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Incyte Reports 2017 Third-Quarter Financial Results and Updates on Key Clinical Programs

On October 31, 2017 Incyte Corporation (Nasdaq: INCY) reported 2017 third-quarter financial results, highlighting 38 percent year-on-year growth in product-related revenue, driven by increased sales of Jakafi (ruxolitinib) in the U.S. and Iclusig (ponatinib) in Europe, and royalties from ex-U.S. sales of Jakavi (ruxolitinib) by Novartis and Olumiant (baricitinib) by Lilly (Press release, Incyte, OCT 31, 2017, View Source [SID1234521336]).

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"We exit the third quarter of 2017 with excellent momentum across the whole business," stated Hervé Hoppenot, Incyte’s Chief Executive Officer. "Jakafi and Iclusig continue to outperform our expectations, and we are now evaluating ten different indications across our five late-stage development candidates. We are also on track to initiate the next wave of pivotal trials planned for the epacadostat development program. We are striving to build Incyte into a world-class biopharmaceutical company, and we are very pleased to report another quarter of significant progress towards that goal."

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Portfolio Update
Cancer – Targeted Therapies
The REACH1 pivotal trial studying ruxolitinib in patients with steroid-refractory acute graft-versus-host disease (GVHD) is on track to deliver results in the first half of 2018. If successful, Incyte anticipates submitting an sNDA seeking accelerated approval of ruxolitinib in this indication during 2018. Three additional pivotal trials are evaluating the role of JAK inhibition in GVHD (REACH2 and REACH3 with ruxolitinib, and GRAVITAS-301 with itacitinib).
The FIGHT and CITADEL programs evaluating INCB54828 (FGFR1/2/3) and INCB50465 (PI3Kδ), respectively, now include multiple different indications in potentially-pivotal trials.

Indication

Status Update
Ruxolitinib (JAK1/JAK2)
Steroid-refractory acute GVHD Pivotal Phase 2 (REACH1) and Phase 3 (REACH2)
Ruxolitinib (JAK1/JAK2)
Steroid-refractory chronic GVHD Phase 3 (REACH3)
Ruxolitinib (JAK1/JAK2)
Essential thrombocythemia Pivotal Phase 2 (RESET-272) open for enrollment
Itacitinib (JAK1)
Treatment-naïve acute GVHD Phase 3 (GRAVITAS-301)
Itacitinib (JAK1)
Non-small cell lung cancer Phase 1/2 in combination with osimertinib (EGFR)
INCB52793 (JAK1)
Advanced malignancies Phase 1/2 dose-escalation
INCB50465 (PI3Kδ)
Diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma Phase II (CITADEL-202 initiated; CITADEL-203, CITADEL-204, CITADEL-205 all open for enrollment)
INCB54828 (FGFR1/2/3)
Bladder cancer, cholangiocarcinoma; 8p11 MPNs
Phase 2 (FIGHT-201, FIGHT-202, FIGHT-203)
INCB57643 (BRD)
Advanced malignancies Phase 1/2 dose-escalation
INCB53914 (PIM)
Advanced malignancies Phase 1/2 dose-escalation
INCB59872 (LSD1)
Acute myeloid leukemia, small cell lung cancer Phase 1/2 dose-escalation
INCB62079 (FGFR4)
Hepatocellular carcinoma Phase 1/2 dose-escalation

Cancer – Immune Therapies
The pivotal Phase 3 ECHO-301 trial of epacadostat plus pembrolizumab in patients with unresectable or metastatic melanoma is now fully-recruited and data are expected in the first half of 2018.
In collaboration with Merck and Bristol-Myers Squibb, preparations for the next wave of eight pivotal Phase 3 trials of epacadostat plus PD-1 antagonists continue as planned. Initiation of these trials are expected before the end of 2017.

In October, Incyte and AstraZeneca announced an expanded clinical trial collaboration and the companies intend to initiate a Phase 3 trial of epacadostat in combination with AstraZeneca’s PD-L1 antagonist durvalumab in patients with Stage III non-small cell lung cancer.
In October, Incyte and MacroGenics announced an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits PD-1. Under this agreement, Incyte will obtain exclusive worldwide rights for the development and commercialization of MGA012 in all indications.

Indication

Status Update
Epacadostat (IDO1)
Unresectable or metastatic melanoma Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1)
Epacadostat (IDO1)
NSCLC, renal, bladder and head & neck cancer Phase 3 in combination with pembrolizumab (PD-1) expected to begin in 2017
Epacadostat (IDO1)
NSCLC, head & neck cancer Phase 3 in combination with nivolumab (PD-1) expected to begin in 2017
Epacadostat (IDO1)
NSCLC Phase 3 in combination with durvalumab (PD-L1) expected to begin in H1 2018
Epacadostat (IDO1)
Multiple tumor types Phase 2 (ECHO-202) expansion cohorts in combination with pembrolizumab (PD-1)
Epacadostat (IDO1)
Multiple tumor types Phase 2 (ECHO-204) expansion cohorts in combination with nivolumab (PD-1)
Epacadostat (IDO1)
Multiple tumor types Phase 2 (ECHO-203) expansion cohorts in combination with durvalumab (PD-L1)
INCB01158 (ARG)1
Solid tumors Phase 1/2
INCSHR1210 (PD-1)2
Solid tumors Phase 1/2; enrollment halted
INCAGN1876 (GITR)3
Solid tumors Phase 1/2
INCAGN1949 (OX40)3
Solid tumors Phase 1/2
PD-1 platform study
Solid tumors Phase 1/2, pembrolizumab (PD-1) in combination with itacitinib (JAK1) or INCB50465 (PI3Kδ)
JAK1 platform study
Solid tumors Phase 1/2, itacitinib (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ)

Notes:
1) INCB01158 co-developed with Calithera
2) INCSHR1210 licensed from Hengrui
3) INCAGN1876 & INCAGN1949 from discovery alliance with Agenus

Non-oncology

Indication

Status Update
Topical ruxolitinib (JAK1/JAK2)
Atopic dermatitis, vitiligo Phase 2

Partnered
In August, Lilly and Incyte announced that Lilly plans to resubmit the New Drug Application (NDA) for baricitinib to the U.S. Food & Drug Administration (FDA) before the end of January 2018. The companies anticipate the FDA will classify the application as a Class II resubmission, which would start a new six-month review cycle.
In September, Lilly and Incyte announced that baricitinib met the primary endpoint in a Phase 2 study in patients with moderate-to-severe atopic dermatitis.
Novartis has stated that it anticipates submitting an NDA for capmatinib, a potent and selective c-MET inhibitor licensed from Incyte, in 2018.

Indication

Status Update
Baricitinib (JAK1/JAK2)1
Rheumatoid arthritis Approved in Europe and Japan; CRL issued by FDA
Baricitinib (JAK1/JAK2)1
Psoriatic arthritis Lilly expects the Phase 3 program to begin in 2018
Baricitinib (JAK1/JAK2)1
Atopic dermatitis Lilly expects the Phase 3 program to begin in late 2017
Baricitinib (JAK1/JAK2)1
Systemic lupus erythematosus Phase 2
Capmatinib (c-MET)2
Non-small cell lung cancer, liver cancer Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation

Notes:
1) Baricitinib licensed to Lilly
2) Capmatinib licensed to Novartis

2017 Third-Quarter Financial Results
Revenues For the quarter ended September 30, 2017, net product revenues of Jakafi were $304 million as compared to $224 million for the same period in 2016, representing 36 percent growth. For the nine months ended September 30, 2017, net product revenues of Jakafi were $831 million as compared to $615 million for the same period in 2016, representing 35 percent growth. For the quarter ended September 30, 2017, net product revenues of Iclusig were $18 million as compared to $13 million for the same period in 2016, representing 42 percent growth. For the nine months ended September 30, 2017, net product revenues of Iclusig were $47 million as compared to $17 million for the same period in 20161.

For the quarter and nine months ended September 30, 2017, product royalties from sales of Jakavi, which has been out-licensed to Novartis outside of the United States, were $41 million and $104 million, respectively, as compared to $30 million and $77 million for the same periods in 2016. For the quarter and nine months ended September 30, 2017, product royalties from sales of Olumiant outside of the United States received from Lilly were $3 million, and $4 million, respectively.

