Search This Blog

Thursday, May 10, 2018

HHS plans more deregulation, with focus on financial risk, non-ACA plans

Providers, insurers and pharmacies can expect a major regulatory overhaul later this year.
The Trump administration’s spring 2018 unified agenda, released on Wednesday, offered a preview into various agencies’ regulatory and deregulatory plans for the near future. Policy changes outlined by the Department of Health and Human Services (HHS) include reduced paperwork burdens for hospitals, greater flexibility for non-ACA-compliant plans, and additional tactics to fight the opioid epidemic, all of which have been previously addressed by the Trump administration.
“Responsible regulatory reform promotes economic growth and innovation, leaving the American people with more freedom to pursue their work and exercise ingenuity,” Neomi Rao, administrator of the Office of Information and Regulatory Affairs at the OMB, said in a statement. She added that the agenda follows President Donald Trump’s executive order to eliminate two regulatory actions for each new regulation.

Hospitals and providers

Long-term care facilities, in particular, are likely to see their pile of regulatory paperwork shrink. One future proposed rule, among the nearly 150 in HHS’ regulatory list, includes the removal of “unnecessary, obsolete, or excessively burdensome” requirements that such providers need to comply with to participate in Medicare and Medicaid.

No further details will be available until the rule is officially proposed, but the agency said the rule would “increase the ability of healthcare professionals to devote resources to improving resident care” instead of paperwork. Hospitals and providers have been calling for paperwork reduction initiatives and appear to have found a friend in the Trump administration.

HHS also plans to streamline the Medicare claims appeals process by fixing cross-references, unclear terms and definitions, and other errors that could be burdensome for providers and beneficiaries.
The American Hospital Association appeared satisfied with the focus on burden reduction.
“We know that efficiencies can be found in many areas, such as streamlined quality reporting, administrative simplification, and less burdensome reporting on the use of electronic health records, among others,” Joanna Hiatt Kim, vice president of payment policy, told FierceHealthcare in an email.
Changes to accountable care organizations are also expected. Some ACOs have been asking the agency for more time in non-financial risk-based contracts, instead of the six-year limit. However, the agency appears to be moving in the opposite direction, as one proposal on the Medicare Shared Savings Program includes “facilitating the transition to performance-based risk,” signaling a greater push for risk-based arrangements.

Plans

One proposed rule would allow more flexibility in the availability of grandfathered health plans, which were in place before the Affordable Care Act (ACA) and exempt from the new requirements, in individual and small group markets. HHS is also expected to push the expansion of health savings accounts and association health plans.

Association health plans were introduced by HHS earlier this year, but experts worried that those plans wouldn’t include enough consumer protections.

Drugs

The agency is also planning additional actions to restructure requirements around prescription drugs. HHS plans to simplify retail pharmacy standards including allowing for “proper recordkeeping when less than the full amount of a prescription for controlled substances is distributed by the pharmacy.”
The agency said the enhancement is critical for pharmacies due to the ongoing opioid crisis.
The Office of Information and Regulatory Affairs plans to announce the total cost of savings from deregulatory actions this fall.

Evolent Health beats views

Shares of Evolent Health are moving higher after the company last night reported Q1 adjusted earnings per share of 2c, versus Bloomberg’s consensus estimate for a loss per share of (4c). The company’s Q1 adjusted revenue of $144.4M topped the Bloomberg consensus of $140.85M. Frank Williams, CEO of Evolent, said in the earnings release, “We are pleased with our first quarter results and our strong start to 2018. We continue to see clear interest and momentum within both the Medicare and Medicaid segments of the market as providers look to enter into and improve on their performance in value-based care arrangements.” The company now expects full year 2018 adjusted revenue to be in the range of approximately $565M-$585M. The consensus estimate is $578M, according to Bloomberg. 2018 adjusted EBITDA is expected to be in the range of approximately $18M-$23M. Bloomberg data shows the consensus EBITDA forecast to be $21.05M. Shares of Evolent Health are up $1.95, or 11.75%, to $18.55 in afternoon trading.

Solid Biosciences target hiked by Leerink

Solid Biosciences price target raised to $28 from $14 at Leerink. Leerink analyst Joseph Schwartz raised his price target on Solid Biosciences to $28 from $14 after he updated his model to reflect Q1 results and increased his probability of success estimate for SGT-001 to 30% from 20%. His probability of success estimate for SB-001 is unchanged at 20%, he noted. Schwartz keeps an Outperform rating on Solid Biosciences shares.

Aptevo target upped by Piper

Aptevo Therapeutics price target raised to $9 from $6 at Piper Jaffray. Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating on Aptevo Therapeutics and raised his price target on Aptevo shares to $9 from $6 after Q1 prophylactic Hemophilia B therapy Ixinity sales of $4.1M beat Piper’s $3M estimate. Additionally, the firm is increasing its FY18 Ixinity sales forecast to $18M.

Prestige Brands beats views

Prestige Brands Holdings (PBH +29.1%) reports revenue rose 6.4% in Q4, driven by solid consumption levels across the Company’s core brands and incremental revenue from the Fleet acquisition.
North American OTC Healthcare segment revenue grew 6.6% to $212.1M, driven by revenues from the acquisition of Fleet as well as consumption growth in the Company’s core OTC brands.
International OTC Healthcare segment revenue up 19% to $24.1M.
Household Cleaning segment revenue fell 7.4% to $19.8M.
Gross margin rate improved 110 bps to 55.2%.
Non-GAAP adjusted EBITDA margin expanded 220 bps to 33.3%.
Advertising & promotion expense rate leveraged 250 bps to 13.8%.
FY2019 Guidance: Revenues: $1.046B to 41.056B; Diluted EPS: $2.96 to $3.04; Free cash flow: $215M or more.

Depomed has Q1 earnings beat

Depomed (DEPO +21%Q1 results ($M): Revenue: 128.4 (+42.0%); Product sales: 44.4 (-50.8% due mainly to license deal with Collegium).
Net income: 33.8 (+226.6%); non-GAAP net income: 21.4 (+386.4%); non-GAAP EBITDA: 31.8 (+25.7%); EPS: 0.48 (+211.6%); non-GAAP EPS: 0.28 (+300.0%).
2018 Guidance: Neurology franchise sales: $120M – 125M; non-GAAP EBITDA: $125M – 135M; net loss: ($33M – 23M).
NUCYNTA ER supply shortages resolved.
Cosyntropin U.S. marketing application to be filed by year-end by development partner Mallinckrodt.
In-licensed new dosage form of migraine med CAMBIA (diclofenac potassium) from Applied Pharma Research S.A. U.S. marketing application expected in 2019.
Agreed to new co-promotion agreement with Allegis Pharmaceuticals for pain med Zipsor (diclofenac potassium). Allegis will add 30 sales reps focused on primary care physicians in certain regions. Revenues to be shared above a mutually agreed-to baseline.
Corporate headquarters relocated to Lake Forest, IL from Newark, CA.

Kala Pharmaceuticals Reports First Quarter 2018

 Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of product candidates using its proprietary mucus-penetrating particle (MPP) technology with an initial focus on the treatment of eye diseases, today reported financial results for the quarter ended March 31, 2018.
“Following the acceptance of our New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for INVELTYS™ for the treatment of inflammation and pain following ocular surgery, our focus during the first quarter of 2018 has been on strengthening our commercial team ahead of the potential FDA approval for INVELTYS,” said Mark Iwicki, Chairman and Chief Executive Officer. “We remain excited about our ophthalmology programs, including KPI-121 0.25%, our product candidate for dry eye disease, as we continue advancing these programs toward approval and commercialization.”
Recent Corporate Highlights
  • Received notification from the FDA of acceptance of our NDA filing for INVELTYS. If approved, INVELTYS could be the first FDA-approved twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.
  • Strengthened the management team with the appointment of Eric Trachtenberg as General Counsel and Corporate Secretary. Mr. Trachtenberg formerly served as General Counsel, Chief Compliance Officer and Corporate Secretary of Aralez Pharmaceuticals, Inc. since February 2016.
  • Presented at the “Spotlight on Dry Eye” session at the Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgery Annual Meeting (OIS @ ASCRS).
  • Presented safety and efficacy data of INVELTYS for the treatment of inflammation and pain following ocular surgery at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
  • Strengthened commercial organization in preparation for the potential approval and launch of INVELTYS with the following key hires:
    • Kathleen McCann Kline, Vice President of Marketing
    • James Patnoe, Vice President of Commercial Operations and Pricing
    • Carl Rennie, Executive Director of Account Management
    • Patrick Bedell, Executive Director of Trade and Alternate Channels
    • Lynette Zickl, Director of Commercial Analytics and Forecasting
Upcoming Milestones and Events
  • Mark Iwicki will provide a corporate overview at the Bank of America Merrill Lynch 2018 Healthcare Conference on Tuesday, May 15, 2018 and at the Jefferies 2018 Global Healthcare Conference on Tuesday, June 5, 2018.
  • PDUFA target action date of August 24, 2018 for INVELTYS.
First Quarter 2018 Financial Results
  • Cash Position: As of March 31, 2018, Kala had cash of $100.5 million compared to $114.6 million as of December 31, 2017. Kala anticipates that its existing cash on hand will enable it to fund operations through at least the next twelve months.
  • R&D Expenses: For the quarter ended March 31, 2018, research and development expenses were $5.7 million compared to $8.0 million for the same period in 2017. The decrease in research and development expenses is primarily due to a decrease in costs associated with our Phase 3 clinical trial of INVELTYS, which completed in the first half of 2017 and our two Phase 3 clinical trials of KPI-121 0.25%, which completed during the fourth quarter of 2017.
  • G&A Expenses: General and administrative expenses for the quarter ended March 31, 2018 were $5.5 million compared to $1.5 million for the same period in 2017. The increase in G&A expenses is primarily attributable to an increase in personnel costs and professional fees associated with operating as a public company, and costs incurred in preparation for becoming a commercial organization.
  • Operating Loss: Loss from operations for the quarter ended March 31, 2018 was $11.1 million compared to $9.6 million for the same period in 2017.
  • Net Loss: Net loss was $11.3 million, or $0.46 per share, for the quarter ended March 31, 2018, compared to a net loss of $9.8 million, or $8.26 per share, for the same period in 2017.
About INVELTYS™ (KPI-121 1%)
INVELTYS™ (KPI-121 1%) is a twice-a-day corticosteroid for the treatment of inflammation and pain following ocular surgery. INVELTYS utilizes Kala’s proprietary mucus-penetrating particle (MPP) technology to enhance penetration into target tissues of the eye. In pre-clinical studies, MPP increased delivery of a corticosteroid into ocular tissues more than three-fold by facilitating penetration through the tear film mucus. Two Phase 3 clinical trials have been successfully completed for INVELTYS and statistical significance was achieved for both primary efficacy endpoints in both trials. In each of these trials, INVELTYS was well tolerated with no treatment-related serious adverse events observed. Kala believes INVELTYS has a favorable treatment profile compared to the standard of care for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen and rapid onset of relief.
About KPI-121 0.25%
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy administered four times a day. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala’s mucus-penetrating particle (MPP) technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the eye. In preclinical studies, MPP technology increased delivery of LE into ocular tissues more than three-fold compared to current LE products by facilitating penetration through the tear film mucus. Kala has completed one Phase 2 and two Phase 3 clinical trials of KPI-121 0.25%. Kala believes that KPI-121 0.25%’s broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions which could benefit from temporary relief of dry eye signs and symptoms.