−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein.
−Removed: This discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
−Removed: amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.
−Removed: statements regarding Sunshine Biopharma, Inc.
−Removed: contained in this Report that are not historical in nature, particularly those that
−Removed: utilize terminology such as “may,” “will,” “should,” “likely,”
−Removed: “expects,” “anticipates,” “estimates,” “believes” or “plans,” or
−Removed: comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
+Added: CONDITION AND RESULTS OF OPERATIONS
+Added: The following discussion should be read in
+Added: conjunction with our consolidated financial statements and notes thereto included herein.
+Added: This discussion includes forward-looking statements
+Added: within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities
+Added: Exchange Act of 1934, as amended, or the Exchange Act.
+Added: The statements regarding Sunshine Biopharma, Inc.
+Added: contained in this Report that
+Added: are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,”
+Added: “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,”
+Added: or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.
−Removed: Important factors known to us that could cause such material differences are identified in this report and in our annual report on
−Removed: Form 10-K for the year ended December 31, 2023.
−Removed: We undertake no obligation to correct or update any forward-looking statements,
−Removed: whether as a result of new information, future events or otherwise, except as may be required under applicable law.
−Removed: You are advised,
−Removed: however, to consult any future disclosures we make on related subjects in future reports we file with the SEC .
−Removed: Sunshine Biopharma
−Removed: are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology
−Removed: and antivirals.
+Added: factors known to us that could cause such material differences are identified in this report and in our annual report on Form 10-K for
+Added: the year ended December 31, 2023.
+Added: We undertake no obligation to correct or update any forward-looking statements, whether as a result
+Added: of new information, future events or otherwise, except as may be required under applicable law.
+Added: You are advised, however, to consult
+Added: any future disclosures we make on related subjects in future reports we file with the SEC.
+Added: About Sunshine Biopharma
+Added: We are a pharmaceutical company offering and researching life-saving
+Added: medicines in a wide variety of therapeutic areas, including oncology and antivirals.
We operate two wholly owned subsidiaries:
−Removed: (i) Nora Pharma Inc.
−Removed: (“Nora Pharma”), a Canadian corporation with
−Removed: a portfolio consisting of 52 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.
−Removed: Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.
−Removed: addition, we are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii)
−Removed: SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer.
−Removed: Development of the latter
−Removed: has been paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023.
−Removed: See “Drugs in
−Removed: Development” below.
−Removed: were incorporated in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma, Inc.
−Removed: in a transaction
−Removed: classified as a reverse acquisition.
−Removed: Sunshine Biopharma, Inc.
−Removed: held an exclusive license to a new anticancer drug bearing the laboratory
−Removed: name, Adva-27a (the “License Agreement”).
−Removed: Upon completion of the reverse acquisition transaction, we changed our name to
+Added: (“Nora Pharma”), a Canadian corporation with a portfolio consisting of 61 generic prescription drugs on the market
+Added: in Canada, and (ii) Sunshine Biopharma Canada Inc.
+Added: (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription
+Added: over-the-counter (“OTC”) products.
+Added: In addition, we are conducting a proprietary drug development program
+Added: which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus infections,
+Added: and (iii) Adva-27a for pancreatic cancer.
+Added: Development of the latter has been paused pending further analysis of unfavorable in vitro results
+Added: obtained in the second half of 2023.
+Added: See “Drugs in Development” below.
+Added: We were incorporated in the State of Colorado on August 31, 2006, and
+Added: on October 15, 2009, we acquired Sunshine Biopharma, Inc.
+Added: in a transaction classified as a reverse acquisition.
Sunshine Biopharma, Inc.
+Added: held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”).
+Added: Upon completion
+Added: of the reverse acquisition, we changed our name to Sunshine Biopharma, Inc.
and began operating as a pharmaceutical company.
−Removed: December 2015, we acquired all worldwide issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697
−Removed: and PCT/CA2014/000029 for the Adva-27a anticancer compound and terminated the License Agreement.
−Removed: Development of Adva-27a has recently
−Removed: been paused pending further analysis of unexpected in vitro results obtained in the latter part of 2023.
−Removed: See “Drugs in Development”
−Removed: early 2020, we initiated a new R&D project focused on the development of a treatment for COVID-19 and on May 22, 2020, we filed a
−Removed: provisional patent application in the United States for the new coronavirus treatment.
