stockguard
5 years ago
Seeking Alpha is proud to welcome Michael Meltzer as a new contributor.
Jan 1, 2020 10:57 AM
$KALA $3.69. MC $128M Cash $97.6M runway through 18 months.
Stock High 2019-9+ 2018- 18 2017 25+
Last secondary offering Summer 2019@8.25
Platform:Amplify Delivery Technology (ADT) increases penetration through tissues thereby improving the medicines concentration at site of needed treatment.
Gem of Pipeline:Eysuvis - .25% KPI 121 for Dry Eye Disease(DED)symptom flare ups. The drug is an improved delivery system for Loteprednol through ADT.
Current blockbuster B&L’s .5% Lotemax gel is currently used off label for DED flares as currently approved treatments XIIDRA and Restasis offer lackluster results leaving patients with breakthrough discomfort multiple times per year. At that time Lotemax is used as a ”rescue med” for a 2 week pulse dose to reboot the immune system and lower the inflammatory response causing DED. I and many other doc’s also piggyback Lotemax on top of initiation of treatment to bring faster relief also for 2 weeks. I would use Eysuvis in this role as well.
Lotemax started as a suspension 4x a day and was called a “soft” steroid. It was effective as a general anti-inflammatory for the eye with a far superior safety record then all other steroids. Through use found it was not effective for very difficult to treat uveitis’s and was formulated to a gel with same concentration to improve permeability. B&L also has a .2% Loteprednol called Alrex which is very weak and rarely used for anything more then allergic red eyes.
My concern with KALA is that they went with too weak a concentration and should have gone with .3% MINIMUM and thought might not be strong enough to get the very difficult to treat and pretty miserable dry eye population to admit they were feeling better. First phase 3,Stride1 hit both primary endpoint conjunctival hyperemia(redness of eye) improvement as well as secondary improvement of symptoms in all patients, as well as in difficult to treat one’s. The second Stride2 hit the primary and failed in the symptom relieve though showed significant aid.
The FDA then demanded a third trial to prove effectivity. KALA made the necessary changes to the patient population to have created apassing “p” in Stride 2 for the Stride 3. It will read out Q1 ‘20. If they reach significance in either full population or in the difficult to treat population they will be able to file an NDA. I believe the changes made will achieve success. Eysuvia has blockbuster potential. Lotemax is a key franchise drug for Bausch&Lomb. If approved, B&L will be forced to purchase Eysuvia to defend their franchise. If KALA issues the same $35 copay assistance as Lotemax, every doctor will switch to the approved label as opposed to continuing off label with a Lotemax Gel.
The largest point of deriskment is KALA already has recently launched an approved drug Inveltys, a 1% Loteprednol suspension with the ADT additive. It is approved for post ocular surgeries. It offers the befit of 2x a day dosing as opposed to 3-4x/day with added safety of Loteprednol as opposed to stronger steroids like Durezol or Prednisilone which have many more side issues.
Inveltys Metrics:
WAC price $245 with copay assistance cards available.
57 sales reps. Expect upping to 75 if get Eysuvis approval.
There were 40,000 Rx’s In Q3- a 30% quarterly sequential improvement.
97,000 Total Rx’s so far.
10.1% market share
2700 individual prescribers to date.
Peak sales estimate-$300 M
Cons: could fail Stride 3, though Inveltys mitigates this by establishing a floor value.
Pro’s: Effective changes to trial population increase likelihood of solid data. Hitting endpoints would bring approval and create a massive competitor to B&L’s Lotemax franchise, that B&L would have to buy Eysuvis as it could well be a blockbuster drug.
stockguard
5 years ago
Loop Capital Reaffirms “Buy” Rating for Adesto Technologies (NASDAQ:IOTS)
Loop Capital restated their buy rating on shares of Adesto Technologies (NASDAQ:IOTS) in a research report sent to investors on Monday morning, AnalystRatings.com reports. They currently have a $13.00 target price on the technology company’s stock.
Several other equities research analysts also recently weighed in on IOTS. TheStreet raised shares of Adesto Technologies from a d rating to a c- rating in a research note on Wednesday, November 6th. Needham & Company LLC reaffirmed a buy rating and set a $12.00 price target on shares of Adesto Technologies in a research note on Wednesday, November 6th. Cowen upped their price target on shares of Adesto Technologies from $9.00 to $11.00 and gave the company an outperform rating in a report on Wednesday, November 6th. Zacks Investment Research lowered shares of Adesto Technologies from a buy rating to a hold rating in a research report on Thursday, November 14th. Finally, Craig Hallum initiated coverage on shares of Adesto Technologies in a research note on Thursday, September 19th. They issued a buy rating and a $13.00 price objective for the company. Four investment analysts have rated the stock with a hold rating and four have given a buy rating to the company’s stock. The company presently has a consensus rating of Buy and a consensus price target of $11.50.
NASDAQ IOTS opened at $7.81 on Monday. The business’s 50 day moving average price is $7.32 and its 200-day moving average price is $8.52. Adesto Technologies has a fifty-two week low of $4.10 and a fifty-two week high of $11.97. The company has a market cap of $229.98 million, a P/E ratio of -27.89 and a beta of 1.09. The company has a debt-to-equity ratio of 0.94, a quick ratio of 1.56 and a current ratio of 1.90.
Adesto Technologies (NASDAQ:IOTS) last issued its quarterly earnings results on Tuesday, November 5th. The technology company reported ($0.02) earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of ($0.03) by $0.01. The company had revenue of $32.03 million during the quarter, compared to the consensus estimate of $32.99 million. Adesto Technologies had a negative return on equity of 13.61% and a negative net margin of 21.81%. As a group, equities analysts predict that Adesto Technologies will post -0.19 EPS for the current year.
In other Adesto Technologies news, CEO Narbeh Derhacobian bought 7,500 shares of the firm’s stock in a transaction dated Thursday, November 21st. The stock was acquired at an average cost of $6.85 per share, for a total transaction of $51,375.00. Following the completion of the transaction, the chief executive officer now owns 494,083 shares in the company, valued at $3,384,468.55. The acquisition was disclosed in a document filed with the SEC, which is available through this link. Also, VP Thomas D. Spade sold 5,057 shares of the business’s stock in a transaction on Wednesday, November 27th. The shares were sold at an average price of $6.98, for a total transaction of $35,297.86. Following the sale, the vice president now directly owns 65,252 shares of the company’s stock, valued at $455,458.96. The disclosure for this sale can be found here. Insiders sold a total of 24,810 shares of company stock worth $178,375 in the last ninety days. 12.36% of the stock is currently owned by corporate insiders.
Institutional investors and hedge funds have recently made changes to their positions in the stock. Tower Research Capital LLC TRC bought a new stake in Adesto Technologies during the 3rd quarter valued at about $36,000. First Interstate Bank bought a new position in Adesto Technologies in the 3rd quarter worth about $77,000. Metropolitan Life Insurance Co NY bought a new position in Adesto Technologies in the 3rd quarter worth about $78,000. Susquehanna International Group LLP purchased a new position in shares of Adesto Technologies during the second quarter worth approximately $95,000. Finally, Virtu Financial LLC purchased a new position in shares of Adesto Technologies during the third quarter worth approximately $165,000. Institutional investors own 75.90% of the company’s stock.
Adesto Technologies Company Profile
Adesto Technologies Corporation, together with its subsidiaries, provides application-specific semiconductors and embedded systems that offer the building blocks of Internet of Things (IoT) edge devices operating on networks worldwide. The company's portfolio of semiconductor and embedded technologies are optimized for connected IoT devices and systems used in industrial, consumer, communications, and medical applications.
Featured Story: Stock Symbol
https://newsfilter.io/articles/loop-capital-reaffirms-buy-rating-for-adesto-technologies-nasdaqiots-a5ad31d1584b80c5c1adb48b27e755f9
77Port
5 years ago
Great quarter results, too: Thursday 8 August 2019.
Second Quarter 2019 Financial Results
Adesto Technologies Corporation (NASDAQ: IOTS) .... financial results for its second quarter ended June 30, 2019.
Revenue increased 7.3% sequentially and 65.8% year-over-year to $30.2 million
GAAP gross margin was 47.9% and non-GAAP gross margin was 48.1%
GAAP operating expenses were $17.4 million and non-GAAP operating expenses were $14.3 million—better than guidance
Adjusted EBITDA was a positive $0.9 million, representing the 9th consecutive quarter of positive adjusted EBITDA
Generated positive free cash flow
Announced the appointment of two highly experienced industrial executives to its board of directors
Commenting on the quarter, Narbeh Derhacobian, Adesto’s President and CEO, stated, “We posted another solid quarter with record revenue as our first-half revenue grew almost 75% over the same period in 2018. All of our divisions posted year-over-year growth in the second quarter.
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