Search This Blog

Monday, December 17, 2018

Merit Medical Acquires Assets of Vascular Insights


Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, today announced that it has acquired substantially all of the assets of Vascular Insights, LLC, based in Quincy, Massachusetts. Vascular Insights’ primary assets are the ClariVein®IC and ClariVein®OC specialty infusion and occlusion catheter systems,  which have been utilized in more than 120,000 cases to treat superficial venous disease, particularly below the knee (BTK), and venous leg ulcers (VLU). The ClariVein systems address a $700 million global market.  The ClariVein IC system has 510(k) clearance from the FDA, the ClariVein OC system is CE-marked, and the systems are covered by 43 patents issued worldwide.
The purchase price was $40 million plus additional milestone payments that could amount to an additional $20 million if certain sales targets are achieved.
“We have had our eye on these products for some time,” said Fred P. Lampropoulos, Merit’s Chairman and CEO. “These products complement our existing peripheral intervention sales platform, add to our capability to provide many existing Merit products, such as our micropuncture and vascular access products, and increase our ability to customize the entire procedure for our customers. Additionally, our global sales footprint allows for expansion of sales in previously underserved areas.”
“We are excited to reach this agreement with Merit,” said James (Chip) Draper, Chief Executive Officer of Vascular Insights. “This acquisition will allow ClariVein to reach more patients in more ways and in more places with the commitment to treat venous disease.”
“I am thrilled that Merit and ClariVein will bring transformative relief to millions of venous disease sufferers worldwide, especially those suffering from debilitating venous leg ulcers,” said Michael Tal, M.D., inventor of the ClariVein systems and co-founder of Vascular Insights.
2018 GUIDANCE
The effect of the Vascular Insights acquisition on Merit’s earnings for 2018 is expected to be dilutive to Merit’s earnings per share on a GAAP basis of approximately ($0.03) per common share and on a non-GAAP basis of approximately ($0.02) per common share, with both Merit’s GAAP, non-GAAP gross margins, and revenue contributions expected to be inconsequential for 2018.  NOTE: Non-GAAP earnings per share dilution and non-GAAP gross margin are non-GAAP financial measures. Information about how Merit uses non-GAAP measures in its business, and an explanation of how these measures relate to their most directly comparable GAAP financial measures, is included under the heading “Non-GAAP Financial Measures” below.
2019 GUIDANCE
The effect of the Vascular Insights acquisition on Merit’s earnings for 2019 is expected to be dilutive to Merit’s earnings per share on a GAAP basis in the range of ($0.05–$0.07) per common share and accretive to Merit’s earnings per share on a non-GAAP basis in the range of $0.00-$0.02 per common share. Merit anticipates GAAP gross margins of 21-28% and non-GAAP gross margins of 60-65% on the ClariVein systems, dilutive to Merit’s GAAP gross margin in the range of 25-30 basis points and accretive to non-GAAP gross margin in the range of 8-14 basis points. Merit anticipates additional 2019 revenues in the range of $10-$11 million. NOTE: Non-GAAP earnings per share accretion and non-GAAP gross margin are non-GAAP financial measures. Information about how Merit uses non-GAAP measures in its business, and an explanation of how these measures relate to their most directly comparable GAAP financial measures, is included under the heading “Non-GAAP Financial Measures” below.
Posted by at No comments:

Teladoc Health Chief Operating Officer and Chief Financial Officer Resigns


Teladoc Health (NYSE: TDOC), the global leader in virtual care, today announced that Mark Hirschhorn has resigned as Executive Vice President, Chief Operating Officer and Chief Financial Officer for Teladoc Health, effective January 1, 2019.
Mr. Hirschhorn said, “While this was a difficult decision, it’s the right one for my family and the company. It has been an enormous privilege to play a role in transforming how people access healthcare around the world, and I know the talented team at Teladoc Health is well positioned to continue advancing this important mission.”
“The Board and I appreciate Mark’s contributions, and we support his decision,” said Teladoc Health CEO Jason Gorevic.
Leadership Transition
The company has initiated a formal search process to fill the roles of Chief Operating Officer and Chief Financial Officer. While the search is underway, two trusted leaders will take on these responsibilities during the transition. Teladoc Health President Peter McClennen will take on the role of Interim Chief Operating Officer and Senior Vice President, Chief Accounting Officer, and Controller Gabriel Cappucci will coordinate all finance activity, until permanent replacements are named. In addition, Mr. Cappucci will continue to have authority over accounting and financial statement preparation.
Mr. Gorevic added, “The Board and I are confident that the Teladoc Health leadership team will continue to execute on our mission and drive a high level of performance across channels and geographies.”
Business Performance
Today, Teladoc Health also reaffirmed its updated guidance provided on November 1, 2018, which reflects the significant momentum it carries into the end of year and into 2019.
For the fourth quarter 2018, it continues to expect:
  • Revenue to be in the range of $119 million to $121 million.
  • EBITDA to be in the range of a loss of $(9) million to a loss of $(11) million.
  • Adjusted EBITDA to be in the range of $4 million to $6 million.
  • Total visits to be between 720,000 and 820,000.
  • Net loss per share, based on 70.4 million weighted average shares outstanding, to be between $(0.36) and $(0.38).
For the full-year 2018, it continues to expect:
  • Revenue to be in the range of $414 million to $416 million.
  • EBITDA to be in the range of a loss of $(36) million to a loss of $(38) million.
  • Adjusted EBITDA to be in the range of $12 million to $14 million.
  • Total U.S. paid membership to be in the range of 22.6 million to 23.5 million and visit fee only access to be available to approximately 9.4 million individuals at December 31, 2018.
  • Total visits to be between 2.5 million to 2.6 million.
  • Net loss per share, based on 65.9 million weighted average shares outstanding, to be between $(1.48) and $(1.50).
Posted by at No comments:

