22 unchanged sentences
We are dependent on KKC for the clinical and commercial supply of Crysvita for all major markets and for the development and commercialization of Crysvita in certain major markets.
−Removed: We have no experience as a company developing a manufacturing facility.
+Added: We have no experience as a company developing a manufacturing facility, such as our gene therapy manufacturing facility in Massachusetts.
We rely on third parties to manufacture our products and product candidates and face a multitude of manufacturing risks .
77 unchanged sentences
Failure to obtain this necessary capital when needed may force us to delay, limit, or terminate our product development efforts or other activities.
−Removed: As of March 31, 2021, our available cash, cash equivalents, and marketable debt securities were $1,047.0 million.
+Added: As of June 30 , 2021, our available cash, cash equivalents, and marketable debt securities were $973.8 million.
We expect we will need additional capital to continue to commercialize our products, and to develop and obtain regulatory approval for, and to commercialize, all of our product candidates.
76 unchanged sentences
In addition to the rarity of these diseases, the eligibility criteria of our clinical studies will further limit the pool of available study participants as we will require patients to have specific characteristics that we can measure or to assure their disease is either severe enough or not too advanced to include them in a study.
−Removed: The process of finding and diagnosing patients is costly, especially since the rare diseases we are studying are commonly under diagnosed.
+Added: The process of finding and diagnosing patients is costly, especially since the rare diseases we are studying are commonly underdiagnosed.
We also may not be able to identify, recruit, and enroll a sufficient number of appropriate patients to complete our clinical studies because of demographic criteria for prospective patients, the perceived risks and benefits of the product candidate under study, the proximity and availability of clinical study sites for prospective patients, and the patient referral practices of physicians.
160 unchanged sentences
We do not have experience as a company, however, in developing a manufacturing facility and we may experience unexpected costs or delays or ultimately be unsuccessful in developing the facility or capability.
+Added: We are dependent on key partners for delivery of power, electricity and other utilities to our manufacturing facility and we cannot assure that such services will be provided at the facility without interruptions, delays or unexpected costs.
+Added: Further, as described in the risk factor below entitled, “ Actual or threatened public health epidemics or outbreaks, including the ongoing COVID-19 pandemic, have and could again materially and adversely impact our business and operating results, ” the COVID-19 pandemic has adversely impacted delivery of raw materials, and increased costs for certain materials, for construction of our facility.
As we expand our commercial footprint to multiple geographies, we may establish multiple manufacturing facilities, which may lead to regulatory delays or prove costly.
43 unchanged sentences
The drug substance and drug product for Mepsevii are currently manufactured by Rentschler under a commercial supply and services agreement, accompanying purchase orders, and other agreements.
−Removed: We experienced disruptions related to the fill and finish activities for the drug product for Mepsevii during the fourth quarter of 2019 and as a result, we have identified an alternative supplier to conduct such activities.
+Added: We experienced disruptions related to the fill and finish activities for the drug product for Mepsevii during the fourth quarter of 2019 and as a result, we identified an alternative supplier to conduct such activities.
We are currently in the process of qualifying and transferring the activities to such alternative supplier, which may take a significant amount of time and expense.
335 unchanged sentences
We have experienced delays in delivery of ancillary clinical trial materials due to government-imposed mandates and other restrictions from COVID-19 and may in the future experience delays or interruptions in supply of drug product or raw materials, or incur increased costs or expenses.
−Removed: For instance, the Presidential Executive Order invoking the Defense Production Act of 1950 has caused certain of our third party manufacturers or suppliers to prioritize and allocate more resources and capacity to supply materials to other companies engaged in the study of treatments or vaccinations for COVID-19, which has resulted in delays or shortages in supply of such materials to us.
+Added: For instance, the Presidential Executive Order invoking the Defense Production Act of 1950 has caused certain of our third party manufacturers or suppliers to prioritize and allocate more resources and capacity to supply materials to other companies engaged in the study or manufacture of treatments or vaccinations for COVID-19, which has resulted in delays or shortages in supply of such materials to us.
Any of these events could adversely impact our clinical trial activities and our ability to meet commercial demand for our product and product candidates and result in loss of revenue.
In response to these events, we are currently seeking alternative sources of supply of drug product or raw materials in an attempt to avoid future potential delays in supply of product, which may result in additional expenses.
−Removed: We may also experience interruptions or delays in sourcing equipment, materials and resources related to construction of our gene therapy manufacturing facility as a result of COVID-19, which could delay the anticipated timing for completion of the plant or result in significant additional expenses.
+Added: We have also experienced interruptions or delays in sourcing certain equipment, materials and resources, and increased costs for certain raw materials, related to construction of our gene therapy manufacturing facility as a result of COVID-19, which could delay the anticipated timing for completion of the plant or result in significant additional expenses.
In an effort to protect the health of our employees, their families and our communities, and in accordance with shelter-in-place direction from state and local government authorities, we have restricted access to our facilities to personnel and third parties who must perform critical activities that must be completed on-site, limited the number of such personnel that can be present at our facilities at any one time, and requested that most of our personnel work remotely, including significant limitations on access to our laboratory space.
11 unchanged sentences
The magnitude and extent to which the outbreak may impact or continue to impact our business operations, clinical trial activities, product candidate approvals, supply chain and commercialization of our products and product candidates will continue to remain highly dependent on future developments, which are very uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the scope and magnitude of any resurgence in the outbreak due to virus mutations or other factors, the timing and availability of treatments and vaccines against the virus, the duration of, or implementation of additional, restrictions to contain the outbreak and the effectiveness of other actions taken in the United States and other countries to contain and address the pandemic.
−Removed: This pandemic may also amplify many of the other risks described throughout the “Risk Factors” section of this Quarterly Report on Form 10-Q.
