Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: June 30, 2024

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from            to          

 

Commission File Number: 001-41282

 

 

SUNSHINE BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Colorado		20-5566275
(State of other jurisdiction of incorporation)		(IRS Employer ID No.)

 

333 Las Olas Way,

CU4 Suite 433

Fort Lauderdale, FL 33301

(Address of principal executive offices)

 

954-515-0810

(Issuer’s Telephone Number)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Common Stock		SBFM		The NASDAQ Stock Market LLC
Common Stock Purchase Warrants		SBFMW		The NASDAQ Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)

 

	Large accelerated filer  ☐	Accelerated filer  ☐
	Non-accelerated filer  ☒	Smaller reporting company  ☒
		Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

 

The number of shares of the registrant’s common stock, par value $0.001, issued and outstanding as of August 16, 2024, was 1,124,341 shares.

 

 

 

 

 

 

TABLE OF CONTENTS

 

		Page
	PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements	3
	Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023	3
	Consolidated Statements of Operations for the Six Months Ended June 30, 2024 and 2023 (Unaudited)	4
	Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023 (Unaudited)	5
	Consolidated Statement of Shareholders' Equity for the Six Months Ended June 30, 2024 and 2023 (Unaudited)	6
	Notes to Unaudited Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4.	Controls and Procedures	22

 

	PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	23
Item 1A.	Risk Factors	23
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3.	Defaults Upon Senior Securities	23
Item 4.	Mine Safety Disclosures	23
Item 5.	Other Information	23
Item 6.	Exhibits	23
	Signatures	24

 

 

 

 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

Sunshine Biopharma, Inc.

Consolidated Balance Sheets

 

		June 30,				December 31,
		2024				2023
		(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents		$	11,507,745			$	16,292,347
Accounts receivable			3,973,550				2,552,362
Inventory			8,490,745				5,734,755
Prepaid expenses			1,776,480				310,591
Total Current Assets			25,748,520				24,890,055
Long-Term Assets:
Property & equipment			541,410				365,868
Intangible assets			2,447,128				1,444,259
Right-of-use-asset			563,920				646,779
Total Long-Term Assets			3,552,458				2,456,906
TOTAL ASSETS		$	29,300,978			$	27,346,961
LIABILITIES
Current Liabilities:
Accounts payable & accrued expenses		$	4,930,055			$	2,585,466
Earnout payable			–				2,547,831
Income tax payable			254,971				299,869
Current portion - right-of-use-liability			114,452				118,670
Total Current Liabilities			5,299,478				5,551,836
Long-Term Liabilities:
Deferred tax liability			48,729				48,729
Right-of-use-liability			462,906				539,035
Total Long-Term Liabilities			511,635				587,764
TOTAL LIABILITIES			5,811,114				6,139,600
SHAREHOLDERS' EQUITY
Preferred Stock, Series B $0.10 par value per share; 1,000,000 shares authorized; 130,000 and 10,000 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			13,000				1,000
Common Stock, $0.001 par value per share; 3,000,000,000 shares authorized; 1,170,510 and 14,012 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			1,171				14
Capital paid in excess of par value			89,842,503				84,415,900
Accumulated comprehensive income (loss)			(683,050	)			696,105
Accumulated (Deficit)			(65,683,759	)			(63,905,658	)
TOTAL SHAREHOLDERS' EQUITY			23,489,865				21,207,361
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY		$	29,300,978			$	27,346,961

 

See Accompanying Notes To These Financial Statements

 

 

 

 

 

Sunshine Biopharma, Inc.

Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

           

 

		3 Months Ended June 30,								6 Months Ended June 30,
		2024				2023				2024				2023
Sales		$	9,303,067			$	5,560,865			$	16,844,113			$	10,454,918
Cost of sales			6,946,810				3,608,118				12,133,519				6,674,049
Gross profit			2,356,257				1,952,747				4,710,594				3,780,869
General & Administrative Expenses:
Accounting			88,394				75,281				440,400				245,031
Consulting			54,048				392,454				101,449				524,069
Director fees			100,000				100,000				200,000				200,000
Legal			223,436				145,815				445,434				259,572
Marketing			256,325				133,177				454,371				261,090
Office			713,245				419,650				1,673,636				938,768
R&D			436,235				368,565				658,268				801,490
Salaries			1,556,176				1,200,167				3,089,888				3,200,424
Taxes			145,805				96,649				221,706				160,367
Depreciation			50,870				34,877				93,488				69,587
Total General & Administrative Expenses:			3,624,533				2,966,635				7,378,640				6,660,398
(Loss) from operations			(1,268,276	)			(1,013,888	)			(2,668,046	)			(2,879,529	)
Other Income (Expense):
Foreign exchange (loss)			286,535				(261	)			280,768				(246	)
Interest income			143,995				203,049				288,084				416,930
Interest expense			(245	)			(3,331	)			(245	)			(7,746	)
Total Other Income (Expense)			430,285				199,457				568,607				408,938
Net (loss) before income taxes			(837,991	)			(814,431	)			(2,099,439	)			(2,470,591	)
Provision for income taxes			343,691				(87,677	)			321,338				(133,947	)
Net (Loss)		$	(494,300	)		$	(902,108	)		$	(1,778,101	)		$	(2,604,538	)
Comprehensive Income (Loss):
Gain (Loss) from foreign exchange translation			(835,450	)			492,049				(1,379,155	)			503,209
Comprehensive Income (Loss)		$	(1,329,750	)		$	(410,059	)		$	(3,157,256	)		$	(2,101,329	)
Basic (Loss) per common share		$	(9.94	)		$	(71.17	)		$	(43.48	)		$	(218.62	)
Weighted Average Common Shares Outstanding (Basic)			49,726				12,675				40,896				11,914

 

           

See Accompanying Notes To These Financial Statements

 

 

 

 

 

 

Sunshine Biopharma, Inc.

