Company profile

Ticker
FULC
Exchange
CEO
Robert J. Gould
Employees
Incorporated in
Location
Fiscal year end
SEC CIK
IRS number
474839948

FULC stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

13 May 20
9 Jul 20
31 Dec 20

News

Company financial data Financial data

Quarter (USD) Mar 20 Dec 19 Sep 19 Jun 19
Revenue 750K
Net income -18.45M -16.12M -16.54M -13.17M
Diluted EPS -0.81 2.2 -0.97 -9.21
Net profit margin -2460%
Operating income -18.8M -16.49M -17.01M -13.49M
Net change in cash -71.33M -4.88M 51.97M -12.82M
Cash on hand 25.38M 96.71M 101.6M 49.63M
Annual (USD) Dec 19 Dec 18
Net income -82.68M -32.59M
Diluted EPS -8.13 -31.14
Operating income -84.22M -33.5M
Net change in cash 23.92M
Cash on hand 96.71M 72.8M

Financial data from company earnings reports

Date Owner Security Transaction Code 10b5-1 $Price #Shares $Value #Remaining
1 Jul 20 Diego Cadavid Common Stock Sell Dispose S Yes 18.3 1,071 19.6K 65,714
30 Jun 20 Wallace Owen B. Common Stock Sell Dispose S Yes 20 141 2.82K 127,088
30 Jun 20 Wallace Owen B. Common Stock Option exercise Aquire M Yes 7.84 141 1.11K 127,229
30 Jun 20 Wallace Owen B. Stock Option Common Stock Option exercise Dispose M Yes 7.84 141 1.11K 84,893
25 Jun 20 Gould Robert J Common Stock Sell Dispose S Yes 20.7968 2,500 51.99K 537,345
25 Jun 20 Diego Cadavid Common Stock Sell Dispose S Yes 22 1,459 32.1K 66,785
25 Jun 20 Diego Cadavid Common Stock Option exercise Aquire M Yes 4.83 1,459 7.05K 68,244
25 Jun 20 Diego Cadavid Stock Option Common Stock Option exercise Dispose M Yes 4.83 1,459 7.05K 12,277
11 Jun 20 Kate Haviland Stock Option Common Stock Grant Aquire A No 17.63 9,285 163.69K 9,285
68.9% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 46 38 +21.1%
Opened positions 11 3 +266.7%
Closed positions 3 4 -25.0%
Increased positions 23 15 +53.3%
Reduced positions 5 11 -54.5%
13F shares
Current Prev Q Change
Total value 192.24M 250.18M -23.2%
Total shares 16.1M 15.07M +6.8%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
TRV GP Iii 5.96M $71.19M 0.0%
TRV GP Iv 2.34M $27.98M 0.0%
FMR 1.78M $21.28M +4.8%
Casdin Capital 1.21M $14.44M -2.4%
Foresite Capital Management IV 998.66K $11.92M -33.4%
BLK BlackRock 621.07K $7.42M +195.2%
Perceptive Advisors 600K $7.16M 0.0%
Logos Global Management 532.52K $6.36M +330.7%
Harvard Management 410.71K $4.9M 0.0%
Bessemer 285.71K $3.41M 0.0%
Largest transactions
Shares Bought/sold Change
Foresite Capital Management IV 998.66K -501.35K -33.4%
BLK BlackRock 621.07K +410.69K +195.2%
Logos Global Management 532.52K +408.89K +330.7%
STT State Street 194.26K +155.21K +397.5%
Fiduciary Trust 125K +105K +525.0%
Millennium Management 185.02K +94.84K +105.2%
NTRS Northern Trust 134.29K +83.23K +163.0%
FMR 1.78M +81.7K +4.8%
Alyeska Investment 0 -75.55K EXIT
Geode Capital Management 120.4K +61.7K +105.1%

