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IGI Laboratories

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IGI Laboratories, Inc. Announces Acquisition Of Three Commercialized Injectable Products, $10M Cash

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The Coming Drug-Patent Cliff Is Pushing This Portfolio Up

Voya Global Advantage and Premium Opportunity Fund Common Shares of Beneficial Interest

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iShares Interest Rate Hedged Long-Term Corporate Bond ETF

IGC Pharma Inc

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<a href="https://www.marijuanamoment.net/senator-presses-attorney-general-garland-on-marijuana-banking-bills-impact-on-criminal-investigations/">https://www.marijuanamoment.net/senator-presses-attorney-general-garland-on-marijuana-banking-bills-impact-on-criminal-investigations/</a>
A Democratic senator on Wednesday pressed Attorney General Merrick Garland about a bipartisan marijuana banking bill, seeking his perspective on a controversial section concerning broader financial regulations.
During a hearing before the Senate Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies, Sen. Jack Reed (D-RI) asked the attorney general for his opinion of Section 10 of the original Secure and Fair Enforcement Regulation (SAFER) Banking Act.
"Section 10 of the original legislation would have compromised law enforcement and national security by requiring banks to notify customers when the government requested termination of an account," Reed said. "In essence, the original language meant that serious criminals could be tipped off that they are under investigation."
"Fortunately, through a bipartisan committee process, we worked to address major flaws in Section 10 and curbed its negative effects," the senator said. "Do you agree that such a policy would handcuff law enforcement and the intelligence community if the bank had to disclose that their account has been terminated by law enforcement?"
Garland replied that while he's familiar with the SAFER Banking Act itself, he wasn't up-to-speed on the specific provisions Reed mentioned.
"As a theoretical matter without commenting on that, obviously, if we are investigating someone and that person is advised of our investigation, that makes our investigation all the more difficult and may compromise it," the attorney general said. "But I can't answer specifically with respect to the statute."
Reed seemed to be using the opportunity at the <a href="https://www.appropriations.senate.gov/hearings/a-review-of-the-presidents-fiscal-year-2025-budget-request-for-the-us-department-of-justice">hearing</a> to reiterate his own concerns about Section 10, which was revised following months of bipartisan negotiations. Republicans broadly favor the language as a means of mitigating the risk of financial regulators taking discriminatory enforcement action against politically controversial industries such as gun manufacturers and payday lending institutions.
Prior to the bill's passage through the Senate Banking Committee last September, Section 10 was also expanded to include a "sense of Congress" provision stipulating that the personal and political beliefs of financial regulators should not influence their decision-making.
Separately on Wednesday, Sen. Jeff Merkley (D-OR) said at a National Cannabis Policy Summit that the section "helped tie the Democratic and Republican supporters together, and it's important element of this bill."
He added that it "has been a really tricky piece, though, because the regulators don't want to be told what to do" and there were "really nitty gritty arguments over every single word in the SAFER Banking Act that affects those customers."
The attorney general, for his part, didn't express an opinion about the broader banking legislation, though he said last year that the Justice Department is "still working on a marijuana policy" amid an ongoing review into cannabis scheduling. The Drug Enforcement Administration (DEA) is currently conducting its own review after receiving a recommendation to reschedule cannabis under the Controlled Substances Act (CSA).
Meanwhile, Garland is also under pressure to issue updated guidance to federal prosecutors to <a href="https://www.marijuanamoment.net/congressional-lawmakers-push-attorney-general-to-issue-overdue-marijuana-guidance-saying-ongoing-legal-limbo-is-unacceptable/">discourage interference in state cannabis programs</a> after an earlier memo was rescinded under the Trump administration.

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'Senator Presses Attorney General Garland On Marijuana Banking Bill's Impact On Criminal Investigations' - Marijuana Moment

Guidance

IGI Laboratories Sees FY15 Rev. $41-43M vs. Est. $39.97M

Earnings

IGI Laboratories Reports Q3 EPS Breakeven vs. Est. $(0.05), Rev. $11.6M vs. Est. $9.36M

IGI Laboratories To Rename Itself To Teligent According To 8-K, Ticker To Be 'TLGT' And Trade On NASDAQ

IGI Laboratories, Inc. Enters Into Agreement To Acquire The Assets Of Canadian Pharmaceutical Company, Alveda Pharmaceuticals, Inc., $47M CAD

Sientra Inc (NASDAQ: <a class="ticker" href="/stock/sien#NASDAQ">SIEN</a>) shares declined 19.31 percent to $8.37 after the company issued a statement regarding the recent ANVISA announcement.
 FireEye Inc (NASDAQ: <a class="ticker" href="/stock/feye#NASDAQ">FEYE</a>) shares dipped 7.92 percent to $30.44. FireEye and F5 Networks, Inc. (NASDAQ: <a class="ticker" href="/stock/ffiv#NASDAQ">FFIV</a>) reported a global partnership to deliver integrated security solutions. Piper Jaffray downgraded FireEye from Overweight to Neutral and lowered the price target from $60.00 to $37.00.
 IGI Laboratories, Inc. (NYSE: <a class="ticker" href="/stock/ig#NYSE">IG</a>) dropped 7.03 percent to $6.48 after the company reported the acquisition of three commercialized injectable products.
 AtriCure Inc. (NASDAQ: <a class="ticker" href="/stock/atrc#NASDAQ">ATRC</a>) shares declined 6.35 percent to $21.02 after the company reported that it has acquired nContact. The company also issued a strong revenue forecast for the third quarter Q3 revs above expectations; provides 2015 and 2016 outlook.
 Valeant Pharmaceuticals Intl Inc (NYSE: <a class="ticker" href="/stock/vrx#NYSE">VRX</a>) shares fell 5.43 percent to $172.42.
 First Defiance Financial (NASDAQ: <a class="ticker" href="/stock/fdef#NASDAQ">FDEF</a>) slipped 1.88 percent to $36.58. Raymond James downgraded First Defiance Financial from Outperform to Market Perform.

IGI Laboratories, Inc. (NYSE MKT: <a class="ticker" href="/stock/ig#NYSE MKT">IG</a>), a New Jersey-based specialty generic pharmaceutical company, today announced it has acquired three currently marketed injectable products from Concordia Pharmaceuticals, Inc., S.A.R.L., for $10 million in cash: Fortaz®, ZinacefTM, and Zantac® Injection. According to IMS Health, the current addressable market in the United States for these products is estimated at $26 million as of August 2015. 
IGI Laboratories logo. 
Jason Grenfell-Gardner, President and CEO of IGI, commented, "This transaction delivers contribution to our fourth quarter of 2015 financial results. It is consistent with our TICO strategy, and accelerates our commercial entry into the sterile injectable market. These products, while branded, compete in genericized markets for these product forms, and thus should allow us to leverage our existing value chain for sales, marketing, and distribution of these products. In addition, ZinacefTM and Fortaz® complement IGI's pipeline of hospital-administered anti-infective injectables, which is a market segment we believe is best served by a portfolio approach. Our business development team will continue to focus on acquiring currently marketed assets that are aligned with our TICO strategy."

Management

IGI Laboratories Names Stephen Richardson Chief Scientific OFficer

Big Pharma is on the verge of a big change. A patent cliff seems to be around the corner, and generic drug makers are bracing themselves to grab their share.

	According to Motif Investing, &ldquo;Branded drugs with sales of $86 billion would lose patent protection during 2013 to 2017 [...] Generic drugs, once available, are typically 30 percent to 80 percent cheaper than the brand names, and can capture 80 percent of the market within the first year.&rdquo;

	This means that, over the next few years, the generic drug industry will face unprecedented growth opportunities. Below is a quick look at an equity portfolio that allocates assets to companies that manufacture generic drugs and thus stand to benefit from the above-mentioned trend over the years to come.
<h3>The Drug-Patent Cliffs Motif</h3>

	<a href="https://www.motifinvesting.com">Motif Investing</a> constantly looks for &ldquo;trends, ideas and world events that could create an investment opportunity,&rdquo; and then picks 10 to 30 related stocks to build portfolios around, weighing them based on their exposure to the coinciding idea, event or trend.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/analyst-ratings/analyst-color/15/08/5767034/kempharm-targets-skyrocket-at-research-firms-after-posit">KemPharm Targets Skyrocket At Research Firms After Positive pK Study</a></bzrelatedlink>
	The <a href="https://www.motifinvesting.com/motifs/drug-patent-cliffs">Drug-Patent Cliffs</a> motif, which allocates 67.1 percent of its assets to generic drugs manufacturers, 30.1 percent of assets to big pharma stocks and 2.9 percent to companies that make biosimilars, has managed to comfortably outperform the S&amp;P 500 over the past year, having returned 34.4 percent.