Consolidated Statements of Cash Flows (Unaudited)

 

		June 30,				June 30,
		2024				2023
Cash Flows From Operating Activities:
Net (Loss)		$	(1,778,101	)		$	(2,604,538	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			93,494				69,594
Stock issued for services			12,000				–
Accounts receivable			(1,867,693	)			(55,160	)
Inventory			(2,949,128	)			(885,243	)
Prepaid expenses			(272,810	)			182,852
Accounts Payable & accrued expenses			2,794,798				(1,103,502	)
Earn-out payable			(2,547,831	)			(1,084,169	)
Income tax payable			(1,247,671	)			(147,980	)
Net Cash Flows (Used In) Operating Activities			(7,762,942	)			(5,628,146	)
Cash Flows From Investing Activities:
Reduction in right-of-use asset			61,074				66,846
Purchase of intangible assets			(234,569	)			(17,645	)
Purchase of equipment			(1,037,450	)			(454,980	)
Net Cash Flows (Used In) Investing Activities			(1,210,944	)			(405,779	)
Cash Flows From Financing Activities:
Proceeds from public offering net (common stock)			8,522,411				4,089,208
Exercise of warrants			45,000				1,156
Purchase of treasury stock			(3,139,651	)			(506,822	)
Lease liability			(58,194	)			(63,870	)
Net Cash Flows Provided by Financing Activities			5,369,566				3,519,672
Cash and Cash Equivalents at Beginning of Period			16,292,347				21,826,437
Net increase (decrease) in cash and cash equivalents			(3,604,320	)			(2,514,253	)
Effect of exchange rate changes on cash			–				9
Foreign currency translation adjustment			(1,180,282	)			417,298
Cash and Cash Equivalents at End of Period		$	11,507,745			$	19,729,491
Supplementary Disclosure of Cash Flow Information:
Cash paid for income taxes		$	956,012			$	–
Stock issued for services		$	12,000			$	–

 

See Accompanying Notes To These Financial Statements

 

 

 

 

 

Sunshine Biopharma, Inc.

Consolidated Statements of Shareholders' Equity (Unaudited)

                   

 

Three Months		Number Of Common Shares				Common				Capital Paid in Excess of Par				Treasury				Number Of Preferred Shares				Preferred				Comprehensive				Accumulated
Periods		Issued				Stock				Value				Stock				Issued				Stock				Income				Deficit				Total
Balance March 31, 2024			49,726				50			$	89,843,624			$	–				130,000			$	13,000			$	152,400			$	(65,189,459	)		$	24,819,615
Exercise of warrants			1,120,784				1,121				(1,121	)			–				–				–				–				–				–
Net (loss)			–				–				–				–				–				–				(835,450	)			(494,300	)			(1,329,750	)
Balance at June 30, 2024			1,170,510			$	1,171			$	89,842,503			$	–				130,000				13,000			$	(683,050	)		$	(65,683,759	)			23,489,865
Balance March 31, 2023			11,070			$	11			$	80,357,504			$	–				10,000			$	1,000			$	173,007			$	(61,102,044	)		$	19,429,478
Common stock and prefunded warrants issued in a private offering			1,225				1				4,089,217				–				–				–				–				–				4,089,218
Exercise of warrants			578				1				1,155				–				–				–				–				–				1,156
Net (loss)			–				–				–				–				–				–				492,049				(902,108	)			(410,059	)
Balance at June 30, 2023			12,873			$	13			$	84,447,876			$	–				10,000			$	1,000			$	665,056			$	(62,004,152	)		$	23,109,793
Six Months Periods
Balance December 31, 2023			14,012			$	14			$	84,415,900			$	–				10,000			$	1,000			$	696,105			$	(63,905,658	)		$	21,207,361
Preferred Stock issued to related party			–				–				–				–				120,000				12,000				–				–				12,000
Common stock and pre-funded warrants issued in an underwritten offering			13,214				13				8,522,398				–				–				–				–				–				8,522,411
Exercise of warrants			1,143,284				1,144				43,856				–				–				–				–				–				45,000
Repurchase of warrants			–				–				(3,139,651	)			–				–				–				–				–				(3,139,651
Net (loss)			–				–				–				–				–				–				(1,379,155	)			(1,778,101	)			(3,157,256	)
Balance at June 30, 2024			1,170,510			$	1,171			$	89,842,503			$	–				130,000				13,000			$	(683,050	)		$	(65,683,759	)		$	23,489,865
Balance December 31, 2022			11,293			$	11			$	80,864,326			$	–				10,000			$	1,000			$	161,847			$	(59,399,614	)		$	21,627,570
Repurchase Stock			(223	)			–				(506,822	)			–				–				–				–				–				(506,822	)
Common stock and prefunded warrants issued in a private offering			1,225				1				4,089,217				–				–				–				–				–				4,089,218
Exercise of warrants			578				1				1,155				–				–				–				–				–				1,156
Net (loss)			–				–				–				–				–				–				503,209				(2,604,538	)			(2,101,329	)
Balance at June 30, 2023			12,873			$	13			$	84,447,876			$	–				10,000			$	1,000			$	665,056			$	(62,004,152	)		$	23,109,793

 

 

See Accompanying Notes To These Financial Statements

 

 

Sunshine Biopharma, Inc.

