See feature articles below:

 

About Broad Street Alerts:

Big opportunities in Small Cap’s

 

 

Broad Street Alerts recent profiles and track record, 153% in verifiable potential gains for our members on the last 3 small cap alerts alone!

 

February 10th, 2016- (NASDAQ: BONT) opened $1.65/share hit a high of $3.00/share within 30 days our member potential gains- 83%

 

March 7th, 2016-(NYSE-MKT: FSI) opened at .91/share and hit 1.10/share within 5 days for gains of 21% for our members.

 

March 24th, 2016- (NASDAQ: ICLD) opened at $.77/share it a high of $1.15/share within 2 days for gains of 49% for our members.

 

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

 

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.

 

Article for: WAC

Thank you. Good morning, everyone. During the first quarter of 2016, we maintained our national ranking as a top 10 servicer, growing the service book of business with the addition of approximately $10 billion of sub servicing arrangements, MSR acquisitions, and originated MSR to $275.7 billion and assisting approximately 12,000 homeowners in attaining modifications of their loans.

We funded loans in our originations and reverse mortgage segments of $5.2 billion, including the origination of approximately 9,500 HARP loans for the quarter. The first quarter activity allowed us to maintain our ranking as a top 15 originator in the nation.

Our first quarter results were impacted by the significant drop in interest rates experienced in the first quarter. We saw the 10-year Treasury decline a total of 49 basis points, from 2.27% on December 31, 2015 and hitting a low of 1.63% during the quarter, before closing on March 31 at 1.78%.

Our assets and liabilities accounted for using fair value methodology incurred non-cash charges relating to changes in inputs and assumptions of approximately $140.5 million after taxes, contributing a loss of $3.95 on a per share basis to the quarter’s GAAP net loss of $4.85 per share. Results reported on an adjusted basis were impacted by the rate movement, as well as the adjusted loss of $17.8 million, or $0.50 per share after tax, reflected negative impacts related to accelerated prepayments and reductions in pipeline MSR values since the date of lock.

Adjusted EBITDA for the quarter was $87.1 million, $74.6 million of which was contributed by our servicing segment, $23.8 million from originations, and a negative adjusted EBITDA of $9.5 million in the reverse mortgage segment. Our reverse segment continues to be impacted by lower gain on sales revenues, as well as the continued elevation of expenses related to regulatory changes, including the issuance of the mortgagee letters beginning in April of 2015 which change the timing and scope of those properties being moved into a due and payable status. These changes, along with the maturing of the portfolio, resulted in the largest number of loans entering this process in the Company’s history during the first quarter of 2016.

Over the course of the quarter, we made progress on a number of important initiatives, including transitioning approximately 1.4 million customers to the industry-standard servicing platform MSP, which is expected to enhance operational efficiencies within our servicing business. We also completed the closure of our retail originations channel which, along with other reorganization activities are expected to result in annualized savings of approximately $28 million.

Finally, we have advanced our early-stage reengineering initiative which we launched in the first quarter, targeted at both providing an exceptional customer experience and cost and revenue efficiencies. We are very enthusiastic about the early results and expect the initial impact of our efforts to be reflected in the second half of 2016, with significant improvements to be realized in 2017.

While we are still early in the process, it is clear that the opportunity to drive dramatic change throughout the organization is substantial. Gary will provide some additional color on our expectations associated with this initiative later in the call.

On the environment, we continue to see an evolution of the operating environment within our sector. The economic outlook predicts moderate growth. Latest expectations published by Fannie Mae included approximately $1.6 trillion of origination volumes for 2016 and a continued low interest rate environment, which remains supportive of the refi loans. The offset is the increased levels of expected prepayments on the portfolio. We believe we will continue to see rate volatility, with the curve reflecting a bias toward higher levels over time, which would serve to improve MSR valuations.

Regulatory oversight of the sector remains high, impacting both the servicing and origination businesses. While the pace of change has moderated, the associated costs continue to be absorbed through the operations.

