VERTEX PHARMACEUTICALS INC / MA
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
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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.
We may be unable to 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 successfully integrate the Crinetics business could have a material adverse effect on our business. 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, including our expectations regarding the
FDA’s review of our biologics license application for accelerated approval of povetacicept with an assigned PDUFA
target action date of November 30, 2026;
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;
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 regarding Crinetics’ business and operations, the commercial potential of PALSONIFY and the
anticipated potential of atumelnant, and that Crinetics will contribute to the diversity of our pipeline and support our
long-term growth objectives;
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, cost of sales, interest income and interest
expenses;
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.