Tg Therapeutics, Inc 10-Q for FY2025 Q3

Tg Therapeutics, Inc. (TGTX)

10-Q 2025-11-05 For: 2025-09-30

Added on April 09, 2026

About this 10-Q

Tg Therapeutics, Inc filed this 10-Q on November 5, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).

Headline figures

Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $161.71M; up 92.8% from $83.88M a year earlier
Net income: $390.9M; up 9974.6% from net income of $3.88M a year earlier
Diluted EPS: $2.43; up 12050.0% from $0.02 a year earlier

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Delaware	36-3898269
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

Title of Class	Trading Symbol(s)	Exchange Name
Common Stock, par value $0.001	TGTX	Nasdaq Capital Market

Large accelerated filer ☒	Accelerated filer ☐

Non-accelerated filer ☐	Smaller reporting company ☐

	Emerging growth company ☐

SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS		3

SUMMARY RISK FACTORS		4

PART I	FINANCIAL INFORMATION	6

Item 1	Financial Statements:	6

	Condensed Consolidated Balance Sheets	6

	Condensed Consolidated Statements of Operations (unaudited)	7

	Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)	8

	Condensed Consolidated Statements of Cash Flows (unaudited)	9

	Notes to Condensed Consolidated Financial Statements (unaudited)	10

Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23

Item 3	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4	Controls and Procedures	28

PART II	OTHER INFORMATION	28

Item 1	Legal Proceedings	28

Item 1A	Risk Factors	28

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	66

Item 3	Defaults of Senior Securities	67

Item 4	Mine Safety Disclosures	67

Item 5	Other Information	67

Item 6	Exhibits	67

●	our ability to advance drug candidates into, and successfully complete, clinical trials;
●	our ability to develop, formulate, manufacture and commercialize our product candidates;

●	our financial performance and cash burn management;
●	our ability to maintain or obtain adequate product liability and other insurance coverage;

●	developments relating to our competitors and our industry;
●	the effects on our company of future regulatory developments or legislative actions, including changes in healthcare, environmental and other laws and regulations to which we are subject, including tariffs that may apply to products that we purchase or sell;
●	prevailing economic, market and business conditions;
●	our ability to retain, attract and hire key personnel;
●	our competitive position;
●	fluctuations in the trading price of our common stock;
●	our use of cash and other resources; and
●	our ability to successfully implement our strategy.

●	If we obtain U.S. Food and Drug Administration (FDA) or approval by any comparable regulatory authority outside of the U.S. for a product candidate and do not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from product sales will be limited.
●	We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market.
●	BRIUMVI, and any of our product candidates for which we in the future obtain approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization.
●	The incidence and prevalence for target patient populations of BRIUMVI and our other product candidates have not been established with precision. If the market opportunities for BRIUMVI and our product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected.
●	We face substantial competition, which may result in others commercializing drugs before or more successfully than we do, resulting in the reduction or elimination of our commercial opportunity.
●	BRIUMVI, as well as any products that we are able to commercialize in the future, may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies, which would harm our business.
●	Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidates that we may develop.

●	We have incurred substantial operating losses since our inception, and we may incur losses in the future.
●	While we do not expect to need to raise additional capital, we may need to do so. If we are unable to raise capital, if needed, we may be required to delay, limit, reduce or eliminate some of our drug development programs or commercialization efforts.
●	Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.

●	If we are unable to maintain or obtain regulatory approval for our product and product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed.
●	Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials or receive regulatory approval. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be negatively impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed.
●	Our product or product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval.
●	Any products or product candidates we may advance through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals.