−Removed: The patent application covers composition subject
−Removed: matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro.
−Removed: On April 30, 2021, we filed a PCT application
−Removed: containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.
−Removed: June 2021, we initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer
−Removed: The data obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in
−Removed: October 20, 2022, we acquired Nora Pharma Inc.
−Removed: (“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater
−Removed: Montreal area.
−Removed: Nora Pharma has 44 employees and operates in a 23,500 square foot facility certified by Health Canada.
−Removed: Nora Pharma currently
−Removed: has 52 generic prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in 2024
−Removed: on the Market
−Removed: Nora Pharma we currently have the following generic prescription drugs on the market in Canada:
+Added: In December 2015, we acquired all worldwide issued (US Patent Number
+Added: 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029 for the Adva-27a anticancer compound and
+Added: terminated the License Agreement.
+Added: Development of Adva-27a has recently been paused pending further analysis of unexpected in vitro results
+Added: obtained in the latter part of 2023.
+Added: See “Drugs in Development” below.
+Added: In early 2020, we initiated a new R&D project focused on the development
+Added: of a treatment for COVID-19 and on May 22, 2020, we filed a provisional patent application in the United States for the new coronavirus
+Added: The patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus
+Added: protease, Mpro.
+Added: On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include the Coronavirus
+Added: Papain-Like protease, PLpro.
+Added: In June 2021, we initiated another R&D project in which we set
+Added: out to determine if certain mRNA molecules can be used as anticancer agents.
+Added: The data obtained for mRNA molecules bearing the laboratory
+Added: name K1.1 became the subject of a new patent application filed in April 2022.
+Added: On October 20, 2022, we acquired Nora Pharma Inc.
+Added: (“Nora Pharma”),
+Added: a Canadian generic pharmaceuticals company based in the greater Montreal area.
+Added: Nora Pharma has 46 employees and operates in a 23,500 square
+Added: foot facility certified by Health Canada.
+Added: Nora Pharma currently has 61 generic prescription drugs on the market in Canada and is planning
+Added: to launch 32 additional generic prescription drugs in 2024 and 2025.
+Added: Products on the Market
+Added: Through Nora Pharma we currently have the following generic prescription
+Added: drugs on the market in Canada:
Action/Indication
7 unchanged sentences
Anti-inflammatory
+Added: Anti-inflammatory
Ciprofloxacin
2 unchanged sentences
Dapagliflozin
+Added: Antibacterial
Central nervous system
Central nervous system
+Added: Antibacterial
Central nervous system
16 unchanged sentences
Central nervous system
+Added: Progesterone*
+Added: Women's Health
Central nervous system
2 unchanged sentences
Cardiovascular
−Removed: Rizatriptan ODT
−Removed: Central nervous system
Cardiovascular
−Removed: Central nervous system
−Removed: Cardiovascular
−Removed: Telmisartan HCTZ
−Removed: Cardiovascular
−Removed: Micardis Plus®
−Removed: Anticonvulsant
−Removed: Tramadol Acetaminophen
−Removed: Central nervous system
−Removed: Central nervous system
+Added: Rizatriptan ODT
Central nervous system
+Added: ________________
+Added: *Sold through distribution agreements
In addition to the 61 drugs currently on the market, we have 32 additional
4 unchanged sentences
to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®.
−Removed: Similar to NEULASTA®, NIOPEG® is a long-acting form of recombinant
+Added: Like NEULASTA®, NIOPEG® is a long-acting form of recombinant
human granulocyte colony-stimulating factor (filgrastim).
2 unchanged sentences
Nora Pharma received Health Canada marketing approval for NIOPEG® on April 17, 2024.
−Removed: We believe the addition of these new products
−Removed: to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater
−Removed: access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
−Removed: in Development
−Removed: following table summarizes our proprietary drugs in development:
+Added: NIOPEG® is anticipated to be on the market in Canada in October 2024.
+Added: We believe the addition of these new products to our existing portfolio
+Added: will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater access to pharmacies
+Added: as we become more of a go-to supplier for every-day and specialty medicines.
