Eli Lilly’s surprise Lartruvo failure, Loxo buy put a dent in its 2019 hopes

It was not so long ago, Dec. 19 to be exact, that Eli Lilly thrilled investors with 2019 revenue and earnings projections that far exceeded what analysts were expecting.

What a difference seven weeks makes.

On Wednesday, Lilly offered up a disappointing cut to those very numbers. Reason number one wasn't surprising: Lilly’s $8 billion takeout of Loxo Oncology, announced in January, means additional spending that will gouge earnings, the company said.

The second reason, on the other hand, only started to play out in the last couple of weeks, growing more serious as days went by. In January, Lilly put up phase 3 data showing that soft tissue sarcoma patients taking a combination of its product Lartruvo with doxorubicin did not fare better than those taking doxorubicin alone.

Lilly stopped marketing the drug. The FDA advised physicians to refrain from prescribing Lartruvo "outside of an investigational study," raising questions about its U.S. approval. Lilly had nabbed its FDA green light based on phase 2 data and conditional approval in Europe, and needed phase 3 data to confirm those nods.

Just how much will those two things cost this year? The company is now expecting revenues between $25.1 billion and $25.6 billion, down from the previous range of $25.3 billion to $25.8 billion. And it expects adjusted earnings per share of $5.55 to $5.65, a far cry from the $5.90 to $6 it had promised in December.

What's more, Lilly’s dampened 2019 forecast came during a fourth-quarter earnings report that analysts deemed OK at best. Revenues of $6.44 billion, up 5% year over year, exceeded analysts’ average expectation of $6.28 billion. Adjusted earnings per share rose 17% from the same period a year ago to $1.33 but fell one penny short of projections.

But the revenue beat was largely driven by Cialis, a product that started losing ground to generic competition last year. Its sales came in at $351 million for the quarter, blowing past the average analyst estimate of $249 million. Problem is, said Credit Suisse analysts in a note to investors Wednesday morning, "that product's recent patent loss makes it less meaningful to the story going forward."

Lilly executives certainly understand that, and they made a point of telling analysts on the quarterly earnings call that 34% of its 2018 revenues came from "newer products."

Still, there were some notable disappointments in that field, too. Fourth-quarter sales of diabetes drugs Jardiance and Basalgar missed estimates at $193 million and $232 million respectively. And sales of CDK 4/6 cancer treatment Verzenio were "surprisingly light" at $83 million, missing estimates by $22 million, Credit Suisse analysts said.

When asked to explain the Verzenio shortfall during the call, Lilly Oncology President Anne White cited changing buying patterns in the U.S. amid in-class competition. "We are seeing flattening in the CDK4/6 market as penetration has occurred," White said. "With Verzenio, our focus is clearly on execution to drive new [prescriptions] and increasing our share of market." White added that half of physicians who try Verzenio go on to write additional prescriptions for the product. Ex-U.S. launches could also help drive growth, she said.

Underperformers like Verzenio, coupled with uncertainty over Lartruvo's future, only put more pressure on other recently launched Lilly products, not the least of which is migraine treatment Emgality. Lilly was the third company to reach the hot new market of CGRP inhibitors, introducing its product in October, and some investors asked for details about how the product is performing.

Lilly Bio-Medicines President Christi Shaw said Lilly is intensifying its marketing efforts for Emgality, launching a direct-to-consumer TV campaign this week. But she conceded that only a third of Emgality prescriptions are coming from primary care doctors, who will be critical to driving the product’s growth.

"This very much will be an expansion into primary care beyond the neurologists," Shaw said. "We’re very bullish on both the market and on Emgality’s ability to compete."

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