A Dark Vector Cognition product

Item 1A. Risk Factors

9K characters. Original on sec.gov · Markdown

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.

We may be unable to complete the Crinetics Acquisition, successfully integrate Crinetics’ business, or realize the

potential commercial benefits of the strategic acquisition, which could adversely affect our business and financial

condition.

Our inability to complete the Crinetics Acquisition or to successfully integrate the Crinetics business could have a

material adverse effect on our business. The Crinetics Acquisition may not be completed for a number of reasons, including

the need to satisfy customary closing conditions, the need for antitrust and/or other regulatory approvals, as well as potential

disputes or litigation that may arise. We provide no assurance that the Crinetics Acquisition will occur or that the closing

conditions to the Crinetics Acquisition will be satisfied in a timely manner or at all. Our realization of the value from the

Crinetics Acquisition relies on successful integration of its operations. We may not be able to integrate Crinetics’ business

successfully into our existing business, make Crinetics’ business profitable, retain key employees or realize anticipated cost

savings or synergies, if any, from the acquisition, which could adversely affect our business and financial condition. Further,

our ongoing business may be disrupted, and our management's attention may be diverted by integration activities. In addition,

the anticipated benefits of the Crinetics Acquisition depend on revenues from PALSONIFY and the commercial potential of

atumelnant. If PALSONIFY does not achieve the sales, market acceptance, or other commercial performance we expect, if

development of atumelnant is delayed or terminated, or if we fail to obtain approval or fail to successfully commercialize

atumelnant, we may not realize the expected revenue growth or income contribution from these assets on the anticipated

timeline, or at all, which could adversely affect our business and financial condition.

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:

  • our financial performance, including revenues, costs and expenses, taxes, and other gains and losses;

  • 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, including the anticipated launch of

povetacicept for the treatment of IgAN, and our ability to obtain label expansions for existing therapies;

  • 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 our BLA for accelerated approval of

povetacicept;

  • 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;

  • our beliefs regarding the approximate patient populations for the disease areas on which we focus;

  • our expectations, plans and anticipated timeline for the pending Crinetics Acquisition, including regarding Crinetics’

business and operations, the commercial potential of PALSONIFY, and the anticipated potential of atumelnant and

Crinetics’ other pipeline assets;

  • 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 maintain and expand 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 June 30, 2026 under our

Share Repurchase Program.

PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal 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)
April 1, 2026 to April 30, 2026375,000$436.21375,000$2,873,410,086
May 1, 2026 to May 31, 2026366,652$434.50366,652$2,714,101,470
June 1, 2026 to June 30, 2026292,000$452.37292,000$2,582,008,580
Total1,033,652$440.171,033,652$2,582,008,580

(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.

Previous: Item 4. Controls and Procedures · Next: Item 5. Other Information