Against this backdrop, we would expect to see acceleration of consolidation amongst the market sub scale participants, as the environment has increased fixed costs for everyone and, in some cases, reduced revenue. Financial institutions continue to focus on their core clients, allowing non-bank participants to gain market share in both servicing and originations, driven by the non-core segment of the market.

As the operating environment for mortgage sector participants continues to evolve, Walter is undertaking a number of transformative actions aimed at driving long-term value for our shareholders. First is to deliver an exceptional customer experience. We are intently focused on pursuing our goal to become a lifelong partner in home ownership for our customers.

The best way to earn our customers’ loyalty is to consistently deliver exceptional service. Exceptional service begins and ends with exceptional employees. Walter has exceptional employees. We are focusing energy company-wide to elevate awareness around the shared values of our high performance culture, values that Walter employees themselves define. Living these shared values will strengthen our Company and should dramatically improve employee satisfaction and directly impact our customer experience in a positive way.

The second key to driving value relates to operational excellence. We are intensely focused on becoming better at what we do. We must be the most efficient operator in the business. As we discussed in our fourth quarter earnings call, we have undertaken a company-wide initiative to reengineer our business processes. Though we are in the early stages of the project, we believe the opportunity is large, reaches every corner of the organization.

Deploying technologies aimed at improving our efficiencies and enhancing our customers’ interactions with us will enable this effort. The transition of approximately 1.4 million customers to MSP was, again, an important step in our efforts to modernize our technology solution, increasing efficiencies and enhancing our ability to provide an exceptional customer experience.

Finally, the efficient allocation of our capital is key to driving value. Our focus is to deleverage our balance sheet so that we can compete from a position of financial strength. We have ongoing dialogue with WCO and other third parties to establish future flow transactions and opportunistic MSR sales generally on a sub service retained basis.

We are also pursuing outsourcing opportunities as an avenue to add business to the servicing portfolio in a capital efficient matter at attractive returns. Our success with these initiatives should free up capital to augment excess cash flow generated by operations and the proceeds from the planned sale of our insurance business, which we plan to utilize to help us meet our leverage reduction targets.

In the current environment, we see significant challenges for participants and barriers to entry to the sector. We believe Walter has the scale, track record, strong relationships and determination needed to meet the challenges and be successful in an evolving sector and we are moving aggressively to transform the organization to drive value for shareholders. With that, I will ask Gary to cover the financial and operational highlights for our business. Gary?

——————————————————————————–

Gary Tillett, Walter Investment Management Corporation – CFO [4]

——————————————————————————–

Thanks, Denmar. In the servicing segment, despite increase prepayments, our servicing UPB grew 4% to $255.3 billion, ranking us as a top 10 national servicer.

The service portfolio increased through $17.5 billion of additions, including approximately $10 billion of sub servicing UPB from our previously announced RCS transaction and approximately $3.6 billion UPB of distressed GSE mortgage loans. This increase was offset by higher than expected levels of prepayments, driven by the low interest rate environment.

The servicing business delivered $74.6 million of adjusted EBITDA and an adjusted EBITDA margin for the quarter of 12 basis points, in line with previously provided targets of 11 basis points to 15 basis points. Servicing’s adjusted loss for the quarter of $1.2 million reflects the impact of continued low interest rates. Included in adjusted earnings are fair value reductions of MSRs related to accelerated prepayments, as well as the effect of pipeline MSR declines since the date of lock.

During the quarter, we transitioned a significant portion of our servicing portfolio to the MSP platform. While provisions for excess costs related to this transfer were included in our operating plans, we incurred approximately $5 million above our expectations for the project, further impacting profitability. Given the low interest rate environment today, we believe the adjusted earnings margin for the servicing sector could be lower than our previously provided target, as we would expect to continue to see elevated levels of prepayments in the near term, particularly in the portfolio accounted for at fair value.