For the quarter and nine months ended September 30, 2017, contract revenues were $15 million and $105 million, respectively, as compared to $3 million and $70 million for the same periods in 2016. The contract revenues in 2017 relate to milestone payments earned.

For the quarter ended September 30, 2017, total revenues were $382 million as compared to $269 million for the same period in 2016. For the nine months ended September 30, 2017, total revenues were $1.1 billion as compared to $779 million for the same period in 2016.
1 In June 2016, Incyte obtained an exclusive license from ARIAD to develop and commercialize Iclusig in Europe and other select ex-U.S. countries.

Year Over Year Revenue Growth
(in thousands, unaudited)

Three Months Ended Nine Months Ended
September 30, % September 30, %
2017 2016 Change 2017 2016 Change
Revenues:
Jakafi net product revenues $ 303,929 $ 223,892
36%

$ 831,044 $ 615,285
35%

Iclusig net product revenues
18,100 12,731
42%

47,459 16,721 -
Product royalty revenues 44,487 29,626
50%

108,477 77,486
40%

Product-related revenues 366,516 266,249
38%

986,980 709,492
39%

Contract revenues 15,000 3,214 - 105,000 69,643 -
Other revenues
18 6 - 80 86 -
Total revenues $ 381,534 $ 269,469
42%

$ 1,092,060 $ 779,221
40%

Research and development expenses Research and development expenses for the quarter and nine months ended September 30, 2017 were $270 million and $879 million, respectively, as compared to $143 million and $420 million for the same periods in 2016. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio as well as upfront and milestone expenses of $209 million related to our collaboration and license agreements with Agenus, Calithera and Merus. Included in research and development expenses for the quarter and nine months ended September 30, 2017 were non-cash expenses related to equity awards to our employees of $23 million and $68 million, respectively.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and nine months ended September 30, 2017 were $91 million and $269 million, respectively, as compared to $76 million and $207 million for the same periods in 2016. Increased selling, general and administrative expenses were driven primarily by additional costs related to the commercialization of Jakafi and the geographic expansion in Europe. Included in selling, general and administrative expenses for the quarter and nine months ended September 30, 2017 were non-cash expenses related to equity awards to our employees of $12 million and $31 million, respectively.

Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration for the quarter and nine months ended September 30, 2017 was a benefit of $16 million and $2 million, respectively, as compared to expense of $8 million and $10 million for the same periods in 2016. The change in fair value of acquisition-related contingent consideration represents the fair market value adjustments of the Company’s contingent liability related to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
Unrealized gain (loss) on long term investments Unrealized gain on long term investments for the quarter ended September 30, 2017 was $23 million as compared to $24 million for the same period in 2016. The unrealized loss on long term investments for the nine months ended September 30, 2017 was $2 million as compared to an unrealized gain of $20 million for the same period in 2016. The unrealized gain or loss on long term investments for the quarter and nine months ended September 30, 2017 represents the fair market value adjustments of the Company’s investments in Agenus and Merus.

Expense related to senior note conversions Expense related to senior note conversions for the nine months ended September 30, 2017 was $55 million related to the conversions of certain of our 2018 and 2020 convertible senior notes.

Net income (loss) Net income for the quarter ended September 30, 2017 was $36 million, or $0.17 per basic and diluted share, as compared to net income of $37 million, or $0.20 per basic and $0.19 per diluted share for the same period in 2016. Net loss for the nine months ended September 30, 2017 was $164 million, or $0.81 per basic and diluted share, as compared to net income of $95 million, or $0.51 per basic and $0.49 per diluted share for the same period in 2016.

Cash, cash equivalents and marketable securities position As of September 30, 2017, cash, cash equivalents and marketable securities totaled $1.3 billion as compared to $809 million as of December 31, 2016. The increase in cash, cash equivalents and marketable securities from December 31, 2016 to September 30, 2017 is primarily due to the recent public offering of 4,945,000 shares of our common stock resulting in net proceeds of $649 million.
2017 Financial Guidance

The Company has updated its full year 2017 financial guidance, as detailed below.

