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Wednesday, May 1, 2019

CVS Health Eases Concerns About Aetna Deal

CVS Health Corp. delivered stronger-than-expected results in its first quarter as a combined health-care company, taking a step toward selling skeptical investors on its acquisition of insurer Aetna Inc.
The Woonsocket, R.I.-based company, which completed the nearly $70 billion takeover in November, said the insurance business performed well while the company saw stronger profits on brand-name drugs and increased sales at its drugstores.
The results mark a shift from February when the company offered a downbeat earnings projection for 2019 that sent shares tumbling. The performance also distinguishes CVS from rival Walgreens Boots Alliance Inc., which reported weaker profits in the most recent quarter and lowered its forecast citing smaller profits from generic drug sales.
The company is under pressure from investors, who are pushing for a clearer picture of its growth prospects. Investors’ focus will now shift to the company’s planned investor day set for June 4, when it has promised to give a more detailed look at its plans.
The Aetna acquisition created an industry giant that combines a retail pharmacy, pharmacy-benefit manager and Aetna’s insurance businesses.
CVS shares had lost a third of their value since it completed the Aetna deal, erasing roughly $34 billion of market value. Shares were up about 5% in afternoon trading.
“None of us are happy with where our stock price is,” CVS Chief Executive Larry Merlo said in an interview. “From our perspective we’re very early. We’re creating a pathway that no one has gone on in an effort to make health care more local and make it more simple.”
“Considering that expectations have been low, we see this as the first positive catalyst that restores investor confidence in this Management team and drive multiple expansion,” SVB Leerink analyst Ana Gupte said.
One sign of investors’ discontent came at a lunch meeting that Mr. Merlo and finance chief Eva Boratto held with investors in early March. The meeting was tense, according to an investor who attended, with the audience pressing the company for a clearer picture of its financial projections for future years. In a note describing the March meeting that came out soon after it occurred, UBS analyst Kevin Caliendo wrote that there appeared to be a “growing credibility issue with investors on how the company is framing the organic path forward for the retail, and consternation that synergy realization isn’t flowing enough to the bottom line to generate accretion from the deal.”
The first-quarter CVS results and call with analysts “will help investor sentiment,” Mr. Caliendo said Wednesday. “The next big hurdle is going to be visibility on 2020 earnings and earnings growth.”
Analysts said that many of the challenges facing CVS are tied to the nature of its core businesses and the policy landscape, and similar issues have hit its competitors.
The health-insurance sector has also recently seen shares slump even among companies with strong earnings results, due to investor worries about policy matters including some Democrats’ interest in universal government-provided health insurance.
CVS has said its deal to bring together drugstores, a pharmacy-benefit manager and an insurer would help it cut health-care costs and improve care. Mr. Merlo has talked about how the merged company will help smooth the fragmented health-care experience for consumers.
CVS is also remaking some of its stores into new health hubs, offering a broader range of services, many aimed at people with chronic health conditions such as diabetes. The company has said it hopes to save money and bolster care by improving patients’ adherence to their prescriptions and pushing care to lower-cost sites, reducing use of emergency rooms.
“Our first full quarter of combined operations was a success in many ways,” Mr. Merlo said in a statement.
On Wednesday, the company reported a first-quarter net income of $1.4 billion, or $1.09 cents a share, up from a profit of $998 million, or 98 cents a share, a year earlier.
The company, which realigned its reporting segments to reflect the combined company, said Aetna contributed $16.6 billion in revenue to its health-benefits segment that was bolstered by strong sales of Medicare products.
CVS reported stronger retail sales from its drugstore chain, which it attributed to success in selling more health-focused offerings, and an increase in pharmacy claims. Prescription volume grew 5.5% from the same period a year ago.
Same-store sales increased 3.8%, beating the FactSet estimate of a 1.2% increase. The retail business will continue to be challenged by lower margins on prescription drugs that will last throughout the year, Mr. Merlo said.
CVS raised it forecast, saying it expects adjusted earnings per share of $6.75 to $6.90, up from $6.68 to $6.88. The improved outlook remains below analyst expectations headed into 2019.

Teva launches generic version of Letairis

Teva Pharmaceutical Industries (TEVA) announced the launch of a generic version of Letairis Tablets, 5 mg and 10 mg, in the U.S. Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. In combination with tadalafil, ambrisentan is indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. For all female patients, ambrisentan tablets are only available through a restricted program called the Ambrisentan Risk Evaluation & Mitigation Strategy due to the risk of fetal harm. Letairis has annual sales of nearly $247 million in the U.S., according to IQVIA (IQV) data as of February 2019.

So-Young IPO: What You Need To Know

This online medical marketplace wants to help beautify China, and it’s looking for investors to help beautify its strategy.

The IPO

So-Young International Inc. will issue 13 million shares on the Nasdaq under ticker SY, according to the firm’s F-1 filing. Priced between $11.80 and $13.80, the offering represents 100 percent of outstanding shares and is expected to bring in about $206.31 million.
Lead underwriters include Deutsche Bank and CICC.
The company qualifies as an emerging growth company and foreign private issuer in the U.S., which exempts management from certain SEC disclosure requirements.

The Company

Launched in 2013, the online platform services as a marketplace for China’s 10,000 plastic surgery service providers. Its site allows users to discover, assess and set appointments with the region’s aesthetic medical professionals.
The company reported 240 million average monthly views in the final quarter of 2018. Through the entire year, it facilitated $306.6 million in transactions representing nearly a third of medical aesthetic treatments booked online.
Estimates suggest China is the second largest medical aesthetic service markets and is positioned to take first by 2021. Total industry revenues are forecasted to reach $52.4 billion by 2023.
As of last year, service providers spent 25.8 percent of revenues, or $4.6 billion, on customer acquisition, with $2.6 billion concentrated online. That rate is projected to grow to $7.2 billion by 2023

The Finances

In 2018, So-Young recorded 138-percent year-over-year revenue growth and 220.2 percent net income growth. Revenue came in at $89.8 million with a net income of $8 million.

Trevi Therapeutics IPO: What You Need To Know

The Street will gain access this week to an investment in the only opioid marketed in the U.S. and Europe without being classified as a controlled substance.

The IPO

Trevi Therapeutics, Inc. will issue nearly 4.7 million shares on the Nasdaq under ticker TRVI, according to the firm’s S-1 filing. Priced between $14 and $16, the offering represents 30.2 percent of outstanding shares and is expected to bring in about $85.87 million.
Lead underwriters include SVB Leerink, Stifel and BMO Capital Markets.
The company qualifies as an emerging growth company under the U.S. JOBS Act, which exempts management from certain SEC disclosure requirements.

The Company

The Connecticut biotech targets chronic pruritis, chronic cough related to idiopathic pulmonary fibrosis, and levodopa-induced dyskinesia related to Parkinson’s disease.
Its nalbuphine ER is in a Phase 2b/3 clinical trial for chronic pruritis that’s expected to yield top-line data in the first half of next year. The candidate is an oral extended release form of a drug that the U.S. has used for pain management for more than two decades.
It is the only opioid the U.S. and Europe have approved for marketing without classification as a controlled substance.
Trevi intends for the product to be the first in the U.S. and Europe that addresses pruritis — a market expected to grow from $10.8 billion in 2016 to $14.3 billion in 2022.

The Finances

Trevi incurred a net loss of $20.55 million in 2018 compared to $12.86 million in 2017. It has not yet generated revenue.
Since its start, Trevi has been backed by life sciences investors such as TPG Biotech, Omega Funds, Lundbeckfonden Ventures, New Enterprise Associates and Aperture Venture Partners.

TransMedics Group IPO: What You Need To Know

Looking to inject new life into your medtech portfolio? One company hits the market this week in an effort to keep your pulse and its pulse pumping.

The IPO

Transmedics Group, Inc. will issue 4.7 million shares on the Nasdaq under ticker TMDX, according to the firm’s S-1 filing. Priced between $15 and $17, the offering represents 24.4 percent of outstanding shares and is expected to bring in about $75 million at the midpoint of the valuation.
Lead underwriters include Morgan Stanley and JPMorgan.
The company qualifies as an emerging growth company under the U.S. JOBS Act, which exempts management from certain SEC disclosure requirements.

The Company

Based in Massachusetts, the medtech company sells proprietary technology to transport lungs, hearts and livers for transplant.
Its Organ Care System replicates elements of each organ’s natural physiological environment. The storage system keeps the heart beating, the lungs breathing, and the liver producing bile. These conditions are intended to prevent injury and oxygen deprivation during transport and thereby reduce organ waste and post-transplant complications.
TransMedics sees an opportunity to support 67,000 donors annually in the U.S., Canada, Australia and the European Union. In the U.S., alone, the opportunity represents about $8 billion.
Management awaits U.S. approval to expand applicability to additional transplant procedures.

The Finances

In 2018, the firm recorded $13 million in revenue leading to a net loss of $23.8 million. The year before, it earned $7.7 million for a loss of $20.8 million.

LivaNova price target lowered to $90 from $120 at Piper Jaffray

Piper Jaffray analyst Matt O’Brien lowered his price target for LivaNova to $90 from $120 after the company announced Q1 results, with revenues in-line with the company’s preannouncement. LivaNova expects Neuromod to be down year over year in 2019, but the analyst believes the impact to the business will be temporary, and he anticipates it will rebound later this year and into 2020. Overall, O’Brien acknowledges the near-term concerns over the story, but continues to believe the base business will stabilize and that the pipeline is receiving no value, making the name an “interesting one for patient investors.” He reiterates an Overweight rating on the shares.
https://thefly.com/landingPageNews.php?id=2901179

Cipla receives final approval for generic version of Gilead’s Letairis

Cipla Limited and its subsidiary Cipla USA, Inc., (hereafter referred to as ‘Cipla’) announce receipt of final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (US FDA).
Cipla’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis. Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.
The U.S. Sales of Letairis Tablets USP stood at $943 million in 2018. The product is available for shipping immediately.