+Added: Drugs in Development
+Added: The following table summarizes our proprietary drugs in development:
Adva-27a (Small Molecule)
6 unchanged sentences
Animal Testing
−Removed: “Adva-27a Anticancer Compound” below
−Removed: Anticancer Compound
−Removed: is a small molecule designed for the treatment of aggressive forms of cancer.
−Removed: A Topoisomerase II inhibitor, Adva-27a has been shown to
−Removed: be effective at destroying Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer
−Removed: cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012).
−Removed: We are the direct owner
−Removed: of all patents pertaining to Adva-27a including U.S.
−Removed: Patents Number 8,236,935 and 10,272,065.
−Removed: In December 2022, we entered into a research agreement
−Removed: with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research Agreement”).
−Removed: In August 2023, we were informed by the JGH that the laboratory results on testing of the Adva-27a molecule were not favorable.
−Removed: conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH of termination of the Research
−Removed: We have paused the IND-enabling studies of Adva-27a pending a review of the results and the possibility of chemical modification
−Removed: of the compound to address the suboptimal performance of the molecule in certain studies.
−Removed: Anticancer mRNA
−Removed: June 2021, we initiated a new research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer
−Removed: The data collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro
−Removed: including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
−Removed: Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects.
−Removed: new mRNA molecules, bearing the laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology.
−Removed: In April 2022, we filed a provisional patent application in the United States covering the subject mRNA molecules.
−Removed: November 2022, we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules
−Removed: into lipid nanoparticles (“LNP”) for use to conduct xenograft mice studies.
−Removed: The initial results of our xenograft mice studies
−Removed: indicate that our K1.1 mRNA-LNP is effective at reducing the size of liver cancer xenograft tumors in mice.
−Removed: We are currently seeking
−Removed: to confirm these results by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.
−Removed: SARS Coronavirus Treatment
−Removed: initial genome expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins,
−Removed: referred to as pp1a and pp1ab.
−Removed: These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and
−Removed: PLpro, to generate 16 different non-structural proteins essential for viral replication.
−Removed: Mpro and PLpro represent attractive anti-viral
−Removed: drug development targets as they play a central role in the early stages of viral replication.
−Removed: PLpro is of particular interest as a therapeutic
−Removed: target in that, in addition to processing essential viral proteins, it is also responsible for suppression of the human immune system
−Removed: making the virus more life-threatening.
−Removed: PLpro is present only in Betacoronaviruses, the subgroup of Coronaviruses represented by the
−Removed: highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
−Removed: Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application
−Removed: in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well
−Removed: February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona
−Removed: for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of
−Removed: three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research
−Removed: Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing
−Removed: license for all intellectual property developed by University of Arizona under the Research Project.
−Removed: In addition, we and the University
−Removed: of Arizona have entered into an option agreement (the “Option Agreement”) whereby we were granted a first option to negotiate
−Removed: a royalty-bearing commercial license for the underlying technology of the Research Project.
−Removed: On September 13, 2022, we exercised our options,
−Removed: and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology
−Removed: related to the Research Project.
−Removed: have recently broadened our objective to include the development of an injectable drug candidate of first-in-class PLpro inhibitor to
−Removed: treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir,
−Removed: due to concerns about drug interactions and possible ‘rebound’ infections and other side effects.
−Removed: are the sole owner of all rights pertaining to Adva-27a.
−Removed: These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.
−Removed: patent applications filed under these two PCT's have been issued in the United States under US Patent Number 8,236,935 and 10,272,065.
−Removed: May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
−Removed: application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an
−Removed: enzyme that is essential for viral replication.
−Removed: The patent application has a priority date of May 22, 2020.
−Removed: On April 30, 2021, we filed
−Removed: a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.
−Removed: priority date of May 22, 2020 has been maintained in the newly filed PCT application.
−Removed: April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells
−Removed: The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant
−Removed: mRNA molecules.
−Removed: February 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules
−Removed: which inhibit the Coronavirus protease, PLpro.
−Removed: wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently on the market in
−Removed: These DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical
−Removed: In addition, we are the owner of four (4) NPN’s
−Removed: issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential
−Removed: 9, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin
+Added: _____________
+Added: *See “ Adva-27a Anticancer Compound ”
+Added: Adva-27a Anticancer Compound
+Added: Adva-27a is a small molecule designed for the treatment of aggressive
+Added: forms of cancer.