We continue to pursue outsourcing opportunities with our clients, as well as transactions with WCO and other potential counter parties, as we look to increase the mix of sub servicing business in our portfolio, adding product to the platform in a capital efficient manner. Through our company-wide initiative to reengineer our processes, we are targeting improvement in core operations through the deployment of technology, with the recent transition of 1.4 million accounts to MSP serving to launch this component of the initiative. Our reengineering efforts are expected to drive continuous improvement of our cost structure and enhancement of revenue opportunities over time.

Let’s now turn to the originations segment, which maintained solid margin performance despite volume declines. Originations funded $5 billion of UPB in the current quarter, a decrease of 9% as compared to the prior-year quarter. However, the combined direct margin of 80 basis points for the current quarter increased 11 basis points over the prior-year quarter, driven by a shift in mix from the lower margin correspondent channel to the higher margin consumer channel.

The segment generated adjusted EBITDA of $23.8 million and adjusted earnings of $17.9 million for the quarter. The Q1 recapture rate increased sequentially to 26% from 23% in the fourth quarter of 2015, as we remain focused on maximizing a retention opportunity resident in our portfolio of approximately 476,000 in the money accounts.

We have also increased our investment in building our consumer lending channel, including the addition of a new leader, and plans to expand our sales force with a goal of increasing our recapture rates and maximizing earnings in the continued low interest rate environment. However, as part of our capital management strategy, we have increased our return holders for MSRs acquired, which has negatively impacted volumes in the correspondent channel. As a result, correspondent channel volumes for 2016 may be negatively impacted.

As announced earlier this year, we exited the retail channel in January as part of our further reorganization efforts in Ditech. As a result, during the first quarter of this year, our indirect expenses in the origination segment decreased from prior year run rate, driven by reductions in support expenses related to this channel and increased cost efficiencies, representing a portion of the $28 million annualized savings expected to be achieved through the closure of the retail channel and our other reorganization activities undertaken in the first quarter.

As part of our efforts to improve the customer experience, we are working to deploy technology solutions, which include investing and digital technologies and point-of-sale services designed to improve our self-serve capabilities. We are piloting these technologies now and expect to roll them out more broadly during the third quarter.

The reverse segment experienced another challenging quarter, with results reflecting the impact of significantly reduced originations volumes and continued elevated expenses driven by increased defaulted mortgage activity resulting from 2015’s regulatory changes. Reverse’s negative adjusted EBITDA of $9.5 million and adjusted loss of $10.4 million for the first quarter of 2016 reflect the impact of lower gain on sale revenues attributable to lower volumes and a reduction in net servicing revenues and fees.

Despite these disappointing results, we believe in the value of the RMS franchise and are taking steps which we believe will drive meaningful improvement to the business. These steps include continuing to strengthen the management team, enhancing sales operations to drive increased consumer channel volumes, and maintaining a disciplined approach to our investments in the correspondent and wholesale channels.

In the default servicing area, we have made significant improvements that should result in materially reduced curtailment charges caused by defaults in the portfolio. Given the current market conditions and the segment’s first quarter losses, we anticipate achieving positive adjusted earnings for the year will be a challenge.

As Denmar mentioned, we currently have a high priority project underway to drive efficiencies across the organization and maintain discipline around capital allocation to improve the financial strength of our balance sheet. We have substantially negotiated the terms of an agreement to sell the insurance business and are awaiting regulatory input before finalizing the agreement.

As we have previously mentioned, our discussions with WCO and other potential counter parties related to future flow transactions and other select MSR sales are an important component of our strategy to enhance our balance sheet strength by reducing our investment in MSRs. To this end, during the quarter we entered into a binding letter of intent to sell $4.6 billion of UPB of GSE MSR to a third party with servicing release.

During the first quarter, we prepaid approximately $7.2 million par value debt for approximately $6.3 million and expect that we will utilize a combination of excess cash flows from operations, proceeds from the planned sale of our insurance business, and potential sales of MSR to further reduce our corporate debt in the future.

And lastly, as we indicated in February, we recently initiated a significant reengineering project designed to improve efficiency across the organization. Based on our preliminary review of certain areas of the Company, we have already identified opportunities for improvement in the $60 million to $75 million range. One-time costs to achieve these improvements are estimated in the $20 million to $25 million range.

