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Meistdiskutierte Wertpapiere
Platz | vorher | Wertpapier | Kurs | Perf. % | Anzahl | ||
---|---|---|---|---|---|---|---|
1. | 1. | 18.002,02 | -1,44 | 264 | |||
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8. | 18. | 5,2900 | -1,89 | 43 |
Nastech Initiates Intranasal Interferon Alpha Phase I Clinical Trial
HAUPPAUGE, N.Y., Jan. 30 /PRNewswire/ -- Nastech Pharmaceutical Company, Inc. (Nasdaq: NSTK - news) announced today it has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of interferon alpha. The objective of the multi-dose Phase I study is to determine nasal absorption, tolerance, and safety of interferon alpha in healthy volunteers.
Interferon alpha is indicated for the treatment of certain forms of cancer and hepatitis. It is a protein of relatively high molecular weight and as such is currently administered by injection only.
``Interferon alpha is a major therapeutic tool in the treatment of a number of important and serious medical conditions, including hairy cell leukemia, malignant melanoma, follicular lymphoma, condylomata acuminata, AIDS-related Kaposi`s Sarcoma, and chronic hepatitis B and C,`` stated Dr. Eric Rowinsky, M.D., Director of Clinical Research, Cancer Therapy and Research Center, San Antonio, TX and Advisor to Nastech on this project. ``The prospect of an alternative route of administration that might provide a unique pharmacokinetic profile for interferon is an interesting approach to improving safety, efficacy, and patient compliance. I look forward to working with Nastech now that this project has moved into the clinical phase of testing.``
``Consistent with Nastech`s new business model, we have embarked on the first of several significant product opportunities in macromolecules that may be administered by the nasal or oral route,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``Interferons are an important class of therapeutic agents that are effective for a wide variety of cancer and viral illnesses. We believe that a Formulation Science strategy resulting in a painless nasal dosage form of interferon alpha may result in greater patient compliance and a broadening market for this important therapy.``
The medical literature suggests that continuous administration of interferon alpha to patients with hepatitis permits the use of a lower dose, with subsequent lowering of significant drug related side effects. Since continuous infusion outside the hospital setting is impractical, the nasal route may allow one to approximate a continuous administration, with the accrued benefits, including improved patient-to-patient dose variability. Finally, in many patients with significant chronic diseases, weight loss, with accompanying loss of skeletal muscle and subcutaneous tissue depots, makes drug injection a less reliable route of administration.
Interferons are a family of glycoproteins derived from human cells that normally have a role in fighting viral infections by preventing virus multiplication in cells. In recent years, interferons are increasingly being studied for applications in treating a host of major diseases. Credit Suisse First Boston estimates that sales of Schering Corporation`s injectable interferon alpha-2b product, Intron A/Rebetron, will increase from $1.4 billion in 2000 to $2.0 billion in 2002.
Nastech Pharmaceutical Company Inc, recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K.
HAUPPAUGE, N.Y., Jan. 30 /PRNewswire/ -- Nastech Pharmaceutical Company, Inc. (Nasdaq: NSTK - news) announced today it has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of interferon alpha. The objective of the multi-dose Phase I study is to determine nasal absorption, tolerance, and safety of interferon alpha in healthy volunteers.
Interferon alpha is indicated for the treatment of certain forms of cancer and hepatitis. It is a protein of relatively high molecular weight and as such is currently administered by injection only.
``Interferon alpha is a major therapeutic tool in the treatment of a number of important and serious medical conditions, including hairy cell leukemia, malignant melanoma, follicular lymphoma, condylomata acuminata, AIDS-related Kaposi`s Sarcoma, and chronic hepatitis B and C,`` stated Dr. Eric Rowinsky, M.D., Director of Clinical Research, Cancer Therapy and Research Center, San Antonio, TX and Advisor to Nastech on this project. ``The prospect of an alternative route of administration that might provide a unique pharmacokinetic profile for interferon is an interesting approach to improving safety, efficacy, and patient compliance. I look forward to working with Nastech now that this project has moved into the clinical phase of testing.``
``Consistent with Nastech`s new business model, we have embarked on the first of several significant product opportunities in macromolecules that may be administered by the nasal or oral route,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``Interferons are an important class of therapeutic agents that are effective for a wide variety of cancer and viral illnesses. We believe that a Formulation Science strategy resulting in a painless nasal dosage form of interferon alpha may result in greater patient compliance and a broadening market for this important therapy.``
The medical literature suggests that continuous administration of interferon alpha to patients with hepatitis permits the use of a lower dose, with subsequent lowering of significant drug related side effects. Since continuous infusion outside the hospital setting is impractical, the nasal route may allow one to approximate a continuous administration, with the accrued benefits, including improved patient-to-patient dose variability. Finally, in many patients with significant chronic diseases, weight loss, with accompanying loss of skeletal muscle and subcutaneous tissue depots, makes drug injection a less reliable route of administration.
Interferons are a family of glycoproteins derived from human cells that normally have a role in fighting viral infections by preventing virus multiplication in cells. In recent years, interferons are increasingly being studied for applications in treating a host of major diseases. Credit Suisse First Boston estimates that sales of Schering Corporation`s injectable interferon alpha-2b product, Intron A/Rebetron, will increase from $1.4 billion in 2000 to $2.0 billion in 2002.
Nastech Pharmaceutical Company Inc, recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K.
Heute sehen wir einen "sell on good news".
Ich bin aber optimistisch.
Bei dem Zeug handelt es sich um ein fertiges Medikament.
Das Patent gilt aber nur für die intravenöse Verabreichung.
(Sagt man das so ? - bin doch kein Medizinmann)
D.h., daß relativ schnell mit der Generierung von CF zu rechnen ist.
Ich bin aber optimistisch.
Bei dem Zeug handelt es sich um ein fertiges Medikament.
Das Patent gilt aber nur für die intravenöse Verabreichung.
(Sagt man das so ? - bin doch kein Medizinmann)
D.h., daß relativ schnell mit der Generierung von CF zu rechnen ist.
Heute waren wir "intrady" schon wieder auf 9,80.
Hallo,
Nastech`s Apomorphin-Spray bekommt Konkurrenz.
Das zeigt mal wieder wie groß das Marktpotenzial alleine bei diesem Produkt ist.
Gruß
bullgerri
Thursday February 1, 9:43 am Eastern Time
Press Release
SOURCE: Competitive Technologies, Inc.
Competitive Technologies Licensee Initiates Study of Sexual Dysfunction Drug
Palatin Technologies Conducting Phase I Safety Study of PT-141 Erectile Dysfunction Drug
FAIRFIELD, Conn., Feb. 1, 2001 (PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT - news) announced today that its exclusive licensee, Palatin Technologies, Inc. (AMEX:PTN - news) has begun enrolling patients in a Phase I safety study of the company`s investigational treatment for erectile dysfunction, PT-141. The double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single, escalating doses of PT-141 administered intranasally to 52 healthy adult male subjects.
Palatin is developing PT-141 as a nasal spray for the treatment of erectile dysfunction. The company submitted an Investigational New Drug application to begin human studies of the drug in late December 2000.
PT-141 is a synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha MSH. Investigators in a small pilot study of PT-14 found that the agent was approximately 80 percent effective in treating men with erectile dysfunction.
PTN is a CTT exclusive licensee for the underlying technology, developed at the University of Arizona, used in developing PT-14. The National Institute of Health estimates that 30 million men suffer from erectile dysfunction. Revenues generated from any FDA approved Palatin products using CTT technologies will produce royalties for CTT and its client, the University of Arizona.
``CTT continues to be encouraged by the progress being made in bringing this drug to the market,`` said Frank R. McPike, Jr., President and CEO of CTT. ``The onset of the safety study is an important step toward regulatory approval and commercial success.``
``We are very excited to be initiating human clinical studies with our first therapeutic product, PT-141,`` said Carl Spana, Ph.D., President and CEO of Palatin Technologies, Inc. ``Preclinical research with PT-141 in several animal species suggests this drug is highly potent and has the potential to be free of the cardiac side effects found in many of today`s treatments for erectile dysfunction.``
Palatin reports that PT-141 works through a mechanism of action, different from currently marketed erectile dysfunction therapies, which involves the direct stimulation of receptors in the central nervous system. As a result of this CNS activity, PTN believes PT-141 has the potential to treat both male and female sexual dysfunction.
Competitive Technologies` licensee PTN, located in Princeton, N.J., is a development-stage medical technology company focused on the discovery, development and commercialization of pharmaceutical products based on its enabling peptide platform technologies and proprietary monoclonal antibody radio-labeling.
About Competitive Technologies, Inc.
Competitive Technologies is a global leader in identifying, developing and commercializing innovative life sciences, physical sciences and digital technologies. Competitive Technologies` specialized expertise and experience make it a valuable partner for inventors, companies and universities of all sizes. CTT has been responsible for closing hundreds of licensing agreements. CTT clients and licensees include: Sony, Matsushita Electric Industrial, the University of Arizona, the University of Colorado, the University of Illinois, NTRU Cryptosystems, Inc., Palatin Technologies, Inc. and Ribozyme Pharmaceuticals, Inc. Competitive Technologies, Inc. is based in Fairfield, Conn., and has affiliates in Osaka, Japan and London, England.
Statements about the Company`s future expectations, including development and regulatory plans, and all other statements in this document other than historical facts are ``forward-looking statements`` within the meaning of applicable Federal Securities Laws and are not guarantees of future performance. These statements involve risks and uncertainties related to market acceptance of and competition for the Company`s licensed technologies and other risks and uncertainties inherent in CTT`s business, including those set forth in Item 1 of the Company`s Form 10-K for the year ended July 31, 2000 and other factors that may be described in CTT`s filings with the SEC, and are subject to change at any time. The Company`s actual results could differ materially from these forward-looking statements. The Company undertakes no obligation to update publicly any forward-looking statement.
--------------------------------------------------------------------------------
CONTACT: Palatin Technologies, Inc.
Stephen T. Wills
(609) 520-1911
E-mail: swills@palatin.com
Web-site: http://www.Palatin.com
Strategic IR, Inc., New York
Johnnie D. Johnson
(212) 754-6565
Fax (212) 754-4333
E-mail: jdjohnson@strategic-ir.com
E-mail: ctt@competitivetech.net
Web site: http://www.competitivetech.net
SOURCE: Competitive Technologies, Inc.
Nastech`s Apomorphin-Spray bekommt Konkurrenz.
Das zeigt mal wieder wie groß das Marktpotenzial alleine bei diesem Produkt ist.
Gruß
bullgerri
Thursday February 1, 9:43 am Eastern Time
Press Release
SOURCE: Competitive Technologies, Inc.
Competitive Technologies Licensee Initiates Study of Sexual Dysfunction Drug
Palatin Technologies Conducting Phase I Safety Study of PT-141 Erectile Dysfunction Drug
FAIRFIELD, Conn., Feb. 1, 2001 (PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT - news) announced today that its exclusive licensee, Palatin Technologies, Inc. (AMEX:PTN - news) has begun enrolling patients in a Phase I safety study of the company`s investigational treatment for erectile dysfunction, PT-141. The double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single, escalating doses of PT-141 administered intranasally to 52 healthy adult male subjects.
Palatin is developing PT-141 as a nasal spray for the treatment of erectile dysfunction. The company submitted an Investigational New Drug application to begin human studies of the drug in late December 2000.
PT-141 is a synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha MSH. Investigators in a small pilot study of PT-14 found that the agent was approximately 80 percent effective in treating men with erectile dysfunction.
PTN is a CTT exclusive licensee for the underlying technology, developed at the University of Arizona, used in developing PT-14. The National Institute of Health estimates that 30 million men suffer from erectile dysfunction. Revenues generated from any FDA approved Palatin products using CTT technologies will produce royalties for CTT and its client, the University of Arizona.
``CTT continues to be encouraged by the progress being made in bringing this drug to the market,`` said Frank R. McPike, Jr., President and CEO of CTT. ``The onset of the safety study is an important step toward regulatory approval and commercial success.``
``We are very excited to be initiating human clinical studies with our first therapeutic product, PT-141,`` said Carl Spana, Ph.D., President and CEO of Palatin Technologies, Inc. ``Preclinical research with PT-141 in several animal species suggests this drug is highly potent and has the potential to be free of the cardiac side effects found in many of today`s treatments for erectile dysfunction.``
Palatin reports that PT-141 works through a mechanism of action, different from currently marketed erectile dysfunction therapies, which involves the direct stimulation of receptors in the central nervous system. As a result of this CNS activity, PTN believes PT-141 has the potential to treat both male and female sexual dysfunction.
Competitive Technologies` licensee PTN, located in Princeton, N.J., is a development-stage medical technology company focused on the discovery, development and commercialization of pharmaceutical products based on its enabling peptide platform technologies and proprietary monoclonal antibody radio-labeling.
About Competitive Technologies, Inc.
Competitive Technologies is a global leader in identifying, developing and commercializing innovative life sciences, physical sciences and digital technologies. Competitive Technologies` specialized expertise and experience make it a valuable partner for inventors, companies and universities of all sizes. CTT has been responsible for closing hundreds of licensing agreements. CTT clients and licensees include: Sony, Matsushita Electric Industrial, the University of Arizona, the University of Colorado, the University of Illinois, NTRU Cryptosystems, Inc., Palatin Technologies, Inc. and Ribozyme Pharmaceuticals, Inc. Competitive Technologies, Inc. is based in Fairfield, Conn., and has affiliates in Osaka, Japan and London, England.
Statements about the Company`s future expectations, including development and regulatory plans, and all other statements in this document other than historical facts are ``forward-looking statements`` within the meaning of applicable Federal Securities Laws and are not guarantees of future performance. These statements involve risks and uncertainties related to market acceptance of and competition for the Company`s licensed technologies and other risks and uncertainties inherent in CTT`s business, including those set forth in Item 1 of the Company`s Form 10-K for the year ended July 31, 2000 and other factors that may be described in CTT`s filings with the SEC, and are subject to change at any time. The Company`s actual results could differ materially from these forward-looking statements. The Company undertakes no obligation to update publicly any forward-looking statement.
--------------------------------------------------------------------------------
CONTACT: Palatin Technologies, Inc.
Stephen T. Wills
(609) 520-1911
E-mail: swills@palatin.com
Web-site: http://www.Palatin.com
Strategic IR, Inc., New York
Johnnie D. Johnson
(212) 754-6565
Fax (212) 754-4333
E-mail: jdjohnson@strategic-ir.com
E-mail: ctt@competitivetech.net
Web site: http://www.competitivetech.net
SOURCE: Competitive Technologies, Inc.
Wir haben noch einen Vorsprung.
Hoffentlich bleibt das auch so.
MfG
Prolet
Hoffentlich bleibt das auch so.
MfG
Prolet
Hallo,
das war ja heute wieder ein Herzschlag-Verlauf.
Runter auf 6,53$ und wieder rauf bis auf 8,43$.
Prolet ich hoffe Du hattest Deine Ration Valium rechtzeitig genommen
Gruß bullgerri
P.S.: es gab in Frankfurt tatsächlich 400 Stück zu 7,75€ und 400 zu 8€...
das war ja heute wieder ein Herzschlag-Verlauf.
Runter auf 6,53$ und wieder rauf bis auf 8,43$.
Prolet ich hoffe Du hattest Deine Ration Valium rechtzeitig genommen
Gruß bullgerri
P.S.: es gab in Frankfurt tatsächlich 400 Stück zu 7,75€ und 400 zu 8€...
Ich habe das leider verschwitzt.
