Shares of Stryker Corp. SYK, +9.49% rose nearly 5% in the extended session Tuesday after the medical-device maker beat Wall Street expectations for its fourth quarter. Stryker said it earned $2.07 billion, or $5.44 a share, in the quarter, versus a loss of 66 cents a share in the year-ago period. Adjusted for one-time items, Stryker earned $2.18 a share, compared with $1.96 a share a year ago. Sales rose 9.4% to $3.8 billion, from $2.2 billion a year ago. Analysts polled by FactSet had expected Stryker to report adjusted earnings of $2.15 a share on sales of $3.7 billion. Stryker shares ended the regular trading day down 0.6%.
https://www.marketwatch.com/story/stryker-stock-5-higher-on-profit-sales-beat-2019-01-29
Wednesday, January 30, 2019
Analysts defend Biogen after Roche discontinues late-stage Alzheimer’s trials
Piper says significant read-through to Biogen drugs would be a “mistake,” while William Blair also highlights differences
An analyst at Piper Jaffray defended his Overweight rating on Biogen (BIIB) following this morning’s news that Roche (RHHBY) is discontinuing Phase 3 trials for its crenezumab drug for early Alzheimer’s disease.
BACKGROUND: Roche and its Genentech unit said Wednesday that it will halt CREAD 1 and CREAD 2, two late-stage clinical trials of its crenezumab drug for early Alzheimer’s disease, after an interim analysis indicated they were unlikely to hit the primary endpoint. Genentech had been working on the drug with AC Immune (ACIU). Roche said its decision to discontinue the studies was based on the results of a pre-planned interim analysis assessing the safety and efficacy of crenezumab conducted by the Independent Data Monitoring Committee, which indicated that crenezumab was “unlikely to meet the primary endpoint” of change from baseline in Clinical Dementia Rating-Sum of Boxes, or CDR-SB, Score. No safety signals for crenezumab were observed in this analysis, and the overall safety profile was similar to that seen in previous trials, the company said.
Roche said an Alzheimer’s Prevention Initiative, or API, study of crenezumab in familial Alzheimer’s disease, or fAD, in Colombia will continue in Phase 3 trials with gantenerumab and a phase 2 anti-tau trial. The company commented that “while the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease.” Meanwhile, AC Immune CEO Andrea Pfiefer said in a statement that the company is “extremely disappointed” about the outcome of the Phase 3 CREAD 1 interim analysis. The executive said AC Immune continues to be “optimistic about the potential future of crenezumab as we await the outcome of the Colombian API study to prevent AD symptoms in patients with familial AD to see if the antibody treatment may provide disease-modifying effects in patients with early-onset disease.”
IN DEFENSE OF BIOGEN: Piper Jaffray analyst Christopher Raymond maintained an Overweight rating on Biogen after Roche said it would discontinue the crenezumab trial. Raymond defended his rating in a research note by saying that key differentiators between crenezumab and BIIB’s aducanumab — and BAN2401 — exist, and, as with other A-beta targeting antibodies that have failed, crenezumab does not possess either the biology or the clinical data set of either aducanumab or BAN2401. Raymond, who recommends buying Biogen on weakness, contended that Biogen’s management has been “quick” to make key distinctions between crenezumab and its own molecules, including that crenezumab “lacks specificity for aggregated forms of a-beta that make up plaques,” and added that while its IgG4 backbone was designed to lower ARIA risk, the lack of effector function “likely hampers efficacy as well in that it hasn’t shown the kind of significant lowering of amyloid plaque burden that we’ve seen from aducanumab and BAN2401.” Given the differences, Raymond said a significant read-through to aducanumab or BAN2401 would be a “mistake.” Meanwhile, William Blair analyst Matt Phipps said there are fundamental differences between Roche’s crenezumab and Biogen’s aducanumab that make any read-through “very limited, if at all.” Roche’s decision to discontinue two Phase 3 studies evaluating crenezumab, an investigational antibody designed to target oligomers of beta-amyloid, in patients with Alzheimer’s disease does not change the analyst’s outlook for aducanumab. While Roche’s news will “undoubtedly be viewed negatively” for aducanumab, Biogen’s investigational antibody designed to target amyloid plaque, there are “very apparent differences between the antibodies,” Phipps contends. He points out that crenezumab has a more similar binding profile to solanezumab, and also is unique in having an IgG4 backbone, which reduces immune effector cell activation in an attempt to reduce the side effect known as amyloid related imaging abnormalities. Phipps keeps an Outperform rating on Biogen.
Tuesday, January 29, 2019
Tokyo stocks fall in morning, hit by drugmakers’ poor performance
Tokyo stocks fell Wednesday morning, as market sentiment was dampened by sharp declines in shares of some pharmaceutical makers.
