Neurocrine Biosciences Reports Fourth Quarter 2002 Results; Company Provides Update On Development Programs
PR Newswire ~ February 3, 2003 ~ 5:05 pm EST
SAN DIEGO, Feb. 3 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. ( Nasdaq: NBIX) today announced its financial results for the fourth quarter ended December 31, 2002. For the three months ended December 31, 2002, the Company reported a net loss of $38.8 million or $1.27 per share compared to a net loss of $14.6 million, or $0.53 per share for the same period last year. For the year ended December 31, 2002 the Company had a net loss of $94.5 million, or $ 3.10 per share compared with a net loss of $36.9 million, or $1.42 per share in 2001.
Revenues attributed to the recently completed Pfizer collaboration have not been reflected in the financial statements for the year ended 2002. These revenues will be recorded upon government approval of the collaboration, expected in the first quarter of 2003. Under the Pfizer collaboration, the two companies will develop and commercialize indiplon, Neurocrine's Phase III compound for the treatment of insomnia. In addition to a $100 million upfront fee, $300 million in pre-commercial milestones, Pfizer will be responsible for substantially all future development and marketing expenses. Upon the indiplon New Drug Application (NDA) filing, Pfizer will fund a 200 person Neurocrine sales force to detail Pfizer's antidepressant, Zoloft(R) (sertraline HCl) and indiplon.
Revenues for the fourth quarter of 2002 were $3.9 million compared with $12.8 million for the same period last year. The $8.9 million decrease in revenues resulted primarily from revenues recognized under the Taisho Pharmaceutical ( Taisho) agreement that decreased by $8.1 million. Revenues for the year ended December 31, 2002 were $18.0 million compared with $41.2 million in 2001. The $ 23.2 million decrease in revenues resulted primarily from $15.5 million of milestones achieved in 2001 under the GlaxoSmithKline agreement and $5.5 million from the Taisho collaboration.
Research and development expenses increased to $41.6 million for the fourth quarter of 2002 compared with $24.7 million for the respective period in 2001. For the year ended December 31, 2002, research and development expenses were $ 108.9 million compared to $74.3 million for the same period last year. During the fourth quarter the company increased certain development expenses associated with the indiplon program relating to patient enrollment and retention to ensure timely completion of the clinical trials. Development expenses associated with the indiplon clinical program were $31.0 million for the fourth quarter and $ 71.6 million for the full year 2002, respectively. As a result of the Pfizer collaboration, total indiplon expenses for 2003 are capped at $15.0 million. Other increased costs for 2002 included personnel and lab costs related to expansion of the company's research and development activities.
General and administration expenses were $3.6 million for the fourth quarter 2002 and 2001. For the year ended December 31, 2002 general and administrative expenditures totaled $12.7 million compared to $10.9 million in 2001. The year to date increase in general and administrative expenses resulted primarily from increased indiplon marketing research and marketing related costs, increased recruiting and relocation costs for new employees, increased insurance costs, and the addition of administrative personnel needed to support expanding research and development activities.
The Company's balance sheet at December 31, 2002 reflected total assets of $ 266.5 million, including cash, cash equivalents, marketable securities and current assets of $248.1 million compared with balances at December 31, 2001 of $346.4 million and $331.5 million, respectively. Upon government approval, expected in the first quarter of this year, the Company will begin to recognize the $100 million initial payment from the Pfizer Collaboration.
"The events of 2002 were significant milestones for Neurocrine, and as a result, the Company is moving closer to realizing our strategic objective of becoming a fully integrated pharmaceutical company. First, we continue to be encouraged by the progress and results of our indiplon program. During 2002 we increased our development expenses associated with these trials to ensure that we will meet our expectations of filing the NDA in the next 12 months. Secondly, we have established a relationship with Pfizer, the largest pharmaceutical company in the world, and a company that is known for its ability to successfully launch and build blockbuster products. We believe Pfizer possesses the resources and commitment to make indiplon a major pharmaceutical product," said Paul Hawran, Executive Vice President and Chief Financial Officer for Neurocrine Biosciences.
"We also expect that 2003 will be a significant year for Neurocrine. The Pfizer collaboration will significantly lower expenses in 2003 by paying for substantially all future indiplon development and marketing expenses, which will free our capital resources for Neurocrine's other development programs in the pipeline. As a result, we anticipate a significant reduction in our operating losses for year end 2003. We expect our net loss to be in the range of $40.0 to $45.0 million with end of 2003 cash reserves estimated at $275.0 million. In addition to completing our indiplon clinical program, we will begin the next phase of developing a commercial infrastructure. We will pursue other opportunities, specifically in-licensing products and projects that will augment our development and commercial product pipeline. As we have done in the past, our ramp up will be conducted slowly, methodically and in keeping with our strategic objectives. As part of this plan, we will continue our Phase II clinical trials in both our multiple sclerosis and diabetes compounds. We anticipate results in the second half of this year from our Phase I GnRH program for female health disorders and expect to nominate a back-up compound for clinical development in our CRF program for anxiety and depression in 2003," added Hawran.
Clinical Program Update:
Indiplon - one of the most comprehensive Insomnia program advances ...
The Indiplon program continues to build momentum. With over 50 clinical trials completed or on-going, involving over 3,800 patients enrolled, all results to date have been in line and have met our expectations. The seven remaining Phase III clinical trials in both the Immediate Release (IR) and Modified Release (MR) formulations have been initiated with results available beginning in the second quarter 2003.
Indiplon- IR Phase III Trials
Results of the First Indiplon Phase III Trial
-- A study in 593 adult subjects with Transient Insomnia to assess safety
and efficacy with the primary endpoint of Latency to Persistent Sleep
(LPS) with a secondary end point of Latency to Sleep Onset (LSO) was
concluded in 2002. Results of this study demonstrated that indiplon-IR
was safe, well tolerated, and achieved rapid sleep induction without
next day residual effects.
On-going Trials....
Building on the success of our consistently positive results in our completed clinical studies, the remaining indiplon-IR Phase III program is focused on demonstrating the long term safety and efficacy in achieving LPS and LSO endpoints in patients suffering from Primary (Chronic) Insomnia. This program will include over 1,600 patients in the following four studies:
-- A safety and efficacy study of two dose levels in approximately 200
adult patients with Primary (Chronic) Insomnia with the primary
endpoint of LPS as measured objectively by polysomnography (PSG).
Enrollment has been completed and results are expected to be announced
early in the second quarter of 2003.
-- A one-year safety study of two dose levels for the long-term treatment
of Primary (Chronic) Insomnia. Enrollment in over 500 patients has
been completed with treatment continuing through mid 2003 with results
anticipated to be released in the third quarter 2003.
-- A study of safety and efficacy of two dose levels in approximately 600
patients with Primary (Chronic) Insomnia, referred to as the RESTFUL
trial. The primary endpoint for this study is LSO as measured by
patient self reported outcomes. The results of this trial are expected
to be announced in third quarter 2003.
-- The fourth Phase III trial will assess the efficacy and safety of two
dose levels in approximately 360 elderly patients with Primary
(Chronic) Insomnia. The primary endpoint for this study is LSO as
measured by patient self reported outcomes. The results of the initial
two week period evaluation are expected to be announced in the fourth
quarter 2003.
Indiplon- MR Phase III Trials
The indiplon-MR program has enrolled over 600 patients in 14 clinical trials to date and continues to advance with initiation of all Phase III trials in 2002. The indiplon-MR Phase III program is focused on broadening the differentiation strategy for the indiplon franchise to include total Sleep Maintenance. Three Phase III clinical trials have been initiated and will include over 1,300 adult and elderly patients in a variety of settings. These studies are:
-- A study of long-term efficacy and safety in Primary (Chronic) Insomnia
(referred to as the SLEEP trial) is currently underway. This trial will
assess two dose levels relative to placebo in approximately 600
patients with Sleep Maintenance Insomnia. The results of this trial
are expected to be announced in the fourth quarter 2003.
-- A 35-day inpatient/outpatient study in 300 elderly patients to assess
Sleep Maintenance. Results are expected in the fourth quarter 2003.
-- The fourth Phase III trial involving 220 patients will assess safety
and efficacy in the elderly for Sleep Maintenance Insomnia. The
results are expected to be reported in the fourth quarter 2003.
Neurocrine Biosciences Reports Fourth Quarter 2002 -2- Neurocrine's GnRH small molecule antagonist successfully completed a Phase I single dose safety clinical trial demonstrating reductions in gonadotropin production (a surrogate measure of efficacy). This compound progressed to a one week multiple dose study in the fourth quarter of 2002 with results expected in the second quarter 2003. In addition, a second development candidate has now been selected for extensive pre-clinical evaluation and is anticipated to begin clinical trials later this year.
The lead clinical compound under Neurocrine's CRF program with GlaxoSmithKline (GSK) has completed two Phase I trials. A second compound is expected to begin Phase I clinical development in 2003 followed by one advanced preclinical candidate by year end.
The IL-4 fusion toxin program for glioblastoma recently completed a Phase II trial with results comparing favorably with results reported for currently available therapies for patients with similar stage disease. These results indicate a safe and well-tolerated dose has been determined and the compound is ready to enter advanced efficacy trials using survival as the valid endpoint. We have also been conducting a Phase I peripheral tumor trial for lung and kidney cancer. The preliminary results of this ongoing study indicate it has met the primary objectives of defining the dose-limiting toxicity and the maximum tolerated dose. We believe this compound is better suited for development by an oncology focused company and will therefore pursue out- licensing opportunities.
Our APL technology platform has resulted in two Phase II products. NBI- 6024 for Type I Diabetes has successfully completed four Phase I/II clinical trials. We are currently conducting a Phase II, dose response, safety and efficacy trial in approximately 170 adult/adolescents with results expected next year. We are also in discussions with the National Institutes of Health (NIH) Type 1 Diabetes Research Group to initiate a second Phase IIb, dose response, safety and efficacy study in approximately 300 subjects. If we receive the requested funding for this study, enrollment should begin by mid year.
Our second APL product, NBI-5788 for Multiple Sclerosis will begin a second Phase II safety and efficacy trial in 144 patients in the second quarter with results expected in 2005.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, malignant brain tumors and peripheral cancers, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at neurocrine.com.
Neurocrine will host a live Webcast to discuss its year end 2002 financial results and provide a company update tomorrow morning, Tuesday, February 4, 2003 at 9:00 AM Eastern Standard Time (EST) / 6:00 AM Pacific Standard Time (PST). Participants may access the live Conference Call by dialing 1-800-245- 3043 ( U.S.) or 1-785-830-1959 (International). The call can also be accessed via the Webcast through the Company's website at neurocrine.com or alternatively through a link provided by PRNewswire at http:// www.firstcallevents.com/service/ajwz373451149gf12.html. |
