1999.

  • Nine Months Ended October 3, 1999:

Total revenues for the nine months ended October 3, 1999 were $67,848,000 an increase of $11,882,000 or 21.2% compared to $55,966,000 for the nine months ended September 27, 1998.  The primary components of revenues for the Company are product sales of ABELCET® and interest, investment and other income.

Net product sales of ABELCET® for the nine months ended October 3, 1999 were $63,060,000 compared to $52,885,000 for the nine months of 1998.  The sales increase of $10,175,000 or 19.2%, is primarily due to higher U.S. and international sales volume.  Unit shipments of ABELCET® worldwide increased by 22.2% over the comparable prior year period.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Results of Operations (Continued)

Domestic sales in the nine months of 1999 were $50,906,000, an increase of $8,351,000 or 19.6% from the comparable prior year period, while unit shipments increased 21.1%. The strong growth is due to the continued market penetration resulting from the successful impact of the tiered pricing program and expansion into the generic amphotericin B marketplace as patients use more drug and are treated for longer periods of time. Based on the latest independent market data available, ABELCET® continues to hold the largest share of the lipid based amphotericin B products sold in the U.S. During 1997, the Company instituted a tiered pricing program (as previously discussed with respect to the three months ended October 3, 1999). The Company provides a reserve for the impact on sales for rebates and chargebacks and periodically evaluates the estimates used in establishing the reserve. The provision for the nine months ended October 3, 1999 was approximately $28,660,000. During September 1999, the Company received FDA marketing clearance and launched a new ABELCET® vial size (50 milligram), which contributed to the U.S. sales increase. The Company expects that this new vial size will encourage more cost-effective utilization of ABELCET® and increase penetration into the market, particularly for pediatric patients.

International product sales were $12,154,000 in the nine months of 1999 versus $10,330,000 in the comparable prior year period, an increase of $1,824,000 or 17.7%.  The increase is primarily due to ABELCET® sales growth in Canada, Europe and Australia.  While international sales revenues increased by 17.7%, unit volume increased by 26.7%.  The principal reason for this difference is the shift of sales from end users (direct distribution) to marketing partners.

Interest, investment and other income for the nine months ended October 3, 1999 and September 27, 1998 were $4,788,000 and $3,081,000, respectively.  The increase of $1,707,000 or 55.4% is primarily due to the realization of revenues from contract manufacturing activities during 1999, receipt of payments from Gilead Sciences, Inc. ("Gilead") (formerly NeXstar Pharmaceuticals, Inc.) as part of the settlement of patent litigation and the availability of higher cash balances for investment during the nine month period.

Expenses

-  Three Months Ended October 3, 1999:

The components of total expenses for the three months ended October 3, 1999 were cost of goods sold, research and development, selling, general and administrative and interest expense. Total expenses for the quarter ended October 3, 1999 were $20,025,000, an increase of $1,070,000 from the comparable prior year period.

Cost of goods sold for the quarter ended October 3, 1999 was $5,069,000 or $151,000 lower than the comparable prior year period.  The decrease is attributable to lower production costs for ABELCET® resulting from manufacturing efficiencies at the Indianapolis manufacturing facility, improved yields due to the implementation of certain process enhancements and lower unit overhead absorption related to the contract manufacturing business.  Partially offsetting the reduction in cost of goods is the impact of higher sales unit volume.  Gross margin in the 1999 period was 76.7% compared to 70.4% in the 1998 period, an improvement of 6.3 percentage points.  This improvement is due to the manufacturing efficiencies discussed above.

 

 

 

 

 

 

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THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Results of Operations (Continued)

Research and development expense was $7,063,000 for the third quarter of 1999, compared to $5,520,000 for the prior year period. The increase of $1,543,000 or 28.0% is primarily due to costs associated with the preparation for the ODAC meeting for EVACETTM in September and increased research and development activity for other projects in the Company's developmental pipeline.

Selling, general and administrative expenses for the quarter ended October 3, 1999 were $7,760,000 compared to $8,027,000 in the 1998 period.  The primary reason for the decrease is due to the lower depreciation and insurance charges in the 1999 quarter, partially offset by costs associated with pre-launch marketing and planning expenses related to EVACETTM during the third quarter of 1999.

Interest expense was $133,000 in the third quarter of 1999 and $188,000 in the third quarter of 1998.  Interest expense is related to capital leases for the Princeton and Indianapolis manufacturing equipment. The decrease is related to the payoff of the mortgage on the Indianapolis land and building as well as the overall reduction in the debt outstanding on capital leases.

-  Nine Months Ended October 3, 1999:

The components of total expenses for the nine months ended October 3, 1999 were cost of goods sold, research and development, selling, general and administrative and interest expense. Total expenses for the nine months ended October 3, 1999 were $59,275,000, a decrease of $2,923,000 from the comparable prior year period.

