Take a look at the Biotechnology ETF (NASDAQ:IBB) and investors will notice how badly the sector is underperforming. Though it is up by around 9% year-to-date, the S&P 500 (NYSE:SPY) is up by 15.6% while the Nasdaq (NASDAQ:QQQ) is up by 20%. Government scrutiny over drug pricing and the high-cost structure of the healthcare system in the U.S. is hurting biotech stocks, too.
Company-specific news is also weighing on specific biotechnology stocks. Those are the ones investors should watch. But as disappointing developments send such stocks lower, which ones should investors buy or sell? Volatility is increasing in markets and is triggered by an inverted yield curve and trade tensions between the U.S. and China. This creates wider price movements for biotech stocks, opening up better entry and exit points for investors.
What are the nine biotech stocks to watch amid the uncertainties ahead?
Regeneron Pharmaceuticals (REGN)
Regeneron Pharmaceuticals (NASDAQ:REGN) started 2019 on a positive note when shares rose steadily and topped $440 by March. Since then, however, even a strong quarterly earnings report, posted on Aug 6, has failed to move the stock higher.
Regeneron reported non-GAAP earnings per share of $6.02. GAAP EPS was $1.68 after revenue grew 19.9% Y/Y to $1.93 billion. Market share for EYLEA grew to 71% of net product sales. And Regeneron has a plan to develop Eylea’s position in diabetic retinopathy. It is educating physicians and patients with the drug as a first-line anti-VEGF treatment.
Sales of Dupixent, which treats patients suffering from Type 2 inflammatory diseases — atopic dermatitis, asthma, and now chronic rhinosinusitis with nasal polyposis – grew 151% Y/Y. Net sales in Q2 was $557 million. Total prescriptions grew 30% sequentially, driven by the growth in approved indications. Its approval for treating atopic dermatitis for adolescents will ensure the drug’s continued growth.
Non-GAAP R&D expenses rose to $589 million, up from $470M Y/Y. Continued investments in its research platform and pipeline will pay off if the company’s history is an indication.
This report shows that Regeneron stock has substantial upside potential from here. If Dupixent sales continue growing in the 150% range, Regeneron stock trading at 12-times forward earnings is too low.
Amarin (NASDAQ:AMRN) was up over 30% year to-date — until August 8. Then ARMN stock fell 23% after-hours when the FDA pushed back an advisory committee date for it’s drug Vascepa.
So markets will have to wait for the review and discussion of Amarin’s supplemental marketing application seeking a cardiovascular benefit claim for Vascepa. But even without the label expansion, Vascepa’s projected revenue is $400 million annualized. In Q2 2019, net total revenue was $100.8 million. Increased Vascepa prescription volume from prior and new prescribers lifted sales.
The company also has plans to double its number of sales reps to 800 by October. This will allow them to expand the number of targeted healthcare professionals from ~50,000 to up to 80,000. Performing more sales calls to prescribers, assisting physicians in the familiarization with Vascepa, and a direct to consumer campaign will support product growth. And despite the FDA setback, Amarin raised its 2019 full-year revenue guidance to $380 million to $420 million. For the current Q3 period, the Vascepa normalized TRx will exceed 700,000.
On the balance sheet, Amarin has $661 million in cash and cash equivalents, lifted from a $440 million equity offering in July 2019. Since it will not need to sell more shares in the near future, investors only need to worry about the FDA decision next.
Arena Pharmaceuticals (ARNA)
Arena Pharmaceuticals dipped to below $52.50 in the days following its earnings report posted on Aug. 8. The company reported an EPS GAAP loss of $1.24 as revenue fell 74.$ Y/Y to $1.02 million. Profits and revenue growth are not expected from Arena in the near future. It is still in the development stage. And although it has a promising pipeline cautious investors may want to avoid the stock for now.
In the second quarter, the company highlighted its key clinical and regulatory goals. It started two trials: the etrasimod Phase 3 ELEVATE UC 52 trial and the olorinab Phase 2 CAPTIVATE trial. Etrasimod is an oral, once-daily selective sphingosine-1-phosphate (S1P) receptor modulator. The drug treats multiple immune and inflammatory diseases, such as ulcerative colitis. The Elevate UC 52 trial has a 12-week induction period followed by 40 weeks of maintenance. Arena started the trial in June. The Elevate UC 12 is also a 12-week trial that will be started at a later date.
Arena spent $51.2 million in R&D in the second quarter, while SG&A totaled $18.4 million. The net loss was $1.24 a share, or $61.4 million. With cash and cash equivalents of over $1.2 billion, investors need not worry about the company issuing shares to raise cash in the near-term.
CRISPR Therapeutics (CRSP)
Gene editing is a very hot area and CRISPR (NASDAQ:CRSP) stock’s uptrend reflects that. CRISPR’s mandate is to create transformative gene-based medicines for serious diseases. The company advanced CRISPR in the clinic with CTX001 in beta-thalassemia and sickle cell disease. The gene-edited allogeneic cell therapies — CTX110, CTX120, and CTX131 — are considered the next-generation immune-oncology platform. The company’s solution enables regenerative medicine through the CRISPR/Cas9-edited allogeneic stem cells.
