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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS
PURSUANT TO SECTIONS 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Mark One
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1999
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OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OF 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to .
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Commission File No. 0-19529
ALTEON INC.
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(Exact name of registrant as specified in its charter)
Delaware 13-3304550
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(State or other jurisdiction of incorporation or organization) ( I.R.S. Employer Identification No.)
170 Williams Drive, Ramsey, New Jersey 07446
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(Address of principal executive offices) (zip code)
(201) 934-5000
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(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
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None None
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Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value
(Title of Class)
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
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Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of Registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [ ]
State the aggregate market value of the equity stock held by
non-affiliates of the Registrant: $86,882,085 at March 17, 2000 based on the
last sales price on that date: $4.50.
Indicate the number of shares outstanding of each of the Registrant's
classes of common stock, as of March 17, 2000:
Class Number of Shares
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Common Stock, $.01 par value 19,314,130
Documents incorporated by reference
The Proxy Statement to be filed with respect to the Annual Meeting of
Stockholders to be held on June 12, 2000 is incorporated by reference into Part
III.
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ITEM 1. BUSINESS.
OVERVIEW
Alteon is engaged in the discovery and development of new
pharmaceutical products for the treatment of cardiovascular and renal diseases
and other disorders of diabetes and aging. Alteon's proprietary technology
focuses on Advanced Glycosylation End-products, or A.G.E.s, which are abnormal
glucose/protein complexes that form as a result of circulating blood glucose
reacting with proteins.
A.G.E. complexes form continuously over time at a rate dependent upon
glucose levels, and subsequently cross-link to other proteins and ultimately
accumulate in various tissues, blood vessels, nerves and organs. As the rate of
accumulation increases, A.G.E. cross-linked proteins become rigid and
aggregated. It is this process which results in progressive loss of function in
these sites in the body. In healthy individuals this process occurs naturally,
though slowly, as the body ages. In diabetic patients, the rate of A.G.E.
accumulation and the extent of protein cross-linking is accelerated. The Company
believes that this is a major factor contributing to diabetic complications. The
Diabetes Control and Complications Trial ("DCCT"), a multi-center investigation
conducted under the auspices of the National Institutes of Health, demonstrated
that elevated blood glucose levels significantly increase the rate of
progression of eye, kidney, blood vessel and nerve complications from diabetes.
More than 50% of people with diabetes in the United States develop diabetic
complications that range from mild to severe.
Studies conducted in animal models at numerous independent institutions
worldwide suggest that A.G.E.s are responsible for diabetic complications
including kidney disease (nephrology), eye disease (retinopathy), nerve disease
(neuropathy) and hardening of the arteries (atherosclerosis). Moreover, a recent
Phase II/III human clinical study conducted by Alteon confirms that inhibiting
the progression of A.G.E.s in diabetic patients can have a significant impact on
proteinuria, cholesterol, triglycerides and retinopathy. Alteon believes that
certain complications, such as atherosclerosis, hypertension and the progressive
decline in renal function that eventually occur in non-diabetics, may also be
A.G.E.-related, as this pathological process is cumulative in effect over the
lifetime of any individual. Pre-clinical studies have also implicated A.G.E.s in
age-related disorders such as cardiovascular disease and Alzheimer's disease.
Alteon's current research and drug development focused on A.G.E.
technology takes three directions: the prevention or inhibition of A.G.E.
formation, the breaking of A.G.E. cross-links between proteins in order to
prevent or reverse damage, and the reduction of the A.G.E. burden through a
novel class of anti-hyperglycemic agents.
ALT-711 is Alteon's lead agent in a class of proprietary compounds
known as A.G.E. Crosslink Breakers. ALT-711 offers the possibility of the first
therapeutic approach to remove A.G.E. cross-links, and the potential to impact
or even reverse tissue damage caused by diabetes and aging. ALT-711 initially is
being developed for cardiovascular indications, but also has potential in a
number of other medical conditions. Alteon has completed a series of Phase I
safety testing of ALT-711, which is expected to enter Phase II trials by
mid-year 2000. Additional A.G.E. Crosslink Breaker compounds for a number of
other indications are under development. Alteon is exploring potential corporate
partnerships for this program. While Alteon plans to fund the Phase II trials,
additional funding will be required for additional trials and development of
ALT-711.
Alteon's lead A.G.E.-Formation Inhibitor, pimagedine, has completed a
Phase II trial in dyslipidemia and a Phase II/III pivotal "ACTION" (A Clinical
Trial In Overt Nephropathy) trial in Type 1 diabetic patients with overt
nephropathy. In the multi-center ACTION trial, pimagedine therapy did not reach
statistical significance in its primary endpoint, the time to doubling of serum
creatinine, but did result in a statistically significant and clinically
meaningful reduction of urinary protein excretion. Pimagedine also reduced, to a
statistically significant extent, cholesterol and triglycerides as well as the
progression of retinopathy. After discussion with the Food and Drug
Administration ("FDA") and with scientific and clinical advisors active in
nephrology research and treatment of renal disease, Alteon is actively exploring
potential corporate partnerships for the continued development of pimagedine,
both in the U.S. and abroad.
Alteon is also utilizing its technical expertise in the field of
diabetes to develop compounds focused on glucose regulation and control. These
anti-hyperglycemic compounds, or glucose lowering agents ("GLA"), are in
pre-clinical studies.
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TECHNOLOGY
The foundation for Alteon's technology is the experimental evidence
that intervention and treatment along the pathway towards A.G.E. cross-link
formation would be likely to provide significant benefit in slowing or reversing
the development of the serious pathologies that develop in the diabetic and
aging populations. ALT-711 and pimagedine are the lead compounds resulting from
Alteon's research in this field.
The following chart illustrates the process of A.G.E. formation and
cross-linking and is qualified by the more detailed description in the text. It
also highlights those areas within the A.G.E. cascade where Alteon is attempting
to offer chemical agents to intervene pharmaceutically.
[ NOTE: THE PRINTED COPY OF THIS FORM 10-K CONTAINS A ]
[ GRAPHICAL REPRESENTATION OF THE FOLLOWING. THE "I" ]
[ REPRESENT ARROWS POINTING FROM "GLUCOSE LOWERING ]
[ AGENTS" TO "GLUCOSE + PROTEINS," FROM "A.G.E. FORMATION INHIBITORS" ]
[ TO "A.G.E.S," AND FROM "A.G.E. CROSSLINK BREAKERS" TO ]
[ "CROSS-LINKED A.G.E.S" ]
ALTEON'S TECHNOLOGY PLATFORM AND PRODUCT PIPELINE
Glucose + Proteins ====> A.G.E.s ====> Cross-linked A.G.E.s
I I I
Glucose Lowering A.G.E.-Formation A.G.E.
Agents And Crosslink
I Cross-link Inhibitors Breakers
I I I
ALT-4037 PIMAGEDINE ALT-711
-------- ---------- -------
| | I | I
| | ALT-946 | ALT-1016
| | ------- | -------
Pre-Clinical Lead | | | |
Type II Diabetes | | | |
| Pre-Clinical | Pre-Clinical
| Lead | Lead
Phase II/III |
Diabetic Phase II Candidate
Kidney Cardiovascular
Disease Disease
A.G.E. CROSSLINK BREAKERS
Structural matrix proteins such as collagen and elastin play an
integral role in the maintenance of cardiovascular elasticity and wall
integrity. They are also prime targets for A.G.E. cross-linking. For example,
collagen isolated from tissues of diabetics and aged individuals is more highly
cross-linked than that isolated from non-diabetics or younger individuals.
Restriction of movement arising from A.G.E. cross-linking of matrix proteins
appears to impair normal functioning of contractile organs, such as blood
vessels and cardiac muscle, which are dependent on flexibility and
distensibility for normal function.
The Company initially is developing the A.G.E. Crosslink Breaker class
of compounds, specifically the lead compound, ALT-711, for cardiovascular
indications. Currently available antihypertensive agents improve arterial
compliance indirectly as they reduce the pressure burden on the vessel wall,
which results in a greater dynamic range of elasticity from the resting state.
This approach lowers peripheral resistance and/or intravascular circulating
volume, leading to a reduction in mean blood pressure. A current subject of
debate is whether any of the available drugs can increase arterial elasticity,
beyond what would be expected from restoring the dynamic range of the vessel
wall with a reduction in blood pressure alone. Pharmacologic intervention
targeting the stiffness of the
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cardiovascular system may decrease the incidence and severity of complications
such as congestive heart failure, myocardial ischemia and cerebrovascular
accidents.
Through its unique mechanism of action, ALT-711 is the first compound
that breaks A.G.E.-derived cross-links between proteins, both in vitro and in
vivo. In the case of collagen, ALT-711 does not disrupt the natural enzymatic
glycosylation sites or peptide bonds that are responsible for maintaining the
normal integrity of the collagen chain. Thus, normal structure and function is
preserved while abnormal cross-linking is reduced.
Studies in animal models in several laboratories around the world have
demonstrated rapid reversal of impaired cardiovascular functions with ALT-711.
In these pre-clinical models, ALT-711 reverses the stiffening of arteries as
well as stiffening of the heart that accompanies the development of diabetes and
aging.
The Company is also evaluating development of the breaker class for
several other indications where A.G.E.s and A.G.E. cross-linking lead to
abnormal function. Data from Phase I trials of ALT-711 suggest that Crosslink
Breakers may have an effect on soft tissue compliance in the bladder (for
treating urinary incontinence). The scientific literature also points to the
possible utility of breaker compounds in ophthalmic and dermatological
conditions, stiff joint disorders, and peritoneal dialysis. See "--ALT-711."
A.G.E.-FORMATION INHIBITORS
Alteon's most advanced therapeutic program has been in the development
of drugs that inhibit A.G.E. formation. These compounds are designed to prevent
the progression of major diabetic and age-related complications by blocking the
formation of A.G.E.s and subsequent cross-linking of A.G.E.s to other proteins.
Alteon's lead compound, pimagedine, has been shown to inhibit A.G.E. formation
and subsequent cross-link formation. Pimagedine is able to have a beneficial
impact on what is thought to be one of the earliest steps in the progression of
nephropathy in diabetic patients. Alteon believes that because pimagedine exerts
its activity by a mechanism uniquely different from currently available
therapies, its benefits will be over and above current standard treatment. Data
from the ACTION I trial of pimagedine suggest that other potential indications
for this compound include proteinuria and retinopathy.
Alteon has identified ALT-946 as a second-generation clinical lead in
the A.G.E. inhibitor category. Further development of the A.G.E. inhibitor class
of compounds is subject to further funding.
See "--Pimagedine Intravenous" and "Pimagedine Topical."
GLUCOSE LOWERING AGENTS
Alteon is also utilizing its technical expertise in the field of
diabetes to develop compounds focused on glucose regulation and control. These
anti-hyperglycemic compounds, or GLA, are in pre-clinical studies. Removing or
lessening the impact of hyperglycemia on the progression of the A.G.E Pathway
also would likely enhance the impact of inhibitors and breakers. With respect to
the cardiovascular arena, an agent that improves insulin responsiveness would
favorably impact the cardiovascular risk from chronic elevated serum
triglycerides and fatty acids.
The GLA Program arose from a search of plant-derived natural products
that would exhibit a beneficial profile of glucose and lipid lowering in animal
models of Type II diabetes. From the inception of this program, several
pre-clinical candidates have been evaluated that display these beneficial
properties. A lead pre-clinical candidate, ALT-4037, lowers glucose and lipids,
restores normal pancreatic sensing of glucose, stimulates greater production of
insulin, and restores insulin sensitivity in skeletal muscle and fat. Further
development of the GLA class of compounds is subject to further funding.
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PRODUCTS UNDER DEVELOPMENT
ALT-711 ORAL
Several classes of novel compounds have been identified which are
capable of breaking the cross-links formed as a result of A.G.E. accumulation.
These compounds are currently under evaluation in various pre-clinical models to
assess their potential for the treatment of a variety of diseases including
cardiovascular disease states and other conditions of soft tissue compliance.
A Phase I program of ALT-711, the Company's lead A.G.E. Crosslink
Breaker compound, was initiated in June 1998. The Phase I program consisted of
four trials, all conducted in Utrecht, The Netherlands. The first trial, a
placebo-controlled, double-blind, single and ascending dose study, enrolled 88
subjects, consisting of a younger cohort, aged 18 to 50 years, and an older
cohort, aged 55 to 75 years. A 14-day multiple dosing trial was then conducted
in 16 older (65 to 75 years) subjects. In the third trial of 12 subjects, aged
65 to 75 years, ALT-711 was administered in ascending doses every other day. In
the final Phase I study, the highest dose of ALT-711 was administered to 12
subjects, aged 65-75 years, over a consecutive 14-day period. Analyses of the
clinical and safety data of each Phase I study did not show any medically
relevant events.
Cardiovascular Disease. The Company's early clinical program on
treating cardiovascular disease is focused on ALT-711, an agent that cleaves the
A.G.E. cross-link that forms between structural matrix proteins such as collagen
and elastin, which play an important role in the maintenance of normal vessel
elasticity. Intervention targeting the stiffness of the cardiovascular system
may decrease the incidence and severity of complications such as congestive
heart failure, myocardial ischemia and cerebrovascular accidents.
Pre-clinical studies of ALT-711 conducted by researchers from The
National Institute on Aging and Johns Hopkins Geriatric Center demonstrated the
ability of the compound to significantly reduce arterial stiffness in elderly
Rhesus monkeys. In this primate study, administration of ALT-711 was found to
significantly reduce aortic stiffness by week 3 which persisted through week 8.
Baseline weight, fasting blood glucose, creatinine and cholesterol did not
change after treatment. In a recent pre-clinical study of ALT-711 in aged dogs,
administration of ALT-711 for one month resulted in an approximate 40% decrease
in age-related ventricular stiffness, or hardening. This decrease was
accompanied by an overall improvement in cardiac function. Reductions in blood
pressure that have been observed in animal models of diabetic hypertension
suggest that Crosslink Breakers also may prove beneficial in the treatment of
systolic hypertension in the elderly.
The Company has filed an investigational new drug application ("IND")
focused on vascular and ventricular compliance, and expects to initiate Phase II
trials of ALT-711 in 2000. Thereafter, subsequent development will require
additional funding.
Other Indications. A.G.E. cross-linking has been shown to affect soft
tissue compliance and interfere with the normal function of other organs of the
body. Early clinical experience in Phase I human studies of ALT-711 suggest that
urinary elastic dysfunction (leading to urinary incontinence) is a potential
therapeutic target. Based on pre-clinical studies, the Company may decide to
pursue additional therapeutic opportunities such as skin aging and
dermatological conditions, stiff joint disorders and peritoneal dialysis,
conditions where A.G.E. cross-linking has contributed to a loss of normal
function, elasticity and flexibility.
ALT-711 OPHTHALMIC
Ophthalmic Conditions. The Company is pursuing investigations into the
role of A.G.E. cross-linking in restricting the flow of fluid through the eye,
the consequence of which causes elevated intraocular pressure, which is central
to the development of glaucoma. Preliminary studies in aged primates demonstrate
a persistent improvement in fluid flow following a single intraocular injection
of ALT-711. In addition, pre-clinical research in diabetic models of retinopathy
demonstrates a reversal in the expression of vascular endothelial-derived growth
factor ("VEGF"). The elevated levels of VEGF receptors were also reduced,
suggesting the possible utility of ALT-711 in proliferative retinopathy.
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PIMAGEDINE ORAL
Alteon has conducted the following Phase II and Phase III trials on
pimagedine:
Overt Nephropathy. Kidney disease is a significant cause of morbidity
and mortality in patients with Type 1 and Type 2 diabetes. It is a chronic and
progressive disease. One of the early signs of kidney damage is microalbuminuria
(characterized by leakage of small amounts of protein into the urine) which
progresses to overt nephropathy (characterized by leakage of large amounts of
protein into the urine and ultimately to end-stage renal disease (advanced renal
disease requiring dialysis). Approximately 34% of patients with Type 1 diabetes
and approximately 10-15% of patients with Type 2 diabetes develop nephropathy.
As of 1995, there were approximately 1,000,000 diabetics diagnosed with kidney
disease in the United States.
The Company conducted a randomized double-blind, placebo-controlled,
multi-center, Phase II/III clinical trial to evaluate the safety and efficacy of
pimagedine in Type 1 diabetic patients with overt nephropathy, the ACTION I
trial. The trial was initiated in January 1994. The primary objective of the
trial was to evaluate the safety and efficacy of pimagedine in preserving renal
function in Type 1 patients. Enrollment in the trial was completed in August
1996 with 690 patients from 56 investigational sites in the United States and
Canada. Patients were treated for a minimum of two years and received twice
daily oral doses of pimagedine, adjusted for kidney function. Under this
protocol, pimagedine treatment was in addition to the best available therapeutic
regimen chosen by the treating physicians.