+Added: This pandemic also amplifies many of the other risks described throughout the “Risk Factors” section of this Quarterly Report on Form 10-Q.
Our future success depends in part on our ability to retain our Founder, President, and Chief Executive Officer and to attract, retain, and motivate other qualified personnel.
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If the associated research and development effort is abandoned, the related assets will be written-off and we will record a noncash impairment loss on our statement of operations.
−Removed: We have not recorded any impairments related to our intangible assets through the end of March 31, 2021 .
+Added: We have not recorded any impairments related to our intangible assets through the end of June 30, 2021 .
We may not be successful in our efforts to identify, license, discover, develop, or commercialize additional product candidates.
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We may acquire or invest in businesses or products that we believe could complement or expand our business or otherwise offer growth opportunities.
−Removed: For example, we acquired Dimension in November 2017 and during the third quarter 2019, we entered into an agreement with GeneTx to collaborate on the development of a product for the treatment of Angelman Syndrome which included an exclusive option to acquire GeneTx.
+Added: For example, we acquired Dimension in November 2017 and during the third quarter 2019, we entered into an agreement with GeneTx to collaborate on the development of a product for the treatment of Angelman Syndrome which includes an exclusive option to acquire GeneTx.
The pursuit of potential acquisitions or investments may divert the attention of management and may cause us to incur various costs and expenses in identifying, investigating, and pursuing them, whether or not they are consummated.
8 unchanged sentences
As a result, increases or decreases in the stock price of Arcturus and Solid common stock will result in accompanying changes in the fair value of our investments, and cause substantial volatility in, our operating results for the reporting period.
−Removed: For instance, the changes in fair value of the Arcturus and Solid investments recognized in the Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020 was a $20.7 million decrease and $7.7 million increase, respectively, primarily due to the lower Arcturus and Solid stock price as of March 31, 2021 compared to the prior year and higher Arcturus stock price as of March 31, 2020 compared to the prior year.
−Removed: The losses and gains in fair value of the equity investments for the three months ended March 31, 2021 and 2020 increased and decreased, respectively, the amount of our net loss during those periods.
−Removed: If the Arcturus or Solid stock price had been lower at March 31, 2021 and 2020 compared to the prior year, we would have reported an even greater net loss for the three months ended March 31, 2021 and 2020.
+Added: For instance, the changes in fair value of the Arcturus and Solid investments recognized in the Consolidated Statements of Operations for the three and six months ended June 30, 2021 was a $31.0 million and a $51.7 million decrease, respectively, primarily due to the lower Arcturus and Solid stock price as of June 30, 2021 compared to the prior period.
+Added: The changes in fair value of the Arcturus investment recognized in the Consolidated Statements of Operations for the three and six months ended June 30, 2020 was a $95.2 and a $102.9 million increase, respectively, primarily due to the higher Arcturus stock price as of June 30, 2020 compared to the prior period.
+Added: The losses and gains in fair value of the equity investments for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 increased and decreased, respectively, the amount of our net loss during those periods.
+Added: If the Arcturus or Solid stock price had been lower at June 30, 2021 and 2020 compared to the prior period, we would have reported an even greater net loss for the three and six months ended June 30, 2021 and for the six months ended June 30, 2020.
As the fair value of our investments in Arcturus and Solid is dependent on the stock price of Arcturus and Solid, which has recently seen wide fluctuations, the value of our investments and the impact on our operating results may similarly fluctuate significantly from quarter to quarter and year to year such that period-to-period comparisons may not be a good indication of the future value of the investments and our future operating results.
41 unchanged sentences
Pursuant to our 2014 Incentive Plan, or the 2014 Plan, our management is authorized to grant stock options and other equity-based awards to our employees, directors, and consultants.
−Removed: At March 31, 2021, 4,192,549 shares were available for future grants under the 2014 Plan.
+Added: At June 30, 2021, 4,103,718 shares were available for future grants under the 2014 Plan.
Through January 1, 2024, the number of shares available for future grant under the 2014 Plan will automatically increase on January 1 of each year by the lesser of 2,500,000 shares or 4% of all shares of our capital stock outstanding as of December 31 of the prior calendar year, subject to the ability of our compensation committee to take action to reduce the size of the increase in any given year.
Pursuant to our 2014 Employee Stock Purchase Plan, or 2014 ESPP, eligible employees can acquire shares of our common stock at a discount to the prevailing market price.
−Removed: At March 31, 2021, 3,995,536 shares were available for issuance under the 2014 ESPP.
+Added: At June 30, 2021, 3,956,907 shares were available for issuance under the 2014 ESPP.
Through January 1, 2024, the number of shares available for issuance under the 2014 ESPP will automatically increase on January 1 of each year by the lesser of 1,200,000 shares or 1% of all shares of our capital stock outstanding as of December 31 of the prior calendar year, subject to the ability of our compensation committee to take action to reduce the size of the increase in any given year.
In February 2021, our board of directors adopted an employment inducement plan with a maximum of 500,000 shares available for grant under the plan.
+Added: At June 30, 2021, 488,223 shares were available for issuance under the inducement plan.
We have registered all the shares under our inducement plan.
In addition, we currently plan to register the increased number of shares available under the 2014 Plan and the 2014 ESPP each year.
−Removed: If our board of directors elects to increase the number of shares available for future grant under the 2014 Plan, the 2014 ESPP or the inducement plan, our stockholders may experience additional dilution, which could cause our stock price to fall.
+Added: If our board of directors elects to increase the number of shares available for future grant
+Added: under the 2014 Plan, the 2014 ESPP or the inducement plan, our stockholders may experience additional dilution, which could cause our stock price to fall.
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
56 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.