1stOncology™: Cancer Intelligence Service – Page 14319 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BeiGene Reports Fourth Quarter and Full Year 2017 Financial Results

On February 28, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated 2018 milestones and financial results for the fourth quarter and full year of 2017 (Press release, BeiGene, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335408 [SID1234524222]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"We had a transformative year in 2017, highlighted by the collaboration with Celgene Corporation for our anti-PD1 antibody, tislelizumab, expansion of the commercial team in China, and execution on the development plans that we believe will be critical to realizing the potential of our portfolio compounds in China and globally," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "We have now enrolled more than 2,300 patients and healthy subjects worldwide in clinical trials of our investigational agents as of the end of January 2018 and are on target for our first NDA filings in China later this year."

"We also strengthened our balance sheet with an $800 million offering this January. This successful financing will support our efforts to further develop our near-term clinical and pipeline programs, as well as continue to build our development and commercial capabilities to help maximize our opportunities in the rapidly evolving Chinese oncology market," continued Mr. Oyler.

Fourth Quarter 2017 and Recent Business Highlights

Clinical Programs:

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

Presented preliminary clinical data from the Phase 1 trial of zanubrutinib in patients with non-Hodgkin’s lymphoma in an oral presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta;

Presented updated Phase 1b data for the combination of zanubrutinib and GAZYVA (obinutuzumab) in patients with chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL) at the ASH (Free ASH Whitepaper) annual meeting;

Presented initial Phase 1b data for the combination of zanubrutinib and the Company’s investigational anti-PD-1 antibody, tislelizumab (BGB-A317), in patients with B-cell malignancies at the ASH (Free ASH Whitepaper) annual meeting;

Completed enrollment in the Phase 2 pivotal trial in China in patients with CLL/SLL; and

Initiated a Phase 1b/2 trial in China of zanubrutinib in combination with rituximab in patients with diffuse large B-cell lymphoma, FL, and marginal zone lymphoma.

Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1 under the collaboration with Celgene Corporation

Presented preliminary results from the Phase 1 trial of tislelizumab in patients with urothelial carcinoma at the 2018 Genitourinary Cancers Symposium;

Presented initial Phase 1b data for the combination of zanubrutinib and tislelizumab in patients with B-cell malignancies at the ASH (Free ASH Whitepaper) annual meeting;

Initiated the following trials:
— Global Phase 3 trial of tislelizumab in patients with previously untreated advanced hepatocellular carcinoma (HCC); and

— Global Phase 3 trial of tislelizumab in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma.

Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Initiated a Phase 2 pivotal trial in China of pamiparib in patients with advanced ovarian cancer.

BGB-A333, an investigational humanized monoclonal antibody against the immune checkpoint receptor ligand PD-L1

Initiated a global Phase 1/2 trial of BGB-A333 monotherapy and in combination with tislelizumab in advanced solid tumors.

Commercial Products

Received approval in China for a new indication for REVLIMID (lenalidomide) in combination with dexamethasone as a treatment for adult patients with previously untreated multiple myeloma who are not eligible for transplant; and

Initiated commercialization of VIDAZA (azacitidine) in China.

Corporate Development:

Entered an exclusive license agreement with Mirati Therapeutics for the development, manufacturing and commercialization of Mirati’s sitravatinib, an investigational tyrosine kinase inhibitor targeting TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, in Asia (excluding Japan), Australia and New Zealand; and

Entered into a commercial supply agreement for tislelizumab with Boehringer Ingelheim.

Expected 2018 Milestones

Zanubrutinib

Present updated Phase 1 and China pivotal trial data;

Submit first NDA in China for mantle cell lymphoma;

Complete enrollment in the global Phase 3 trial for Waldenstrom’s macroglobulinemia in Q3 2018; and

Initiate a global head-to-head Phase 3 trial versus ibrutinib in relapsed/refractory CLL.

Tislelizumab

Present updated Phase 1 data and China pivotal trial data;

Submit first NDA in China for Hodgkin’s lymphoma;

Complete enrollment in the Phase 2 pivotal trial in China for urothelial carcinoma; and

Initiate additional global and China-focused pivotal trials.

Pamiparib

Present updated Phase 1 data;

Initiate a global Phase 3 trial in gastric cancer in 1H 2018; and

Initiate a Phase 3 trial in China as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.

Commercial Products

Expand provincial reimbursement for ABRAXANE (nanoparticle albumin-bound paclitaxel) in China.

