4 unchanged sentences
We have reported positive results from two Phase 3 clinical trials evaluating the effect of sotagliflozin on long-term outcomes related to cardiovascular death and heart failure in approximately 10,500 and 1,200 patients, respectively.
−Removed: We are now preparing a resubmission of our application for regulatory approval to market sotagliflozin in the United States for heart failure after voluntarily withdrawing our initial application to correct a technical issue with the initial submission.
+Added: Food and Drug Administration, or FDA, has accepted for filing our submission of an application for regulatory approval to market sotagliflozin for the reduction of the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure, including those with worsening heart failure, and reduction in the risk of cardiovascular death, hospitalization for heart failure, urgent heart failure visits, nonfatal myocardial infarction and nonfatal stroke in adults with type 2 diabetes, chronic kidney disease and other cardiovascular risk factors, including a history of heart failure.
+Added: We are now preparing for the commercial launch of sotagliflozin in the United States, if approved.
We have reported positive results from three Phase 3 clinical trials evaluating the effect of sotagliflozin on type 1 diabetes in approximately 800, 800 and 1,400 patients, respectively.
−Removed: Food and Drug Administration, or FDA, issued a complete response letter regarding our application for regulatory approval to market sotagliflozin for type 1 diabetes in the United States.
+Added: The FDA issued a complete response letter regarding our application for regulatory approval to market sotagliflozin for type 1 diabetes in the United States.
At our request, the FDA has issued a public Notice of Opportunity for Hearing on whether there are grounds for denying approval of our application and the hearing process is ongoing.
• We are developing LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain.
−Removed: We have reported results from two Phase 1 clinical trials of LX9211 and are now conducting a Phase 2 clinical trial of LX9211 in diabetic peripheral neuropathic pain and a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia.
+Added: We have reported positive top-line results from a Phase 2 clinical trial of LX9211 in painful diabetic neuropathic pain and are conducting a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia, from which we expect top-line results in the fourth quarter of 2022.
LX9211 has received Fast Track designation from the FDA for development in diabetic peripheral neuropathic pain.
9 unchanged sentences
Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including the success of our ongoing nonclinical and clinical development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts;
−Removed: our success in establishing new collaborations and licenses and our receipt of milestones, royalties and other payments under such arrangements;
+Added: our success in establishing new collaborations and
+Added: licenses and our receipt of milestones, royalties and other payments under such arrangements;
and general and industry-specific economic conditions which may affect research, development and commercialization expenditures.
Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests.
−Removed: may determine, as we have with certain of our drug candidates, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.
+Added: We may determine, as we have with certain of our drug candidates, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.
Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.
−Removed: Since our inception, we have incurred significant losses and, as of March 31, 2022, we had an accumulated deficit of $1.5 billion.
+Added: Since our inception, we have incurred significant losses and, as of June 30, 2022, we had an accumulated deficit of $1.5 billion.
Our losses have resulted principally from costs incurred in research and development, selling, general and administrative costs associated with our operations, and non-cash stock-based compensation expenses associated with stock options and restricted stock units granted to employees and consultants.
13 unchanged sentences
The guidance is effective for annual periods beginning after December 15, 2020, including interim periods therein.
−Removed: The adoption of ASU 2019-12 in the first quarter of 2021 did not have a material impact on our condensed consolidated financial statements.
+Added: The adoption of ASU 2019-12 in the first quarter of 2021 did not have a material impact on the condensed consolidated financial statements.
In August 2020, the FASB issued ASU No.
1 unchanged sentence
ASU 2020-06 also requires the application of the if-converted method for calculating earnings per diluted share, as the treasury stock method will no longer be permitted for convertible instruments.
−Removed: The adoption of ASU 2020-06 during the first quarter of 2022 did not have a material impact on our condensed consolidated financial statements.
+Added: The adoption of ASU 2020-06 during the first quarter of 2022 did not have a material impact on the condensed consolidated financial statements.
Results of Operations
Research and Development Expenses
−Removed: Research and development expenses and dollar and percentage changes as compared to the corresponding period in the prior year are as follows (dollar amounts are presented in millions):
−Removed: Three Months Ended March 31,
+Added: Research and development expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):
+Added: Three Months Ended June 30, Six Months Ended June 30,
+Added: 2022 2021 2022 2021
Total research and development expense $ 13.4 $ 10.3 $ 28.3 $ 22.9
2 unchanged sentences
Research and development expenses consist primarily of third-party and other services principally related to nonclinical and clinical development activities, salaries and other personnel-related expenses, stock-based compensation expense, and facility and equipment costs.
−Removed: • Third-party and other services – Third-party and other services for the three months ended March 31, 2022 increased 32% to $9.5 million, as compared to the corresponding period in 2021 primarily due to increases in professional and consulting fees relating to preparations for the resubmission of our application for regulatory approval to market sotagliflozin in the United States for heart failure.
+Added: • Third-party and other services – Third-party and other services for the three months ended June 30, 2022 increased 37% to $7.6 million, and for the six months ended June 30, 2022 increased 34% to $17.0 million, as compared to the corresponding periods in 2021 primarily due to increases in both clinical trial and related development and professional and consulting fees relating to preparations for the submission of our application for regulatory approval to market sotagliflozin in the United States for heart failure.
Third-party and other services relate principally to our clinical trial and related development activities, such as nonclinical and clinical studies and contract manufacturing.
−Removed: • Personnel – Personnel costs for the three months ended March 31, 2022 increased 10% to $3.2 million, as compared to the corresponding period in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.
+Added: • Personnel – Personnel costs for the three months ended June 30, 2022 increased 61% to $3.5 million, and for the six months ended June 30, 2022 increased 32% to $6.7 million, as compared to the corresponding periods in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.
Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
−Removed: • Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2022 decreased 20% to $1.0 million, as compared to the corresponding period in 2021, primarily due to cancellation of unvested share-based awards during 2021.
−Removed: • Facilities and equipment – Facilities and equipment costs for each of the three months ended March 31, 2022 and 2021 were $0.3 million.
−Removed: • Other – Other costs for each of the three months ended March 31, 2022 and 2021 were $0.9 million.
+Added: • Stock-based compensation – Stock-based compensation expenses for the three months ended June 30, 2022 decreased 7% to $1.1 million, and for the six months ended June 30, 2022 decreased 14% to $2.1 million, as compared to the corresponding periods in 2021, primarily due to cancellation of unvested share-based awards during 2021.
+Added: • Facilities and equipment – Facilities and equipment costs for the three months ended June 30, 2022 and 2021 were $0.3 million and $0.4 million, respectively.
+Added: Facilities and equipment costs for the six months ended June 30, 2022 and 2021 were $0.6 million and $0.7 million, respectively.
+Added: • Other – Other costs for the three months ended June 30, 2022 and 2021 were $0.9 million and $1.0 million, respectively.
+Added: Other costs for the six months ended June 30, 2022 and 2021 were $1.8 million and $1.9 million, respectively.
Selling, General and Administrative Expenses
Selling, general and administrative expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30, Six Months Ended June 30,
+Added: 2022 2021 2022 2021
Total selling, general and administrative expense $ 10.7 $ 7.9 $ 19.2 $ 16.2
2 unchanged sentences
Selling, general and administrative expenses consist primarily of personnel costs to support our research and development activities, professional and consulting fees, stock-based compensation expense, and facility and equipment costs.
−Removed: • Personnel – Personnel costs for the three months ended March 31, 2022 increased 5% to $3.3 million, as compared to the corresponding period in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.
+Added: • Personnel – Personnel costs for the three months ended June 30, 2022 increased 79% to $4.2 million, and for the six months ended June 30, 2022 increased 36% to $7.6 million, as compared to the corresponding periods in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.
Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
−Removed: • Professional and consulting fees – Professional and consulting fees for the three months ended March 31, 2022 decreased 5% to $2.3 million, as compared to the corresponding period in 2021, primarily due to lower legal fees, partially offset by higher marketing and professional fees.
−Removed: • Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2022 increased 11% to $1.7 million, as compared to the corresponding period in 2021.
−Removed: • Facilities and equipment – Facilities and equipment costs for each of the three months ended March 31, 2022 and 2021 were $0.3 million.
−Removed: • Other – Other costs for the three months ended March 31, 2022 and 2021 were $0.9 million and $0.8 million, respectively.
+Added: • Professional and consulting fees – Professional and consulting fees for the three months ended June 30, 2022 increased 24% to $3.5 million, and for the six months ended June 30, 2022 increased 11% to $5.7 million, as compared to the corresponding periods in 2021, primarily due to higher marketing and professional fees, partially offset by lower legal fees.
+Added: • Stock-based compensation – Stock-based compensation expenses for the three months ended June 30, 2022 increased 8% to $1.7 million, and for the six months ended June 30, 2022 increased 10% to $3.5 million as compared to the corresponding periods in 2021.
+Added: • Facilities and equipment – Facilities and equipment costs for the three months ended June 30, 2022 and 2021 were $0.3 million and $0.4 million, respectively.
+Added: Facilities and equipment costs for the six months ended June 30, 2022 and 2021 were $0.6 million and $0.7 million, respectively.
+Added: • Other – Other costs for the three months ended June 30, 2022 and 2021 were $1.0 million and $0.8 million, respectively.
+Added: Other costs for the six months ended June 30, 2022 and 2021 were $1.8 million and $1.6 million, respectively.
Net Loss and Net Loss per Common Share
Net loss and Net loss per Common Share.
−Removed: Net loss was $23.5 million, or $0.16 per share, in the three months ended March 31, 2022 as compared to a net loss of $21.0 million, or $0.15 per share, in the corresponding period in 2021.
+Added: Net loss was $24.6 million, or $0.16 per share, in the three months ended June 30, 2022 as compared to a net loss of $18.1 million, or $0.13 per share, in the corresponding period in 2021.
+Added: Net loss was $48.1 million, or $0.32 per share, in the six months ended June 30, 2022 as compared to a net loss of $39.0 million, or $0.27 per share, in the corresponding period in 2021.
Our quarterly operating results have fluctuated in the past and are likely to do so in the future, and we believe that quarter-to-quarter comparisons of our operating results are not a good indication of our future performance.
3 unchanged sentences
In March 2022, we entered into a loan and security agreement with Oxford Finance LLC that provides up to $150 million in borrowing capacity, available in four tranches, under which $25 million has been funded.
−Removed: As of March 31, 2022, we had $86.5 million in cash, cash equivalents and short-term investments.
+Added: As of June 30, 2022, we had $62.0 million in cash, cash equivalents and short-term investments.
As of December 31, 2021, we had $86.7 million in cash, cash equivalents and short-term investments.
−Removed: We used cash of $23.4 million from operations in the three months ended March 31, 2022.
+Added: We used cash of $47.8 million from operations in the six months ended June 30, 2022.
This consisted primarily of the net loss for the period of $48.1 million and a net decrease in operating liabilities net of assets of $5.8 million, partially offset by non-cash charges of $5.6 million related to stock-based compensation expense.
−Removed: Investing activities used cash of $4.4 million in the three months ended March 31, 2022, primarily due to net purchases of investments.
−Removed: Financing activities provided cash of $23.3 million primarily from $24.2 million of net proceeds from the Oxford debt financing during March 2022, which was partially offset by
−Removed: $0.9 million used to repurchase common stock by retaining shares in substitution of the tax withholding obligations of recipients of restricted stock units granted under our 2017 Equity Incentive Plan with respect to the vesting of such restricted stock units.
+Added: Investing activities used cash of $18.1 million in the six months ended June 30, 2022, primarily due to net purchases of investments.
+Added: Financing activities provided cash of $23.3 million primarily from $24.2 million of net proceeds from the Oxford debt financing during March 2022, which was partially offset by $0.9 million used to repurchase common stock by retaining shares in substitution of the tax withholding obligations of recipients of restricted stock units granted under our 2017 Equity Incentive Plan with respect to the vesting of such restricted stock units.
Other commitments.
7 unchanged sentences
The term of the lease extends from June 1, 2015 through December 31, 2022, and provides for escalating yearly base rent payments starting at $482,000 and increasing to $646,000 in the final year of the lease.
+Added: In July 2022, Lexicon Pharmaceuticals (New Jersey), Inc.
+Added: entered into an agreement to lease a 22,000 square-foot office space in Bridgewater, New Jersey to which we plan to relocate our New Jersey offices.
+Added: The term of the lease is expected to commence in December 2022, will extend for ten years and 11 months from such commencement date and provides for escalating yearly base rent payments starting at $820,000 and increasing to $986,000 in the final year of the lease.
Our future capital requirements will be substantial and will depend on many factors, including the success of our ongoing nonclinical and clinical development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts;
18 unchanged sentences
We currently do not hedge interest rate exposure or hold any derivative financial instruments in our investment portfolio.
−Removed: We had approximately $86.5 million in cash and cash equivalents and short-term investments as of March 31, 2022.
+Added: We had approximately $62.0 million in cash and cash equivalents and short-term investments as of June 30, 2022.
We believe that the working capital available to us will be sufficient to meet our cash requirements for at least the next 12 months.
−Removed: We are subject to interest rate sensitivity on our outstanding Oxford Term Loans as they contain a floating rate tied to the 30-day LIBOR rate.
+Added: We are subject to interest rate sensitivity on our outstanding Oxford Term Loans as they contain a floating rate tied to the 30-
+Added: day LIBOR rate.
The Oxford Term Loans interest is payable in cash monthly and matures in March 2027, unless earlier repaid in accordance with their terms.
5 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.