Cost of goods sold for the nine months ended October 3, 1999 was $14,855,000 or $388,000 lower than the comparable prior year period.  The decrease is attributable to lower production costs for ABELCET® resulting from manufacturing efficiencies at the Indianapolis facility, improved yields due to the implementation of certain process enhancements and lower unit overhead absorption related to the contract manufacturing business.  Partially offsetting the reduction in the cost of goods is the impact of higher sales unit volume.  Gross margin in the 1999 period was 76.4% compared to 71.2% in the 1998 period, an improvement of 5.2 percentage points.  This improvement is due to the manufacturing efficiencies discussed above.

Research and development expense was $20,084,000 for the nine months of 1999, compared to $21,293,000 for the prior year period. The reduction of $1,209,000 or 5.7% is primarily due to the completion of the Phase III clinical trials of EVACETTM for which the Company filed a NDA with the FDA in December 1998, partially offset by increased research and development activity for other projects in the Company's developmental pipeline and costs associated with the preparation for the ODAC meeting for EVACETTM in September.

Selling, general and administrative expenses for the nine months ended October 3, 1999 were $23,894,000 compared to $25,063,000 in 1998 period.  The primary reason for the decrease of $1,169,000 is due to the shift in European selling and marketing activities to marketing partners and the resulting reduction of international selling and marketing costs, partially offset by costs associated with pre-launch marketing and planning expenses for EVACETTM.

Interest expense was $442,000 in the nine months of 1999 and $599,000 in the comparable 1998 period.  Interest expense is related to capital leases for the Princeton and Indianapolis manufacturing equipment. The decrease is primarily related to the payoff of the mortgage on the Indianapolis land and building in the third quarter of 1999 as well as the overall reduction in the debt outstanding on capital leases.

 

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THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Results of Operations (Continued)

Tax Provision

During the third quarter of 1999, the Company recorded a provision for taxes of $300,000 resulting from the application of the Federal Alternative Minimum Tax ("AMT") rules and Statement of Financial Standards No.109, Accounting for Income Taxes. Under AMT regulations, the Company's net operating losses cannot be fully utilized to offset the tax liability.

Net Income/ (Loss) and Net Income/ (Loss) per Share

Net income for the third quarter of 1999 was $3,091,000 or $0.08 per share (basic & diluted) compared to a net loss of ($308,000) or ($0.01) per share (basic and diluted) for the third quarter of 1998. Net income for the nine months ended October 3, 1999 was $8,273,000 or $0.21 per share (basic & diluted) compared to a net loss of ($6,232,000) or ($0.16) per share (basic and diluted) for the nine months ended September 27, 1998.  The number of shares of Common Stock used in 1999 included contingently issuable shares since the Company reported a net income in this period.  The Company did not include such shares in the 1998 period as the inclusion would have been anti-dilutive.

Liquidity and Capital Resources

The Company had $67,908,000 in cash, restricted cash and marketable securities as of October 3, 1999. Included in this amount were cash and cash equivalents of $17,983,000, short-term investments of $44,403,000 and restricted cash of $5,522,000.  The Company invests its cash reserves in a diversified portfolio of high-grade corporate marketable and United States Government-backed securities.

Cash and marketable securities (both short-term and restricted cash) increased $13,565,000 from January 3, 1999 to October 3, 1999.  The primary components of the favorable impact on cash flow for the nine months was net income (net of depreciation, amortization and other non-cash charges) of $13,541,000 and stock option exercises of $3,776,000. The major uses of funds were payments on the capital lease, payoff of the note payable totaling $2,435,000 and the buildup of inventory of $1,619,000.

Inventories at October 3, 1999 increased $1,619,000 from January 3, 1999, primarily due to the building of raw material levels to meet current manufacturing demand and to ensure an adequate supply of key ingredients.

In July 1993, the Company entered into a capitalized lease financing agreement for certain manufacturing equipment providing for an initial lease term followed by options to extend the lease, or to return or purchase the equipment.  In December 1996, the agreement was amended to include an additional $6,101,000 of manufacturing equipment.  In November 1997 and January 1998, the Company exercised its options to purchase certain manufacturing equipment under the original 1993 lease for $1,583,000 and $495,000, respectively.  These amounts have been refinanced as a capital lease obligation under the lease agreement for a three-year period.  The lease is collateralized by $3,748,000 in a standby letter of credit which is in turn collateralized by AAA rated securities owned by the Company.  Pursuant to the December 1996 lease amendment, the Company is required to maintain a minimum balance of $25,000,000 in cash and marketable securities, including those securities collateralizing the letters of credit.  In addition, the Company completed an U.S. working capital revolving credit line agreement in early 1997, with a maximum capacity of $14,000,000.  All borrowings must be secured by approved accounts receivable and finished goods inventories.  There have been no advances made against this line through the date of this report.

