"Of course, the most significant event of 1997 was the year-end approval
of PathoGenesis' first drug, TOBI," said Wilbur H. Gantz, president and chief
executive officer. "We estimate that about $5 million to $5.5 million in
orders went to fill the pipeline, and TOBI reorders are now coming in
continually. Our 21 sales people are focused initially on the 113 centers
accredited by the CF Foundation -- 69 of which participated in the TOBI
clinical trials. Our sales force has reported good acceptance of TOBI by
these caregivers and their patients."
PathoGenesis Corp. Reports 1997 Results, Initial Sales of Its First Drug
PR Newswire, Thursday, January 29, 1998 at 16:35
SEATTLE, Jan. 29 /PRNewswire/ -- PathoGenesis Corp. (NASDAQ:PGNS) today
reported results for the fourth quarter and year ended Dec. 31, 1997. The
company also reported initial sales of its first drug, TOBI(TM) (tobramycin
solution for inhalation) for cystic fibrosis patients, which were booked in
January.
For 1997, PathoGenesis reported a net loss of $33.0 million, or $2.10 per
share based on 15.7 million average shares outstanding. For 1996, the net
loss was $21.3 million, or $1.66 per share based on 12.8 million average
shares outstanding. The increase in shares is a result of a follow-on stock
offering in March 1997 and option exercises.
Revenues from grants and royalties for the year were $442,000, up slightly
from $440,000 in 1996. PathoGenesis' research and development costs were
$28.0 million in 1997, including a $1.5 million milestone payment to the
Cystic Fibrosis Foundation and Children's Hospital and Medical Center,
Seattle, upon TOBI's approval by the U.S. Food and Drug Administration.
Development costs also increased in 1997 from $20.7 million in 1996 due to
progress in the clinical development of TOBI and an oral tuberculosis drug,
PA-1648. General and administrative expenses were $10.6 million in 1997,
mainly due to costs associated with the market launch of TOBI, compared with
the $4.2 million reported in 1996.
"Of course, the most significant event of 1997 was the year-end approval
of PathoGenesis' first drug, TOBI," said Wilbur H. Gantz, president and chief
executive officer. "We estimate that about $5 million to $5.5 million in
orders went to fill the pipeline, and TOBI reorders are now coming in
continually. Our 21 sales people are focused initially on the 113 centers
accredited by the CF Foundation -- 69 of which participated in the TOBI
clinical trials. Our sales force has reported good acceptance of TOBI by
these caregivers and their patients."
Gantz said the process of obtaining reimbursement authorization by third
party payors is proceeding satisfactorily. PathoGenesis has a Medicaid drug
rebate agreement in effect and more than half the state Medicaid agencies have
now completed their procedures to add TOBI to their lists of approved drugs.
Also in 1997, PathoGenesis initiated three Phase II clinical trials. Two
studies are investigating the use of TOBI in follow-on indications,
tuberculosis and bronchiectasis (a form of severe chronic bronchitis). The
third trial is studying an oral drug, PA-1648, in tuberculosis patients.
Results of the three trials are expected to be announced in the second half of
1998.
Fourth Quarter Results
For the fourth quarter of 1997, PathoGenesis had a net loss of $11.8
million, or 73 cents per share based on 16.2 million shares outstanding. In
the same period of 1996, the net loss was $6.5 million, or 47 cents per share,
based on 13.9 million shares outstanding.
Revenues were $117,000 in the fourth quarter of 1997, versus $157,000 in
the year-earlier period. Research and development expenses were $9.1 million
for the 1997 quarter, due in part to a $1.5 million milestone payment upon
approval of TOBI and clinical development costs. This represents a 45 percent
increase from $6.2 million for the 1996 quarter. General and administrative
expenses were $4.2 million in the fourth quarter of 1997, mainly due to
commercialization expenditures, versus $1.3 million in the fourth quarter of
1996.
At Dec. 31, 1997, PathoGenesis had cash and marketable securities of $79.0
million, compared with $60.7 million at the end of 1996.
PathoGenesis Corp. develops drugs for treating serious infectious diseases
where there is a significant need for improved therapy. The company is
currently developing drug candidates to treat chronic lung infections in
cystic fibrosis and bronchiectasis patients, as well as tuberculosis
infections. PathoGenesis is headquartered in Seattle and has additional
facilities in Skokie, Ill.; Annandale, N.J.; and Brentford, Middlesex, U.K.
Its stock is traded on the Nasdaq National Market System under the symbol
PGNS. The company's Web site is located at www.pathogenesis.com.
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
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 these and other
factors is available in PathoGenesis' Annual Report on Form 10-K for 1996 and
other documents filed with the Securities and Exchange Commission.
PathoGenesis Corp.
Consolidated Statements of Operations
(Dollars in thousands, except per share data)
Three Months Ended Year Ended
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
1997 1996 1997 1996
Revenue:
Grants and royalties $ 117 $ 157 $ 442 $ 440
Operating expenses:
Research and development 9,057 6,237 28,018 20,673
General and administrative 4,207 1,321 10,582 4,241
Total operating expenses 13,264 7,558 38,600 24,914
Operating income (loss) (13,147) (7,401) (38,158) (24,474)
Other income (expense):
Investment income, net 1,380 934 5,278 3,294
Other expense (55) (32) (158) (84)
Net other income 1,325 902 5,120 3,210
Net loss $ (11,822) $ (6,499) $ (33,038) $(21,264)
Net loss per common share* $ (0.73) $ (0.47) $ (2.10) $ (1.66)
Weighted average common
shares outstanding 16,202,537 13,904,060 15,704,151 12,829,386
Balance Sheet Highlights Dec. 31,
(in thousands) 1997 1996
Cash, cash equivalents and
investment securities $ 79,041 $ 60,688
Total current assets 87,190 61,809
Total assets 97,596 69,999
Total current liabilities 8,107 2,974
Long-term liability 0 98
Total stockholders' equity 89,489 66,926
* Net loss per share assuming dilution is the same as basic net loss per
share, since shares issuable for stock options and warrants would be
anti-dilutive.
SOURCE PathoGenesis Corporation
-0- 01/29/98
/CONTACT: Alan Meyer, 206-467-8100, or Maryellen Thielen, 847-583-5424,
both of PathoGenesis Corp.; or Barbara Lindheim of Noonan-Russo, 212-696-4455,
X237/
/Web site: pathogenesis.com |
