On May 4, 2018 Celgene Corporation (NASDAQ:CELG) reported net product sales of $3,531 million for the first quarter of 2018, a 20 percent increase from the same period in 2017 (Press release, Celgene, MAY 4, 2018, View Source [SID1234526130]). Celgene reported first quarter 2018 total revenue of $3,538 million, a 19 percent increase compared to $2,962 million in the first quarter of 2017.

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!

Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported net income of $846 million and diluted earnings per share (EPS) of $1.10 for the first quarter of 2018. For the first quarter of 2017, GAAP net income was $932 million and diluted EPS was $1.15.

Adjusted net income for the first quarter of 2018 increased 16 percent to $1,572 million compared to $1,355 million in the first quarter of 2017. For the same period, adjusted diluted EPS increased 23 percent to $2.05 (inclusive of approximately $0.05 dilution from the Juno acquisition) from $1.67.

"Strong global demand and excellent commercial execution drove our exceptional first quarter results, leading to improvement in our 2018 financial guidance," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "With multiple catalysts for growth expected over the next 12 to 18 months, we are reaffirming our 2020 outlook."

First Quarter 2018 Financial Highlights

Unless otherwise stated, all comparisons are for the first quarter of 2018 compared to the first quarter of 2017. The adjusted operating expense categories presented below exclude share-based employee compensation expense, research and development asset acquisition expense, collaboration-related upfront expense and a benefit associated with the adjustment to clinical trial and development activity wind-down costs. Please see the attached Use of Non-GAAP Financial Measures and Reconciliation of GAAP to Adjusted Net Income for further information relevant to the interpretation of adjusted financial measures and reconciliations of these adjusted financial measures to the most comparable GAAP measures, respectively.

Net Product Sales Performance

REVLIMID sales for the first quarter increased 19 percent to $2,234 million. Sales growth was primarily volume-driven due to increases in treatment duration and market share. U.S. sales of $1,487 million and international sales of $747 million increased 21 percent and 15 percent year-over-year, respectively.
POMALYST/IMNOVID sales for the first quarter were $453 million, an increase of 24 percent year-over-year. U.S. sales were $300 million and international sales were $153 million, an increase of 39 percent and 3 percent year-over-year, respectively. POMALYST/IMNOVID sales growth was primarily volume-driven due to increases in treatment duration and market share.
OTEZLA sales for the first quarter were $353 million, a 46 percent increase year-over-year. First quarter U.S. sales of $276 million and international sales of $77 million increased 39 percent and 79 percent, year-over-year, respectively. OTEZLA sales in the U.S. were primarily volume-driven due to increasing demand and improved access pull-through in contracted health plans. OTEZLA international sales growth was driven primarily by increasing adoption in key ex-U.S. markets.
ABRAXANE sales for the first quarter were $262 million, an 11 percent increase year-over-year. U.S. sales were $159 million and international sales were $103 million, an increase of 12 percent and 10 percent, year-over-year, respectively. ABRAXANE sales were positively impacted by buying patterns. Growth in Europe was driven by market share gains for ABRAXANE in pancreatic cancer.
In the first quarter, all other product sales, which include IDHIFA, THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product primarily sold in the U.S., were $229 million compared to $226 million in the first quarter of 2017.
Research and Development (R&D)

On a GAAP basis, R&D expenses were $2,203 million for the first quarter of 2018 versus $995 million for the same period in 2017. The first quarter increase was primarily due to an increase in research and development asset acquisition expense relating to our acquisition of Impact Biomedicines, Inc. (Impact), an increase in share-based compensation expense related to our acquisition of Juno Therapeutics, Inc. (Juno), and increased spending related to clinical trial and other R&D activity, partially offset by a reduction of one-time charges related to wind-down costs associated with the GED-0301 clinical trials in Crohn’s disease and certain development activities.

Adjusted R&D expenses were $694 million for the first quarter of 2018 compared to $595 million for the first quarter of 2017. The first quarter increase was primarily due to increased spending related to clinical trial and other R&D activities.