CRISPR has a deep pipeline of programs, with most of them still in the research phase. Still, it has three programs in the clinical phase. After it completes enrollment, investors will have plenty of clinical data to interpret in the years ahead. Patients with Sickle Cell Disease (SCD) and beta-Thalassemia, both of which are a hemoglobinopathy, suffer from anemia, pain, and even early death. By editing the gene, the company aims to mimic variants of naturally occurring hereditary persistence of fetal hemoglobin.
The first step of the clinical trial, following enrollment of 45 adult patients, is to assess the safety and efficacy of CTX001. Mice studies suggest it may achieve 80% allelic editing, over 90% of cells modified, and over 30% HbF.
CRISPR is in a hot area of gene editing and if it can treat patients successfully, the value of the company will soar.
United Therapeutics (UTHR)
United Therapeutics (NASDAQ:UTHR) stock enjoyed the $110 – $120 range up until March. Then the company’s declining revenue growth in Q4/2018 began scaring off investors. But by the second quarter, performance improved. The company reported non-GAAP EPS of $3.63, $0.89 higher than consensus. GAAP EPS was $4.66. United Therapeutics reported revenue of $373.6 million, falling 16% from last year.
Its prostacyclin product franchise (Remodulin, Tyvaso, and Orenitram), is being used by patients to treat pulmonary arterial hypertension. The company is advancing the drug delivery systems and has late-stage clinical programs in cardiopulmonary diseases. The company’s management is set on tripling its business over the next few years. This is possible with a dozen products in its pipeline and many FDA-approved product platforms. It has three new Remodulin products in the pipeline, and after these products gain FDA approval, United’s sales could triple.
In the COPD and interstitial lung disease space, the company awaits for approval for Tyvaso. And new indications for Uptravi, which treats pulmonary hypertension, will also drive sales higher.
In the near-term, generic competition for Remodulin is moderating in the U.S. and in the EU. And as new products come online, markets will realize UTHR stock at a forward P/E of 9.5 times is too low.
Exelixis (NASDAQ:EXEL) posted Q2 results on July 31. Its non-GAAP EPS was $0.29, while GAAP EPS was $0.25, down 11% from last year. Cabometyx is its best-in-class TKI driving its growth. Revenue rose 29.1% Y/Y to $240.3 million. $46.6 million of that revenue came from collaboration. This included a $20 million milestone from Daiichi Sankyo for the commercial launch of Minnebro tablets for the treatment of hypertension.
The company ended the quarter with cash and cash equivalents of $1.16 billion.
Exelixis forecast COGS (cost of goods sold) to be between 4% and 5% of net product revenues. R&D expenses will be between $330 million and $350 million. SG&A will be between $220 million – $240 million.
Exelixis has four ongoing pivotal trials. It initiated three Phase 3 studies since late 2018 and early 2019. The company is now actively enrolling patients worldwide. Management is optimistic with positive data from its ongoing pivotal trials in first-line RCC and first-line HCC refractory DTC. Investors also believe the company’s strong prospects, although EXEL stock trades at a P/E of just 10.6 times.
Exelixis increased expenses in the second quarter, with R&D spending up 93%. These efforts will pay off as the company wins more indications for Cabometyx. The drug is the number one prescribed for TKI in RCC.
In the near term, strong efficacy data and overall survival benefit numbers will drive demand for Cabometyx higher.
Nektar Therapeutics (NKTR)
On Aug 9, Nektar Therapeutics (NASDAQ:NKTR) revealed a “softening in response rates” in its Phase 1/2 PIVOT-02 study. This evaluated NKTR-214 with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo. The problem is that two of its earliest production patches of bempeg were different than the other 20 batches produced. This would explain the outlier variances as more clinical data matured and became available.
As a result of this discovery, Nektar developed a comprehensive control strategy to limit variances in raw materials. But it also means it may build new IP around the product using new assays and control strategies.
On its conference call, the company said Bristol-Myers is still committed to the bempeg development program:
They remain very committed to the bempeg development program, particularly in light of the recent breakthrough designation in melanoma and the tremendous opportunity for both companies. They are highly committed to the ongoing registrational trials in first-line melanoma, first-line urothelial cancer, and first-line renal cell carcinoma, as well as our new expansion cohort of second-line non-small cell lung cancer patients in PIVOT.
NKTR shares may not rebound for a while until it reports updated data from its studies.
Novo Nordisk (NVO)
Novo Nordisk (NYSE:NVO) is firing on all cylinders after reporting revenue growth of 9.6% Y/Y. Its diabetes and obesity reported combined sales growth of 10% and 6% and constant exchange rates. The company’s product pipeline grew after it had a handful of product approvals and filings since May. For example, in Japan, it filed its semaglutide for treating Type II diabetes.
For 2019, Novo forecast operating profit growth in the range of 4% to 6%.
Novo’s diabetes drug is a revenue growth driver. As the global diabetes market leadership rose to 28.3%. its insulin volume market share increased. Additionally, market share grew after Novo launched Ozempic in 18 European markets. In the U.S., Opempic’s launch led to a stabilization in the TRx market share at around 45%.
Sales of Saxenda, which is a weight-loss drug, increased 56% in the first half of 2019. Novo Nordisk’s market share is 50%. And now that it has been launched in 43 countries, the company will invest in market development activities to drive sales.
Although Novo stock is trading at close to its 52-week high, this is justified by the higher sales forecast. Investment opportunities and R&D activities starting in the second half of the year will ensure that the company maintains its pace of growth.
Disclosure: As of this writing, the author did not hold a position in any of the aforementioned securities.