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Tuesday, May 7, 2019

Lannett mired in price-fixing lawsuits, DOJ in the fray

Embattled generic drug maker Lannett Company (LCI -10.8%) is down on modestly higher volume after reporting Q1 results after the close yesterday. Sales were flat and earnings were off 17%.
The company, and many of its generic compatriots, are facing lawsuits from a range of U.S. states and an investigation by the U.S. Department of Justice. On May 1, it and one of its employees received written notice from a number of state attorneys general that they plan to bring charges of price-fixing and anti-competitive behavior related to certain of its products (10-Q, page 22-25).

IQVIA Announces Offering of Senior Notes

IQVIA Holdings Inc.(“IQVIA”) (NYSE: IQV) today announced that its wholly-owned subsidiary, IQVIA Inc. (the “Issuer”), intends to raise $1,100,000,000 in gross proceeds through an offering of senior notes due 2027. The net proceeds from the notes offering will be used to repay existing borrowings under the Issuer’s revolving credit facility, to pay fees and expenses related to the notes offering and for other general corporate purposes. The consummation of the notes offering is subject to market and other customary conditions.

Sutro says one program clears IND, Celgene opts out of three others

As previously disclosed, under the 2017 amended license agreement between Sutro Biopharma (STRO) and Celgene (CELG), Celgene was advancing four preclinical collaboration programs, one of which is an antibody-drug conjugate targeting B-cell maturation antigen for the treatment of multiple myeloma. Celgene has worldwide development and commercialization rights with respect to this BCMA antibody-drug conjugate. Sutro Biopharma this morning disclosed that the FDA recently cleared the investigational new drug application for the BCMA ADC. Sutro will continue to be responsible for clinical supply manufacturing and certain development services for the BCMA ADC and is entitled to development and regulatory milestone payments and tiered royalties from Celgene, it added. With respect to the remaining three collaboration programs, Celgene has decided to not retain the option to acquire U.S. clinical development and commercialization rights to a second collaboration program. Celgene is therefore not paying Sutro Biopharma the $12.5M option maintenance fee due on IND clearance for the first collaboration program. Consequently, the U.S. clinical development and commercialization rights to the other three collaboration programs remain owned by Sutro, without any further option to Celgene. For any products resulting from these three programs, Celgene will own ex-U.S. development and commercialization rights and will be obligated to pay Sutro development and regulatory milestone payments and tiered royaltie

Phibro Animal Health sees FY19 EPS $1.50-$1.55, consensus $1.68

Our updated guidance for fiscal year 2019 is shown in detail on the schedule included with this press release. We have reduced our expectations for sales and profits due to several headwinds, including: lower seasonal sales than expected to the domestic poultry sector; the effect of African Swine Fever on our business in China; continued declines in the domestic dairy sector; and customer rotations in some of our international countries. The company now sees FY19 revenue $828M-$833M, consensus $854.19M.

Intersect ENT cut to Underperform from Market Perform at Northland

Northland analyst Suraj Kalia downgraded Intersect ENT to Underperform from Market Perform after the company cut its FY19 sales guidance and announced an “abrupt CEO change,” which he tells investors “telegraphs implicit weakness in the outlook.” The analyst, who said he has always had concerns that expectations on new product launches were overtly enthusiastic, cut his price target on Intersect ENT shares to $20 from $28.

Insmed sees FY19 Arikayce revenue $90M-$105M

Insmed continues to expect cash-based operating expenses to be in the range of $150M-$170M for the first half of 2019. In addition, the Company expects capital expenditures, including spend related to the buildout of a new corporate headquarters facility as well as payments classified within other assets for the future right-of-use asset related to the buildout of an additional third-party manufacturing facility, to be in the range of $25M-$35M for the first half of 2019.

Celgene says analysis shows oral ozanimod reduced brain volume loss

Celgene Corporation announced the results of a post-hoc analysis of data from the Phase 3 RADIANCE Part B trial showing that ozanimod reduced cortical grey matter volume loss versus first-line treatment, Avonex, in adults with relapsing multiple sclerosis across all age groups, including patients ages 18 to 25. The analysis will be presented at the 2019 American Academy of Neurology Annual Meeting in Philadelphia, May 4-10, 2019. RADIANCE evaluated two doses of oral ozanimod compared with interferon beta-1a in 1,313 patients with RMS between the ages of 18 and 55 years old. In this post-hoc analysis of 874 patients, treatment effect on serial brain volume, including thalamic volume and cortical grey matter, was evaluated by patient age at baseline, 12 months and 24 months. Patients in the 18 to 25 age group tended to have greater brain volume at baseline but more active disease as measured by gadolinium-enhancing MRI lesions. There was also a trend for this age group to experience greater whole brain volume loss at both 12 and 24 months compared with the older groups. Patients across all age groups treated with ozanimod lost less cortical grey matter volume than did those treated with interferon beta-1a over 24 months, including patients in the 18 to 25 age group. In the RADIANCE Part B trial, the most common adverse reactions that were higher with ozanimod than with interferon beta-1a were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase and increases of gamma-glutamyl transferase.