●	We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
●	Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
●	If we fail to adequately understand and comply with the local laws and customs as we expand into new international markets, these operations may incur losses or otherwise adversely affect our business and results of operations.
●	Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

●	We rely on third parties to generate clinical, preclinical and other data necessary to support the regulatory applications needed to conduct clinical trials and submit for marketing approval. We rely on third parties to help conduct our planned clinical trials. If these third parties do not perform their services as required, we may not be able to obtain regulatory approval for or commercialize our product or product candidates when expected or at all.
●	We contract with third parties for the manufacture and testing of BRIUMVI for commercial supply, as well as all of our clinical product supply, and we expect to continue to do so. This reliance on third parties increases the risk that we will not have sufficient quantities of our products or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
●	The third parties upon whom we rely for the supply of starting materials, intermediates, active pharmaceutical ingredient (API)/drug substance, drug product, and other materials used in our drug candidates are our sole source of supply, and the loss or disruption of any of these suppliers could significantly harm our business.
●	Because we have in-licensed BRIUMVI and our product candidates from third parties, any dispute with or non-performance by our licensors will adversely affect our ability to develop and commercialize the applicable product or product candidate.
●	We are dependent upon our relationships with collaboration and commercialization partners to further develop, fund, manufacture and commercialize our drug products and our product candidates. If such relationships are unsuccessful, or if a collaboration or commercialization partner terminates its collaboration or commercialization agreement with us, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by a collaboration or commercialization partner to perform its duties under its collaboration or commercialization agreement with us may negatively affect us.

●	Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies. If the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired. At the same time, if the scope of our patent protection is too broad, our competitors may challenge the validity and enforceability of our patents.
●	Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
●	We may not be able to enforce our intellectual property rights throughout the world.
●	If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
●	We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
●	If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.

●	If we fail to attract and keep key management, commercial, and clinical development personnel, we may be unable to successfully develop or commercialize our product and product candidates.
●	We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
●	Certain of our executive officers, directors, principal stockholders and their affiliates maintain the ability to exercise significant influence over our company and all matters submitted to stockholders for approval.
●	Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates’ development programs and our commercialization of any products for which we receive regulatory approval.
●	Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

●	Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell our stock at a profit.
●	We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.

	*September 30,*			*December 31,*
	*2025*			*2024*
	*(Unaudited)*			*(Note 1)*
Assets
Current assets:
Cash and cash equivalents	$	74,081		$	179,894
Short-term investment securities		57,501			131,106
Accounts receivable, net		265,384			129,185
Inventories		146,953			110,458
Other current assets		55,846			15,716
Total current assets		599,765			566,359
Restricted cash		1,329			1,298
Long-term investment securities		48,757			808
Right of use assets		6,501			7,151
Deferred tax assets		366,627			—
Other noncurrent assets		2,045			2,074
Total assets	$	1,025,024		$	577,690

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	112,336		$	58,296
Other current liabilities		1,993			4,627
Lease liability – current portion		1,068			1,157
Deferred revenue - current portion		26,399			11,414
Accrued compensation		15,014			15,185
Total current liabilities		156,810			90,679
Deferred revenue, non-current portion		8,348			12,085
Loan payable – non-current		245,340			244,429
Lease liability – non-current		7,308			8,133
Total liabilities	$	417,806		$	355,326
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value per share (190,000,000 and 175,000,000 shares authorized, 158,754,176 and 156,204,159 shares issued, 155,210,533 and 155,836,256 shares outstanding at September 30, 2025 and December 31, 2024, respectively)		159			156
Additional paid-in capital		1,812,345			1,760,396
Treasury stock, at cost, 3,543,643 and 367,903 shares at September 30, 2025 and December 31, 2024, respectively		(100,234	)		(8,994	)
Accumulated deficit		(1,105,052	)		(1,529,194	)
Total stockholders’ equity		607,218			222,364
Total liabilities and stockholders’ equity	$	1,025,024		$	577,690

	*Three months ended*						*Nine months ended*
	*September 30,*						*September 30,*
	*2025*			*2024*			*2025*			*2024*
Revenue:
Product revenue, net	$	159,317		$	83,297		$	417,815		$	206,381
License, milestone, royalty and other revenue		2,392			582			5,898			14,438
Total revenue	$	161,709		$	83,879		$	423,713		$	220,819