In November 1998, the Company announced results of an analysis of data
from the ACTION I trial. Although the results showed that pimagedine reduced the
risk of doubling of serum creatinine, the study's primary endpoint, the data did
not reach statistical significance. However, pimagedine therapy did result in a
statistically significant and clinically meaningful reduction of urinary protein
excretion. Pimagedine also reduced to a statistically significant extent,
cholesterol and triglycerides as well as the progression of retinopathy.
Additional data suggested a trend toward improvements in other measures of renal
function including estimated creatinine clearance and glomerular filtration
rate. The drug was generally well tolerated.
After discussion with medical and clinical consultants and the FDA,
Alteon is actively exploring potential corporate partnerships for the continued
development of pimagedine and expects to pursue development if funding is
obtained.
A second Phase III trial of pimagedine, in patients with Type 2
diabetes and overt nephropathy (ACTION II), was initiated in July 1995 and used
a trial design similar to the ACTION I trial. The objective of this study was to
evaluate the safety and efficacy of pimagedine in preserving renal function in
Type 2 patients. In March 1998, the Company discontinued this trial because of
an insufficient risk/benefit ratio based upon data then available.
End-Stage Renal Disease ("ESRD"). In January 1996, the Company
initiated a Phase II study to evaluate the safety and efficacy of pimagedine in
diabetic patients with ESRD on hemodialysis. This clinical trial enrolled
approximately 120 patients who received oral doses of pimagedine three times per
week in conjunction with their dialysis treatment. After the ACTION I results
were unblinded in November 1998, the Company evaluated this program as part of
its overall evaluation of further development of pimagedine and the trial was
ended in April 1999. Data from the study was inconclusive.
Dyslipidemia. In April 1997, Alteon and Gamida completed a randomized,
double-blind, placebo-controlled, Phase II clinical trial to evaluate the effect
of pimagedine on plasma lipid levels and A.G.E.s in patients with diabetes and
elevated serum cholesterol levels. Dyslipidemia is a condition characterized by
an abnormal lipid profile. The elevation of one lipid component, low-density
lipoprotein, is known to be a significant risk factor in cardiovascular disease.
Diabetic patients are twice as likely as non-diabetic individuals to die from
coronary artery disease, and the annual incidence of cardiovascular
complications is increased significantly in patients with Type 2 diabetes. This
Phase II clinical trial enrolled 89 patients in Israel who were treated for a
minimum of three months and who received twice daily oral doses of pimagedine,
adjusted for kidney function. The primary objective of this study was to
evaluate the safety and efficacy of pimagedine in reducing levels of low-density
lipoproteins ("LDLs") in Type 2 diabetic patients with varying degrees of renal
function and elevated LDLs.
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A comprehensive statistical report of the trial after audit of the
results concluded that lipid parameters between pimagedine and placebo treatment
arms showed steeper decreases in the pimagedine arm in almost all parameters and
in all populations. In cholesterol, triglycerides and very low-density
lipoproteins ("VLDL") the decreases were significant by "last observation
carried forward" analysis. In LDL, the decrease in the pimagedine group was
significant at the 8th week. While not an endpoint of the Israeli trial, albumin
in the urine was also reduced in patients identified as having albuminuria
(excretion of more than 30 mg of albumin in 24 hours).
At this time, the Company has no plans to develop pimagedine solely for
this indication.
PIMAGEDINE INTRAVENOUS
Stroke. Every year approximately 500,000 patients in the United States
suffer a stroke and approximately one-third of these individuals die, making
stroke the third leading cause of death by disease. According to the American
Heart Association, in 1994 the economic cost of stroke due to health care
expense and loss of productivity was estimated to be nearly $30 billion.
Individuals at increased risk for stroke include those with hypertension,
smokers, obese individuals, diabetics and those with hyperlipidemia. Currently,
several pharmaceutical and biopharmaceutical companies are conducting
pre-clinical studies and clinical trials on numerous compounds for the treatment
of stroke.
Animal studies have demonstrated that pimagedine, when given prior to
or after indication of stroke by occlusion of the middle cerebral artery,
reduced the volume of tissue death by 30%.
Alteon has completed acute toxicity studies in animals with an
intravenous formulation of pimagedine. The Company has filed an IND with the
FDA. Additional development of intravenous pimagedine will require additional
funding.
PIMAGEDINE TOPICAL
Inflammatory Skin Disease. Nitric oxide ("NO") has been shown to play a
role in the inflammatory disease process. Independent researchers have reported
that treatment with pimagedine reduces inflammation in specific pre-clinical
models. Pimagedine has also been shown to decrease the migration of macrophages
(inflammatory cells) to the site of tissue damage and prevent the release of
cytokines and consequent release of NO. Based on these findings, the Company
believes that pimagedine could have a beneficial effect in certain inflammatory
diseases such as contact dermatitis and eczema. Currently, topical steroids are
the treatment of choice for these indications but are contraindicated for
prolonged use. A topical formulation of pimagedine has been developed. The
Company has filed an IND for these indications. Additional development of
topical pimagedine will require additional funding.
ALT-4037
ALT-4037 has been identified as the pre-clinical lead in the Glucose
Lowering Agent class of compounds. ALT-4037 is a novel compound that lowers
blood glucose, triglycerides and free fatty acid levels in pre-clinical animal
models of Type 2 diabetes. Pre-clinical findings demonstrate an improvement in
pancreatic function following chronic dosing with ALT-4037. The Company has put
this research program on hold as it focuses its resources on the development of
the A.G.E. breaker class.
CORPORATE STRATEGIC ALLIANCES
Genentech, Inc.
In December 1997, Alteon and Genentech entered into a stock purchase
agreement and a development collaboration and license agreement providing for
the development and marketing of pimagedine and second-generation
A.G.E.-Formation Inhibitors. Pursuant to the stock purchase agreement Genentech
purchased $5,610,000 of Common Stock and $31,934,000 of Series G Preferred Stock
and Series H Preferred Stock for an aggregate purchase price of $37,544,000.
Genentech's obligations to purchase shares of Alteon's stock terminated
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December 31, 1998. Pursuant to a letter agreement dated February 11, 1999,
between Alteon and Genentech, the development collaboration and license
agreement terminated effective June 30, 1999.
Yamanouchi Pharmaceutical Co., Ltd.
In July 1989, Alteon and Yamanouchi entered into a series of agreements
pursuant to which the parties formed a strategic alliance to develop and
commercialize Alteon's A.G.E.-related technology in Japan, South Korea, Taiwan
and The People's Republic of China (the "Yamanouchi Territory"). Under this
arrangement, the parties agreed to collaborate on further research and
development, Yamanouchi purchased shares of Alteon stock and Alteon granted to
Yamanouchi an exclusive license to commercialize Alteon's technology in the
Yamanouchi Territory in exchange for royalty payments on net sales, if any.
Yamanouchi has the right to terminate the agreement upon 90 days' prior written
notice to Alteon. This license expires as to each product in each licensed
country upon the later of 15 years from the date of the agreement, the
expiration of the last patent applicable to the product or five years after the
first commercial sale of the product in the country.
Pursuant to the license agreement, Alteon granted Yamanouchi the right
to manufacture pimagedine bulk material for sale in the Yamanouchi Territory.
With respect to certain second-generation A.G.E.-Formation Inhibitors, Alteon
has the option to supply all of Yamanouchi's reasonable requirements of active
ingredient bulk materials for sale within the Yamanouchi Territory.
Alteon and Yamanouchi also entered into a research and development
collaboration agreement to provide for joint collaboration on further research
and development, specifically Alteon's A.G.E.-formation and protein
cross-linking technology. Yamanouchi also agreed to fund pre-clinical studies,
including most toxicology studies on pimagedine and any other products that the
parties jointly agree to develop including a second-generation A.G.E.-Formation
Inhibitor and a macrophage stimulator. The collaboration agreement provides that
any joint development program is terminable by either party upon 60 days' prior
written notice. The agreement terminated in June 1999. Since then the parties
have been in discussions regarding the continuation of their collaboration on
pimagedine.
Pursuant to the research and development collaboration agreement,
Yamanouchi provided financial support for most of the pre-clinical toxicity
studies and completed Phase I clinical trials on pimagedine in Japan.
Yamanouchi has not conducted Phase II clinical trials in Japan.
Roche Diagnostics
In December 1994, the Company entered into an exclusive licensing
arrangement with Roche for Alteon's technology for diagnostic applications.
Under this alliance, Alteon will be entitled to receive royalties based on net
sales of research and commercial assays developed by Roche and based on Alteon's
A.G.E. technology. Roche will receive exclusive worldwide rights to the
technology for diagnostic applications outside the Yamanouchi Territory.
Under the agreement, Roche has agreed to develop immunoassays to detect
A.G.E.-hemoglobin, ApoB-A.G.E. and A.G.E.-serum protein/peptides. Development of
reagents and formats for the A.G.E. competitive ELISA and a procedure for
measuring hemoglobin-A.G.E. was completed in 1998. Continuation of the program
to adapt these reagents to automated clinical assays is contingent upon FDA
approval of pimagedine and will advance along with any product launch of
pimagedine.
The agreement gives Roche discretion over commercial development. Roche
may terminate the license agreement upon 90 days' prior written notice.
Gamida
In November 1995, the Company entered into clinical testing and
distribution agreements with Gamida. Under these agreements, Gamida conducted,
at its own expense, a Phase II multi-site clinical trial in Israel, in
accordance with the protocol developed by Alteon, to evaluate pimagedine in
patients with diabetes and elevated serum cholesterol levels. Gamida will
receive the exclusive right to distribute pimagedine, if successfully developed
and approved for marketing, in Israel, Bulgaria, Cyprus, Jordan and South
Africa. The distribution agreement is for a term ending 10 years after the date
of regulatory approval for the sale of pimagedine in Israel; thereafter, it will
be
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automatically renewed for successive three-year periods unless terminated by
either party on the last day of the initial or renewal term.
IDEXX
In June 1997, Alteon entered into a license and supply agreement with
IDEXX pursuant to which Alteon licensed to IDEXX pimagedine as a potential
therapeutic in companion animals (dogs, cats and horses) and its A.G.E.
diagnostics technology for companion animal use. IDEXX will be responsible for
the development, licensing and marketing of pimagedine and A.G.E. diagnostics
for such use on a worldwide basis. Alteon will be entitled to receive milestone
payments and royalties on sales of the licensed products.
ACADEMIC RESEARCH AND LICENSE AGREEMENTS
Washington University, St. Louis
In June 1995, the Company obtained an exclusive, worldwide,
royalty-bearing license from Washington University for patents covering the use
of pimagedine as an inhibitor of inducible nitric oxide synthase ("iNOS"). The
agreement requires the Company to pay certain licensing fees upon the attainment
of development milestones as well as a royalty on net sales or a share of
sub-licensing profits on products covered by the patents. The license also
covers patents developed through any subsequent research collaboration between
the parties which Alteon agrees to fund.
Cerami Consulting Corporation and Warren Laboratories
Effective May 17, 1999, the Company terminated its consulting agreement
with Cerami Consulting Corporation and its research agreement with Kenneth S.
Warren Laboratories, Inc. The company retained the rights to results and
inventions resulting from these agreements.
The Rockefeller University
Pursuant to an agreement with Rockefeller University, Alteon has
exclusive, worldwide and perpetual rights to the technology and inventions
relating to A.G.E.s and other protein cross-linking, including those relating to
the complications of diabetes and aging. See "--Patents, Trade Secrets and
Licenses."
The Picower Institute for Medical Research
Pursuant to an agreement with The Picower Institute, a not-for-profit
biomedical science institution, the Company has received an exclusive worldwide,
royalty-bearing license for certain commercial health care applications of
A.G.E.-related inventions. See "--Patents, Trade Secrets and Licenses."
MANUFACTURING
The Company has no manufacturing facilities for either production of
bulk chemicals or the manufacturing of pharmaceutical dosage forms. The Company
relies on third party contract manufacturers to produce the raw materials and
chemicals used as the active drug ingredients in its pharmaceutical products and
to perform the tasks necessary to process, package and distribute these products
in finished form.
Such third party contractors will be inspected by the Company and its
consultants to confirm compliance with current Good Manufacturing Practice
("cGMP") required for pharmaceutical products. The Company believes it will be
able to obtain sufficient quantities of bulk chemical at reasonable prices to
satisfy anticipated needs. There can be no assurance, however, that the Company
can continue to meet its needs for supply of bulk chemicals or that
manufacturing limitations will not delay clinical trials or possible
commercialization. See "--Corporate Strategic Alliances."
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MARKETING AND SALES
Alteon plans to market and sell its products, if successfully developed
and approved, directly or through co-promotion or other licensing arrangements
with third parties. Such arrangements may be exclusive or nonexclusive and may
provide for marketing rights worldwide or in a specific market.
For certain of its products Alteon has licensed exclusive marketing
rights, formed joint marketing arrangements or granted distribution rights
within specified territories with its corporate partners, Yamanouchi, Roche,
Gamida, and IDEXX. See "--Corporate Strategic Alliances."
PATENTS, TRADE SECRETS AND LICENSES
Proprietary protection for the Company's product candidates, processes
and know-how is important to its business. Alteon aggressively files and
prosecutes patents covering its proprietary technology, and, if warranted, will
defend its patents and proprietary technology. As appropriate, the Company seeks
patent protection for its proprietary technology and products in the United
States and Canada and in key commercial European and Asia/Pacific countries. The
Company also relies upon trade secrets, know-how, continuing technological
innovation and licensing opportunities to develop and maintain its competitive
position.
Pimagedine is not a novel compound and is not protected by a
composition-of-matter patent. In 1992, a United States patent on the use of
pimagedine was issued to Rockefeller University and subsequently exclusively
licensed to Alteon with claims relating to the inhibition of A.G.E. formation.
The patent claims the new use of a known agent for the treatment of the
complications of diabetes and aging. In 1994, corresponding patents were granted
in France, Germany, Italy, the United Kingdom and other European countries. A
corresponding patent was issued in Japan in 1995. The Company continues to
pursue and patent chemical analogs of known A.G.E.-Formation Inhibitors, as well
as novel compounds having potential inhibitory properties.
Alteon has obtained several patents covering certain novel compounds in
the A.G.E. Crosslink Breaker category. These patents and additional patent
applications contain compound, composition and method of treatment claims for
several chemical classes of Crosslink Breaker compounds. The novel compounds
have the ability to break what were previously believed to be permanent,
A.G.E.-mediated bonds between proteins. The use of these compounds offers the
possibility of the first therapeutic approach to the removal of A.G.E.
cross-links.
The Company believes that its licensed and owned patents provide a
substantial proprietary base that will allow Alteon and its collaborative
partners to commercialize products in this field. There can be no assurance,
however, that pending or future applications will issue, that the claims of any
patents which do issue will provide any significant appreciation of the
Company's technology, or that the Company's directed discovery research will
yield compounds and products of therapeutic and commercial value.
In 1987, the Company acquired an exclusive, royalty-free, worldwide
license (including the right to sub-license to others) to issued patents, patent
applications and trade secrets from Rockefeller University relating to the
A.G.E.-formation and cross-linking technology currently under development at
Alteon. The inventors of the patented technology include Drs. Michael A.
Brownlee, Anthony Cerami, Helen Vlassara and Peter C. Ulrich. Additional patent
applications have since been filed on discoveries made in support of the
technology from research conducted at Rockefeller University, The Picower
Institute and the Company's laboratories.
Pursuant to the Company's agreement with The Picower Institute, certain
patentable inventions and discoveries relating to A.G.E. technology have been
licensed exclusively to the Company. In consultation with the Company, The
Picower Institute is responsible for the worldwide filing and prosecution of
patent applications and maintenance of patents for such inventions. Alteon will
contribute 50% of the cost of such activities.
As of December 31, 1999, the Company's patent estate of owned and/or
licensed patent rights consisted of 100 issued patents or allowed United States
patent applications, none of which expire prior to 2005, and 23 pending patent
applications in the United States, the majority of which are A.G.E.-related.
Included in Alteon's patent estate are two issued United States patents on the
use of pimagedine for inhibition of iNOS, licensed from Washington
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University. Alteon also owns or has exclusive rights to over 25 issued or
granted non-United States patents and has over 70 patent applications pending in
Europe, Japan, Australia and Canada.
The Company intends to continue to focus its research and development
efforts on the synthesis of novel compounds and on the search for additional
therapeutic applications to expand and broaden the Company's rights within its
technological and patent base. The Company is also prepared to in-license
additional technology that may be useful in building its proprietary position.
Where appropriate, the Company utilizes trade secrets and unpatentable
improvements to enhance its technology base and improve its competitive
position. Alteon requires all employees, scientific consultants and contractors
to execute confidentiality agreements as a condition of engagement by the
Company. There can be no assurance, however, that the Company can limit
unauthorized or wrongful disclosures of unpatented trade secret information.
The Company believes that its estate of licensed and owned issued
patents, if upheld, and pending applications, if granted and upheld, will be a
substantial factor in the Company's success. The patent positions of
pharmaceutical firms, including Alteon, are generally uncertain and involve
complex legal and factual questions. Consequently, even though Alteon is
currently prosecuting such patent applications in the United States and foreign
patent offices, the Company does not know whether any of such applications will
result in the issuance of any additional patents or, if any additional patents
are issued, whether the claims thereof will provide significant proprietary
protection or will be circumvented or invalidated.
Competitors or potential competitors have filed for or have received
United States and foreign patents and may obtain additional patents and
proprietary rights relating to compounds or processes competitive with those of
the Company. Accordingly, there can be no assurance that the Company's patent
applications will result in patents being issued or that, if issued, the claims
of the patents will afford protection against competitors with similar
technology; nor can there be any assurance that others will not obtain patents
that the Company would need to license or circumvent. See "--Competition."
The Company's success will depend, in part, on its ability to obtain
patent protection for its products, preserve its trade secrets and operate
without infringing on the proprietary rights of third parties. There can be no
assurance that the Company's current patent estate will enable the Company to
prevent infringement by third parties or that competitors will not develop
competitive products outside the protection that may be afforded by the claims
of such patents. To the extent the Company relies on trade secrets and
unpatented know-how to maintain its competitive technological position, there
can be no assurance that others may not develop independently the same or
similar technologies. Failure to maintain its current patent estate or to obtain
requisite patent and trade secret protection, which may become material or
necessary for product development, could delay or preclude the Company or its
licensees or marketing partners from marketing their products and could thereby
have a material adverse effect on the Company's business, financial condition
and results of operations.
GOVERNMENT REGULATION
The Company and its products are subject to comprehensive regulation by
the FDA in the United States and by comparable authorities in other countries.
These national agencies and other federal, state and local entities regulate,
among other things, the pre-clinical and clinical testing, safety,
effectiveness, approval, manufacturing, labeling, marketing, export, storage,
record keeping, advertising and promotion of the Company's products.
The process required by the FDA before the Company's products may be
approved for marketing in the United States generally involves (i) pre-clinical
new drug laboratory and animal tests, (ii) submission to the FDA of an IND,
which must become effective before clinical trials may begin, (iii) adequate and
well-controlled human clinical trials to establish the safety and efficacy of
the drug for its intended indication, (iv) submission to the FDA of an NDA, and
(v) FDA review of the NDA in order to determine, among other things, whether the
drug is safe and effective for its intended uses. There is no assurance that the
FDA review process will result in product approval on a timely basis, if at all.
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Pre-clinical tests include laboratory evaluation of product chemistry
and formulation, as well as animal studies to assess the potential safety and
efficacy of the product. Certain pre-clinical tests are subject to FDA
regulations regarding current Good Laboratory Practices. The results of the
pre-clinical tests are submitted to the FDA as part of an IND and are reviewed
by the FDA prior to the commencement of clinical trials or during the conduct of
the clinical trials, as appropriate.
Clinical trials are conducted under protocols that detail such matters
as the objectives of the study, the parameters to be used to monitor safety and
the efficacy criteria to be evaluated. Each protocol must be submitted to the
FDA as part of the IND. Further, each protocol must be reviewed and approved by
an institutional review board.
Clinical trials are typically conducted in three sequential phases,
which may overlap. During Phase I, when the drug is initially given to human
subjects, the product is tested for safety, dosage tolerance, absorption,
metabolism, distribution and excretion. Phase II involves studies in a limited
patient population to (i) evaluate preliminarily the efficacy of the product for
specific, targeted indications, (ii) determine dosage tolerance and optimal
dosage, and (iii) identify possible adverse effects and safety risks. Phase III
trials are undertaken in order to further evaluate clinical efficacy and to
further test for safety within an expanded patient population. The FDA may
suspend clinical trials at any point in this process if it concludes that
clinical subjects are being exposed to an unacceptable health risk.
FDA approval of the Company's products, including a review of the
manufacturing processes and facilities used to produce such products, will be
required before such products may be marketed in the United States. The process
of obtaining approvals from the FDA can be costly, time consuming and subject to
unanticipated delays. There can be no assurance that approvals of the Company's
proposed products, processes, or facilities will be granted on a timely basis,
if at all. Any delay or failure to obtain such approvals would have a material
adverse effect on the Company's business, financial condition and results of
operations. Moreover, even if regulatory approval is granted, such approval may
include significant limitations on indicated uses for which a product could be
marketed.
Among the conditions for NDA approval is the requirement that the
prospective manufacturer's manufacturing procedures conform to cGMP
requirements, which must be followed at all times. In complying with those
requirements, manufacturers (including a drug sponsor's third party contract
manufacturers) must continue to expend time, money and effort in the area of
production and quality control to ensure compliance. Domestic manufacturing
establishments are subject to periodic inspections by the FDA in order to
assess, among other things, cGMP compliance. To supply a product for use in the
United States, foreign manufacturing establishments must comply with cGMP and
are subject to periodic inspection by the FDA or by regulatory authorities in
certain of such countries under reciprocal agreements with the FDA.
Both before and after approval is obtained, a product, its
manufacturer, and the holder of the NDA for the product are subject to
comprehensive regulatory oversight. Violations of regulatory requirements at any
stage, including the pre-clinical and clinical testing process, the approval
process, or thereafter (including after approval) may result in various adverse
consequences, including the FDA's delay in approving or refusal to approve a
product, withdrawal of an approved product from the market, and/or the
imposition of criminal penalties against the manufacturer and/or NDA holder. In
addition, later discovery of previously unknown problems may result in
restrictions on such product, manufacturer, or NDA holder, including withdrawal
of the product from the market. Also, new government requirements may be
established that could delay or prevent regulatory approval of the Company's
products under development.
The FDA has implemented accelerated approval procedures for certain
pharmaceutical agents that treat serious or life-threatening diseases and
conditions, especially where no satisfactory alternative therapy exists. The
Company cannot predict the ultimate impact, however, of the FDA's accelerated
approval of procedures on the timing or likelihood of approval of any of its
potential products or those of any competitor. In addition, the approval of a
product under the accelerated approval procedures may be subject to various
conditions, including the requirement to verify clinical benefit in
post-marketing studies, and the authority on the part of the FDA to withdraw
approval under streamlined procedures if such studies do not verify clinical
benefit.
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For marketing outside the United States, the Company will be subject to
foreign regulatory requirements governing human clinical trials and marketing
approval for drugs and diagnostic products. The requirements governing the
conduct of clinical trials, product licensing, pricing and reimbursement vary
widely from country to country. The Company does not currently have any
facilities or personnel outside of the United States.
In addition to regulations enforced by the FDA, the Company also is
subject to regulation under the Occupational Safety and Health Act, the
Environmental Protection Act, the Toxic Substances Control Act, the Resource
Conservation and Recovery Act and other present and potential future federal,
state or local regulations. The Company's research and development involves the
controlled use of hazardous materials, chemicals and various radioactive
compounds. Although the Company believes that its safety procedures for handling
and disposing of such materials comply with the standards prescribed by state
and federal regulations, the risk of accidental contamination or injury from
these materials cannot be completely eliminated. In the event of such an
accident, the Company could be held liable for any damages that result and any
such liability could exceed the resources of the Company.
COMPETITION
A number of companies are pursuing the research and development of
pharmaceutical agents to treat cardiovascular and renal disease and other
disorders of diabetes and aging. The Company is not aware of any other
pharmaceutical company developing an A.G.E.-Formation Inhibitors that has
reached the clinical development stage of demonstrating efficacy with a relevant
physiological endpoint. The Company has no knowledge of any company pursuing a
product to break cross-linked A.G.E. proteins. Conversely, Alteon is aware of
many companies which are pursuing research and development of compounds for the
lowering of glucose levels, for cardiovascular and renal diseases, and the
selective inhibition if iNOS.
Many of the Company's potential competitors have substantially greater
financial, technical and human resources than the Company and may be better
equipped to develop, manufacture and market products. In addition, many of these
companies have extensive experience in pre-clinical testing and human clinical
trials. These companies may develop and introduce products and processes
competitive with or superior to those of the Company.
The Company's competition will be determined in part by the potential
indications for which the Company's compounds are developed and ultimately
approved by regulatory authorities. For certain of the Company's potential
products, an important factor in competition may be the timing of market
introduction of its or its competitors' products. Accordingly, the relative
speed with which Alteon can develop products, complete the clinical trials and
approval processes and supply commercial quantities of the products to the
market are important competitive factors. The Company expects that competition
among products approved for sale will be based on, among other things, product
efficacy, safety, reliability, availability, price and patent position.
Competitive drugs based on other therapeutic mechanisms may be
efficacious in treating diabetic complications. The development by others of
non-A.G.E.-related treatment modalities for these diabetic and/or other
age-related complications could render pimagedine and other Alteon products in
the diabetic field non-competitive or obsolete. Therapeutic approaches being
pursued include curing diabetes via gene therapy or islet cell transplantation,
as well as pharmaceutical intervention with agents such as the aldose reductase
inhibitors.
Results of the DCCT showed that tight glucose control reduced the
incidence of diabetic complications. Numerous companies are pursuing other
methods to manage glucose control and to reduce the incidence of diabetic
complications. In addition, several companies have initiated research with drugs
that inhibit vascularization as a potential treatment of diabetic retinopathy.
In the event one or more of these initiatives are successful, the market for
some of the Company's products may be reduced or eliminated.
The treatment of diabetic complications with use of existing agents
such as lipid lowering agents or A.C.E. inhibitors also appears beneficial. The
A.C.E. inhibitor, captopril, has been approved by the FDA for patients with
diabetic nephropathy. Alteon's clinical trials were designed assuming patients'
baseline therapy would include A.C.E. inhibitor treatment. The patent covering
captopril expired in March 1996. Other pharmaceutical companies have chosen to
market and sell this drug, which has led to a significant decrease in its price.
Sales of captopril may reduce or eliminate the market for any product developed
by the Company for this indication.
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In addition, a broad range of cardiovascular drugs is under
development, which could reduce or eliminate the market for any cardiovascular
product developed by the Company.
The Company's competitive position also depends upon its ability to
attract and retain qualified personnel, obtain protection or otherwise develop
proprietary products or processes and secure sufficient capital resources.
MEDICAL AND CLINICAL ADVISORS
The Company's Medical and Clinical Advisors consist of individuals with
recognized expertise in the medial and pharmaceutical science and related fields
who advise the Company about present and long-term scientific planning, research
and development. These advisors consult and meet with Company management
informally on a frequent basis. All advisors are employed by employers other
than the Company and may have commitments to, or consulting or advisory
agreements with, other entities that may limit their availability to the
Company. These companies may also be competitors of Alteon. The advisors have
agreed, however, not to provide any services to any other entities that might
conflict with the activities that they provide. Each member also has executed a
confidentiality agreement for the benefit of the Company.
The following persons are Medical and Clinical Advisors:
Michael A. Brownlee, M.D., Anita and Jack Saltz Professor of Diabetes
Research, Departments of Medicine and Pathology, Albert Einstein
College of Medicine.
Jay N. Cohn, M.D., Professor of Medicine, University of Minnesota
Medical School; immediate Past-President of the International Society
of Hypertension.
Richard J. Glassock, M.D., MACP, Professor Emeritus, UCLA School of
Medicine; Past-President, National Kidney Foundation; Past-President,
American Society of Nephrology.
Jan Lessem, M.D., Ph.D., FACC, Chief Medical Officer and Vice
President, Clinical Research and Development, OraPharma, Inc.; former
Vice President and Corporate Officer, Drug Strategy and Medical
Director, Takeda America, Inc.; Director of Clinical Investigations,
SmithKline Beecham Pharmaceuticals.
Seth A. Rudnick, M.D., Venture Partner, Caanan Partners; former
Chairman, President and CEO, CytoTherapeutics, Inc..
Mark E. Williams, M.D., Director of Dialysis, Joslin Diabetes Center;
Chairman, National Scientific Council on Diabetic Kidney Disease,
National Kidney Foundation.
EMPLOYEES
As of March 15, 2000, Alteon employed 20 persons (6 of whom held a
Ph.D., M.D. or other advanced degree), of whom 7 were engaged in research and
development and 13 were engaged in administration and management. Alteon
believes that it has been successful in attracting skilled and experienced
personnel. None of the Company's employees are covered by collective bargaining
agreements and all employees are covered by confidentiality agreements. The
Company believes that its relationship with its employees is good.
FORWARD-LOOKING STATEMENTS
Statements in this Form 10-K that are not statements or descriptions of
historical facts are "forward-looking" statements under Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995 and are subject to numerous risks and
uncertainties. These forward-looking statements and other forward-looking
statements made by the Company or its representatives are based on a number of
assumptions. The words "believes," "expects," "anticipates," "intends,"
"estimates" or other expressions which are predictions of or indicate future
events and trends and which do not relate to historical matters identify
forward-looking statements. Readers are cautioned not to place undue reliance on
these forward-looking
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statements as they involve risks and uncertainties, and actual results could
differ materially from those currently anticipated due to a number of factors,
including those set forth in this section and elsewhere in, or incorporated by
reference into, this Form 10-K. These factors include, but are not limited to,
the risks set forth below. The forward-looking statements represent the
Company's judgment and expectations as of the date of this Report. The Company
assumes no obligation to update any such forward-looking statements.
Alteon may not be able to obtain sufficient additional funding to meet
its needs or to allow it to continue the research, product development,
pre-clinical testing and clinical trials of its product candidates.
Alteon anticipates that its existing available cash and cash
equivalents and short-term investments will be adequate to satisfy its working
capital requirements for its current and planned operations into 2001. Alteon
will require substantial new funding in order to continue the research, product
development, pre-clinical testing and clinical trials of its product candidates,
including ALT-711 and pimagedine. The Company will also require additional
funding for operating expenses, the pursuit of regulatory approvals for its
product candidates and the establishment of marketing and sales capabilities.
The Company's future capital requirements will depend on many factors, including
continued scientific progress in its research and development programs, the size
and complexity of these programs, progress with pre-clinical testing and
clinical trials, the time and costs involved in obtaining regulatory approvals,
the costs involved in filing, prosecuting and enforcing patent claims, competing
technological and market developments, the establishment of additional
collaborative arrangements, the cost of manufacturing arrangements,
commercialization activities, and the cost of product in-licensing and strategic
acquisitions, if any. There can be no assurance that the Company's cash reserves
and other liquid assets, including funding that may be received from the
Company's corporate partners and equity sales and interest income earned
thereon, will be adequate to satisfy its capital and operating requirements.
Alteon intends to seek funding initially through arrangements with
corporate collaborators. It may in the future seek funding through public or
private sales of the Company's securities, including equity securities, when and
if conditions permit. In addition, the Company may pursue opportunities to
obtain debt financing, including capital leases, in the future. There can be no
assurance, however, that additional funding will be available on reasonable
terms, if at all. Any additional equity financing would be dilutive to the
Company's stockholders. If adequate funds are not available, Alteon may be
required to curtail significantly or eliminate one or more of its research and
development programs. If Alteon obtains funds through arrangements with
collaborative partners or others, it may be required to relinquish rights to
certain of its technologies or product candidates.
Alteon may not successfully develop or derive revenues from any products.
All of the Company's product candidates are in the research or
development stage, and all revenues to date have been generated from
collaborative research agreements and financing activities, or interest income
earned on these funds. No revenues have been generated from product sales. There
can be no assurance that product revenues can be realized on a timely basis, if
at all.
Alteon has not yet requested or received regulatory approval for any
product from the FDA or any other regulatory body. Before obtaining regulatory
approvals for the commercial sale of any of its products under development, the
Company must demonstrate through pre-clinical studies and clinical trials that
the product is safe and effective for use in each target indication. The results
from pre-clinical studies and early clinical trials may not be predictive of
results that will be obtained in large-scale testing, and there can be no
assurance that any clinical trials undertaken by the Company will demonstrate
sufficient safety and efficacy to obtain the requisite regulatory approvals or
will result in marketable products.
There can be no assurance that Alteon will succeed in the development
and marketing of any therapeutic or diagnostic product. To achieve profitable
operations, the Company must, alone or with others, successfully identify,
develop, introduce and market proprietary products. Such products will require
significant additional investment, development and pre-clinical and clinical
testing prior to potential regulatory approval and commercialization.
The development of new pharmaceutical products is highly uncertain and
subject to a number of significant risks. Potential products that appear to be
promising at early stages of development may not reach the market for a number
of reasons. Potential products may be found ineffective or cause harmful side
effects during pre-clinical
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testing or clinical trials, fail to receive necessary regulatory approvals, be
difficult to manufacture on a large scale, be uneconomical, fail to achieve
market acceptance or be precluded from commercialization by proprietary rights
of third parties. There can be no assurance that the Company will undertake
additional clinical trials or that the Company's product development efforts
will be successfully completed, that required regulatory approvals can be
obtained or that any products, if introduced, will be successfully marketed or
achieve customer acceptance. Commercial availability of any Alteon products,
including ALT-711 and pimagedine, is not expected for a number of years, if at
all.
Alteon may never generate profits.
At December 31, 1999, the Company had an accumulated deficit of
$121,496,049. The Company anticipates that it will incur substantial,
potentially greater losses in the future. There can be no assurance that the
Company's products under development will be successfully developed or that its
products, if successfully developed, will generate revenues sufficient to enable
the Company to earn a profit. Alteon expects to incur substantial additional
operating expenses over the next several years as its research, development and
clinical trial activities increase. Alteon does not expect to generate revenues
from the sale of products, if any, for a number of years. The Company's ability
to achieve profitability depends in part on its ability to enter into agreements
for product development, obtain regulatory approval for its products and develop
the capacity, or enter into agreements, for the manufacture, marketing and sale
of any products. There can be no assurance that Alteon will obtain required
regulatory approvals, or successfully develop, manufacture, commercialize and
market product candidates or that the Company will ever achieve product revenues
or profitability.
The Company may not be able to form and maintain collaborative
relationships which its business strategy requires.
The Company's strategy for development and commercialization of certain
of its products is dependent upon entering into various arrangements with
research collaborators, corporate partners and others and upon the subsequent
success of these third parties in performing their obligations.
Alteon has established collaborative arrangements with Yamanouchi,
Roche, IDEXX and Gamida with respect to the development of drug therapies and
diagnostics utilizing the Company's scientific platforms. Alteon is seeking to
establish new collaborative relationships to provide the funding necessary for
continuation of its product development but there can be no assurance that such
effort will be successful. The Company will, in some cases, be dependent upon
these outside partners to conduct pre-clinical testing and clinical trials and
to provide adequate funding for the Company's development programs. Under
certain of these arrangements, the Company's corporate partners may have all or
a significant portion of the development and regulatory approval
responsibilities. Failure of the corporate partners to develop marketable
products or to gain the appropriate regulatory approvals on a timely basis, if
at all, would have a material adverse effect on the Company's business,
financial condition and results of operations.
In most cases, the Company cannot control the amount and timing of
resources that its corporate partners devote to the Company's programs or
potential products. If any of the Company's corporate partners breach or
terminate their agreements with the Company or otherwise fail to conduct their
collaborative activities in a timely manner, the pre-clinical or clinical
development or commercialization of product candidates or research programs will
be delayed, and the Company will be required to devote additional resources to
product development and commercialization or terminate certain development
programs. The termination of collaborative arrangements would have a material
adverse effect on the Company's business, financial condition and results of
operations. There can be no assurance that disputes will not arise in the future
with respect to the ownership of rights to any technology developed with
third-parties. These and other possible disagreements between collaborators and
the Company could lead to delays in the collaborative research, development or
commercialization of certain product candidates or could require or result in
litigation or arbitration, which would be time-consuming and expensive and would
have a material adverse effect on the Company's business, financial condition
and results of operations.
Alteon's corporate partners may develop, either alone or with others,
products that compete with the development and marketing of the Company's
products. Competing products, either developed by the corporate partners or to
which the corporate partners have rights, may result in their withdrawal of
support with respect to all
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or a portion of the Company's technology, which would have a material adverse
effect on the Company's business, financial condition and results of operations.
The Company may not be able to protect the proprietary rights that are
critical to its success.
The Company's success will depend on its ability to obtain patent
protection for its products, preserve its trade secrets, prevent third parties
from infringing upon its proprietary rights and operate without infringing upon
the proprietary rights of others, both in the United States and abroad.
The degree of patent protection afforded to pharmaceutical inventions
is uncertain and the Company's potential products are subject to this
uncertainty. Pimagedine is not a novel compound and is not covered by a
composition-of-matter patent. The patents covering pimagedine are use patents
containing claims covering therapeutic indications and the use of specific
compounds and classes of compounds to inhibit A.G.E. formation. Use patents may
afford a lesser degree of protection in certain foreign countries due to their
patent laws. Competitors may develop and commercialize pimagedine or
pimagedine-like products for indications outside of the protection provided by
the claims of the Company's use patents. Physicians, pharmacies and wholesalers
could then substitute for the Company's pimagedine products. Substitution for
the Company's pimagedine products would have a material adverse effect on the
Company's business, financial condition and results of operations.
ALT-711 is a novel compound protected by a composition-of-matter
patent, and the Company has several patent applications pending to protect
proprietary technology and potential products. There can be no assurance,
however, that these patents will provide any significant protection of the
Company's technology or products, or that the Company will enjoy any patent
protection beyond the expiration dates of its currently issued patents.
There can be no assurance that competitors will not develop competitive
products to pimagedine and/or ALT-711 outside the protection that may be
afforded by the claims of the Company's patents. The Company is aware that other
parties have been issued patents and have filed patent applications in the
United States and foreign countries with respect to other agents which impact
A.G.E. or A.G.E. cross-link formation.
The Company also relies upon unpatented trade secrets and improvements,
unpatented know-how and continuing technological innovation to maintain, develop
and expand its competitive position, which it seeks to protect, in part, by
confidentiality agreements with its corporate partners, collaborators, employees
and consultants. The Company also has invention or patent assignment agreements
with its employees and certain, but not all, corporate partners and consultants.
There can be no assurance that relevant inventions will not be developed by a
person not bound by an invention assignment agreement. There can be no assurance
that binding agreements will not be breached, that the Company would have
adequate remedies for such breach, or that the Company's trade secrets will not
otherwise become known to or be independently discovered by competitors.
The Company cannot be certain that regulatory approvals will be obtained
for its products.
Alteon's research, pre-clinical testing and clinical trials of its
product candidates are, and the manufacturing and marketing of its products will
be, subject to extensive and rigorous regulation by numerous governmental
authorities in the United States and in other countries where the Company
intends to test and market its product candidates.
Prior to marketing, any product developed by the Company must undergo
an extensive regulatory approval process. This regulatory process, which
includes pre-clinical testing and clinical trials, and may include
post-marketing surveillance, of each compound to establish its safety and
efficacy, can take many years and can require the expenditure of substantial
resources. Data obtained from pre-clinical and clinical activities are
susceptible to varying interpretations which could delay, limit or prevent
regulatory approval. In addition, delays or rejections may be encountered based
upon changes in FDA policy for drug approval during the period of product
development and FDA regulatory review of each submitted NDA. Similar delays may
also be encountered in foreign countries. There can be no assurance that
regulatory approval will be obtained for any drugs developed by the Company.
Moreover, regulatory approval may entail limitations on the indicated uses of
the drug. Further, even if regulatory approval is obtained, a marketed drug and
its manufacturer are subject to continuing review and discovery of previously
unknown problems with a product or manufacturer which may have adverse effects
on the
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Company's business, financial condition and results of operations, including
withdrawal of the product from the market. Violations of regulatory requirements
at any stage, including pre-clinical testing and clinical trials, the approval
process or post-approval, may result in various adverse consequences including
the FDA's delay in approving, or its refusal to approve, a product withdrawal of
an approved product from the market and the imposition of criminal penalties
against the manufacturer and NDA holder. None of the Company's products have
been approved for commercialization in the United States or elsewhere. No
assurance can be given that the Company will be able to obtain FDA approval for
any products. Failure to obtain requisite governmental approvals or failure to
obtain approvals of the scope requested will delay or preclude the Company or
its licensees or marketing partners from marketing the Company's products or
limit the commercial use of such products and will have a material adverse
effect on the Company's business, financial condition and results of operations.
There is intense competition for cures and therapies for diabetes,
cardiovascular diseases and the other conditions for which the Company seeks to
develop products.
The Company is engaged in pharmaceutical fields characterized by
extensive research efforts and rapid technological progress. Many established
pharmaceutical and biotechnology companies with resources greater than those of
the Company are attempting to develop products that would be competitive with
the Company's products. Other companies may succeed in developing products that
are safer, more efficacious or less costly than any that may be developed by
Alteon and may also be more successful than Alteon in production and marketing.
Rapid technological development by others may result in the Company's products
becoming obsolete before the Company recovers a significant portion of the
research, development or commercialization expenses incurred with respect to
those products.
Certain technologies under development by other pharmaceutical
companies could result in a cure for diabetes or the reduction of the incidence
of diabetes and its complications. For example, a number of companies are
investigating islet cell transplantation as a possible cure for Type I diabetes.
Results of a study conducted by the National Institutes of Health, known as the
DCCT, published in 1993, showed that tight glucose control reduced the incidence
of diabetic complications. Numerous companies are pursuing methods to control
glucose levels. In addition, several large companies have initiated or expanded
research, development and licensing efforts to build a diabetic pharmaceutical
franchise focusing on diabetic nephropathy, neuropathy, retinopathy and related
conditions. An example of this is research seeking anti-angiogenesis drugs for
the potential treatment of diabetic retinopathy. Furthermore, the Company is
aware of several pharmaceutical companies that are developing and marketing
thiazolidinedione derivatives ("glitazones") for the treatment of Type II
diabetes. It is possible that one or more of these initiatives may reduce or
eliminate the market for some of the Company's products.
In addition, a broad range of cardiovascular drugs is under development
by many pharmaceutical and biotechnology companies. It is possible that one or
more of these initiatives may reduce or eliminate the market for some of the
Company's products.
Efforts to reduce healthcare costs may affect our operations.
The Company's business, financial condition and results of operations
may be materially adversely affected by the continuing efforts of government and
third-party payors to contain or reduce the costs of health care through various
means. For example, in certain foreign markets, pricing and/or profitability of
prescription pharmaceuticals are subject to government control. In the United
States, the Company expects that there will continue to be federal and state
initiatives to control and/or reduce pharmaceutical expenditures. In addition,
increasing emphasis on managed care in the United States will continue to put
pressure on pharmaceutical pricing. Cost control initiatives could decrease the
price that the Company receives for any products it may develop and sell in the
future and have a material adverse effect on the Company's business, financial
condition and results of operations. Further, to the extent that cost control
initiatives have a material adverse effect on the Company's corporate partners,
the Company's ability to commercialize its products may be adversely affected.
The Company's ability to commercialize pharmaceutical products may
depend in part on the extent to which reimbursement for the products will be
available from government health administration authorities, private health
insurers and other third-party payors. Significant uncertainty exists as to the
reimbursement status of newly approved health care products, and third-party
payors, including Medicare, are increasingly challenging the prices
19
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charged for medical products and services. There can be no assurance that any
third-party insurance coverage will be available to patients for any products
developed by the Company. Government and other third-party payors are
increasingly attempting to contain health care costs by limiting both coverage
and the level of reimbursement for new therapeutic products and by refusing in
some cases to provide coverage for uses of approved products for disease
indications for which the FDA has not granted labeling approval. If adequate
coverage and reimbursement levels are not provided by government and other
third-party payors for the Company's products, the market acceptance of these
products would be adversely affected.
Alteon has no experience in marketing or sales and may have to rely on
others to market and sell any products the Company may development.
For certain of its products, the Company has licensed exclusive
marketing rights to its corporate partners or formed collaborative marketing
arrangements within specified territories in return for royalties to be received
on sales, a share of profits or beneficial transfer pricing. These agreements
are terminable at the discretion of the Company's partners upon as little as 90
days' prior written notice. If the licensee or marketing partner terminates an
agreement or fails to market a product successfully, the Company's business,
financial condition and results of operations may be adversely affected.
Alteon currently has no experience in marketing or selling
pharmaceutical products. In order to achieve commercial success for any approved
product, Alteon must either develop a marketing and sales force or, where
appropriate or permissible, enter into arrangements with third parties to market
and sell its products. There can be no assurance that Alteon will develop
successfully marketing and sales experience or that it will be able to enter
into marketing and sales agreements with others on acceptable terms, if at all,
or that any such arrangements, if entered into, will not be terminated. If the
Company develops its own marketing and sales capability, it will compete with
other companies that currently have experienced, well funded and larger
marketing and sales operations. To the extent that the Company enters into
co-promotion or other sales and marketing arrangements with other companies, any
revenues to be received by Alteon will be dependent on the efforts of others,
and there can be no assurance that their efforts will be successful.
Alteon has no experience in manufacturing products and may have to rely on
others to manufacture any products the Company may develop.
The Company has no experience in manufacturing products for commercial
purposes and does not have manufacturing facilities. Consequently, the Company
is dependent on contract manufacturers for the production of products for
development and commercial purposes. The manufacture of the Company's products
for clinical trials and commercial purposes is subject to cGMP regulations
promulgated by the FDA. The Company has contracted or will be contracting with
third parties for the manufacture and distribution of ALT-711 and pimagedine.
However, in the event that the Company is unable to obtain or retain third-party
manufacturing for its products, it will not be able to proceed with clinical
trials or commercialize such products as planned. There can be no assurance that
the Company will be able to enter into agreements for the manufacture of future
products with manufacturers whose facilities and procedures comply with cGMP and
other regulatory requirements. The Company's current dependence upon others for
the manufacture of its products may adversely affect its profit margin, if any,
on the sale of future products and the Company's ability to develop and deliver
such products on a timely and competitive basis.
Use of any products the Company develops may result in liability claims.
The use of any of the Company's potential products in clinical trials
and the sale of any approved products, including the testing and
commercialization of pimagedine or ALT-711, may expose the Company to liability
claims resulting from the use of products or product candidates. These claims
might be made directly by consumers, pharmaceutical companies or others. The
Company maintains product liability insurance coverage for claims arising from
the use of its products in clinical trials. However no assurance can be given
that the Company will be able to maintain insurance or, if maintained, that
insurance can be acquired at a reasonable cost or in sufficient amounts to
protect the Company against losses due to liability that could have a material
adverse effect on the Company's business, financial conditions and results of
operations. There can be no assurance that the Company will be able to obtain
commercially reasonable product liability insurance for any product approved for
marketing in
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the future or that insurance coverage and the resources of the Company would be
sufficient to satisfy any liability resulting from product liability claims. A
successful product liability claim or series of claims brought against the
Company could have a material adverse effect on its business, financial
condition and results of operations.
Alteon may be unable to attract and retain the key personnel on whom its
success depends.
The Company is highly dependent on the principal members of its
management and scientific staff. The loss of services of any of these personnel
could impede the achievement of the Company's development objectives.
Furthermore, recruiting and retaining qualified scientific personnel to perform
research and development work in the future will also be critical to the
Company's success. There can be no assurance that the Company will be able to
attract and retain personnel on acceptable terms given the competition between
pharmaceutical and health care companies, universities and non-profit research
institutions for experienced scientists. In addition, the Company relies on
consultants to assist the Company in formulating its research and development
strategy. All of Alteon's consultants are employed outside the Company and may
have commitments to or consulting or advisory contracts with other entities that
may limit their availability to the Company.
Alteon's operations involve a risk of injury or damage from hazardous
materials.
The Company's research and development activities involve the
controlled use of hazardous materials, chemicals and various radioactive
compounds. Although the Company believes that its safety procedures for handling
and disposing of hazardous materials comply with the standards prescribed by
state and federal regulations, the risk of accidental contamination or injury
from these materials cannot be completely eliminated. In the event of an
accident, the Company could be held liable for any damages or fines that result.
Such liability could have a material adverse effect on the Company's business,
financial condition and results of operations.
ITEM 2. PROPERTIES.
The Company leases a 37,000 square foot building in Ramsey, New
Jersey, which contains its executive and administrative offices and research
laboratory space. The lease, which commenced on November 1, 1993, has a 10-year
term. In addition, the lease has two five-year renewal options.
ITEM 3. LEGAL PROCEEDINGS.
The Company is not a party to any material litigation.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
Not applicable.
ITEM 5. MARKET FOR THE COMPANY'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS.
The Company's Common Stock - was traded on the Nasdaq Market until
December 10, 1999, under the symbol "ALTN." Since December 13, 1999, the
Company's Common Stock has been traded on the Over-the-Counter Bulletin Board
("OTCBB") under the symbol ALTN. The following table sets forth, for the
calendar periods indicated, the range of high and low sale prices for the Common
Stock of the Company on the Nasdaq Market or the OTCBB, as applicable:
High Low
---- ---
1998
----
First Quarter $13.125 $4.563
Second Quarter 5.500 3.250
Third Quarter 5.000 2.188
Fourth Quarter 5.500 0.531
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High Low
---- ---
1999
----
First Quarter $1.6875 $0.6875
Second Quarter 1.0625 0.6250
Third Quarter 1.4375 0.5625
Fourth Quarter 1.3438 0.5000
As of March 17, 2000, there were 340 holders of the Common Stock,
with beneficial stockholders in excess of 400. On March 17, 2000, the last sale
price reported on the OTCBB for the Common Stock was $4.50 per share.
Effective with the close of business on December 10, 1999, the
Company's Common Stock was delisted from the Nasdaq Stock Market because it did
not satisfy the $1.00 per share minimum bid price required for listing on the
Nasdaq Stock Market. Effective December 13, 1999, the Common Stock has been
traded on the OTCBB. The delisting from the Nasdaq Stock Market could have a
material adverse effect on the Company's ability to raise capital on favorable
terms or at all.
The Company has neither paid nor declared dividends on its Common
Stock since its inception and does not plan to pay dividends in the foreseeable
future. Any earnings that the Company may realize will be returned to finance
the growth of the Company.
The market prices for securities of biotechnology and pharmaceutical
companies, including Alteon, have historically been highly volatile, and the
market has from time to time experienced significant price and volume
fluctuations that are unrelated to the operating performance of particular
companies. Factors such as fluctuations in the Company's operating results,
announcements of technological innovations or new therapeutic products by the
Company or others, clinical trial results, developments concerning agreements
with collaborators, governmental regulation, developments in patent or other
proprietary rights, public concern as to safety of drugs developed by the
Company or others, future sales of substantial amounts of Common Stock by
existing stockholders and general market conditions can have an adverse effect
on the market price of the Common Stock.
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ITEM 6. SELECTED FINANCIAL DATA.
The selected financial data set forth below should be read in
conjunction with the audited financial statements and related notes included
elsewhere in this Annual Report on Form 10-K. The selected financial data for
the five years ended December 31, 1999, has been derived from the audited
financial statements of the Company.
YEARS ENDED DECEMBER 31,
1995 1996 1997 1998 1999
---- ---- ---- ---- ----
(in thousands, except per share data)
STATEMENT OF OPERATIONS DATA:
Revenues:
Investment income ................... $ 1,888 $ 2,295 $ 1,510 $ 1,321 $ 835
Other income ........................ -- -- -- -- 600
-------- -------- -------- -------- --------
Total revenues .................... 1,888 2,295 1,510 1,321 1,435
Expenses:
Research and development ............... 10,004 17,494 23,264 24,592 10,598
Elimination of previously accrued
loss contingency .................. -- -- -- (1,771) --
General and administrative .......... 3,699 3,517 3,633 4,842 4,357
Interest ............................ 68 47 25 4 --
-------- -------- -------- -------- --------
Total expenses .................... 13,771 21,058 26,922 27,667 14,955
-------- -------- -------- -------- --------
Net loss before benefit for income taxes (11,883) (18,763) (25,412) (26,346) (13,520)
Income tax benefit ..................... -- -- -- -- 2,588
-------- -------- -------- -------- --------
Net loss ............................... (11,883) (18,763) (25,412) (26,346) (10,932)
Preferred stock dividends
and discount amortization ........... -- -- 1,091 2,207 2,707
-------- -------- -------- -------- --------
Net loss applicable to common
stockholders ........................ $(11,883) $(18,763) $(26,503) $(28,553) $(13,639)
======== ======== ======== ======== ========
Basic loss per share to common
stockholders ........................ $ (0.90) $ (1.20) $ (1.60) $ (1.57) $ (0.72)
======== ======== ======== ======== ========
Diluted loss per share to common
stockholders ........................ $ (0.90) $ (1.20) $ (1.60) $ (1.57) $ (0.72)
======== ======== ======== ======== ========
Weighted average common shares used
in computing basic and diluted loss
per share ........................... 13,170 15,640 16,566 18,211 19,055
======== ======== ======== ======== ========
DECEMBER 31,
1995 1996 1997 1998 1999
---- ---- ---- ---- ----
(in thousands)
BALANCE SHEET DATA:
Cash, cash equivalents and
short-term investments ......... $ 45,197 $ 34,500 $ 28,974 $ 24,132 $ 12,370
Working capital ................... 44,433 26,542 22,390 20,093 10,425
Total assets ...................... 52,216 40,139 33,508 27,652 15,021
Long-term capital lease obligations 467 162 -- -- --
Accumulated deficit ............... (34,037) (52,800) (79,303) (107,857) (121,496)
Stockholders' equity .............. 49,716 31,371 26,455 23,338 12,827
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATION
OVERVIEW
Since its inception in October 1986, Alteon has devoted
substantially all of its resources to its research, drug discovery and
development programs. To date, Alteon has not generated any revenues from the
sale of products and does not expect to generate any such revenues for a number
of years, if at all. Alteon has incurred an accumulated deficit of $121,496,049
as of December 31, 1999, and expects to incur operating losses, potentially
greater than losses in prior years, for a number of years.
Alteon has financed its operations through proceeds from an initial
public offering of Common Stock in 1991, a follow-on offering of Common Stock
completed in 1995, and private placements of common and preferred equity
securities, revenue from present and former collaborative relationships,
reimbursement of certain of Alteon's research and development expenses by its
collaborative partners, investment income earned on cash balances and short-term
investments and the sale of its New Jersey State Net Operating Losses ("NOLs")
carryforwards.
In December 1997, Alteon and Genentech entered into a stock purchase
agreement and a development collaboration and license agreement providing for
the development and marketing of pimagedine and second-generation
A.G.E.-Formation Inhibitors. Pursuant to the stock purchase agreement Genentech
purchased Common Stock, Series G Preferred Stock and Series H Preferred Stock
for an aggregate purchase price of $37,544,000. Genentech's obligations to
purchase shares of Alteon's stock terminated December 31, 1998. Pursuant to a
letter agreement dated February 11, 1999, between Alteon and Genentech, the
development collaboration and license agreement terminated effective June 30,
1999.
Although the Company anticipates increased expenditures in research
and development expenses as it develops products and conducts its clinical
trials, a portion of such development expenses are expected to be reimbursed by
Alteon's collaborative partners. Yamanouchi funded pre-clinical studies,
including most toxicology studies, on pimagedine. Gamida conducted, at its own
expense, a Phase II clinical trial in Israel to evaluate pimagedine in patients
with diabetes and elevated serum cholesterol levels, which was completed in
April 1997. Yamanouchi and Gamida do not fund Alteon's research or early product
development expenses.
In August 1999, Alteon and Taisho Pharmaceutical Co., Ltd.
("Taisho") entered into an agreement under which Taisho was granted an exclusive
option through December 31, 1999, to acquire a license to Alteon's lead A.G.E.
Crosslink Breaker, ALT-711, for Japan, South Korea, Taiwan and China for a
non-refundable option fee of $600,000. This amount is reflected in "Other
income" in the statement of operations. The option expired on December 31, 1999.
In December 1999, Alteon sold $27.7 million of its gross state net
operating loss carryforwards and $645,000 of its state research and development
tax credit carryforwards under the State of New Jersey's Technology Business Tax
Certificate Transfer Program (the "Program"). The Program allowed qualified
technology and biotechnology businesses in New Jersey to sell unused amounts of
net operating loss carryforwards and defined research and development tax
credits for cash. The total tax value sold was $3,137,000 and the total proceeds
received by the Company were $2,588,000, which was recorded as a tax benefit in
the statement of operations.
The Company's business is subject to significant risks including,
but not limited to, (i) its ability to obtain funding, (ii) the risks inherent
in its research and development efforts, including clinical trials, (iii)
uncertainties associated both with obtaining and enforcing its patents and with
the patent rights of others, (iv) the lengthy, expensive and uncertain process
of seeking regulatory approvals, (v) uncertainties regarding government reforms
and product pricing and reimbursement levels, (vi) technological change and
competition, (vii) manufacturing uncertainties, and (viii) dependence on
collaborative partners and other third parties. Even if the Company's product
candidates appear promising at an early stage of development, they may not reach
the market for numerous reasons. Such reasons include the possibilities that the
products will prove ineffective or unsafe during clinical trials, will fail to
receive necessary regulatory approvals, will be difficult to manufacture on a
large scale, will be uneconomical to market or will be precluded from
commercialization by proprietary rights of third parties.
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RESULTS OF OPERATIONS
Years Ended December 1999, 1998, 1997
Revenues
Total revenues for 1999, 1998 and 1997 were $1,435,000, $1,321,000
and $1,510,000, respectively. Revenues in 1999, 1998 and 1997 were derived from
interest earned on cash and cash equivalents and short-term investments and
other income. The increase in revenues in 1999 over 1998 was attributed to other
income from the option agreement with a potential corporate partner, offset by
the decrease in investment income due to a decrease in cash and cash equivalents
and short-term investment balances during most of 1999.
Operating Expenses
The Company's total expenses decreased to $14,955,000 in 1999, from
$27,667,000 in 1998 and $26,922,000 in 1997 and consisted primarily of research
and development expenses Research and development expenses, net of
reimbursements from its collaborative partners, were $10,598,000 in 1999,
$24,592,000 in 1998, and $23,264,000 in 1997. Research and development expenses
decreased in 1999 from 1998 by $13,994,000, or 56.9%. This decrease was
primarily due to decreased expenses related to the closure of the ACTION I and
ESRD trials. Research and development expenses increased in 1998 from 1997 by
$1,328,000, or 5.7%, due to the increased expenses related to the A.G.E.
Crosslink Breaker program including Phase I clinical trial costs and the
expansion of the ESRD trial offset by a decrease in the ACTION trial costs due
to the termination of the ACTION II trial.
General and administrative expenses were $4,357,000 in 1999 as
compared to $4,842,000 in 1998 and $3,633,000 in 1997. The decrease in 1999 over
1998 was due to decreased personnel related and investor relations costs and
patent fees offset by increased consulting expenditures.
Interest expense was $0 in 1999, $4,000 in 1998 and $25,000 in 1997.
The decrease in interest expense was primarily due to the Company's exercise of
its purchase option in June 1998 on its capital lease arrangement, which
commenced in June 1994 for leasehold improvements on the Company's headquarters
and research facility.
Net Loss
At December 31, 1999, the Company had available Federal net
operating tax loss carryforwards ("NOLs"), which expire in various amounts from
the years 2006 through 2014, of approximately $111.8 million for income tax
purposes and State net operating loss carryforwards, which expire in the years
2000 through 2007, of approximately $81 million. In addition, the Company had
Federal research and development credit carryforwards of approximately $4.5
million and State research and development tax credit carryforwards of
approximately $2.5 million. The Company had net losses of $10,932,000 in 1999,
$26,346,000 in 1998 and $25,412,000 in 1997.
The Company does not believe that inflation has had a material
impact on the results of its operations.
LIQUIDITY AND CAPITAL RESOURCES
Alteon had cash and cash equivalents and short-term investments at
December 31, 1999, of $12,370,000 compared to $24,132,000 at December 31, 1998.
This is a decrease in cash and cash equivalents and short-term investments for
the twelve months ended December 31, 1999, of $11,762,000. This consisted of
$11,770,000 of cash used in operations consisting primarily of research and
development expenses, personnel and related costs and facility expenses. Also
included in the cash used in operations was $2,588,000 from the sale of the
Company's NOLs and $600,000 of other income from the option agreement with
Taisho. Capital expenditures consisted of $158,000. This was offset by $166,000
of financing activities primarily related to the sale of Common Stock. As of
December 31, 1999, Alteon had invested $7,520,000 in capital equipment and
leasehold improvements.
In December 1999, Alteon sold $2,588,210 of its NOLs under the State
of New Jersey's Technology Business Tax Certificate Transfer Program (the
"Program"). The Program allowed qualified technology and
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biotechnology businesses in New Jersey to sell unused amounts of NOLs and
defined research and development tax credits for cash.
In August 1999, Alteon and Taisho entered into an agreement under
which Taisho was granted an exclusive option through December 31, 1999, to
acquire a license to Alteon's lead A.G.E. Crosslink Breaker, ALT-711, for Japan,
South Korea, Taiwan and China for a non-refundable option fee of $600,000. This
amount is reflected in "Other income" in the Statement of Operations. The option
expired on December 31, 1999.
The Company's research and development expenses, to date, have been
funded primarily by research and development collaborative arrangements and
sales of equity securities. In programs that are subject to joint development
agreements, the Company expects to incur substantial additional research and
development costs, including costs related to drug discovery, pre-clinical
research and clinical trials. The Company anticipates that it will be able to
offset a portion of its research and development expenses and its clinical
development expenses with funding from its collaborative partners.
Alteon anticipates that its existing available cash and cash
equivalents and short-term investments will be adequate to satisfy its working
capital requirements for its current and planned operations into 2001.
In December 1997, Alteon and Genentech entered into a stock purchase
agreement and a development collaboration and license agreement providing for
the development and marketing of pimagedine and second-generation
A.G.E.-Formation Inhibitors. Pursuant to the stock purchase agreement Genentech
purchased Common Stock, Series G Preferred Stock and Series H Preferred Stock
for an aggregate purchase price of $37,544,000. Genentech's obligations to
purchase shares of Alteon's stock terminated December 31, 1998. Pursuant to a
letter agreement dated February 11, 1999, between Alteon and Genentech, the
development collaboration and license agreement terminated effective June 30,
1999.
The amount of the Company's future capital requirements will depend on
numerous factors, including the progress of the Company's research and
development programs, the conduct of pre-clinical tests and clinical trials, the
development of regulatory submissions, the costs associated with protecting
patents and other proprietary rights, the development of marketing and sales
capabilities and the availability of third party funding.
Because of the Company's long-term capital requirements, it may seek
access to the public or private equity markets whenever conditions are
favorable. The Company may also seek additional funding through corporate
collaborations and other financing vehicles, potentially including off-balance
sheet financing through limited partnerships or corporations. There can be no
assurance that such funding will be available at all or on terms acceptable to
the Company. If adequate funds are not available, the Company may be required to
curtail significantly one or more of its research or development programs. If
the Company obtains funds through arrangements with collaborative partners or
others it may be required to relinquish rights to certain of its technologies or
product candidates.
Alteon's corporate partners may develop, either alone or with others,
products that compete with the development and marketing of the Company's
products. Competing products, either developed by the corporate partners or to
which the corporate partners have rights, may result in their withdrawal of
support with respect to all or a portion of the Company's technology, which
would have a material adverse effect on the Company's business, financial
condition and results of operations.
The Company's current priorities are the development of ALT-711, its
lead A.G.E. Crosslink Breaker candidate, and the continued development of
pimagedine. The Company is focusing its resources on the development of ALT-711,
and is actively seeking one or more corporate partners to help fund further
development. After consultation with the FDA, the Company also has decided to
continue the development of pimagedine and is actively seeking one or more
corporate partners to provide necessary funding. The Company believes that
additional development of these compounds and other product candidates will
require the Company to find sources of funding.
Effective with the close of business on December 10, 1999, the
Company's Common Stock was delisted from the Nasdaq Stock Market because it did
not satisfy the $1.00 per share minimum bid price required for listing
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on the Nasdaq Stock Market. Effective December 13, 1999, the Common Stock has
been traded on the OTCBB. The delisting from the Nasdaq Stock Market could have
a material adverse effect on the Company's ability to raise capital on favorable
terms.
The Company initiated a program to assess the risks of year 2000
compliance, remediate all non-compliant systems and to assess the readiness of
key third parties. The critical aspects of the year 2000 readiness program were
completed in the third quarter of 1999. The Company has not experienced any
significant business disruptions related to the transition to the year 2000.
Total costs to address the year 2000 issue were not material to the Company's
financial position, results of operations or cash flows.
ITEM 7a. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
The Company's exposure to market risk for changes in interest rates
relates primarily to the Company's investment in marketable securities. The
Company does not use derivative financial instruments in its investments. The
Company's investments consist primarily of debt instruments of the U.S.
government, government agencies, financial institutions and corporations with
strong credit ratings. The table below presents principal amounts and related
weighted average interest rates expected by maturity date for the Company's
investment portfolio.
2000 2001 2002 2003 2004 Thereafter
---- ---- ---- ---- ---- ----------
Assets
-------
Cash equivalents:
Fixed rate $5,335,529 --- --- --- --- ---
Average interest rate 5.02% --- --- --- --- ---
Short-term investments:
Fixed rate $7,034,258 --- --- --- --- ---
Average interest rate 5.82% --- --- --- --- ---
Total investment securities: $12,369,787 --- --- --- --- ---
Average interest rate 5.42% --- --- --- --- ---
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The financial statements required to be filed pursuant to this Item 8
are appended to this Annual Report on Form 10-K. A list of the financial
statements filed herewith is found at "Index to Financial Statements and
Schedules" on page F-1.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
Not applicable.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY.
For information concerning this item, see the information under
"Election of Directors," "Executive Officers" and "Section 16(a) Beneficial
Ownership Reporting Compliance" in the Company's Proxy Statement to be filed
with respect to the Annual Meeting of Stockholders to be held on June 12, 2000,
which information is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION.
For information concerning this item, see the information under
"Executive Compensation" in the Company's Proxy Statement to be filed with
respect to the Annual Meeting of Stockholders to be held on June 12, 2000, which
information is incorporated herein by reference.
27
28
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
For information concerning this item, see the information under
"Security Ownership of Certain Beneficial Owners and Management" in the
Company's Proxy Statement to be filed with respect to the Annual Meeting of
Stockholders to be held on June 12, 2000, which information is incorporated
herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
For information concerning this item, see the information under
"Certain Relationships and Related Transactions" in the Company's Proxy
Statement to be filed with respect to the Annual Meeting of Stockholders to be
held on June 12, 2000, which information is incorporated herein by reference.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K.
(a) Financial Statements.
The Company's audited financial statements, financial statement
schedules and the Report of Independent Public Accountants are appended to this
Annual Report on Form 10-K. Reference is made to the Index to Financial
Statements and Schedules on page F-1.
(b) Reports on Form 8-K.
On January 7, 2000, the Company filed a current report on Form 8-K,
dated January 5, 2000, regarding the Company's sale of net operating loss
carryforwards under the State of New Jersey's Technology Business Tax
Certificate Transfer Program.
On January 7, 2000 the Company filed a current report on Form 8-K,
dated December 13, 1999, announcing that it has been notified that the its
common stock had been delisted from trading on the Nasdaq SmallCap Market.
On November 23, 1999, the Company filed a current report on Form
8-K, dated November 23, 1999, announcing that it had been approved to sell net
operating loss carryforwards under the State of New Jersey's Technology Business
Tax Certificate Transfer Program.
On November 16, 1999, the Company filed a current report on Form 8-K,
dated November 11, 1999, announcing the financial results for the third quarter
ended September 30, 1999.
On November 16, 1999, the Company filed a current report on Form 8-K,
dated November 8, 1999, announcing that the first data on the Phase III ACTION I
trial of pimagedine in Type 1 diabetic patients with overt nephropathy has been
published and presented at the American Society of Nephrology ("ASN") 32nd
Annual Meeting and Scientific Exposition in Miami Beach, Florida.
October 15, 1999, the Company filed a current report on Form 8-K,
dated September 27, 1999, announcing that it ha been notified by the Nasdaq
Listing Qualifications Panel that the Company had been granted a temporary
exception from the $1.00 per share minimum bid requirement and will continue to
be listed with Nasdaq on the Nasdaq SmallCap Market.
(c) Exhibits.
The exhibits required to be filed are listed on the Index to Exhibits
attached hereto, which is incorporated herein by reference.
28
29
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized this 29th day of March
2000.
ALTEON INC.
By:/s/ Kenneth I. Moch
----------------------
Kenneth I. Moch
President and Chief Executive Officer
29
30
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Mark Novitch Chairman of the Board March 29, 2000
- ---------------- --------------
Mark Novitch
/s/ Kenneth I. Moch President and Chief Executive Officer March 29, 2000
- ------------------- (principal executive officer) --------------
Kenneth I. Moch
/s/ Elizabeth O'Dell Vice President, Finance and Administration, March 29, 2000
- -------------------- Secretary and Treasurer (principal finance and --------------
Elizabeth O'Dell accounting officer)
/s/ Edwin Bransome, Jr. M.D. Director March 29, 2000
- ---------------------------- --------------
Edwin Bransome, Jr. M.D.
/s/ Marilyn G. Breslow Director March 29, 2000
- ---------------------- --------------
Marilyn G. Breslow
/s/ Alan J. Dalby Director March 29, 2000
- ----------------- --------------
Alan J. Dalby
/s/ David McCurdy Director March 29, 2000
- ----------------- --------------
David McCurdy
/s/ George M. Naimark, Ph.D. Director March 29, 2000
- ---------------------------- --------------
George M. Naimark, Ph.D.
30
31
EXHIBIT INDEX
Exhibit
No. Description of Exhibit
--- ----------------------
3.1 Restated Certificate of Incorporation, as amended. (Incorporated by
reference to Exhibit 3.1 to the Company's Report on Form 10-Q filed on
November 10, 1999).
3.2 Certificate of the Voting Powers, Designations, Preference and Relative
Participating, Optional and Other Special Rights and Qualifications,
Limitations or Restrictions of Series F Preferred Stock of the Company.
(Incorporated by reference to Exhibit 4.2 to the Company's Current
Report on Form 8-K filed on August 4, 1995).
3.3 Certificate of Retirement of Alteon Inc. (Incorporated by reference to
Exhibit 3.1 to the Company's Report on Form 10-Q filed on November 10,
1999).
3.4 Certificate of Designations of Series G Preferred Stock of Alteon Inc.
(Incorporated by reference to Exhibit 3.4 to the Company's Annual
Report on Form 10-K for the year ended December 31, 1997).
3.5 Certificate of Amendment of Certificate of Designations of Series G
Preferred Stock of Alteon Inc. (Incorporated by reference to Exhibit
3.4 to the Company's Report on Form 10-Q filed on August 14, 1998).
3.6 Certificate of Designations of Series H Preferred Stock of Alteon Inc.
(Incorporated by reference to Exhibit 3.5 to the Company's Annual
Report on Form 10-K for the year ended December 31, 1997).
3.7 Amended Certificate of Designations of Series H Preferred Stock of
Alteon Inc. (Incorporated by reference to Exhibit 3.6 to the Company's
Report on Form 10-Q filed on August 14, 1998).
3.8 By-laws, as amended. (Incorporated by reference to Exhibit 3.1 to the
Company's Current Report on Form 8-K filed on April 22, 1996).
4.1 Stockholders' Rights Agreement dated as of July 27, 1995 between Alteon
Inc. and Registrar and Transfer Company, as Rights Agent. (Incorporated
by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K
filed on August 4, 1995).
4.2 Amendment to Stockholders' Rights Agreement dated as of April 24, 1997
between Alteon Inc. and Registrar and Transfer Company, as Rights
Agent. (Incorporated by reference to Exhibit 4.4 to the Company's
Current Report on Form 8-K filed on May 9, 1997).
4.3 Registration Rights Agreement dated as of April 24, 1997 between Alteon
Inc. and the investors named on the signature page thereof.
(Incorporated by reference to Exhibit 4.1 to the Company's Current
Report on Form 8-K filed on May 9, 1997).
4.4 Form of Common Stock Purchase Warrant. (Incorporated by reference to
Exhibit 4.2 to the Company's Current Report on Form 8-K filed on May 9,
1997).
4.5 Amendment to Stockholders' Rights Agreement dated as of December 1,
1997 between Alteon Inc. and Registrar and Transfer Company, as Rights
Agent. (Incorporated by reference to Exhibit 4.1 to the Company's
Current Report on Form 8-K filed on December 10, 1997).
10.1+ Amended and Restated 1987 Stock Option Plan. (Incorporated by reference
to Exhibit 10.1 to the Company's Annual Report on Form 10-K for the
year ended December 31, 1997).
10.2+ Amended 1995 Stock Option Plan. (Incorporated by reference to Exhibit
10.2 to the Company's Report on Form 10-Q filed May 12, 1999).
E-1
32
10.3 Form of Employee's or Consultant's Invention Assignment, Confidential
Information and Non-Competition Agreement executed by all key employees
and consultants as employed or retained from time to time.
(Incorporated by Reference to Exhibit 10.1 to the Company's
Registration Statement on Form S-1 (File Number 33-42574) which became
effective on November 1, 1991).
10.4 Amendment and Assignment of Research and Option Agreement dated as of
September 25, 1987 among Telos Development Corporation ("Telos"), The
Rockefeller University ("The Rockefeller"), the Company and Anthony
Cerami. (Incorporated by reference to Exhibit 10.5 to the Company's
Registration Statement on Form S-1 (File Number 33-42574) which became
effective on November 1, 1991).
10.5 License Agreement dated as of September 25, 1987 among Telos, Applied
Immune Sciences, Inc., the Company and The Rockefeller as amended by
letter agreement dated September 25, 1987 and letter agreement dated
August 15, 1991. (Incorporated by reference to Exhibit 10.6 to the
Company's Registration Statement on Form S-1 (File Number 33-42574)
which became effective on November 1, 1991).
10.6* License Agreement dated as of June 16, 1989 between the Company and
Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"). (Incorporated by
reference to Exhibit 10.17 to the Company's Registration Statement on
Form S-1 (File Number 33-42574) which became effective on November 1,
1991).
10.7* Research and Development Collaboration Agreement dated as of June 16,
1989 between the Company and Yamanouchi. (Incorporated by reference to
Exhibit 10.18 to the Company's Registration Statement on Form S-1 (File
Number 33-42574) which became effective on November 1, 1991).
10.8* Research and License Agreement dated as of September 5, 1991 between
the Company and The Picower Institute for Medical Research.
(Incorporated by reference to Exhibit 10.29 to the Company's
Registration Statement on Form S-1 (File Number 33-42574) which became
effective on November 1, 1991).
10.9 Amendment dated as of September 17, 1992 to the Research and
Development Collaboration Agreement dated as of June 16, 1989, between
the Company and Yamanouchi. (Incorporated by reference to Exhibit 10.31
to the Company's Annual Report on Form 10-K for the year ended December
31, 1992).
10.10 Lease Agreement dated January 11, 1993 between Ramsey Associates and
the Company. (Incorporated by reference to Exhibit 10.34 to the
Company's Annual Report on Form 10-K for the year ended December 31,
1992).
10.11* License Agreement dated as of December 30, 1994 between the Company and
Corange International Limited. (Incorporated by reference to Exhibit
10.38 to the Company's Annual Report on Form 10-K for the year ended
December 31, 1994).
10.12+ Employment Agreement dated as of March 27, 1995 between the Company and
Kenneth Cartwright. (Incorporated by reference to Exhibit 10.37 to the
Company's Annual Report on Form 10-K for the year ended December 31,
1995).
10.13* Research Collaboration and License Agreement dated as of June 2, 1995
between Washington University and the Company. (Incorporated by
reference to Exhibit 10.1 to the Company's Quarterly Report on Form
10-Q filed on August 11, 1995).
10.14 Distribution Agreement dated September 25, 1995 between the Company and
Eryphile BV. (Incorporated by reference to Exhibit 10.1 to the
Company's Current Report on Form 8-K filed on November 24, 1995).
10.15+ Employment Agreement dated as of October 21, 1995 between the Company
and Elizabeth O'Dell. (Incorporated by reference to Exhibit 10.42 to
the Company's Annual Report on Form 10-K for the year ended December
31, 1995).
E-2
33
10.16+ Alteon Inc. Change in Control Severance Benefits Plan. (Incorporated by
reference to Exhibit 10.1 to the Company's Current Report on Form 8-K
filed on March 13, 1996).
10.17+ Letter Agreement dated January 29, 1997 between the Company and Kenneth
Cartwright amending Employment Agreement dated March 27, 1995.
(Incorporated by reference to Exhibit 10.31 to the Company's Annual
Report on Form 10-K for the year ended December 31, 1997).
10.18+ Letter Agreement dated January 29, 1997 between the Company and
Elizabeth A. O'Dell amending Employment Agreement dated October 21,
1995. (Incorporated by reference to Exhibit 10.32 to the Company's
Annual Report on Form 10-K for the year ended December 31, 1997).
10.19+ Letter Agreement dated March 27, 1997 between the Company and Kenneth
Cartwright amending Employment Agreement dated March 27, 1995, as
amended. (Incorporated by reference to Exhibit 10.34 to the Company's
Annual Report on Form 10-K for the year ended December 31, 1997).
10.20 Preferred Stock Investment Agreement dated as of April 24, 1997 between
Alteon Inc. and the investors named on the signature page thereof.
(Incorporated by reference to Exhibit 10.1 to the Company's Current
Report on Form 8-K filed on May 9, 1997).
10.21* License and Supply Agreement dated June 17, 1997 between IDEXX
Laboratories, Inc. and Alteon Inc. (Incorporated by reference to
Exhibit 10.1 to the Company's Report on Form 10-Q filed on August 13,
1997).
10.22+ Letter Agreement dated October 21, 1997 between the Company and
Elizabeth A. O'Dell amending Employment Agreement dated October 21,
1995, as amended. (Incorporated by reference to Exhibit 10.2 to the
Company's Report on Form 10-Q filed on November 12, 1997).
10.23 Stock Purchase Agreement dated as of December 1, 1997 between Alteon
Inc. and Genentech, Inc. (Incorporated by reference to Exhibit 10.1 to
the Company's Current Report on Form 8-K filed on December 10, 1997).
10.24* Development Collaboration and License Agreement dated as of December 1,
1997 between Alteon Inc. and Genentech, Inc. (Incorporated by reference
to Exhibit 10.2 to the Company's Current Report on Form 8-K filed on
December 10, 1997).
10.25* Letter Agreement dated as of April 1, 1998 between Alteon Inc. and
Cerami Consulting Corporation. (Incorporated by reference to Exhibit
10.1 to the Company's Report on Form 10-Q filed on August 14, 1998).
10.26* Letter Agreement dated as of April 1, 1998 between Alteon Inc. and
Kenneth S. Warren Laboratories, Inc. (Incorporated by reference to
Exhibit 10.2 to the Company's Report on Form 10-Q filed on August 14,
1998).
10.27 Amendment to Stock Purchase Agreement and Development Collaboration and
License Agreement dated as of April 29, 1998 between the Company and
Genentech, Inc. (Incorporated by reference to Exhibit 10.1 to the
Company's Current Report on Form 8-K filed on May 6, 1998).
10.28+ Amended and Restated Employment Agreement dated as of December 15, 1998
between the Company and Kenneth I. Moch.
10.29 Letter Agreement dated February 11, 1999 between the Company and
Genentech, Inc. (Incorporated by reference to Exhibit 10.1 to the
Company's Current Report on Form 8-K filed on February 19, 1999).
10.30+ Employment Agreement dated as of June 2, 1999 between the Company and
F. Kenneth Andrews (Incorporated by reference to Exhibit 10.1 to the
Company's Current Report on Form 10-Q filed on November 10, 1999).
E-3
34
23.1 Consent of Independent Public Accountants.
27 Financial Data Schedule.
- ---------------
* Confidentiality has been granted for a portion of this exhibit.
+ Denotes a management contract or compensatory plan or arrangement required to
be filed as an exhibit pursuant to Item 14(c) to this Form 10-K.
E-4
35
Form 10-K - Item 14(a) (1)
Alteon Inc.
List of Financial Statements
Page
----
The following financial statements of Alteon Inc. are included in Item 8:
Report of independent public accountants - Arthur Andersen LLP .............................. F-2
Financial statements:........................................................................ F-3
Balance sheets as of December 31, 1998 and 1999..................................... F-3
Statements of operations for the years ended December 31, 1997, 1998 and 1999....... F-4
Statements of stockholders' equity for the years ended December 31, 1997, 1998
and 1999 ........................................................................... F-5
Statements of cash flows for the years ended December 31, 1997, 1998 and 1999....... F-6
Notes to financial statements ...................................................... F-7 -- F-14
F-1
36
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS
To Alteon Inc.:
We have audited the accompanying balance sheets of Alteon Inc. (a Delaware
corporation) as of December 31, 1998 and 1999, and the related statements of
operations, stockholders' equity and cash flows for each of the three years in
the period ended December 31, 1999. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with auditing standards generally accepted
in the United States. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements are free
of material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Alteon Inc. as of December 31,
1998 and 1999, and the results of its operations and its cash flows for each of
the three years in the period ended December 31, 1999, in conformity with
generally accepted accounting principles.
Arthur Andersen LLP
Roseland, New Jersey
March 2, 2000
F-2
37
ALTEON INC.
BALANCE SHEETS
DECEMBER 31,
-----------------------------------
1998 1999
------------- -------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents ............................................... $ 10,839,586 $ 5,335,529
Short-term investments .................................................. 13,292,666 7,034,258
Other current assets .................................................... 274,145 248,983
------------- -------------
Total current assets ................................................. 24,406,397 12,618,770
Property and equipment, net ............................................... 2,985,156 2,399,305
Deposits and other assets ................................................. 260,080 2,815
------------- -------------
Total assets ........................................................... $ 27,651,633 $ 15,020,890
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable ........................................................ $ 1,035,417 $ 431,000
Accrued expenses ........................................................ 3,277,858 1,763,202
------------- -------------
Total liabilities .................................................... 4,313,275 2,194,202
------------- -------------
CONTINGENCIES AND COMMITMENTS (NOTES 3 AND 6)
STOCKHOLDERS' EQUITY:
Preferred stock, $.01 par value; 1,993,329 shares authorized and
771 and 839 of Series G, 2,315 and 2,518 of Series H shares issued
and outstanding as of December 31, 1998 and 1999, respectively ........ 31 34
Common stock, $.01 par value; 40,000,000 shares
authorized and 18,814,740 and 19,189,701 shares issued and
outstanding as of December 31, 1998 and 1999, respectively ............ 188,147 191,897
Additional paid-in capital .............................................. 131,005,033 134,129,513
Accumulated deficit ..................................................... (107,856,621) (121,496,049)
Accumulated other comprehensive income .................................. 1,768 1,293
------------- -------------
Total stockholders' equity ........................................... 23,338,358 12,826,688
------------- -------------
Total liabilities and stockholders' equity ................................ $ 27,651,633 $ 15,020,890
============= =============
See accompanying notes to financial statements
F-3
38
ALTEON INC.
STATEMENTS OF OPERATIONS
YEAR ENDED DECEMBER 31,
------------------------------------------------------
1997 1998 1999
------------ ------------ ------------
Revenues:
Investment income ................................ $ 1,510,673 $ 1,320,538 $ 834,661
Other income ..................................... -- -- 600,000
------------ ------------ ------------
1,510,673 1,320,538 1,434,661
------------ ------------ ------------
Expenses:
Research and development ......................... 23,264,385 24,591,769 10,598,008
Elimination of previously accrued loss contingency -- (1,770,975) --
General and administrative ....................... 3,632,917 4,842,176 4,356,447
Interest ......................................... 25,061 3,610 --
------------ ------------ ------------
Total expenses ................................ 26,922,363 27,666,580 14,954,455
------------ ------------ ------------
Net loss before benefit for income taxes ........... (25,411,690) (26,346,042) (13,519,794)
Income tax benefit ................................. -- -- 2,588,210
------------ ------------ ------------
Net loss ........................................... (25,411,690) (26,346,042) (10,931,584)
Preferred stock dividends and discount amortization 1,091,401 2,207,205 2,707,844
------------ ------------ ------------
Net loss applicable to common stockholders ......... $(26,503,091) $(28,553,247) $(13,639,428)
============ ============ ============
Basic loss per share to common stockholders ........ $ (1.60) $ (1.57) $ (0.72)
============ ============ ============
Diluted loss per share to common stockholders ...... $ (1.60) $ (1.57) $ (0.72)
============ ============ ============
Weighted average common shares used in
computing basic and diluted loss per share ..... 16,566,290 18,210,902 19,054,750
============ ============ ============
See accompanying notes to financial statements
F-4
39
ALTEON INC.
STATEMENT OF STOCKHOLDERS' EQUITY
PREFERRED STOCK COMMON STOCK ADDITIONAL
----------------- --------------------- PAID-IN ACCUMULATED
SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT
------ ------ ------ ------ ------------- -------------
Balance, December 31, 1996 ......................... -- -- 15,702,825 $ 157,028 $ 84,018,146 $ (52,800,283)
Net loss ....................................... -- -- -- -- -- (25,411,690)
Change in unrealized losses .................... -- -- -- -- -- --
Comprehensive loss ............................. -- -- -- -- -- --
Issuance of 6%, cumulative preferred
stock valued at $1,000 per share,
net of transaction costs ................... 5,000 50 -- -- 4,812,277 --
Conversion of all 6%, cumulative
preferred stock to common stock ............ (5,000) (50) 1,203,099 12,031 (12,014) --
Preferred stock discount amortization .......... -- -- -- -- 1,065,161 (1,065,161)
Issuance of Series G preferred stock
valued at $10,000 per share to
Genentech, Inc., net of transaction
costs ...................................... 939 9 -- -- 9,266,313 --
Issuance of Series G preferred stock
dividends .................................. 3 -- -- -- 26,240 (26,240)
Issuance of common stock to Genentech, Inc ..... -- -- 837,314 8,373 5,601,627 --
Exercise of employee stock options ............. -- -- 179,081 1,791 119,165 --
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- -- -- -- 688,104 --
------ ------- ----------- --------- ------------ -------------
Balance, December 31, 1997 ......................... 942 9 17,922,319 179,223 105,585,019 (79,303,374)
Net loss ....................................... -- -- -- -- -- (26,346,042)
Change in unrealized losses .................... -- -- -- -- -- --
Comprehensive loss ............................. -- -- -- -- -- --
Issuance of Series H preferred stock valued
at $10,000 per share to Genentech, Inc.,
net of transaction costs ................... 2,254 23 -- -- 22,543,706 --
Issuance of Series G and H preferred stock
dividends .................................. 133 1 -- -- 1,327,768 (1,327,768)
Conversion of Series G preferred stock
to common stock ............................ (243) (2) 822,204 8,222 (8,220) --
Preferred stock discount amortization .......... -- -- -- -- 879,437 (879,437)
Exercise of employee stock options ............. -- -- 70,217 702 195,451 --
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- -- -- -- 481,872 --
------ ------- ----------- --------- ------------ -------------
Balance, December 31, 1998 ......................... 3,086 31 18,814,740 188,147 131,005,033 (107,856,621)
Net loss ....................................... -- -- -- -- -- (10,931,584)
Change in unrealized losses .................... -- -- -- -- -- --
Comprehensive loss ............................. -- -- -- -- -- --
Issuance of Series G and H preferred stock
dividends .................................. 272 3 -- -- 2,707,841 (2,707,844)
Exercise of employee stock options ............. -- -- 374,961 3,750 162,691 --
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- -- -- -- 253,948 --
------ ------- ---------- --------- ------------ -------------
Balance, December 31, 1999 ......................... 3,358 $ 34 19,189,701 $ 191,897 $134,129,513 $(121,496,049)
====== ======= ========== ========= ============ =============
ACCUMULATED
OTHER TOTAL
COMPREHENSIVE STOCKHOLDERS'
INCOME/(LOSS) EQUITY
------------- -------------
Balance, December 31, 1996 ......................... $ (3,717) $ 31,371,174
Net loss ....................................... -- (25,411,690)
Change in unrealized losses .................... (2,224) (2,224)
-------------
Comprehensive loss ............................. -- (25,413,914)
-------------
Issuance of 6%, cumulative preferred
stock valued at $1,000 per share,
net of transaction costs ................... -- 4,812,327
Conversion of all 6%, cumulative
preferred stock to common stock ............ -- (33)
Preferred stock discount amortization .......... -- --
Issuance of Series G preferred stock
valued at $10,000 per share to
Genentech, Inc., net of transaction
costs ...................................... -- 9,266,322
Issuance of Series G preferred stock
dividends .................................. -- --
Issuance of common stock to Genentech, Inc ..... -- 5,610,000
Exercise of employee stock options ............. -- 120,956
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- 688,104
------------- -------------
Balance, December 31, 1997 ......................... (5,941) 26,454,936
Net loss ....................................... -- (26,346,042)
Change in unrealized losses .................... 7,709 7,709
-------------
Comprehensive loss ............................. -- (26,338,333)
-------------
Issuance of Series H preferred stock valued
at $10,000 per share to Genentech, Inc.,
net of transaction costs ................... -- 22,543,729
Issuance of Series G and H preferred stock
dividends .................................. -- 1
Conversion of Series G preferred stock
to common stock ............................ -- --
Preferred stock discount amortization .......... -- --
Exercise of employee stock options ............. -- 196,153
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- 481,872
------------- -------------
Balance, December 31, 1998 ......................... 1,768 23,338,358
Net loss ....................................... -- (10,931,584)
Change in unrealized losses .................... (475) (475)
-------------
Comprehensive loss ............................. -- (10,932,059)
-------------
Issuance of Series G and H preferred stock
dividends .................................. -- --
Exercise of employee stock options ............. -- 166,441
Deferred compensation expense in connection
with the issuance of non-qualified stock
options and options granted to non-employees -- 253,948
------------- -------------
Balance, December 31, 1999 ......................... $ 1,293 $ 12,826,688
============= =============
See accompanying notes to financial statements
F-5
40
ALTEON INC.
STATEMENTS OF CASH FLOWS
YEAR ENDED DECEMBER 31,
---------------------------------------------
1997 1998 1999
------------- ------------- -------------
Cash Flows from Operating Activities:
Net loss ................................................... $ (25,411,690) $ (26,346,042) $ (10,931,584)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization ........................ 711,839 678,773 743,820
Amortization of deferred compensation ................ 688,104 481,872 253,948
Changes in operating assets and liabilities:
Other current assets .............................. 180,489 194,535 25,162
Other assets ...................................... 5,613 1,278 257,265
Accounts payable and accrued expenses ............. (1,409,900) (2,577,746) (2,119,073)
------------- ------------- -------------
Net cash used in operating activities ............. (25,235,545) (27,567,330) (11,770,462)
------------- ------------- -------------
Cash Flows from Investing Activities:
Capital expenditures ....................................... (21,187) (480,566) (157,969)
Purchases of marketable securities ......................... (105,272,696) (115,976,783) (54,461,475)
Sales and maturities of marketable securities .............. 112,934,079 111,241,889 60,719,408
Restricted cash ............................................ 103,400 620,400 --
------------- ------------- -------------
Net cash provided by (used in) investing activities 7,743,596 (4,595,060) 6,099,964
------------- ------------- -------------
Cash Flows from Financing Activities:
Proceeds from issuance of common stock ..................... 5,730,956 196,153 166,441
Proceeds from issuance of preferred stock .................. 14,078,616 22,543,729 --
Payments under capital lease obligations ................... (305,317) (161,581) --
Proceeds from sales-leaseback financing .................... 125,516 -- --
------------- ------------- -------------
Net cash provided by financing activities ......... 19,629,771 22,578,301 166,441
------------- ------------- -------------
Net (decrease)/increase in cash and cash equivalents ......... 2,137,822 (9,584,089) (5,504,057)
Cash and cash equivalents, beginning of period ............... 18,285,853 20,423,675 10,839,586
------------- ------------- -------------
Cash and cash equivalents, end of period ..................... $ 20,423,675 $ 10,839,586 $ 5,335,529
============= ============= =============
Supplemental disclosures of cash flow information:
Cash paid for interest ............................ $ 25,061 $ 3,610 $ --
============= ============= =============
See accompanying notes to financial statements
F-6
41
NOTES TO FINANCIAL STATEMENTS
NOTE 1 -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization and Business
Alteon Inc. (the "Company") is engaged in the discovery and development
of new pharmaceutical products for the treatment of cardiovascular and renal
disease and other disorders of diabetes and aging. The Company conducts its
business in one operating segment. Alteon's proprietary technology focuses on
Advanced Glycosylation End-products, or A.G.E.s, formed as a result of
circulating blood glucose reacting with proteins. All of the Company's products
are in research or development, and no revenues have been generated from product
sales. The Company's lead A.G.E. Crosslink Breaker compound, ALT-711, has
completed a series of Phase I human clinical trials and is expected to enter
Phase II trials in 2000. The Company is seeking a corporate partner to help fund
the continued development of its lead A.G.E.-Formation Inhibitor, pimagedine,
based on the results of a Phase III trial of pimagedine in Type 1 diabetic
patients with overt nephropathy. Alteon is also pursuing the development of a
novel series of glucose lowering agent compounds.
The Company's business is subject to significant risks including, but
not limited to, (i) its ability to obtain funding, (ii) its uncertainty of
future profitability, (iii) the risks inherent in its research and development
efforts, including clinical trials, (iv) uncertainties associated both with
obtaining and enforcing its patents and with the patent rights of others, (v)
the lengthy, expensive and uncertain process of seeking regulatory approvals,
(vi) uncertainties regarding government reforms and product pricing and
reimbursement levels, (vii) technological change and competition, (viii)
manufacturing uncertainties, and (ix) dependence on collaborative partners and
other third parties. Even if the Company's product candidates appear promising
at an early stage of development, they may not reach the market for numerous
reasons. Such reasons include the possibilities that the products will prove
ineffective or unsafe during clinical trials, will fail to receive necessary
regulatory approvals, will be difficult to manufacture on a large scale, will be
uneconomical to market or will be precluded from commercialization by
proprietary rights of third parties. Alteon will require substantial new funding
in order to continue the research, product development, pre-clinical testing and
clinical trials of its product candidates. If adequate funding is not available,
the Company may be required to curtail significantly one or more of its research
or development programs and other Company activities.
Pervasiveness of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents and Short-Term Investments
Cash and cash equivalents include cash and highly liquid investments,
which have a maturity of less than three months at the time of purchase.
Short-term investments are recorded at fair market value. As of December 31,
1999, short-term investments were invested in debt instruments of the U.S.
government, government agencies, financial institutions and corporations with
strong credit ratings.
They consist of the following:
DECEMBER 31,
-----------------------------
1998 1999
----------- -----------
U.S. Government Agency Funds ............... $ 8,107,933 $ --
Corporate Obligations ...................... 5,184,733 7,034,258
----------- -----------
$13,292,666 $ 7,034,258
=========== ===========
These amounts represent market value of the short-term investments at
December 31, 1998 and December 31, 1999. The amortized cost of these short-term
investments was $13,291,910 and $7,033,844 at December 31, 1998 and December 31,
1999, respectively.
F-7
42
NOTE 1 -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Property and Equipment
Property and equipment are stated at cost. Depreciation and
amortization are computed using the straight-line method over the useful lives
of owned assets, which range from three to five years. Leasehold improvements
and equipment under capital leases are amortized using the straight-line method
over the shorter of the lease term or the useful life of the assets.
Research and Development
Expenditures for research and development are charged to operations as
incurred.
Net Loss Per Share
Basic loss per share is based on the average numbers of shares
outstanding during the year. Diluted loss per share is the same as basic loss
per share, as the inclusion of common stock equivalents would be antidilutive.
Recently Issued Accounting Standards
In December 1999, the Securities and Exchange Commission staff issued
Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements"
(SAB 101). The bulletin draws on existing accounting rules and provides specific
guidance on how those accounting rules should be applied, and specifically
addresses revenue recognition for non-refundable technology access fees in the
biotechnology industry. SAB 101 is effective for fiscal years beginning after
December 15, 1999. The Company is evaluating SAB 101 and the effect it may have
on our financial statements. At this time, the Company believes that SAB 101
will not have a material impact on our financial position or results of
operations.
In June 1998, Statement of Financial Accounting Standards No. 133 -
"Accounting for Derivative Instruments and Hedging Activities" (SFAS No. 133)
was issued. SFAS No. 133 requires all derivatives to be measured at fair value
and recognized as assets or liabilities on the balance sheet. Changes in the
fair value of derivatives should be recognized in either net income or other
comprehensive income, depending on the designated purpose of the derivative. In
June 1999, the Financial Accounting Standards Board delayed the required
adoption of SFAS No. 133, for companies with fiscal years beginning after June
15, 2000. The adoption of SFAS No. 133 is not expected to have a material impact
on the Company's financial position or results of operations.
Reclassifications
Certain prior year amounts have been reclassified to conform to current
year presentation.
NOTE 2 -- PROPERTY AND EQUIPMENT
DECEMBER 31,
--------------------------
1998 1999
----------- -----------
Laboratory equipment ............................. $ 1,324,828 $ 1,261,640
Furniture and equipment .......................... 681,362 682,124
Computer equipment ............................... 598,920 360,713
Leasehold improvements ........................... 5,215,069 5,215,069
----------- -----------
7,820,179 7,519,546
Less: Accumulated depreciation & amortization ... (4,835,023) (5,120,241)
----------- -----------
$ 2,985,156 $ 2,399,305
=========== ===========
F-8
43
NOTE 3 -- COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Genentech, Inc. ("Genentech")
In December 1997, Alteon and Genentech entered into a stock purchase
agreement and a development collaboration and license agreement providing for
the development and marketing of pimagedine and second-generation
A.G.E.-Formation Inhibitor. Pursuant to the stock purchase agreement Genentech
purchased Common Stock, Series G Preferred Stock and Series H Preferred Stock
for an aggregate purchase price of $37,544,000. Genentech's obligations to
purchase shares of Alteon's stock terminated December 31, 1998. Pursuant to a
letter agreement dated February 11, 1999 between Alteon and Genentech, the
development collaboration and license agreement terminated effective June 30,
1999.
NOTE 4 -- OTHER DEVELOPMENT AGREEMENTS
In 1989, the Company and Yamanouchi Pharmaceutical Co., Ltd.
