Exact Sciences (NASDAQ: EXAS) appears to be at the cusp of reaching an all-time high level for its stock. The company reported fantastic fourth-quarter results after the market closed on Thursday.
Revenue soared 71% year over year. And although Exact Sciences still isn't profitable, its Q4 loss beat Wall Street expectations. The stock's jump of more than 8% in intraday trading on Friday wasn't surprising at all after Exact Sciences' strong performance.
But Exact Sciences' sales for its Cologuard DNA test for colon cancer are likely to soar even more in the near future. Here are three key reasons why.
Image source: Exact Sciences.
1. Help from a big friend
One of the few negatives in Exact Sciences' Q4 results was that operating expenses were slightly higher than expected. However, there was a really good reason behind the higher costs.
Exact Sciences CFO Jeff Elliott said in the company's Q4 conference call that operating expenses were a little higher than anticipated because of added payments to Pfizer (NYSE: PFE). But those payments to Pfizer stemmed from a boost to Cologuard sales resulting from the two companies' partnership.
The relationship with Pfizer has gotten off to such a great start that Exact Sciences CEO Kevin Conroy said his company's first priority for 2019 was to "power our partnership with Pfizer." In particular, Conroy stated that Exact Sciences and Pfizer plan to aggressively focus on large health systems and reaching OB-GYNs.
Conroy noted that more than half of the primary care physicians in the U.S. are either employed by or affiliated with large health systems. Targeting these large systems will take time, but over the long run the focus from Exact Sciences and Pfizer should pay off in higher sales for Cologuard.
Exact Sciences' sales team hasn't called on OB-GYNs in the past. But around 4,000 of these specialists have ordered Cologuard. Cancer screening is something OB-GYNs frequently discuss with women during their visits, and Exact Sciences and Pfizer plan to expand their outreach to the 30,000-plus OB-GYNs in the United States.
2. A greater focus on customer care
You might not think customer support staff would boost sales. But that's exactly what Exact Sciences' customer care team does.
Elliott said in the Q4 conference call that the company's data shows that its "customer care efforts nearly doubled the compliance rate for Cologuard" last year. The compliance rate is the measure of how often patients complete their Cologuard tests and send the tests in to be analyzed. Exact Sciences' customer care team follows up with patients through emails, phone calls, text messages, and letters, and sometimes they even use incentives such as gift cards.
These efforts pay off. Exact Sciences can only bill payers for tests that have been completed. The company plans to grow its customer care team in 2019, a move that Elliot says offers "a very attractive return on investment."
3. New label, new products
Exact Sciences thinks an additional addressable market of close to $4 billion could be just around the corner. The company estimates that securing a label expansion for Cologuard to be used for people aged 45 through 49 would open up another $4 billion market opportunity. It's currently approved only for ages 50 to 85.
The American Cancer Society changed its guidelines for colon cancer screening last year. Instead of beginning screening at age 50, the organization now recommends that screenings begin at 45 for average-risk patients.
Conroy said Exact Sciences has already met with the U.S. Food and Drug Administration about expanding the label for Cologuard to lower the minimum age to 45. The company expects to submit its application for FDA approval of this label expansion in the first half of this year. If all goes well, Exact Sciences should be able to begin marketing Cologuard to younger ages beginning in the first half of 2020.
The company is also working with the Mayo Clinic on a new version of Cologuard. This new version, dubbed "Cologuard 2.0," could improve the sensitivity and specificity of the DNA test and help lower the cost of goods. Exact Sciences thinks the product could boost U.S. sales by at least 5% to 10%. It will probably be a few years before the new version could reach the market, though.
And a potential game changer
Exact Sciences' efforts related to promoting Cologuard should allow the company to increase its revenue considerably over the next several years. However, the company also has a potential game-changer in development.
Conroy listed advancing the company's liquid biopsy program as another top priority for Exact Sciences. Liquid biopsies are blood tests that allow multiple types of cancer to be detected at very early stages.
Exact Sciences and Mayo Clinic are developing liquid biopsy tests for the early detection and diagnosis of the top 15 types of cancer. So far, the team has identified biomarkers -- substances in the blood or tissue that point to the presence of cancer -- for 13 of these cancers.
The top focus right now is on developing a more accurate test for liver cancer testing. Exact Sciences has made solid progress on this front and expects to begin enrollment in a clinical study in March that matches its liquid biopsy up against the current standard of care for liver cancer screening -- ultrasound with an alpha-fetoprotein test.
Some analysts think liquid biopsy will be a $13 billion market by 2030. Others project that global liquid biopsy market could even reach $100 billion in the future. Either way, success for Exact Sciences in this arena opens up a much larger opportunity for a company that already has great growth prospects.
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