Es lief aber auch zu gut. ;-)
Erinnerst Du Dich noch an die "New Line of Credit" ?
Diese Typen halten bei 10 USD den Deckel drauf.
Unter 10 USD werden ihnen die rabattierten jungen Aktien noch besser schmecken.
Umgekehrt werden sie natürlich kräftig pushen, wenn sie sich erstmal bedient haben.
Da bleibt wirklich nizr noch das Beruhigungsmittel.
Gruß
Prolet
Es lief aber auch zu gut. ;-)
Erinnerst Du Dich noch an die "New Line of Credit" ?
Diese Typen halten bei 10 USD den Deckel drauf.
Unter 10 USD werden ihnen die rabattierten jungen Aktien noch besser schmecken.
Umgekehrt werden sie natürlich kräftig pushen, wenn sie sich erstmal bedient haben.
Da bleibt wirklich nizr noch das Beruhigungsmittel.
Gruß
Prolet
Ich glaube wir brauchen nicht mehr lange auf die 10$ warten, wenn es so weiter läuft wie bisher.
Eine schwache NASDAQ wäre auch hilfreich.
Eine schwache NASDAQ wäre auch hilfreich.
Hi bullgerri,
nur zur Info:
wo hast Du den Chart her?
Danke
nur zur Info:
wo hast Du den Chart her?
Danke
Friday February 23, 8:17 am Eastern Time
Press Release
SOURCE: Nastech Pharmaceutical Company Inc.
Nastech Reports Fourth Quarter Results
HAUPPAUGE, N.Y., Feb. 23 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) reported a net loss of $1.3 million, or $0.19 a share basic and diluted, for the fourth quarter of 2000, versus year-ago net losses of $2.8 million, or $0.44 a share. Revenue increased $154,000 to $1.4 million. For the full year, net losses were $9.7 million or $1.51 a share basic and diluted, on revenues of $4.8 million versus year-ago losses of $8.4 million, or $1.32 a share, on revenues of $5.6 million.
For the quarter, total revenues from the Company`s vitamin B-12 product, Nascobal®, were $184,000 compared to $198,000 the prior year; however, total Nascobal® revenues increased 23 percent, to $907,000 for the year compared to $740,000 in 1999. Royalty payments from Bristol-Myers Squibb Company for Stadol®NS(TM), an opioid analgesic, increased 23 percent to $1 million in the quarter and increased 5 percent to $3.1 million for the year. Royalty payments from Bristol-Myers are scheduled to terminate at time of patent expiry in August 2001.
Total expenses for the quarter were $2.7 million, a decrease of $1.3 million, or 33 percent, from a year ago as expenditures for late stage development in the Company`s clinical program decreased while the Company expanded and incurred less cost in earlier stage pre-clinical and clinical development. Total expenses for the year increased 4 percent to $14.5 million, including a $2.3 million write-off of in-process research and development costs associated with the acquisition of Atossa HealthCare, Inc. in the third quarter.
``The year 2000 was a period of dynamic change, strategic refocusing, and accomplishment for Nastech,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``Our accomplishments during 2000, which include the successful completion of certain Phase II clinical safety and efficacy trials for our leading products in erectile dysfunction and pain management, and more recently, initiation of clinical studies in macromolecules beginning with interferon alpha, demonstrate the Company`s continued commitment to creating a Formulation Science leader focused on significant product opportunities.``
Corporate Progress
* In January 2001, Nastech initiated intranasal interferon alpha Phase I
clinical trials in healthy volunteers. Intranasal interferon alpha is
Nastech`s first large molecule product candidate to enter clinical
development as part of its new focus in Formulation Science.
* Results from a Phase II pilot trial using the Company`s intranasal
formulation of apomorphine for the treatment of erectile dysfunction
showed that 82% of subjects reported achieving "sufficient erection"
for sexual intercourse. In addition, there were no serious side effects
in the study. The Company also announced it is moving forward with Phase
II at-home clinical efficacy trials using this proprietary formulation
for the treatment of erectile dysfunction.
* The Company completed a Phase I study of intranasal apomorphine for the
treatment of sexual dysfunction in women. There were no significant
side effects of the Nastech formulation, and it showed rapid appearance
in the bloodstream.
* The Company announced pilot Phase II results of an intranasal
formulation of morphine for the treatment of breakthrough pain. In the
study, 66 percent of breakthrough pain episodes were treated
successfully within 20 minutes with the Nastech formulation and pain
relief typically began within five minutes. There were no changes in
any safety parameter and no adverse events.
* The Company acquired Atossa HealthCare, Inc., founded by Nastech
Chairman and CEO, Dr. Steven C. Quay. The merger enables the Company
to develop new capabilities in the area of women`s health beginning
with the further development of Atossa`s lead product, a diagnostic
test kit for the early detection of breast cancer.
* The Company entered into a new equity line of credit that will allow it
to sell, at its discretion, up to 1.2 million common shares over the
next three years.
* Nastech reported positive results from a Phase I clinical trial of a
new formulation of butorphanol tartrate for acute migraine pain.
* The Company received FDA approval to fully manufacture Nascobal®, its
FDA-approved intranasal product for the treatment of vitamin B-12
deficiencies, in its cGMP manufacturing facility.
Nastech Pharmaceutical Company Inc, recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K.
NASTECH PHARMACEUTICAL COMPANY INC.
SELECTED FINANCIAL INFORMATION
Statement of Operations Data (in thousands, except per share amounts):
Year Year Quarter Quarter
Ended Ended Ended Ended
December December December December
31, 31, 31, 31,
2000 1999 2000 1999
Revenues:
Product sales $447 $325 $75 $69
License fee, royalty
and research income $3,694 $4,222 $1,209 $941
Interest income $644 $1,084 $126 $246
Total revenues $4,785 $5,631 $1,410 $1,256
Costs and expenses:
Cost of product sales $358 $268 $72 $58
Research and development $7328 $9649 $1452 $2796
Acquired in-process
research
and development 2,300
Royalties $1,517 $1,436 $486 $391
Sales and marketing $825 $1,051 $259 $310
General and
administrative $2,148 $1,577 $410 $453
Total costs and
expenses $14,476 $13,981 $2,679 $4,008
Net Loss $(9,691) $(8,350) $(1,269) $(2,752)
Net loss per common share:
Basic and diluted $(1.51) $(1.32) $(.19) $(.44)
Weighted average
shares outstanding
Basic and diluted 6,437 6,335 6,803 6,248
Balance Sheet Data: December 31, December 31,
2000 1999
Cash and cash
equivalents (1) $6,256 $14,638
Working capital $5,799 $12,912
Property,intangibles
and other assets $3,766 $3,713
Total assets $11,661 $20,199
Accumulated deficit $(30,003) $(20,312)
Stockholders` equity $9,565 $16,625
(1)Including short-term investments
Contact: Matthew D. Haines, Director, Corporate Communications of Nastech Pharmaceutical Company Inc., 631-273-0101, ext. 329, mhaines@nastech.com; or Media - Ellie Kline, 212-696-4455, ext. 254, Investors - David Walsey, 212-696-4455, ext. 230, both of Noonan-Russo Communications, for Nastech Pharmaceutical Company Inc.
SOURCE: Nastech Pharmaceutical Company Inc.
Press Release
SOURCE: Nastech Pharmaceutical Company Inc.
Nastech Reports Fourth Quarter Results
HAUPPAUGE, N.Y., Feb. 23 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) reported a net loss of $1.3 million, or $0.19 a share basic and diluted, for the fourth quarter of 2000, versus year-ago net losses of $2.8 million, or $0.44 a share. Revenue increased $154,000 to $1.4 million. For the full year, net losses were $9.7 million or $1.51 a share basic and diluted, on revenues of $4.8 million versus year-ago losses of $8.4 million, or $1.32 a share, on revenues of $5.6 million.
For the quarter, total revenues from the Company`s vitamin B-12 product, Nascobal®, were $184,000 compared to $198,000 the prior year; however, total Nascobal® revenues increased 23 percent, to $907,000 for the year compared to $740,000 in 1999. Royalty payments from Bristol-Myers Squibb Company for Stadol®NS(TM), an opioid analgesic, increased 23 percent to $1 million in the quarter and increased 5 percent to $3.1 million for the year. Royalty payments from Bristol-Myers are scheduled to terminate at time of patent expiry in August 2001.
Total expenses for the quarter were $2.7 million, a decrease of $1.3 million, or 33 percent, from a year ago as expenditures for late stage development in the Company`s clinical program decreased while the Company expanded and incurred less cost in earlier stage pre-clinical and clinical development. Total expenses for the year increased 4 percent to $14.5 million, including a $2.3 million write-off of in-process research and development costs associated with the acquisition of Atossa HealthCare, Inc. in the third quarter.
``The year 2000 was a period of dynamic change, strategic refocusing, and accomplishment for Nastech,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``Our accomplishments during 2000, which include the successful completion of certain Phase II clinical safety and efficacy trials for our leading products in erectile dysfunction and pain management, and more recently, initiation of clinical studies in macromolecules beginning with interferon alpha, demonstrate the Company`s continued commitment to creating a Formulation Science leader focused on significant product opportunities.``
Corporate Progress
* In January 2001, Nastech initiated intranasal interferon alpha Phase I
clinical trials in healthy volunteers. Intranasal interferon alpha is
Nastech`s first large molecule product candidate to enter clinical
development as part of its new focus in Formulation Science.
* Results from a Phase II pilot trial using the Company`s intranasal
formulation of apomorphine for the treatment of erectile dysfunction
showed that 82% of subjects reported achieving "sufficient erection"
for sexual intercourse. In addition, there were no serious side effects
in the study. The Company also announced it is moving forward with Phase
II at-home clinical efficacy trials using this proprietary formulation
for the treatment of erectile dysfunction.
* The Company completed a Phase I study of intranasal apomorphine for the
treatment of sexual dysfunction in women. There were no significant
side effects of the Nastech formulation, and it showed rapid appearance
in the bloodstream.
* The Company announced pilot Phase II results of an intranasal
formulation of morphine for the treatment of breakthrough pain. In the
study, 66 percent of breakthrough pain episodes were treated
successfully within 20 minutes with the Nastech formulation and pain
relief typically began within five minutes. There were no changes in
any safety parameter and no adverse events.
* The Company acquired Atossa HealthCare, Inc., founded by Nastech
Chairman and CEO, Dr. Steven C. Quay. The merger enables the Company
to develop new capabilities in the area of women`s health beginning
with the further development of Atossa`s lead product, a diagnostic
test kit for the early detection of breast cancer.
* The Company entered into a new equity line of credit that will allow it
to sell, at its discretion, up to 1.2 million common shares over the
next three years.
* Nastech reported positive results from a Phase I clinical trial of a
new formulation of butorphanol tartrate for acute migraine pain.
* The Company received FDA approval to fully manufacture Nascobal®, its
FDA-approved intranasal product for the treatment of vitamin B-12
deficiencies, in its cGMP manufacturing facility.
Nastech Pharmaceutical Company Inc, recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K.
NASTECH PHARMACEUTICAL COMPANY INC.
SELECTED FINANCIAL INFORMATION
Statement of Operations Data (in thousands, except per share amounts):
Year Year Quarter Quarter
Ended Ended Ended Ended
December December December December
31, 31, 31, 31,
2000 1999 2000 1999
Revenues:
Product sales $447 $325 $75 $69
License fee, royalty
and research income $3,694 $4,222 $1,209 $941
Interest income $644 $1,084 $126 $246
Total revenues $4,785 $5,631 $1,410 $1,256
Costs and expenses:
Cost of product sales $358 $268 $72 $58
Research and development $7328 $9649 $1452 $2796
Acquired in-process
research
and development 2,300
Royalties $1,517 $1,436 $486 $391
Sales and marketing $825 $1,051 $259 $310
General and
administrative $2,148 $1,577 $410 $453
Total costs and
expenses $14,476 $13,981 $2,679 $4,008
Net Loss $(9,691) $(8,350) $(1,269) $(2,752)
Net loss per common share:
Basic and diluted $(1.51) $(1.32) $(.19) $(.44)
Weighted average
shares outstanding
Basic and diluted 6,437 6,335 6,803 6,248
Balance Sheet Data: December 31, December 31,
2000 1999
Cash and cash
equivalents (1) $6,256 $14,638
Working capital $5,799 $12,912
Property,intangibles
and other assets $3,766 $3,713
Total assets $11,661 $20,199
Accumulated deficit $(30,003) $(20,312)
Stockholders` equity $9,565 $16,625
(1)Including short-term investments
Contact: Matthew D. Haines, Director, Corporate Communications of Nastech Pharmaceutical Company Inc., 631-273-0101, ext. 329, mhaines@nastech.com; or Media - Ellie Kline, 212-696-4455, ext. 254, Investors - David Walsey, 212-696-4455, ext. 230, both of Noonan-Russo Communications, for Nastech Pharmaceutical Company Inc.
SOURCE: Nastech Pharmaceutical Company Inc.
Hallo,
der Chart sieht nun leider etwas angeschlagen aus aber ich denke wir liegen direkt auf einer Unterstützung bei 6,5$.
Ich hätte gedacht, eine schwache Nasdaq würde die Anleger in die Nebenwerte treiben aber das scheint z.Zt. nicht der Fall zu sein.
Warten wir ab was passiert.
Gruß
bullgerri
der Chart sieht nun leider etwas angeschlagen aus aber ich denke wir liegen direkt auf einer Unterstützung bei 6,5$.
Ich hätte gedacht, eine schwache Nasdaq würde die Anleger in die Nebenwerte treiben aber das scheint z.Zt. nicht der Fall zu sein.
Warten wir ab was passiert.
Gruß
bullgerri
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Oh, oh, oh
TrendSpotter (TM) Sell
Short Term Indicators
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Price vs. 20 Day Moving Average Sell
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Sell
Short Term Indicators Average: 60% - Sell
Medium Term Indicators
40 Day Commodity Channel Index Sell
Price vs. 50 Day Moving Average Sell
20 - 100 Day MACD Oscillator Buy
50 Parabolic Time/Price Sell
Medium Term Indicators Average: 50% - Sell
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Oh, oh, oh
Habt Ihr mal ein paar Kommentare hierzu ?
Ist noch ganz frisch.
Nastech Initiates Nasal `Triptan` Phase I Clinical Trial
HAUPPAUGE, N.Y., March 5 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) announced today that it commenced enrollment in a Phase I clinical trial in the United States to evaluate the nasal administration of a selective serotonergic agent to be used for the treatment of migraine pain. The objective of the multi-dose Phase I study is to determine nasal absorption, tolerance, and safety of this agent in healthy volunteers. Selective serotonergic agents commonly referred to as ``triptans`` in commerce, are primarily available in oral dosage form. The Company`s intranasal formulation seeks to offer an alternate dosage form providing rapid onset of action of migraine pain relief and reduced adverse events, such as episodes of nausea and vomiting, as compared to oral dosage forms. Triptan products, such as Imitrex® (Glaxo), Zomig® (AstraZeneca), and Maxalt® (Merck) have aggregate sales revenues in excess of $1 billion per year.
``Patients and physicians dissatisfied with current acute migraine pain therapies need a fast and effective alternative designed to restore quality of life,`` stated W. Thomas Garland, M.D., of Radiant Research and advisor to Nastech on this project. ``Moreover, patients who have difficulty taking injections or swallowing pills would also benefit from improved therapeutic outcome, convenience, and ease of use.``
``Triptans are an important class of therapeutic agents that are effective for moderate-to-severe migraine pain, but current formulations fail to provide rapid pain relief,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``By using Formulation Science, we intend to fill the need for faster acting pain relief while providing a more favorable side effect profile for the betterment of migraine sufferers.``
It is estimated that more than 23 million people in the U.S. alone suffer from migraine, which can severely limit a migraine sufferer`s ability to function in normal daily routines. Attacks occur periodically, and can last from a few hours to several days.