 

Page 15 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Results of Operations (Continued)

On July 14, 1997, the Company reacquired all development, manufacturing and marketing rights to EVACETTM from Pfizer Inc ("Pfizer").  As part of the agreement, the Company has obtained from Pfizer a credit line of up to $10,000,000 to continue the development of EVACETTM.  To the extent that any funding is actually used by the Company, the outstanding principal and interest would be repayable on the earlier of 180 days after FDA clearance to market EVACETTM or in twenty quarterly installments commencing July 14, 2002. Pfizer at its option may elect to receive payment in the form of shares of Common Stock. At the end of the third quarter of 1999, there were no borrowings under this facility.

The Company had a mortgage-backed note to partially fund the purchase of the Indianapolis manufacturing facility.  The Company paid off the remaining principal balance and interest in the third quarter of 1999.

On April 23, 1997 the Company issued 1,000,000 shares of Common Stock at $20.875 per share to a private investor for cash of $20,875,000. At October 26, 1999, this investor has reported total holdings of approximately 22.85% of the Company's outstanding shares of Common Stock.

The Company expects to finance its operations and capital spending requirements from, among other things, the proceeds received from product sales, interest earned on investments and the proceeds from maturity or sale of certain investments.  Cash may also be provided to the Company by leasing arrangements for capital expenditures, financing of receivables and inventory under its line of credit, a line of credit from a former licensing partner, the licensing of its products and technology and the sale of equity or debt securities.  The Company believes that its product revenues and revenues from other sources, coupled with its available cash and marketable securities reserves, will be sufficient to meet its expected operating and capital cash flow requirements for the intermediate term.

Year 2000 Compliance

The Year 2000 computer issue ("Y2K") refers to a condition in computer software where a two-digit field rather than a four-digit field is used to distinguish a calendar year.  For example, 1998 would be stored as "98", rather than "1998".  The basic problem is that when the year changes from 1999 (99) to the year 2000 (00), some computer programs will be unable to distinguish the correct date.  Such a situation could significantly interfere with the conduct of the Company's business, disrupt its operations and materially impact its financial condition.

In order to address this situation, the Company has conducted a Year 2000 assessment of its core business information systems including a wide variety of other information systems and related business processes (hereinafter, collectively referred to as the "Systems") used in its operations.  The goal of the assessment was to identify and determine the Y2K readiness of the Company's Systems. The task of assessing the Systems from a Y2K readiness perspective has been accomplished. Accordingly, the Company has developed a comprehensive remediation plan and scheduled the necessary hardware, software, and sub-component upgrades to remediate non-Y2K compliant systems.  The Systems investigated were categorized into the following three areas:

 

 

 

 

 

 

 

 

Page 16 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Results of Operations (Continued)

The first category involves the traditional management information systems that include computers, telecommunication devices, application software, operating system software, and related peripherals. Due to the fact that the majority of the Systems installed and in use at the Company are new and utilize current technologies, the effort and expense to bring these Systems into Y2K compliance will not be material. Overall estimated costs for Systems remediation is expected to be less than $100,000. A portion of this estimate, $50,000, is for the replacement or upgrade of components that are, or would have been, included in 1999 and 2000 capital budgets but have been accelerated due to the Y2K issue. Approximately two thirds of the estimated $100,000 cost has already been expended to make the required hardware and software upgrades. All remaining tasks will be completed during the fourth quarter.

The second category involves manufacturing and facility systems including machines and devices used to manufacture, store, and test the Company's product.  It also includes the systems that control and monitor the Company's facilities such as HVAC, fire suppression, and elevators.  Equipment used in the manufacture and storage of product has been reviewed with regard to Y2K readiness.  Again, because of the absence of older legacy systems, a minimal amount of effort was required to make these systems compliant. Of the systems reviewed, substantially all were found to be compliant with no remedial actions required. The cost associated with bringing non- compliant equipment up to standard was less than $30,000.

The third category involves research systems including computer-controlled devices, calibration equipment, and similar instruments.  A review of the research systems equipment found the majority of the computers and laboratory equipment to be Y2K compliant.  The cost of replacing non-Y2K ready equipment was $30,000 and has been completed.

In addition to the assessment of the Systems, key suppliers and customers have been identified.  A survey form was developed and has been sent to each of these business entities in order to determine if their systems are Y2K compliant.  This is significant since delays in the shipment and receipt of critical supplies can impact the Company's production.  Problems would also exist if customers become unable to pay for the Company's product (e.g., their accounts payable system fails) or if they cannot electronically order, store, or track product in compliance with FDA requirements.  The Company is proactively addressing the Y2K issue with these vendors and suppliers in order to minimize risk from these external factors.

