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AbbVie Reports First-Quarter 2017 Financial Results

On April 27, 2017 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2017 (Press release, AbbVie, APR 27, 2017, View Source [SID1234518701]).

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"AbbVie delivered strong first quarter results, with double-digit EPS and operational revenue growth, exceeding our guidance for the quarter," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "As we look ahead to the remainder of the year we expect continued strong commercial execution and significant pipeline progress. This includes a dozen pivotal trial read-outs and several regulatory submissions and approvals, further supporting our ability to drive top-tier performance over the long term. 2017 is an important year for AbbVie and we are off to an excellent start."

First-Quarter Results

Worldwide GAAP net revenues were $6.538 billion in the first quarter, increasing 10.1 percent, excluding a 0.4 percent unfavorable impact from foreign exchange.
Global HUMIRA sales increased 15.1 percent on a reported basis, or 15.8 percent operationally, excluding a 0.7 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 22.8 percent in the quarter. Internationally, HUMIRA sales grew 4.6 percent, excluding a 1.7 percent unfavorable impact from foreign exchange.
First-quarter global IMBRUVICA net revenues were $551 million, with U.S. sales of $457 million and international profit sharing of $94 million for the quarter, reflecting growth of 44.7 percent.
On a GAAP basis, the gross margin ratio in the first quarter was 75.3 percent. The adjusted gross margin ratio was 79.9 percent.
On a GAAP basis, selling, general and administrative expense was 20.9 percent of net revenues. The adjusted SG&A expense was 20.7 percent of net revenues.
On a GAAP basis, research and development expense was 17.4 percent of net revenues. The adjusted R&D expense was 16.9 percent, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the first quarter was 37.0 percent. The adjusted operating margin was 42.3 percent.
On a GAAP basis, net interest expense was $247 million. On a GAAP basis, the tax rate in the quarter was 18.0 percent. The adjusted tax rate was 18.2 percent.
Diluted EPS in the first quarter was $1.06 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.28, up 11.3 percent.
Key Events from the First Quarter

AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application for IMBRUVICA in chronic graft-versus-host-disease (cGVHD), after failure of one or more lines of systemic therapy. cGVHD is a serious and debilitating complication of stem cell or bone marrow transplant. If approved, IMBRUVICA will be the first therapy specifically approved to treat this condition. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.
AbbVie announced that the U.S. FDA approved IMBRUVICA to treat patients with marginal zone lymphoma (MZL), an indolent form of non-Hodgkin’s lymphoma (NHL). There are currently no other approved treatments specifically indicated for patients with MZL. This approval marks the fifth unique type of blood cancer indication for IMBRUVICA.
AbbVie announced that its Phase 3 studies of veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, in patients with squamous non-small cell lung cancer (NSCLC) and triple-negative breast cancer did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel. Based on these Phase 3 data, AbbVie will not continue development in these indications. Studies of veliparib in non-squamous NSCLC, BRCA1/2 breast cancer and ovarian cancer are ongoing.
AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced detailed results from a Phase 2b clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo in women with uterine fibroids. The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo. Uninterrupted treatment with elagolix was associated with decreased symptom severity and improved quality of life. Phase 3 trials evaluating elagolix as a potential treatment for uterine fibroids are ongoing. Additionally, the Phase 3 program in endometreosis is nearing completion, with regulatory submission planned for later this year.
AbbVie announced that the U.S. FDA accepted its New Drug Application and granted priority review for its investigational, pan-genotypic, once-daily, ribavirin-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). Additionally, AbbVie announced that its marketing authorization application was validated and is under accelerated assessment by the European Medicines Agency (EMA), and that priority review was granted by the Japanese Ministry of Health, Labour and Welfare. The company anticipates commercialization of the next-generation combination in 2017.
AbbVie recently presented data on G/P from the Phase 3 EXPEDITION-1 study and the Phase 3 ENDURANCE-3 study at the International Liver Conference for the European Association for the Study of the Liver. The EXPEDITION-1 study results demonstrated that 99 percent of chronic HCV infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis achieved sustained virologic response at 12 weeks post-treatment (SVR12). The ENDURANCE-3 study results demonstrated that 95 percent of patients infected with genotype 3 chronic HCV, without cirrhosis and who are new to treatment, achieved SVR12 following 8 weeks of treatment. Together with previously reported data, these new study results reinforce G/P’s potential to provide a faster path to cure for the majority of patients living with HCV across all genotypes, as well as offer a potential cure to patients with specific treatment challenges.
AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the EMA granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV and minimal to moderate fibrosis. VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
AbbVie announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer’s disease and progressive supranuclear palsy (PSP). In recognition of the lack of treatment options available to patients with PSP, the U.S. FDA granted Fast Track Designation to ABBV-8E12. The FDA and EMA also granted Orphan Drug Designations to ABBV-8E12 for PSP.
Full-Year 2017 Outlook

