XERS 10-Q

Xeris Biopharma Holdings, Inc. (XERS)

10-Q 2023-08-08 For: 2023-06-30

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Added on April 11, 2026

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☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2023
or
☐			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: 001-40880


			<						As a company, we have a limited operating history and limited experience commercializing pharmaceutical products and have incurred significant losses since inception. We may continue to incur losses over the next few years and may not be able to achieve or sustain revenues or profitability in the future.
			<						We may never be profitable and we may not be able to continue operations without additional fundings.
			<						We may require additional capital to sustain our business, and this capital may cause dilution to our stockholders and might not be available on terms favorable to us, or at all, which could force us to delay, reduce or eliminate our product development programs or commercialization efforts.
			<						Our business depends entirely on the commercial success of our products and product candidates. Even if approved, our product candidates may not be accepted in the marketplace and our business may be materially harmed.
			<						We operate in a competitive business environment, which may have an adverse impact on our revenue. If we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected and we may not successfully commercialize our products or product candidates, even if approved.
			<						If we are unable to establish or do not maintain sufficient marketing, sales and distribution capabilities or enter into agreements with third parties to market, sell and distribute our products on terms acceptable to us, we may not be able to generate product revenue and our business, results of operations, and financial condition will be materially adversely affected.
			<						Our reliance on third-party suppliers, including single-source suppliers, together with a limited number of possible suppliers and long development lead-times for alternate sources for Gvoke, Keveyis, and Recorlev or our product candidates could harm our ability to develop our product candidates or to continue to commercialize Gvoke, Keveyis, Recorlev or any product candidates that are approved.
			<						Reimbursement decisions by third-party payors and consolidation within the healthcare industry and among competitors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used and pricing pressure may impact our ability to sell our products at prices necessary to support our current business strategies.
			<						Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed indications for our product candidates. If our clinical trials fail to demonstrate efficacy and safety to the satisfaction of the Food and Drug Administration ("FDA") or other regulatory authorities, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
			<						Gvoke, Keveyis, Recorlev and our product candidates may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to include safety warnings, require them to be taken off the market or otherwise limit their sales.
			<						Our failure to successfully identify, develop and market additional product candidates, or acquire additional product candidates or enter into collaborations or other commercial agreements could impair our ability to grow.
			<						Our success depends on our ability to protect our intellectual property and proprietary formulation science, as well as the ability of our collaborators to protect their intellectual property and proprietary formulation science.
			<						Our stock price has been and will likely continue to be volatile, and you may lose part or all of your investment.
			<						Our data collection and processing activities are governed by restrictive regulations governing the use, processing and, in certain jurisdictions, cross-border transfer of personal information.


			Page
Part I. Financial Information
	Item 1. Financial Statements
		Condensed Consolidated Balance Sheets as of June 3 0 , 2023 and December 31, 2022	4
		Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and s ix months ended June 3 0 , 2023 and 2022	5
		Condensed Consolidated Statements of Stockholders’ Equity for the three an d six months ended June 3 0 , 2023 and 2022	6
		Condensed Consolidated Statements of Cash Flow for the six months ended June 3 0 , 2023 and 2022	7
		Notes to Condensed Consolidated Financial Statements	9
	Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations		24
	Item 3. Quantitative and Qualitative Disclosures About Market Risk		31
	Item 4. Controls and Procedures		32
Part II. Other Information
	Item 1. Legal Proceedings		32
	Item 1A. Risk Factors		33
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		67
	Item 3. Defaults Upon Senior Securities		67
	Item 4. Mine Safety Disclosures		67
	Item 5. Other Information		67
	Item 6. Exhibits		67
	Signatures		69


	June 30, 2023		December 31, 2022
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	46,170	$	121,966
Short-term investments	34,498		—
Trade accounts receivable, net	30,225		30,830
Inventory	36,538		24,735
Prepaid expenses and other current assets	8,310		9,287
Total current assets	155,741		186,818
Property and equipment, net	6,552		5,516
Operating lease right-of-use assets	23,632		3,992
Goodwill	22,859		22,859
Intangible assets, net	115,186		120,607
Other assets	4,808		4,730
Total assets	$	328,778	$	344,522
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	11,621	$	4,606
Current operating lease liabilities	1,935		1,580
Other accrued liabilities	19,413		36,786
Accrued trade discounts and rebates	17,034		16,818
Accrued returns reserve	11,320		11,173
Current portion of contingent value rights	16,637		—
Other current liabilities	1,718		2,658
Total current liabilities	79,678		73,621
Long-term debt, net of unamortized debt issuance costs	188,182		187,075
Non-current operating lease liabilities	34,871		9,402
Non-current contingent value rights	6,911		25,688