It is believed that migraine symptoms are due to local cranial vasodilation and/or the release of vasoactive and pro-inflammatory peptides from sensory nerve endings, oftentimes leading to nausea and vomiting in severe migraine pain sufferers. These changes may be caused by alterations in serotonin, a naturally occurring neurotransmitter. Serotonin affects nerve cells by stimulating and interacting with certain receptors, which in turn trigger certain responses in the cells. Triptans mimic certain actions of serotonin by activating specific 5-HT receptors that constrict blood vessels that may be dilated and distended during a migraine attack.
Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science, a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety, to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Ist noch ganz frisch.
Nastech Initiates Nasal `Triptan` Phase I Clinical Trial
HAUPPAUGE, N.Y., March 5 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) announced today that it commenced enrollment in a Phase I clinical trial in the United States to evaluate the nasal administration of a selective serotonergic agent to be used for the treatment of migraine pain. The objective of the multi-dose Phase I study is to determine nasal absorption, tolerance, and safety of this agent in healthy volunteers. Selective serotonergic agents commonly referred to as ``triptans`` in commerce, are primarily available in oral dosage form. The Company`s intranasal formulation seeks to offer an alternate dosage form providing rapid onset of action of migraine pain relief and reduced adverse events, such as episodes of nausea and vomiting, as compared to oral dosage forms. Triptan products, such as Imitrex® (Glaxo), Zomig® (AstraZeneca), and Maxalt® (Merck) have aggregate sales revenues in excess of $1 billion per year.
``Patients and physicians dissatisfied with current acute migraine pain therapies need a fast and effective alternative designed to restore quality of life,`` stated W. Thomas Garland, M.D., of Radiant Research and advisor to Nastech on this project. ``Moreover, patients who have difficulty taking injections or swallowing pills would also benefit from improved therapeutic outcome, convenience, and ease of use.``
``Triptans are an important class of therapeutic agents that are effective for moderate-to-severe migraine pain, but current formulations fail to provide rapid pain relief,`` stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``By using Formulation Science, we intend to fill the need for faster acting pain relief while providing a more favorable side effect profile for the betterment of migraine sufferers.``
It is estimated that more than 23 million people in the U.S. alone suffer from migraine, which can severely limit a migraine sufferer`s ability to function in normal daily routines. Attacks occur periodically, and can last from a few hours to several days.
It is believed that migraine symptoms are due to local cranial vasodilation and/or the release of vasoactive and pro-inflammatory peptides from sensory nerve endings, oftentimes leading to nausea and vomiting in severe migraine pain sufferers. These changes may be caused by alterations in serotonin, a naturally occurring neurotransmitter. Serotonin affects nerve cells by stimulating and interacting with certain receptors, which in turn trigger certain responses in the cells. Triptans mimic certain actions of serotonin by activating specific 5-HT receptors that constrict blood vessels that may be dilated and distended during a migraine attack.
Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science, a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety, to provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Hallo,
ich würde sagen bei Nastech platzt bald die Produkt-Pipeline!
Dies ist ja nun neben Stadol das zweite Produkt um den vielversprechenden "Migräne-Markt" in Angriff zu nehmen.
Finanztechnisch bin ich sehr zuversichtlich. Ich kann mir nicht vorstellen, dass Nastech bei wackliger Finanzlage in dieser Geschwindigkeit neue Tests in Angriff nimmt. Sollte Scolopamin demnächst die Zulassung bekommen, bin ich völlig überzeugt.
Gruß
bullgerri
P.S.:Ich würde auch gern weitere Meinungen hören.
ich würde sagen bei Nastech platzt bald die Produkt-Pipeline!
Dies ist ja nun neben Stadol das zweite Produkt um den vielversprechenden "Migräne-Markt" in Angriff zu nehmen.
Finanztechnisch bin ich sehr zuversichtlich. Ich kann mir nicht vorstellen, dass Nastech bei wackliger Finanzlage in dieser Geschwindigkeit neue Tests in Angriff nimmt. Sollte Scolopamin demnächst die Zulassung bekommen, bin ich völlig überzeugt.
Gruß
bullgerri
P.S.:Ich würde auch gern weitere Meinungen hören.
Das mit der geborstenen (total zerfetzt, explodiert) Produktpipeline ist schon angenehm.
Mich stört allerdings, das man schon wieder an der Migräne arbeitet.
Mich stört allerdings, das man schon wieder an der Migräne arbeitet.
Was ist so schlecht mit migraine-markt ?
von the-bulls,com:
"laut einer Studie von SG Cowen im wachstumsstarken Markt für Migränetherapien tätig, dessen Umsatzvolumen von 2,5 Mrd. USD im Jahr 1999 bis 2001 auf über 3,8 Mrd. USD anwachsen sollte. Ein nasaler Migränespray, der innerhalb weniger Minuten wirkt und Abhilfe verschafft, würde Millionen Betroffenen das Leben erheblich erleichtern und könnte sich sogar zu einem echten Blockbuster entwickeln "
PS! Blockbuster= Verkauf über 1 Milliarde USD pro Jahr
Mfg
Austrobull
von the-bulls,com:
"laut einer Studie von SG Cowen im wachstumsstarken Markt für Migränetherapien tätig, dessen Umsatzvolumen von 2,5 Mrd. USD im Jahr 1999 bis 2001 auf über 3,8 Mrd. USD anwachsen sollte. Ein nasaler Migränespray, der innerhalb weniger Minuten wirkt und Abhilfe verschafft, würde Millionen Betroffenen das Leben erheblich erleichtern und könnte sich sogar zu einem echten Blockbuster entwickeln "
PS! Blockbuster= Verkauf über 1 Milliarde USD pro Jahr
Mfg
Austrobull
so schnell kann es gehen und man steht wieder am Anfang...
Gruß
bullgerri
Privat Placement !!!!
Nastech schafft Finanzierung im toten IPO Umfeld und in schwierigsten Market Umfeld seit 1973 (Ölkrise etc).
Das sagt schon alles, dazu braucht man nicht zufügen.
Thursday March 22, 10:53 am Eastern Time
Press Release
SOURCE: Nastech Pharmaceutical Company Inc.
Nastech Announces $4.2 Million Private Placement
HAUPPAUGE, N.Y., March 22 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) announced today that it has raised approximately $4.2 million in gross proceeds through a private sale of 860,000 newly issued shares of its common stock to a select group of investors, including SAFECO Growth Opportunities Fund and an asset management division of a leading money center bank. Jesup & Lamont Securities Corporation acted as placement agent for the Company.
``With this financing, Nastech has attracted an elite group of biomedical investors and secured additional resources to fund ongoing research and development and working capital,`` stated Steven C. Quay, Chairman, President and Chief Executive Officer of Nastech Pharmaceutical Company Inc.
The newly issued shares of common stock were not registered under the Securities Act of 1933, as amended, and cannot be offered or resold absent registration or an applicable exemption from registration. The Company has agreed to use its best efforts to register the shares within 120 days.
Nastech Pharmaceutical Company Inc., recognized as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science, a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety and provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K/A.
Contact: Matthew D. Haines, Director, Corporate Communications of Nastech Pharmaceutical Company Inc., 631-273-0101, ext. 329, mhaines@nastech.com; or Hala Bashir, media, 212-696-4455, ext. 356, or David Walsey, investors, 212-696-4455, ext. 230, both of Noonan/Russo Communications, for Nastech Pharmaceutical Company Inc.
SOURCE: Nastech Pharmaceutical Company Inc.
Email this story - Most-emailed articles - Most-viewed articles
Nastech schafft Finanzierung im toten IPO Umfeld und in schwierigsten Market Umfeld seit 1973 (Ölkrise etc).
Das sagt schon alles, dazu braucht man nicht zufügen.
Thursday March 22, 10:53 am Eastern Time
Press Release
SOURCE: Nastech Pharmaceutical Company Inc.
Nastech Announces $4.2 Million Private Placement
HAUPPAUGE, N.Y., March 22 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - news) announced today that it has raised approximately $4.2 million in gross proceeds through a private sale of 860,000 newly issued shares of its common stock to a select group of investors, including SAFECO Growth Opportunities Fund and an asset management division of a leading money center bank. Jesup & Lamont Securities Corporation acted as placement agent for the Company.
``With this financing, Nastech has attracted an elite group of biomedical investors and secured additional resources to fund ongoing research and development and working capital,`` stated Steven C. Quay, Chairman, President and Chief Executive Officer of Nastech Pharmaceutical Company Inc.
The newly issued shares of common stock were not registered under the Securities Act of 1933, as amended, and cannot be offered or resold absent registration or an applicable exemption from registration. The Company has agreed to use its best efforts to register the shares within 120 days.
Nastech Pharmaceutical Company Inc., recognized as a leader in nasal drug delivery technology, is dedicated to improving patient care by using Formulation Science, a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety and provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com.
Nastech Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company`s ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company`s ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company`s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company`s ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company`s research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company`s filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors`` in the Company`s most recent Annual Report on Form 10-K/A.
Contact: Matthew D. Haines, Director, Corporate Communications of Nastech Pharmaceutical Company Inc., 631-273-0101, ext. 329, mhaines@nastech.com; or Hala Bashir, media, 212-696-4455, ext. 356, or David Walsey, investors, 212-696-4455, ext. 230, both of Noonan/Russo Communications, for Nastech Pharmaceutical Company Inc.
SOURCE: Nastech Pharmaceutical Company Inc.
Email this story - Most-emailed articles - Most-viewed articles
Zu 4.88 USD hätte ich die Dinger auch gekauft.
Zur Migräne : Sicher ein interessanter Markt, aber warum mit 2 Produkten losziehen ?
Zur Migräne : Sicher ein interessanter Markt, aber warum mit 2 Produkten losziehen ?
Prolet !
Du kannst die heute zu 4,25 USD in diesem momentan verrückten Markt kaufen.
Die Migräne sind zwei verschieden Arten, breaktrough pain
und kopfschmerzen.
MfG
Du kannst die heute zu 4,25 USD in diesem momentan verrückten Markt kaufen.
Die Migräne sind zwei verschieden Arten, breaktrough pain
und kopfschmerzen.
MfG
Seis wies will mit dem Kopfweh.
Verbilligen ist jetzt eine Alternative (obwohl momentan 11%+).
Ich zögere aber noch, da das Depot schon an Nastech hängt.
Die letzten Wochen waren hart.
Aber schau Dir doch mal mein Posting vom 15.02 hier im Thread an.
Wenn man bei so einem marktengen Wert einen Institutionellen zur Kurspflege an Board hat, dann hat das Leben einiges zu bieten.
Zum Beispiel kann man Short-Seller schlachten. Oder wichtige Widerstände (z.B. 10 USD) knacken.
Zum Thema Marktkapitalisierung.
"The newly issued shares of common stock were not registered under the Securities Act of 1933, as amended, and cannot be offered or resold absent registration or an applicable exemption from registration. The Company has agreed to use its best efforts to register the shares within 120 days."
Nach deutschen Gepflogenheiten müssten die neuen Aktien (deren Wert) nach der Registrierung zur Börsenkapitalisierung addiert werden.
Wenn das in Amiland auch so ist, dann kommen wir dem "Covering" durch ANALysten wieder ein Stück näher.
Ron Sommer hat das ja mit dem Bestand des Bundes so gemacht.
Er hat sich für diese Wertpapiere die Erlaubnis zum Börsenhandel geholt und ist so zum Indexschwergewicht geworden.
Kennt sich jemand mit den amerikanischen Usancen aus ?
MfG Prolet
Verbilligen ist jetzt eine Alternative (obwohl momentan 11%+).
Ich zögere aber noch, da das Depot schon an Nastech hängt.
Die letzten Wochen waren hart.
Aber schau Dir doch mal mein Posting vom 15.02 hier im Thread an.
Wenn man bei so einem marktengen Wert einen Institutionellen zur Kurspflege an Board hat, dann hat das Leben einiges zu bieten.
Zum Beispiel kann man Short-Seller schlachten. Oder wichtige Widerstände (z.B. 10 USD) knacken.
Zum Thema Marktkapitalisierung.
"The newly issued shares of common stock were not registered under the Securities Act of 1933, as amended, and cannot be offered or resold absent registration or an applicable exemption from registration. The Company has agreed to use its best efforts to register the shares within 120 days."
Nach deutschen Gepflogenheiten müssten die neuen Aktien (deren Wert) nach der Registrierung zur Börsenkapitalisierung addiert werden.
Wenn das in Amiland auch so ist, dann kommen wir dem "Covering" durch ANALysten wieder ein Stück näher.
Ron Sommer hat das ja mit dem Bestand des Bundes so gemacht.
Er hat sich für diese Wertpapiere die Erlaubnis zum Börsenhandel geholt und ist so zum Indexschwergewicht geworden.
Kennt sich jemand mit den amerikanischen Usancen aus ?
MfG Prolet
10-K405: NASTECH PHARMACEUTICAL CO INC
FRIDAY, MARCH 30, 2001 8:01 PM
- Edgar Online
(EDGAR Online via COMTEX) -- MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Except for historical information contained herein, the statements in this Item are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements involve known and unknown risks and uncertainties that reflect our intentions, expectations or beliefs concerning future events. (See Item 1, "Risk Factors".)
Nastech Pharmaceutical Company Inc. is a Formulation Science company and recognized as a leader in nasal drug delivery technology. Formulation Science is a systematic approach to drug development using biophysics, physical chemistry and pharmacology to maximize therapeutic efficacy and safety, which sometimes involves a change in route of administration. The technology is essential in designing an optimized, customizable dosage form and in delivering difficult protein and large molecule drugs that can currently only be delivered by injection.
Historically, our core technology involves the research, development and manufacture of nasally administered prescription pharmaceuticals that are currently delivered in oral, injectable or other dosage forms. The nasal delivery of certain pharmaceuticals may enable more rapid systemic absorption, lower required dosages, quicker onset of desired effect, and painless, convenient patient self-administration, resulting in improved patient compliance and pharmacoeconomics. We intend to broaden our focus on difficult to formulate drugs, primarily proteins and peptides, that are currently administered by injection.
We receive licensing revenues on two commercial products - Stadol(R) NS(TM) and Nascobal(R). Stadol(R) NS(TM) is an opioid analgesic which is used for the treatment of moderate to severe pain and the acute pain of migraine. The product is currently marketed by Bristol-Myers Squibb Co. (BMS) under an agreement that generates quarterly royalties to us. Unless the patent is extended, royalties from BMS are scheduled to terminate at time of patent expiry in August 2001. This event, if it occurs, should adversely affect the recording of revenue and contribution to operations in the second half of year 2001.
In 1997, Stadol(R) NS(TM) was classified as a Schedule IV substance by the federal government. "Schedules" are used by the federal government to classify certain narcotic prescription products depending on the potency and potential abuse liability. Schedule I narcotics require the greatest amount of control by manufacturers, distributors, physicians and others in various channels of distribution, including import and export restrictions, and Schedule V substances require the least amount of control. Prior to 1997, Stadol(R) NS(TM) had not been classified and had peak sales in 1996 of $112 million. After the classification of Stadol(R) NS(TM) as a Schedule IV substance in 1997, sales by BMS declined to $108 million in 1997, $86 million in 1998, and increased to approximately $100 million in 1999 and 2000. We believe that the classification of Stadol(R) NS(TM) as a Schedule IV substance, and the resulting increased controls and regulations imposed on BMS to prevent potential abuse liability, contributed to the downward trend in sales.