AbbVie is confirming its GAAP diluted EPS guidance for the full-year 2017 of $4.55 to $4.65. AbbVie expects to deliver adjusted diluted EPS for the full-year 2017 of $5.44 to $5.54, representing growth of 13.9 percent at the mid-point. The company’s 2017 adjusted diluted EPS guidance excludes $0.89 per share of intangible asset amortization expense and other specified items.

Seattle Genetics Reports First Quarter 2017 Financial Results

On April 27, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company, reported financial results for the first quarter ended March 31, 2017 (Press release, Seattle Genetics, APR 27, 2017, View Source [SID1234518719]).

The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, vadastuximab talirine (SGN-CD33A) and enfortumab vedotin (ASG-22ME) activities, as well as progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs.

"We continue to successfully execute on our ADCETRIS commercial objectives, and are positioned to achieve several important clinical development milestones during 2017. Notably, we expect to report top-line data from the phase 3 ECHELON-1 trial this year. ECHELON-1 has the potential to redefine the way newly diagnosed classical Hodgkin lymphoma patients are treated for the first time in decades. In addition, we are on track to submit a supplemental BLA to the FDA in mid-2017 for ADCETRIS use in CTCL based on data from the ALCANZA trial," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Across our pipeline, enrollment in our phase 3 CASCADE trial of vadastuximab talirine (SGN-CD33A) is strong. And, based on positive feedback from the FDA, we plan to advance enfortumab vedotin (ASG-22ME) into a pivotal trial in metastatic urothelial cancer later this year. We are delivering on our goal of building Seattle Genetics into a multi-product oncology company addressing the substantial unmet medical needs of cancer patients."

ADCETRIS Program Highlights

ALCANZA Phase 3 Trial: A supplemental Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is planned for mid-2017. The supplemental BLA is based on positive data from the phase 3 ALCANZA trial as well as data from two investigator-sponsored trials in cutaneous T-cell lymphoma (CTCL). ADCETRIS previously received Breakthrough Therapy Designation for the most common subtypes of CTCL: mycosis fungoides and primary cutaneous anaplastic large cell lymphoma.
ECHELON-1 Phase 3 Trial: Top-line data are anticipated in 2017 from the phase 3 ECHELON-1 trial in frontline classical Hodgkin lymphoma. ECHELON-1 is evaluating ADCETRIS as part of a combination regimen in newly diagnosed patients with advanced Hodgkin lymphoma.
ECHELON-2 Phase 3 Trial: Top-line data are expected in 2018 from the phase 3 ECHELON-2 trial in frontline CD30-expressing mature T-cell lymphoma (MTCL), also known as peripheral T-cell lymphoma (PTCL).
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma or frontline MTCL.

Vadastuximab Talirine (SGN-CD33A) Program Highlights

CASCADE Phase 3 Trial: Enrollment is proceeding well in the global, randomized phase 3 CASCADE clinical trial evaluating vadastuximab talirine in combination with hypomethylating agents (HMAs) in older patients with newly diagnosed acute myeloid leukemia (AML).
Planned Phase 2 Trial: A randomized phase 2 trial in younger patients with newly diagnosed AML is planned for the second half of 2017. The trial will assess the standard-of-care regimen known as 7+3 versus 7+3 in combination with vadastuximab talirine.
Enfortumab Vedotin (ASG-22ME) Program Highlights

Planned Registrational Trial: Based on positive feedback from the FDA, Seattle Genetics and its collaborator Astellas plan to initiate in the second half of 2017 a pivotal phase 2 trial of single-agent enfortumab vedotin for metastatic urothelial cancer patients who have been previously treated with a checkpoint inhibitor therapy.
ASCO: Updated data from a phase 1 trial in metastatic urothelial cancer will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 2 – 6, 2017 in Chicago, IL.
Phase 1 Trial in Japan: Astellas and Seattle Genetics initiated a phase 1 trial in Japan to evaluate the tolerability and pharmacokinetics of enfortumab vedotin in patients with metastatic urothelial cancer. The trial will enable future studies and regulatory submission in Japan.
Other Recent Activities

