Item 1A. Risk Factors
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Item 1A. Risk Factors
The information presented below supplements the risk factors set forth in Part I, Item 1A. “Risk Factors” of our Annual
Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 13, 2026. There
have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q and, in particular, our Management’s Discussion and Analysis of Financial
Condition and Results of Operations set forth in Part I, Item 2, contain a number of forward-looking statements. Forward-
looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,”
“expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning.
Such statements may relate to:
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our financial performance, including revenues, costs and expenses, taxes, and other gains and losses;
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product development, including our development timelines, timing of data from our ongoing and planned clinical
trials, regulatory authority filings and other submissions for our therapies, including the potential to file for
accelerated approvals, and communications with regulatory authorities;
- our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to
receive our medicines through new approvals, label extensions and reimbursement agreements, treatment of younger
patients, increased survival, and expansion into additional geographies;
- our ability to continue to launch, commercialize and market our products and our ability to obtain label expansions
for existing therapies, including the anticipated launch of povetacicept for the treatment of IgAN;
- our ability to obtain and maintain adequate coverage, pricing, and reimbursement from third-party payors for our
products;
- the data that will be generated by ongoing and planned clinical trials, preclinical and nonclinical studies, and the
ability to use that data to advance compounds, continue development or support regulatory filings, or accelerate
regulatory approval, including our expectations regarding the FDA’s review of the BLA for povetacicept on an
expedited basis of six months from the date of FDA acceptance of the BLA;
- our plans to continue investing in our research and development programs, including anticipated timelines for our
programs, and our strategy to develop our pipeline programs, alone or with third party-collaborators;
- our ability to use our research programs to identify and develop new product candidates to address serious diseases
and significant unmet medical needs;
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our beliefs regarding the approximate patient populations for the disease areas on which we focus;
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plans for and prospects of our business development activities, including the potential benefits and therapeutic scope
of our collaborations, our ability to integrate and continue operations of acquired businesses, and our ability to
successfully capitalize on these opportunities;
- the establishment, development and maintenance of collaborative relationships, including potential milestone
payments or other obligations, and other potential business development activities, including the identification of
potential collaborative partners or acquisition targets;
- our plans to build and maintain our global supply chains and manufacturing infrastructure and capabilities, including
for biologics, cell and gene therapies;
- our ability to expand and protect our intellectual property portfolio and otherwise maintain exclusive rights to
products;
- our expectations or beliefs regarding any legal proceedings in which we are involved, including any litigation,
arbitration or other similar proceedings involving our products, product candidates or activities;
- potential fluctuations in foreign currency exchange rates and the effectiveness of our foreign currency management
program;
- our expectations regarding cash generated by operations, our cash balance and expected generation and net interest
income;
- our expectations regarding our provision for or benefit from income taxes and the utilization of our deferred tax
assets; and
- our liquidity and our expectations regarding the possibility of raising additional capital.
Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and
could cause actual events or results to differ materially from those indicated in any such statements. These risks,
uncertainties, and other factors include, but are not limited to, those described in our “Risk Factors” in Item 1A of our Annual
Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 13, 2026, and those
described from time to time in our future reports filed with the Securities and Exchange Commission.
Any such forward-looking statements are made on the basis of our views and assumptions as of the date of the filing and
are not estimates of future performance. Except as required by law, we undertake no obligation to publicly update any
forward-looking statements. The reader is cautioned not to place undue reliance on any such statements.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Repurchases of Equity Securities
In May 2025, our Board of Directors authorized a share repurchase program (our “Share Repurchase Program”),
pursuant to which we were authorized to repurchase up to $4.0 billion of our common stock. The Share Repurchase Program
does not have an expiration date and can be discontinued at any time.
The table set forth below shows repurchases of securities by us during the three months ended March 31, 2026 under our
Share Repurchase Program.
| Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (1) | Approximate Dollar Value of Shares that May Yet be Purchased Under the Plans or Programs (1) | |||
| January 1, 2026 to January 31, 2026 | 257,009 | $460.37 | 257,009 | $3,263,144,316 | |||
| February 1, 2026 to February 28, 2026 | 210,126 | $474.46 | 210,126 | $3,163,447,298 | |||
| March 1, 2026 to March 31, 2026 | 274,000 | $461.53 | 274,000 | $3,036,987,553 | |||
| Total | 741,135 | $464.79 | 741,135 | $3,036,987,553 |
(1) Under our Share Repurchase Program, we are authorized to purchase shares from time to time through open market or privately
negotiated transactions. Such purchases may be pursuant to Rule 10b5-1 plans or other means as determined by our management and
in accordance with the requirements of the Securities and Exchange Commission.
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