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Tuesday, July 31, 2018

Sanofi Q2 Sales Down, but Plans to Fix Diabetes Division


For its second-quarter financial report, Paris-based Sanofi reported a decrease in net sales for the quarter of 5.7 percent, down to 8.176 billion euros. Sanofi Genzyme sales grew 14.1 percent, driven by Dupixent and consolidation of Bioverativ, which it acquired earlier this year. Bioverativ was a spinoff from Biogen. Bioverativ spun off from Biogen’s hemophilia unit in January 2017. Sanofi bought it for $11.6 billion in January 2018.
The company’s second-quarter earnings per share (EPS) rose 1.5 percent to 1.25 euros. Its Emerging Market sales grew 5.2 percent, with double-digit growth in China.
“In the second quarter, we achieved significant milestones in building our new rare Blood Disorder franchise and the successful continued execution of the global roll-out of Dupixent,” said Olivier Brandicourt, Sanofi’s chief executive officer, in a statement. “As the impact from the U.S. losses of exclusivity peaked in the second quarter, the growth of our diversified businesses largely compensated for these headwinds. We look forward to entering a new growth phase led by our increasing focus on Specialty Care and our leadership positions in Emerging Markets and Vaccines.”
Sanofi’s diabetes and cardiovascular franchises, however, which have struggled in the U.S. after it lost exclusivity for insulin drug Lantus, had a 9.4 percent on-year decline. Earlier this month, Sanofi told Dow Jones Newswires that it is attempting to convince intermediaries, particularly in the U.S., to approach its insulin products in a different way, in order to increase sales. It’s not clear if that will help since most companies in the diabetes market are struggling with U.S. pricing for insulin-related products.
MarketWatch writes, “On Tuesday the company again declined to specify which intermediaries it has been in talks with, as formulary decisions haven’t yet been announced. But a company spokesman confirmed that Medicare bids for 2019 have been submitted, with decisions expected in October. The company also confirmed that data from the Bright study, which has informed Sanofi’s new insulin unbundling strategy, will be presented to Medicare, but declined to comment on whether Medicare bundles its insulins.”
Overall, Sanofi Genzyme (Specialty Care) reported 14.1 percent growth, Sanofi Pasteur (Vaccines) reported a decrease of 15.7 percent, Diabetes & Cardiovascular reported a drop of 15.6 percent, Consumer Healthcare grew by 4.1 percent, and General Medicines & Emerging Markets dropped 3.7 percent.
In the quarterly conference call, Brandicourt indicated Sanofi is positioning itself for a new phase of growth. And with both its acquisition of Bioverativ and Ablynx, both in January, the company shows a heavy push into blood disorders. Ablynx’s most advanced pipeline product is caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
PMLive notes, “A bright point was the rare blood disorder business bolted on with the $11.6 billion acquisition of Bioverativ, up 15.5 percent on a pro forma basis to 257 million euros, and Sanofi is hoping that the 3.9 billion euro takeover of antibody specialist Ablynx and lead rare disease drug caplacizumab will also pay off in the years to come.”

United Therapeutics: FDA approves implantable system application


United Therapeutics (UTHR) announced approval by the FDA of a new drug application, or NDA, for the use of Remodulin injection in the Implantable System for Remodulin, or ISR. The ISR has been developed under a collaboration with Medtronic (MDT). In December 2017, Medtronic received FDA approval of a premarket application, or PMA, for a proprietary intravascular infusion catheter to be used with its SynchroMed II implantable infusion pump and related infusion system components in order to deliver Remodulin for the treatment of pulmonary arterial hypertension, or PAH. Remodulin was originally approved by the FDA to treat PAH by continuous subcutaneous and intravenous routes of administration in 2002 and 2004, respectively, using external pumps. In the case of intravenous users, the therapy can be very burdensome and brings a risk of sepsis due to the use of a central indwelling catheter. The ISR provides patients a new option for delivery of intravenous Remodulin, where the entire delivery system is implanted into the body and will be refilled by healthcare professionals at intervals of up to 16 weeks depending on the patient’s dose, using a syringe needle through the patient’s skin.

Bristol-Myers: EC approves Opdivo for treatment of adults with melanoma


Bristol-Myers Squibb announced that the European Commission has approved Opdivo for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumor types in the European Union.

Illumina price target raised to $330 from $280 at Deutsche Bank


Deutsche Bank analyst Dan Leonard raised his price target for Illumina to $330 saying the “strong beat” in Q2 on stronger NovaSeq demand supports his thesis. The analyst sees upside for estimates over the next 6-12 months and reiterates a Buy rating on the shares.

Novocure announces published results of Phase 2 ovarian cancer med trial


Novocure announced that the results of its INNOVATE phase 2 pilot trial have been published in Gynecologic Oncology. The INNOVATE trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields combined with weekly paclitaxel in recurrent ovarian cancer. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Progression free survival of recurrent ovarian cancer patients treated with Tumor Treating Fields plus weekly paclitaxel was more than double that of weekly paclitaxel-treated historical controls. Median progression free survival in the Tumor Treating Fields-treated group was 8.9 months and median overall survival was not yet reached. Median one-year survival in the Tumor Treating Fields-treated group was 61%. The median compliance of patients with Tumor Treating Fields in the first three months of treatment was 77%. Two cases of severe skin irritation due to Tumor Treating Fields were reported. No other serious device-related adverse events were reported.

NuVasive cuts FY18 adjusted EPS view to $2.37-$2.40 from $2.44-$2.47

FY18 consensus $2.44

NewLink Genetics announces organizational changes


The company has completed an organizational realignment that will support these clinical development efforts within its current financial capacity, substantially cut future expenses, and extend its cash runway into the second half of 2021.The organizational changes include a reduction in headcount of approximately 30%, and include the following changes to senior leadership, effective immediately:Jack Henneman has been appointed Chief Administrative Officer for a transition period to end with his retirement from NewLink in November 2018;Carl Langren has been promoted to Chief Financial Officer; Lori Lawley has been promoted to Vice President, Finance and Controller; Brad Powers has been promoted to General Counsel.