Costs and expenses:
Cost of revenue		28,093			9,341			62,572			23,087
Research and development:
Noncash compensation		5,335			3,028			12,984			8,000
Other research and development		35,543			17,110			106,038			62,417
Total research and development		40,878			20,138			119,022			70,417

Selling, general and administrative:
Noncash compensation		12,351			8,745			36,035			22,593
Other selling, general and administrative		51,022			33,221			133,254			92,742
Total selling, general and administrative		63,373			41,966			169,289			115,335

Total costs and expenses		132,344			71,445			350,883			208,839

Operating income		29,365			12,434			72,830			11,980

Other expense (income):
Interest expense		6,721			10,832			20,194			16,967
Other income		(3,265	)		(2,666	)		(9,661	)		(5,128	)
Total other expense, net		3,456			8,166			10,533			11,839

Net income before taxes	$	25,909		$	4,268		$	62,297		$	141
Income tax benefit (expense)		364,986			(388	)		361,845			(89	)
Net income	$	390,895		$	3,880		$	424,142		$	52

Net income per common share:
Basic	$	2.69		$	0.03		$	2.90		$	0.00
Diluted	$	2.43		$	0.02		$	2.62		$	0.00

Weighted-average shares of common stock outstanding
Basic		145,416,901			145,102,479			146,273,554			145,342,337
Diluted		160,997,977			160,714,388			162,102,373			160,366,927

						*Additional*
	*Common Stock*					*paid-in*			*Treasury Stock*					*Accumulated*
	*Shares*			*Amount*		*capital*			*Shares*		*Amount*			*Deficit*			*Total*
Balance at January 1, 2024		151,465,598		$	151	$	1,713,162			41,309	$	(234	)	$	(1,552,577	)	$	160,502
Issuance of common stock in connection with exercise of options		2,500			—		10			—		—			—			10
Issuance of restricted stock		3,304,468			4		(4	)		—		—			—			—
Forfeiture of restricted stock		(165,514	)		—		—			—		—			—			—
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		10,304			—		—			—			10,304
Net loss		—			—		—			—		—			(10,707	)		(10,707	)
Balance at March 31, 2024		154,607,052		$	155	$	1,723,472			41,309	$	(234	)	$	(1,563,284	)	$	160,109
Issuance of common stock in connection with exercise of options		27,250			*		135			—		—			—			135
Issuance of restricted stock		332,138			*		—			—		—			—			—
Forfeiture of restricted stock		(92,593	)		*		—			—		—			—			—
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		10,445			—		—			—			10,445
Net income		—			—		—			—		—			6,879			6,879
Balance at June 30, 2024		154,873,847		$	155	$	1,734,052			41,309	$	(234	)	$	(1,556,405	)	$	177,568
Issuance of common stock in connection with exercise of options		35,313			*		199			—		—			—			199
Issuance of restricted stock		1,038,407			1		(1	)		—		—			—			—
Forfeiture of restricted stock		(36,666	)		*		*			—		—			—			—
Purchase of Treasury Stock		—			—		—			92,301		(2,149	)		—			(2,149	)
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		12,659			—		—			—			12,659
Net loss		—			—		—			—		—			3,880			3,880
Balance at September 30, 2024		155,910,901		$	156	$	1,746,909			133,610	$	(2,383	)	$	(1,552,525	)	$	192,157

						*Additional*
	*Common Stock*					*paid-in*			*Treasury Stock*					*Accumulated*
	*Shares*			*Amount*		*capital*			*Shares*		*Amount*			*Deficit*			*Total*
Balance at January 1, 2025		156,204,159		$	156	$	1,760,396			367,903	$	(8,994	)	$	(1,529,194	)	$	222,364
Issuance of common stock in connection with exercise of options		5,000			*		20			—		—			—			21
Issuance of restricted stock		2,547,179			2		(2	)		—		—			—			—
Forfeiture of restricted stock		(20,052	)		*		*			—		—			—			—
Purchase of Treasury Stock		—			—		—			199,695		(6,123	)		—			(6,123	)
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		15,967			—		—			—			15,967
Net income										—		—			5,060			5,060
Balance at March 31, 2025		158,736,286		$	159	$	1,776,381			567,598	$	(15,117	)	$	(1,524,134	)	$	237,289
Issuance of common stock in connection with exercise of options		46,650			*		432			—		—			—			432
Issuance of restricted stock		176,467			*		*			—		—			—			—
Forfeiture of restricted stock		(173,068	)		*		*			—		—			—			—
Purchase of Treasury Stock					—		—			193,500		(6,875	)		—			(6,875	)
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		17,399			—		—			—			17,399
Net income		—			—					—		—			28,187			28,187
Balance at June 30, 2025		158,786,335		$	159	$	1,794,212			761,098	$	(21,992	)	$	(1,495,947	)	$	276,432
Issuance of restricted stock		11,000			*		*			—		—			—			—
Forfeiture of restricted stock		(43,159	)		*		*			—		—			—			—
Purchase of Treasury Stock		—			—		—			2,782,545		(78,242	)		—			(78,242	)
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		18,133			—		—			—			18,133
Net income		—			—		—			—		—			390,895			390,895
Balance at September 30, 2025		158,754,176		$	159	$	1,812,345			3,543,643	$	(100,234	)	$	(1,105,052	)	$	607,218

	*As of*
	*September 30,*
	*2025*		*2024*
Unvested restricted stock		11,031,573		10,645,967
Options		4,362,316		4,631,966
Warrants		165,214		312,272
Shares issuable upon note conversion		21,973		21,704
Total		15,581,076		15,611,909

	*Three months ended September 30,*				*Nine months ended September 30,*
	*2025*		*2024*		*2025*		*2024*
Total product revenue, net	$	159,317	$	83,297	$	417,815	$	206,381
License, milestone, royalty and other revenue		2,392		582		5,898		14,438
Total Revenue	$	161,709	$	83,879	$	423,713	$	220,819

	*September 30, 2025*			*December 31, 2024*
Customer 1		41	%		32	%
Customer 2		20	%		25	%
Customer 3		26	%		25	%
Customer 4		13	%		17	%

	*September 30, 2025*
	*Amortized*		*Gross*		*Gross*
	*cost, as*		*unrealized*		*unrealized*		*Estimated*
(in thousands)	*adjusted*		*holding gains*		*holding losses*		*fair value*
Short-term obligations of domestic governmental agencies (maturing between October 2025 and September 2026) (held-to-maturity)	$	57,501	$	42	$	—	$	57,543
Long-term obligations of domestic governmental agencies (maturing between October 2026 and May 2027) (held-to-maturity)		46,733		172		—		46,905
Total short-term and long-term investment securities	$	104,234	$	214	$	—	$	104,448

	*September 30, 2025*		*December 31, 2024*
Raw Materials	$	4,059	$	28,151
Work in Process		121,806		68,369
Finished Goods		21,088		13,938
Total Inventory	$	146,953	$	110,458

	*Financial assets and liabilities at fair value as of September 30, 2025*
(in thousands)	*Level 1*		*Level 2*		*Level 3*		*Total*

Equity Investments	$	1,756	$	—	$	—	$	1,756
Total Assets	$	1,756	$	—	$	—	$	1,756

Forward Contract Liabilities	$	—	$	1,138	$	—	$	1,138
5% Notes	$	—	$	—	$	824	$	824
Total Liabilities	$	—	$	1,138	$	824	$	1,962

	*Restricted Stock*
	*September 30,*			*September 30,*
	*2025*			*2024*
Restricted stock awards outstanding, beginning of year		11,843,586			9,639,068
Changes during the year:
Granted		2,734,646			4,675,013
Vested		(1,810,349	)		(1,873,310	)
Expired or Forfeited		(236,279	)		(294,773	)
Restricted stock awards outstanding, end of period		12,531,604			12,145,998

