1stOncology™: Cancer Intelligence Service – Page 15385 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Astellas Reports Financial Results for FY2017

On April 26, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported the financial results for fiscal year 2017 ending March 31, 2018 ("FY2017") (Press release, Astellas Pharma US, APR 26, 2018, View Source [SID1234525731]).

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!

"Key global products including XTANDI continued to demonstrate steady growth in FY2017. We also have made continual investments in the creation of future innovation, including the acquisition of Universal Cells, Inc. in February 2018. The additional cell therapy capabilities of Universal Cells, including proprietary Universal Donor Cell technology, enables Astellas to accelerate our innovative research and development focus within cell therapy," said Kenji Yasukawa, Ph.D., president and CEO, Astellas. "We remain committed to creating medical solutions from a multi-dimensional perspective – including disease, biology and modality – to turn innovative science into value for patients."

Sales Highlights
Sales in FY2017 decreased 0.9% compared to those in the previous fiscal year ("year-on-year") to ¥1,300.3 billion due to the impact of certain items such as the transfer of the global dermatology business in April 2016 and the transfer of long-listed products in Japan in April 2017.

Oncology franchise
Sales of XTANDI increased 16.8% year-on-year to ¥294.3 billion. Sales grew steadily in all regions of the world.

Urology OAB franchise
Sales of Betanis / Myrbetriq / BETMIGA increased 27.2% year-on-year to ¥125.7 billion. Sales increased in all regions of the world. Sales of Vesicare, however, decreased 11.9% year-on-year to ¥102.3 billion.

Transplantation franchise
Sales of Prograf increased 6.6% year-on-year to ¥198.5 billion, and continued to grow in EMEA1 and the Asia and Oceania regions.

Other new and key products
In the Japanese market, continued growth was achieved for products such as Celecox for the treatment of inflammation and pain, Symbicort for the treatment of bronchial asthma, Suglat for the treatment of type 2 diabetes, and Cimzia for the treatment of adult patients with rheumatoid arthritis. Meanwhile, we have been working on steadily increasing market penetration for new products Repatha for the treatment of hypercholesterolemia (launched in April 2016) and Linzess for the treatment of irritable bowel syndrome with constipation (launched March 2017). In the Americas, sales of azole antifungal CRESEMBA grew.

Sales by Region2
Sales in Japan and EMEA decreased, while sales in the Americas and the Asia and Oceania increased. As for the Japanese market, sales decreased 15.3% year-on-year to ¥383.4 billion largely due to the impact of transferring 16 long-listed products in April 2017, and the introduction of generics for Micardis for the treatment of hypertension in June 2017. In EMEA, sales decreased due to the continued impact of transferring the dermatology business in April 2016, yet sales increased when excluding this item.

FY2018 Guidance
The forecasts for fiscal year 2018 ending March 31, 2019 ("FY2018") (core basis) are as shown in the following table. The sales forecast is ¥1,278.0 billion (- 1.7% year-on-year). Core operating profit is forecasted at ¥262.0 billion (-2.5% year-on-year). In FY2018, we expect negative impact on sales and profit due to a decreased amount of recognized deferred income following the transfer of the global dermatology business and the transfer of long-listed products in Japan, foreign exchange, and other factors. Despite the negative impact of the NHI drug price revision in Japan and other factors, we are forecasting sales and core operating profit, excluding the factors associated with previously discussed business transfers and the impact of foreign exchange, to remain largely unchanged year-on-year.

Strategic Highlights in FY2017

Astellas continues to create sustainable growth over the mid-to-long term through the pursuit of three main strategies: "Maximizing the Product Value," "Creating Innovation" and "Pursuing Operational Excellence." The company achieved many accomplishments against these strategies as outlined below:

Maximizing the Product Value

Continued to maximize the growth of the Oncology franchise centered on XTANDI and the Urology OAB franchise including Vesicare and Betanis / Myrbetriq / BETMIGA with new launches across various countries and a growth in franchise sales globally.

In January 2018, Amgen Astellas BioPharma K.K. launched sales in Japan of the Repatha SC injection 420 mg Auto Mini Doser, an additional dosage formulation of Repatha.

In November 2017, executed a co-promotion agreement in Japan with MSD K.K. for SUJANU Combination Tablets, a combination drug of the DPP-4 inhibitor sitagliptin phosphate hydrate (JANUVIA Tablets) and Suglat Tablets.

Creating Innovation
The following are highlights of developments with external partners announced during FY2017.

In April 2017, the Alliance Station was opened by Astellas and Kyoto University as part of a new open innovation initiative to develop advanced medical treatments.

In May 2017, completed the acquisition of Ogeda SA in Belgium and gained the NK3 receptor antagonist fezolinetant (ESN364), which is in development for menopause-related vasomotor symptoms.

In May 2017, signed an agreement to broaden the scope of an existing collaborative research agreement with the Institute of Medical Science of the University of Tokyo utilizing the MucoRice rice-based oral vaccine. Furthermore, in December 2017, a collaborative research agreement was signed aiming at the practical application of the rice-based oral vaccine MucoRice-CTB with the Institute of Medical Science of the University of Tokyo, Chiba University, and ASAHI KOGYOSHA CO., LTD.

In October 2017, launched "JOINUS," a new drug discovery program using a drug-repositioning compound library jointly conducted by Astellas, Mitsubishi Tanabe Pharma, and Daiichi Sankyo.

In October 2017, entered into an exclusive worldwide license agreement with Universal Cells Inc. for the worldwide research, development, and commercialization of new cell therapies and acquired Universal Cells Inc. in February 2018.

In November 2017, exercised an exclusive option right to acquire Mitobridge, Inc. and in January 2018, Mitobridge, Inc. became a wholly-owned subsidiary of Astellas.

In February 2018, entered into a global exclusive licensing agreement on development / commercialization of an immunostimulating gene loading oncolytic virus with Tottori University.

The following are the main development advances achieved during FY2017.

In January 2018, filed applications in Europe and the U.S. for approval of an additional indication for non-metastatic castration-resistant prostate cancer based on the results of the Phase 3 PROSPER trial obtained in September 2017. Furthermore, in February 2018, an approval of XTANDI Tablets (additional dosage form) was received in Japan for castration-resistant prostate cancer.

FLT3/AXL inhibitor gilteritinib (ASP2215) was granted Orphan Drug designation in the U.S. in July 2017, in Europe in January 2018, and in Japan in March 2018. Furthermore, gilteritinib received Fast Track Designation in the U.S. in October 2017 for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia.

In May 2017, MSD K.K filed an application for approval in Japan with regard to the indication of type 2 diabetes for SUJANU Combination Tablets, a combination drug of JANUVIA Tablets and Suglat Tablets. In March 2018, MSD K.K. obtained the approval.

In June 2017, filed an application for approval in the U.S. for the use of mirabegron in combination with solifenacin 5 mg.

In July 2017, filed an application for marketing approval in Japan with regard to fidaxomicin for the treattment of infectious enteritis.

In August 2017, Amgen Astellas BioPharma K.K. obtained approval in Japan for the Repatha SC Injection 420 mg Auto Mini Doser (additional dosage formulation).

In September 2017, filed an application for approval for Linzess in Japan, as an additional indication for chronic constipation.

In November 2017, submitted a new drug application in Japan for a 12-week extended-release formulation of Gonax for the treatment of prostate cancer (additional dosage formulation).

In January 2018, Amgen Astellas BioPharma K.K. submitted an application in Japan for the bispecific CD19-directed CD3 T cell engager antibody construct blinatumomab (AMG103) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

In January 2018, submitted an application for the additional indication of Suglat for the treatment of type 1 diabetes mellitus in Japan.

In February 2018, obtained approval in Europe for solifenacin (YM905) oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 to 18 years.

In March 2018, enfortumab vedotin, an Antibody-Drug Conjugate (ADC), was granted Breakthrough Therapy Designation in the U.S.

Pursuing Operational Excellence
The following are the main operational excellence initiatives engaged during FY2017.

In April 2017, the asset purchase agreement to allow the transfer of 16 long-listed products in Japan to LTL Pharma Co., Ltd. came into effect. In FY2017, the affected products were transferred to LTL Pharma Co., Ltd.

In April 2017, we established a new global function that will manage the respective regional legal functions and intellectual property functions of Japan, the Americas, EMEA, and Asia and Oceania.

In October 2017, transferred to Maruho Co., Ltd. the manufacturing and marketing approvals in Japan for Protopic, a treatment for atopic dermatitis.

Terminated research operations of Agensys, Inc. by March 2018.

[Enhancing and strengthening the corporate governance system]

Resolved at the meeting of the Board of Directors held in January 2018 to transition to a company with an Audit & Supervisory Committee. This results in further enhancing deliberation on matters such as business strategy in the Board of Directors and further strengthening the supervisory functions of the Board of Directors.

The transition is subject to approval at the Company’s 13th Term Annual Shareholders Meeting to be held in June 2018.

Alnylam to Webcast Conference Call Discussing First Quarter 2018 Financial Results

On April 26, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the first quarter ending March 31, 2018 on Thursday, May 3, 2018, after the U.S. financial markets close (Press release, Alnylam, APR 26, 2018, http://investors.alnylam.com/news-releases/news-release-details/alnylam-webcast-conference-call-discussing-first-quarter-2018 [SID1234525730]).

Management will provide an update on the Company and discuss first quarter 2018 results as well as expectations for the future via conference call on Thursday, May 3, 2018 at 4:30 pm ET. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 3294608. A replay of the call will be available beginning at 7:30 pm ET on the day of the call. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international) and refer to conference ID 3294608.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

Aduro Biotech Presents Early Observations From its Personalized Neoantigen-based pLADD Therapy Clinical Study at European Neoantigen Summit

On April 26, 2018 Aduro Biotech, Inc. (Nasdaq:ADRO) reported preliminary observations from a case study of a patient with metastatic colorectal cancer treated in Aduro’s ongoing Phase 1 study of its personalized neoantigen-based immunotherapy (pLADD) (Press release, Aduro Biotech, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344899 [SID1234525729]). This Phase 1 proof-of-concept study is designed to evaluate the safety and tolerability of pLADD immunotherapy in adults with metastatic colorectal cancer that is microsatellite stable (MSS). Data were presented at the European Neoantigen Summit held in Amsterdam (April 24-26, 2018).

The immunological data presented demonstrated that neoantigens isolated and sequenced from the patient’s tissue samples, and engineered into a personalized immunotherapy, induced neoantigen-specific CD8+ T cells undetectable before pLADD treatment started. In addition to adaptive immunity, pLADD induced an innate response exemplified by gamma delta T cells, also thought to be important for successful immunotherapy. The patient’s neoantigens were selected using state-of-the-art algorithm identification technology developed by Aduro’s collaborator, Hanlee Ji, M.D., associate professor of medicine at the Stanford University School of Medicine.

"Although early, the immunological data obtained from this case study is encouraging, as it indicates that our pLADD immunotherapy has the potential to induce a sustained, antigen-specific effect on the immune system," said Andrea van Elsas, Ph.D., chief scientific officer of Aduro. "We believe our pLADD approach could offer a differentiated treatment option to patients with MSS colorectal cancer, who represent the vast majority of the colorectal cancer patient population and who have not been responsive to immune checkpoint inhibitors. In addition, these preliminary observations support our plan to combine pLADD with checkpoint inhibitors, which we believe could enhance the overall response in this patient setting. We look forward to reporting additional immunological data from this Phase 1 trial before the end of 2018."

Preclinical data presented showed that mouse pLADD strains targeting tumor-specific neoepitopes induced a robust immune response, including induction of cytokines, chemokines, and antigen-specific CD8+ T cells. In preclinical models of pLADD, remodeling of the tumor microenvironment with an increase in the CD8:Treg ratio was observed. The combination of pLADD with an anti-PD-1 antibody led to a sustained immune response and significantly improved efficacy in these mouse tumor models.

Clinical Design of Phase 1 pLADD Trial in Adults with Metastatic Corlorectal Cancer
The Phase 1 single-arm clinical trial (see www.clinicaltrials.gov, identifier NCT03189030) is designed to evaluate the safety and tolerability of a personalized immunotherapy using patient-specific neoantigens and Aduro’s proprietary Listeria platform technology. The trial is enrolling patients with metastatic colorectal cancer that is microsatellite stable.

About pLADD
Personalized LADD, or pLADD, is a second-generation LADD technology that is designed to leverage the immune-activating activity of the Listeria bacterial vector in combination with neoantigens, which are unique, patient-specific tumor markers exclusively expressed in an individual’s tumor cells. Once administered, pLADD therapies are expected to mobilize the immune system in two ways–first, through the immediate recognition of the presence of Listeria as being foreign, and subsequently, through a specific and customized immune attack on cells containing the tumor neoantigens presented by pLADD.

To create a patient-specific pLADD therapy, a physician begins by removing tumor cells from the patient. These cells are analyzed in order to molecularly characterize (sequence) the tumor, including any mutations that are unique to the patient’s own tumor cells. Predictive algorithms for antigen processing are run to identify pertinent tumor antigens. Aduro then creates a pLADD strain engineered to enable the presentation of multiple selected neoantigens in dendritic cells, with the aim of inducing a targeted, robust anti-cancer immune response.

Aduro received an exclusive license (for use with Listeria based therapetutics) to the proprietary bioinformatics algorithms and computational workflows for neoantigen identification and selection from Stanford University based on technology developed by Dr. Hanlee Ji. The accurate identification of neoantigens, tumor markers that are unique to an individual’s tumor, is believed to be critical in the development of a patient-specific cancer treatment. Aduro’s LADD technology, which has been shown in clinical studies to remodel the tumor microenvironment, will be used to create a patient-specific immunotherapy that is engineered to enable the presentation of multiple selected neoantigens in dendritic cells, with the aim of inducing a targeted, robust anti-cancer immune response.

AbbVie Reports First-Quarter 2018 Financial Results

On April 26, 2018 AbbVie (NYSE:ABBV) reported its financial results for the first quarter ended March 31, 2018 (Press release, AbbVie, APR 26, 2018, View Source [SID1234525728]).

"AbbVie is off to an excellent start in 2018, delivering first quarter revenue and EPS growth well ahead of expectations," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Since our inception, we have strived to create a business that has multiple strong growth drivers. This quarter clearly demonstrates that level of diversity, with HUMIRA, IMBRUVICA and MAVYRET all delivering significant contributions to our growth. Based on the robust performance of the business, we are increasing our full-year EPS guidance, with the new midpoint reflecting industry-leading year-over-year growth of 38 percent."

First-Quarter Results

Worldwide net revenues were $7.934 billion in the first quarter, up 21.4 percent year-over-year on a GAAP basis. On an operational basis, net revenues increased 17.6 percent, excluding a 3.8 percent favorable impact from foreign exchange.
Global HUMIRA sales increased 14.4 percent on a reported basis, or 10.7 percent operationally, excluding a 3.7 percent favorable impact from foreign exchange. In the U.S., HUMIRA sales grew 11.4 percent in the quarter. Internationally, HUMIRA sales grew 9.3 percent, excluding a 10.7 percent favorable impact from foreign exchange.
First-quarter global IMBRUVICA net revenues were $762 million, with U.S. sales of $624 million and international profit sharing of $138 million for the quarter, reflecting growth of 38.5 percent.
First-quarter global HCV net revenues were $919 million.
On a GAAP basis, the gross margin ratio in the first quarter was 75.7 percent. The adjusted gross margin ratio was 80.2 percent.
On a GAAP basis, selling, general and administrative expense was 22.6 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues.
On a GAAP basis, research and development expense was 15.7 percent of net revenues. The adjusted R&D expense was 15.0 percent, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the first quarter was 36.6 percent. The adjusted operating margin was 44.1 percent.
On a GAAP basis, net interest expense was $251 million. On a GAAP basis, the tax rate in the quarter was 0.5 percent. The adjusted tax rate was 7.6 percent.
Diluted EPS in the first quarter was $1.74 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.87, up 46.1 percent.
Recent Events

AbbVie submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for risankizumab for treatment of patients with moderate to severe plaque psoriasis. The company expects to submit its regulatory filing with the European Medicines Agency (EMA) imminently. The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe chronic plaque psoriasis across four Phase 3 studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. Risankizumab is being developed in collaboration with Boehringer Ingelheim.
At the Annual Meeting of the American Academy of Dermatology (AAD), AbbVie presented new positive results from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab compared to placebo or ustekinumab for the treatment of patients with moderate to severe plaque psoriasis. In the ultIMMa-1 and ultIMMa-2 trials, risankizumab met all co-primary and ranked secondary endpoints, demonstrating significantly higher rates of skin clearance at week 16 and at one year of treatment, compared to ustekinumab. In addition, through one year of treatment, significantly more patients receiving risankizumab self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 compared with ustekinumab. The safety profile was consistent with all previously reported studies, and there were no new safety signals detected across the studies.
AbbVie announced positive top-line results from the Phase 3 SELECT-COMPARE trial, which evaluated the company’s oral JAK-1 selective inhibitor, upadacitinib, in patients with moderate to severe rheumatoid arthritis who were on a stable background of methotrexate and had an inadequate response. The results showed that after 12 weeks, upadacitinib (15 mg, once-daily) met the study’s primary endpoints of ACR20 and clinical remission, and all ranked secondary endpoints versus either placebo or adalimumab. Additionally, following 26 weeks of treatment, upadacitinib significantly inhibited radiographic progression (mTSS) from baseline, compared to placebo. The safety profile of upadacitinib was consistent with previously reported Phase 3 SELECT trials and the Phase 2 studies, with no new safety signals detected. The company expects to report data from an additional pivotal study (SELECT-EARLY) and submit regulatory applications later this year, with commercialization anticipated in 2019.
At the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), AbbVie presented new 52 week data from the Phase 2 CELEST study, which evaluated upadacitinib in adult patients with moderately to severely active Crohn’s disease, the majority of whom had failed two or more biologics. Results from the 16-week induction phase were previously presented at Digestive Disease Week in May 2017. Patients who responded to treatment in the 16-week induction phase entered the 36-week double-blinded extension phase of the study, which evaluated multiple dosing regimens of upadacitinib through one year. Results of the CELEST extension phase showed that many patients treated with upadacitinib who achieved clinical response after the 16-week induction phase maintained their response to treatment after the 36-week extension phase. The overall safety profile of upadacitinib in the CELEST study was consistent with that observed in other upadacitinib studies, with no new safety signals detected. Phase 3 trials evaluating upadacitinib in Crohn’s disease are ongoing.
AbbVie presented at AAD new positive results from a Phase 2b study evaluating upadacitinib in patients with moderate to severe atopic dermatitis. AbbVie previously announced positive top-line data demonstrating that all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percentage change in the Eczema Area and Severity Index (EASI) score versus placebo) and all skin and itch-specific secondary endpoints at 16 weeks. AbbVie also presented data showing significant reduction of select symptoms, including reduction in itch (pruritus) at Week 1 and improvement in the extent and severity of skin lesions at Week 2, across all doses. Based on the Phase 2b results, the FDA granted Breakthrough Therapy Designation for upadacitinib in atopic dermatitis. The Phase 3 program for upadacitinib in atopic dermatitis is expected to begin later this year.
AbbVie announced top-line results from the Phase 2 TRINITY study evaluating rovalpituzumab tesirine (Rova-T) for third-line treatment of patients with DLL3-expressing relapsed/refractory (R/R) small cell lung cancer (SCLC). Although Rova-T demonstrated single agent responses in advanced SCLC patients, after consulting with the FDA, based on the magnitude of effect across multiple parameters in this single-arm study, the company will not seek accelerated approval for Rova-T in third-line R/R SCLC. Safety data in the TRINITY study were consistent with previously reported studies of Rova-T. The full TRINITY data have been submitted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Ongoing Phase 3 studies, MERU and TAHOE, will continue to investigate Rova-T in first- and second-line SCLC, with readouts expected in the 2020 timeframe.
AbbVie, in cooperation with Neurocrine Biosciences, announced notification by the FDA that extended time is required to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to the third quarter of 2018. The NDA for elagolix is supported by data from the largest prospective randomized clinical trials conducted to date for endometriosis. The safety and efficacy of elagolix were evaluated in nearly 1,700 women with moderate-to-severe endometriosis-associated pain. Based on AbbVie’s review of the data, the company remains confident in its NDA and anticipates approval in the third quarter.
AbbVie, also in cooperation with Neurocrine Biosciences, announced positive top-line results from the Phase 3 ELARIS UF-I and ELARIS UF-II studies evaluating elagolix (300 mg twice daily) alone and in combination with low-dose hormone (add-back) therapy in women with uterine fibroids. At month six, elagolix, in combination with add-back therapy, met the primary efficacy endpoint in both studies, demonstrating reduced heavy menstrual bleeding compared to placebo. All ranked secondary endpoints in both studies were also met. The observed safety profile of elagolix in both Phase 3 studies was similar to observations in prior Phase 2 studies in uterine fibroids, which included hypoestrogenic effects, such as hot flush and reduction in bone mineral density. Data from both pivotal studies will support regulatory submissions for elagolix in uterine fibroids and will be presented at a medical conference later this year.
Following reports of inflammatory encephalitis and meningoencephalitis and the initiation of an Article 20 referral procedure by the EMA, AbbVie, together with Biogen, announced the voluntary worldwide withdrawal of ZINBRYTA for relapsing multiple sclerosis. Given the nature and complexity of reported adverse events, characterizing the evolving benefit/risk profile of ZINBRYTA would not be possible going forward given the limited number of patients being treated.
AbbVie and Voyager Therapeutics announced an exclusive strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases. This collaboration combines AbbVie’s monoclonal antibody expertise, global clinical development and commercial capabilities with Voyager’s gene therapy platform and expertise that enables generating adeno-associated viral vectors for the treatment of neurodegenerative diseases.
AbbVie announced a global resolution of all intellectual property-related litigation with Samsung Bioepis over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Samsung Bioepis a non-exclusive license to AbbVie’s intellectual property relating to HUMIRA beginning on certain dates in certain countries in which AbbVie has intellectual property, including on June 30, 2023 in the U.S. and on October 16, 2018 in most countries in the European Union. Under the terms of the agreement, Samsung Bioepis will pay royalties to AbbVie for licensing its HUMIRA patents once its adalimumab biosimilar product is launched.
AbbVie announced that its board of directors increased the company’s quarterly cash dividend by 35 percent from $0.71 per share to $0.96 per share and authorized a new $10 billion stock repurchase program. The cash dividend is payable May 15, 2018 to stockholders of record at the close of business on April 13, 2018. Since the company’s inception in 2013, AbbVie has increased its dividend by 140 percent.
Full-Year 2018 Outlook

AbbVie is updating its GAAP diluted EPS for the full-year 2018 to $6.82 to $6.92. AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2018 from $7.33 to $7.43 to $7.66 to $7.76. The midpoint of this guidance reflects year-over-year growth of 38 percent. The company’s 2018 adjusted diluted EPS guidance excludes $0.84 per share of intangible asset amortization expense, changes in the fair value of contingent consideration, a one-time net tax benefit related to the timing of the phase in of provisions of the U.S. tax reform legislation on certain subsidiaries, and other specified items.

AbbVie’s adjusted EPS guidance range reflects an effective tax rate approaching 9 percent in 2018. In 2018, AbbVie will experience a one-time net tax benefit related to the timing of the phase in of provisions of the new legislation on certain subsidiaries. This benefit has been excluded from the adjusted EPS guidance, and included in the GAAP guidance range.

AbbVie continues to anticipate the company’s adjusted effective tax rate to increase to 13 percent over the next five years as a result of increased domestic income and investment.

Tender Offer for Common Stock

AbbVie is announcing today that it plans to commence a tender offer to purchase for cash up to $7.5 billion in value of shares of its common stock through a modified "Dutch auction" tender offer at a specified price range to be determined. AbbVie expects to commence the tender offer as early as May 1, 2018.

The tender offer forms a part of AbbVie’s $10 billion stock repurchase program announced on February 15, 2018.
(Press release, AbbVie, APR 26, 2018, View Source [SID1234525728])

Pacira Pharmaceuticals Announces Timing for First Quarter 2018 Financial Results Webcast and Conference Call

On April 26, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that it will report its first quarter financial results before the open of the U.S. markets on Thursday, May 3, 2018 (Press release, Pacira Pharmaceuticals, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344859 [SID1234525722]). The announcement will be followed by a conference call at 8:30 a.m. ET. Participating in the call from Pacira will be Dave Stack, chairman and chief executive officer, and other members of the company’s senior management team.

The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 6585169. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 6585169. The replay of the call will be available for one week from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.