Selling, General, and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $864 million for the first quarter of 2018 compared to $620 million for the same period in 2017. The first quarter increase was primarily due to an increase in share-based compensation expense related to our acquisition of Juno and an increase in promotional activities and legal expenses.

Adjusted SG&A expenses were $671 million for the first quarter of 2018 compared to $539 million for the first quarter of 2017. The first quarter increase was primarily due to an increase in promotional activities and legal expenses.

Cash, Cash Equivalents, Marketable Debt Securities and Publicly-Traded Equity Securities

Operating cash flow was $(325) million in the first quarter of 2018, compared to $853 million for the first quarter of 2017, which was primarily impacted by the $1.1 billion upfront cash payment to acquire Impact Biomedicines (fedratinib).

In the first quarter, Celgene completed two strategic acquisitions for over $10 billion. We repurchased approximately 29.0 million shares at a total cost of approximately $2.7 billion. Celgene raised $4.5 billion in a debt offering to finance a portion of the acquisition of Juno. Celgene ended the quarter with approximately $4.7 billion in cash, cash equivalents, marketable debt securities and publicly-traded equity securities.

Product and Pipeline Updates

Hematology & Oncology

At the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, data presentations are expected to include:
Updated durability and safety data from the pivotal TRANSCEND NHL-001 trial evaluating liso-cel (JCAR017) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). In addition, the pivotal TRANSCEND NHL-001 trial completed enrollment in April.
In collaboration with partner bluebird bio, updated data from the CRB-401 phase I trial evaluating bb2121 in patients with relapsed and/or refractory multiple myeloma (RRMM).
Results from the phase III OPTIMISMM trial evaluating POMALYST in combination with bortezomib and dexamethasone (PVd) in patients with second-line multiple myeloma.
Results from the phase III RELEVANCE trial with REVLIMID in combination with rituximab (R²) in patients with previously untreated follicular lymphoma (FL).
Primary progression-free survival (PFS) and safety analysis from the Genentech-sponsored phase III IMpower131 trial evaluating atezolizumab plus chemotherapy (carboplatin and ABRAXANE) as first-line treatment in patients with advanced squamous non-small cell lung cancer (NSCLC).
In April, Celgene initiated the pivotal TRANSCEND WORLD trial evaluating liso-cel in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the EU and Japan. These data are expected to support international registration submissions for liso-cel in DLBCL.
The phase I TRANSCEND CLL-004 trial evaluating liso-cel in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) initiated in the first quarter.
The phase I EVOLVE trial evaluating JCARH125, a chimeric antigen receptor (CAR) T cell therapy targeting B-cell maturation antigen (BCMA), in patients with RRMM initiated in the first quarter.
Celgene’s partner BeiGene initiated the phase III trial evaluating BGB-A317 (tislelizumab) versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC) in the first quarter. In addition, a phase II trial evaluating tislelizumab in patients with previously treated advanced HCC was initiated.
Inflammation & Immunology

In February, Celgene announced it received a Refusal To File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for ozanimod in relapsing multiple sclerosis (RMS). Following a Type A meeting with the FDA in early April, Celgene expects to resubmit the NDA in the first quarter of 2019.
Following a meeting with European regulatory authorities, Celgene expects to submit a Marketing Authorization Application (MAA) for ozanimod in RMS in the first quarter of 2019.
At the 2018 American Academy of Neurology (AAN) Annual meeting in April, data from new analyses of both pivotal phase III SUNBEAM and RADIANCE Part B trials evaluating ozanimod in RMS were presented. These new analyses show dose-dependent effects of ozanimod on annualized relapse rate (ARR) versus interferon beta-1a (Avonex) across subgroups, including baseline disability and prior exposure to disease-modifying therapies, that were consistent with the overall ARR primary endpoint. In addition, data presentations of exploratory endpoints showed reductions in cortical grey matter and thalamic volume loss consistent with the reductions in whole brain volume loss seen in SUNBEAM at one year and RADIANCE Part B at two years for ozanimod compared with Avonex. The overall safety and tolerability profile for ozanimod has been consistent across the RADIANCE Part A, SUNBEAM and RADIANCE Part B studies.
In February, data from the phase II randomized, double-blind, placebo-controlled proof of concept study evaluating OTEZLA in patients with ulcerative colitis (UC) were presented at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO). In addition, these phase II data have also been accepted for an encore presentation at the Digestive Disease Week (DDW) meeting in June. Celgene plans to initiate the pivotal program with OTEZLA in UC in 2018.
Business Updates

In March, Celgene announced that it completed the acquisition of Juno, a biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. The Juno acquisition positions Celgene as a global cellular immunotherapy company by adding a novel scientific platform and scalable manufacturing capabilities, in addition to liso-cel, an investigational CD19-directed CAR T currently in a clinical development program for relapsed and/or refractory DLBCL.

Celgene acquired all the outstanding shares of common stock of Juno through a tender offer for $87 per share in cash, or an aggregate of approximately $9.1 billion. The transaction was funded through a combination of existing cash, cash equivalents, debt securities available-for-sale and new debt.
In February, Celgene completed the acquisition of Impact, a privately-held biotechnology company developing fedratinib, a highly selective Janus kinase 2 (JAK2) inhibitor, for myelofibrosis. This acquisition strengthens Celgene’s commitment to myelofibrosis, a disease with high unmet medical need, and expands strategic development options within Celgene’s myeloid portfolio of assets.

Under the terms of the agreement, Celgene paid approximately $1.1 billion upfront, contingent consideration based upon regulatory approvals of up to $1.4 billion (including $1.25 billion for myelofibrosis), and contingent consideration of up to $4.5 billion based upon the achievement of sales in any four consecutive calendar quarters between $1.0 billion and $5.0 billion.
In March, Celgene and Prothena Corporation (Prothena) announced a global collaboration to develop new therapies for a broad range of neurodegenerative diseases. The multi-year research and development collaboration is focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target. For each of the programs, Celgene has an exclusive right to license clinical candidates in the U.S. at Investigational New Drug (IND) filing, and if exercised, would also have a right to expand the license to global rights at the completion of phase I.

Under the terms of the collaboration, Prothena received a $150 million upfront payment (which includes an equity investment) plus future potential exercise payments and regulatory and commercial milestones for each licensed program. Prothena will also receive additional royalties on net sales of any resulting marketed products.
In March, Celgene and Vividion Therapeutics Inc., (Vividion) announced a multi-year strategic research collaboration focused on the identification and development of unique small molecules against targets for a range of oncology, inflammatory and neurodegenerative indications. The collaboration utilizes Vividion’s platform to identify ligands and discover drug candidates against a selected list of high-value, difficult-to-drug targets.

Under the terms of the collaboration, Vividion received an upfront payment of $101 million (which includes an equity investment). Celgene will have the right to opt in to programs at IND acceptance and Celgene will receive exclusive worldwide rights for certain programs, including the first program. In addition, other programs will allow for Celgene and Vividion to share equally either U.S. or worldwide development costs and commercialization profits and losses.
In early March, Celgene’s partner bluebird bio opted in on their right to co-develop and co-promote bb2121, an investigational anti-BCMA CAR T cell therapy for the treatment of patients with RRMM in the United States. The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121. Celgene and bluebird bio amended and restated the collaboration agreement in 2015 to focus on developing product candidates targeting BCMA.
Organizational Updates

Celgene recently announced the election of Hans Bishop, Patricia "Pat" Hemingway Hall and John Weiland to the Board of Directors.

Mr. Bishop is a 30-year industry veteran and pioneer in the field of cellular immunotherapy whose expertise will help Celgene lead in this extremely promising area of science. He was most recently President and CEO of Juno, a cellular immunotherapy company that he co-founded in 2013 and led until Juno was acquired by Celgene in March 2018.

Ms. Hemingway Hall has more than 30 years of experience with a focus on the U.S. health insurance market and deep understanding of the U.S. market access landscape which will help to shape Celgene’s strategy in an increasingly complex environment. She most recently was CEO of Health Care Service Corporation (HCSC), the nation’s largest mutual health insurance company, which operates as Blue Cross and Blue Shield in Illinois, Montana, New Mexico, Oklahoma and Texas, from 2008 until her retirement in 2015.

Mr. Weiland has over 30 years in the healthcare industry with significant expertise and experience across therapeutic areas and geographies. His leadership and insight will help to inform and direct Celgene’s long-term growth strategy. He was most recently the President and Chief Operating Officer of C. R. Bard, Inc. (Bard), with worldwide responsibility for all of Bard’s business operations prior to it being acquired by Becton, Dickinson and Company (BD) in December 2017.
First Quarter 2018 Conference Call and Webcast Information

Celgene will host a conference call to discuss the first quarter of 2018 operational and financial performance on Friday, May 4, 2018, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon May 4, 2018, until midnight ET May 11, 2018. To access the replay in the U.S., dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The participant passcode is 6196716.

On May 4, 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 that the company will present at the Deutsche Bank 43rd Annual Health Care Conference in Boston (Press release, Agios Pharmaceuticals, MAY 4, 2018, View Source;p=RssLanding&cat=news&id=2347174 [SID1234526129]). The presentation is scheduled for 9:20 AM ET on Tuesday, May 8, 2018.

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!

A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

On May 4, 2018 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases, reported that it has enrolled over 300 of the planned total of 444 patients, in the ongoing confirmatory Phase III study investigating TALICIA (RHB-105)1 for H. pylori infection (ERADICATE Hp2) (Press release, RedHill Biopharma, MAY 4, 2018, View Source;LNGID=1&TMID=178&FID=1384&PID=0&IID=7172 [SID1234526123]).

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!

RedHill remains on track to potentially complete enrollment of the ERADICATE Hp2 study in the third quarter of 2018 and expects to announce top-line results in the fourth quarter of 2018.

TALICIA was granted QIDP (Qualified Infectious Disease Product) designation by the FDA under the GAIN Act, including Fast-Track development, priority New Drug Application (NDA) review of 6 months, if filed, and extended U.S. market exclusivity for a total of eight years.

The two-arm, randomized, double-blind, active comparator, confirmatory Phase III study was designed to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection at up to 65 clinical sites in the U.S.. The primary endpoint is eradication of H. pylori infection at 43 through 71 days after initiation of treatment.

Subject to a successful outcome and additional regulatory feedback, the ERADICATE Hp2 study is expected to complete the package required for a potential U.S. NDA for TALICIA. The filing is planned for early 2019 and, if accepted for review, the FDA could potentially approve TALICIA in the second half of 2019.

The ERADICATE Hp2 confirmatory Phase III study with TALICIA (RHB-105) is registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health (NIH), which provides access to information on publicly and privately supported clinical studies.

The first Phase III study with TALICIA (ERADICATE Hp study) successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA. Notably, the 89.4% efficacy in eradicating H. pylori infection with TALICIA was also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate in the mITT population (p=0.006), further supporting the potential efficacy of TALICIA. Treatment with TALICIA appeared to be safe and well tolerated.

About H. pylori
H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma and is estimated to affect over half of the adult population worldwide2.

The 2015 worldwide and U.S. markets for H. pylori eradication therapies were estimated at approximately $4.83 billion and $1.45 billion, respectively3.

About TALICIA (RHB-105):
TALICIA (RHB-105) is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A first Phase III study with TALICIA (ERADICATE Hp study) was completed in the U.S. with positive results. The study demonstrated an overall success rate of 89.4% in eradicating H. pylori and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard-of-care efficacy levels of 70%, with high statistical significance (p<0.001). A confirmatory Phase III study (ERADICATE Hp2 study) is ongoing in the U.S. Additional studies may be required, subject to FDA review. TALICIA was previously granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter (6 months) NDA review time by the FDA, if filed. If approved, TALICIA will also receive an additional five years of exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases and cancer. RedHill commercializes and promotes three gastrointestinal products in the U.S.: Donnatal – a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg – a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions; and EnteraGam – a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s key clinical-stage development programs include: (i) TALICIA (RHB-105) for the treatment of Helicobacter pylori infection with an ongoing confirmatory Phase III study and positive results from a first Phase III study; (ii) RHB-104 with an ongoing first Phase III study for Crohn’s disease and a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA (RHB-102) with positive results from a Phase III study for acute gastroenteritis and gastritis and positive results from a Phase II study for IBS-D; (iv) YELIVA (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase IIa study for cholangiocarcinoma; (v) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vi) RHB-107 (formerly MESUPRON), a Phase II-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at: www.redhillbio.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully promote Donnatal and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and commercialize EnteraGam; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 22, 2018. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

1 TALICIA (RHB-105) is an investigational new drug, not available for commercial distribution.

1 Hunt, R. H., et al. "Helicobacter pylori in developing countries." World Gastroenterology Organisation Global Guidelines (2010): 1-15.

1 Jerry Rosenblatt, Ph.D., member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. Pylori Eradication Market, May 18, 2015.

On May 4, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that it will report financial results for its 2018 first quarter on Wednesday, May 9, 2018, after market close (Press release, NantHealth, MAY 4, 2018, View Source;p=RssLanding&cat=news&id=2347044 [SID1234526122]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

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!

The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 8963439. The call will be broadcast via the Internet at www.nanthealth.com.

On May 4, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended March 31, 2018 (Press release, ImmunoGen, MAY 4, 2018, View Source [SID1234526121]).

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 have achieved a number of important milestones to start the year, led by the advancement of mirvetuximab soravtansine," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "Our FORWARD I registration trial continues as planned following the successful outcome of the pre-specified interim futility analysis and the completion of enrollment in the trial earlier than expected. This accelerated accrual reflects the significant interest expressed by the oncology community in mirvetuximab and the need for new treatments in platinum-resistant ovarian cancer. In addition, as we look to expand the eligible patient population for this program, we were also pleased to report encouraging data for mirvetuximab in combination with Keytruda from our FORWARD II trial at SGO in March and look forward to presenting additional data from FORWARD II during 2018, with a poster presentation at ASCO (Free ASCO Whitepaper) for the mirvetuximab and Avastin expansion cohort. Finally, with our continued evolution towards a commercial-stage company, we have strengthened our management team with the addition of Blaine McKee as Chief Business Officer."

Recent Progress

Mirvetuximab Soravtansine

In April, ImmunoGen announced the completion of patient enrollment two months ahead of schedule in its Phase 3 FORWARD I trial. FORWARD I is designed to support full approval of mirvetuximab as a single-agent therapy for platinum-resistant ovarian cancer.
In April, ImmunoGen successfully completed a pre-specified interim analysis for futility after 80 progression-free survival (PFS) events in FORWARD I. The study will continue as planned based on the recommendation of the Independent Data Monitoring Committee and the Company is on-track to report top-line results in first half of 2019.
In March, ImmunoGen presented data from the dose-escalation FORWARD II cohort evaluating mirvetuximab in combination with Keytruda (pembrolizumab) at the Society of Gynecologic Oncology (SGO) Annual Meeting, demonstrating encouraging efficacy and favorable tolerability in patients with platinum-resistant ovarian cancer. Notably, in the subset of eight patients with medium or high levels of folate receptor alpha (FRα) expression, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median PFS of 8.6 months (95% CI 1.6, upper bound not yet reached), and duration of response of 36.1 weeks. Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study and expects to present data from this cohort later this year.
Early-Stage Pipeline – Novel IGN Compounds

IMGN779 is a CD33-targeting ADC in a Phase 1 dose-finding study in relapsed/refractory acute myeloid leukemia (AML). Dose escalation is continuing with both biweekly and weekly dosing schedules. The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN779 for the treatment of AML.
IMGN632 is a CD123-targeting ADC in a Phase 1 dose-finding study for AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Research and Innovation

In April, ImmunoGen presented three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting the Company’s ongoing innovation in ADCs, including advancements to payloads and targets for enhanced anti-tumor activity as well as insights into factors that determine the clinical efficacy of ADCs.
Anticipated Upcoming Events

Report updated data from the FORWARD II mirvetuximab plus Avastin (bevacizumab) combination expansion cohort in approximately 50 patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting;
Anticipate partner Takeda to begin clinical testing of TAK-164 in 2Q 2018;
Report initial findings from the FORWARD II mirvetuximab plus pembrolizumab combination expansion cohort in 35 patients in the second half of the year;
Report additional data from IMGN779 Phase 1 dose finding study in 4Q 2018 and identify the recommended Phase 2 dose before the end of the year;
Report initial data from IMGN632 Phase 1 dose finding study in 4Q 2018; and
Advance ADAM9 program into IND-enabling activities before year-end.
Financial Results

Revenues for the quarter ended March 31, 2018 were $19.8 million, compared to $28.5 million for the quarter ended March 31, 2017. License and milestone fees of $11.5 million for the first quarter of 2018 included $10.9 million and $0.5 million of recognized upfront fees previously received from Takeda and Debiopharm, respectively, compared to recognition of $12.7 million of a non-cash fee related to the Company’s license agreement with CytomX and $6 million in partner milestone payments received in the first quarter of 2017. Revenues in the first quarter of 2018 included $7.2 million in non-cash royalty revenues, compared with $7.6 million for the same quarter in 2017, reflecting a change in accounting standards for recognizing royalty revenue. Revenues for the first quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $0.7 million of clinical materials revenue, compared with $1.5 million and $0.7 million, respectively, for the same quarter in 2017.

Operating expenses, including R&D and G&A expenses, for the first quarter of 2018 were $56.6 million, compared to $41.4 million for the same quarter in 2017. R&D expenses for the first quarter of 2018 increased to $44.8 million, compared to $32.9 million for the first quarter of 2017, primarily due to increased clinical trial and drug supply costs driven largely by the accelerated timing of completing patient enrollment in the FORWARD I Phase 3 clinical trial. General and administrative expenses increased in the first quarter of 2018 to $10.0 million, compared to $8.1 million in the same quarter of 2017, primarily due to increased third-party service fees and stock-based compensation. Operating expenses for the first quarter of 2018 also included a $1.7 million restructuring charge due to the workforce reduction related to the decommissioning of our Norwood facility as previously announced by the Company, compared to a $0.4 million charge in the same quarter of 2017 related to losses recorded on leased office space in Waltham.

ImmunoGen reported a net loss of $38.6 million, or $0.30 per basic and diluted share, for the first quarter of 2018, compared to a net loss of $17.3 million, or $0.20 per basic and diluted share, for the same quarter last year.

ImmunoGen had $218.4 million in cash and cash equivalents as of March 31, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $50.0 million for the first quarter of 2018, compared with $33.0 million for the first quarter of 2017. Capital expenditures were $1.0 million and $0.4 million for the first quarter of 2018 and 2017, respectively.

Financial Guidance

ImmunoGen has updated its operating expenses guidance for 2018. ImmunoGen now expects:

operating expenses between $200 million and $205 million.
Guidance for revenues and cash remains unchanged:

revenues between $60 million and $65 million; and
cash and cash equivalents at December 31, 2018 between $115 million and $120 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.

Conference Call Information
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 719-325-4799; the conference ID is 2070974. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 18, 2018.