Notes to Unaudited Consolidated Financial Statements

For the Six Months Ended June 30, 2024 and 2023

 

Note 1 – Description of Business

 

The Company was incorporated under the name Mountain West Business Solutions, Inc. on August 31, 2006, in the State of Colorado. Effective October 15, 2009, the Company acquired Sunshine Biopharma, Inc. in a transaction classified as a reverse acquisition. Upon completion of the reverse acquisition, the Company changed its name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical company.

 

Sunshine Biopharma operates two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio of pharmaceutical products consisting of 61 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

 

The Company has determined that it has two reportable segments:

 

	·	Prescription Generic Pharmaceuticals (“Generic Pharmaceuticals”)
	·	Nonprescription Over-The-Counter Products (“OTC Products)

 

Through June 30, 2024, sales from the Generic Pharmaceuticals segment represented approximately 97% of total revenues of the Company while the remaining approximately 3% was generated from the sale of OTC Products. Based on these results, the Company deems segmentation reporting to be immaterial at June 30, 2024.

 

The Company is not subject to material customer concentration risks as it sells its products directly to pharmacies in several Canadian provinces. However, in Canada provincial governments reimburse patients for their prescription drugs expenditures to various degrees under drug reimbursement programs, making generic drugs prices highly dependent on governmental policies which may change over time. The most recent negotiations between the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association have resulted in updated generic pricing for certain products which took effect on October 1, 2023. The updated prices are valid for three years and the agreement may be extended for an additional two years.

 

In addition, the Company is engaged in the development of the following proprietary drugs:

 

	·	Adva-27a, a small chemotherapy molecule for treatment of pancreatic cancer (IND-enabling studies were paused on November 2, 2023)
	·	K1.1 mRNA, a lipid nano-particle (LNP) targeted for liver cancer
	·	SBFM-PL4, a protease inhibitor for treatment of Coronavirus infections

 

 

  

Note 2 – Basis of Presentation

 

The unaudited consolidated financial statements of the Company for the three and six months periods ended June 30, 2024 and 2023, have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2023, was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024. These financial statements should be read in conjunction with that report.

 

On April 17, 2024 and August 8, 2024, the Company completed a 1-for-100 and a 1-for-20 reverse split of its common stock, respectively (the “Reverse Splits”). The share amounts, warrants, and related parameters specified in this report have been adjusted to reflect both Reverse Splits on a retroactive basis.

 

Note 3 – Underwritten Public Offering

 

On February 15, 2024, the Company completed an underwritten public offering for gross proceeds of approximately $10 million, before deducting fees to the underwriter and other offering expenses payable by the Company. The net proceeds received by the Company were $8,522,411.

 

The offering consisted of 35,714 Units, consisting of (i) 13,214 Common Units, with each Common Unit consisting of one share of common stock, one-tenth of a Series A warrant to purchase one share of common stock (“Series A Warrant”) and two-tenths of a Series B warrant to purchase one share of common stock (“Series B Warrant”), and (ii) 22,500 Pre-Funded Units, with each Pre-Funded Unit consisting of one pre-funded warrant to purchase one share of common stock (“Pre-Funded Warrants”), one-tenth of a Series A Warrant and two-tenths of a Series B Warrant. The public offering price was $280.00 per Common Unit and $278.00 per Pre-Funded Unit. The Pre-Funded Warrants have an exercise price of $2.00 per share. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full. The initial exercise price of each Series A Warrant was $4,200.00 per share of common stock or pursuant to an alternative cashless exercise option. Under the alternative cashless exercise provision, which became effective following stockholder approval in March 2024, each Series A Warrant was exercisable on a cashless basis for two shares of common stock. The Series A Warrants were exercisable immediately and expire 30 months after the initial issuance date. The initial exercise price of each Series B Warrant was $4,760.00 per share of common stock. The Series B Warrants are exercisable immediately and expire 60 months after the initial issuance date.

 

In addition (effective following the stockholder approval), the Series A Warrants and Series B Warrants included a provision under which, following a reverse split of the common stock, the exercise price will be adjusted to the lowest volume weighted average price (“VWAP”) for the five trading days immediately preceding and immediately following the date of reverse stock split, and the number of shares issuable upon exercise of the Series A Warrants or Series B Warrants will be adjusted such that the aggregate exercise price of the Series A Warrants or Series B Warrants will remain unchanged. The Series B Warrants do not include an alternate cashless exercise provision and can only be exercised for cash so long as the Company’s registration statement for such warrants and underlying shares remains effective.

 

In addition, the Company granted the underwriter, Aegis Capital Corp. ("Aegis"), a 45-day option to purchase up to an additional 15% of the total number of shares of common stock and/or Pre-Funded Warrants and/or Series A Warrants and/or Series B Warrants sold in the offering, solely to cover overallotments, if any. On February 15, 2024, Aegis partially exercised its over-allotment option for a total of 415 Series A Warrants and 830 Series B Warrants.