Current

Previous
Jakafi net product revenues $1,125-$1,135 million $1,090-$1,120 million
Iclusig net product revenues $60-$65 million Unchanged
Research and development expenses* $1,250-$1,300 million $1,050-$1,150 million
Selling, general and administrative expenses $340-$360 million Unchanged
Change in fair value of acquisition-related contingent consideration $5-$7 million $30-$35 million

* Includes upfront and milestone expenses of $359 million related to the amended Agenus collaboration, and the Merus, Calithera, and MacroGenics collaborations

Conference Call and Webcast Information

Incyte will hold its 2017 third-quarter financial results conference call and webcast this morning at 10:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13672268.
If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13672268.
The conference call will also be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations".

Dr. Reddy’s Q2 and H1 FY18 Financial Results

On October 31, 2017 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY) reported its consolidated financial results for the second quarter and half year ended September 30, 2017 under International Financial Reporting Standards (IFRS) (Press release, Dr Reddy’s, OCT 30, 2017, View Source [SID1234521341]).

Q2 FY18: Key Highlights

Revenues at Rs. 35.5 billion [QoQ growth: 7%; YoY decline: 1%]
Gross Profit Margin at 53.3% [Q1 FY18: 51.6%; Q2FY 17: 56.0%]
Research & Development (R&D) spend at Rs. 4.2 billion. [11.8% of Revenues]
Selling, general & administrative (SG&A) expenses at Rs. 11.0 billion [YoY decrease: 6%]
EBITDA at Rs. 6.9 billion [19.4% of Revenues]
Profit after tax at Rs. 2.8 billion [8.0% of Revenues]
H1 FY18: Key Highlights

Revenues at Rs. 68.6 billion [YoY growth: 1%]
Gross Profit Margin at 52.5% [H1 FY17: 56.1%]
Research & Development (R&D) spend at Rs. 9.3 billion. [13.5% of Revenues]
Selling, general & administrative (SG&A) expenses at Rs. 22.8 billion [YoY decrease: 5%]
EBITDA at Rs. 10.2 billion [14.9% of Revenues]
Profit after tax at Rs. 3.4 billion [5.0% of Revenues]
Commenting on the results, CEO and Co-chairman, G.V. Prasad said, "Healthy performances in India, Emerging Markets, Europe and PSAI businesses, as well as continued focus on cost control, have contributed to sequential growth in our topline as well as bottom line, with an EBITDA increase of 105% over the previous quarter.

Looking ahead, we expect to see results from products launched in the U.S. during the first half of this fiscal. We will continue to focus on the launching of new products, as well as on improving operational efficiencies and quality management systems across the company."

All amounts in millions, except EPS
All US dollar amounts based on convenience translation rate of I USD = Rs. 65.30

Dr. Reddy’s Laboratories Limited and Subsidiaries
Consolidated Income Statement

Particulars Q2 FY 18 Q2 FY 17 Growth %
($) (Rs.) % ($) (Rs.) %
Revenues 543 35,460 100.0 549 35,857 100.0 (1 )
Cost of revenues 254 16,559 46.7 241 15,760 44.0 5
Gross profit 289 18,901 53.3 308 20,097 56.0 (6 )
Operating Expenses
Selling, general & administrative expenses 169 11,032 31.1 180 11,774 32.8 (6 )
Research and development expenses 64 4,175 11.8 80 5,214 14.5 (20 )
Other operating expense / (income) (2 ) (114 ) (0.3 ) (4 ) (277 ) (0.8 ) (59 )
Results from operating activities 58 3,808 10.7 52 3,386 9.4 12
Finance expense / (income), net 0 24 0.1 (6 ) (365 ) (1.0 )
Share of (profit) of equity accounted investees, net of income tax (1 ) (92 ) (0.3 ) (1 ) (84 ) (0.2 ) 10
Profit before income tax 59 3,876 10.9 59 3,835 10.7 1
Income tax expense 16 1,027 2.9 14 885 2.5 16
Profit for the period 44 2,849 8.0 45 2,950 8.2 (3 )

Diluted EPS 0.26 17.15 0.27 17.76 (3 )

EBITDA Computation

Particulars Q2 FY 18 Q2 FY 17
($) (Rs.) ($) (Rs.)
Profit before income tax 59 3,876 59 3,835
Interest (income) / expense net* 1 72 (5 ) (329 )
Depreciation 32 2,078 29 1,897
Amortization 13 862 15 950
Impairment - - 1 67
EBITDA 105 6,888 98 6,420
EBITDA (% to sales) 19.4 17.9

* – Includes income from Investments

Key Balance Sheet Items

Particulars As on 30th Sep 17 As on 30th June 17

($)
(Rs.) ($) (Rs.)
Cash and cash equivalents and Other current Investments 257 16,793 223 14,572
Trade receivables 646 42,203 630 41,140
Inventories 413 26,998 430 28,095
Property, plant and equipment 887 57,905 882 57,611
Goodwill and Other Intangible assets 760 49,634 744 48,564
Loans and borrowings (current & non-current) 822 53,668 773 50,462
Trade payables 217 14,193 203 13,225
Equity 1,866 1,21,840 1,890 1,23,423

Revenue Mix by Segment [Year on year]

Particulars Q2 FY 18 Q2 FY 17 Growth %
($) (Rs.) % ($) (Rs.) %
Global Generics 438 28,618 81 % 444 28,995 81 % -1
North America 14,318 16,134 -11
Europe* 2,424 1,776 36
India 6,370 6,251 2
Emerging Markets# 5,506 4,834 14
PSAI 87 5,654 16 % 89 5,784 16 % -2
North America 962 1,135 -15
Europe 1,938 2,095 -7
India 436 575 -24
Rest of World 2,318 1,979 17
Proprietary Products & Others 18 1,188 3 % 17 1,078 3 % 10
Total 543 35,460 100 % 549 35,857 100 % -1

Revenue Mix by Segment [Sequential]

Particulars Q2 FY 18 Q1 FY 18 Growth %
($) (Rs.) % ($) (Rs.) %
Global Generics 438 28,618 81 420 27,455 83 % 4
North America 14,318 14,946 -4
Europe* 2,424 2,075 17
India 6,370 4,687 36
Emerging Markets# 5,506 5,747 -4
PSAI 87 5,654 16 71 4,651 14 % 22
North America 962 779 23
Europe 1,938 1,863 4
India 436 288 51
Rest of World 2,318 1,721 35
Proprietary Products & Others 18 1,188 3 16 1,053 3 % 13
Total 543 35,460 100 % 508 33,159 100 % 7
* Europe primarily includes Germany, UK and out licensing sales business
# Emerging Markets refers to Russia, other CIS countries, Romania and Rest of the World markets including Venezuela

Segmental Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 28.6 billion, year-on-year marginal decline of 1%; decline primarily on account of lower contribution from North America offset by increased contribution from Europe, India and Emerging Markets.

Revenues from North America at Rs. 14.3 billion. Year-on-year decline of 11%, primarily on account of higher price erosions due to channel consolidation and increased competition in some of our key products namely Valgancyclovir, Azacitidine, Esomeprazole, etc.

During the quarter we launched 4 new products i.e. Sevelamer Carbonate, Cefixime OS, Bupropion XL and Metaxalone tabs. Since Sevelamer carbonate was launched post the cut-off date for revenue recognition, no sales have been recorded during the quarter.

As of 30th September 2017, cumulatively 103 generic filings are pending for approval with the USFDA (100 ANDAs and 3 NDAs under 505(b)(2) route). Of these 100 ANDAs, 60 are Para IVs out of which we believe 28 have ‘First to File’ status.
Revenues from Emerging Markets at Rs. 5.5 billion, year-on-year growth of 14%.
Revenues from Russia at Rs. 3.2 billion, year-on-year growth of 20%. In constant currency i.e. in Ruble terms year-on-year growth of 13%. Growth driven by higher volume uptake in base business and new products.
Revenues from other CIS countries and Romania market at Rs. 0.9 billion, year-on-year growth of 3%.
Revenues from Rest of World (RoW) territories at Rs. 1.4 billion, year-on-year growth of 9%.
Revenues from India at Rs. 6.4 billion, year-on-year growth of 2%. Partial recovery was witnessed in the inventory holding by the channel post the transition to the GST regime. Pre-GST transition, the reported numbers included the excise duty component with a corresponding charge in the income statement. Post the transition, revenues reported are lower to the extent of the ED component, though it’s a profit neutral adjustment. Normalizing for this and some other transition related adjustments, the comparable year-on-year growth would be around 10%.
Revenues from Europe at Rs. 2.4 billion, year-on-year growth of 37%. Growth primarily driven by new launches and volume uptake in some of the key products.
Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 5.7 billion, year-on-year decline of 2%. On a sequential basis revenues registered a growth of 22% aided by improved order flow and supply situations.
During the quarter, 16 DMFs were filed globally of which 2 were in the US. The cumulative number of DMF filings as of 30th September, 2017 was 780.
Income Statement Highlights:

Gross profit margin at 53.3% and declined by ~270 bps over that of previous year, decline primarily on account of higher price erosions due to channel consolidation and increased competitive intensity in some of our key molecules in the US. Gross profit margin for GG and PSAI business segments are at 59.2% and 19.6% respectively.

Gross profit margins improved 170 bps sequentially, aided by favorable manufacturing overheads leverage (higher revenues and lower overheads).
SG&A expenses at Rs. 11.0 billion, a decrease of 6% both year-on-year and sequentially. In Q2 FY17 the company had accrued a potential liability of Rs. 344 million towards NPPA provision. After adjusting the base, the marginal decline is primarily on account of prudent control on spend.
Research & development expenses at Rs. 4.2 billion. As % to Revenues- Q2 FY18: 11.8% | Q1 FY 18: 15.3% | Q2 FY17: 14.5%]. Compared to the trend, spend is lower partially on account of deferment in some of the milestone related payments to subsequent quarters. Focus continues on building complex generics, biosimilars and differentiated products pipeline.
Net Finance expense at Rs. 24 million compared to the net finance income of Rs. 365 million in Q2FY17. The incremental expense of Rs. 389 million is on account of:
Net foreign exchange gain of Rs. 47 million in the current quarter vs net foreign exchange gain of Rs. 37 million in the previous year.
Decrease in profit on sales of investments by Rs. 289 million.
Net increase in interest expense of Rs. 110 million.
Profit after Tax at Rs. 2.8 billion.
Diluted earnings per share is at Rs. 17.15.
Capital expenditure is at Rs. 2.8 billion.
Earnings Call Details (06:30 pm IST, 09:00 am EDT, October 31, 2017)

The Company will host an earnings call to discuss the performance and answer any questions from participants. This call will be accessible through an audio dial-in and a web-cast.

Audio conference Participants can dial-in on the numbers below
Primary number:
91 22 3960 0616
Secondary number:
91 22 6746 5826
International Toll Free Number
USA
18667462133

UK
08081011573
Singapore
8001012045
Hong Kong
800964448

Playback of call:
91 22 3065 2322, 91 22 6181 3322
Conference ID:
375#
Web-cast
More details will be provided through our website, www.drreddys.com
Transcript of the event will be available at www.drreddys.com. Playback will be available for a few days.

Aclaris Therapeutics to Announce Third Quarter 2017 Financial Results on November 7, 2017

On October 31, 2017 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biotechnology company, reported that it will release its third quarter financial results before the market open on November 7, 2017 (Press release, Aclaris Therapeutics, OCT 31, 2017, View Source [SID1234521552]).

Management will conduct a conference call at 8:00 AM ET that day to discuss the Company’s financial results and provide a general business update. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 99295180 prior to the start of the call.

Verseon to Present Preclinical Data on Novel Anticancer Candidates for Use against Multidrug Resistant Cancers

On November 1, 2017 Verseon reported that it will present preclinical data on its novel anticancer drug candidates, which have shown promising results in preliminary testing against tumor cell lines resistant to major chemotherapy agents. The results will be shown at the BIO-Europe conference held in Berlin from November 6–8, 2017 (Press release, Verseon, OCT 31, 2017, View Source [SID1234521459]).

Cancer still remains a primary concern with almost 1.7 million people in the US newly diagnosed with some form of cancer in 2016. Currently, chemotherapy is essential to the treatment of most cancers. However, tumors in many patients become resistant to chemotherapy agents over time, limiting the effectiveness of available drugs.

Dr. Anirban Datta, Verseon’s Director of Discovery Biology, will present the first preclinical results on a new class of anticancer agents, which are potent against a range of cancer cell lines in cell-based assays. In particular, he will highlight the effectiveness of these new drug candidates against cancer cell lines resistant to established chemotherapy agents.

“We are really excited about these results as they show that our novel chemotherapy agents are largely unaffected by mechanisms of multidrug resistance. This fills an important need for the treatment of many cancers, especially for patients with recurrent solid tumors,” said Dr. Datta.

Verseon uses its innovative computer-driven drug discovery platform to generate new drug candidates for a variety of indications. This platform provides access to many more drug-like molecules than are available to conventional pharmaceutical companies. Verseon currently has active programs in anticoagulation, diabetic macular edema, hereditary angioedema, and oncology.

Details of the presentation are as follows:

Date: Tuesday, November 7, 2017

Time: 5:15 PM

Location: CityCube Berlin, Room M3 on Level 3

Xenetic Biosciences Appoints Jeffrey F. Eisenberg as Chief Executive Officer

On October 31, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that it has appointed Jeffrey F. Eisenberg as Chief Executive Officer. M. Scott Maguire will continue to serve Xenetic during the management transition (Press release, Xenetic Biosciences, OCT 31, 2017, View Source [SID1234521377]).

“On behalf of everyone at Xenetic, we would like to thank Scott for his years of commitment and dedication to the Company. Mr. Maguire joined a company with a collection of patents and transformed the Company into a clinical-stage business, listing the company on NASDAQ last year. His efforts were critical in securing an exclusive license deal with, and a series of equity investments from, Shire plc (LSE: SHP, NASDAQ: SHPG) (formerly Baxalta, Baxter Incorporated and Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors employing Xenetic’s proprietary PolyXen technology platform,” commented Adam Logal, Chairman of the Board of Xenetic. “We believe that Jeff’s appointment today as Chief Executive Officer is an important step in the continued evolution of Xenetic. His industry experience and professional track record are perfectly aligned with the Company’s strategic priorities, and I believe he will do a tremendous job leading the Xenetic team and driving the Company to its next phase of growth.”

Mr. Eisenberg joined the Xenetic management team in December 2016 as Chief Operating Officer and has served on the Company’s Board of Directors since July 2016. He is a seasoned life science executive with over 20 years of broad operational expertise. Over the course of his career, Mr. Eisenberg has led all crucial areas of R&D, operations, manufacturing/quality, business development, strategic partnering, product development, commercialization, and talent management. Prior to joining Xenetic, his most recent position was Chief Executive Officer of Noven Pharmaceuticals, where during his tenure as CEO revenues more than doubled, the company’s cash increased by more than 300%, and two new products were launched following the successful filings of New Drug Applications (NDAs) submitted to the U.S. Food and Drug Administration. Mr. Eisenberg also was responsible for leading Noven’s Novogyne joint venture with Novartis (NYSE: NVS), an entity that generated over $300 million in revenue in its last full year of operation.

Mr. Eisenberg commented, “I am very pleased to be appointed to lead Xenetic at this pivotal point in the Company’s history, and I am prepared for this exciting challenge. We have a strong team in place, and together we will focus on continuing to fundamentally transform Xenetic on multiple fronts. We look forward to advancing our ongoing Phase 2 study of our flagship product, XBIO-101 as candidate for the treatment of progestin resistant endometrial cancer and announcing interim data from the study in 2018. Beyond XBIO-101, we believe there is an opportunity to build a growing pipeline of partnerships utilizing our proven PolyXen platform technology.”