In July 1997, we entered into an exclusive licensing agreement for Nascobal(R) in the U.S. with Schwarz Pharma and commercially launched the product in October 1997. Under the agreement we received minimum royalties of $2 million in 1998 and retain global manufacturing rights. The minimum royalty expired in December 1998. Sales re-orders of Nascobal(R) in 1999 and 1998 were below expectations as a result of a marketing issue which required a change in the packaging configuration of the product. We shipped the new package configuration to Schwarz Pharma beginning in 1999.
In December 1999, we reacquired the marketing rights to intranasal scopolamine hydrobromide from Schwarz Pharma. We made a payment of $250,000 to Schwarz Pharma which has been reflected as an expense in research and development for the year ended December 31, 1999. We agreed to pay Schwarz Pharma one-half of any future consideration received by Nastech in respect to intranasal scopolamine until Schwarz Pharma receives payments totaling $3,500,000 plus an additional amount for interest that will accrue at a rate of 8.5% per annum beginning December 15, 2000. As any payment to Schwarz Pharma is contingent on whether we will receive proceeds from the future sale or license of intranasal scopolamine, no liability has been recorded for this agreement. We are currently seeking a marketing partner for this product.
We intend to commit significant financial resources in the future to internally fund multiple research and development projects through early stage feasibility studies with the goal of achieving greater economic benefit from product sales. In addition, our future profitability is primarily affected by, among others, the success of product sales by our licensees, our investment and achievement of milestones in research and development programs, regulatory uncertainties with respect to our filings with the FDA, and the success of our financing activities. As a result of the uncertainties associated with these factors and the increased investment in research and development, we anticipate operating losses in the foreseeable future.
RESULTS OF OPERATIONS
Year Ended December 31, 2000 Compared to Year Ended December 31, 1999
Revenues decreased by $846,000, or 15%, to $4.8 million primarily as a result of a decline in milestone payments on intranasal scopolamine from Schwarz Pharma and a reduction in interest income. Total revenues from Schwarz Pharma on scopolamine were $0 in 2000 and $750,000 in 1999. Total Nascobal(R) revenues were $907,000 in 2000 compared to $740,000 in 1999. Royalty income on sales of Nascobal(R) increased $45,000, or 11%, to $460,000 in 2000 as compared to $415,000 in 1999. Royalty income received from BMS on sales of Stadol NS increased $153,000, or 5%, to $3.1 million in 2000 as compared to $2.9 million in 1999.
Total costs and expenses increased by $495,000 or 4%, to $14.5 million in 2000. The details of the increase follow:
Research and development expense decreased by $2.3 million, or 24%, to $7.3 million as expenditures for late stage development in our clinical program for intranasal scopolamine decreased while we expanded earlier stage clinical development. These early stage studies were executed under less costly contracts with third parties, and certain activities were performed in-house. Included in the research and development expense in 1999 is the $250,000 paid to Schwarz Pharma for the reacquisition of the rights to intranasal scopolamine.
In process research and development expense of $2.3 million is the result of the acquisition of Atossa HealthCare in August, 2000. In connection with this acquisition, we have recorded a charge of approximately $2.3 million in the accompanying consolidated statement of operations during the year ended December 31, 2000, based on our estimate of the fair value of the acquired in-process research and development (in process R&D). The in-process R&D was valued based on the income approach of the assets acquired. The underlying premise of this approach is that the value of an asset can be measured by the present worth of the net economic benefit (cash receipts less cash outlays) to be received over the life of the asset. Significant assumptions and estimates used in the valuation of in-process R&D included the stage of development of the test kit; future revenues based on royalties; growth rates for the test kit; product sales cycles; the estimated life to the test kit of 17 years from the date of introduction; an effective income tax rate of 40%; a probability of success factor of 20%; and a discount rate of 60% to reflect present value and the risk of developing the acquired technology into a commercially viable product.
Royalties expense increased by $81,000, or 6%, to $1.5 million in 2000 as a result of the increase in sales of Stadol NS by BMS and the related royalty payable to the University of Kentucky Research Foundation (UKRF) under a separate agreement with UKRF. Royalties expense increases or decreases approximately in proportion to royalty income associated with Stadol NS.
Sales and marketing costs decreased by $226,000, or 22%, from 1999 primarily from a decrease in market research and staffing costs. General and administrative expense increased by $571,000, or 36%, to $2.1 million related primarily to compensation expense to the estate of our former Chief Executive Officer.
Year Ended December 31, 1999 Compared to Year Ended December 31, 1998
Revenues decreased by $4.0 million, or 41%, to $5.6 million primarily as a result of a decline in product sales and royalty income of Nascobal(R) and milestone payments on intranasal scopolamine. Total revenues from Schwarz Pharma on Nascobal(R) were $740,000 in 1999 compared to $2.5 million in 1998. The revenue for the year ended December 31, 1998 included $2 million as a minimum royalty from Schwarz Pharma on Nascobal(R). Sales re-orders of Nascobal(R) were below expectation as a result of the marketing issue noted above. Accordingly, royalty income on sales of Nascobal(R) decreased $1.6 million, or 79%, to $415,000. Total milestone payments on scopolamine decreased $2.2
million or 75% to $750,000 in 1999. Royalty income received from BMS on sales of Stadol NS increased $374,000, or 15%, to $2.9 million in 1999.
Total costs and expenses increased by $3.5 million or 34%, to $14 million in 1999. The details of the increase follow:
Research and development expense increased by $3.6 million, or 60%, to $9.6 million primarily as a result of our clinical programs for intranasal scopolamine, morphine and apomorphine. Included in the increase is the $250,000 paid to Schwarz Pharma in connection to reacquiring the rights to intranasal scopolamine. In September 1998, we also entered into an operating lease for a larger R&D facility and intend to pursue additional internally funded projects in the future.
Royalties expense increased by $185,000, or 15%, to $1.4 million in 1999as a result of the increase in sales of Stadol NS by BMS and the related royalty payable to the University of Kentucky Research Foundation (UKRF) under a separate agreement with UKRF. Royalties expense increases or decreases approximately in proportion to royalty income associated with Stadol NS.
Sales and marketing costs increased by $176,000 or 20% from 1998 and arises from an increase in market research and consulting fees.
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 2000, our liquidity included cash and cash equivalents of $6.3 million compared to cash and cash equivalents and short term investments of $14.6 million at December 31, 1999. Accounts, royalties and fee receivables at December 31, 2000 consist principally of receivables pursuant to the BMS and Schwarz Pharma agreements.
We have an accumulated deficit of $30 million as of December 31, 2000. We expect operating losses in the foreseeable future as we continue our research toward the development of commercial products. Our development efforts and the future revenues from sales of these products are expected to generate contract research, milestones, license fees, royalties and manufacturing product sales for us. We have financed our operations primarily through the sale of common stock and warrants in the public market and also through revenues resulting from royalties provided by our collaborative partners and, to a lesser extent, from sales of manufactured product.
We face certain risks and uncertainties regarding future profitability that arise from our ability to obtain additional funding, protection of patents and property rights, uncertainties regarding our technologies, competition and technological change, government regulations including the need for product approvals, and attracting and retaining key officers and employees.
As of December 31, 2000, we have $5.8 million of working capital. In the past, we received significant revenues from royalties for Stadol NS. The patent on Stadol NS expires in August 2001. The amount of royalties we will continue to receive, if any, after the patent expiry is uncertain. This event, if it occurs, could adversely affect the recording of revenue and contribution to operations in the second half of year 2001. We expect to raise additional capital in fiscal 2001 to fund our operations. As discussed in note 12, we entered into a equity line of credit that will allow us to issue during a 3-year term up to 1.2 million shares of common stock to an investor that are discounted from the fair market value on the date of issuance. If we are unable to raise adequate working capital in 2001, we would be required to curtail or reduce our research and development efforts.
In July 2000, we entered into an equity line of credit agreement. Under the equity line, we have the option, at our discretion, to issue during a three-year term up to 1.2 million shares of our common stock to an investor at prices that are discounted from the fair market value on the date of issuance. We believe that the funds that can be drawn down under the equity line will provide us with adequate working capital through at least December 31, 2001. In the event the equity line of credit does not provide us with adequate working capital due to a significant decline in the market price of our common stock, we may be required to curtail our research and development activities.
NEW ACCOUNTING PRONOUNCEMENTS
In June 1999, the FASB issued SFAS No. 137, deferring the required implementation of SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activity". We will adopt this SFAS in the first quarter of fiscal 2001. Implementation of this statement is not expected to have an affect on our financial position or results of operations.
ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable
ITEM 8 - INDEX TO FINANCIAL STATEMENTS
INDEPENDENT AUDITORS` REPORT ..................................................................................................21
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Consolidated Balance Sheets at December 31, 2000 and 1999 ...........................................................22
Consolidated Statements of Operations for the years ended December 31, 2000, 1999 and 1998 ..........................23
Consolidated Statements of Stockholder`s Equity for the years ended December 31, 2000, 1999 and 1998 ................24
Consolidated Statements of Cash Flows for the years ended December 31, 2000, 1999 and 1998 ..........................25
Notes to Consolidated Financial Statements .....................................................................26 - 35
INDEPENDENT AUDITORS` REPORT
To the Board of Directors and Stockholders Nastech Pharmaceutical Company Inc.:
We have audited the accompanying consolidated balance sheets of Nastech Pharmaceutical Company Inc. and subsidiary (the Company) as of December 31, 2000 and 1999, and the related consolidated statements of operations, stockholders` equity and cash flows for each of the years in the three-year period ended December 31, 2000. These consolidated financial statements are the responsibility of the Company`s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
We conducted our audits in accordance with auditing standards generally accepted in the United States of America. 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 consolidated financial statements referred to above present fairly, in all material respects, the financial position of Nastech Pharmaceutical Company Inc. and subsidiary as of December 31, 2000 and 1999 and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2000, in conformity with accounting principles generally accepted in the United States of America.
/s/ KPMG LLP
Melville, New York February 2, 2001, except for Note 16, which is as of March 22, 2001
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
DECEMBER 31, DECEMBER 31,
2000 1999
----------------- -----------------
ASSETS
Current assets:
Cash and cash equivalents........................ $ 6,256 $ 10,652
Short-term investments........................... -- 3,986
Accounts receivable.............................. 74 25
Royalties and fees receivable.................... 1,201 1,011
Inventories...................................... 174 279
Prepaid expenses and sundry assets............... 190 533
----------------- ---------------
Total current assets...................... 7,895 16,486
----------------- ---------------
Property and equipment.............................. 5,259 4,666
Less: Accumulated depreciation and
amortization..................................... 1,694 986
----------------- ---------------
Property and equipment, net............... 3,565 3,680
----------------- ---------------
Goodwill, net....................................... 147 --
Other assets........................................ 54 33
----------------- ---------------
Total assets............................. $ 11,661 $ 20,199
================= ===============
LIABILITIES AND STOCKHOLDERS`
EQUITY
Current liabilities:
Accounts payable................................. $ 648 $ 2,059
Royalties payable................................ 487 664
Accrued expenses and sundry liabilities.......... 961 851
----------------- ---------------
Total current liabilities................. 2,096 3,574
----------------- ---------------
Commitments and Contingencies
Stockholders`equity:
Preferred stock, $.01 par value;
authorized: 100,000 shares; issued
and outstanding:
none............................................. -- --
Common stock, $0.006 par value; authorized:
25,000,000 shares; issued 6,880,485 and
6,267,485 shares at December 31, 2000
and 1999,
respectively.................................. 41 38
Additional paid-in capital....................... 39,678 37,050
Accumulated deficit.............................. (30,003) (20,312)
----------------- ---------------
9,716 16,776
Less: Treasury stock, at cost, 77,000 shares 151 151
----------------- ---------------
Total stockholders`equity................. 9,565 16,625
----------------- ---------------
Total liabilities and stockholders`
equity.................................... $ 11,661 $ 20,199
================= ===============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
YEARS ENDED
DEC. 31, DEC. 31, DEC. 31,
2000 1999 1998
------------- -------------- --------------
Revenues:
Product sales................................... $ 447 $ 325 $ 516
License fee, royalty and research income........ 3,694 4,222 7,632
Interest income................................. 644 1,084 1,442
------------ ---------- ------------
Total revenues............................... 4,785 5,631 9,590
------------ ---------- ------------
Costs and expenses:
Cost of product sales........................... 358 268 589
Research and development........................ 7,328 9,649 6,014
Acquired in-process research and development.... 2,300 --- ---
Royalties....................................... 1,517 1,436 1,251
Sales and marketing............................. 825 1,051 875
General and administrative...................... 2,148 1,577 1,737
------------ ---------- ------------
Total costs and expenses..................... 14,476 13,981 10,466
------------ ---------- ------------
Net loss........................................... $ (9,691) $ (8,350) $ (876)
------------ ---------- ------------
Net loss per common share-basic and diluted........ $ (1.51) $ (1.32) $ (.14)
------------ ---------- ------------
Average shares outstanding-basic and diluted....... 6,437 6,335 6,296
------------ ---------- ------------
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS` EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999 AND 1998
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK
-------------------------
ADDITIONAL TOTAL
SHARES AMOUNT PAID-IN ACCUMULATED TREASURY STOCKHOLDERS`
CAPITAL DEFICIT STOCK EQUITY
------------- ----------- ---------- -------------- ------------ -------------
BALANCE, DECEMBER 31, 1997 ................. 6,101,020 $ 37 $ 35,978 $ (11,086) $ --- $ 24,929
Shares issued in connection with
exercise underwriter`s warrants ......... 270,000 1 1,402 --- --- 1,403
Shares issued in connection with
exercise of stock options ............... 6,000 --- 46 --- --- 46
Fractional shares redeemed in connection
with reverse stock split ................ (105) --- --- --- --- ---
Net loss year ended December 31, 1998 --- --- --- (876) --- (876)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 1998 ................. 6,376,915 $ 38 $ 37,426 $ (11,962) $ --- $ 25,502
Redemption of shares in connection
with reverse/forward stock split ........ (110,736) --- (395) --- --- (395)
Shares issued in connection with
exercise of stock options ............... 5,000 --- 19 --- --- 19
Acquisition of treasury stock .............. --- --- --- --- (151) (151)
Fractional shares redeemed in
connection with reverse stock split...... (3,694) --- --- --- --- ---
Net loss year ended December 31, 1999 ...... --- --- --- (8,350) --- (8,350)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 1999 ................. 6,267,485 $ 38 $ 37,050 $ (20,312) $ (151) $ 16,625
Common stock issued for acquisition of
Atossa HealthCare, Inc ................. 600,000 3 2,450 --- --- 2,453
Value of warrants issued in connection
with equity financing agreement ........ --- --- 100 --- --- 100
Compensation related to stock options ...... --- --- 34 --- --- 34
Shares issued in connection with exercise
of stock option ........................ 13,000 --- 44 --- --- 44
Net loss year ended December 31, 2000 --- --- --- (9,691) --- (9,691)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 2000 ................. 6,880,485 $ 41 $ 39,678 $ (30,003) $ (151) $ 9,565
============ ======== ========== ============ ========= ============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
YEARS ENDED
-------------------------------------------------
DEC. 31, DEC. 31, DEC. 31,
2000 1999 1998
------------- ------------- -------------
OPERATING ACTIVITIES:
Net loss ............................ $ (9,691) $ (8,350) $ (876)
Adjustments to reconcile net loss
to net cash used in operating
activities:
Acquired in-process research and
development cost .............. 2,300 --- ---
Compensation related to stock
options ....................... 34 --- ---
Value of warrants issued in
connection with equity
financing agreement ........... 100 --- ---
Depreciation and amortization .... 732 384 300
Changes in assets and liabilities:
Accounts and other receivables .... (239) 1,249 (1,348)
Inventories ....................... 105 111 (20)
Prepaid expenses and other assets 322 (271) (233)
Accounts payable .................. (1,411) 1,434 (872)
Royalties payable ................. (177) 67 406
Accrued expenses and sundry
liabilities ................... 63 57 40
------------- ------------- -------------
Net cash used in operating
activities ........................... (7,862) (5,319) (2,603)
------------- ------------- -------------
INVESTING ACTIVITIES:
Property and equipment ............... `(593) (3,031) (625)
Short-term investments-acquisitions. --- (3,986) ---
Short-term investments-redemptions ... 3,986 --- ---
Cash received upon acquisition of
Atossa HealthCare, Inc............ 29 --- ---
------------- ------------- -------------
Net cash provided by (used in) investing
activities............................ 3,422 (7,017) (625)
------------- ------------- -------------
FINANCING ACTIVITIES:
Redemption of common
shares ............................... --- (395) ---
Acquisition of treasury stock ........ --- (151) ---
Exercise of stock options............. 44 19 46
Exercise of warrants.................. --- --- 1,403
------------- ------------- -------------
Net cash provided by (used in) financing
activities............................... 44 (527) 1,449
------------- ------------- -------------
Net decrease in cash and cash equivalents. (4,396) (12,863) (1,779)
Cash and cash equivalents--beginning..... 10,652 23,515 25,294
------------- ------------- -------------
Cash and cash equivalents--ending......... $ 6,256 $ 10,652 $ 23,515
============= ============= =============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Three Years Ended December 31, 2000
NOTE 1 -- BUSINESS AND BASIS OF PRESENTATION
Business
Historically, our business involves research, development, manufacturing and commercialization of nasally administered forms of prescription pharmaceuticals. By using biophysics, physical chemistry and pharmacology in drug development, we seek to maximize therapeutic efficacy and safety, which sometimes involve a change in route of administration.