Presence at AACR (Free AACR Whitepaper): Seattle Genetics’ ADC and immuno-oncology programs and technology advances were highlighted in 14 presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Data described novel ADC linker technologies, the ability of ADCETRIS to activate antitumor immune responses, which support continued clinical evaluation in combination with checkpoint inhibitors, and preclinical data on two immuno-oncology agents, SEA-CD40 and SGN-2FF.
ADC Collaborations: In April 2017, Seattle Genetics generated a milestone under its ongoing ADC collaboration with AbbVie triggered by AbbVie’s exercise of an exclusive option to Seattle Genetics’ ADC technology for a specific target antigen.
First Quarter 2017 Financial Results

Total revenues in the first quarter ended March 31, 2017 were $109.1 million, compared to first quarter of 2016 revenues of $111.2 million. Revenues in the first quarter of 2017 included:

ADCETRIS net sales of $70.3 million, a 20 percent increase from net sales of $58.6 million in the first quarter of 2016.
Royalty revenues of $17.0 million, compared to $32.3 million in the first quarter of 2016. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues in the first quarter of 2016 included a $20.0 million sales milestone payment from Takeda.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaling $21.8 million, compared to $20.2 million in the first quarter of 2016.
Total costs and expenses for the first quarter of 2017 were $168.4 million, compared to $132.2 million for the first quarter of 2016. The increase in 2017 costs and expenses was primarily driven by investment in enfortumab vedotin, vadastuximab talirine, ADCETRIS product supply to Takeda and the company’s pipeline programs.

Non-cash, share-based compensation cost for the first quarter of 2017 was $14.5 million, compared to $12.2 million for the first quarter of 2016.

Net loss for the first quarter of 2017 was $60.0 million, or $0.42 per share, compared to a net loss of $20.5 million, or $0.15 per share, for the first quarter of 2016.

As of March 31, 2017, Seattle Genetics had $536.4 million in cash, cash equivalents and investments.

Ipsen reports strong first quarter 2017 sales growth of 19,1%

On April 27, 2017 Ipsen, a global specialty-driven pharmaceutical group, reported sales for the first quarter of 2017 (Press release, Ipsen, APR 27, 2017, View Source [SID1234518698]).

2017 first quarter sales

In the first quarter of 2017, Consolidated Group sales grew 19.1% to €438.0 million driven by Specialty Care growth of 25.4%1 including growth of 86.3%1 from North America.

Commenting on the first quarter 2017 performance, David Meek, Chief Executive Officer of Ipsen said: "In the first quarter, Specialty Care continued to drive remarkable organic top-line growth for Ipsen, led by the outstanding performance of Somatuline, both in the United States and Europe, as well as a strong acceleration for Dysport. We continue to face headwinds in certain emerging markets for our Consumer Healthcare business." David Meek continued, "After the successful closing of the Onivyde transaction, our largest acquisition to date, we are focused on the successful execution of the Onivyde and Cabometyx launches. These two important products strengthen our presence in Oncology and will contribute meaningfully to our top-line growth and profitability in the coming years."

Ipsen confirms its financial targets for 2017, with Specialty Care sales growth year-on-year greater than +18.0%1, Consumer Healthcare sales growth year-on-year greater than +4.0%1 and Core Operating margin greater than 24% of net sales.

In addition, Ipsen announces the change in name of its Primary Care division to Consumer Healthcare. This reflects the evolution over the last two years of the promotional model from classical prescription-based to a combination of prescription and over-the-counter (OTx) in select countries with gastrointestinal portfolios. The transaction announced in February to acquire a portfolio of select consumer healthcare assets from Sanofi will strengthen the evolution of the Consumer Healthcare portfolio in France and Central Europe with the strategic intent to further develop the OTx model in most geographies.

View Ipsen’s full Q1 report at View Source

FDA Approves XATMEP™, the First and Only Ready-To-Use Methotrexate Oral Solution

On April 26, 2017 Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, reported that the United States Food and Drug Administration (FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution (Press release, Silvergate Pharmaceuticals, APR 26, 2017, View Source [SID1234625387]). XATMEP is indicated for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.