 

On February 13, 2024, the Company obtained stockholder approval for (i) adjustment of the number of underlying shares and exercise price for both the Series A Warrants and the Series B warrants, and (ii) the alternate cashless exercise provision for the Series A warrants.

 

 

 

 

As of June 30, 2024, all of the Pre-Funded Warrants and all of the Series A warrants have been exercised resulting in the Company issuing 22,500 and 1,120,784 shares of common stock, respectively. In connection with such exercises, the Company received net proceeds of $45,000 and $0, respectively.

 

As of August 16, 2024, the only securities remaining outstanding in connection with this offering are 13,612,927 Series B Warrants exercisable at $2.7879 per share. These warrants are subject to further adjustments per the Series B Warrant Agreement.

 

Note 4 – Acquisition of Nora Pharma Inc.

 

On October 20, 2022, the Company acquired all of the issued and outstanding shares of Nora Pharma Inc. (“Nora Pharma”), a Canadian privately held pharmaceutical company. The purchase price for the shares was $18,860,637 (USD), $14,346,637 of which was paid in cash and the remainder was paid through the issuance of 1,850 shares of the Company’s common stock valued at $4,514,000 or $2,440 per share. Nora Pharma sells generic pharmaceutical products in Canada. Nora Pharma’s operations are authorized by a Drug Establishment License issued by Health Canada.

 

The following table summarizes the allocation of the purchase price as of October 20, 2022, the acquisition date using Nora Pharma’s balance sheet assets and liabilities:

Schedule of allocation of purchase price
Accounts receivable		$	1,358,121
Inventory			3,181,916
Intangible assets			659,571
Equipment & furniture			210,503
Other assets			1,105,093
Total assets			6,515,204
Liabilities assumed			(5,981,286	)
Net assets			533,918
Goodwill			18,326,719
Total Consideration		$	18,860,637

 

The value of the 1,850 common shares issued as part of the consideration paid for Nora Pharma was determined based on the closing market price of the Company’s common shares on the acquisition date, October 20, 2022 ($2,440 per share).

 

 

 

 

 

The Company impaired 100% of the goodwill amount in 2022 and plans to depreciate the intangible assets as detailed in Note 5 below.

 

As part of the consideration paid for Nora Pharma, the Company agreed to a $5,000,000 CAD ($3,632,000 USD) earn-out amount payable to Mr. Malek Chamoun, the Seller of Nora Pharma and its current President. The earnout is payable in the form of twenty (20) payments of $250,000 CAD for every $1,000,000 CAD increase in gross sales (as defined in the Purchase Agreement) above Nora Pharma’s June 30, 2022 gross sales, provided that his employment with the Company is not terminated pursuant to the Company’s employment agreement with him. The total earn-out amount of $3,632,000 has been recorded as a salary payable. During the fiscal year ended December 31, 2023, the Company paid an earn-out amount of $1,084,169 for the fiscal year ended December 31, 2022. On April 22, 2024, the Company paid an earn-out amount of $3,093,878 CAD (approximately $2,291,761 USD) for the earn-out realized in fiscal year 2023. The current remaining earn-out balance is $479,207 CAD (approximately $354,968 USD).

 

Note 5 – Intangible Assets

 

Intangible assets, net consisted of the following:

Schedule of intangible assets
		June 30, 2024				December 31, 2023
Balance at beginning of the year		$	1,444,259				776,856
Purchase of additional intangible assets (licenses)			1,077,380				710,372
Total			2,521,639				1,487,228
Less accumulated amortization			(74,511	)			(42,969	)
Finite-lived intangible assets, net		$	2,447,128			$	1,444,259

 

As of June 30, 2024, the estimated amortization amounts of the Company’s intangible assets for each of the next five years are as follows: 

Schedule of estimated amortization expense
2025		$	73,257
2026			73,257
2027			73,257
2028			39,300
2029			1,889

 

Note 6 – Reverse Stock Splits

 

Effective April 17, 2024 and August 8, 2024, the Company completed a 1-for-100 and a 1-for-20 reverse split of its common stock (the “Reverse Splits”). The Company had previously completed three (3) reverse stock splits including a 1-for-200 on February 9, 2022, and two 1-for-20 reverse stock splits, one in 2019 and the other in 2020. The Company’s financial statements included in this report reflect all five (5) reverse stock splits on a retroactive basis for all periods presented and for all references to common stock, unless specifically stated otherwise.

 

 

 

 

Note 7 – Capital Stock

 

The Company’s authorized capital is comprised of 3,000,000,000 shares of common stock, par value $0.001, and 30,000,000 shares of preferred stock, $0.10 par value. As of June 30, 2024, the Company had authorized 1,000,000 shares of Series B Preferred Stock. The Series B Preferred Stock is non-convertible and non-redeemable. It has a liquidation preference equal to the stated value of $0.10, relative to the common stock and gives the holder the right to 1,000 votes per share. As of June 30, 2024, 130,000 shares of Series B Preferred Stock were outstanding and held by the Company’s Chief Executive Officer.

 

On February 17, 2022, the Company completed a public offering and received net proceeds of $6,833,071 from the offering. Pursuant to the public offering, the Company issued and sold an aggregate of 941 shares of common stock and 20,051 warrants to purchase shares of common stock (the “Tradeable Warrants”).

 

On October 12, 2023, the Company held a special meeting of the holders of the outstanding Tradeable Warrants in which the holders of the majority of the outstanding Tradeable Warrants approved an amendment to the Warrant Agent Agreement to eliminate the provision that prohibited the Company’s CEO from exercising his voting rights under the Series B Preferred Stock, as well as to lower the exercise price of the Tradeable Warrants from $4,440 to $220.00. The Company entered into the amendment to the Warrant Agent Agreement on October 18, 2023.

 

On March 14, 2022, the Company completed a private placement and received net proceeds of $6,781,199. In connection with this private placement, the Company issued (i) 1,150 shares of its common stock together with investor warrants (“Investor Warrants”) to purchase up to 1,150 shares of common stock, and (ii) 651 pre-funded warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant exercisable for one share of common stock, together with Investor Warrants to purchase up to 6,511 shares of common stock. Each share of common stock and accompanying Investor Warrant was sold together at a combined offering price of $4,440.00 and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $4,438.00. The Pre-Funded Warrants were immediately exercisable, at an exercise price of $2.00, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Investor Warrants have an exercise price of $4,440.00 per share (subject to adjustment as set forth in the warrant), are exercisable upon issuance and will expire five years from the date of issuance.

 

On April 28, 2022, the Company completed another private placement and received net proceeds of $16,752,915. In connection with this private placement, the Company issued (i) 1,236 shares of its common stock together with warrants (“April Warrants”) to purchase up to 2,472 shares of common stock, and (ii) 1,195 pre-funded warrants (“Pre-Funded Warrants”) with each Pre-Funded Warrant exercisable for one share of common stock, together with April Warrants to purchase up to 2,390 shares of common stock. Each share of common stock and accompanying two April Warrants were sold together at a combined offering price of 8,020.00 and each Pre-Funded Warrant and accompanying two April Warrants were sold together at a combined offering price of $8,018.00. The Pre-Funded Warrants were immediately exercisable, at an exercise price of $2.00, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The April Warrants have an exercise price of $7,520.00 per share (subject to adjustment as set forth in the warrant), are exercisable upon issuance and will expire five years from the date of issuance.

 

 

 

On October 20, 2022, the Company issued 1,850 shares of common stock as part of the acquisition of Nora Pharma. These shares were valued at $4,514,000, or 2,440.00 per share.

 

On January 19, 2023, the Company announced a stock repurchase program of up to $2 million (“Stock Repurchase Program”). During the six months ended June 30, 2023, the Company repurchased a total of 2,228 shares of common stock at an average price of $2,274.20 per share for a total cost of $506,822. The 2,228 repurchased common shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 11,292 to 9,064.

 

On May 16, 2023, the Company completed a private placement pursuant to a securities purchase agreement with an institutional investor for gross proceeds of approximately $5 million, before deducting fees to the placement agent and other offering expenses payable by the Company. The net proceeds received by the Company were $4,089,218. In connection with the private placement, the Company issued (i) 1,225 shares of common stock, (ii) 1,751 pre-funded warrants (the “May Pre-Funded Warrants”), and (iii) investor warrants (the “May Warrants”) to purchase up to 5,952 shares of common stock. Each share of common stock and accompanying two May Warrants were sold together at a combined offering price of $1,680.00 and each May Pre-Funded Warrant and accompanying two May Warrants were sold together at a combined offering price of $1,678.00. The May Pre-Funded Warrants are immediately exercisable, at an exercise price of $2.00, and may be exercised at any time until all of the May Pre-Funded Warrants are exercised in full. The May Warrants have an exercise price of $1,180.00 per share (subject to adjustment as set forth therein), are exercisable upon issuance and will expire five and a half years from the date of issuance.

 

In 2022 and 2023, the Company issued a total of 5,396 shares of common stock in connection with warrant exercises for aggregate net proceeds of $13,196,681.

 

In July 2023, the Company repurchased a total of 34 shares of common stock under the Stock Repurchase Program announced on January 19, 2023, at an average price of $1,009.20 per share for a total cost of $34,321. In October 2023, the 34 repurchased common shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 12,873 to 12,839.

 

On November 16, 2023, the Company issued 1,173 shares of common stock and received net proceeds of $2,346 in connection with the exercise of all 1,173 remaining May Pre-Funded Warrants at an exercise price of $2.00 per share.

 

On February 8, 2024, the Company issued 20,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $0.10 per share.

 

On February 15, 2024, the Company completed an underwritten public offering and in connection therewith it issued an aggregate of 35,714 shares of common stock, of which 22,500 shares were issued in connection with pre-funded warrant exercises.

 

On March 4, 2024, the Company issued 100,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $0.10 per share.

 

As of June 30, 2024 and December 31, 2023, the Company had a total of 1,170,510 and 14,012 shares of common stock issued and outstanding, respectively.

 

The Company has declared no dividends since inception.

 

 

 

 

Note 8 – Warrants

 

The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10 or ASC 815-40. Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.

 

In 2022, 2023, and during the six months ended June 30, 2024, the Company completed five (5) financing events, and in connection therewith, it issued warrants as follows:

Schedule of warrants issued with financing
Type		Number		Exercise Price		Expiry Date
2022 Pre-Funded Warrants		1,846		$2.00		Unlimited
Tradeable Warrants		2,051		$4,440.00		February 2027
Investor Warrants		1,801		$4,440.00		March 2027
April Warrants		4,862		$7,520.00		April 2027
May Pre-Funded Warrants		1,751		$2.00		Unlimited
May Investor Warrants		5,952		$1,180.00		November 2028
2024 Pre-Funded Warrants		22,500		$2.00		Unlimited
Series A Warrants		3,986*		$4,200.00*		August 2026
Series B Warrants		7,973*		$4,760.00*		February 2029

_______________________

*	Subject to adjustments per the Series A and Series B Warrant Agreements.