We have an accumulated deficit of $30.0 million as of December 31, 2000. We expect operating losses in the foreseeable future as we continue our research toward the development of commercial products. Our development efforts and the future revenues from sales of these products are expected to generate contract research, milestones, license fees, royalties and manufacturing product sales for us. We have financed our operations primarily through the sale of common stock in the public market and also through revenues resulting from royalties provided by our collaborative partners (note 8) and, to a lesser extent, from sales of manufactured product.
We face certain risks and uncertainties regarding future profitability that arise from our ability to obtain additional funding, protection of patents and property rights, uncertainties regarding our technologies, competition and technological change, government regulations including the need for product approvals, and attracting and retaining key officers and employees.
As of December 31, 2000, we have $5.8 million of working capital. In the past, we received significant revenues from royalties for Stadol NS. The patent on Stadol NS expires in August 2001. The amount of royalties we will continue to receive, if any, after the patent expiry is uncertain. This event, if it occurs, could adversely affect the recording of revenue and contribution to operations in the second half of year 2001. We expect to raise additional capital in fiscal 2001 to fund our operations. As discussed in note 12, we entered into a equity line of credit that will allow us to issue during a 3-year term up to 1.2 million shares of common stock to an investor that are discounted from the fair market value on the date of issuance. If we are unable to raise adequate working capital in 2001, we would be required to curtail or reduce our research and development efforts.
NOTE 2 -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND RELATED MATTERS
Principles of Consolidation
The financial statements include the accounts of Nastech Pharmaceutical Company Inc. and its wholly-owned subsidiary, Atossa HealthCare, Inc. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and temporary investments of highly-rated investment grade commercial paper with maturities of three months or less when purchased. At December 31, 2000 and 1999, cash equivalents totaled $6.3 million and $10.6 million, respectively.
Investments
Short-term investments consist of highly-rated investment grade commercial paper having original maturities greater than three months and up to one year. There were no material unrealized holding gains or losses at December 31, 1999.
Inventories
Inventories are stated at the lower of cost (first-in, first-out basis) or market and consist principally of raw materials.
Patents
The cost of acquired patents is capitalized and amortized over the remaining legal life of the patents at acquisition or their useful life, whichever is shorter. Legal costs and fees related to patent applications developed by us are charged to expense as incurred.
Property and Equipment
Property and equipment are carried at cost and depreciated using straight-line and accelerated methods over estimated useful lives ranging from 5 to 7 years. Leasehold improvements are carried at cost and amortized using the straight-line method over the lesser of the estimated useful life or the remaining lease term. When assets are sold or retired, the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in the period. Expenditures for maintenance and repairs are charged to expense as incurred.
Revenue Recognition
We have entered into various collaborative arrangements and licensing contracts with other pharmaceutical companies. Under these arrangements and contracts, we generally recognize income from royalties based upon the sale of licensed products as reported by licensees. Upfront payments are generally recognized over the term of the license agreements. We have not, however, received any upfront payments from licensees during the three years ended December 31, 2000. Milestone payments, which reduce the development risk associated with a product and are determinable based on the terms of the license agreement, are typically progress payments for specific events of development, such as completion of pre-clinical or clinical activities, regulatory submission or approval, or manufacturing objectives prior to commercialization of a product. Milestone payments are generally non-refundable and are recognized upon completion of a milestone activity. A substantial portion of our revenues are derived from licensing agreements with Bristol-Myers Squibb and Schwarz Pharma, Inc. Revenue from sale of Nascobal is recognized at the time of shipment.
On December 31, 1999, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements" (SAB No. 101). SAB No. 101 provides the SEC staff`s views on the recognition of revenue including non-refundable technology access fees received by biotechnology companies in connection with research collaborations with third parties. SAB No. 101 states that in certain circumstances the SEC staff believes that upfront fees, even if non-refundable, should be deferred and recognized systematically over the term of the research agreement. SAB No. 101B, which amends the implementation date for SAB No. 101, required registrants to adopt the accounting guidance contained therein by no later than the fourth fiscal quarter of the fiscal year beginning after December 15, 1999. There was no impact on our financial position or results of operations as a result of adopting the provisions of SAB No. 101.
Net Loss per Common Share
Basic and diluted net loss per common share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. The effect of employee stock options and warrants totaling 2,130,745, 1,239,512 and 1,054,750 at December 31, 2000, 1999 and 1998, respectively, were not included in the net loss per share calculation because their effect would have been anti-dilutive.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
Long-Lived Assets
We review our long-lived assets (property and equipment and goodwill) for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the expected cash flows, undiscounted and without interest, is less than the carrying amount of the asset, an impairment loss is recognized as the amount by which the carrying amount of the asset exceeds its fair value.
Stock-Based Compensation
We account for stock-based compensation using the intrinsic value method in accordance with APB No. 25, "Accounting for Stock Issued to Employees." Effective July 1, 1996, we adopted the disclosure requirements of SFAS No. 123, "Accounting for Stock-Based Compensation", which requires the disclosure of pro forma net income and earnings per share as if we adopted the fair value-based method in measuring compensation expense as of the beginning of fiscal 1996 (see Note 9).
Comprehensive Income
Effective January 1, 1998, we adopted SFAS No. 130, "Reporting Comprehensive Income." SFAS No. 130 requires that all items recognized under accounting standards as components of comprehensive income be reported in an annual financial statement that is displayed with the same prominence as other annual financial statements. Other comprehensive income may include foreign currency translation adjustments, minimum pension liability adjustments and unrealized gains and losses on marketable securities classified as available-for-sale. Our operations did not give rise to items includible in comprehensive income, which were not already included in net income. Accordingly, our comprehensive income is the same as our net income for all periods presented.
Fair Value Financial Instruments
We consider the fair value of all financial instruments to not be materially different from their carrying value at year-end as all financial instruments have short-term maturities.
Derivative Instruments and Hedging Activities
The Financial Accounting Standards Board issued Statement of Financial Accounting Standards (SFAS) No. 133, "Accounting for Derivative Instruments and Hedging Activities" as amended by SFAS 137 and SFAS 138, which will be adopted by us in the first quarter of fiscal 2001. SFAS 133 establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts and for hedging activities. It requires that an entity recognize all derivatives as either assets or liabilities in the balance sheet and measures those instruments at fair value. Implementation of this statement is not expected to have a material impact on our financial position or results of operations.
NOTE 3 -- PROPERTY AND EQUIPMENT
Property and equipment consist of the following:
DECEMBER 31,
2000 1999
------------ ------------
(In thousands)
Furniture and fixtures..................... $ 372 $ 335
Machinery and equipment.................... 2,243 2,027
Computer equipment......................... 392 316
Leasehold improvements..................... 2,252 1,988
-------- --------
5,259 4,666
Less accumulated depreciation
and amortization.......................... 1,694 986
-------- --------
Net property and equipment................. $ 3,565 $ 3,680
======== ========
NOTE 4 -- ACCRUED EXPENSES
Accrued expenses at December 31, 2000 and 1999 are comprised of (in thousands):
2000 1999
------------ --------------
Accrued payroll and employee benefits $ 211 $ 330
Deferred rent payable 263 184
Amount due to former shareholders (Note 5) 140 ---
Accrued expenses 347 337
---------- ------------
$ 961 $ 851
========== ============
NOTE 5 -- STOCKHOLDERS` EQUITY
In connection with a public offering of common stock in 1997, we issued to the representatives of the underwriters warrants to purchase in the aggregate up to 69,000 shares of Common Stock (the "Representatives` Warrants") at an exercise price per share equal to 120% of the public offering price per share. The Representatives` Warrants are exercisable for a period of four years commencing January 24, 1998. The holders of the Representatives` Warrants will have no voting, dividend or other stockholder rights until the Representatives` Warrants are exercised. We granted the representatives certain registration rights related to the Representatives` Warrants.
In connection with a public offering of common stock and warrants in 1994, underwriter`s warrants were exercised during 1998 resulting in proceeds to us of $1,403,000.
In July 1999, our shareholders approved a 1:100 reverse split of our common stock followed immediately by a 100:1 forward split. We effectuated these transactions on August 17, 1999. The purpose of these transactions is to enable a redemption of odd-lot shares and reduce certain annual administrative costs. As of December 31, 2000, we have redeemed 110,736 of such shares at a cost of $395,000 and subsequently retired these shares. We also acquired 77,000 shares of our common stock in 1999 at an aggregate cost of $151,000. These shares are being held as treasury stock.
We are authorized to issue up to 100,000 shares of preferred stock, the designations, powers, preferences and rights of which may be determined, from time to time, by our Board of Directors.
We have a stockholder rights plan designed to protect our stockholders from coercive or unfair takeover tactics. Under the plan, we declared a dividend of one preferred stock purchase right for each share of common stock outstanding on March 17, 2000. Each preferred stock purchase right entitles the holder to purchase from us 1/1000 of a share of Series A Junior Participating Preferred Stock for $50. In the event any acquiring entity or group accumulates or initiates a tender offer to purchase 15% or more of our common stock, then each holder of a preferred stock purchase right, other than the acquiring entity, will have the right to receive, upon exercise of the preferred stock purchase right, shares of our common stock or shares in the acquiring entity having a value equal to two times the exercise price of the preferred stock purchase right.
NOTE 6 -- STOCK OPTION PLAN
Under our stock option plans we are authorized to grant options to purchase a maximum of 2,500,000 shares of common stock (subject to adjustment in the event of stock splits, stock dividends, recapitalization and other capital adjustments) to our employees, officers and directors and other persons who provide us services. The options to be granted under the Plan are designated as either incentive stock options or non-incentive stock options by the Board of Directors which also has discretion as to the person to be granted options, the number of shares subject to the options and the terms of the option agreements. Only employees, including officers and part-time employees, may be granted incentive stock options.
The plans provide that options granted thereunder shall be exercisable during a period of no more than ten years (five years in the case of 10% shareholders) from the date of grant, depending upon the specific stock option agreement, and that, with respect to incentive stock options, the option exercise price shall be at least equal to 100% of the fair market value of the common stock at the time of grant (110% in the case of 10% shareholders). Pursuant to the provisions of the Incentive Stock Option Plan, the aggregate fair market value (determined on the date of grant) of the common stock with respect to which incentive stock options are exercisable for the first time by an employee during any calendar year shall not exceed $100,000. The plans are administered by our Board of Directors.
In August 1998, our Board of Directors approved a stock option exchange program in which it offered all holders the right to exchange their options for the same number of new options with a lower exercise price but with a modified term of vesting. All outstanding options (786,350) with an exercise price greater than $5.63 per share were eligible for this program and were exchanged during 1998. No charge was recorded to earnings as the new exercise price was in excess of the market value on the date of the exchange.
Data relating to these plans are as follows:
Year Ended Year Ended Year Ended
Dec. 31, 2000 Dec. 31, 1999 Dec. 31, 1998
------------------------- ------------------------- ------------------------
Weighted Weighted Weighted
Average Average Average
Exercise Exercise Exercise
Shares Price Shares Price Shares Price
-------------------------------------------------------------------------------
Outstanding at beginning of period 1,170,512 $4.84 985,750 $5.49 878,150 $10.47
Granted 1,163,300 6.79 429,050 3.29 903,650 5.91
Exercised (13,000) 3.37 (5,000) 3.72 (6,000) 7.73
Expired (103,000) 5.08 (25,000) 3.72 -- --
Canceled (135,000) 5.12 -- -- (786,350) 11.18
Terminated (70,567) 3.26 (214,288) 3.92 (3,700) 9.96
--------- --------- --------
Outstanding at end of period 2,012,245 6.00 1,170,512 4.84 985,750 5.49
========= ========= ========
The following table summarizes additional information on our stock options outstanding at December 31, 2000:
Options Outstanding Options Exercisable
-------------------------------------------------------------------------- -----------------------------------
Weighted-average Weighted- Weighted-average
Range of Number remaining average Number exercisable
exercise prices outstanding contractual life exercise price exercisable price
-------------------------------------------------------------------------- -----------------------------------
$ 1.94 - $ 3.63 173,450 3.20 $2.82 127,488 $2.16
$ 4.09 - $ 5.13 849,800 3.96 $4.40 310,000 $1.74
$ 5.50 - $ 8.75 688,995 2.70 $5.72 610,617 $4.99
$12.00 - $ 15.00 300,000 4.58 $13.00 --- ---
--------- -----------------
Totals 2,012,245 1,048,105
========= =================
NOTE 7 -- INCOME TAXES
Our net deferred tax assets as of December 31, 2000 and 1999, are estimated as follows (in thousands) :
2000 1999
Deferred tax assets:
Net operating loss carryforwards.................. $ 10,496 $ 7,798
Federal and State tax credits..................... 1,416 1,106
Depreciation...................................... 384 263
Other............................................. 249 131
-------- -------
Total deferred tax assets .................. $ 12,545 $ 9,298
Valuation allowance............................... (12,545) (9,298)
-------- -------
Net deferred taxes ............................... --- ---
======== =======
A valuation allowance for 2000 and 1999 has been applied to offset the
respective deferred tax assets in recognition of the uncertainty that such tax
benefits will be realized.
