ADDED
Market f or Registrant's Common Equity, Related Stockholder Matters a nd Issuer Purchases of Equity Securities 88 Item 6.
We have incurred significant losses since our inception, and could continue to incur losses, which, together with our limited history as a commercial-stage company, makes it difficult to assess our future viability; Our capital requirements are difficult to predict and may change.
We may require substantial additional financing to achieve our goals or for strategic purposes, and a failure to obtain this capital if or when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate certain operations, efforts, or strategic initiatives; Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our future operating results to fall below expectations; Our estimated market opportunities are subject to numerous uncertainties and may prove to be inaccurate.
The loss of these manufacturers or their sub-suppliers, their failure or inability to comply with manufacturing or other regulations, or their failure to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business; We rely on third parties to conduct our nonclinical studies and our clinical trials.
If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates; Risks related to our intellectual property could materially adversely impact our business, competitive position, financial condition, and results of operations; and Risks related to government regulation of our industry and required approvals could materially adversely impact our business, competitive position, financial condition, and results of operations.
Any use which we or a third-party makes of the DR Materials, or any reliance on it, or decisions to be made based on it, are the sole responsibilities of us and such third-party.
We launched our lead product, ZORYVE cream 0.3%, in August 2022 after obtaining our initial FDA approval for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g.
In November 2025, our supplemental New Drug Application (sNDA) was accepted for filing by the FDA to potentially expand the indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026.
In February 2026, Health Canada accepted our Supplement to a New Drug Submission (SNDS) for ZORYVE cream 0.3% for individuals down to 2 years old.
ZORYVE foam became commercially available in the United States in January 2024 and became commercially available in Canada in December 2024 following approval by Health Canada.
REMOVED
Market For Registrant's Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities 97 Item 6.
and Canadian market sales for our products and product candidates, if approved for commercial uses; our commercialization, marketing, and manufacturing capabilities and strategy; the success of competing therapies that are or may become available; our ability to attract and retain key management and technical personnel; our expectations regarding our ability to obtain, maintain, and enforce intellectual property protection for our products and product candidates; and our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing.
We have incurred significant losses since our inception, and could continue to incur losses, which, together with our limited history as a commercial-stage company, makes it difficult to assess our future viability; Due to the recent commercialization of products approved for commercial sale, as well as our development strategy and continued development of our pipeline of product candidates, our capital requirements are difficult to predict and may change.
We may require substantial additional financing to achieve our goals, and a failure to obtain this capital if or when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate certain operations or efforts; Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our future operating results to fall below expectations; Our estimated market opportunities are subject to numerous uncertainties and may prove to be inaccurate.
The loss of these manufacturers or their sub-suppliers, or their failure to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business; If our third-party manufacturers fail to comply with manufacturing or other regulations, our financial results and financial condition will be adversely affected; We rely on third parties to conduct our nonclinical studies and our clinical trials.
We launched our lead product, ZORYVE (roflumilast) cream 0.3% (ZORYVE cream 0.3%) in August 2022 after obtaining our initial U.S.
Food and Drug Administration (FDA) approval for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g.
We are currently working with the FDA to potentially further expand this indication in plaque psoriasis down to 2 years of age following the generation of additional clinical data.
ZORYVE foam became commercially available in the United States in late January 2024, and was approved by Health Canada in October 2024 and became commercially available in Canada in December 2024.
In addition to the approval of ZORYVE cream 0.3% for plaque psoriasis and ZORYVE foam for seborrheic dermatitis, we also received FDA approval for and commercially launched ZORYVE (roflumilast) cream 0.15% (ZORYVE cream 0.15%), (collectively, ZORYVE), in July 2024 for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients 6 years of age and older, with no limitation on location, body surface area treated, concomitant use, or duration of use specified in the approved labelling.