 

 

As of June 30, 2024, all of the 2022 Pre-Funded Warrants, all of the May Pre-Funded Warrants, all of the 2024 Pre-Funded Warrants, a total of 1,569 Tradeable Warrants, 1,401 Investor Warrants, and all of the Series A Warrants were exercised resulting in aggregate proceeds of $13,241,681 received by the Company.

 

 

 

 

 

On February 11, 2024, the Company redeemed all of the April Warrants and all of the May Investor Warrants for an aggregate purchase price of $3,139,651.

 

The Company’s outstanding warrants as of August 16, 2024 consisted of the following:

Schedule of warrants outstanding
Type		Number		Exercise Price		Expiry Date
Tradeable Warrants		481		$220.00		February 2027
Investor Warrants		400		$4,440.00		March 2027
Series B Warrants		13,612,927*		$2.7879*		February 2029

_____________________

*	As adjusted and subject to further adjustments per the Series B Warrant Agreements.

 

 

Note 9 – Earnings Per Share

 

The following table sets forth the computation of basic and diluted net income per share for the quarters ended June 30:

Schedule of earnings per share computation
		2024				2023
Net gain (loss) attributable to common stock		$	(494,300	)		$	(902,108	)
Basic weighted average outstanding shares of common stock			49,726				12,675
Dilutive common share equivalents			–				–
Dilutive weighted average outstanding shares of common stock			49,726				12,675
Net gain (loss) per share attributable to common stock		$	(9.94	)		$	(71.17	)

 

Note 10 – Lease

 

The Company has obligations as a lessee for office and warehouse space with initial non-cancellable terms in excess of one year. The Company classified the lease as an operating lease. The lease contains a renewal option for a period of five years. Because the Company is certain to exercise the renewal option, the optional period is included in determining the lease term, and associated payments under the renewal option are included in the lease payments. The Company’s lease does not include termination options for either party to the lease or restrictive financial or other covenants. Payments due under the lease include fixed payments plus a variable payment. The Company’s lease requires it to make variable payments for the Company’s proportionate share of building’s property taxes, insurance, and common area maintenance. These variable lease payments are not included in lease payments used to determine lease liability and are recognized as variable costs when incurred.

 

Amounts reported on the balance sheet as of June 30, 2024, were as follows:

Schedule of lease information
Operating lease ROU asset		$563,920
Operating lease liability - Short-term		$114,452
Operating lease liability - Long-term		$462,906
Remaining lease term		5 years 6 months
Discount rate		6%

 

Amounts disclosed for ROU assets obtained in exchange for lease obligations and reductions of ROU assets resulting from reductions of lease obligations include amounts reduced from the carrying amount of ROU assets resulting from deferred rent.

 

 

 

 

Maturities of lease liabilities under non-cancellable operating leases at June 30, 2024 are as follows:

Schedule of maturities of lease liabilities
2024			$	56,479
2025			$	114,859
2026			$	108,790
2027			$	102,470
2028			$	96,517
Thereafter			$	98,243

 

Note 11 – Management and Director Compensation

 

The Company paid its officers cash compensation totaling $1,120,356 and $225,000, and $1,382,842 and $1,045,000 for the three and six months periods ended June 30, 2024 and 2023, respectively. Of the $1,382,842 amount, $400,000 was paid to Advanomics Corporation, a company controlled by the CEO of the Company.

 

The Company paid its directors aggregate cash compensation totaling $100,000 for each of the three months periods ended June 30, 2024 and 2023, and $200,000 for each of the six months periods ended June 30, 2024 and 2023.

 

Note 12 – Income Taxes

 

In calculating the provision for income taxes on an interim basis, the Company uses an estimate of the annual effective tax rate based upon currently known facts and circumstances and applies that rate to its year-to-date earnings or losses. The Company’s effective tax rate is based on expected income and statutory tax rates and takes into consideration permanent differences between financial statement and tax return income applicable to the Company in the various jurisdictions in which the Company operates. The effect of discrete items, such as changes in estimates, changes in rates or tax status, and unusual or infrequently occurring events, is recognized in the interim period in which the discrete item occurs. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained or as the result of new judicial interpretations or regulatory or tax law changes.

 

Our income tax (expense) / benefit of $343,691 and $321,338 for the three and six months ended June 30, 2024, respectively, is primarily due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.

 

Our income tax (expense) / benefit $(87,677) and $(133,947) for the three and six months ended June 30, 2023, respectively, is primarily due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.

 

Deferred tax assets are regularly reviewed for recoverability by jurisdiction and valuation allowances are established based on historical and projected future taxable losses and the expected timing of the reversal of existing temporary differences. The Company as recorded valuation allowances against the majority of its deferred tax assets of June 30, 2024, and the Company expects to maintain these valuation allowances until there is sufficient evidence that future earnings can be achieved, which is uncertain at this time.

 

The Company's consolidated financial statements contain various tax related entries the same being due to the operations of the two Canadian subsidiaries and are in compliance with Canadian tax laws.