Kineta Licensing Deal With Pfizer Potentially Worth More Than $500 M


Seattle clinical-stage biotechnology company Kineta Inc. on Monday said it signed a licensing agreement potentially worth more than $500 million to develop new cancer immunotherapies with drug giant Pfizer.
Kineta said its Kineta Immuno-Oncology unit will receive $15 million upfront from Pfizer and will be eligible for up to $505 million in potential milestone payments.
Kineta said the companies will work to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic cell death in tumors, providing direct tumor cell killing and enhanced antitumor immune responses.
New York-based Pfizer will receive exclusive rights to Kineta’s RIG-I screening platform and related compounds and technologies.
Kineta in April said it agreed to collaborate with Roche Holding Genentech on development of a nonopioid pain therapy in a deal that included up to $359 million on potential milestone payments.
Posted by at No comments:

Roche SMA treatment risdiplam granted PRIME designation by EMA


Roche announced that the European Medicines Agency has granted PRIME designation for the company’s investigational oral medicine risdiplam for the treatment of people with SMA. PRIME designation is granted by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency, and thus potentially enabling them to reach patients earlier. Risdiplam, an orally administered, survival motor neuron-2 gene splicing modifier, has shown improvements in motor function in people with SMA Types 1, 2 and 3. An increasing body of clinical evidence suggests that SMA is a multisystem disorder, and the loss of SMN protein may affect many tissues and cells beyond the central nervous system. Risdiplam is systemically distributed and designed to durably increase SMN protein levels in the central nervous system and throughout the body.
Posted by at No comments:

Goldman starts Argenx at Conviction Buy, upgrades Orchard to Buy


Goldman Sachs analyst Graig Suvannavejh initiated coverage of Argenx (ARGX) with a Buy rating and $154 price target while adding the shares to his firm’s Pan-Europe Conviction List. The company has “unique” antibody technology and a “promising” Phase 3 asset in efgartigimod for the treatment of severe autoimmune disorders, Suvannavejh tells investors in a research note. He believes efgartigimod has a “best-in-class profile” and could reach peak global risk-adjusted sales of EUR 1.6B. Further, Argenx has been advancing cusatuzumab, a novel anti-CD70 antibody for potential use in blood cancers, says the analyst. Suvannavejh also upgraded Orchard Therapeutics (ORTX) to Buy from Neutral and raised his price target for the shares to $21 from $18. The analyst projects $1.2B in peak global sales or Orchard’s leading programs and sees “limited” clinical risk. With multiple sets of clinical data expected throughout 2019 on three late-stage candidates currently in registrational trials, anticipated news flow in 2019 could position shares of Orchard well for potential appreciation, Suvannavejh writes.
Posted by at No comments:

Insys Therapeutics provides update to strategic review process


INSYS Therapeutics provided an update on its product pipeline, which includes cannabidiol oral solution as well as epinephrine and naloxone nasal sprays. “Our strategic shift in focus away from opioids and to pharmaceutical-grade cannabinoids and novel drug delivery systems continues to gain momentum and has been driven by our strong commitment to advancing our diverse product pipeline,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “Through this intense focus on our reprioritized pipeline over the last year, which has been anchored by a patient-centric mission and commitment, we are radically transforming this company. As we look forward, we have the potential to submit six new drug applications over the next three years, two of which are scheduled for 2019.” INSYS previously announced plans to begin a strategic alternative review of its opioid-related assets and the process remains on schedule. Nine companies have signed confidential disclosure agreements and have begun a review of confidential information materials. The company will provide an update on the process during the fourth quarter 2018 earnings call in early 2019.
Posted by at No comments:

Evofem AMPOWER Phase 3 trial meets primary endpoint


Evofem announced that its Phase 3 clinical trial of Amphora for the prevention of pregnancy, AMPOWER, successfully met its primary endpoint. AMPOWER assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers in the U.S. The primary endpoint of the study was the pregnancy rate over seven cycles of use as assessed by the Kaplan-Meier statistical method. Top-line data analysis demonstrates a cumulative pregnancy rate of 14% over seven cycles of use. This corresponds to an 86.0% efficacy rate, which meets the pre-determined endpoint of this clinical trial. In women who correctly used Amphora per study protocol, the cumulative pregnancy rate was 1.3% over seven cycles of use. This corresponds to a 98.7% efficacy rate. The results demonstrate that when Amphora is used as directed, the efficacy in which women can have confidence is similar to other frequently used contraceptive methods. Overall in the AMPOWER study there were more than 24,000 acts of intercourse in which Amphora use was reported. Of these, Amphora was used as directed 88.9% of the time. There were minimal side effects reported by AMPOWER study participants, and there were no serious treatment-related adverse events reported. This outcome supports the potential of Amphora, Evofem’s multipurpose vaginal pH regulator, to become the first non- hormonal, on-demand, woman-controlled prescription birth control vaginal gel.
Posted by at No comments:
Subscribe to: Posts (Atom)