Eli Lilly and Co on Tuesday cut its annual profit forecast for the third time, as a stronger dollar piled more pressure on the drugmaker struggling with lower insulin prices and generic competition for its cancer drug.
The company now expects adjusted full-year earnings of $7.70 to $7.85 per share, compared to its prior forecast of $7.90 to $8.05.
The drugmaker said it took an additional $300 million hit from the stronger dollar.
Multinational companies such as Abbott Laboratories and Johnson & Johnson have been hit by the dollar's strength against a basket of currencies.
Sales of Mounjaro, Lilly's newly-approved diabetes drug, was $187.3 million, with over half coming from the United States
Solid Third-Quarter 2022 Revenues of $22.6 Billion
Due to Exceptionally Strong Growth Achieved in the Prior-Year Quarter, Revenues Declined 2% Operationally
Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 2% Operationally
Third-Quarter 2022 Reported Diluted EPS(2) of $1.51, Reflecting 6% Growth Over Third-Quarter 2021, Including a $0.15 Incremental Benefit in the Current Period Related to Tax Resolutions for Multiple Years Impacting Both Reported(2) and Adjusted(3) Diluted EPS
Raises Lower End of Full-Year 2022 Revenue Guidance(4) to a Range of $99.5 to $102.0 Billion, Reflecting an Improved Operational Outlook Combined with Incremental Unfavorable Foreign Exchange Impacts
Raises 2022 Revenue Guidance for Comirnaty(1) by $2 Billion to ~$34 Billion and Reaffirms Revenue Guidance for Paxlovid of ~$22 Billion, Despite Unfavorable Impacts from Foreign Exchange
Raises and Narrows Full-Year 2022 Adjusted Diluted EPS(3) Guidance from $6.30 to $6.45 to $6.40 to $6.50
Pipeline Programs That Have Achieved Positive Phase 3 Readouts Since Previous Earnings Release Include RSVpreF Vaccine in Older Adults & Maternal, Prevnar 20/Apexxnar in Pediatrics, Talzenna/Xtandi Combination in mCRPC and Pentavalent Meningococcal Vaccine in Adolescents and Young Adults
Pfizer to Host Analyst Event on December 12 in New York City, Where It Will Showcase Its Portfolio of Upcoming Product Launches and Other Pipeline Programs with High-Value Potential
–Total net product revenues grew to $713 million (+20% Y/Y) as a result of strong Jakafi® (ruxolitinib) and Opzelura™ (ruxolitinib) cream net product revenues
– Jakafi net product revenues of $620 million in Q3’22 (+13% Y/Y); raising the bottom end of full year guidance to a new range of $2.38 to $2.40 billion
– Opzelura net product revenues of $38 million in Q3'22 driven by robust demand and broadening payer access; launch in vitiligo underway
– Pipeline progresses with positive povorcitinib data in hidradenitis suppurativa at EADV, oral PD-L1 update at SITC and the pending acquisition of Villaris Therapeutics and auremolimab, a novel anti-IL-15Rβ mAb
—$66.0 million in ORLADEYO Q3 2022 net revenue; on-track to more than double sales in 2022 vs 2021—
—Underlying patient trends remain strong with nine percent paid patient growth in Q3 2022—
—Company expands complement pipeline by advancing second oral Factor D inhibitor, BCX10013, into clinical development with goal of once-daily dosing, and adding discovery targets—
—BCX9930 patient screening underway, data expected from approximately 15 newly-enrolled patients in mid-2023—
U.S. Ocaliva® net sales of $77.6 million; 16.4% growth over the prior year quarter
Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted operating expense guidance to $350 million to $365 million
As of September 30, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $497.8 million
Company remains on track to resubmit new drug application (NDA) for obeticholic acid (OCA) in liver fibrosis due to NASH by end of 2022 based on the positive Phase 3 REGENERATE study
INGREZZA® (valbenazine) Third Quarter Net Product Sales of $376 Million
INGREZZA® (valbenazine) 2022 Net Product Sales Guidance Raised to $1.4 - $1.425 Billion
Supplemental New Drug Application (sNDA) of Valbenazine For the Treatment of Chorea in Patients with Huntington Disease Submitted to the U.S. Food and Drug Administration
The latest front in the Biden administration’s crusade to bypass the congressional appropriations process and expand the welfare state comes in the form of themedicalization of everyday life through Medicaid coverageof “health-related social needs.”
