MannKind Corporation (NASDAQ:MNKD) Spikes On Afrezza New Insulin Label

MannKind Corporation (NASDAQ:MNKD)

MannKind Corporation (NASDAQ:MNKD) shares gained 40.1% after the U.S. Food and Drug Administration approved a favorable label change for Afrezza. Human Insulin, Afrezza, is now approved for glycemic control in adult patients with type 1 and type 2 diabetes. According to the company, it is the only inhaled rapid-acting mealtime insulin available in the United States.

The biopharmaceutical company has also confirmed that it successfully exchanged new common stock for outstanding warrants issued last year. The exchange strengthened investors’ confidence as it showed the company’s commitment to cleaning up opportunities for capital flexibility.

MNKD Stock Performance

MannKind Corporation (NASDAQ:MNKD) has gained more than 100% since the start of the month. However, the stock is up by more than 30% for the year. The stock is currently trading at 14-month high and traders are waiting to see if it will continue to rise after registering a new 52 week high of $6.51 a share.

MannKind Corporation (NASDAQ:MNKD)

Afrezza’s new label has revitalized investor confidence on the stock. The biotech company has been under pressure as investors reacted negatively to anemic sales reports. However, the label change should unlock the product’s blockbuster potential.

Afrezza New Label

The new label update includes data that describes the action profile by dosage strength as well as clarity on starting and adjusting mealtime dosage. To conform with current FDA guidance, the label also includes updated pregnancy lactation section.

“These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” said Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) – University of Colorado.

Mannkind’s Financial Woes

MannKind Corporation (NASDAQ:MNKD) needs to capitalize on the new label if it is to continue rising higher in the market. The company still faces a string of changes after exiting the recent quarter with only $44 million in cash. Observers question if that amount will be sufficient to support operations going forward.

The company may have to look for additional funds to be able to ramp up the Afrezza commercial launch. Investors may wish to consider bracing themselves for secondary offerings given the spike in MNKD stock.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $MNKD and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

MannKind Corporation (NASDAQ:MNKD) Makes Announcement Ahead of Q2 Financial Release

MannKind Corporation (NASDAQ:MNKD)

MannKind Corporation (NASDAQ:MNKD) will be announcing their Q2 2017 financial report after the market closes today. However this morning, prior to the market open, Mannkind and One Drop announced that they have taken the initial step in their collaboration. The collaboration takes the form of a randomized controlled trial named A-ONE. A-ONE will investigate the use of Afrezza® inhaled insulin and One Drop’s integrated digital diabetes care platform. Shares in the pre-market are down 2.5% at $1.19 on light volume. Mannkind stock price chart:

MannKind Corporation (NASDAQ:MNKD)
Mannkind Stock Price Chart

MannKind Corporation (NASDAQ:MNKD) and One Drop announced a memorandum of understanding in May of 2017. The collaboration is intended to study One Drop’s Mobile app, One Drop Premium and Afrezza®, MannKind’s inhaled rapid-acting mealtime insulin. One Drop Premium is a bundling of One Drop’s Mobile app, Chrome meter and test strips, and Experts coaching service. One goal of the collaboration is to identify ways of simplifying the complexity of starting and staying on mealtime insulin along with Customized Coaching to help people afflicted with type 2 Diabetes achieve their A1C goals.

People with type 2 diabetes, who meet the inclusion criteria, will be randomly assigned one of two treatments – Afrezza® with One Drop Premium or, One Drop Premium alone. Changes in hemoglobin A1C, quality of life, self-care, treatment satisfaction, and other metrics will be assessed.

In its prior quarterly financial report, MannKind Corporation (NASDAQ:MNKD) reported a loss of $16 on $3 million in revenue. Losses, adjusted for non-recurring gains, came to (-$0.22) per share. However the market responded positively and shares gained almost 43% to end the day at $1.60. On Friday shares of MannKind Corporation (NASDAQ:MNKD) closed at $1.22.

After four consecutive years of losses, MannKind Corporation (NASDAQ:MNKD) posted a per share profit of $1.37 for 2016 on sales of $174.8 million. But, so far, investors have shunned the company’s shares and MNKD is down over 61% YTD, and down over 75% for the year. However, for the quarter, MNKD shares are up over 53%.

No doubt that traders will be paying close attention to this afternoon’s financial release as they try to determine if the company’s break-through diabetes treatment can bring performance to the bottom line.

MannKind Corporation (NASDAQ:MNKD) will release its Q2 2017 financial results on Monday, August 7, 2017 at 5:00 PM EST on August 7, 2017. To participate in the live call by telephone, dial (888) 771-4371 or (847) 585-4405 and enter the passcode: 44096373.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $MNKD and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Why Aren’t Investors Buying Up Shares of MannKind Corporation (NASDAQ:MNKD)?