Implementation of many of the actions related to this phase of the project is already in process and we expect to see a meaningful impact on results in the second half of 2016. Based on the findings of this preliminary analysis, we accelerated a more comprehensive review of the business, which includes expanding the scope of the project company-wide and going deeper into areas already reviewed. We expect to find additional significant opportunities as we move forward and plan to provide an update on the second quarter earnings call.

We are not satisfied with our recent performance and are fully focused on improvement in the future. I will now turn the call back to Denmar for a quick wrap-up review. Denmar?

——————————————————————————–

Denmar Dixon, Walter Investment Management Corporation – CEO [5]

——————————————————————————–

Thank you, Gary. I will be brief. The summary for the key takeaways for the business are as follows. We see a market opportunity set that we believe we can successfully deploy the strengths of our platform against. We see three keys necessary to drive shareholder value, a great customer experience, best-in-class operational efficiency, and intelligent capital allocation.

We plan to meaningfully improve customer experience by first focusing on our own employees and our cultural values. On an operating basis, we are identifying significant opportunities to reduce cash costs, drive revenue and create efficiency gains across the platform for a redesign of our processes and the deployment of technology solutions. In addition to our operational transformation, we will focus on our balance sheet-related actions. We’re targeting a significant reduction in leverage and pursuing several transactions to add to service UPB in a capital efficient manner.

Source – Reuters

 

 

 

Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.

 

 

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See feature articles below: (Nasdaq: SRPT)

About Broad Street Alerts:
Big opportunities in Small Cap’s

Broad Street Alerts recent profiles and track record, 217% in verifiable potential gains for our members on the last 4 small cap alerts alone!

February 10th, 2016- (NASDAQ: BONT) opened $1.65/share hit a high of $3.00/share within 30 days our member potential gains- 83%

March 7th, 2016-(NYSE-MKT: FSI) opened at .91/share and hit 1.10/share within 5 days for gains of 21% for our members.

March 24th, 2016- (NASDAQ: ICLD) opened at $.77/share it a high of $1.15/share within 2 days for gains of 49% for our members.

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.
Report on : (Nasdaq: SRPT)
Sarepta Therapeutics, Inc (NASDAQ:SRPT) released its first quarter results recently. The company reported a non-Gaap net loss of $ 52.5 million or $ 1.15 per share when compared to non-Gaap net loss of $ 47.4 million or $ 1.15 per share for first quarter of 2015. The research and development expenses were $ 35.9 million for the first quarter 2016 when compared to $ 36.7 million for last year. General and administrative expenses increased to $ 16.6 million for this year when compared to $ 11 million for last year. The company’s cash position at the end of first quarter of 2016 was $140.6 million which decreased due to commercial launch activities and ongoing operations. The cash position was $ 204 million last year during the same period.

“The Peripheral and Central Nervous System Advisory Committee met last week to review eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, and we await our May 26 PDUFA date,” said Edward Kaye, M.D. Sarepta’s interim chief executive officer and chief medical officer.” “Following the FDA’s decision, we plan to provide a clinical and corporate update.”

So the next important date to watch will be May 26 when the FDA will decide to approve eteplirsen or not.

The stock fell on April 26 after FDA rejected the approval of Duchenne muscular dystrophy (DMD) candidate etiplirsen. One of the main reasons was the small sample size of 12 patients and the trial was not placebo-controlled. The DMD community was strongly in favour of the present environment. But there are still hopes as emotional meeting was held at a hotel in Hyattsville, Maryland wherein hundreds of patients and doctors urged the US FDA to approve the drug since the patients had benefitted Sarepta’s eteplisren. The panel had voted 7-3 with three abstentions saying that the clinical trial of 12 patients did not provide substantial evidence that the drug is effective. The subsequent meeting was also attended by Dr.Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research also made supportive comments with regard to the drug after hearing patient and doctors views.

