Company profile

Ticker
XENE
Exchange
CEO
Simon Neil Pimstone
Employees
Incorporated in
Fiscal year end
SEC CIK

XENE stock data

(
)

Calendar

6 Aug 19
22 Sep 19
31 Dec 19

News

Company financial data Financial data

Quarter (USD) Jun 19 Mar 19 Dec 18 Sep 18
Revenue
Net income -10.01M -11.34M -8.56M -14.38M
Diluted EPS -0.37 -0.42 -0.29 -0.63
Operating income -10.51M -11.76M -8.43M -14.18M
Net change in cash -15.11M -15.57M -20.21M 40.53M
Cash on hand 37.08M 52.18M 67.75M 87.96M
Annual (USD) Dec 18 Dec 17 Dec 16 Dec 15
Revenue 311K 1.8M 15.58M
Net income -34.5M -30.7M -23M -15.75M
Diluted EPS -1.63 -1.72 -1.48 -1.1
Net profit margin -9873% -1275% -101%
Operating income -38.02M -32.58M -24.82M -9.36M
Net change in cash 47.27M 3.39M -41.56M -13.38M
Cash on hand 67.75M 20.49M 17.1M 58.65M

Financial data from company earnings reports

Financial report summary

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Risks
  • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
  • We have not generated any significant royalty revenue from product sales and may never become profitable on a U.S. GAAP basis.
  • We will likely need to raise additional funding, which may not be available on acceptable terms, if at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • We may allocate our limited resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are party to a loan and security agreement that contains operating and financial covenants that may restrict our business and financing activities and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
  • Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.
  • We are subject to risks associated with currency fluctuations which could impact our results of operations.
  • We, or our collaborators, may fail to successfully develop our product candidates.
  • We and our collaborators face substantial competition in the markets for our product candidates, which may result in others discovering, developing or commercializing products before us or doing so more successfully than we or our collaborators do.
  • We have no marketed proprietary products and have not yet advanced a product candidate beyond Phase 2 clinical trials, which makes it difficult to assess our ability to develop our future product candidates and commercialize any resulting products independently.
  • If we are not successful in discovering, acquiring or in-licensing product candidates in addition to XEN496, XEN1101, XEN901, and XEN007, our ability to expand our business and achieve our strategic objectives may be impaired.
  • Our approach to drug discovery is unproven, and we do not know whether we will be able to develop any products of commercial value.
  • If we fail to attract and retain senior management and key personnel, we may be unable to successfully develop our product candidates, perform our obligations under our collaboration agreements, conduct our clinical trials and commercialize our product candidates.
  • Our employees, collaborators and other personnel may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • We may encounter difficulties in managing our growth, including headcount, and expanding our operations successfully.
  • Our business and operations could suffer in the event of system failures.
  • U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company.
  • We may become subject to income tax in jurisdictions in which we are organized or operate, which would reduce our future earnings.
  • Acquisitions or joint ventures could disrupt our business, cause dilution to our shareholders and otherwise harm our business.
  • The regulatory approval processes of the FDA, EMA, Health Canada and regulators in other jurisdictions are lengthy, time-consuming and inherently unpredictable. If we, or our collaborators, are unable to obtain regulatory approval for our product candidates in a timely manner, or at all, our business will be substantially harmed.
  • Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials are prolonged, delayed or not completed, we, or our collaborators, may be unable to commercialize our product candidates on a timely basis.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.
  • We may find it difficult to enroll patients in our clinical studies, including for ultra-orphan, orphan or niche indications, which could delay or prevent clinical studies of our product candidates.
  • AHC, KCNQ2-DEE and SCN8A-EE have no FDA-approved treatments, and the clinical endpoints required to obtain approval are not well defined.
  • If we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed.
  • The FDA has granted RPD designation to XEN007 for treatment of AHC; however, we may not be able to realize any value from such designation.
  • Results of pre-clinical studies may not be predictive of clinical trial results and results of earlier clinical trials may not be predictive of the results of later-stage clinical trials and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, Health Canada or foreign regulatory authorities.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Even if we obtain and maintain approval for our product candidates from one jurisdiction, we may never obtain approval for our product candidates in other jurisdictions, which would limit our market opportunities and adversely affect our business.
  • We work with outside scientists and their institutions in executing our business strategy of developing product candidates. These scientists may have other commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to develop viable product candidates.
  • If, in the future, we are unable to establish our own sales, marketing and distribution capabilities or enter into licensing or collaboration agreements for these purposes, we may not be successful in independently commercializing any future products.
  • Even if we receive regulatory approval to commercialize any of the product candidates that we develop independently, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
  • Even if we or our collaborators receive approval to commercialize our products, unfavorable pricing regulations and challenging third-party coverage and reimbursement practices could harm our business.
  • Recently enacted and future legislation may increase the difficulty and cost for us to commercialize any products that we or our collaborators develop and affect the prices we may obtain.
  • Foreign governments tend to impose strict price controls, which may adversely affect our future profitability.
  • Our prospects for successful development and commercialization of our partnered products and product candidates are dependent upon the research, development and marketing efforts of our collaborators.
  • We may not be successful in establishing new collaborations or maintaining our existing alliances, which could adversely affect our ability to develop future product candidates and commercialize future products.
  • We intend to rely on third-party manufacturers to produce our clinical product candidate supplies. Any failure by a third-party manufacturer to produce acceptable supplies for us may delay or impair our ability to initiate or complete our clinical trials or commercialize approved products.
  • We rely on third parties to monitor, support, conduct, and/or oversee pre-clinical studies and clinical trials of the product candidates that we are developing independently and, in some cases, to maintain regulatory files for those product candidates. We may not be able to obtain regulatory approval for our product candidates or commercialize any products that may result from our development efforts, if we are not able to maintain or secure agreements with such third parties on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us.
  • We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our products or product candidates.
  • Our intellectual property rights will not necessarily provide us with competitive advantages.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Our patents covering one or more of our products or product candidates could be found invalid or unenforceable if challenged.
  • Patent protection and patent prosecution for some of our product candidates is dependent on, and the ability to assert patents and defend them against claims of invalidity is maintained by, third parties.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • Claims that our product candidates or the sale or use of our future products infringe the patent or other intellectual property rights of third parties could result in costly litigation or could require substantial time and money to resolve, even if litigation is avoided.
  • Unfavorable outcomes in intellectual property litigation could limit our research and development activities and/or our ability to commercialize certain products.
  • If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties, we could lose license rights that are important to our business.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information, which would harm our competitive position.
  • Recent court decisions could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • If we do not obtain protection under the Hatch-Waxman Act and similar legislation outside of the U.S. by extending the patent terms for our product candidates, our business may be materially harmed.
  • We have not registered our corporate name as a trademark in all of our potential markets, and failure to secure those registrations could adversely affect our business.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current and any future products.
  • Our current and future operations in the U.S. and elsewhere will be subject, directly or indirectly, to applicable federal and state anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from serious disaster.
  • The market price of our common shares may be volatile, and purchasers of our common shares could incur substantial losses.
  • Future sales of our common shares in the public market could cause the market price of our common shares to fall.
  • Provisions in our corporate charter documents and Canadian law could make an acquisition of us, which may be beneficial to our shareholders, more difficult and may prevent attempts by our shareholders to replace or remove our current management and/or limit the market price of our common shares.
  • U.S. civil liabilities may not be enforceable against us, our directors, or our officers.
  • We are governed by the corporate and securities laws of Canada which in some cases have a different effect on shareholders than the corporate laws of Delaware, U.S. and U.S. securities laws.
  • An active trading market for our common shares may not be maintained.
  • We are an emerging growth company and a smaller reporting company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to such companies could make our common shares less attractive to investors.
  • Complying with the laws and regulations affecting public companies will increase our costs and the demands on management and could harm our operating results and our ability to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common shares.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the market price of our common shares.
  • Future sales and issuances of our common shares, preferred shares, or rights to purchase common shares, including warrants or pursuant to our equity incentive plans, could cause you to incur dilution and could cause the market price of our common shares to fall.
  • We are at risk of securities class action litigation.
  • Nasdaq may delist our securities from its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
  • If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the market price of our common shares and the trading volume of our common shares could decline.
  • Our management team has broad discretion as to the use of the net proceeds from previous public and private equity and debt financings and the investment of these proceeds may not yield a favorable return. We may invest the proceeds in ways with which our shareholders disagree.
  • We do not anticipate paying any cash dividends on our common shares in the foreseeable future.
Management Discussion
  • Research and development expenses increased by $2.8 million and $6.4 million in the three and six months ended June 30, 2019 as compared to the three and six months ended June 30, 2018, respectively. For the three months ended June 30, 2019, the increase was primarily attributable to increased spending on our XEN1101 and XEN496 product candidates and an increase in pre-clinical, discovery and other internal program expenses.
  • For the six months ended June 30, 2019, the increase in research and development expenses was primarily attributable to increased spending on all our clinical development product candidates (XEN496, XEN901 and XEN1101).
  • General and administrative expenses increased by $0.1 million and $0.5 million in the three and six months ended June 30, 2019 as compared to the three and six months ended June 30, 2018, respectively. General and administrative expenses for the three months ended June 30, 2019 did not change significantly as compared to the three months ended June 30, 2018.
Content analysis ?
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H.S. junior Avg
New words: CAE, community, developmental, documentation, evidence, granule, PK
Removed: pilot, prescribe, supporting