Q2 results round-up

With the majority of the big pharma Q2 results published, Richard Staines gives a round-up of an eventful results season.

Most of the major pharma companies have reported their Q2 figures, and not even worries over president Trump’s crackdown on pricing in the US and Brexit uncertainties have been enough to dampen spirits.

Many pharma companies have gone as far as upping their forecasts as a result of new products hitting the market.

Sanofi was a prime example – it seems to be shaking off the sales hangover caused by the US patent loss of its big-selling insulin, Lantus (insulin glargine).

Working with R&D partner Regeneron Sanofi has managed to develop the eczema and asthma drug Dupixent (dupilumab), which is proving to be one of the most successful drug launches in recent years.

Sales of Dupixent were up 168% to 496 million euros ($551 million) compared with last year after a first approval in March 2017.

The company’s diabetes franchise is suffering because of tough market competitions in the US, where cut-price biosimilars of Lantus have gained market share.

Analysts will get a more complete picture of the diabetes market when Novo Nordisk reports its results on Friday (9 August).

AZ on the rebound

AstraZeneca also gave an upbeat sales forecast on the back of its Q2 results, which showed the company’s next generation of cancer drugs continue to revive the UK firm’s fortunes after years in the doldrums.

CEO Pascal Soriot said the company has enjoyed four successive quarters of sales growth, although profits were down slightly.

Soriot predicted a continued upturn in sales despite headwinds from Brexit, and the patent expiry on its older cancer drug Faslodex (fulvestrant).

AZ’s UK-based rival GlaxoSmithKline also revised its estimates upwards although it was always expecting a decline in revenue because of generic competition to its key respiratory diseases drug Advair (fluticasone+salmeterol) in the US.

Earnings per share guidance is now a decline of -3% to -5%, instead of the previous range of -5% to -9%.

GSK also had some big news after closing its over the counter joint venture deal with Pfizer, and confirming the widely reported appointment of former AZ exec Jonathan Symonds as its new chairman.

Amgen looks to new cancer drug

Across the Atlantic, Amgen unveiled some decidedly uninspiring results showing revenues were down around 3%, although the fall was not as steep as that expected by analysts.

This was down to unexpectedly high turnover of immunology drug Enbrel (etanercept), and some price increases.

But low-cost competition to hyperparathyroidism drug Sensipar (cinacalcet) and for white blood cell booster Neulasta (pegfilgrastim) continues to bite, and its newer cholesterol drug Repatha (evolocumab) is struggling to gain traction.

Sales of recently launched migraine prevention drug Aimovig (erenumab) could begin to offset some of these declines.

And in the even longer term Amgen has high hopes for its KRAS targeting cancer drug, known only as AMG 510 for now.

Amgen had data from a very early trial showing two patients with colorectal and appendiceal cancer had seen their tumours shrink after taking AMG-510, and the company plans to start a phase 2 study that could allow approval if data are strong enough.

Gilead finds new HIV revenues

Gilead had a good story to tell investors after hiking its revenue forecasts on the back of stronger than expected sales for HIV drugs.

Sales of HIV drugs accounted for 71% of total sales and rose to $4.04 billion from $3.67 billion last year.

This was driven by Biktarvy, a three-drug cocktail in a single pill that keeps HIV, designed to be more tolerable and convenient than its older combinations typically based around the “backbone” of Truvada plus another pill.

Biktarvy was only approved in the US in February last year, but is already a blockbuster with sales of almost $1.2 billion.

Hepatitis C drug sales continued their decline, caused by tough competition in a shrinking market where many patients have been cured over the last few years, thanks to drugs from Gilead and its competitors including AbbVie.

Merck & Co also smashed its estimates on the back of its cancer immunotherapy Keytruda which saw a 58% increase in sales to $2.6 billion this quarter alone.

Bristol-Myers Squibb with its rival cancer immunotherapy blockbuster Opdivo (nivolumab) posted better than expected revenues of $6.3 billion, up 10%.

BMS posted some mixed results from Opdivo – combined with BMS’ other immunotherapy Yervoy and chemotherapy, it improved survival in patients with non-squamous non-small cell lung cancer whose tumours express the biomarker PD-L1.

But a combination of Opdivo and chemo was not so effective in NSCLC regardless of PD-L1 expression. Celgene, which is set to merge with BMS, also beat its earnings forecast and revenue guidance.

Roche awaits biosimilar competition

Swiss pharma Roche has also raised its guidance despite the impending threat of biosimilar competition to its key cancer drugs in the US market.

Growth products like multiple sclerosis treatment Ocrevus (ocrelizumab), new haemophilia drug Hemlibra (emicizumab) and cancer immunotherapy Tecentriq (atezolizumab) gathered momentum.

Biosimilar competition to two of Roche’s ‘big three’ antibodies – Rituxan/MabThera (rituximab) and Herceptin (trastuzumab) – continued to gather pace in international markets but held up reasonably well in the US. The two slipped 4% to CHF 3.39 billion and 9% to CHF 3.26 billion respectively in the first six months of the year.

The third of the trio, cancer antibody Avastin (bevacizumab), is still holding fairly firm with a 7% sales rise to CHF3.66 billion. However, new biosimilars are being launched for this product too – most recently from Amgen/Allergan in the US – and pressure is expected to build in the second half of the year.

The other big Swiss pharma Novartis restated its guidance upwards, driven by mounting sales of psoriasis drug, Cosentyx (secukinumab).

For pharma there are some important months follow: so far president Trump has not made good on threats to take on high drug costs in the US.

Biosimilars could come into play too, providing some price relief for the US health system but woes for the pharma companies relying on older biologic drugs for large parts of their revenue.

And with the uncertainty over Brexit on the other side of the Atlantic, there are some potential headwinds to face in Q3.