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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-----------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 13, 1997
PATHOGENESIS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 0-27150 91-1542150
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
201 Elliott Avenue West, Seattle, Washington 98119
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (206) 467-8100
Not Applicable
(Former name or former address, if changed since last report)
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Item 5. Other Events.
Annexed hereto as Exhibit 1 is a copy of a press release issued by
PathoGenesis Corporation (the "Company") on February 13, 1997 announcing the
results for the fourth quarter and the year ended December 31, 1996.
In connection with the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, the Company is hereby filing as
Exhibit 2 cautionary statements identifying important factors that could cause
the Company's actual results to differ materially from those projected in
forward looking statements of the Company made by or on behalf of the Company in
the press release annexed hereto as Exhibit 1.
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Item 7. Exhibits
1. Press Release dated February 13, 1997.
2. Cautionary Statements for Purposes of the "Safe Harbor"
Provisions of the Private Securities Litigation Reform Act of
1995.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed by the undersigned
hereunto duly authorized.
PATHOGENESIS CORPORATION
(Registrant)
By: /s/ Alan R. Meyer
-------------------------------
Alan R. Meyer
Senior Vice President and
Chief Financial Officer
Date: February 18, 1997
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EXHIBIT INDEX
Exhibit Page Number
------- -----------
1. Press Release dated February 13,
1997.
2. Cautionary Statements for Purposes
of the "Safe Harbor" Provisions of
the Private Securities Litigation
Reform Act of 1995.
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EXHIBIT 1
SEATTLE, Feb. 13 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq: PGNS) today
reported results for the fourth quarter and year ended Dec. 31, 1996.
For 1996, the development stage company reported a net loss of $21.3
million, or $1.66 per share based on 12.8 million average shares outstanding. In
1995, the net loss was $18.0 million or $2.20 per share based on 8.2 million
average shares outstanding. The difference in shares occurred because of a
follow-on stock offering of 2.875 million shares completed in May 1996.
Revenues from grants and royalties were $440,000 for 1996. The
company's 1996 research and development costs were $20.7 million, compared with
$15.7 million for 1995. General and administrative expenses were $4.2 million in
1996 versus $3.6 million in the same period a year ago.
For the fourth quarter of 1996, PathoGenesis reported a net loss of
$6.5 million, or 47 cents per share, compared with a net loss of $4.9 million,
or 53 cents per share, in the comparable 1995 quarter. Due to its 1996 stock
offering, the company had 13.9 million average shares outstanding for the fourth
quarter of 1996 versus 9.2 million shares outstanding for the fourth quarter of
1995.
Fourth quarter 1996 revenues were $157,000. Research and development
expenses for the quarter were $6.2 million, compared with $4.4 million for the
fourth quarter of 1995. General and administrative expenses were $1.3 million in
the last quarter of 1996, versus $805,000 in the same period a year ago, as
PathoGenesis moves closer to introducing its first product.
In the fourth quarter, PathoGenesis completed Phase III clinical trials
on its most advanced drug candidate, TOBITM (tobramycin for inhalation) to treat
pseudomonal infections in cystic fibrosis patients. Also during the year, the
company completed a series of Phase I clinical trials in healthy study subjects
to test the safety and dosage levels of PA-1648, a drug being developed to treat
tuberculosis infections. In addition, company scientists presented data from
preclinical studies on PA-824 for treatment of tuberculosis, including
drug-resistant strains, at the Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC).
At Dec. 31, 1996, PathoGenesis had cash and marketable securities of
$60.7 million, compared with $37.4 million at the end of 1997.
PathoGenesis Corp. develops drugs for treating serious infectious
diseases where there is a significant need for improved therapy. The company is
currently developing TOBI (tobramycin for inhalation) for treating chronic lung
infections in cystic fibrosis and bronchiectasis patients, as well as TOBI,
PA-1648 and PA-824 for treating tuberculosis infections.
Note: This news release contains "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
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achievements expressed or implied by such forward-looking statements. Factors
that might cause such a difference include, but are not limited to, those
discussed under the heading "Risk Factors" in the company's prospectus dated
April 25, 1996, which was filed with the Securities and Exchange Commission.
PATHOGENESIS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
<TABLE>
<CAPTION>
THREE MONTHS ENDED YEAR ENDED
12/31/96 12/31/95 12/31/96 12/31/95
-------- -------- -------- --------
<S> <C> <C> <C> <C>
Revenues:
Grants and royalties $ 157 $ -- $ 440 $ --
Operating expenses:
Research and
development................. 6,237 $ 4,402 $ 20,673 $ 15,668
General and
administrative.............. 1,321 805 4,241 3,609
----------- ---------- ----------- ----------
Total operating
expenses.................... 7,558 5,207 24,914 19,277
----------- ---------- ----------- ----------
Operating income (loss)..... (7,401) (5,207) (24,474) (19,277)
Other income (expense):
Investment income, net.... 902 329 3,210 1,253
Net income (loss)......... $ 6,499 $ (4,878) $ (21,264) $ (18,024)
=========== ========== =========== ==========
Net income (loss) per common
share......................... $ (0.47) $ (0.53) $ (1.66) $ (2.20)
=========== ========== =========== ==========
Weighted average common
shares outstanding.......... 13,904,060 9,169,454 12,829,386 8,209,643
</TABLE>
<TABLE>
<CAPTION>
December 31,
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Balance Sheet Highlights: 1996 1995
---- ----
<S> <C> <C>
(in thousands)
Cash, cash equivalents and investment
securities.......................... $60,688 $37,447
Total current assets.................... 61,809 38,884
Total assets............................ 69,999 46,963
Total current liabilities............... 2,974 3,453
Long-term liability..................... 98 462
Total stockholders' equity.............. 66,926 43,048
</TABLE>
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EXHIBIT 2
CAUTIONARY STATEMENTS FOR PURPOSES OF THE "SAFE HARBOR"
PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
The Company wishes to caution readers that the following important factors,
among others, as more fully described under the heading "Risk Factors" in the
Company's prospectus (the "Prospectus"), dated April 25, 1996, filed with the
Securities and Exchange Commission pursuant to the requirements of Rule 424(b)
promulgated under the Securities Act of 1933, could affect, PathoGenesis'
product development efforts relating to its lead drug candidate, TOBI(TM)
(tobramycin for inhalation), as well as any other drug candidates that the
Company may seek to develop in the future.
The Company's product development efforts are subject to a variety of
uncertainties inherent in the development of pharmaceutical products. These
uncertainties include the possibilities that the Company's drug candidates will
be found to be ineffective, unsafe, toxic or otherwise fail to meet applicable
regulatory standards or receive necessary regulatory clearances; that any such
drug candidates, if safe and effective, will be difficult to develop into
commercially viable products, to manufacture on a large scale or be uneconomical
to market; or that proprietary rights of third parties will preclude the Company
from marketing any products developed by the Company. There is, therefore,
substantial uncertainty whether the Company's product development efforts will
prove to be successful. Moreover, the Company is seeking to develop new
treatments for conditions that are also the subject of research and development
efforts by other companies and entities. The Company's competitors may succeed
in developing technologies or products that are more effective or cost effective
than those of the Company. Rapid technological changes or developments by others
may result in the Company's drug candidates becoming obsolete or noncompetitive.
There can be no assurance that regulatory approvals will be obtained or will be
as broad as sought, that TOBI(TM) will be capable of being produced in
commercial quantities at reasonable costs or that any products, if introduced,
will achieve market acceptance.
