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Management’s business plan can be outlined as follows: ● Complete enrollment and report preliminary results in the pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL; ● Initiate a Phase 3 clinical trial of oral BDP, known as SGX203, for the treatment of pediatric Crohn’s disease; ● Continue to collect the long-term follow-up safety data from the SGX942 Phase 2 proof-of-concept study in the treatment of oral mucositis in head and neck cancer patients and publish the findings from this study; ● Obtain FDA agreement on a pivotal Phase 2b/3 protocol of SGX942 in the treatment of oral mucositis in head and neck cancer patients; ● Continue development of RiVax™ in combination with ThermoVax® technology to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; ● Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; ● Acquire or in-license new clinical-stage compounds for development; and ● Explore other business development and merger/acquisition strategies. |
Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2015: ● In February 2015, the Company issued 701,786 shares of common stock in connection with the exercise of stock warrants; ● In March 2015, the Company issued 482,000 shares of common stock in connection with the exercise of stock warrants; ● In March 2015, the Company issued 153,010 shares of common stock pursuant to the Lincoln Park facility; ● In April 2015, the Company issued 356,786 shares of common stock in connection with the exercise of stock warrants; ● In April 2015, the Company issued 8,125 shares of common stock in connection with the exercise of stock options; ● In May 2015, the Company issued 76,364 shares of common stock pursuant to the Lincoln Park facility; ● In June 2015, the Company issued 384,237 shares of common stock pursuant to the Lincoln Park facility; ● In June 2015, the Company issued 198,714 shares of common stock in connection with the exercise of stock warrants; ● In July 2015, the Company issued 7,143 shares of common stock in connection with the exercise of stock warrants; ● In September 2015, the Company issued 609,535 shares of common stock pursuant to an Equity Line Purchase Agreement; ● In September 2015, the Company issued 25,000 shares of common stock in connection with the exercise of stock options; ● In October 2015, the Company issued 151,843 shares of common stock pursuant to the Lincoln Park facility; ● In November 2015, the Company issued 75,894 shares of common stock pursuant to the Lincoln Park facility; ● In December 2015, the Company issued 3,936,235 shares of common stock pursuant to an Equity Line Purchase Agreement; ● In nine separate transactions, the Company issued 166,282 fully vested shares of common stock as partial consideration for services performed. |
The following items represent transactions in the Company’s common stock for the year ended December 31, 2014: ● In January 2014, the Company issued 77,889 shares of common stock in connection with the cashless exercise of 250,000 stock warrants; ● In March 2014, the Company issued 76,932 shares of common stock pursuant to the Lincoln Park facility; ● In April 2014, the Company issued 76,907 shares of common stock pursuant to the Lincoln Park facility; ● In May 2014, the Company issued 43,067 shares of common stock upon the execution of an agreement to evaluate specific oncology technology; ● In May 2014, the Company issued 29,172 shares of common stock upon the exercise of vested stock options; ● In July 2014, the Company issued 76,904 shares of common stock pursuant to the Lincoln Park facility; ● In July 2014, the Company issued 7,500 shares of common stock upon the exercise of vested stock options; ● In August 2014, the Company issued 65,115 shares of common stock with the cashless exercise of 336,081 stock warrants; ● In September 2014, the Company issued 1,849,113 shares of common stock in connection with the Hy BioPharma Acquisition of in process research and development. |
An outline for our business strategy follows: ●Conduct a Phase 3 clinical trial for SGX301 for the treatment of CTCL; ●Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ●Initiate a Phase 3 clinical trial of oral BDP, known as SGX203, for the treatment of pediatric Crohn’s disease; ●Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis; ●Develop RiVax™ and VeloThrax™ in combination with our ThermoVax™ technology, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ●Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; ●Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; ●Acquire or in-license new clinical-stage compounds for development; and ●Explore other business development and merger/acquisition strategies, an example of which is our collaboration with Intrexon. |
Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere in this Annual Report and also include: ● our ability to obtain additional funding to develop our product candidates; ● delays in the commencement, enrollment and timing of clinical trials; ● the success of our product candidates through all phases of clinical development; ● any delays in regulatory review and approval of product candidates in clinical development; ● our ability to obtain and maintain regulatory approval for our product candidates in the United States and foreign jurisdictions; ● potential side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved drug, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market; ● our dependence on third-party contract manufacturing organizations (“CMOs”) to supply or manufacture our products; ● our dependence on contract research organizations to conduct our clinical trials; ● our ability to establish or maintain collaborations, licensing or other arrangements; ● market acceptance of our product candidates; ● our ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations; ● competition from existing products or new products that may emerge; ● the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our products; ● our ability to discover and develop additional product candidates; ● our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; ● our ability to attract and retain key personnel to manage our business effectively; ● our ability to build our finance infrastructure and improve our accounting systems and controls; ● potential product liability claims; ● potential liabilities associated with hazardous materials; and ● our ability to obtain and maintain adequate insurance policies. |
If any of our product candidates cause serious adverse events or undesirable side effects: ● regulatory authorities may impose a clinical hold which could result in substantial delays and adversely impact our ability to continue development of the product; ● regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies; ● we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; ● we may be required to implement a risk minimization action plan, which could result in substantial cost increases and have a negative impact on our ability to commercialize the product; ● we may be required to limit the patients who can receive the product; ● we may be subject to limitations on how we promote the product; ● sales of the product may decrease significantly; ● regulatory authorities may require us to take our approved product off the market; ● we may be subject to litigation or product liability claims; and ● our reputation may suffer. |
An outline of our business strategy follows: ● Conduct a Phase 3 clinical trial of SGX301 for the treatment of CTCL; ● Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ● Conduct a Phase 3 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; ● Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute radiation enteritis; ● Develop RiVax™ and VeloThrax™ in combination with our ThermoVax™ technology to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; ● Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; ● Acquire or in-license new clinical-stage compounds for development; and ● Explore other business development and merger/acquisition strategies, an example of which is our collaboration with Intrexon. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: ●pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; ●provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and ●provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
The Schedule 13D indicates that (a) Mr. Cavazza has sole voting and dispositive power with respect to (i) 59,539 shares held by Mr. Paolo Cavazza and (ii) 164,146 shares of common stock and warrants to purchase 87,804 shares held by SINAF SA, and (b) Mr. Cavazza, Sigma-Tau Finanziaria S.p.A., Sigma-Tau International S.A., Sigma-Tau America S.A. and Sigma-Tau Pharmaceuticals, Inc. have shared voting and dispositive power with respect to 2,711,392 shares of common stock and warrants to purchase 357,069 shares of common stock exercisable within 60 days of the date of March 17, 2015 held by Sigma-Tau Pharmaceuticals, Inc. Sigma-Tau Pharmaceuticals, Inc. is a direct wholly-owned subsidiary of Sigma-Tau America S.A., which is a direct wholly-owned subsidiary of Sigma-Tau International S.A., which is a direct wholly-owned subsidiary of Sigma-Tau Finanziaria S.p.A. Mr. Paolo Cavazza directly and indirectly owns 38% of Sigma-Tau Finanziaria S.p.A. SINAF SA is an indirect wholly owned subsidiary of Aptafin S.p.A., which is owned by Mr. Paolo Cavazza and members of his family. |
Management’s business strategy can be outlined as follows: ●Conduct a Phase 3 clinical trial of SGX301 for the treatment of CTCL; ●Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ●Conduct a Phase 3 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; ●Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic GI GVHD; ●Develop RiVax™ and VeloThrax™ in combination with its proprietary vaccine heat stabilization technology known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ●Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; ●Continue to apply for and secure additional government funding for each of its BioTherapeutics and Vaccine/BioDefense programs through grants, contracts and/or procurements; ●Acquire or in-license new clinical-stage compounds for development; and ●Explore other business development and merger/acquisition strategies an example of which is the collaboration with Intrexon. |
Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2014: ●In January 2014, the Company issued 77,889 shares of common stock in connection with the cashless exercise of 250,000 stock warrants; ●In March 2014, the Company issued 76,932 shares of common stock pursuant to the Lincoln Park facility; ●In April 2014, the Company issued 76,907 shares of common stock pursuant to the Lincoln Park facility; ●In May 2014, the Company issued 43,067 shares of common stock upon the execution of an agreement to evaluate specific oncology technology; ●In May 2014, the Company issued 29,172 shares of common stock upon the exercise of vested stock options; ●In July 2014, the Company issued 76,904 shares of common stock pursuant to the Lincoln Park facility; ●In July 2014, the Company issued 7,500 shares of common stock upon the exercise of vested stock options; ●In August 2014, the Company issued 65,115 shares of common stock with the cashless exercise of 336,081 stock warrants; ●In September 2014, the Company issued 1,849,113 shares of common stock in connection with the Hy BioPharma Acquisition of in process research and development. |
An outline for our business strategy follows: · Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; · Initiate a Phase 2/3 clinical trial of oral BDP, known as SGX203, for the treatment of pediatric Crohn’s disease; · Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis, and treatment of chronic graft-versus-host disease (“GI GVHD”); · Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; · Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; · Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; · Acquire or in-license new clinical-stage compounds for development · Explore other business development and merger/acquisition strategies, an example of which is our collaboration with Intrexon. |
