On April 25, 2019 Celgene Corporation (NASDAQ:CELG) reported net product sales of $4,024 million for the first quarter of 2019, a 14 percent increase from the same period in 2018 (Press release, Celgene, APR 25, 2019, View Source [SID1234535404]). Celgene reported first quarter 2019 total revenue of $4,025 million, a 14 percent increase compared to $3,538 million in the first quarter of 2018.

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Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported net income of $1,545 million and diluted earnings per share (EPS) of $2.14 for the first quarter of 2019. For the first quarter of 2018, GAAP net income was $846 million and diluted EPS was $1.10.

Adjusted net income for the first quarter of 2019 increased 17 percent to $1,834 million compared to $1,572 million in the first quarter of 2018. For the same period, adjusted diluted EPS increased 24 percent to $2.55 from $2.05.

"In the first quarter, we delivered strong top- and bottom-line growth while advancing our innovative pipeline with multiple regulatory submissions in the U.S. and EU," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "Our excellent operating performance continues to generate positive momentum into the expected closing of the Bristol-Myers Squibb transaction during the third quarter of 2019."

First Quarter 2019 Financial Highlights

Unless otherwise stated, all comparisons are for the first quarter of 2019 compared to the first quarter of 2018. The adjusted operating expense categories presented below exclude share-based employee compensation expense, collaboration-related upfront expense, research and development asset acquisition 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 were $2,577 million, an increase of 15 percent year-over-year. U.S. sales of $1,686 million and international sales of $891 million increased 13 percent and 19 percent year-over-year, respectively. REVLIMID sales growth was driven by increases in treatment duration and market share
POMALYST/IMNOVID sales for the first quarter were $557 million, an increase of 23 percent year-over-year. U.S. sales were $390 million and international sales were $167 million, an increase of 30 percent and 9 percent year-over-year, respectively. POMALYST/IMNOVID sales growth was driven primarily by increases in treatment duration and market share
OTEZLA sales for the first quarter were $389 million, a 10 percent increase year-over-year. U.S. sales of $301 million and international sales of $88 million increased 9 percent and 14 percent year-over-year, respectively. OTEZLA sales growth in the U.S. was driven by increases in demand, while international sales were driven by continued expansion in key ex-U.S. markets.
ABRAXANE sales for the first quarter were $286 million, a 9 percent increase year-over-year. U.S. sales were $196 million and international sales were $90 million, an increase of 23 percent and a decrease of 13 percent year-over-year, respectively. ABRAXANE sales growth was driven primarily by increases in demand and customer buying patterns.
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 $215 million compared to $229 million in the first quarter of 2018.
Research and Development (R&D)

On a GAAP basis, R&D expenses were $1,216 million for the first quarter of 2019 compared to $2,203 million for the same period in 2018. Adjusted R&D expenses were $874 million for the first quarter of 2019 compared to $694 million for the first quarter of 2018. The current period included an increase in R&D expense associated with the acquisition of Juno Therapeutics and regulatory submission-related work on multiple programs. Additional R&D expenses (only included on a GAAP basis) decreased in 2019, as outlined in the attached Reconciliation of GAAP to Adjusted Net Income.

Selling, General and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $773 million for the first quarter of 2019 compared to $864 million for the same period in 2018. Adjusted SG&A expenses were $654 million for the first quarter of 2019 compared to $671 million for the first quarter of 2018. Additional SG&A expense (only included on a GAAP basis) decreased in 2019, as outlined in the attached Reconciliation of GAAP to Adjusted Net Income.

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

Operating cash flow was $1.5 billion in the first quarter of 2019, compared to $(325) million for the first quarter of 2018. Celgene ended the quarter with approximately $7.7 billion in cash, cash equivalents, marketable debt securities and publicly-traded equity securities.

2019 Product Sales and Earnings Guidance Reaffirmed

**Not meaningful as the 2019 measures exclude the impact of any strategic transactions, impairments, loss contingencies, changes in the fair value of equity investments, costs associated with the Bristol-Myers Squibb Company (Bristol-Myers Squibb) and Celgene transaction and non-operating tax adjustments that have not yet occurred.