At December 31, 2000, we have available net operating loss carryforwards for Federal and State income tax reporting purposes of approximately $25,400,000, and have available Federal and State tax credits of approximately $1,400,000, which are available to offset future taxable income, if any. These carryforwards expire beginning in 2001 through 2020. Our ability to use such net operating loss and Federal and State tax credit carryforwards is limited by change of control provisions under Section 382 of the Internal Revenue Code.
NOTE 8 -- COMMITMENTS
(a) Employment Agreements and Accrued Compensation
Certain of our officers have employment agreements that provide base compensation and annual incentive compensation. Our Chief Executive Officer, Dr. Steven C. Quay, the founder of Atossa Healthcare, has an employment agreement expiring August 8, 2003, from which he receives base compensation of $300,000 per year, and annual incentive compensation of up to $50,000 based on the achievement of certain business objectives of the Company.
In connection with the employment agreement, Dr. Quay was issued 600,000 stock options at exercise prices at or above market, which vest over a three year period.
(b) Leases:
We lease space for our research and development activities under a lease expiring October 31, 2009 and lease office and manufacturing space under a lease expiring on June 30, 2005. The lease for the research and development facility has a 5 year renewal option. The following is a schedule of future minimum lease payments (in thousands):
2001....................................... $ 319
2002....................................... 333
2003....................................... 361
2004....................................... 391
2005....................................... 373
Thereafter................................. 1,478
--------
Total.............................. $ 3,255
========
Rental expense for the aforementioned spaces aggregated approximately $381,000, $418,000, and $173,000 for the years ended December 31, 2000, 1999 and 1998, respectively.
NOTE 9 -- CONTRACTUAL AGREEMENTS
In January 1986, we sublicensed to BMS our development and commercial exploitation rights with respect to our licensed patent rights for the nasal delivery of Butorphanol Tartrate, in exchange for which BMS agreed to pay us a royalty based on the net sales of such product (the "BMS Agreement"). We must pay a percentage of these royalties to the University of Kentucky Research Foundation ("UKRF") under our separate license agreement with UKRF. The BMS Agreement, which may be terminated by BMS at any time upon 60 days written notice to us, is concurrent with our licensed patent rights to nasal Butorphanol Tartrate. The nasal Butorphanol Tartrate patent expires in the year 2001 in the United States, subject to any right of extension or renewal. In December 1991, the FDA granted marketing clearance to BMS for this product, which is marketed by BMS as Stadol NS and quarterly royalty payments to us by BMS are continuing. During 1997, Stadol NS was classified by the FDA as a Schedule IV substance under the Controlled Substances Act which has negatively affected sales by BMS and royalties to us.
In July 1997, we exclusively licensed to Schwarz Pharma the right to market our Nascobal(R) (Cyanocobalamin, USP) Gel in the U.S. We retained worldwide manufacturing rights and the agreement provided for a fixed manufacturing transfer price to Schwarz Pharma. Pursuant to the agreement we will receive royalty payments from Schwarz Pharma based upon the net sales of Nascobal(R). The minimum royalty payment in 1998 was $2 million, and the royalty rate in each subsequent year is based in part, upon sales volume. The minimum royalty expired in December 1998. We also receive revenues from the sale of Nascobal to Schwarz Pharma. Aggregate sales and royalty payments amounted to $907,000 in 2000, $740,000 in 1999 and $2.5 million in 1998. The term of the agreement is for the later of 15 years or the expiration of the applicable patent which expires in 2005.
In December 1997, we exclusively licensed to Schwarz Pharma the right to market our intranasal scopolamine gel in the U.S. Under the terms of the agreement, we were to receive royalty and manufacturing payments from Schwarz Pharma. In addition, Schwarz Pharma made research milestone payments to us of $3,750,000 through December 1999 of which $750,000 and $3,000,000 was recognized in the years ended December 31, 1999 and 1998, respectively,
In December 1999, we reacquired the marketing rights to intranasal scopolamine from Schwarz Pharma. We made a payment of $250,000 to Schwarz Pharma, which has been reflected as research and development expense for the year ended December 31, 1999. We also agreed to pay one-half of any future consideration received from the sale or license of intranasal scopolamine until Schwarz Pharma receives payments totaling $3,500,000 plus an additional amount for interest that will accrue at a rate of 8.5% per annum beginning December 2000. As any payment to Schwarz Pharma is contingent on whether we will receive proceeds from the future sale or license of intranasal scopolamine, no liability has been recorded for this agreement as of December 31, 2000.
In September 1997, we entered into an agreement with Meda AB of Goteborg, Sweden ("Meda"), giving Meda the exclusive right to market Nascobal(R) in Sweden, Denmark, Norway and Finland. Pursuant to the agreement, we will receive revenue from the sale of Nascobal(R) to Meda and a license fee upon the occurrence of certain regulatory approvals and commercial events in the Nordic countries.
In July 1998, we entered into an agreement with Cambridge Laboratories ("Cambridge"), giving Cambridge the exclusive right to market Nascobal(R) in several European countries, Australia and New Zealand. Pursuant to the agreement, we will receive revenue from the sale of Nascobal(R) to Cambridge.
Our two largest customers accounted for 97%, 98% and 99% of total revenues, excluding interest, in 2000, 1999 and 1998 respectively. These revenues by customer were $3.1 million and $907,000 in 2000, $2.9 million and $1.5 million in 1999, and $5.5 million and $2.6 million in 1998. No other customer accounted for more than 10% of revenues, excluding interest.
NOTE 10 -- STOCK-BASED COMPENSATION
The per share weighted average fair value of stock options granted during the years ended December 31, 2000, 1999, and 1998 was $2.32, $1.50 and $3.82 respectively, on the date of grant using the Black Scholes option-pricing model with the following weighted-average assumptions:
YEAR ENDED YEAR ENDED YEAR ENDED
DEC. 31, 2000 DEC. 31, 1999 DEC. 31, 1998
------------- ------------- -------------
Expected dividend yield 0% 0% 0%
Risk free interest rate 5.0% 6.0% 4.75%
Expected stock volatility 71% 53% 63%
Expected option life 5 years 5 years 5 years
We apply APB Opinion No. 25 in accounting for our stock options and, accordingly, no compensation cost (except in 2000 with the amount of $34,000 for options granted below market value - See Note 13), has been recognized in the financial statements for our stock options which have an exercise price equal to the fair value of the stock on the date of the grant. Had we determined compensation cost based on the fair value at the grant date for our stock options under SFAS No. 123, our net loss would have been reported as the pro forma amounts indicated below:
YEAR ENDED YEAR ENDED YEAR ENDED
DEC. 31, 2000 DEC. 31, 1999 DEC. 31, 1998
FRIDAY, MARCH 30, 2001 8:01 PM
- Edgar Online
(EDGAR Online via COMTEX) -- MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Except for historical information contained herein, the statements in this Item are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements involve known and unknown risks and uncertainties that reflect our intentions, expectations or beliefs concerning future events. (See Item 1, "Risk Factors".)
Nastech Pharmaceutical Company Inc. is a Formulation Science company and recognized as a leader in nasal drug delivery technology. Formulation Science is a systematic approach to drug development using biophysics, physical chemistry and pharmacology to maximize therapeutic efficacy and safety, which sometimes involves a change in route of administration. The technology is essential in designing an optimized, customizable dosage form and in delivering difficult protein and large molecule drugs that can currently only be delivered by injection.
Historically, our core technology involves the research, development and manufacture of nasally administered prescription pharmaceuticals that are currently delivered in oral, injectable or other dosage forms. The nasal delivery of certain pharmaceuticals may enable more rapid systemic absorption, lower required dosages, quicker onset of desired effect, and painless, convenient patient self-administration, resulting in improved patient compliance and pharmacoeconomics. We intend to broaden our focus on difficult to formulate drugs, primarily proteins and peptides, that are currently administered by injection.
We receive licensing revenues on two commercial products - Stadol(R) NS(TM) and Nascobal(R). Stadol(R) NS(TM) is an opioid analgesic which is used for the treatment of moderate to severe pain and the acute pain of migraine. The product is currently marketed by Bristol-Myers Squibb Co. (BMS) under an agreement that generates quarterly royalties to us. Unless the patent is extended, royalties from BMS are scheduled to terminate at time of patent expiry in August 2001. This event, if it occurs, should adversely affect the recording of revenue and contribution to operations in the second half of year 2001.
In 1997, Stadol(R) NS(TM) was classified as a Schedule IV substance by the federal government. "Schedules" are used by the federal government to classify certain narcotic prescription products depending on the potency and potential abuse liability. Schedule I narcotics require the greatest amount of control by manufacturers, distributors, physicians and others in various channels of distribution, including import and export restrictions, and Schedule V substances require the least amount of control. Prior to 1997, Stadol(R) NS(TM) had not been classified and had peak sales in 1996 of $112 million. After the classification of Stadol(R) NS(TM) as a Schedule IV substance in 1997, sales by BMS declined to $108 million in 1997, $86 million in 1998, and increased to approximately $100 million in 1999 and 2000. We believe that the classification of Stadol(R) NS(TM) as a Schedule IV substance, and the resulting increased controls and regulations imposed on BMS to prevent potential abuse liability, contributed to the downward trend in sales.
In July 1997, we entered into an exclusive licensing agreement for Nascobal(R) in the U.S. with Schwarz Pharma and commercially launched the product in October 1997. Under the agreement we received minimum royalties of $2 million in 1998 and retain global manufacturing rights. The minimum royalty expired in December 1998. Sales re-orders of Nascobal(R) in 1999 and 1998 were below expectations as a result of a marketing issue which required a change in the packaging configuration of the product. We shipped the new package configuration to Schwarz Pharma beginning in 1999.
In December 1999, we reacquired the marketing rights to intranasal scopolamine hydrobromide from Schwarz Pharma. We made a payment of $250,000 to Schwarz Pharma which has been reflected as an expense in research and development for the year ended December 31, 1999. We agreed to pay Schwarz Pharma one-half of any future consideration received by Nastech in respect to intranasal scopolamine until Schwarz Pharma receives payments totaling $3,500,000 plus an additional amount for interest that will accrue at a rate of 8.5% per annum beginning December 15, 2000. As any payment to Schwarz Pharma is contingent on whether we will receive proceeds from the future sale or license of intranasal scopolamine, no liability has been recorded for this agreement. We are currently seeking a marketing partner for this product.
We intend to commit significant financial resources in the future to internally fund multiple research and development projects through early stage feasibility studies with the goal of achieving greater economic benefit from product sales. In addition, our future profitability is primarily affected by, among others, the success of product sales by our licensees, our investment and achievement of milestones in research and development programs, regulatory uncertainties with respect to our filings with the FDA, and the success of our financing activities. As a result of the uncertainties associated with these factors and the increased investment in research and development, we anticipate operating losses in the foreseeable future.
RESULTS OF OPERATIONS
Year Ended December 31, 2000 Compared to Year Ended December 31, 1999
Revenues decreased by $846,000, or 15%, to $4.8 million primarily as a result of a decline in milestone payments on intranasal scopolamine from Schwarz Pharma and a reduction in interest income. Total revenues from Schwarz Pharma on scopolamine were $0 in 2000 and $750,000 in 1999. Total Nascobal(R) revenues were $907,000 in 2000 compared to $740,000 in 1999. Royalty income on sales of Nascobal(R) increased $45,000, or 11%, to $460,000 in 2000 as compared to $415,000 in 1999. Royalty income received from BMS on sales of Stadol NS increased $153,000, or 5%, to $3.1 million in 2000 as compared to $2.9 million in 1999.
Total costs and expenses increased by $495,000 or 4%, to $14.5 million in 2000. The details of the increase follow:
Research and development expense decreased by $2.3 million, or 24%, to $7.3 million as expenditures for late stage development in our clinical program for intranasal scopolamine decreased while we expanded earlier stage clinical development. These early stage studies were executed under less costly contracts with third parties, and certain activities were performed in-house. Included in the research and development expense in 1999 is the $250,000 paid to Schwarz Pharma for the reacquisition of the rights to intranasal scopolamine.
In process research and development expense of $2.3 million is the result of the acquisition of Atossa HealthCare in August, 2000. In connection with this acquisition, we have recorded a charge of approximately $2.3 million in the accompanying consolidated statement of operations during the year ended December 31, 2000, based on our estimate of the fair value of the acquired in-process research and development (in process R&D). The in-process R&D was valued based on the income approach of the assets acquired. The underlying premise of this approach is that the value of an asset can be measured by the present worth of the net economic benefit (cash receipts less cash outlays) to be received over the life of the asset. Significant assumptions and estimates used in the valuation of in-process R&D included the stage of development of the test kit; future revenues based on royalties; growth rates for the test kit; product sales cycles; the estimated life to the test kit of 17 years from the date of introduction; an effective income tax rate of 40%; a probability of success factor of 20%; and a discount rate of 60% to reflect present value and the risk of developing the acquired technology into a commercially viable product.
Royalties expense increased by $81,000, or 6%, to $1.5 million in 2000 as a result of the increase in sales of Stadol NS by BMS and the related royalty payable to the University of Kentucky Research Foundation (UKRF) under a separate agreement with UKRF. Royalties expense increases or decreases approximately in proportion to royalty income associated with Stadol NS.
Sales and marketing costs decreased by $226,000, or 22%, from 1999 primarily from a decrease in market research and staffing costs. General and administrative expense increased by $571,000, or 36%, to $2.1 million related primarily to compensation expense to the estate of our former Chief Executive Officer.
Year Ended December 31, 1999 Compared to Year Ended December 31, 1998
Revenues decreased by $4.0 million, or 41%, to $5.6 million primarily as a result of a decline in product sales and royalty income of Nascobal(R) and milestone payments on intranasal scopolamine. Total revenues from Schwarz Pharma on Nascobal(R) were $740,000 in 1999 compared to $2.5 million in 1998. The revenue for the year ended December 31, 1998 included $2 million as a minimum royalty from Schwarz Pharma on Nascobal(R). Sales re-orders of Nascobal(R) were below expectation as a result of the marketing issue noted above. Accordingly, royalty income on sales of Nascobal(R) decreased $1.6 million, or 79%, to $415,000. Total milestone payments on scopolamine decreased $2.2
million or 75% to $750,000 in 1999. Royalty income received from BMS on sales of Stadol NS increased $374,000, or 15%, to $2.9 million in 1999.
Total costs and expenses increased by $3.5 million or 34%, to $14 million in 1999. The details of the increase follow:
Research and development expense increased by $3.6 million, or 60%, to $9.6 million primarily as a result of our clinical programs for intranasal scopolamine, morphine and apomorphine. Included in the increase is the $250,000 paid to Schwarz Pharma in connection to reacquiring the rights to intranasal scopolamine. In September 1998, we also entered into an operating lease for a larger R&D facility and intend to pursue additional internally funded projects in the future.
Royalties expense increased by $185,000, or 15%, to $1.4 million in 1999as a result of the increase in sales of Stadol NS by BMS and the related royalty payable to the University of Kentucky Research Foundation (UKRF) under a separate agreement with UKRF. Royalties expense increases or decreases approximately in proportion to royalty income associated with Stadol NS.
Sales and marketing costs increased by $176,000 or 20% from 1998 and arises from an increase in market research and consulting fees.
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 2000, our liquidity included cash and cash equivalents of $6.3 million compared to cash and cash equivalents and short term investments of $14.6 million at December 31, 1999. Accounts, royalties and fee receivables at December 31, 2000 consist principally of receivables pursuant to the BMS and Schwarz Pharma agreements.
We have an accumulated deficit of $30 million as of December 31, 2000. We expect operating losses in the foreseeable future as we continue our research toward the development of commercial products. Our development efforts and the future revenues from sales of these products are expected to generate contract research, milestones, license fees, royalties and manufacturing product sales for us. We have financed our operations primarily through the sale of common stock and warrants in the public market and also through revenues resulting from royalties provided by our collaborative partners and, to a lesser extent, from sales of manufactured product.
We face certain risks and uncertainties regarding future profitability that arise from our ability to obtain additional funding, protection of patents and property rights, uncertainties regarding our technologies, competition and technological change, government regulations including the need for product approvals, and attracting and retaining key officers and employees.
As of December 31, 2000, we have $5.8 million of working capital. In the past, we received significant revenues from royalties for Stadol NS. The patent on Stadol NS expires in August 2001. The amount of royalties we will continue to receive, if any, after the patent expiry is uncertain. This event, if it occurs, could adversely affect the recording of revenue and contribution to operations in the second half of year 2001. We expect to raise additional capital in fiscal 2001 to fund our operations. As discussed in note 12, we entered into a equity line of credit that will allow us to issue during a 3-year term up to 1.2 million shares of common stock to an investor that are discounted from the fair market value on the date of issuance. If we are unable to raise adequate working capital in 2001, we would be required to curtail or reduce our research and development efforts.
In July 2000, we entered into an equity line of credit agreement. Under the equity line, we have the option, at our discretion, to issue during a three-year term up to 1.2 million shares of our common stock to an investor at prices that are discounted from the fair market value on the date of issuance. We believe that the funds that can be drawn down under the equity line will provide us with adequate working capital through at least December 31, 2001. In the event the equity line of credit does not provide us with adequate working capital due to a significant decline in the market price of our common stock, we may be required to curtail our research and development activities.
NEW ACCOUNTING PRONOUNCEMENTS
In June 1999, the FASB issued SFAS No. 137, deferring the required implementation of SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activity". We will adopt this SFAS in the first quarter of fiscal 2001. Implementation of this statement is not expected to have an affect on our financial position or results of operations.
ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable
ITEM 8 - INDEX TO FINANCIAL STATEMENTS
INDEPENDENT AUDITORS` REPORT ..................................................................................................21
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Consolidated Balance Sheets at December 31, 2000 and 1999 ...........................................................22
Consolidated Statements of Operations for the years ended December 31, 2000, 1999 and 1998 ..........................23
Consolidated Statements of Stockholder`s Equity for the years ended December 31, 2000, 1999 and 1998 ................24
Consolidated Statements of Cash Flows for the years ended December 31, 2000, 1999 and 1998 ..........................25
Notes to Consolidated Financial Statements .....................................................................26 - 35
INDEPENDENT AUDITORS` REPORT
To the Board of Directors and Stockholders Nastech Pharmaceutical Company Inc.:
We have audited the accompanying consolidated balance sheets of Nastech Pharmaceutical Company Inc. and subsidiary (the Company) as of December 31, 2000 and 1999, and the related consolidated statements of operations, stockholders` equity and cash flows for each of the years in the three-year period ended December 31, 2000. These consolidated financial statements are the responsibility of the Company`s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
We conducted our audits in accordance with auditing standards generally accepted in the United States of America. 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 consolidated financial statements referred to above present fairly, in all material respects, the financial position of Nastech Pharmaceutical Company Inc. and subsidiary as of December 31, 2000 and 1999 and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2000, in conformity with accounting principles generally accepted in the United States of America.
/s/ KPMG LLP
Melville, New York February 2, 2001, except for Note 16, which is as of March 22, 2001
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
DECEMBER 31, DECEMBER 31,
2000 1999
----------------- -----------------
ASSETS
Current assets:
Cash and cash equivalents........................ $ 6,256 $ 10,652
Short-term investments........................... -- 3,986
Accounts receivable.............................. 74 25
Royalties and fees receivable.................... 1,201 1,011
Inventories...................................... 174 279
Prepaid expenses and sundry assets............... 190 533
----------------- ---------------
Total current assets...................... 7,895 16,486
----------------- ---------------
Property and equipment.............................. 5,259 4,666
Less: Accumulated depreciation and
amortization..................................... 1,694 986
----------------- ---------------
Property and equipment, net............... 3,565 3,680
----------------- ---------------
Goodwill, net....................................... 147 --
Other assets........................................ 54 33
----------------- ---------------
Total assets............................. $ 11,661 $ 20,199
================= ===============
LIABILITIES AND STOCKHOLDERS`
EQUITY
Current liabilities:
Accounts payable................................. $ 648 $ 2,059
Royalties payable................................ 487 664
Accrued expenses and sundry liabilities.......... 961 851
----------------- ---------------
Total current liabilities................. 2,096 3,574
----------------- ---------------
Commitments and Contingencies
Stockholders`equity:
Preferred stock, $.01 par value;
authorized: 100,000 shares; issued
and outstanding:
none............................................. -- --
Common stock, $0.006 par value; authorized:
25,000,000 shares; issued 6,880,485 and
6,267,485 shares at December 31, 2000
and 1999,
respectively.................................. 41 38
Additional paid-in capital....................... 39,678 37,050
Accumulated deficit.............................. (30,003) (20,312)
----------------- ---------------
9,716 16,776
Less: Treasury stock, at cost, 77,000 shares 151 151
----------------- ---------------
Total stockholders`equity................. 9,565 16,625
----------------- ---------------
Total liabilities and stockholders`
equity.................................... $ 11,661 $ 20,199
================= ===============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
YEARS ENDED
DEC. 31, DEC. 31, DEC. 31,
2000 1999 1998
------------- -------------- --------------
Revenues:
Product sales................................... $ 447 $ 325 $ 516
License fee, royalty and research income........ 3,694 4,222 7,632
Interest income................................. 644 1,084 1,442
------------ ---------- ------------
Total revenues............................... 4,785 5,631 9,590
------------ ---------- ------------
Costs and expenses:
Cost of product sales........................... 358 268 589
Research and development........................ 7,328 9,649 6,014
Acquired in-process research and development.... 2,300 --- ---
Royalties....................................... 1,517 1,436 1,251
Sales and marketing............................. 825 1,051 875
General and administrative...................... 2,148 1,577 1,737
------------ ---------- ------------
Total costs and expenses..................... 14,476 13,981 10,466
------------ ---------- ------------
Net loss........................................... $ (9,691) $ (8,350) $ (876)
------------ ---------- ------------
Net loss per common share-basic and diluted........ $ (1.51) $ (1.32) $ (.14)
------------ ---------- ------------
Average shares outstanding-basic and diluted....... 6,437 6,335 6,296
------------ ---------- ------------
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS` EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999 AND 1998
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK
-------------------------
ADDITIONAL TOTAL
SHARES AMOUNT PAID-IN ACCUMULATED TREASURY STOCKHOLDERS`
CAPITAL DEFICIT STOCK EQUITY
------------- ----------- ---------- -------------- ------------ -------------
BALANCE, DECEMBER 31, 1997 ................. 6,101,020 $ 37 $ 35,978 $ (11,086) $ --- $ 24,929
Shares issued in connection with
exercise underwriter`s warrants ......... 270,000 1 1,402 --- --- 1,403
Shares issued in connection with
exercise of stock options ............... 6,000 --- 46 --- --- 46
Fractional shares redeemed in connection
with reverse stock split ................ (105) --- --- --- --- ---
Net loss year ended December 31, 1998 --- --- --- (876) --- (876)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 1998 ................. 6,376,915 $ 38 $ 37,426 $ (11,962) $ --- $ 25,502
Redemption of shares in connection
with reverse/forward stock split ........ (110,736) --- (395) --- --- (395)
Shares issued in connection with
exercise of stock options ............... 5,000 --- 19 --- --- 19
Acquisition of treasury stock .............. --- --- --- --- (151) (151)
Fractional shares redeemed in
connection with reverse stock split...... (3,694) --- --- --- --- ---
Net loss year ended December 31, 1999 ...... --- --- --- (8,350) --- (8,350)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 1999 ................. 6,267,485 $ 38 $ 37,050 $ (20,312) $ (151) $ 16,625
Common stock issued for acquisition of
Atossa HealthCare, Inc ................. 600,000 3 2,450 --- --- 2,453
Value of warrants issued in connection
with equity financing agreement ........ --- --- 100 --- --- 100
Compensation related to stock options ...... --- --- 34 --- --- 34
Shares issued in connection with exercise
of stock option ........................ 13,000 --- 44 --- --- 44
Net loss year ended December 31, 2000 --- --- --- (9,691) --- (9,691)
------------ -------- ---------- ------------ --------- ------------
BALANCE, DECEMBER 31, 2000 ................. 6,880,485 $ 41 $ 39,678 $ (30,003) $ (151) $ 9,565
============ ======== ========== ============ ========= ============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
YEARS ENDED
-------------------------------------------------
DEC. 31, DEC. 31, DEC. 31,
2000 1999 1998
------------- ------------- -------------
OPERATING ACTIVITIES:
Net loss ............................ $ (9,691) $ (8,350) $ (876)
Adjustments to reconcile net loss
to net cash used in operating
activities:
Acquired in-process research and
development cost .............. 2,300 --- ---
Compensation related to stock
options ....................... 34 --- ---
Value of warrants issued in
connection with equity
financing agreement ........... 100 --- ---
Depreciation and amortization .... 732 384 300
Changes in assets and liabilities:
Accounts and other receivables .... (239) 1,249 (1,348)
Inventories ....................... 105 111 (20)
Prepaid expenses and other assets 322 (271) (233)
Accounts payable .................. (1,411) 1,434 (872)
Royalties payable ................. (177) 67 406
Accrued expenses and sundry
liabilities ................... 63 57 40
------------- ------------- -------------
Net cash used in operating
activities ........................... (7,862) (5,319) (2,603)
------------- ------------- -------------
INVESTING ACTIVITIES:
Property and equipment ............... `(593) (3,031) (625)
Short-term investments-acquisitions. --- (3,986) ---
Short-term investments-redemptions ... 3,986 --- ---
Cash received upon acquisition of
Atossa HealthCare, Inc............ 29 --- ---
------------- ------------- -------------
Net cash provided by (used in) investing
activities............................ 3,422 (7,017) (625)
------------- ------------- -------------
FINANCING ACTIVITIES:
Redemption of common
shares ............................... --- (395) ---
Acquisition of treasury stock ........ --- (151) ---
Exercise of stock options............. 44 19 46
Exercise of warrants.................. --- --- 1,403
------------- ------------- -------------
Net cash provided by (used in) financing
activities............................... 44 (527) 1,449
------------- ------------- -------------
Net decrease in cash and cash equivalents. (4,396) (12,863) (1,779)
Cash and cash equivalents--beginning..... 10,652 23,515 25,294
------------- ------------- -------------
Cash and cash equivalents--ending......... $ 6,256 $ 10,652 $ 23,515
============= ============= =============
See accompanying notes to consolidated financial statements.
NASTECH PHARMACEUTICAL COMPANY INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Three Years Ended December 31, 2000
NOTE 1 -- BUSINESS AND BASIS OF PRESENTATION
Business
Historically, our business involves research, development, manufacturing and commercialization of nasally administered forms of prescription pharmaceuticals. By using biophysics, physical chemistry and pharmacology in drug development, we seek to maximize therapeutic efficacy and safety, which sometimes involve a change in route of administration.
We have an accumulated deficit of $30.0 million as of December 31, 2000. We expect operating losses in the foreseeable future as we continue our research toward the development of commercial products. Our development efforts and the future revenues from sales of these products are expected to generate contract research, milestones, license fees, royalties and manufacturing product sales for us. We have financed our operations primarily through the sale of common stock in the public market and also through revenues resulting from royalties provided by our collaborative partners (note 8) and, to a lesser extent, from sales of manufactured product.
We face certain risks and uncertainties regarding future profitability that arise from our ability to obtain additional funding, protection of patents and property rights, uncertainties regarding our technologies, competition and technological change, government regulations including the need for product approvals, and attracting and retaining key officers and employees.
As of December 31, 2000, we have $5.8 million of working capital. In the past, we received significant revenues from royalties for Stadol NS. The patent on Stadol NS expires in August 2001. The amount of royalties we will continue to receive, if any, after the patent expiry is uncertain. This event, if it occurs, could adversely affect the recording of revenue and contribution to operations in the second half of year 2001. We expect to raise additional capital in fiscal 2001 to fund our operations. As discussed in note 12, we entered into a equity line of credit that will allow us to issue during a 3-year term up to 1.2 million shares of common stock to an investor that are discounted from the fair market value on the date of issuance. If we are unable to raise adequate working capital in 2001, we would be required to curtail or reduce our research and development efforts.
NOTE 2 -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND RELATED MATTERS
Principles of Consolidation
The financial statements include the accounts of Nastech Pharmaceutical Company Inc. and its wholly-owned subsidiary, Atossa HealthCare, Inc. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and temporary investments of highly-rated investment grade commercial paper with maturities of three months or less when purchased. At December 31, 2000 and 1999, cash equivalents totaled $6.3 million and $10.6 million, respectively.
Investments
Short-term investments consist of highly-rated investment grade commercial paper having original maturities greater than three months and up to one year. There were no material unrealized holding gains or losses at December 31, 1999.
Inventories
Inventories are stated at the lower of cost (first-in, first-out basis) or market and consist principally of raw materials.
Patents
The cost of acquired patents is capitalized and amortized over the remaining legal life of the patents at acquisition or their useful life, whichever is shorter. Legal costs and fees related to patent applications developed by us are charged to expense as incurred.
Property and Equipment
Property and equipment are carried at cost and depreciated using straight-line and accelerated methods over estimated useful lives ranging from 5 to 7 years. Leasehold improvements are carried at cost and amortized using the straight-line method over the lesser of the estimated useful life or the remaining lease term. When assets are sold or retired, the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in the period. Expenditures for maintenance and repairs are charged to expense as incurred.
Revenue Recognition
We have entered into various collaborative arrangements and licensing contracts with other pharmaceutical companies. Under these arrangements and contracts, we generally recognize income from royalties based upon the sale of licensed products as reported by licensees. Upfront payments are generally recognized over the term of the license agreements. We have not, however, received any upfront payments from licensees during the three years ended December 31, 2000. Milestone payments, which reduce the development risk associated with a product and are determinable based on the terms of the license agreement, are typically progress payments for specific events of development, such as completion of pre-clinical or clinical activities, regulatory submission or approval, or manufacturing objectives prior to commercialization of a product. Milestone payments are generally non-refundable and are recognized upon completion of a milestone activity. A substantial portion of our revenues are derived from licensing agreements with Bristol-Myers Squibb and Schwarz Pharma, Inc. Revenue from sale of Nascobal is recognized at the time of shipment.
On December 31, 1999, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements" (SAB No. 101). SAB No. 101 provides the SEC staff`s views on the recognition of revenue including non-refundable technology access fees received by biotechnology companies in connection with research collaborations with third parties. SAB No. 101 states that in certain circumstances the SEC staff believes that upfront fees, even if non-refundable, should be deferred and recognized systematically over the term of the research agreement. SAB No. 101B, which amends the implementation date for SAB No. 101, required registrants to adopt the accounting guidance contained therein by no later than the fourth fiscal quarter of the fiscal year beginning after December 15, 1999. There was no impact on our financial position or results of operations as a result of adopting the provisions of SAB No. 101.