Fourth Quarter and Full Year 2017 Financial Results

Cash, Cash Equivalents, and Short-Term Investments were $837.52 million as of December 31, 2017, compared to $757.44 million at September 30, 2017 and $368.17 million at December 31, 2016. This includes approximately $139.50 million of cash, cash equivalents and short-term investments at December 31, 2017, held by our joint venture, BeiGene Biologics, to build a commercial biologics facility in Guangzhou, China and to fund research and development of biologics drug candidates in China. Cash and cash equivalents as of December 31, 2017 do not include the net proceeds raised in the January 2018 public offering.

The increase of $80.08 million in the in the fourth quarter of 2017 was primarily due to the receipt of $170.95 million from Celgene as part of upfront licensing fees from the tislelizumab collaboration, offset by increased research and development spending and capital expenditures as we continue to advance our pipeline.

The increase of $469.35 million from the prior year period was primarily due to cash received from Celgene from the tislelizumab collaboration, including upfront licensing fees of $263.00 million and an equity investment of $150.00 million, and net proceeds of $188.52 million from our August 2017 follow-on public offering, offset by increased cash used in operations and for capital expenditures.

Capital expenditures for the quarter and year ended December 31, 2017 were $18.93 million and $58.73 million, compared to $8.06 million and $23.50 million, respectively, for the same periods in 2016, primarily attributable to increased investment in our manufacturing facilities in Guangzhou and Suzhou.

Revenue for the fourth quarter and year ended December 31, 2017 was $18.17 million and $238.39 million, respectively, compared to nil and $1.07 million in the same periods in 2016, attributable to product and collaboration revenue under the Celgene collaboration.

Product revenue from sales of ABRAXANE and REVLIMID in China totaled $15.61 million and $24.43 million for the fourth quarter and from August 31, 2017 (the closing of the Celgene transaction) to December 31, 2017, respectively.

Collaboration revenue totaled $2.57 million and $213.96 million for the fourth quarter and year ended December 31, 2017, respectively, reflecting recognition of the upfront licensing fees from Celgene in the third quarter and deferred upfront fees recognized in the fourth quarter.

Expenses for the fourth quarter and year ended December 31, 2017 were $121.97 million and $336.84 million, respectively, compared to $37.27 million and $118.13 million in the same periods in 2016.

Cost of sales for the fourth quarter and from August 31 to December 31, 2017 were $3.03 million and $4.97 million, respectively. Cost of sales relates to the cost of acquiring ABRAXANE and REVLIMID for distribution in China.

R&D Expenses for the fourth quarter and year ended December 31, 2017 were $91.34 million and $269.02 million, respectively, compared to $28.93 million and $98.03 million in the same periods in 2016. The increase in R&D expenses was primarily attributable to increased spending on our ongoing late-stage clinical trials, increased manufacturing costs for our drug candidates due to expansion of ongoing clinical programs, and increased employee compensation expense as a result of increased headcount to support our clinical programs. Additionally, R&D-associated share-based compensation expense was $10.95 million and $30.61 million for the fourth quarter and year ended December 31, 2017, respectively, compared to $2.90 million and $8.08 million for the same periods in 2016, due to increased headcount and a higher share price.

SG&A Expenses for the fourth quarter and year ended December 31, 2017 were $27.42 million and $62.60 million, respectively, compared to $8.34 million and $20.10 million in the same periods in 2016. The increase in SG&A expenses was primarily attributable to increased headcount, including employees transferred from Celgene China in connection with the license agreement for Celgene’s commercial products in China, as well as higher professional service fees related to the Celgene transaction and patent prosecution activities, and costs to support our growing operations. In addition, SG&A-associated share-based compensation expense was $5.51 million and $12.25 million for the fourth quarter and year ended December 31, 2017, respectively, compared to $1.05 million and $2.55 million for the same periods in 2016.

Net Loss for the fourth quarter and year ended December 31, 2017 was $99.28 million and $93.30 million, respectively, compared to a net loss of $37.60 million and $119.22 million in the same periods in 2016.

Financial Summary
Select Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
(Audited)

December 31, 2017 December 31, 2016
Cash, cash equivalents and short‑term investments $ 837,516 $ 368,174
Working capital 763,509 339,341
Property and equipment, net 62,568 25,977
Total assets 1,046,479 405,813
Total liabilities 362,248 52,906
Noncontrolling interest 14,422 —
Total equity $ 684,231 $ 352,907

Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. Dollars, except for number of American Depositary Shares (ADSs) and per ADS data)