	<img alt="" src="https://www.benzinga.com/files/u82070/drug_cliff.png" /> 
	Source: Motif Investing

	The motif comprises 18 stocks in three segments:

	67.1 percent: Generic Drugs (up 24.2 percent over the past year)
<ul>
<li>
		20.0 percent: Perrigo Company plc Ordinary Shares (NYSE: <a class="ticker" href="/stock/prgo#NYSE">PRGO</a>)</li>
<li>
		13.2 percent: Mylan NV (NASDAQ: <a class="ticker" href="/stock/myl#NASDAQ">MYL</a>)</li>
<li>
		8.8 percent: Dr.Reddy&#39;s Laboratories Ltd (ADR) (NYSE: <a class="ticker" href="/stock/rdy#NYSE">RDY</a>)</li>
<li>
		6.5 percent: Taro Pharmaceutical Industries Ltd. (NYSE: <a class="ticker" href="/stock/taro#NYSE">TARO</a>)</li>
<li>
		4.5 percent: Endo International plc - Ordinary Shares (NASDAQ: <a class="ticker" href="/stock/endp#NASDAQ">ENDP</a>)</li>
<li>
		3.2 percent: Akorn, Inc. (NASDAQ: <a class="ticker" href="/stock/akrx#NASDAQ">AKRX</a>)</li>
<li>
		3.1 percent: Mallinckrodt PLC (NYSE: <a class="ticker" href="/stock/mnk#NYSE">MNK</a>)</li>
<li>
		2.1 percent:Impax Laboratories Inc (NASDAQ: <a class="ticker" href="/stock/ipxl#NASDAQ">IPXL</a>)</li>
<li>
		1.8 percent: Sagent Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/sgnt#NASDAQ">SGNT</a>)</li>
<li>
		1.0 percent: Cambrex Corporation (NYSE: <a class="ticker" href="/stock/cbm#NYSE">CBM</a>)</li>
<li>
		1.0 percent: IGI Laboratories, Inc. (NYSE: <a class="ticker" href="/stock/ig#NYSE">IG</a>)</li>
<li>
		0.9 percent: Lannett Company, Inc. (NYSE: <a class="ticker" href="/stock/lci#NYSE">LCI</a>)</li>
<li>
		0.9 percent: Amphastar Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/amph#NASDAQ">AMPH</a>)</li>
</ul>

	30.1 percent: Big Pharma (up 30.6 percent over the past year) 
<ul>
<li>
		22.7 percent: Teva Pharmaceutical Industries Ltd (ADR) (NYSE: <a class="ticker" href="/stock/teva#NYSE">TEVA</a>)</li>
<li>
		7.3 percent: Abbott Laboratories (NYSE: <a class="ticker" href="/stock/abt#NYSE">ABT</a>)</li>
</ul>

	2.9 percent: Biosimilars (up 108.7 percent over the past year)
<ul>
<li>
		1.0 percent: Pfenex Inc (NYSE: <a class="ticker" href="/stock/pfnx#NYSE">PFNX</a>)</li>
<li>
		1.0 percent: Momenta Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="/stock/mnta#NASDAQ">MNTA</a>)</li>
<li>
		0.9 percent: Coherus Biosciences Inc (NASDAQ: <a class="ticker" href="/stock/chrs#NASDAQ">CHRS</a>)</li>
</ul>
Image Credit: <a href="https://pixabay.com/en/pills-tablets-capsule-drug-640025/">Public Domain</a>

In a report published Friday, Roth Capital Partners analyst Scott R. Henry upgraded the rating on IGI Laboratories, Inc. (NYSE: <a class="ticker" href="/stock/ig#NYSE">IG</a>) from Neutral to Buy, while raising the price target from $7 to $11.
Analyst Scott R Henry cited "stabilization of the econazole nitrate franchise, a lower valuation, and potential ANDA pipeline catalysts coming out of 2015 and into 2016" as the impetus for the upgrade.
IGI Laboratories develops, manufactures, and markets topical formulations in the US, besides developing, manufacturing, filling and packaging topical semi-solid and liquid products for the pharmaceutical and cosmetics industries.
The company reported better-than-expected 2Q15 revenues of $8.9 million, driven by new contract wins for the econazole nitrate franchise. The company hinted at a potential stabilization of its revenue stream.
Saying that 2016 could be a "Breakout" year for IGI Laboratories, the Roth Capital Parners report noted, "Our forecast now targets ~$16M per year from this franchise in 2016+. We expect only modest new approvals in 2015 (perhaps 1 additional product launch)."
"However, the year 2016 could bring old ANDA approvals (could be as high as 9 launches) and new accelerated GDUFA approvals (could be as high as 5 launches). This bolus of 14 potential approvals could start the hyper revenue growth that investors have been waiting for," the report added.

Analyst Color

Upgrades

Price Target

Analyst Ratings

Roth Capital: Time To Buy IGI Labs, 2016 Could Be 'Breakout Year'

Roth Capital upgrades IGI Laboratories (NYSEMKT: IG) from Neutral to Buy and raises the price target from $7.00 to $11.00.

Roth Capital Upgrades IGI Laboratories to Buy, Raises PT to $11.00

IGI Labs Reports Q2 Loss $0.03 vs Loss $0.08, Sales $8.89M Vs Est $7.63M

IGI Laboratories, Inc. (NYSE MKT: <a class="ticker" href="/stock/ig#NYSE MKT">IG</a>), a New Jersey-based specialty generic pharmaceutical company, today announced it has launched its seventh product, diclofenac sodium 1.5% topical solution, after receipt of the final approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The Company now markets seven products in twelve presentations in an IGI label.
Diclofenac sodium topical solution 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain from osteoarthritis of the knee. Based on IMS Health data for May 2015, the total addressable market for this product is approximately $13.3 million. IGI originally submitted this ANDA to the FDA in December 2010. 
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today's action by the FDA represents our second drug approval for a product organically developed from beginning to end by our IGI team. In anticipation of this approval, we have already secured orders from our customers, and we are ready to fulfill these orders immediately.'' 
''We now have twenty-seven submissions, exclusive of our four partnered submissions, pending approval by the FDA, with a combined addressable market of over $939 million based on May 2015 data from IMS Health, and another fifteen more submissions planned before the end of this year. Our team continues to execute our R&amp;D plan as part of our mission to become a leading player in the specialty generic prescription drug market."

IGI Laboratories, Inc. Announces FDA Approval And Commercial Launch Of Diclofenac Sodium, 1.5%

IGI Laboratories, Inc. (NYSE MKT: <a class="ticker" href="/stock/ig#NYSE MKT">IG</a>), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its fourth abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-six.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our team continues to execute on the targets we have established for 2015 submissions. We believe our current pipeline of twenty-six submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of over $841 million based on April 2015 data from IMS Health."

IGI Laboratories, Inc. Announces Fourth ANDA Submission of 2015

IGI Labs Expecting Q2 Gross Margin in 34-35% Range, Reaffirms Sales Guidance; Sees FY Sales $35M-$40M vs $38.7M Est.

Insider Trades

IGI Laboratories Director Gale Buys 30,000 Shares @$5.04/Share -Form 4

Avondale Partners downgraded IGI Laboratories (NYSEMKT: IG) from Outperform to Market Perform.-sources

Downgrades

Earlier: Avondale Partners Downgraded IGI Laboratories to Market Perform

Oppenheimer downgrades IGI Laboratories (NYSEMKT: IG) from Outperform to Perform.-sources

Oppenheimer Downgrades IGI Laboratories to Perform

IGI Laboratories, Inc. (NYSE: <a class="ticker" href="/stock/ig#NYSE">IG</a>) shares tumbled 29.18 percent to $5.63 after the company reported downbeat Q1 earnings and announced the second ANDA submission of 2015.
 Lumber Liquidators Holdings Inc (NYSE: <a class="ticker" href="/stock/ll#NYSE">LL</a>) shares slipped 17.32 percent to $27.63 after the company reported results for the first quarter. The Toano, Virginia-based company reported a quarterly loss of $7.78 million, or $0.29 per share, versus a year-ago profit of $13.7 million, or $0.49 per share.
 Stratasys, Ltd. (NASDAQ: <a class="ticker" href="/stock/ssys#NASDAQ">SSYS</a>) shares dipped 16.92 percent to $42.62 following the release of weak guidance. Dougherty &amp; Company downgraded Stratasys from Buy to Neutral.
 Wynn Resorts, Limited (NASDAQ: <a class="ticker" href="/stock/wynn#NASDAQ">WYNN</a>) shares fell 14.03 percent to $112.17 after the company reported downbeat Q1 results and lowered its dividend to $0.50 per share from $1.5 per share. 
 Buffalo Wild Wings (NASDAQ: <a class="ticker" href="/stock/bwld#NASDAQ">BWLD</a>) shares dropped 12.59 percent to $160.57 after the company reported weaker-than-expected results for the first quarter.
 Internap Corp (NASDAQ: <a class="ticker" href="/stock/inap#NASDAQ">INAP</a>) shares declined 10.26 percent to $9.36 after the company reported downbeat Q1 results and issued a weak FY15 revenue forecast.
 DHI Group Inc (NYSE: <a class="ticker" href="/stock/dhx#NYSE">DHX</a>) shares dropped 8.96 percent to $8.07. DH Group reported Q1 earnings of $0.09 per share on revenue of $63.8 million.
 Ascendis Pharma A/S (NASDAQ: <a class="ticker" href="/stock/asnd#NASDAQ">ASND</a>) shares fell 4 percent to $17.50 after the company reported results of its Phase 1 study of TransCon Treprostinil.