("Yamanouchi") formed a strategic alliance to develop and commercialize the
Company's A.G.E. technology. Under this arrangement, the parties agreed to
collaborate on further research and development, and the Company granted to
Yamanouchi an exclusive license to commercialize the Company's technology in
Japan, South Korea, Taiwan and The People's Republic of China.
In December 1994, the Company entered into an exclusive licensing
arrangement for Alteon's diagnostic technology with Roche Diagnostic GmbH,
formerly Corange International Limited, acting through its subsidiary Boehringer
Mannheim Diagnostics ("Roche"). Under the agreement, Roche received exclusive
worldwide rights to Alteon's technology for diagnostics application, subject to
an option held by Yamanouchi for Japan, South Korea, Taiwan and The People's
Republic of China. Yamanouchi is Alteon's exclusive licensee for its A.G.E.
technology in the aforementioned countries. Pursuant to the agreement, Alteon
received an initial payment in January 1995, and will be entitled to receive
ongoing royalties based on net sales of research test kits and commercial assays
developed by Roche, which are based on Alteon's A.G.E. technology.
In June 1995, the Company obtained an exclusive, worldwide,
royalty-bearing license from Washington University for patents covering the use
of pimagedine as an inhibitor of inducible nitric oxide synthase. The agreement
requires the Company to pay certain licensing fees upon the attainment of
development milestones as well as a royalty on net sales or a share of
sub-licensing profits of products covered by the patents. The license also
covers patents developed through any subsequent research collaboration between
the parties, which Alteon agrees to fund.
In November 1995, the Company entered into clinical testing and
distribution agreements with Gamida for Life ("Gamida"), formerly Eryphile BV.
Under these agreements, Gamida conducted, at its own expense, a Phase II
multi-site clinical trial in Israel, in accordance with the protocol developed
by Alteon, evaluating pimagedine in patients with diabetes and elevated serum
cholesterol levels. Gamida will receive the exclusive right to distribute
pimagedine, if successfully developed and approved for marketing, in Israel,
Bulgaria, Cyprus, Jordan and South Africa. The distribution agreement is for a
term ending 10 years after the date of regulatory approval for the sale of
pimagedine in Israel; thereafter, it will be automatically renewed for
successive three-year periods unless terminated by either party on the last day
of the initial or a renewal term.
In June 1997, Alteon entered into a license and supply agreement with
IDEXX Laboratories, Inc. ("IDEXX") pursuant to which Alteon licensed to IDEXX
pimagedine as a potential therapeutic in companion animals (dogs, cats and
horses) and its A.G.E. diagnostics technology for companion animal use. IDEXX
will be responsible for the development, licensing and marketing of pimagedine
and A.G.E. diagnostics for such use on a worldwide basis. Alteon will be
entitled to receive milestone payments and royalties on sales of the licensed
products.
F-9
44
NOTE 4 -- OTHER DEVELOPMENT AGREEMENTS (CONTINUED)
In August 1999, Alteon and Taisho Pharmaceutical Co., Ltd. ("Taisho")
entered into an agreement under which Taisho was granted an exclusive option
through December 31, 1999 to acquire a license to Alteon's lead A.G.E. Crosslink
Breaker, ALT-711, for Japan, South Korea, Taiwan and China for a non-refundable
option fee of $600,000. This amount is reflected in other income in the
statement of operations. The option expired on December 31, 1999.
Alteon's commercial partners may develop, either alone or with others,
products that compete with the development and marketing of the Company's
products. Competing products, either developed by the commercial partners or to
which the commercial partners have rights, may result in their withdrawal of
support with respect to all or a portion of the Company's technology, which
would have a material adverse effect on the Company's business, financial
condition and results of operations.
The Company has also entered into various arrangements with independent
research laboratories to conduct studies in conjunction with the development of
the Company's technology. The Company receives certain rights to inventions or
discoveries that may arise from this research. (See Note 9.)
NOTE 5 -- ACCRUED EXPENSES
DECEMBER 31,
--------------------------
1998 1999
---------- ----------
Accrued clinical trial expense ................. $1,958,457 $ 923,756
Accrued payroll and related expenses ........... 670,946 402,288
Accrued consultants/contracts .................. 16,767 --
Accrued rent ................................... 265,410 210,498
Accrued professional ........................... 197,161 145,769
Accrued patent ................................. 48,215 20,000
Other .......................................... 120,902 60,891
---------- ----------
$3,277,858 $1,763,202
========== ==========
The Company's headquarters and research facility rent is being expensed
on a straight-line basis over the ten-year lease period. (See Note 6.)
NOTE 6 -- CONTINGENCIES AND COMMITMENTS
Contingencies
In December 1990, the Company and Marion Merrell Dow, Inc., which was
subsequently acquired by an affiliate of Hoechst AG and renamed Hoechst Marion
Roussel, Inc. ("HMRI"), formed a strategic alliance to develop and commercialize
the Company's A.G.E. technology for therapeutics in the areas of diabetic and
aging complications. In 1996, HMRI ended the collaboration as a result of HMRI's
continuing prioritization of its new product pipeline, and the Company regained
all rights granted to HMRI covering the Company's technology. In June 1998, the
Company and HMRI resolved various open issues arising from the termination of
their collaboration. As a result, the previously established accrual in the
amount of $1.8 million has been eliminated and credited to the statement of
operations.
F-10
45
NOTE 6 -- CONTINGENCIES AND COMMITMENTS (CONTINUED)
Commitments
The Company leases its headquarters and research facility and related
equipment and furniture under non-cancelable operating leases. As of December
31, 1999, future minimum rentals under operating leases that have initial or
remaining non-cancelable terms in excess of one year are as follows:
OPERATING
LEASES
----------
2000................................................ 578,191
2001................................................ 536,500
2002................................................ 536,500
2003................................................ 447,083
2004................................................ --
Thereafter.......................................... --
----------
$2,098,274
==========
Rent expense for each of the years in the three-year period ended
December 31, 1999, was $573,962, $584,510 and $590,943, respectively.
NOTE 7 -- STOCKHOLDERS' EQUITY
Common/Preferred Stock Issuances
On November 1, 1991, the Company completed an initial public offering
of Common Stock with net proceeds to the Company of $47,406,581. In conjunction
with the offering, all of the then outstanding shares of Preferred Stock were
converted into 6,725,627 shares of Common Stock.
In October and November 1995, the Company completed a follow-on
offering of Common Stock, which included the sale of 2,000,000 shares and
300,000 shares, respectively, at a price of $9.00 per share which provided net
proceeds to the Company of $19,035,000.
On April 24, 1997, the Company raised $4.8 million net of offering
costs, through the issuance of 5,000 shares of its $0.01 par value, 6%
Cumulative Convertible Preferred Stock ("Preferred Stock"). This stock was
convertible at a discount to market. In connection with this issuance, the
Company issued to the purchasers, warrants to purchase 60,000 shares of its
Common Stock at an exercise price of $4.025 per share. As of December 1997, all
the Preferred Stock has been converted and approximately $1,065,000 of Preferred
Stockholder Dividends were recorded which included the amortization of the
conversion discount and warrants, and the 6% preferred dividends.
In December 1997, the Company and Genentech entered into a stock
purchase agreement pursuant to which Genentech agreed to buy shares of Common
Stock, Series G Preferred Stock and Series H Preferred Stock. (See Note 3.) In
December 1997, Genentech purchased Common Stock and Series G Preferred Stock
for an aggregate purchase price of $15,000,000. On July 27, 1998 and October 1,
1998, Genentech purchased $8,000,000 and $14,544,000 respectively, of Series H
Preferred Stock. As of December 31, 1998 and 1999, respectively, approximately
$2,207,000 and $2,708,000 of Preferred Stockholder Dividends and amortization
of Preferred Stock conversion discount were recorded. Series G Preferred Stock
and Series H Preferred Stock Dividends are payable quarterly in shares at a
rate of 8.5%. Each share of Series G Preferred Stock and Series H Preferred
Stock is convertible at any time into a number of shares of Common Stock
determined by dividing $10,000 by the average of the closing sales price of the
Common Stock, as reported on the Over-the-Counter Bulletin Board ("OTCBB") for
the twenty business days immediately preceding the date of conversion (the
"Conversion Price").
F-11
46
NOTE 7 -- STOCKHOLDERS' EQUITY (CONTINUED)
Effective with the close of business on December 10, 1999 the Company's
Common Stock was delisted from the Nasdaq Stock Market because it did not
satisfy the $1.00 per share minimum bid price required for listing on the Nasdaq
Stock Market. Effective December 13, 1999, the Common Stock has been traded on
the OTCBB. The delisting from the Nasdaq Stock Market could have a material
adverse effect on the Company's ability to raise capital on favorable terms or
at all.
Stock Option Plan
The Company has established two stock option plans for its employees,
officers, directors, consultants and independent contractors. Options to
purchase up to 4,192,000 shares of Common Stock may be granted under the first
plan and options to purchase up to 4,000,000 million shares of common stock may
be granted under the second plan.
The plans are administered by a committee of the Board of Directors,
which may grant either non-qualified or incentive stock options. The committee
determines the exercise price and vesting schedule at the time the option is
granted. Options vest over various periods and may expire no later than 10 years
from date of grant. Each option entitles the holder to purchase one share of
Common Stock at the indicated exercise price. The plans also provide for certain
antidilution and change in control rights, as defined.
The following table summarizes the activity in the Company's stock
options:
WEIGHTED AVERAGE
EXERCISE PRICE EXERCISE PRICE
OPTIONS PER SHARE PER SHARE
---------- -------------- ----------------
Balance, December 31, 1996 .......... 3,160,795 $ 6.44
Granted ............................. 852,110 $3.88 - 6.56 5.60
Exercised ........................... (179,081) 0.30 - 6.56 .68
Canceled ............................ (174,384) 0.89 - 14.13 6.75
---------- --------
Balance, December 31, 1997 .......... 3,659,440 $ 6.51
Granted ............................. 1,232,950 0.88 - 8.50 1.98
Exercised ........................... (70,217) 0.30 - 8.63 2.79
Canceled ............................ (22,913) 3.88 - 15.00 8.72
---------- --------
Balance, December 31, 1998 .......... 4,799,260 $ 5.39
Granted ............................. 1,928,701 0.78 - 1.125 0.99
Exercised ........................... (374,961) 0.30 - 0.60 0.44
Canceled ............................ (1,277,804) 0.81 - 15.00 3.88
---------- --------
Balance, December 31, 1999 .......... 5,075,196 $ 3.40
==========
At December 31, 1999, 2,594,760 options were exercisable at a weighted
average price of $5.60 per share. The weighted average fair value of the options
granted was $2.89, $1.71 and $0.53 during 1997, 1998 and 1999, respectively. The
outstanding stock options at December 31, 1999 have a weighted average remaining
contractual life of 7.0 years. Included in options at December 31, 1999, are
380,000 options granted to certain executives with option prices ranging from
$0.813 per share to $1.063 per share. Such options vest upon the earlier of 5
years after grant or upon achievement of certain Company milestones.
The Company accounts for its stock option plans under APB Opinion No.
25, under which no compensation cost (excluding those options granted below fair
market value) has been recognized. Had compensation costs for these plans been
determined consistent with FASB Statement No. 123, the Company's pro forma net
loss and loss per share applicable to common stockholders for 1997, 1998 and
1999 would have been $28.0 million, $30.5 million and $13.5 million and, $1.74,
$1.67 and $0.71, respectively. The 1999 pro forma net loss and loss per share
applicable to common stockholders reflects a benefit for the reversal of
previously recognized pro forma compensation costs on options forfeited in 1999.
Consistent with FASB Statement No. 123, the Company elected not to estimate
these forfeitures in the prior period pro forma compensation cost calculation.
Because FASB Statement No. 123 has not been applied to options granted prior to
January 1, 1995, the resulting pro forma compensation cost may not be
representative of that to be expected in future years.
F-12
47
NOTE 7 -- STOCKHOLDERS' EQUITY (CONTINUED)
Under FASB Statement No. 123, the fair value of each stock option grant
is estimated on the date of grant using the Black-Scholes option pricing model
with the following assumptions used for grants in 1997, 1998 and 1999,
respectively: risk free interest rates ranging 5.73% to 6.78%, 4.32% to 5.63%
and 4.73% to 6.07%, respectively; expected life of 2.02 years over the vesting
periods; and expected volatility of 70%.
In February 1999, the Board of Directors approved the repricing of
1,063,000 stock options outstanding as of February 2, 1999.
NOTE 8 -- SAVINGS AND RETIREMENT PLAN
The Company maintains a savings and retirement plan under Section
401(k) of the Internal Revenue Code which allows eligible employees to annually
contribute a portion of their annual salary to the plan. In 1998, the Company
began making discretionary contributions at a rate of 25% of an employee's
contribution up to a maximum of 5% of their base salary. The Company made
contributions of $57,000 as of December 31, 1998 and $49,000 as of December 31,
1999.
NOTE 9 -- RELATED PARTY TRANSACTIONS
Since the Company's inception, the Company has entered into certain
collaborative agreements with organizations with which Dr. Anthony Cerami, a
former member of the Company's Board of Directors, was affiliated. These
organizations included The Picower Institute for Medical Research ("The Picower
Institute"), The Rockefeller University, Cerami Consulting Corporation and the
Kenneth S. Warren Laboratories, Inc. The Company paid to the organizations
$284,000, $731,000 and $243,000 in 1997, 1998, and 1999, respectively. In
addition, the Company paid patent maintenance fees for technology related to the
organizations of $168,000, $207,000 and $73,000 in 1997, 1998 and 1999,
respectively. Although the Company has terminated its collaborative relationship
with The Picower Institute, the Company has a royalty obligation on all net
sales and other revenues associated with certain technologies developed.
Effective May 17, 1999, the Company terminated its consulting agreement with
Cerami Consulting Corporation and its research agreement with Kenneth S. Warren
Laboratories, Inc. In addition, Dr. Cerami resigned from the Company's Board of
Directors on April 19, 1999.
The Chairman of the Company's Scientific Advisory Board and two other
Scientific Advisory Board members provide consulting services to the Company.
Consulting fees paid to these members totaled $136,000, $89,000 and $55,000 in
1997, 1998 and 1999, respectively.
In 1993, a former Company officer (see Note 11) received a loan, which
bore interest at a rate equal to the prime rate as published in the Wall Street
Journal, adjusted quarterly, for the purpose of purchasing a home. The loan was
secured by a second mortgage on the premises purchased by the officer. On
November 3, 1999, the Company received a payment of $268,073 representing the
total amount of principal and interest due.
NOTE 10 -- INCOME TAXES
At December 31, 1999, the Company had available Federal net operating
loss carryforwards ("NOLs"), which expire in the years 2006 through 2014, of
approximately $111.8 million for income tax purposes and State net operating
loss carryforwards, which expire in the years 2000 through 2007, of
approximately $81 million. In addition, the Company has Federal research and
development tax credit carryforwards of approximately $4.5 million and State
research and development tax credit carryforwards of approximately $2.5 million.
The amount of Federal net operating loss and research and development tax credit
carryforwards which can be utilized in any one period may become limited by
Federal income tax regulations if a cumulative change in ownership of more than
50% occurs within a three year period.
F-13
48
NOTE 10 -- INCOME TAXES (CONTINUED)
The components of the deferred tax assets and the valuation allowance
are as follows:
DECEMBER 31,
-------------------------------
1998 1999
------------ ------------
NOL carryforwards ........................ $ 40,700,000 $ 42,900,000
Research and development credit .......... 6,700,000 7,000,000
Other temporary differences .............. 4,200,000 4,700,000
------------ ------------
Gross deferred tax assets ................ 51,600,000 54,600,000
Valuation allowance ...................... (51,600,000) (54,600,000)
------------ ------------
Net-deferred tax assets .................. $ -- $ --
============ ============
A valuation allowance was established since the realization of the
deferred tax assets is uncertain. In December 1999, Alteon sold $27.6 million of
its gross State net operating loss carryforwards and $645,000 of its State
research and development tax credit carryforwards under the State of New
Jersey's Technology Business Tax Certificate Transfer Program (the "Program").
The Program allowed qualified technology and biotechnology businesses in New
Jersey to sell unused amounts of net operating loss carryforwards and defined
research and development tax credits for cash. The total tax value sold was
$3,137,000 and the total proceeds received by the Company were $2,588,000, which
was recorded as a tax benefit on the statement of operations.
NOTE 11 -- KEY EMPLOYEES
The Chairman and Chief Executive Officer resigned from the Company
effective December 31, 1998 and the President and Chief Operating Officer
retired from the Company effective January 31, 1999. In December 1998, the
Senior Vice President, Finance and Business Development and Chief Financial
Officer was elected to the Board of Directors and to the office of President and
Chief Executive Officer. A member of the Board of Directors was elected to the
position of Chairman.
F-14