The 225-issue Nikkei Stock Average shed 109.51 points, or 0.53 percent, from Tuesday to 20,555.13. The broader Topix index of all First Section issues on the Tokyo Stock Exchange was down 5.23 points, or 0.34 percent, to 1,551.86.
Decliners were also led by securities house, consumer credit, and electric power and gas issues.
While many market players took to the sidelines ahead of key events, two Japanese pharmaceutical companies’ announcement on Tuesday that they failed to create a new medicine for the treatment of chronic stroke exerted a negative impact on the market, brokers said.
Sumitomo Dainippon Pharma Co. and San Bio Co. said their study conducted in the United States aimed at producing the medicine was unsuccessful in meeting its “primary endpoint.”
“Retail investors grew cautious about bio-tech issues following the release of the disappointing results by the drugmakers,” said Hiroaki Kuramochi, chief market analyst at Saxo Bank Securities Ltd.
The announcement came as many investors have adopted a wait-and-see stance ahead of the release of the outcome of the U.S.Federal Reserve’s policy-setting meeting and trade negotiations between the United States and China.
Sumitomo Dainippon Pharma plunged 700 yen, or 18.6 percent, to a lower limit for the day of 3,065, while San Bio, listed on the Tokyo Stock Market’s Mothers for start-up companies, was untraded amid a glut of selling orders.
Lonza 2018 9% Organic Sales Growth and Strong Profitability Driven by Healthcare
- Lonza delivered its Full-Year 2018 results with sales of CHF 5.5 billion at a record 27.3% CORE EBITDA margin for Lonza’s continuing operations
- Outperformance in Pharma & Biotech with 14% sales growth and margins up 260 bps was combined with positive momentum in the Consumer Health division
- Lonza continued to benefit from the performance and synergies of the successfully integrated Capsugel businesses, having completed the first full year as a combined company
- The challenging environment for cyclical parts of the Consumer & Resources Protection portfolio continued to have a negative impact on the business throughout the year; countermeasures are being implemented to improve profitability
- Lonza launched further growth initiatives to expand its global and technological footprint, especially in biologics, including the expansion of Ibex™ Solutions in Visp (CH)
- Mid-Term 2022 Guidance confirmed and 2019 Outlook announced
- Review of the business portfolio to be accelerated to further strengthen company’s position along the Healthcare Continuum®
- At the Annual General Meeting, the Board of Directors will propose a stable dividend for shareholders of CHF 2.75 per share for 2018
Outlook 2019
In 2019 Lonza will focus on the thorough execution of its growth projects in what is expected to be a year of significant investments. Lonza is also factoring into its outlook the continued macro-economic uncertainty and some potential ongoing headwinds in the cyclical parts of Lonza’s Specialty Ingredients businesses.
Based on these assumptions, Lonza is providing the following outlook for Full-Year 2019:
- Mid-to-high-single digit sales growth
- Sustained high CORE EBITDA margin level
In addition, Lonza will accelerate the review of its current portfolio to further strengthen the company’s position along the Healthcare Continuum®. At the same time, Lonza will continue to focus on operational and commercial excellence while investing in innovation and growth, especially in the biologics businesses. Lonza will also be continuing to implement measures to counter the cyclical-exposed businesses. An update on profitability measures and outlook will be provided with the Q1 Qualitative Business Update 2019.
The Outlook 2019 is based on the present business composition for Lonza’s continuing operations (excluding the Water Care business unit), the present macro-economic environment, current visibility and constant exchange rates. The Outlook 2019 is a next step toward achieving Lonza’s Mid-Term Guidance 2022. After becoming fully operational, all investments previously announced are expected to accelerate top-line growth and profitability from 2021 and to contribute to Lonza’s mid-term targets.
AC Immune Discontinues Phase 3 Alzheimer’s Studies
- Decision follows Independent Data Monitoring Committee analysis
- The Alzheimer’s Prevention Initiative (API) study of crenezumab in familial Alzheimer’s disease continues
- The Phase II anti-tau TAURIEL trial led by Roche in partnership with AC Immune continues
AC Immune SA (NASDAQ: ACIU) announced today that Roche, the parent company of its collaboration partner, is discontinuing the CREAD 1 and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule, crenezumab, in people with prodromal to mild sporadic Alzheimer’s disease (AD). The decision came after an interim analysis conducted by the Independent Data Monitoring Committee (IDMC). Alzheimer’s disease (AD) is a progressive, fatal disease that gradually destroys memory, thinking skills and problem solving, and impairs daily functioning such as the ability to manage one’s own activities.
The IDMC analysis indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. This decision was not related to safety of the investigational product. No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in previous trials.
Crenezumab continues to be studied in a landmark trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk of developing familial AD (fAD), under the Alzheimer’s Prevention Initiative (API), which began in 2013. This study will determine if treating people carrying this mutation with crenezumab prior to the onset of AD symptoms will slow or prevent the decline of cognitive and functional abilities. This study is in collaboration with the Banner Institute and is funded by the National Institute on Aging.
