Tg Therapeutics, Inc 10-Q for FY2024 Q3

Tg Therapeutics, Inc. (TGTX)

10-Q 2024-11-07 For: 2024-09-30

Added on April 09, 2026

About this 10-Q

Tg Therapeutics, Inc filed this 10-Q on November 7, 2024, covering the quarter ended September 30, 2024 (FY2024 Q3).

Headline figures

Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $83.88M; down 49.4% from $165.82M a year earlier
Net income: $3.88M; down 96.6% from net income of $113.93M a year earlier
Diluted EPS: $0.02; down 97.3% from $0.73 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	26

Item 3	Quantitative and Qualitative Disclosures About Market Risk	35

Item 4	Controls and Procedures	35

PART II	OTHER INFORMATION	35

Item 1	Legal Proceedings	35

Item 1A	Risk Factors	36

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	82

Item 3	Defaults of Senior Securities	82

Item 4	Mine Safety Disclosures	82

Item 5	Other Information	82

Item 6	Exhibits	83

●	our ability to obtain and maintain regulatory approvals for our product candidates, including azercabtagene zapreleucel (azer-cel), and our ability to maintain regulatory approval of BRIUMVI® (ublituximab) for the treatment of relapsing forms of multiple sclerosis (RMS) or any other future indication in the United States (U.S.), the European Union (EU) and the United Kingdom (UK);
●	our ability to adapt and expand our commercial infrastructure to successfully launch, market and sell BRIUMVI and our other product candidates;
●	our ability to maintain a reliable supply of our products that meets market demand;
●	the success of the ongoing commercialization of BRIUMVI or any future products or combinations of products, including the anticipated rate and degree of market acceptance and pricing and reimbursement;
●	the initiation, timing, progress and results of our preclinical studies and clinical trials;
●	our ability to advance drug candidates into, and successfully complete, clinical trials;
●	our ability to develop, formulate, manufacture and commercialize our product candidates;
●	our ability to establish and maintain contractual relationships and partnerships, on commercially reasonable terms, with third parties for manufacturing, distribution, marketing and supply and a range of other support functions for our clinical development and commercialization efforts;
●	the implementation of our business model and strategic plans for our business and drug candidates;
●	the scope of protection we are able to establish and maintain for intellectual property rights covering our product and product candidates;
●	estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
●	our ability to maintain and establish collaborations and enter into strategic arrangements, if desired;
●	our ability to meet any of our financial projections or guidance, including without limitation short and long-term revenue projections or guidance and changes to the assumptions underlying those projections or guidance;
●	our ability to obtain sufficient capital to fund our planned operations;
●	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;
●	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 are unable to maintain current approval of BRIUMVI, our business will be materially harmed.
●	We cannot predict when or if we will obtain regulatory approval to commercialize our product candidates, including azer-cel in non-oncology indications.
●	We have limited experience operating as a commercial company, and, as a result, the marketing and sale of BRIUMVI for the treatment of RMS may be less successful than anticipated.
●	If BRIUMVI or any of our future product candidates (if approved) do not achieve broad market acceptance among physicians, patients, payors or the medical community, the revenues that we generate from product sales will be limited.
●	If the market opportunities for BRIUMVI and any future products for which we may receive approval, including azer-cel in non-oncology indications, are smaller than we estimate or if any approval we obtain is based on a narrower patient population or the labeling includes warnings or limitations that are not acceptable to patients or healthcare providers, our revenue will be adversely affected.
●	We face substantial competition for treatments for our target indications, including from companies with greater resources than we have, which may result in others commercializing drugs before or more successfully than we do, which could result in the reduction or elimination of our commercial opportunity.
●	If we are unable to generate sufficient revenue, we may need to raise substantial additional capital to sustain our business.
●	Product liability lawsuits could cause us to incur substantial liabilities and limit product commercialization.

●	If we are unable to maintain or obtain regulatory approval for our product or product candidates and ultimately cannot commercialize our product or product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
●	Our product and product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or significantly limit their commercial profile following marketing approval, if any, or result in withdrawal from the market if approved.
●	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. 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 impacted, as more patient data or additional endpoints are analyzed.
●	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 extensive regulation, including new legislative and regulatory proposals, including efforts to control, set or cap pricing for approved drugs, which may increase our costs and adversely affect our ability to market our products, obtain collaborators and raise capital.
●	If we fail to comply with various healthcare laws and regulations, we may incur losses or be subject to liability.
●	If we fail to comply with regulatory requirements, any product candidate may fail to receive regulatory approval and any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties.

●	Our reliance on third parties for commercial and clinical supply of raw materials and our product and product candidates increases the risk that we will not have sufficient quantities of our product or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
●	If the third parties on which we rely to conduct our clinical trials and generate clinical, preclinical, and other data necessary to support our regulatory applications 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.
●	Because we have in-licensed our product and 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.

●	Our success depends upon our ability to obtain and protect our intellectual property, and if the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
●	Our patent protection could be reduced or eliminated for non-compliance with various procedural and other requirements imposed by governmental patent agencies.
●	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 or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming to defend against such lawsuits, and an unfavorable outcome in any such lawsuit would have a material adverse effect on our business.
●	If we are unable to protect the confidentiality of our trade secrets, our business may be significantly harmed.

●	While we have recently generated net income, we have incurred significant 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.

●	Patients and healthcare providers have raised concerns that immunosuppressive products, like anti-CD20 antibodies and other B-cell targeted agents, may increase the risk of acquiring viruses or lead to more severe complications upon infection. These concerns may impact the commercial potential for BRIUMVI and other immunosuppressive products that we have in development.
●	We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion.
●	Our ability to continue our clinical development and commercialization activities will depend on our ability to attract and maintain key management and other personnel.
●	Certain of our executive officers, directors and other stockholders own more than 5% of our outstanding common stock and may be able to influence our management and the outcome of matters submitted to shareholders for approval.
●	Certain anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition more difficult, which could limit the price investors might be willing to pay for our common stock.
●	Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit and could subject us to securities and shareholder derivative litigation.
●	Significant disruptions of information technology systems, breaches of data security or unauthorized disclosures of sensitive data could harm our business and subject us to liability or reputational damage.

	*September 30,*			*December 31,*
	*2024*			*2023*
	*(Unaudited)*			*(Note 1)*
Assets
Current assets:
Cash and cash equivalents	$	195,822		$	92,933
Short-term investment securities		145,219			124,575
Accounts receivable, net		115,727			51,093
Inventories		84,669			39,823
Other current assets		32,632			9,519
Total current assets		574,069			317,943
Restricted cash		1,295			1,285
Long-term investment securities		1,125			—
Right of use assets		7,411			8,050
Other noncurrent assets(1)		2,114			2,309
Total assets	$	586,014		$	329,587

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	101,407		$	38,471
Other current liabilities		3,298			1,479
Lease liability – current portion		1,231			1,446
Deferred revenue - current portion		9,093			152
Accrued compensation		10,085			12,172
Total current liabilities		125,114			53,720
Deferred revenue, non-current portion		16,166			6,016
Loan payable – non-current		244,158			100,118
Lease liability – non-current		8,419			9,231
Total liabilities		393,857			169,085
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value per share (190,000,000 and 175,000,000 shares authorized, 155,910,901 and 151,465,598 shares issued, 155,777,291 and 151,424,289 shares outstanding at September 30, 2024 and December 31, 2023, respectively)		156			151
Additional paid-in capital		1,746,909			1,713,162
Treasury stock, at cost, 133,610 and 41,309 shares at September 30, 2024 and December 31, 2023, respectively		(2,383	)		(234	)
Accumulated deficit		(1,552,525	)		(1,552,577	)
Total stockholders’ equity		192,157			160,502
Total liabilities and stockholders’ equity	$	586,014		$	329,587

	*Three months ended*						*Nine months ended*
	*September 30,*						*September 30,*
	*2024*			*2023*			*2024*			*2023*
Revenue:
Product revenue, net	$	83,297		$	25,068		$	206,381		$	48,868
License, milestone, royalty and other revenue		582			140,747			14,438			140,823
Total revenue	$	83,879		$	165,815		$	220,819		$	189,691

Costs and expenses:
Cost of revenue		9,341			3,509			23,087			6,277
Research and development:
Noncash compensation		3,028			2,915			8,000			10,162
Other research and development		17,110			11,838			62,417			48,581
Total research and development		20,138			14,753			70,417			58,743

Selling, general and administrative:
Noncash compensation		8,745			6,269		$	22,593			18,386
Other selling, general and administrative		33,221			26,500		$	92,742			73,167
Total selling, general and administrative		41,966			32,769			115,335			91,553

Total costs and expenses		71,445			51,031			208,839			156,573

Operating income		12,434			114,784			11,980			33,118

Other expense (income):
Interest expense		10,832			3,713		$	16,967			10,184
Other income		(2,666	)		(2,859	)	$	(5,128	)		(4,154	)
Total other expense, net		8,166			854			11,839			6,030

Net income before taxes	$	4,268		$	113,930		$	141		$	27,088
Income tax expense	$	388			—		$	89			—
Net income	$	3,880		$	113,930		$	52		$	27,088

Net income per common share:
Basic	$	0.03		$	0.80		$	0.00		$	0.19
Diluted	$	0.02		$	0.73		$	0.00		$	0.19

Weighted-average shares of common stock outstanding
Basic		145,102,479			142,871,227			145,342,337			141,571,785
Diluted		160,714,388			155,871,749			160,366,927			145,952,913

						*Additional*
	*Common Stock*					*paid-in*			*Treasury Stock*					*Accumulated*
	*Shares*			*Amount*		*capital*			*Shares*		*Amount*			*Deficit*			*Total*
Balance at January 1, 2023		146,426,697		$	146	$	1,623,924			41,309	$	(234	)	$	(1,565,249	)	$	58,587
Issuance of common stock in connection with exercise of options		66,701			*		363			—		—			—			363
Issuance of restricted stock		3,017,736			3		(3	)		—		—			—			—
Warrants issued with debt financing		—			—		595			—		—			—			595
Forfeiture of restricted stock		(73,787	)		*		—			—		—			—			—
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		7,120			—		—			—			7,120
Net loss		—			—		—			—		—			(39,232	)		(39,232	)
Balance at March 31, 2023		149,437,347			149		1,631,999			41,309		(234	)		(1,604,481	)		27,433
Issuance of common stock in connection with exercise of options		76,955			*		751			—		—			—			751
Issuance of restricted stock		95,000			*		*			—		—			—			—
Forfeiture of restricted stock		(25,679	)		*		*			—		—			—			—
Issuance of common stock in public offering (net of offering costs of $0.8 million)		1,385,700			2		46,295											46,297
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		13,582			—		—			—			13,582
Net loss		—			—		—			—		—			(47,610	)		(47,610	)
Balance at June 30, 2023		150,969,323			151		1,692,627			41,309		(234	)		(1,652,091	)		40,453
Issuance of common stock in connection with exercise of options		102,500			*		420			—		—			—			420
Issuance of restricted stock		457,501			*		*			—		—			—			—
Forfeiture of restricted stock		(38,593	)		*		*			—		—			—			—
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		9,966			—		—			—			9,966
Net loss		—			—		—			—		—			113,930			113,930
Balance at September 30, 2023		151,490,731			151		1,703,013			41,309		(234	)		(1,538,161	)		164,769

	*Nine months ended*
	*September 30,*
	*2024*			*2023*
CASH FLOWS FROM OPERATING ACTIVITIES

Net income	$	52		$	27,088
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on extinguishment of debt		4,607			0
Noncash stock compensation expense		30,593			28,548
Depreciation and amortization		59			173
Amortization of premium (discount) on investment securities		(5,287	)		(704	)
Amortization of debt issuance costs		1,692			1,739
Amortization of leasehold interest		159			159
Noncash change in lease liability and right of use asset		1,402			1,473
Change in fair value of equity investments		253			—
Change in fair value of notes payable		151			(71	)
Changes in assets and liabilities:
Increase in inventory		(42,031	)		(31,432	)
Increase in other current assets		(23,047	)		(10,365	)
Increase in accounts receivable		(64,634	)		(39,320	)
Increase (decrease) in accounts payable and accrued expenses		60,850			(2,372	)
Decrease in lease liabilities		(1,790	)		(1,780	)
Increase in other current liabilities		2,851			2,024
Increase in deferred revenue		19,244			6,637
Net cash used in operating activities		(14,876	)		(18,203	)

CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from maturity of short-term securities		237,200			72,551
Investment in held-to-maturity securities		(252,625	)		(78,447	)
Investment in long-term securities		(1,375	)		—
Purchases of Property, Plant and Equipment		(24	)		—
Net cash used in investing activities		(16,824	)		(5,896	)

CASH FLOWS FROM FINANCING ACTIVITIES
Payment of loan payable		(107,553	)		—
Issuance of common stock, net		—			46,297
Proceeds from exercise of options		344			1,534
Proceeds from debt financings		244,815			25,000
Financing costs paid		(858	)		(125	)
Purchase of treasury stock		(2,149	)		—

	*As of*
	*September 30,*
	*2024*		*2023*
Unvested restricted stock		10,645,967		8,454,545
Options		4,631,966		4,697,029
Warrants		312,272		312,272
Shares issuable upon note conversion		21,704		20,646
Total		15,611,909		13,484,492

	*September 30, 2024*
	*Amortized*		*Gross*		*Gross*
	*cost, as*		*unrealized*		*unrealized*		*Estimated*
(in thousands)	*adjusted*		*holding gains*		*holding losses*		*fair value*
Short-term investments:
Obligations of domestic governmental agencies (maturing between October 2024 and March 2025) (held-to-maturity)	$	145,219	$	122	$	3	$	145,338
Total short-term investments	$	145,219	$	122	$	3	$	145,338

	*December 31, 2023*
	*Amortized*		*Gross*		*Gross*
	*cost, as*		*unrealized*		*unrealized*		*Estimated*
	*adjusted*		*holding gains*		*holding losses*		*fair value*
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2024 and June 2024) (held-to-maturity)	$	124,575	$	30	$	53	$	124,552
Total short-term investments	$	124,575	$	30	$	53	$	124,552

(in thousands)	*Three months ended September 30,*				*Nine months ended September 30,*
	*2024*		*2023*		*2024*		*2023*
Total product revenue, net	$	83,297	$	25,068	$	206,381	$	48,868
License Revenue		38		140,038		114		140,114
Milestone Revenue		—		—		12,500		—
Royalty Revenue		229		—		412		—
Other Revenue		315		709		1,412		709
Total Revenue	$	83,879	$	165,815	$	220,819	$	189,691

	*September 30, 2024*
Raw Materials	$	1,734
Work in Process		74,973
Finished Goods		7,962
Total Inventory	$	84,669

	*Financial assets and liabilities at fair value as of September 30, 2024*
(in thousands)	*Level 1*		*Level 2*		*Level 3*		*Total*

Equity Investments	$	872	$	—	$	—	$	872
Total Assets	$	872	$	—	$	—	$	872

Forward Contract Liabilities	$	—	$	2,568	$	—	$	2,568
5% Notes	$	—	$	—	$	508	$	508
Total Liabilities	$	—	$	2,568	$	508	$	3,076

	Financial assets and liabilities at fair value as of December 31, 2023
	Level 1		Level 2		Level 3		Total

5% Notes	$	—	$	—	$	357	$	357
Total Liabilities	$	—	$	—	$	357	$	357

	*Stock Options*			*Restricted Stock*
Equity awards outstanding, beginning of year		4,697,029			9,639,068
Changes during the year:
Granted		—			4,675,013
Exercised or vested		(65,063	)		(1,873,310	)
Expired or Forfeited		—			(294,773	)
Equity awards outstanding, end of period		4,631,966			12,145,998

(in thousands)	Restricted Stock
Unrecognized compensation cost	$	31,204
Expected weighted-average period in years of compensation cost to be recognized		3.8

	Amended Term Loan
Exercise price	$	14.70
Common share price on date of issuance	$	15.04
Volatility		0.88	%
Risk-free interest rate		3.6	%
Expected dividend yield		—
Contractual term (in years)		7.00

	The First Amendment
	September 30,			December 31,
(in thousands)	2024			2023
Loan payable	$	95,000		$	95,000
Add: Accreted Liability of final payment fee		12,553			10,230
		107,553			105,230
Less: unamortized debt issuance and debt discount costs					(5,112	)
		107,553			100,118
Less: principal payments		(107,553	)		—
Total loan payable		—			100,118
Less: current portion		—			—
Loan payable non-current	$	—		$	100,118

	The Initial Term Loan
	September 30,
(in thousands)	2024
Loan payable	$	250,000
Add: Accreted Liability of final payment fee		—
		250,000
Less: unamortized debt issuance and debt discount costs		(5,842	)
		244,158
Less: principal payments		—
Total loan payable		244,158
Less: current portion		—
Loan payable non-current	$	244,158

	*Operating*
(in thousands)	*leases*
Remainder of 2024	$	598
2025		2,100
2026		2,080
2027		1,913
2028		1,827
After 2029		4,715
Total lease payments		13,233
Less: interest		(3,583	)
Present value of lease liabilities(*)	$	9,650

Clinical Drug Candidate: (molecular target)	Initial Target Disease	Stage/Status of Development
Ublituximab (anti-CD20 mAb)	Relapsing Forms of Multiple Sclerosis (RMS)	APPROVED
Subcutaneous ublituximab	RMS	Phase 1
Azer-cel	Progressive Forms of Multiple Sclerosis	IND Accepted

	●	In December 2020, we announced positive topline 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.
	●	In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab in patients with RMS and that the first patients have been dosed.
	●	Additional data sets from the ULTIMATE I & II Phase 3 trials continue to be presented at major medical meetings, including five year long term data which was presented for the first time at the 2024 ECTRIMS meeting in September, and updated data from the ENHANCE Phase 3b trial evaluating RMS patients who switch from an IV anti-CD20 therapy to BRIUMVI and evaluating a shorter infusion time of as low as 30 minutes for BRIUMVI.

	Three months ended
	September 30,
(in thousands)	2024			2023
Product revenue, net	$	83,297		$	25,068
License, milestone, royalty and other revenue		582			140,747
Total Revenue	$	83,879		$	165,815

Costs and expenses:
Cost of revenue		9,341			3,509
Research and development:
Noncash compensation		3,028			2,915
Other research and development		17,110			11,838
Total research and development		20,138			14,753

General and administrative:
Noncash compensation		8,745			6,269
Other selling, general and administrative		33,221			26,500
Total general and administrative		41,966			32,769

Total costs and expenses		71,445			51,031

Interest expense		10,832			3,713
Other income		(2,666	)		(2,859	)
Total other expense, net		8,166			854

Net income before taxes		4,268			113,930
Income tax expense		388			—
Net income	$	3,880		$	113,930

	Nine months ended
	September 30,
(in thousands)	2024			2023
Product revenue, net	$	206,381		$	48,868
License, milestone, royalty and other revenue		14,438			140,823
Total Revenue	$	220,819		$	189,691

Costs and expenses:
Cost of revenue		23,087			6,277
Research and development:
Noncash compensation		8,000			10,162
Other research and development		62,417			48,581
Total research and development		70,417			58,743

General and administrative:
Noncash compensation		22,593			18,386
Other selling, general and administrative		92,742			73,167
Total general and administrative		115,335			91,553

Total costs and expenses		208,839			156,573

Interest expense		16,967			10,184
Other income		(5,128	)		(4,154	)
Total other expense, net		11,839			6,030

Net income before taxes		141			27,088
Income tax expense		89			—
Net income	$	52		$	27,088

	●	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 foreign marketing approval for our product and product candidates;
	●	obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA, MHRA and EMA 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;
	●	expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties;
	●	obtain, develop, maintain, protect, and defend our intellectual property portfolio; and
	●	achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.