Three Months Ended
December 31,
(Unaudited) Twelve Months Ended
December 31,
(Audited)
2017 2016 2017 2016
Revenue
Product revenue, net $ 15,606 $ — $ 24,428 $ —
Collaboration revenue 2,568 — 213,959 1,070
Total revenues 18,174 — 238,387 1,070
Expenses
Cost of sales – products (3,030) — (4,974) —
Research and development (91,340) (28,933) (269,018) (98,033)
Selling, general and administrative (27,415) (8,337) (62,602) (20,097)
Amortization of intangible assets (187) — (250) —
Total expenses (121,972) (37,270) (336,844) (118,130)
Loss from operations (103,798) (37,270) (98,457) (117,060)
Interest (expense) income, net (527) 47 (4,108) 383
Changes in fair value of financial instruments — — — (1,514)
Gain (loss) on sale of available-for-sale securities 34 (338) 44 (1,415)
Other income (expense), net 9,926 (289) 11,457 443
Loss before income taxes (94,365) (37,850) (91,064) (119,163)
Income tax (expense) benefit (4,915) 252 (2,235) (54)
Net loss $ (99,280) $ (37,598) $ (93,299) $ (119,217)
Less: Net loss attributable to noncontrolling interest 43 — (194) —
Net loss attributable to BeiGene, Ltd. $ (99,323) $ (37,598) $ (93,105) (119,217)
Net Loss per ADS, basic and diluted $ (2.19) $ (1.05) $ (2.23) $ (3.84)
Weighted-average number of ADSs outstanding – basic and diluted 45,402,681 35,663,284 41,783,497 31,047,650

Consolidated Statements of Comprehensive Income (Loss) (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)

Three Months Ended
December 31,
(Unaudited)
Twelve Months Ended
December 31,
(Audited)
2017 2016 2017 2016
Net loss $ (99,280) $ (37,598) $ (93,299) $ (119,217)
Other comprehensive (loss) income, net of tax of nil:
Foreign currency translation adjustments (134) (232) 851 (245)
Unrealized holding gain, net (354) 251 (296) 1,108
Comprehensive loss (99,768) (37,579) (92,744) (118,354)
Less: Comprehensive loss attributable to noncontrolling interests 73 — (105) —
Comprehensive loss attributable to BeiGene, Ltd. $ (99,841) $ (37,579) $ (92,639) $ (118,354)

Conatus Pharmaceuticals to Report Fourth Quarter and Full Year 2017 Financial Results

On February 28, 2018 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported that it will report financial results for the fourth quarter and full year ended December 31, 2017, after the market close on Wednesday, March 7, 2018 (Press release, Conatus Pharmaceuticals, FEB 28, 2018, View Source [SID1234524225]). Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time on Wednesday, March 7, 2018, to discuss the financial results and provide a corporate update.

To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 7095658. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

Daiichi Sankyo, Inc. Aligns U.S. Commercial Operations to Current Portfolio and Upcoming Cancer Pipeline

On February 28, 2018 Daiichi Sankyo, Inc. ("the Company") reported that it will reorganize its U.S. Commercial organization as it continues to maximize opportunities for its current portfolio and prepare for its upcoming oncology pipeline (Press release, Daiichi Sankyo, FEB 28, 2018, View Source [SID1234524227]). The U.S. restructuring will streamline the Company’s operations, enable it to best serve its current patients and maximize its contribution to the development of medicines that change the standard of care. As part of the reorganization, the Company will reduce headcount by approximately 280 employees from various locations in the U.S.

"Our priorities are to bring spending in line with revenue, shift resources to maximize Injectafer and our abuse-deterrent pain treatments, and prepare for exciting potential new treatments for patients with cancer being developed by our R&D organization," said Ken Keller, President, Administrative and Commercial, Daiichi Sankyo, Inc. "While the decision to reduce our workforce is a very difficult one, the changes are necessary to position us for long-term success. We are grateful for the contributions of all employees, and we are committed to making this process as easy and as streamlined as possible."

Daiichi Sankyo will offer outplacement services, severance and other support to all employees who are directly affected.

Foamix Reports Fiscal Year 2017 Financial Results and Provides Corporate Update

On February 28, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix Pharmaceuticals" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported financial results for the fiscal year ended December 31, 2017 (Press release, Foamix, FEB 28, 2018, View Source [SID1234524231]).

Clinical and Corporate Update:

FMX101, the Company’s minocycline foam 4% is currently being evaluated in a third Phase 3 study (Study 22) in patients with moderate-to severe acne.
Top-line results are expected in the third quarter of 2018.
The expected timing of an NDA filing for FMX101 is planned for the end of 2018.
FMX103, 1.5% minocycline foam, is currently being evaluated in two Phase 3 studies (Studies 11 and 12) in patients with moderate-to severe papulopustular rosacea. Long term safety is concurrently being evaluated in the open label Study 13.
Top-line results are expected in late third quarter or early fourth quarter of 2018.
Enrollment in the open-label long term safety study (Study 13) continues to progress as scheduled. A significant number of patients have enrolled into this study and we continue to observe low discontinuation rates.
The expected timing of an NDA filing for FMX103 is planned for 2019.
In January and February 2018, Bayer and Foamix filed joint complaints against each of Teva and Perrigo, respectively, alleging patent infringement under U.S. patent laws arising out of the submissions by Teva and Perrigo of ANDAs seeking approval to manufacture and sell generic versions of Bayer’s Finacea Foam. We are committed to defending our own intellectual property rights globally, including patents we have licensed to other pharmaceutical companies as part of our collaboration efforts.
In January 2018, as part of the orderly transition in management, CEO David Domzalski was appointed to the Board of Directors to replace former CEO and co-founder Dr. Dov Tamarkin.
In January 2018, the Company changed its filing status with the SEC and Nasdaq from a "Foreign Private Issuer" to a U. S. Domestic filer.

FMX101 Open Label Safety Study Results

A total of 657 patients were enrolled in the open-label safety extension after an initial 12 weeks of double-blinded therapy in Phase 3 studies 04 and 05. Of these, 291 completed an additional 40-weeks for a total of 52 weeks on FMX101 therapy. The primary endpoint was safety.
As previously communicated, no serious drug-related adverse events were reported during the open-label safety extension, validating earlier data demonstrating that FMX101 appears to be well tolerated with an acceptable safety profile. Specific findings included:
Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portion of Studies 04 and 05, with the most frequently reported treatment-emergent adverse event being nasopharyngitis (common cold).
Application-site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment. Four patients discontinued the study for an application-site adverse event.
In the assessment of facial dermal tolerability at week 52, more than 95% of patients had "none" or "mild" scoring of erythema, dryness, hyperpigmentation, peeling, and itching. No severe local tolerability scores were recorded.

Efficacy Results at 52 weeks:

Efficacy was also measured as a secondary endpoint in the open-label study for FMX101. During the study, patients were allowed to discontinue therapy with FMX101 if they believed their acne had sufficiently improved. Patients could re-start therapy as needed and were also allowed to use other acne medications concomitantly.
The following summarizes efficacy results for subjects who had been assigned FMX101 therapy for 52 weeks:
At week 52, 37.7% of patients from Study 04 had an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear); 50.3% of subjects from Study 05 had an IGA score of 0 or 1.
At week 52, patients from Study 04 had a 64.3% reduction in inflammatory lesions; patients from Study 05 had a 78% reduction in inflammatory lesions.
At week 52, patients from Study 04 had a 52.5% reduction in non-inflammatory lesions; patients from Study 05 had a 59.6% reduction in non-inflammatory lesions.

Details on the open-label study results for FMX101 are contained within the most recent Investor Presentation, available on the Company’s website at View Source

Financial Results for the Year Ended December 31, 2017

Revenues
Revenues for the year ended December 31, 2017 were $3.7 million, compared with $5.5 million for the same period in 2016. The decrease is mainly due to a decrease of $2.5 million in contingent payments from Bayer, that were payable for 2016 due to Bayer’s achievement of certain sale targets during that year, offset by an increase in royalty payments in the amount of $565,000 from Bayer for the sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the year were $57.8 million, compared to $25.9 million in 2016. The increase in research and development expenses resulted primarily from an increase of $28.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $3.0 million in payroll and payroll related expenses primarily due to an increase in headcount.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year were $11.5 million, compared to $9.2 million in 2016. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.9 million in payroll and other payroll-related expenses mostly due to an increase in headcount and salary raises.

Net Loss
For the year ended December 31, 2017, the Company recorded a net loss of $65.7 million, or $1.76 per share, basic and diluted, compared with a loss of $29.3 million or $0.91 per share, basic and diluted, for the year ended December 31, 2016.

Cash & Cash Equivalents
At December 31, 2017, the Company had $76.4 million in cash and investments compared to $131 million at the end of December 2016. The Company believes, based on its current business plan, that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements throughout the completion of its third pivotal Phase 3 clinical trial for its lead product candidate FMX101 and its two pivotal Phase 3 clinical trials for FMX103.

Conference Call & Webcast
Wednesday, February 28 @ 8:30am Eastern Time
Toll Free: 800-289-0438
International: 323-794-2423
Conference ID: 2903389
Webcast: View Source

Replays, Available through March 14:
Toll-Free: 844-512-2921
International: 412-317-6671
Conference ID: 2903389

Heat Biologics, Inc. presentation dated February 28, 2018

On February 28, 2018 Heat Biologics, Inc. presented Analyst and Investor day presentation (Presentation, Heat Biologics, FEB 28, 2018, View Source [SID1234524235]).