Net Loss per Common Share
Basic and diluted net loss per common share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. The effect of employee stock options and warrants totaling 2,130,745, 1,239,512 and 1,054,750 at December 31, 2000, 1999 and 1998, respectively, were not included in the net loss per share calculation because their effect would have been anti-dilutive.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
Long-Lived Assets
We review our long-lived assets (property and equipment and goodwill) for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the expected cash flows, undiscounted and without interest, is less than the carrying amount of the asset, an impairment loss is recognized as the amount by which the carrying amount of the asset exceeds its fair value.
Stock-Based Compensation
We account for stock-based compensation using the intrinsic value method in accordance with APB No. 25, "Accounting for Stock Issued to Employees." Effective July 1, 1996, we adopted the disclosure requirements of SFAS No. 123, "Accounting for Stock-Based Compensation", which requires the disclosure of pro forma net income and earnings per share as if we adopted the fair value-based method in measuring compensation expense as of the beginning of fiscal 1996 (see Note 9).
Comprehensive Income
Effective January 1, 1998, we adopted SFAS No. 130, "Reporting Comprehensive Income." SFAS No. 130 requires that all items recognized under accounting standards as components of comprehensive income be reported in an annual financial statement that is displayed with the same prominence as other annual financial statements. Other comprehensive income may include foreign currency translation adjustments, minimum pension liability adjustments and unrealized gains and losses on marketable securities classified as available-for-sale. Our operations did not give rise to items includible in comprehensive income, which were not already included in net income. Accordingly, our comprehensive income is the same as our net income for all periods presented.
Fair Value Financial Instruments
We consider the fair value of all financial instruments to not be materially different from their carrying value at year-end as all financial instruments have short-term maturities.
Derivative Instruments and Hedging Activities
The Financial Accounting Standards Board issued Statement of Financial Accounting Standards (SFAS) No. 133, "Accounting for Derivative Instruments and Hedging Activities" as amended by SFAS 137 and SFAS 138, which will be adopted by us in the first quarter of fiscal 2001. SFAS 133 establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts and for hedging activities. It requires that an entity recognize all derivatives as either assets or liabilities in the balance sheet and measures those instruments at fair value. Implementation of this statement is not expected to have a material impact on our financial position or results of operations.
NOTE 3 -- PROPERTY AND EQUIPMENT
Property and equipment consist of the following:
DECEMBER 31,
2000 1999
------------ ------------
(In thousands)
Furniture and fixtures..................... $ 372 $ 335
Machinery and equipment.................... 2,243 2,027
Computer equipment......................... 392 316
Leasehold improvements..................... 2,252 1,988
-------- --------
5,259 4,666
Less accumulated depreciation
and amortization.......................... 1,694 986
-------- --------
Net property and equipment................. $ 3,565 $ 3,680
======== ========
NOTE 4 -- ACCRUED EXPENSES
Accrued expenses at December 31, 2000 and 1999 are comprised of (in thousands):
2000 1999
------------ --------------
Accrued payroll and employee benefits $ 211 $ 330
Deferred rent payable 263 184
Amount due to former shareholders (Note 5) 140 ---
Accrued expenses 347 337
---------- ------------
$ 961 $ 851
========== ============
NOTE 5 -- STOCKHOLDERS` EQUITY
In connection with a public offering of common stock in 1997, we issued to the representatives of the underwriters warrants to purchase in the aggregate up to 69,000 shares of Common Stock (the "Representatives` Warrants") at an exercise price per share equal to 120% of the public offering price per share. The Representatives` Warrants are exercisable for a period of four years commencing January 24, 1998. The holders of the Representatives` Warrants will have no voting, dividend or other stockholder rights until the Representatives` Warrants are exercised. We granted the representatives certain registration rights related to the Representatives` Warrants.
In connection with a public offering of common stock and warrants in 1994, underwriter`s warrants were exercised during 1998 resulting in proceeds to us of $1,403,000.
In July 1999, our shareholders approved a 1:100 reverse split of our common stock followed immediately by a 100:1 forward split. We effectuated these transactions on August 17, 1999. The purpose of these transactions is to enable a redemption of odd-lot shares and reduce certain annual administrative costs. As of December 31, 2000, we have redeemed 110,736 of such shares at a cost of $395,000 and subsequently retired these shares. We also acquired 77,000 shares of our common stock in 1999 at an aggregate cost of $151,000. These shares are being held as treasury stock.
We are authorized to issue up to 100,000 shares of preferred stock, the designations, powers, preferences and rights of which may be determined, from time to time, by our Board of Directors.
We have a stockholder rights plan designed to protect our stockholders from coercive or unfair takeover tactics. Under the plan, we declared a dividend of one preferred stock purchase right for each share of common stock outstanding on March 17, 2000. Each preferred stock purchase right entitles the holder to purchase from us 1/1000 of a share of Series A Junior Participating Preferred Stock for $50. In the event any acquiring entity or group accumulates or initiates a tender offer to purchase 15% or more of our common stock, then each holder of a preferred stock purchase right, other than the acquiring entity, will have the right to receive, upon exercise of the preferred stock purchase right, shares of our common stock or shares in the acquiring entity having a value equal to two times the exercise price of the preferred stock purchase right.
NOTE 6 -- STOCK OPTION PLAN
Under our stock option plans we are authorized to grant options to purchase a maximum of 2,500,000 shares of common stock (subject to adjustment in the event of stock splits, stock dividends, recapitalization and other capital adjustments) to our employees, officers and directors and other persons who provide us services. The options to be granted under the Plan are designated as either incentive stock options or non-incentive stock options by the Board of Directors which also has discretion as to the person to be granted options, the number of shares subject to the options and the terms of the option agreements. Only employees, including officers and part-time employees, may be granted incentive stock options.
The plans provide that options granted thereunder shall be exercisable during a period of no more than ten years (five years in the case of 10% shareholders) from the date of grant, depending upon the specific stock option agreement, and that, with respect to incentive stock options, the option exercise price shall be at least equal to 100% of the fair market value of the common stock at the time of grant (110% in the case of 10% shareholders). Pursuant to the provisions of the Incentive Stock Option Plan, the aggregate fair market value (determined on the date of grant) of the common stock with respect to which incentive stock options are exercisable for the first time by an employee during any calendar year shall not exceed $100,000. The plans are administered by our Board of Directors.
In August 1998, our Board of Directors approved a stock option exchange program in which it offered all holders the right to exchange their options for the same number of new options with a lower exercise price but with a modified term of vesting. All outstanding options (786,350) with an exercise price greater than $5.63 per share were eligible for this program and were exchanged during 1998. No charge was recorded to earnings as the new exercise price was in excess of the market value on the date of the exchange.
Data relating to these plans are as follows:
Year Ended Year Ended Year Ended
Dec. 31, 2000 Dec. 31, 1999 Dec. 31, 1998
------------------------- ------------------------- ------------------------
Weighted Weighted Weighted
Average Average Average
Exercise Exercise Exercise
Shares Price Shares Price Shares Price
-------------------------------------------------------------------------------
Outstanding at beginning of period 1,170,512 $4.84 985,750 $5.49 878,150 $10.47
Granted 1,163,300 6.79 429,050 3.29 903,650 5.91
Exercised (13,000) 3.37 (5,000) 3.72 (6,000) 7.73
Expired (103,000) 5.08 (25,000) 3.72 -- --
Canceled (135,000) 5.12 -- -- (786,350) 11.18
Terminated (70,567) 3.26 (214,288) 3.92 (3,700) 9.96
--------- --------- --------
Outstanding at end of period 2,012,245 6.00 1,170,512 4.84 985,750 5.49
========= ========= ========
The following table summarizes additional information on our stock options outstanding at December 31, 2000:
Options Outstanding Options Exercisable
-------------------------------------------------------------------------- -----------------------------------
Weighted-average Weighted- Weighted-average
Range of Number remaining average Number exercisable
exercise prices outstanding contractual life exercise price exercisable price
-------------------------------------------------------------------------- -----------------------------------
$ 1.94 - $ 3.63 173,450 3.20 $2.82 127,488 $2.16
$ 4.09 - $ 5.13 849,800 3.96 $4.40 310,000 $1.74
$ 5.50 - $ 8.75 688,995 2.70 $5.72 610,617 $4.99
$12.00 - $ 15.00 300,000 4.58 $13.00 --- ---
--------- -----------------
Totals 2,012,245 1,048,105
========= =================
NOTE 7 -- INCOME TAXES
Our net deferred tax assets as of December 31, 2000 and 1999, are estimated as follows (in thousands) :
2000 1999
Deferred tax assets:
Net operating loss carryforwards.................. $ 10,496 $ 7,798
Federal and State tax credits..................... 1,416 1,106
Depreciation...................................... 384 263
Other............................................. 249 131
-------- -------
Total deferred tax assets .................. $ 12,545 $ 9,298
Valuation allowance............................... (12,545) (9,298)
-------- -------
Net deferred taxes ............................... --- ---
======== =======
A valuation allowance for 2000 and 1999 has been applied to offset the
respective deferred tax assets in recognition of the uncertainty that such tax
benefits will be realized.
At December 31, 2000, we have available net operating loss carryforwards for Federal and State income tax reporting purposes of approximately $25,400,000, and have available Federal and State tax credits of approximately $1,400,000, which are available to offset future taxable income, if any. These carryforwards expire beginning in 2001 through 2020. Our ability to use such net operating loss and Federal and State tax credit carryforwards is limited by change of control provisions under Section 382 of the Internal Revenue Code.
NOTE 8 -- COMMITMENTS
(a) Employment Agreements and Accrued Compensation
Certain of our officers have employment agreements that provide base compensation and annual incentive compensation. Our Chief Executive Officer, Dr. Steven C. Quay, the founder of Atossa Healthcare, has an employment agreement expiring August 8, 2003, from which he receives base compensation of $300,000 per year, and annual incentive compensation of up to $50,000 based on the achievement of certain business objectives of the Company.
In connection with the employment agreement, Dr. Quay was issued 600,000 stock options at exercise prices at or above market, which vest over a three year period.
(b) Leases:
We lease space for our research and development activities under a lease expiring October 31, 2009 and lease office and manufacturing space under a lease expiring on June 30, 2005. The lease for the research and development facility has a 5 year renewal option. The following is a schedule of future minimum lease payments (in thousands):
2001....................................... $ 319
2002....................................... 333
2003....................................... 361
2004....................................... 391
2005....................................... 373
Thereafter................................. 1,478
--------
Total.............................. $ 3,255
========
Rental expense for the aforementioned spaces aggregated approximately $381,000, $418,000, and $173,000 for the years ended December 31, 2000, 1999 and 1998, respectively.
NOTE 9 -- CONTRACTUAL AGREEMENTS
In January 1986, we sublicensed to BMS our development and commercial exploitation rights with respect to our licensed patent rights for the nasal delivery of Butorphanol Tartrate, in exchange for which BMS agreed to pay us a royalty based on the net sales of such product (the "BMS Agreement"). We must pay a percentage of these royalties to the University of Kentucky Research Foundation ("UKRF") under our separate license agreement with UKRF. The BMS Agreement, which may be terminated by BMS at any time upon 60 days written notice to us, is concurrent with our licensed patent rights to nasal Butorphanol Tartrate. The nasal Butorphanol Tartrate patent expires in the year 2001 in the United States, subject to any right of extension or renewal. In December 1991, the FDA granted marketing clearance to BMS for this product, which is marketed by BMS as Stadol NS and quarterly royalty payments to us by BMS are continuing. During 1997, Stadol NS was classified by the FDA as a Schedule IV substance under the Controlled Substances Act which has negatively affected sales by BMS and royalties to us.
In July 1997, we exclusively licensed to Schwarz Pharma the right to market our Nascobal(R) (Cyanocobalamin, USP) Gel in the U.S. We retained worldwide manufacturing rights and the agreement provided for a fixed manufacturing transfer price to Schwarz Pharma. Pursuant to the agreement we will receive royalty payments from Schwarz Pharma based upon the net sales of Nascobal(R). The minimum royalty payment in 1998 was $2 million, and the royalty rate in each subsequent year is based in part, upon sales volume. The minimum royalty expired in December 1998. We also receive revenues from the sale of Nascobal to Schwarz Pharma. Aggregate sales and royalty payments amounted to $907,000 in 2000, $740,000 in 1999 and $2.5 million in 1998. The term of the agreement is for the later of 15 years or the expiration of the applicable patent which expires in 2005.
In December 1997, we exclusively licensed to Schwarz Pharma the right to market our intranasal scopolamine gel in the U.S. Under the terms of the agreement, we were to receive royalty and manufacturing payments from Schwarz Pharma. In addition, Schwarz Pharma made research milestone payments to us of $3,750,000 through December 1999 of which $750,000 and $3,000,000 was recognized in the years ended December 31, 1999 and 1998, respectively,
In December 1999, we reacquired the marketing rights to intranasal scopolamine from Schwarz Pharma. We made a payment of $250,000 to Schwarz Pharma, which has been reflected as research and development expense for the year ended December 31, 1999. We also agreed to pay one-half of any future consideration received from the sale or license of intranasal scopolamine until Schwarz Pharma receives payments totaling $3,500,000 plus an additional amount for interest that will accrue at a rate of 8.5% per annum beginning December 2000. As any payment to Schwarz Pharma is contingent on whether we will receive proceeds from the future sale or license of intranasal scopolamine, no liability has been recorded for this agreement as of December 31, 2000.
In September 1997, we entered into an agreement with Meda AB of Goteborg, Sweden ("Meda"), giving Meda the exclusive right to market Nascobal(R) in Sweden, Denmark, Norway and Finland. Pursuant to the agreement, we will receive revenue from the sale of Nascobal(R) to Meda and a license fee upon the occurrence of certain regulatory approvals and commercial events in the Nordic countries.
In July 1998, we entered into an agreement with Cambridge Laboratories ("Cambridge"), giving Cambridge the exclusive right to market Nascobal(R) in several European countries, Australia and New Zealand. Pursuant to the agreement, we will receive revenue from the sale of Nascobal(R) to Cambridge.
Our two largest customers accounted for 97%, 98% and 99% of total revenues, excluding interest, in 2000, 1999 and 1998 respectively. These revenues by customer were $3.1 million and $907,000 in 2000, $2.9 million and $1.5 million in 1999, and $5.5 million and $2.6 million in 1998. No other customer accounted for more than 10% of revenues, excluding interest.
NOTE 10 -- STOCK-BASED COMPENSATION
The per share weighted average fair value of stock options granted during the years ended December 31, 2000, 1999, and 1998 was $2.32, $1.50 and $3.82 respectively, on the date of grant using the Black Scholes option-pricing model with the following weighted-average assumptions:
YEAR ENDED YEAR ENDED YEAR ENDED
DEC. 31, 2000 DEC. 31, 1999 DEC. 31, 1998
------------- ------------- -------------
Expected dividend yield 0% 0% 0%
Risk free interest rate 5.0% 6.0% 4.75%
Expected stock volatility 71% 53% 63%
Expected option life 5 years 5 years 5 years
We apply APB Opinion No. 25 in accounting for our stock options and, accordingly, no compensation cost (except in 2000 with the amount of $34,000 for options granted below market value - See Note 13), has been recognized in the financial statements for our stock options which have an exercise price equal to the fair value of the stock on the date of the grant. Had we determined compensation cost based on the fair value at the grant date for our stock options under SFAS No. 123, our net loss would have been reported as the pro forma amounts indicated below:
YEAR ENDED YEAR ENDED YEAR ENDED
DEC. 31, 2000 DEC. 31, 1999 DEC. 31, 1998
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