Molina Healthcare (MOH-6.6%) slips on 25% higher volume on the heels of preliminary exchange enrollment of ~350K lives last quarter, below the estimate of 407K at Stephens.
Analyst Scott Fidel lowered his estimate of 2020 non-GAAP EPS by $0.20 to $11.65 on the basis of the estimated $250M expected revenue shortfall in his valuation model, trimming his fair value target by $5 to $145 while maintaining his Equal Weight rating.
Per Bloomberg, consensus non-GAAP EPS is $11.82. Seven Buys, eight Holds and one Sell.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet tomorrow to review and discuss two opioid drug applications.
Morning session: Esteve Pharmaceuticals S.A.’s tramadol and celecoxib, a combination of an opioid and NSAID for the management of acute pain.
Afternoon session: Intellipharmaceutics International’s (OTC:IPCIF-13.1%) extended-release oxycodone for the management of moderate-to-severe pain.
Eli Lilly and Co said on Tuesday it plans to sell two versions of insulin products at half their current U.S. list prices, eight months after it started selling a half-priced version of its widely-used Humalog injection.
Lilly will sell new versions of Humalog Junior KwikPen and Humalog Mix75/25, which contains a mix of fast- and intermediate-acting insulin, at a list price of $265.20 for a pack of five KwikPens. They will be available at that price by mid-April, the company said.
Major insulin makers Lilly, Sanofi SA and Novo Nordisk have been pushing to make the life-sustaining diabetes medicine available for lower costs to counter heavy criticism from lawmakers and patients.
People with Type 1 diabetes need insulin to control blood sugar levels, and it is also used by some with advanced Type 2 diabetes as well. But its cost in the United States nearly doubled from 2012 to 2016, and stories have emerged of patients forced into risky rationing of the medicine due to its cost.
Lilly has called insulin a highly rebated product, meaning that list price does not reflect the actual cost. Drugmakers often argue they have to keep list prices high because of rebates or discounts they must pay to pharmacy benefit managers and health insurers to get products on their lists of covered drugs.
“Real change to our reimbursement system is needed. Insurance coverage should ensure no one with diabetes is forced to ration or skip doses for financial reasons,” Mike Mason, president of Lilly’s diabetes unit, said in a statement on Tuesday.
Lilly in May started selling a half-priced version of Humalog called Insulin Lispro.
For the week of Dec. 30, around 22% of U.S. prescriptions for Humalog were filled with the company’s half-priced version, according to data compiled by retail drug price tracker GoodRx from sources including pharmacies and insurers.
Novo Nordisk said earlier this month it would offer free insulin to U.S. patients in immediate need, following its announcement in September that U.S. patients can buy three vials or two packs of pens of its analog insulins for $99.
In April, a U.S. congressional committee called on executives from Novo, Sanofi and Lilly to testify about the rising costs of insulin.
Shares of SmileDirectClub Inc (SDC.O) rose 17.4% on Tuesday after the online dentistry company said it would sell aligners directly to dentists, widening its distribution channel after a deal with rival Align Technology Inc (ALGN.O) expired last month.
Shares of Align, which manufactured clear aligners for SmileDirectClub, were down 3.9% at $286.47.
SmileDirectClub, which sold its aligners online after virtual consultations using 3D imaging technology, said it was no longer obligated to stick to the direct-to-consumer channel as agreed with Align, which also makes clear aligners called Invisalign.
In 2016, Align signed a supply agreement to manufacture for SmileDirectClub. As part of the transaction, Align had acquired a 17% stake in SmileDirectClub for $46.7 million, which it no longer holds.
SmileDirectClub said starting this year it would provide its clear aligners to dentists and orthodontists, an in-office option.
“We have seen increasing demand from the dentists and orthodontists in our network who wish to provide SmileDirectClub clear aligners to their in-office patients,” Co-Founder Alex Fenkell said.
The addition of a new distribution channel should benefit the company’s volumes, Evercore ISI analyst Elizabeth Anderson said.
“However, many questions remain including dentists’/orthodontists’ willingness to take up a product that they have heretofore seen as a competitor.”
SmileDirectClub said it will support the new distribution channel through its existing clear aligner manufacturing operation in Antioch, Tennessee.
The Nashville, Tennessee-based company’s IPO was priced at $23 per share on Sept. 11, above the expected range. However, SmileDirectClub ended 2019 nearly 62% lower.
3D printer OEM 3D Systems and Israeli bioprinting material developer CollPlant have announced a joint development agreement seeking to create tissue and scaffold bioprinting solutions for third party collaborators.
Through their collaboration, the two companies aim to combine their respective expertise in order to accelerate breakthroughs in the biomedical industry. This includes 3D Systems’ 3D printing technologies and healthcare expertise, and CollPlant’s proprietary recombinant human collagen (rhCollagen), a bioInk technology currently used to 3D bioprint tissues and organs.
“3D Systems is excited to work with CollPlant to develop groundbreaking bioprinted tissue and scaffold technologies,” explains Chuck Hull, co-founder, and chief technology officer, 3D Systems. “We believe 3D printing to be a key technology for regenerative medicine, and this collaboration is one of many we are entering to play an integral role in this exciting field.”
“COMBINING OUR INNOVATIVE 3D PRINTING TECHNOLOGIES WITH COLLPLANT’S RHCOLLAGEN BASED BIOINKS HAS THE POTENTIAL TO MAKE A SIGNIFICANT IMPACT IN BIOPRINTING AND REGENERATIVE MEDICINE.”
3D bioprinted soft tissue implant with vascularization channels perfused with red ink. The implant was printed using 3D Systems’ stereolithography bioprinter and BioInk that is based on CollPlant’s rhCollagen. Photo via CollPlant.
CollPlant’s proprietary bioink
With its main focus surrounding regenerative medicine, CollPlant’s proprietary development is its rhCollagen product. A 3D printable bioink, rhCollagen acts as a support material for biological matter, i.e. human stem cells. It is plant-based and harvested from genetically engineered tobacco plants.
CollPlant has taken part in a number of projects seeking to use and develop its rhCollagen material for 3D bioprinting a functional organ. Such an achievement lies decades away from being a reality, with the application of the material still in its early stages. Nevertheless, the company is laying the foundations for supporting its ambitions in the future.
In 2018, Maryland-based biotechnology firm United Therapeutics Corporation formed a licensing agreement with CollPlant to use its bio-ink technology for the development of 3D bioprinted lung models. Recently, CollPlant also announced it was testing its 3D bioprinting technology as a viable option for breast implants.
Bottles of CollPlant rhCollagen bioink. Image via CollPlant
3D Systems has also exhibited a sustained interest in the field of biotechnology and biomedicine over the years. The company has formed various partnerships within the field, including multi-year agreement with United Therapeutics Corporation to develop organs suitable for human transplants. Their collaboration is focused on regenerative medicine for human lungs. Additionally, 3D Systems has partnered with Antleron, a Belgium-based biotechnology company, to develop regenerative products for personalized patient care.
Accelerating breakthroughs in regenerative medicine
Both 3D Systems and CollPlant have now identified market demand for a comprehensive solution to produce tissues and scaffolds for regenerative medicine applications. Working together, the companies plan to create integrated 3D bioprinting solutions, consisting of 3D bioprinters and bioinks, enabling the production of tissues and scaffolds.
As part of the agreement, these ‘solutions’ will comprise a combination of 3D Systems’ 3D printers, CollPlant’s bioinks, and new formulations of rhCollagen-based bioinks jointly developed by the companies. “We strongly believe that our proven rhCollagen is the finest building block for regenerative medicine tissues and scaffolds available today,” Yehiel Tal, chief executive officer of CollPlant, adds.
“As the leading additive manufacturing printing solutions company, 3D Systems is the perfect partner for us. Together, we can offer the best combined technology for 3D bioprinting. We are honored to have established this important collaboration and we look forward to working together to advance 3D bioprinting technology to the commercial phase.”
The WSJ reports that New Jersey lawmakers have passed legislation tightening regulations on e-cigarettes, including a ban on flavored vaping products.
Penalties for retailers selling tobacco or vaping products to customers under the age of 21 will be stiffened, the use of coupons or discounts to purchase the items will be banned as will the sale of vaping liquids that contain more than 2% nicotine.
Governor Phil Murphy, a Democrat, will need to sign the package into law.
Several weeks ago, the FDA announced its proposed policy banning the sale of flavors (except menthol and tobacco) in pod-based e-cigs.
Denali Therapeutics (DNLI+17.5%) announces positive early-stage data on lead candidate DNL201 in Parkinson’s disease (PD) as part of its pipeline update. Highlights:
DNL201: Phase 1b data met all biomarker goals for both doses tested while being generally well-tolerated at the lower dose. At the higher dose, most subjects experienced mild or moderate adverse events (AEs). One participant experienced a severe AE (headache) that led to dose reduction and there was one discontinuation (headache and nausea). All treatment-emergent AEs were manageable and reversible.
DNL151: Phase 1 results in healthy volunteers met all safety and biomarker goals.
The company will select either DNL201 or DNL151 to advance into Phase 2/3 for PD.
DNL310: IND filed in U.S. for Hunter syndrome (mucopolysaccharidosis type II). Assuming FDA sign-off, a Phase 1/2 study is next up.
DNL343: A Phase 1 study in healthy volunteers should launch soon.