Deferred tax liabilities	2,843		3,518
Other liabilities	2,652		31
Total liabilities	315,137		299,335
Commitments and contingencies (Note 15)





Stockholders’ equity:
Preferred stock—par value $0.0001, 25,000,000 shares and 25,000,000 shares authorized and no shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	—		—
Common stock—par value $0.0001, 350,000,000 shares and 350,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively; 138,012,130 and 136,273,090 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	14		14
Additional paid in capital	605,151		599,966
Accumulated deficit	(591,446)		(554,770)
Accumulated other comprehensive loss	(78)		(23)
Total stockholders’ equity	13,641		45,187
Total liabilities and stockholders’ equity	$	328,778	$	344,522


	Three Months Ended June 30,				Six Months Ended June 30,
	2023		2022		2023		2022
Product revenue, net	$	36,893	$	25,260	$	69,158	$	47,170
Royalty, contract and other revenue	1,115		46		2,046		209
Total revenue	38,008		25,306		71,204		47,379
Costs and expenses:
Cost of goods sold	7,555		4,810		12,874		11,083
Research and development	6,087		3,718		10,925		9,968
Selling, general and administrative	37,635		32,984		71,240		68,897
Amortization of intangible assets	2,710		2,710		5,421		5,421
Total costs and expenses	53,987		44,222		100,460		95,369
Loss from operations	(15,979)		(18,916)		(29,256)		(47,990)
Other income (expense):
Interest and other income	1,223		195		2,523		263
Interest expense	(6,528)		(3,448)		(12,744)		(6,969)
Change in fair value of warrants	(14)		516		(14)		1,737
Change in fair value of contingent value rights	781		(4,871)		2,140		(7,687)
Total other expense	(4,538)		(7,608)		(8,095)		(12,656)
Net loss before benefit from income taxes	(20,517)		(26,524)		(37,351)		(60,646)
Benefit from income taxes	675		339		675		747
Net loss	$	(19,842)	$	(26,185)	$	(36,676)	$	(59,899)

Other comprehensive loss, net of tax:
Unrealized gains (losses) on investments	(49)		14		(55)		(21)

Comprehensive loss	$	(19,891)	$	(26,171)	$	(36,731)	$	(59,920)

Net loss per common share - basic and diluted	$	(0.14)	$	(0.19)	$	(0.27)	$	(0.44)

Weighted average common shares outstanding - basic and diluted	137,338,071		135,529,968		137,250,465		135,282,749


	Common Stock			Additional Paid In Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
	Shares	Amount
Balance, December 31, 2021	124,873,316	$	13	$	555,359	$	(31)	$	(460,110)	$	95,231
Net loss	—	—		—		—		(33,714)		(33,714)
Issuance of common stock related to Armistice equity offering	10,238,908	1		29,999		—		—		30,000
Issuance of warrants related to loan agreement	—	—		2,080		—		—		2,080
Exercise of stock options	11,228	—		8		—		—		8
Vesting of restricted stock units (net of 197,257 shares withheld for tax)	404,743	—		(416)		—		—		(416)
Stock-based compensation	—	—		3,301		—		—		3,301

Other comprehensive loss	—	—		—		(35)		—		(35)
Balance, March 31, 2022	135,528,195	$	14	$	590,331	$	(66)	$	(493,824)	$	96,455
Net loss	—	—		—		—		(26,185)		(26,185)




Exercise of stock options	2,561	—		(3)		—				(3)
Vesting of restricted stock units (net of 1,317 shares withheld for tax)	—	—		—		—		—		—
Stock-based compensation	—	—		3,152		—		—		3,152
Issuance of common stock through employee stock purchase plan	389,987	—		510		—		—		510
Other comprehensive loss	—	—		—		14		—		14
Balance, June 30, 2022	135,920,743	$	14	$	593,990	$	(52)	$	(520,009)	$	73,943


	As of June 30,
		2023		2022
Cash flows from operating activities:
Cash and cash equivalents		$	46,170	$	95,340
Restricted cash included in Other assets (1)		4,426		—
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows		$	50,596	$	95,340


	June 30, 2023
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Total Fair Value

Investments:
U.S. government securities	$	34,553	$	—	$	(55)	$	34,498


Total available-for-sale investments	$	34,553	$	—	$	(55)	$	34,498


	June 30, 2023		December 31, 2022

Raw materials	$	13,439	$	7,410
Work in process	6,418		11,367
Finished goods	16,681		5,958
Inventory	$	36,538	$	24,735


	June 30, 2023		December 31, 2022

Lab equipment	$	3,968	$	3,841
Furniture and fixtures	1,626		1,355
Computer equipment	781		474
Office equipment	70		8
Software	353		307
Leasehold improvements	6,038		5,065
Total property and equipment	12,836		11,050
Less: accumulated depreciation and amortization	(6,284)		(5,534)
Property and equipment, net	$	6,552	$	5,516


	Life (Years)	June 30, 2023						December 31, 2022
	Life (Years)	Gross assets		Accumulated amortization		Net		Gross assets		Accumulated amortization		Net
Definite-lived intangible asset - Keveyis	5	$	11,000	$	(3,850)	$	7,150	$	11,000	$	(2,750)	$	8,250
Definite-lived intangible asset - Recorlev	14	121,000		(12,964)		108,036		121,000		(8,643)		112,357
Total intangible assets		$	132,000	$	(16,814)	$	115,186	$	132,000	$	(11,393)	$	120,607


2023 remaining	5,422
2024	10,843
2025	10,843
2026	10,293
2027	8,643

Thereafter	69,142
Total	$	115,186


	June 30, 2023		December 31, 2022
Accrued employee costs	$	10,968	$	13,400
Supply agreement - current portion	—		6,720
Accrued supply chain costs	190		562
Accrued marketing costs	1,977		2,593
Accrued research and development costs	455		1,411
Accrued restructuring charges	802		2,799
Accrued interest expense	1,088		4,656

Accrued other costs	3,933		4,645
Other accrued liabilities	$	19,413	$	36,786


	Restructuring Costs



Balance accrued at December 31, 2022	2,799

Payments	(1,997)
Balance accrued at June 30, 2023	$	802


	June 30, 2023		December 31, 2022

Convertible Notes	$	47,175	$	47,175
Loan facility	145,012		144,487
Less: unamortized debt issuance costs	(4,005)		(4,587)
Long-term debt, net of unamortized debt issuance costs	$	188,182	$	187,075


Warrants classified as liabilities:	Outstanding Warrants	Exercise Price per Warrant	Expiration Date
2018 Term A Warrants	53,720	$11.169	February 2025
2018 Term B Warrants	40,292	$11.169	September 2025
	94,012
Warrants classified as equities:
Warrants in connection with CRG loan agreement	309,122	$9.410	July 2024
Warrants in connection with CRG loan amendment in January 2018	978,628	$12.760	January 2025
Warrants in connection with Avenue Capital loan agreement	209,633	$2.390	May 2025
Warrants in connection with Avenue Capital loan agreement	209,633	$2.390	December 2025
Warrants in connection with Horizon and Oxford loan agreement	125,999	$3.130	December 2026
Warrants in connection with Armistice securities purchase agreement	5,119,454	$3.223	February 2027
Warrants in connection with Hayfin Loan Agreement	1,315,789	$2.280	March 2029
	8,268,258


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Contractual Life (Years)
Outstanding - December 31, 2022	9,700,161	$	5.37	4.76
Granted	—	—


Exercised	(14,036)	2.33
Forfeited	(11,846)	5.49
Expired	(366,433)	9.08
Outstanding - June 30, 2023	9,307,846	$	5.23	4.40
Vested and expected to vest at June 30, 2023	9,307,846	$	5.23	4.40
Exercisable - June 30, 2023	8,968,523	$	5.24	4.28


	Number of Units	Weighted Average Grant Date Fair Value Per Share
Unvested balance - December 31, 2022	5,255,560	$	3.25
Granted	7,499,400	1.31
Vested	(1,904,422)	3.69
Forfeited	(247,767)	1.75
Unvested balance - June 30, 2023	10,602,771	$	1.83


	As of June 30,
	2023	2022
Shares to be issued upon conversion of Convertible Notes	15,416,667	15,416,667
Vested and unvested stock options	9,307,846	10,009,493
Restricted stock units	10,602,771	5,381,154
Warrants	8,362,270	8,362,270
Total anti-dilutive securities excluded from EPS computation 1	43,689,554	39,169,584


	Total as of June 30, 2023		Level 1		Level 2		Level 3

Assets
Cash and cash equivalents:
Cash and money market funds	$	46,170	$	46,170	$	—	$	—

Investments:
U.S. government securities	$	34,498	$	34,498	$	—	$	—





Other assets:
Restricted cash	$	4,426	$	4,426	$	—	$	—

Liabilities
Current portion of contingent value rights	$	16,637	$	—	$	—	$	16,637
Non-current contingent value rights	$	6,911	$	—	$	—	$	6,911
Warrant liabilities	$	23	$	—	$	—	$	23


	Total as of December 31, 2022		Level 1		Level 2		Level 3
Assets
Cash and cash equivalents:
Cash and money market funds	$	121,966	$	121,966	$	—	$	—








Other assets:
Restricted cash	$	4,348	$	4,348	$	—	$	—

Liabilities
Contingent value rights	$	25,688	$	—	$	—	$	25,688
Warrant liabilities	$	9	$	—	$	—	$	9




Balance at December 31, 2022	$	25,688
Change in fair value of CVRs	(2,140)
Balance at June 30, 2023	$	23,548

Balance at Current portion of contingent value rights	$	16,637
Balance at Non-current contingent value rights	6,911
Balance at June 30, 2023	$	23,548


	Three Months Ended June 30,				Six Months Ended June 30,
Lease cost	2023		2022		2023		2022
Operating lease expense	$	1,350	$	533	$	1,763	$	1,000
Variable lease cost	302		215		652		440
Sublease income	(54)		(52)		(108)		(104)
Total lease cost	$	1,598	$	696	$	2,307	$	1,336


2023 remaining	$	730
2024	3,495
2025	6,080
2026	6,232
2027	6,389
Thereafter	51,990
Total lease payments	74,916
Less: Effect of discounting to net present value	(38,110)
Present value of lease liabilities	$	36,806

Operating lease liabilities, current	1,935
Operating lease liabilities, non-current	34,871
Total operating lease liabilities	$	36,806


			<						continue our marketing and selling efforts related to commercialization of Gvoke, Keveyis and Recorlev;
			<						continue our research and development efforts; and
			<						continue to operate as a public company.


			<						Drive growth through effective commercial execution of our innovative products. We have three innovative commercial products (Gvoke, Keveyis, and Recorlev) all of which fill unique, unmet needs. Additionally, Gvoke and Recorlev are in the very early stages of their product lifecycles and both leverage our experienced and growing leadership presence in the endocrinology community. We are focused on executing against the opportunities made possible by Gvoke, Recorlev, and Keveyis in order to maintain our momentum of growth and enable the financial self-sufficiency of our Company.
			<						Continue to leverage our proprietary formulation science and expertise to develop our internal new product candidates. We have established a proven capability to bring new and innovative products through the development and regulatory process to successful commercialization. XeriSol and XeriJect have broad application and have the potential to be utilized across a range of potential product candidates in multiple therapeutic areas. Our immediate focus is on developing XP-8121, a once weekly subcutaneous injection of levothyroxine, and eventually generating significant benefits for patients and value for our company.
			<						Collaborate with pharmaceutical and biotechnology companies to apply our formulation science to enhance the formulations of their proprietary products and candidates. We are pursuing formulation and development partnerships to apply our XeriSol and XeriJect formulation platforms to enhance the drug delivery and clinical profile of other companies’ proprietary drugs and biologics. We currently are collaborating with several major pharmaceutical companies on the development of formulations of their proprietary therapeutics with XeriSol or XeriJect. Our strategic goal is to ultimately enter into commercial licensing agreements with these partners upon successful completion of formulation development.


			<						the cost of acquiring and manufacturing preclinical study and clinical trial materials and manufacturing costs related to commercial production and scale-up until a product is approved and initially available for commercial sale;
			<						expenses incurred under agreements with contract research organizations ("CROs") as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
			<						personnel-related expenses, which include salaries, benefits and stock-based compensation;
			<						laboratory materials and supplies used to support our research activities;
			<						outsourced product development services;
			<						expenses relating to regulatory activities, including filing fees paid to regulatory agencies; and
			<						allocated expenses for facility-related costs.


	Three Months Ended June 30,				Change			Six Months Ended June 30,				Change
	2023		2022		$		%	2023		2022		$		%
Product revenue:
Gvoke	$	15,638	$	11,479	$	4,159	36.2	$	30,671	$	23,932	$	6,739	28.2
Keveyis	14,088		12,812		1,276		10.0	26,843		22,136		4,707		21.3
Recorlev	7,167		969		6,198		nm	11,644		1,102		10,542		nm
Product revenue, net	36,893		25,260		11,633		46.1	69,158		47,170		21,988		46.6
Royalty, contract and other revenue	1,115		46		1,069		nm	2,046		209		1,837		nm
Total revenue	38,008		25,306		12,702		50.2	71,204		47,379		23,825		50.3

Cost and expenses:
Cost of goods sold, excluding amortization of intangible assets	7,555		4,810		2,745		57.1	12,874		11,083		1,791		16.2
Research and development	6,087		3,718		2,369		63.7	10,925		9,968		957		9.6
Selling, general and administrative	37,635		32,984		4,651		14.1	71,240		68,897		2,343		3.4
Amortization of intangible assets	2,710		2,710		—		—	5,421		5,421		—		—
Total cost and expenses	53,987		44,222		9,765		22.1	100,460		95,369		5,091		5.3
Loss from operations	(15,979)		(18,916)		2,937		(15.5)	(29,256)		(47,990)		18,734		(39.0)
Other income (expense):
Interest and other income	1,223		195		1,028		nm	2,523		263		2,260		nm
Interest expense	(6,528)		(3,448)		(3,080)		89.3	(12,744)		(6,969)		(5,775)		82.9
Change in fair value of warrants	(14)		516		(530)		(102.7)	(14)		1,737		(1,751)		nm
Change in fair value of contingent considerations	781		(4,871)		5,652		nm	2,140		(7,687)		9,827		nm
Total other expense	(4,538)		(7,608)		3,070		(40.4)	(8,095)		(12,656)		4,561		(36.0)
Net loss before benefit from income taxes	(20,517)		(26,524)		6,007		(22.6)	(37,351)		(60,646)		23,295		(38.4)
Benefit from income taxes	675		339		336		99.1	675		747		(72)		(9.6)
Net loss	$	(19,842)	$	(26,185)	$	6,343	(24.2)	$	(36,676)	$	(59,899)	$	23,223	(38.8)


			<						our degree of success in commercializing Gvoke, Keveyis and Recorlev;
			<						the costs of commercialization activities, including product marketing, sales and distribution;
			<						the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates;
			<						the effect on our product development activities of actions taken by the FDA or other regulatory authorities;
			<						the number and types of future products we develop and commercialize;
			<						the emergence of competing technologies and products and other adverse market developments; and
			<						the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims.


	Six Months Ended June 30,
(in thousands)	2023		2022

Net cash used in operating activities	$	(39,884)	$	(69,018)
Net cash (used in)/provided by investing activities	(35,527)		18,584
Net cash (used in)/provided by financing activities	(307)		78,504


			<						execute our Gvoke, Keveyis and Recorlev commercial strategies in the United States;
			<						continue our research and development efforts;
			<						seek regulatory approval for new product candidates and product enhancements; and
			<						continue to operate as a public company.


			<						obtain commercial quantities of our products at acceptable cost levels;


			<						successfully manage inventory;
			<						sell and distribute our products on terms acceptable to us;
			<						achieve an adequate level of market acceptance of our products in the medical community and with third-party payors, including placement in accepted clinical guidelines for the conditions for which our product candidates are intended to target;
			<						obtain and maintain third-party coverage and adequate reimbursement for our products;
			<						compete effectively against our competitors; and
			<						launch and commercialize our products utilizing our own sales force or by entering into partnership or co-promotion arrangements with third parties.


			<						a covered benefit under health plans;
			<						safe, effective and medically necessary;
			<						appropriate for the specific patient;
			<						cost-effective; and
			<						neither experimental nor investigational.


			<						regulatory authorities may withdraw approvals of such product, require us to take our approved product off the market or ask us to voluntarily remove the product from the market;
			<						regulatory authorities may require the addition of labeling statements, specific warnings, contraindications or the issuance of field alerts to physicians and pharmacies;
			<						regulatory authorities may impose conditions under a risk evaluation and mitigation strategy ("REMS") including distribution of a medication guide to patients outlining the risks of such side effects or imposing distribution or use restrictions;
			<						we may be required to change the way a product is administered, conduct additional clinical trials or change the labeling of the product;
			<						we may be subject to limitations on how we may promote the product;
			<						sales of the product may decrease significantly;
			<						we may be subject to litigation or products liability claims; and
			<						our reputation may suffer.


			<						our suppliers may fail to comply with regulatory requirements or make errors in manufacturing raw materials, components or products that could negatively affect the efficacy or safety of our products or cause delays in shipments of our products;
			<						we may be subject to price fluctuations due to terms within long-term supply arrangements with suppliers or lack of long-term supply arrangements for key materials and products;
			<						given the long lead times to change suppliers, existing suppliers may utilize that as leverage in negotiations with us in a manner that is adverse to our business;
			<						our suppliers may lose access to critical services or sustain damage to a facility, including losses due to natural disasters, geo-political events, or epidemics that may result in a sustained interruption in the manufacture and supply of our products;
			<						fluctuations in demand for our products or a supplier’s demand from other customers may affect their ability or willingness to deliver materials or products in a timely manner or may lead to long-term capacity constraints at the supplier;
			<						we may not be able to find new or alternative sources or reconfigure our products and manufacturing processes in a timely manner if necessary raw materials or components become unavailable;
			<						our suppliers may encounter financial or other hardships unrelated to our demand for materials, products and services, which could inhibit their ability to fulfill our orders and meet our requirements; and
			<						the possibility of breach or termination of a manufacturing agreement or purchase order by the third party.


			<						could determine that we cannot rely on the Section 505(b)(2) regulatory pathway or other pathways we have selected, as applicable, for our product candidates;
			<						could determine that the information provided by us was inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of our product candidates for any indication;
			<						may not find the data from bioequivalence studies and/or clinical trials sufficient to support the submission of an NDA or to obtain marketing approval, including any findings that the clinical and other benefits of our product candidates do not outweigh their safety risks;
			<						may disagree with our trial design or our interpretation of data from preclinical studies, bioequivalence studies and/or clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our trials;


			<						may determine that we have identified the wrong listed drug or drugs or that approval of our Section 505(b)(2) application for any of our product candidates is blocked by patent or non-patent exclusivity of the listed drug or drugs or of other previously approved drugs with the same conditions of approval as any of our product candidates (as applicable);
			<						may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the manufacturing of our product candidates;
			<						may audit some or all of our clinical research and human factors study sites to determine the integrity of our data and may reject any or all of such data;
			<						may approve our product candidates for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials or implementation of a REMS;
			<						may change its criteria for approval, policies or adopt new regulations; or
			<						may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.


			<						regulatory authorities may require the addition of labeling statements, including "black box" warnings, contraindications or dissemination of field alerts to physicians and pharmacies;
			<						we may be required to change instructions regarding the way the product is administered, conduct additional clinical trials or change the labeling of the product;
			<						we may be subject to limitations on how we may promote the product;
			<						sales of the product may decrease significantly;
			<						regulatory authorities may require us to take our approved product off the market;
			<						we may be subject to litigation or products liability claims; and
			<						our reputation may suffer.