Our Products in Development The following tables summarize the products that we are currently developing: BioTherapeutic Products Soligenix Product Therapeutic Indication Stage of Development SGX942 Oral Mucositis in Head and Neck Cancer IND clearance and Phase 2 trial initiated in the second half of 2013, with data expected in the second half of 2014 SGX203 Pediatric Crohn’s disease Phase 1/2 clinical trial completed June 2013, data pharmacokinetic (PK)/pharmacodynamic (PD) profile and safety confirmed; Phase 2/3 clinical trial planned for the second half of 2014, with data expected in the second half of 2015 SGX201 Acute Radiation Enteritis Phase 1/2 clinical trial complete; safety and preliminary efficacy demonstrated; Phase 2 trial planned for the second half of 2014, with data expected in the second half of 2015 orBec® Treatment of Chronic GI GVHD Phase 2 trial initiated in the second half of 2013, with data expected in the second half of 2014 Vaccine Thermostability Platform Soligenix Product Indication Stage of Development ThermoVax™ Thermostability of aluminum adjuvanted vaccines Pre-clinical BioDefense Products Soligenix Product Indication Stage of Development RiVax™ Vaccine against Ricin Toxin Poisoning Phase 1B trial complete; safety and neutralizing antibodies for protection demonstrated; Phase 2 trial planned for the first half of 2015 VeloThrax™ Vaccine against Anthrax Poisoning Pre-clinical; Phase 1 clinical trial planned for second half of 2015 OrbeShield™ Therapeutic against GI ARS Pre-clinical program initiated SGX943/SGX101 Melioidosis Pre-clinical BioTherapeutics Overview SGX94 In December 2012, we acquired a drug technology, we refer to as SGX94, representing what we believe is a novel approach to modulation of the innate immune system. |
An outline of our business strategy follows: · Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; · Initiate a Phase 2/3 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; · Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic graft-versus-host disease (“GVHD”); · Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; · Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GI ARS; · Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; · Acquire or in-license new clinical-stage compounds for development; and · Explore other business development and merger/acquisition strategies, an example of which is our collaboration with Intrexon. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: · pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; · provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and · provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
The Schedule 13D indicates that (a) Mr. Cavazza has sole voting and dispositive power with respect to (i) 59,539 shares held by Mr. Paolo Cavazza and (ii) 164,146 shares of common stock and warrants to purchase 87,804 shares held by SINAF SA, and (b) Mr. Cavazza, Sigma-Tau Finanziaria S.p.A., Sigma-Tau International S.A., Sigma-Tau America S.A. and Sigma-Tau Pharmaceuticals, Inc. have shared voting and dispositive power with respect to 2,711,392 shares of common stock and warrants to purchase 357,069 shares of common stock exercisable within 60 days of the date of this prospectus held by Sigma-Tau Pharmaceuticals, Inc. Sigma-Tau Pharmaceuticals, Inc. is a direct wholly-owned subsidiary of Sigma-Tau America S.A., which is a direct wholly-owned subsidiary of Sigma-Tau International S.A., which is a direct wholly-owned subsidiary of Sigma-Tau Finanziaria S.p.A. Mr. Paolo Cavazza directly and indirectly owns 38% of Sigma-Tau Finanziaria S.p.A. SINAF SA is an indirect wholly owned subsidiary of Aptafin S.p.A., which is owned by Mr. Paolo Cavazza and members of his family. |
Management’s business plan can be outlined as follows: · Conduct a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; · Initiate Phase 2/3 clinical trial of oral BDP, known as SGX203, for the treatment of pediatric Crohn’s disease; · Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic GVHD; · Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; · Advance the preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasure for the treatment of GIARS; · Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; · Acquire or in-license new clinical-stage compounds for development; and · Explore other business development and merger/acquisition strategies, an example of which is our collaboration with Intrexon. |
An outline for our business strategy follows: ● Initiate a Phase 1/2 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; ● Initiate a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ● Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic graft-versus-host disease (“GVHD”); ● Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; and ● Explore other business development and merger/acquisition strategies. |
Our Products in Development The following tables summarize the products that we are currently developing: BioTherapeutic Products Soligenix Product Therapeutic Indication Stage of Development SGX942 Oral Mucositis in Head and Neck Cancer IND clearance and Phase 2 trial planned SGX203 Pediatric Crohn’s disease Phase 1/2 clinical trial planned SGX201 Acute Radiation Enteritis Phase 1/2 clinical trial complete; safety and preliminary efficacy demonstrated orBec® Treatment of Chronic GI GVHD Phase 2 trial planned Vaccine Thermostability Platform Soligenix Product Indication Stage of Development ThermoVax™ Thermostability of aluminum adjuvanted vaccines Pre-clinical BioDefense Products Soligenix Product Indication Stage of Development RiVax™ Vaccine against Ricin Toxin Poisoning Phase 1B trial complete; safety and neutralizing antibodies for protection demonstrated VeloThrax™ Vaccine against Anthrax Poisoning Pre-clinical OrbeShield™ Therapeutic against GI ARS Follow-on pre-clinical study initiated; Initial pre-clinical study complete; successful protection in canines BioTherapeutics Overview SGX94 In December 2012, we acquired a novel drug technology, we refer to as SGX94, representing a unique approach to modulation of the innate immune system. |
An outline of our business strategy follows: ● Initiate a Phase 1/2 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; ● Initiate a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ● Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic graft-versus-host disease (“GVHD”); ● Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; and ● Explore other business development and merger/acquisition strategies. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: ● pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; ● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and ● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
Management’s business plan can be outlined as follows: ● Initiate a Phase 1/2 clinical trial of oral BDP, known as SGX203 for the treatment of pediatric Crohn’s disease; ● Initiate a Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer; ● Evaluate the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the GI tract such as prevention of acute radiation enteritis, prevention of acute radiation syndrome, and treatment of chronic GVHD; ● Develop RiVax™ and VeloThrax™ in combination with our proprietary vaccine heat stabilization technology, known as ThermoVax™, to develop new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● Continue to apply for and secure additional government funding for each of our BioTherapeutics and Vaccines/BioDefense programs through grants, contracts and/or procurements; and ● Explore other business development and merger/acquisition strategies. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: ▪ pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; ▪ provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and ▪ provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
Name Capacity Date /s/ Christopher J. Schaber Chairman of the Board, Chief Executive Officer March 27, 2012 Christopher J. Schaber, PhD and President (principal executive officer) /s/ Keith L. Brownlie Director March 27, 2012 Keith L. Brownlie, CPA /s/ Tamar D. Howson Director March 27, 2012 Tamar D. Howson /s/ Gregg A. Lapointe Director March 27, 2012 Gregg A. Lapointe, CPA /s/ Evan Myrianthopoulos Director March 27, 2012 Evan Myrianthopoulos /s/ Robert J. Rubin Director March 27, 2012 Robert J. Rubin, MD /s/ Virgil D. Thompson Director March 27, 2012 Virgil D. Thompson /s/ Jerome Zeldis Director March 27, 2012 Jerome Zeldis, MD, PhD /s/ Joseph M. Warusz Vice President of Finance, Acting Chief Financial Officer March 27, 2012 Joseph M. Warusz, CPA and Corporate Secretary (principal accounting officer) SOLIGENIX, INC. AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS Soligenix, Inc. and Subsidiaries Consolidated Balance Sheets As of December 31, (1) Adjusted to reflect the reverse stock split of 1-for-20 effective February 1, 2012. |
Our business strategy can be outlined as follows: ● complete the confirmatory Phase 3 clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); ● identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau to commercialize orBec® in the U.S., Canada and Mexico; ● complete the Phase1/2 clinical trial for SGX201 (oral BDP) in the prevention of acute radiation enteritis; ● evaluate and/or initiate additional trials to explore the effectiveness of orBec®/oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute GVHD, treatment of chronic GVHD, radiation injury, and Crohn’s disease; ● continue to secure additional government funding for each of our BioDefense programs through grants, contracts and/or procurements; ● use RiVaxTM to support development efforts with our heat stabilization technology into the development of new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● acquire or in-license new clinical-stage compounds for development; and ● explore other business development and acquisition strategies. |
Our business strategy can be outlined as follows: ● complete the confirmatory Phase 3 clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); ● identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau to commercialize orBec® in the U.S., Canada and Mexico; ● complete the Phase 1/2 clinical trial for SGX201 (oral BDP) in the prevention of acute radiation enteritis; ● evaluate and/or initiate additional trials to explore the effectiveness of orBec®/oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute GVHD, treatment of chronic GVHD, radiation injury, and Crohn’s disease; ● continue to secure additional government funding for each of our BioDefense programs through grants, contracts and/or procurements; ● use RiVaxTM to support development efforts with our heat stabilization technology into the development of new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● acquire or in-license new clinical-stage compounds for development; and ● explore other business development and acquisition strategies. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: ● pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; ● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and ● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
Management’s business strategy can be outlined as follows: ● complete the confirmatory Phase 3 clinical trial for orBec® in the treatment of acute gastrointestinal GI GVHD; ● identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau to commercialize orBec® in the U.S., Canada and Mexico; ● complete the Phase 1/2 clinical trial for SGX201 (oral BDP) in the prevention of acute radiation enteritis; ● evaluate and/or initiate additional trials to explore the effectiveness of orBec®/oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as prevention of acute GVHD, treatment of chronic GVHD, radiation injury, and Crohn’s disease; ● continue to secure additional government funding for each of our BioTherapeutics and BioDefense programs through grants, contracts and/or procurements; ● use RiVaxTM to support development efforts with our heat stabilization technology into the development of new heat stable vaccines in biodefense and infectious diseases with the potential to collaborate and/or partner with other companies in these areas; ● acquire or in-license new clinical-stage compounds for development; and ● explore other business development and acquisition strategies. |
Our business activities can be outlined as follows: · complete the pivotal Phase 3 confirmatory clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); · identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau Pharmaceuticals, Inc. to commercialize orBec® in the U.S., Canada and Mexico; · conduct and complete a Phase 2 clinical trial of orBec® for the prevention of acute GVHD; · evaluate and initiate additional clinical trials to explore the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal tract such as radiation enteritis, radiation injury and Crohn’s disease; · reinitiate development of our other biotherapeutics products, including LPMTM Leuprolide; · continue to secure additional government funding for each of our BioDefense programs through grants, contracts and procurements; · convert our biodefense vaccine programs from early stage development to advanced development and manufacturing with the potential to collaborate and/or partner with other companies in the biodefense area; · make orBec® available worldwide through the Named Patient Access Program for the treatment of acute GI GVHD; · acquire or in-license new clinical-stage compounds for development; and · explore other business development and acquisition strategies. |
Our business activities can be outlined as follows: · complete the pivotal Phase 3 confirmatory clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease ("GI GVHD") ; · identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau") to commercialize orBec® in the U.S., Canada and Mexico; · conduct and complete a Phase 2 clinical trial of orBec® for the prevention of acute GVHD; · evaluate and initiate additional clinical trials to explore the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal tract such as radiation enteritis, radiation injury and Crohn’s disease; · reinitiate development of our other biotherapeutics products, including LPMTM Leuprolide; · continue to secure additional government funding for each of our BioDefense programs through grants, contracts and procurements; · convert our biodefense vaccine programs from early stage development to advanced development and manufacturing with the potential to collaborate and/or partner with other companies in the biodefense area; · make orBec® available worldwide through the Named Patient Access Program for the treatment of acute GI GVHD; · acquire or in-license new clinical-stage compounds for development; and · explore other business development and acquisition strategies. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; • provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
Management’s business activities can be outlined as follows: · complete the pivotal Phase 3 confirmatory clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); · identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau") to commercialize orBec® in the U.S., Canada and Mexico; · conduct and complete a Phase 2 clinical trial of orBec® for the prevention of acute GVHD; · evaluate and initiate additional clinical trials to explore the effectiveness of oral BDP in other therapeutic indications involving inflammatory conditions of the gastrointestinal tract such as radiation enteritis, radiation injury and Crohn’s disease; · reinitiate development of our other biotherapeutics products, including LPMTM Leuprolide; · continue to secure additional government funding for each of our BioDefense programs through grants, contracts and procurements; · convert our biodefense vaccine programs from early stage development to advanced development and manufacturing with the potential to collaborate and/or partner with other companies in the biodefense area; · make orBec® available worldwide through the Named Patient Access Program for the treatment of acute GI GVHD; · acquire or in-license new clinical-stage compounds for development; and · explore other business development and acquisition strategies. |
Our business strategy is to: (a) initiate and execute the pivotal Phase 3 confirmatory clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); (b) identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau Pharmaceuticals, Inc. (“Sigma-Tau”) to commercialize orBec® in the U.S., Canada and Mexico, we will be paid a 35% royalty on net sales in these territories by Sigma-Tau and they will be responsible for the expense associated with all launch preparation and post-approval sales and marketing activities; (c) conduct a Phase 2 clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (“GVHD”); (d) evaluate and initiate additional clinical trials to explore the effectiveness of oral beclomethasone dipropionate (oral “BDP”) in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as radiation enteritis, radiation injury and Crohn’s disease; (e) make orBec® available worldwide through named patient access programs (“NPAP”) for the treatment of acute GI GVHD; (f) reinitiate development of our other biotherapeutics products, namely LPMTM Leuprolide; (g) continue to secure additional government funding for each of our biodefense programs, RiVaxTM and BT-VACCTM, through grants, contracts and procurements; (h) convert our biodefense vaccine programs from early stage development to advanced development and manufacturing with the potential to collaborate and/or partner with other companies in the biodefense area; (i) acquire or in-license new clinical-stage compounds for development; and (j) explore other business development and acquisition strategies under which we may be considered to be an attractive acquisition candidate by another company. |
Our business strategy is to: (a) initiate and execute the pivotal Phase 3 confirmatory clinical trial for orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”); (b) identify a development and marketing partner for orBec® for territories outside of North America, as we have granted an exclusive license to Sigma-Tau Pharmaceuticals, Inc. (“Sigma-Tau”) to commercialize orBec® in the U.S., Canada and Mexico, Sigma-Tau will pay us a 35% royalty on net sales in these territories and they will be responsible for the expense associated with all launch preparation and post-approval sales and marketing activities; (c) conduct a Phase 2 clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (“GVHD”); (d) evaluate and initiate additional clinical trials to explore the effectiveness of oral beclomethasone dipropionate (oral “BDP”) in other therapeutic indications involving inflammatory conditions of the gastrointestinal (“GI”) tract such as radiation enteritis, radiation injury and Crohn’s disease; (e) make orBec® available worldwide through named patient access programs (“NPAP”) for the treatment of acute GI GVHD; (f) reinitiate development of our other biotherapeutics products, namely LPMTM Leuprolide; (g) continue to secure additional government funding for each of our biodefense programs, RiVaxTM and BT-VACCTM, through grants, contracts and procurements; (h) convert our biodefense vaccine programs from early stage development to advanced development and manufacturing with the potential to collaborate and/or partner with other companies in the biodefense area; (i) acquire or in-license new clinical-stage compounds for development; and (j) explore other business development and acquisition strategies under which we may be considered to be an attractive acquisition candidate by another company. |
Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by the Company’s Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; • provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
Our ability to implement this strategy depends, among other things, on our ability to: · enter into distribution and other strategic arrangements with third-party retailers and other potential distributors of our products; · compete successfully in the product categories in which we choose to operate; · introduce timely, new, cost-effective, and appealing products and innovate successfully within our existing product categories; · develop and maintain consumer interest in and demand for our brands considering prevailing consumer tastes and preferences; · increase our brand recognition and loyalty; · enter into strategic arrangements with third-party suppliers to obtain necessary raw materials; · identify suitable acquisition candidates or joint venture partners and accurately assess their value, growth potential, strengths, weaknesses, contingent and other liabilities, and potential profitability; · negotiate acquisitions and joint ventures on terms acceptable to us; and · integrate acquired brands, products, or joint ventures into our company and our business strategy. |
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Report of Independent Registered Accounting Firm Consolidated Balance Sheets as of December 31, 2020 and 2019 Consolidated Statements of Operations for the Years Ended December 31, 2020 and 2019 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2020 and 2019 Consolidated Statements of Cash Flows for the Years Ended December 31, 2020 and 2019 Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Lifeway Foods, Inc. and Subsidiaries: Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Lifeway Foods, Inc. and Subsidiaries (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2020, and the related notes (collectively referred to as the “financial statements”). |
We have served as the Company's auditor since 2015 Chicago, Illinois March 25 2021 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2020 and 2019 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Operations For the Years Ended December 31, 2020 and 2019 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders’ Equity For the Years Ended December 31, 2020 and 2019 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2020 and 2019 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2020 and 2019 (In thousands) Note 1 - Basis of presentation The accompanying consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. |
Our ability to implement this strategy depends, among other things, on our ability to: · enter into distribution and other strategic arrangements with third-party retailers and other potential distributors of our products; · compete successfully in the product categories in which we choose to operate; · introduce timely, new, cost-effective, and appealing products and innovate successfully within our existing product categories; · develop and maintain consumer interest in and demand for our brands considering prevailing consumer tastes and preferences; · increase our brand recognition and loyalty; · enter into strategic arrangements with third-party suppliers to obtain necessary raw materials; · identify suitable acquisition candidates or joint venture partners and accurately assess their value, growth potential, strengths, weaknesses, contingent and other liabilities, and potential profitability; · negotiate acquisitions and joint ventures on terms acceptable to us; and · integrate acquired brands, products, or joint ventures into our company and our business strategy. |
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Reports of Independent Registered Accounting Firm Consolidated Balance Sheets as of December 31, 2019 and 2018 Consolidated Statements of Operations for the Years Ended December 31, 2019 and 2018 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2019 and 2018 Consolidated Statements of Cash Flows for the Years Ended December 31, 2019 and 2018 Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Lifeway Foods, Inc. and Subsidiaries: Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Lifeway Foods, Inc. and Subsidiaries (the “Company”) as of December 31, 2019 and 2018, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2019, and the related notes (collectively referred to as the “financial statements”). |
Chicago, Illinois April 14, 2020 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2019 and 2018 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Operations For the Years Ended December 31, 2019 and 2018 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders’ Equity For the Years Ended December 31, 2019 and 2018 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2019 and 2018 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2019 and 2018 (In thousands) Note 1 - Basis of presentation The accompanying consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. |
Our ability to implement this strategy depends, among other things, on our ability to: · enter into distribution and other strategic arrangements with third-party retailers and other potential distributors of our products; · compete successfully in the product categories in which we choose to operate; · introduce timely, new, cost-effective, and appealing products and innovate successfully within our existing product categories; · develop and maintain consumer interest in and demand for our brands considering prevailing consumer tastes and preferences; · increase our brand recognition and loyalty; · enter into strategic arrangements with third-party suppliers to obtain necessary raw materials; · identify suitable acquisition candidates or joint venture partners and accurately assess their value, growth potential, strengths, weaknesses, contingent and other liabilities, and potential profitability; · negotiate acquisitions and joint ventures on terms acceptable to us; and · integrate acquired brands, products, or joint ventures into our company and our business strategy. |
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Reports of Independent Registered Accounting Firm Consolidated Balance Sheets as of December 31, 2018 and 2017 Consolidated Statements of Operations for the Years ended December 31, 2018 and 2017 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2018 and 2017 Consolidated Statements of Cash Flows for the Years Ended December 31, 2018 and 2017 Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Lifeway Foods, Inc. and Subsidiaries: Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Lifeway Foods, Inc. and Subsidiaries (the “Company”) as of December 31, 2018 and 2017, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2018, and the related notes (collectively referred to as the “financial statements”). |
Chicago, Illinois April 16, 2019 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2018 and 2017 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Operations For the Years Ended December 31, 2018 and 2017 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders’ Equity For the Years Ended December 31, 2018 and 2017 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2018 and 2017 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2018 and 2017 (In thousands) Note 1 - Basis of presentation The accompanying consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. |
