Earnings out! Loss of $.17 vs estimate of $.38. Even though the headline in the annoucement says, loss widens, I'd interpret this as being extremely bullish in that their loss was a lot less than expected.
Interneuron Pharmaceuticals Announces Third Quarter Fiscal 1997 Results
BusinessWire, Tuesday, August 12, 1997 at 16:41
LEXINGTON, Mass.--(BW HealthWire)--Aug. 12, 1997--
Recent Activity Includes Development of Once-a-day Formulation of
Redux(TM) and Completion of Progenitor IPO
Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC) today announced
the consolidated results of its operations for the three and nine
month periods ended June 30, 1997.
Total consolidated revenues were $17,395,000 for the three month
period ended June 30, 1997 and $54,861,000 for the nine month period
ended June 30, 1997. This compares to revenues of $2,167,000 for the
three month period ended June 30, 1996 and $8,415,000 for the nine
month period ended June 30, 1996.
The Company reported net losses of $7,174,000 or $0.17 per share
for the 1997 three month period and $17,955,000 or $0.44 per share for
the 1997 nine month period, compared to net losses of $6,173,000 or
$0.16 per share and $21,318,000 or $0.60 per share for the 1996 three
and nine month periods, respectively.
"Increased revenues at Interneuron during fiscal year 1997 have
been accompanied by increased investment in a number of advanced
clinical stage products," said Glenn L. Cooper, M.D., president and
chief executive officer at Interneuron. "The most significant recent
development at Interneuron was announced on July 15 following a
preliminary analysis of our second Phase 3 trial with CerAxon(TM)
(citicoline) among patients with ischemic stroke. Results of this
trial, combined with previously announced data from our first pivotal
trial and significant clinical and post-marketing data from abroad,
will form the basis of the submission of Interneuron's New Drug
Application (NDA) for CerAxon(TM) before the end of 1997.
"Additional advanced-stage clinical trial activity is continuing
on schedule for two other Interneuron products," said Dr. Cooper.
"Enrollment in the Phase 3 trial of bucindolol, under development
through our Intercardia subsidiary as a treatment for congestive heart
failure, is continuing on schedule, with total patients currently
numbering approximately 1900. Our pivotal trial with pagoclone for
anxiety is also continuing as planned, with enrollment expected to
conclude in mid-1998. In addition, LidodexNS, in pre-clinical
development for the acute treatment of migraine headaches, will join
the ranks of Interneuron's clinical-stage products after the
Investigational New Drug application (IND) is submitted later this
year.
"Increased revenues during fiscal year 1997 primarily reflect
royalties and manufacturing revenues from Redux, which was launched in
June, 1996," said Dr. Cooper. "Redux sales continue to be adversely
affected by negative publicity surrounding weight loss drugs and
recent reports of potential serious side effects reported with the
combined use of fenfluramine and phentermine," said Dr. Cooper.
The Company's consolidated revenues of $17,395,000 for the three
month period ended June 30, 1997 includes $14,886,000 in product
revenue related to sales of Redux and $2,383,000 in contract and
license fees paid to Interneuron and its subsidiaries. Of the
$14,886,000 in Redux product revenue, approximately $10,464,000
represents royalties on sales of Redux and approximately $4,303,000
represents revenue from the sale of Redux capsules to American Home
Products (AHP). The Company's consolidated revenues of $54,861,000 for
the nine month period ended June 30, 1997 includes $45,796,000 in
product revenue related to sales of Redux and $8,661,000 in contract
and license fees paid to Interneuron and its subsidiaries. Of the
$45,796,000 in Redux product revenue, approximately $27,449,000
represents royalties on sales of Redux and $18,196,000 represents
primarily revenue from the sale of Redux capsules to AHP.
Interneuron recognizes Redux royalty revenue and associated
expenses in the quarter following shipments by AHP to distributors.
Cost of product revenue totaled approximately $9,144,000 for the
three month period ended June 30, 1997 and $31,047,000 for the nine
month period ended June 30, 1997, compared to approximately $661,000
for the 1996 three month period and $727,000 for the 1996 nine month
period. These costs included primarily expenses associated with the
sale of Redux capsules and, for the 1997 periods, royalties due to Les
Laboratoires Servier, licensor of Redux to Interneuron.
Consolidated research and development expenses totaled
$10,500,000 for the three month period ended June 30, 1997 compared to
$4,955,000 for the corresponding 1996 three month period, and
$27,984,000 for the nine month period ended June 30, 1997 compared to
$11,615,000 for the corresponding 1996 nine month period. The
Company's major research and development costs principally reflect
Phase 3 clinical trials with CerAxon(TM) for stroke and pivotal
clinical trials with pagoclone for anxiety. Future periods will
include significant research and development expenses related to Phase
4 studies with Redux expected to commence shortly, the development of
a once-a-day formulation of Redux, filing of an NDA for CerAxon(TM)
and additional, ongoing clinical testing of CerAxon(TM).
Consolidated selling, general and administrative expenses
increased to $7,372,000 for the three month period ended June 30,
1997, from $4,297,000 for the 1996 three month period and to
$18,716,000 for the nine month period ended June 30, 1997 from
$11,178,000 for the 1996 nine month period. This increase primarily
reflects expenses incurred in connection with the copromotion of
Redux, promotional expenses incurred for PMS Escape and increased
costs relating to business development activities and the company's
growth.
Included in the losses for fiscal year 1997 are approximately
$286,000 for the three month period ended June 30, 1997 and $2,547,000
for the nine month period ended June 30, 1997, for the purchase of
in-process research and development primarily relating to the purchase
by Interneuron of the common stock of Intercardia, Inc., a
majority-owned subsidiary.
During the second quarter of fiscal 1997, Interneuron announced
authorization to repurchase up to 1,500,000 shares of its common
stock. For the three month period ended June 30, 1997, the Company
repurchased 75,000 of its own shares for a purchase price of
approximately $1,359,000. As of June 30, 1997, the Company has
repurchased 217,500 of its own shares for a purchase price of
approximately $3,978,000.
Interneuron also initiated during the second quarter of fiscal
1997 the purchase of up to 200,000 shares of common stock of its
majority-owned subsidiary, Intercardia, Inc. For the three month
period ended June 30, 1997, the Company purchased 20,000 shares of
Intercardia common stock for a purchase price of approximately
$401,000. As of June 30, 1997, Interneuron has purchased 124,400
shares of Intercardia common stock for a purchase price of
approximately $2,837,000 bringing its percentage ownership of
Intercardia to approximately 61 percent of the outstanding common
stock.
Weighted average common shares increased to approximately
41,048,000 for the 1997 three month period from 38,300,000 for the
1996 three month period and to approximately 41,055,000 for the 1997
nine month period from 35,702,000 for the 1996 nine month period.
At June 30, 1997, on a consolidated basis, the Company had cash,
cash equivalents and marketable securities of approximately
$152,000,000.
Once-a-day Redux
The Company has also recently concluded agreements with AHP and
Servier for the development and commercialization in the U.S. of a
sustained release, once-a-day form of Redux, a currently available
twice-a-day prescription product for the management of obesity.
Interneuron agreed to pay Servier $2,000,000 in connection with
the signing of the agreement. Interneuron will also make future
licensing fee and regulatory review milestone payments to Servier.
Under terms of the agreement between Interneuron and AHP, these two
companies will share the costs of clinical development, including
Phase 3 clinical trials and related studies, and costs of submitting
an NDA for once-a-day Redux.
Royalty rates on sales of once-a-day Redux payable from AHP
to Interneuron and from Interneuron to Servier will approximate the
rates on the currently marketed twice-a-day formulation of Redux.
Dr. Cooper noted that AHP has filed an IND for once-a-day Redux,
clinical trials have commenced and AHP would be responsible for filing
the NDA and for manufacturing the product. "Pending the completion of
the clinical trial program for once-a-day Redux and assuming FDA
approval of the product, we look forward to an extended period of
market exclusivity based upon the once-a-day dosage form," said Dr.
Cooper.
Progenitor IPO
On August 12, 1997, Interneuron's Progenitor, Inc. subsidiary
completed an initial public offering of 2,750,000 units, each unit
consisting of one share of Progenitor common stock and one five-year
warrant to purchase one share of Progenitor common stock. The Progenitor
IPO resulted in net proceeds to Progenitor of approximately
$16,600,000. Interneuron purchased 500,000 units of the Progenitor IPO
for a total of $3,500,000. Concurrent with the Progenitor IPO,
Progenitor sold 1,023,256 shares to Amgen Inc. pursuant to a stock
purchase agreement for a purchase price of $4,500,000 in cash and a
$1,000,000 promissory note. Simultaneously with the closing of the
Progenitor IPO, Progenitor completed a merger with Mercator Genetics,
Inc. Interneuron's ownership in Progenitor's outstanding capital stock
decreased from approximately 76 percent at September 30, 1996 to
approximately 37 percent as a result of the Progenitor IPO and the
Mercator acquisition.
Interneuron Pharmaceuticals is a diversified biopharmaceutical
company engaged in the development and commercialization of a
portfolio of products and product candidates primarily for
neurological and behavioral disorders. Interneuron is also developing
products and technologies, generally outside the central nervous
system field, through four subsidiaries: Intercardia, Inc. focused on
cardiovascular disease, Progenitor, Inc. focused on developmental
genomics, Transcell Technologies, Inc. focused on carbohydrate-based
drug discovery, and InterNutria, Inc. focused on dietary supplement
products.
Except for the descriptions of historical facts contained herein,
this news release contains forward-looking statements that involve
risks and uncertainties as detailed from time to time in Interneuron's
SEC filings under the Securities Act of 1933 and the Securities
Exchange Act of 1934, including, in particular, risks relating to
product commercialization, such as marketing, safety and regulatory,
patent, product liability, manufacturing and supply, contractual
obligations and other risks, uncertainties relating to clinical
trials, the early stage of products under development, risks relating
to the product launches and managing growth, government regulation,
patent risks, dependence on third parties and competition.
*T
INTERNEURON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS For the
three and nine months ended June 30, 1997 and 1996
(Amounts in thousands except per share amounts)
(Unaudited)
For the three months For the nine months
ended June 30, ended June 30,
1997 1996 1997 1996
Revenues:
Product revenue $ 15,012 $ 1,100 $ 46,200 $ 1,167
Contract and license
fees 2,383 1,067 8,661 7,248
Total revenues 17,395 2,167 54,861 8,415
Costs and expenses:
Cost of product
revenue 9,144 661 31,047 727
Research and
development 10,500 4,955 27,984 11,615
Selling, general
and administrative 7,372 4,297 18,716 11,178
Purchase of in-process
research and development 286 -- 2,547 8,234
Total costs and expenses 27,302 9,913 80,294 31,754
Net loss from operations (9,907) (7,746) (25,433) (23,339)
Investment income, net 2,191 1,129 6,788 2,119
Minority interest 542 444 690 (98)
Net loss ($ 7,174) ($ 6,173) ($17,955) ($21,318)
Net loss per common share($ 0.17) ($ 0.16) ($ 0.44) ($ 0.60)
Weighted average common
shares outstanding 41,048 38,300 41,055 35,702
INTERNEURON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
June 30, Sept. 30,
1997 1996
Cash, cash equivalents and marketable
securities $ 151,776 $ 169,608
Other assets 21,815 16,830
Total assets $ 173,591 $ 186,438
Current liabilities $ 29,039 $ 21,761
Long-term liabilities 1,778 542
Minority interest 18,372 19,373
Capital 249,135 251,540
Accumulated deficit (124,733) (106,778)
Total stockholders' equity 124,402 144,762
Total liabilities and stockholders' equity $ 173,591 $ 186,438
*T
CONTACT: Interneuron Pharmaceuticals, Inc.
Thomas F. Farb William B. Boni
(617) 402-3404 (617) 402-3410
KEYWORD: MASSACHUSETTS
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL EARNINGS
URL: interneuron.com
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