Duchenne is a rare genetic disorder which is caused by a lack of dystrophin which is a protein to keep muscles healthy. Eteplirsen is expected to increase the production of dystrophin. Its occurance is 1 in 3600 male and there is no drug to treat this disease.

The FDA had similarly rejected BioMarin Pharmaceutical Inc (NASDAQ:BMRN) drug Kyndrisa in the month of January 2016.

A lot of analysts have differing view on Sarepta. Oppenheimer raised the price target of the stock to $ 60. Oppenheimer believes if eteplirsen is approved that itself could add $ 32 a share based on revenue potential through 2030. Jefferies downgraded the stock to sell with a $ 7 price target and they see little chance that the drug will be approved.

Incase the drug gets approved later this month the stock is expected to shoot higher as the expected revenue from eteplirsen is very high but incase the drug doesn’t get approved the stock is expected to fall. The company in that case would have to partner with a big pharmaceuticals company or do the placebo controlled study by raising more equity. The company’s other pipeline drugs for approvals are in early stages of approval so a lot depends on eteplirsen. The DMD community will also watch the FDA findings closely.

About Sarepta Therapeutics:

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases.
Source: Inside Stock Trader & ACAD Charts

Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.

See feature articles below: (Nasdaq: ARIA)

About Broad Street Alerts:
Big opportunities in Small Cap’s

Broad Street Alerts recent profiles and track record, 217% in verifiable potential gains for our members on the last 4 small cap alerts alone!

February 10th, 2016- (NASDAQ: BONT) opened $1.65/share hit a high of $3.00/share within 30 days our member potential gains- 83%

March 7th, 2016-(NYSE-MKT: FSI) opened at .91/share and hit 1.10/share within 5 days for gains of 21% for our members.

March 24th, 2016- (NASDAQ: ICLD) opened at $.77/share it a high of $1.15/share within 2 days for gains of 49% for our members.

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.
Report on : (Nasdaq: INCY, ARIA)
Incyte (INCY – Get Report) chose to buy a turnkey European commercial operation instead of building one. The company found a willing seller in Ariad Pharmaceuticals (ARIA – Get Report) , which was looking to shed its European operations to save money.

Under terms of the deal announced Monday, Incyte is paying $140 million to acquire Ariad’s European operations, which includes 125 sales and marketing employees and European rights to the leukemia drug Iclusig. In addition to the cash payment, Incyte will pay Ariad a royalty of 32%-50% on future European Iclusig sales.

Iclusig sales in Europe were $27 million in 2015.

The deal makes good strategic sense for both companies. Incyte will use its new European business hub for the future launch of cancer and immunology drugs from its pipeline, if eventually approved. Generating a small amount of extra revenue from Iclusig, net the Ariad royalty, is a bonus.

Must Read: Acadia Drug Approval May Entice Biogen, Teva as Buyers

Ariad, in turn, sheds an expensive European business and can focus Iclusig marketing efforts on the U.S. The deal includes a buyback provision that allows a potential acquirer of Ariad to repurchase Iclusig European rights from Incyte.

Iclusig U.S. sales in 2015 totaled $85.7 million.

Separately, Incyte reported $183 million in Jakafi sales for the first quarter, slightly below consensus expectations. The company refined 2016 Jakafi sales guidance to $815 million-$830 million, which already brackets current consensus. Novartis co-markets Jakafi, which is approved to treat blood-related diseases, including the bone marrow disorder myelofibrosis.

Incyte’s pipeline includes drugs used by the immune system to target and kill cancer cells.

Incyte shares are flat at $71.08 in Monday trading. Ariad shares are up 2% to $7.12.

 

Source: The Street & ACAD Charts

Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.

See feature articles below:

 

About Broad Street Alerts:

Big opportunities in Small Cap’s

 

 

Broad Street Alerts recent profiles and track record, 153% in verifiable potential gains for our members on the last 3 small cap alerts alone!

 

February 10th, 2016- (NASDAQ: BONT) opened $1.65/share hit a high of $3.00/share within 30 days our member potential gains- 83%

 

March 7th, 2016-(NYSE-MKT: FSI) opened at .91/share and hit 1.10/share within 5 days for gains of 21% for our members.

 

March 24th, 2016- (NASDAQ: ICLD) opened at $.77/share it a high of $1.15/share within 2 days for gains of 49% for our members.

 

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

 

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.

 

Article for: ACLS

BEVERLY, Mass. (AP) _ Axcelis Technologies Inc. (ACLS) on Monday reported first-quarter earnings of $1.9 million.

On a per-share basis, the Beverly, Massachusetts-based company said it had profit of 2 cents.

The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for earnings of 1 cent per share.

The semiconductor services company posted revenue of $67.5 million in the period, also topping Street forecasts. Three analysts surveyed by Zacks expected $66.5 million.

For the current quarter ending in July, Axcelis said it expects revenue in the range of $60 million.

Source – Automated Insights / Zacks

 

 

 

Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.

 

 

Stock market

 

Hot small cap stocks

 

small cap stock picks

 

Biotech stocks

 

FDA approval stocks

 

FDA calendar

 

Trade stocks

 

Become a day trader

 

Day trade stocks for a living

 

PDUFA date set

 

micro cap stocks

 

Best stocks 2016

 

Hottest small cap stocks

 

Best stock picks

 

Who to follow for stock picks

 

Apple news stock picks

 

Stock picks on apple news

See feature articles below:

 

About Broad Street Alerts:

Big opportunities in Small Cap’s

 

 

Broad Street Alerts recent profiles and track record, 153% in verifiable potential gains for our members on the last 3 small cap alerts alone!

 

February 10th, 2016- (NASDAQ: BONT) opened $1.65/share hit a high of $3.00/share within 30 days our member potential gains- 83%

 

March 7th, 2016-(NYSE-MKT: FSI) opened at .91/share and hit 1.10/share within 5 days for gains of 21% for our members.

 

March 24th, 2016- (NASDAQ: ICLD) opened at $.77/share it a high of $1.15/share within 2 days for gains of 49% for our members.

 

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

 

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.

 

Article for: CMRX

DURHAM, N.C., May 09, 2016 (GLOBE NEWSWIRE) — Chimerix (CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported top-line results from an interim analysis of the AdVise trial of brincidofovir for serious adenovirus (AdV) infection and other corporate updates including financial results for the first quarter ended March 31, 2016.

“We are pleased to share top-line results today from AdVise, which show a rapid antiviral effect in patients with adenovirus infection, and a correlation of viral response to mortality at day 90 and week 24 in patients with disseminated infection,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer. “Brincidofovir has demonstrated antiviral activity across a range of viral diseases with limited treatment options. We remain committed to determining the optimal use of brincidofovir in key indications, including the development of intravenous brincidofovir, which is expected to enter clinical studies in the third quarter of 2016. With strong financial resources and patent exclusivity until 2034, we are well-positioned to advance our brincidofovir development program toward potential regulatory decisions.”

Company Highlights:

AdVise trial and brincidofovir program for treatment of adenovirus
Today, Chimerix provided topline results from an interim analysis of week 24 data from AdVise which shows a strong antiviral effect which was correlated with overall survival. The company is working closely with medical advisors to plan a prospective, comparative trial in patients with serious adenovirus (AdV) infection.

In August 2015, the Company completed enrollment of the AdVise trial of brincidofovir (BCV) as a treatment for serious AdV infection. Pediatric and adult patients who have undergone allogeneic hematopoietic cell transplants (HCT) are at especially high risk for serious or fatal AdV infections due to profound immunodeficiency. Mortality rates of 50 to 80 percent have been reported in the literature for disseminated AdV disease. Rates of AdV infection with virus detected in the blood or other body fluids are higher in pediatric transplant recipients than in adults, and have resulted in many medical centers instituting screening protocols to detect AdV infection before the virus causes serious disease. There is currently no approved therapy for AdV infection, and although progression to disseminated disease in pediatric HCT recipients occurs in a small proportion of patients with AdV viremia, mortality rates for pediatric patients with confirmed AdV disease is greater than 50 percent in the first three months after diagnosis.

Pediatric and adult patients who were enrolled in the AdVise study were placed into Cohort A, B, or C based on their underlying immunodeficiency and extent of AdV disease:

Cohort A – allogeneic HCT recipients with asymptomatic or limited AdV infection
Cohort B – allogeneic HCT recipients with disseminated AdV disease
Cohort C – autologous HCT recipients, solid organ transplant recipients, and other immunocompromised patients
All subjects enrolled in the AdVise trial received 12 weeks of open-label oral brincidofovir, and are followed for 24 weeks after completing treatment. Final data will include follow-up through week 36 (24 weeks after the last dose of BCV), and will be available in the second half of 2016.

Top-line results from the AdVise trial at week 24 include the following:

BCV rapidly reduced AdV levels in the blood (viral load to a level below the limit of detection) in a majority of these highly immunocompromised patients, even in patients who had previously received cidofovir. Rapid reductions in AdV viral load were correlated with improved survival at day 90 and at week 24 following diagnosis in pediatric patients.
Two-thirds of the subjects in AdVise Cohort B (disseminated AdV disease) were pediatric allogeneic HCT recipients. Pediatric subjects had a 32 percent all-cause mortality at day 90, and 42 percent all-cause mortality at week 24. There was a smaller group of adult allogeneic HCT recipients in Cohort B, and AdV diagnoses occurred in patients with less evidence of immune reconstitution (lower lymphocyte count) than in pediatric patients. In adults, all-cause mortality at day 90 was 57 percent and at week 24 was 71 percent.
Importantly, treatment discontinuations due to gastrointestinal (GI) adverse effects were low (8 percent), particularly in pediatric subjects (4 percent). Treatment discontinuations due to graft-versus-host-disease (GVHD) were low in both pediatric and adult patients (3 percent each). The overall safety profile of brincidofovir was consistent with prior trials, including no apparent drug-related nephrotoxicity or myelosuppression.
Despite a rigorous attempt to collect historic controls from the same medical centers as patients from AdVise, the baseline risk factors for the control patients as assessed by medical reviewers did not reflect the high-risk patients enrolled in AdVise and thus did not provide a valid comparison for outcomes. Controls were selected based upon age, transplant type, and presence or absence of disseminated AdV infection. However, other unmatched characteristics known to confer an increased risk of AdV-related mortality, such as confirmed end-organ AdV disease, low lymphocyte count, and GVHD, were less frequent in the matched controls. A meaningful difference in overall survival between AdVise and the historic controls was thus not observed.
In the absence of a valid comparator cohort for the open-label data from AdVise, the company is planning a prospective, comparative trial of brincidofovir in AdV that will allow stratification of patients based on risk factors for outcomes. The Company plans to meet with the U.S. Food and Drug Administration (FDA) in the coming months to review data from the interim analyses of AdVise and to discuss the regulatory pathway for brincidofovir in AdV, including the design of a potential comparative trial. A similar review is also planned with European regulators.
Brincidofovir for the treatment of AdV continues to be available through the expanded access Study CMX001-351 (NCT 02596997) and through an Emergency IND or foreign equivalent, with approximately 100 patients treated to-date in 2016.
W. Garrett Nichols, MD, MS, Chimerix’s Chief Medical Officer said, “The recently completed AdVise trial is the largest clinical study ever conducted in serious adenovirus infections. The risk factors and predictors of improved survival in pediatric and adult patients with adenovirus disease identified from the prior studies of brincidofovir in adenovirus infection, and now further informed by data from AdVise, will guide the design of a comparative trial of brincidofovir as a potential treatment for adenovirus infection.”

Intravenous (IV) formulation of brincidofovir expected to enter clinic in the third quarter of 2016
Chimerix is advancing an IV formulation of brincidofovir as a potential candidate for the prevention and treatment of CMV and BK virus in HCT and kidney transplant recipients. An IND application for the IV formulation of BCV is anticipated to be filed with the FDA in the third quarter of 2016, with initial clinical studies expected to begin soon thereafter. Preclinical results to date have demonstrated the potential to decrease the GI side effects of orally-administered brincidofovir, which could be advantageous in the critical first weeks after HCT when the GI tract is recovering from conditioning chemotherapy.

Second smallpox efficacy study to be conducted in the second half of 2016
Brincidofovir is in development for the treatment of smallpox under the FDA’s Animal Rule, which allows for the conduct of efficacy studies in animal models for conditions that are not appropriate for study in human subjects. In February 2016, Chimerix presented positive results from a pivotal study of brincidofovir in the rabbit model for smallpox at the American Society for Microbiology Biodefense and Emerging Diseases Research Meeting in Arlington, Virginia. The Company expects to conduct a second animal efficacy study for oral brincidofovir for smallpox in the second half of 2016, to be followed by a meeting with the FDA to discuss any additional data that may be required for a regulatory decision for brincidofovir for the treatment of smallpox.

Regulatory update provided on brincidofovir for the prevention of cytomegalovirus (CMV)
Following a review of the results from the Phase 3 trial of brincidofovir for prevention of CMV in HCT recipients and discussion with the FDA in early 2016, Chimerix elected to close the SUSTAIN and SURPASS trials for prevention of CMV disease in kidney transplant recipients. The oral brincidofovir IND for CMV prevention is currently on a partial clinical hold, pending completion of additional analyses of the SUPPRESS data and subsequent submission to the FDA.

Orphan Medicinal Product Designation granted from European Commission
In late April, the European Commission issued a positive decision for an orphan drug designation for brincidofovir for the prevention of cytomegalovirus disease. Companies that obtain orphan designation benefit from a number of incentives in the European Union, including scientific advice specific for designated orphan medicines and market exclusivity for 10 years with an additional two years for medicines that have complied with an agreed pediatric investigation plan.

First Quarter 2016 Financial Results
Chimerix reported a net loss of $26.3 million, or $0.57 per basic and diluted share, for the first quarter of 2016. During the same period in 2015, the company recorded a net loss of $22.3 million, or $0.54 per basic and diluted share.

Revenues for the first quarter of 2016 were consistent at $1.2 million compared to $1.2 million for the same period in 2015. Revenue during these periods related to reimbursable expenses associated with the company’s ongoing development contract with the Biomedical Advanced Research and Development Authority (BARDA).

Research and development expenses increased to $20.9 million for the first quarter of 2016, compared to $17.4 million for the same period in 2015. This increase was primarily due to increased employee-related compensation and benefits, the effect of costs related to the Phase 3 SUSTAIN and SURPASS trials, partially offset by a reduction in costs for the Phase 3 SUPPRESS trial and an increase related to the development of the IV formulation and the expanded access brincidofovir program.

General and administrative expenses increased to $6.9 million for the first quarter of 2016, compared to $6.1 million for the same period in 2015. The increase was primarily due to increased employee-related compensation and benefits offset by a reduction in commercialization expense.

Loss from operations was $26.6 million for the first quarter of 2016, compared to a loss from operations of $22.3 million for the same period in 2015. The variance was primarily due to the increased research and development, and general and administrative expenses, as previously discussed.

Chimerix’s balance sheet at March 31, 2016 included $314.5 million of capital available to fund operations, no debt, and approximately 46.2 million outstanding shares of common stock.

Today’s Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss its first quarter 2016 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 99330956.

A live audio webcast of the call will also be available on the Investors section of Chimerix’s website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

About Chimerix
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel antivirals to address unmet medical needs. Chimerix’s proprietary lipid conjugate technology has produced brincidofovir, a clinical-stage nucleotide analog, CMX157 which was licensed to ContraVir Pharmaceuticals in 2014, and early clinical candidates including CMX669. For further information, please visit Chimerix’s website, www.chimerix.com.

 

 

Source – Company Press Release

 

 

 

 

 

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