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Reports of Independent Registered Accounting Firm Consolidated Balance Sheets as of December 31, 2017 and 2016 Consolidated Statements of Income (Loss) and Comprehensive Income (Loss) for the Years ended December 31, 2017 and 2016 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2017 and 2016 Consolidated Statements of Cash Flows for the Years Ended December 31, 2017 and 2016 Notes to Consolidated Financial Statements REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM The Board of Directors and Stockholders of Lifeway Foods, Inc. and Subsidiaries Morton Grove, Illinois We have audited the accompanying consolidated balance sheets of Lifeway Foods, Inc. and Subsidiaries (the “Company”) as of December 31, 2017 and 2016, and the related consolidated statements of income (loss) and comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2017, and the related notes (collectively referred to as the “financial statements”). |
Chicago, Illinois March 30, 2018 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2017 and 2016 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income (Loss) and Comprehensive Income (Loss) December 31, 2017 and 2016 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders’ Equity For the Years Ended December 31, 2017 and (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2017 and (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2017 and 2016 (In thousands) Note 1 - Basis of presentation The accompanying consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. |
Chicago, Illinois April 7, 2017 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2016 and 2015 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income December 31, 2016 and 2015 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders' Equity For the Years Ended December 31, 2016 and (In thousands, except share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2016 and (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2016 and 2015 (In thousands) Note 1 - Basis of presentation The accompanying consolidated financial statements and accompanying notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. |
During the fiscal years ended December 31, 2014 and 2013 through September 12, 2015 neither the Company nor anyone acting on the Company's behalf consulted with MHM in any capacity, nor consulted with any member of that firm, as to the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered as to the consolidated financial statements, nor was a written report or oral advice rendered that was an important factor considered by the Company or any of its employees in reaching a decision as to an accounting, auditing or financial reporting issue, or any matter that was either the subject of a disagreement, as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto, or a reportable event within the meaning set forth in Item 304(a)(1)(v) of Regulation S-K. On August 20, 2015, the Company was notified by its independent registered public accounting firm, Crowe Horwath LLP ("Crowe") that it would not stand for reappointment as the Company's independent registered public accounting firm for 2015. |
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2015 and 2014 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income December 31, 2015, 2014 and 2013 (In thousands, except per share data) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Stockholders' Equity For the Years Ended December 31, 2015, 2014 and 2013 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2015, 2014 and 2013 (In thousands) See accompanying notes to consolidated financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2015, 2014 and 2013 (In thousands) Note 1 - Basis of presentation and out of period adjustments Our Consolidated Financial Statements include the accounts of Lifeway Foods, Inc. and all of its wholly owned subsidiaries (collectively "Lifeway" or the "Company"). |
During the fiscal years ended December 31, 2014 and 2013 through September 12, 2015 neither the Company nor anyone acting on the Company's behalf consulted with MHM in any capacity, nor consulted with any member of that firm, as to the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered as to the consolidated financial statements, nor was a written report or oral advice rendered that was an important factor considered by the Company or any of its employees in reaching a decision as to an accounting, auditing or financial reporting issue, or any matter that was either the subject of a disagreement, as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto, or a reportable event within the meaning set forth in Item 304(a)(1)(v) of Regulation S-K. On August 20, 2015, the Company was notified by its independent registered public accounting firm, Crowe Horwath LLP ("Crowe") that it would not stand for reappointment as the Company's independent registered public accounting firm for 2015. |
Date: March 15, 2016 By: /s/ John P. Waldron John P. Waldron Chief Financial Officer KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
- 27 - LIFEWAY FOODS, INC. Reports of Independent Registered Public Accounting Firms Consolidated Statements of Financial Condition for the Years Ended December 31, 2014 and 2013 Consolidated Statements of Income and Comprehensive Income for the Years Ended December 31, 2014, 2013 and 2012 Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2014, 2013 and 2012 Consolidated Statements of Cash Flows for the Years Ended December 31, 2014, 2013 and 2012 Notes to Consolidated Financial Statements December 31, 2014, 2013 and 2012 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM The Board of Directors and Stockholders of Lifeway Foods, Inc. and Subsidiaries Morton Grove, Illinois We have audited the accompanying consolidated statement of financial condition of Lifeway Foods, Inc. and Subsidiaries (the “Company”) as of December 31, 2014 and the related consolidated statements of income and comprehensive income, changes in stockholders’ equity, and cash flows for the year then ended. |
/s/ Crowe Horwath LLP Oak Brook, Illinois August 13, 2015 LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Financial Condition December 31, 2014 and 2013 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income December 31, 2014, 2013 and 2012 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders’ Equity For the Years Ended December 31, 2014, 2013 and 2012 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2014, 2013 and 2012 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2014, 2013 and 2012 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (the “Company” or “Lifeway”), an Illinois corporation, commenced operations in February 1986, and was incorporated under the laws of the State of Illinois on May 19, 1986. |
Pursuant to the charter, the Compensation Committee is responsible for, among other things: ● reviewing the Company’s overall compensation philosophy and strategy; ● evaluating and determining the compensation of the Chief Executive Officer; ● evaluating and setting, in conjunction with the Chief Executive Officer, the compensation of other officers; ● reviewing and approving the annual Compensation Discussion and Analysis; ● evaluating and approving the components and amounts of compensation of the Company’s employees; ● evaluating, considering and approving, in its discretion, grants and awards made under the Company’s equity-based compensation plans, if any, subject to any limitations prescribed by the Board and subject to any authority delegated by the Committee to the subcommittee described below; ● evaluating, considering and approving, in its discretion, compensation for non-employee members of the Board of Directors; and ● managing and controlling the operation and administration of the Company’s equity incentive plans. |
Date: August 13, 2015 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer, Treasurer, Chief Operating Officer and Secretary KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
Date: April 1, 2014 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer, Treasurer, Chief Operating Officer and Secretary KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
Date: April 1, 2013 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer, Treasurer, Chief Operating Officer and Secretary KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
/s/ Plante & Moran, PLLC Chicago, IL March 30, 2012 - 14 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Financial Condition December 31, 2011 and 2010 See accompanying notes to financial statements - 15 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income For the Years Ended December 31, 2011 and 2010 See accompanying notes to financial statements - 16 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders' Equity For the Years Ended December 31, 2011 and 2010 See accompanying notes to financial statements - 17 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2011 and 2010 See accompanying notes to financial statements - 18 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2011 and 2010 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (the “Company” or “Lifeway”) commenced operations in February 1986 and incorporated under the laws of the state of Illinois on May 19, 1986. |
Date: March 30, 2012 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer and Treasurer KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
/s/ Plante & Moran, PLLC Grand Rapids, MI March 31, 2011 - 21 - LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2010 and 2009 - 22 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Financial Condition December 31, 2010 and 2009 See accompanying notes to financial statements - 23 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income For the Years Ended December 31, 2010 and 2009 See accompanying notes to financial statements - 24 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders' Equity For the Years Ended December 31, 2010 and 2009 See accompanying notes to financial statements - 25 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2010 and 2009 See accompanying notes to financial statements - 26 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2010 and 2009 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (The “Company”) commenced operations in February 1986 and incorporated under the laws of the state of Illinois on May 19, 1986. |
Date: March 31, 2011 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer and Treasurer KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
Plante & Moran, PLLC Grand Rapids, MI March 31, - 22 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Financial Condition December 31, 2009 and 2008 See accompanying notes to financial statements - 23 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income For the Years Ended December 31, 2009 and 2008 See accompanying notes to financial statements - 24 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders' Equity For the Years Ended December 31, 2009 and 2008 See accompanying notes to financial statements - 25 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2009 and 2008 See accompanying notes to financial statements - 26 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2009 and 2008 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (the “Company”) commenced operations in February 1986 and incorporated under the laws of the state of Illinois on May 19, 1986. |
- 34 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2009 and 2008 Note 8 - ACCRUED EXPENSES Accrued expenses consist of the following: Note 9 - NOTES PAYABLE Notes payable consist of the following: - 35 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2009 and 2008 Note 9 - NOTES PAYABLE - Continued Maturities of notes payables are as follows: Note 10 - PROVISION FOR INCOME TAXES The provision for income taxes consists of the following: A reconciliation of the provision for income taxes and the income tax computed at the statutory rate is as follows: - 36 - LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2009 and 2008 Note 10 - PROVISION FOR INCOME TAXES - Continued Amounts for deferred tax assets and liabilities are as follows: Note 11 - SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for interest and income taxes are as follows: Note 12 - STOCK AWARD AND STOCK OPTION PLANS The Company has a registration statement filed with the Securities and Exchange Commission in connection with a Consulting Service Compensation Plan covering up to 1,200,000 of the Company’s common stock shares. |
Date: March 31, 2010 By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer and Treasurer KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
PURCHASES OF THE COMPANY’S SECURITIES Period (a) Total Numbers of Shares (or Units) Purchased (b) Average Price Paid per Share (or Unit) (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs January 1, 2008 to January 31, 2008* 3,000 $ 9.53 3,000 97,000 February 1, 2008 to February 28, 2008 * 15,800 10.12 15,800 81,200 March 1, 2008 to March 31, 2008* 18,200 9.59 18,200 63,000 April 1, 2008 to April 31, 2008* 21,745 12.80 21,745 41,255 May 1, 2008 to May 31, 2008* 24,418 12.47 24,418 16,837 June 1, 2008 to June 30, 2008* 7,656 12.12 7,656 9,181 July 1, 2008 to July 30, 2008* 9,181 11.03 9,181 *Total 100,000 $ 11.09 100,000 December 1, 2008 to December 31, 2008** 12,009 $ 8.22 12,009 87,991 **Total 12,009 $ 8.22 12,009 87,991 * Pursuant to the share repurchase program approved on December 17, 2007 for 100,000 split adjusted shares with a plan expiration date of one year. |
Plante & Moran, PLLC Grand Rapids, MI March 31, LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Financial Condition December 31, 2008 and 2007 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Income and Comprehensive Income For the Years Ended December 31, 2008 and 2007 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders’ Equity For the Years Ended December 31, 2008 and 2007 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Years Ended December 31, 2008 and 2007 See accompanying notes to financial statements LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2008 and 2007 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (The “Company”) commenced operations in February 1986 and incorporated under the laws of the state of Illinois on May 19, 1986. |
LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2008 and 2007 Note 7 - ACCRUED EXPENSES Accrued expenses consist of the following: Note 8 - NOTES PAYABLE Notes payable consist of the following: Maturities of notes payables are as follows: LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2008 and 2007 Note 9 - PROVISION FOR INCOME TAXES The provision for income taxes consists of the following: A reconciliation of the provision for income taxes and the income tax computed at the statutory rate is as follows: Amounts for deferred tax assets and liabilities are as follows: LIFEWAY FOODS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements December 31, 2008 and 2007 Note 10 - SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for interest and income taxes are as follows: Note 11 - STOCK AWARD AND STOCK OPTION PLANS The Company has a registration statement filed with the Securities and Exchange Commission in connection with a Consulting Service Compensation Plan covering up to 1,200,000 of the Company’s common stock shares. |
By: /s/ Edward P. Smolyansky Edward P. Smolyansky Chief Financial and Accounting Officer and Treasurer Date: March 31, 2009 KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Julie Smolyansky and Edward P. Smolyansky, and each of them individually, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments to this Report together with all schedules and exhibits thereto, (ii) act on, sign and file with the Securities and Exchange Commission any and all exhibits to this Report and any and all exhibits and schedules thereto, (iii) act on, sign and file any and all such certificates, notices, communications, reports, instruments, agreements and other documents as may be necessary or appropriate in connection therewith and (iv) take any and all such actions which may be necessary or appropriate in connection therewith, granting unto such agents, proxies and attorneys-in-fact, and each of them individually, full power and authority to do and perform each and every act and thing necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, and hereby approving, ratifying and confirming all that such agents, proxies and attorneys-in-fact, any of them or any of his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. |
/s/ GLEESON, SKLAR, SAWYERS & CUMPATA LLP Gleeson, Sklar, Sawyers & Cumpata LLP Elgin, Illinois February 9, 1996 LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEET DECEMBER 31, 1995 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEET DECEMBER 31, 1995 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF INCOME FOR THE YEARS ENDED DECEMBER 31, 1995 AND 1994 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE YEARS ENDED DECEMBER 31, 1995 AND 1994 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 1995 AND 1994 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS - CONTINUED FOR THE YEARS ENDED DECEMBER 31, 1995 AND 1994 SEE ACCOMPANYING NOTES TO FINANCIAL STATEMENTS LIFEWAY FOODS, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1995 AND 1994 Note 1 - NATURE OF BUSINESS Lifeway Foods, Inc. (The "Company") commenced operations in February, 1986, and incorporated under the laws of the State of Illinois on May 19, 1986. |
The impacts include, but are not limited to, significant reductions or volatility in demand and increased pricing pressures for one or more of the Company's products; •decreased financial viability of the Company’s suppliers, which could cause them to change the terms on which they are willing to provide products; •the inability or failure of customers to timely meet payment obligations or significant disruptions in their ability to do so, which may be caused by their own financial or operational difficulties, which may have a negative material impact on the Company's cash flow, liquidity and statements of operations; •a recession or prolonged period of economic slowdown, which may significantly reduce the Company’s cash flow and negatively impact the cost and access to capital and funding sources for the Company; •the Company’s inability to maintain compliance with covenants under the revolving credit facilities; or •the reduced availability of key employees or members of management due to quarantine or illness as a result of COVID-19 may temporarily affect the financial performance and results of operations. |
The success of the Company's acquisition of Byte depends upon its ability to realize anticipated benefits which may not be realized on a timely basis, or at all, for a variety of reasons, including, but not limited to, the following: •challenges due to expanding into a new customer base through the direct-to-consumer channel; •the effect of future regulatory or legislative actions on the Company or the industries and market segments in which it operates; •the ability to hire and retain key personnel; •continued support of Dentsply Sirona’s products by influential dental and medical professionals; •the potential impact on relationships with customers, suppliers, competitors, management and other employees; •unexpected challenges related to scaling the operations; •the continued strength of the clear aligner market; and •unexpected changes or increased expenses relating to competitive factors in the clear aligner market; Additionally, if the Company makes acquisitions, it may incur debt, assume contingent liabilities and/or additional risks, or create additional expenses, any of which might adversely affect its financial results. |
Risks and uncertainties that Dentsply Sirona faces with respect to Dentsply Sirona’s patents and patent applications include the following: •the pending patent applications that Dentsply Sirona has filed, or to which Dentsply Sirona has exclusive rights, may not result in issued patents or may take longer than Dentsply Sirona expects to result in issued patents; •the allowed claims of any patents that are issued may not provide meaningful protection; •Dentsply Sirona may be unable to develop additional proprietary technologies that are patentable; •the patents licensed or issued to Dentsply Sirona may not provide a competitive advantage; •other companies may challenge patents licensed or issued to Dentsply Sirona; •disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by Dentsply Sirona and Dentsply Sirona’s respective licensors; and •other companies may design around the technologies patented by Dentsply Sirona. |
Reconciliation of changes in the defined benefit obligations, fair value of assets and statement of funded status were as follows: The amounts recognized in the accompanying Consolidated Balance Sheets, net of tax effects, were as follows: Amounts recognized in AOCI were as follows: Information for pension plans with a projected or accumulated benefit obligation in excess of plan assets were as follows: Components of net periodic benefit cost were as follows: Other changes in plan assets and benefit obligations recognized in AOCI were as follows: Assumptions The weighted average assumptions used to determine benefit obligations for the Company’s plans, principally in foreign locations were as follows: The weighted average assumptions used to determine net periodic benefit cost for the Company’s plans, principally in foreign locations were as follows: To develop the assumptions for the expected long-term rate of return on assets, the Company considered the current level of expected returns on risk free investments (primarily U.S. government bonds), the historical level of the risk premium associated with the other asset classes in which the assets are invested and the expectations for future returns of each asset class. |
Risks and uncertainties that Dentsply Sirona faces with respect to Dentsply Sirona’s patents and patent applications include the following: •the pending patent applications that Dentsply Sirona has filed, or to which Dentsply Sirona has exclusive rights, may not result in issued patents or may take longer than Dentsply Sirona expects to result in issued patents; •the allowed claims of any patents that are issued may not provide meaningful protection; •Dentsply Sirona may be unable to develop additional proprietary technologies that are patentable; •the patents licensed or issued to Dentsply Sirona may not provide a competitive advantage; •other companies may challenge patents licensed or issued to Dentsply Sirona; •disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by Dentsply Sirona and Dentsply Sirona’s respective licensors; and •other companies may design around the technologies patented by Dentsply Sirona. |
Risks and uncertainties that Dentsply Sirona faces with respect to Dentsply Sirona’s patents and patent applications include the following: •the pending patent applications that Dentsply Sirona has filed, or to which Dentsply Sirona has exclusive rights, may not result in issued patents or may take longer than Dentsply Sirona expects to result in issued patents; •the allowed claims of any patents that are issued may not provide meaningful protection; •Dentsply Sirona may be unable to develop additional proprietary technologies that are patentable; •the patents licensed or issued to Dentsply Sirona may not provide a competitive advantage; •other companies may challenge patents licensed or issued to Dentsply Sirona; •disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by Dentsply Sirona and Dentsply Sirona’s respective licensors; and •other companies may design around the technologies patented by Dentsply Sirona. |
The following table summarizes information about NQSOs outstanding for the year ended December 31, 2018: The following table summarizes the unvested RSU transactions for the year ended December 31, 2018: NOTE 14 - INCOME TAXES The components of (loss) income before income taxes for the years ended December 31 were as follows: The components of the provision (benefit) for income taxes from operations for the years ended December 31 were as follows: The reconciliation of the U.S. federal statutory tax rate to the effective rate for the years ended December 31 is as follows: The tax effect of significant temporary differences giving rise to deferred tax assets and liabilities for the years ended December 31 were as follows: Deferred tax assets and liabilities are included in the following Consolidated Balance Sheet line items at December 31: The Company has $78.4 million of foreign tax credit carryforwards at December 31, 2018, of which $38.6 million will expire in 2024, $38.9 million will expire in 2025, and $0.9 million will expire in 2028. |
Risks and uncertainties that Dentsply Sirona faces with respect to Dentsply Sirona’s patents and patent applications include the following: • the pending patent applications that Dentsply Sirona has filed, or to which Dentsply Sirona has exclusive rights, may not result in issued patents or may take longer than Dentsply Sirona expects to result in issued patents; • the allowed claims of any patents that are issued may not provide meaningful protection; • Dentsply Sirona may be unable to develop additional proprietary technologies that are patentable; • the patents licensed or issued to Dentsply Sirona may not provide a competitive advantage; • other companies may challenge patents licensed or issued to Dentsply Sirona; • disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by Dentsply Sirona and Dentsply Sirona’s respective licensors; and • other companies may design around the technologies patented by Dentsply Sirona. |
Potential difficulties Dentsply Sirona may encounter as part of the integration process include, but are not limited to, the following: • the inability to successfully combine DENTSPLY and Sirona’s businesses in a manner that permits Dentsply Sirona to achieve the full revenue and cost synergies anticipated to result from the Merger; • complexities associated with managing the combined businesses, including the challenge of integrating complex systems, technology, networks and other assets of each of the companies in a seamless manner that minimizes any adverse impact on customers, suppliers, employees and other constituencies; • coordinating geographically separated organizations, systems and facilities; • addressing possible differences in business backgrounds, corporate cultures and management philosophies; • integrating the workforces of the two companies while maintaining focus on providing consistent, high quality customer service; • potential unknown liabilities and unforeseen increased or new expenses, delays or regulatory conditions associated with the Merger; • Dentsply Sirona’s current and prospective employees may experience uncertainty about their roles within Dentsply Sirona following the Merger, which may have an adverse effect on the ability of Dentsply Sirona to attract or retain key management and other key personnel; and • No assurance can be given that Dentsply Sirona will be able to attract or retain key management personnel and other key employees to the same extent that DENTSPLY and Sirona have previously been able to attract or retain employees, which could have a negative impact on their respective businesses. |
Risks and uncertainties that Dentsply Sirona faces with respect to Dentsply Sirona’s patents and patent applications include the following: • the pending patent applications that Dentsply Sirona has filed, or to which Dentsply Sirona has exclusive rights, may not result in issued patents or may take longer than Dentsply Sirona expects to result in issued patents; • the allowed claims of any patents that are issued may not provide meaningful protection; • Dentsply Sirona may be unable to develop additional proprietary technologies that are patentable; • the patents licensed or issued to Dentsply Sirona may not provide a competitive advantage; • other companies may challenge patents licensed or issued to Dentsply Sirona; • disputes may arise regarding inventions and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by Dentsply Sirona and Dentsply Sirona’s respective licensors; and • other companies may design around the technologies patented by Dentsply Sirona. |
The Company issued 87.5 million euros in the following series: 17.5 million euros aggregate principal amount bearing interest of 0.98%, Series N Senior Notes due October 27, 2024; 14.5 million euros aggregate principal amount bearing interest of 1.31%, Series O Senior Notes due October 27, 2027; 3.0 million euros aggregate principal amount bearing interest of 1.31%, Series P Senior Notes due October 27, 2027; 15.5 million euros aggregate principal amount bearing interest of 1.50%, Series Q Senior Notes due October 27, 2029; 2.0 million euros aggregate principal amount bearing interest of 1.50%, Series R Senior Notes due October 27, 2029; 6.5 million euros aggregate principal amount bearing interest of 1.58%, Series S Senior Notes due October 27, 2030; 11.0 million euros aggregate principal amount bearing interest of 1.58%, Series T Senior Notes due October 27, 2030; 10.5 million euros aggregate principal amount bearing interest of 1.65%, Series U Senior Notes due October 27, 2031; and 7.0 million euros aggregate principal amount bearing interest of 1.65%, Series V Senior Notes due October 27, 2031. |
The Company issued 262.5 million euros in the following series: 52.5 million euros aggregate principal amount bearing interest of 0.98%, Series A Senior Notes due October 27, 2024; 43.5 million euros aggregate principal amount bearing interest of 1.31%, Series B Senior Notes due October 27, 2027; 9.0 million euros aggregate principal amount bearing interest of 1.31%, Series C Senior Notes due October 27, 2027; 46.5 million euros aggregate principal amount bearing interest of 1.50%, Series D Senior Notes due October 27, 2029; 6.0 million euros aggregate principal amount bearing interest of 1.50%, Series E Senior Notes due October 27, 2029; 19.5 million euros aggregate principal amount bearing interest of 1.58%, Series F Senior Notes due October 27, 2030; 33.0 million euros aggregate principal amount bearing interest of 1.58%, Series G Senior Notes due October 27, 2030; 31.5 million euros aggregate principal amount bearing interest of 1.65%, Series H Senior Notes due October 27, 2031; and 21.0 million euros aggregate principal amount bearing interest of 1.65%, Series I Senior Notes due October 27, 2031. |
If the Merger is not completed, the ongoing businesses and financial results of the Company and/or Sirona may be adversely affected and DENTSPLY and/or Sirona will be subject to several risks, including the following: • having to pay certain significant costs relating to the merger without receiving the benefits of the merger, including, in certain circumstances, a termination fee of $280 million, in the case of DENTSPLY, and a termination fee of $205 million, in the case of Sirona; • the potential loss of key personnel during the pendency of the merger as employees may experience uncertainty about their future roles with the combined company; • DENTSPLY and Sirona will have been subject to certain restrictions on the conduct of their businesses which may have prevented the respective companies from making certain acquisitions or dispositions or pursuing certain business opportunities while the merger was pending; and • having had the focus of each companies’ management on the merger instead of on pursuing other opportunities that could have been beneficial to the companies. |
Potential difficulties the combined company may encounter as part of the integration process include, but are not limited to, the following: • the inability to successfully combine DENTSPLY and Sirona’s businesses in a manner that permits the combined company to achieve the full revenue and cost synergies anticipated to result from the Merger; • complexities associated with managing the combined businesses, including the challenge of integrating complex systems, technology, networks and other assets of each of the companies in a seamless manner that minimizes any adverse impact on customers, suppliers, employees and other constituencies; • coordinating geographically separated organizations, systems and facilities; • addressing possible differences in business backgrounds, corporate cultures and management philosophies; • integrating the workforces of the two companies while maintaining focus on providing consistent, high quality customer service; and • potential unknown liabilities and unforeseen increased or new expenses, delays or regulatory conditions associated with the Merger. |
On December 11, 2015, the Company executed a new Note Purchase Agreement in a private placement with institutional investors to sell 295.5 million Swiss francs and 289.0 million euros aggregate principal amount of senior notes (“Private Placement Notes”) at a weighted average interest rate of 1.69% to be issued on December 11, 2015, February 19, 2016 and August 15, 2016 in various aggregate principal amounts as follows: • On December 11, 2015 the Company issued the following: 25.0 million Swiss francs aggregate principal amount bearing interest of 0.86%, Series A Senior Notes due December 11, 2025; 30.0 million euros aggregate principal amount bearing interest of 2.05%, Series B Senior Notes due December 11, 2025; 67.0 million euros aggregate principal amount bearing interest of 2.05%, Series C Senior Notes due December 11, 2025; 8.0 million Swiss francs aggregate principal amount bearing interest of 1.02%, Series D Senior Notes due December 11, 2027; and 15.0 million euros aggregate principal amount bearing interest of 2.24%, Series E Senior Notes due December 11, 2027. |
Offsetting of financial assets and liabilities under netting arrangements at December 31, 2013: Offsetting of financial assets and liabilities under netting arrangements at December 31, 2012: The following tables summarize the amount of gains (losses) recorded in the Company’s Consolidated Statements of Operations related to the Company’s cash flow hedges for the years ended December 31, 2013 and 2012: The following tables summarize the amount of gains (losses) recorded in the Company’s Consolidated Statements of Operations related to the Company’s hedges of net investments for the years ended December 31, 2013 and 2012: The following tables summarize the amount of gains (losses) recorded in the Company’s Consolidated Statements of Operations related to the Company’s hedges of fair value for the years ended December 31, 2013 and 2012: The following table summarizes the amounts of gains (losses) recorded in the Company’s Consolidated Statements of Operations related to the Company’s hedges not designated as hedging for the years ended December 31, 2013 and 2012: (a) The gains and losses on these derivative transactions offset the gains and losses generated by the revaluation of the underlying non-functional currency balances which are recorded in “Other expense (income), net” on the Consolidated Statements of Operations. |
The following tables summarize the notional amounts and fair value of the Company's fair value hedges at December 31, 2012: The following tables summarize the fair value and consolidated balance sheet location of the Company's derivatives at December 31, 2012 and 2011: The following tables summarize the statements of operations impact of the Company’s cash flow hedges for the years ended December 31, 2012 and 2011: The following tables summarize the statements of operations impact of the Company’s hedges of net investments for the years ended December 31, 2012 and 2011: The following tables summarize the statements of operations impact of the Company’s hedges of fair value for the years ended December 31, 2012 and 2011: The following table summarizes the statements of operations impact of the Company’s hedges not designated as hedging for the years ended December 31, 2012 and 2011: (a) The gains and losses on these derivative transactions offset the gains and losses generated by the revaluation of the underlying non-functional currency balances and are recorded in “Other expense (income), net” on the Consolidated Statements of Operations. |
The Company may fail to realize the anticipated benefits of the integration on a timely basis, or at all, for a variety of reasons, including, but not limited to, the following: • difficulties entering new markets or manufacturing in new geographies where the Company has no or limited direct prior experience; • difficulties managing Astra Tech's healthcare business in which the Company's management has no or limited direct prior experience; • difficulties in coordinating geographically separate organizations; • failure to identify or assess the magnitude of certain liabilities we are assuming in the acquisition, which could result in unexpected litigation or regulatory exposure, unfavorable accounting treatment, unexpected increases in taxes due, a loss of anticipated tax benefits or other adverse effects on the Company's business, operating results or financial condition; • failure to realize the anticipated increase in the Company's revenues due to the acquisition if customers adjust their purchasing decisions and allocate more market share to the Company's competitors; • difficulties or delays in incorporating acquired technologies or products with the Company's existing product lines and maintaining uniform standards, controls, processes and policies; • failure to successfully manage relationships with the Company's combined supplier and customer base; • difficulties in modifying Astra Tech's existing accounting and internal control systems to comply with Section 404 of the Sarbanes-Oxley Act of 2002, to which Astra Tech is not currently and had not been historically subject to, which could adversely impact the effectiveness of internal control over financial reporting for the combined company; and • loss of key employees including sales representatives. |
Properties The following is a listing of DENTSPLY's principal manufacturing and distribution locations as of December 31, 2011: Location Function Leased or Owned United States: Milford, Delaware (1) Manufacture of dental consumable products Owned Bradenton, Florida (3) Manufacture of orthodontic accessory products Leased Baldwin, Georgia (3) Manufacture of orthodontic accessory products Leased Des Plaines, Illinois (1) Manufacture and assembly of dental handpieces Leased Elgin, Illinois (1) Manufacture of dental x-ray film holders, film Owned/Leased mounts and accessories Waltham, Massachusetts (3) Manufacture and distribution of dental implant products Leased Bohemia, New York (3) Manufacture and distribution of orthodontic Leased products and materials Maumee, Ohio (4) Manufacture and distribution of investment casting products Owned Lancaster, Pennsylvania (5) Distribution of dental products Leased York, Pennsylvania (4) Manufacture and distribution of artificial teeth Owned and other dental laboratory products York, Pennsylvania (1) Manufacture of small dental equipment, bone grafting Owned products, and preventive dental products Johnson City, Tennessee (3) Manufacture and distribution of endodontic Leased instruments and materials Foreign: Beringen, Belgium (4) Manufacture and distribution of dental products Owned Leuven, Belgium (4) Manufacture and distribution of 3D digital implantology Leased Catanduva, Brazil (3) Manufacture and distribution of dental anesthetic products Owned Petropolis, Brazil (3) Manufacture and distribution of artificial teeth, Owned dental consumable products and endodontic material Shanghai, China (4) Manufacture and distribution of dental products Leased Tianjin, China (2) Manufacture and distribution of dental products Leased Ivry Sur-Seine, France (4) Manufacture and distribution of investment casting products Leased Bohmte, Germany (4) Manufacture and distribution of dental laboratory products Owned Hanau, Germany (4) Manufacture and distribution of precious metal dental Owned alloys, dental ceramics and dental implant products Konstanz, Germany (1) Manufacture and distribution of dental consumable products Owned Mannheim, Germany (4) Manufacture and distribution of dental implant products Owned/Leased Munich, Germany (3) Manufacture and distribution of endodontic Owned instruments and materials Radolfzell, Germany (5) Distribution of dental products Leased Rosbach, Germany (4) Manufacture and distribution of dental ceramics Owned Badia Polesine, Italy (1) Manufacture and distribution of dental consumable products Owned/Leased Otawara, Japan (2) Manufacture and distribution of precious metal dental Owned alloys, dental consumable products and orthodontic products Mexicali, Mexico (3) Manufacture and distribution of orthodontic Leased products and materials Hoorn, Netherlands (4) Manufacture and distribution of precious metal Owned dental alloys and dental ceramics HA Soest, Netherlands (3) Distribution of orthodontic products Leased Warsaw, Poland (1) Manufacture and distribution of dental consumable products Owned Las Piedras, Puerto Rico (4) Manufacture of crown and bridge materials Owned Mölndal, Sweden (3) Manufacture and distribution of dental implant products and Owned consumable medical devices Ballaigues, Switzerland (3) Manufacture and distribution of endodontic Owned instruments, plastic components and packaging material Le Creux, Switzerland (3) Manufacture and distribution of endodontic instruments Owned (1) These properties are included in the U.S., Germany, and Certain Other European Regions Consumable Businesses segment. |
Properties The following is a listing of DENTSPLY's principal manufacturing and distribution locations as of December 31, 2010: Location Function Leased or Owned United States: Milford, Delaware (1) Manufacture of dental consumable products Owned Bradenton, Florida (3) Manufacture of orthodontic accessory products Leased Baldwin, Georgia (3) Manufacture of orthodontic accessory products Leased Des Plaines, Illinois (1) Manufacture and assembly of dental handpieces Leased Elgin, Illinois (1) Manufacture of dental x-ray film holders, film Owned/Leased mounts and accessories Bohemia, New York (3) Manufacture and distribution of orthodontic Leased products and materials Maumee, Ohio (4) Manufacture and distribution of investment Owned casting products Lancaster, Pennsylvania (5) Distribution of dental products Leased York, Pennsylvania (4) Manufacture and distribution of artificial teeth Owned and other dental laboratory products York, Pennsylvania (1) Manufacture of small dental equipment, bone grafting Owned products, and preventive dental products Johnson City, Tennessee (3) Manufacture and distribution of endodontic Leased instruments and materials Foreign: Beringen, Belgium (4) Manufacture and distribution of dental products Owned/Leased Leuven, Belgium (4) Manufacture and distribution of 3D digital implantology Leased Catanduva, Brazil (3) Manufacture and distribution of dental Owned anesthetic products Petropolis, Brazil (3) Manufacture and distribution of artificial teeth, Owned dental consumable products and endodontic material Shanghai, China (4) Manufacture and distribution of dental products Leased Tianjin, China (2) Manufacture and distribution of dental products Leased Ivry Sur-Seine, France (4) Manufacture and distribution of investment casting products Leased - 13 - Bohmte, Germany (4) Manufacture and distribution of dental Owned laboratory products Hanau, Germany (4) Manufacture and distribution of precious metal dental Owned alloys, dental ceramics and dental implant products Konstanz, Germany (1) Manufacture and distribution of dental consumable Owned products Mannheim, Germany (4) Manufacture and distribution of dental Owned/Leased implant products Munich, Germany (3) Manufacture and distribution of endodontic Owned instruments and materials Radolfzell, Germany (5) Distribution of dental products Leased Rosbach, Germany (4) Manufacture and distribution of dental ceramics Owned Badia Polesine, Italy (1) Manufacture and distribution of dental consumable Owned/Leased products Nasu, Japan (2) Manufacture and distribution of precious metal dental Owned alloys, dental consumable products and orthodontic products Mexicali, Mexico (3) Manufacture and distribution of orthodontic Leased products and materials Hoorn, Netherlands (4) Manufacture and distribution of precious metal Owned dental alloys and dental ceramics HA Soest, Netherlands (3) Distribution of orthodontic products Leased Warsaw, Poland (1) Manufacture and distribution of dental consumable Owned products Las Piedras, Puerto Rico (4) Manufacture of crown and bridge materials Owned Ballaigues, Switzerland (3) Manufacture and distribution of endodontic Owned instruments, plastic components and packaging material Le Creux, Switzerland (3) Manufacture and distribution of endodontic instruments Owned (1) These properties are included in the U. S., Germany, and Certain Other European Regions Consumable Businesses segment. |
Properties The following is a listing of DENTSPLY's principal manufacturing and distribution locations as of December 31, 2009: Location Function Leased or Owned United States: Milford, Delaware (1) Manufacture of dental consumable products Owned Bradenton, Florida (3) Manufacture of orthodontic accessory products Leased Baldwin, Georgia (3) Manufacture of orthodontic accessory products Leased Des Plaines, Illinois (1) Manufacture and assembly of dental handpieces Leased Elgin, Illinois (1) Manufacture of dental x-ray film holders, film mounts and accessories Owned/Leased Bohemia, New York (3) Manufacture and distribution of orthodontic products and materials Leased Maumee, Ohio (4) Manufacture and distribution of investment casting products Owned Lancaster, Pennsylvania (5) Distribution of dental products Leased York, Pennsylvania (4) Manufacture and distribution of artificial teeth and other dental laboratory products Owned York, Pennsylvania (1) Manufacture of small dental equipment, bone grafting products, and preventive dental products Owned Johnson City, Tennessee (3) Manufacture and distribution of endodontic instruments and materials Leased Foreign: Beringen, Belgium (4) Manufacture and distribution of dental products Owned/Leased Leuven, Belgium (4) Manufacture and distribution of 3D digital implantology Leased Catanduva, Brazil (3) Manufacture and distribution of dental anesthetic products Owned Petropolis, Brazil (3) Manufacture and distribution of artificial teeth and dental consumable products Owned Shanghai, China (4) Manufacture and distribution of dental products Leased Tianjin, China (2) Manufacture and distribution of dental products Leased Ivry Sur-Seine, France (2) Manufacture and distribution of investment casting products Leased Bohmte, Germany (4) Manufacture and distribution of dental laboratory products Owned - 12 - Hanau, Germany (4) Manufacture and distribution of precious metal dental Owned alloys, dental ceramics and dental implant products Konstanz, Germany (1) Manufacture and distribution of dental consumable Owned products Mannheim, Germany (4) Manufacture and distribution of dental Owned/Leased implant products Munich, Germany (3) Manufacture and distribution of endodontic Owned instruments and materials Radolfzell, Germany (5) Distribution of dental products Leased Rosbach, Germany (4) Manufacture and distribution of dental ceramics Owned Badia Polesine, Italy (1) Manufacture and distribution of dental consumable Owned/Leased products Nasu, Japan (2) Manufacture and distribution of precious metal dental Owned alloys, dental consumable products and orthodontic products Hoorn, Netherlands (4) Manufacture and distribution of precious metal Owned dental alloys and dental ceramics HA Soest, Netherlands (3) Distribution of orthodontic products Leased Warsaw, Poland (1) Manufacture and distribution of dental consumable Owned products Las Piedras, Puerto Rico (4) Manufacture of crown and bridge materials Owned Ballaigues, Switzerland (3) Manufacture and distribution of endodontic Owned instruments, plastic components and packaging material Le Creux, Switzerland (3) Manufacture and distribution of endodontic instruments Owned (1) These properties are included in the U. S., Germany, and Certain Other European Regions Consumable Businesses segment. |
Properties The following is a listing of DENTSPLY's principal manufacturing and distribution locations as of December 31, 2008: Location Function Leased or Owned United States: Milford, Delaware (1) Manufacture of dental consumable products Owned Bradenton, Florida (3) Manufacture of orthodontic accessory products Leased Baldwin, Georgia (3) Manufacture of orthodontic accessory products Leased Des Plaines, Illinois (1) Manufacture and assembly of dental handpieces Leased Elgin, Illinois (1) Manufacture of dental x-ray film holders, film Owned/Leased mounts and accessories Englewood, New Jersey (1) Distribution of dental consumable products Leased Hackensack, New Jersey (1) Distribution of dental consumable products Leased Bohemia, New York (3) Manufacture and distribution of orthodontic Leased products and materials Maumee, Ohio (4) Manufacture and distribution of investment Owned casting products Middletown, Pennsylvania (1) Distribution of dental products Leased York, Pennsylvania (4) Manufacture and distribution of artificial teeth Owned and other dental laboratory products York, Pennsylvania (1) Manufacture of small dental equipment, bone grafting Owned products, and preventive dental products Johnson City, Tennessee (3) Manufacture and distribution of endodontic Leased instruments and materials Foreign: Beringen, Belgium (4) Manufacture and distribution of dental products Owned/Leased Leuven, Belgium (4) Manufacture and distribution of 3D digital implantology Leased Catanduva, Brazil (3) Manufacture and distribution of dental Owned anesthetic products Petropolis, Brazil (3) Manufacture and distribution of artificial teeth Owned and dental consumable products Shanghai, China (4) Manufacture and distribution of dental products Leased Tianjin, China (2) Manufacture and distribution of dental products Leased - 12 - Ivry Sur-Seine, France (4) Manufacture and distribution of investment casting Leased products Bohmte, Germany (4) Manufacture and distribution of dental Owned laboratory products Hanau, Germany (4) Manufacture and distribution of precious metal dental Owned alloys, dental ceramics and dental implant products Konstanz, Germany (1) Manufacture and distribution of dental consumable Owned products Mannheim, Germany (4) Manufacture and distribution of dental Owned/Leased implant products Munich, Germany (3) Manufacture and distribution of endodontic Owned instruments and materials Radolfzell, Germany (5) Distribution of dental products Leased Rosbach, Germany (4) Manufacture and distribution of dental ceramics Owned Badia Polesine, Italy (1) Manufacture and distribution of dental consumable Owned/Leased products Nasu, Japan (2) Manufacture and distribution of precious metal dental Owned alloys, dental consumable products and orthodontic products Hoorn, Netherlands (4) Manufacture and distribution of precious metal Owned dental alloys and dental ceramics HA Soest, Netherlands (3) Distribution of orthodontic products Leased Warsaw, Poland (1) Manufacture and distribution of dental consumable Owned products Las Piedras, Puerto Rico (4) Manufacture of crown and bridge materials Owned Ballaigues, Switzerland (3) Manufacture and distribution of endodontic Owned instruments, plastic components and packaging material Le Creux, Switzerland (3) Manufacture and distribution of endodontic instruments Owned (1) These properties are included in the United States, Germany, and Certain Other European Regions Consumable Businesses segment. |
Properties The following is a listing of DENTSPLY's principal manufacturing and distribution locations as of December 31, 2006: Leased Location Function or Owned Hanau, Germany (3) Manufacture and distribution of precious metal Owned dental alloys, dental ceramics and dental implant products Konstanz, Germany (1) Manufacture and distribution of consumable Owned dental products Mannheim, Germany (3) Manufacture and distribution of dental Owned implant products Munich, Germany (2) Manufacture and distribution of endodontic Owned instruments and materials Radolfzell, Germany (4) Distribution of dental products Leased Rosbach, Germany (3) Manufacture and distribution of dental ceramics Owned Nasu, Japan (3) Manufacture and distribution of precious metal Owned dental alloys, consumable dental products and orthodontic products Yokohama City, Japan (3) Manufacture and distribution of dental products Leased Hoorn, Netherlands (3) Manufacture and distribution of precious metal Owned dental alloys and dental ceramics Las Piedras, Puerto Rico (3) Manufacture of crown and bridge materials Owned Ballaigues, Switzerland (2) Manufacture and distribution of endodontic Owned instruments Ballaigues, Switzerland (2) Manufacture and distribution of endodontic Owned instruments, plastic components and packaging material Le Creux, Switzerland (2) Manufacture and distribution of endodontic Owned instruments (1) - These properties are included in the U.S., Europe, Commonwealth of Independent States (“CIS”), Middle East, Africa Consumable Business/Canada segment. |
Exhibits and Financial Statement Schedule (a) Documents filed as part of this Report The following consolidated financial statements of the Company are filed as part of this Annual Report on Form 10-K and are covered by the Report of Independent Registered Public Accounting Firm also filed as part of this report: Management’s Report on Internal Control Over Financial Reporting Report of Independent Registered Public Accounting Firm Consolidated Statements of Income - Years ended December 31, 2006, 2005 and 2004 Consolidated Balance Sheets - December 31, 2006 and 2005 Consolidated Statements of Stockholders' Equity and Comprehensive Income - Years ended December 31, 2006, 2005 and 2004 Consolidated Statements of Cash Flows - Years ended December 31, 2006, 2005 and 2004 Notes to Consolidated Financial Statements Financial Statement Schedule The following financial statement schedule is filed as part of this Annual Report on Form 10-K and is covered by the Report of Independent Registered Public Accounting Firm: Schedule II -- Valuation and Qualifying Accounts. |
The following is a summary of the status of the Plans as of December 31, 2005, 2004 and 2003 and changes during the years ending on those dates: Outstanding Exercisable -------------------- -------------------- Weighted Weighted Available Average Average for Exercise Exercise Grant Shares Price Shares Price Shares December 31, 2002 7,691,589 $ 24.50 4,649,889 $ 18.99 7,253,405 Authorized (Lapsed) - 177,882 Granted 1,434,300 43.84 (1,434,300) Exercised (829,155) 19.30 - Expired/Canceled (119,277) 29.38 119,277 --------- --------- December 31, 2003 8,177,457 28.35 5,225,300 22.22 6,116,264 Authorized (Lapsed) - 8,100 Granted 1,127,799 53.61 (1,127,799) Exercised (2,117,484) 21.03 - Expired/Canceled (252,817) 26.57 252,817 --------- --------- December 31, 2004 6,934,955 34.76 4,498,889 27.99 5,249,382 Authorized (Lapsed) - 36,900 Granted 1,330,482 55.36 (1,330,482) Exercised (1,265,760) 25.40 - Expired/Canceled (69,230) 62.74 69,230 --------- --------- December 31, 2005 6,930,447 $ 40.14 4,626,109 $ 33.85 4,025,030 ========= ========= The following table summarizes information about stock options outstanding under the Plans at December 31, 2005: The Company uses the Black-Scholes option pricing model to value option awards. |
The rollforward of the common shares and the treasury shares outstanding is as follows: Common Treasury Outstanding Shares Shares Shares (in thousands) Balance at December 31, 2002 81,388 (2,990) 78,398 Exercise of stock options - 853 853 ------ ------ ------ Balance at December 31, 2003 81,388 (2,137) 79,251 Exercise of stock options - 2,165 2,165 Repurchase of common stock at cost - (785) (785) ------ ------ ------ Balance at December 31, 2004 81,388 (757) 80,631 Exercise of stock options - 1,226 1,226 Repurchase of common stock at cost - (3,002) (3,002) ------ ------ ------ Balance at December 31, 2005 81,388 (2,533) 78,855 ====== ====== ====== NOTE 13 - INCOME TAXES The components of income before income taxes from continuing operations are as follows: Year Ended December 31, 2005 2004 2003 ---- ---- ---- (in thousands) United States ("U.S.") $ 53,473 $111,779 $113,994 Foreign 17,565 162,376 137,202 ------ ------- ------- $ 71,038 $274,155 $251,196 ======== ======== ======== The components of the provision for income taxes from continuing operations are as follows: Year Ended December 31, 2005 2004 2003 ---- ---- ---- (in thousands) Current: U.S. federal $ 62,892 $ 20,706 $ 28,693 U.S. state 2,717 197 1,941 Foreign 51,793 35,908 18,298 ------ ------ ------ Total 117,402 56,811 48,932 Deferred: U.S. federal (63,821) 2,556 12,077 U.S. state (1,129) 479 2,466 Foreign (26,827) 4,023 17,868 ------ ------ ------ Total (91,777) 7,058 32,411 ------ ------ ------ $ 25,625 $ 63,869 $ 81,343 ======== ======== ======== The reconcilation of the U.S. federal statutory tax rate to the effective rate is as follows: Year Ended December 31, 2005 2004 2003 Statutory federal income tax rate 35.0% 35.0% 35.0% Effect of: State income taxes, net of federal benefit 2.5 0.2 1.1 Federal benefit of R&D credits (2.4) (1.5) (0.2) Tax effect of international operations 10.7 (6.3) (5.0) Net effect of tax audit activity 7.2 (2.0) - Federal benefit of extraterritorial income exclusion (2.6) (0.9) (0.9) Federal tax on unremitted earnings of certain foreign subsidiaries (15.6) 1.0 2.5 Section 965 Repatriation 6.6 - - Other (5.3) (2.2) (0.1) Effective income tax rate on continuing operations 36.1% 23.3% 32.4% The tax effect of temporary differences giving rise to deferred tax assets and liabilities are as follows: Current and noncurrent deferred tax assets and liabilities are included in the following balance sheet captions: December 31, 2005 2004 (in thousands) Prepaid expenses and other current assets $ 82,371 $40,369 Income taxes payable - (1,857) Other noncurrent assets 12,671 20,175 Deferred income taxes (42,912) (58,196) The Company's effective tax rate for 2005 was 36.1%. |
Reconciliations of changes in the above plans' benefit obligations, fair value of assets, and statement of funded status are as follows: The amounts recognized in the accompanying Consolidated Balance Sheets are as follows: December 31, 2005 2004 (in thousands) Accumulated benefit obligation $ 141,538 $ 141,077 Increase in other comprehensive loss 16,539 3,118 Information for pension plans with an accumulated benefit obligation in excess of plan assets: December 31, 2005 2004 (in thousands) Projected benefit obligation $ 151,847 $ 99,910 Accumulated benefit obligation 141,538 89,566 Fair value of plan assets 68,357 18,885 Components of the net periodic benefit cost for the plans are as follows: The weighted average assumptions used to determine benefit obligations for the Company's plans, principally in foreign locations, are as follows: The weighted average assumptions used to determine net periodic benefit cost for the Company's plans, principally in foreign locations, are as follows: Assumed health care cost trend rates have an impact on the amounts reported for postretirement benefits. |
Date Chairman of the Board, Director, and Chief Executive Officer (Principal Executive Officer) /s/ William R. Jellison March 10, 2006 - ------------------------- -------------------- William R. Jellison Date Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) /s/ John C. Miles II March 10, 2006 - ------------------------- -------------------- John C. Miles II Date Director /s/ Dr. Michael C. Alfano March 10, 2006 - ------------------------- -------------------- Dr. Michael C. Alfano Date Director /s/ Eric K. Brandt March 10, 2006 - ------------------------- -------------------- Eric K. Brandt Date Director /s/ Paula H. Cholmondeley March 10, 2006 - ------------------------- -------------------- Paula H. Cholmondeley Date Director /s/ Michael J. Coleman March 10, 2006 - ------------------------- -------------------- Michael J. Coleman Date Director /s/ William F. Hecht March 10, 2006 - ------------------------- -------------------- William F. Hecht Date Director /s/ Leslie A. Jones March 10, 2006 - ------------------------- -------------------- Leslie A. Jones Date Director /s/ Wendy L. Dixon March 10, 2006 - ------------------------- -------------------- Wendy L. Dixon Date Director /s/ Francis J. Lunger March 10, 2006 - ------------------------- -------------------- Francis J. Lunger Date Director /s/ W. Keith Smith March 10, 2006 - ------------------------- -------------------- W. Keith Smith Date Director Date |
NOTE 10 - ACCRUED LIABILITIES Accrued liabilities consist of the following: December 31, 2004 2003 (in thousands) Payroll, commissions, bonuses, other cash compensation and employee benefits $ 57,738 $ 56,892 General insurance 15,844 15,852 Sales and marketing programs 15,757 15,944 Restructuring and other costs (Note 15) 6,224 7,781 Accrued Oraqix payments -- 16,000 Warranty liabilities 3,681 3,629 Other 80,521 56,586 $179,765 $172,684 A reconciliation of changes in the Company's warranty liability for 2004 is as follows: December 31, (in thousands) Balance, beginning of the year $ 3,629 Accruals for warranties issued during the year 2,010 Accruals related to pre-existing warranties (460) Warranty settlements made during the year (1,635) Reclassification to liabilities of discontinued operations -- Effects of exchange rate changes 137 Balance, end of the year $ 3,681 NOTE 11 - FINANCING ARRANGEMENTS Short-Term Borrowings Short-term bank borrowings amounted to $1.5 million and $0.8 million at December 31, 2004 and 2003, respectively. |
The rollforward of the common shares and the treasury shares outstanding is as follows: Common Treasury Outstanding Shares Shares Shares (in thousands) Balance at December 31, 2001 81,389 (3,509) 77,880 Exercise of stock options -- 519 519 Fractional share payouts (1) -- (1) Balance at December 31, 2002 81,388 (2,990) 78,398 Exercise of stock options -- 853 853 Balance at December 31, 2003 81,388 (2,137) 79,251 Exercise of stock options -- 2,165 2,165 Repurchase of common stock at cost -- (785) (785) Balance at December 31, 2004 81,388 (757) 80,631 NOTE 13 - INCOME TAXES The components of income before income taxes from continuing operations are as follows: Year Ended December 31, 2004 2003 2002 (in thousands) United States ("U.S.") $111,779 $113,994 $116,160 Foreign 162,376 137,202 97,930 $274,155 $251,196 $214,090 The components of the provision for income taxes from continuing operations are as follows: Year Ended December 31, 2004 2003 2002 (in thousands) Current: U.S. federal $20,706 $28,693 $ 47,627 U.S. state 197 1,941 2,520 Foreign 35,908 18,298 28,737 Total 56,811 48,932 78,884 Deferred: U.S. federal 2,556 12,077 (7,586) U.S. state 479 2,466 (908) Foreign 4,023 17,868 59 Total 7,058 32,411 (8,435) $63,869 $81,343 $ 70,449 Current and noncurrent deferred tax assets and liabilities are included in the following balance sheet captions: December 31, 2004 2003 (in thousands) Prepaid expenses and other current assets $ 40,369 $ 41,427 Income taxes payable (1,857) (1,270) Other noncurrent assets 20,175 26,800 Deferred income taxes (58,196) (66,861) The Company's effective tax rate for 2004 was 23.3%. |
Date Vice Chairman of the Board and Chief Executive Officer and a Director (Principal Executive Officer) /s/ William R. Jellison March 16, 2005 - ------------------------- -------------------- William R.Jellison Date Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) /s/ Dr. Michael C. Alfano March 16, 2005 - ------------------------- -------------------- Dr. Michael C. Alfano Date Director /s/ Eric K. Brandt March 16, 2005 - ------------------------- -------------------- Eric K. Brandt Date Director /s/ Paula H. Cholmondeley March 16, 2005 - ------------------------- -------------------- Paula H. Cholmondeley Date Director /s/ Michael J. Coleman March 16, 2005 - ------------------------- -------------------- Michael J. Coleman Date Director /s/ William F. Hecht March 16, 2005 - ------------------------- -------------------- William F. Hecht Date Director /s/ Leslie A. Jones March 16, 2005 - ------------------------- -------------------- Leslie A. Jones Date Director / /s/Edgar H. Schollmaier March 16, 2005 - ------------------------- -------------------- Edgar H. Schollmaier Date Director /s/ W. Keith Smith March 16, 2005 - ------------------------- -------------------- W. Keith Smith Date Director |
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