Portfolio Updates

At the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, select oral data presentations include:
First clinical data from the phase I/II trial evaluating CELMoD agent iberdomide (CC-220) in patients with relapsed and/or refractory multiple myeloma (RRMM);
Updated data, including minimal residual disease (MRD) response, from the phase I TRANSCEND CLL-004 trial evaluating liso-cel in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL). Liso-cel recently received Regenerative Medicine Advanced Therapy (RMAT) designation in this setting. In addition, the Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for liso-cel in non-Hodgkin lymphoma (NHL) remains on-track for the second half of 2019;
Data from the phase III apact trial evaluating ABRAXANE as adjuvant therapy in patients with surgically resected pancreatic cancer. In March, Celgene announced that the phase III apact trial did not achieve the primary endpoint of improvement in disease-free survival, compared to gemcitabine alone. Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance, with ABRAXANE in combination with gemcitabine compared to gemcitabine alone. The safety profile observed in the apact study was consistent with previously reported studies of ABRAXANE.
Celgene reported top-line results from the phase III ROBUST trial evaluating REVLIMID plus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) chemotherapy (R2-CHOP) in patients with previously untreated activated B-cell (ABC) subtype diffuse large B-cell lymphoma (DLBCL). The trial did not meet the primary endpoint of demonstrating superiority in progression-free survival (PFS) compared to placebo plus R-CHOP. The safety profile of R2-CHOP was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
In April, Celgene and Acceleron Pharma announced the submission of a BLA to the U.S. FDA for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. In addition, Celgene plans to submit a marketing application for both indications to the European Medicines Agency (EMA) in April 2019.
In March, Celgene announced that the EMA Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for REVLIMID in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant and for POMALYST/IMNOVID in combination with bortezomib and dexamethasone (PVd) for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including REVLIMID.
In March, Celgene announced the submission of a New Drug Application (NDA) to the U.S. FDA for ozanimod in patients with relapsing forms of multiple sclerosis (RMS) and the submission of a Marketing Authorization Application (MAA) to the EMA for ozanimod in relapsing-remitting multiple sclerosis (RRMS). In addition, the phase III TRUE NORTH trial evaluating ozanimod in patients with ulcerative colitis (UC) completed enrollment in April.
In March, Celgene announced that the U.S. FDA granted Priority Review designation for the NDA for fedratinib in patients with myelofibrosis. The Prescription Drug User Fee Act (PDUFA) date for the submission is September 3, 2019. The EU MAA submission is now planned by year-end 2019.
In March, Roche announced the accelerated approval of TECENTRIQ (atezolizumab) in combination with ABRAXANE for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA approved test. This accelerated approval is based on results from the phase III IMpassion130 study.
In February, Celgene announced that the FDA granted Priority Review designation for the supplemental New Drug Application (sNDA) for REVLIMID in combination with rituximab (R²) in patients with relapsed and/or refractory indolent NHL. The PDUFA date for the submission is June 27, 2019.
Business Updates

On April 12, 2019, the stockholders of Celgene voted to adopt the proposed merger and the stockholders of Bristol-Myers Squibb voted to approve the issuance of shares of Bristol-Myers Squibb common stock in connection with the proposed merger. The parties continue to expect the transaction to close in the third quarter of 2019, subject to customary closing conditions and regulatory approvals.
First Quarter 2019 Earnings Information

Due to the pending transaction with Bristol-Myers Squibb, Celgene is not hosting a conference call in conjunction with its first-quarter 2019 earnings release and does not expect to do so for future quarters. Please direct any questions regarding this press release to Celgene Investor Relations or Celgene Communications.

On April 25, 2019 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the first quarter of fiscal year 2019 (Press release, Illumina, APR 25, 2019, View Source [SID1234535403]).

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First quarter 2019 results:

Revenue of $846 million, an 8% increase compared to $782 million in the first quarter of 2018
GAAP net income attributable to Illumina stockholders for the quarter of $233 million, or $1.57 per diluted share, compared to $208 million, or $1.41 per diluted share, for the first quarter of 2018
Non-GAAP net income attributable to Illumina stockholders for the quarter of $237 million, or $1.60 per diluted share, compared to $214 million, or $1.45 per diluted share, for the first quarter of 2018 (see the table entitled "Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $198 million compared to $255 million in the first quarter of 2018
Free cash flow (cash flow from operations less capital expenditures) of $142 million for the quarter compared to $165 million in the first quarter of 2018
Gross margin in the first quarter of 2019 was 69.1% compared to 68.8% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.2% for the first quarter of 2019 compared to 69.8% in the prior year period.

Research and development (R&D) expenses for the first quarter of 2019 were $169 million compared to $137 million in the prior year period. R&D expenses as a percentage of revenue were 20.0%, including 0.8% attributable to Helix. This compares to R&D expenses as a percentage of revenue of 17.5% in the prior year period, including 0.8% attributable to Helix.

Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $211 million compared to $183 million in the prior year period. Excluding acquisition-related expenses and amortization of acquired intangible assets, non-GAAP SG&A expenses as a percentage of revenue were 23.0%, including 0.7% attributable to Helix. This compares to 22.9% in the prior year period, including 1.1% attributable to Helix.

Depreciation and amortization expenses were $47 million and capital expenditures for free cash flow purposes were $56 million during the first quarter of 2019. At the close of the quarter, the company held $3.6 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of December 30, 2018.

"This was a strong start to the year, with $846 million in revenue and more than $1 billion in orders for the first time in Illumina’s history," said Francis deSouza, President and CEO. "Our growth is driven by a broad range of sequencing applications, with 14% sequencing consumable growth in the first quarter, including more than 20% growth in clinical sequencing consumables."

Updates since our last earnings release:

Launched the S Prime (SP) flow cell, enabling smaller batch sizes and lower output sequencing methods on the NovaSeq System
Launched TruSight Oncology 500 as a Research Use Only product, empowering laboratories with comprehensive genomic profiling
Authorized a share repurchase program to repurchase $550 million of outstanding common stock and repurchased approximately $63 million of common stock in the first quarter
Welcomed Susan E. Siegel to Illumina’s Board of Directors, adding leadership experience in personalized medicine and digital health
Accelerated Helix’s path to independence to allow Helix to address a broader opportunity in population and consumer genomics; as a result, Helix will be deconsolidated effective April 25, 2019
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2019, the company continues to expect revenue growth in the range of 13% to 14%, and now expects GAAP earnings per diluted share attributable to Illumina stockholders of $6.29 to $6.39 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $6.63 to $6.73 due to the favorable impact of the Helix deconsolidation.

Except for acquisition-related expenses incurred during the first quarter of 2019 which are reflected in our GAAP guidance, this guidance excludes any impact from the pending acquisition of Pacific Biosciences, which we expect to close in mid-2019.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, April 25, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (844) 647-5490, or 1 (615) 247-0295 outside North America, both with passcode 9153579.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income attributable to Illumina stockholders and diluted earnings per share attributable to Illumina stockholders are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

On April 25, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the first quarter ended March 31, 2019 (Press release, Seattle Genetics, APR 25, 2019, View Source [SID1234535402]). The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.

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"In the first quarter we achieved an important milestone toward becoming a multi-product oncology company with the announcement of positive topline results from the pivotal trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer, and we plan to submit an application for approval to the FDA in 2019," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We continue to execute on expanding ADCETRIS use in the two frontline indications, and maintain our 2019 net sales guidance of $610 million to $640 million in the U.S. and Canada. We have also advanced our other late-stage programs, including reaching target enrollment in the HER2CLIMB pivotal trial of tucatinib in HER2-positive metastatic breast cancer. We expect to report topline results from HER2CLIMB in 2019."

ADCETRIS and Late-Stage Pipeline Highlights

ADCETRIS Ex-U.S. Regulatory Activities in Frontline Hodgkin Lymphoma: In February 2019, Takeda received approval from the European Commission to extend the marketing authorization for ADCETRIS to include ADCETRIS in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients with previously untreated CD30-positive stage IV classical Hodgkin lymphoma. As a result, Seattle Genetics received a $30 million milestone payment from Takeda.
Enfortumab Vedotin (EV) Pivotal Trial Positive Topline Results; Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting: In March 2019, Seattle Genetics and Astellas announced positive topline results from the first cohort of the EV-201 clinical trial that enrolled 128 patients with locally advanced or metastatic urothelial cancer who previously received both platinum chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The companies plan to submit a Biologics License Application under the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway in 2019.
Tucatinib HER2CLIMB Pivotal Trial Update: Seattle Genetics previously announced enrollment of 480 patients in the HER2CLIMB trial to enable analysis of the primary endpoint of progression-free survival (PFS), with topline data expected to be reported in 2019. In April 2019, Seattle Genetics achieved enrollment of 120 additional patients in HER2CLIMB to reach the target enrollment of 600 patients to support the analyses of key secondary endpoints, including overall survival as well as PFS in patients with brain metastases.
Tisotumab Vedotin (TV) innovaTV 204 Pivotal Trial Update: In March 2019, Seattle Genetics and Genmab completed enrollment in the innovaTV 204 pivotal trial evaluating TV in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. The trial is designed to support a potential regulatory submission under the FDA’s accelerated approval pathway.
FIRST QUARTER 2019 FINANCIAL RESULTS

Revenues: Total revenues in the first quarter ended March 31, 2019 increased to $195.2 million, compared to $140.6 million for the same period in 2018. Revenues are comprised of the following three components:

Net Product Sales: ADCETRIS net sales for the U.S. and Canada in the first quarter were $135.0 million, a 42 percent increase over net sales of $95.4 million in the first quarter of 2018.
Royalty Revenues: Royalty revenues in the first quarter were $15.6 million, compared to $15.7 million in the first quarter of 2018. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda. First quarter 2019 net sales of ADCETRIS in Takeda’s territories increased over the comparable period in 2018; however, royalty revenues for the period in 2018 included additional amounts attributable to Takeda’s portion of certain third-party royalty obligations that expired at the end of 2018.
Collaboration and License Agreement Revenues: Amounts earned under the company’s ADCETRIS and ADC collaborations were $44.6 million in the first quarter of 2019, compared to $29.6 million for the same period in 2018. Collaboration revenues for the first quarter of 2019 included the earned portion of a $30.0 million milestone from Takeda triggered by European Commission approval of ADCETRIS in combination with AVD in adult patients with previously untreated CD30-positive stage IV classical Hodgkin lymphoma.
Research and Development (R&D) Expenses: R&D expenses in the first quarter were $158.3 million, compared to $152.5 million in the first quarter of 2018. The increase reflects additional investment in the company’s late-stage pipeline including EV, tucatinib and TV.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the first quarter were $80.3 million, compared to $66.2 million in the first quarter of 2018. The increase was primarily attributed to costs to support commercialization efforts related to frontline ADCETRIS indications, the company’s late-stage programs and higher infrastructure costs to support the company’s continued growth.

Non-cash, share-based compensation cost for the first three months of 2019 was $25.7 million, compared to $16.8 million for the same period in 2018.

Net Loss

Net loss for the first quarter of 2019 was $13.3 million, or $0.08 per diluted share, compared to a net loss of $111.7 million, or $0.73 per diluted share, for the first quarter of 2018. Net loss in the first quarter of 2019 included a non-cash net investment gain of $38.1 million associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market.

Cash and Investments

As of March 31, 2019, cash and investments were $418.3 million. In addition, the company held stock investments, primarily in Immunomedics common stock, valued at $151.9 million.

2019 FINANCIAL OUTLOOK

The company’s 2019 financial guidance is detailed below, including updates to its expectations for R&D and SG&A expenses driven primarily by positive results from the EV-201 pivotal trial.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its first quarter 2019 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 877-260-1479 (domestic) or 334-323-0522 (international). The conference ID is 6169352. A replay of the live event and supporting slides will be available for at least 30 days. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 6169352. The telephone replay will be available until 5:00 p.m. PT on April 29, 2019.

On April 25, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that abstracts related to trials of the company’s lead therapeutic, vofatamab, have been accepted for presentation at the upcoming 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 31 to June 4, 2019 in Chicago, Illinois (Press release, Rainier Therapeutics, APR 25, 2019, View Source [SID1234535401]).

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"We are pleased to have abstracts related to our ongoing Phase 2 vofatamab trials accepted for a poster discussion and poster presentations at ASCO (Free ASCO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes a preliminary analysis of clinical activity in FIERCE-22 and an interim analysis in FIERCE-21."

Poster Discussion & Poster Presentation:

FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.

Abstract: 4511

Poster Discussion Session: Genitourinary (Nonprostate) Cancer
Date/Time: Monday, June 3, 2019, 4:30 PM – 6:00 PM,
Location: Hall D2

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #337
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM,
Location: Hall A

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

Poster Presentation:

Interim analysis of the FIERCE-21 phase 2 (P2) study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Abstract: 4547

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #373
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM
Location: Hall A

Presenter: Begona Mellado, MD, PhD, Hospital Clinic de Barcelona

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-21 and FIERCE-22.

FIERCE-21 is a Phase 2 trial evaluating vofatamab in combination with docetaxel and separately vofatamab as monotherapy in patients with locally advanced or metastatic bladder cancer with FGFR3 mutation/fusions who have relapsed after, or are refractory to, at least one prior line of chemotherapy.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

For additional information on FIERCE-21, please visit www.clinicaltrials.gov (NCT02401542) and for more information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).

Rainier Therapeutics also plans to study vofatamab in non-muscle invasive bladder cancer (NMIBC) – the FIERCE-23 trial.

On April 25, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported results for the first quarter of 2019 and increased its full-year 2019 earnings outlook (Press release, Baxter, APR 25, 2019, View Source [SID1234535400]).

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"We are pleased with the solid start to 2019, establishing a foundation for accelerating performance over the course of the year," said José (Joe) E. Almeida, chairman and chief executive officer. "Our first quarter results reflect the value of our diversified portfolio, an increased emphasis on high-value innovation and an ongoing focus on operational excellence. We remain committed to executing on our strategy to deliver enhanced performance in 2019 and beyond."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $2.6 billion, a decrease of 2% on a reported basis and an increase of 2% on both a constant currency and an operational basis. Operational sales in the first quarter exclude the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

Sales in the U.S. totaled $1.1 billion, decreasing 2% on both a reported and operational basis. International sales of $1.5 billion decreased 1% on a reported basis and increased 5% on a constant currency basis.

Performance in the quarter was driven by growth of Baxter’s peritoneal dialysis and continuous renal replacement therapies, certain generic injectable pharmaceuticals, and hemostats and sealants. In addition, increased demand for Baxter’s hospital pharmacy compounding and cytotoxic contract manufacturing services also contributed to growth in the quarter. Sales growth in the quarter was partially offset by expected lower sales of Medication Delivery and Nutritional therapies. Baxter’s performance in International markets reflects growth across both the Europe, Middle East and Africa (EMEA) and Asia Pacific (APAC) regions.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter’s three geographic segments and six global business units (GBUs).

Baxter reported net income of $347 million, or $0.66 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results include special items totaling $52 million after-tax, which were primarily related to business optimization charges and intangible asset amortization, partially offset by an insurance recovery from a legacy product-related matter. On an adjusted basis, Baxter’s first quarter net income totaled $399 million, or $0.76 per diluted share, ahead of the company’s expectations of $0.66 to $0.68 per diluted share. Adjusted earnings per diluted share advanced 9% in the quarter, driven by solid operational performance as well as benefits from a lower tax rate and share count as compared to the prior-year period.

Business Highlights

Baxter continues to achieve notable milestones in pursuit of its Mission for patients and emphasis on accelerating profitable growth. Among recent highlights, the company:

Launched ready-to-use eptifibatide, a platelet aggregation inhibitor that prevents platelets from sticking together and clotting, using the company’s proprietary GALAXY container technology. Baxter’s premix presentation is the first of its kind available in a flexible container, offering healthcare providers preparation efficiencies and helping to avoid potential dosing errors.
Announced U.S. Food and Drug Administration (FDA) approval for faster preparation of Floseal Hemostatic Matrix. This next generation of Floseal has 20% fewer components and steps to prepare,2 making it easier and faster for operating room nurses to get Floseal into the hands of surgeons to help stop bleeding during procedures.
Initiated a collaboration with bioMérieux, a world leader in the field of in vitro diagnostics, to develop future biomarkers with the goal of rapidly identifying and informing treatment of acute kidney injury (AKI). The efforts are meant to help diagnose AKI earlier so a patient can have improved therapy options, reflecting Baxter’s growth strategy of addressing patient needs across the continuum of care.
Announced that a NantHealth digital health solution is now available to connect Baxter’s Prismaflex technology, used in the intensive care unit to treat patients with acute kidney injury, to a hospital’s electronic medical record (EMR) system. Digitally connected healthcare solutions have the potential to positively impact patient care in many ways, from reducing reliance on manual documentation to converting data into meaningful insights to improve care.
Announced the planned U.S. launch of Clinolipid (20% Lipid Injectable Emulsion), Baxter’s proprietary olive oil-based lipid emulsion, later this year. The announcement was made at the 2019 ASPEN Nutrition Science & Practice Conference, where Baxter featured its diverse portfolio of parenteral nutrition products to address and help improve care for malnourished patients.
Received recognition from multiple organizations for its commitment to workplace excellence, including:
Forbes Magazine, which included Baxter on its annual list of America’s Best Large Employers for the fifth consecutive year.
The National Association for Female Executives (NAFE), which cited Baxter among its 2019 NAFE Top Companies for Executive Women.
The Human Rights Campaign Foundation (HRC), which cited Baxter as a 2019 Best Place to Work for LGBTQ Equality based on Baxter’s perfect score on HRC’s Corporate Equality Index.
2019 Financial Outlook

For full-year 2019: Based on solid first quarter performance, Baxter is raising its earnings outlook for 2019. The company now expects adjusted earnings from continuing operations, before special items, of $3.27 to $3.35 per diluted share. The company continues to expect sales growth of 0 to 1 percent on a reported basis, 2 to 3 percent on a constant currency basis and 3 to 4 percent on an operational basis.

For second-quarter 2019: The company expects sales to decline approximately 2 percent on a reported basis, and to grow approximately 2 percent on a constant currency basis and 2 to 3 percent on an operational basis. The company expects adjusted earnings from continuing operations, before special items, of $0.80 to $0.82 per diluted share.

Full-year and quarterly operational sales estimates for 2019 have been adjusted for the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

A webcast of Baxter’s first-quarter 2019 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 25, 2019. Please see www.baxter.com for more information regarding this and future investor events and webcasts.