UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
/x/ |
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For Quarter Ended September 30, 1999
or
/ / |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 33-90516
NEOPHARM, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
|
51-0327886 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification Number) |
100 Corporate North
Suite 215
Bannockburn, Illinois 60015
(Address of principal executive offices) (Zip Code)
(847) 295-8678
(Registrant's telephone number, including area code)
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 / /
Indicate
the number of shares outstanding of each of the issuer's classes of common stock, as of the close of the period covered by this report:
Title of each class
|
|
Number of shares outstanding
|
Common Stock ($.0002145 par value) |
|
10,996,747 |
NEOPHARM, INC.
(A DELAWARE CORPORATION)
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Page Number
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PART I. |
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Financial Information |
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ITEM 1. |
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Financial Statements |
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Balance Sheet |
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3 |
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Statement of Operations |
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4 |
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Statement of Cash Flows |
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5 |
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Notes to Financial Statements |
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6 |
ITEM 2. |
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Management's Discussion and Analysis of Financial Condition and Results of Operations |
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7 |
PART II. |
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Other Information |
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12 |
SIGNATURE PAGE |
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13 |
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2
PART IFINANCIAL INFORMATION
Item 1Financial Statements
NEOPHARM, INC.
(A Delaware corporation)
Balance Sheet
(Unaudited)
|
|
September 30,
1999
|
|
December 31,
1998
|
|
ASSETS |
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,554,862 |
|
$ |
40,681 |
|
Other receivables |
|
|
22,949 |
|
|
|
|
Deferred taxes |
|
|
|
|
|
1,640,000 |
|
Prepaid expenses |
|
|
30,304 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
25,608,115 |
|
|
1,680,681 |
|
Equipment and furniture |
|
|
|
|
|
|
|
Equipment |
|
|
85,447 |
|
|
82,690 |
|
Furniture |
|
|
79,290 |
|
|
78,877 |
|
Less accumulated depreciation |
|
|
(87,700 |
) |
|
(60,700 |
) |
|
|
|
|
|
|
Total equipment, furniture, net |
|
|
77,037 |
|
|
100,867 |
|
|
|
|
|
|
|
Total assets |
|
$ |
25,685,152 |
|
$ |
1,781,548 |
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
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Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued liabilities: |
|
|
|
|
|
|
|
Obligations under research agreements |
|
$ |
280,068 |
|
$ |
260,000 |
|
Accounts payable and accrued liabilities |
|
|
314,769 |
|
|
275,926 |
|
Accrued compensation |
|
|
|
|
|
67,500 |
|
Deferred Taxes |
|
|
1,092,000 |
|
|
|
|
|
|
|
|
|
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Total current liabilities |
|
|
1,686,837 |
|
|
603,426 |
|
|
|
|
|
|
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Stockholders' equity |
|
|
|
|
|
|
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Common stock, $.0002145 par value;
15,000,000 shares authorized:
10,996,747 and 8,341,779 shares issued and outstanding, respectively |
|
|
2,359 |
|
|
1,789 |
|
Additional paid-in capital |
|
|
25,171,970 |
|
|
6,637,378 |
|
Deficit accumulated during the development stage |
|
|
(1,176,014 |
) |
|
(5,461,045 |
) |
|
|
|
|
|
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Total stockholders' equity |
|
|
23,998,315 |
|
|
1,178,122 |
|
|
|
|
|
|
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Total liabilities and stockholders' equity |
|
$ |
25,685,152 |
|
$ |
1,781,548 |
|
|
|
|
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|
The
accompanying notes are an integral part of these balance sheets.
3
NEOPHARM, INC.
(A Delaware corporation)
Statement of Operations
Three and Nine Months Ended September 30, 1999 and 1998
(Unaudited)
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|
Three Months September 30,
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Nine Months September 30,
|
|
|
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1999
|
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1998
|
|
1999
|
|
1998
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing Revenues |
|
$ |
2,000,000 |
|
$ |
|
|
$ |
11,000,000 |
|
$ |
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
567,698 |
|
|
372,786 |
|
|
2,585,024 |
|
|
921,085 |
|
General and administrative |
|
|
501,462 |
|
|
325,346 |
|
|
1,601,811 |
|
|
936,747 |
|
|
|
|
|
|
|
|
|
|
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Total Expenses |
|
|
1,069,160 |
|
|
698,132 |
|
|
4,186,835 |
|
|
1,857,832 |
|
Income (loss) from operations |
|
|
930,840 |
|
|
(698,132 |
) |
|
6,813,165 |
|
|
(1,857,832 |
) |
Interest income |
|
|
232,397 |
|
|
15,587 |
|
|
330,992 |
|
|
81,037 |
|
Interest expense |
|
|
|
|
|
|
|
|
2,126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income (expense)net |
|
|
232,397 |
|
|
15,587 |
|
|
328,866 |
|
|
81,037 |
|
Net income (loss) Before income taxes |
|
$ |
1,163,237 |
|
$ |
(682,545 |
) |
$ |
7,142,031 |
|
$ |
(1,776,795 |
) |
|
|
|
|
|
|
|
|
|
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Income taxes |
|
|
465,000 |
|
|
|
|
|
2,857,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net Income (loss) |
|
$ |
698,237 |
|
$ |
(682,545 |
) |
$ |
4,285,031 |
|
$ |
(1,776,795 |
) |
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|
|
|
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Net Income (loss) per Share |
|
|
|
|
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|
|
|
|
|
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Basic |
|
$ |
.07 |
|
$ |
(.08 |
) |
$ |
.47 |
|
$ |
(.22 |
) |
|
|
|
|
|
|
|
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Diluted |
|
$ |
.06 |
|
$ |
(.08 |
) |
$ |
.38 |
|
$ |
(.22 |
) |
|
|
|
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Weighted average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
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Basic |
|
|
10,359,936 |
|
|
8,195,810 |
|
|
9,086,064 |
|
|
8,195,810 |
|
|
|
|
|
|
|
|
|
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Diluted |
|
|
11,491,752 |
|
|
8,214,956 |
|
|
11,279,475 |
|
|
8,258,190 |
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|
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|
|
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The
accompanying notes are an integral part of these statements.
4
NEOPHARM, INC.
(A Delaware corporation)
Statement of Cash Flows
Nine months ended September 30, 1999 and 1998
(Unaudited)
|
|
Sept. 30,
1999
|
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Sept. 30,
1998
|
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Cash flows used in operating activities: |
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
4,285,031 |
|
$ |
(1,776,795 |
) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
27,000 |
|
|
18,084 |
|
Deferred income taxes |
|
|
2,732,000 |
|
|
|
|
Changes in assets and liabilities: |
|
|
|
|
|
|
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(Increase) decrease in other assets |
|
|
(53,253 |
) |
|
7,535 |
|
Increase (decrease) in accounts payable and accrued liabilities |
|
|
(8,589 |
) |
|
(170,231 |
) |
Net cash provided by (used in) operating activities |
|
|
6,982,189 |
|
|
(1,921,407 |
) |
|
|
|
|
|
|
Cash flows used in investing activities: |
|
|
|
|
|
|
|
Purchase of equipment and furniture |
|
|
(3,170 |
) |
|
(99,966 |
) |
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(3,170 |
) |
|
(99,966 |
) |
|
|
|
|
|
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Cash flows from financing activities: |
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
9,460,777 |
|
|
|
|
Proceeds from exercise of warrants, net |
|
|
9,074,385 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
18,535,162 |
|
|
|
|
|
|
|
|
|
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Net increase (decrease) in cash |
|
|
25,514,181 |
|
|
(2,021,373 |
) |
Cash, beginning of period |
|
|
40,681 |
|
|
2,776,697 |
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
25,554,862 |
|
$ |
755,324 |
|
|
|
|
|
|
|
Supplemental disclosure of cash paid for: |
|
|
|
|
|
|
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Interest |
|
$ |
2,126 |
|
$ |
|
|
Income taxes |
|
|
125,000 |
|
|
|
|
The
accompanying notes are an integral part of these statements.
5
NEOPHARM, INC.
(A Delaware corporation)
NOTES TO FINANCIAL STATEMENTS
September 30, 1999
Note 1 Basis of Presentation
The financial information herein is unaudited, other than the Balance Sheet at December 31, 1998, which is derived from the audited financial
statements.