 

Note 13 – Subsequent Events

 

Effective August 8, 2024, the Company completed a 1-for-20 reverse split of its common stock (the “Reverse Split”). As a result of the Reverse Split, the exercise price of Series B Warrants adjusted to $2.7879 per share and the number of Series B Warrants adjusted to 13,612,927. All share amounts, warrants, and related parameters specified in this report have been adjusted to reflect the Reverse Split.

 

Subsequent to June 30, 2024, the Company issued 53,831 shares of common stock upon the exercise of 53,831 Series B Warrants and received $150,075 in net proceeds.

 

 

 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

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

 

About Sunshine Biopharma

 

We 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 61 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

 

In 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.

 

History

 

We were incorporated in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma, Inc. in a transaction classified as a reverse acquisition. 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, we changed our name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical company.

 

In 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” below.

 

In 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 provisional patent application in the United States for the new coronavirus treatment. The patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro. On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.

 

In 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.

 

On October 20, 2022, we acquired Nora Pharma Inc. (“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma has 46 employees and operates in a 23,500 square foot facility certified by Health Canada. Nora Pharma currently has 61 generic prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in 2024 and 2025.

 

 

 

Products on the Market

 

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

 

Drug		Action/Indication		Reference Brand
Abiraterone*		Oncology		Zytiga®
Alendronate		Osteoporosis		Fosamax®
Amlodipine		Cardiovascular		Norvasc®
Apixaban		Cardiovascular		Eliquis®
Aripiprazole		Antipsychotic		Abilify®
Atorvastatin		Cardiovascular		Lipitor®
Azithromycin		Antibacterial		Zithromax®
Candesartan		Hypertension		Atacand®
Candesartan HCTZ		Hypertension		Atacand Plus®
Celecoxib		Anti-inflammatory		Celebrex®
Cetirizine		Allergy		Reactine®
Clobetasol*		Anti-inflammatory		Clobex®
Ciprofloxacin		Antibiotic		Cipro®
Citalopram		Central nervous system		Celexa®
Clindamycin		Antibiotic		Dalacin®
Clopidogrel		Cardiovascular		Plavix®
Dapagliflozin		Diabetes		Forxiga®
Daptomycin*		Antibacterial		Cubicin®
Dasatinib*		Oncology		Sprycel®
Donepezil		Central nervous system		Aricept®
Duloxetine		Central nervous system		Cymbalta®
Dutasteride		Urology		Avodart®
Ertapenem*		Antibacterial		Invanz®
Escitalopram		Central nervous system		Cipralex®
Ezetimibe		Cardiovascular		Ezetrol®
Finasteride		Urology		Proscar®
Flecainide		Cardiovascular		Tambocor®
Fluconazole		Antifungal		Diflucan®
Fluoxetine		Central nervous system		Prozac®
Hanzema®*		Dermatology		Toctino®
Hydroxychloroquine		Antimalarial		Plaquenil®
Lacosamide		Central nervous system		Vimpat®
Letrozole		Oncology		Femara®
Levetiracetam		Central nervous system		Keppra®
Mirtazapine		Central nervous system		Remeron®
Metformin		Diabetes		Glucophage®
Montelukast		Allergy		Singulair®
Olmesartan		Cardiovascular		Olmetec®
Olmesartan HCTZ		Cardiovascular		Olmetec Plus®
Pantoprazole		Gastroenterology		Pantoloc®
Paroxetine		Central nervous system		Paxil®
Perindopril		Cardiovascular		Coversyl®
Pravastatin		Cardiovascular		Pravachol®
Pregabalin		Central nervous system		Lyrica®
Progesterone*		Women's Health		Prometrium®
Quetiapine		Central nervous system		Seroquel®
Quetiapine XR		Central nervous system		Seroquel XR®
Ramipril		Cardiovascular		Altace®
Rivaroxaban*		Cardiovascular		Xarelto®
Rizatriptan ODT		Central nervous system		Maxalt® ODT

________________ 

*Sold through distribution agreements

 

 

In addition to the 61 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®. Like 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. NIOPEG® is anticipated to be on the market in Canada in October 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.

 

Drugs in Development

 

The following table summarizes our proprietary drugs in development:

 

Drug Candidate		Therapeutic Area		Development Stage
Adva-27a (Small Molecule)		Oncology (Pancreatic Cancer)		Paused*
K1.1 (mRNA LNP)		Oncology (Liver Cancer)		Animal Testing
SBFM-PL4 (Small Molecule)		Antiviral (SARS Coronavirus)		Animal Testing

_____________

*See “Adva-27a Anticancer Compound” below

 

Adva-27a Anticancer Compound

 

Adva-27a is a small molecule designed for the treatment of aggressive forms of cancer. A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). We are the direct owner of all patents pertaining to Adva-27a including U.S. Patents Number 8,236,935 and 10,272,065.

 

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 test results of the Adva-27a molecule were not favorable. After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH of termination of the Research Agreement. 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.

 

K1.1 Anticancer mRNA

 

In 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 agents. The data collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects. These new mRNA molecules, bearing the laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology. In April 2022, we filed a provisional patent application in the United States covering the subject mRNA molecules.

 

In 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.

 

 

 

SBFM-PL4 SARS Coronavirus Treatment

 

The initial genome expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab. These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins essential for viral replication. Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in the early stages of viral replication. PLpro is of particular interest as a therapeutic target in that, in addition to processing essential viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening. PLpro is present only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.