+Added: A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells
+Added: including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER
+Added: RESEARCH, Volume 32, Pages 4423-4432, October 2012).
+Added: We are the direct owner of all patents pertaining to Adva-27a including U.S.
+Added: Number 8,236,935 and 10,272,065.
+Added: In December 2022, we entered into a research
+Added: agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research
+Added: In August 2023, we were informed by the JGH that the laboratory test results of the Adva-27a molecule
+Added: were not favorable.
+Added: After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH
+Added: of termination of the Research Agreement.
+Added: We have paused the IND-enabling studies of Adva-27a pending a review of the results and
+Added: the possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain
+Added: K1.1 Anticancer mRNA
+Added: In June 2021, we initiated a new research project in which we set out
+Added: to determine if certain mRNA molecules can be used as anti-cancer agents.
+Added: The data collected to date have shown that a selected group
+Added: of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian
+Added: adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
+Added: Studies using non-transformed (normal) human cells (HMEC cells)
+Added: showed that these mRNA molecules had little cytotoxic effects.
+Added: These new mRNA molecules, bearing the laboratory name K1.1, are readily
+Added: adaptable for delivery into patients using the mRNA vaccine technology.
+Added: In April 2022, we filed a provisional patent application in the
+Added: United States covering the subject mRNA molecules.
+Added: In November 2022, we concluded an agreement with a specialized commercial
+Added: partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (“LNP”) for use to conduct xenograft
+Added: mice studies.
+Added: The initial results of our xenograft mice studies indicate that our K1.1 mRNA-LNP is effective at reducing the size of liver
+Added: cancer xenograft tumors in mice.
+Added: We are currently seeking to confirm these results by conducting additional xenograft experiments on a
+Added: broader scale and in more detailed dose-response studies.
+Added: SBFM-PL4 SARS Coronavirus Treatment
+Added: The initial genome expression products following infection by Betacoronavirus,
+Added: the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab.
+Added: These two polyproteins are cleaved at 15 specific
+Added: sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins essential for viral replication.
+Added: Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in the early stages of viral replication.
+Added: PLpro is of particular interest as a therapeutic target in that, in addition to processing essential viral proteins, it is also responsible
+Added: for suppression of the human immune system making the virus more life-threatening.
+Added: PLpro is present only in Betacoronaviruses, the subgroup
+Added: of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
+Added: Our Anti-Coronavirus research effort has been focused on developing
+Added: an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject matter pertaining
+Added: to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.
+Added: In February 2022, we expanded our PLpro inhibitors research effort
+Added: by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the
+Added: in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed
+Added: by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”).
+Added: Under the agreement, the University of Arizona
+Added: granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of
+Added: Arizona under the Research Project.
+Added: In addition, we and the University of Arizona have entered into an option agreement (the “Option
+Added: Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial license for the underlying technology
+Added: of the Research Project.
+Added: On September 13, 2022, we exercised our options, and on February 24, 2023, we entered into an exclusive worldwide
+Added: license agreement with the University of Arizona for all of the technology related to the Research Project.
+Added: We have recently broadened our objective to include the development
+Added: of an injectable drug candidate of first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in
+Added: patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible ‘rebound’
+Added: infections and other side effects.
+Added: Intellectual Property
+Added: We are the sole owner of all rights pertaining to Adva-27a.
+Added: rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.
+Added: The patent applications filed under these two PCT's have been issued in
+Added: the United States under US Patent Number 8,236,935 and 10,272,065.
+Added: On May 22, 2020, we filed a provisional patent application in the United
+Added: States for a new treatment for Coronavirus infections.
+Added: Our patent application covers composition subject matter pertaining to small molecules
+Added: for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication.
+Added: The patent application has a
+Added: priority date of May 22, 2020.
+Added: On April 30, 2021, we filed a PCT application containing new research results and extending coverage to
+Added: include the Coronavirus Papain-Like protease, PLpro.
+Added: The priority date of May 22, 2020 has been maintained in the newly filed PCT application.
+Added: On April 20, 2022, we filed a provisional patent application in the
+Added: United States covering mRNA molecules capable of destroying cancer cells in vitro.
+Added: The patent application contains composition and utility
+Added: subject matter pertaining to the structure and sequence of the relevant mRNA molecules.
+Added: Effective February 24, 2023, we became the exclusive, worldwide licensee
+Added: of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease, PLpro.
+Added: Our wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued
+Added: by Health Canada for prescription drugs currently on the market in Canada.
+Added: These DIN’s were secured through in-licenses or cross-licenses
+Added: from international manufacturers of generic pharmaceutical products.
+Added: In addition, we are the owner of four (4) NPN’s issued by Health
+Added: Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential•9, (ii)
+Added: NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin
D, (iii) NPN 80125047 which authorizes us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes
us to manufacture and sell the OTC product, Taurine.
−Removed: of Operations
−Removed: of results of operations for the three months ended March 31, 2024 and 2023
−Removed: During the three months ended March 31, 2024,
−Removed: we generated $7,541,046 in sales, compared to $4,894,053 for the three months ended March 31, 2023, an increase of $2,646,993, or 54%.
−Removed: The increase is attributable to new product launches and expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma.
−Removed: The direct cost for generating these sales was $5,186,709 (69%) for the three months ended March 31, 2024, compared to $3,065,931 (63%)
−Removed: for the three months ended March 31, 2023.
−Removed: The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of
−Removed: the generic prescription drugs sold by Nora Pharma.
−Removed: Our gross profit grew to $2,354,337 for the three months ended March 31, 2024, compared
−Removed: to $1,828,122 for the three months ended March 31, 2023.
−Removed: General and administrative expenses during the
−Removed: three-month period ended March 31, 2024, were $3,704,926, compared to $3,657,103 during the three-month period ended March 31, 2023, an
−Removed: increase of $47,823.
−Removed: This modest increase was the net result of increases and decreases in our specific expense categories.
−Removed: we saw increased costs in accounting ($182,256), legal ($114,549), marketing ($70,133) and office ($428,753).
−Removed: The categories that decreased
−Removed: were consulting ($84,214), R&D ($210,892) and salaries ($466,545).
−Removed: Overall, we incurred a loss of $1,350,589 from our operations for
−Removed: the three months ended March 31, 2024, compared to a loss of $1,828,981 from our operations in the three-month period ended March 31,
−Removed: In addition, we had interest income of $144,089
−Removed: during the three months ended March 31, 2024, compared to a net interest income of $213,881 during the three months ended March 31, 2023,
−Removed: as a result of interest earned on less cash on hand.
−Removed: As a result, we incurred a net loss of $1,283,801
−Removed: ($0.02 per share) for the three months ended March 31, 2024, compared to a net loss of $1,702,430 ($0.08 per share) for the three-month
−Removed: period ended March 31, 2023.
−Removed: and Capital Resources
−Removed: As of March 31, 2024, we had cash and cash equivalents of $17,434,208.
+Added: Results of Operations
+Added: Comparison of
+Added: results of operations for the three months ended June 30, 2024 and 2023
+Added: During the three months ended June 30, 2024, we
+Added: generated $9,303,067 in sales, compared to $5,560,865 for the three months ended June 30, 2023, an increase of $3,742,202, or 67%.
+Added: increase is attributable to expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma.
+Added: The direct cost for generating
+Added: these sales was $6,946,810 (75%) for the three months ended June 30, 2024, compared to $3,608,118 (65%) for the three months ended June
+Added: The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of the generic prescription drugs.
+Added: Our gross profit grew to $2,356,257 for the three months ended June 30, 2024, compared to $1,952,747 for the three months ended June 30,
+Added: and administrative expenses during the three-month period ended June 30, 2024, were $3,624,533, compared to $2,966,635 during the three-month
+Added: period ended June 30, 2023, an increase of $657,898.
+Added: The increase was due to increases in legal fees ($77,621), marketing ($123,148),
+Added: office expense ($293,595), R&D ($67,670), and salaries ($356,009).
+Added: The increase in salaries was due to the hiring of two (2) new
+Added: employees and a bonus paid to the CEO of the Company.
+Added: The only expense category that saw a decrease was consulting, which was reduced
+Added: Overall, we incurred a loss of $1,268,276 from our operations for the three months ended June 30, 2024, compared to a loss
+Added: of $1,013,888 from our operations in the three-month period ended June 30, 2023.
+Added: addition, we had interest income of $143,995 during the three months ended June 30, 2024, compared to net interest income of $203,049
+Added: during the three months ended June 30, 2023, as a result of less interest earned on cash on hand.
+Added: a result, we incurred a net loss of $494,300 ($9.94 per share) for the three months ended June 30, 2024, compared to a net loss of $902,108
+Added: ($71.17 per share) for the three-month period ended June 30, 2023.
+Added: Comparison of results of operations
+Added: for the six months ended June 30, 2024 and 2023
+Added: During the six months ended June 30 2024, we generated
+Added: revenues of $16,844,113, compared to revenue of $10,454,918 for the six months ended June 30, 2023, an increase of $6,389,195, or 61%.
+Added: The increase is attributable to increased sales generated by our wholly owned subsidiary, Nora Pharma.
+Added: The direct cost for generating
+Added: these revenues was $12,133,519 for the six months ended June 30, 2024 (72%), compared to $6,674,049 (64%) for the six months ended June
+Added: The increase in the cost of goods sold in 2024 is due to an increase in the cost of manufacturing of generic prescription drugs.
+Added: Our gross profit increased to $4,710,594 for the six months ended June 30, 2024, compared to a gross profit of $3,780,869 for the same
+Added: period in 2023.
+Added: and administrative expenses during the six-month period ended June 30, 2024, were $7,378,640, compared to $6,660,398 during the six-month
+Added: period ended June 30, 2023, an increase of $718,242.
+Added: The increase was a result of increases in accounting ($195,369), legal ($185,862),
+Added: marketing ($193,281), and office costs ($734,868).
+Added: The three expense categories that saw a decrease were salaries ($110,536), consulting
+Added: ($422,620) and R&D ($143,222).
+Added: Overall, we incurred a loss of $2,668,046 from our operations in the six-month period ended June 30,
+Added: 2024, compared to a loss from operations of $2,879,529 in the similar period of 2023.
+Added: addition, we had interest income of $288,084 during the six months ended June 30, 2024, compared to interest income of $416,930 during
+Added: the six months ended June 30, 2023.
+Added: The decrease was due to the Company having less cash on hand.
+Added: a result, we incurred a net loss of $1,778,101 ($43.48 per share) for the six-month period ended June 30, 2024, compared to a net loss
+Added: of $2,604,538 ($218.62 per share) for the six-month period ended June 30, 2023.
+Added: Liquidity and Capital Resources
+Added: As of June 30, 2024, we had cash and cash equivalents of $11,507,745.
Net cash used in operating activities was $7,762,942
−Removed: during the three months ended March 31, 2024, compared to $1,850,106 during the three-month period ended March 31, 2023.
−Removed: was a result of increased business activities by Nora Pharma.
+Added: during the six months ended June 30, 2024, compared to $5,628,146 during the six-month period ended June 30, 2023.
+Added: The increase was a
+Added: result of increased business activities by Nora Pharma.
Cash flows used in investing activities were $1,210,944
−Removed: for the three months ended March 31, 2024, compared to $146,303 for the three months ended March 31, 2023.
−Removed: The increase was the result
−Removed: of cash invested in Nora Pharma.
+Added: for the six months ended June 30, 2024, compared to $405,779 for the six months ended June 30, 2023.
+Added: The increase was the result of cash
+Added: invested in Nora Pharma to finance increase in inventory and expansion of product line.
Cash flows provided by financing activities were
−Removed: $5,398,149 during the three months ended March 31, 2024, compared to $538,299 during the three months ended March 31, 2023.
−Removed: was primarily as a result of one offering made during the three months ended March 31, 2024, compared to no financing events completed
−Removed: during the three months ended March 31, 2023.
−Removed: are not generating adequate revenues from our operations to fully implement our business plan as set forth herein.
−Removed: We believe our existing
−Removed: cash on hand will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24
+Added: $5,369,566 during the six months ended June 30, 2024, compared to $3,519,672 during the six months ended June 30, 2023.
+Added: The increase was
+Added: primarily a result of the approximately $10 million financing event completed in February 2024, compared to an approximately $5 million
+Added: financing event completed in May 2023.
+Added: We are not generating adequate revenues from our operations to fully
+Added: implement our business plan as set forth herein.
+Added: We believe our existing cash on hand will be sufficient to fund our pharmaceuticals sales
+Added: operations and research and development activities for the next 24 months.
There is no assurance our estimates will be accurate.
−Removed: We have no committed sources of capital and we anticipate that we will
−Removed: need to raise additional capital in the future, including for further research and development activities and possibly clinical trials,
−Removed: as well as expansion of our generic pharmaceuticals operations.
−Removed: Additional capital may not be available on terms acceptable to us, or
−Removed: Accounting Estimates
−Removed: discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been
−Removed: prepared in accordance with accounting principles generally accepted in the United States.
−Removed: The preparation of these financial statements
−Removed: requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure
−Removed: of contingent assets and liabilities.
−Removed: On an on-going basis, we evaluate our estimates based on historical experience and on various other
−Removed: assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about
−Removed: the carrying values of assets and liabilities that are not readily apparent from other sources.
−Removed: Actual results may differ from these
−Removed: estimates under different assumptions or conditions.
−Removed: a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31,
−Removed: 2023, including our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.
−Removed: Adopted Accounting Standards
−Removed: February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC
−Removed: Paragraphs Pursuant to SEC Staff Accounting Bulletin No.
−Removed: 119 and Update to SEC Section on Effective Date Related to Accounting Standards
−Removed: 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies.
−Removed: ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December
−Removed: The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate
−Removed: a material impact on results of operations.
−Removed: The Company is in the process of determining the effects adoption will have on its consolidated
−Removed: financial statements.
−Removed: August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
−Removed: – Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”).
−Removed: ASU 2020-06 simplifies the accounting
−Removed: for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on
−Removed: an entity’s own equity.
−Removed: The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
−Removed: periods within those fiscal years.
−Removed: Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including
−Removed: interim periods within those fiscal years.
−Removed: The Company is evaluating the impact of this guidance on its unaudited consolidated financial
−Removed: Balance-Sheet Arrangements
+Added: have no committed sources of capital and we anticipate that we will need to raise additional capital in the future, including for further
+Added: research and development activities and possibly clinical trials, as well as expansion of our generic pharmaceuticals operations.
+Added: capital may not be available on terms acceptable to us, or at all.
+Added: Critical Accounting Estimates
+Added: The discussion and analysis of our financial condition and results
+Added: of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted
+Added: in the United States.
+Added: The preparation of these financial statements requires us to make estimates and judgments that affect the amounts
+Added: of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
+Added: On an on-going basis, we evaluate
+Added: our estimates based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
+Added: the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
+Added: from other sources.
+Added: Actual results may differ from these estimates under different assumptions or conditions.
+Added: For a detailed list of significant accounting policies, please see
+Added: our annual report on Form 10-K for the fiscal year ended December 31, 2023, including our financial statements and notes thereto included
+Added: therein as filed with the SEC on March 28, 2024.
+Added: Recently Adopted Accounting Standards
+Added: In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit
+Added: Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No.
+Added: 119 and Update
+Added: to SEC Section on Effective Date Related to Accounting Standards Update No.
+Added: 2016-02, Leases (Topic 842) which amends the effective date
+Added: of the original pronouncement for smaller reporting companies.
+Added: ASU 2016-13 and its amendments will be effective for the Company for interim
+Added: and annual periods in fiscal years beginning after December 15, 2022.
+Added: The Company believes the adoption will modify the way the Company
+Added: analyzes financial instruments, but it does not anticipate a material impact on results of operations.
+Added: The Company is in the process of
+Added: determining the effects adoption will have on its consolidated financial statements.
+Added: In August 2020, the FASB issued ASU 2020-06, Debt – Debt with
+Added: Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815
+Added: – 40), (“ASU 2020-06”).
+Added: ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics
+Added: of liabilities and equity, including convertible instruments and contracts on an entity’s own equity.
+Added: The ASU2020-06 amendments
+Added: are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years.
+Added: Early adoption is permitted,
+Added: but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years.
+Added: The Company is
+Added: evaluating the impact of this guidance on its unaudited consolidated financial statements.
+Added: Off Balance-Sheet Arrangements
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
−Removed: are a smaller reporting company and are not required to provide the information under this item.
+Added: We are a smaller reporting company and are not required to provide
+Added: the information under this item.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.