Exelixis Inc. (NASDAQ:EXEL) just reported the best quarter the company has had. Ever. The biotech beat analysts' revenue estimates. It beat analysts' earnings estimates.
As you might imagine, Exelixis' executives were quite upbeat in the company's first-quarter results conference call. Here are five things management said after the earnings blowout.
1. We're profitable on an operating basis
Exelixis was able to say for the first time something many biotechs never get to say. The company reported an operational profit for the first time ever, posting diluted earnings per share of $0.05.
When asked about future profitability, Exelixis CEO Mike Morrissey didn't directly answer the question. However, Morrissey stated that he was pleased with the company's first-quarter performance but not satisfied. He stressed that the primary goal for Exelixis is to generate free cash flow and reinvest in the business. The first quarter was a good start in achieving that goal.
2. We're close to becoming debt-free
Chris Senner, Exelixis' CFO, had even more good news to report. Senner stated that the company had prepaid its $80 million term loan with Silicon Valley Bank in March. The loan was due to be repaid at the end of May.
The only remaining debt Exelixis has now is the Deerfield notes totaling a little over $113 million. This debt isn't due until July 1, 2018. However, Senner said the company plans to retire the full amount in July 2017. At that point, Exelixis will be totally debt-free.
3. Cabometyx is rocking
The great news about profitability and early debt retirement stems from tremendous success for Cabometyx. P.J. Haley, Exelixis' senior vice-president in charge of the biotech's commercial operations, noted volume growth in the first quarter of around 40% compared to the fourth quarter of 2016. Net revenue for the cabozantinib franchise (which includes Cabometyx and Cometriq) totaled $68.9 million in the quarter.
Cabometyx continues to grow treatment volume at the expense of established kidney cancer drug Inlyta. The following chart shared by Haley tells the story.
Haley said the company estimates that Cabometyx now has a market share of 30% as a second-line and later treatment for renal cell carcinoma (RCC). That's up from 27% in the fourth quarter of 2016.
4. Expect more growth to come
Exelixis fully expects to increase revenue for Cabometyx even more in the second-line market. The company thinks it will be able to expand the prescriber base as well as encourage more current prescribers to use the drug earlier rather than later.
The big opportunity for the drug, though, is as a first-line treatment of RCC. Exelixis plans to submit a supplemental New Drug Application (NDA) for the indication in the third quarter of 2017.
In addition, important news should be on the way related to use of Cabometyx in treating second-line advanced hepatocellular cancer (HCC). A second independent data monitoring committee review is expected in the second half of this year. The final review is scheduled for 2018.
5. Combos will be key
Another major opportunity for growth could stem from combination therapies including Cabometyx. Exelixis is working with Bristol-Myers Squibb (NYSE:BMY) on a late-stage clinical study of Cabometyx in combination with Opdivo and with Opdivo plus Yervoy as a first-line treatment of RCC. This study is expected to begin in mid-2017.
Bristol-Myers Squibb and Exelixis are splitting the costs of this late-stage study. However, Exelixis won't have to foot all of its portion of the costs. The biotech's partner, French pharmaceutical company Ipsen, opted in to fund 35% of Exelixis' half of the study's costs.
Exelixis and Bristol-Myers Squibb are also considering expanding into other indications, including bladder cancer and HCC. Both Ipsen and Japanese drugmaker Takeda can participate in these future studies if they choose to do so.
Exelixis is also collaborating with Roche (OTC:RHHBY) on a late-stage study of Cabometyx and Tecentriq in treating several solid tumors. Exelixis is funding this study, with Ipsen picking up part of the tab. Roche is supplying Tecentriq for the study.
Mike Morrissey said Exelixis is "talking to everybody in some shape, manner, or form" about other potential combinations with Cabometyx. Although he noted that he can't reveal much about discussions at this point, the company is looking to expand collaboration opportunities "across the board." He added that everyone should "stay tuned." With Exelixis' tremendous first quarter and promising opportunities, I expect that's exactly what investors will do.