Repligen Reports Third Quarter 2001 Results
Company Updates Progress on Product Development Programs
NEEDHAM, Mass., Feb. 1 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN - news) today reported a loss of $1,583,000, or $.06 per share, on revenues
of $1,159,000 for the third quarter of fiscal year 2001 ended December 31, 2000. This compares to a loss of $1,735,000, or $.08 per share, on revenues of
$864,000 for the third quarter of fiscal year 2000. Expenses for the quarter were $2,742,000, compared to $2,599,000 in the same quarter of fiscal year 2000.
Total revenue for the period largely increased as a result of an increase in investment income due to higher cash and investment balances offset by decreased
research and development revenues.
Total revenue for the first nine months of fiscal year 2001 ended December 31, 2000 was $3,349,000, with expenses of $7,115,000, for a loss of $3,766,000, or
$0.14 per share. This compares with a loss of $2,962,000, or $0.14 per share, with revenues of $2,535,000 and expenses of $5,497,000, for the first nine months
of fiscal year 2000. Cash and investments at December 31, 2000 were $31,409,000. The increase in year to date revenue was largely attributable to an increase in
investment income due to higher average cash balances offset by decreased research and development revenues.
``We made significant progress in our secretin and CTLA4 development programs during the quarter,'' stated Walter C. Herlihy, President and CEO of Repligen.
``Our strong financial position enabled us to initiate a third development program in mitochondrial disease in December through a licensing agreement with the
University of California, San Diego consistent with our objective to become the leading company in the development of drugs for pediatric developmental disorders.''
Update on Product Development Programs
Secretin for Autism
During the quarter, we completed enrollment for our Phase 2 clinical trial
of secretin for autism. Approximately 130 patients were enrolled, and to date
more than 80 patients have completed the three dose protocol. We expect to
complete the dosing and evaluation of all patients by March 2001. Following
completion of the trial, we intend to report the results of the primary and
secondary endpoints. The primary endpoint is a reduction in the symptoms of
autism using standardized testing protocols. Secondary endpoints include
improvements in gastrointestinal function and the evaluation of the
improvements in the symptoms of autism in subsets of patients defined by age,
severity of symptoms and several biological markers of gastrointestinal
dysfunction. A comprehensive description of all results will be submitted to
appropriate scientific conferences and peer-reviewed journals.
We believe that this is the largest clinical trial carried out to date in autism and the only trial to make multiple biological measurements and systemically assess the
symptomatology of autism in the same patient population. We believe the data obtained in this trial will enable us to plan and execute additional clinical trials in this
patient population with far greater precision than previously possible.
During the quarter, we also initiated a series of experiments to evaluate the neurological activity of secretin in animal models. Insights into the activity of secretin on
the nervous system may provide additional guidance for product development and a biological rationale for its use.
Uridine for Mitochondrial Disease
In December, we announced an agreement with the University of California, San Diego (UCSD) in which we acquired exclusive rights to a patent application for the
use of uridine, and analogs of uridine for the treatment of mitochondrial disease. Mitochondria are structures essential for many cellular functions, including energy
production, and are the only non-dietary source of uridine, an essential component for the production of RNA and DNA. Forms of mitochondrial disease affect
approximately 20,000 people in the United States and result in symptoms including seizures, skeletal and heart muscle weakness and neurological and cognitive
defects. Over the last three years, 15 patients with mitochondrial defects have been treated with uridine or an analog, triacetyl uridine (TAU), at the UCSD
Mitochondrial and Metabolic Disease Center. These studies have shown that uridine and TAU are well tolerated in this population for more than two years. Some of
these patients have also shown marked improvements in their symptoms including cognitive performance, muscle control and renal function. Pending approval by the
Food and Drug Administration (FDA), we intend to initiate a placebo-controlled clinical trial in mitochondrial patients later this year.
CTLA4-Ig for Stem Cell Transplantation
In October, we received approval from the FDA to evaluate CTLA4-Ig in patients receiving a stem cell transplant (SCT) for leukemia and other diseases for which
a SCT is indicated. This study will seek to extend and confirm the observation from Phase 1 studies that CTLA4-Ig can block Graft vs. Host Disease (``GVHD'' or
rejection) in patients receiving a SCT from a ``genetically mismatched'' donor. We intend to request FDA approval for a second clinical study in patients receiving a
SCT in which the patients are not exposed to high doses of radiation prior to the transplant. If CTLA4-Ig is active against GVHD, it could increase the use of this
therapy to a wider range of patients for whom the current morbidity and mortality of a SCT is too high.
SecreFlo(TM) for Pancreatic Diagnosis
In April 2000, we announced that the FDA had issued an ``approvable letter'' for the use of synthetic porcine secretin (SecreFlo(TM)) for the diagnostic assessment
of pancreatic function. The ``approvable letter'' indicated that SecreFlo(TM) could be approved, pending a satisfactory response to a series of additional questions
concerning the manufacture and quality control of the product. The FDA has recently specified that our partner, ChiRhoClin, must manufacture an additional lot of
product produced at a second site and confirm that it meets all quality control criteria.
SELECTED FINANCIAL DATA
Operating Statement Data:
Three-Months Ended Nine-Months Ended
December 31, December 31,
2000 1999 2000 1999
Revenues:
Product $615,000 $558,000 $1,495,000 $1,370,000
Investment income 539,000 131,000 1,603,000 334,000
Other 5,000 175,000 251,000 831,000
1,159,000 864,000 3,349,000 2,535,000
Costs and expenses:
Research and
development 1,781,000 1,864,000 4,206,000 3,086,000
Selling, general
and administrative 568,000 443,000 1,957,000 1,636,000
Cost of products
sold 393,000 292,000 952,000 775,000
2,742,000 2,599,000 7,115,000 5,497,000
Net loss $(1,583,000)$ (1,735,000) $(3,766,000) $ (2,962,000)
Net loss per
common share
outstanding $ (0.06) $(0.08) $ (0.14) $(0.14)
Weighted average
common shares
outstanding 26,576,000 22,194,000 26,531,000 20,951,000
Balance Sheet Data:
December 31, 2000
Cash and investments $31,409,000
Total assets $33,430,000
Stockholders' equity $32,281,000
Repligen Corporation develops new drugs for debilitating pediatric disorders including autism, cancer, and immune and metabolic disorders. Repligen also
manufactures and markets a set of patented products based on Protein A, which are used by the pharmaceutical industry to produce therapeutic antibodies. Its
corporate headquarters are located at 117 Fourth Avenue, Needham MA, 02494. Additional information may be requested from www.repligen.com. |