	Stock Options
	September 30,			September 30,
	2025			2024
Stock options outstanding, beginning of year		4,470,216			4,697,029
Changes during the year:
Granted		—			—
Exercised		(51,650	)		(65,063	)
Expired or Forfeited		(56,250	)		—
Stock options outstanding, end of period		4,362,316			4,631,966

	*The Initial Term Loan*			*The Initial Term Loan*
	*September 30,*			*December 31,*
(in thousands)	*2025*			*2024*
Loan payable	$	250,000		$	250,000
Add: Accreted Liability of final payment fee		—			—
		250,000			250,000
Less: unamortized debt issuance and debt discount costs		(4,660	)		(5,571	)
		245,340			244,429
Less: principal payments		—			—
Total loan payable		245,340			244,429
Less: current portion		—			—
Loan payable non-current	$	245,340		$	244,429

	*Operating*
(in thousands)	*leases*
Remainder of 2025	$	519
2026		2,080
2027		1,913
2028		1,827
2029		1,827
After 2030		2,889
Total lease payments		11,055
Less: interest		(2,679	)
Present value of lease liabilities(*)	$	8,376

Clinical Drug Candidate: (molecular target)	Initial Target Disease	Stage/Status of Development
Ublituximab IV (anti-CD20 mAb)	RMS	APPROVED
Ublituximab IV Simplified Dosing Schedule	RMS	Phase 3 completed enrollment
Ublituximab Subcutaneous (anti-CD20 mAb)	RMS	Phase 3 enrolling
Azer-cel	Progressive Forms of Multiple Sclerosis	Phase 1 enrolling

	●	In December 2020, we announced positive top-line results from the ULTIMATE I & II trials. Both studies met their primary endpoint of significantly reducing ARR over a 96-week period (p<0.005 in each study) with BRIUMVI demonstrating an ARR of <0.10 in each of the studies. Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively. Key secondary MRI endpoints were also met.
	●	On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.
	●	On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.
	●	Additional BRIUMVI data continues to be presented at major medical meetings. Most recently data was presented at ECTRIMS 2025, including six year long term data from the ULTIMATE I & II Phase 3 trials; updated data from the ENHANCE trial evaluating modified dosing regimens for BRIUMVI in patients with RMS, and 2025 data from ENABLE, the first Phase 4 observational study for patients with RMS starting treatment on BRIUMVI.
	●	In August 2025, we announced patient enrollment commenced into a randomized Phase 3 pivotal cohort to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ongoing ENHANCE trial.

	Three months ended
	September 30,
(in thousands)	2025			2024
Product revenue, net	$	159,317			83,297
License, milestone, royalty and other revenue		2,392			582
Total Revenue	$	161,709		$	83,879

Costs and expenses:
Cost of revenue		28,093			9,341
Research and development:
Noncash compensation		5,335			3,028
Other research and development		35,543			17,110
Total research and development		40,878			20,138

General and administrative:
Noncash compensation		12,351			8,745
Other selling, general and administrative		51,022			33,221
Total general and administrative		63,373			41,966

Total costs and expenses		132,344			71,445

Interest expense		6,721			10,832
Other income		(3,265	)		(2,666	)
Total other expense, net		3,456			8,166

Net income before taxes		25,909			4,268
Income tax benefit (expense)		364,986			(388	)
Net income	$	390,895		$	3,880

	Nine months ended
	September 30,
(in thousands)	2025			2024
Product revenue, net	$	417,815		$	206,381
License, milestone, royalty and other revenue		5,898			14,438
Total Revenue	$	423,713		$	220,819

Costs and expenses:
Cost of revenue		62,572			23,087
Research and development:
Noncash compensation		12,984			8,000
Other research and development		106,038			62,417
Total research and development		119,022			70,417