"XATMEP is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets or compounding into a liquid formulation," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

XATMEP (methotrexate) Oral Solution, 2.5 mg/mL, is a ready-to-use product that requires no preparation, facilitating accuracy and ease of dispensing at the pharmacy. XATMEP is manufactured under CGMPs in accordance with FDA regulations. It eliminates the need for needles, crushing or splitting tablets or for compounding tablets into a liquid formulation. It requires refrigeration but may be stored at room temperature for 60 days after dispensing. XATMEP is available through an extensive network of pharmacies and a qualified mail-order service. For additional information on how to obtain XATMEP, please call 1-855-379-0382.

INDICATIONS

XATMEP is a folate analog metabolic inhibitor indicated for the:

management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
About XATMEP

XATMEP (methotrexate) Oral Solution was developed, primarily, to meet the need for a ready-to-use, 2.5 mg/mL, methotrexate oral solution for the treatment of pediatric patients for the indications stated above. Currently, there is no FDA-approved, ready-to-use oral liquid formulation of methotrexate for use by pediatric patients requiring body surface area (BSA) dosing (mg/m2) or who have difficulty swallowing or cannot consume tablets, or those with needle-phobia. Silvergate Pharmaceuticals, Inc.’s XATMEP (methotrexate) Oral Solution resolves these unmet medical needs in pediatric patients.

IMPORTANT SAFETY INFORMATION

XATMEP includes a BOXED WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY

See full prescribing information for complete boxed warning.

Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal (5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic (5.7).
Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy (4). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP (5.9, 8.1, 8.3).
ADDITIONAL IMPORTANT SAFETY INFORMATION

XATMEP is contraindicated in patients who are hypersensitive to methotrexate.
XATMEP is contraindicated in patients who are pregnant or nursing.
Warnings and Precautions:

Monitor closely and modify dose or discontinue XATMEP as appropriate.

Methotrexate can cause the following severe, life-threatening or fatal adverse reactions:

Bone marrow suppression: pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia.
Serious infections: bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal, hepatitis B reactivation, tuberculosis, Herpes zoster and cytomegalovirus infections.
Renal toxicity and renal impairment, including acute renal failure.
Gastrointestinal toxicity: diarrhea, stomatitis, vomiting, hemorrhagic enteritis, fatal intestinal perforation. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant us of NSAIDs.
Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure.
Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases at all dose levels.
Hypersensitivity: anaphylaxis.
Dermatologic reactions: toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme. Radiation dermatitis and "sunburn" may be recalled.
Secondary malignancies: lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate is withdrawn.
Embryo-fetal toxicity and fetal death: Consider the risks and benefits of XATMEP and risks to the fetus when prescribing to a pregnant patient with a neoplastic disease. XATMEP is contraindicated in non-neoplastic disease.
Immunizations may be ineffective when given during XATMEP therapy.
Immunization with live virus vaccines is not recommended during XATMEP therapy.
Effects on reproduction: Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. Effective contraception should be practiced by patients of reproductive potential while receiving XATMEP therapy, and for 3 and 6 months afterwards for males and females, respectively.
Third-space accumulation: Evacuate significant third-space accumulation prior to methotrexate administrations.
Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.
Closely monitor laboratory parameters for hematology, renal function and liver function. Increase monitoring during initial dosing, dose changes and during periods of increased risk of elevated methotrexate blood levels (e.g., dehydration).
Improper dosing: Once weekly dosing is appropriate. Fatal toxicity has been reported with daily dosing. An accurate millimeter measuring device should be used.
Advise women not to breastfeed.
Adverse Reactions: See full prescribing information for additional adverse reactions.

Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests.

Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased risk to infection.

Drug Interactions:

Oral antibiotics: Hematologic and gastrointestinal toxicity may increase.
Hepatotoxins: May increase hepatoxicity.
Probenecid: Consider alternative drugs as may increase methotrexate exposure.
Theophylline: May reduce theophylline clearance.
To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

Please see accompanying full Prescribing Information, including the complete BOXED WARNING.

About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc., is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications that are safe, effective, and readily available.

Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For more information, please visit View Source

Reference: XATMEP [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2017.

10-Q – Quarterly report [Sections 13 or 15(d)]

MediciNova has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .