Piper Jaffray analyst Christopher Raymond sees “yet another perplexing disconnect between fundamentals and stock action” following Alexion Pharmaceuticals’ Q4 results. With a beat and above consensus fiscal 2019 earnings guidance, the market seems focused on Alexion’s below consensus revenue guidance, Raymond tells investors in a post-earnings research note titled “Q418 Beat, FY19 Revenue Guidance a Bit of a Sandbag; Buyers Right Here.” The sales outlook “seems to presuppose everything but the kitchen sink with respect to any type of headwind,” says the analyst. He thinks Alexion’s management team has continued to deliver without reward from the market. Further, there is “very real potential” for the company to be taken out, Raymond adds. He’s a buyer of the stock at current levels with an Overweight rating and $180 price target. Alexion in afternoon trading is down 2% to $123.79.
https://thefly.com/landingPageNews.php?id=2858553
Monday, February 4, 2019
Idexx Laboratories under pressure as Wall Street digests quarterly results
Shares of Idexx Laboratories (IDXX) are slipping although the company reported better than expected quarterly results on Friday. Commenting on the earnings release, Bank of America Merrill Lynch analyst Michael Ryskin told investors that he believes the “story stays intact” despite lots of moving pieces and fiscal year guide refinements. QUARTERLY RESULTS: On Friday, Idexx Laboratories reported fourth quarter earnings per share of 98c and revenue of $549.39M, both above analysts’ consensus of 91c and $546.7M, respectively. For fiscal year 2018, the company reported earnings per share of $4.26, better than the expected $4.20, and revenue of $2.213B, which was also slightly better than analysts’ consensus of $2.21B. Additionally, Idexx raised its 2019 earnings per share outlook range by 4c from the midpoint of prior guidance to $4.66-$4.78, reflecting flow through of strong 2018 profit performance, partially offset by lower estimates for projected share-based compensation tax benefits. The company also reaffirmed 2019 revenue guidance of $2.385B-$2.425B and said it achieved revenue growth in the fourth quarter of 9% on a reported basis and 10% on an organic basis, driven by CAG Diagnostics recurring revenue growth of 12% reported and 13% organic. Analysts currently expected FY19 EPS of $4.69 and revenue of $2.41B. STORY REMAINS INTACT: In a post-earnings note, Bank of America Merrill Lynch’s Ryskin told investors that, for the most part, the Idexx core business continues to impress as CAG recurring revenues posted their best year since 2015, and Consumables finished the year on a “particularly good note.” The only pocket of softness continues to be the International reference lab, he pointed out, adding that with Idexx’s emphasis on driving in-clinic/point-of-care placements and revenues, it seems increasingly likely that OUS reference lab will remain somewhat subdued throughout 2019. Overall, Ryskin believes the negative reaction to the fourth quarter results seems to be largely driven by a number of refinements to the 2019 guide as the company now sees CAG recurring as 11%-12% versus prior 11.5%-12.5%, and constant currency OpM expansion is now 50-80bps versus prior 50-100bps. Following the analyst’s conversations with Idexx, he does not see these changes as an indication of any material change in the outlook, and are more reflective of fine-tuning the model following fourth quarter results. He reiterated a Buy rating and $235 price target on the shares. PRICE ACTION: In afternoon trading, shares of Idexx Laboratories have dropped just over 1% to $203.17.
Abiomed heart pump benefits continue to outweighs risks, FDA tells doctors
In a letter to cardiologists and transplant surgeons, the FDA said it is evaluating recent interim post-approval study results which suggest a higher mortality rate for patients treated with the Abiomed Impella RP System than the rate previously observed in the premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery, the agency explained. “The FDA wants to ensure you are aware of the mortality rate that has been observed in the ongoing PAS,” the letter stated. It added, “Although the FDA is concerned about the high mortality rate from the interim PAS results, we believe that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.
https://thefly.com/landingPageNews.php?id=2858557
https://thefly.com/landingPageNews.php?id=2858557
Uncommon Fungal Infections Affect Area Pets
In 2018, fungal infections rarely seen in the northeastern United States affected pets in New Jersey. Dr. Melanie Puchot, Internal Medicine specialist at NorthStar VETS, said, “These are uncommon infections in our area, especially in pets with no travel history. We want to make pet parents aware of this because the infections might otherwise be missed or misdiagnosed.”
Dr. Puchot has done extensive research on two of these infections, Histoplasmosis and Cryptococcosis, which can be viewed at http://www.northstarvets.com/new-fungal-infections. Dr. Puchot added, “Pets travel now more than ever, and get exposed to other pets in many settings like parks and retail stores. Combined with warmer, wetter weather, it has allowed for cases never-before seen in this area to start appearing.”
Histoplasmosis
- Fungal infection that can infect dogs, cats and humans
- Spread by inhalation of the fungus in soil (not transmissible from patient to patient)
- Most commonly found in the Ohio and Mississippi River valleys and in the Southeastern U.S.
- Major clinical signs include cough, rapid breathing, GI upset, anemia, enlargement of organs, and eye inflammation
- In pets, can look like a growth, asthma, IBD, and heart failure
- Can be treated and managed with a long course of appropriate anti-fungals
Cryptococcosis
- Fungal infection that can infect cats, dogs and humans (but is most common in cats)
- Spready by inhalation of the fungus in soil (not likely transmissible from patient to patient)
- The fungus can be found worldwide, but in the United States is most commonly found on the west coast and in Canada
- Major clinical signs include upper respiratory tract infection, ulcers and lesions, eye infection, and neurologic signs like inflammation of the brain
- In pets, the nasal cavity is the primary site of infection and can cause rhinitis
- Any travel history, even years prior, can be considered significant for risk of infection
About NorthStar VETS
Located in Robbinsville, NJ, NorthStar VETS is the region’s leader in providing advanced veterinary services by board-certified, residency trained, or highly experienced veterinarians 24/7. As an American Animal Hospital-Accredited (AAHA) Referral Practice, NorthStar VETS continues to set the standard in medical excellence for dogs, cats, birds, exotics, and other family pets. www.northstarvets.com
Lilly and Incyte’s Olumiant Hits the Mark in Two Phase 3 Atopic Dermatitis Trials
Two Phase III trials for atopic dermatitis therapy in development by Eli Lilly and Company and Incyte Corporation hit the mark at 16 weeks. The two late-stage studies are part of a five clinical trial study program aimed at determining the safety and efficacy of baricitinib in treating these patients.
This morning, Eli Lilly and Incyte said baricitinib hit the mark in BREEZE-AD1 and BREEZE-AD2, two Phase III studies evaluating baricitinib as a monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis. Moderate-to-severe AD is characterized by intense itching, resulting in visibly damaged skin and sleep loss.
Lilly’s announcement today was brief in the details. The company only noted that in both Phase III trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator’s Global Assessment for AD (IGA) score of clear or almost clear, in comparison to placebo. According to the scale, clear skin has a score of zero and almost clear skin as a score of one. The BREEZE-AD1 and BREEZE-AD2 trials are two of five studies that will be part of the placebo-controlled data program intended to support global registrations, Eli Lilly said. Full data results from the BREEZE-AD1 and BREEZE-AD2 trials will be shared at future conferences, as well as in peer-reviewed journals. Topline data from other ongoing Phase III trials expected later this year will also be shared, the company said.
Baricitinib has been approved as a treatment for moderately to severely active rheumatoid arthritis. It is sold under the brand name Olumiant. Olumiant is a once-daily, oral JAK inhibitor. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. Olumiant has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3, Eli Lilly noted.
In today’s announcement, the companies touted the safety results of baricitinib. At 16 weeks in both trials, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo. The most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.
Lotus Mallbris, head of immunology development at Eli Lilly, noted that there are limited treatment options, particularly oral treatments, for atopic dermatitis, an inflammatory skin disease.
“We are encouraged that baricitinib met the primary endpoints in these two studies, and look forward to seeing the collective results of all five studies,” Mallbris said in a statement.
Six ‘Obesity-Related’ Cancers on Rise in US Young Adults
In the United States from 1995 to 2014, the incidence of six of 12 obesity-related malignancies increased among “young” adults (25-49 years), according to a new observational study.
However, the incidences for these cancers — except for colorectal cancer —also rose in older adults (50 years or older), acknowledge the authors, led by Hyuna Sung, PhD, cancer epidemiologist and principal scientist, Surveillance and Health Services Research Program at the American Cancer Society. The study was published online today in The Lancet Public Health.
But the young adults, who were the focus of the study, had larger annual percentage increases than the older adults.
In young adults, the six obesity-related cancers that increased in incidence in were multiple myeloma, colorectal, uterine corpus, gallbladder, kidney, and pancreatic cancer.
On the other hand, the six obesity-related cancers that did not increase in young people were breast, esophageal, gastric cardia, liver and intrahepatic bile duct, thyroid, and ovarian.
Despite the findings, the study is not evidence of a causal relationship between obesity and cancer.
Furthermore, an expert not involved with the study questioned the concept of “obesity-related” cancers.
“The obesity–cancer story is far from clear and while the authors selected cancers that might be obesity related, they also might be related to other factors not considered that may be changing over time but that were not examined,” Ruth Etzioni, PhD, a biostatistician at Fred Hutchinson Cancer Research Center in Seattle, told Medscape Medical News.
“I worry about inflammatory articles like this one misinforming the public,” she added.
The obesity–cancer story is far from clear.
Nevertheless, senior author Ahmedin Jemal, DVM, PhD, vice president of the Surveillance and Health Services Research Program at the American Cancer Society, sounded an alarm about the results.
“Our findings expose a recent change that could serve as a warning of an increased burden of obesity-related cancers to come in older adults,” he said in a press statement. “Most cancers occur in older adults, which means that as the young people in our study age, the burden of obesity-related cancer cases and deaths are likely to increase even more.”
Jemal and coauthors called for increased obesity screening in young adults.
In an accompanying editorial, Catherine Marinac, PhD, and Brenda Birmann, ScD, of Harvard University in Boston, Massachusetts, say that it is “plausible” as well as “provocative” that obesity is driving the reported results. But, they add, the investigators’ interpretation of that relationship is “speculative.”
Furthermore, the editorialists write that they would have liked to have heard the study authors’ thoughts about why only some obesity-related cancers were on the rise in young adults — and not all 12.
Both sets of experts call for further research to uncover the exposures responsible for these “emerging trends.”
Eighteen Other Cancers Examined
Notably, the study authors also report that, among the six cancers on the rise in the young adults, there was a steeper increase in progressively younger ages (P wald < .05).
For example, over the study period, the average annual change for pancreatic cancer was equal or less than 1% in people ages 40 to 84, 1.3% in those ages 35 to 39, and 2.5% in 30 to 34-year-olds. In the youngest age group (ages 25-29), it was 4.3%.
The investigators did not look at solely obesity-related cancers.
The researchers also reviewed incidence data on 18 other (non–obesity-related) cancers. And the findings were telling, they suggested: “…the incidence increased in successive younger generations for only two of the 18 additional cancers, and decreased for about half of the remaining cancer types.”
In their study discussion section, the authors comment extensively about obesity in the United States and suggest their new findings may be related to recent trends showing increases in body weight.
“These [cancer incidence] trends might have been influenced by the rapid rise in overweight or obesity prevalence in the USA. Between 1980 and 2014, overweight or obesity prevalence in the USA increased by more than 100% (from 14.7% to 33.4%) among children and adolescents and by 60% among adults aged 20-74 years (from 48.5% to 78.2%),” they write.
Lead author Sung commented at length about food quality as a possible contributor to the newly found trends: “Obesity is associated with health conditions that can contribute to the risk of cancer. For example, diabetes, gallstones, inflammatory bowel disease, and poor diet can all increase the burden of cancer,” she said. “The quality of the American diet also has worsened in recent decades. More than half of adults who were 20 to 49 years old between 2010 to 2012 reported poor dietary habits, such as eating little fruits, vegetables, whole grains, fish, and shellfish at the same time as eating too much salt, fast food, and sugary drinks.”
The study was funded by the American Cancer Society and the National Cancer Institute. The study authors, editorialists, and Etzioni have disclosed no relevant financial relationships.
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