Based on the assessment of its Systems, the Company believes that the costs of addressing the Y2K issue will be less than $200,000.  Also based on the assessment of its Systems, the Company believes that it has minimized the potential for disruption of its business because of the Y2K event.  System tests simulating the spanning of critical Y2K dates did not reveal any date transition problems. Additionally, personnel will be onsite on January 1, 2000 in order to test the equipment and make certain that there are no unanticipated disruptions with the systems or service. Disaster recovery preparations have also been broadened to include redundant computer file servers and other network equipment. However, if key third parties such as suppliers and customers are not Y2K ready, such problems could have a material adverse impact on the Company's business.  To minimize the impact of supplier product shortages that may result, the Company plans to have sufficient supplies on hand to meet its production requirements.  The Company will also ensure that its customers have an adequate supply of ABELCET® on hand to meet anticipated needs.

 

 

 

 

 

Page 17 of 20

 

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Certain Risk Factors

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and the Company intends that such forward-looking statements be subject to the safe harbors created thereby.  Examples of these forward-looking statements include, but are not limited to, (i) the progress of clinical trials and preclinical studies regarding EVACETTM, TLC ELL-12 and other oncology products in the Company's research pipeline, (ii) the ability of ABELCET® to maintain its position as the leading lipid-based formulation of amphotericin B in the U.S., (iii) the likelihood of future domestic and international regulatory approvals for EVACETTM or any other product in the research pipeline, (iv) possible new licensing or contract manufacturing agreements, (v) future product revenues from ABELCET®, EVACETTM or any other product in the research pipeline, (vi) the future uses of capital, and financial needs of the Company, (vii) manufacturing efficiencies and other benefits to be realized from use of the Indianapolis facility and (viii) resolution of Year 2000 computer issues.  While the Company, based on management's current beliefs and judgment, makes these statements, they are subject to risks and uncertainties that could cause actual results to vary.  In evaluating such statements, stockholders and investors should specifically consider a number of factors and assumptions, including those discussed in the text and financial statements and their accompanying footnotes in this Report, as well as the Company's 1998 Form 10-K including the risk factors identified therein and from time-to-time the Company's other filings with the Securities and Exchange Commission.

Among these factors and assumptions that could affect the forward-looking statements in this Report are the following: (a) the commercialization of ABELCET®

is still ongoing and the ultimate rate of sales of ABELCET® is uncertain; (b) the Company's other products are in development and have not yet received regulatory approval for sale, and it is difficult to predict if and when such approvals will be received and, if approved, whether the products can be successfully developed, manufactured and marketed; (c) competitors of the Company have developed and are developing products that are competitive with the Company's products; (d) the rate of sales of the Company's products could be affected by regulatory actions, decisions by government health administration authorities or private health coverage insurers as to the level of reimbursement for the Company's products; (e) risks associated with international sales, such as currency exchange rates, currency controls, tariffs, duties, taxes, export license requirements and foreign regulations may adversely affect the Company's foreign operations; (f) uncertainty that key customers, vendors and suppliers of the Company will be Y2K compliant; (g) the levels of protection afforded by the Company's patents and other proprietary rights is uncertain and may be challenged; and (h) the Company has incurred annual losses in each prior year since its inception and there can be no assurance of profitability in any future annual period.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

 

PART II -    OTHER INFORMATION

ITEM 1.      Legal Proceedings

The Company is a party in an adversarial proceeding filed in the United States Bankruptcy Court in Delaware by a chapter 7 bankruptcy trustee for the estate of the FoxMeyer Corporation, et al.  The complaint seeks to avoid and recover purported preferential transfers pursuant to 11 U.S.C. Sec. 547 and Sec. 550 from the Company in the amount of $2.3 million.  The Company believes it has meritorious defenses regarding this claim.

The Company is currently a party to various other legal actions arising out of the normal course of business, none of which are expected to have a material effect on the Company's financial position or results of operations.  

 

ITEM 6.      Exhibits and Reports on Form 8K

(a)  Exhibits

     27     Financial Data Schedule

  1. Reports on Form 8-K

     During the quarter for which this report on Form 10-Q is filed, no reports on Form 8-K have been filed.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 19 of 20

THE LIPOSOME COMPANY, INC. AND SUBSIDIARIES

 

 

 

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.

 

DATE: November 3, 1999

THE LIPOSOME COMPANY, INC.

 

 

  By:/s/ Charles A. Baker               

     Charles A. Baker

     Chairman of the Board and

     Chief Executive Officer

 

 

  By:/s/ Lawrence R. Hoffman            

     Lawrence R. Hoffman

     Vice President and

     Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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