Emergent BioSolutions (EBS) Misses Q1 EPS by 22c, Offers Guidance

Emergent BioSolutions (NYSE: EBS) reported Q1 EPS of ($0.13), $0.22 worse than the analyst estimate of $0.09. Revenue for the quarter came in at $190.6 million versus the consensus estimate of $201.16 million.

GUIDANCE:

Emergent BioSolutions sees Q2 2019 revenue of $200-220 million, versus the consensus of $254.14 million.

Emergent BioSolutions sees FY2019 revenue of $1.06-1.14 billion, versus the consensus of $1.08 billion.

https://www.streetinsider.com/Earnings/Emergent+BioSolutions+%28EBS%29+Misses+Q1+EPS+by+22c%2C+Offers+Guidance/15447459.html

Novo Nordisk Diabetes and Obesity Drugs Boost Net Profit

Danish pharmaceutical company Novo Nordisk AS (NOVO-B.KO) on Friday posted forecast-beating first-quarter net profit on the strength of its diabetes and obesity treatments, but the negative effects of foreign-exchange hedges weighed on the result.

Net profit for the three months ended March 31 fell to 10.45 billion Danish kroner ($1.57 billion) from DKK10.75 billion a year earlier, beating the DKK9.74 billion forecast by analysts in a FactSet poll. Sales rose 8.8% to DKK29.29 billion against analysts’ expectations of DKK28.93 billion.

“We delivered very solid performance in international operations, driven by sales growth in all regions, meanwhile, sales in the U.S. were negatively impacted by inventory reductions,” said Chief Executive Lars Fruergaard Jorgensen.

Sales in the quarter were boosted by Novo Nordisk’s diabetes and obesity treatments, but margins came under pressure due to lower margin insulin products and lower prices, primarily related to the insulin market in the U.S.

The company reiterated intensifying global competition both within diabetes and biopharmaceuticals, especially within the hemophilia-inhibitor segment.

In addition, continued pricing pressure within diabetes is expected, especially in the U.S.

Foreign-exchange losses totaled DKK876 million in the quarter compared with a gain of DKK1.11 billion last year.

“This development reflects a loss on foreign-exchange hedging, involving especially the U.S. dollar versus the Danish krone,” the company said.

For 2019, sales growth measured in local currencies is still seen at 2% to 5%, but reported growth is now expected to be around three percentage points higher, from a previous expectation of around two percentage points higher.

Operating profit growth is still expected to be 2% to 6% measured in local currencies, while reported figures are now expected to be around five percentage points higher from previous guidance of around 4 percentage points higher.

However, the company said it now sees a loss of around DKK3.3 billion under financial items this year, due to foreign-exchange hedging losses. It previously saw a loss of around DKK2.4 billion.

https://www.marketscreener.com/NOVO-NORDISK-AS-1412980/news/Novo-Nordisk-Diabetes-and-Obesity-Drugs-Boost-Net-Profit-28528930/

5 things to know about telehealth fraud

Telehealth fraud appears to be on the rise, as more patients are opting into virtual appointments with their physicians via audio and video technology, Legal Reader reports.

Five things to know about telehealth fraud:

1. Numerous states have their own laws and regulations for telehealth services, so Medicare or Medicaid patients should check whether their state insurance can reimburse for telemedicine transactions.

2. Telehealth fraud initially began with improper coding and billing of services, which grew through practices such as claims from non-eligible or non-listed institutional providers as well as claims from unacceptable means of communication.

3. Telehealth transactions are susceptible to kickback measures. An example of this is the federal government’s recent charging of 24 defendants, who included top executives from telehealth companies and owners of medical equipment companies, for their alleged participation in a $1.2 billion telehealth fraud scheme.

Federal prosecutors claim telemarketers would call Medicare beneficiaries to get them to accept free or low-cost DME braces, regardless of medical necessity. The telemarketers would transfer the beneficiaries to telehealth companies for consultations, and those physicians would allegedly prescribe the orthopedic braces to patients without in-person consultations. The alleged defendants received kickbacks from the medical brace companies.

4. Physicians are the most common victims of telehealth schemes, according to the report. Physicians’ names and accounts can be used to collect payment from insurance companies for patients who haven’t visited the clinic in-person yet.

5. Fast daily patient turnover rates, difficulty communicating with the clinic’s management and issues with contacting patients are some signs physicians can look out for to avoid becoming a victim of a telehealth scheme.

To access the full report, click here.

https://www.beckershospitalreview.com/telehealth/5-things-to-know-about-telehealth-fraud.html

Cigna’s strong financial start to 2019 backed by Express Scripts acquisition

Cigna reported strong financial performance in the first quarter of 2019, bolstered mostly by its acquisition of Express Scripts.

The insurer reported nearly $1.5 billion in adjusted income in Q1, up about 50% compared to just over $1 billion in the first quarter of 2018. Adjusted revenues also soared in this quarter, jumping from $11.4 billion to $33.4 billion.

Much of the year over year change can be attributed to the Express Scripts deal, the company said (PDF), as its pharmacy membership jumped from 8.8 million in March 2018 to 74.9 million in March 2019, following the deal.

Membership in medical plans increased by 32,000 members from the end of 2018 and 224,000 from Q1 2018, reaching 17 million, Cigna said. Express Scripts also added 1.7 million customers in Q1 2019.

“Our combination with Express Scripts is fueling additional innovative programs for the benefit of our customers and patients, as we accelerate our efforts to improve the affordability of health care,” CEO David Cordani said in the release.

Cigna followed in the footsteps of other major payers this quarter and raised its 2019 guidance as a result of its Q1 performance. It projects between $6.24 billion and $6.4 billion in income for 2019, up from earlier estimates of $6.2 billion to $6.4 billion. The company also increased its revenue projections by $1 billion.

Earnings per share are projected to be $16.25 to $16.65, up from $16 to $16.50, Cigna said. This represents a 14% to 17% per share growth over 2018.

https://www.fiercehealthcare.com/payer/cigna-s-strong-financial-start-to-2019-backed-by-express-scripts-acquisition

Acacia Pharma : Receives Complete Response Letter From Fda for Barhemsys

Acacia Pharma Group plc(“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a second Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for BARHEMSYS^® (amisulpride injection). The letter identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in BARHEMSYS.

As previously, no concerns were raised by FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval.

“We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards,” said Dr Julian Gilbert, CEO of Acacia Pharma. “As there were no other issues raised with our application, we remain confident that BARHEMSYS is approvable. We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for BARHEMSYS.”

Conference Call Information

The Acacia Pharma management team will host a conference call Friday, 3 May 2019, at 14.00 CEST, 13:00 BST, 07:00 EST. Please join the event conference 5-10 min prior to the start using the confirmation code and any of the phone numbers provided below.

Password: Acacia Pharma

Location	Phone Number
Belgium	0800 746 68
United Kingdom	0808 109 0700
United States	1 866 966 5335
International	+44 (0) 20 3003 2666

https://www.marketscreener.com/ACACIA-PHARMA-GROUP-41692449/news/Acacia-Pharma-Receives-Complete-Response-Letter-From-Fda-for-Barhemsys-28528460/

AstraZeneca OKd on type 2 diabetes time-release in US

The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).

The approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-Qternmet-XR-approved-in-the-US-for-type-2-diabetes-28528650/

Intercept upgraded to Outperform from Market Perform at Wells Fargo

https://thefly.com/landingPageNews.php?id=2902787