Data from the CREAD 1 and 2 studies will be made available to the scientific community by Roche at an upcoming scientific meeting. AC Immune looks forward to receiving and reviewing the data in detail and sharing it as appropriate following peer review.
CREAD 1 and 2 were two-year global, randomized, double-blind, placebo-controlled, parallel-group Phase III studies testing the efficacy and safety of crenezumab in 1,500 patients worldwide with early AD with confirmed evidence of cerebral beta amyloid pathology (CSF or amyloid PET). These studies used doses four times higher than that studied in the Phase II trials. CREAD 1 was initiated in early 2016 and CREAD 2 in mid-2017.
As reported by Roche today, the TAURIEL Phase II trial of an anti-tau antibody (RG-6100) in Alzheimer’s disease, run by Roche in partnership with AC Immune will continue.
Prof. Andrea Pfeifer, CEO of AC Immune, said: “We are extremely disappointed about the outcome of the Phase III CREAD 1 interim analysis and we also would like to thank patients and caregivers for their participation. We continue to be optimistic about the potential future of crenezumab as we await the outcome of the Colombian API study to prevent AD symptoms in patients with familial AD to see if the antibody treatment may provide disease-modifying effects in patients with early-onset disease.”
Dr. Pfeifer continued, “We remain committed to our on-going pre-clinical and clinical candidates targeting Tau and neuro-inflammation to treat Alzheimer’s disease, neuro-orphan diseases and Parkinson’s disease, which are partnered with five leading pharmaceutical partners, including Roche’s subsidiary Genentech.”
Novartis strong ’18 sales growth, core margin expansion, advanced therapies
Novartis International AG / Novartis delivered strong sales growth with core margin expansion, built leading advanced therapy platforms and focused the company in 2018 . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.
- Full year net sales up 5% (cc[1], +6% USD) driven by strong performance of growth drivers:
- Pharmaceuticals BU grew 7% (cc) driven by Cosentyx USD 2.8 billion (+36% cc) and Entresto USD 1.0 billion (+102% cc)
- Oncology BU grew 9% (cc) driven by AAA[2] (USD 0.4 billion) including Lutathera, Promacta/Revolade USD 1.2 billion (+35% cc) and Tafinlar + Mekinist USD 1.2 billion (+31% cc)
- Full year core[1] operating income grew 8% mainly driven by higher sales and gross margin expansion
- Net income was USD 12.6 billion (+64%) including a USD 5.7 billion net gain from the divestment of OTC JV. Operating income declined 5% mainly due to M&A transactions and restructurings
- Free cash flow[1] grew 12% to USD 11.7 billion driven by strong operating cash flows
- Focused the company with transformational deals during 2018:
- Consumer healthcare JV stake divested to GSK for USD 13.0 billion
- Announced proposal to spin-off Alcon Division[3]; on track for H1 2019
- Sandoz began transformation with reshaping the portfolio[4], geographic focus and a leaner cost structure
- Built leading advanced therapy platforms:
- Gene therapy – Acquired AveXis and in-licensed Luxturna
- Radioligand therapy – Acquired AAA and Endocyte
- Cell therapy – Expanding Kymriah global manufacturing including multiple collaborations
- Four additional products reached blockbuster status in 2018; Lutathera, Aimovig and Kymriah for DLBCL were launched; additional ten key launches on track by 2020
- Alcon sales grew 5% (cc, +6% USD) and core operating income grew 10%; expanding core margin
- Sandoz sales down -3% (cc, -2% USD) due to US price pressure; Biopharmaceuticals grew 24% (cc)
- Dividend of CHF 2.85 per share, an increase of 2%, proposed for 2018
- 2019 Group guidance[5]:
- New focused medicines company[6] – Net sales expected to grow mid single digit (cc); core operating income expected to grow mid to high single digit (cc)
- Current Group structure[7] – Net sales expected to grow low to mid single digit (cc); core operating income expected to grow mid single digit (cc)
2019 Outlook
Barring unforeseen events
New focused medicines company guidance*
Excluding Alcon and the Sandoz US oral solids and dermatology business from both 2018 and 2019
Excluding Alcon and the Sandoz US oral solids and dermatology business from both 2018 and 2019
- Group net sales in 2019 are expected to grow mid-single digit (cc).
- From a divisional perspective, we expect net sales performance (cc) in 2019 to be as follows:
- Innovative Medicines: grow mid single digit
- Sandoz: broadly in line with prior year
- Group core operating income in 2019 is expected to grow mid to high single digit (cc).
Bausch Health Reduces Debt By Additional $100M
Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company” or “we”) today announced it has paid down an additional $100 million of its senior secured term loans using cash generated from operations.
“As Bausch Health pivots to offense in 2019, we continue to remain committed to reducing our overall debt using cash flow generated from operations,” said Joseph C. Papa, chairman and CEO, Bausch Health.
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