What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-20 compared with 2023-11-13 · 155 added, 190 removed, 140 unchanged (71% of the section changed)

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following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein.

discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the

Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

The statements regarding Sunshine

Biopharma, Inc.

contained in this Report that are not historical in nature, particularly those that utilize terminology such as “may,”

“will,” “should,” “likely,” “expects,” “anticipates,” “estimates,”

“believes” or “plans,” 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.

Important 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 the year ended December 31, 2022.

We undertake no obligation to correct or update any forward-looking

statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.

advised, however, to consult any future disclosures we make on related subjects in future reports to the SEC .

This discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as

amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

statements regarding Sunshine Biopharma, Inc.

contained in this Report that are not historical in nature, particularly those that

utilize terminology such as “may,” “will,” “should,” “likely,”

“expects,” “anticipates,” “estimates,” “believes” or “plans,” 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.

Important 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 the year ended December 31, 2023.

We undertake no obligation to correct or update any forward-looking statements,

whether as a result of new information, future events or otherwise, except as may be required under applicable law.

You are advised,

however, to consult any future disclosures we make on related subjects in future reports we file with the SEC .

Sunshine Biopharma

are a pharmaceutical company offering and researching life-saving medicines

in a wide variety of therapeutic areas, including oncology and antivirals.

In addition to pursuing our own drug development program, we

operate two wholly owned subsidiaries:

are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology

and antivirals.

We operate two wholly owned subsidiaries:

(i) Nora Pharma Inc.

(“Nora Pharma”), a Canadian corporation with a portfolio consisting

of 51 generic prescription drugs on the market in Canada and 32 additional drugs scheduled to be launched in Canada in 2024 and 2025,

and (ii) Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription

over-the-counter (“OTC”) products.

(“Nora Pharma”), a Canadian corporation with

a portfolio consisting of 52 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.

Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

addition, we are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii)

SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer.

Development of the latter

has been paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023.

See “Drugs in

Development” below.

were incorporated in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma, Inc.

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classified as a reverse acquisition.

Biopharma, Inc.

held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”).

Upon completion of the reverse acquisition transaction, we changed our name to Sunshine Biopharma, Inc.

and began operating as a pharmaceutical

Sunshine Biopharma, Inc.

held an exclusive license to a new anticancer drug bearing the laboratory

name, Adva-27a (the “License Agreement”).

Upon completion of the reverse acquisition transaction, we changed our name to

Sunshine Biopharma, Inc.

and began operating as a pharmaceutical company.

December 2015, we acquired all worldwide issued (US Patent Number 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 terminated the License Agreement.

Development of Adva-27a has recently

been paused pending further analysis of unexpected in vitro results obtained in the latter part of 2023.

See “Drugs in Development”

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

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containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.

June 2021, we initiated another R&D project in which we set out to determine if certain

mRNA molecules can be used as anticancer agents.

The data obtained for mRNA molecules bearing

the laboratory name K1.1 became the subject of a new patent application filed in April 2022.

October 2022, we acquired Nora Pharma, a Canadian generic pharmaceuticals company based in the greater Montreal area.

Nora Pharma has

41 employees and operates in a 15,000 square foot facility certified by Health Canada.

Nora Pharma currently sells 51 generic prescription

drugs in Canada.

The consolidated financial statements contained in this report include the results of operations of Nora Pharma and

Sunshine Canada.

Prescription Drugs on the Market

a result of the acquisition of Nora Pharma we now have the following generic prescription drugs on the market in Canada:

June 2021, we initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer

The data obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in

October 20, 2022, we acquired Nora Pharma Inc.

(“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater

Montreal area.

Nora Pharma has 44 employees and operates in a 23,500 square foot facility certified by Health Canada.

Nora Pharma currently

has 52 generic prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in 2024

on the Market

Nora Pharma we currently have the following generic prescription drugs on the market in Canada:

Action/Indication

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Cardiovascular

Antipsychotic

Cardiovascular

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Central nervous system

Prescription Drugs Pipeline

addition to the 51 drugs on the market, we currently have the following

roster of generic prescription drugs scheduled to be launched in 2024 and 2025:

Group A (2 Products)

Cardiovascular,

Under manufacturing

Group B (6 Products)

Oncology, Gastroenterology,

Under regulatory review

Group C (3 Products)

Central Nervous System,

Diabetes , CNS*

Under regulatory review

Group D (5 Products)

Cardiovascular, Urology,

Endocrinology

Under regulatory review

Group E (16 Products)

Cardiovascular, Oncology,

Anti-infectives, Anti-inflammatory, Diabetes, Gastroenterology, CNS*

Soon to be under regulatory

* Central Nervous

believe the addition of these products to our existing portfolio will strengthen our presence in the Canadian generic drugs marketplace

and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.

Drugs in Development

are currently developing the following drug candidates:

In addition to the 52 drugs currently on the market, we have 32 additional

drugs scheduled to be launched in 2024 and 2025.

These new drugs will address various human health areas including cardiovascular, oncology,

gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.

Among the new drugs

to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®.

Similar to NEULASTA®, NIOPEG® is a long-acting form of recombinant

human granulocyte colony-stimulating factor (filgrastim).

It is indicated to decrease the incidence of infection in patients with non-myeloid

malignancies receiving anti-neoplastic therapy.

Nora Pharma received Health Canada marketing approval for NIOPEG® on April 17, 2024.

We believe the addition of these new products

to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater

access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.

in Development

following table summarizes our proprietary drugs in development:

Adva-27a (Small Molecule)

Oncology (Pancreatic Cancer)

9 - Subsequent Events

K1.1 (mRNA LNP)

Oncology (Liver Cancer)

Animal Testing

SBFM-PL4 (Small Molecule)

Antiviral (COVID-19)

To be determined

Anticancer Drug

Antiviral (SARS Coronavirus)

Animal Testing

“Adva-27a Anticancer Compound” below

Anticancer Compound

is a small molecule designed for the treatment of aggressive forms of cancer.

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Patents Number 8,236,935 and 10,272,065.

December 2022, we entered into a research agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling

studies of Adva-27a (the “Research Agreement”).

In August 2023, we were informed by the JGH that the lab results on testing

of the Adva-27a molecule were not favorable.

After conclusion of an internal review of the lab results on November 2, 2023, we provided

notice to JGH of termination of the Research Agreement.

We have now paused the IND-enabling studies of Adva-27a pending a review of the

possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain studies.

In December 2022, we entered into a research agreement

with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research Agreement”).

In August 2023, we were informed by the JGH that the laboratory results on testing of the Adva-27a molecule were not favorable.

conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH of termination of the Research

We have paused the IND-enabling studies of Adva-27a pending a review of the results and the possibility of chemical modification

of the compound to address the suboptimal performance of the molecule in certain studies.

Anticancer mRNA

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In April 2022, we filed a provisional patent application in the United States covering the subject mRNA molecules.

recently concluded an agreement with a specialized partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles,

ready for use to conduct studies in xenograft mice.

We anticipate commencing such studies later this year.

Coronavirus Treatment

November 2022, we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules

into lipid nanoparticles (“LNP”) for use to conduct xenograft mice studies.

The initial results of our xenograft mice studies

indicate that our K1.1 mRNA-LNP is effective at reducing the size of liver cancer xenograft tumors in mice.

We are currently seeking

to confirm these results by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.

SARS Coronavirus Treatment

initial genome expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins,

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three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research

Under the agreement, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing

Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing

license for all intellectual property developed by University of Arizona under the Research Project.

In addition, the Company and the

University of Arizona entered into an option agreement (the “Option Agreement”) whereby the Company was granted a first option

to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project.

On September 13, 2022, we exercised

our options, and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all

of the technology related to the Research Project.

have recently expanded our objective to include the development of an injectable candidate of first-in-class PLpro inhibitor to

treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or

Remdesivir, due to concerns about drug interaction and possible ‘rebound’ infections and other side effects.

are the sole owner of all worldwide rights pertaining to Adva-27a.

In addition, we and the University

of Arizona have entered into an option agreement (the “Option Agreement”) whereby we were granted a first option to negotiate

a royalty-bearing commercial license for the underlying technology of the Research Project.

On September 13, 2022, we exercised our options,

and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology

related to the Research Project.

have recently broadened our objective to include the development of an injectable drug candidate of first-in-class PLpro inhibitor to

treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir,

due to concerns about drug interactions and possible ‘rebound’ infections and other side effects.

are the sole owner of all rights pertaining to Adva-27a.

These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.

The patent applications filed under these two PCT's have been issued in the United States (US Patent Number 8,236,935 and 10,272,065),

Europe, and Canada.

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.

May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.

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mRNA molecules.

