text:
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: September 29, 2021
GENFIT S.A.
Parc Eurasanté
885, avenue Eugène Avinée 59120 Loos, France
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
EXHIBIT LIST
Exhibit Description
99.1 Press Release dated September 29, 2021
Date: September 29, 2021 By: /s/ Pascal PRIGENT
Name: Pascal PRIGENT
GENFIT Reports First Half-Year 2021 Financial Results and Provides Corporate Update
- Financial highlights
o Cash and cash equivalents totaled €104 million as of June 30, 2021 (including €11 million non-dilutive financing obtained in the first half 2021)
o Net income totaled €9 million for the first half 2021, due to a one-off revenue following the successful outcome of the convertible debt restructuring in January and the OCEANEs conversions in the first quarter
- Positive developments with elafibranor in PBC (ELATIVETM Phase 3)
o Foresee completion of enrolment in first quarter 2022
o Timeline for potential FDA filing now estimated in second half 2023, based on a successful Phase 3 trial outcome
- New clinical data expected in several indications, starting as early as the third quarter 2022
o NTZ in ACLF (Phase 1)
o Elafibranor in PSC (Phase 2 PoC)
o Elafibranor in PBC (exploratory and complementary study to ELATIVE™ in treatment-naïve patients)
Lille, France; Cambridge, MA; September 29, 2021 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced its first half-year financial results and provided a corporate update.
The Half Year Business and Financial Report is available to the public and was filed with the French Autorité des marchés financiers (French Financial Markets Authority) today. The condensed consolidated financial statements are included in this press release and the complete financial statements are available on the "Investors" page of the GENFIT website.
Conference Call in English on September 29, 2021 at 4:15pm EDT | 9:15 BST | 10:15pm CEST, and in French on September 30, 2021 at 7:30am CEST | 1:30am EDT
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com
Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by phone five minutes prior to the start time:
- English session dial-in information:
o United States/Canada Tollfree: 800-289-0438 | United Kingdom Tollfree: 0800 358 6377 | France Tollfree: 0805 101 219
o Confirmation Code: 6014676
- French session dial-in information:
o Confirmation Code: 3525672 A replay will be available shortly after the call.
Pascal Prigent, CEO of GENFIT, commented: "We are pleased with the progress made in the first half of 2021. Our lead program, the development of elafibranor in PBC, is on track, with the pace of patient enrolment for our Phase 3 ELATIVETM clinical trial broadly in line with our expectations. Our updated R&D strategy, announced in May 2021, has allowed us to concentrate our efforts on new growth drivers in therapeutic areas with significant unmet medical needs and, as a result, we will start generating new clinical data as early as September next year. Financially, we are pleased with the successful outcome of the convertible debt restructuring. It has given us, in addition to the €11 million State Guaranteed Loan, more visibility and flexibility. Lastly, on the diagnostics side, the first qualitative feedback obtained from our partner Labcorp confirms the interest for NASHnextTM, although the conditions for commercial success have not yet been met."
I. Key aspects of business activity
o Elafibranor development program in PBC
Patient enrolment for the Phase 3 ELATIVETM clinical trial progressed well throughout the first half of 2021 and we expect to complete enrolment in the first quarter of 2022. We anticipate being able to announce ELATIVETM topline data between the end of the first quarter and the middle of the second quarter 2023. We now expect to file our new drug application (NDA) with the Food and Drug Administration (FDA) during the second half 2023, subject to a successful trial outcome. Based on these projections, we are targeting a potential approval of elafibranor in PBC in the US in the second half 2024.
In February 2021, the Company announced the publication, in the Journal of Hepatology, of the positive results of the Phase 2 clinical trial evaluating elafibranor in patients with PBC and an incomplete response to ursodeoxycholic acid (UDCA). These results show a clinically significant improvement on the primary and composite biochemical evaluation criteria and a positive trend on the improvement of pruritus, while preserving a favorable tolerability profile.
During a KOL analyst event organized the same month, the Company provided details of the results of three market studies undertaken by IQVIA 1 evaluating the commercial opportunity presented by elafibranor if approved as a second-line treatment in PBC. The presentation and the related references are available on the Company's website. These studies support that elafibranor is expected to gain a significant market share in the PBC market, the size of which is expected to reach about $1billion a year at the time of elafibranor's commercial launch. 2
o Re-focusing our R&D efforts on programs with high potential
In May, the Company announced the new strategic direction for its research and development (R&D) programs, with a pipeline now focused on two therapeutic areas with serious health implications: cholestatic diseases and Acute on Chronic Liver Failure. The rationale behind this approach is to maximize our chances of success in the therapeutic areas that represent high costs for the healthcare system and in which there are significant unmet medical needs for patients. More details on this new strategic positioning are available on the "News" section of the Company's "Investors & Media" website page.
Clinical data is expected as early as the third quarter of 2022 in the two franchises : for NTZ in ACLF (Phase 1), for elafibranor in PSC (Phase 2 PoC) and for elafibranor in PBC (exploratory and complementary study to ELATIVE™ in treatment-naïve patients).
o Diagnostic program in NASH
In May, the Company announced the launch of the non-invasive diagnostic test NASHnext™, based on GENFIT's NIS4® technology, by our partner Labcorp. NASHnext™ is now commercially available in the US and Canada and its purpose is to diagnose at-risk NASH in patients presenting with at least one metabolic risk factor. The initial feedback from Labcorp confirms interest in this test and its market, however, significant commercial success is going to be dependent upon availability of approved therapeutic options as well as re-imbursement for NASHnext™, which is not expected in the immediate future.
1 IQVIA is a well-known leader in research and consulting services in the pharmaceutical industry
2 IQVIA Commercial Opportunity Presentation, 2020 – Research on File, November 2019
We continue to see strong interest in the research area and the use of NIS4® in clinical trials continues to grow. We are also committed to continue to grow the body of evidence supporting the use of NIS4®. In June, the Company presented new data on NIS4® at the International Liver Congress™ 2021, organized by the European Association for the Study of the Liver (EASL) and at the 81st Scientific Sessions of the American Diabetes Association (ADA). These data show the clinical performance of NIS4® for diagnosing at-risk NASH in patients with type 2 diabetes compared to other non-invasive tests. They highlight the potential of NIS4® technology to be a valuable clinical tool, either alone or in sequential combination with other blood-based non-invasive tests, in identifying at-risk NASH in patients with and without type 2 diabetes.
o Governance
At the Company's annual shareholders meeting in June, where the new strategic directions and perspectives for the Company were presented, shareholders adopted, by a large majority of the votes cast, all the resolutions recommended by the Board of Directors, including the financial authorizations to allow the Company to access financing solutions that are adapted to future market conditions, and to seize new opportunities.
Several additions were also made in the first half of 2021 to our Board of Directors and Executive Committee. In March, the Board of Directors appointed Mr. Jean-François Tiné to replace Mr. Philippe Moons, and two new members were added to the Executive Committee: Thomas Baetz, Chief Finance Officer and Stefanie Magner, Chief Compliance Officer and VP International Legal Affairs.
II. Key financial events of the first half-year 2021
o Partial buyback operation and amendment of the terms of the OCEANEs
In January, the Company announced the success of the partial buyback offer and amendment of the terms of 6,081,081 bonds convertible or exchangeable into new or existing shares (OCEANEs) due in October 2022, and issued in the context of the convertible loan of €180 million in October 2017. The renegotiation of the bond debt – approved by more than 98% of shareholders that took part in the vote – has enabled the Company to defer its final maturity date to October 16, 2025 and reduce its nominal amount by half. The conversion ratio went from 1 OCEANE for 1 share to 1 OCEANE for 5.5 shares.
o Reduction of the residual bond debt amount thanks to the conversion of OCEANEs into shares
Following the implementation of the partial buyback operation and the approval of the amendment of the terms of the OCEANEs, the Company received OCEANE conversion notifications as follows: 552,238 of the new OCEANEs were converted in January 2021; 483, 330 of the new OCEANEs were converted in February 2021 and 216, 591 of the new OCEANEs were converted at the end of March 2021. As a result, at June 30, 2021, the Company's share capital was €11, 443, 812.50, represented by 45,775,250 shares. In August 2021, after the half-year period, 10,000 OCEANEs were converted, and the Company therefore recognized a capital increase of €13,750, corresponding to the issuance of 55,000 new shares.
At the date of the current half-year report, the par value of residual bond debt is approximately €56.9 million, i.e. less than a third of the initial nominal debt amount of €180 million.
o New non-dilutive financing for shareholders
In June, the Company announced the signing of a loan agreement for €11 million. The loan, granted in the context of the COVID-19 pandemic by a syndicate of 4 French banks (BNP Paribas, Natixis, CIC Nord Ouest et Crédit du Nord), is 90% guaranteed by the French government. In July, after the first half-year period, the Company obtained an additional loan of €2 million from BPI France, also 90% guaranteed by the French government. These two loans have an initial term of one year with repayment options up to six years.
III. Key aspects of the first half 2021 financial results
o Cash and cash equivalents
As of June 30, 2021, GENFIT had €104.4 million in cash and cash equivalents (€171 million as of December 31, 2020) which essentially came from using €47.5 million for the partial buyback of the OCEANEs in January 2021 and the State-guaranteed loan amounting to €11 million in June 2021.
o Operating income
Operating income amounted to €3.4 million in the first half 2021 (compared with €5.9 million in the first half 2020), which essentially came from the Research Tax Credit of €3.2 million (€5.2 million for the first half 2020).
o Operating expenses
Operating expenses amounted to €33 million in the first half 2021 (compared with €55 million in the first half 2020), of which 70% represented R&D expenses.
The decrease in operating expenses is due to:
· The decrease in R&D expenses which amounted to €23.1 million in the first half 2021 compared with €36.9 million in the first half 2020, mainly due to the termination of the RESOLVE-IT trial from July 2020;
· The decrease in marketing and pre-commercialization expenses, which amounted to €0.8 million in the first half 2021 (as opposed to €9.5 million in the first half 2020), is mainly due to the discontinuation of the pre-commercialization work for elafibranor in NASH;
· The decrease in general and administrative expenses, which amounted to €7.6 million in the first half 2021 (compared with €8.3 million in the first half 2020) was due to the execution of a cost-saving plan over 3 years, announced in September 2020. Savings on administrative expenses (-9.6%) were realized despite restructuration and reorganization expenses of €1.8 million in the first half 2021 (including a €0.2 million reversal of a provision and €1.9 million in fees related to the renegotiation of the OCEANEs in January 2021).
o Financial results
In the first half 2021, GENFIT registered a one-off financial income of €35.6 million corresponding to a repurchase bonus following the renegotiation of the OCEANEs in January 2021. The financial result, including the one-off financial income and foreign exchange gains and losses amounted to
€35.7 million in the first half 2021 (compared with €4 million in the first half 2020).
o Net gains (net losses)
Taking into account the cash and cash equivalents, operating income and one-off financial income, GENFIT generated a half-year net gain of €9.1 million at June 30, 2021 (compared with a net loss of €53.0 million at June 30, 2020). The net loss in 2020 amounted to €101.2 million.
The table below presents the condensed Consolidated Statement of Operations under IFRS for the first half 2021, with comparative figures for the first half 2020.
(in € thousands, except earnings per share data) For the six-month period ended
Revenues and other income
Revenue 122 11
Other income 5 745 3 417
Revenues and other income 5 867 3 428
Operating expenses and other operating income (expenses)
Research and development expenses
General and administrative expenses (8 251) (7 632)
Marketing and market access expenses (9 490) (783)
Reorganization and restructuring expenses — (1 786)
Other operating income (expenses) (423 ) 301
Operating income (loss) (49 163) (29 551)
Financial income (1)
Financial expenses (6 102) (5 107)
Financial profit (loss) (4 007) 35 714
Net profit (loss) before tax (53 170) 6 163
Income tax benefit (expense) 159
Net profit (loss) (53 011) 9 058
Attributable to owners of the Company (53 011) 9 058
Attributable to non-controlling interests — —
Basic and diluted earnings (loss) per share
Basic earnings (loss) per share (€/share) (1,36 ) 0,21
Diluted earnings (loss) per share (€/share) (1,36 ) 0,19
(1): Of which Financial income incurred by renegotiating the convertible bond
debt OCEANE — 35 578
Further information is provided in the above "Key aspects of business activity" and "Key financial events of the first half 2021" sections of this press release and in the condensed consolidated financial statements at June 30, 2021 under IFRS as well as the management discussion of the results are provided in the appendix at the end of this press release. The condensed consolidated financial statements as well as the statutory auditors' report on those financial statements are included in the 2021 Half Year Business and Financial Report and available on the "Investors" page of the GENFIT website.
We encourage investors to take into consideration all the information presented in our 2020 Annual Report on Form 20-F ("Form 20-F") filed with the U.S. Securities Exchange Commission and the 2020 Universal Registration Document filed under n°D.20-0503 with the French Autorité des Marchés Financiers (AMF) on April 23, 2021 and in this Half-Year Business and Financial Report before deciding to invest in Company shares; these documents are available on GENFIT's website: www.genfit.com and on the website of the AMF (www.amf-france.org). This includes, in particular, the risk factors described in Item 2 of the Form 20-F (and the contents of this section) and section 2 of the 2020 Universal Registration Document, as well as the update provided in section 8 of the 2021 Half-Year Business and Financial report, of which the realization may have (or has had in some cases) material adverse effect on the Group and its activity, financial situation, results, development or perspectives, and which are of importance in the investment decision-making process.
Half-year Consolidated Financial Results at June 30, 2021
The Condensed Consolidated Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Group were prepared in accordance with International Financial Reporting Standards (IFRS).
The limited review procedures on the condensed consolidated financial statements have been performed. The half-year consolidated financial statements for the period ended June 30, 2021 were approved by Board of Directors on September 29, 2021.
The condensed consolidated financial statements as well as the notes to the consolidated financial statements for the period ended June 30, 2021 and the statutory auditor's report on the consolidated financial statements are included in appendices of the Half Year Business and Financial Report at June 30, 2021 and available on the "Investors" page of the GENFIT website.
Condensed Consolidated Statement of Financial Position
ASSETS As of
(in € thousands) December 31, 2020 June 30, 2021
Cash and cash equivalents 171 029 104 379
Current trade and others receivables 11 919 13 842
Other current assets 1 765 3 058
Inventories 4 4
Total - Current assets 184 717 121 283
Non-current assets
Intangible assets 791 704
Property, plant and equipment 11 648 10 328
Other non-current financial assets 1 458 1 398
Deferred tax assets — —
Total - Non-current assets 13 897 12 429
Total - Assets 198 614 133 712
SHAREHOLDERS' EQUITY AND LIABILITIES As of
Current convertible loans 1 312 417
Other current loans and borrowings 3 035 2 457
Current trade and other payables 25 564 27 231
Current deferred income and revenue 124 122
Current provisions 1 031 736
Total - Current liabilities 31 067 30 964
Non-current liabilities
Non-current convertible loans 169 470 46 913
Other non-current loans and borrowings 11 873 21 144
Non-current trade and other payables 450 447
Non-current employee benefits 1 148 1 071
Deferred tax liabilities 767 608
Total - Non-current liabilities 183 709 70 183
Shareholders' equity
Share capital 9 722 11 444
Share premium 379 057 416 965
Retained earnings (accumulated deficit) (303 629) (404 849)
Currency translation adjustment (92 ) (52 )
Net profit (loss) (101 221) 9 058
Total shareholders' equity - Group share (16 162) 32 566
Non-controlling interests — —
Total - Shareholders' equity (16 162) 32 566
Total - Shareholders' equity & liabilities 198 614 133 712
Condensed Consolidated Statement of Operations
For the six-month period ended
(in € thousands, except earnings per share data) June 30, 2020 June 30, 2021
Research and development expenses (36 867) (23 079)
Marketing and market access expenses (9 490) (783 )
Financial income (1) 2 095 40 822
Income tax benefit (expense) 159 2 895
(1): Of which Financial income incurred by renegotiating the convertible bond debt OCEANE — 35 578
Condensed Statement of Cash Flows
For the six-month
period ended For the year
ended For the six-month
period ended
(in € thousands) June 30, 2020 December 31, 2020 June 30, 2021
+ Net profit (loss) (53 011) (101 221) 9 058
+ Non-controlling interests — — —
Reconciliation of net loss to net cash used in operating activities
Adjustments for:
+ Depreciation and amortization on tangible and intangible assets 1 737 3 559 1 511
+ Impairment and provision for litigation 124 3 015 (1 424)
+ Expenses related to share-based compensation 513 1 236 217
- Gain on disposal of property, plant and equipment (2 ) 80 330
+ Net finance expenses (revenue) 5 848 10 335 2 590
+ Income tax expense (benefit) (159 ) (428 ) (2 895)
+ Other non-cash items including Research Tax Credit litigation 92 (1 818) (35 506)
Operating cash flows before change in working capital (44 859) (85 242) (26 118)
Change in:
Decrease (increase) in trade receivables and other assets 1 523 318 (3 216)
(Decrease) increase in trade payables and other liabilities (2 026) (11 447) 1 518
Change in working capital (504 ) (11 129) (1 698)
Income tax paid — — 6
Net cash flows used in operating activities (45 362) (96 371) (27 810)
Cash flows from investment activities
- Acquisition of property, plant and equipment (785 ) (900 ) (21 )
+ Proceeds from disposal of / reimbursement of property, plant and equipment — — 224
- Acquisition of financial instruments (49 ) (66 ) 12
Net cash flows provided by (used in ) investment activities (834 ) (966 ) 215
+ Proceeds from issue of share capital (net) — 7 —
+ Proceeds from subscription / exercise of share warrants — — —
+ Proceeds from new loans and borrowings net of issue costs — — 10 905
- Repayments of loans and borrowings — 207 (48 028)
- Payments on lease debts (1 601) (2 150) (1 009)
- Financial interests paid (including finance lease) (3 230) (7 762) (1 058)
+ Financial interests received — 1 442 224
Net cash flows provided by (used in ) financing activities (4 831) (8 256) (38 966)
Increase (decrease) in cash and cash equivalents (51 027) (105 593) (66 561)
Cash and cash equivalents at the beginning of the period 276 748 276 748 171 029
Effects of exchange rate changes on cash — (126 ) (88 )
Cash and cash equivalents at the end of the period 225 721 171 029 104 379
Discussion of the 2021 half-year results
Comments on the condensed statement of net income for the periods ended June 30, 2020 and June 30, 2021
(i) Revenue and other income
The Company's revenue and other income results primarily from the research tax credit.
Revenue and other income For the six-month period ended
(in € thousands) June 30, 2020 June 30, 2021
Revenues 122 11
Government grants and subsidies 3 (0 )
CIR tax credit 5 224 3 244
Other operating income 519 174
TOTAL 5 867 3 428
Revenue and other income was €3,428 thousand at June 30, 2021 compared with € 5,867 thousand at June 30, 2020. The change in revenue results mainly from a decrease from one half-year to another of the estimated amount of the research tax credit, proportional to the amount of eligible R&D expenses.
(ii) Operating expenses by destination
The tables below break down operating expenses by destination mainly into research and development expenses, general and administrative expense, markets and market access expenses and reorganization and restructuring expenses for the half years ended June 30, 2021 and 2020.
(in € thousands)
For the six-month period ended June 30, 2020 Of which:
Contracted
(maintenance,
fees, travel,
taxes…)
Depreciation,
Gain /
(loss) on
disposal of
plant and
Research and development expenses (36 867) (1 197) (24 337) (6 591) (3 287) (1 455) —
General and administrative expenses (8 251) (133) (41) (3 845) (3 963) (269) —
Marketing and market access expenses (9 490) (4) (1) (744) (8 697) (44) —
Reorganization and restructuring expenses — — — — — — —
Other operating income and (expenses) (423) — — — (425) — 2
TOTAL (55 031) (1 333) (24 379) (11 180) (16 372) (1 769) 2
Research and development expenses (23 079) (642) (15 029) (4 842) (2 334) (225) (6)
General and administrative expenses (7 632) (73) (48) (3 336) (4 123) (51) —
Marketing and market access expenses (783) (2) (1) (465) (316) 0 —
Reorganization and restructuring expenses (1 786) (3) — — (1 942) 158 —
Other operating income (expenses) 301 — — — 637 — (336)
TOTAL (32 979) (721) (15 078) (8 643) (8 078) (117) (343)
Operating expenses in the first half 2021 amounted to €32,979 thousand compared to €55,031 in first half 2020.
They include, in particular:
· research and development expenses, which mainly include employee-related expenses for employees in research and development functions (€4,842 thousand at June 30, 2021 compared to €6,591 thousand at June 30, 2020), the cost of consumables
and contracted research and development activities (particularly clinical and pharmaceutical expenses) (representing €15,671 thousand at June 30, 2021 compared to €25,534 thousand at June 30, 2020) and expenses related to intellectual property. These research and development expenses amounted to €23,079 thousand at June 30, 2021 compared to €36,867 thousand at June 30, 2020, or 70% and 67% of operating expenses, respectively.
The decrease in contracted research and development expenses is mainly due to the termination of RESOLVE-IT study from July 2020; the study was still active in the first half of 2020.
Changes in employee-related expenses for employees in research and development functions reflects a decrease in headcount (from 128 at June 30 ,2020 to 74 at June 30, 2021).
· general and administrative expenses, which include the costs of personnel not assigned to research (€3,336 thousand at June 30, 2021 compared to €3,845 thousand at June 30, 2020), and administrative costs. These general and administrative expenses amounted to €7,632 thousand in the first half 2021 compared to €8,251 thousand in the first half 2020, or 23% and 15% of operating expenses, respectively.
Changes in general and administrative expenses are mainly related to the increased cost of insurance premiums in the first half 2021 related to the Company's listing on the Nasdaq.
Changes in employee-related expenses paid to employees in general and administrative functions was primarily the result of a decrease in headcount (from 68 at June 30, 2020 to 44 at June 30, 2021).
· marketing and pre-marketing expenses, which include the costs of personnel assigned to marketing and business development (€465 thousand in the first half 2021 compared to €744 thousand in the first half 2020), and costs related to the preparation of the commercialization of elafibranor and NIS4® in NASH (market research, marketing strategy, medical communication, market access…) (€316 thousand in the first half 2021 compared to €8,697 thousand in the first half 2020).
Marketing and pre-commercialization expenses decreased significantly starting in the second half 2020 due to the discontinuation of the pre-commercialization work for elafibranor in NASH following the termination of this program in July 2020.
· reorganization and restructuring expenses, which mainly include the expenses for the renegotiation of the OCEANEs convertible bonds (representing an expense of €1,939 thousand in the first half 2021) and adjustments to provisions for employee expenses under the Workforce Reduction Plan begun in 2020 and the termination of the RESOLVE-IT study (reversal of provisions of €158 thousand in the first half 2021). By comparison, these expenses did not exist in the first half 2020.
(iii) Operating expenses by type
Broken down by type instead of by destination, operating expenses mainly included the following:
Contracted research and development activities
Contracted research and development expenses amounted to €15,078 thousand in the first half 2021 compared to €24,379 thousand in the first half 2020, corresponding to a 38% decrease, which is mainly due to the termination of the RESOLVE-IT study.
Employee expenses For the six-month period ended
Wages and salaries (7 811) (5 734)
Social security costs (2 769) (2 729)
Changes in pension provision (87 ) 37
Share-based compensation (513 ) (217 )
TOTAL (11 180) (8 643)
Employee expenses excluding share-based compensation amounted to €8,426 thousand in the first half 2021 compared to €10,667 thousand in the first half 2020, or a 22% decrease, due to a decrease in headcount (from 203 at June 30, 2020 to 122 at June 30, 2021).
The amount recognized as share-based compensation (BSA, BSAAR, SO and AGA) without having any impact on cash and cash equivalents amounted to €217 thousand in the first half 2021 compared to €513 thousand in the first half 2020. The expenses recorded in the first half of 2021 relate to the BSA, SO and AGA plans implemented between 2016 and 2021.
Other expenses amount to €8,078 thousand in the first half 2021 compared to €16,372 thousand in the first half 2020. They include, in particular:
· "fees," which mainly include legal, audit, and accounting, the fees of various advisors (press relations, investor relations, communication, IT), as well as the fees of certain scientific advisers. This amount also includes intellectual property expenditures corresponding to fees incurred by the Company in connection with the registration and protection of its patents;
· insurance premiums specific to the listing of the Company's shares on Nasdaq: a recurring Directors & Officers civil liability insurance policy;
· expenses related to the pre-marketing of elafibranor and NIS4 in NASH (market research, marketing strategy, medical communication, market access…);
· expenses related to the use and maintenance of Group offices;
· expenses related to external service providers (security, reception, clinical trial management and IT); and
· expenses related to business travel and conferences mainly for employees as well as the costs of participation in scientific, medical and financial conferences.
These changes are mainly related to a decrease in expenses following a cost savings plan implemented in the summer 2020.
(iv) Financial income (expense)
Financial income as of June 30, 2021 amounted to a gain of €35,714 thousand compared to financial expense of €4,007 thousand in the previous half year.
This change is mainly due to the buyback bonus obtained as part of the renegotiation of OCEANEs (€35,578 thousand), unrealized and realized foreign exchange gains in the amount of € 5,019 thousand in the first half of 2021 ( compared to € 938 thousand in the first half of 2020), partially offset by foreign exchange losses of € 2,291 thousand in the first half of 2021 (compared to € 246 thousand in the first half of 2020) and by interest expenses (€2,758 thousand in the first half of 2021 compared to € 5,777 thousand in the first half of 2020), the decrease of which is related to a decrease in the bond debt following the partial repurchase and the conversions of OCEANEs carried out during the first semester of 2021.
(v) Net income (loss)
The first half 2021 resulted in net income of €9,058 compared to a net loss of €53,011 thousand compared in the first half 2020. The net loss for the 2020 fiscal year amounted to €101,221 thousand.
Comments on the Group's Statement of Financial Position at June 30, 2021
At June 30, 2021 the total amount of the Group's Statement of Financial Position amounted to €133,712 thousand compared to €198,614 thousand as of December 31, 2020.
At June 30, 2021, the Group's cash, cash equivalents and other financial assets amounted to €105,777 thousand, compared to €172,486 thousand as of December 31, 2020.
With €104 million in cash and cash equivalents at June 30, 2021, and taking into account payments made at the date of this report, we estimate that the cost reduction program initiated during the summer 2020 will allow us, as announced in September 2020, to limit our cash burn to an aggregate €120 million for both periods 2021 and 2022, (not including the partial OCEANEs buyback completed in January 2021). The distribution between 2021 and 2022 should be modified as a result of new non-dilutive financing (state-guaranteed loan, or PGE) secured in 2021, the new orientations of our R&D programs communicated last May, the deferment of some payments from 2021 to 2022, notably related to the closure of the RESOLVE-IT trial and the anticipation of regulatory fees to prepare the submission of elafibranor in PBC to the regulatory authorities.
(i) Non current assets
Non-current assets, which include trade and other receivables, goodwill and intangible, tangible, and financial assets, decreased and amount to €12,429 thousand as of June 30, 2021 compared with €13,897 thousand at December 31, 2020.
(ii) Current assets
Current assets amounted to €121,283 thousand at June 30, 2021 compared to €184,717 thousand as of December 31, 2020.
Cash and cash equivalents went from €171,029 thousand at December 31, 2020 to €104,379 thousand at June 30, 2021, or a decrease of 39%. Cash is mainly placed in low risk, highly-liquid short term investments.
The variation of trade and other receivables is mainly due to the recognition of the estimated amount of the Research Tax Credit receivable for the first half 2021 and the repayment of the Research Tax Credit for 2020 during the first half 2021. Additional details regarding these receivables are provided in note 6.9 to the 2021 half year condensed consolidated financial statements.
The variation of other receivables corresponds to the increase in expenses recognized in advance related to current operating expenses, and in particular, the Directors & Officers civil liability insurance.
(iii) Shareholders' equity
As of June 30, 2021, the Group's shareholders' equity totaled €32,566 thousand compared to €16,162 thousand as of December 31, 2020.
The change in the Company's shareholders equity is mainly due to the recognition of income resulting from the bonus corresponding to the partial buyback of OCEANEs as well as capital increases following conversions of OCEANEs in the first half of 2021.
The Notes to the 2021 half year condensed consolidated financial statements summarized hereafter, as well as the Table of Changes in Shareholders' Equity established under IFRS provide details on the change in the Company's share capital and the Group's shareholders' equity, respectively.
(iv) Non-current liability
This mainly concerns:
· The convertible bond (OCEANE) renegotiated in January 2021 and due October 2025;
· As well as the part of contractual obligations of the following liabilities reaching maturity in more than one year:
o A conditional advance granted to GENFIT SA by Bpifrance for the purpose of financing the research programs detailed in Note 12.2.1 "Refundable and
Conditional Advances" of the notes to the 2021 half year condensed consolidated financial statements included herein; and
o bank loan, include the State-guaranteed Loan taken out in June 2021; and
o the debt related to operating leases pursuant to IFRS 16, as of January 1, 2019.
(v) Current liabilities
Liabilities - Current As of
Current other loans and borrowings 3 035 2 457
TOTAL 31 067 30 964
This balance sheet item mainly includes interest payments on the OCEANE due October 2025, bank loans and trade and social security payables and debts under operating leases. Changes in current liabilities are mainly due to changes in contracted research and development activities expenses.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades.
Today, GENFIT has a robust and diversified pipeline, with different compounds and technologies evaluated at different development stages and in different liver diseases.
Leveraging its internal assets and in-house expertise, GENFIT's R&D is focused on cholestatic diseases and Acute on Chronic Liver Failure (ACLF): two therapeutic areas with significant unmet medical needs. Currently, the ELATIVE™ Phase 3 clinical trial evaluating elafibranor (elafibranor is an investigational compound that has not been reviewed and has not received approval by any regulatory authority) in patients with Primary Biliary Cholangitis (PBC) is being conducted following a successful Phase 2 clinical trial. A Phase 2 clinical development program is also underway with elafibranor in Primary Sclerosing Cholangitis (PSC), and a Phase 1 clinical program with nitazoxanide in ACLF has been initiated.
As part of GENFIT's comprehensive approach to clinical management of patients with liver diseases, the Company is also developing NIS4®, a new non-invasive blood-based diagnostic technology, which could enable easier identification of patients with at-risk NASH. Since May 2021,
Labcorp® has commercialized NASHnext™, powered by NIS4®, for use in the clinic. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) test.
GENFIT has facilities in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext's regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
GENFIT FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding GENFIT's corporate strategy and objectives, the potential sizes of the markets for PBC, PSC and ACLF, commercial certainty within these markets and the outcome of the ELATIVE™ phase 3 trial of elafibranor in PBC, timelines for completion of the ELATIVE™ trial and receipt of market authorization if the results are positive, timelines for and success of the commercial deployment of the diagnostic test powered by NIS4® developed by GENFIT's partner Labcorp and the size of the market for which it is designed, the ability of the NIS4® technology to facilitate the development of an IVD test approvable by the regulatory authorities, and our ability to significantly reduce our projected cash burn over the next several years. The use of certain words, including "consider", "contemplate", "think", "aim", "expect", "understand", "should", "aspire", "estimate", "believe", "wish", "may", "could", "allow", "seek", "encourage" or "have confidence" or (as the case may be) the negative forms of such terms or any other variant of such terms or other terms similar to them in meaning is intended to identify forward-looking statements. Although the Company believes its projections are based on reasonable expectations and assumptions of the Company's management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, the impact of the COVID-19 pandemic, exchange rate fluctuations and the Company's continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company's public filings with the French Autorité des Marchés Financiers ("AMF"), including those listed in Chapter 2 "Main Risks and Uncertainties" of the Company's 2020 Universal Registration Document filed with the AMF on 23 April 2021 under n° D.21-0350, which is available on the Company's website (www.genfit.com) and on the website of
the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission ("SEC") including the Company's 2020 Annual Report on Form 20-F filed with the SEC on April 23, 2021. In addition, even if the Company's results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
GENFIT | Investors
Tel: +1 (617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com


text:
CEQ Issues Final Rule to Modernize NEPA Regulations
On July 15, 2020, the Council on Environmental Quality ("CEQ") announced its final rule modernizing and clarifying its procedural regulations implementing the National Environmental Policy Act ("NEPA"). The final rule, titled "Update to the Regulations Implementing the Procedural Provisions of the National Environmental Policy Act," is the first major revision to CEQ's NEPA regulations in over 40 years, and is the latest in a series of efforts by the Trump Administration to streamline federal agency processes for permitting infrastructure projects. CEQ describes its efforts on this rule as intended to "facilitate more efficient, effective, and timely NEPA reviews by Federal agencies by simplifying regulatory requirements, codifying certain guidance and case law relevant to these regulations, revising the regulations to reflect current technologies and agency practices, eliminating obsolete provisions, and improving the format and readability of the regulations." To this end, the rule modifies almost all aspects of the regulations governing how federal agencies meet their environmental review obligations under NEPA. Although the ultimate practical impact of these changes is uncertain, the rule fundamentally alters the timing of, procedures for, and content of NEPA reviews, and will have important implications for parties seeking federal permits and other program approvals or authorizations.
The final rule will be effective September 14, 2020; however, the timing may be impacted by Congressional review and/or anticipated litigation.
Background on NEPA Regulations
NEPA applies to a broad range of actions with a federal nexus, including federal permit applications, federal land management decisions, highway construction, and other infrastructure development. Through the NEPA process, federal agencies must evaluate the environmental and related social and economic effects of their proposed actions.
NEPA reviews have long been the subject of significant criticism and litigation—including over the length of time they take to complete, inconsistent implementation within and across agencies, adequacy of public participation processes, and disputes over the scope and detail of the environmental documents produced by the agencies. CEQ's efforts here focus on reducing the time required to complete NEPA reviews and placing clearer boundaries on the scope of the effects analysis, with the goal of expediting permitting decisions and narrowing litigation risk. An overview of the precursors and additional context for the development of this rule is provided in our previous alert on the proposed rule.
Overview of Changes
Under the final rule, the NEPA review process is altered in both subtle and direct ways. Among the notable changes are:
Presumptive Timelines and Page Limits: NEPA reviews will have presumptive time limits of one year for environmental assessments ("EAs") and two years for environmental impact statements ("EISs"), and page limits of 75 pages (not including appendices) for EAs, 150 pages for routine EISs, and 300 pages for EISs covering matters of "unusual scope or complexity." Exceptions can be granted on a case-by-case basis.
One Federal Decision and Adherence to Joint Schedules for Reviews and Agency Action: The final rule reinforces and codifies elements of the One Federal Decision policy under Executive Order No. 13807, titled "Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects." Where multiple federal agencies have discretionary decision making authority for a proposed project, the agencies must coordinate on scheduling and, where practicable, issue a single environmental document that can be relied on for each agency's permitting or authorization decision as well as, to the extent practicable, a joint record of decision ("ROD") or finding of no significant impact ("FONSI"). The joint schedules must reflect applicant input and extend to any authorizations required for a proposed action, as well as provide a means for resolution of inter-agency disputes and other issues that may cause delays in the schedule.
Front-loading of Analyses: The final rule makes important changes to the scoping process for an EIS, which, together with the adoption of shorter time limits and enforceable schedules, will place a premium on earlier data collection and analysis by permit applicants. Under the rule, scoping may begin "as soon as practicable after the proposal for action is sufficiently developed for agency consideration," and agencies may require "appropriate pre-application procedures or work" prior to publishing a notice of intent. Further, the notice of intent ("NOI") now must include, among other information, a preliminary description of the proposed action and alternatives and a brief summary of expected impacts. This approach not only places a priority on early data collection, but also affects the timing of the review because the issuance of the NOI starts the clock on the two year presumptive time limit for completion of an EIS. Although CEQ advises that "agencies should not unduly delay publication of the NOI," the approach to scoping and pre-application procedures under this rule gives agencies the ability to effectively extend the timeframe for EISs through pre-filing data requirements for permit applicants and other activities.
Scope of Effects Analysis: The final rule incorporates a number of significant changes to the overall scope of effects and alternatives to be analyzed, including:
Changing the definition of "major federal action," which triggers NEPA review, to exclude non-federal projects with "minimal Federal funding or minimal Federal involvement where the agency does not exercise sufficient control and responsibility over the outcome of the project." Included under this exclusion are certain federal loans, loan guarantees, and other forms of financial assistance.
Doing away with the concepts of direct, indirect, and cumulative effects, and instead focusing the analysis on those effects that are reasonably foreseeable and that have a reasonably close causal relationship to the proposed action. Further, CEQ clarifies that a "but for" causal relationship is not sufficient, and that the standard is analogous to proximate cause in tort law.
Clarifying that "reasonable alternatives" must be "technically and economically feasible" and meet the purpose and need for the proposed action. Specifically, when the agency's action involves a non-federal applicant, the development of reasonable alternatives must consider the goals of the applicant.
Uncertainty for cumulative effects and climate change analysis: The final rule repeals the specific requirement to consider cumulative effects, but allows for incorporation of such analysis if such effects are reasonably foreseeable and have a reasonably close causal relationship. Similarly, the final rule allows for incorporation of climate trends into the discussion of environmental baseline conditions (i.e., the "affected environment") but would exclude the discussion of speculative conditions.
Additional Structure for Environmental Assessments: Historically, action agencies have followed varied practices regarding the scope and content of their EAs. While still maintaining a level of flexibility for agency implementation, the final rule encourages more standardized approaches. Specifically, agencies are directed to follow the same rules as applied to an EIS in relation to the level of data available, methodologies and scientific accuracy, and accommodation of other surveys and analysis that may be required for lead or cooperating agency permitting or authorization determinations.
More Detailed Direction on Categorical Exclusions: The final rule includes additional direction on agencies' use of categorical exclusions ("CEs") as a means to avoid detailed environmental review of actions that normally do not have significant effects. In addition to clarifying that the presence of extraordinary circumstances does not necessarily preclude the application of a CE, the final rule also includes provisions that would allow federal agencies to adopt other agencies' CEs.
Greater Role for Applicants: The final rule allows applicants to assume a greater role in the preparation of environmental documents. Specifically, it allows both EAs and EISs to be prepared by project applicants or contractors under the supervision of the agency, provided that agencies retain ultimate responsibility for the accuracy, scope, and content of the document.
Greater Roles for Tribes: CEQ makes a series of changes to its rules to further integrate Tribes into NEPA reviews by: (i) recognizing that Tribes may assume NEPA implementing responsibility under certain statutory authorities; (ii) requiring federal agencies to coordinate with affected Tribes in the development of NEPA review timelines; (iii) allowing for Tribes, with the lead agency's agreement, to be cooperating agencies; and (iv) ensuring that federal agencies further coordinate with Tribes on the analysis of a proposed action's potential effects on Tribal lands, resources, or areas of historic significance. In conjunction with coordinating on the potential effects of an action on Tribal resources and historic significance, the rule eliminates existing provisions that limit Tribal interests to reservations.
Public Involvement and Implications for Litigation: Throughout the rule, CEQ emphasizes the need for disclosure or public involvement—in contrast to prior focus on public participation. The final rule includes several provisions designed to encourage commenters to provide the agency with "all available information prior to the agency's decision, rather than disclosing information after the decision is made or in subsequent litigation." It requires that public comments be as specific as possible and submitted during the prescribed comment periods, providing that agencies need only respond to "substantive" comments and that comments or objections not submitted will be deemed "forfeited as unexhausted." The final rule also establishes a rebuttable presumption that an agency has considered submitted alternatives, information, and analyses in the final EIS. Further, agencies are given more discretion in determining the need for public meetings or hearings, which, traditionally, have been a key step in the development of an EIS. The final rule also scraps the mandatory 30-day comment period on final EISs included in the proposed rule, although it retains the current 30-day waiting period between publication of notice of a final EIS and issuance of a ROD. The extent to which any of these provisions ultimately may limit judicial review will be within the purview of reviewing courts.
Implementation of the new rule
The revised regulations apply to all NEPA processes begun after the September 14, 2020 effective date. CEQ states that agencies also have the discretion to apply the revised regulations to ongoing activities and environmental reviews. Going forward, federal agencies must revise their agency-specific NEPA implementing regulations by September 14, 2021. In the interim, the final rule explicitly states that, where existing agency NEPA procedures are inconsistent with the new CEQ regulations as adopted, the new regulations shall apply, upon their effective date, "unless there is a clear and fundamental conflict with an applicable statute." Additionally, the rule supersedes existing CEQ guidance materials, but clarifies that CEQ will publish a separate notice to withdraw such guidance.
As we observed in our alert on the proposed rule, this Administration is not unique in recognizing that NEPA can delay and/or add significant costs to important infrastructure projects and that the environmental review process can and should be improved. Since NEPA's enactment in 1970, administrations of both parties and Congress have sought to improve the process and make it more efficient. Applicants, stakeholders, courts, and others all at times have found certain elements of implementation of the statute and regulations to lack clarity. In that context, some of the changes made in the final rule have the potential to reduce costs and delays historically associated with NEPA compliance. The extent to which that might be the case, however, depends upon how the final rule is implemented by the federal agencies whose responsibility it is to conduct the environmental reviews mandated by the statute. In addition, given the controversial nature of some of the changes in the final rule, legal challenges to the rule are inevitable. The Congressional Review Act and the potential for a change in administrations and congressional leadership raise additional questions regarding the future of the final rule. Particularly in the transition period until agencies have updated their own NEPA implementation procedures and key legal questions are addressed, project proponents and others whose activities are subject to NEPA review will need to work closely with their permitting agencies to address the NEPA procedures that the agency will follow.
Van Ness Feldman closely monitors and counsels clients on NEPA-related issues. If you would like more information on how these updates may impact your business, please contact Jonathan Simon, Joe Nelson, Molly Lawrence, Tyson Kade, or any member of the firm's Land, Water, and Natural Resources practice in Washington, D.C. at (202) 298-1800 or in Seattle, WA at (206) 623-9372.
1/29/2021 – Hydro Newsletter - Volume 8, Issue 2
1/4/2021 – Hydro Newsletter - Volume 8, Issue 1
11/30/2020 – Hydro Newsletter - Volume 7, Issue 12
9/30/2020 – Hydro Newsletter - Volume 7, Issue 10
8/7/2020 – Updated: CEQ Issues Final Rule to Modernize NEPA Regulations
Alert Authors
Rachael L. Lipinski
Jonathan D. Simon
Tyson C. Kade
Molly A. Lawrence
Joseph B. Nelson

redpajama_set_name: RedPajamaCommonCrawl


Have you ever taken a 'staycation' before? A staycation is a vacation at home and it is really growing in popularity with the economic condition of our country. I would love to share with you great things that can be done in Richmond, Virginia (and surrounding areas) if you ever decide to look for staycation enjoyment or if you have desire to visit our area.
Richmond is a very beautiful city and there are a lot of wonderful things to do in the open area. One of our favorite places to go, when we desire to get up close with nature is Maymont Park, which has over 100 beautiful acres to walk, explore or just relax. We have had picnics here, enjoyed the animals, Italian gardens, Japanese gardens and threw the ball around. Many people flock to this area for painting opportunities, photo sessions and even weddings. Simply gorgeous and free to the public, with donation boxes at the gates. A few other of our favorite places to visit for nature studies is Pony Pastures, Three Lakes Nature Park, Meadows Farm Museum and Canal Walk.
If you enjoy outdoor concerts, you will want to check out the Pocahontas Live concerts. Our family have great memories of listening to the Richmond Symphony, while enjoying our picnic dinner on the lawn. One of our favorite concerts of the summer is on July 4th at Dogwood Dell. It is put on by the Richmond Concert Band, which includes my husband's brother and his family. They play at other locations through the year, as well.
I absolutely love theatre and one of my favorite local places to go is Theatre IV. They are one of the 'splurge' things that I would recommend. In addition to this historical theatre, we also brag of the Bryd Theatre. You can almost feel the history in this theatre, from the aged seats, decor and history of the famous patrons of the past. For only $2 a person, this is a must for any time of the year! Our newly renovated Virginia Museum of Fine Art is also a great place of lover of fine art to visit.
We recently went to Busch Gardens, in Williamsburg, Virginia about 45 minutes east of Richmond, for the first time and I would highly recommend it for a great family day! Their sister park, Water Country, USA is one of my favorite parks to visit, maybe because my husband leaves all the cares of life in the parking lot and easily turns into a kid again or just the way the water makes me feel giddy all over. Then of course, there is Colonial Williamsburg, Jamestown and Yorktown, all in the same area. Just about 30 minutes north of Richmond, is the popular King's Dominon. I hope you enjoy these tips for staycation enjoyment for Richmond, Virginia. Come back tomorrow and I will share with you Staycations Across the United States.


Since MFormats version 1.2.1.8461 you are able to transmit a timecode data with an MWebRTC object by embedding it into the bottom line of each frame.
Once this option is enabled, the MWebRTC object will transform the timecode into binary format, encode into black and white color scheme and append to 4 bottom lines of each frame.
On a web page, you can parse this data and transform back into the timecode.
MFormats SDK: "C:\Program Files (x86)\Medialooks\MFormats SDK\Samples WebRTC\C#\Sample Streamer C#"
"C:\Program Files (x86)\Medialooks\MPlatform SDK\Samples WebRTC\C#\Streamer Sample C#"
1. Get the frame's canvas.
2. Pick 4 bottom lines of the frame.
4. Separate into 34 segments.
5. The first and last pieces are ignored to minimize the distortion.
6. The remaining 32 pieces in a middle will be used to encode the timecode values: hours, minutes, seconds and frames. Each one will have its own 8-segment section.
7. Get the frame timecode.
9. Use 4 8-segment sections to encode hours, minutes, seconds and frames values by color manipulation: black for 0 and white for 1.
10. Transmit frame by WebRTC as usual.
NOTE: The gray grid on the images is displayed for visualization purposes only. MWebRTC object does not paint any grid lines, only Black and White colors for 0 and 1.
After that operation, you can cut 4 bottom lines to keep the picture clear and do not show blinking segments to the customer.


text:
The Surgery
A Henmore Health Brand
Henmore Health | The Surgery | Clifton Road | Ashbourne | Derbyshire, DE6 1RR
Early and Late Surgeries
28 day Prescribing
Patient Transport
Virtual Patient Group Sign Up
Urine Sample Policy
We will no longer accept urine samples that have not been requested by a clinician and have the associated form. This is because if you have symptoms, we really need to know more than just the results of a sample in order to make a safe decision about your treatment.
If you think that you have symptoms which may indicate the possibility of a "water Infection" (UTI) please call the surgery and inform them of your symptoms.
The reception will then arrange for a clinician to assess you that day.
The most common symptoms of a Water Infection (UTI) include:
Pain when passing urine
Increased frequency of urination (going to the toilet more often)
Passing small amounts of urine, but still feeling the need to urinate
Appearance of blood in your urine
Pain below your 'Belly Button' or one sided pain in the mid back region
At your appointment, the clinician will discuss your symptoms with you, examine you and treat any condition diagnosed as appropriate and in line with current national guidance. You may be asked to bring/provide a urine sample but in accordance with current national guidance, not in all cases.
So, if you feel you have symptoms which may suggest a Water Infection (UTI), please call up the surgery first and speak to the receptionist.
DO NOT bring down a urine sample unless you have been asked to by a clinician.
Visit The Surgery's Facebook page for up to date information on Health Matters and news from your GP surgery.
#Appointmentsavailablenextweek
Our campaign to bring routine appointments available next week every week has been successful since its inception. Today The Surgery is one of the most accessible practices in the county.
All patients have a named GP who is responsible for their overall care at the practice. If you would like to know who is your Named GP, please contact the surgery. If you have a preference as to which GP that is, the surgery will make reasonable efforts to accommodate this request.
The named accountable GP will take lead responsibility for the coordination of all services required under the contract and ensure they are delivered to each of their patients where required (based on the clinical judgment). These responsibilities do not change the way you access care outside of our opening hours.
This does not mean that they will be the only GP who provides your care. Patients are free to see any GP or nurse subject to availability. As all patients have electronic medical records, all clinicians in the surgery have the most accurate and up-to-date information and will be able to help you.
Many thanks to all our patients who let us know that they are unable to attend their appointment. Because they did, we were able to offer their appointment to another patient.
Unfortunately, many did not let us know. This will have made it harder for patients to get an appointment before issues became urgent. Please consider the effect that not attending your appointments may have on other patients and the availability of appointments in general.
We really appreciate being told as soon as possible if you cannot attend, as we can reuse your appointment for another patient in need.
We have been made aware that patients are being telephoned by callers claiming to be 'Joint Consultants' to discuss their general health. The caller will name check the GP Practice closest to the persons address, giving them the impression that they are working alongside the NHS. There is no such legitimate consultation currently underway and the callers are only seeking to gain patient medical information. Once they have obtained the information the caller will try to sell alternative medicines to the patient and obtain their payment details.
We would advise patients not to respond to cold callers, and not to give any information/ bank details in response to such calls. The public can register for free with the Telephone Preference Service at www.tpsonline.org.uk or by calling 0845 070 0707, to help reduce such calls.
Innovative Tiered Care Model at The Surgery
At a time of significant pressure placed upon the NHS, GP surgeries across the UK are equally feeling the strain with GP recruitment in crisis and budgets stretched. According to news last week, 3 week waiting lists for a GP appointment is becoming the norm. However at The Surgery on Clifton Road the story is much more positive. They have recently implemented an innovative Tiered Care Model which is transforming patient access, widening services and increasing an already high standard of quality (as published in last year's CQC report).
The clinical team of GPs and nurses has been expanded with Advanced Nurse/Clinical Practitioners and a full time Clinical Pharmacist. These highly skilled roles form the latest component of the 18 month project, and has led to an efficient model of care that provides the right clinician at the appropriate time, when the patient needs them.
'On the day', urgent care is now strongly supported by Victoria Hetherington, an Advanced Nurse Practitioner whose experience includes A and E and urgent out of hours primary care.With a wide scope and prescribing capabilities, she provides a high level of urgent care to patients needing an 'on the day' appointment.
Sunil Kandukuri (an experienced Pharmacist) is employed to undertake Medication and Chronic Disease reviews, manage the repeat prescription system, provide up to date pharmaceutical protocols and news to the team and provide minor ailment clinics alongside Vicky.
Kiri Allen (Nurse Prescriber) is involved in caring for housebound patients and those resident in Ashbourne's care homes, providing continuity and a bespoke care pathway for these patients.
All of this has resulted in The Surgery being able to release GPs, expanding on their available appointments which are now fully bookable online at The Surgery website. Making "Routine appointments available next week" was the mission, and Danny Smart (Business Manager) had this to say about the transition: "Bringing about a transformation on this scale is always challenging for staff and for patients, but I hope that the result is a robust system that has once again made GP access acceptable and to the highest standard".
When asked about the outcome, Rachel Taft (Practice Manager) said "As a team we are immensely proud of what we have achieved. Reducing the GP waiting list to a week and often less is a major accomplishment, particularly at this time of year. The team has always worked hard to provide the highest possible services to patients and it's great to now see that effort pay dividends. I am so pleased that the work we are doing now will result in a wider range of services and an even higher quality of care for our patients. Patients have been reporting to us that they have noticed a significant positive change over the last few months, and this means so much to all of us here".
The Surgery hopes to further expand the clinical team as the project approaches completion, and attract new GPs by proving that The Surgery can offer a good work/life balance for GPs and staff working here. Dr David Ward (GP Partner), who has been at The Surgery for 24 years, says that never before have they been more optimistic moving toward the end of the decade.
In addition, The Surgery now accepts registrations for patients who work in the area but live elsewhere as part of NHS Choices and patients' right to register wherever they please. For more information on this, registering for online booking and any other services The Surgery offers, please contact Debbie Newton, Patient Services Manager.
Health News from the BBC and the NHS
BBC Health
'My sister died after taking a line of cocaine'
Research for the BBC by NHS Digital shows a huge rise in mental and physical illness linked to cocaine.
Rules could be in place within weeks after a study found ex-players are more likely to die of dementia.
The US state was to distribute 100,000 condoms for free as part of an HIV-prevention campaign.
A major study will assess if new - and existing - drugs can help people with motor neurone disease.
Running Stories: 'Epilepsy was a blessing in disguise'
Ellie-May is a runner who stopped partying and lost mates due to epilepsy but running changed that.
A 'fractured' relationship between two doctors is described in hospital board papers.
NHS Choices Behind the Headlines
Symptoms, conditions, medicines, treatments and guides
Find conditions...
Cancer treatment response may be affected by gut bacteria
"Gut bacteria 'boost' cancer therapy," BBC News reports. The news comes from research into whether people...
Could a blood test in middle age predict dementia risk?
"Tissue inflammation blood test points to dementia risk," is the headline in The Times. Researchers in...
Acid reflux drugs linked to increased stomach cancer risk
"A drug commonly used to treat acid reflux is linked to a more than doubled risk of developing stomach...
Nutrient drink for Alzheimer's has disappointing result in trial
A new study investigating the effects of a nutrient drink for Alzheimer's disease has led to very different...
Marriage may help lower dementia risk
"Marriage and having close friends may help protect against dementia, according to Loughborough University...
Afternoon open heart surgery 'leads to fewer complications'
"Afternoon heart surgery has lower risk of complications, study suggests," says The Guardian. Researchers...
Report calls for better mental health support in the workplace
"Up to 300,000 people with long-term mental health problems have to leave their jobs each year, a report...
Blood-thinning drugs may reduce dementia risk in people with irregular heartbeats
"Common blood thinning drugs halve the risk of dementia for patients who have an irregular heartbeat,"...
New genetic variants associated with breast cancer identified
"Do you have one of the 180 breast cancer genes? One in five women has a variant that raises her risk...
Where should I go for help?
Ebola advice
Patient Guide to GP Services
Patient Data - how we use it
Local services and organisations
Bereavement Support Contacts
Patient Recommendations
Useful Contact Numbers
Flu and Shingles
Insurance reports


Dan Deacon's video for "True Thrush" has quite an amazing concept. Make a very short film, show it to someone, and have that person recreate it. Then show that new version to more people and have them try to recreate it. Repeat those last two step over and over. The result is quite amazing. Check it out above.


text:
Château Thivin
It is no surprise that Château Thivin is the benchmark domaine of the Côte de Brouilly; everything about it is exceptional. Built in the fifteenth century on an ancient volcano which juts out steeply into the valley below, Thivin is the oldest estate on Mont Brouilly. Even more important, however, is its tremendous success since farmer Zaccharie Geoffray purchased the château with its two hectares of land at auction in 1877. His son Claude expanded the property over the next few decades, and his son, also named Claude, boosted the prestige of the zone in the face of the Great Depression when he played a pivotal role in the creation of the Côte de Brouilly appellation. With his wife Yvonne, he also helped to bring greater recognition to the entire region with the establishment of the Maison du Beaujolais in 1953. Over the years the family continued to promote the appellation, receiving many influential artists and journalists at the château. The French novelist, Colette, wrote admiringly of her visit to Thivin, for example. In 1976, Richard Olney took Kermit to visit on their first wine trip together. It was Olney's top recommendation in the whole of the Beaujolais region. The current generation of the Geoffray family continues their tradition. Today their grandnephew Claude, his wife Evelyne, and their son Claude-Edouard continue the tradition as staunch and proud defenders of the terroir of the Côte de Brouilly.
Thivin's Côte de Brouilly parcels are predominantly south-facing and are planted entirely with Gamay vines that average 50 years of age. The soil is plowed and composted regularly while cover crops are left between some rows to encourage microbiotic activity. Absolutely no insecticides are used. On a slope with a grade of 48% and crumbly surface, implementing these techniques is essential to safeguard the soil from erosion, but it isn't easy! Each section of the vineyard is harvested and vinified separately to preserve the unique characteristics afforded by variations in exposure and altitude. Even the estate's vineyards in the Brouilly appellation are planted on a moderately steep hillside of decomposed pink granite, while most of the appellation is planted on the flat valley floor. Traditional whole-cluster fermentation keeps the characteristic fruity qualities of Gamay, after which the grapes are transferred to cuves by gravity without being crushed. Each vintage spends a few months in large oak foudres before bottling. The resulting wines, according to Kermit, resemble "…a country squire who is not afraid to get his boots muddy. Handsome, virile, earthy, and an aristocrat."
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Administering Last Rites at Champion Hill
Diary accounts extracted from:
"The Confederacy's Fighting Chaplain: Father John B. Bannon"
By Phillip Thomas Tucker
Father John B. Bannon was born in Ireland in 1829 and was ordained as a priest in 1853. Shortly after his ordination, he was sent to St. Louis, Missouri. Father Bannon was loved not only by his parishioners but also by the city at large which, by 1861, boasted of having the second largest Irish population in the Southern and border states. When the war erupted Father Bannon enlisted as Chaplain in the 1st Missouri Confederate Brigade. A Confederate veteran later described Bannon's actions on the battlefield during the war: "While his mission was one of peace, he became noted for his bravery in the field in attending the wounded and the dying in very exposed places. He was both a pious and practical man, and became a ministering angel wherever broken and bruised humanity needed help and consolation." At the close of the war Bannon returned to Ireland and resumed his priesthood.
Photograph from "The Confederacy's Fighting Chaplain: Father John B. Bannon" by Philip T. Tucker
One of the casualties during the Battle of Champion Hill was a Rebel gunner from Guibor's Battery named Private McGolfe. Suffering from a fatal wound but not yet dead, McGolfe was taken to a barn which had been converted into a field hospital. When Father Bannon went to minister to the dying, he found McGolfe lying on the ground in a foul mood — not so much because he was injured but because a fatally wounded Yankee soldier was lying beside him.
From the Diary of Father John Bannon
Strange to say, he was in his full senses, and kept roaring out, "Take away this Yankee, boy, I can't lie quiet here with this Yankee by me." I went up and spoke to him; he knew my voice, but his sight was gone; and on my mentioning confession to him, "Oh!" said he, "time enough for that. I'm not so bad as that goes to; I shall be right enough again in a day or two." No, McGolfe, I replied, you are dying. Your skull is split open, and your legs and arms are smashed; you cannot live out the day, and you must prepare to meet God's judgment.
McGolfe replied, "Well take away this Yankee: I can't make my confession with this Yankee close to me. He disturbs my mind: take him away!" I said, never mind the Yankee attend to your own soul.
The Yankee, I found, was a poor German, who understood no English: so I induced McGolfe to make his confession at once. I then went to the German and from the few words which I understood, I made out that the poor fellow was a Catholic, and recently enlisted. He was evidently in the best disposition, kissed fervently the crucifix which I held to him, and seemed intensely grateful at meeting with a Catholic Priest. I did therefore all I could for him, and went to see if any other cases wanted help…. [Father Bannon then addressed the surgeon in charge and asked if there were more injured he needed to see.]
Have you any here for me? I asked. "Yes," said the surgeon, pointing to one of the wounded. "I think he must be one of yours, for he is an Irishman." I stooped down to the man and asked if he was a Catholic. He was; and of such a regiment, such a company. He was shot through the bowels, and the bullet had broken his spine. He had not long to live. Why, I asked, I was with your regiment last night but I don't remember you. Were you with me, or how was it? "No, Father," he answered. "I knew you would be coming, and I watched to keep out of your way, for I did not wish to meet you." I remarked, You unfortunate follow! Do you see now how the devil deceives you; and how nearly he had you by the throat. The dying man replied, "Indeed, I was a fool, Father and I am sorry for it with all my heart."
He made a good end, poor fellow, and I was careful to take down his name and the address of his family in Ireland, as I always did in similar cases; for I knew how great a consolation it is to Irish fathers and mothers to hear from a Priest that their child died well. He was the son of a small farmer in Meath and his family had heard nothing of him for several years.
The following day, on May 17, Father Bannon followed the retreating army to Vicksburg and encountered the ambulance wagons carrying the wounded and dying. In one of the wagons lay Pvt. McGolfe who by some miracle was still alive.
Whom have you got in there? I asked. "McGolfe," was the reply. What! Is he still alive? I exclaimed, and rode up to the wagon. "Ah, Father, is that you?" The wretched man had neither hand nor foot that he could use. I was delighted to find him still sensible, for my heart rather misgave me about his treatment of the poor German, and I was apprehensive that his dispositions yesterday were not as good as they might have been. My delight was increased when McGolfe went on to say, "I can't help thinking of that poor Yankee. I behaved like a brute to him. He died last night, but after you left him he never stopped saying his prayers, and he prayed like a good one. He made me think, I can tell you. I'm just sorry for the way I treated him, and if you can give me any more penance for it, do. Now if you'll stop by me, I'd like to make my confession again."
And, he began to accuse himself out loud before all the men about, so that I expostulated with him, and told him to speak lower.
"No," he said, "I have been a bad man, and they all know it. I have given bad example, and I want to do some penance for it" - and he continued his confession at the top of his voice. When he had finished, I consoled him, telling him I should give him no penance, for he had done enough. I then gave him the last absolution, and in an hour he was a corpse.
Phillip Thomas Tucker is United States Air Force Historian, Air Force Flight Test Center, Edwards Air Force Base, California. The book The Confederacy's Fighting Chaplain: Father John B. Bannon, published by The University of Alabama Press, 1992, is available at Amazon.com.
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Home > node > Inspector George Gently, BBC One review - power, corruption and lies in his last-ever case
Inspector George Gently, BBC One review - power, corruption and lies in his last-ever case | reviews, news & interviews
Inspector George Gently, BBC One review - power, corruption and lies in his last-ever case
No more friends in the North East
by Mark SandersonTuesday, 31 October 2017
Towering performance: Martin Shaw as George Gently
And now the end is near… and so Inspector George Gently faces his final case. Deemed too political to be broadcast in its original slot in May – 10 days before the General Election – Gently and the New Age was postponed until 8.30pm last night.
An ignominious time for a crime show that often burst the bonds of genre to create drama of real power. At least, in more ways than one, it went out with a bang.
It is December 1970 and yet the winter of discontent seems to have already begun. A scab – or, as John Bacchus (Lee Ingleby) suggests, "a non-union worker" – is stabbed as he crosses the picket line outside a local factory. In fact, the dead man turns out to have been an undercover journalist investigating the company's secret links with Ted Heath's ruling Tories.
Meanwhile, old warhorse Gently (Martin Shaw) – whose initials are GG – is two weeks from retirement. Having just helped send down a few bent coppers at the Old Bailey, he is asked to investigate the investigation into the murder of a young woman in Washington four years ago. The chief suspect appears to be the local MP Michael Clements (Richard Harrington, pictured right, fresh from Poldark and Hinterland), a Downing Street contender until he was booted out of Harold Wilson's cabinet for protesting against the Vietnam war.
Clements is the cheerleader for a development project known as Marwick Point that will see a new bridge built across the Humber. His catchphrase (echoing George Osborne's Northern Powerhouse) is "Believe in the North!" Unfortunately, his enthusiasm for Europe is only matched by his taste for female company. When Gently gets too close, he offers to tell him who really killed his wife Isabella in a hit-and-run incident that has cast a shadow over the inspector's life ever since. His thirst for knowledge (and revenge) is so great that he grants Clements a week's grace.
Of course it all ended in tears. Gently refused to compromise as more and more details of high-level conspiracy and corruption leaked out. Like one of Conrad's doomed heroes, his duty (to uphold the rule of law; to stand up for common decency) is his reason for living. Without it – and without his wife – he is nothing.
Shaw gave a towering performance that provided a fitting climax to the 24 episodes that comprise Peter Flannery's portrait of 1960s Geordieland. The froideur that had lately developed between him and his sidekick Bacchus was subtly resolved in Robert Murphy's script that highlighted the social aspiration that new towns represented – even if the trees were all the same height. Director Bryn Higgins has a fine eye for the North East's industrial and architectural heritage, and ensured the characters appeared as real people rather than regional stereotypes.
Ingleby (pictured above), who first showed off his talents in Nature Boy (2000), is known for The A Word and Line of Duty today, but he has never been better than in the scenes with Shaw. Like John Thaw and Kevin Whately as Morse and Lewis before them, the pair struck sparks off each other in the 10 years they have been together.
Will the series return as Bacchus? Viewers around the world will hope so, however unlikely. In the meantime the end of Gently provides the perfect excuse, should one be needed, to watch Flannery's magnificent Our Friends in the North (1996) again.
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Q: Can i sell my own software that uses parts of PSEXEC I just have a quick licensing question about PSEXEC by sysinternals.
As some of you may know if you have ever used PSEXEC, it is confusing to learn at first. I have created a program that makes it easier to use, and was wondering if I am allowed to sell that program (even if PSEXEC is included with it?). I looked in the sysinternals license agreement, but couldn't really find the answer to my question.
The agreement is here: http://technet.microsoft.com/en-us/sysinternals/bb469936
The main download and info page for PSEXEC is here: http://technet.microsoft.com/en-us/sysinternals/bb469936
Please let me know if I will be allowed to sell my program.
(I assume i am on the right stackexchange site, but let me know if I should move my question)
Thanks!

A: I am no lawyer, but from the agreement:

You may not:

*

*...

*rent, lease or lend the software;

*transfer the software or this agreement to any third party;

Makes it pretty clear that selling it is a no-go.
Anyways, psexec uses pretty standard API calls to do its work, you'd be better off just reimplementing it, in fact I think they used to have, and still might, a doc explaining just how all the sysinternals tools worked.

redpajama_set_name: RedPajamaStackExchange


Goikoetxea M.J., Beaumont J., González A., López B., Querejeta R., Larman M., Díez J.
To investigate whether cardiac expression of the nuclear peroxisome proliferator-activated receptor alpha (PPARalpha) is altered in patients with hypertensive heart disease (HHD).
We studied endomyocardial septal biopsies from 24 patients with essential hypertension divided into three groups: 6 without left ventricular hypertrophy (LVH) (HT group), 10 with LVH (LVH group), and 8 with LVH and heart failure (HF) (HF group). The expression of two PPARalpha isoforms (the native active and the truncated inhibitory) was analyzed by Western blot and reverse transcription polymerase chain reaction (RT-PCR), and two PPARalpha target genes were evaluated by RT-PCR. Histomorphological features were evaluated in a second myocardial sample from LVH and HF groups.
Whereas the expression of native PPARalpha protein was lower (p<0.05) in LVH and HF groups than in the HT group, truncated PPARalpha protein was overexpressed (p<0.001) in the HF group as compared with LVH and HT groups. The mRNA expression of native and truncated PPARalpha was similar in the three groups of hypertensives. In addition, a progressive decrease (p for trend<0.05) in the two PPARalpha target genes mRNA expression was observed among HT, LVH and HF groups. The amount of truncated PPARalpha protein correlates directly with cardiomyocytes apoptosis and inversely with cardiomyocytes density in patients with HHD. In addition, the expression of truncated PPARalpha protein was directly correlated with left ventricular volumes, and inversely with ejection fraction in all hypertensives.
These findings suggest that post-transcriptional regulation of PPARalpha isoforms is altered in patients with HHD, namely in those developing HF. An excess of the truncated inhibitory isoform may be involved in hypertensive left ventricular failure and remodeling.


With cyber attacks on the rise, NATO has decided to heavily invest in its defense capabilities. In July, Secretary General Jens Stoltenberg said the alliance had serious concerns about the latest developments in the cyber domain.
"NATO has decided, and we are now implementing, a strong reinforcement and strengthening of our cyberdefenses," he said during a visit to Ukraine last month.
The statement followed a reminder that a major cyber attack against one NATO member can trigger Article 5, the alliance's collective defense principle.
Despite growing concerns about cyber threats, the alliance's latest official update on the rules of engagement in case of a cyber attack was issued in 2014. It did not provide any specifics and mentioned that a decision on when Article 5 should be invoked would be taken on a case-by-case basis.
Michael Brady, Citadel Fellow of Intelligence and Security Studies, told Grasswire that NATO's cyber strategy is still in its infancy and will not reach maturation for many years.
He said there is a limited number of scenarios that could put the alliance's principle of common defense in motion.
Nazli Choucri, Professor of Political Science at MIT, told Grasswire that a plausible scenario for a cyber attack that invokes Article 5 includes massive damage and a known source that admits being the initiator of the damage.
"But this is an extreme and rather unlikely case," she noted.
Brady, who served as the director of Presidential Emergency Operations Center in the White House under President George W. Bush, explained that during a large-scale cyber offensive, a hostile nation-state would seek to target satellites, electrical grid, nuclear power plants, water treatment and air traffic control facilities.
"There are other cyber offensive operations including propaganda, fake media, social media manipulation, stock market manipulation and other similar operations that would not likely result in Article 5 for various reasons," he said, noting that those actions are considered criminal activities.
At present, the world is witnessing a fundamental change and transformation in the character of war, U.S. Cyber Command head Lt. Gen. Paul Nakasone said on Tuesday.
"We should anticipate cyber attacks, not only cyber attacks in an area of conflict but against the homeland, certainly against our critical infrastructure and key resources," he said at the TechNet Augusta forum.
Nakasone suggested that Ukraine is currently serving as a testing ground for cyber warfare.
It is "a virtual training center, some might call it, for a well-resourced cyber actor," he said.