General and administrative:
Noncash compensation		36,035			22,593
Other selling, general and administrative		133,254			92,742
Total general and administrative		169,289			115,335

Total costs and expenses		350,883			208,839

Interest expense		20,194			16,967
Other income		(9,661	)		(5,128	)
Total other expense, net		10,533			11,839

Net income before taxes		62,297			141
Income tax benefit (expense)		361,845			(89	)
Net income	$	424,142		$	52

	●	the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained;
	●	the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments;
	●	the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products;
	●	the indications for which our products are approved, and other aspects of the approved labeling for such products;
	●	acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments;
	●	the potential and perceived advantages or disadvantages of our products compared to alternative treatments;
	●	our ability to offer our products for sale at competitive prices;
	●	the availability of adequate reimbursement by third-party payors and government authorities;
	●	the extent of patient cost-sharing obligations, including copays and deductibles;
	●	changes in regulatory requirements by government authorities for our products;
	●	relative convenience and ease of administration;
	●	the prevalence and severity of side effects and adverse events;
	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
	●	the effectiveness of our sales and marketing efforts, as well as those of any current or future partners;
	●	protecting our rights in our intellectual property portfolio;
	●	our ability to maintain a reliable supply of our products that meets market demand; and
	●	favorable or unfavorable publicity relating to our products or relating to the Company.

	●	regulatory authorities may withdraw approval or limit the approved indications for use of such products;
	●	regulatory authorities may require the addition of new or different labeling statements, including warnings or boxed warnings, precautions, or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product;
	●	we may be required to change the way such drug candidates are distributed or administered, or to conduct additional clinical trials;
	●	regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS), a plan to mitigate risks, which could include a Medication Guide, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;
	●	we may be subject to regulatory investigations and government enforcement actions;
	●	we may decide to remove such drug candidates from the marketplace;
	●	we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model;
	●	we could be sued and held liable for injury caused to individuals exposed to or taking our products; and
	●	our reputation may suffer.

	●	research and development resources, including personnel and technology;
	●	regulatory experience;
	●	pharmaceutical development, clinical trial and pharmaceutical commercialization experience;
	●	experience and expertise in exploitation of intellectual property rights; and
	●	capital resources.

	●	the costs and time associated with the initial and ongoing training of commercialization personnel on the applicable disease states, products, competitors, and legal and regulatory compliance matters;
	●	the inability of commercialization personnel to obtain access to physicians or to effectively promote or provide education about BRIUMVI and any future approved products;
	●	the lack of complementary drugs to be offered by the Company, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
	●	decisions by third-party payors to deny reimbursement of or delay coverage decisions regarding BRIUMVI or following approval of any product candidates;
	●	our inability to maintain a healthcare compliance program including effective mechanisms for compliance monitoring;
	●	our inability to establish and maintain commercial partnerships outside the U.S.;
	●	our inability, or the inability of a third party with whom we have partnered, to maintain the necessary regulatory approvals required to operate in markets outside of the U.S.;
	●	the timing of product availability for commercial sale following approval and continued product supply; and
	●	unforeseen costs and expenses associated with creating a commercialization organization.

	●	decreased demand for any products that we may commercialize;
	●	injury to our reputation and significant negative media attention;
	●	withdrawal of clinical trial participants;
	●	significant costs to defend the related litigation, including the risk that any individuals who may face such related litigation may in turn seek to recover from us;
	●	substantial monetary awards to trial participants or patients;
	●	loss of revenue; and
	●	the inability to commercialize any products or product candidates that we may develop.

	●	successfully complete clinical trials that meet their clinical endpoints;
	●	initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and non-U.S. marketing approval for our product and product candidates;
	●	obtain approval from the FDA and comparable regulatory authorities outside of the U.S. to market and sell our product and product candidates, and maintain FDA and other global approvals of BRIUMVI for RMS;
	●	establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates;