On October 26, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported an interim communication on the nine months ended 30 September 2017 that presents all material developments with a focus on Q3 2017 and provides the Company’s current outlook (Press release, 4SC, OCT 26, 2017, View Source [SID1234521182]). The full communication is available for download on 4SC’s website.
Jason Loveridge, Ph.D., CEO of 4SC, commented:

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"With the conclusion of a successful capital increase generating gross proceeds of ca. EUR 41 million we are now well positioned to reach our stated goals over the next few years: to create significant value for our shareholders by executing on accelerated routes to market for our core cancer products resminostat, 4SC-202 and 4SC-208.

We will continue to enroll patients in our pivotal RESMAIN study of resminostat in cutaneous T-cell lymphoma (CTCL) and are looking forward to the initiation of a Phase II study of resminostat in patients with biliary tract cancer by our Japanese development partner Yakult Honsha Co., Ltd. (Yakult Honsha).

After opening the first clinical center within our SENSITIZE study of 4SC-202 in combination with a checkpoint inhibitor in melanoma patients in Q3 2017, we are anticipating to enroll the first patient in Q4 2017. Furthermore, we are expecting the investigator-initiated Phase II EMERGE study of 4SC-202 in combination with another checkpoint inhibitor in patients with microsatellite-stable gastrointestinal tumors to be initiated in Q1 2018.

Formal preclinical testing of 4SC-208 in order to initiate Phase I clinical evaluation is ongoing according to plan.

Finally, we aim to continue to enhance the value of 4SC and to add to our funds through signing deals with the right industry partners to pursue further development of our non-core assets as we did with the Kv1.3 inhibitors which we recently licensed to Maruho Co., Ltd. (Maruho)."

Key highlights of Q3 2017 and beyond

Ca. EUR 41 million secured from successful capital increase; proceeds forecast to be sufficient to finance 4SC’s accelerated development strategy into 2020
Patient enrollment and opening of study centers well on track for the ongoing pivotal RESMAIN study, which examines the potential of resminostat as maintenance therapy in patients with advanced CTCL
Preclinical data presented on resminostat’s potential to significantly alleviate itching in CTCL patients – one of the major disease burdens
Promising results of a Phase I study of resminostat in combination with S-1 chemotherapy in Japanese patients with biliary tract or pancreatic cancer presented by Yakult Honsha, 4SC’s development partner for resminostat in Japan
Phase Ib/II study SENSITIZE of 4SC-202 in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab (Keytruda(R), Merck) in patients with advanced-stage melanoma initiated with the opening of the first study centers
US composition of matter patent secured for structurally related compounds including 4SC-208; preclinical testing ongoing
Preclinical inhibitors of the Kv1.3 ion channel out-licensed to Maruho in return for up to EUR 208 million in upfront, development and commercial milestones plus single-digit royalties
Business outlook

Continue patient enrollment in the pivotal RESMAIN study of resminostat in CTCL
Yakult Honsha to initiate Phase II study of resminostat in Japanese patients with biliary tract cancer
Enroll patients in the Phase Ib/II study SENSITIZE of 4SC-202 in melanoma
Initiate Phase II investigator-initiated study EMERGE of 4SC-202 in patients with microsatellite-stable gastrointestinal tumors
Continue preclinical testing of 4SC-208 to initiate a Phase I clinical study immediately thereafter
Pursue further licensing deals for non-core assets and continue evaluating potential partnering opportunities with pharmaceutical and biotech companies to progress the clinical development of 4SC’s core pipeline assets
Development of cash balance in Q3 2017 and financial forecast

As of 30 September 2017, 4SC holds cash balance/funds of EUR 43,353 thousand as compared to EUR 4,638 thousand as of 30 June 2017. The increase results from a successful cash capital increase in July with gross proceeds of ca. EUR 41 million. The monthly use of cash from operations was within the range forecasted for 2017 amounting to EUR 739 thousand on average in the first nine months of 2017 (9M 2016 EUR 857 thousand). The decrease in 2017 was mainly driven by the upfront payment from the licensing agreement with Maruho offset by an increase in expenses for the preparation of the Phase Ib/II clinical study SENSITIZE of 4SC-202. The Management Board of 4SC confirms that the proceeds of the capital raise will finance 4SC’s stated goals into 2020.

Conference Call

4SC will not hold a telephone conference along with today’s Q3 2017 Interim Communication. According to 4SC’s policy, the Company will only hold conference calls when there is significant or material newsflow.

Further information

About resminostat

Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body’s immune response to cancer.

Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a Phase II pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC. A Phase II study in biliary tract cancer is planned by 4SC’s development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

About 4SC-202

4SC-202 is an orally administered small molecule with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response, open the tumor microenvironment and encourage infiltration of immune cells into the tumor.

4SC-202 has been investigated in a Phase I study with 24 mostly heavily pretreated patients with several types of highly advanced hematologic cancers, and was proven to be tolerated. Positive signs of anti-tumor efficacy were observed with one complete remission for 28 months and one partial responder for 8 months.

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating 4SC-202’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of 4SC-202 in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of 4SC-202 in combination with the anti-PD-L1 checkpoint inhibitor avelumab, which will be conducted by an academic partner in gastrointestinal cancers, is expected to start soon.

As soon as results from the aforementioned trials will be available, 4SC plans to advance 4SC-202 into a pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel cell carcinoma (MCC).

About 4SC-208

Data from several preclinical in vivo models has established the efficacy of 4SC-208 in inhibiting the Hedgehog/GLI signaling. Inhibition of this signaling pathway has emerged as a highly effective strategy in obstructing the tumorigenic capacity of cancer stem cells, as well as tumor development, proliferation and survival.

Available inhibitors of Hedgehog signaling target the pathway upstream of the transcription factor GLI, whereas 4SC-208 inhibits at the level of GLI and is thus potentially able to avoid the tumor recurrence and relapse observed in response to currently available inhibitors.

4SC believes that 4SC-208 is a promising drug candidate and expects to complete formal preclinical testing in 2018 and to enter into a Phase I/II clinical study immediately thereafter. Cancer indications that are particularly promising are those where resistance to therapies targeting the Hedgehog/GLI pathway are emerging, such as in basal cell carcinoma.

Den 26 oktober 2017 rapporterade Xspray Pharma att de har fått godkännande för två sökta patent i USA (Press release, Xspray, OCT 26, 2017, View Source [SID1234523286]). Patentet omfattar komposition avseende produktkandidaterna HyNap-Sora och HyNap-Nilo. Det är Xsprays andra och tredje produktpatent som godkänns på huvudmarknaden i USA på kort tid. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och USA avseende HyNap-Dasa och har pågående ansökningsärenden för flera motsvarande patent i bland annat Japan och Europa.
"Nu har vi patent beviljade i USA som täcker de tre produkter vi avser att introducera på den amerikanska marknaden efter respektive original-substanspatent har löpt ut (under perioden 2020-2023). Vi har arbetar systematiskt och strategiskt med våra innovationer både för att förverkliga dem till produkter men också genom att säkra värdet med ett fullgott patentskydd. Jag ser det här som en bekräftelse på det arbetet," säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för två patent i USA avseende produktkandidaterna HyNap-Sora och HyNap-Nilo som är tänkta för behandling av vissa cancerformer. Det är Xsprays andra och tredje produktpatent som godkänns på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Med dessa patent, och de positiva resultaten från vår kliniska studie som vi nyligen offentliggjorde, har vi tagit viktiga steg mot målet att utveckla våra tre första produkter för lansering på den amerikanska marknaden," kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

Den 26 oktober 2017 rapporterade Xspray Pharma att de har fått godkännande för två sökta patent i USA (Press release, Xspray, OCT 26, 2017, View Source [SID1234523286]). Patentet omfattar komposition avseende produktkandidaterna HyNap-Sora och HyNap-Nilo. Det är Xsprays andra och tredje produktpatent som godkänns på huvudmarknaden i USA på kort tid. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och USA avseende HyNap-Dasa och har pågående ansökningsärenden för flera motsvarande patent i bland annat Japan och Europa.
"Nu har vi patent beviljade i USA som täcker de tre produkter vi avser att introducera på den amerikanska marknaden efter respektive original-substanspatent har löpt ut (under perioden 2020-2023). Vi har arbetar systematiskt och strategiskt med våra innovationer både för att förverkliga dem till produkter men också genom att säkra värdet med ett fullgott patentskydd. Jag ser det här som en bekräftelse på det arbetet," säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för två patent i USA avseende produktkandidaterna HyNap-Sora och HyNap-Nilo som är tänkta för behandling av vissa cancerformer. Det är Xsprays andra och tredje produktpatent som godkänns på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Med dessa patent, och de positiva resultaten från vår kliniska studie som vi nyligen offentliggjorde, har vi tagit viktiga steg mot målet att utveckla våra tre första produkter för lansering på den amerikanska marknaden," kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

On October 26, 2017 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that Dr. Monica Mita of Cedars-Sinai Medical Center and Principal Investigator of the RGX-104-001 study, will present at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Rgenix, OCT 26, 2017, View Source [SID1234523090]). The conference is scheduled to take place from Thursday, October 26 to Monday, October 30 in Philadelphia.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The details of Rgenix’s presentation are as follows:

Event: AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper): Discovery, Biology, and Clinical Applications

Date: October 29, 2017

Time: 12:30 P.M. – 4:00 P.M. EST

Description: Poster B001, "A phase 1 trial of RGX-104, a first-in-class immunotherapy targeting the liver-X nuclear hormone receptor (LXR), in patients with refractory malignancies"

Location: Hall E, Pennsylvania Convention Center, 1101 Arch St, Philadelphia, PA 19107

Dr. Mita will present data from the Phase 1 trial of RGX-104, a first-in-class investigational immunotherapy.

About RGX-104

RGX-104 is a potent small molecule agonist of the Liver X Receptor (LXR). Activation of the LXR-ApoE pathway by RGX-104 stimulates the innate immune response in cancer via depletion of myeloid-derived suppressor cells and activation of dendritic cells, leading to stimulation of T cells and anti-tumor immunity in tumor models. LXR activation also blocks the ability of tumors to recruit blood vessels. These combined effects result in suppression of tumor growth and metastasis in a broad array of pre-clinical models. The LXR-ApoE pathway was originally identified as a cancer target using a novel microRNA-based discovery platform developed by Rgenix’s scientific co-founders at The Rockefeller University.

Rgenix is conducting a Phase 1a/b clinical trial of RGX-104 in patients with advanced solid malignancies and lymphoma—for more information about the clinical trial, please visit: View Source

On October 26, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the third quarter ended September 30, 2017 (Press release, Gilead Sciences, OCT 26, 2017, View Source [SID1234521213]).

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The financial results that follow represent a year-over-year comparison of the third quarter 2017 to the third quarter 2016. Total revenues were $6.5 billion in 2017 compared to $7.5 billion in 2016. Net income was $2.7 billion or $2.06 per diluted share in 2017 compared to $3.3 billion or $2.49 per diluted share in 2016. Non-GAAP net income, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, was $3.0 billion or $2.27 per diluted share in 2017 compared to $3.7 billion or $2.75 per diluted share in 2016.

Three Months Ended Nine Months Ended
September 30, September 30,
(In millions, except per share amounts) 2017 2016 2017 2016
Product sales $ 6,402 $ 7,405 $ 19,825 $ 22,737
Royalty, contract and other revenues 110 95 333 333
Total revenues $ 6,512 $ 7,500 $ 20,158 $ 23,070

Net income attributable to Gilead $ 2,718 $ 3,330 $ 8,493 $ 10,393
Non-GAAP net income* $ 2,990 $ 3,677 $ 9,311 $ 12,128

Diluted earnings per share $ 2.06 $ 2.49 $ 6.44 $ 7.59
Non-GAAP diluted earnings per share*
$ 2.27 $ 2.75 $ 7.06 $ 8.87
* Non-GAAP net income and non-GAAP diluted earnings per share exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

Product Sales

Total product sales for the third quarter of 2017 were $6.4 billion compared to $7.4 billion for the same period in 2016. Product sales for the third quarter of 2017 were $4.5 billion in the United States, $1.2 billion in Europe and $663 million in other locations. Product sales for the third quarter of 2016 were $5.1 billion in the United States, $1.4 billion in Europe and $931 million in other locations.

Antiviral Product Sales

Antiviral product sales, which include sales of our HIV, chronic hepatitis B (HBV) and chronic hepatitis C (HCV) products, were $5.8 billion for the third quarter of 2017 compared to $6.8 billion for the same period in 2016.

HIV and HBV product sales were $3.6 billion compared to $3.5 billion for the same period in 2016. The increase was primarily due to the continued uptake of our tenofovir alafenamide (TAF) based products, Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg).
HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg), Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) and Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg), were $2.2 billion compared to $3.3 billion for the same period in 2016. The decline was due to lower sales of Harvoni and Sovaldi across all major markets, partially offset by sales of Epclusa, which was approved in the United States and Europe in June and July 2016, respectively, and sales of Vosevi, which was approved in the United States and Europe in July 2017.
Other Product Sales

Other product sales, which include Letairis (ambrisentan), Ranexa (ranolazine) and AmBisome (amphotericin B liposome for injection), were $559 million for the third quarter of 2017 compared to $564 million for the same period in 2016.

Operating Expenses

Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2017 2016 2017 2016
Research and development expenses (R&D) $ 789 $ 1,141 $ 2,584 $ 3,890
Non-GAAP R&D expenses* $ 745 $ 981 $ 2,446 $ 2,790

Selling, general and administrative expenses (SG&A) $ 879 $ 831 $ 2,626 $ 2,406
Non-GAAP SG&A expenses* $ 806 $ 780 $ 2,440 $ 2,256
* Non-GAAP R&D and SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

During the third quarter of 2017, compared to the same period in 2016:

R&D expenses decreased primarily due to the 2016 impacts of a $200 million milestone expense associated with Nimbus Apollo, Inc. (Nimbus) and a $117 million impairment charge related to in-process R&D.
Non-GAAP R&D expenses* decreased primarily due to the 2016 impact of a $200 million milestone expense associated with Nimbus.
Cash, Cash Equivalents and Marketable Securities

As of September 30, 2017, Gilead had $41.4 billion of cash, cash equivalents and marketable securities compared to $36.6 billion as of June 30, 2017. This increase was primarily due to the issuance of $3.0 billion aggregate principal amount of senior unsecured notes in September 2017 to partially fund the purchase of Kite Pharma, Inc. (Kite). The acquisition was completed in October 2017. Cash flow from operating activities was $2.7 billion for the quarter. During the third quarter of 2017, Gilead paid cash dividends of $682 million and utilized $153 million on stock repurchases.

Revised Full Year 2017 Guidance

Gilead revises its full year 2017 guidance, initially provided on February 7, 2017 and revised on July 26, 2017:

(In millions, except percentages and per share amounts) Initially Provided
February 7, 2017
Reiterated
May 2, 2017
Updated
July 26, 2017
Updated
October 26, 2017
Net Product Sales $22,500 – $24,500 $24,000 – $25,500 $24,500 – $25,500
Non-HCV Product Sales $15,000 – $15,500 $15,500 – $16,000 $16,000 – $16,500
HCV Product Sales $7,500 – $9,000 $8,500 – $9,500 $8,500 – $9,000
Non-GAAP*
Product Gross Margin 86% – 88% 86% – 88% 86% – 87%
R&D Expenses $3,100 – $3,400 $3,200 – $3,400 $3,300 – $3,400
SG&A Expenses $3,100 – $3,400 $3,200 – $3,400 $3,300 – $3,400
Effective Tax Rate 25.0% – 28.0% 25.0% – 28.0% 25.0% – 27.0%
Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-based Compensation and Other Expenses $0.84 – $0.91 $0.86 – $0.93 $1.02 – $1.17

* Non-GAAP Product Gross Margin, R&D and SG&A expenses and effective tax rate exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP full year 2017 guidance is provided in the tables on page 9.

Corporate Highlights

In August, Gilead and Kite announced that the companies had signed a definitive agreement under which Gilead would acquire all of Kite’s outstanding shares of common stock for $180 per share in cash. The acquisition was completed in early October 2017 for approximately $11.2 billion, excluding $0.7 billion relating to the portion of stock-based compensation attributable to the post combination period.
Product and Pipeline Updates announced by Gilead during the Third Quarter of 2017 include:

Antiviral and Liver Diseases Programs

Announced that the China Food and Drug Administration has approved Sovaldi for the treatment of HCV infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
Announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Gilead’s new drug application (NDA) for an investigational, fixed-dose combination of bictegravir (50 mg) (BIC), an integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a priority review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act of February 12, 2018.
Announced that FDA has approved expanded labeling for Epclusa, the first all-oral, pan-genotypic, once-daily single-tablet regimen for the treatment of adults with HCV infection, to include use in patients co-infected with HIV.
Announced that the European Commission and FDA approved Vosevi, a once-daily single-tablet regimen for the treatment of HCV infection in adults with genotypes 1-6. Vosevi is the first and only single-tablet regimen for patients who have previously failed therapy with direct-acting antiviral (DAA) treatments and is the latest regimen in Gilead’s portfolio of sofosbuvir-based HCV DAA treatments.
Announced detailed 48-week results from two Phase 3 studies evaluating the efficacy and safety of BIC/FTC/TAF for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50 mg). The data was presented in two late-breaker sessions at the 9th International AIDS Conference in Paris. In addition, our marketing authorization application for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency.
Non-GAAP Financial Information

The information presented in this document has been prepared by Gilead in accordance with U.S. generally accepted accounting principles (GAAP), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7, 8 and 9.

Conference Call

At 4:30 p.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss results from its third quarter 2017 and a general business update. To access the webcast live via the internet, please connect to the company’s website at www.gilead.com/investors 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) and dial the conference ID 89229005 to access the call.

A replay of the webcast will be archived on the company’s website for one year, and a phone replay will be available approximately two hours following the call through October 28, 2017. To access the phone replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international) and dial the conference ID 89229005.