Financial report summary

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Competition
PTC Therapeutics
Risks
  • Risks Related to our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for stockholders to evaluate the success of our business to date and to assess our future viability.
  • The COVID-19 pandemic, which began in late 2019 and has spread worldwide, may affect our ability to initiate and complete current or future preclinical studies or clinical trials, disrupt regulatory activities or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on our business and operations.
  • In the past, we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern and it is possible that we may identify conditions and events in the future that raise substantial doubt about our ability to continue as a going concern.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • Our ability to use our net operating losses and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • Risks Related to the Discovery and Development of our Product Candidates
  • We are early in our development efforts, and we only have one product candidate in clinical trials. Our other product candidate recently completed IND-enabling studies. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • We may not be successful in our efforts to use our product engine to build a pipeline of product candidates.
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. The results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Because we are developing some of our product candidates for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulatory authorities may not consider the endpoints of our clinical trials to predict or provide clinically meaningful results.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates.
  • If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are conducting Phase 2b and Phase 2 open label clinical trials of losmapimod in patients with FSHD in Europe and currently plan to conduct additional clinical trials for our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
  • Risks Related to the Commercialization of our Product Candidates
  • Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for any of our product candidates, if approved, may be smaller than we estimate.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates if and when they are approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • If the market opportunities for our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer. Because the target patient populations of our product candidates are small, and the addressable patient population even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • We expect to rely on contract manufacturing organizations to manufacture our product candidates. If we are unable to enter into such arrangements as expected or if such organizations do not meet our supply requirements, development and/or commercialization of our product candidates may be delayed.
  • Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that, if they materialize, could harm our business.
  • Clinical trial and product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, which may harm our business.
  • We plan to contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • We have entered into, and may in the future enter into, collaborations with third parties for the development or commercialization of our product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates and our business could be adversely affected.
  • If we are not able to establish or maintain collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Risks Related to our Intellectual Property
  • If we are unable to obtain, maintain, enforce and protect patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for any product candidates we may develop, our business may be materially harmed.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Although we or our licensors are not currently involved in any litigation, we may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be subject to claims by third parties asserting that our employees, consultants or contractors have wrongfully used or disclosed confidential information of third parties, or we have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
  • A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process.
  • A Breakthrough Therapy designation by the FDA for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Even if the FDA agrees that we may pursue an accelerated approval NDA submission, that does not guarantee that the NDA will receive an accelerated approval, or a complete response letter, nor does submission of an accelerated approval NDA ensure that the product candidate will receive a faster development or regulatory review process.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad.
  • Any product candidate for which we obtain marketing approval could be subject to post-marketing restrictions or withdrawal from the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
  • The efforts of the Trump administration to pursue regulatory reform may limit the FDA’s ability to engage in oversight and implementation activities in the normal course, and that could negatively impact our business.
  • Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions.
  • Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • If we or any third-party manufacturers we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, be precluded from developing manufacturing and selling certain products outside the United States or be required to develop and implement costly compliance programs, which could adversely affect our business, results of operations and financial condition.
  • Our employees, independent contractors, consultants and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.
  • Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Risks Related to our Common Stock
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control all matters submitted to stockholders for approval.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • An active trading market for our common stock may not be sustained.
  • If securities analysts do not publish or cease publishing research or reports or publish misleading, inaccurate or unfavorable research about our business or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
  • A significant portion of our total outstanding shares are eligible to be sold into the market in the near future, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.
  • Our certificate of incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers and employees.
Management Discussion
  • Collaboration revenue was $0.8 million for the three months ended March 31, 2020 under the Acceleron Collaboration Agreement. We did not record any collaboration revenue during the three months ended March 31, 2019. We recognize revenue under the Acceleron Collaboration Agreement based on our pattern of performance related to the identified performance obligation, which is the period over which we will perform research services under the Acceleron Collaboration Agreement.
  • Research and development expense decreased by $20.1 million from $34.6 million for the three months ended March 31, 2019 to $14.5 million for the three months ended March 31, 2020. The decrease in research and development expense was primarily attributable to a $25.6 million decrease in IPR&D expenses associated with the recognition of the fair value attributable to the right of reference and license agreement with GSK during the three months ended March 31, 2019, partially offset by increases in research and development expenses as a result of the following:
  • General and administrative expenses increased by $2.5 million from $2.6 million for the three months ended March 31, 2019 to $5.1 million for the three months ended March 31, 2020. The increase in general and administrative expenses was primarily attributable to the following:
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