MannKind Corporation (NASDAQ:MNKD)

Share volume for MannKind Corporation (NASDAQ:MNKD) was extremely light on Friday but the biotech firm still remains one of the most discussed stocks in social media trading forums. Barely more than 1.1 million shares of MNKD traded hands on Friday. MNKD has a listed daily volume average of close to 3.6 million which puts Friday’s activity about 70% below the average. Shares were up 3.13% despite the S&P 500 being slightly down, but this makes sense as MNKD has been more than three times as risky, historically speaking, to hold as the broader stock index.

MannKind Corporation (NASDAQ:MNKD)
Unadjusted one year MNKD candlebar graph

As far as the trader’s forums are concerned, few stocks generate as much chatter as MannKind Corporation (NASDAQ:MNKD). The two that battle for the lead are Delcath Systems, Inc.

(NASDAQ:DCTH) and CytRx Corporation (NASDAQ:CYTR). However, MannKind may be the better play when all is said and done. Their ground-breaking, diabetic-focused drug Afrezza has already received FDA approval and is being marketed in a variety of media. The real question for MannKind shareholders is whether or not the drug will see a rate of sales increase that would save the company from having to seek “strategic alternatives” such as a sale, merger, or licensing agreement.

Right now, the market appears to be unimpressed by Afrezza’s performance. For 2016 the company booked, for the first time ever, sales figures – but, in early March, it also had to undergo a 1:5 reverse split to maintain compliance with exchange regulations. Their annual revenue number came in at $ 176 million and resulted in a $1.37 per share profit. But here is what the market thought of that performance which was released to the public on March 16, 2017 – MNKD shares ended up by over 3% for the day to close at $2.22 then went on a massive slide over the next few weeks and on May 3 MNKD shares closed under $0.70.

Short-sellers have been relentless as they bet that the company will not be able to turn the business around and recoup its development expenses at a rate that justifies the investment. Since 2011, analysts have either downgraded or reiterated their ratings on MannKind Corporation (NASDAQ:MNKD) and most now have MNKD’s target price below $0.25. Sadly, at the end of the day, Mannkind developed a sought-after, ground-breaking drug but may have ignored, while developing it, the business economics required to create investor demand.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $MNKD and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Challenging Times For MannKind Corporation (NASDAQ:MNKD)?

MannKind Corporation (NASDAQ:MNKD)

MannKind Corporation (NASDAQ:MNKD) has key debt payments due in the approaching months as its cash burn rate remains restricted by covenants making the refinancing increasingly challenging. Analysts have a divided view on the cash position of the company.

The stock price of MannKind made a new 52-week low on Monday, and could be a stock to watch in today’s trading. MNKD declined to as low as $1.29 in the last trading session after starting the day at $1.49. By the closing bell, the stock was sitting at $1.38 per share for a decline of over 6%.

The highlights

According to MannKind Corporation (NASDAQ:MNKD) management, the company began the year off with cash of almost $70 million. This comes pretty close to the cash flow assumptions that most of the analysts have been giving. They anticipate project cash at the close of Q1 to come around $41.3 million. In addition to the cash balance, the company secured a credit line of $30.1 million. Deerfield has an agreement with Mannkind that needs it to have cash/credit of $25 million at the close of any given quarter.

In 20 weeks, the firm will be out of cash and it will require to use its credit line. Then in 30 weeks, the firm will be in default of contracts, and will have nearly exhausted the credit line – there are not more than 10 months of credit and cash left.

What shareholders need to be conscious of is that analysts do not consider the probability that MannKind Corporation (NASDAQ:MNKD) will require to take some measure much earlier. In fact, the firm will likely intend to extend the debt outflows of $5 million and $15 million earlier than many consider.

The problem the company faces is that it has little leverage. Also, renegotiating debt will be a tough process. As of now, there exists no Sanofi settlement to depend on. This leaves prospect of renegotiation at disapproving terms, dilution, or drawing an association that infuses cash.

Next problem with MannKind Corporation (NASDAQ:MNKD) is that revenue from Afrezza sales has failed to impress anyone. After two years in the industry, a failed association with Sanofi, a re-launch in last July, and a re-launch earlier in this year, sales of Afrezza lead to less than 300 scripts/week while weekly net revenue is trivial at best. Simply said, the company has failed to make enough funds to qualify for capital it needs.

4/03/2017
Ticker Symbol MNKD
Last Price a/o 3:21 PM EST  $1.38
Average Volume 3.27M
Market Cap (mlns)  $ 138.37M
Shares Outstanding (mlns) 100.27M
Share Float (mlns) 73.40M
Inside Ownership 0.10%
Short Float 26.97%
Short Interest Ratio 6.05
Quarterly Return 116.74%
YTD Return 116.74%
Year Return -18.34%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.