The
accompanying unaudited statements of NeoPharm, Inc. (the "Company") have been prepared in accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not contain all of the information
and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of the Company, the accompanying unaudited interim financial statements contain all
adjustments (consisting of normal recurring adjustments) necessary to present fairly the Company's financial position as of September 30, 1999, the results of operations for the three and nine
months ended September 30, 1999 and 1998 and the changes in cash flows for the nine month periods ended September 30, 1999 and 1998.
While
the Company believes that the disclosures presented are adequate to make the information not misleading, it is suggested that these financial statements be read in conjunction
with the financial
statements and notes included in the Company's 1998 Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Note 2 Earnings Per Share
The following table sets forth the computation of the basic and diluted earnings per share from continuing operations:
|
|
For the three months ended:
|
|
For the nine months ended:
|
|
|
|
Sept. 30,
1999
|
|
Sept. 30
1998
|
|
Sept. 30,
1999
|
|
Sept. 30
1998
|
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) from continuing operations |
|
$ |
698,237 |
|
$ |
(682,545 |
) |
$ |
4,285,031 |
|
$ |
(1,776,795 |
) |
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic income (loss) per
share-weighted Average shares |
|
|
10,359,936 |
|
|
8,195,810 |
|
|
9,086,064 |
|
|
8,195,810 |
|
Effect of Dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
783,389 |
|
|
19,146 |
|
|
871,272 |
|
|
62,380 |
|
Warrant exercise |
|
|
348,427 |
|
|
|
|
|
1,322,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares |
|
|
1,131,816 |
|
|
19,146 |
|
|
2,193,411 |
|
|
62,380 |
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted income (loss) per
share-weighted Average shares and assumed conversions |
|
|
11,491,752 |
|
|
8,214,956 |
|
|
11,279,475 |
|
|
8,258,190 |
|
Basic income (loss) per share |
|
$ |
.07 |
|
$ |
(.08 |
) |
$ |
.47 |
|
$ |
(.22 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted income (loss) per share |
|
$ |
.06 |
|
$ |
(.08 |
) |
$ |
.38 |
|
$ |
(.22 |
) |
|
|
|
|
|
|
|
|
|
|
6
Item 2Management's Discussion and Analysis of Financial Condition and Results of Operations
Any statements made by NeoPharm Inc. (the "Company") in this quarterly report that are forward looking are made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that important factors may affect the Company's actual results and could cause such results to differ materially
from forward-looking statements made by or on behalf of the Company. Such factors include, but are not limited to, changing market conditions, the impact of competitive products and pricing, the
timely development, approval by the Food and Drug Administration ("FDA") and foreign health authorities, and market acceptance of the Company's products in development, the Company's ability to
further raise capital, the Company's dependence on key personnel, and other factors referenced under "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year
ended December 31, 1998.
Overview
NeoPharm is a pharmaceutical Company engaged in the research and development of drugs for the diagnosis and treatment of various forms of cancer. Presently the
Company has several drugs which are in varying stages of development; liposome encapsulated doxorubicin ("LED"), liposome encapsulated paclitaxel ("LEP"), liposome encapsulated antisense
oligodeoxynucleotide ("LE-AON" and with LED and LEP the "Liposome Products"), IL-13 PE38QQR ("IL-13"), Mesothelin ss-(dsFv)-PE38 ("Mesothelin Mab") and
BUdR (Broxuridine). IL-13 and Mesothelin Mab are both Ligand Target Cytotoxins intended to specifically target cancer cells and leave normal cells unaffected.
The
Company has obtained rights to its various products as a result of agreements and relationships entered protein known into with various third parties including the National Cancer
Institute ("NCI"), the United States Food and Drug Administration ("FDA"), the National Institute of Health ("NIH") and Georgetown University.
To
date, the Company has been engaged primarily in research and development of its developmental stage products. The Company has developed expertise in identification, development and
preparation for regulatory approval of cancer drugs for both therapeutic and diagnostic purposes, although the Company has no products that are currently approved for sale. The Company currently has
no marketing or sales staff and has conducted its activities primarily through consultants and at university research facilities. To date, the Company's sole source of revenue has come from the
licensing of technology it has developed. The Company has moved from its development stage upon the licensing of its LEP and LED products as discussed below.
NeoPharm, Inc.,
was incorporated in Delaware under the name OncoMed, Inc. in June 1990, and changed its name to NeoPharm, Inc. in March, 1995.
NeoPharm Products
The Company's Liposome Products consist of spheres of subcellular size composed primarily of phospholipids, certain of which are the primary components of
living cell membranes, and can be made to contain and deliver drugs. This membrane encapsulation feature of liposomes enables the entrapped drug to be circulated in the bloodstream in higher
concentrations for longer periods of time than the free drug. When certain drugs, including chemotherapeutic agents, are administered in conjunction with liposomes, they have been shown to produce
fewer and less severe local and systemic side effects. Although liposomes have been investigated and used for many years as drug delivery systems, the
difficulty in producing liposomes on a large scale, as well as the limited shelf life of many liposomes, have limited their use in clinical settings.
Two
multi-institutional Phase II trials are in progress with LED, one in advanced prostate cancer and the other in recurrent breast cancer. Additional studies are planned, including
LED in combination
7
with other drugs and for cancer of the liver. The Phase I trial of LEP began in September 1998, and is continuing to accrue patients. Phase II studies, both with LEP alone and in combination
with other drugs, are planned in patients with breast cancer, prostate cancer, and several other cancer types.
In
February 1999, the Company signed a License Agreement with Pharmacia and Upjohn ("P&U") to develop and commercialize LEP and LED worldwide. The Company received a $9,000,000
nonrefundable up-front payment upon execution of the License Agreement and will receive milestone payments as clinical progress occurs under the License Agreement. The first milestone
payment in the amount of $2,000,000 was received on July 12, 1999. The Company will also receive royalties on overseas sales and a co-promotion profit split on sales in the United
States. Pursuant to the License Agreement, P&U will assume all further responsibility for, and the costs associated with, the further development and testing of LED and LEP and the obtaining of all
regulatory approvals. In addition, the Company sold 452,861 shares of its common stock to P&U upon the transfer of certain Investigatory New Drug ("IND") applications to P&U in accordance with a
separate Stock Purchase Agreement at a price of $8,000,000 ($17.6655 per share) which was 110% of the then market price of the common stock during the sixty (60) day period preceeding the
transfer of the INDs. The final IND was transferred on July 14, 1999 and P&U purchase 452,861 shares of the Company's common stock on July 23, 1999.
The
Company has two license and research agreements with Georgetown University that cover the use of certain technologies used in the Company's LED and LEP products. In
January 1999, the Company and Georgetown University agreed to amend the agreements to reduce the level of future sublicense royalties on LEP and LED sales payable to Georgetown in return for a
one time sublicense fee of $800,000. The Company made the $800,000 payment to Georgetown in March 1999, after the execution of the P&U agreement.
Extensive
research by the scientists at FDA and NCI have demonstrated that some solid human tumors such as kidney cancer (renal cell carcinoma), brain cancer (glioblastoma), Kaposi's
sarcoma and breast carcinoma express high numbers of IL-13 receptors on their cell surfaces. These receptor sites become a specific target for the IL-13 chimeric protein for
inducing cytotoxicity at nanogram concentration. On the other hand, normal organs of the body are shown to exhibit minimal receptors sites thereby sparing these organs from any toxic effect.
In
October 1997, the Company entered into an exclusive worldwide licensing agreement with the FDA and the NIH to develop and commercialize a chimeric human protein known as
"IL13-PE38QQR." The National Institute of Health license requires a $75,000 non-refundable license issue payment and minimum annual royalty payments of $10,000, which increase
to $25,000 after our first commercial sale. The National Institute of Health license also provides for milestone payments which, if all milestones were to be attained, would require payments
aggregating to $785,000 and royalties of 4% based on future product sales, if any. We are also required to pay the costs of filing and maintaining product patents on the licensed products as they are
incurred.
The
Company successfully scaled up the production of this chimeric protein to complete preclinical studies during the second quarter of 1999. A Phase I clinical program in humans with
renal cell carcinoma and glioblastoma was initiated in October, 1999.
The
Company also recently entered into a Licensing Agreement with the NIH for Mesothelin Mab for head and neck cancer and mesothelioma. Like IL-13, Mesothelin Mab targets
mesothelin receptors on cancer cells and delivers a cytotoxin to destroy the cancer cell while leaving normal cells alone. Mesothelin Mab is expected to enter Phase I Clinical Studies in the early
part of 2000. The terms and conditions of the Mesothelin Mab License Agreements with the National Institute of Health are substantially the same as those described above for our agreement with the
National Institute of Health for IL-13 chimeric protein-therapy, with the exception that milestone payments by the Company (if all milestones were to be attained) would aggregate to
$500,000. The royalty payable on future product
8
sales if any, would be 5% and the Company has agreed to reimburse the National Institute of Health, within 60 days of a request for up to $175,000 of previously incurred patent prosecution
costs. Additionally, the Company finalized a Cooperative Research and Development Agreement (CRADA) with the NCI on May 19, 1999 for the development of Mesothelin Mab. Under the terms of the
agreement, the company paid a $100,000 up front payment and is required to pay $50,000 every six months during the four year term of the agreement.
In
December 1996, the Company filed an NDA for BUdR (Broxine®) as a diagnostic agent useful for assisting in the determination of prognosis of breast cancer. After
review by the Oncology Drugs Advisory Committee, the FDA did not approve the application. Based on multiple discussions with the Agency, the Company is developing additional data to a address the
concerns raised, and is also exploring opportunities to license or sell this product.
Results of OperationsThree Months Ended September 30, 1999 vs. Three Months Ended September 30, 1998
The Company received $2,000,000 of licensing revenue during the three month period ended September 30, 1999. This revenue represents the first milestone
payment received under the P&U agreement. The Company had no revenue for the comparable period in the prior year.
Research
and development expenses for the three month period ended September 30, were $567,698 compared to $372,786 for the same period in 1998. Research and development
payroll and related travel expenses increased approximately $112,000 over the 1998 period. The Company's research and development expenses related to LED and LEP have been substantially eliminated due
to the licensing agreement with P&U. However, the Company has redirected its research and development activities toward its other compounds and as a result has seen its research cost increase by
approximately $83,000 over the 1998 period.
General
and administrative expenses for the three month period ended September 30, 1999 were $501,462 compared to $325,346 for the same period is 1998. General and
administrative expense increased primarily due to increased investor relations activity, increased professional fees related to licensing activities and other corporate matters.
The
Company generated interest income on excess cash balances of $232,397 and $15,587 for the three month periods ended September 30, 1999 and September 30, 1998
respectively.
The
Company recorded an income tax expense of $465,000 for the three month period ended September 30, 1999. No income tax expense or benefit was recorded for the comparable
period in the prior year.
The
net income for the three months ended September 30, 1999 was $698,237 compared to a net loss of $682,545 for the three month period ended September 30, 1998.
Net
income per share for the three month period ended September 30, 1999 was $0.07 basic and $0.06 diluted compared to a net loss per share of $0.08 basic and diluted for the
three month period ended September 30, 1998.
Results of OperationsNine months ended September 30, 1999 vs. Nine months ended September 30, 1998.
The Company received $11,000,000 of licensing revenue during the nine month period ended September 30, 1999. This revenue represents the up-front
payment and first milestone payment received under the P&U agreement. The Company had no revenue for the nine month period ended September 30, 1998.
Research
and development expenses increased by approximately $1,663,939 for the nine month period ended September 30, 1999 compared to the nine month period ended
September 30, 1998. The
9
increase was due primarily to the sublicensing fee paid to Georgetown of $800,000 increased payroll of $377,000 due to employee bonuses and additional staff being present for the full 1999 period and
other expenditures of approximately $487,000 related to other licensing and direct research activities.
General
and administrative expenses increased by $665,064 for the nine month period ended September 30, 1999 compared to the nine month period ended September 30, 1998
due to additional payroll costs and bonuses of approximately $112,000 increased insurance costs of $51,000 increased investor relations activities and professional fees of approximately $444,000
relocation expenses for a corporate executive of $50,000 and other miscellaneous expenses of approximately $8,000.
The
Company generated interest income on excess cash balance of $330,992 and $81,037 for the nine month periods ended September 30, 1999 and September 30, 1998
respectively.
The
Company incurred $2,126 of interest expense during the nine months ended September 30, 1999. The Company recorded no intersest expense for the same period in 1998.
The
Company recorded income tax expense of $2,857,000 for the nine month period ended September 30, 1999. The Company recorded no income tax expense for the same period in
1998.
Net
income for the nine month ended September 30, 1999 was $4,285,031 compared to a net loss of $1,776,795 for the period ended September 30, 1998.
Net
income per share for the nine month period ended September 30, 1999 was $0.47 basic and $0.38 diluted compared to a net loss per share of $0.22 basic and diluted for the
nine month period ended September 30, 1998.
Liquidity and Capital Resources
Cash expenditures exceeded revenues from the Company's inception until the 1st Quarter of 1999. Operations have principally been funded through a loan from the
Company's Chairman, a bank line-of-credit and since January 1996, the initial public offering of common stock. The Company expects to incur additional expenses,
resulting in potentially significant losses, as it continues and expands its research and development activities and undertakes additional clinical trials of compounds obtained under proprietary
licenses. The Company also expects to incur substantial administrative and commercialization expenditures in the future as it seeks FDA approval of drugs under development and initiates marketing
activities.
From
October 1998 through February 1999 the Company had a $3,000,000 line of credit in place with the John N. Kapoor Trust dtd 9/20/89, an entity affiliated with the
Company's Chairman. The Company borrowed $250,000 on the line of credit on January 8, 1999. The $250,000 plus accrued interest of $1,062 was repaid on January 29, 1999. The line of
credit terminated upon the signing of the licensing agreement with P&U on February 19, 1999.
At
September 30, 1999, the Company's cash and cash equivalents were $25,554,862 compared to $40,681 at December 31, 1998. This increase in cash and cash equivalents of
$25,514,181 was the result of cash generated by operating activities of $6,982,189, cash used to purchase equipment and furniture of $3,170 and cash provided by financing activities of $18,535,162.
The
Company called its 837,067 redeemable common stock purchase warrants and the 67,500 warrants underlying its representative's warrants on June 24, 1999. The period for
exercising the outstanding warrants closed at the close of business on July 27, 1999. Warrant holders exercised 836,942 of the redeemable warrants and 67,500 of the underlying warrants for
total net proceeds to the Company of $9,074,385.
Pursuant
to its license agreement, P&U purchased 452,861 shares of the Company's common stock at a per share price of $17.6655 on July 23, 1999.
10
The
Company plans to finance its immediate needs principally from its existing capital resources and interest thereon, and to the extent available, through collaborative agreements
with corporate partners and future public and private financing. The Company's long term capital needs will require substantial additional funding in order to continue its research and product
development programs. The Company's long-term capital requirements and the adequacy of its available funds will depend upon many factors, including results of research and development,
results of product testing, relationships with potential partnerships and collaborations, and the FDA regulatory process. No assurance can be given that additional funding will be available when
needed or on terms acceptable to the Company. Insufficient funds may require the Company to delay, scale-back or eliminate certain of its research and development programs or to license
third parties to commercialize products or technologies that the Company would otherwise undertake itself.
The Year 2000 Issue
The Year 2000 issue is the result of computer programs being written using two digits rather than four to define the applicable year. Computer equipment
software and devices with imbedded technology that are time sensitive may treat years as occurring between 1900 and the end of 1999 and may not
self-convert to reflect the upcoming change in the century. If not corrected, this problem could result in system failures or miscalculations and erroneous results by, or at, Year 2000.
The
Company conducted an assessment of its business systems that could encounter Year 2000 problems. This assessment included both information technology systems and
non-information technology systems. Based on this internal assessment, the Company has not identified any material year 2000 issues. The Company retained an outside consultant to review
its assessment. The consultant recommended several minor corrective measures which have been completed. The cost of the review and corrective measures was less than $5,000.
Because
the Company expects that its internal systems will be Year 2000 compliant, the Company belives that the most likely worst case scenario would result from third parties failing
to achieve Year 2000 compliance. The Company relies on vendors, service providers and collaboration partners for raw materials, contract manufacturing, research activities, product testing, clinical
trials, administrative services and other services ("Service Providers"). The Company is in the process of surveying its Service Providers to determine if they are Year 2000 compliant or have
effective plans in place to address the Year 2000 issue and to determine the extent of the Company's vulnerability to the failure of its Service Providers to remedy such issues. Based upon the
responses that the Company receives from its Service Providers, the Company will assess its risks and develop appropriate contingency plans as needed. The Company does not currently have a contingency
plan in place; however it is the Company's intention to complete its contingency plan by prior to year end.
The
Company does not expect the Year 2000 issue to have a material adverse impact on the Company's business or results of operations. However, no assurance can be given that
unanticipated or undiscovered Year 2000 problems will not arise that could have a material adverse effect on the Company's business and results of operations. In addition, there can be no assurance
that Year 2000 non-compliance by any of the Company's significant Service Providers will not have a material adverse effect on the Company's business or results of operations.
11
PART IIOTHER INFORMATION
Item 1. |
|
Legal Proceedings |
|
None |
Item 2. |
|
Changes in Securities
On July 23, 1999, the Company sold, in a private offering made pursuant to Section 4(2) of the Securities Act of 1933 (the "Act"), 452,861 shares of its common stock, par value $.0002145, to Pharmicia & UpJohn ("P & U"). The
sale was made pursuant to a Stock Purchase Agreement entered into between P & U and the Company in February, 1999 and which provided for the Company to sell $8,000,000 of common stock to P & U at such time as certain Investigating New
Drug ("IND") applications were transferred to P & U by the Company and at a stock price per share equal to 110% of the then market price of the common stock during the sixty (60) day period preceding the transfer of the IND's. The final IND
was transferred on July 14, 1999. Thereafter, P & U purchased the shares of the Company's common stock at a price per share of $17.6655 in accordance with the terms of the Stock Purchase Agreement. No commissions or underwriting discounts
were paid in connection with this sale. The Company has granted certain registration rights to P & U pursuant to a separate Registration Rights Agreement. |
|
|
During the quarter ended September 30, 1999, the Company issued 1,808,884 shares of its common stock,par value $.0002145, to those holders of its redeemable common stock purchase warrants or redeemable warrants underlying its Representative's
Warrants, who had exercised their rights to purchase shares of the Company's common stock subsequent to the Company's notice of redemption of the warrants of each type. |
|
|
Each redeemable common stock purchase warrant was exercisable for two shares of the Company's common stock at a purchase price of $9.80 per warrant ($4.90 per share). Each redeemable warrant underlying the Representative's Warrants was exercisable
for two shares of the Company's common stock at a purchase price of $13.72 per warrant ($6.86 per share). A total of 1,673,884 shares of common stock were issued to holders of the redeemable common stock purchase warrants with net proceeds to the
Company of $8,160,351 and an additional 135,000 shares of common stock were issued to holders of the redeemable warrants underlying the Representatives Warrants with net proceeds to the Company of $914,034. |
|
|
The issuance of shares of common stock was made pursuant to a registration statement which had been declared effective as of June 24, 1999. There were no underwriters involved in the transactions and no commissions or underwriting discounts were
paid. |
Item 3. |
|
Defaults Upon Senior Securities |
|
None |
Item 4. |
|
Submission of Matters to a Vote of Security-Holders |
|
None |
Item 5. |
|
Other Information |
|
None |
Item 6. |
|
Exhibits and Reports on Form 8-K |
|
|
(a) Exhibits |
|
|
|
|
(i) |
|
Stock Purchase Agreement, dated February 19, 1999 between Pharmacia & UpJohn and the Company as filed with the Commission as Exhibit 10.2 to the Company's report on Form 8-K (File No. 33-09516)
, is incorporated by reference. |
|
|
|
|
(ii) |
|
Prospectus dated June 24, 1999, as filed with the Commission as part of the Company's Registration Statement on Form S-3 as amended on Form S-1 (File No. 333-68133), is incorporated by
reference. |
|
|
(b) Reports on Form 8-K |
|
|
|
|
|
|
A report on Form 8-K was filed by the Company on July 7, 1999 to report the Company's call of its redeemable common stock purchase warrants and redeemable warrants underlying its Representative's
Warrants. |
12
SIGNATURE PAGE
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.
|
|
NEOPHARM, INC. |
|
|
By: |
/s/ KEVIN M. HARRIS Kevin M. Harris, Chief Financial Officer and authorized officer |
|
|
|
Date: November 15, 1999 |
13
PART IFINANCIAL INFORMATION
Item 1Financial Statements
Note 1 Basis of Presentation
Note 2 Earnings Per Share
Item 2Management's Discussion and Analysis of Financial Condition and Results of Operations
PART IIOTHER INFORMATION
SIGNATURE PAGE