 

Our Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.

 

In February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”). 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, 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.

 

We 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.

 

Intellectual Property

 

We 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 under US Patent Number 8,236,935 and 10,272,065.

 

On May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections. Our patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication. The patent application has a priority date of May 22, 2020. On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro. The priority date of May 22, 2020 has been maintained in the newly filed PCT application.

 

On April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro. The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.

 

Effective 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.

 

 

 

 

Our wholly owned subsidiary, Nora Pharma, owns 152 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.

 

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.

 

Results of Operations

 

Comparison of results of operations for the three months ended June 30, 2024 and 2023

 

During the three months ended June 30, 2024, we 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%. The increase is attributable to expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma. The direct cost for generating 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 30, 2023. The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of the generic prescription drugs. 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, 2023.

 

General 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 period ended June 30, 2023, an increase of $657,898. The increase was due to increases in legal fees ($77,621), marketing ($123,148), office expense ($293,595), R&D ($67,670), and salaries ($356,009). The increase in salaries was due to the hiring of two (2) new employees and a bonus paid to the CEO of the Company. The only expense category that saw a decrease was consulting, which was reduced by $338,406. Overall, we incurred a loss of $1,268,276 from our operations for the three months ended June 30, 2024, compared to a loss of $1,013,888 from our operations in the three-month period ended June 30, 2023.

 

In addition, we had interest income of $143,995 during the three months ended June 30, 2024, compared to net interest income of $203,049 during the three months ended June 30, 2023, as a result of less interest earned on cash on hand.

 

As 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 ($71.17 per share) for the three-month period ended June 30, 2023.

 

Comparison of results of operations for the six months ended June 30, 2024 and 2023

 

During the six months ended June 30 2024, we generated 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%. The increase is attributable to increased sales generated by our wholly owned subsidiary, Nora Pharma. The direct cost for generating 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 30, 2023. The increase in the cost of goods sold in 2024 is due to an increase in the cost of manufacturing of generic prescription drugs. 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 period in 2023.

 

General 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 period ended June 30, 2023, an increase of $718,242. The increase was a result of increases in accounting ($195,369), legal ($185,862), marketing ($193,281), and office costs ($734,868). The three expense categories that saw a decrease were salaries ($110,536), consulting ($422,620) and R&D ($143,222). Overall, we incurred a loss of $2,668,046 from our operations in the six-month period ended June 30, 2024, compared to a loss from operations of $2,879,529 in the similar period of 2023.

 

In addition, we had interest income of $288,084 during the six months ended June 30, 2024, compared to interest income of $416,930 during the six months ended June 30, 2023. The decrease was due to the Company having less cash on hand.

 

As 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 of $2,604,538 ($218.62 per share) for the six-month period ended June 30, 2023.

 

 

 

Liquidity and Capital Resources

 

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 during the six months ended June 30, 2024, compared to $5,628,146 during the six-month period ended June 30, 2023. The increase was a result of increased business activities by Nora Pharma.

 

Cash flows used in investing activities were $1,210,944 for the six months ended June 30, 2024, compared to $405,779 for the six months ended June 30, 2023. The increase was the result of cash invested in Nora Pharma to finance increase in inventory and expansion of product line.

 

Cash flows provided by financing activities were $5,369,566 during the six months ended June 30, 2024, compared to $3,519,672 during the six months ended June 30, 2023. The increase was primarily a result of the approximately $10 million financing event completed in February 2024, compared to an approximately $5 million financing event completed in May 2023.

 

We are not generating adequate revenues from our operations to fully implement our business plan as set forth herein. 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 months. There is no assurance our estimates will be accurate. We currently 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 at all.

 

Critical Accounting Estimates

 

The 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.

 

For a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2023, including our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.

 

Recently Adopted Accounting Standards

 

In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022. The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate a material impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated financial statements.

 

In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is evaluating the impact of this guidance on its unaudited consolidated financial statements.

 

Off Balance-Sheet Arrangements

 

None.

 

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company and are not required to provide the information under this item.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report.

 

These controls are designed to ensure that information required to be disclosed in the reports we file or submit pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our management, including our CEO and CFO, to allow timely decisions regarding required disclosure.

 

Based on this evaluation, our management, including our CEO and CFO concluded that our disclosure controls and procedures were effective as of June 30, 2024, at reasonable assurance levels.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

 

 

 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

We are not party to, and our property is not the subject of, any material legal proceedings.

 

ITEM 1A. RISK FACTORS

 

We are a smaller reporting company and are not required to provide the information under this item.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.

 

ITEM 5. OTHER INFORMATION

 

During the quarter ended June 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

 

ITEM 6. EXHIBITS

 

Exhibit No.		Description
31.1		Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
31.2		Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2022*
32.1		Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**
101		Inline XBRL Document Set for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.*
104		Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set.*

__________________

	*	Filed herewith.
	**	Furnished herewith.

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized, on August 16, 2024.

 

	SUNSHINE BIOPHARMA, INC.
	By:	/s/ Dr. Steve N. Slilaty
		Dr. Steve N. Slilaty
		Chief Executive Officer (principal executive officer)
	By:	/s/ Camille Sebaaly
		Camille Sebaaly
		Chief Financial Officer (principal financial and accounting officer)