To all: nice summary and recommendation of CYTO copied from the CYTO thread:
>>Dear StockProClub Members,
CYTOGEN Corporation
Ticker Symbol: CYTO
Exchange: Nasdaq
Last Trade Sept 22: 4 1/4
Change +7/16 (+11.48%)
Prev Close 3 13/16
Volume 380,100
Day's Range 3 13/16 - 4 1/4
Bid 4 3/16
Ask 4 1/4
Open 3 13/16
52-week Range 3 5/8 - 7 1/8
CYTOGEN is a biopharmaceutical company that discovers, develops, and
markets products for diagnosing and treating disease. The company uses
its patented and proprietary technologies to develop specific in-vivo
cancer diagnostic imaging and therapeutic products. CYTOGEN's priority
products include OncoScint CR/OV, an antibody-based diagnostic imaging
agent for colorectal and ovarian cancer; Samarium 153 EDTMP, a cancer
therapy agent (now in Phase III clinical trials) for treating bone pain associated with bone metastases; and ProstaScint, a prostate cancer diagnostic imaging product. CYTOGEN has licensed to The DuPont Merck Pharmaceutical Company the manufacturing and comarketing rights to Samarium. For the six months ended 6/30/97, revenues rose from $2.8
million to $6 million.
In March 1997, CYTOGEN received clearance from the U.S. Food and Drug
Administration ("FDA") to market the Quadramet(R) pain relief drug,
CYTOGEN's treatment for the severe pain associated with cancer that
spreads to the bone. In October 1996, CYTOGEN received marketing
approval from FDA for the ProstaScint(R) imaging agent, CYTOGEN's
prostate cancer diagnostic imaging product. OncoScint CR/OV(R) was
approved by FDA in December 1992 for single administration per patient
and in November 1995, FDA approved repeat administration per patient.
All three products are currently available in the market place.
In 1996, CYTOGEN and Elan Corporation, plc and affiliated corporations
(collectively, "Elan") created Targon, a U.S.-based cancer company.
Through this collaboration, CYTOGEN contributed its own funds to Targon and received funds from Elan which are restricted to use for Targon. At June 30, 1997 and December 31, 1996, the aggregate amount of these funds totaled $9.1 million and $9.9 million.
In March 1997, the Company received marketing clearance from FDA for
Quadramet. As a result of the clearance CYTOGEN recorded a milestone
payment of $2.0 million from The DuPont Merck Pharmaceutical Company
("DuPont Merck"), for manufacturing and marketing rights to Quadramet,
and also recorded a $4.0 million milestone payment to The Dow Chemical
Company ("Dow") for the exclusive license to Quadramet.
On July 21, 1997 Targon entered into an agreement with Elan pursuant to which Targon acquired an exclusive worldwide license for a controlled release oral morphine pain relief product (the "Oral Morphine Product"),
for an up-front license fee of $7.5 million. CYTOGEN received from Elan $10.0 million in exchange for a three-year interest bearing note with principal due in full at the end of year three. Targon received $10.0 million from CYTOGEN in exchange for a three year interest bearing note with principal due in full at the end of year three to purchase the Oral Morphine Product and to provide working capital for product development.
In February 1997, CYTOGEN launched its second FDA-approved product,
ProstaScint, a monoclonal antibody-based imaging agent developed to
detect the presence and extent of metastatic prostate cancer. In
connection with the launch, CYTOGEN has developed its PIE/TM/ (Partners in Excellence) accreditation program by establishing a network of qualified nuclear medicine sites and physicians. Each site is trained and certified in acquiring, processing and interpreting the
antibody-derived images. As of July 28, 1997 there are 141 PIE sites in operation. ProstaScint is available only at such qualified sites, thus providing quality control and support. C.R. Bard, Inc. ("Bard") is currently marketing ProstaScint to urologists while CYTOGEN markets
ProstaScint to the medical imaging community through its PIE Program.
Both companies work together to market ProstaScint to managed care
organizations.
In June 1997, DuPont Merck launched into the market place CYTOGEN's
third FDA-approved product, Quadramet, a treatment for the pain
associated with bone metastases, a condition that occurs when cancer
spreads to the bone. Since that time, hospitals and physicians have
made applications to amend their federal and/or state licenses for radioactive products to include Quadramet, a process which varies state by state. Therefore, revenue from the sale of Quadramet is not likely to be meaningful until the second half of this year. DuPont Merck manufactures, markets and distributes Quadramet through its radiopharmaceuticals operations in the U.S.
Revenues. Total revenues for the three and six months ended June 30,
1997 were $2.2 million and $6.0 million, respectively, compared to $1.6 million and $2.8 million recorded in the same periods of 1996. The increase from the prior year periods is attributable to increased
product related revenues from sales of ProstaScint. The 1997
year-to-date revenues were further increased by a $2.0 million milestone payment recorded in the first quarter of 1997 from DuPont Merck upon FDA clearance of Quadramet.
For the three and six months ended June 30, 1997, product related
revenues were $1.3 million and $2.2 million, respectively, compared to $359,000 and $742,000 recorded for the same periods of 1996. The
increase from the prior year periods is attributable primarily to sales of ProstaScint which was launched in February 1997.
License and contract revenues for the three and six months ended June
30, 1997 were $837,000 and $3.8 million, respectively, compared to $1.2 million and $2.0 million recorded in the same periods of 1996. The second quarter decrease from the prior year period is primarily
attributable to lower contract revenue realized from Elan for a research program that combined CYTOGEN's technology with Elan's drug delivery system technology.
Operating Expenses. Operating expenses for the three and six months
ended June 30, 1997 were $8.8 million and $20.7 million, respectively,
compared to $7.1 million and $14.4 million recorded in the same periods of 1996. The second quarter increase from the prior year period is attributable primarily to expenses associated with Targon and AxCell, two new strategic business units established during the second half of last year. The year-to-date increase from the prior year period is attributable primarily to a one-time $4.0 million milestone payment to Dow recorded in the first quarter of 1997 upon FDA clearance of Quadramet, and to Targon and AxCell related expenses. The current year operating expenses reflect the Company's objective to focus its efforts on its highest priority products and technology, which are (i) ProstaScint, (ii) Quadramet, (iii) the autolymphocyte therapy for metastatic renal cell carcinoma and (iv) the Genetic Diversity Library technology.
Research and development expenses for the three and six months ended
June 30, 1997 were $5.7 million and $14.5 million, respectively,
compared to $4.6 million and $9.3 million recorded in the same periods of 1996. These expenses principally reflect product development efforts and support for various ongoing clinical trials. The second quarter increase from the prior year period is attributable primarily to expenses associated with Targon and AxCell. The year- to-date increase from the prior year period is attributable primarily to the aforementioned $4.0 million milestone payment to Dow, and to Targon and AxCell related expenses.
Selling and marketing expenses for the three and six months ended June
30, 1997 were $1.4 million and $2.5 million, respectively, compared to
$1.1 million and $1.9 million recorded in the same periods of 1996. The increase from the prior year periods is primarily attributable to
expenses associated with the launch of ProstaScint, including expenses
to establish the PIE Program.
General and administrative expenses for the three and six months ended
June 30, 1997 were $1.8 million and $3.7 million, respectively, compared to $1.3 million and $3.2 million recorded in the comparable periods of 1996. The increase from the prior year periods is primarily attributable to accruals for year-end merit awards which will normalize by year-end to prior year levels.
Interest Income/Expense. Interest income for the three and six months
ended June 30, 1997 were $299,000 and $682,000, respectively, compared
to $387,000 and $767,000 realized in the same periods of the prior
year. The decrease from the prior year periods is due primarily to lower cash and short term investment balances for the periods.
Interest expense for the three and six months ended June 30, 1997 was
$73,000 and $146,000, respectively, compared to $111,000 and $225,000
recorded in the same periods of 1996. The decrease from the prior year
periods is due to lower outstanding debt balances in 1997.
ProstaScint. Beginning in 1997, product related revenues included sales of ProstaScint. CYTOGEN is co-promoting ProstaScint with Bard. During the term of the co-promotion agreement, Bard will receive
performance-based compensation for its services.
Quadramet. With FDA clearance of Quadramet, the product was made
available for purchase in late May, was launched by DuPont Merck in late June 1997 and reached the market place at the end of the quarter.
Revenue from Quadramet sales is not likely to be meaningful until the
second half of this year. Pursuant to the terms of an agreement between CYTOGEN and DuPont Merck, in April 1997, CYTOGEN received a $2.0 million milestone payment from DuPont Merck in connection with FDA clearance of Quadramet. The agreement also provides for
future payments towards additional clinical programs, additional
payments upon achievement of certain other milestones and payments based on sales, including guaranteed minimum payments.
OncoScint CR/OV. In 1994, the Company reacquired all U.S marketing
rights to OncoScint from Knoll Pharmaceuticals Company ("Knoll") and is required to pay to Knoll as follows: $1.6 million in 1997 which was paid on July 1, 1997 and $1.7 million in 1998. In that same year, the Company reacquired the exclusive marketing and distribution rights in Europe from Chiron B.V. ("Chiron") and is required to pay to Chiron in 1997 the $377,000 outstanding balance from the resulting liability.
During the third quarter of 1997, Targon entered into an agreement with Elan to purchase the Oral Morphine Product. After the up-front license fee payment to Elan, the agreement provides Targon with $2.5 million for product development. The three-year $10.0 million interest bearing note with Elan will be due in full at the end of year three. Additional payments may be due Elan by Targon in the future if and as certain milestones are met.
CYTOGEN acquired an exclusive license in the U.S., Canada and Latin
America from Dow for Quadramet. In April 1997, the Company paid to Dow $4.0 million in connection with FDA clearance of Quadramet. The
agreement provides for additional payments by the Company upon
achievement of certain milestones and royalties on net sales of the
product once commercialized, including guaranteed minimum payments.
CYTOGEN announced a variety of media events ranging from product
information on CNBC television to published clinical trial results, all of which are a part of the Company's active participation in Prostate Disease Awareness Month (September) and Prostate Cancer Awareness Week (September 21-27, 1997).
CYTOGEN believes the upcoming events will provide valuable information
to physicians, patients and their families on current developments in
the care for this disease and welcomes the opportunity for its products to be featured. Developing products to better diagnose and treat prostate cancer has been a major area of commitment for CYTOGEN. With the approval and launch this year of ProstaScint(R) (kit for the
preparation of indium In 111 Capromab Pendetide) and Quadramet(R)
(Samarium Sm 153 Lexidronam Injection), along with the encouraging clinical findings with the PSMA vaccine, there is much positive news from CYTOGEN to bring to physicians, prostate cancer patients and their families. Broader awareness of these important developments will ensure that people know about these new options for treatment and can help to relieve the suffering from this dreaded disease.
The Company's Quadramet product, a drug developed as a treatment for
patients with severe chronic pain associated with cancer that spreads to the bone, will be the subject of a segment included in CNBC's Today's Health program scheduled to air on Sunday, September 28, 1997 at 3:00 p.m. (EST). The segment will feature a physician who has used Quadramet as well as a cancer patient who has received the product. The Fall issue of Family Urology will contain a pain management article by Dr. Oliver Sartor, Associate Professor of Oncology, Louisiana State University, which discusses various cancer pain management options including Samarium Sm 153 Lexidronam Injection.
The Company's ProstaScint prostate cancer imaging agent, a non-invasive (non-surgical) diagnostic agent available to prostate cancer patients considered at high risk for cancer spread outside the prostate, is to be described in Family Circle's Fall special issue entitled Your Family's Health in a prostate cancer patient's story.
The recently published September 1997 issue of ``The Prostate'' contains an article detailing results from a phase I clinical trial conducted using CYTOGEN's PSMA (prostate specific membrane antigen) technology in the development of a prostate cancer vaccine. The clinical trials are being conducted by the Pacific Northwest Cancer Foundation located in Seattle, Washington.
The Company is also participating in a series of Prostate Cancer Patient Advocacy Meetings, which will address the roles of ProstaScint and Quadramet in meeting the needs of prostate cancer patients. These
meetings are scheduled for September 27th in Philadelphia, PA and
Morristown, NJ; October 3rd in Orlando, FL; October 16th in New York
City; October 31st and November 1st in Columbia, SC; November 12th at
the New Jersey Prostate Cancer Summit, New Brunswick, NJ; and December
11th at the Mercer County Prostate Cancer Support Group in New Jersey.
For the most current news on CYTOGEN and a current listing of PIE(TM)
(Partners In Excellence) sites, visit the Company's web site at
cytogen.com, or call 800-758-5804, extension 224650, to
receive news releases by facsimile.<< |