The Centers for Medicare and Medicaid Services recently approved three section 1115 demonstration initiatives that allow Oregon, Massachusetts and Arizona to use Medicaid funds to pay nonmedical expenses such as housing supports (rent, relocation expenses, furniture), meals, air conditioning and air purifiers “during climate emergencies” and transportation services.
CMS Administrator Chiquita Brooks-LaSure argues such measures are needed “to address the root social causes of health concerns, like lack of access to nutritious food and housing insecurity.”
This is an unnecessary and potentially enormous expansion of Medicaid, the government-funded health program for low-income families, children and the disabled — and, in Medicaid expansion states, low-income adults. Medicaid covers roughly one in four Americans. It is financed partly by the federal government (about two-thirds on average) and partly by the individual states. States have leeway in spending their portion, but strict rules limit how they can use the federal chunk.
Before these recent approvals, adding nonmedical services to the program could have been considered fraud, waste and abuse. But section 1115 waivers allow state Medicaid programs to create demonstration projects that use federal Medicaid and Children’s Health Insurance Program funds in ways federal rules would not otherwise permit.
Of course, once Medicaid spending can be used for housing and food, there’s no logical stopping point. Clothing, heating fuel, gasoline, phones and computers could all arguably be linked to Medicaid recipients’ health and well-being.
And since states pay on average only one-third of the cost, they have a tremendous incentive to include all kinds of good and services, particularly ones previously provided with state-only dollars, under the Medicaid umbrella. Expect a slew of waiver applications with an ever-expanding list of health-related “social needs” to cover.
Section 1115 waivers are supposed to be budget neutral, meaning federal spending under the waiver cannot exceed what it would have been without the waiver. But, as the Government Accountability Office has noted, CMS budget-neutrality determinations are lax, “lack transparency” and often increase federal financial liability. And new, more flexible CMS policies allow purported savings from previous waiver cycles to offset federal spending for new waivers.
The Centers for Medicare and Medicaid Services is also creating Medicare Advantage models that will include benefits like meal delivery and rental support.AP Photo/Pablo Martinez Monsivais, File
Indeed, Medicaid has been on GAO’s “list of high-risk programs” since 2003, “in part because of concerns about inadequate fiscal oversight, including oversight of section 1115 demonstrations.”
Team Biden is not stopping with Medicaid either. CMS’s Center for Medicare and Medicaid Innovation announced it’s developing Medicare Advantage models that address the social determinants of health by providing supplemental benefits such as nonmedical transport, meal delivery and rental support to some 3.7 million “underserved” MA enrollees.
It’s also testing a Health-Related Social Needs Screening Tool for Medicare and Medicaid beneficiaries. The agency claims — without any sense of irony — that clinicians can “easily” use the eight-page, 26-question tool “as part of their busy clinical workflows with people of all different ages, backgrounds, and settings” to “inform patients’ treatment plans and make referrals to community services.”
Expanding the definition of government-funded health care is consistent with other administration actions to expand the welfare state. It has repeatedly extended the public-health emergency — an emergency President Joe Biden acknowledged is over — which prohibits states from removing an estimated 16 million ineligible beneficiaries from the Medicaid rolls. Now these beneficiaries can look forward to nonmedical benefits too.
Taxpayers should ask their elected officials why Medicaid is paying for housing, food, air conditioners and other nonmedical services. Other public-welfare programs with large federal funding streams already address these areas, and most Medicaid recipients already receive benefits from these programs.
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And Congress should ask why the administration is unilaterally subverting a medical-welfare program to cover nonmedical services that Congress has already funded. Expanding Medicaid to cover health-related social needs is a bad policy, and it’s one that Congress, not executive-branch bureaucrats, should decide.
Joel Zinberg is a senior fellow at the Competitive Enterprise Institute and director of the Paragon Health Institute’s Public Health and American Well-Being Initiative. Gary Alexander is director of Paragon’s Medicaid and Health Safety Net Reform Initiative.