Our wholly owned subsidiary, Nora Pharma, owns 180 Drug Identification Numbers (“DIN’s”) issued by Health

Canada for prescription drugs currently on the market in Canada.

These DIN’s were secured through in-licenses or cross-licenses

from international manufacturers of generic pharmaceutical products.

addition, we are the owner of two Natural Product Numbers (“NPN’s”) issued by Health Canada:

NPN 80089663 authorizes

us to manufacture and sell our in-house developed OTC product, Essential 9™, and NPN 80093432 authorizes us to manufacture and

sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D ™ .

February 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules

which inhibit the Coronavirus protease, PLpro.

wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently on the market in

These DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical

In addition, we are the owner of four (4) NPN’s

issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential

9, (ii) 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.

of Operations

of results of operations for the three months ended September 30, 2023 and 2022

the three months ended September 30, 2023, we generated $5,957,668 in sales, compared to $132,808 for the three months ended September

30, 2022, an increase of $5,824,860.

The increase is attributable to sales generated by our wholly owned subsidiary,

The direct cost for generating these sales was $3,967,412 (66.6%) for the three months ended September 30, 2023, compared

to $65,783 (49.5%) for the three months ended September 30, 2022.

The increase in the cost of goods sold in 2023 is due to increased

cost of manufacturing of the generic prescription drugs sold by Nora Pharma.

Our gross profit grew to $1,990,256 for the three months

ended September 30, 2023, compared to $67,025 for the three months ended September 30, 2022.

and administrative expenses during the three-month period ended September 30, 2023, were $2,769,730, compared to $1,785,005 during the

three-month period ended September 30, 2022, an increase of $984,725.

This increase was the result of increased overhead associated with

being a Nasdaq listed company and expenses related to Nora Pharma operations.

Specifically, we incurred increased costs in consulting

($58,929), office ($467,397), salaries ($549,377) and taxes ($52,586).

of results of operations for the three months ended March 31, 2024 and 2023

During the three months ended March 31, 2024,

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%.

The increase is attributable to new product launches and expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma.

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%)

for the three months ended March 31, 2023.

The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of

the generic prescription drugs sold by Nora Pharma.

Our gross profit grew to $2,354,337 for the three months ended March 31, 2024, compared

to $1,828,122 for the three months ended March 31, 2023.

General and administrative expenses during the

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

increase of $47,823.

This modest increase was the net result of increases and decreases in our specific expense categories.

we saw increased costs in accounting ($182,256), legal ($114,549), marketing ($70,133) and office ($428,753).

The categories that decreased

were consulting ($84,214), R&D ($210,892) and salaries ($466,545).

Overall, we incurred a loss of $1,350,589 from our operations for

the three months ended September 30, 2023, compared to a loss of $1,717,980 from our operations in the three-month period ended September

addition, we had net interest income of $168,904 during the three months ended September 30, 2023, compared to a net interest income

of approximately $260,936 during the three months ended September 30, 2022, as a result of interest earned on cash on hand.

a result, we incurred a net loss of $651,482 ($0.04 per share) for the three months ended September 30, 2023, compared to a net loss

of $1,457,019 ($0.08 per share) for the three-month period ended September 30, 2022.

of results of operations for the nine months ended September 30, 2023 and 2022

the nine months ended September 30 2023, we generated revenues of $16,412,586, compared to revenues of $405,760 for the nine months ended

September 30, 2022, an increase of $16,006,826.

The increase is attributable to sales generated by our recently acquired wholly owned

subsidiary, Nora Pharma.

The direct cost for generating these revenues was $10,641,461 (64.8%) for the nine months ended September 30,

2023, compared to $200,311 (49.4%) for the nine months ended September 30, 2022.

The increase in the cost of goods sold in 2023 is due

to increased cost of manufacturing of the generic prescription drugs sold by Nora Pharma.

Our gross profit increased to $5,771,125 for

the nine months ended September 30, 2023, compared to a gross profit of $205,449 for the same period in 2022.

and administrative expenses during the nine-month period ended September 30, 2023 were $9,369,203 compared to $3,842,589 during the nine-month

period ended September 30, 2022, an increase of $5,526,614.

This increase was the result of increased overhead associated with being

a Nasdaq listed company and expenses related to Nora Pharma operations.

Specifically, we incurred increased costs in accounting ($63,608),

consulting ($475,817), office costs ($972,328), research and development ($269,407), salaries ($3,239,801) and taxes ($212,953).

we incurred a loss of $3,598,078 from our operations in the nine-month period ended September 30, 2023, compared to a loss from operations

of $3,637,140 in the similar period of 2022.

addition, we had net interest income of $517,163 during the nine months ended September 30, 2023, compared to a net interest income of

$394,118 during the nine months ended September 30, 2022, as a result of interest earned on cash on hand.

a result, we incurred a net loss of $3,256,020 ($0.12 per share) for the nine-month period ended September 30, 2023, compared to a net

loss of $3,232,125 ($0.26 per share) for the nine-month period ended September 30, 2022.

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,

In addition, we had interest income of $144,089

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,

as a result of interest earned on less cash on hand.

As a result, we incurred a net loss of $1,283,801

($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

period ended March 31, 2023.

and Capital Resources

As of September

30, 2023, we had cash or cash equivalents of $18,846,140.

cash used in operating activities was $6,085,435 during the nine months ended September 30, 2023, compared to $3,001,746 during the nine-month

period ended September 30, 2022.

The increase was a result of the addition of Nora Pharma’s operations.

flows used in investing activities were $386,920 for the nine months ended September 30, 2023, compared to $0 for the nine months ended

September 30, 2022.

The increase was the result of cash invested in Nora Pharma.

flows provided by financing activities were $3,456,106 during the nine months ended September 30, 2023, compared to $41,561,363 during

the nine months ended September 30, 2022.

The decrease was primarily as a result of one offering made during the nine months ended September

30, 2023, compared to three offerings completed in February, March, and April 2022, and due to our repurchase of a total of $540,629

in common stock in the first and third quarter of 2023.

As of March 31, 2024, we had cash and cash equivalents of $17,434,208.

Net cash used in operating activities was $3,185,159

during the three months ended March 31, 2024, compared to $1,850,106 during the three-month period ended March 31, 2023.

was a result of increased business activities by Nora Pharma.

Cash flows used in investing activities were $668,736

for the three months ended March 31, 2024, compared to $146,303 for the three months ended March 31, 2023.

The increase was the result

of cash invested in Nora Pharma.

Cash flows provided by financing activities were

$5,398,149 during the three months ended March 31, 2024, compared to $538,299 during the three months ended March 31, 2023.

was primarily as a result of one offering made during the three months ended March 31, 2024, compared to no financing events completed

during the three months ended March 31, 2023.

are not generating adequate revenues from our operations to fully implement our business plan as set forth herein.

On February 17, 2022,

we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in an underwritten public offering.

On March 14, 2022, we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in a private placement.

On April 28, 2022, we received net proceeds of approximately $16.8 million from the sale of common stock and warrants in a private placement.

On May 16, 2023, we received net proceeds of approximately $4.1 million from the sale of common stock and warrants in a private placement.

We believe our existing cash will be sufficient to fund our operations, including general and administrative expenses, research and development

activities, and the generic pharmaceuticals sales business, for the next 18 to 24 months.

There is no assurance our estimates will be

estimates that we will need additional capital in the amount of approximately $30 million

for expansion of our drug development activities and generic pharmaceuticals operations,

including possibly a Phase I clinical trial.

Additional capital may not be available on terms

acceptable to us, or at all.

Currently, we do not have any committed arrangements for

financing and can provide no assurance that we will be able to obtain financing when required.

No assurance can be given that we will obtain access to capital markets in the future or

that financing, adequate to satisfy the cash requirements of implementing our business will

be available on acceptable terms.

Our inability to obtain acceptable financing could have

an adverse effect upon the results of our operations and financial condition.

We believe our existing

cash on hand will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24

There is no assurance our estimates will be accurate.

We have no committed sources of capital and we anticipate that we will

need to raise additional capital in the future, including for further research and development activities and possibly clinical trials,

as well as expansion of our generic pharmaceuticals operations.

Additional capital may not be available on terms acceptable to us, or

Accounting Estimates

discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have

been prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these financial

statements requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and

related disclosure of contingent assets and liabilities.

On an on-going basis, we evaluate our estimates based on historical

experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form

the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions or conditions.

discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been

prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these financial statements

requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure

of contingent assets and liabilities.

On an on-going basis, we evaluate our estimates based on historical experience and on various other

assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about

the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these

estimates under different assumptions or conditions.

a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31,

2022, including our financial statements and notes thereto included therein as filed with the SEC on April 4, 2023.

2023, including our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.

Adopted Accounting Standards

22 unchanged sentences

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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis