MannKind Corporation is a biopharmaceutical company focusing on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. Based in Danbury, Connecticut, the company was founded in February 1991. MannKind Corporation was named after its founder, Alfred E. Mann.3 Its revenue was $63 million in 2019.1 Its shares trade on Nasdaq under the symbol MNKD.1Wikipedia text CC BY-SA 4.0
MannKind Corporation is a biopharmaceutical company focusing on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. Based in Danbury, Connecticut, the company was founded in February 1991.3
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Revenue91011128$349.0M in 2025+454% since 2019Operating income91011128$38.8M in 2025Net income91011128$5.9M in 2025
Revenue1314$109.4M in Q2 FY2026+21% since Q1 FY2026Operating income1314-$350.0K in Q2 FY2026−79% since Q1 FY2026Net income1314-$19.0M in Q2 FY2026+15% since Q1 FY2026
Every line of the income statement as filed: the last 3 fiscal years, latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
Total revenues
$349.0M
$285.5M
$199.0M
Cost of goods sold - commercial, excluding amortization of acquired intangible assets
$26.8M
$17.4M
$20.9M
Research and development
$66.3M
$45.9M
$31.3M
Selling, general and administrative
$144.1M
$94.3M
$94.3M
Amortization of acquired intangible assets
$4.0M
Loss (gain) on foreign currency transaction
$7.7M
-$3.9M
$1.9M
Total expenses
$310.2M
$212.9M
$190.3M
Income from operations
$38.8M
$72.6M
$8.7M
Interest income, net
$8.1M
$12.6M
$6.2M
Interest expense on liability for sale of future royalties
-$14.4M
-$16.2M
-$185.0K
Interest expense
-$13.8M
-$12.0M
-$15.2M
Interest expense on financing liability
-$9.8M
-$9.8M
-$9.8M
Impairment of available-for-sale investment
-$6.4M
-$1.6M
-$170.0K
Gain on bargain purchase
$5.3M
Other (expense) income
-$1.0M
$32.0K
$122.0K
Loss on settlement of debt
-$20.4M
Total other expense
-$37.4M
-$42.1M
-$19.1M
Income before income tax (benefit) expense
$1.4M
$30.5M
-$10.4M
Income tax (benefit) expense
-$4.5M
$2.9M
$1.6M
Net Income (Loss)
$5.9M
$27.6M
-$11.9M
Net income (loss) per share - basic
$0.02
$0.10
-$0.04
Weighted average shares used to compute net income (loss) per share - basic
305.6M shares
274.4M shares
267.0M shares
Net income (loss) per share - diluted
$0.02
$0.10
-$0.04
Weighted average shares used to compute net income (loss) per share - diluted
314.1M shares
283.8M shares
267.0M shares
No quarter-by-quarter statement was filed.
Total assets9151011128$792.2M in 2025+745% since 2019Total liabilities9151011128$843.2M in 2025+197% since 2019Shareholders’ equity1011128-$51.0M in 2025−73% since 2019Cash9151011128$74.9M in 2025+150% since 2019Long-term debt9151011128$354.6M in 2025+198% since 2019
Total assets1314$732.3M in Q2 FY2026−8% since Q1 FY2025Total liabilities1314$799.5M in Q2 FY2026−5% since Q1 FY2025Shareholders’ equity1314-$67.2M in Q2 FY2026+32% since Q1 FY2025Cash1314$52.9M in Q2 FY2026−29% since Q1 FY2025Long-term debt1314$319.1M in Q2 FY2026+0% since Q1 FY2026
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$74.9M
$46.3M
Short-term investments
$96.5M
$150.9M
Accounts receivable, net
$38.4M
$11.8M
Inventory
$35.3M
$27.9M
Prepaid expenses and other current assets
$46.6M
$31.4M
Total current assets
$291.6M
$268.3M
Restricted cash
$745.0K
$737.0K
Long-term investments
$5.0M
$5.5M
Property and equipment, net
$82.4M
$85.4M
Goodwill
$67.6M
$1.9M
Developed technology - on-body infusor
$190.0M
IPR&D - ReadyFlow Formulation
$129.6M
Other intangible assets
$5.1M
$5.3M
Other assets
$20.1M
$26.8M
Total assets
$792.2M
$393.8M
Accounts payable
$9.0M
$6.8M
Accrued expenses and other current liabilities
$64.6M
$40.3M
Senior convertible notes - current
$36.3M
Liability for sale of future royalties - current
$14.3M
$12.3M
Contingent consideration - current
$21.1M
Financing liability - current
$10.3M
$10.1M
Deferred revenue - current
$15.3M
$12.4M
Total current liabilities
$171.0M
$81.8M
Liability for sale of future royalties - long term
$137.0M
$137.4M
Financing liability - long term
$93.1M
$93.9M
Deferred revenue long term
$40.0M
$51.2M
Recognized loss on purchase commitments long term
$66.0M
$58.2M
Operating lease liability
$10.7M
$11.6M
Contingent consideration -long term
$5.1M
Milestone liabilities
$2.0M
$2.5M
Term loan
$318.4M
Senior convertible notes
$36.1M
Total liabilities
$843.2M
$472.7M
Common stock, $0.01 par value - 800,000,000 shares authorized; 307,832,587 and 302,959,782 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
$3.1M
$3.0M
Additional paid-in capital
$3.1B
$3.1B
Accumulated other comprehensive income
$115.0K
$1.1M
Accumulated deficit
-$3.2B
-$3.2B
Total stockholders' deficit
-$51.0M
-$78.8M
-$246.2M
-$250.5M
Total liabilities and stockholders' deficit
$792.2M
$393.8M
Undesignated preferred stock, par value
$0.01
$0.01
Undesignated preferred stock, shares authorized
10.0M shares
10.0M shares
Undesignated preferred stock, shares issued
0 shares
0 shares
Undesignated preferred stock, shares outstanding
0 shares
0 shares
Common stock, par value
$0.01
$0.01
Common stock, shares authorized
800.0M shares
800.0M shares
Common stock, shares issued
307.8M shares
303.0M shares
Common stock, shares outstanding
307.8M shares
303.0M shares
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$74.9M
$46.3M
Short-term investments
$96.5M
$150.9M
Accounts receivable, net
$38.4M
$11.8M
Inventory
$35.3M
$27.9M
Prepaid expenses and other current assets
$46.6M
$31.4M
Total current assets
$291.6M
$268.3M
Restricted cash
$745.0K
$737.0K
Long-term investments
$5.0M
$5.5M
Property and equipment, net
$82.4M
$85.4M
Goodwill
$67.6M
$1.9M
Developed technology - on-body infusor
$190.0M
IPR&D - ReadyFlow Formulation
$129.6M
Other intangible assets
$5.1M
$5.3M
Other assets
$20.1M
$26.8M
Total assets
$792.2M
$393.8M
Accounts payable
$9.0M
$6.8M
Accrued expenses and other current liabilities
$64.6M
$40.3M
Senior convertible notes - current
$36.3M
Liability for sale of future royalties - current
$14.3M
$12.3M
Contingent consideration - current
$21.1M
Financing liability - current
$10.3M
$10.1M
Deferred revenue - current
$15.3M
$12.4M
Total current liabilities
$171.0M
$81.8M
Liability for sale of future royalties - long term
$137.0M
$137.4M
Financing liability - long term
$93.1M
$93.9M
Deferred revenue long term
$40.0M
$51.2M
Recognized loss on purchase commitments long term
$66.0M
$58.2M
Operating lease liability
$10.7M
$11.6M
Contingent consideration -long term
$5.1M
Milestone liabilities
$2.0M
$2.5M
Term loan
$318.4M
Senior convertible notes
$36.1M
Total liabilities
$843.2M
$472.7M
Common stock, $0.01 par value - 800,000,000 shares authorized; 307,832,587 and 302,959,782 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
$3.1M
$3.0M
Additional paid-in capital
$3.1B
$3.1B
Accumulated other comprehensive income
$115.0K
$1.1M
Accumulated deficit
-$3.2B
-$3.2B
Total stockholders' deficit
-$51.0M
-$78.8M
-$246.2M
-$250.5M
Total liabilities and stockholders' deficit
$792.2M
$393.8M
Undesignated preferred stock, par value
$0.01
$0.01
Undesignated preferred stock, shares authorized
10.0M shares
10.0M shares
Undesignated preferred stock, shares issued
0 shares
0 shares
Undesignated preferred stock, shares outstanding
0 shares
0 shares
Common stock, par value
$0.01
$0.01
Common stock, shares authorized
800.0M shares
800.0M shares
Common stock, shares issued
307.8M shares
303.0M shares
Common stock, shares outstanding
307.8M shares
303.0M shares
Cash from operations91011128$18.3M in 2025Capital spending91011128$4.6M in 2025+78% since 2019Free cash flow91011128$13.7M in 2025
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
Net income (loss)
$5.9M
$27.6M
-$11.9M
Stock-based compensation
$24.2M
$21.4M
$17.6M
Interest on liability for sale of future royalties
$14.4M
$16.2M
$185.0K
Sold portion of royalty revenue
-$12.8M
-$10.2M
-$2.1M
Write-off of inventory
$10.4M
$3.9M
$4.6M
Depreciation and amortization
$12.3M
$7.4M
$4.5M
Loss (gain) on foreign currency transaction
$7.7M
-$3.9M
$1.9M
Impairment loss on available-for-sale investment
$6.4M
$1.6M
$170.0K
Net accretion of investments
-$2.6M
-$5.1M
-$925.0K
Non-cash lease expense of right-of-use assets
$1.2M
$1.7M
$1.3M
Change in fair value of contingent liability
$1.0M
Amortization of debt discount and issuance costs
$854.0K
$1.6M
$2.1M
Loss on settlement of debt
$20.4M
Gain on bargain purchase
-$5.3M
Loss on estimated returns of acquired product
$1.4M
Other, net
$155.0K
$380.0K
-$84.0K
Change in deferred tax liability
-$5.0M
Accounts receivable, net
-$4.8M
$2.7M
$2.3M
Inventory
-$6.6M
-$3.2M
-$11.3M
Prepaid expenses and other current assets
-$10.0M
-$6.6M
-$7.3M
Other assets
-$1.9M
-$3.6M
$263.0K
Accounts payable
-$16.7M
-$2.8M
-$1.5M
Accrued expenses and other current liabilities
$3.3M
-$2.7M
$6.6M
Deferred revenue
-$8.3M
-$15.3M
$39.5M
Recognized loss on purchase commitments
-$2.7M
-$9.4M
Operating lease liabilities
-$873.0K
-$2.3M
-$2.4M
Net cash provided by operating activities
$18.3M
$42.5M
$34.1M
Purchase of available-for-sale securities
-$157.8M
-$7.0M
Proceeds from maturities of available-for-sale securities
$215.3M
$58.1M
Acquisition of scPharma, net of cash acquired
-$347.7M
Issuance of note receivable
-$10.0M
Purchase of property and equipment
-$4.6M
-$9.7M
-$42.4M
Purchase of held-to-maturity securities
-$273.8M
-$79.1M
Proceeds from maturities of held-to-maturity securities
$135.3M
$119.2M
Proceeds from insurance claim
$396.0K
$382.0K
Net cash used in investing activities
-$304.8M
-$96.6M
-$2.0M
Proceeds from term loan
$325.0M
Payment of loan issuance costs
-$7.3M
Payments for taxes related to net issuance of common stock associated with restricted stock units and stock options
-$3.3M
-$6.1M
-$10.2M
Principal payments on financing liability
-$726.0K
-$398.0K
-$189.0K
Proceeds from market price stock purchase plan and employee stock purchase plan
$2.0M
$3.1M
$1.8M
Milestone Right Agreement payment
-$639.0K
-$752.0K
-$924.0K
Principal and early extinguishment payments on MidCap credit facility
-$36.6M
-$6.7M
Proceeds from sale of future royalties
$150.0M
Issuance costs associated with sale of future royalties
-$4.0M
Principal and early extinguishment payments on senior convertible notes
-$87.7M
Principal and early extinguishment payments on Mann Group convertible note
-$8.9M
Net cash provided by (used in) financing activities
$315.1M
-$137.3M
$136.6M
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
$28.6M
-$191.4M
$168.7M
Interest paid in cash
$14.7M
$17.5M
$18.3M
Income taxes paid in cash
$1.7M
$4.3M
Non-cash contingent consideration from acquisition of scPharma
$25.2M
Debt forgiven as part of scPharma acquisition
$10.0M
Payments of senior convertible note principal through common stock issuances
$116.4M
Amortization of liability for sale of future royalties
$1.4M
$3.6M
Purchases of property and equipment included in accounts payable and accrued expenses
$619.0K
$1.7M
$1.7M
Assumption of right-of-use-asset and operating lease liability
$10.1M
Non-cash acquisition of intangible asset
$4.3M
Non-cash acquisition of property and equipment
$959.0K
Right-of-use asset modification
$728.0K
Goodwill adjustment for a net reduction in liabilities
$497.0K
Receivable for insurance claim on damaged equipment
$445.0K
Accrued issuance costs associated with liability for sale of future royalties
MannKind Corporation sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
State Street CorporationFiled SCHEDULE 13G on MannKind Corporation, latest May 12, 2026 (4 filings since Feb 10, 2022)
VANGUARD GROUP INCFiled SCHEDULE 13G/A on MannKind Corporation, latest Mar 27, 2026 (4 filings since Feb 10, 2022)
BlackRockFiled SC 13G/A on MannKind Corporation, latest Jan 25, 2024 (3 filings since Feb 1, 2022)
MannKind CorporationValencia, California, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What MannKind Corporation reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
In 2001, we acquired a facility in Danbury, Connecticut that included two buildings comprised of approximately 190,000 square feet on 17.5 acres. In September 2008, we completed the construction of approximately 140,000 square feet of new manufacturing space providing us with two buildings totaling approximately 328,000 square feet, housing our research and development, manufacturing and certain administrative functions. The Danbury facility contains our principal executive offices. We believe the Danbury facility has sufficient space, including unimproved manufacturing space, to satisfy anticipated commercial demand for Afrezza and Tyvaso DPI.
The rest of Item 2
On November 8, 2021, we sold a portion of the Danbury facility to an affiliate of Creative Manufacturing Properties (the “Purchaser”) for a sales price of $102.3 million and entered into a 20-year lease agreement with the Purchaser, with four renewal options of five years each. See Note 7 – Property and Equipment and Note 16 – Commitments and Contingencies in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.
Westlake Village, CA
As of December 31, 2025, we leased a total of approximately 24,475 square feet of office space in Westlake Village, California pursuant to a lease that expires in July 2028. See Note 16 – Commitments and Contingencies in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.
Marlborough, MA
We assumed certain leased real property (the “Marlborough Lease”) pursuant to the Asset Purchase Agreement entered into in May 2022 with Zealand Pharma A/S and Zealand Pharma US, Inc. The Marlborough Lease pertains to certain premises in a building located in Marlborough, Massachusetts. As of December 31, 2025, we leased a total of approximately 20,000 square feet of building space pursuant to a lease that expires in February 28, 2026. See Note 16 – Commitments and Contingencies in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.
Bedford, MA
In July 2024, we assumed certain leased real property (the "Bedford Lease") in connection with the Pulmatrix Transaction. The Bedford Lease pertains to approximately 20,000 square feet in a building located in Bedford, Massachusetts. The monthly base rent payments of $101,282 are subject to 3% annual increases, plus the estimated cost of maintaining the property and common areas by the landlord. We also assumed from Pulmatrix a $0.7 million obligation to repay landlord-funded tenant improvements at a rate of $6,000 per month through the end of the lease term in November 2033. We have the right to extend the lease term for an additional five-year term.
Burlington, MA and Salem, NH
In connection with the merger with scPharma in October 2025, we assumed a 9,342 square foot facility in Burlington, Massachusetts which was previously entered into as a sublease in August 2023 and extends through August 2029. We also assumed a 1,855 square foot facility in Salem, New Hampshire which extends through August 2026. Both facilities house general and administrative as well as research and development activities. See Note 16 – Commitments and Contingencies in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.
Founded in February 1991, the company's present form is a result of a 2003 merger of three companies owned by Alfred E. Mann: Pharmaceutical Discovery Corporation (PDC), the cancer vaccine developer CTL ImmunoTherapies, Inc., and its sister company Allecure Corp, which was developing an allergy vaccine technology. Pharmaceutical Discovery was purchased in 2001 from Solomon Steiner; with that purchase MannKind acquired the Technosphere molecule and Medtone inhaler, upon which was developed its lead product, Afrezza (inhalable insulin).
The FDA approved Afrezza on June 27, 2014.
On August 11, 2014 MannKind entered into an exclusive global licensing agreement with Sanofi for Afrezza sales. Under the agreement, MannKind received $150 million cash from Sanofi, in exchange for sharing profits and losses of sales of Afrezza, with 65% for Sanofi and 35% for MannKind. On January 5, 2016, MannKind Corporation announced the termination of the license and collaboration agreement with Sanofi. By December 2017, the company had lost 11% of its trading volume due to the poor sales.
In March 2020, the company announced it was working with fellow pharmaceutical company Immix Biopharma to try to develop an inhalable treatment for acute respiratory distress syndrome, a lung disease.
The firm has developed Afrezza a rapid-acting insulin peaking 12 to 15 minutes after inhalation and exiting the body within 2–3 hours. The inhalation technology uses a miniature, breath-powered inhaler in combination with single-use cartridges containing pre-metered doses. Initial pharmacokinetic studies were followed by studies of safety and efficiency involving Technosphere formulations of different therapeutic proteins.
Facilities
MannKind has a large corporate office in Westlake Village, California. The Afrezza manufacturing facility is in Danbury, Connecticut. In 2022, the company moved its official headquarters to Danbury.
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
416 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 52 major events, 246 insider forms, 13 large holders, 85 other. The latest 20:
76 open-market trades by officers, directors and large owners since October 2021: 18 buys and 58 sales. Grants, option exercises and gifts are left out.
BlackRockSC 13G/A, 3 filings Feb 1, 2022 to Jan 25, 202487
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How MannKind Corporation is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).16
Risk factors and legal proceedings
The risks MannKind Corporation names in Item 1A of its 10-K filed Feb 26, 2026: 50 risks under these headings, as written.16
RISKS RELATED TO OUR BUSINESS
The products that we or our collaboration partner are commercializing may only achieve a limited degree of commercial success.
If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially.
In order to increase adoption and sales of our products, we need to continue to develop our commercial organization, including maintaining and growing a highly experienced and skilled workforce with qualified sales representatives.
Manufacturing risks may adversely affect our ability to manufacture our products and Tyvaso DPI, which could reduce our gross margin and profitability.
If our suppliers fail to deliver materials and services needed for commercial manufacturing in a timely and sufficient manner or fail to comply with applicable regulations, and if we fail to timely identify and qualify alternative suppliers, our business, financial condition and results of operations would be harmed and the market price of our common stock and other securities could decline.
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
If third-party payers do not cover our approved products, such products might not be prescribed, used or purchased, which would adversely affect our revenues.
We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire.
We may need to raise additional capital to fund our operations.
If our data or information technology systems, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
We expect that our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period.
The other 39 risks
The Blackstone Credit Facility contains restrictive covenants that may materially limit our operating flexibility. A default under the instruments governing our indebtedness, including the Blackstone Credit Facility, could materially and adversely affect our financial position.
We may incur losses and may not generate positive or sufficient cash flow from operations in the future which may have an adverse impact on our working capital, total assets and stockholders' equity and our ability to service all of our indebtedness and commitments.
Our business, product sales, results of operations and ability to access capital could be adversely affected by the effects of health pandemics or epidemics, in regions where we or third parties distribute our products or where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
If we do not obtain regulatory approval of our products in foreign jurisdictions, we will not be able to market in such jurisdictions, which could limit our commercial revenues. We may not be able to establish additional regional partnerships or other arrangements with third parties for the commercialization of our products outside of the United States.
Continued testing of our products and product candidates may not yield successful results, and even if it does, we may still be unable to successfully commercialize our current or future products.
If we do not achieve our projected development goals in the timeframes we expect, our business, financial condition and results of operations will be harmed and the market price of our common stock and other securities could decline.
The long-term safety and efficacy of approved products may differ from clinical studies, which could negatively impact sales and could lead to reputational harm or other negative effects.
Our products, product candidates and technology may not be able to compete effectively or may be rendered obsolete.
Reports of side effects or safety concerns in related technology fields or in other companies’ clinical studies could delay or prevent us from obtaining regulatory approval for our product candidates or negatively impact public perception of our approved products.
If product liability claims are brought against us, we may incur significant liabilities and suffer damage to our reputation.
If we lose any key employees, our operations and our ability to execute our business strategy could be materially harmed.
If our internal controls over financial reporting are not considered effective, our business, financial condition and market price of our common stock and other securities could be adversely affected.
Changes or modifications in financial accounting standards may harm our results of operations.
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
Our ability to use net operating loss carryforwards to offset future taxable income may be subject to limitations.
Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
We may undertake internal restructuring activities in the future that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
Changes in funding or staffing for the FDA, the SEC and 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 functions on which the operation of our business may rely, which could negatively impact our business.
We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
RISKS RELATED TO GOVERNMENT REGULATION
Our product candidates must undergo costly and time-consuming rigorous nonclinical and clinical testing and we must obtain regulatory approval prior to the sale and marketing of any product in each jurisdiction. The results of this testing or issues that develop in the review and approval by a regulatory agency may subject us to unanticipated delays or prevent us from marketing any products.
If we do not comply with regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined or forced to remove a product from the market, subject to criminal prosecution, or experience other adverse consequences, including restrictions or delays in obtaining regulatory marketing approval.
We are subject to stringent, ongoing government regulation.
Healthcare legislation may impact the net sales of commercial products sold by us or any partner.
If we or any partner fails to comply with federal and state healthcare laws, including fraud and abuse and health information laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the United States, we could be subject to additional reimbursement requirements, fines, sanctions and exposure under other laws which could have a material adverse effect on our business, results of operations and financial condition.
RISKS RELATED TO INTELLECTUAL PROPERTY
If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably.
If we become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, we would be required to devote substantial time and resources to prosecute or defend such proceedings.
If our technologies conflict with the proprietary rights of others, we may incur substantial costs as a result of litigation or other proceedings and we could face substantial monetary damages and be precluded from commercializing our products, which would materially harm our business and financial condition.
We may not obtain trademark registrations for our potential trade names.
RISKS RELATED TO OUR COMMON STOCK
Our stock price is volatile.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Because we do not expect to pay dividends in the foreseeable future, you must rely on stock appreciation for any return on any investment in our common stock.
Future sales of shares of our common stock in the public market, or the perception that such sales may occur, may depress our stock price and adversely impact the market price of our common stock and other securities.
If other biotechnology and biopharmaceutical companies or the securities markets in general encounter problems, the market price of our common stock and other securities could be adversely affected.
GENERAL RISK FACTORS
Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price.
Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.
Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
Legal proceedings
See Note 16 – Commitments and Contingencies in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.