SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the Quarterly Period ended September 30, 1997
OR
[ ] Transition Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Commission file number 0-27150
PATHOGENESIS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 91-1542150
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
201 Elliott Avenue West
Seattle, Washington 98119
(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (206) 467-8100
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, par value $.001 per share
---------------------------------------
(Title of class)
Preferred Stock Purchase Rights
-------------------------------
(Title of class)
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 [ ]
At September 30, 1997, the number of shares outstanding of the registrant's
Common Stock, par value $.001 per share, was 16,140,801 shares.
PATHOGENESIS CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED BALANCE SHEETS
September 30, December 31,
1997 1996
------------- -------------
ASSETS
Current assets
Cash and cash equivalents $ 11,633,979 $ 14,785,818
Investment securities 78,196,624 45,901,978
Interest receivable 829,370 298,437
Inventory 4,585,074 --
Other current assets 744,292 823,092
------------- -------------
Total current assets 95,989,339 61,809,325
------------- -------------
Restricted securities 675,000 675,000
------------- -------------
Property and equipment, at cost:
Leasehold improvements 7,561,333 6,766,935
Furniture and equipment 7,885,169 5,967,110
------------- -------------
15,446,502 12,734,045
Less accumulated depreciation and amortization 6,606,694 5,320,039
------------- -------------
Net property and equipment 8,839,808 7,414,006
------------- -------------
Other assets, net 120,453 100,370
------------- -------------
Total assets $ 105,624,600 $ 69,998,701
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,607,421 $ 812,259
Compensation and benefits 940,943 774,258
Clinical development costs 1,927,733 818,629
Other accrued expenses 1,036,697 569,068
------------- -------------
Total current liabilities 5,512,794 2,974,214
------------- -------------
Long-term liability -- 98,273
Stockholders' equity:
Preferred stock $.01 par value
Authorized 1,000,000 shares; issued and
outstanding none -- --
Common stock $.001 par value. Authorized
60,000,000 shares; 16,140,801
shares and 13,930,760 shares issued
and outstanding at September 30, 1997 and
December 31, 1996, respectively 16,141 13,931
Additional paid-in capital 190,390,525 134,727,920
Deferred compensation (1,394,771) --
Unrealized gain (loss) on investment securities 101,359 (30,204)
Deficit accumulated during the development stage (89,001,448) (67,785,433)
------------- -------------
Total stockholders' equity 100,111,806 66,926,214
------------- -------------
Total liabilities and stockholders' equity $ 105,624,600 $ 69,998,701
============= =============
PATHOGENESIS CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
NUMBER OF
COMMON PRICE ADDITIONAL
SHARES PER COMMON PAID-IN DEFERRED
DATE DESCRIPTION OUTSTANDING SHARE STOCK CAPITAL COMPENSATION
---- ----------- ----------- ----- ----- ------- ------------
Feb to Mar 1992 Shares issued for cash 1,870,000 $0.08 1,870 147,730
June to Dec 1992 Shares issued for cash net of
issue costs of $744,966 4,308,500 10.00 4,309 42,335,725
November 1992 Repurchase of common stock
through forgiveness
of note receivable (25,000) 10.00 (25) (249,975)
Repurchase of common stock for
cash (46,875) 0.08 (47) (3,703)
Net loss for the period ended
December 31, 1992
----------------------------------------------------------
Balances at December 31, 1992 6,106,625 6,107 42,229,776 --
October 1993 Shares issued in payment of
license fees 50,000 10.00 50 499,950
Net loss for the year ended
December 31, 1993
----------------------------------------------------------
Balances at December 31, 1993 6,156,625 6,157 42,729,726 --
March 1994 Shares issued for cash net of
issue costs of $1,251,739 1,690,677 12.00 1,690 19,093,694
Unrealized loss on investment
securities
Net loss for the year ended
December 31, 1994
----------------------------------------------------------
Balances at December 31, 1994
7,847,302 7,847 61,823,421 --
March 1995 Shares issued in payment of
license fees 50,000 12.00 50 599,950
April to Aug 1995 Exercise of stock options for
cash 413 10.00 1 4,124
November 1995 Shares issued for cash net of
issue costs of $2,904,274 3,000,000 10.00 3,000 27,092,726
Unrealized gain on investment
securities
Net loss for the year ended
December 31, 1995
----------------------------------------------------------
Balances at December 31, 1995
10,897,715 10,898 89,520,221 --
Redemption of fractional shares
(48) 12.00 (0) (576)
February 1996 Shares issued in payment of
license fees 6,250 10.00 6 62,494
February 1996 Repurchase of common stock for
cash (45,000) 0.08 (45) (3,555)
May 1996 Shares issued for cash net of
issue costs of $3,213,410 2,875,000 16.25 2,875 43,502,465
Exercise of stock options and
warrants for cash and
cancellation of warrants 196,843 10.82 197 1,646,871
Unrealized loss on investment
securities
Net loss for the year ended
December 31, 1996
----------------------------------------------------------
Balances at December 31, 1996
13,930,760 13,931 134,727,920 --
Jan to Sept 1997 Exercise of stock options and
warrants for cash and
cancellation of warrants 110,041 10.60 110 925,799
March 1997 Shares issued for cash net of
issue costs of $3,555,118 2,100,000 27.00 2,100 53,142,782
June to Sept 1997 Compensation from stock options
1,594,024 (1,394,771)
Unrealized gain on investment
securities
Net loss for the nine months
ended September 30, 1997
----------------------------------------------------------
Balances at September 30, 1997 16,140,801 $16,141 190,390,525 (1,394,771)
(RESTUBBED TABLE CONTINUED FROM ABOVE)
UNREALIZED ACCUMULATED
GAIN DURING THE TOTAL
(LOSS) ON DEVELOPMENT STOCKHOLDERS'
DATE DESCRIPTION INVESTMENTS STAGE EQUITY
---- ----------- ----------- ----------- -------------
Feb to Mar 1992 Shares issued for cash 149,600
June to Dec 1992 Shares issued for cash net of
issue costs of $744,966 42,340,034
November 1992 Repurchase of common stock
through forgiveness
of note receivable (250,000)
Repurchase of common stock for
cash (3,750)
Net loss for the period ended
December 31, 1992 (2,930,285) (2,930,285)
--------------------------------------------
Balances at December 31, 1992 (2,930,285) 39,305,599
October 1993 Shares issued in payment of
license fees 500,000
Net loss for the year ended
December 31, 1993 (10,804,878) (10,804,878)
--------------------------------------------
Balances at December 31, 1993 (13,735,163) 29,000,721
March 1994 Shares issued for cash net of
issue costs of $1,251,739 19,095,384
Unrealized loss on investment
securities (172,809) (172,809)
Net loss for the year ended
December 31, 1994 (14,762,117) (14,762,117)
--------------------------------------------
Balances at December 31, 1994
(172,809) (28,497,280) 33,161,179
March 1995 Shares issued in payment of
license fees 600,000
April to Aug 1995 Exercise of stock options for
cash 4,125
November 1995 Shares issued for cash net of
issue costs of $2,904,274 27,095,726
Unrealized gain on investment
securities 211,267 211,267
Net loss for the year ended
December 31, 1995 (18,023,923) (18,023,923)
--------------------------------------------
Balances at December 31, 1995
38,458 (46,521,203) 43,048,374
Redemption of fractional shares
(576)
February 1996 Shares issued in payment of
license fees 62,500
February 1996 Repurchase of common stock for
cash (3,600)
May 1996 Shares issued for cash net of
issue costs of $3,213,410 43,505,340
Exercise of stock options and
warrants for cash and
cancellation of warrants 1,647,068
Unrealized loss on investment
securities (68,662) (68,662)
Net loss for the year ended
December 31, 1996 (21,264,230) (21,264,230)
--------------------------------------------
Balances at December 31, 1996
(30,204) (67,785,433) 66,926,214
Jan to Sept 1997 Exercise of stock options and
warrants for cash and
cancellation of warrants 925,909
March 1997 Shares issued for cash net of
issue costs of $3,555,118 53,144,882
June to Sept 1997 Compensation from stock options
199,253
Unrealized gain on investment
securities 131,563 131,563
Net loss for the nine months
ended September 30, 1997 (21,216,015) (21,216,015)
--------------------------------------------
Balances at September 30, 1997 101,359 (89,001,448) 100,111,806
PATHOGENESIS CORPORATION
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS
December 10,
1991
Three Months Ended Nine Months Ended (Incorporation)
September 30, September 30, Through
-------------------------- ---------------------------- September 30,
1997 1996 1997 1996 1997
----------- ----------- ------------ ------------ --------------
Revenue:
Grants and royalties $ 76,503 $ 160,539 $ 324,914 $ 282,843 $ 764,794
Operating expenses:
Research and development 6,943,439 4,940,519 18,960,568 14,437,674 77,062,106
General and administrative 3,019,762 995,666 6,374,766 2,919,173 23,752,291
------------ ----------- ------------- ------------- -------------
Total operating expenses 9,963,201 5,936,185 25,335,334 17,356,847 100,814,397
------------ ----------- ------------- ------------- -------------
Operating loss (9,886,698) (5,775,646) (25,010,420) (17,074,004) (100,049,603)
------------ ----------- ------------- ------------- -------------
Other income (expense):
Investment income, net 1,403,010 1,012,981 3,897,650 2,360,209 11,372,697
Other expense (49,924) (24,547) (103,245) (51,789) (324,542)
------------ ----------- ------------- ------------- -------------
Net other income 1,353,086 988,434 3,794,405 2,308,420 11,048,155
============ =========== ============= ============= =============
Net loss $(8,533,612) $(4,787,212) $(21,216,015) $(14,765,584) $(89,001,448)
============ =========== ============= ============= =============
Net loss per common share $ (0.53) $ (0.35) $ (1.37) $ (1.18)
============ =========== ============= =============
Weighted average common shares
outstanding 16,119,363 13,759,209 15,526,611 12,468,547
============ =========== ============= =============
PATHOGENESIS CORPORATION
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS
December 10,
1991
(Incorporation)
Nine Months Ended Through
September 30, September 30,
1997 1996 1997
------------- ------------- -------------
Cash flows from operating
activities:
Net loss $ (21,216,015) $ (14,765,584) $ (89,001,448)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 1,507,462 1,202,884 6,943,025
Amortization of investment premiums (discounts) 33,082 (135,877) 372,349
Amortization of deferred compensation 199,253 -- 199,253
Common stock issued in payment of license fees -- -- 1,159,000
Loss on sale of furniture and equipment 35,796 315 98,970
Change in certain assets and liabilities:
Interest receivable (530,933) 429,116 (829,370)
Inventory (4,585,074) -- (4,585,074)
Other current assets 78,800 231,012 (744,292)
Other assets, net -- 3,613 (100,370)
Accounts payable 795,162 (1,019,630) 1,607,421
Compensation and benefits 166,685 (416,333) 1,000,943
Clinical development costs 1,109,104 108,025 1,927,733
Other accrued expenses 467,629 71,318 1,036,697
Long-term liability (98,273) (227,508) --
------------- ------------- -------------
Net cash used in operating activities (22,037,322) (14,518,649) (80,915,163)
------------- ------------- -------------
Cash flows from investing
activities:
Purchases of investment securities (159,419,600) (87,656,851) (410,424,072)
Sales of investment securities 127,223,435 81,394,672 331,281,458
Purchases of property and equipment (3,045,143) (514,430) (16,057,986)
Proceeds from sale of furniture and equipment 56,000 100 96,100
Issuance of note receivable -- -- (250,000)
------------- ------------- -------------
Net cash used in investing activities (35,185,308) (6,776,509) (95,354,500)
------------- ------------- -------------
Cash provided by financing activities -
Net proceeds from issuance of common stock 53,144,882 43,501,168 185,326,540
Proceeds from exercise of stock options 925,909 361,013 2,577,102
------------- ------------- -------------
Total cash provided from financing activities 54,070,791 43,862,181 187,903,642
Net increase (decrease) in cash and cash equivalents (3,151,839) 22,567,023 11,633,979
Cash and cash equivalents at beginning of period 14,785,818 575,297 --
------------- ------------- -------------
Cash and cash equivalents at end of period $ 11,633,979 $ 23,142,320 $ 11,633,979
============= ============= =============
PATHOGENESIS CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 1997 AND 1996
(1) BASIS OF PRESENTATION
The accompanying consolidated financial statements and related notes
have been prepared pursuant to Securities and Exchange Commission rules and
regulations for interim financial statements. Accordingly, certain information
and footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been condensed or
omitted pursuant to such rules and regulations. The accompanying financial
statements and related notes should be read in conjunction with the audited
financial statements included in the Company's Annual Report on Form 10-K for
the year ended December 31, 1996.
The information furnished reflects, in the opinion of management, all
adjustments necessary for a fair presentation of the results for the interim
periods presented. Interim results are not necessarily indicative of results
for a full year.
(2) INVENTORIES
Inventories are stated at the lower of cost (first in first out) or
market. As of September 30, 1997 inventories of the following:
Raw Material .................... $3,461,169
Work in Process ................. 1,123,905
Total ........................... $4,585,074
6
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Statements in this Quarterly Report on Form 10-Q that are not
historical fact constitute "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties or other factors
which may cause actual results, performance or achievements of the Company to
be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Factors that might
cause such a difference include, but are not limited to, uncertainties related
to the Company's absence of products and dependence on TOBI, government
regulation, the development of drug candidates, competition and pharmaceutical
pricing. Further information regarding such factors is discussed in
PathoGenesis' 1996 Annual Report on Form 10-K, which was filed with the
Securities and Exchange Commission.
RESULTS OF OPERATIONS
Overview
The Company develops novel drugs to treat serious human infectious
diseases where there is a significant need for improved therapy. Since its
incorporation in December 1991, the Company has been engaged in research and
development, clinical trials and administrative activities. The Company's lead
drug candidate, TOBI(TM) (tobramycin solution for inhalation), is a stable,
premixed, proprietary formulation of the antibiotic tobramycin for delivery by
inhalation. In October 1996, the Company completed its two pivotal Phase III
clinical trials of TOBI for the treatment of Pseudomonas aeruginosa lung
infections in people with cystic fibrosis. The Company filed a New Drug
Application ("NDA") for TOBI in cystic fibrosis patients with the United States
Food and Drug Administration ("FDA") in July 1997. The FDA has agreed to an
expedited review of such NDA and is actively reviewing the file; however, there
can be no assurance as to the outcome or timing of the FDA's review of such
filing. The FDA has set the date of November 21, 1997 for a meeting of the
Anti-Infective Drugs Advisory Committee, where the Company has been asked to
present data on TOBI. The Company also commenced Phase II clinical trials of
TOBI in patients suffering from bronchiectasis (a form of severe chronic
bronchitis) in September 1997 and in patients with tuberculosis in October
1997. The Company's third drug candidate, PA-1648, a derivative of the
antibiotic rifampin, is being developed for the treatment of tuberculosis. The
Company commenced Phase II clinical trials of PA-1648 in tuberculosis patients
in October 1997.
Financial results for the first nine months of 1997 reflect a planned
increase in operating expenses for activities related to advancing potential
products through the development process. Such activities include product
development, clinical trials and marketing. The Company expects to invest in
additional clinical, regulatory and product development efforts over the next
few years.
The Company currently has no sources of revenue from any of its drug
candidates, has incurred losses since its inception and had an accumulated
deficit through September 30, 1997 of $89,001,448. The Company's results of
operations may vary significantly from period to period depending on several
factors, such as the timing of approval (if ever), sales of TOBI (if and when
approved), certain expenses and the progress of the Company's research and
development efforts.
THREE MONTHS ENDED SEPTEMBER 30, 1997 AND 1996
Revenues in the third quarter of 1997 represented income received from
a two-year competitive grant from the FDA and royalties from sales of a
proprietary combinatorial chemistry system invented by the Company. Revenue
from grants and royalties in the third quarter decreased by $84,036 to $76,503
in 1997 from $160,539 for the comparable period in 1996. This decrease was due
to lower unit sales of the combinatorial chemistry system.
Research and development expense for the third quarter increased by
$2,002,920 to $6,943,439 in 1997 from $4,940,519 for the comparable period in
1996. Such increase was due primarily to increases in personnel and
professional costs relating to clinical development, NDA preparation and
filing, and the commencement of European operations. General and
administrative expense for the third quarter increased by $2,024,096 to
$3,019,762 in 1997 from $995,666 for the comparable period in 1996. This
increase was due to costs of additional personnel and higher professional
costs relating to marketing, recruiting and investor relations. The Company
is in the process of implementing a sales and marketing program in
anticipation of the approval of TOBI for cystic fibrosis. Accordingly,
the Company expects general and administrative expense to increase in
future periods.
7
Other income primarily represents investment income from the Company's
investment securities. In the third quarter, investment income, net increased
by $390,029 to $1,403,010 in 1997 from $1,012,981 for the comparable period in
1996. Such increase was due primarily to higher average invested cash balances.
NINE MONTHS ENDED SEPTEMBER 30, 1997 AND 1996
Revenue from grants and royalties for the first nine months increased
by $42,071 to $324,914 in 1997 from $282,843 for the comparable period in 1996.
Revenues for the first nine months of 1997 represented income received from a
two-year competitive grant from the FDA and royalties from sales of a
proprietary combinatorial chemistry system invented by the Company.
Research and development expense for the first nine months increased
by $4,522,894 to $18,960,568 in 1997 from $14,437,674 for the comparable period
in 1996. Such increase was due primarily to increases in personnel and
professional costs relating to clinical development, NDA preparation and
filing, and the commencement of European operations. General and
administrative expense for the first nine months increased by $3,455,593 to
$6,374,766 in 1997 from $2,919,173 for the comparable period in 1996. This
increase was due to costs of additional personnel and higher professional
costs relating to marketing, recruiting and investor relations. The Company
is in the process of implementing a sales and marketing program in
anticipation of the approval of TOBI for cystic fibrosis. Accordingly,
the Company expects general and administrative expense to increase in future
periods.
Other income primarily represents investment income from the Company's
investment securities. In the first nine months, investment income net
increased by $1,537,441 to $3,897,650 in 1997 from $2,360,209 for the
comparable period in 1996. Such increase was due primarily to higher average
invested cash balances.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations since inception primarily by
the issuance of equity securities. Through September 30, 1997, the Company has
raised $61,331,268 from private sales of Common Stock and $123,745,948 from
public offerings of Common Stock. Through September 30, 1997, the Company has
earned net interest and investment income of $11,372,697 from investments.
The Company's combined cash, cash equivalents and investment
securities totaled $89,830,603 at September 30, 1997, an increase of
$29,142,807 from the balance at December 31, 1996. This increase was due
primarily to the net proceeds to the Company from the public offering of
2,100,000 shares of Common Stock in March 1997. The primary uses of cash
during the quarter ended September 30, 1997, were to finance the Company's
operations and working capital requirements. From the Company's inception
through September 30, 1997, the Company has purchased approximately $16.1
million of property and equipment.
Historically the primary uses of cash have been to finance the
Company's operations, consisting of research and development programs and
general and administrative infrastructure. Beginning in the third quarter
ended September 30, 1997, cash and investments were used to build up inventory
in anticipation of the approval of TOBI for cystic fibrosis, in addition to the
normal operating activity.
The Company plans to continue its policy of investing excess funds in
government securities and investment grade, interest-bearing securities
primarily with a maturity of one-and-one-half years or less.
The Company anticipates that its existing capital resources should be
sufficient to meet its operating expenses and capital requirements through at
least the next 24 months. Until such time as the Company can generate
sufficient levels of cash from operations, the Company will have to continue to
finance future cash needs through some or all of the sources previously used or
through other means. The Company does not expect to generate a positive
internal cash flow for at least the next year due to spending for research and
clinical development programs and the expected cost of commercializing its
first products. The Company may need to arrange additional financing for the
future operation of its business, including the development and
commercialization of its various drug candidates. There can be no assurances
that such additional financing can be obtained, and if obtained, at reasonable
terms.
In February 1997, the Financial Accounting Standards Board issued
Financial Accounting Standard No. 128, "Earnings Per Share." This statement
will change the computation, presentation and disclosure requirements for
earnings per share ("EPS"). The statement will be effective for interim and
annual reporting periods ending after December 15, 1997. This statement will
replace "primary" EPS with "basic" EPS, the principal difference being the
exclusion of common stock equivalents in the computation of basic EPS. In
addition, this statement will require the dual presentation of basic and
diluted EPS on the face of the consolidated statement of operations. EPS
computed pursuant to this statement is not expected to be materially different
from the historical net loss per share previously presented.
8
PART II - OTHER INFORMATION
Item 1. Legal Proceedings None.
Item 2. Changes in Securities None.
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 Exhibit 27.
Financial Data Schedule.
(b) Reports on Form 8-K None
9
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.
PATHOGENESIS CORPORATION
Date: November 14, 1997 By: /s/ Wilbur H. Gantz
--------------------------------
Wilbur H. Gantz
President and Chief
Executive Officer
Date: November 14, 1997 By: /s/ Alan R. Meyer
--------------------------------
Alan R. Meyer
Senior Vice President and
Chief Financial Officer
10